Sec. 1087. 9/11 Responder and Survivor Health Funding Correction Act of 2023
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Title XXXIII of the Public Health Service Act ( 42 U.S.C. 300mm et seq. ) is amended— in section 3306 ( 42 U.S.C. 300mm–5 )— by redesignating paragraphs
(5)through
(11)and paragraphs
(12)through
(17)as paragraphs
(6)through
(12)and paragraphs
(14)through (19), respectively; by inserting after paragraph
(4)the following: The term Federal agency means an agency, office, or other establishment in the executive, legislative, or judicial branch of the Federal Government. ; and by inserting after paragraph (12), as so redesignated, the following: The term uniformed services has the meaning given the term in section 101(a) of title 10, United States Code. ; and in section 3311(a) ( 42 U.S.C. 300mm–21(a) )— in paragraph (2)(C)(i)— in subclause (I), by striking ; or and inserting a semicolon; in subclause (II), by striking ; and and inserting a semicolon; and by adding at the end the following: 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 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 in paragraph (4)(A)— by striking
(A)and inserting the following: In general .—The The ; by inserting or subclause
(III)or
(IV)of paragraph (2)(C)(i) after or (2)(A)(ii) ; and by adding at the end the following: 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. . Title XXXIII of the Public Health Service Act ( 42 U.S.C. 300mm et seq. ) is amended by adding at the end the following: 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). Out of any money in the Treasury not otherwise appropriated, there is appropriated for fiscal year 2024 $444,000,000 for deposit into the Special Fund, which amounts shall remain available in such Fund through fiscal year 2033. 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)). Any amounts that remain in the Special Fund on September 30, 2033, shall be deposited into the Treasury as miscellaneous receipts. 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). 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. 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). 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). Any amounts that remain in the Pentagon/Shanksville Fund on September 30, 2033, shall be deposited into the Treasury as miscellaneous receipts. . Title XXXIII of the Public Health Service Act ( 42 U.S.C. 300mm et seq. ) is amended— 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 ; 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 ; in section 3331 ( 42 U.S.C. 300mm–41 )— 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 in subsection (d)— in paragraph (1)(A), by inserting or the World Trade Center Health Program Special Fund under section 3353 after section 3351 ; 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 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 in section 3351(b) ( 42 U.S.C. 300mm–61(b) )— 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 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. Section 505(q) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(q) ) is amended— in paragraph (1)— in subparagraph (A)(i), by inserting , 10.31, after 10.30 ; in subparagraph (E)— by striking application and and inserting application or ; by striking If the Secretary and inserting the following: If the Secretary ; and by striking the second sentence and inserting the following: In determining whether a petition was submitted with the primary purpose of delaying an application, the Secretary may consider the following factors: 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. 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. Whether the petitioner has submitted multiple or serial petitions or supplements to petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions. 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. Whether the petition was submitted without relevant data or information in support of the scientific positions forming the basis of such petition. 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. 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. 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. Other relevant and appropriate factors, which the Secretary shall describe in guidance. The Secretary may issue or update guidance, as appropriate, to describe factors the Secretary considers in accordance with subclause (I). ; by striking subparagraph (F); by redesignating subparagraphs
(G)through
(I)as subparagraphs
(F)through (H), respectively; and in subparagraph (H), as so redesignated, by striking submission of this petition and inserting submission of this document ; in paragraph (2)— by redesignating subparagraphs
(A)through
(C)as subparagraphs
(C)through (E), respectively; by inserting before subparagraph (C), as so redesignated, the following: 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. 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. ; in subparagraph (C), as so redesignated— in the heading, by striking ; within 150 days in clause (i), by striking during the 150-day period referred to in paragraph (1)(F), ; and by amending clause
(ii)to read as follows: 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. ; by amending subparagraph (D), as so redesignated, to read as follows: 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. 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. 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 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 in paragraph (4)— by striking in the paragraph heading and all that follows through Exceptions This subsection does and inserting ; Exceptions.— This subsection does by striking subparagraph (B); and by redesignating clauses
(i)and
(ii)as subparagraphs
(A)and (B), respectively, and adjusting the margins accordingly.
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6 references not yet in our index
- 42 USC 300mm–5
- 42 USC 300mm–21(a)
- 42 USC 300mm–21(a)(4)(B)(i)(II)
- 42 USC 300mm–31(a)(3)(B)(i)(II)
- 42 USC 300mm–41
- 42 USC 300mm–61(b)
Citation graph
cites case law
Sec. 1087
9/11 Responder and Survivor Health Funding Correction Act of 2023
Cite42 USC 300mm–5
Cite42 USC 300mm–21(a)
Cite42 USC 300mm–21(a)(4)(B)(i)(II)
Cite42 USC 300mm–31(a)(3)(B)(i)(II)
Cite42 USC 300mm–41
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