[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1477 Reported in Senate (RS)]
Calendar No. 446
104th CONGRESS
2d Session
S. 1477
[Report No. 104-284]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act to improve the regulation of food, drugs, devices, and
biological products, and for other purposes.
_______________________________________________________________________
June 20, 1996
Reported with an amendment
Calendar No. 446
104th CONGRESS
2d Session
S. 1477
[Report No. 104-284]
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act to improve the regulation of food, drugs, devices, and
biological products, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 13, 1995
Mrs. Kassebaum (for herself, Mr. Inhofe, and Mr. Frist) introduced the
following bill; which was read twice and referred to the Committee on
Labor and Human Resources
June 20, 1996
Reported by Mrs. Kassebaum, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act to improve the regulation of food, drugs, devices, and
biological products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Food and Drug
Administration Performance and Accountability Act of 1995''.</DELETED>
<DELETED>TITLE I--MISSION AND ACCOUNTABILITY</DELETED>
<DELETED>SEC. 101. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Food and Drug
Administration Regulatory Reform Act of 1995''.</DELETED>
<DELETED>SEC. 102. THE MISSION OF THE FOOD AND DRUG
ADMINISTRATION.</DELETED>
<DELETED> Section 903(a) (21 U.S.C. 393(a)) is amended by adding at
the end thereof the following: ``The mission of the Administration is
to promote and protect the health of the American people by--</DELETED>
<DELETED> ``(1) facilitating the rapid and efficient
development and availability of products subject to its
regulation;</DELETED>
<DELETED> ``(2) protecting the public from unsafe or
ineffective products subject to its regulation; and</DELETED>
<DELETED> ``(3) enforcing the applicable statutes and
regulations in a timely, fair, consistent, and decisive
manner.''.</DELETED>
<DELETED>SEC. 103. PERFORMANCE STANDARDS AND REVIEW.</DELETED>
<DELETED> Section 903(b) (21 U.S.C. 393(b)) is amended by adding at
the end thereof the following new paragraph:</DELETED>
<DELETED> ``(3) Performance standards and review.--Within
180 days after the date of enactment of this paragraph, the
Commissioner, after consultation with representatives of
patient advocacy groups, health professionals, and the
regulated industries, shall publish in the Federal Register
quantifiable performance standards for action by the
Administration on applications or submissions (including
petitions, notifications, or any other similar form of request)
for the review of a product that is a new drug, biological
product, new animal drug, device, or food additive and that is
subject to premarket review or approval of any kind under this
Act. The performance standards shall be reviewed, and after
consultation with representatives of patient advocacy groups,
health professionals, and the regulated industries, may be
revised, annually by the Commissioner. The performance
standards shall establish objectives for the Administration
that--</DELETED>
<DELETED> ``(A) expedite action on applications for
new drugs and devices under sections 505(b)(1) and 515,
and for biological products under section 351(a) of the
Public Health Service Act (42 U.S.C. 262(a))--
</DELETED>
<DELETED> ``(i) for a serious, life-
threatening, or seriously debilitating disease
or condition; or</DELETED>
<DELETED> ``(ii) for any other condition if
a new drug, device, or biological product--
</DELETED>
<DELETED> ``(I) provides therapy not
available from other approved therapy;
or</DELETED>
<DELETED> ``(II) offers significant
improvement over other approved
therapy;</DELETED>
<DELETED> ``(B) reduce backlogs on all applications
with the objective of eliminating all backlogs by
January 1, 2000; and</DELETED>
<DELETED> ``(C) establish a schedule to bring the
Administration into full compliance by July 1, 1998,
with the time periods specified in this Act for action
on all applications.</DELETED>
<DELETED>For applications for which there is no statutory time
period, the applicable time period for action shall be 180
days. The Commissioner shall prepare and publish in the Federal
Register for public comment an annual report comparing the
performance of the Administration with the applicable
performance standards, analyzing any failure to achieve any of
the standards, and setting forth a plan to achieve compliance
with the standards that have not been met.''.</DELETED>
<DELETED>SEC. 104. INFORMATION SYSTEM.</DELETED>
<DELETED> Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at
the end thereof the following new section:</DELETED>
<DELETED>``SEC. 906. INFORMATION SYSTEM.</DELETED>
<DELETED> ``The Secretary shall establish and maintain an
information system to track the status and progress of each application
or submission (including a petition, notification, or other similar
form of request) submitted to the Food and Drug Administration
requesting agency action. The system shall permit access by the
applicant.''.</DELETED>
<DELETED>SEC. 105. POLICY STATEMENTS.</DELETED>
<DELETED> Section 701(a) (21 U.S.C. 371(a)) is amended--</DELETED>
<DELETED> (1) by striking ``(a) The'' and inserting ``(a)(1)
The''; and</DELETED>
<DELETED> (2) by adding at the end thereof the following new
paragraph:</DELETED>
<DELETED> ``(2)(A) The Secretary shall establish a procedure
governing the development and use of all policy statements of general
applicability (including any guideline, points-to-consider, protocol,
recommendation, or similar document regardless of the form or
designation) that are not promulgated as regulation. The procedure
shall provide an opportunity for affected persons to participate in the
development and continued use of the policy by sharing expertise,
experience, or providing comment before the policy is adopted and after
the policy is implemented.</DELETED>
<DELETED> ``(B) The Secretary shall establish a procedure for the
formal publication and compilation of all policy statements of general
applicability (including any guideline, points-to-consider, protocol,
recommendation, or similar document regardless of the form or
designation) that are not promulgated as regulations.''.</DELETED>
<DELETED>SEC. 106. ADVISORY COMMITTEES.</DELETED>
<DELETED> Section 904 (21 U.S.C. 394) is amended--</DELETED>
<DELETED> (1) by striking ``Without'' and inserting ``(a) In
General.--Without''; and</DELETED>
<DELETED> (2) by adding at the end thereof the following new
subsections:</DELETED>
<DELETED> ``(b) Delegation of Appointment Authority.--The
Commissioner may delegate the appointment and oversight authority
granted under subsection (a) to a center director. The center director
may not authorize any office or division of the center to carry out the
appointment and oversight authority granted under this
subsection.</DELETED>
<DELETED> ``(c) Membership and Meeting Requirements.--</DELETED>
<DELETED> ``(1) Scope.--A scientific review group may
determine the matters that the group will consider and may
establish an appropriate agenda with respect to the
determination of the matters.</DELETED>
<DELETED> ``(2) Nonvoting members.--A scientific review
group shall include a nonvoting industry representative and a
nonvoting public representative.</DELETED>
<DELETED> ``(3) Notification of scope of discussion.--To the
extent feasible, the specific matters and questions to be
discussed at a meeting of a scientific review group shall be
publicly announced and published in the Federal Register at
least 30 days prior to the date of the meeting.</DELETED>
<DELETED> ``(4) Terms.--A member of a scientific review
group shall serve for a term of 3 years, which may be renewed
for a second term. An individual may serve on more than one
scientific review group. The chairperson of a scientific review
group shall be a member who has served at least 3 years. The
term of the chairperson may be renewed for not more than 3
terms.</DELETED>
<DELETED> ``(5) Training.--Prior to service on a scientific
review group, a member of the group shall be given adequate
education and training relating to the responsibilities of the
member.</DELETED>
<DELETED> ``(6) Frequency of meetings.--The Secretary shall
take whatever action is necessary to ensure that regular
meetings are held by scientific review groups, at appropriate
intervals and for a sufficient length of time, so that any
matter to be reviewed by any scientific review group shall be
presented to the group not more than 90 days after the matter
is ready for review by the group. The meetings shall occur not
less than 6 times each year unless there are compelling reasons
for fewer meetings.</DELETED>
<DELETED> ``(d) Persons Involvement With Review Groups.--</DELETED>
<DELETED> ``(1) In general.--All persons, including
employees of the Secretary, shall have the same rights and
responsibilities regarding--</DELETED>
<DELETED> ``(A) the submission of data and
information to, and contact and discussion with, a
scientific review group;</DELETED>
<DELETED> ``(B) the participation of the persons at
meetings of the group; and</DELETED>
<DELETED> ``(C) access to data and information
submitted to a scientific review group (except for data
and information that are not available for public
disclosure under section 552 of title 5, United States
Code).</DELETED>
<DELETED> ``(2) Submission of information to fda.--In a case
in which a scientific review group reviews an application
(including a petition, notification, or other similar request),
all related data and information that are not available for
public disclosure under section 552 of title 5, United States
Code, shall be exchanged between the applicant and the Food and
Drug Administration at the time the data and information are
submitted to the scientific review group but shall not
otherwise be publicly disclosed.</DELETED>
<DELETED> ``(3) Participation in meetings.--Any meetings of
a scientific review group shall provide adequate time for
initial presentations and for response to any differing views
and shall encourage free and open participation by all
interested persons.</DELETED>
<DELETED> ``(e) FDA Actions.--Within 60 days after the date a
scientific review group makes its conclusions and recommendations on
any matter under review of the group, the Food and Drug Administration
official responsible for the matter shall review the conclusions and
recommendations of the group, shall make a final determination on the
matter, and shall notify the affected persons of the determination in
writing and, if the determination differs from the conclusions and
recommendations of the group, shall include the reasons for the
difference.</DELETED>
<DELETED> ``(f) Definition.--For purposes of this section, the term
`center director' means a director of a center within the Food and Drug
Administration.''.</DELETED>
<DELETED>SEC. 107. APPEALS WITHIN THE FOOD AND DRUG
ADMINISTRATION.</DELETED>
<DELETED> Chapter IX (21 U.S.C. 391 et seq.), as amended by section
104, is further amended by adding at the end thereof the following new
section:</DELETED>
<DELETED>``SEC. 907. APPEALS WITHIN THE FOOD AND DRUG
ADMINISTRATION.</DELETED>
<DELETED> ``(a) Employee Decisions.--The Secretary shall by
regulation establish a system for the appeal within the Food and Drug
Administration of any decision by an employee of the Food and Drug
Administration, except that this subsection shall not apply to
decisions involving formal administrative or judicial proceedings. The
Secretary shall make publicly known the existence of the internal
appeal system and the procedures for an internal appeal.</DELETED>
<DELETED> ``(b) Review by Scientific Review Group.--</DELETED>
<DELETED> ``(1) In general.--Any person shall have the right
to request an evaluation by an appropriate scientific review
group established under section 904 of any significant
scientific issue pending before, or significant scientific
decision made by, the Secretary under this Act. An appropriate
scientific review group shall review the request and determine
whether to conduct an evaluation within 30 days after the date
the request is received by the Secretary.</DELETED>
<DELETED> ``(2) Scope.--The issues a scientific review group
shall evaluate shall include, but not be limited to, matters
involving a decision by the Secretary not to permit a clinical
investigation to begin or to continue, a refusal by the
Secretary to file an application, a protocol design, and
decisions relating to a pending application (including a
petition, notification, or other similar request), where the
same issue has not previously been reviewed by a scientific
review group.</DELETED>
<DELETED> ``(3) Time limitation.--If a scientific review
group agrees to conduct an evaluation on an issue under
paragraph (1), the evaluation shall be scheduled for the next
meeting of the group.</DELETED>
<DELETED> ``(c) Additional Informal and Formal Procedures.--
</DELETED>
<DELETED> ``(1) In general.--For purposes of obtaining
conclusions and recommendations regarding the resolution of any
dispute, the Secretary is authorized to use such additional
informal and formal procedures as may be considered useful. The
procedures may include, but not be limited to, the use of--
</DELETED>
<DELETED> ``(A) panels of qualified Food and Drug
Administration officials;</DELETED>
<DELETED> ``(B) panels of qualified government
employees who are not employees of the Food and Drug
Administration; and</DELETED>
<DELETED> ``(C) outside mediators and arbitrators
who are not government employees.</DELETED>
<DELETED> ``(2) Application of faca.--The Federal Advisory
Committee Act (5 U.S.C. App) shall not apply to a panel
described in paragraph (1).</DELETED>
<DELETED> ``(d) Review of Recommendations.--Within 60 days after any
matter that is presented for resolution pursuant to this section has
been the subject of conclusions and recommendations, the Food and Drug
Administration official responsible for the matter shall personally
review the conclusions and recommendations, make a final determination
on the matter, and notify the parties of the determination in writing
and if the determination differs from the conclusions and
recommendations, the reasons for the difference.''.</DELETED>
<DELETED>TITLE II--EXPEDITED ACCESS TO PRODUCTS FOR SERIOUSLY ILL
PATIENTS</DELETED>
<DELETED>SEC. 201. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Patient Rights Regulatory
Reform Act of 1995''.</DELETED>
<DELETED>SEC. 202. ACCESS TO UNAPPROVED THERAPIES.</DELETED>
<DELETED> Chapter V (21 U.S.C. 351 et seq.) is amended by adding at
the end thereof the following new section:</DELETED>
<DELETED>``SEC. 543. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND
DIAGNOSTICS.</DELETED>
<DELETED> ``(a) In General.--Any person may request from a
manufacturer or distributor, and any manufacturer or distributor may
provide to a person after compliance with the provisions of this
section, an investigational drug (including a biological product) or
device for the diagnosis, monitoring, or treatment of a serious disease
or condition, life-threatening or seriously debilitating disease or
condition, and any other disease or condition designated by the
Secretary as appropriate for expanded access under this section by the
person if--</DELETED>
<DELETED> ``(1) the person has no comparable or satisfactory
alternative therapy available to treat, diagnose, or monitor
the disease or condition; or</DELETED>
<DELETED> ``(2) the risk to the person from the
investigational drug or device is not greater than the risk
from the disease or condition.</DELETED>
<DELETED> ``(b) Protocols.--A manufacturer or distributor may submit
to the Secretary one or more expanded access protocols covering
expanded access use of a drug or device described in subsection (a).
The protocols shall be subject to the provisions of section 505(i) for
a drug and section 520 (g) and (m) for a device and may include any
form of use of the drug or device outside a clinical investigation,
prior to approval of the drug or device for marketing, including but
not limited to protocols for treatment, use, parallel track, single
patient protocols, emergency use, and uncontrolled trials.</DELETED>
<DELETED> ``(c) Fees.--A manufacturer or distributor may charge for
an investigational drug or device under an expanded access protocol,
but the price of the drug or device may not be more than that necessary
to recover the costs of manufacture, research, development, and
handling for the drug or device.</DELETED>
<DELETED> ``(d) Notification of Availability.--The manufacturer or
distributor may inform national, State, and local medical associations
and societies, and voluntary health associations, about the
availability of an investigational drug or device for expanded access
use pursuant to this section but--</DELETED>
<DELETED> ``(1) shall state that the drug or device is
investigational;</DELETED>
<DELETED> ``(2) shall not represent that the drug or device
is safe or effective for any use; and</DELETED>
<DELETED> ``(3) shall not otherwise promote or advertise the
availability of the product for expanded access use.</DELETED>
<DELETED>SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES.</DELETED>
<DELETED> Section 520(m) (21 U.S.C. 360j(m)) is amended--</DELETED>
<DELETED> (1) in paragraph (2), by inserting at the end
thereof the following flush sentences:</DELETED>
<DELETED>``The request shall be in the form of an application to the
Secretary. Within 30 days of the date of the receipt of the
application, the Secretary shall issue an order approving or denying
the application.'';</DELETED>
<DELETED> (2) by striking paragraph (5); and</DELETED>
<DELETED> (3) by striking paragraph (6).</DELETED>
<DELETED>SEC. 204. EXPEDITING APPROVAL OF NEW DRUGS, BIOLOGICS, AND
MEDICAL DEVICES FOR SERIOUS CONDITIONS.</DELETED>
<DELETED> (a) New Drugs.--Section 505(c)(1) (21 U.S.C. 355(c)(1)) is
amended by adding at the end thereof the following flush
sentence:</DELETED>
<DELETED>``In a case in which an application submitted under section
505(b)(1) for a new drug, or section 351(a) of the Public Health
Service Act a biological product, for a life-threatening disease or
condition, a seriously debilitating disease or condition, or for any
other serious disease or condition that provides therapy or diagnosis
not available from another approved drug or biological product or
offers significant improvement over another approved drug or biological
product, the Secretary shall approve or deny approval of the
application within 120 days after the receipt of the
application.''.</DELETED>
<DELETED>TITLE III--REVITALIZING THE INVESTIGATION OF NEW
PRODUCTS</DELETED>
<DELETED>SEC. 301. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Investigational Products
Regulatory Reform Act of 1995''.</DELETED>
<DELETED>SEC. 302. TIMELY REVIEW AND REASONABLE DATA REQUIREMENTS FOR
CLINICAL RESEARCH ON DRUGS AND BIOLOGICAL
PRODUCTS.</DELETED>
<DELETED> Section 505(i) (21 U.S.C. 355(i)) is amended--</DELETED>
<DELETED> (1) by striking ``(i) The'' and inserting ``(i)(1)
The'';</DELETED>
<DELETED> (2) by redesignating paragraphs (1), (2), and (3)
as subparagraphs (A), (B), and (C), respectively; and</DELETED>
<DELETED> (3) by adding at the end thereof the following new
paragraph:</DELETED>
<DELETED> ``(2)(A) A clinical investigation of a new drug (including
a biological product) may begin 30 days after the date the Secretary
receives from the sponsor a notification containing information about
the drug and the clinical investigation unless, prior to the 30-day
period, the Secretary informs the sponsor in writing that the
investigation may not begin, and specifies the basis for the decision
and the information needed in order for the clinical investigation to
commence.</DELETED>
<DELETED> ``(B) Within 1 year after the date of enactment of the
Food and Drug Administration Performance and Accountability Act of
1995, the Secretary, after consultation with representatives of patient
advocacy groups and the regulated industries, shall publish in the
Federal Register criteria for the type and amount of information
relating to the safety of an investigational drug to be included in a
notification described in subparagraph (A), taking into account the
recommendations of the International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for Human
Use. The Secretary shall periodically review, and may revise, the
criteria.</DELETED>
<DELETED> ``(C) The Commissioner shall establish a mechanism to
ensure the fair and consistent application of safety standards for
clinical investigations.''.</DELETED>
<DELETED>SEC. 303. TIMELY REVIEW AND REASONABLE DATA REQUIREMENTS FOR
CLINICAL RESEARCH ON DEVICES.</DELETED>
<DELETED> Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at
the end thereof the following new paragraphs:</DELETED>
<DELETED> ``(6) The procedures and conditions prescribed pursuant to
paragraph (2)(A) shall be subject to subparagraphs (B) and (C) of
section 505(i)(2).</DELETED>
<DELETED> ``(7) The Secretary shall, within 120 days of the date of
enactment of this paragraph, by regulation amend the content of parts
812 and 813 of title 21 of the Code of Federal Regulations to update
the procedures and conditions under which devices intended for human
use may upon application be granted an exemption from certain
requirements under this Act. The regulation shall--</DELETED>
<DELETED> ``(A) permit developmental changes in devices,
including manufacturing changes, in response to information
collected during an investigation without requiring an
additional approval of an application for an investigational
device exemption or the approval of a supplement to the
application, if the changes do not constitute a significant
change in design or a significant change in basic principles of
operation; and</DELETED>
<DELETED> ``(B) permit, without approval of a supplement to
an application for an investigational device exemption, changes
or modifications to clinical protocols that do not affect the
validity of data or information resulting from the completion
of an approved protocol.''.</DELETED>
<DELETED>SEC. 304. COLLABORATIVE RESEARCH DESIGN.</DELETED>
<DELETED> Chapter V (21 U.S.C. 351 et seq.), as amended by section
202, is further amended by adding at the end thereof the following new
section:</DELETED>
<DELETED>``SEC. 544. COLLABORATIVE RESEARCH DESIGN.</DELETED>
<DELETED> ``(a) Review of Design.--</DELETED>
<DELETED> ``(1) Request.--Any person who intends to sponsor
a preclinical or clinical investigation of a drug (including a
biological product) or device may request a meeting with the
Secretary to review the design of one or more protocols or part
or all of a development plan for the drug or device.</DELETED>
<DELETED> ``(2) Form.--A request described in paragraph (1)
shall be in writing and shall include a proposal for which the
review is requested.</DELETED>
<DELETED> ``(3) Written review.--The Secretary shall meet
with the person within 30 days of the request and shall provide
to the person a written review of the proposal, including any
deficiencies in the proposal. A written summary shall be made
of the meeting. The summary shall include the written review of
the proposal and, after agreement by the individuals who
attended the meeting, shall be made part of the product review
file maintained by the Food and Drug Administration.</DELETED>
<DELETED> ``(b) Modification of Agreements.--Agreements reached
through meetings under subsection (a) may be changed in writing by
mutual consent of the sponsor and the Secretary at any time.</DELETED>
<DELETED> ``(c) Modification of Agreements by the FDA.--Agreements
reached through meetings under subsection (a) may be changed
unilaterally only--</DELETED>
<DELETED> ``(1) by the director of the office of the Food
and Drug Administration responsible for regulating a drug or
device subject to review under this section, who may not
delegate such responsibility; and</DELETED>
<DELETED> ``(2) in writing and specifying the basis therefor
and demonstrating the substantial public health reasons that
require the change.</DELETED>
<DELETED> ``(d) Panel Review.--</DELETED>
<DELETED> ``(1) In general.--Any person requesting a meeting
under subsection (a) may obtain review from a panel established
under subsection 513(b) of a determination of the Secretary to
disapprove a protocol or product development plan.</DELETED>
<DELETED> ``(2) Agreement modifications.--Any person who has
reached an agreement with the Secretary under subsection (b)
may obtain review from a panel described in paragraph (1) of a
modification of the agreement under subsection
(c).''.</DELETED>
<DELETED>TITLE IV--EFFICIENT, ACCOUNTABLE, AND FAIR PRODUCT
REVIEW</DELETED>
<DELETED>SEC. 401. REFERENCE.</DELETED>
<DELETED> This title may be cited as the ``Product Review Regulatory
Reform Act of 1995''.</DELETED>
<DELETED>SEC. 402. THE CONTENT AND REVIEW OF AN APPLICATION.</DELETED>
<DELETED> Chapter VII (21 U.S.C. 371 et seq.) is amended by adding
at the end thereof the following new subchapter:</DELETED>
<DELETED>``SUBCHAPTER D--REVIEW OF APPLICATIONS</DELETED>
<DELETED>``SEC. 741. CONTENT AND REVIEW OF AN APPLICATION.</DELETED>
<DELETED> ``(a) In General.--This section applies to any application
(including a petition, notification, or other similar request)
submitted for a food additive, new drug, biological product, new animal
drug, animal feed bearing or containing a new animal drug, device, or
color additive.</DELETED>
<DELETED> ``(b) Filing Requirements.--The Commissioner shall
establish a mechanism to ensure the fair and consistent application of
filing requirements.</DELETED>
<DELETED> ``(c) Classification of a Product.--Within 60 days of the
receipt of a written request of any person for information respecting
the classification of a product as a drug, biological product, or
device or the component of the Food and Drug Administration that will
regulate the product (including a request respecting a combination
product subject to section 503(g)) the Secretary shall provide the
person a written statement of the classification of the product or the
component of the Food and Drug Administration that will regulate the
product. The Secretary's statement shall be binding and may not be
changed by the Secretary except with the written agreement of the
person who submitted the request. If the Secretary does not provide the
statement within the 60-day period, the classification and component
designated by the person submitting the request shall be final and
binding and may not be changed by the Secretary except with the written
agreement of the person. All radiopharmaceutical products shall be
regulated in a separate division under the Center for Devices and
Radiological Health.</DELETED>
<DELETED> ``(d) Reasonable Data Requirements.--Within 1 year after
the date of enactment of the Food and Drug Administration Performance
and Accountability Act of 1995, the Secretary, after consultation with
patient advocacy groups and the regulated industries, shall publish in
the Federal Register criteria for the type and amount of information
relating to safety and effectiveness to be included in an application
for the approval of a product, or a new use of an approved product,
described in subsection (c). In developing the criteria, the Secretary
shall consider any recommendations of the International Conference on
Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use.''.</DELETED>
<DELETED>SEC. 403. CONTRACTS FOR EXPERT REVIEW.</DELETED>
<DELETED> Chapter VII (21 U.S.C. 371 et seq.), as amended by section
402, is further amended by adding at the end thereof the following new
section:</DELETED>
<DELETED>``SEC. 742. CONTRACTS FOR EXPERT REVIEW.</DELETED>
<DELETED> ``(a) In General.--The Secretary may contract with outside
organizations and individuals, with expertise in relevant disciplines,
to review, evaluate, and make conclusions and recommendations to the
Secretary on parts or all of any application (including a petition,
notification, or other similar request for Food and Drug Administration
action). Any such contract shall be subject to the requirements of
section 708. Funds obtained under part 2 of subchapter C may be used
for external review of any drug (including a biological product) for
which a user fee was paid.</DELETED>
<DELETED> ``(b) Review of Expert's Evaluation.--</DELETED>
<DELETED> ``(1) In general.--Subject to paragraph (2), the
Food and Drug Administration official responsible for any
matter for which expert review is used pursuant to this section
shall personally review the conclusions and recommendations of
the expert review organization or individual and shall make a
final decision regarding the matter under review within 60 days
after receiving the conclusions and recommendation.</DELETED>
<DELETED> ``(2) Limitation.--A final decision under
paragraph (1) shall be made within the applicable prescribed
time period for review of an application as set forth in this
Act.''.</DELETED>
<DELETED>SEC. 404. PROMPT AND EFFICIENT REVIEW.</DELETED>
<DELETED> Chapter VII (21 U.S.C. 371 et seq.), as amended by section
403, is further amended by adding at the end thereof the following new
section:</DELETED>
<DELETED>``SEC. 743. PROMPT AND EFFICIENT REVIEW.</DELETED>
<DELETED> ``(a) In General.--The provisions of this section shall
apply to any of the following applications (including a petition,
notification, or other similar request):</DELETED>
<DELETED> ``(1) An application for approval of a human food
additive or animal feed additive under section 409.</DELETED>
<DELETED> ``(2) An application for approval of a new drug
under section 505(b)(1).</DELETED>
<DELETED> ``(3) An application for approval of a new animal
drug or an animal feed bearing or containing a new animal drug
under subsection (b)(1) or (m) of section 512,
respectively.</DELETED>
<DELETED> ``(4) A submission for a determination that a
device is substantially equivalent to a predicate device under
sections 513(f)(1) and 513(i).</DELETED>
<DELETED> ``(5) An application for approval of a device
under section 515.</DELETED>
<DELETED> ``(6) An application for the listing of a color
additive under section 721.</DELETED>
<DELETED> ``(b) Review Procedures and Policies.--The Secretary shall
establish procedures and policies to facilitate a collaborative review
process between the Food and Drug Administration and the applicant with
respect to an application or submission described in subsection (a). As
part of this collaborative process--</DELETED>
<DELETED> ``(1) open, informal, and prompt communications
shall be encouraged;</DELETED>
<DELETED> ``(2) meetings (except meetings with respect to
submissions to determine substantial equivalence of a device to
a predicate device) shall be held after the expiration of one-
half of the statutory time period for review of the application
and after the expiration of three-quarters of such period, or
within 15 days after a scientific review group has convened and
made recommendations on an application, unless the Food and
Drug Administration and the applicant determine that a meeting
is unnecessary; and</DELETED>
<DELETED> ``(3) the Secretary shall, prior to the meetings
described in paragraph (2), present to the applicant in writing
a description of any deficiencies of the application and the
information necessary to bring the application into a form that
would require approval.</DELETED>
<DELETED> ``(c) Approval, Disapproval, and Classification.--
</DELETED>
<DELETED> ``(1) Approval based on failure to act.--Beginning
1 year after the date of publication of an applicable
performance standard under section 903(b), or 18 months after
the date of enactment of the Food and Drug Administration
Performance and Accountability Act of 1995, whichever occurs
first, if the Secretary fails to meet a time period for action
on an application established in the standard and the product
that is a new drug, biological product, new animal drug,
device, or food additive that is the subject of the application
has met the marketing requirements of the European Union or the
United Kingdom, at the request of the applicant the application
shall be deemed to be approved unless, within 30 days after the
expiration of the time period established in the standard, the
Secretary notifies the applicant in writing that the
application is disapproved, setting forth the reasons for
disapproval, and, with the consent of the applicant, publishes
a notice, within 30 days of notifying the applicant, in the
Federal Register disapproving the application under paragraph
(2) and setting forth the reasons for the
disapproval.</DELETED>
<DELETED> ``(2) Appeal.--A person whose application has been
disapproved under this subsection may appeal using one of the
following procedures:</DELETED>
<DELETED> ``(A) Procedures under the act.--The
procedures established for the product under other
provisions of this Act.</DELETED>
<DELETED> ``(B) Appeal.--An appeal to a United
States District Court to determine whether the
Secretary's decision is supported by substantial
evidence in the administrative record.</DELETED>
<DELETED> ``(d) Contracts for Expert Review.--</DELETED>
<DELETED> ``(1) In general.--Beginning July 1, 1998, if the
Secretary in any fiscal year fails to meet the statutory time
period for action on an application for at least 95 percent of
the applications in a particular category, the Secretary shall
in the following fiscal year, with the consent of the
applicant, contract with expert individuals and organizations
under section 742 to review new applications and applications
for which the Secretary has failed to meet the statutory time
period for action for the particular product
category.</DELETED>
<DELETED> ``(2) Approval.--If an individual or organization
selected to conduct a review under paragraph (1) determines
that an application described in paragraph (1) should be
approved, the application shall be considered to be approved
unless, within 30 days after the date the Secretary receives
the determination of the individual or organization, the
Secretary publishes a notice in the Federal Register
disapproving the application and setting forth the reasons for
disapproval. An applicant may appeal the disapproval under
subsection (c)(2).''.</DELETED>
<DELETED>SEC. 405. GOOD MANUFACTURING PRACTICE INSPECTION.</DELETED>
<DELETED> Chapter VII is (21 U.S.C. 371 et seq.), as amended by
section 404, is further amended by adding at the end thereof the
following new section:</DELETED>
<DELETED>``SEC. 744. GOOD MANUFACTURING PRACTICE INSPECTION.</DELETED>
<DELETED> ``(a) In General.--In order to comply with inspection
requirements of this Act, the Secretary may accredit organizations to
conduct inspections under section 704 to evaluate compliance of a
manufacturer with applicable requirements for good manufacturing
practice.</DELETED>
<DELETED> ``(b) Eligibility Requirements.--The Secretary shall by
regulation establish the requirements that an organization shall meet
to be eligible to be accredited to participate as a qualified
organization to conduct inspections under subsection (a).</DELETED>
<DELETED> ``(c) Accreditation.--Within 90 days after the date the
Secretary receives an application for accreditation under this section,
the Secretary shall review the application and determine whether an
applicant is in compliance with the requirements established under this
section. Within the 90-day period, the Secretary shall grant
accreditation or shall deny accreditation and specify in writing the
reasons for the denial and the requirements that shall be met to obtain
accreditation.</DELETED>
<DELETED> ``(d) Revocation of Accreditation.--The Secretary may at
any time revoke accreditation granted under subsection (c) for failure
to comply with the requirements established under this section after
specifying in writing the reasons for the revocation and the
requirements that shall be met to retain accreditation and after an
informal hearing on the revocation.</DELETED>
<DELETED> ``(e) Inspections.--Any organization accredited under this
subsection that conducts an inspection under this subsection at the
request of the Secretary shall--</DELETED>
<DELETED> ``(1) apply all relevant principles of good
manufacturing practice established in this Act and in
regulations promulgated by the Secretary; and</DELETED>
<DELETED> ``(2) provide to the Secretary and the
manufacturer within 30 days after the completion of the
inspection an adequate report of the findings of the
inspection.</DELETED>
<DELETED> ``(f) Limitation.--When an accredited organization has
conducted a good manufacturing practice inspection under section 704,
the Secretary may not perform such an inspection for a period of 2
years after the date of the receipt of the report required under
subsection (e)(2), unless justified by good cause.''.</DELETED>
<DELETED>SEC. 406. ENVIRONMENTAL IMPACT REVIEW.</DELETED>
<DELETED> Chapter VII (21 U.S.C. 371 et seq.), as amended by section
405, is further amended by adding at the end thereof the following new
section:</DELETED>
<DELETED>``SEC. 745. ENVIRONMENTAL IMPACT REVIEW.</DELETED>
<DELETED> ``Notwithstanding any provision of other law, no action by
the Secretary pursuant to this Act shall be subject to an environmental
assessment, an environmental impact statement, or other environmental
consideration unless the director of the office responsible for the
action demonstrates, in writing and specifying the basis therefor--
</DELETED>
<DELETED> ``(1) that there is a reasonable probability that
the environmental impact of the action is sufficiently
substantial and within the factors that the Secretary is
authorized to consider under this Act; and</DELETED>
<DELETED> ``(2) that consideration of the environmental
impact will directly affect the decision on the
action.''.</DELETED>
<DELETED>SEC. 407. INFORMATION EXCHANGE.</DELETED>
<DELETED> Chapter VII (21 U.S.C. 371 et seq.), as amended by section
406, is further amended by adding at the end thereof the following new
sections:</DELETED>
<DELETED>``SEC. 746. DISSEMINATION OF INFORMATION ON DRUGS.</DELETED>
<DELETED> ``(a) Dissemination.--</DELETED>
<DELETED> ``(1) In general.--Notwithstanding sections 301(d)
and 502(f), and subject to the requirements of paragraph (2)
and subsection (b), a person may disseminate to any person that
is a health care practitioner or other provider of health care
goods or services, a pharmacy benefit manager, a health
maintenance organization or other managed health care
organization, or a health care insurer or governmental agency,
written information, or an oral or written summary of the
written information, concerning--</DELETED>
<DELETED> ``(A) a treatment use for an
investigational new drug (including a biological
product) approved by the Secretary for such treatment
use; or</DELETED>
<DELETED> ``(B) a use (whether or not such use is
contained in the official labeling) of a new drug for
which an approval of an application filed under section
505(b) is in effect.</DELETED>
<DELETED> ``(2) Requirements.--A person may disseminate
information under paragraph (1)(B) only if--</DELETED>
<DELETED> ``(A) the information is an unabridged--
</DELETED>
<DELETED> ``(i) reprint or copy of a peer-
reviewed article from a scientific or medical
journal that is published by an organization
that is independent of the pharmaceutical
industry; or</DELETED>
<DELETED> ``(ii) chapter, authored by an
expert or experts in the disease to which the
use relates, from a recognized reference
textbook that is published by an organization
that is independent of the pharmaceutical
industry;</DELETED>
<DELETED> ``(B) the text of the information has been
approved by a continuing medical education accrediting
agency that is independent of the pharmaceutical
industry as part of a scientific or medical educational
program approved by the agency;</DELETED>
<DELETED> ``(C) the information relates to a use
that is recognized under Federal law for purposes of
third-party coverage or reimbursement, and--</DELETED>
<DELETED> ``(i) the text of the information
has been approved by an organization referred
to in such Federal law; and</DELETED>
<DELETED> ``(ii) the information is part of
a disease management program or treatment
guideline with respect to the use; or</DELETED>
<DELETED> ``(D) the information is an accurate and
truthful summary of the information described in
subparagraph (A), (B), or (C).</DELETED>
<DELETED> ``(b) Disclosure Statement.--In order to afford a full and
fair evaluation of the information described in subsection (a), a
person disseminating the information shall include a statement that
discloses--</DELETED>
<DELETED> ``(1) if applicable, that the use of a new drug
described in subparagraph (A) or (B) of subsection (a)(1) and
the information with respect to the use have not been approved
by the Food and Drug Administration;</DELETED>
<DELETED> ``(2) if applicable, that the information is being
disseminated at the expense of the sponsor of the new
drug;</DELETED>
<DELETED> ``(3) if applicable, that one or more authors of
the information being disseminated are employees of or
consultants to the sponsor of the new drug; and</DELETED>
<DELETED> ``(4) the official labeling for the drug and
biological product, or in the case of a treatment use of an
investigational new drug, the investigator brochure and all
updates thereof.</DELETED>
<DELETED> ``(c) Definition.--As used in this section, the term
`expense' includes financial, in-kind, and other contributions provided
for the purpose of disseminating the information described in
subsection (a).</DELETED>
<DELETED> ``(d) Special Rule.--In the case of a professional
disagreement between the Secretary and other qualified experts with
respect to the application of section 502(a), the Secretary may not use
section 502 to prohibit the dissemination of information in the types
of circumstances and under the conditions set forth in subsections (a)
and (b).</DELETED>
<DELETED>``SEC. 747. DISSEMINATION OF INFORMATION ON DEVICES.</DELETED>
<DELETED> ``(a) In General.--Notwithstanding sections 301, 501(f),
501(i), 502(a), 502(f), and 502(o), or any other provision of law, and
subject to subsections (b) and (c), a person may disseminate to any
person that is a health care practitioner or other provider of health
care goods or services, a pharmacy benefit manager, a health
maintenance organization or other managed health care organization, or
a health care insurer or governmental agency, written or oral
information (including information exchanged at scientific and
educational meetings, workshops, or demonstrations) relating to a use,
whether or not the use is described in the official labeling, of a
device produced by a manufacturer registered pursuant to section
510.</DELETED>
<DELETED> ``(b) Disclosure Statements and Requirements.--</DELETED>
<DELETED> ``(1) Disclosure statements.--To the extent
practicable, the requirement with respect to a statement of
disclosure under subsection (b) of section 746 shall apply to
the dissemination of written and oral information under this
section, except that this paragraph shall not apply to the
dissemination of written or oral information with respect to
the intended use described in the labeling of a
device.</DELETED>
<DELETED> ``(2) Additional requirements.--A person may
disseminate information under subsection (a) only if--
</DELETED>
<DELETED> ``(A) the information is an unabridged--
</DELETED>
<DELETED> ``(i) reprint or copy of a peer-
reviewed article from a scientific or medical
journal that is published by an organization
that is independent of the medical device
industry; or</DELETED>
<DELETED> ``(ii) chapter, authored by an
expert or experts in the medical specialty to
which the use relates, from a recognized
reference textbook that is published by an
organization that is independent of the medical
device industry;</DELETED>
<DELETED> ``(B) the information has been approved by
a continuing medical education accrediting agency that
is independent of the medical device industry as part
of a scientific or medical educational program approved
by the agency;</DELETED>
<DELETED> ``(C) the information relates to a use
that is recognized under Federal law for purposes of
third-party reimbursement, and--</DELETED>
<DELETED> ``(i) the text of the information
has been approved by an organization referred
to in such Federal law; and</DELETED>
<DELETED> ``(ii) the information is part of
a disease management program or treatment
guideline with respect to such use;
or</DELETED>
<DELETED> ``(D) the oral or written information is--
</DELETED>
<DELETED> ``(i) part of an exchange of
information solely among health care
practitioners, health care reimbursement
officials, and the industry;</DELETED>
<DELETED> ``(ii) exchanged for educational
or scientific purposes; or</DELETED>
<DELETED> ``(iii) presented at continuing
medical education programs, seminars,
workshops, or demonstrations.</DELETED>
<DELETED> ``(3) Applicability.--The requirements under
subsection (a)(1)(A) and (B) of section 746 shall not apply
with respect to devices.</DELETED>
<DELETED>``SEC. 748. POLICY ON INFORMATION DISSEMINATION.</DELETED>
<DELETED> ``(a) Construction.--Notwithstanding section 502 (a), (f),
and (o), or any other provision of law, the written or oral
dissemination of information relating to a new use of a new drug or
device, in accordance with sections 746 and 747, shall not be construed
as evidence of a new intended use of the new drug or device that is
different from the intended use of the new drug or device set forth in
the official labeling. The dissemination shall not be considered as
labeling, adulteration, or misbranding of the new drug or
device.</DELETED>
<DELETED> ``(b) Respond to Unsolicited Questions.--Nothing in this
Act shall affect the ability of manufacturers to respond fully to
unsolicited questions from health care practitioners and other persons
about drugs (including biological products) or devices.</DELETED>
<DELETED>``SEC. 749. APPROVAL OF NEW USES.</DELETED>
<DELETED> ``(a) In General.--As an alternative to the procedures
established in section 505(c)(1) for a new drug (including a biological
product) and section 515(d)(1)(A) for a device, the Secretary shall
approve an application under this section for a new use of a previously
approved new drug or device if experts qualified by scientific training
and experience to evaluate the safety and effectiveness of drugs or
devices conclude that a new use that has not been reviewed or approved
by the Secretary represents sound medical practice based upon reliable
clinical experience and other confirmatory information, unless the
Secretary demonstrates that there are other compelling public health
reasons related to the safety or effectiveness of the drug or device
why approval would harm the health of individual patients.</DELETED>
<DELETED> ``(b) Petition.--The holder of an approved application may
submit a petition to the Secretary presenting information that new use
of a previously approved new drug or device meets the criteria for
approval established in this subsection. The petition shall include
data and information relating to the new use and shall demonstrate that
the new use--</DELETED>
<DELETED> ``(1) has existed in clinical practice for at
least five years;</DELETED>
<DELETED> ``(2) is common among clinicians experienced in
the field; and</DELETED>
<DELETED> ``(3) represents reasonable medical practice based
upon reliable clinical experience and other confirmatory
information.</DELETED>
<DELETED> ``(c) Action on Petition.--Upon receipt of the petition,
the Secretary shall obtain the conclusions and recommendations of a
scientific review group established under section 904 and grant or deny
the petition within 180 days of the receipt of the
petition.''.</DELETED>
<DELETED>SEC. 408. EFFECTIVENESS, OUTCOME, AND COST-EFFECTIVENESS
STANDARDS.</DELETED>
<DELETED> Section 741, as added by section 402, is amended by adding
at the end thereof the following new subsection:</DELETED>
<DELETED> ``(e) In reviewing an application for a product that is a
new drug, biological product, new animal drug, animal feed bearing or
containing a new animal drug, or device the determination of
effectiveness shall not include the evaluation of--</DELETED>
<DELETED> ``(1) relative effectiveness, unless the
effectiveness of the product is explicitly compared to the
effectiveness of another product in the labeling;</DELETED>
<DELETED> ``(2) any potential use not explicitly included in
the labeling;</DELETED>
<DELETED> ``(3) the cost-effectiveness of the product
described in this subsection as compared to the cost-
effectiveness of a similar product, unless the labeling
explicitly includes a representation about cost-effectiveness;
and</DELETED>
<DELETED> ``(4) the clinical outcome resulting from use of a
device, unless the labeling explicitly includes a
representation regarding clinical outcome.''.</DELETED>
<DELETED>SEC. 409. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT
REVIEW.</DELETED>
<DELETED> Section 201 (21 U.S.C. 321) is amended by adding at the
end thereof the following:</DELETED>
<DELETED> ``(gg) For purposes of reviewing any application,
notification or petition, or any document, with respect to a product
that is a new drug, biological product, new animal drug, device, or
food additive that is submitted to the Secretary to obtain approval of
marketing, or to establish or clarify the regulatory status of the
product, the term `day' means a calendar day (excluding any calendar
day between the date of receipt by the submitter of a written
communication from the Secretary setting forth the action of the
Secretary on a submission and the date of receipt by the Secretary of
the written response of the submitter to the action) in which the
Secretary has responsibility to review such a submission.''.</DELETED>
<DELETED>TITLE V--DRUG, BIOLOGICAL PRODUCTS, DEVICES EXPORT
REFORM</DELETED>
<DELETED>SEC. 501. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Drug, Biological
Products, Devices Export Reform Act of 1995''.</DELETED>
<DELETED>SEC. 502. EXPORT OF DRUGS AND DEVICES.</DELETED>
<DELETED> (a) Exports and Imports.--Section 801 (21 U.S.C. 381) is
amended--</DELETED>
<DELETED> (1) in subsection (d), by adding at the end
thereof the following new paragraph:</DELETED>
<DELETED> ``(3) No component, part or accessory of a drug,
biological product, or device, including a drug in bulk form, shall be
excluded from importation into the United States under paragraph (a),
if the component, part, or accessory will be incorporated into a
device, drug, or biological product that will be exported from the
United States in accordance with subsection (e) of section 802 or
section 351(h) of the Public Health Service Act.'';</DELETED>
<DELETED> (2) in subsection (e)(1), by striking the second
sentence; and</DELETED>
<DELETED> (3) in subsection (e)(2), by inserting before the
period at the end thereof the following: ``or that the device
is eligible for export under section 802''.</DELETED>
<DELETED> (b) Export of Certain Unapproved Drugs and Devices.--
Section 802 (21 U.S.C. 382) is amended to read as follows:</DELETED>
<DELETED>``SEC. 802. EXPORTS OF CERTAIN UNAPPROVED PRODUCTS.</DELETED>
<DELETED> ``(a) In General.--A drug (including a biological product)
intended for human or animal use or a device for human use--</DELETED>
<DELETED> ``(1)(A) which, in the case of a drug--</DELETED>
<DELETED> ``(i) requires approval by the Secretary
under section 505 or section 512; or</DELETED>
<DELETED> ``(ii) requires licensing by the Secretary
under section 351 of the Public Health Service Act or
by the Secretary of Agriculture under the Act of March
4, 1913 (known as the Virus-Serum Toxin Act),</DELETED>
<DELETED>before the drug may be introduced or delivered for
introduction into interstate commerce to a country;
and</DELETED>
<DELETED> ``(B) which--</DELETED>
<DELETED> ``(i) does not have such approval or
license;</DELETED>
<DELETED> ``(ii) is not exempt from such sections or
Act; and</DELETED>
<DELETED> ``(iii) is introduced or delivered for
introduction into interstate commerce to a country;
or</DELETED>
<DELETED> ``(2) which, in the case of a device--</DELETED>
<DELETED> ``(A) does not comply with an applicable
requirement under section 514 or 515;</DELETED>
<DELETED> ``(B) is exempt under section 520(g) from
section 514 or 515; or</DELETED>
<DELETED> ``(C) is a banned device under section
516,</DELETED>
<DELETED>is adulterated, misbranded, and in violation of such sections
or Act unless the export of the drug or device is authorized under
subsection (b), (c), (e), or (f) or under section 801(e)(2).</DELETED>
<DELETED> ``(b) Exportation to Any Country or a Specific Country.--
</DELETED>
<DELETED> ``(1) Exportations to any country.--Except as
otherwise provided in this section, a drug (including a
biological product) or device may be exported to any country,
if the drug or device complies with the laws of that country
and has valid marketing authorization by the appropriate
approval authority--</DELETED>
<DELETED> ``(A) in Australia, Canada, Israel, Japan,
New Zealand, or Switzerland; or</DELETED>
<DELETED> ``(B) in the European Union or a country
in the European Economic Area (the countries in the
European Union and the European Free Trade Association)
if the drug or device is marketed in that country or
the drug or device is authorized for general marketing
in the European Economic Area.</DELETED>
<DELETED> ``(2) Exportation to a certain country.--A drug or
device may be exported to the countries described in paragraph
(1) if the drug or device complies with the laws of any such
country and has a valid marketing authorization by the
appropriate approval authority in that country.</DELETED>
<DELETED> ``(c) Exportation to a Country With a Regulatory System.--
</DELETED>
<DELETED> ``(1) In general.--A drug or device may be
exported under this section to any other country that has an
adequate regulatory system to protect the health of the
citizens of such a country. The Comptroller General, in
consultation with the Secretary and other appropriate parties,
shall develop a list of countries to which a drug or device may
be exported under this paragraph and a list of recommended
criteria for additions or deletions of countries to the list of
countries.</DELETED>
<DELETED> ``(2) Request designation.--An appropriate country
official, manufacturer, or exporter, may request the Secretary
to designate a country to receive drugs or devices exported
under this section that meets the requirements of paragraph (1)
by submitting documentation in support of such designation to
the Secretary. Any person other than an appropriate country
official requesting such designation shall provide a letter
from the country indicating the desire of the country to be
designated.</DELETED>
<DELETED> ``(3) Time limitation for designation.--If the
Secretary fails to, within 90 days of the date of the receipt
of a request under paragraph (2), respond to the request with a
denial of the requested designation, the request shall be
considered granted and the country that is the subject of the
request shall be designated as eligible to receive drugs or
devices exported under this subsection.</DELETED>
<DELETED> ``(4) Withdrawal of designation.--If information
is provided to the Secretary that indicates that, due to a
public health emergency or systematic patterns of abuse of the
regulatory system in a country designated under paragraph (3),
the country is no longer able to carry out the functions
described in paragraph (1), or if the country no longer meets
the requirements for designation under this subsection, the
Secretary may withdraw the designation of the
country.</DELETED>
<DELETED> ``(d) Limitations.--A drug or device may not be exported
under this section if--</DELETED>
<DELETED> ``(1) the drug or device is not manufactured,
processed, packaged, and held in conformity with current good
manufacturing practice or is adulterated under paragraph (1),
(2)(A), or (3) of section 501(a) or subsection (c) or (d) of
section 501;</DELETED>
<DELETED> ``(2) the drug or device is not labeled and
advertised in accordance with the requirements and conditions
for use of any country in which the drug or device is approved,
either in English or the predominant language of the country to
which the drug or device is being exported, except that with
respect to advertising alternative methods of communication
that are consistent with the requirements of the approving
country shall be allowed if authorized by the receiving
country;</DELETED>
<DELETED> ``(3) the requirements of subparagraphs (A)
through (D) of section 801(e)(1) have not been met;</DELETED>
<DELETED> ``(4) the drug or device has been the subject of a
finding by the Secretary under section 505, 512 or 515 or under
section 351 of the Public Health Service Act (42 U.S.C. 262),
or by the Secretary of Agriculture under the Act of March 4,
1913 (37 Stat. 832-833) (commonly known as the `Virus Serum
Toxin Act') that the drug or device has not been shown to be
safe or effective for labeled indication of the drug or
device;</DELETED>
<DELETED> ``(5) the Secretary finds that the drug or device
poses an unreasonable and substantial risk to public health in
the receiving country;</DELETED>
<DELETED> ``(6) the drug or device is the subject of a
notice by the Secretary or the Secretary of Agriculture of a
determination that the possibility of reimportation of the
exported drug or device would present an imminent hazard to the
public health and safety of the United States and the only
means of limiting the hazard is to prohibit the export of the
drug or device; or</DELETED>
<DELETED> ``(7) the drug or device will be re-exported or
transshipped to a country not authorized to receive an exported
drug or device under this section.</DELETED>
<DELETED>In making a finding under paragraph (5), the Secretary, to the
maximum extent possible, shall consult with the affected
country.</DELETED>
<DELETED> ``(e) Exportation of Drug for Investigational Use.--A drug
intended for investigational use in any country described in subsection
(b) or designated under subsection (c) may be exported in accordance
with the laws of that country and still be exempt from regulation under
section 505(i) or section 512(j).</DELETED>
<DELETED> ``(f) Exportation of a Drug for Tropical Disease.--
</DELETED>
<DELETED> ``(1) In general.--A drug (including a biological
product) that is to be used in the prevention or treatment of a
tropical disease may, upon approval of an application submitted
under paragraph (2), be exported if--</DELETED>
<DELETED> ``(A) the Secretary finds, based on
credible scientific evidence, including clinical
investigations, that the drug is safe and effective in
the country to which the drug is to be exported in the
prevention or treatment of a tropical disease in such
country;</DELETED>
<DELETED> ``(B) the drug is manufactured, processed,
packaged, and held in conformity with current good
manufacturing practice and is not adulterated under
paragraphs (1), (2)(A), and (3) of subsection (a), and
subsection (c) or (d), of section 501;</DELETED>
<DELETED> ``(C) the outside of the shipping package
is labeled with the following statement: `This drug may
be sold or offered for sale only in the following
countries:', the blank space being filled with a list
of the countries to which export of the drug is
authorized under this subsection;</DELETED>
<DELETED> ``(D) the drug is not the subject of a
notice by the Secretary or the Secretary of Agriculture
of a determination that the manufacture of the drug in
the United States for export to a country is contrary
to the public health and safety of the United States;
and</DELETED>
<DELETED> ``(E) the requirements of subparagraphs
(A) through (D) of section 801(d)(1) have been
met.</DELETED>
<DELETED> ``(2) Application.--Any person may apply to have a
drug exported under paragraph (1). The application shall--
</DELETED>
<DELETED> ``(A) describe the drug to be
exported;</DELETED>
<DELETED> ``(B) list each country to which the drug
is to be exported;</DELETED>
<DELETED> ``(C) contain a certification by the
applicant that the drug will not be exported to a
country for which the Secretary cannot make a finding
described in paragraph (1)(A);</DELETED>
<DELETED> ``(D) identify the establishments in which
the drug is manufactured; and</DELETED>
<DELETED> ``(E) demonstrate to the Secretary that
the drug meets the requirements of paragraph
(1).</DELETED>
<DELETED> ``(3) Required reporting.--The holder of an
approved application for the export of a drug under this
subsection shall report to the Secretary--</DELETED>
<DELETED> ``(A) the receipt of any information
indicating that the drug is being or may have been
exported from a country for which the Secretary made a
finding under paragraph (1)(A) to a country for which
the Secretary cannot make such a finding; and</DELETED>
<DELETED> ``(B) the receipt of any information
indicating any adverse reactions to such
drug.</DELETED>
<DELETED> ``(4) Additional limitations.--</DELETED>
<DELETED> ``(A) Failure to meet certain
requirements.--If the Secretary determines that--
</DELETED>
<DELETED> ``(i) a drug for which an
application is approved under paragraph (2)
does not continue to meet the requirements of
paragraph (1);</DELETED>
<DELETED> ``(ii) the holder of the
application has not made the report required by
paragraph (3); or</DELETED>
<DELETED> ``(iii) the manufacture of the
drug in the United States for export is
contrary to the public health and safety of the
United States and an application for the export
of the drug has been approved under paragraph
(2),</DELETED>
<DELETED>then before taking action against the holder of an
application for which a determination was made under clause
(i), (ii), or (iii), the Secretary shall notify the holder in
writing of the determination and provide the holder 30 days to
take such corrective actions as may be required by the
Secretary to prevent the Secretary from taking action against
the holder. If the Secretary takes action against the holder
because of the determination, the Secretary shall provide the
holder a written statement specifying the reasons for the
determination and provide the holder, on request, an
opportunity for an informal hearing with respect to the
determination.</DELETED>
<DELETED> ``(B) Limitation on the exportation of a
hazardous drug by an importer.--If at any time the
Secretary, or in the absence of the Secretary, the
official designated to act on behalf of the Secretary
determines that--</DELETED>
<DELETED> ``(i) the holder of an approved
application under paragraph (2) is exporting a
drug from the United States to an
importer;</DELETED>
<DELETED> ``(ii) the importer is exporting
the drug to a country for which the Secretary
cannot make a finding under paragraph (1)(A);
and</DELETED>
<DELETED> ``(iii) the export presents an
imminent hazard to the public health in the
country,</DELETED>
<DELETED>the Secretary shall immediately prohibit the
export of the drug to the importer, provide the person
exporting the drug from the United States prompt notice
of the determination, and afford the person an
opportunity for an expedited hearing. A determination
by the Secretary under this subparagraph may not be
stayed pending final action by a reviewing court. The
authority conferred by this subparagraph may not be
delegated by the Secretary.</DELETED>
<DELETED> ``(C) Limitation on the exportation of a
hazard drug by a holder.--If the Secretary, or in the
absence of the Secretary, the official designated to
act on behalf of the Secretary determines that the
holder of an approved application under paragraph (2)
is exporting a drug to a country for which the
Secretary cannot make a finding under paragraph (1)(A),
and that the export of the drug presents an imminent
hazard, the Secretary shall immediately prohibit the
export of the drug to such country, provide the holder
prompt notice of the determination, and afford the
holder an opportunity for an expedited hearing. A
determination by the Secretary under this subparagraph
may not be stayed pending final action by a reviewing
court. The authority conferred by this subparagraph
shall not be delegated by the Secretary.</DELETED>
<DELETED> ``(D) Limitation on the exportation of
other drugs by a holder.--If the Secretary receives
credible evidence that the holder of an application
approved under paragraph (2) is exporting a drug to a
country for which the Secretary cannot make a finding
under paragraph (1)(A), the Secretary shall give the
holder 60 days to provide information to the Secretary
respecting such evidence and shall provide the holder
an opportunity for an informal hearing on such
evidence. Upon the expiration of such 60 days, the
Secretary shall prohibit the export of such drug to
such country if the Secretary determines the holder is
exporting the drug to a country for which the Secretary
cannot make a finding under paragraph (1)(A).</DELETED>
<DELETED> ``(E) Limitation of the exportation of
other drugs by an importer.--If the Secretary receives
credible evidence that an importer is exporting a drug
to a country for which the Secretary cannot make a
finding under paragraph (1)(A), the Secretary shall
notify the holder of the application authorizing the
export of such drug of such evidence and shall require
the holder to investigate the export by such importer
and to report to the Secretary within 14 days of the
receipt of such notice the findings of the holder. If
the Secretary determines that the importer has exported
a drug to such a country, the Secretary shall prohibit
such holder from exporting such drug to the importer
unless the Secretary determines that the export by the
importer was unintentional.''.</DELETED>
<DELETED>SEC. 503. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS.</DELETED>
<DELETED> Subsection (h) of section 351 of the Public Health Service
Act (42 U.S.C. 262) is amended to read as follows:</DELETED>
<DELETED> ``(h) A partially processed biological product that--
</DELETED>
<DELETED> ``(1) is not in a form applicable to the
prevention, treatment, or cure of diseases or injuries of
man;</DELETED>
<DELETED> ``(2) is not intended for sale in the United
States; and</DELETED>
<DELETED> ``(3) is intended for further manufacture into
final dosage form outside the United States,</DELETED>
<DELETED>shall be subject to no restriction on the export of the
product under this Act or the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq.) if the product is manufactured, processed,
packaged, and held in conformity with current good manufacturing
practice and meets the requirements of section 801(e)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(1)).''.</DELETED>
<DELETED>TITLE VI--DRUG AND BIOLOGICAL PRODUCTS REGULATORY
REFORM</DELETED>
<DELETED>SEC. 601. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Drug and Biological
Product Regulatory Reform Act of 1995''.</DELETED>
<DELETED>SEC. 602. NEW DRUG APPROVAL STANDARD.</DELETED>
<DELETED> Section 505(d) (21 U.S.C. 355(d)) is amended by adding at
the end thereof the following new sentence: ``Substantial evidence may
consist of data from one well-controlled clinical investigation (which
may be waived by the Secretary) and confirmatory evidence (obtained
either before or after such investigation).''.</DELETED>
<DELETED>SEC. 603. PILOT AND SMALL SCALE MANUFACTURE.</DELETED>
<DELETED> Section 505(c) (21 U.S.C. 355(c)) is amended by adding at
the end thereof the following new paragraph:</DELETED>
<DELETED> ``(4) A new drug or biological product manufactured in a
pilot or other small facility may be used to demonstrate the safety and
effectiveness of the drug or product and to obtain approval prior to
scaling up to a larger facility, unless the Secretary demonstrates in
writing and specifying in detail the reasons, after an informal
hearing, that a full scale production facility is necessary to ensure
the safety or effectiveness of the drug or product.''.</DELETED>
<DELETED>SEC. 604. MANUFACTURING CHANGES.</DELETED>
<DELETED> Chapter VII (21 U.S.C. 371 et seq.), as amended by section
407, is further amended by adding at the end thereof the following new
section:</DELETED>
<DELETED>``SEC. 750. MANUFACTURING CHANGES.</DELETED>
<DELETED> ``(a) In General.--A change in the manufacture of a new
drug, biological product, or new animal drug, may be made in accordance
with this section.</DELETED>
<DELETED> ``(b) Drug and Biological Product.--A change in the
manufacture of a new drug, a biological product that is the subject of
a monograph in an official compendium, a biological product that can be
adequately characterized by chemical, physical, or biological means, or
a new animal drug shall require--</DELETED>
<DELETED> ``(1) validation; and</DELETED>
<DELETED> ``(2)(A) if there is no change in the approved
qualitative and quantitative formulation or in the approved
release specifications, or if there is a change in the approved
qualitative or quantitative formula or in the approved release
specifications of a type permitted by the Secretary by
regulation, may be made at any time and shall be reported
annually to the Secretary; and</DELETED>
<DELETED> ``(B) for any other change, shall require
completion of an appropriate study demonstrating equivalence
according to criteria established by the Secretary (unless such
requirement is waived by the Secretary), may be made at any
time, and shall be reported to the Secretary through a
supplement or amendment submitted at the time the change is
made.</DELETED>
<DELETED> ``(c) Biological Product Not Subject to a Monograph.--A
change in the manufacture of a biological product that is not the
subject of a monograph in an official compendium and cannot be
adequately characterized by chemical, physical, or biological means
shall require validation and--</DELETED>
<DELETED> ``(1) if the change relates solely to a
modification of the manufacturing facility or change in
personnel, with no change in the approved manufacturing process
or release specifications, may be made at any time and shall be
reported annually to the Secretary; and</DELETED>
<DELETED> ``(2) for any other change, shall require
completion of a bioassay or other appropriate study
demonstrating equivalence according to criteria established by
the Secretary (unless such requirement is waived by the
Secretary), may be made at any time, and shall be reported to
the Secretary through an amendment submitted at the time the
change is made.</DELETED>
<DELETED> ``(d) Special Determination for a Biological Product.--A
determination shall be made prior to approval of a biological product
under section 351(a) of the Public Health Service Act (42 U.S.C.
262(a)) whether the product can be adequately characterized for
purposes of this subsection. With respect to biological products
approved prior to the date of enactment of the Food and Drug
Administration Performance and Accountability Act of 1995, the
determination shall be made within 90 days after the date of enactment
of such Act. Any determination under this subsection is subject to
change based upon new scientific information.''.</DELETED>
<DELETED>SEC. 605. INSULIN AND ANTIBIOTICS.</DELETED>
<DELETED> (a) Certification of Drugs Containing Insulin.--Section
506 (21 U.S.C. 356) is repealed.</DELETED>
<DELETED> (b) Certification of Antibiotics.--Section 507 (21 U.S.C.
357) is repealed.</DELETED>
<DELETED> (c) Exportation.--Section 802 (21 U.S.C. 382), as amended
by section 502(b), is further amended by adding at the end thereof the
following new subsection:</DELETED>
<DELETED> ``(g) Exportation of Unapproved Products.--Insulin and
antibiotics may be exported without regard to the requirements in this
section if the insulin and antibiotics meet the requirements in
subsection (e)(1).''.</DELETED>
<DELETED>SEC. 606. BIOLOGICAL PRODUCTS.</DELETED>
<DELETED> (a) Modernization of Regulation of Biological Products.--
</DELETED>
<DELETED> (1) In general.--Section 351 of the Public Health
Service Act (42 U.S.C. 262) is amended by striking ``Sec. 351.
(a)'' and all that follows through ``exchange the same.'' and
inserting the following:</DELETED>
<DELETED> ``Sec. 351. (a)(1) Except as provided in paragraph (4), no
person shall introduce or deliver for introduction into interstate
commerce any biological product unless--</DELETED>
<DELETED> ``(A) a product license has been issued for the
biological product;</DELETED>
<DELETED> ``(B) the biological product has been propagated,
manufactured, or prepared in accordance with good manufacturing
practices established by the Secretary under section 501(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a));
and</DELETED>
<DELETED> ``(C) each package of the biological product is
plainly marked with the proper name of the biological product
contained therein, the name, address and license number of the
manufacturer of the biological product, and the expiration date
of the biological product.</DELETED>
<DELETED> ``(2) The Secretary shall establish, by regulation,
requirements for product license applications for biological products.
A product license application for a biological product, other than
blood, blood components, and blood products, shall be approved based
upon a demonstration that the product that is the subject of the
application is safe and effective in accordance with section 505(d) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)). A license
application for blood, a blood component, or a blood product shall be
approved based upon a demonstration that the product that is the
subject of the application is safe, pure, and, where appropriate,
potent.</DELETED>
<DELETED> ``(3)(A) If the Secretary determines that grounds for a
suspension or revocation of a license for a biological product exist
that constitute a danger to health, the Secretary shall suspend the
license, notify the licensee of the suspension, and require
notification of the suspension to any consignee. Within 30 days after
the date of the receipt by the licensee of a notification of
suspension, the Secretary shall afford the licensee an opportunity for
a hearing in accordance with section 554 of title 5, United States
Code.</DELETED>
<DELETED> ``(B) If at any time before the Secretary has taken final
action to suspend or revoke a license the licensee requests an
inspection by the Secretary to determine whether the licensee is in
compliance with applicable standards, the Secretary shall conduct an
inspection within 30 days of the date of the request. If the Secretary
fails to conduct the inspection within the 30 days, the action to
suspend or revoke the license shall become null and void. If the
inspection confirms that the licensee is in compliance with all
applicable requirements, the Secretary shall withdraw any proposed
action within 30 days of the inspection.</DELETED>
<DELETED> ``(4) The requirements of paragraph (1) do not apply to a
biological product for which there is in effect an investigational new
drug application under section 505(i) of the Federal Food, Drug, and
Cosmetic Act.''.</DELETED>
<DELETED> (2) Labeling.--Section 351(b) of the Public Health
Service Act (42 U.S.C. 262(b)) is amended to read as
follows:</DELETED>
<DELETED> ``(b) No person shall falsely label or mark any package or
container of any biological product or alter any label or mark on the
package so as to falsify the label or mark.''.</DELETED>
<DELETED> (3) Inspection.--Section 351(c) of the Public
Health Service Act (42 U.S.C. 262(c)) is amended by striking
``virus, serum, toxin, antitoxin, vaccine, blood, blood
component, or blood product, or derivative allergenic product
or other product aforesaid'' and inserting ``biological
product''.</DELETED>
<DELETED> (4) Definition; application.--Part F of title III
of the Public Health Service Act (42 U.S.C. 262 et seq.) is
amended by adding at the end thereof the following new
subsections:</DELETED>
<DELETED> ``(i) For purposes of this section, the term `biological
product' means a virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic biologic product, or
arsphenamine or its derivative (or any other analogous biological
product) applicable to the prevention, treatment, or cure of diseases
or conditions of human beings.</DELETED>
<DELETED> ``(j)(1) Sections 505(i), 903, and 904 of the Federal
Food, Drug, and Cosmetic Act shall apply to all biological products and
references in those sections to new drug applications shall be deemed
to include product license applications.</DELETED>
<DELETED> ``(2) Requirements involving labeling or advertising for
biological products shall be established in accordance with sections
201(m) and 502(n) of the Federal Food, Drug, and Cosmetic
Act.</DELETED>
<DELETED> (b) Harmonization of Regulation of Biological Products and
New Drugs.--Not later than 2 years after the date of enactment of this
section, the Secretary of Health and Human Services shall harmonize
regulations governing product license applications required under
section 351 of the Public Health Service Act (42 U.S.C. 262) with the
regulations governing new drug applications required under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).</DELETED>
<DELETED>SEC. 607. REQUIREMENTS FOR EMERGING BIOTECHNOLOGY
PRODUCTS.</DELETED>
<DELETED> Not later than 180 days after the date of enactment of
this Act, the Secretary of Health and Human Services shall establish
proposed regulations governing products of human tissue and cell
therapy that shall--</DELETED>
<DELETED> (1) ensure the safety and effectiveness of the
products under section 351 of the Public Health Service Act (42
U.S.C. 262 et seq.); and</DELETED>
<DELETED> (2) take in account whether regulation of
facilities in which the products are manufactured or processed
is sufficient to ensure safety and effectiveness of the
products.</DELETED>
<DELETED>TITLE VII--DEVICE REGULATORY REFORM</DELETED>
<DELETED>SEC. 701. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Medical Device Reform Act
of 1995''.</DELETED>
<DELETED>SEC. 702. PREMARKET NOTIFICATION.</DELETED>
<DELETED> (a) Exemption of Certain Devices.--Section 510 (21 U.S.C.
360) is amended--</DELETED>
<DELETED> (1) in subsection (k), by striking ``intended for
human use'' and inserting `` intended for human use (except a
device that is classified into class I under section 513 or 520
or a device that is classified into class II under section 513
or 520, and is exempt from the requirements of this subsection
under subsection (l))'';</DELETED>
<DELETED> (2) by adding at the end of subsection (k) (as
amended by paragraph (1)) the following:</DELETED>
<DELETED>``The Secretary shall review the notification required by this
subsection and make a determination under section 513(f)(1)(A) within
90 days of receiving the notification.''; and</DELETED>
<DELETED> (3) by adding at the end thereof the following new
subsections:</DELETED>
<DELETED> ``(l) Within 30 days of the date of enactment of this
subsection, the Secretary shall publish in the Federal Register a list
of each type of class II device that does not require a report under
subsection (k) to provide reasonable assurance of safety and
effectiveness. Each type of class II device so identified by the
Secretary not to require the report shall be exempt from the
requirement to file a report under subsection (k) as of the date of the
publication of the list in the Federal Register. Beginning on the date
that is 1 day after the date of the publication of a list under this
subsection, any person may petition the Secretary to exempt a type of
class II device from subsection (k). The Secretary shall respond to the
petition within 120 days of the receipt of the petition and determine
whether or not to grant the petition in whole or in part.</DELETED>
<DELETED> ``(m) The Secretary may not withhold a determination of
the initial classification of a device under subsection 513(f)(1)
because of a failure to comply with any provision of this Act unrelated
to a substantial equivalence decision, including a finding that the
facility in which a device is manufactured is not in compliance with
good manufacturing practice requirements as set forth in regulations
promulgated under the authority of subsection 520(f).''.</DELETED>
<DELETED> (b) Initial Classification.--Section 513(f)(1) (21 U.S.C.
360c(f)(1)) is amended in the second sentence, by striking the period
at the end thereof and inserting the following: ``, unless within 30
days of receiving an order classifying the device into class III, the
individual who submits a notification under section 510(k) requests an
advisory committee review and recommendation with respect to the
classification of the device and a final order of classification from
the Secretary. After the request, a device classified into class III
under this paragraph shall not be deemed to be finally classified until
an advisory committee established under subsection (b) reviews the
request with respect to the classification of the device and, within 60
days of the date of receiving the request, recommends to the Secretary
a classification for the device based on the classification criteria
set forth in subparagraphs (A) through (C) of subsection(a)(1).
Thereafter, the Secretary shall have 10 days to determine by order the
final classification of the device by applying the classification
criteria set forth in subparagraphs (A) through (C) of
subsection(a)(1).</DELETED>
<DELETED> (c) Substantial Equivalence.--Section 513(i)(1) (21 U.S.C.
360c(i)(1)) is amended by adding at the end thereof the following new
subparagraph:</DELETED>
<DELETED> ``(C) For the purpose of determining the intended use of a
predicate device under paragraph (A), each use included within a
general use for the predicate device shall be deemed a legally marketed
use of the predicate device for purposes of premarket notifications
required under subsection 510(k).''.</DELETED>
<DELETED> (d) Device Modification.--Section 513(i) (21 U.S.C.
360c(i)) is amended by adding at the end thereof the following new
paragraph:</DELETED>
<DELETED> ``(4) Any change or modification to a device initially
classified under section 513(f), other than a major change (including
any major modification) in the intended use, shall not require an
additional submission under section 510(k) if such change or
modification is supported by appropriate data or information, and the
change or modification can be shown to not adversely affect the safety
or effectiveness of the device. All data or information relied upon to
document that a change to (including any modification of) the device
does not require an additional notification under section 510(k) shall
be made available to the Secretary upon request and shall be
maintained, at least for a period of time equal to the commercial life
of the device.''.</DELETED>
<DELETED>SEC. 703. MEDICAL DEVICE APPROVAL STANDARDS.</DELETED>
<DELETED> Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is
amended--</DELETED>
<DELETED> (1) by striking ``well-controlled investigations''
and inserting ``a scientific investigation'';</DELETED>
<DELETED> (2) by striking ``clinical investigations'' and
inserting ``a clinical investigation'';</DELETED>
<DELETED> (3) by striking ``investigations it'' and
inserting ``investigation it''; and</DELETED>
<DELETED> (4) by adding the following to the end thereof the
following new sentence: ``The Secretary may require a well-
controlled clinical investigation to demonstrate effectiveness
if the director of the Office of Device Evaluation explains in
writing the basis therefor.''.</DELETED>
<DELETED>SEC. 704. TRACKING.</DELETED>
<DELETED> Section 519(e) (21 U.S.C. 360i(e)) is amended to read as
follows:</DELETED>
<DELETED>``device tracking</DELETED>
<DELETED> ``(e) The Secretary may by regulation require a
manufacturer to adopt a method of tracking a class II or class III
device--</DELETED>
<DELETED> ``(1) the failure of which would be life-
threatening or have permanently debilitating effects;
and</DELETED>
<DELETED> ``(2) which is--</DELETED>
<DELETED> ``(A) permanently implanted; or</DELETED>
<DELETED> ``(B) life sustaining or life supporting
and used outside a device user facility.''.</DELETED>
<DELETED>SEC. 705. POSTMARKET SURVEILLANCE.</DELETED>
<DELETED> Section 522(1) (21 U.S.C. 360l) is amended to read as
follows:</DELETED>
<DELETED>``SEC. 522. POSTMARKET SURVEILLANCE.</DELETED>
<DELETED> ``(a) In General.--The Secretary may require a
manufacturer to conduct postmarket surveillance for any device of the
manufacturer first introduced or delivered for introduction into
interstate commerce after January 1, 1991, that--</DELETED>
<DELETED> ``(1) is a permanent implant the failure of which
may cause serious, adverse health consequences or
death;</DELETED>
<DELETED> ``(2) is intended for a use in supporting or
sustaining human life; or</DELETED>
<DELETED> ``(3) potentially presents a serious risk to human
health.</DELETED>
<DELETED> ``(b) Surveillance Approval.--Each manufacturer required
to conduct a surveillance of a device under subsection (a) shall,
within 30 days of receiving notice from the Secretary that the
manufacturer is required under this section to conduct the
surveillance, submit for the approval of the Secretary, a protocol for
the required surveillance. The Secretary, within 60 days of the date of
the receipt of the protocol, shall determine if the principal
investigator proposed to be used in the surveillance has sufficient
qualifications and experience to conduct the surveillance and if the
protocol will result in collection of useful data or other information
necessary to protect the public health and to provide safety and
effectiveness information for the device. The Secretary may not approve
the protocol until the protocol has been reviewed by a qualified
scientific and technical review committee established by the
Secretary.''.</DELETED>
<DELETED>SEC. 706. DEVICE DISTRIBUTOR REPORTING.</DELETED>
<DELETED> Section 519 (21 U.S.C. 360i) is amended--</DELETED>
<DELETED> (1) by striking ``, importer, or distributor''
each place it appears and inserting ``or importer'';</DELETED>
<DELETED> (2) in subsection (a)--</DELETED>
<DELETED> (A) in paragraph (8), by striking ``;
and'' and inserting a period; and</DELETED>
<DELETED> (B) by striking paragraph (9);
and</DELETED>
<DELETED> (3) by striking subsection (f).</DELETED>
<DELETED>SEC. 707. PREMARKET APPROVAL.</DELETED>
<DELETED> (a) Action on Application.--Section 515(d) (21 U.S.C.
360e(d)) is amended--</DELETED>
<DELETED> (1) in paragraph (1)(A), by striking ``paragraph
(2) of this subsection'' each place it appears and inserting
``paragraph (4)'';</DELETED>
<DELETED> (2) in paragraph (1)(B), by adding at the end
thereof the following new clause:</DELETED>
<DELETED> ``(iii) The Secretary shall accept and review data and any
other information from investigations conducted under the authority of
regulations required by section 520(g) to make a determination of
whether there is a reasonable assurance of safety and effectiveness of
a device subject to a pending application under this section if--
</DELETED>
<DELETED> ``(I) the data or information is derived from
investigations of an earlier version of the device, the device
has been modified during or after the investigations, and the
modification of the device does not constitute a significant
change in the design or in the basic principles of operation of
the device that would invalidate the data or information;
or</DELETED>
<DELETED> ``(II) the data or information on a device
approved under this section is available for use under this Act
and is relevant to the design and intended use of the device
subject to the pending application.'';</DELETED>
<DELETED> (3) by redesignating paragraphs (2) and (3) as
paragraphs (4) and (5), respectively; and</DELETED>
<DELETED> (4) by inserting after paragraph (1) the following
new paragraph:</DELETED>
<DELETED> ``(2) Each application received under section 515(c) shall
be reviewed in the following manner to achieve final action on the
application within 180 days of the receipt of the
application:</DELETED>
<DELETED> ``(A) The Secretary shall meet with an applicant
within 90 days of the receipt of the application to discuss the
review status of the application. If the application does not
appear in a form that would require an approval under
subsection (d), the Secretary shall in writing, and prior to
the meeting, present to the applicant a description of any
deficiencies in the application and what information is
required to bring the application into a form that would
require an approval.</DELETED>
<DELETED> ``(B) The Secretary shall refer an application to
a panel established under section 513 for review and an
approval recommendation, unless a panel is not required under
subsection (c)(2), within 30 days of the date of the meeting
referred to in subparagraph (A) or at the next scheduled panel
meeting following the meeting referred to in subparagraph (A),
whichever occurs later.</DELETED>
<DELETED> ``(C) The Secretary shall meet with the applicant
within 15 days of the date of the panel review to discuss the
status of the application, including a discussion on what
action is necessary to bring the application into a form that
would require approval under this subsection. Prior to the
meeting, the Secretary shall in writing shall set forth an
agenda for the meeting (including a complete description of the
subject matter to the discussed at the meeting), and a full
description of the additional information necessary to bring
the application into a form that would require an approval
under subsection (d). Participation of the applicant at such a
meeting shall be at the discretion of the applicant.</DELETED>
<DELETED> ``(D) The Secretary shall meet with the applicant
not later than 135 days after the receipt of an application
under subsection (c), if an advisory panel is not required
under subsection (c)(2), and inform the applicant whether or
not the application is in a form that would require approval
under subsection (d). If the application is in such form, the
Secretary shall, at or prior to the meeting, present in writing
to the applicant a description of all additional information
necessary to require an approval of the application under
subsection (d). If the application is not in such form, the
Secretary shall deny approval of the application and prior to
the meeting, present in writing to the applicant each basis for
denying approval of the application and the additional
information required to bring the application into a form that
would require approval.</DELETED>
<DELETED> ``(E) The Secretary shall issue an order approving
or denying an application within 180 days of the receipt of the
application under subsection (c).</DELETED>
<DELETED> ``(3)(A) Except as provided in subparagraph (B), the time
for the review of an application by the Secretary under this subsection
shall take not more than 180 days and may not be extended if the
application is amended.</DELETED>
<DELETED> ``(B) The Secretary may not take more than 120 days for
the review of an application subject to an expedited review under
paragraph (1)(A) and may not extend the 120-day period if the
application is amended.''.</DELETED>
<DELETED> (b) Regulations.--The Secretary shall revise through
notice and comment procedures the regulations set forth in part 814 of
title 21 of the Code of Federal Regulations, to conform to the
amendment made by paragraph (1) and to eliminate premarket approval of
supplements that relate to manufacturing changes and other changes that
do not affect device safety or effectiveness.</DELETED>
<DELETED>SEC. 708. DEVICE PERFORMANCE STANDARDS.</DELETED>
<DELETED> (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d)
is amended by adding at the end thereof the following new
subsection:</DELETED>
<DELETED>``product review</DELETED>
<DELETED> ``(c)(1) For the purpose of facilitating a review of a
device under sections 510(k), 515, and 520, any person may submit a
petition under this subsection for the recognition by the Secretary of
an existing performance standard for a device.</DELETED>
<DELETED> ``(2) A petition under this subsection shall be made
following the adoption of a voluntary performance standard by any
qualified governmental or nongovernmental organization established to
develop performance standards.</DELETED>
<DELETED> ``(3) The petition shall identify the specific standard,
the organization that adopted the standard, and the date on which the
standard was adopted by the organization.</DELETED>
<DELETED> ``(4) Upon the receipt of a petition under this
subsection, the Secretary shall place the petition on public display
and within 30 days after the date of the receipt of the petition, the
Secretary shall publish a notice in the Federal Register setting forth
the proposed standard, stating that the entire application is publicly
available for review, and providing 60 days for public
comment.</DELETED>
<DELETED> ``(5) Within 150 days after the receipt by the Secretary
of the application, the Secretary shall--</DELETED>
<DELETED> ``(A)(i) grant the petition in whole or in part;
or</DELETED>
<DELETED> ``(ii) deny the petition in whole or in part if
the Secretary demonstrates that the standard does not establish
an adequate performance standard for the functions of a device
for which the standard is represented to apply; and</DELETED>
<DELETED> ``(B) publish a notice of the determination in the
Federal Register.</DELETED>
<DELETED> ``(6) Upon the approval of the petition, the Secretary
shall publish in the Federal Register the order listing the name of the
recognized standard and shall provide any person who requests the
recognized standard a copy of the standard.</DELETED>
<DELETED> ``(7) Following the publication of a final regulation
listing a recognized standard, any premarket notification for a device
submitted under sections 510(k), 513(f)(1), and 513(i) and any
premarket approval application submitted under section 515 may include
a certification of compliance with the standard, which shall constitute
full and complete satisfaction of the requirements for safety and
effectiveness for the functions of the device for which the standard is
represented to apply.</DELETED>
<DELETED> ``(8) Any modification of a recognized standard shall be
subject to review under the procedure established in this subsection
for the modified standard to become a recognized standard.''.</DELETED>
<DELETED> (b) Adulterated Device.--Section 501(e) (21 U.S.C. 351(e))
is amended by striking ``section 514'' and inserting ``section
514(b)''.</DELETED>
<DELETED>TITLE VIII--ANIMAL DRUG REGULATORY REFORM</DELETED>
<DELETED>SEC. 801. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Animal Drug Regulatory
Reform Act of 1995''.</DELETED>
<DELETED>SEC. 802. NEW ANIMAL DRUG APPROVAL STANDARDS.</DELETED>
<DELETED> (a) Substantial Evidence.--Section 512(d)(3) (21 U.S.C.
360b(d)(3)) is amended by adding at the end thereof the following new
sentences: ``Substantial evidence shall consist of at least data from
one scientifically sound study (designed and conducted in a manner that
is consistent with generally recognized scientific procedures and
principles), which may be waived by the Secretary, and confirmatory
evidence obtained before or after the study. The Director of the Center
for Veterinary Medicine may require a field trial as part of
substantial evidence if the Director of the Center for Veterinary
Medicine demonstrates, in writing and specifying the basis therefor,
that no other form of scientifically sound study is adequate to show
the effectiveness of the drug.''.</DELETED>
<DELETED> (b) Combination of Drugs.--Section 512(d) (21 U.S.C.
360b(d)) is amended by adding at the end thereof the following new
paragraph:</DELETED>
<DELETED> ``(4) If a new animal drug contains more than one active
ingredient or the labeling provides for the drug's use in combination
with one or more other animal drugs, in evaluating such combination the
Secretary shall consider whether--</DELETED>
<DELETED> ``(A) the combination affects the safety of any
active ingredient;</DELETED>
<DELETED> ``(B) the combination interferes with a method of
analysis for any active ingredient;</DELETED>
<DELETED> ``(C) if the active ingredients have the same
intended effect, each of the active ingredients makes a
significant contribution to the labeled effectiveness;
and</DELETED>
<DELETED> ``(D) if the active ingredients do not have the
same intended effect, the active ingredients provide
appropriate concurrent therapy for a labeled target
population.''.</DELETED>
<DELETED> (c) Approval.--Section 512(c)(2)(F)(iii) (21 U.S.C.
360b(c)(2)(F)(iii)) is amended--</DELETED>
<DELETED> (1) by striking ``reports of new clinical or field
investigations (other than bioequivalence or residue studies)
and'' and inserting ``substantial evidence of effectiveness as
defined in subsection (d)(4), any study of animal safety, or'';
and</DELETED>
<DELETED> (2) by striking ``essential to'' and inserting ``,
required for''.</DELETED>
<DELETED>SEC. 803. RESIDUE LIMITATION.</DELETED>
<DELETED> Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is amended
to read as follows:</DELETED>
<DELETED> ``(F) on the basis of information in the
application or otherwise available to the Secretary, any
labeled use of the drug will result in an unsafe residue of the
drug;''.</DELETED>
<DELETED>SEC. 804. ADULTERATED DRUGS.</DELETED>
<DELETED> Section 501(a)(2) (21 U.S.C. 351(a)(2)) is amended--
</DELETED>
<DELETED> (1) in subparagraph (A), by striking ``health;
or'' and inserting ``health''; and</DELETED>
<DELETED> (2) in subparagraph (B), by striking ``possess;''
and inserting the following: ``possess; or (C) if it is a drug
intended for use by animals other than man and the methods used
in, or the facilities or controls used for, its manufacture,
processing, packing, or holding do not conform to or are not
operated or administered in conformity with current good
manufacturing practice requirements (appropriate for animal
drugs) adopted pursuant to regulations issued by the Secretary
to ensure that such drug meets the requirements of this Act as
to safety and has the identity and strength, and meets the
quality and purity characteristics, which it purports or is
represented to possess for use in animals other than
man;''.</DELETED>
<DELETED>TITLE IX--FOOD REGULATORY REFORM</DELETED>
<DELETED>SEC. 901. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Food Regulatory Reform
Act of 1995''.</DELETED>
<DELETED>SEC. 902. INDIRECT FOOD ADDITIVES.</DELETED>
<DELETED> (a) Approval.--Section 409 (21 U.S.C. 348) is amended by
adding at the end thereof the following new subsection:</DELETED>
<DELETED>``alternative approval procedure</DELETED>
<DELETED> ``(j)(1) As an alternative to the approval procedure
established under subsection (b), any person may submit a notification
for an indirect food additive under this subsection.</DELETED>
<DELETED> ``(2) Any person who proposes to begin the introduction or
delivery for introduction into interstate commerce of a product
intended for use as an indirect food additive may submit to the
Secretary, at least 90 days prior to making such introduction or
delivery, a notification containing information demonstrating that the
labeled use of the product is safe.</DELETED>
<DELETED> ``(3)(A) Within 90 days after the receipt of the
notification by the Secretary, the Secretary shall either--</DELETED>
<DELETED> ``(A)(i) approve the notification if the product
is safe for its intended use; or</DELETED>
<DELETED> ``(ii) disapprove the notification if there is a
reasonable possibility that the article is not safe for its
intended use; and</DELETED>
<DELETED> ``(B) publish a notice of this determination in
the Federal Register and, if the notification is approved,
promulgate an appropriate regulation pursuant to subsection
(c).</DELETED>
<DELETED>If the Secretary does not publish such a notice in the Federal
Register within the 90-day period, the notification shall be deemed to
be approved and the Secretary shall immediately approve the
notification and promulgate an appropriate regulation in the Federal
Register pursuant to subsection (c).''.</DELETED>
<DELETED> (b) Definition.--Section 201 (21 U.S.C. 321), as amended
by section 606(c), is further amended by adding at the end thereof the
following new subsection:</DELETED>
<DELETED> ``(ii) The term `indirect food additive' means a food
additive that is intended to contact food but that is not intended for
consumption as a food ingredient.''.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Administration
Performance and Accountability Act of 1996''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References.
TITLE I--MISSION AND ACCOUNTABILITY
Sec. 101. Short title.
Sec. 102. The mission of the Food and Drug Administration.
Sec. 103. Performance standards and review.
Sec. 104. Interagency collaboration.
Sec. 105. Information system.
Sec. 106. Policy statements.
Sec. 107. Scientific review groups.
Sec. 108. Appeals within the Food and Drug Administration.
Sec. 109. Appointment and term of the Commissioner of Food and Drugs.
TITLE II--EXPEDITED ACCESS TO PRODUCTS FOR SERIOUSLY ILL PATIENTS
Sec. 201. Short title.
Sec. 202. Access to unapproved therapies.
Sec. 203. Expanding humanitarian use of devices.
Sec. 204. Expediting approval of new drugs, biologics, and medical
devices for serious conditions.
TITLE III--REVITALIZING THE INVESTIGATION OF NEW PRODUCTS
Sec. 301. Short title.
Sec. 302. Timely review and reasonable data requirements for clinical
research on drugs and biological products.
Sec. 303. Timely review and reasonable data requirements for clinical
research on devices.
Sec. 304. Sense of the committee concerning mutual recognition
agreements.
Sec. 305. Collaborative research design.
TITLE IV--EFFICIENT, ACCOUNTABLE, AND FAIR PRODUCT REVIEW
Sec. 401. Short title.
Sec. 402. The content and review of an application.
Sec. 403. Contracts for expert review.
Sec. 404. Prompt and efficient review.
Sec. 405. Good manufacturing practice inspection.
Sec. 406. Environmental impact review.
Sec. 407. Effectiveness, outcome, and cost-effectiveness standards.
Sec. 408. Definition of a day for purposes of product review.
Sec. 409. Approval of supplemental applications for approved products.
Sec. 410. Pediatric studies marketing exclusivity.
Sec. 411. Notifications for device market clearance.
TITLE V--DRUG AND BIOLOGICAL PRODUCTS REGULATORY REFORM
Sec. 501. Short title.
Sec. 502. New drug approval standard.
Sec. 503. Pilot and small scale manufacture.
Sec. 504. Manufacturing changes.
Sec. 505. Insulin and antibiotics.
Sec. 506. Modernization of regulation of biological products.
Sec. 507. Effective medication guides.
Sec. 508. State and local requirements respecting nonprescription drugs
intended for human use.
Sec. 509. Requirement of radiopharmaceuticals.
TITLE VI--DEVICE REGULATORY REFORM
Sec. 601. Short title.
Sec. 602. Premarket notification.
Sec. 603. Medical device approval standards.
Sec. 604. Tracking.
Sec. 605. Postmarket surveillance.
Sec. 606. Device distributor reporting.
Sec. 607. Premarket approval.
Sec. 608. Device performance standards.
Sec. 609. Accredited-party participation.
TITLE VII--ANIMAL DRUG REGULATORY REFORM
Sec. 701. Short title.
Sec. 702. Evidence of effectiveness.
Sec. 703. Limitation of residues.
Sec. 704. Adulterated drugs.
Sec. 705. Veterinary feed directives.
Sec. 706. Timeframes for approval.
TITLE VIII--FOOD REGULATORY REFORM
Sec. 801. Short title.
Sec. 802. Indirect food additives.
Sec. 803. Health claims of food products.
TITLE IX--ESTABLISHMENT OF CENTERS FOR EDUCATION AND RESEARCH ON DRUGS,
DEVICES, AND BIOLOGICAL PRODUCTS
Sec. 901. Centers for Education and Research on Drugs, Devices, and
Biological Products.
TITLE X--PROGRAM IN CLINICAL PHARMACOLOGY
Sec. 1001. Reauthorization of clinical pharmacology program.
SEC. 3. REFERENCES.
Except as otherwise expressly provided, whenever in this Act an
amendment or repeal is expressed in terms of an amendment to, or repeal
of, a section or other provision, the reference shall be considered to
be made to a section or other provision of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321 et seq.).
TITLE I--MISSION AND ACCOUNTABILITY
SEC. 101. SHORT TITLE.
This title may be cited as the ``Food and Drug Administration
Regulatory Reform Act of 1996''.
SEC. 102. THE MISSION OF THE FOOD AND DRUG ADMINISTRATION.
Section 903(a) (21 U.S.C. 393(a)) is amended by adding at the end
thereof the following: ``The mission of the Administration is to
promote and protect the public health by--
``(1) facilitating the rapid and efficient development and
availability of articles subject to the regulation of the
Administration;
``(2) protecting the public from unsafe or ineffective
articles subject to the regulation of the Administration; and
``(3) enforcing the applicable statutes and regulations in
a timely, fair, consistent, and decisive manner.''.
SEC. 103. PERFORMANCE STANDARDS AND REVIEW.
Section 903(b) (21 U.S.C. 393(b)) is amended by adding at the end
thereof the following new paragraph:
``(3) Performance standards and review.--
``(A) In general.--Not later than 180 days after
the date of enactment of this paragraph, the Secretary,
after consultation with experts in the development,
clinical investigation, and regulation of drugs,
biological products, new animal drugs, devices, food
additives, and color additives and representatives of
patient and consumer advocacy groups, health and
technology professionals, and the regulated industries,
shall develop and publish in the Federal Register
quantifiable performance standards for action by the
Administration on--
``(i) applications or submissions
(including petitions, notifications, or any
other similar form of request) for review of a
protocol, a product investigation, a product
approval, a new use approval, a manufacturing
change, a change in labeling, or any other form
of regulatory action relating to the review of
an article that is a new drug, biological
product, new animal drug, device, food
additive, or color additive and that is subject
to premarket review or approval under this Act;
and
``(ii) the scheduling of advisory committee
meetings, and the action taken by the
Administration following an advisory committee
recommendation, relating to the applications
and submissions described in clause (i).
``(B) Review of performance standards.--The
performance standards required by subparagraph (A)
shall be reviewed annually by the Secretary, and after
consultation with experts in the development, clinical
investigation, and regulation of drugs, biological
products, new animal drugs, devices, food additives,
and color additives, and representatives of patient and
consumer advocacy groups, health and technology
professionals, and the regulated industries, may be
revised, annually by the Secretary.
``(C) Agency objectives.--The performance standards
required by subparagraph (A) shall establish objectives
for the Administration that--
``(i) expedite the clinical investigation
of an article that is a new drug, device, or
biological product through closer collaboration
between the Administration and the sponsor of
the investigation;
``(ii) expedite the review of an
application for a new drug, device, or
biological product--
``(I) for an immediately life-
threatening disease or condition; or
``(II) for any other serious
condition if the new drug, device, or
biological product provides therapy
that is not available from another
approved therapy or offers significant
improvement over another approved
therapy or diagnostic or monitoring
agents;
``(iii) reduce backlogs in the review of
all applications with the objective of
eliminating all backlogs in the review of
applications by January 1, 1998;
``(iv) establish a schedule to bring the
Administration into full compliance by July 1,
1998, with the time periods specified in this
Act for the review of all applications; and
``(v) improve the consistency and fairness
of the regulatory process of the
Administration.
The Secretary shall issue such other performance
standards that the Secretary determines will contribute
to the efficient, fair, and effective operation of the
Administration.
``(D) Annual report.--The Secretary shall prepare
and publish in the Federal Register for public comment
an annual report that--
``(i) provides detailed data on the actual
performance of the Administration relating to
the action taken by the Administration with
respect to the applications and submissions
described in subparagraph (A)(i) and the
activities relating to advisory committees
described in subparagraph (A)(ii);
``(ii) compares the performance of the
Administration with each applicable performance
standard developed and published under
subparagraph (A);
``(iii) describes--
``(I) any priorities established
with respect to action to be taken by
the Administration on matters relating
to the applications and submissions
described in subparagraph (A)(i) and
the activities relating to advisory
committees described in subparagraph
(A)(ii);
``(II) how such priorities are
implemented; and
``(III) the data on each priority
category;
``(iv) analyzes any failure to achieve any
of the performance standards;
``(v) identifies regulatory policies that
have a significant impact on compliance with
the performance standards and analyzes how such
policies could be modified in order to achieve
compliance with the performance standards; and
``(vi) sets forth a plan to achieve
compliance with the performance standards that
have not been met.
``(E) Statistical information.--The report
described in subparagraph (D) shall include a full
statistical presentation relating to all applications,
petitions, or notifications for a new drug, device,
biological product, new animal drug, food additive, or
color additive approved by the Administration during
the year, taking into account the date of--
``(i) the submission of any investigational
application;
``(ii) the application of any clinical
hold;
``(iii) the submission of any application,
petition, or notification for approval or
clearance;
``(iv) the acceptance for filing of any
application, petition, or notification for
approval or clearance;
``(v) the occurrence of any unapprovable
action;
``(vi) the occurrence of any approvable
action; and
``(vii) the approval or clearance of any
application, petition, or notification.''.
SEC. 104. INTERAGENCY COLLABORATION.
Section 903(b) (21 U.S.C. 393(b)), as amended by section 103, is
further amended by adding at the end thereof the following new
paragraph:
``(4) Interagency collaboration.--The Secretary shall
implement programs and policies that will foster collaboration
between the Administration, the National Institutes of Health,
and other Federal science-based agencies, to enhance the
scientific expertise available to the Commissioner for the
evaluation of emerging medical therapies, including
complementary therapies, and advances in nutrition and food
science.''.
SEC. 105. INFORMATION SYSTEM.
Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at the end
thereof the following new section:
``SEC. 906. INFORMATION SYSTEM.
``The Secretary shall establish and maintain an information system
to track the status and progress of each application or submission
(including a petition, notification, or other similar form of request)
for the approval or clearance of a drug, biological product, new animal
drug, device, food additive, or color additive submitted to the Food
and Drug Administration. The system shall permit access by the
applicant, petitioner, or the person who submits a notification.''.
SEC. 106. POLICY STATEMENTS.
Section 701(a) (21 U.S.C. 371(a)) is amended--
(1) by striking ``(a) The'' and inserting ``(a)(1) The'';
and
(2) by adding at the end thereof the following new
paragraph:
``(2)(A) Not later than 180 days after the date of enactment of the
Food and Drug Administration Performance and Accountability Act of
1996, the Secretary shall establish a procedure governing the
development and use of all policy statements of general applicability
that provide guidance relating to the conduct of preclinical or
clinical investigations or other testing to support an application or
submission (including a petition, notification, or any other similar
form of request) under section 409, 505, 510(k), 512, 515, or 721 or
that provide guidance on the submission of an application or submission
(including a petition, notification, or any other similar form of
request) under section 409, 505, 510(k), 512, 515, or 721 (including
any guidance, guideline, points-to-consider, protocol, recommendation,
or similar document regardless of the form or designation). The
procedure shall provide an opportunity for affected persons to
participate in the development and continued use of a policy statement
by sharing expertise or experience, or providing comment, before the
policy statement is adopted and after the policy statement is
implemented, except that if the Secretary determines that there is a
public health need to issue the policy statement immediately, the
Secretary shall provide an opportunity for affected persons to provide
comment promptly after the policy statement is issued.
``(B) The Secretary shall establish a procedure for the periodic
compilation and publication of all policy statements of general
applicability (including any guideline, points-to-consider, protocol,
recommendation, or similar document regardless of the form or
designation).''.
SEC. 107. SCIENTIFIC REVIEW GROUPS.
Section 904 (21 U.S.C. 394) is amended--
(1) by striking ``Without'' and inserting ``(a) In
General.--Without''; and
(2) by adding at the end thereof the following new
subsections:
``(b) Delegation of Appointment Authority.--The Commissioner may
not delegate the appointment and oversight authority granted under
subsection (a).
``(c) Membership and Meeting Requirements.--
``(1) Scope.--The Commissioner shall consult with a
scientific review group in determining the matters that the
group will consider at the meetings of the scientific review
group.
``(2) Notification of scope of discussion.--To the extent
feasible, the specific matters (including questions) to be
discussed at a meeting of a scientific review group shall be
publicly announced and published in the Federal Register at
least 30 days prior to the date of the meeting.
``(3) Terms.--A member of a scientific review group shall
serve for a term of 3 years, and may have such membership
renewed for not more than 1 additional term. An individual may
serve on more than one scientific review group. The chairperson
of a scientific review group shall be a member who has served
on the scientific group for at least 3 years. The term of the
chairperson may be renewed for not more than 3 terms.
``(4) Training.--Prior to service on a scientific review
group, a member of the group shall be given adequate education
and training relating to the responsibilities of the member.
``(5) Frequency of meetings.--The Secretary shall take
whatever action is necessary to ensure that regular meetings
are held by scientific review groups, at appropriate intervals
and for a sufficient length of time. The meetings shall occur
not less than 3 times each year unless the Secretary determines
that there are sufficient reasons for fewer meetings.
``(d) Access to Information; Participation by Interested Persons in
Meetings.--
``(1) In general.--When a scientific review group reviews
an application or submission (including a petition,
notification, or any other similar form of request) for
approval or clearance, or some part thereof, submitted for an
article under section 409, 505, 510(k), 513(f), 512, 515, or
721, the Secretary shall provide the person who submitted the
application or submission with copies of all documents provided
to the members of the scientific review group in preparation
for a meeting of the scientific review group. The Secretary
shall provide such documents to the person at the same time
such documents are provided to the members of the scientific
review group. Before the meeting, the person shall have an
opportunity to submit documents to the members of the
scientific review group in response to the Secretary's
documents. The person shall provide the documents to the
Secretary, who shall immediately provide copies of the
documents to the members of the scientific review group.
``(2) Participation in meetings.--Any meeting of a
scientific review group shall include adequate time for initial
presentations and for response to any differing views and the
group shall encourage free and open participation by all
interested persons.
``(e) FDA Actions.--Not later than 60 days after the date a
scientific review group makes its conclusions and recommendations on
any matter under review of the group, the official of the Food and Drug
Administration responsible for the matter shall review the conclusions
and recommendations of the group, make a final determination on the
matter, and notify the affected persons of the determination in writing
and, if the determination differs from the conclusions and
recommendations of the group, include the reasons for the
difference.''.
SEC. 108. APPEALS WITHIN THE FOOD AND DRUG ADMINISTRATION.
Chapter IX (21 U.S.C. 391 et seq.), as amended by section 105, is
further amended by adding at the end thereof the following new section:
``SEC. 907. APPEALS WITHIN THE FOOD AND DRUG ADMINISTRATION.
``(a) Employee Decisions.--The Secretary shall by regulation
establish an internal appeal system within the Food and Drug
Administration for the appeal of any decision made by an employee of
the Food and Drug Administration, except that this subsection shall not
apply to decisions involving formal administrative or judicial
proceedings. As the final stage in the internal appeal system, the
Secretary shall provide for the right to request an evaluation by an
appropriate scientific review group of a final decision of the
Secretary on an appeal involving a significant scientific issue. Upon
receipt of such a request, the Secretary shall refer the request to the
chairperson of the appropriate scientific review group, or a member
designated by the chairperson, who shall review the request and
determine whether the scientific review group should conduct an
evaluation. The Secretary shall make publicly known the existence of
the internal appeal system and the procedures for an internal appeal.
``(b) Review by Scientific Review Group.--
``(1) In general.--The sponsor of a preclinical or clinical
investigation, or the applicant for the approval or clearance
of an application or submission (including a petition,
notification, or any other similar form of request), shall have
the right to request an evaluation by an appropriate scientific
review group established under section 904 of any significant
scientific issue pending before, or any significant scientific
decision made by, the Secretary under this Act. An appropriate
scientific review group shall review the request and determine whether
to conduct an evaluation within 30 days after the date the request is
received by the Secretary.
``(2) Scope.--The significant scientific issues that a
scientific review group may evaluate include matters involving
a decision by the Secretary not to permit a clinical
investigation to begin or to continue, a refusal by the
Secretary to file an application, a protocol design, and
decisions relating to a pending application or submission
(including a petition, notification, or any other similar form
of request). The significant scientific issues shall not have
been previously reviewed by a scientific review group.
``(3) Time limitation.--If a scientific review group agrees
to conduct an evaluation on an issue under paragraph (1), the
evaluation shall be scheduled for the next meeting of the
group.
``(c) Additional Informal and Formal Procedures.--
``(1) In general.--For purposes of obtaining conclusions
and recommendations regarding the resolution of any significant
scientific dispute, the Secretary is authorized to use such
additional informal and formal procedures as may be considered
useful. The procedures may include the use of--
``(A) panels of qualified Food and Drug
Administration officials to make conclusions and
recommendations regarding the resolution of any
significant scientific dispute;
``(B) panels of qualified Federal Government
employees who are not employees of the Food and Drug
Administration to make conclusions and recommendations
regarding the resolution of any significant scientific
dispute; and
``(C) outside mediators and arbitrators who are not
Federal Government employees to make conclusions and
recommendations regarding the resolution of any
significant scientific dispute.
``(2) Application of faca.--The Federal Advisory Committee
Act (5 U.S.C. App. 2) shall not apply to a panel described in
paragraph (1).
``(d) Review of Recommendations.--Not later than 60 days after the
date on which a matter that is presented for resolution under this
section has been the subject of conclusions and recommendations, the
official of the Food and Drug Administration responsible for the matter
shall review the conclusions and recommendations, make a final
determination on the matter, and notify the parties of the
determination in writing and if the determination differs from the
conclusions and recommendations, the reasons for the difference.''.
SEC. 109. APPOINTMENT AND TERM OF THE COMMISSIONER OF FOOD AND DRUGS.
(a) Purpose.--It is the purpose of this section to promote
increased accountability of the Commissioner of Food and Drugs by
providing for a limited term of appointment for the Commissioner of
Food and Drugs.
(b) Limitation.--Section 903(b)(1) (21 U.S.C. 393(b)(1)) is amended
by striking ``the Senate.'' and inserting ``the Senate for a term of 5
years. The Commissioner shall be appointed to serve 1 term. An
individual serving in the office of Commissioner may be removed from
office only pursuant to a finding by the President of neglect of duty
or malfeasance in office.''.
(c) Applicability.--The amendment made by subsection (b) shall not
apply to the tenure of the individual who is serving as the
Commissioner of Food and Drugs on the date of enactment of this Act.
TITLE II--EXPEDITED ACCESS TO PRODUCTS FOR SERIOUSLY ILL PATIENTS
SEC. 201. SHORT TITLE.
This title may be cited as the ``Patient Rights Regulatory Reform
Act of 1996''.
SEC. 202. ACCESS TO UNAPPROVED THERAPIES.
Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end
thereof the following new subchapter:
``Subchapter D--Unapproved Therapies and Diagnostics and Collaborative
Research
``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.
``(a) In General.--Any person, through a licensed health care
practitioner or licensed health care professional, may request from a
manufacturer or distributor, and any manufacturer or distributor may
provide to a person after compliance with the provisions of this
section, an investigational drug (including a biological product) or
investigational device for the diagnosis, monitoring, or treatment of a
serious disease or condition, an immediately life-threatening or
seriously debilitating disease or condition, or any other disease or
condition designated by the Secretary as appropriate for expanded
access under this section if--
``(1) the person has no comparable or satisfactory
alternative therapy available to treat, diagnose, or monitor
the disease or condition;
``(2) the risk to the person from the investigational drug
or device is not greater than the risk from the disease or
condition; and
``(3) an exemption for the investigational drug or device
is in effect under a regulation promulgated pursuant to section
505(i) or 520(g) and the sponsor and investigators comply with
such regulation.
``(b) Protocols.--A manufacturer or distributor may submit to the
Secretary 1 or more expanded access protocols covering expanded access
use of a drug or device described in subsection (a). The protocols
shall be subject to the provisions of section 505(i) for a drug and
section 520(g) for a device and may include any form of use of the drug
or device outside a clinical investigation, prior to approval of the
drug or device for marketing, including protocols for treatment, use,
parallel track, emergency use, uncontrolled trials, and single patient
protocols.
``(c) Fees.--A manufacturer or distributor may assess a fee for an
investigational drug or device under an expanded access protocol so
long as the fee is not more than that necessary to recover the costs of
the manufacture and handling of the drug or device. The Secretary shall
be notified in advance of the assessing of any such fees.
``(d) Notification of Availability.--The Commissioner shall inform
national, State, and local medical associations and societies,
voluntary health associations, and other appropriate persons about the
availability of an investigational drug or device under expanded access
protocols under this section. Such notification shall identify--
``(1) the investigational drug or device;
``(2) the expanded access use of the investigational drug
or device; and
``(3) the name and address of the manufacturer or
distributor that is providing the investigational drug or
device for expanded access use.''.
SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES.
Section 520(m) (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (2), by inserting at the end thereof the
following flush sentences:
``The request shall be in the form of an application submitted to the
Secretary. Not later than 30 days after the date of the receipt of the
application, the Secretary shall issue an order approving or denying
the application.'';
(2) by striking paragraph (5); and
(3) by striking paragraph (6).
SEC. 204. EXPEDITING APPROVAL OF NEW DRUGS, BIOLOGICS, AND MEDICAL
DEVICES FOR SERIOUS CONDITIONS.
(a) New Drugs.--Section 505(c)(1) (21 U.S.C. 355(c)(1)) is amended
by adding at the end thereof the following flush sentence:
``In a case in which an application is submitted under subsection
(b)(1) for a new drug, or section 351(a) of the Public Health Service
Act for a biological product, that is intended for use for an
immediately life-threatening or serious disease or condition and that
provides therapy or diagnosis not available from another approved drug
or biological product or offers significant improvement over another
approved drug or biological product, the Secretary shall approve or
deny approval of the application within 180 days after the receipt of
the application.''.
(b) Premarket Approval.--
(1) Amendment.--Section 515(d)(1)(A) (21 U.S.C.
360e(d)(1)(A)) is amended by adding at the end thereof the
following flush sentence:
``With respect to an application submitted under this subsection for a
device for a life-threatening disease or condition, a seriously
debilitating disease or condition, or for any other serious disease or
condition that provides therapy or diagnosis not available from another
approved device or offers a significant improvement over another
approved device, the Secretary shall approve or deny the approval of
the application within 180 days after the receipt of the
application.''.
(2) Effective date.--The amendment made by paragraph (1)
shall take effect on July 1, 1998.
TITLE III--REVITALIZING THE INVESTIGATION OF NEW PRODUCTS
SEC. 301. SHORT TITLE.
This title may be cited as the ``Investigational Products
Regulatory Reform Act of 1996''.
SEC. 302. TIMELY REVIEW AND REASONABLE DATA REQUIREMENTS FOR CLINICAL
RESEARCH ON DRUGS AND BIOLOGICAL PRODUCTS.
Section 505(i) (21 U.S.C. 355(i)) is amended--
(1) by striking ``(i) The'' and inserting ``(i)(1) The'';
(2) by redesignating paragraphs (1), (2), and (3) as
subparagraphs (A), (B), and (C), respectively; and
(3) by adding at the end thereof the following new
paragraphs:
``(2)(A) A clinical investigation of a new drug (including a
biological product) may begin 30 days after the date on which the
Secretary receives from the sponsor of the investigation a notification
containing information about the drug and the clinical investigation
unless, prior to the 30-day period, the Secretary informs the sponsor
in writing that the investigation may not begin, and specifies the
basis for the decision and the information needed in order for the
clinical investigation to commence.
``(B) Not later than 1 year after the date of enactment of the Food
and Drug Administration Performance and Accountability Act of 1996, the
Secretary, after consultation with experts in the development, clinical
investigation, and regulation of drugs, physicians and other health
care practitioners, and representatives of patient and consumer
advocacy groups and the regulated industries, shall publish in the
Federal Register criteria for the type and amount of information
relating to the safety of an investigational drug to be included in a
notification described in subparagraph (A). In the establishment of the
criteria, the Secretary shall take into account the recommendations of
the International Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use. The Secretary shall
periodically review, and may revise, the criteria.
``(C) The Secretary shall establish a mechanism to ensure the fair
and consistent application of safety standards for clinical
investigations.
``(3)(A) The Secretary may place a clinical hold on any ongoing
clinical investigation if the Secretary determines that such action is
necessary for the protection of human subjects.
``(B) If the Secretary places a clinical hold on a clinical
investigation, the Secretary shall immediately advise the sponsor for
the investigation in writing of such action, and provide the sponsor an
opportunity to meet with the Secretary, not later than 10 business days
after the receipt of such a communication, to discuss the clinical
hold. Not later than 10 days after such a meeting, the Secretary shall
provide to the sponsor in writing the conditions for the withdrawal of
the clinical hold. Any written request received by the Secretary from
the sponsor requesting that a clinical hold be removed shall receive a
decision, in writing and specifying the reasons therefor, not later
than 20 days after the receipt of the request.''.
SEC. 303. TIMELY REVIEW AND REASONABLE DATA REQUIREMENTS FOR CLINICAL
RESEARCH ON DEVICES.
Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end
thereof the following new paragraphs:
``(6) The procedures and conditions prescribed pursuant to
paragraph (2)(A) shall be subject to subparagraphs (B) and (C) of
section 505(i)(2), except that the provision of subparagraph (B) of
such section relating to the consideration of the recommendations of
the International Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use shall not apply to
this paragraph.
``(7) The Secretary shall, not later than 120 days after the date
of enactment of this paragraph, by regulation amend the content of
parts 812 and 813 of title 21 of the Code of Federal Regulations to
update the procedures and conditions under which devices intended for
human use may upon application be granted an exemption from certain
requirements under this Act. The regulation shall--
``(A) permit developmental changes in devices, including
manufacturing changes, in response to information collected
during an investigation without requiring an additional
approval of an application for an investigational device
exemption or the approval of a supplement to the application,
if the sponsor of the investigation determines that, prior to
making any changes, the changes do not constitute a significant
change in design or a significant change in basic principles of
operation; and
``(B) permit, without approval of a supplement to an
application for an investigational device exemption, changes or
modifications to clinical protocols that do not affect the
validity of data or information resulting from the completion
of an approved protocol so long as such changes do not affect
any patient protection provisions of the protocol.''.
SEC. 304. SENSE OF THE COMMITTEE CONCERNING MUTUAL RECOGNITION
AGREEMENTS.
(a) Findings.--The Committee on Labor and Human Resources of the
Senate finds that there have been lengthy discussions between the
members of the European Union and the Commissioner of Food and Drugs on
the issue of mutual recognition agreements relating to the regulation
of drugs, biological products, devices, foods, food additives, and
color additives, and the regulation of good manufacturing practices.
(b) Sense of the Committee.--It is the sense of the Committee on
Labor and Human Resources of the Senate that--
(1) the Secretary of Health and Human Services, in
consultation with the Secretary of Commerce, should move toward
the acceptance of mutual recognition agreements relating to the
regulation of drugs, biological products, devices, foods, food
additives, and color additives, and the regulation of good
manufacturing practices, reached between the European Union and
the Commissioner of Food and Drugs;
(2) the Secretary of Health and Human Services should
regularly participate in meetings with other foreign
governments to discuss and reach agreement on methods and
approaches to harmonize regulatory requirements; and
(3) the Office of International Relations of the Department
of Health and Human Services (as established under section 803
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 383))
should have the responsibility of ensuring that the process of
harmonizing international regulatory requirements is
continuous.
SEC. 305. COLLABORATIVE RESEARCH DESIGN.
Chapter V (21 U.S.C. 351 et seq.), as amended by section 202, is
further amended by adding at the end thereof the following new section:
``SEC. 552. COLLABORATIVE RESEARCH DESIGN.
``(a) Review of Design.--
``(1) Request.--Any person who intends to sponsor a
preclinical or clinical investigation of a drug (including a
biological product) or device may request a meeting with the
Secretary to review the design of 1 or more protocols for the
preclinical or clinical testing of the drug or device.
``(2) Form.--A request described in paragraph (1) shall be
in writing and shall include any protocol for which the review
is requested. A protocol shall be designed so that the fewest
number of patients and procedures necessary to obtain data
necessary for the approval of a new drug, biological product,
or device is required, consistent with public health and
safety.
``(3) Written review.--The Secretary shall meet with the
person within 30 days after the request and shall provide to
the person a written review of the protocol, including any
deficiencies in the protocol. A written summary shall be made
of the meeting. The summary shall include the written review of
the protocol and, after agreement by the person and the
Secretary, shall be made part of the product review file
maintained by the Food and Drug Administration.
``(b) Modification of Agreements.--Any agreements reached through
meetings with respect to the design of any protocol under subsection
(a) may be modified only in accordance with the following provisions:
``(1) An agreement may be modified at any time by mutual
consent of the sponsor of a preclinical or clinical
investigation and the Secretary.
``(2) An agreement may be modified by the sponsor
unilaterally, if the change is to a protocol and the change is
one that would not require the approval of the Secretary under
the applicable regulations.
``(3) An agreement may be modified by the Secretary
unilaterally, if the change to the agreement is--
``(A) made by the director of the office of the
Food and Drug Administration responsible for regulating
the drug or device that is the subject of the
agreement; and
``(B) set forth in writing, including an
explanation of the scientific or clinical need for the
change.
The director described in paragraph (3)(A) may not delegate the
regulatory responsibility described in such paragraph.
``(c) Appeals.--Any person requesting a meeting under subsection
(a) may appeal the decision of the Secretary to disapprove or modify an
agreement or protocol under section 907.
``(d) Guidelines and Limitation.--The Secretary shall issue
guidelines to implement this section. Such guidelines shall address the
responsibilities of the person requesting the meeting, as well as the
responsibilities of the Secretary. Repeated failure to follow the
guidelines may be grounds for a refusal by the Secretary to meet with a
person requesting a meeting under this section.''.
TITLE IV--EFFICIENT, ACCOUNTABLE, AND FAIR PRODUCT REVIEW
SEC. 401. SHORT TITLE.
This title may be cited as the ``Product Review Regulatory Reform
Act of 1996''.
SEC. 402. THE CONTENT AND REVIEW OF AN APPLICATION.
Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end
thereof the following new subchapter:
``Subchapter D--Review of Applications, Inspections, Environmental
Impact Reviews, and Manufacturing Changes
``SEC. 741. CONTENT AND REVIEW OF AN APPLICATION.
``(a) In General.--This section applies to an application or
submission (including a petition, notification, or any other similar
form of request) submitted for approval or clearance of a new drug,
device, biological product, new animal drug, animal feed bearing or
containing a new animal drug, color additive, or food additive.
``(b) Filing Requirements.--Not later than 60 days after the date
of enactment of this section, the Commissioner shall establish and
publish in the Federal Register a mechanism to ensure the fair and
consistent application of filing requirements.
``(c) Classification of a Product.--Not later than 60 days after
the receipt of a written request of a person who submits an application
or submission (including a petition, notification, or any other similar
form of request) for information respecting the classification of an
article as a drug, biological product, or device or the component of
the Food and Drug Administration that will regulate the article
(including a request respecting a combination product subject to
section 503(g)), the Secretary shall provide the person a written
statement that identifies the classification of the article or the
component of the Food and Drug Administration that will regulate the
article. The Secretary's statement shall be binding and may not be
modified by the Secretary except with the written agreement of the
person who submitted the request. If the Secretary does not provide the
statement within the 60-day period, the classification and component
designated by the person submitting the request shall be final and
binding and may not be modified by the Secretary except with the
written agreement of the person.
``(d) Reasonable Data Requirements.--Not later than 1 year after
the date of enactment of the Food and Drug Administration Performance
and Accountability Act of 1996, the Secretary, after consultation with
experts in the development and testing of articles that are new drugs,
biological products, devices, food additives, new animal drugs, animal
feed bearing or containing a new animal drug, color additives, or food
additives, experts in the regulation of such articles, consumer and
patient advocacy groups, and the regulated industries, shall publish in
the Federal Register criteria for the type and amount of information
relating to safety or effectiveness to be included in an application
for the approval of an article that is a new drug, biological product,
device, food additive, new animal drug, animal feed bearing or
containing a new animal drug, color additive, or food additive, or a
new use of an approved article that is a new drug, biological product,
device, food additive, new animal drug, animal feed bearing or
containing a new animal drug, color additive, or food additive. In
establishing the criteria for drugs, the Secretary shall consider any
recommendations of the International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for Human
Use.''.
SEC. 403. CONTRACTS FOR EXPERT REVIEW.
Chapter VII (21 U.S.C. 371 et seq.), as amended by section 402, is
further amended by adding at the end thereof the following new section:
``SEC. 742. CONTRACTS FOR EXPERT REVIEW.
``(a) In General.--
``(1) Authority.--The Secretary may contract with outside
organizations and individuals, with expertise in relevant
disciplines, to review, evaluate, and make conclusions and
recommendations to the Secretary on parts or all of any
application or submission (including a petition, notification,
or any other similar form of request). The Secretary shall
retain full authority to make determinations with respect to
the approval or disapproval of any article, or the
classification of a device under section 513(f)(1). Any such
contract shall be subject to the requirements of section 708.
Funds obtained under part 2 of subchapter C may be used for
external review of any drug (including a biological product)
for which a user fee was paid.
``(2) Increased efficiency and expertise through
contracts.--The Secretary shall use the authority granted in
paragraph (1)--
``(A) for the review of categories of indirect food
additive petitions and notifications for clearance
under section 510(k);
``(B) whenever contracts will improve the
efficiency, timeliness, and quality of the review of
applications or submissions (including petitions,
notifications, or any other similar form of requests)
for the approval or clearance of new drugs, new animal
drugs, biological products, devices, and food
additives; and
``(C) whenever contracts will increase the
scientific and technical expertise that is necessary to
keep informed of emerging new therapies and
technologies that pose significant new scientific and
technical issues.
The Secretary shall retain full authority to make
determinations with respect to the approval or disapproval of
an article, or the classification of an article as a device
under section 513(f)(1).
``(b) Eligibility Requirements.--Not later than 90 days after the
date of enactment of this section, the Secretary shall by regulation
establish the requirements that an organization or individual shall
meet to be eligible to conduct reviews under subsection (a). Such
regulations shall provide for the protection of confidential or
proprietary information and shall provide for protection against
conflicts of interest.
``(c) Review of Expert's Evaluation.--
``(1) In general.--Subject to paragraph (2), the official
of the Food and Drug Administration responsible for any matter
for which expert review is used pursuant to this section shall
review the conclusions and recommendations of the expert review
organization or individual and shall make a final decision
regarding the matter under review within 60 days after
receiving the conclusions and recommendation.
``(2) Limitation.--A final decision under paragraph (1)
shall be made within the applicable prescribed time period for
review of an application as set forth in this Act.
``(d) Report to Congress.--Not later than 2 years after the date of
enactment of this section, the Secretary shall prepare and submit to
Congress a report on the use of the authority to contract with outside
organizations and individuals for expert reviews. Such report shall
include an evaluation of the extent to which such contracting improves
the efficiency of review and the expertise available to the Food and
Drug Administration.''.
SEC. 404. PROMPT AND EFFICIENT REVIEW.
Chapter VII (21 U.S.C. 371 et seq.), as amended by section 403, is
further amended by adding at the end thereof the following new section:
``SEC. 743. PROMPT AND EFFICIENT REVIEW.
``(a) In General.--The provisions of this section shall apply to
any of the following applications, petitions, and notifications:
``(1) A petition for the issuance of a regulation
prescribing the safe use of a human food additive or animal
feed additive under section 409.
``(2) An application for approval of a new drug under
section 505.
``(3) An application for approval of a new animal drug or
an animal feed bearing or containing a new animal drug under
subsection (b) or (m) of section 512, respectively.
``(4) A notification submitted under section 510(k) for
classification of a device.
``(5) An application for approval of a device under section
515.
``(6) A petition for issuance of a regulation for the
listing of a color additive under section 721.
``(b) Review Procedures and Policies.--The Secretary shall
establish procedures and policies to facilitate a collaborative review
process between the Commissioner and the applicant, petitioner, or
person who submits a notification with respect to an application,
petition, or notification described in subsection (a). As part of this
collaborative process--
``(1) open, informal, and prompt communications shall be
encouraged;
``(2) meetings (except that meetings shall not be required
with respect to matters relating to a notification submitted
under section 510(k)) shall be held before the expiration of
one-half of the statutory time period for review of the
application or petition and before the expiration of three-
quarters of such period, or within 15 days after a scientific
review group has convened and made recommendations on an
application or petition, unless the Commissioner and the
applicant or petitioner determine that a meeting is
unnecessary;
``(3) by mutual consent, the Commissioner and the applicant
or petitioner may establish a different schedule for meetings
required under paragraph (2); and
``(4) the Secretary shall, prior to the meetings described
in paragraph (2), present to the applicant or petitioner in
writing a description of any deficiencies of the application or
petition and the information necessary to bring the application
or petition into a form that would require approval.
The Secretary and the applicant or petitioner may agree to supersede
any procedures and policies adopted under this section and the
requirements of paragraphs (2) and (3). Any such agreement shall be in
writing, and shall specify how any such agreement shall be modified or
set aside.
``(c) Approval, Disapproval, and Classification.--
``(1) Consideration of international approvals.--Beginning
July 1, 1998, if the Secretary fails to meet a time period for
action on an application or notification for the approval or
clearance of an article that is a new drug, device, biological
product, or new animal drug that offers a significant
improvement over an existing approved article or a petition for
the approval of a direct food additive that has the potential
to make foods more wholesome and contribute to a healthier
diet, and such an article has been approved for marketing in
the European Union or the United Kingdom, the Secretary shall,
within 30 days after a request of a person who submits an
application, notification, or petition described in this
paragraph, either approve or disapprove the application,
notification, or petition and notify the person in writing of
that decision. In the case of a disapproval, or a determination
that a device is not substantially equivalent, such
notification shall set forth the reasons for the disapproval or
the determination.
``(2) Appeal.--A person whose application, notification, or
petition has been disapproved (including a determination that a
device does not meet the requirements relating to substantial
equivalence) under paragraph (1) may obtain judicial review
under--
``(A) section 505(h) for the disapproval of a new
drug under paragraph (1);
``(B) section 517 for the disapproval of a device
or a determination of not substantially equivalent
relating to a device under paragraph (1);
``(C) chapter VII of title 5, United States Code,
for the disapproval of a license for a biological
product under paragraph (1);
``(D) section 512(h) for the disapproval of a new
animal drug under paragraph (1); and
``(E) section 409(g) for the disapproval of a
direct food additive under paragraph (1).
``(d) Contracts for Expert Review.--
``(1) In general.--Beginning July 1, 1998, if the Secretary
in any fiscal year fails to meet the statutory time period for
action on an application, notification, or petition for at
least 95 percent of the applications, notifications, and
petitions submitted in a particular product category, the
Secretary shall--
``(A) in the following fiscal year, contract with
expert organizations and individuals under section 742,
to review applications, notifications, and petitions of
persons who submit the applications, notifications, and
petitions in that following fiscal year and who consent
to the review; and
``(B) in the following fiscal year and with the
consent of the persons described in this subparagraph,
contract with expert organizations and individuals
under section 742, to review applications,
notifications, and petitions that were submitted by
persons in any preceding fiscal year and that the
Secretary has failed to review within the statutory
time period for action on the applications,
notifications, and petitions with respect to the
particular product category.
``(2) Approval.--If an organization or individual selected
to conduct a review under paragraph (1) recommends the approval
or clearance of an application, notification, or petition
described in paragraph (1), the Secretary shall, within 60 days
after receiving the determination of the organization or
individual (but not later than the time period for review set
forth in this Act), either approve or disapprove the
application, notification, or petition, and, in the case of a
disapproval, notify the person who submitted the application,
notification, or petition in writing of the basis for the
disapproval. The person may appeal an adverse decision under
subsection (c)(2).''.
SEC. 405. GOOD MANUFACTURING PRACTICE INSPECTION.
Chapter VII is (21 U.S.C. 371 et seq.), as amended by section 404,
is further amended by adding at the end thereof the following new
section:
``SEC. 744. GOOD MANUFACTURING PRACTICE INSPECTION.
``(a) In General.--In order to comply with the inspection
requirements of this Act, the Secretary may accredit organizations to
conduct inspections under section 704 to evaluate compliance of a
manufacturer with applicable requirements for good manufacturing
practice.
``(b) Eligibility Requirements.--If the Secretary elects to
accredit organizations to conduct inspections under section 704, the
Secretary shall by regulation, within 90 days after the date of
enactment of this section, establish the requirements that an
organization shall meet to be eligible to be accredited to participate
as a qualified organization to conduct inspections under subsection
(a). Such regulation shall provide for the protection of confidential
or proprietary information and shall provide for protection against
conflicts of interest.
``(c) Accreditation.--Not later than 90 days after the date on
which the Secretary receives an application for accreditation under
this section, the Secretary shall review the application and determine
whether an applicant is in compliance with the requirements established
under this section. Within the 90-day period, the Secretary shall grant
accreditation or shall deny accreditation and specify in writing the
reasons for the denial and the requirements that shall be met to obtain
accreditation.
``(d) Revocation of Accreditation.--The Secretary may at any time
revoke accreditation granted under subsection (c) for failure to comply
with the requirements established under this section after specifying
in writing the reasons for the revocation and the requirements that
shall be met to retain accreditation and after an informal hearing on
the revocation.
``(e) Inspections.--Any organization accredited under this section
that conducts an inspection under this section at the request of the
Secretary shall--
``(1) apply all relevant principles of good manufacturing
practice established in this Act and in regulations promulgated
by the Secretary;
``(2) provide to the Secretary and the manufacturer within
30 days after the completion of the inspection a report of the
findings of the inspection; and
``(3) immediately provide the Secretary with a notice of
any condition that could cause or contribute to a significant
threat to the public health.''.
SEC. 406. ENVIRONMENTAL IMPACT REVIEW.
Chapter VII (21 U.S.C. 371 et seq.), as amended by section 405, is
further amended by adding at the end thereof the following new section:
``SEC. 745. ENVIRONMENTAL IMPACT REVIEW.
``Notwithstanding any other provision of law, no action by the
Secretary pursuant to this Act shall be subject to an environmental
assessment, an environmental impact statement, or other environmental
consideration unless the director of the office responsible for the
action demonstrates, in writing--
``(1) that there is a reasonable probability that the
environmental impact of the action is sufficiently substantial
and within the factors that the Secretary is authorized to
consider under this Act; and
``(2) that consideration of the environmental impact will
directly affect the decision on the action.''.
SEC. 407. EFFECTIVENESS, OUTCOME, AND COST-EFFECTIVENESS STANDARDS.
Section 741, as added by section 402, is amended by adding at the
end thereof the following new subsection:
``(e) Limitation on Determination of Effectiveness.--In a review of
an application for an article that is a new drug, device, biological
product, new animal drug, or animal feed bearing or containing a new
animal drug, the determination of effectiveness shall not include the
evaluation of--
``(1) any potential use not included in the labeling;
``(2) the cost-effectiveness of an article described in
this subsection, unless the proposed labeling explicitly
includes a representation about cost-effectiveness; and
``(3) the clinical outcome resulting from the use of a
diagnostic device, unless the labeling explicitly includes a
representation regarding clinical outcome.''.
SEC. 408. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT REVIEW.
Section 201 (21 U.S.C. 321) is amended by adding at the end thereof
the following new paragraph:
``(gg) For purposes of reviewing any application or submission
(including a petition, notification, or any other similar form of
request), or any document, with respect to an article that is a new
drug, device, biological product, new animal drug, an animal feed
bearing or containing a new animal drug, color additive, or food
additive, that is submitted to the Secretary to obtain marketing
approval, to obtain classification of a device under section 513(f)(1),
or to establish or clarify the regulatory status of the article, the
term `day' means a calendar day in which the Secretary has
responsibility to review such a submission (excluding any calendar day
between the date of receipt by the submitter of a written communication
from the Secretary setting forth the action of the Secretary on a
submission and the date of receipt by the Secretary of the written
response of the submitter to the action).''.
SEC. 409. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS.
(a) Performance Standards.--Not later than 180 days after the date
of enactment of this section, the Secretary of Health and Human
Services shall publish in the Federal Register performance standards
for the prompt review of supplemental applications submitted for
approved articles under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq.).
(b) Guidance to Industry.--Not later than 180 days after the date
of enactment of this section, the Secretary of Health and Human
Services shall issue guidances to clarify the requirements and
facilitate the submission of data to support the approval of
supplemental applications for the approved articles described in
subsection (a). The guidances shall--
(1) clarify circumstances in which published matter may be
the basis for approval of a supplemental application;
(2) specify data requirements that will avoid duplication
by recognizing the availability of data previously submitted in
support of an original application; and
(3) define supplemental applications that are eligible for
priority review.
(c) Responsibilities of Centers.--The Secretary of Health and Human
Services shall designate an individual in each center within the Food
and Drug Administration (except the Center for Food Safety and Applied
Nutrition) to be responsible for--
(1) encouraging the prompt review of supplemental
applications for approved products; and
(2) working with sponsors to facilitate the development and
submission of data to support supplemental applications.
(d) Collaboration.--The Secretary of Health and Human Services
shall implement programs and policies that will foster collaboration
between the Food and Drug Administration, the National Institutes of
Health, professional medical and scientific societies, and others
persons, to identify published and unpublished studies that could
support a supplemental application, and to encourage sponsors to make
supplemental applications or conduct further research in support of a
supplemental application based, in whole or in part, on such studies.
SEC. 410. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by inserting after section 505 the following
new section:
``SEC. 505A. PEDIATRIC STUDIES FOR NEW DRUG APPLICATIONS.
``(a) Market Exclusivity for Approved Applications With Pediatric
Studies Submitted by an Applicant.--If an application submitted under
section 505(b)(1) is approved on or after the date of enactment of this
section, and such application includes reports of pediatric studies
described and requested in subsection (c), and such studies are
completed and the reports thereof submitted in accordance with
subsection (c)(2) or completed and the reports thereof accepted in
accordance with subsection (c)(3), the Secretary may not make the
approval of an application submitted under section 505(b)(2) or 505(j)
that refers to the drug for which the section 505(b)(1) approval is
granted effective prior to the expiration of 6 months from the earliest
date on which the approval of such application for the drug under
section 505(b)(2) or 505(j), respectively, could otherwise be made
effective under the applicable provisions of this chapter.
``(b) Market Exclusivity for Approved Applications With Pediatric
Studies Requested by the Secretary.--If the Secretary makes a written
request for pediatric studies described in subsection (c) to the holder
of an approval under section 505(b)(1) for a drug, and such studies are
completed and the reports thereof submitted in accordance with
subsection (c)(2) or completed and the reports thereof accepted in
accordance with subsection (c)(3), the Secretary may not make the
approval of an application submitted under section 505(b)(2) or 505(j)
that refers to the drug subject to the section 505(b)(1) approval
effective prior to the expiration of 6 months from the earliest date on
which an approval of such application under section 505(b)(2) or
505(j), respectively, could otherwise be made effective under the
applicable provisions of this chapter. Nothing in this subsection shall
affect the ability of the Secretary to make effective a section
505(b)(2) or 505(j) approval for a subject drug if such approval is
proper under such section and is made effective prior to the submission
of the reports of pediatric studies described in subsection (c).
``(c) Conduct of Pediatric Studies.--
``(1) Agreement for studies.--The Secretary may, pursuant
to a written request for studies and after consultation with
the sponsor of an application or holder of an approval for a
drug under section 505(b)(1), agree with the sponsor or holder
concerning the conduct of pediatric studies for such drug.
``(2) Written protocols to meet the studies requirement.--
If the sponsor or holder and the Secretary agree upon written
protocols for such studies, the studies requirement of
subsection (a) or (b) is satisfied upon the completion of the
studies in accordance with the protocols and the submission of
the reports thereof to the Secretary. Not later than 60 days
after the submission of the report of the studies, the
Secretary shall determine if such studies were or were not
conducted in accordance with the written protocols and reported
in accordance with the requirements of the Secretary for filing
and so notify the sponsor or holder.
``(3) Other methods to meet the studies requirement.--If
the sponsor or holder and the Secretary have not agreed in
writing on the protocols for the studies, the studies
requirement of subsection (a) or (b) is satisfied when such
studies have been completed and the reports accepted by the
Secretary. Not later than 90 days after the submission of the
reports of the studies, the Secretary shall accept or reject
such reports and so notify the sponsor or holder. The
Secretary's only responsibility in accepting or rejecting the
reports shall be to determine, within 90 days, that the studies
fairly respond to the written request, that such studies have
been conducted in accordance with commonly accepted scientific
principles and protocols, and that such studies have been
reported in accordance with the requirements of the Secretary
for filing.
``(d) Delay of Effective Date for Certain Applications; Period of
Market Exclusivity.--If the Secretary determines that an approval of an
application under section 505(b)(2) or 505(j) for a drug may be made
effective after the submission of reports of pediatric studies under
this section but before the Secretary has determined whether the
requirements of subsection (c) have been satisfied, the Secretary may
delay the effective date of any approval under section 505(b)(2) or
505(j), respectively, until the determination under subsection (c) is
made, but such delay shall not exceed 90 days. In the event that the
requirements of this section are satisfied, the 6-month period referred
to in subsection (a) or (b) shall be deemed to have begun on the date
an approval of an application under section 505(b)(2) or 505(j),
respectively, would have been permitted absent action under this
subsection.
``(e) Notice of Determinations on Studies Requirement.--The
Secretary shall publish notice of any determination that the
requirements of paragraph (2) or (3) of subsection (c) have been met
and that approvals under section 505(b)(2) or 505(j) for a drug will be
subject to deferred effective dates under this section.
``(f) Definitions.--As used in this section, the term `pediatric
studies' or `studies' means at least 1 human clinical investigation in
a population of adolescent age or younger. At the Secretary's
discretion, pharmacokinetic studies may be considered as clinical
investigations.''.
SEC. 411. NOTIFICATIONS FOR DEVICE MARKET CLEARANCE.
Section 510(k) (21 U.S.C. 360(k)) is amended by striking ``report
to'' and inserting ``shall notify the Secretary to report to''.
TITLE V--DRUG AND BIOLOGICAL PRODUCTS REGULATORY REFORM
SEC. 501. SHORT TITLE.
This title may be cited as the ``Drug and Biological Product
Regulatory Reform Act of 1996''.
SEC. 502. NEW DRUG APPROVAL STANDARD.
Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end
thereof the following new sentence: ``Substantial evidence may consist
of data from 1 well-controlled clinical investigation and confirmatory
evidence obtained prior to, or after, such investigation.''.
SEC. 503. PILOT AND SMALL SCALE MANUFACTURE.
Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end
thereof the following new paragraph:
``(4) A new drug or biological product manufactured in a pilot or
other small facility may be used to demonstrate the safety and
effectiveness of the drug or product and to obtain approval prior to
scaling up to a larger facility, unless the Secretary demonstrates in
writing and specifies in detail the reasons, after an informal hearing,
that a full scale production facility is necessary to ensure the safety
or effectiveness of the drug or product.''.
SEC. 504. MANUFACTURING CHANGES.
Chapter VII (21 U.S.C. 371 et seq.), as amended by section 406, is
further amended by adding at the end thereof the following new section:
``SEC. 746. MANUFACTURING CHANGES.
``(a) In General.--A change in the manufacture of a new drug,
biological product, or new animal drug, may be made in accordance with
this section.
``(b) Drug and Biological Product.--A change in the manufacture of
a new drug, a biological product that is the subject of a monograph in
an official compendium, a biological product that can be adequately
characterized by chemical, physical, or biological means, or a new
animal drug--
``(1) shall require validation; and
``(2)(A) if there is no change in the approved qualitative
and quantitative formulation relating to the new drug,
biological product, or new animal drug or in the approved
release specifications relating to the new drug, biological
product, or new animal drug, or if there is a change in the
approved qualitative or quantitative formula or in the approved
release specifications of a type permitted by the Secretary by
regulation, may be made at any time so long as the change is
reported annually to the Secretary; or
``(B) in the case of a change other than a change described
in subparagraph (A), shall require completion of an appropriate
study demonstrating equivalence according to criteria
established by the Secretary (unless such requirement is waived
by the Secretary), may be made at any time, and shall be
reported to the Secretary through a supplement or amendment
submitted at the time the change is made.
``(c) Biological Product Not Subject to a Monograph.--A change in
the manufacture of a biological product that is not the subject of a
monograph in an official compendium and cannot be adequately
characterized by chemical, physical, or biological means--
``(1) shall require validation; and
``(2)(A) if the change relates solely to a modification of
the manufacturing facility or change in personnel, with no
change in the approved manufacturing process or release
specifications, may be made at any time so long as the change
is reported annually to the Secretary; or
``(B) in the case of a change other than a change described
in subparagraph (A), shall require completion of a bioassay or
other appropriate study demonstrating equivalence according to
criteria established by the Secretary (unless such requirement
is waived by the Secretary), may be made at any time, and shall
be reported to the Secretary through an amendment submitted at
the time the change is made.
``(d) Special Determination for a Biological Product.--A
determination shall be made, prior to the approval of a biological
product under section 351(a) of the Public Health Service Act (42
U.S.C. 262(a)), whether the product can be adequately characterized for
purposes of this section. With respect to biological products approved
prior to the date of enactment of the Food and Drug Administration
Performance and Accountability Act of 1996, the determination shall be
made not later than 90 days after the date of enactment of such Act.
Any determination made under this subsection is subject to change based
upon new scientific information.''.
SEC. 505. INSULIN AND ANTIBIOTICS.
(a) Certification of Drugs Containing Insulin.--Section 506 (21
U.S.C. 356) is repealed.
(b) Certification of Antibiotics.--Section 507 (21 U.S.C. 357) is
repealed.
(c) Exportation.--Section 802 (21 U.S.C. 382) is amended--
(1) by redesignating subsection (h) as subsection (i); and
(2) by inserting after subsection (g) the following new
subsection:
``(h) Exportation of Unapproved Products.--Insulin and antibiotics
may be exported without regard to the requirements in this section if
the insulin and antibiotics meet the requirements of section
801(e)(1).''.
SEC. 506. MODERNIZATION OF REGULATION OF BIOLOGICAL PRODUCTS.
(a) In General.--Section 351 of the Public Health Service Act (42
U.S.C. 262) is amended by striking ``Sec. 351. (a)'' and all that
follows through ``barter, or exchange the same.'' and inserting the
following:
``Sec. 351. (a)(1) Except as provided in paragraph (6), no person
shall introduce or deliver for introduction into interstate commerce
any biological product unless--
``(A) a license is in effect for the biological product;
and
``(B) each package of the biological product is plainly
marked with the proper name of the biological product contained
therein, the name, address, and applicable license number of
the manufacturer of the biological product, and the expiration
date of the biological product.
``(2) The license required under paragraph (1)(A) shall, as
determined by the Secretary, cover the biological product, any facility
in which the biological product is manufactured, processed, packed, or
held, or both the product and facility.
``(3)(A) The Secretary shall establish, by regulation, requirements
for license applications for biological products.
``(B) Except as provided in subparagraph (D), a license application
that covers a biological product shall be approved based upon a
demonstration that--
``(i) the product that is the subject of the application is
safe and effective in accordance with sections 505(c) and
505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355 (c) and (d)), or meets standards designed to ensure that
the product is safe, pure, and where appropriate, potent; and
``(ii) the methods used in, and the facilities and control
used for, the manufacture, processing, packing, and holding of
such product meet standards designed to ensure that the product
meets the requirements of clause (i).
``(C) A license application that covers a facility shall ensure
that the product and the facility meet standards designed to ensure
that the product meets applicable requirements of subparagraph (B).
``(D) A license application for blood or a blood component
(including plasma) shall be approved based on a demonstration that the
product is safe, pure, and where appropriate, potent, and that the
facility in which the product is manufactured, processed, packed, or
held meets standards designed to ensure that such product is safe,
pure, and where appropriate, potent.
``(4)(A) Requirements prescribed under paragraph (3) shall include
a requirement for preapproval inspection under subsection (c).
``(B) A license shall be approved only on condition that the
licensee agrees to permit inspection of the facility of the licensee in
accordance with subsection (c).
``(5)(A) Except as provided in subparagraph (C), an approved
license for a biological product may be revoked if the Secretary
determines, on the record after providing an opportunity for a hearing
in accordance with section 554 of title 5, United States Code, that the
requirements for approval as specified in paragraph (3) are no longer
met with respect to such product, or that other public health reasons,
prescribed by regulation, exist. No action to revoke a license based on
the findings of an inspection shall be initiated prior to the
submission and review by the Secretary of a written response submitted
by the licensee to a notice of inspectional findings so long as such
written response is received within 30 days after the date of receipt
by the licensee of the findings. The revocation of any product license
shall not prevent the continued use of any licensed biological product
that has been sold and delivered by the licensee unless the biological
product is subject to recall under subsection (d).
``(B) If at any time before the Secretary has taken final action to
revoke a license, the licensee requests an inspection by the Secretary
to determine whether the licensee is in compliance with applicable
standards, the Secretary shall conduct an inspection within 30 days
after the date of the request. If the inspection confirms that the
licensee is not in compliance with applicable standards, the 30-day
requirement for inspection shall not apply to any subsequent request by
the licensee under this subparagraph for inspection. If the inspection
confirms that the licensee is in compliance with all applicable
requirements, the Secretary shall withdraw any proposed action within
30 days after the inspection.
``(C) If the Secretary determines that conditions exist that
constitute a danger to health, the Secretary shall suspend the license,
notify the licensee that the licensee's license is suspended, and
require notification of the suspension to any consignee. Within 30 days
thereafter, the Secretary shall initiate the hearing process under
subparagraph (A).
``(6) The requirements of paragraph (1) do not apply to a
biological product for which there is in effect an investigational new
drug application under section 505(i) of the Federal Food, Drug, and
Cosmetic Act.''.
(b) Deletion of ELA Requirement.--Section 351(d) of the Public
Health Service Act (42 U.S.C. 262(d)) is amended--
(1) by striking ``(d)(1)'' and all that follows through
``of this section.'';
(2) by redesignating paragraph (2)(A) as subsection (d)(1);
(3) by redesignating subparagraph (B) as paragraph (2); and
(4) in paragraph (2) (as so redesignated), by striking
``subparagraph (A)'' and inserting ``paragraph (1)''.
(c) Labeling.--Section 351(b) of the Public Health Service Act (42
U.S.C. 262(b)) is amended to read as follows:
``(b) No person shall falsely label or mark any package or
container of any biological product or alter any label or mark on the
package so as to falsify the label or mark.''.
(d) Inspection.--Section 351(c) of the Public Health Service Act
(42 U.S.C. 262(c)) is amended by striking ``virus, serum,'' and all
that follows through ``other product aforesaid'' and inserting
``biological product''.
(e) Definition; Application.--Section 351 of the Public Health
Service Act (42 U.S.C. 262) is amended by adding at the end thereof the
following new subsections:
``(i) For purposes of this section, the term `biological product'
means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood,
blood component or derivative, allergenic biologic product, or
arsphenamine or its derivative (or any other analogous biological
product) applicable to the prevention, treatment, or cure of diseases
or conditions of human beings.
``(j)(1) Sections 505(i), 903, and 904 of the Federal Food, Drug,
and Cosmetic Act shall apply to all biological products, and references
in such sections to new drug applications shall be deemed to include
product license applications for biological products.
``(2) Requirements involving labeling or advertising for biological
products shall be established in accordance with sections 201(m) and
502(n) of the Federal Food, Drug, and Cosmetic Act.''.
SEC. 507. EFFECTIVE MEDICATION GUIDES.
Chapter IX (21 U.S.C. 391 et seq.), as amended by section 108, is
further amended by adding at the end thereof the following new section:
``SEC. 908. EFFECTIVE MEDICATION GUIDES.
``(a) In General.--Not later than 30 days after the date of
enactment of this section, the Secretary shall request that national
organizations representing health care professionals, consumer
organizations, voluntary health agencies, the pharmaceutical industry,
drug wholesalers, patient drug information database companies, and
other relevant parties collaborate to develop a long-range
comprehensive action plan to achieve goals consistent with the goals of
the proposed rule of the Food and Drug Administration on `Prescription
Drug Product Labeling: Medication Guide Requirements (60 Fed. Reg.
44182; relating to the provision of oral and written prescription
information to consumers).
``(b) Plan.--The plan described in subsection (a) shall--
``(1) identify the plan goals;
``(2) assess the effectiveness of the current private-
sector approaches used to provide oral and written prescription
information to consumers;
``(3) develop guidelines for providing effective oral and
written prescription information consistent with the findings
of any such assessment;
``(4) develop a mechanism to assess periodically the
quality of the oral and written prescription information and
the frequency with which the information is provided to
consumers; and
``(5) provide for compliance with relevant State board
regulations.
``(c) Limitation on the Authority of the Secretary.--The Secretary
shall have no authority to implement the proposed rule described in
subsection (a), or to develop any similar regulation, policy statement,
or other guideline specifying a uniform content or format for written
information voluntarily provided to consumers about prescription drugs
if, not later than 120 days after the date of enactment of this
section, the national organizations described in subsection (a) develop
and begin to implement a comprehensive, long-range action plan (as
described in subsection (a)) regarding the provision of oral and
written prescription information.
``(d) Secretary Review.--Not later than January 1, 2001, the
Secretary shall review the status of private-sector initiatives
designed to achieve the goals of the plan described in subsection (a),
and if such goals are not achieved, the limitation in subsection (c)
shall not apply, and the Secretary shall seek public comment on other
initiatives that may be carried out to meet such goals. The Secretary
shall not delegate such review authority to the Commissioner.''.
SEC. 508. STATE AND LOCAL REQUIREMENTS RESPECTING NONPRESCRIPTION DRUGS
INTENDED FOR HUMAN USE.
Subchapter A of chapter V (21 U.S.C. 351 et seq.) is amended by
inserting after section 522 the following new section:
``SEC. 523. STATE AND LOCAL REQUIREMENTS RESPECTING NONPRESCRIPTION
DRUGS INTENDED FOR HUMAN USE.
``(a) Limitation.--
``(1) In general.--Except as provided in subsection (b), no
State or political subdivision thereof may establish or
continue in effect any requirement--
``(A) that relates to the regulation of a drug
intended for human use that is not subject to the
requirements of section 503(b)(1); and
``(B) that is different from or in addition to, or
that is otherwise not identical with, a requirement of
this Act or the Fair Packaging and Labeling Act (15
U.S.C. 1451 et seq.), and the administrative
implementation of such Act.
``(2) Special rule.--For purposes of this section, a
requirement relating to the regulation of a drug described in
paragraph (1) shall be deemed to include any requirement
relating to the subject matter in any provision of this Act,
the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.),
and any requirement relating to the dissemination of
information in any manner about such drug, but shall not
include any requirement relating to the dispensing of a drug
only upon prescription of a practitioner licensed by law to
administer such drug.
``(b) Exemption.--Upon application of a State, the Secretary may by
regulation, after providing notice and an opportunity for written and
oral presentation of views, exempt from the provisions of subsection
(a), under such conditions as the Secretary may impose, a proposed
requirement relating to the regulation of a drug intended for human
use--
``(1) that is justified by compelling local conditions or
protects an important public interest that would otherwise be
unprotected;
``(2) that would not cause any drug intended for human use
that is not subject to the requirements of section 503(b)(1) to
be in violation of any applicable requirement or prohibition
under Federal law; and
``(3) that would not unduly burden interstate commerce.''.
SEC. 509. REQUIREMENT OF RADIOPHARMACEUTICALS.
(a) Requirements.--
(1) Regulations.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human
Services, after consultation with patient advocacy groups,
associations, physicians licensed to use radiopharmaceuticals,
and the regulated industry, shall establish proposed
regulations governing the approval of a radiopharmaceutical
designed for diagnosis and monitoring that shall assess the
safety and effectiveness of the radiopharmaceutical taking into
account the appropriate use of the radiopharmaceutical in the
practice of medicine, the pharmacological and toxicological
activity of the radiopharmaceutical, and the estimated absorbed
radiation dose of the radiopharmaceutical. Not later than 1
year after the date of enactment of this Act, the Secretary
shall issue final regulations.
(2) Special rule.--In the case of a radiopharmaceutical
intended to be used for diagnostic purposes, the indications
for which such radiopharmaceutical is approved under this
section may refer to manifestations of disease (such as
biochemical, physiological, anatomic, or pathological
processes) common to or present in 1 or more disease states, or
may refer to a diagnostic procedure used in the diagnosis of 1
or more diseases or conditions.
(b) Approval.--All applications or petitions requesting approval of
a radiopharmaceutical and all other matters relating to such
radiopharmaceutical shall be reviewed and acted upon by a single office
in the Center for Drug Evaluation and Research, and that office shall
report directly to the director of the Center for Drug Evaluation and
Research. A single scientific review group may provide conclusions and
recommendations regarding any such matter relating to the approval of a
radiopharmaceutical. Such group shall be appointed and administered
pursuant to section 904 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 394), as amended by section 107.
(c) Definition.--As used in this section, the term
``radiopharmaceutical'' means--
(1) an article that is intended for use in vivo in the
diagnosis, cure, mitigation, treatment, or prevention of a
disease or a manifestation of disease in man, and that exerts
its primary effect by the spontaneous disintegration of
unstable nuclei with the emission of ionizing radiation; or
(2) a reagent kit or nuclide generator that is intended to
be used in the preparation of any such article.
(d) Approval Assessed Under Performance Standards.--The approval of
radiopharmaceuticals shall be assessed under quantifiable performance
standards established by the Secretary under section 903(b)(3) of the
Federal Food, Drug, and Cosmetic Act, as added by section 103.
TITLE VI--DEVICE REGULATORY REFORM
SEC. 601. SHORT TITLE.
This title may be cited as the ``Medical Device Reform Act of
1996''.
SEC. 602. PREMARKET NOTIFICATION.
(a) Exemption of Certain Devices.--Section 510 (21 U.S.C. 360) is
amended--
(1) in subsection (k), by striking ``intended for human
use'' and inserting ``intended for human use (except a device
that is classified into class I under section 513 or 520 and is
not identified in a list under subsection (n), or a device that
is classified into class II under section 513 or 520 and is
exempt from the requirements of this subsection under
subsection (l))'';
(2) by adding at the end of subsection (k) the following
flush sentence:
``The Secretary shall review the notification required by this
subsection and make a determination under section 513(f)(1)(A) within
90 days of receiving the notification.''; and
(3) by adding at the end thereof the following new
subsections:
``(l) Not later than 30 days after the date of enactment of this
subsection, the Secretary shall publish in the Federal Register a list
of each type of class II device that does not require a notification
under subsection (k) to provide reasonable assurance of safety and
effectiveness. Each type of class II device so identified by the
Secretary not to require the notification shall be exempt from the
requirement to provide notification under subsection (k) as of the date
of the publication of the list in the Federal Register. Beginning on
the date that is 1 day after the date of the publication of a list
under this subsection, any person may petition the Secretary to exempt
a type of class II device from the notification requirement of
subsection (k). The Secretary shall respond to the petition within 120
days of the receipt of the petition and determine whether or not to
grant the petition in whole or in part.
``(m) The Secretary may not withhold a determination of the initial
classification of a device under section 513(f)(1) because of a failure
to comply with any provision of this Act unrelated to a substantial
equivalence decision, including a failure to comply with good
manufacturing practices under section 520(f).
``(n) Not later than 15 days after the date of enactment of this
subsection, the Secretary shall publish in the Federal Register a list
of each type of class I device that shall not be considered exempt from
the notification requirement of section 510(k) because such
notification is necessary to protect the public health. If the
Secretary fails to publish the list within 15 days after the date of
enactment of this subsection, all types of class I devices shall be
exempt from the requirement to provide notification under section
510(k).''.
(b) Initial Classification.--Section 513(f)(1) (21 U.S.C.
360c(f)(1)) is amended in the second sentence, by striking the period
at the end thereof and inserting the following: ``, unless within 30
days of receiving an order classifying the device into class III, the
individual who submits a notification under section 510(k) requests an
advisory committee review and recommendation with respect to the
classification of the device and a final order of classification from
the Secretary. After the request, a device classified into class III
under this paragraph shall not be deemed to be finally classified until
an advisory committee established under subsection (b) reviews the
request with respect to the classification of the device and, within 60
days of the date of receiving the request, recommends to the Secretary
a classification for the device based on the classification criteria
set forth in subparagraphs (A) through (C) of subsection(a)(1).
Thereafter, the Secretary shall have 10 days after the date of
receiving the recommendation of the advisory committee to determine by
order the final classification of the device by applying the
classification criteria set forth in subparagraphs (A) through (C) of
subsection(a)(1).''.
(c) Substantial Equivalence.--Section 513(i)(1)(A) (21 U.S.C.
360c(i)(1)(A)) is amended by inserting after ``intended use'' the
following: ``, which, as determined by the Secretary, shall include
each use reasonably included within a general use,''.
(d) Device Modification.--Section 513(i) (21 U.S.C. 360c(i)) is
amended by adding at the end thereof the following new paragraph:
``(4)(A) Any change or modification to a device initially
classified under section 513(f), other than a major change (including
any major modification) in the intended use or a change or modification
in design that is significant and significantly affects safety or
effectiveness, shall not require an additional notification under
section 510(k) if, prior to the commercial distribution of the device--
``(i) the change or modification is supported by
appropriate data or information, (including data or information
demonstrating compliance with good manufacturing practice
regulations promulgated under section 520(f)); and
``(ii) the change or modification is shown by such data or
information to not adversely affect the safety or effectiveness
of the device.
``(B) All data or information relied upon to document that a change
to (including any modification of) the device does not require an
additional notification under section 510(k) shall be made available to
the Secretary upon request and shall be maintained, at least for a
period of time equal to the expected life of the device or 2 years
after the date of commercial distribution of the device by the
manufacturer, whichever is greater.''.
SEC. 603. MEDICAL DEVICE APPROVAL STANDARDS.
(a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A))
is amended--
(1) by striking ``well-controlled'' and inserting ``one or
more well-controlled''; and
(2) by striking ``clinical investigations'' and inserting
``one or more clinical investigations''.
(b) Supplement to Application.--Section 513(a)(3) (21 U.S.C.
360c(a)(3)) is amended by adding at the end thereof the following new
subparagraphs:
``(C) The Secretary shall accept, for the purpose of facilitating a
review of a premarket application, a supplement to a premarket
application, or a premarket notification of a device, retrospective or
historical clinical data as a control, or for use, in determining
whether there is a reasonable assurance of effectiveness of a device if
sufficient valid data are available and the effects of the device on
the cure, mitigation, treatment, or prevention of a disease are clearly
defined and well understood.
``(D) The Secretary may not require a person intending to conduct
clinical trials to conduct clinical trials using prospective concurrent
controls in determining whether there is a reasonable assurance of
effectiveness for a device or whether a device is substantially
equivalent to a predicate device unless--
``(i) the effects of the device on the cure, mitigation,
treatment, or prevention of a disease or condition are not
clearly defined and well understood as determined by the
Secretary;
``(ii) retrospective or historical data are not available
that meet the standards of the Secretary for quality and
completeness; or
``(iii) there is a compelling public health reason to not
rely on retrospective or historical data as a control.''.
SEC. 604. TRACKING.
Section 519(e) (21 U.S.C. 360i(e)) is amended to read as follows:
``Device Tracking
``(e) The Secretary may by regulation require a manufacturer to
adopt a method of tracking a class II or class III device--
``(1) the failure of which would be reasonably likely to be
life-threatening or have serious adverse health consequences;
and
``(2) which is--
``(A) permanently implantable; or
``(B) life sustaining or life supporting and used
outside a device user facility.
Any patient receiving a device subject to tracking under this section
may refuse to release, or refuse permission to release, the patient's
name, address, social security number, or other identifying information
for the purpose of tracking.''.
SEC. 605. POSTMARKET SURVEILLANCE.
Section 522 (21 U.S.C. 360l) is amended to read as follows:
``SEC. 522. POSTMARKET SURVEILLANCE.
``(a) In General.--The Secretary may require a manufacturer to
conduct postmarket surveillance for any device of the manufacturer
that--
``(1) is a permanent implant the failure of which may cause
serious, adverse health consequences or death;
``(2) is intended for a use in supporting or sustaining
human life; or
``(3) potentially presents a serious risk to human health
or creates public health concerns that justify surveillance
under this section.
``(b) Surveillance Approval.--Each manufacturer required to conduct
a surveillance of a device under subsection (a) shall, within 30 days
of receiving notice from the Secretary that the manufacturer is
required under this section to conduct the surveillance, submit for the
approval of the Secretary, a protocol for the required surveillance.
The Secretary, within 60 days of the date of the receipt of the
protocol, shall determine if the principal investigator proposed to be
used in the surveillance has sufficient qualifications and experience
to conduct the surveillance and if the protocol will result in
collection of useful data or other information necessary to protect the
public health and to provide safety and effectiveness information for
the device. The Secretary may not approve the protocol until the
protocol has been reviewed by a qualified scientific and technical
review committee established by the Secretary.''.
SEC. 606. DEVICE DISTRIBUTOR REPORTING.
Section 519 (21 U.S.C. 360i) is amended--
(1) by striking ``, importer, or distributor'' each place
it appears and inserting ``or importer'';
(2) in subsection (a)--
(A) in paragraph (7), by striking the semicolon at
the end thereof and inserting ``; and'';
(B) in paragraph (8), by striking ``; and'' and
inserting a period; and
(C) by striking paragraph (9); and
(3) in subsection (d), by striking ``, importer, and
distributor'' and inserting ``and importer''.
SEC. 607. PREMARKET APPROVAL.
(a) Action on Application.--Section 515(d) (21 U.S.C. 360e(d)) is
amended--
(1) in paragraph (1)(A), by striking ``paragraph (2) of
this subsection'' each place it appears and inserting
``paragraph (4)'';
(2) in paragraph (1)(B), by adding at the end thereof the
following new clause:
``(iii) The Secretary shall accept and review data and any other
information from investigations conducted under the authority of
regulations required by section 520(g) to make a determination of
whether there is a reasonable assurance of safety and effectiveness of
a device subject to a pending application under this section if--
``(I) the data or information is derived from
investigations of an earlier version of the device, the device
has been modified during or after the investigations, and the
modification of the device does not constitute a significant
change in the design or in the basic principles of operation of
the device that would invalidate the data or information; or
``(II) the data or information on a device approved under
this section is available for use under this Act and is
relevant to the design and intended use of the device subject
to the pending application.'';
(3) by redesignating paragraphs (2) and (3) as paragraphs
(4) and (5), respectively; and
(4) by inserting after paragraph (1) the following new
paragraphs:
``(2) Each application received under section 515(c) shall be
reviewed in the following manner to achieve final action on the
application within 180 days of the receipt of the application:
``(A) The Secretary shall meet with an applicant within 90
days of the receipt of the application to discuss the review
status of the application. If the application does not appear
in a form that would require an approval under this subsection,
the Secretary shall in writing, and prior to the meeting,
present to the applicant a description of any deficiencies in
the application and what information is required to bring the
application into a form that would require an approval.
``(B) The Secretary shall refer an application to a panel
established under section 513 for review and an approval
recommendation (unless a panel is not required under subsection
(c)(2)) within 30 days of the date of the meeting referred to
in subparagraph (A) or at the next scheduled panel meeting
following the meeting referred to in subparagraph (A),
whichever occurs first.
``(C) The Secretary shall meet with the applicant within 15
days of the date of the panel review to discuss the status of
the application, including a discussion on what action is
necessary to bring the application into a form that would
require approval under this subsection. Prior to the meeting,
the Secretary shall in writing, set forth an agenda for the
meeting (including a complete description of the subject matter
to be discussed at the meeting), and a full description of the
additional information required to bring the application into a
form that would require an approval under this subsection.
Participation of the applicant at such a meeting shall be at
the discretion of the applicant.
``(D) The Secretary shall meet with the applicant not later
than 135 days after the receipt of an application under
subsection (c), if an advisory panel is not required under
subsection (c)(2), and inform the applicant whether or not the
application is in a form that would require approval under this
subsection. If the application is in such form, the Secretary
shall, at or prior to the meeting, present in writing to the
applicant a description of all additional information necessary
to require an approval of the application under this
subsection. If the application is not in such form, the
Secretary shall deny approval of the application and prior to
the meeting, present in writing to the applicant each basis for
denying approval of the application and the additional
information required to bring the application into a form that
would require approval.
``(E) The Secretary shall issue an order approving or
denying an application within 180 days of the receipt of the
application under subsection (c).
``(3) The time for the review of an application by the Secretary
under this subsection shall not take more than 180 days and such time
may not be extended if the application is amended.''.
(b) Revisions of Regulations.--
(1) Premarket approval of applications.--The Secretary of
Health and Human Services shall revise, through notice and
comment procedures, the regulations set forth in part 814 of
title 21 of the Code of Federal Regulations, to conform to the
amendment made by subsection (a).
(2) Premarket approval of supplements.--The Secretary of
Health and Human Services shall revise regulations relating to
premarket approval of devices to eliminate premarket approval
of supplements that relate to manufacturing or product changes
(excluding changes in intended use) of a device that have been
demonstrated through appropriate data or information to not
adversely affect safety or effectiveness. The Secretary of
Health and Human Services shall require the manufacturer of a
device to notify the Secretary of Health and Human Services of
significant manufacturing changes or other changes not subject
to a supplement under section 515 within 10 days of
implementing such changes. All information relied upon in
making such changes shall be made a part of the device master
record. The information shall be maintained for a period of
time equal to the period of time for the design and expected
life of the device, but not less than 2 years after the date of
release of the device for commercial distribution by the
manufacturer.
SEC. 608. DEVICE PERFORMANCE STANDARDS.
(a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended
by adding at the end thereof the following new subsection:
``Performance Standards of Standard-Setting Organizations
``(c)(1) For the purpose of facilitating a review of a device under
section 510(k), 513(f), 515, or 520, the Secretary shall recognize
appropriate device performance standards developed by any standard-
setting organization accredited by the American National Standards
Institute (ANSI), the International Standards Organization (ISO), or
the International Electrotechnical Commission (IEC).
``(2)(A) For any standard-setting organization not identified in
paragraph (1), and for the purpose of facilitating a review of devices
under section 510(k), 513(f), 515, or 520, the Secretary shall
establish a procedure governing the certification by the Food and Drug
Administration of the competence of such an organization to develop
standards for devices.
``(B) A certification of a standard-setting organization not
identified in paragraph (1) shall be based on formal, written criteria
that include requirements with respect to the role of the organization
in the scientific community, scientific or medical expertise, standard-
writing experience, conflict of interest considerations, and the
openness of the standard-setting process of the organization.
``(C) The Secretary may impose a reasonable one-time fee on the
standard-setting organization for certification pursuant to this
paragraph.
``(3)(A) Upon being notified by a standard-setting organization
described in paragraph (1) that a standard has been adopted by the
organization, the Secretary shall recognize the standard by publishing
a notice in the Federal Register listing the name of the standard.
``(B) Upon being notified by a standard-setting organization
certified under paragraph (2) that a standard has been adopted by the
organization, the Secretary shall review and may recognize the standard
by publishing a notice in the Federal Register listing the name of the
standard.
``(4) The Secretary may withdraw recognition of a performance
standard adopted by a standard-setting organization described in
paragraph (1) or a standard-setting organization certified under
paragraph (2) if the Secretary determines that the standard is
insufficient to facilitate a review of a device. The Secretary shall
notify the standard-setting organization and specify the basis for the
withdrawal.
``(5) The Secretary shall promulgate regulations under which the
Secretary may withdraw the certification of a standard-setting
organization described in paragraph (2), or may no longer rely upon
standards adopted by a standard-setting organization described in
paragraph (1), if the Secretary determines that such organization no
longer possesses the appropriate scientific or medical expertise,
conflict of interest practices, standard-writing experience, or any
other qualification necessary to the development of device standards.
``(6) As provided for in this section, the Secretary may promulgate
performance standards for a device that differs from or is not
established by, an organization described in paragraph (1) or an
organization certified under paragraph (2).
``(7) The Secretary shall not require, as a condition for approving
an application under section 515 or 520 or classifying a device under
sections 510(k) and 513(f), conformity with a device standard
recognized under this subsection if the person requesting such approval
or classification submits evidence to demonstrate a reasonable
assurance that the device is substantially equivalent to a legally
marketed predicate device or provides reasonable assurance that the
device is safe and effective.
``(8) A performance standard recognized pursuant to this subsection
for a device--
``(A) shall include provisions to provide reasonable
assurance of the safe and effective performance of the device;
``(B) shall, where necessary to provide reasonable
assurances of the safe and effective performance of the device,
include--
``(i) provisions with respect to the construction,
components, ingredients, and properties of the device
and the compatibility of the device with power systems
and connections to the systems;
``(ii) provisions for the testing (on a sample
basis or, if necessary, on an individual basis) of the
device or, if it is determined that no other more
practicable means are available to the Secretary to
assure the conformity of a device to the standard,
provisions for the testing (on a sample basis or, if
necessary, on an individual basis) of the device by the
Secretary or by another person at the direction of the
Secretary;
``(iii) provisions for the measurement of the
performance characteristics of the device; and
``(iv) provisions requiring that the results of
each or certain of the tests of the device required to
be made under clause (ii) demonstrate that the device
is in conformity with those portions of the standard
for which the test or tests were required; and
``(C) shall, where appropriate, require the procedures, for
the proper installation, maintenance, operation, and use of the
device.
``(9) The Secretary shall accept a certification by a person who
has made a submission pursuant to section 510(k), 515, or 520 that the
device conforms with each standard identified in the certification. The
Secretary may, where appropriate, require data demonstrating conformity
with a standard recognized under this subsection.
``(10) The Secretary shall require a person who makes a
certification under paragraph (9) that a device conforms to an
applicable performance standard recognized under this subsection or who
makes a certification that a device conforms to a standard established
under subsection (a) or (b) to maintain data demonstrating conformity
of the device to the standard for a period of time equal to the period
of time for the design and expected life of the device. Such data shall
be made available to the Secretary upon request.''.
(b) Adulterated Device.--Section 501(e) (21 U.S.C. 351(e)) is
amended--
(1) by striking ``(e)'' and inserting ``(e)(1)'';
(2) by striking ``section 514'' and inserting ``section
514(b)''; and
(3) by inserting at the end thereof the following:
``(2) If it is, or purports to be or is represented as, a device
which is certified to be in compliance with any voluntary standard
recognized under section 514(c), unless such a device is in all
respects in conformity with such a standard.''.
SEC. 609. ACCREDITED-PARTY PARTICIPATION.
Subchapter A of chapter V (21 U.S.C. 351 et seq.), as amended by
section 508, is further amended by adding at the end the following new
section:
``SEC. 523A. ACCREDITED-PARTY PARTICIPATION.
``(a) In General.--Not later than 1 year after the date of
enactment of this section, the Secretary shall accredit persons,
including any entity or any individual who is not an employee of the
Department to review and initially classify devices under section
513(f)(1) that are subject to a report under section 510(k) and to
review and recommend to the Secretary approval or denial of
applications submitted under section 515(c)(1).
``(b) Accreditation.--Not later than 6 months after the date of
enactment of this section, the Secretary shall establish and publish in
the Federal Register requirements to accredit or deny accreditation to
a person who makes a request for accreditation to carry out the
activities described in subsection (a). The requirements shall, at a
minimum, advise such person how to become accredited, and set forth
criteria for accreditation including criteria to avoid conflicts of
interest and to ensure that persons to be accredited are capable of
maintaining the confidentiality of submissions consistent with section
552 of title 5, United States Code, and the regulations of the Food and
Drug Administration. The Secretary shall respond to a request for
accreditation not later than 60 days after the receipt of the request.
The accreditation of a person shall specify the activities under
subsection (a) which such person is authorized to carry out in the
place of the Secretary.
``(c) Withdrawal of Accreditation.--The Secretary may suspend or
withdraw the accreditation of any person accredited under this section,
after providing notice and an opportunity for an informal hearing, if
such person acts in a manner that is substantially inconsistent with
the purposes of this section, including the failure to avoid conflicts
of interest, the failure to protect confidentiality of information, or
the failure to competently review premarket submissions for devices.
``(d) Selection and Compensation.--A person who submits a premarket
submission for a device to the Secretary for review and classification,
or approval of a device, shall have the option to select an accredited
person to review such submission. The Secretary shall identify for the
person no less than 2 accredited persons from whom the selection may be
made. Compensation for an accredited person shall be determined by
agreement between the accredited person and the person who engages the
services of the accredited person.
``(e) Review by Secretary.--
``(1) In general.--If a person exercises the option to
obtain review of a premarket submission that is an application
or a notification by an accredited person, the Secretary shall
complete a filing review for a premarket approval application
under section 515(c)(1) not later than 30 days after the
receipt of such application, or shall ensure the completeness
of a premarket notification submission under section 510(k) not
later than 15 days after the receipt of such submission, prior
to referring the premarket submission for review by the
accredited person selected by the person submitting the
premarket submission.
``(2) Report on classification, approval, or denial.--The
Secretary shall require an accredited person, upon recommending
a classification of a device or approval or disapproval of an
application for a device, to report to the Secretary the
reasons of the accredited person for such classification or
approval or disapproval. For devices reviewed and initially
classified under section 513(f)(1) and subject to a report
under section 510(k), the Secretary shall have not more than 15
days to review the submission. For applications submitted under
section 515(c)(1), the Secretary shall have not more than 45
days to review the application. The Secretary may change the
classification under section 513(f)(1), or the approval or
disapproval of the application under section 515(d), that is
recommended by the accredited person, and in such case shall
notify the person making the submission of the detailed reasons
for the change.
``(f) Duration.--This section shall remain in force for a period of
3 years from the date on which the Secretary accredits the first person
to conduct initial classifications under section 513(f)(1) and to
conduct premarket approval reviews under section 515.
``(g) Reports.--
``(1) Implementation of accreditation process.--Not later
than 1 year after the date of enactment of this section, the
Secretary shall prepare and submit to the committees of
Congress with oversight authority over the Food and Drug
Administration a report concerning each action the Secretary
has taken to implement the accreditation of persons to
undertake the activities described in subsection (a).
``(2) Examination of the use of accredited persons.--
``(A) In general.--Not later than 2 years after the
date on which the Secretary accredits the first person
to conduct initial classifications under section
513(f)(1) and to conduct premarket approval reviews
under section 515, the Secretary shall contract with an
independent research organization to prepare and submit
to the Secretary a written report examining the use of
accredited persons under this section. The Secretary
shall submit the report to the committees described in
paragraph (1) not later than 30 months after the date
on which the Secretary accredits the first person to
conduct initial classifications under section 513(f)(1)
and to conduct premarket approval reviews under section
515.
``(B) Contents.--The report by the independent
research organization described in subparagraph (A)
shall identify the benefits or detriments to public and
patient health of using accredited persons to conduct
such reviews, and shall summarize all relevant data,
including data on the review of accredited persons
(including review times, recommendations, and
compensation), and data on the review of the Secretary
(including review times, changes, and reasons for
changes).''.
TITLE VII--ANIMAL DRUG REGULATORY REFORM
SEC. 701. SHORT TITLE.
This title may be cited as the ``Animal Drug Regulatory Reform Act
of 1996''.
SEC. 702. EVIDENCE OF EFFECTIVENESS.
(a) Substantial Evidence.--Section 512(d) (21 U.S.C. 360b(d)) is
amended--
(1) by striking paragraph (3); and
(2) by adding at the end thereof the following new
paragraph:
``(4)(A) As used in this subsection and subsections (c)(2)(F)(iii)
and (e)(1)(C), the term `substantial evidence' means evidence from 1 or
more scientifically sound studies, including as appropriate in vitro
studies, studies in laboratory animals (including a target species),
bioequivalence studies, and any studies voluntarily undertaken by or
for the applicant, that taken together provide reasonable assurance
that the drug will have the claimed or intended effect of the drug.
``(B) For purposes of subparagraph (A), a study shall be considered
to be scientifically sound if the study is designed and conducted in a
manner that is consistent with generally recognized scientific
procedures and principles.''.
(b) Combination of Drugs.--Section 512(d) (21 U.S.C. 360b(d)) is
amended by inserting before paragraph (4) (as added by subsection (a))
the following new paragraph:
``(3) In a case in which a new animal drug contains more than 1
active ingredient, or the labeling of the drug prescribes, recommends,
or suggests use of the drug in combination with another animal drug,
and the active ingredients or drugs in the combination have been
separately approved for particular uses and species prior to the
approval of the application for the same uses and species in
combination (or, in the absence of such approvals, after evaluating the
safety and efficacy of the combination itself), the Secretary may only
consider with respect to the combination whether any of the active
ingredients or any of the drugs in the combination, respectively, at
the longest withdrawal time of any of the active ingredients or drugs
in the combination, respectively--
``(A) is above its safe concentration (such as exceeding
its established tolerance, as measured by its marker residue);
or
``(B) interferes with the methods of analysis for another
of the active ingredients or drugs in the combination,
respectively.''.
(c) Supplemental Applications.--Section 512(c)(2)(F)(iii) (21
U.S.C. 360b(c)(2)(F)(iii)) is amended--
(1) by striking ``reports of new clinical or field
investigations (other than bioequivalence or residue studies)
and'' and inserting ``substantial evidence of effectiveness as
defined in subsection (d)(4), any study of animal safety, or'';
and
(2) by striking ``essential to'' and inserting ``, required
for''.
(d) Minor Species and Uses.--Section 512(d)(1) (21 U.S.C.
360b(d)(1)) is amended by adding at the end the following new sentence:
``Subparagraph (E) shall not apply to a claim for use of the drug
described in subparagraph (E) in a minor species, or for a minor use of
the drug, as the terms `minor species' and `minor use' are defined in
regulations issued by the Secretary, if there is an application filed
under subsection (b) for the drug, and the application is approved,
prior to the submission of the claim.''.
(e) Withdrawal of Approval.--Section 512(e)(1)(C) (21 U.S.C.
360b(e)(1)(C)) is amended by inserting after ``substantial evidence''
the following: ``(as defined in subsection (d)(4))''.
(f) Implementation.--
(1) In general.--Not later than 6 months after the date of
enactment of this Act, the Secretary shall issue proposed
regulations implementing the amendments made by this section.
Not later than 18 months after the date of enactment of this
Act, the Secretary shall issue final regulations implementing
the amendments.
(2) Contents.--In issuing regulations implementing the
amendments made by this section, and in taking an action to
review an application for approval of a new animal drug under
section 512 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b), or a request for an investigational exemption for
a new animal drug under subsection (j) of such section, that is
pending or has been submitted prior to the effective date of
the regulations, the Secretary shall--
(A) further define the term ``substantial
evidence'', as defined in subsection (d)(4) of such
section, in a manner that encourages the submission of
applications for production drugs that conserve food
resources, of applications for veterinary prescription
drugs whose use is designed to rely on the experience
and training of practitioners in establishing effective
doses for such drugs, and of supplemental applications,
including applications seeking approval for uses of
animal drugs in minor species, for minor uses of such
drugs, and for permitted unlabeled uses of such drugs;
(B) take into account the proposals contained in
the citizen petition (FDA Docket No. 91P-0434/CP)
jointly submitted by the American Veterinary Medical
Association and the Animal Health Institute, dated
October 21, 1991; and
(C)(i) provide for the opportunity for a conference
prior to the submission of an application for approval
of a new animal drug under such section, and prior to
the submission of a request for an investigational
exemption under subsection (j) of such section, to make
a decision establishing any submission or
investigational requirement relating to the application
or request (which decision shall bind the Secretary and
the applicant or requester unless the Secretary by
order determines that a documented scientific issue
that occurred subsequent to the conference requires the
decision to be modified in order to ensure that an
appropriate determination can be made with respect to
the safety or effectiveness of the animal drug
involved); and
(ii) not later than 10 days after each such
conference, by written order, provide a scientific
justification specific to the animal drug and intended
uses under consideration for requiring studies of types
other than the types of studies specified in subsection
(d)(4) of such section, as being essential to provide
substantial evidence of effectiveness for the intended
uses of the drug.
SEC. 703. LIMITATION OF RESIDUES.
Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is amended to read
as follows:
``(F) on the basis of information submitted to the
Secretary as part of the application or any other information
before the Secretary with respect to such drug, any use
prescribed, recommended, or suggested in labeling proposed for
such drug will result in a residue of such drug in excess of a
tolerance found by the Secretary to be safe for such drug;''.
SEC. 704. ADULTERATED DRUGS.
Section 501(a)(2) (21 U.S.C. 351(a)(2)) is amended--
(1) in subparagraph (A), by striking ``health; or'' and
inserting ``health;''; and
(2) in subparagraph (B), by striking ``possess;'' and
inserting the following: ``possess; or (C) if it is a drug
intended for use by animals other than man and the methods used
in, or the facilities or controls used for, its manufacture,
processing, packing, or holding do not conform to or are not
operated or administered in conformity with current good
manufacturing practice requirements (appropriate for animal
drugs) adopted pursuant to regulations issued by the Secretary
to ensure that such drug meets the requirements of this Act as
to safety and has the identity and strength, and meets the
quality and purity characteristics, which it purports or is
represented to possess for use in animals other than man;''.
SEC. 705. VETERINARY FEED DIRECTIVES.
(a) Written or Oral Orders.--Section 503(f)(1)(A) (21 U.S.C.
353(f)(1)(A)) is amended by striking ``other than man'' and inserting
the following: ``other than man, other than a veterinary feed directive
drug intended for use in animal feed or an animal feed bearing or
containing a veterinary feed directive drug,''.
(b) General Requirements.--Chapter V (21 U.S.C. 351 et seq.) is
amended by inserting after section 503 the following new section:
``veterinary feed directives drugs
``Sec. 504. (a)(1) A drug intended for use in or on animal feed
that is limited by an approved application filed pursuant to section
512(b) to use under the professional supervision of a licensed
veterinarian is a veterinary feed directive drug. Any animal feed
bearing or containing a veterinary feed directive drug shall be fed to
animals only by or upon the lawful veterinary feed directive issued by
a licensed veterinarian in the course of the professional practice of
the veterinarian. When labeled, distributed, held, and used in
accordance with this section, a veterinary feed directive drug and any
animal feed bearing or containing a veterinary feed directive drug
shall be exempt from section 502(f).
``(2) A veterinary feed directive is lawful if it--
``(A) contains such information as the Secretary may, by
general regulation or by order, require; and
``(B) is in compliance with the conditions and indications
for use of the drug set forth in the notice published pursuant
to section 512(i).
``(3)(A) Any persons involved in the distribution or use of animal
feed bearing or containing a veterinary feed directive drug, and the
licensed veterinarian issuing the veterinary feed directive, shall
maintain a copy of the veterinary feed directive applicable to each
such feed, except in the case of a person distributing such feed to
another person for further distribution, such person distributing the
feed shall maintain a written acknowledgment from the person to whom
the feed is shipped stating that that person shall not ship or move
such feed to an animal production facility without a veterinary feed
directive or ship such feed to another person for further distribution
unless that person has provided the same written acknowledgment to the
immediate supplier of that person.
``(B) Every person required under subparagraph (A) to maintain
records, and every person in charge or custody thereof, shall, upon
request of an officer or employee designated by the Secretary, permit
such officer or employee at all reasonable times to have access to and
copy and verify such records.
``(C) Any person who distributes animal feed bearing or containing
a veterinary feed directive drug shall upon first engaging in such
distribution notify the Secretary of the name and place of business of
that person. The failure to provide such notification shall be deemed
to be an act which results in the drug being misbranded.
``(b) A veterinary feed directive drug and any feed bearing or
containing a veterinary feed directive drug shall be deemed to be
misbranded if the drug and feed labeling fails to bear such cautionary
statement and such other information as the Secretary may, by general
regulation or by order, prescribe, or the drug and feed advertising
fails to conform to the conditions and indications for use published
pursuant to section 512(i) or fails to contain the general cautionary
statement prescribed by the Secretary.
``(c) Neither a drug subject to this section, nor animal feed
bearing or containing such a drug, shall be deemed to be a prescription
article under any Federal or State law.''.
(c) Conforming Amendments.--Section 512 (21 U.S.C. 360b) is
amended--
(1) in subsection (a)(2)(C), by striking ``its labeling''
and inserting ``its labeling, its distribution, its holding,'';
(2) in subsection (i), by striking ``requirements)'' and
inserting ``requirements and any requirement that an animal
feed bearing or containing the new animal drug be limited to
use under the professional supervision of a licensed
veterinarian)''; and
(3) in subsection (m)(4)(B)(i)--
(A) by striking ``paragraph (5)(A) of this
subsection'' and inserting ``paragraph (5)(A) or under
section 504(a)(3)(A)''; and
(B) by striking ``subparagraph (B) of such
paragraph'' and inserting ``paragraph (5)(B) or section
504(a)(3)(B)''.
(d) Prohibited Acts.--Section 301(e) (21 U.S.C. 331(e)) is
amended--
(1) by striking ``section 412'' and inserting ``section
412, 504,''; and
(2) by striking ``under section 412,'' and inserting
``under section 412, 504,''.
SEC. 706. TIMEFRAMES FOR APPROVAL.
The first sentence of section 512(c)(1) (21 U.S.C. 360b(c)(1)) is
amended by striking ``one hundred and eighty'' and inserting ``90''.
TITLE VIII--FOOD REGULATORY REFORM
SEC. 801. SHORT TITLE.
This title may be cited as the ``Food Regulatory Reform Act of
1996''.
SEC. 802. INDIRECT FOOD ADDITIVES.
(a) Approval.--Section 409 (21 U.S.C. 348) is amended by adding at
the end thereof the following new subsection:
``Alternative Approval Procedure
``(j)(1) As an alternative to the approval procedure established
under subsection (b), any person may submit a notification for an
indirect food additive under this subsection.
``(2) Any person who proposes to begin the introduction or delivery
for introduction into interstate commerce of an article intended for
use as an indirect food additive may submit to the Secretary, at least
90 days prior to making such introduction or delivery, a notification
containing information demonstrating that the labeled use of the
article is safe.
``(3) Within 90 days after the receipt of the notification by the
Secretary, the Secretary shall--
``(A) either--
``(i) approve the notification if the article is
safe for its intended use; or
``(ii) disapprove the notification if the article
has not been shown to be safe for its intended use; and
``(B) publish a notice of this determination in the Federal
Register and, if the notification is approved, promulgate an
appropriate regulation pursuant to subsection (c).''.
(b) Definition.--Section 201 (21 U.S.C. 321), as amended by section
408, is further amended by adding at the end thereof the following new
paragraph:
``(hh) The term `indirect food additive' means a food additive that
is intended to contact food but that is not intended for consumption as
a food ingredient.''.
SEC. 803. HEALTH CLAIMS OF FOOD PRODUCTS.
Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at the
end thereof the following new subparagraph:
``(C) Notwithstanding the provisions of subparagraphs (A)(i) and
(B), a claim of the type described in paragraph (1)(B) which is not
authorized by the Secretary in a regulation promulgated in accordance
with subparagraph (B) shall be authorized and may be made if--
``(i) an authoritative scientific body of the United States
Government with official responsibility for public health
protection or research directly relating to human nutrition
(such as the National Institutes of Health or the Centers for
Disease Control and Prevention), the National Academy of
Sciences, or subdivisions of the scientific body or the
National Academy of Sciences, has published statements,
conclusions, or recommendations in effect recognizing that the
relationship between the nutrient and disease or health-related
condition to which the claim refers is supported by pertinent
scientific evidence; and
``(ii) the manufacturer or distributor of the food for
which such claim is made has submitted to the Secretary at
least 90 days before the first introduction of such food into
interstate commerce a notice of claim, including a concise
description of the basis upon which such manufacturer or
distributor relied for determining that the requirements of
clause (i) have been satisfied.''.
TITLE IX--ESTABLISHMENT OF CENTERS FOR EDUCATION AND RESEARCH ON DRUGS,
DEVICES, AND BIOLOGICAL PRODUCTS
SEC. 901. CENTERS FOR EDUCATION AND RESEARCH ON DRUGS, DEVICES, AND
BIOLOGICAL PRODUCTS.
Chapter IX (21 U.S.C. 391 et seq.), as amended by section 507, is
further amended by adding at the end thereof the following new section:
``SEC. 909. CENTERS FOR EDUCATION AND RESEARCH ON DRUGS, DEVICES, AND
BIOLOGICAL PRODUCTS.
``(a) In General.--The Secretary, acting through the Commissioner,
shall establish a consortium of 3 or more centers for research and
education on drugs, devices, and biological products in accordance with
subsection (b).
``(b) Grant Authority.--The Secretary, acting through the
Commissioner, shall make grants to 3 or more private entities to assist
each of the entities in the establishment and operation of a center for
research and education on drugs, devices, and biological products. In
awarding a grant under this subsection, the Secretary shall use a peer-
review selection procedure.
``(c) Authorized Grant Activities.--
``(1) Required activities.--A grant awarded under
subsection (b) shall be used to--
``(A) conduct state-of-the-art clinical and
laboratory research that--
``(i) increases awareness of new uses of
drugs, devices, or biological products and the
unforeseen risks of new uses of drugs, devices,
or biological products;
``(ii) provides objective clinical
information to--
``(I) health care practitioners or
other providers of health care goods or
services;
``(II) pharmacy benefit managers;
``(III) health maintenance
organizations or other managed health
care organizations; and
``(IV) health care insurers or
governmental agencies; and
``(iii) improves the quality of health care
while reducing the cost of health care through
the prevention of adverse effects of drugs,
devices, or biological products and the
consequences of such effects, such as
unnecessary hospitalizations; and
``(B) conduct research on the comparative
effectiveness and safety of drugs, devices, or
biological products.
``(2) Discretionary activities.--A grant awarded under
subsection (b) may be used to conduct--
``(A) surveillance of the adverse effects of drugs,
devices, or biological products;
``(B) a study of new or unapproved uses for
marketed drugs, devices, or biological products; or
``(C) a study of the therapeutic characteristics of
clinically special populations, such as children,
women, and elderly individuals.
``(3) Limitation.--A grant awarded under subsection (b) may
not be used to assist the Secretary in the review of new drugs.
``(d) Application.--An entity that desires to receive a grant under
this section shall submit to the Secretary an application at such time,
in such manner, and accompanied by such information as the Secretary
may require.
``(e) Establishment of an Oversight Committee.--The Secretary shall
establish within the Food and Drug Administration a committee to
provide oversight of the research and educational activities of the
consortium of centers described in subsection (a). The committee shall
be composed of--
``(1) a representative from each of the centers;
``(2) a representative from the Food and Drug
Administration;
``(3) a representative from consumer advocacy groups; and
``(4) a representative from the pharmaceutical, device, or
biological products industry.
``(f) Report.--Not later than September 30, 1999, the Secretary
shall prepare and submit to the Chairmen and Ranking Members of the
Committee on Labor and Human Resources of the Senate and the Committee
on Commerce of the House of Representatives a report on the activities
of the consortium of centers established pursuant to this section. The
report shall include an analysis on the impact of the centers on the
safe use of drugs, devices, and biological products and recommendations
on whether the funding for the centers should be extended and
increased.
``(g) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $9,000,000 for fiscal year 1997,
$12,000,000 for fiscal year 1998, $15,000,000 for fiscal year 1999, and
$15,000,000 for fiscal year 2000.''.
TITLE X--PROGRAM IN CLINICAL PHARMACOLOGY
SEC. 1001. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PROGRAM.
Section 2(b) of Public Law 102-222 (105 Stat. 1677) is amended by
striking ``to carry out this section'' and inserting ``, and fiscal
years 1997 and 1998, $1,900,000 for each fiscal year, to carry out this
section''.