[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2055 Reported in Senate (RS)]
<DOC>
Calendar No. 388
114th CONGRESS
2d Session
S. 2055
To amend the Public Health Service Act and the Federal Food, Drug, and
Cosmetic Act with respect to national health security.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 17, 2015
Mr. Burr (for himself, Mr. Casey, Mr. Isakson, and Mr. Roberts)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
March 14, 2016
Reported by Mr. Alexander, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Public Health Service Act and the Federal Food, Drug, and
Cosmetic Act with respect to national health security.
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 ``Medical Countermeasure
Innovation Act of 2015''.</DELETED>
<DELETED>SEC. 2. MEDICAL COUNTERMEASURE GUIDELINES.</DELETED>
<DELETED> (a) Strategic National Stockpile and Security
Countermeasure Procurements.--Section 319F-2 of the Public Health
Service Act (42 U.S.C. 247d-6b) is amended--</DELETED>
<DELETED> (1) in subsection (a), by adding at the end the
following:</DELETED>
<DELETED> ``(3) Utilization guidelines.--The Secretary shall
ensure timely and accurate recommended utilization guidelines
for qualified countermeasures (as defined in section 319F-1),
qualified pandemic and epidemic products (as defined in section
319F-3), and security countermeasures (as defined in subsection
(c)), including for such products in the stockpile.'';
and</DELETED>
<DELETED> (2) in subsection (g)--</DELETED>
<DELETED> (A) by amending paragraph (4) to read as
follows:</DELETED>
<DELETED> ``(4) Report on security countermeasure
procurement.--Not later than March 1 of each year in which the
Secretary determines that the amount of funds available for
procurement of security countermeasures is less than
$1,500,000,000, the Secretary shall submit to the Committee on
Appropriations and the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Appropriations
and the Committee on Energy and Commerce of the House of
Representatives a report detailing the amount of such funds
available for procurement and the impact such amount of funding
will have--</DELETED>
<DELETED> ``(A) in meeting the security
countermeasure needs identified under this section;
and</DELETED>
<DELETED> ``(B) on the annual Public Health
Emergency Medical Countermeasures Enterprise and
Strategy Implementation Plan (pursuant to section
2811(d)).''.</DELETED>
<DELETED>SEC. 3. CLARIFICATION ON BARDA CONTRACTING
AUTHORITY.</DELETED>
<DELETED> (a) In General.--Section 319F-2(g) of the Public Health
Service Act (42 U.S.C. 247d-6b(g)) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(5) Clarification on contracting authority.--The
Secretary, acting through the Director of the Biomedical
Advanced Research and Development Authority, shall carry out
the programs funded by the special reserve fund (for the
procurement of security countermeasures under subsection (c)
and for carrying out section 319L), including the execution of
procurement contracts, grants, and cooperative agreements
pursuant to this section and section 319L.''.</DELETED>
<DELETED> (b) BARDA Contracting Authority.--Section 319L(c)(3) of
the Public Health Service Act (42 U.S.C. 247d-7c) is amended by
inserting ``, including the execution of procurement contracts, grants,
and cooperative agreements pursuant to this section'' before the
period.</DELETED>
<DELETED>SEC. 4. COUNTERMEASURES BUDGET PLAN.</DELETED>
<DELETED> Section 2811(b)(7) of the Public Health Service Act (42
U.S.C. 300hh-10(b)(7)) is amended--</DELETED>
<DELETED> (1) by striking the first sentence and inserting
``Develop, and update not later than March 1 of each year, a
coordinated 5-year budget plan based on the medical
countermeasure priorities described in subsection (d),
including with respect to chemical, biological, radiological,
and nuclear agent or agents that may present a threat to the
Nation, including such agents that are novel or emerging
infectious diseases, and the corresponding efforts to develop
qualified countermeasures (as defined in section 319F-1),
security countermeasures (as defined in section 319F-2), and
qualified pandemic or epidemic products (as defined in section
319F-3) for each such threat.'';</DELETED>
<DELETED> (2) in subparagraph (C), by striking ``; and'' and
inserting a semicolon;</DELETED>
<DELETED> (3) in subparagraph (D), by striking ``to the
appropriate committees of Congress upon request.'' and
inserting ``, not later than March 15 of each year, to the
Committee on Appropriations and the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Appropriations and the Committee on Energy and Commerce of
the House of Representatives; and''; and</DELETED>
<DELETED> (4) by adding at the end the following:</DELETED>
<DELETED> ``(E) not later than March 15 of each
year, be made publicly available.''.</DELETED>
<DELETED>SEC. 5. PRIORITIZING THE ANIMAL RULE GUIDANCE.</DELETED>
<DELETED> Section 565(c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb-4(c)) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(3) Written explanation.--The Secretary shall
provide to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives a written explanation, not
later than the last day of each month after the date of
enactment of the Medical Countermeasure Innovation Act of 2015
in which the Secretary fails to finalize such guidance, for why
the Secretary has failed to finalize the guidance as required
by this subsection.''.</DELETED>
<DELETED>SEC. 6. STREAMLINING THE PROJECT BIOSHIELD PROCUREMENT
PROCESS.</DELETED>
<DELETED> Section 319F-2(c) of the Public Health Service Act (42
U.S.C. 247d-6b(c)) is amended--</DELETED>
<DELETED> (1) in paragraph (4)(A)(ii), by striking ``make a
recommendation under paragraph (6) that the special reserve
fund as defined in subsection (h) be made available for the
procurement of such countermeasure'' and inserting ``make
available the special reserve fund as defined in subsection (h)
for procurement of such countermeasure, as
applicable'';</DELETED>
<DELETED> (2) in paragraph (6)--</DELETED>
<DELETED> (A) by striking subparagraphs (A), (B),
and (E);</DELETED>
<DELETED> (B) by redesignating subparagraphs (C) and
(D) as subparagraphs (A) and (B),
respectively;</DELETED>
<DELETED> (C) by amending subparagraph (A), as so
redesignated, to read as follows:</DELETED>
<DELETED> ``(A) Notice to appropriate congressional
committees.--The Secretary shall notify the Committee
on Appropriations and the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Appropriations and the Committee on Energy
and Commerce of the House of Representatives of each
decision to make available the special reserve fund as
defined in subsection (h) for procurement of a security
countermeasure, including, where available, the number
of, the nature of, and other information concerning
potential suppliers of such countermeasure, and whether
other potential suppliers of the same or similar
countermeasures were considered and rejected for
procurement under this section and the reasons
therefore.''; and</DELETED>
<DELETED> (D) in the heading, by striking
``Recommendation for president's approval'' and
inserting ``Recommendations for procurement'';
and</DELETED>
<DELETED> (3) in paragraph (7)--</DELETED>
<DELETED> (A) by striking subparagraph
(A);</DELETED>
<DELETED> (B) by striking subparagraph (B) and
inserting the following:</DELETED>
<DELETED> ``(A) Payments from special reserve
fund.--The special reserve fund as defined in
subsection (h) shall be available for payments made by
the Secretary to a vendor for procurement of a security
countermeasure in accordance with the provisions of
this paragraph.''; and</DELETED>
<DELETED> (C) by redesignating subparagraph (C) as
subparagraph (B).</DELETED>
<DELETED>SEC. 7. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR AGENTS
THAT PRESENT NATIONAL SECURITY THREATS.</DELETED>
<DELETED> Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by inserting after
section 565 the following:</DELETED>
<DELETED>``SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR
AGENTS THAT PRESENT NATIONAL SECURITY THREATS.</DELETED>
<DELETED> ``(a) Definitions.--In this section:</DELETED>
<DELETED> ``(1) The term `priority review' with respect to a
human drug application as defined in section 735(1), means
review and action by the Secretary on such application not
later than 6 months after receipt by the Secretary of such
application, as described in the Manual of Policies and
Procedures in the Food and Drug Administration and goals
identified in the letters described in section 101(b) of the
Food and Drug Administration Safety and Innovation
Act.</DELETED>
<DELETED> ``(2) Priority review voucher.--The term `priority
review voucher' means a voucher issued by the Secretary to the
sponsor of a material threat medical countermeasure application
that entitles the holder of such voucher to priority review of
a single human drug application submitted under section
505(b)(1) or section 351 of the Public Health Service Act after
the date of approval of the material threat medical
countermeasure application.</DELETED>
<DELETED> ``(3) Material threat medical countermeasure
application.--The term `material threat medical countermeasure
application' means an application that--</DELETED>
<DELETED> ``(A) is a human drug application as
defined in section 735(1)--</DELETED>
<DELETED> ``(i) to prevent, or treat harm
from a biological, chemical, radiological, or
nuclear agent identified as a material threat
under section 319F-2(c)(2)(A)(ii) of the Public
Health Service Act, or</DELETED>
<DELETED> ``(ii) to mitigate, prevent, or
treat harm from a condition that may result in
adverse health consequences or death and may be
caused by administering a drug, or biological
product against such agent;</DELETED>
<DELETED> ``(B) the Secretary deems eligible for
priority review;</DELETED>
<DELETED> ``(C) is approved after the date of
enactment of the Medical Countermeasure Innovation Act
of 2015; and</DELETED>
<DELETED> ``(D) is for a human drug, no active
ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other
application under section 505(b)(1) or section 351 of
the Public Health Service Act.</DELETED>
<DELETED> ``(b) Priority Review Voucher.--</DELETED>
<DELETED> ``(1) In general.--The Secretary shall award a
priority review voucher to the sponsor of a material threat
medical countermeasure application upon approval by the
Secretary of such material threat medical countermeasure
application.</DELETED>
<DELETED> ``(2) Transferability.--The sponsor of a material
threat medical countermeasure application that receives a
priority review voucher under this section may transfer
(including by sale) the entitlement to such voucher to a
sponsor of a human drug for which an application under section
505(b)(1) or section 351 of the Public Health Service Act will
be submitted after the date of the approval of the material
threat medical countermeasure application. There is no limit on
the number of times a priority review voucher may be
transferred before such voucher is used.</DELETED>
<DELETED> ``(3) Notification.--</DELETED>
<DELETED> ``(A) In general.--The sponsor of a human
drug application shall notify the Secretary not later
than 90 calendar days prior to submission of the human
drug application that is the subject of a priority
review voucher of an intent to submit the human drug
application, including the date on which the sponsor
intends to submit the application. Such notification
shall be a legally binding commitment to pay for the
user fee to be assessed in accordance with this
section.</DELETED>
<DELETED> ``(B) Transfer after notice.--The sponsor
of a human drug application that provides notification
of the intent of such sponsor to use the voucher for
the human drug application under subparagraph (A) may
transfer the voucher after such notification is
provided, if such sponsor has not yet submitted the
human drug application described in the
notification.</DELETED>
<DELETED> ``(c) Priority Review User Fee.--</DELETED>
<DELETED> ``(1) In general.--The Secretary shall establish a
user fee program under which a sponsor of a human drug
application that is the subject of a priority review voucher
shall pay to the Secretary a fee determined under paragraph
(2). Such fee shall be in addition to any fee required to be
submitted by the sponsor under chapter VII.</DELETED>
<DELETED> ``(2) Fee amount.--The amount of the priority
review user fee shall be determined each fiscal year by the
Secretary and based on the average cost incurred by the agency
in the review of a human drug application subject to priority
review in the previous fiscal year.</DELETED>
<DELETED> ``(3) Annual fee setting.--The Secretary shall
establish, before the beginning of each fiscal year beginning
after September 30, 2015, for that fiscal year, the amount of
the priority review user fee.</DELETED>
<DELETED> ``(4) Payment.--</DELETED>
<DELETED> ``(A) In general.--The priority review
user fee required by this subsection shall be due upon
the submission of a human drug application under
section 505(b)(1) or section 351 of the Public Health
Service Act for which the priority review voucher is
used.</DELETED>
<DELETED> ``(B) Complete application.--An
application described under subparagraph (A) for which
the sponsor requests the use of a priority review
voucher shall be considered incomplete if the fee
required by this subsection and all other applicable
user fees are not paid in accordance with the
Secretary's procedures for paying such fees.</DELETED>
<DELETED> ``(C) No waivers, exemptions, reductions,
or refunds.--The Secretary may not grant a waiver,
exemption, reduction, or refund of any fees due and
payable under this section.</DELETED>
<DELETED> ``(5) Offsetting collections.--Fees collected
pursuant to this subsection for any fiscal year--</DELETED>
<DELETED> ``(A) shall be deposited and credited as
offsetting collections to the account providing
appropriations to the Food and Drug Administration;
and</DELETED>
<DELETED> ``(B) shall not be collected for any
fiscal year except to the extent provided in advance in
appropriation Acts.</DELETED>
<DELETED> ``(d) Notice of Issuance of Voucher and Approval of
Products Under Voucher.--The Secretary shall publish a notice in the
Federal Register and on the Internet Website of the Food and Drug
Administration not later than 30 calendar days after the occurrence of
each of the following:</DELETED>
<DELETED> ``(1) The Secretary issues a priority review
voucher under this section.</DELETED>
<DELETED> ``(2) The Secretary approves a drug pursuant to an
application submitted under section 505(b) of this Act or
section 351(a) of the Public Health Service Act for which the
sponsor of the application used a priority review voucher under
this section.</DELETED>
<DELETED> ``(e) Eligibility for Other Programs.--Nothing in this
section precludes a sponsor who seeks a priority review voucher under
this section from participating in any other incentive program,
including under this Act, except that no sponsor of a material threat
medical countermeasure application may receive more than one priority
review voucher with respect to such drug.</DELETED>
<DELETED> ``(f) Relation to Other Provisions.--The provisions of
this section shall supplement, not supplant, any other provisions of
this Act or the Public Health Service Act that encourage the
development of medical countermeasures.''.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medical Countermeasure Innovation
Act of 2016''.
SEC. 2. MEDICAL COUNTERMEASURE GUIDELINES.
(a) Strategic National Stockpile and Security Countermeasure
Procurements.--Section 319F-2 of the Public Health Service Act (42
U.S.C. 247d-6b) is amended--
(1) in subsection (a), by adding at the end the following:
``(3) Utilization guidelines.--The Secretary shall ensure
timely and accurate recommended utilization guidelines for
qualified countermeasures (as defined in section 319F-1),
qualified pandemic and epidemic products (as defined in section
319F-3), and security countermeasures (as defined in subsection
(c)), including for such products in the stockpile.''; and
(2) in subsection (g)--
(A) by amending paragraph (4) to read as follows:
``(4) Report on security countermeasure procurement.--Not
later than March 1 of each year in which the Secretary
determines that the amount of funds available for procurement
of security countermeasures is less than $1,500,000,000, the
Secretary shall submit to the Committee on Appropriations and
the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Appropriations and the Committee on
Energy and Commerce of the House of Representatives a report
detailing the amount of such funds available for procurement
and the impact such amount of funding will have--
``(A) in meeting the security countermeasure needs
identified under this section; and
``(B) on the annual Public Health Emergency Medical
Countermeasures Enterprise and Strategy Implementation
Plan (pursuant to section 2811(d)).''; and
SEC. 3. CLARIFICATION ON BARDA CONTRACTING AUTHORITY.
(a) In General.--Section 319F-2(g) of the Public Health Service Act
(42 U.S.C. 247d-6b(g)) is amended by adding at the end the following:
``(5) Clarification on contracting authority.--The
Secretary, acting through the Director of the Biomedical
Advanced Research and Development Authority, shall carry out
the programs funded by the special reserve fund (for the
procurement of security countermeasures under subsection (c)
and for carrying out section 319L), including the execution of
procurement contracts, grants, and cooperative agreements
pursuant to this section and section 319L.''.
(b) BARDA Contracting Authority.--Section 319L(c)(3) of the Public
Health Service Act (42 U.S.C. 247d-7c) is amended by inserting ``,
including the execution of procurement contracts, grants, and
cooperative agreements pursuant to this section'' before the period.
SEC. 4. COUNTERMEASURES BUDGET PLAN.
Section 2811(b)(7) of the Public Health Service Act (42 U.S.C.
300hh-10(b)(7)) is amended--
(1) by striking the first sentence and inserting ``Develop,
and update not later than March 1 of each year, a coordinated
5-year budget plan based on the medical countermeasure
priorities described in subsection (d), including with respect
to chemical, biological, radiological, and nuclear agent or
agents that may present a threat to the Nation, including such
agents that are novel or emerging infectious diseases, and the
corresponding efforts to develop qualified countermeasures (as
defined in section 319F-1), security countermeasures (as
defined in section 319F-2), and qualified pandemic or epidemic
products (as defined in section 319F-3) for each such
threat.'';
(2) in subparagraph (C), by striking ``; and'' and
inserting a semicolon;
(3) in subparagraph (D), by striking ``to the appropriate
committees of Congress upon request.'' and inserting ``, not
later than March 15 of each year, to the Committee on
Appropriations and the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Appropriations
and the Committee on Energy and Commerce of the House of
Representatives; and''; and
(4) by adding at the end the following:
``(E) not later than March 15 of each year, be made
publicly available in a manner that does not compromise
national security.''.
SEC. 5. MEDICAL COUNTERMEASURES INNOVATION.
Section 319L(c)(4) of the Public Health Service Act (42 U.S.C.
247d-7e(c)(4)) is amended by adding at the end the following:
``(E) Medical countermeasures innovation partner.--
``(i) In general.--To support the purposes
described in paragraph (2), the Secretary,
acting through the Director of BARDA, may enter
into an agreement (including through the use of
grants, contracts, cooperative agreements, or
other transactions as described in paragraph
(5)) with an independent, non-profit entity
to--
``(I) foster and accelerate the
development and innovation of medical
countermeasures and technologies that
may assist advanced research and
development of qualified
countermeasures and qualified pandemic
or epidemic products, including through
the use of strategic venture capital
practices and methods;
``(II) promote the development of
new and promising technologies that
address urgent medical countermeasure
needs, as identified by the Secretary;
``(III) address unmet public health
needs that are directly related to
medical countermeasure requirements,
such as novel antimicrobials for
multidrug resistant organisms and
multiuse platform technologies for
diagnostics, prophylaxis, vaccines, and
therapeutics; and
``(IV) provide expert consultation
and advice to foster viable medical
countermeasure innovators, including
helping qualified countermeasure
innovators navigate unique industry
challenges with respect to developing
chemical, biological, radiological, and
nuclear countermeasure products.
``(ii) Eligibility.--
``(I) In general.--To be eligible
to enter into an agreement under clause
(i) an entity shall--
``(aa) be an independent,
non-profit entity;
``(bb) have a demonstrated
record of being able to create
linkages between innovators and
investors and leverage such
partnerships and resources for
the purpose of addressing
identified strategic needs of
the Federal Government;
``(cc) have experience in
promoting novel technology
innovation;
``(dd) be problem driven
and solution focused based on
the needs, requirements, and
problems identified by the
Secretary under clause (iv);
``(ee) demonstrate the
ability, or the potential
ability, to promote the
development of medical
countermeasure products;
``(ff) demonstrate
expertise, or the capacity to
develop or acquire expertise,
related to technical and
regulatory considerations with
respect to medical
countermeasures; and
``(gg) not be within the
Department of Health and Human
Services.
``(II) Partnering experience.--In
selecting an entity with which to enter
into an agreement under clause (i), the
Secretary shall place a high value on
the demonstrated experience of the
entity in partnering with the Federal
Government to meet identified strategic
needs.
``(iii) Not agency.--An entity that enters
into an agreement under clause (i) shall not be
deemed to be a Federal agency for any purpose,
including for any purpose under title 5, United
States Code.
``(iv) Direction.--Pursuant to an agreement
entered into under this subparagraph, the
Secretary, acting through the Director of
BARDA, shall provide direction to the entity
that enters into an agreement under clause (i).
As part of this agreement the Director of BARDA
shall--
``(I) communicate the medical
countermeasure needs, requirements, and
problems to be addressed by the entity
under the agreement;
``(II) develop a description of
work to be performed by the entity
under the agreement;
``(III) provide technical feedback
and appropriate oversight over work
carried out by the entity under the
agreement, including subsequent
development and partnerships consistent
with the needs and requirements set
forth in this subparagraph;
``(IV) ensure fair consideration of
products developed under the agreement
in order to maintain competition to the
maximum practical extent, as applicable
and appropriate under applicable
provisions of this section; and
``(V) ensure, as a condition of the
agreement--
``(aa) a comprehensive set
of policies that demonstrate a
commitment to transparency and
accountability;
``(bb) protection against
conflicts of interest through a
comprehensive set of policies
that address potential
conflicts of interest, ethics,
disclosure, and reporting
requirements;
``(cc) that the entity
provides monthly accounting on
the use of funds provided under
such agreement; and
``(dd) that the entity
provides on a quarterly basis,
reports regarding the progress
made toward meeting the
identified needs set forth in
the agreement.
``(v) Supplement not supplant.--Activities
carried out under this subparagraph shall
supplement, and not supplant, other activities
carried out under this section.
``(vi) No establishment of entity.--To
prevent unnecessary duplication and target
resources effectively, nothing in this
subparagraph shall be construed to authorize
the Secretary to establish within the
Department of Health and Human Services an
entity for the purposes of carrying out this
subparagraph.
``(vii) Transparency and oversight.--Upon
request, the Secretary shall provide to
Congress the information provided to the
Secretary under clause (iv)(V)(dd).
``(viii) Independent evaluation.--Not later
than 4 years after the date of enactment of
this subparagraph, the Government
Accountability Office shall conduct an
independent evaluation, and submit to the
Secretary and the appropriate committees of
Congress a report, concerning the activities
conducted under this subparagraph. Such report
shall include recommendations with respect to
any agreement or activities carried out
pursuant to this subparagraph.
``(ix) Sunset.--This subparagraph shall
have no force or effect after September 30,
2022.''.
SEC. 6. STREAMLINING THE PROJECT BIOSHIELD PROCUREMENT PROCESS.
Section 319F-2(c) of the Public Health Service Act (42 U.S.C. 247d-
6b(c)) is amended--
(1) in paragraph (4)(A)(ii), by striking ``make a
recommendation under paragraph (6) that the special reserve
fund as defined in subsection (h) be made available for the
procurement of such countermeasure'' and inserting ``and
subject to the availability of appropriations, make available
the special reserve fund as defined in subsection (h) for
procurement of such countermeasure, as applicable'';
(2) in paragraph (6)--
(A) by striking subparagraphs (A), (B), and (E);
(B) by redesignating subparagraphs (C) and (D) as
subparagraphs (A) and (B), respectively;
(C) by amending subparagraph (A), as so
redesignated, to read as follows:
``(A) Notice to appropriate congressional
committees.--The Secretary shall notify the Committee
on Appropriations and the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Appropriations and the Committee on Energy
and Commerce of the House of Representatives of each
decision to make available the special reserve fund as
defined in subsection (h) for procurement of a security
countermeasure, including, where available, the number
of, the nature of, and other information concerning
potential suppliers of such countermeasure, and whether
other potential suppliers of the same or similar
countermeasures were considered and rejected for
procurement under this section and the reasons
therefore.''; and
(D) in the heading, by striking ``Recommendation
for president's approval'' and inserting
``Recommendations for procurement''; and
(3) in paragraph (7)--
(A) by striking subparagraph (A);
(B) by striking subparagraph (B) and inserting the
following:
``(A) Payments from special reserve fund.--The
special reserve fund as defined in subsection (h) shall
be available for payments made by the Secretary to a
vendor for procurement of a security countermeasure in
accordance with the provisions of this paragraph.'';
and
(C) by redesignating subparagraph (C) as
subparagraph (B).
SEC. 7. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR AGENTS THAT PRESENT
NATIONAL SECURITY THREATS.
Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section
565 the following:
``SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR AGENTS THAT
PRESENT NATIONAL SECURITY THREATS.
``(a) Definitions.--In this section:
``(1) The term `priority review' with respect to a human
drug application as defined in section 735(1), means review and
action by the Secretary on such application not later than 6
months after receipt by the Secretary of such application, as
described in the Manual of Policies and Procedures in the Food
and Drug Administration and goals identified in the letters
described in section 101(b) of the Food and Drug Administration
Safety and Innovation Act.
``(2) Priority review voucher.--The term `priority review
voucher' means a voucher issued by the Secretary to the sponsor
of a material threat medical countermeasure application that
entitles the holder of such voucher to priority review of a
single human drug application submitted under section 505(b)(1)
or section 351(a) of the Public Health Service Act after the
date of approval of the material threat medical countermeasure
application.
``(3) Material threat medical countermeasure application.--
The term `material threat medical countermeasure application'
means an application that--
``(A) is a human drug application as defined in
section 735(1)--
``(i) to prevent, or treat harm from a
biological, chemical, radiological, or nuclear
agent identified as a material threat under
section 319F-2(c)(2)(A)(ii) of the Public
Health Service Act, or
``(ii) to mitigate, prevent, or treat harm
from a condition that may result in adverse
health consequences or death and may be caused
by administering a drug, or biological product
against such agent; and
``(B) the Secretary deems eligible for priority
review;
``(C) is approved after the date of enactment of
the Medical Countermeasure Innovation Act of 2016; and
``(D) is for a human drug, no active ingredient
(including any ester or salt of the active ingredient)
of which has been approved in any other application
under section 505(b)(1) or section 351(a) of the Public
Health Service Act.
``(b) Priority Review Voucher.--
``(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a material threat medical
countermeasure application upon approval by the Secretary of
such material threat medical countermeasure application.
``(2) Transferability.--The sponsor of a material threat
medical countermeasure application that receives a priority
review voucher under this section may transfer (including by
sale) the entitlement to such voucher to a sponsor of a human
drug for which an application under section 505(b)(1) or
section 351(a) of the Public Health Service Act will be
submitted after the date of the approval of the material threat
medical countermeasure application. There is no limit on the
number of times a priority review voucher may be transferred
before such voucher is used.
``(3) Notification.--
``(A) In general.--The sponsor of a human drug
application shall notify the Secretary not later than
90 calendar days prior to submission of the human drug
application that is the subject of a priority review
voucher of an intent to submit the human drug
application, including the date on which the sponsor
intends to submit the application. Such notification
shall be a legally binding commitment to pay for the
user fee to be assessed in accordance with this
section.
``(B) Transfer after notice.--The sponsor of a
human drug application that provides notification of
the intent of such sponsor to use the voucher for the
human drug application under subparagraph (A) may
transfer the voucher after such notification is
provided, if such sponsor has not yet submitted the
human drug application described in the notification.
``(c) Priority Review User Fee.--
``(1) In general.--The Secretary shall establish a user fee
program under which a sponsor of a human drug application that
is the subject of a priority review voucher shall pay to the
Secretary a fee determined under paragraph (2). Such fee shall
be in addition to any fee required to be submitted by the
sponsor under chapter VII.
``(2) Fee amount.--The amount of the priority review user
fee shall be determined each fiscal year by the Secretary and
based on the average cost incurred by the agency in the review
of a human drug application subject to priority review in the
previous fiscal year.
``(3) Annual fee setting.--The Secretary shall establish,
before the beginning of each fiscal year beginning after
September 30, 2015, for that fiscal year, the amount of the
priority review user fee.
``(4) Payment.--
``(A) In general.--The priority review user fee
required by this subsection shall be due upon the
submission of a human drug application under section
505(b)(1) or section 351(a) of the Public Health
Services Act for which the priority review voucher is
used.
``(B) Complete application.--An application
described under subparagraph (A) for which the sponsor
requests the use of a priority review voucher shall be
considered incomplete if the fee required by this
subsection and all other applicable user fees are not
paid in accordance with the Secretary's procedures for
paying such fees.
``(C) No waivers, exemptions, reductions, or
refunds.--The Secretary may not grant a waiver,
exemption, reduction, or refund of any fees due and
payable under this section.
``(5) Offsetting collections.--Fees collected pursuant to
this subsection for any fiscal year--
``(A) shall be deposited and credited as offsetting
collections to the account providing appropriations to
the Food and Drug Administration; and
``(6) shall not be collected for any fiscal year except to
the extent provided in advance in appropriation Acts.
``(d) Notice of Issuance of Voucher and Approval of Products Under
Voucher.--The Secretary shall publish a notice in the Federal Register
and on the Internet Website of the Food and Drug Administration not
later than 30 calendar days after the occurrence of each of the
following:
``(1) The Secretary issues a priority review voucher under
this section.
``(2) The Secretary approves a drug pursuant to an
application submitted under section 505(b) of this Act or
section 351(a) of the Public Health Service Act for which the
sponsor of the application used a priority review voucher under
this section.
``(e) Eligibility for Other Programs.--Nothing in this section
precludes a sponsor who seeks a priority review voucher under this
section from participating in any other incentive program, including
under this Act, except that no sponsor of a material threat medical
countermeasure application may receive more than one priority review
voucher issued under any section of this Act with respect to such drug.
``(f) Relation to Other Provisions.--The provisions of this section
shall supplement, not supplant, any other provisions of this Act or the
Public Health Service Act that encourage the development of medical
countermeasures.''.
SEC. 8. GAO REPORT.
(a) Study.--The Comptroller General of the United States shall
conduct a study on the effectiveness of priority review vouchers under
section 565A of the Federal Food, Drug, and Cosmetic Act (as added by
section 7) in providing incentives for the development of material
threat medical countermeasures applications under such section 565A. In
conducting such study, the Comptroller General shall examine the
following:
(1) The impact of the priority review voucher in attracting
investment into the development of material threat medical
countermeasures and the impact of such investment, as
applicable, on the development of such countermeasures.
(2) How the drugs for which priority review vouchers were
awarded under such section 565A--
(A) addressed identified medical countermeasure
needs; and
(B) impacted United States preparedness against
chemical, biological, radiological, and nuclear
threats, including both identified threats and
naturally-occurring threats.
(3) How many material threat medical countermeasures were
licensed or approved, or otherwise significantly advanced in
clinical development, in the 10 years following the enactment
of such section 565A compared to the 10 years prior to the
enactment of such section.
(4) An analysis of the drugs for which such priority review
vouchers were used, which shall include--
(A) the indications for which such drugs were
approved under section 505(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) or section
351(a) of the Public Health Service Act (42 U.S.C.
262);
(B) whether unmet medical needs were addressed
through the approval of such drugs, including, for each
such drug--
(i) if an alternative therapy was
previously available to treat the indication;
and
(ii) if the drug provided a benefit or
advantage over another available therapy;
(C) the value of the priority review voucher if
transferred; and
(D) the length of time between the date on which a
priority review voucher was awarded and the date on
which it was used.
(5) With respect to the priority review voucher program
under such section 565A--
(A) how many priority review vouchers were awarded
under such section 565A and how many of such awarded
vouchers were redeemed for priority review of a drug
application in the 10 years following the date of
enactment of such section;
(B) the resources associated with the Food and Drug
Administration implementation of such section 565A and
review of applications for which a voucher awarded
under such section 565A is redeemed for priority
review; and
(C) recommendations, if any, with respect to how
such section 565A could be improved to better achieve
the objective of incentivizing the timely development
of medical countermeasures to address identified
chemical, biological, radiological, and nuclear
threats, including for medical countermeasures that
might otherwise not be developed, potentially eligible
for an emergency use authorization, licensed, or
approved.
(b) Consultations.--In conducting the study under subsection (a),
the Comptroller General of the United States shall consult with--
(1) drug manufacturers involved in the research and
development of medical countermeasures to address biological,
chemical, radiological, and nuclear threats;
(2) stakeholders involved in investing in the research and
development of medical countermeasures, including venture
capitalists;
(3) the Federal Government agencies responsible for
advancing, reviewing, and procuring medical countermeasures,
including--
(A) the Department of Health and Human Services,
including the Office of the Assistant Secretary for
Preparedness and Response, the Biomedical Advanced
Research and Development Authority, and the Food and
Drug Administration; and
(B) the Department of Defense; and
(4) biodefense stakeholders, as applicable.
(c) Initial Assessment.--Not later than 7 years after the date of
enactment of this Act, the Comptroller General of the United States
shall submit to the Committee on Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce of the House of
Representatives an initial assessment of the effectiveness of the
priority review voucher program set forth in section 565A of the
Federal Food, Drug, and Cosmetic Act (as added by section 7).
(d) Report.--Not later than 12 years after the date of enactment of
this Act, the Comptroller General of the United States shall submit to
the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of
Representatives a report containing the results of the study conducted
under subsection (a).
(e) Protection of National Security.--The Comptroller General of
the United States shall conduct the study and issue the assessment and
report under this section in a manner that does not compromise national
security.
Calendar No. 388
114th CONGRESS
2d Session
S. 2055
_______________________________________________________________________
A BILL
To amend the Public Health Service Act and the Federal Food, Drug, and
Cosmetic Act with respect to national health security.
_______________________________________________________________________
March 14, 2016
Reported with an amendment