[Congressional Record Volume 169, Number 129 (Wednesday, July 26, 2023)]
[Senate]
[Pages S3665-S3666]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  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.
                                 ______