Amendment to the Countermeasure Injury Compensation Program

Section 319F–4 of the Public Health Service Act (42 U.S.C. 247d–6e) is amended—(1)in subsection (b)—(A)in paragraph (1), by striking under 319F–3(b) and inserting under section 319F–3(b);(B)in paragraph (2)—(i)by striking and be in the same amount and all that follows through shall not apply and inserting be in the same amount, and be subject to the same conditions as is prescribed by section 2115;(C)by striking paragraphs (3) and (4) and inserting the following:

(3)

Determination of eligibility and compensation

Compensation shall be awarded under this section to eligible individuals in accordance with the procedure set forth in sections 2111, 2112, 2113, and 2121 for purposes of the National Vaccine Injury Compensation Program, subject to the other provisions of this section.

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(D)by inserting before paragraph (5) the following:

(4)

Time for filing petitions

(A)

Previously submitted requests

(i)

Pending claims

In the case of a request for compensation submitted under this section before the date of enactment of the Countermeasure Injury Compensation Fund Amendment Act for which no compensation has been provided prior to such date of enactment, in order to be eligible for compensation under this section, not later than 28 months after such date of enactment, the individual shall submit a new petition under this section, consistent with the amendments made by the Countermeasure Injury Compensation Fund Amendment Act.(ii)

Previously paid claims

In the case of a request for compensation submitted under this section and paid under this section before the date of enactment of the Countermeasure Injury Compensation Fund Amendment Act that relates to a COVID–19 countermeasure, the individual receiving such compensation may submit a subsequent petition under this section for additional compensation in the amount the individual would have received for such claim under this section after such date of enactment, less the amount already received by the individual.(B)

Subsequent petitions

In the case of a an injury or death resulting from the administration or use of a covered countermeasure to which subparagraph (A) does not apply, a petition for benefits or compensation under this section shall be filed not later than—(i)subject to clause (ii)—(I)in the case of serious physical injury, 3 years after the first symptom or manifestation of onset of a significant aggravation of a covered injury; or(II)in the case of death—(aa)2 years after death from the administration or use of the covered countermeasure; and (bb)4 years after the occurrence of the first symptom or manifestation of onset or of the significant aggravation of the injury from which the death resulted; and(ii)in the case that a covered countermeasure is added to the table under paragraph (5)(A) and the effect is to permit an individual who was not, before such addition, eligible to seek compensation under this section, such individual may file a petition for such compensation not later than 2 years after the effective date of the addition of such countermeasure.

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(E)in paragraph (5), by striking subparagraphs (B) and (C) and inserting the following:

(B)

Amendment with respect to COVID–19 vaccines

(i)

In general

Not later than 60 days after receipt of the report under subparagraph (C)(iii), the Secretary, taking into consideration such report, shall amend the covered countermeasure injury table established under subparagraph (A) to include all injuries related to COVID–19 vaccines that meet the standard described in subparagraph (A). In amending such table, the Secretary shall consider injuries caused by use of any vaccine that is, or was, the subject of an emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act.(ii)

Explanation of certain determinations

With respect to any recommendation of the COVID–19 Vaccine Commission included in the report under subparagraph (C)(iii) that the Secretary does not adopt pursuant to this subparagraph, the Secretary, not later than 7 days after the covered countermeasure injury table has been amended pursuant to clause (i), shall publish a written explanation of the determination not to adopt such recommendation.(C)

COVID–19 Vaccine Commission

(i)

In general

There is established a commission to be known as the COVID–19 Vaccine Commission (referred to in this subparagraph as the Commission) that is tasked with identifying covered injuries related to COVID–19 vaccines, for purposes of recommending to the Secretary injuries for inclusion on the covered countermeasure injury table, as described in subparagraph (B).(ii)

Membership

(I)

In general

The Commission shall be composed of the following:(aa)The Secretary, or a designee of the Secretary, to serve as an ex officio member.(bb)The following members, selected, not later than 30 days after the date of enactment of the Countermeasure Injury Compensation Fund Amendment Act, in accordance with subclause (II):(AA)3 members appointed by the Chair of the Committee on Health, Education, Labor, and Pensions of the Senate. (BB)3 members appointed by the Ranking Member of the Committee on Health, Education, Labor, and Pensions of the Senate. (CC)3 members appointed by the Chair of the Committee on Energy and Commerce of the House of Representatives.(DD)3 members appointed by the Ranking Member of the Committee on Energy and Commerce of the House of Representatives.(II)

Eligibility

Members selected to serve on the Commission pursuant to subclause (I)(bb) shall—(aa)be chosen on the basis of their experience, integrity, impartiality, and good judgement; (bb)at the time of appointment, not be elected or appointed officers or employees in the executive, legislative, or judicial branch of the Federal Government; and(cc)at the time of appointment, not be a member of the board or an employee of an entity whose product is under review, or expected to be under review, by the Commission.(III)

No compensation

Members of the Commission shall not be compensated. (IV)

Conflict of interest

Each member of the Commission shall recuse themselves from advising on a covered countermeasure for which the member has a conflict of interest as described in section 208 of title 18, United States Code.(iii)

Report

No later than one year after the date of enactment of the Countermeasure Injury Compensation Fund Amendment Act, the Commission shall submit to the Secretary and make publicly available a report identifying covered injuries considered for purposes of inclusion on the covered countermeasure injury table pursuant to subparagraph (B), and the vote counts and outcomes for each such injury.(iv)

Sunset

The Commission established under this subparagraph shall be terminated upon publication of the report under clause (iii).

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(F)by redesignating paragraph (6) as paragraph (7); (G)by inserting after paragraph (5) the following:

(6)

Electronic filing of petitions

The clerk of the United States Court of Federal Claims shall provide an option for the electronic filing of a petition to initiate a proceeding for compensation under this section.

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(H)in paragraph (7), as so redesignated—(i)by striking sections 262, 263, 264, 265, and 266 and inserting sections 2111, 2112, 2113, 2115, and 2121;(ii)in subparagraph (A), by striking terms vaccine and smallpox vaccine and inserting term vaccine;(iii)by amending subparagraph (B) to read as follows:

(B)the term Vaccine Injury Table shall be deemed to mean the table established under paragraph (5)(A);

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(iv)by redesignating subparagraph (C) as subparagraph (F); and(v)by inserting after subparagraph (B) the following:

(C)the term factors unrelated to the administration of the vaccine shall be deemed to mean factors unrelated to the administration or use of a covered countermeasure;(D)(i)the terms petition, petition under section 2111, and petition filed under section 2111 shall be deemed to mean a request for compensation under this section; and(ii)the term petitioner shall be deemed to mean a covered individual, as defined in subsection (e), who makes a request for benefits or compensation under this section;(E)the term vaccine-related injury or death shall be deemed to mean a covered injury, as defined in subsection (e); and

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(2)in subsection (d)—(A)in paragraph (1), by striking , or if the Secretary fails and all that follows through 319F–3(d) and inserting a period; and(B)in paragraph (5), by striking under subsection (a) the Secretary determines that a covered individual qualifies for compensation and inserting a covered individual is determined under subsection (a) to be eligible for compensation under this section.