S.Amdt. 1057

SA 1057. Mrs. GILLIBRAND submitted an amendment intended to be
proposed by her to the bill S. 2226, to authorize appropriations for
fiscal year 2024 for military activities of the Department of Defense,
for military construction, and for defense activities of the Department
of Energy, to prescribe military personnel strengths for such fiscal
year, and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place in subtitle G of title X, insert
the following:

SEC. ___. 9/11 RESPONDER AND SURVIVOR HEALTH FUNDING
CORRECTION ACT OF 2023.

(a) Department of Defense, Armed Forces, or Other Federal
Worker Responders to the September 11 Attacks at the Pentagon
and Shanksville, Pennsylvania.--Title XXXIII of the Public
Health Service Act (42 U.S.C. 300mm et seq.) is amended--
(1) in section 3306 (42 U.S.C. 300mm-5)--
(A) by redesignating paragraphs (5) through (11) and
paragraphs (12) through (17) as paragraphs (6) through (12)
and paragraphs (14) through (19), respectively;
(B) by inserting after paragraph (4) the following:
``(5) The term `Federal agency' means an agency, office, or
other establishment in the executive, legislative, or
judicial branch of the Federal Government.''; and
(C) by inserting after paragraph (12), as so redesignated,
the following:
``(13) The term `uniformed services' has the meaning given
the term in section 101(a) of title 10, United States
Code.''; and
(2) in section 3311(a) (42 U.S.C. 300mm-21(a))--
(A) in paragraph (2)(C)(i)--
(i) in subclause (I), by striking ``; or'' and inserting a
semicolon;
(ii) in subclause (II), by striking ``; and'' and inserting
a semicolon; and
(iii) by adding at the end the following:
``(III) was an employee of the Department of Defense or any
other Federal agency, worked during the period beginning on
September 11, 2001, and ending on September 18, 2001, for a
contractor of the Department of Defense or any other Federal
agency, or was a member of a regular or reserve component of
the uniformed services; and performed rescue, recovery,
demolition, debris cleanup, or other related services at the
Pentagon site of the terrorist-related aircraft crash of
September 11, 2001, during the period beginning on September
11, 2001, and ending on the date on which the cleanup of the
site was concluded, as determined by the WTC Program
Administrator; or
``(IV) was an employee of the Department of Defense or any
other Federal agency, worked during the period beginning on
September 11, 2001, and ending on September 18, 2001, for a
contractor of the Department of Defense or any other Federal
agency, or was a member of a regular or reserve component of
the uniformed services; and performed rescue, recovery,
demolition, debris cleanup, or other related services at the
Shanksville, Pennsylvania, site of the terrorist-related
aircraft crash of September 11, 2001, during the period
beginning on September 11, 2001, and ending on the date on
which the cleanup of the site was concluded, as determined by
the WTC Program Administrator; and''; and
(B) in paragraph (4)(A)--
(i) by striking ``(A) In general.--The'' and inserting the
following:
``(A) Limit.--
``(i) In general.--The'';
(ii) by inserting ``or subclause (III) or (IV) of paragraph
(2)(C)(i)'' after ``or (2)(A)(ii)''; and
(iii) by adding at the end the following:
``(ii) Certain responders to the september 11 attacks at
the pentagon and shanksville, pennsylvania.--The total number
of individuals who may be enrolled under paragraph (3)(A)(ii)
based on eligibility criteria described in subclause (III) or
(IV) of paragraph (2)(C)(i) shall not exceed 500 at any
time.''.
(b) Additional Funding for the World Trade Center Health
Program.--Title XXXIII of the Public Health Service Act (42
U.S.C. 300mm et seq.) is amended by adding at the end the
following:

``SEC. 3353. SPECIAL FUND.

``(a) In General.--There is established a fund to be known
as the World Trade Center Health Program Special Fund
(referred to in this section as the `Special Fund'),
consisting of amounts deposited into the Special Fund under
subsection (b).
``(b) Amount.--Out of any money in the Treasury not
otherwise appropriated, there is appropriated for fiscal year
2024 $419,000,000 for deposit into the Special Fund, which
amounts shall remain available in such Fund through fiscal
year 2033.
``(c) Uses of Funds.--Amounts deposited into the Special
Fund under subsection (b) shall be available, without further
appropriation and without regard to any spending limitation
under section 3351(c), to the WTC Program Administrator as
needed at the discretion of such Administrator, for carrying
out any provision in this title (including sections 3303 and
3341(c)).
``(d) Remaining Amounts.--Any amounts that remain in the
Special Fund on September 30, 2033, shall be deposited into
the Treasury as miscellaneous receipts.

``SEC. 3354. PENTAGON/SHANKSVILLE FUND.

``(a) In General.--There is established a fund to be known
as the World Trade Center Health Program Fund for Certain WTC
Responders at the Pentagon and Shanksville, Pennsylvania
(referred to in this section as the `Pentagon/Shanksville
Fund'), consisting of amounts deposited into the Pentagon/
Shanksville Fund under subsection (b).
``(b) Amount.--Out of any money in the Treasury not
otherwise appropriated, there is appropriated for fiscal year
2024 $232,000,000 for deposit into the Pentagon/Shanksville
Fund, which amounts shall remain available in such Fund
through fiscal year 2033.
``(c) Uses of Funds.--
``(1) In general.--Amounts deposited into the Pentagon/
Shanksville Fund under subsection (b) shall be available,
without further appropriation and without regard to any
spending limitation under section 3351(c), to the WTC Program
Administrator for the purpose of carrying out section 3312
with regard to WTC responders enrolled in the WTC Program
based on eligibility criteria described in subclause (III) or
(IV) of section 3311(a)(2)(C)(i).
``(2) Limitation on other funding.--Notwithstanding
sections 3331(a), 3351(b)(1), 3352(c), and 3353(c), and any
other provision in this title, for the period of fiscal years
2024 through 2033, no amounts made available under this title
other than those amounts appropriated under subsection (b)
may be available for the purpose described in paragraph (1).
``(d) Remaining Amounts.--Any amounts that remain in the
Pentagon/Shanksville Fund on September 30, 2033, shall be
deposited into the Treasury as miscellaneous receipts.''.
(c) Conforming Amendments.--Title XXXIII of the Public
Health Service Act (42 U.S.C. 300mm et seq.) is amended--
(1) in section 3311(a)(4)(B)(i)(II) (42 U.S.C. 300mm-
21(a)(4)(B)(i)(II)), by striking ``sections 3351 and 3352''
and inserting ``this title'';
(2) in section 3321(a)(3)(B)(i)(II) (42 U.S.C. 300mm-
31(a)(3)(B)(i)(II)), by striking ``sections 3351 and 3352''
and inserting ``this title'';
(3) in section 3331 (42 U.S.C. 300mm-41)--
(A) in subsection (a), by striking ``the World Trade Center
Health Program Fund and the World Trade Center Health Program
Supplemental Fund'' and inserting ``(as applicable) the Funds
established under sections 3351, 3352, 3353, and 3354''; and
(B) in subsection (d)--
(i) in paragraph (1)(A), by inserting ``or the World Trade
Center Health Program Special Fund under section 3353'' after
``section 3351'';
(ii) in paragraph (1)(B), by inserting ``or the World Trade
Center Health Program Fund for Certain WTC Responders at the
Pentagon and Shanksville, Pennsylvania under section 3354''
after ``section 3352''; and
(iii) in paragraph (2), in the flush text following
subparagraph (C), by inserting ``or the World Trade Center
Health Program Fund for Certain WTC Responders at the
Pentagon and Shanksville, Pennsylvania under section 3354''
after ``section 3352''; and
(4) in section 3351(b) (42 U.S.C. 300mm-61(b))--
(A) in paragraph (2), by inserting ``, the World Trade
Center Health Program Special Fund under section 3353, or the
World Trade Center Health Program Fund for Certain WTC
Responders at the Pentagon and Shanksville, Pennsylvania
under section 3354'' before the period at the end; and
(B) in paragraph (3), by inserting ``, the World Trade
Center Health Program Special Fund under section 3353, or the
World Trade Center Health Program Fund for Certain WTC
Responders at the Pentagon and Shanksville, Pennsylvania
under section 3354'' before the period at the end.
(d) Ensuring Timely Access to Generics.--Section 505(q) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q))
is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)(i), by inserting ``, 10.31,'' after
``10.30'';
(B) in subparagraph (E)--
(i) by striking ``application and'' and inserting
``application or'';
(ii) by striking ``If the Secretary'' and inserting the
following:
``(i) In general.--If the Secretary''; and
(iii) by striking the second sentence and inserting the
following:
``(ii) Primary purpose of delaying.--

``(I) In general.--In determining whether a petition was
submitted with the primary purpose of delaying an
application, the Secretary may consider the following
factors:

``(aa) Whether the petition was submitted in accordance
with paragraph (2)(B), based on when the petitioner knew the
relevant information relied upon to form the basis of such
petition.
``(bb) When the petition was submitted in relation to when
the petitioner reasonably should have known the relevant
information relied upon to form the basis of such petition.
``(cc) Whether the petitioner has submitted multiple or
serial petitions or supplements to petitions raising issues
that reasonably

[[Page S3666]]

could have been known to the petitioner at the time of
submission of the earlier petition or petitions.
``(dd) Whether the petition was submitted close in time to
a known, first date upon which an application under
subsection (b)(2) or (j) of this section or section 351(k) of
the Public Health Service Act could be approved.
``(ee) Whether the petition was submitted without relevant
data or information in support of the scientific positions
forming the basis of such petition.
``(ff) Whether the petition raises the same or
substantially similar issues as a prior petition to which the
Secretary has responded substantively already, including if
the subsequent submission follows such response from the
Secretary closely in time.
``(gg) Whether the petition requests changing the
applicable standards that other applicants are required to
meet, including requesting testing, data, or labeling
standards that are more onerous or rigorous than the
standards the Secretary has determined to be applicable to
the listed drug, reference product, or petitioner's version
of the same drug.
``(hh) The petitioner's record of submitting petitions to
the Food and Drug Administration that have been determined by
the Secretary to have been submitted with the primary purpose
of delay.
``(ii) Other relevant and appropriate factors, which the
Secretary shall describe in guidance.

``(II) Guidance.--The Secretary may issue or update
guidance, as appropriate, to describe factors the Secretary
considers in accordance with subclause (I).'';

(C) by striking subparagraph (F);
(D) by redesignating subparagraphs (G) through (I) as
subparagraphs (F) through (H), respectively; and
(E) in subparagraph (H), as so redesignated, by striking
``submission of this petition'' and inserting ``submission of
this document'';
(2) in paragraph (2)--
(A) by redesignating subparagraphs (A) through (C) as
subparagraphs (C) through (E), respectively;
(B) by inserting before subparagraph (C), as so
redesignated, the following:
``(A) In general.--A person shall submit a petition to the
Secretary under paragraph (1) before filing a civil action in
which the person seeks to set aside, delay, rescind,
withdraw, or prevent submission, review, or approval of an
application submitted under subsection (b)(2) or (j) of this
section or section 351(k) of the Public Health Service Act.
Such petition and any supplement to such a petition shall
describe all information and arguments that form the basis of
the relief requested in any civil action described in the
previous sentence.
``(B) Timely submission of citizen petition.--A petition
and any supplement to a petition shall be submitted within
180 days after the person knew the information that forms the
basis of the request made in the petition or supplement.'';
(C) in subparagraph (C), as so redesignated--
(i) in the heading, by striking ``within 150 days'';
(ii) in clause (i), by striking ``during the 150-day period
referred to in paragraph (1)(F),''; and
(iii) by amending clause (ii) to read as follows:
``(ii) on or after the date that is 151 days after the date
of submission of the petition, the Secretary approves or has
approved the application that is the subject of the petition
without having made such a final decision.'';
(D) by amending subparagraph (D), as so redesignated, to
read as follows:
``(D) Dismissal of certain civil actions.--
``(i) Petition.--If a person files a civil action against
the Secretary in which a person seeks to set aside, delay,
rescind, withdraw, or prevent submission, review, or approval
of an application submitted under subsection (b)(2) or (j) of
this section or section 351(k) of the Public Health Service
Act without complying with the requirements of subparagraph
(A), the court shall dismiss without prejudice the action for
failure to exhaust administrative remedies.
``(ii) Timeliness.--If a person files a civil action
against the Secretary in which a person seeks to set aside,
delay, rescind, withdraw, or prevent submission, review, or
approval of an application submitted under subsection (b)(2)
or (j) of this section or section 351(k) of the Public Health
Service Act without complying with the requirements of
subparagraph (B), the court shall dismiss with prejudice the
action for failure to timely file a petition.
``(iii) Final response.--If a civil action is filed against
the Secretary with respect to any issue raised in a petition
timely filed under paragraph (1) in which the petitioner
requests that the Secretary take any form of action that
could, if taken, set aside, delay, rescind, withdraw, or
prevent submission, review, or approval of an application
submitted under subsection (b)(2) or (j) of this section or
section 351(k) of the Public Health Service Act before the
Secretary has taken final agency action on the petition
within the meaning of subparagraph (C), the court shall
dismiss without prejudice the action for failure to exhaust
administrative remedies.''; and
(E) in clause (iii) of subparagraph (E), as so
redesignated, by striking ``as defined under subparagraph
(2)(A)'' and inserting ``within the meaning of subparagraph
(C)''; and
(3) in paragraph (4)--
(A) by striking ``Exceptions'' in the paragraph heading and
all that follows through ``This subsection does'' and
inserting ``Exceptions.--This subsection does'';
(B) by striking subparagraph (B); and
(C) by redesignating clauses (i) and (ii) as subparagraphs
(A) and (B), respectively, and adjusting the margins
accordingly.
______