---
kind: "section"
citation: "42 U.S.C. § 247d–6e"
title: "42"
title_heading: "The Public Health and Welfare"
number: "247d–6e"
heading: "Covered countermeasure process"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/247d-6e"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter II — General Powers and Duties"
  - "Part B — Federal-State Cooperation"
---

# §247d–6e. Covered countermeasure process

- (a) **Establishment of Fund—** Upon the issuance by the [Secretary](/usc/42/201.md?p=c) of a declaration under [section 247d–6d(b) of this title](/usc/42/247d–6d.md?p=b), there is hereby established in the Treasury an emergency fund designated as the “Covered Countermeasure Process Fund” for purposes of providing timely, uniform, and adequate compensation to eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure pursuant to such declaration, which Fund shall consist of such amounts designated as emergency appropriations under [section 402](/usc/42/402.md) of H. Con. Res. 95 of the 109th Congress, this emergency designation shall remain in effect through October 1, 2006.
- (b) **Payment of compensation—**
  - (1) **In general—** If the [Secretary](/usc/42/201.md?p=c) issues a declaration under [247d–6d(b)](/usc/42/247d–6d.md?p=b) of this title, the [Secretary](/usc/42/201.md?p=c) shall, after amounts have by law been provided for the Fund under [subsection (a)](#a), provide compensation to an eligible individual for a covered injury directly caused by the administration or use of a covered countermeasure pursuant to such declaration.
  - (2) **Elements of compensation—** The compensation that shall be provided pursuant to [paragraph (1)](#b-1) shall have the same elements, and be in the same amount, as is prescribed by sections [239c](/usc/42/239c.md), [239d](/usc/42/239d.md), and [239e](/usc/42/239e.md) of this title in the case of certain individuals injured as a result of administration of certain countermeasures against smallpox, except that [section 239e(a)(2)(B) of this title](/usc/42/239e.md?p=a-2-B) shall not apply.
  - (3) **Rule of construction—** Neither reasonable and necessary medical benefits nor lifetime total benefits for lost employment income due to permanent and total disability shall be limited by [section 239e of this title](/usc/42/239e.md).
  - (4) **Determination of eligibility and compensation—** Except as provided in this section, the procedures for determining, and for reviewing a determination of, whether an individual is an eligible individual, whether such individual has sustained a covered injury, whether compensation may be available under this section, and the amount of such compensation shall be those stated in [section 239a of this title](/usc/42/239a.md) (other than in [subsection (d)(2)](/usc/42/239a.md?p=d-2) of such section), in [regulations](/usc/42/201.md?p=d) issued pursuant to that section, and in such additional or alternate [regulations](/usc/42/201.md?p=d) as the [Secretary](/usc/42/201.md?p=c) may promulgate for purposes of this section. In making determinations under this section, other than those described in [paragraph (5)(A)](#b-5-A) as to the direct causation of a covered injury, the [Secretary](/usc/42/201.md?p=c) may only make such determination based on compelling, reliable, valid, medical and scientific evidence.
  - (5) **Covered countermeasure injury table—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) shall by regulation establish a table identifying covered injuries that shall be presumed to be directly caused by the administration or use of a covered countermeasure and the time period in which the first symptom or manifestation of onset of each such adverse effect must manifest in order for such presumption to apply. The [Secretary](/usc/42/201.md?p=c) may only identify such covered injuries, for purpose of inclusion on the table, where the [Secretary](/usc/42/201.md?p=c) determines, based on compelling, reliable, valid, medical and scientific evidence that administration or use of the covered countermeasure directly caused such covered injury.
    - (B) **Amendments—** The provisions of [section 239b of this title](/usc/42/239b.md) (other than a provision of [subsection (a)(2)](/usc/42/239b.md?p=a-2) of such section that relates to accidental vaccinia inoculation) shall apply to the table established under this section.
    - (C) **Judicial review—** No court of the United States, or of any [State](/usc/42/201.md?p=f), shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the [Secretary](/usc/42/201.md?p=c) under this paragraph.
  - (6) **Meanings of terms—** In applying sections [239a](/usc/42/239a.md), [239b](/usc/42/239b.md), [239c](/usc/42/239c.md), [239d](/usc/42/239d.md), and [239e](/usc/42/239e.md) of this title for purposes of this section—
    - (A) the terms “vaccine” and “smallpox vaccine” shall be deemed to mean a covered countermeasure;
    - (B) the terms “smallpox [vaccine injury table](/usc/42/300aa–33.md?p=6-B)” and “table established under [section 239b of this title](/usc/42/239b.md)” shall be deemed to refer to the table established under [paragraph (4)](#b-4); and
    - (C) other terms used in those sections shall have the meanings given to such terms by this section.
- (c) **Voluntary program—** The [Secretary](/usc/42/201.md?p=c) shall ensure that a [State](/usc/42/201.md?p=f), local, or Department of Health and Human [Services](/usc/42/201.md?p=a) plan to administer or use a covered countermeasure is consistent with any declaration under [247d–6d](/usc/42/247d–6d.md) of this title and any applicable guidelines of the Centers for Disease Control and Prevention and that potential [participants](/usc/42/300gg–91.md?p=d-11) are educated with respect to contraindications, the voluntary nature of the [program](/usc/42/274l–1.md?p=4), and the availability of potential benefits and compensation under this part.
- (d) **Exhaustion; exclusivity; election—**
  - (1) **Exhaustion—** Subject to [paragraph (5)](#d-5), a covered individual may not bring a civil action under [section 247d–6d(d) of this title](/usc/42/247d–6d.md?p=d) against a covered person (as such term is defined in [section 247d–6d(i)(2) of this title](/usc/42/247d–6d.md?p=i-2)) unless such individual has exhausted such remedies as are available under [subsection (a)](#a), except that if amounts have not by law been provided for the Fund under [subsection (a)](#a), or if the [Secretary](/usc/42/201.md?p=c) fails to make a final determination on a request for benefits or compensation filed in accordance with the requirements of this section within 240 days after such request was filed, the individual may seek any remedy that may be available under [section 247d–6d(d) of this title](/usc/42/247d–6d.md?p=d).
  - (2) **Tolling of statute of limitations—** The time limit for filing a civil action under [section 247d–6d(d) of this title](/usc/42/247d–6d.md?p=d) for an injury or death shall be tolled during the pendency of a claim for compensation under [subsection (a)](#a).
  - (3) **Rule of construction—** This section shall not be construed as superseding or otherwise affecting the application of a requirement, under [chapter 171](/usc/28/chptVI/ch171.md) of title 28, to exhaust administrative remedies.
  - (4) **Exclusivity—** The remedy provided by [subsection (a)](#a) shall be exclusive of any other civil action or proceeding for any claim or suit this section encompasses, except for a proceeding under [section 247d–6d of this title](/usc/42/247d–6d.md).
  - (5) **Election—** If under [subsection (a)](#a) the [Secretary](/usc/42/201.md?p=c) determines that a covered individual qualifies for compensation, the individual has an election to accept the compensation or to bring an action under [section 247d–6d(d) of this title](/usc/42/247d–6d.md?p=d). If such individual elects to accept the compensation, the individual may not bring such an action.
- (e) **Definitions—** For purposes of this section, the following terms shall have the following meanings:
  - (1) **Covered countermeasure—** The term “covered countermeasure” has the meaning given such term in [section 247d–6d of this title](/usc/42/247d–6d.md).
  - (2) **Covered individual—** The term “covered individual”, with respect to administration or use of a covered countermeasure pursuant to a declaration, means an individual—
    - (A) who is in a population specified in such declaration, and with respect to whom the administration or use of the covered countermeasure satisfies the other specifications of such declaration; or
    - (B) who uses the covered countermeasure, or to whom the covered countermeasure is administered, in a good faith belief that the individual is in the category described by [subparagraph (A)](#e-2-A).
  - (3) **Covered injury—** The term “covered injury” means serious physical injury or death.
  - (4) **Declaration—** The term “declaration” means a declaration under [section 247d–6d(b) of this title](/usc/42/247d–6d.md?p=b).
  - (5) **Eligible individual—** The term “eligible individual” means an individual who is determined, in accordance with [subsection (b)](#b), to be a covered individual who sustains a covered injury.

## Source credit

(July 1, 1944, ch. 373, title III, § 319F–4, as added Pub. L. 109–148, div. C, § 3, Dec. 30, 2005, 119 Stat. 2829.)

## Notes

### Editorial Notes

### References in Text

H. Con. Res. 95 of the 109th Congress, referred to in subsec. (a), is H. Con. Res. 95, Apr. 28, 2005, 119 Stat. 3633, which is not classified to the Code.