42 USC 247d-6a - Authority for use of certain procedures regarding qualified countermeasure research and development activities

U.S Code last checked for updates: May 06, 2024

§ 247d–6a.

Authority for use of certain procedures regarding qualified countermeasure research and development activities

(a)

In general

(1)

Authority

(2)

Definitions

In this section:

(A)

Qualified countermeasure

The term “qualified countermeasure” means a drug (as that term is defined by section 321(g)(1) of title 21), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 321(h) of title 21), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)—

(i)

to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security;

(ii)

to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in this subparagraph; or

(iii)

is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).

(B)

Infectious disease

(3)

Interagency cooperation

(A)

In general

(B)

Limitation

(4)

Availability of facilities to the Secretary

(5)

Transfers of qualified countermeasures

(b)

Expedited procurement authority

(1)

Increased simplified acquisition threshold for qualified countermeasure procurements

(A)

In general

For any procurement by the Secretary of property or services for use (as determined by the Secretary) in performing, administering, or supporting qualified countermeasure research or development activities under this section that the Secretary determines necessary to respond to pressing research and development needs under this section, the amount specified in section 134 of title 41, as applicable pursuant to section 3101(b)(1)(A) of title 41, shall be deemed to be $25,000,000 in the administration, with respect to such procurement, of—

(i)

section 3305(a)(1) of title 41 and its implementing regulations; and

(ii)

section 3101(b)(1)(B) of title 41 and its implementing regulations.

(B)

Application of certain provisions

Notwithstanding subparagraph (A) and the provision of law and regulations referred to in such subparagraph, each of the following provisions shall apply to procurements described in this paragraph to the same extent that such provisions would apply to such procurements in the absence of subparagraph (A):

(i)

Chapter 37 of title 40 (relating to contract work hours and safety standards).

(ii)

Section 8703(a) of title 41.

(iii)

Section 4706 of title 41 (relating to the examination of contractor records).

(iv)

Section 3131 of title 40 (relating to bonds of contractors of public buildings or works).

(v)

Section 3901 of title 41 (relating to contingent fees to middlemen).

(vi)

Section 6962 of this title.

(vii)

Section 1354 of title 31 (relating to the limitation on the use of appropriated funds for contracts with entities not meeting veterans employment reporting requirements).

(C)

Internal controls to be instituted

(D)

Authority to limit competition

(2)

Procedures other than full and open competition

(A)

In general

(B)

Relation to other authorities

(C)

Applicable government-wide regulations

(3)

Increased micropurchase threshold

(A)

In general

(B)

Internal controls to be instituted

(C)

Exception to preference for purchase card mechanism

(4)

Review

(A)

Review allowed

Notwithstanding subsection (f), section 1491 of title 28, and section 3556 of title 31, review of a contracting agency decision relating to a procurement described in paragraph (1) may be had only by filing a protest—

(i)

with a contracting agency; or

(ii)

with the Comptroller General under subchapter V of chapter 35 of title 31.

(B)

Override of stay of contract award or performance committed to agency discretion

Notwithstanding section 1491 of title 28 and section 3553 of title 31, the following authorizations by the head of a procuring activity are committed to agency discretion:

(i)

An authorization under section 3553(c)(2) of title 31 to award a contract for a procurement described in paragraph (1) of this subsection.

(ii)

An authorization under section 3553(d)(3)(C) of such title to perform a contract for a procurement described in paragraph (1) of this subsection.

(c)

Authority to expedite peer review

(1)

In general

The Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, employ such expedited peer review procedures (including consultation with appropriate scientific experts) as the Secretary, in consultation with the Director of NIH, deems appropriate to obtain assessment of scientific and technical merit and likely contribution to the field of qualified countermeasure research, in place of the peer review and advisory council review procedures that would be required under sections 241(a)(3), 284(b)(1)(B), 284(b)(2), 284a(a)(3)(A), 289a, and 289c of this title, as applicable to a grant, contract, or cooperative agreement—

(A)

that is for performing, administering, or supporting qualified countermeasure research and development activities; and

(B)

the amount of which is not greater than $1,500,000.

(2)

Subsequent phases of research

(d)

Authority for personal services contracts

(1)

In general

(2)

Federal Tort Claims Act coverage

(A)

In general

(B)

Exclusivity of remedy

(C)

Recourse in case of gross misconduct or contract violation

(i)

In general

(ii)

Venue

(3)

Internal controls to be instituted

(A)

In general

(B)

Determination of employee status to be final

(4)

Number of personal services contracts limited

(e)

Streamlined personnel authority

(1)

In general

(2)

Limitations

The authority provided for under paragraph (1) shall be exercised in a manner that—

(A)

recruits and appoints individuals based solely on their abilities, knowledge, and skills;

(B)

does not discriminate for or against any applicant for employment on any basis described in section 2302(b)(1) of title 5;

(C)

does not allow an official to appoint an individual who is a relative (as defined in section 3110(a)(3) of such title) of such official;

(D)

does not discriminate for or against an individual because of the exercise of any activity described in paragraph (9) or (10) of section 2302(b) of such title; and

(E)

accords a preference, among equally qualified persons, to persons who are preference eligibles (as defined in section 2108(3) of such title).

(3)

Internal controls to be instituted

(f)

Actions committed to agency discretion

(July 1, 1944, ch. 373, title III, § 319F–1, as added Pub. L. 108–276, § 2(a), July 21, 2004, 118 Stat. 835; amended Pub. L. 109–417, title IV, § 403(a), Dec. 19, 2006, 120 Stat. 2874; Pub. L. 113–5, title IV, § 402(g)(1), Mar. 13, 2013, 127 Stat. 195; Pub. L. 116–22, title VII, § 705(a)(1), June 24, 2019, 133 Stat. 964.)

cite as: 42 USC 247d-6a