Sec. 301. Transition of certain countermeasures between compensation programs

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In the case of a request for compensation submitted under section 319F–4 of the Public Health Service Act ( 42 U.S.C. 247d–6e ) for an injury or death related to a COVID–19 vaccine that the Secretary determines to be ineligible pursuant to subparagraph

(B)of such section 319F–4(b)(4), as added by subsection (b)(1), the Secretary shall, not later than 30 days after such determination, notify the individual submitting the request of such determination. An individual who receives a notification described in subparagraph

(A)shall be eligible to submit a petition to the United States Court of Federal Claims under section 2111 of the Public Health Service Act ( 42 U.S.C. 300aa–11 ) with respect to the same vaccine administration claimed in the request submitted under section 319F–4 of such Act ( 42 U.S.C. 247d–6e ), provided that such petition is submitted not later than the later of— 1 year after receiving such notification under subparagraph (A); or the last date on which the individual otherwise would be eligible to submit a petition relating to such injury, as specified in section 2116 of the Public Health Service Act ( 42 U.S.C. 300aa–16 ). To be eligible to submit a petition in accordance with subparagraph (B), the petitioner shall have submitted the request for compensation under section 319F–4 of the Public Health Service Act that was determined to be ineligible not later than the deadline for filing a petition under section 2116 of the Public Health Service Act ( 42 U.S.C. 300aa–16 ) that applies with respect to the administration of such vaccine. If a special master determines that— a petition submitted under section 2111 of the Public Health Service Act ( 42 U.S.C. 300aa–11 ) related to a COVID–19 vaccine is ineligible for the National Vaccine Injury Compensation Program under subtitle 2 of title XXI of the Public Health Service Act ( 42 U.S.C. 300aa–10 et seq. ) because it relates to a vaccine administered at a time when the vaccine was not included in the Vaccine Injury Table under section 2114 of such Act ( 42 U.S.C. 300aa–14 ); and the vaccine was administered when it was a covered countermeasure subject to a declaration under section 319F–3(b) of such Act (42 U.S.C. 247d–6d(b)), the special master shall, not later than 30 days after such determination, notify the petitioner of such determination. An individual who receives a notification described in subparagraph

(A)shall be eligible to submit a request for compensation under section 319F–4(b) of the Public Health Service Act ( 42 U.S.C. 247d–6e ) with respect to the same vaccine administration claimed in the petition submitted under section 2111 of such Act— not later than 1 year after receiving such notification; or in the case that the notification is issued after judicial review of the petition under subsection

(e)or

(f)of section 2112 of such Act ( 42 U.S.C. 300aa–12 ), not later than 1 year after the decision of the United States Court of Federal Claim or the mandate is issued by the United States Court of Appeals for the Federal Circuit pursuant to such subsection

(e)or (f). To be eligible to submit a request for compensation in accordance with subparagraph (B), the individual submitting the request shall have submitted the petition under section 2111 of the Public Health Service Act ( 42 U.S.C. 300aa–11 ) that was determined to be ineligible not later than one year after the date of administration of the vaccine. Section 319F–4 of the Public Health Service Act ( 42 U.S.C. 247d–6e ) is amended— in subsection (b)(4)— by striking Except as provided and inserting the following: Except as provided ; and by adding at the end the following: Notwithstanding any other provision of this section, no individual may be eligible for compensation under this section with respect to a vaccine that, at the time it was administered, was included in the Vaccine Injury Table under section 2114. ; and in subsection (d)(3)— by striking This section and inserting the following: This section ; and by adding at the end the following: A covered individual shall not be considered to have exhausted remedies as described in paragraph (1), nor be eligible to seek remedy under section 319F–3(d), unless such individual has provided to the Secretary all supporting documentation necessary to facilitate the determinations required under subsection (b)(4). . Title XXI of the Public Health Service Act ( 42 U.S.C. 300aa–1 et seq. ) is amended— in section 2111(a)(2)(A) ( 42 U.S.C. 300aa–11(a)(2)(A) ), in the matter preceding clause (i), by inserting containing the information required under subsection

(c)after unless a petition ; in section 2112(d) ( 42 U.S.C. 300aa–12(d) )— by adding at the end of paragraph

(1)the following: Such designation shall not occur until the petitioner has filed all materials required under section 2111(c). ; and in paragraph (3)(A)(ii), by striking the petition was filed and inserting on which the chief special master makes the designation pursuant to paragraph

(1); in section 2114(e) ( 42 U.S.C. 300aa–14(e) )— in paragraph (2), in the matter preceding subparagraph (A), by striking 2 years and inserting 6 months ; and by adding at the end the following: Notwithstanding paragraphs

(2)and (3), the Secretary may not revise the Vaccine Injury Table to include a vaccine for which the Centers for Disease Control and Prevention has issued a recommendation for routine use in children or pregnant women until at least one application for such vaccine has been approved under section 351. Upon such revision of the Vaccine Injury Table, all vaccines to prevent the same infectious disease, including vaccines authorized under emergency use pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act, shall be considered included in the Vaccine Injury Table. ; and in section 2116 ( 42 U.S.C. 300aa–16 ), by adding at the end the following: Notwithstanding subsections

(a)and (b), an injury or death related to a vaccine administered at a time when the vaccine was a covered countermeasure subject to a declaration under section 319F–3(b) shall not be eligible for compensation under the Program. .

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42 USC 247d–6e
42 USC 300aa–11
42 USC 300aa–16
42 USC 300aa–10
42 USC 300aa–14
42 USC 247d–6d(b)
42 USC 300aa–12
42 USC 300aa–1
42 USC 300aa–11(a)(2)(A)
42 USC 300aa–12(d)
42 USC 300aa–14(e)

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cites case law

Sec. 301

Transition of certain countermeasures between compensation programs

Cite42 USC 247d–6e

Cite42 USC 300aa–11

Cite42 USC 300aa–16

Cite42 USC 300aa–10

Cite42 USC 300aa–14

Cites 11 · showing 5Cited by 0 across 0 sources