[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1477 Introduced in Senate (IS)]
104th CONGRESS
1st Session
S. 1477
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 introduced the following bill; which was read twice and
referred to the Committee on Labor and Human Resources
_______________________________________________________________________
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,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Administration
Performance and Accountability Act of 1995''.
TITLE I--MISSION AND ACCOUNTABILITY
SEC. 101. SHORT TITLE.
This title may be cited as the ``Food and Drug Administration
Regulatory Reform Act of 1995''.
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 health of the American people by--
``(1) facilitating the rapid and efficient development and
availability of products subject to its regulation;
``(2) protecting the public from unsafe or ineffective
products subject to its regulation; 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.--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--
``(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))--
``(i) for a serious, life-threatening, or
seriously debilitating disease or condition; or
``(ii) for any other condition if a new
drug, device, or biological product--
``(I) provides therapy not
available from other approved therapy;
or
``(II) offers significant
improvement over other approved
therapy;
``(B) reduce backlogs on all applications with the
objective of eliminating all backlogs by January 1,
2000; and
``(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.
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.''.
SEC. 104. 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)
submitted to the Food and Drug Administration requesting agency action.
The system shall permit access by the applicant.''.
SEC. 105. 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) 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.
``(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.''.
SEC. 106. ADVISORY COMMITTEES.
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
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.
``(c) Membership and Meeting Requirements.--
``(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.
``(2) Nonvoting members.--A scientific review group shall
include a nonvoting industry representative and a nonvoting
public representative.
``(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.
``(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.
``(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.
``(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.
``(d) Persons Involvement With Review Groups.--
``(1) In general.--All persons, including employees of the
Secretary, shall have the same rights and responsibilities
regarding--
``(A) the submission of data and information to,
and contact and discussion with, a scientific review
group;
``(B) the participation of the persons at meetings
of the group; and
``(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).
``(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.
``(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.
``(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.
``(f) Definition.--For purposes of this section, the term `center
director' means a director of a center within the Food and Drug
Administration.''.
SEC. 107. APPEALS WITHIN THE FOOD AND DRUG ADMINISTRATION.
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:
``SEC. 907. APPEALS WITHIN THE FOOD AND DRUG ADMINISTRATION.
``(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.
``(b) Review by Scientific Review Group.--
``(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.
``(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.
``(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 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--
``(A) panels of qualified Food and Drug
Administration officials;
``(B) panels of qualified government employees who
are not employees of the Food and Drug Administration;
and
``(C) outside mediators and arbitrators who are not
government employees.
``(2) Application of faca.--The Federal Advisory Committee
Act (5 U.S.C. App) shall not apply to a panel described in
paragraph (1).
``(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.''.
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 1995''.
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 section:
``SEC. 543. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.
``(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--
``(1) the person has no comparable or satisfactory
alternative therapy available to treat, diagnose, or monitor
the disease or condition; or
``(2) the risk to the person from the investigational drug
or device is not greater than the risk from the disease or
condition.
``(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.
``(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.
``(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--
``(1) shall state that the drug or device is
investigational;
``(2) shall not represent that the drug or device is safe
or effective for any use; and
``(3) shall not otherwise promote or advertise the
availability of the product 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 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.'';
(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 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.''.
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 1995''.
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
paragraph:
``(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.
``(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.
``(C) The Commissioner shall establish a mechanism to ensure the
fair and consistent application of safety standards for clinical
investigations.''.
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).
``(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--
``(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
``(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.''.
SEC. 304. 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. 544. 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 one or more protocols or part
or all of a development plan for the drug or device.
``(2) Form.--A request described in paragraph (1) shall be
in writing and shall include a proposal for which the review is
requested.
``(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.
``(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.
``(c) Modification of Agreements by the FDA.--Agreements reached
through meetings under subsection (a) may be changed unilaterally
only--
``(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
``(2) in writing and specifying the basis therefor and
demonstrating the substantial public health reasons that
require the change.
``(d) Panel Review.--
``(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.
``(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).''.
TITLE IV--EFFICIENT, ACCOUNTABLE, AND FAIR PRODUCT REVIEW
SEC. 401. REFERENCE.
This title may be cited as the ``Product Review Regulatory Reform
Act of 1995''.
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
``SEC. 741. CONTENT AND REVIEW OF AN APPLICATION.
``(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.
``(b) Filing Requirements.--The Commissioner shall establish a
mechanism to ensure the fair and consistent application of filing
requirements.
``(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.
``(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.''.
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.--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.
``(b) Review of Expert's Evaluation.--
``(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.
``(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.''.
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 (including a petition, notification,
or other similar request):
``(1) An application for approval of a human food additive
or animal feed additive under section 409.
``(2) An application for approval of a new drug under
section 505(b)(1).
``(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.
``(4) A submission for a determination that a device is
substantially equivalent to a predicate device under sections
513(f)(1) and 513(i).
``(5) An application for approval of a device under section
515.
``(6) An application 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 Food and Drug Administration and the applicant with
respect to an application or submission described in subsection (a). As
part of this collaborative process--
``(1) open, informal, and prompt communications shall be
encouraged;
``(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
``(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.
``(c) Approval, Disapproval, and Classification.--
``(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.
``(2) Appeal.--A person whose application has been
disapproved under this subsection may appeal using one of the
following procedures:
``(A) Procedures under the act.--The procedures
established for the product under other provisions of
this Act.
``(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.
``(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 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.
``(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).''.
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 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.--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).
``(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.
``(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
subsection that conducts an inspection under this subsection 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; and
``(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.
``(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.''.
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 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--
``(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. INFORMATION EXCHANGE.
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:
``SEC. 746. DISSEMINATION OF INFORMATION ON DRUGS.
``(a) Dissemination.--
``(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--
``(A) a treatment use for an investigational new
drug (including a biological product) approved by the
Secretary for such treatment use; or
``(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.
``(2) Requirements.--A person may disseminate information
under paragraph (1)(B) only if--
``(A) the information is an unabridged--
``(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
``(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;
``(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;
``(C) the information relates to a use that is
recognized under Federal law for purposes of third-
party coverage or reimbursement, and--
``(i) the text of the information has been
approved by an organization referred to in such
Federal law; and
``(ii) the information is part of a disease
management program or treatment guideline with
respect to the use; or
``(D) the information is an accurate and truthful
summary of the information described in subparagraph
(A), (B), or (C).
``(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--
``(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;
``(2) if applicable, that the information is being
disseminated at the expense of the sponsor of the new drug;
``(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
``(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.
``(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).
``(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).
``SEC. 747. DISSEMINATION OF INFORMATION ON DEVICES.
``(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.
``(b) Disclosure Statements and Requirements.--
``(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.
``(2) Additional requirements.--A person may disseminate
information under subsection (a) only if--
``(A) the information is an unabridged--
``(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
``(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;
``(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;
``(C) the information relates to a use that is
recognized under Federal law for purposes of third-
party reimbursement, and--
``(i) the text of the information has been
approved by an organization referred to in such
Federal law; and
``(ii) the information is part of a disease
management program or treatment guideline with
respect to such use; or
``(D) the oral or written information is--
``(i) part of an exchange of information
solely among health care practitioners, health
care reimbursement officials, and the industry;
``(ii) exchanged for educational or
scientific purposes; or
``(iii) presented at continuing medical
education programs, seminars, workshops, or
demonstrations.
``(3) Applicability.--The requirements under subsection
(a)(1)(A) and (B) of section 746 shall not apply with respect
to devices.
``SEC. 748. POLICY ON INFORMATION DISSEMINATION.
``(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.
``(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.
``SEC. 749. APPROVAL OF NEW USES.
``(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.
``(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--
``(1) has existed in clinical practice for at least five
years;
``(2) is common among clinicians experienced in the field;
and
``(3) represents reasonable medical practice based upon
reliable clinical experience and other confirmatory
information.
``(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.''.
SEC. 408. 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) 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--
``(1) relative effectiveness, unless the effectiveness of
the product is explicitly compared to the effectiveness of
another product in the labeling;
``(2) any potential use not explicitly included in the
labeling;
``(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
``(4) the clinical outcome resulting from use of a device,
unless the labeling explicitly includes a representation
regarding clinical outcome.''.
SEC. 409. 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:
``(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.''.
TITLE V--DRUG, BIOLOGICAL PRODUCTS, DEVICES EXPORT REFORM
SEC. 501. SHORT TITLE.
This title may be cited as the ``Drug, Biological Products, Devices
Export Reform Act of 1995''.
SEC. 502. EXPORT OF DRUGS AND DEVICES.
(a) Exports and Imports.--Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (d), by adding at the end thereof the
following new paragraph:
``(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.'';
(2) in subsection (e)(1), by striking the second sentence;
and
(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''.
(b) Export of Certain Unapproved Drugs and Devices.--Section 802
(21 U.S.C. 382) is amended to read as follows:
``SEC. 802. EXPORTS OF CERTAIN UNAPPROVED PRODUCTS.
``(a) In General.--A drug (including a biological product) intended
for human or animal use or a device for human use--
``(1)(A) which, in the case of a drug--
``(i) requires approval by the Secretary under
section 505 or section 512; or
``(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),
before the drug may be introduced or delivered for introduction
into interstate commerce to a country; and
``(B) which--
``(i) does not have such approval or license;
``(ii) is not exempt from such sections or Act; and
``(iii) is introduced or delivered for introduction
into interstate commerce to a country; or
``(2) which, in the case of a device--
``(A) does not comply with an applicable
requirement under section 514 or 515;
``(B) is exempt under section 520(g) from section
514 or 515; or
``(C) is a banned device under section 516,
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).
``(b) Exportation to Any Country or a Specific Country.--
``(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--
``(A) in Australia, Canada, Israel, Japan, New
Zealand, or Switzerland; or
``(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.
``(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.
``(c) Exportation to a Country With a Regulatory System.--
``(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.
``(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.
``(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.
``(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.
``(d) Limitations.--A drug or device may not be exported under this
section if--
``(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;
``(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;
``(3) the requirements of subparagraphs (A) through (D) of
section 801(e)(1) have not been met;
``(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;
``(5) the Secretary finds that the drug or device poses an
unreasonable and substantial risk to public health in the
receiving country;
``(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
``(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.
In making a finding under paragraph (5), the Secretary, to the maximum
extent possible, shall consult with the affected country.
``(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).
``(f) Exportation of a Drug for Tropical Disease.--
``(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--
``(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;
``(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;
``(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;
``(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
``(E) the requirements of subparagraphs (A) through
(D) of section 801(d)(1) have been met.
``(2) Application.--Any person may apply to have a drug
exported under paragraph (1). The application shall--
``(A) describe the drug to be exported;
``(B) list each country to which the drug is to be
exported;
``(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);
``(D) identify the establishments in which the drug
is manufactured; and
``(E) demonstrate to the Secretary that the drug
meets the requirements of paragraph (1).
``(3) Required reporting.--The holder of an approved
application for the export of a drug under this subsection
shall report to the Secretary--
``(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
``(B) the receipt of any information indicating any
adverse reactions to such drug.
``(4) Additional limitations.--
``(A) Failure to meet certain requirements.--If the
Secretary determines that--
``(i) a drug for which an application is
approved under paragraph (2) does not continue
to meet the requirements of paragraph (1);
``(ii) the holder of the application has
not made the report required by paragraph (3);
or
``(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),
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.
``(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--
``(i) the holder of an approved application
under paragraph (2) is exporting a drug from
the United States to an importer;
``(ii) the importer is exporting the drug
to a country for which the Secretary cannot
make a finding under paragraph (1)(A); and
``(iii) the export presents an imminent
hazard to the public health in the country,
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.
``(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.
``(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).
``(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.''.
SEC. 503. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS.
Subsection (h) of section 351 of the Public Health Service Act (42
U.S.C. 262) is amended to read as follows:
``(h) A partially processed biological product that--
``(1) is not in a form applicable to the prevention,
treatment, or cure of diseases or injuries of man;
``(2) is not intended for sale in the United States; and
``(3) is intended for further manufacture into final dosage
form outside the United States,
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)).''.
TITLE VI--DRUG AND BIOLOGICAL PRODUCTS REGULATORY REFORM
SEC. 601. SHORT TITLE.
This title may be cited as the ``Drug and Biological Product
Regulatory Reform Act of 1995''.
SEC. 602. 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 one well-controlled clinical investigation (which may be
waived by the Secretary) and confirmatory evidence (obtained either
before or after such investigation).''.
SEC. 603. 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 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.''.
SEC. 604. MANUFACTURING CHANGES.
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:
``SEC. 750. 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 shall require--
``(1) validation; and
``(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
``(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.
``(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--
``(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
``(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.
``(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.''.
SEC. 605. 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), as amended by
section 502(b), is further amended by adding at the end thereof the
following new subsection:
``(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).''.
SEC. 606. BIOLOGICAL PRODUCTS.
(a) Modernization of Regulation of Biological Products.--
(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:
``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--
``(A) a product license has been issued for the biological
product;
``(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
``(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.
``(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.
``(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.
``(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.
``(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.''.
(2) 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.''.
(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''.
(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:
``(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 those sections to new drug applications shall be deemed to include
product license applications.
``(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.
(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).
SEC. 607. REQUIREMENTS FOR EMERGING BIOTECHNOLOGY PRODUCTS.
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--
(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
(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.
TITLE VII--DEVICE REGULATORY REFORM
SEC. 701. SHORT TITLE.
This title may be cited as the ``Medical Device Reform Act of
1995''.
SEC. 702. 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 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) (as amended by
paragraph (1)) the following:
``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) 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.
``(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).''.
(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).
(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:
``(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).''.
(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) 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.''.
SEC. 703. MEDICAL DEVICE APPROVAL STANDARDS.
Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended--
(1) by striking ``well-controlled investigations'' and
inserting ``a scientific investigation'';
(2) by striking ``clinical investigations'' and inserting
``a clinical investigation'';
(3) by striking ``investigations it'' and inserting
``investigation it''; and
(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.''.
SEC. 704. 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 life-threatening or
have permanently debilitating effects; and
``(2) which is--
``(A) permanently implanted; or
``(B) life sustaining or life supporting and used
outside a device user facility.''.
SEC. 705. POSTMARKET SURVEILLANCE.
Section 522(1) (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
first introduced or delivered for introduction into interstate commerce
after January 1, 1991, 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.
``(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. 706. 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 (8), by striking ``; and'' and
inserting a period; and
(B) by striking paragraph (9); and
(3) by striking subsection (f).
SEC. 707. 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
paragraph:
``(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 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.
``(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.
``(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.
``(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.
``(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)(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.
``(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.''.
(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.
SEC. 708. 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:
``product review
``(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.
``(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.
``(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.
``(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.
``(5) Within 150 days after the receipt by the Secretary of the
application, the Secretary shall--
``(A)(i) grant the petition in whole or in part; or
``(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
``(B) publish a notice of the determination in the Federal
Register.
``(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.
``(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.
``(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.''.
(b) Adulterated Device.--Section 501(e) (21 U.S.C. 351(e)) is
amended by striking ``section 514'' and inserting ``section 514(b)''.
TITLE VIII--ANIMAL DRUG REGULATORY REFORM
SEC. 801. SHORT TITLE.
This title may be cited as the ``Animal Drug Regulatory Reform Act
of 1995''.
SEC. 802. NEW ANIMAL DRUG APPROVAL STANDARDS.
(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.''.
(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:
``(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--
``(A) the combination affects the safety of any active
ingredient;
``(B) the combination interferes with a method of analysis
for any active ingredient;
``(C) if the active ingredients have the same intended
effect, each of the active ingredients makes a significant
contribution to the labeled effectiveness; and
``(D) if the active ingredients do not have the same
intended effect, the active ingredients provide appropriate
concurrent therapy for a labeled target population.''.
(c) Approval.--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''.
SEC. 803. RESIDUE LIMITATION.
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 in the application or
otherwise available to the Secretary, any labeled use of the
drug will result in an unsafe residue of the drug;''.
SEC. 804. 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;''.
TITLE IX--FOOD REGULATORY REFORM
SEC. 901. SHORT TITLE.
This title may be cited as the ``Food Regulatory Reform Act of
1995''.
SEC. 902. 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 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.
``(3)(A) Within 90 days after the receipt of the notification by
the Secretary, the Secretary shall either--
``(A)(i) approve the notification if the product is safe
for its intended use; or
``(ii) disapprove the notification if there is a reasonable
possibility that the article is not 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).
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).''.
(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:
``(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.''.
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