42 U.S.C. § 299c–1: Peer review with respect…

Summary

Every application for a grant, cooperative agreement, or contract under this law must get a technical and scientific peer review. Each review group must send its findings and recommendations to the Director in the form the Director requires. The Director cannot approve an application unless a peer review group recommends approval. The Director must set up whatever review groups are needed and may do so without following some usual federal hiring and pay rules. Members must be highly qualified. No more than 25 percent of a group can be U.S. officers or employees, and those employees cannot get extra pay for this work. Groups can continue until a law changes that. Members must sign written agreements to keep nonpublic information confidential and to step aside if they have a conflict of interest (for example, employment by an affected organization, stock ownership, or other financial ties). For awards with direct costs of $100,000 or less, the Director may use simpler review procedures to encourage new researchers and clinical or provider-based studies. The Director must issue rules for how peer review is done.

Title 42, §299c–1

The Public Health and Welfare, Source: USLM XML via OLRC

(a)Requirement of review

(1)In general

Appropriate technical and scientific peer review shall be conducted with respect to each application for a grant, cooperative agreement, or contract under this subchapter.

(2)Reports to Director

Each peer review group to which an application is submitted pursuant to paragraph (1) shall report its finding and recommendations respecting the application to the Director in such form and in such manner as the Director shall require.

(b)Approval as precondition of awards

The Director may not approve an application described in subsection (a)(1) unless the application is recommended for approval by a peer review group established under subsection (c).

(c)Establishment of peer review groups

(1)In general

The Director shall establish such technical and scientific peer review groups as may be necessary to carry out this section. Such groups shall be established without regard to the provisions of title 5 that govern appointments in the competitive service, and without regard to the provisions of chapter 51, and subchapter III of chapter 53, of such title that relate to classification and pay rates under the General Schedule.

(2)Membership

The members of any peer review group established under this section shall be appointed from among individuals who by virtue of their training or experience are eminently qualified to carry out the duties of such peer review group. Officers and employees of the United States may not constitute more than 25 percent of the membership of any such group. Such officers and employees may not receive compensation for service on such groups in addition to the compensation otherwise received for these duties carried out as such officers and employees.

(3)Duration

Notwithstanding section 1013(a) of title 5, peer review groups established under this section may continue in existence until otherwise provided by law.

(4)Qualifications

Members of any peer review group shall, at a minimum, meet the following requirements:

(A)Such members shall agree in writing to treat information received, pursuant to their work for the group, as confidential information, except that this subparagraph shall not apply to public records and public information.

(B)Such members shall agree in writing to recuse themselves from participation in the peer review of specific applications which present a potential personal conflict of interest or appearance of such conflict, including employment in a directly affected organization, stock ownership, or any financial or other arrangement that might introduce bias in the process of peer review.

(d)Authority for procedural adjustments in certain cases

In the case of applications for financial assistance whose direct costs will not exceed $100,000, the Director may make appropriate adjustments in the procedures otherwise established by the Director for the conduct of peer review under this section. Such adjustments may be made for the purpose of encouraging the entry of individuals into the field of research, for the purpose of encouraging clinical practice-oriented or provider-based research, and for such other purposes as the Director may determine to be appropriate.

(e)Regulations

The Director shall issue regulations for the conduct of peer review under this section.

Notes & Related Subsidiaries

Editorial Notes

References in Text

The provisions of title 5 that govern appointments in the competitive service, referred to in subsec. (c)(1), are classified generally to section 3301 et seq. of Title 5, Government Organization and Employees.

Prior Provisions

A prior section 299c–1, act July 1, 1944, ch. 373, title IX, § 922, as added Pub. L. 101–239, title VI, § 6103(c), Dec. 19, 1989, 103 Stat. 2201; amended Pub. L. 101–508, title IV, § 4118(f)(2)(F), Nov. 5, 1990, 104 Stat. 1388–70; Pub. L. 102–410, § 5(d), Oct. 13, 1992, 106 Stat. 2098, related to peer review with respect to grants and contracts, prior to the general amendment of this subchapter by Pub. L. 106–129.

Amendments

2022—Subsec. (c)(3). Pub. L. 117–286, which directed amendment of “section 941(c)(3) of the Public Health Service Act” by substituting “section 1013(a) of title 5,” for “section 14(a) of the Federal Advisory Committee Act,”, was executed to this section, which is section 942 of the Public Health Service Act, to reflect the probable intent of Congress.

§299c–1 Peer Review with Respect to Grants and Contracts