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21 U.S.C. § 360bbb–4a — Priority review to encourage treatments for agents that present national security threats
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section:
(1) **Human drug application** — The term “human drug application” has the meaning given such term in [section 379g(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379g/1&num=0&edition=prelim).
(2) **Priority review** — The term “priority review”, with respect to a human drug application, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures in the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Food and Drug Administration Safety and Innovation Act.
(3) **Priority review voucher** — The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a material threat medical countermeasure application that entitles the holder of such voucher to priority review of a single human drug application submitted under [section 355(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b/1&num=0&edition=prelim) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)] after the date of approval of the material threat medical countermeasure application.
(4) **Material threat medical countermeasure application** — The term “material threat medical countermeasure application” means an application that—
(A) is a human drug application for a drug intended for use—
(i) to prevent, or treat harm from a biological, chemical, radiological, or nuclear agent identified as a material threat under section 319F–2(c)(2)(A)(ii) o
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360bbb–4a
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Source file: Laws/federal/codes/united-states-code/title-21/section-360bbb4a-priority-review-to-encourage-treatments-for-agents-that-present-national--5c530060bb.md
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Source location: Title 21, Chapter 9, § 360bbb–4a; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Definitions** In this section:
(1) **Human drug application** — The term “human drug application” has the meaning given such term in [section 379g(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379g/1&num=0&edition=prelim).
(2) **Priority review** — The term “priority review”, with respect to a human drug application, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures in the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Food and Drug Administration Safety and Innovation Act.
(3) **Priority review voucher** — The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a material threat medical countermeasure application that entitles the holder of such voucher to priority review of a single human drug application submitted under [section 355(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b/1&num=0&edition=prelim) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)] after the date of approval of the material threat medical countermeasure application.
(4) **Material threat medical countermeasure application** — The term “material threat medical countermeasure application” means an application that—
(A) is a human drug application for a drug intended for use—
(i) to prevent, or treat harm from a biological, chemical, radiological, or nuclear agent identified as a material threat under section 319F–2(c)(2)(A)(ii) of the Public Health Service Act [[42 U.S.C. 247d–6b(c)(2)(A)(ii)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6b/c/2/A/ii&num=0&edition=prelim)]; or
(ii) to 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, or biological product against such agent; and
(B) the Secretary determines eligible for priority review;
(C) is approved after December 13, 2016; and
(D) is for—
(i) a human drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under [section 355(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b/1&num=0&edition=prelim); or
(ii) a biological product, no active ingredient of which has been approved in any other application under section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)].
**(b) Priority review voucher**
(1) **In general** — The Secretary shall award a priority review voucher to the sponsor of a material threat medical countermeasure application upon approval by the Secretary of such material threat medical countermeasure application.
(2) **Transferability** — The sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under [section 355(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b/1&num=0&edition=prelim) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)] will be submitted after the date of the approval of the material threat medical countermeasure application. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.
(3) **Notification**
(A) *In general* — The sponsor of a human drug application shall notify the Secretary not later than 90 calendar days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application, including the date on which the sponsor intends to submit the application. Such notification shall be a legally binding commitment to pay for the user fee to be assessed in accordance with this section.
(B) *Transfer after notice* — The sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under subparagraph (A) may transfer the voucher after such notification is provided, if such sponsor has not yet submitted the human drug application described in the notification.
**(c) Priority review user fee**
(1) **In general** — The Secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2). Such fee shall be in addition to any fee required to be submitted by the sponsor under subchapter VII.
(2) **Fee amount** — The amount of the priority review user fee shall be determined each fiscal year by the Secretary and based on the average cost incurred by the agency in the review of a human drug application subject to priority review in the previous fiscal year.
(3) **Annual fee setting** — The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2016, for that fiscal year, the amount of the priority review user fee.
(4) **Payment**
(A) *In general* — The priority review user fee required by this subsection shall be due upon the submission of a human drug application under [section 355(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b/1&num=0&edition=prelim) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)] for which the priority review voucher is used.
(B) *Complete application* — An application described under subparagraph (A) for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the Secretary’s procedures for paying such fees.
(C) *No waivers, exemptions, reductions, or refunds* — The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section.
(5) **Offsetting collections** — Fees collected pursuant to this subsection for any fiscal year—
(A) 11 So in original. No subpar. (B) has been enacted. shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and
(6) 22 So in original. Probably should be designated as subpar. (B). shall not be collected for any fiscal year except to the extent provided in advance in appropriation Acts.
**(d) Notice of issuance of voucher and approval of products under voucher** The Secretary shall publish a notice in the Federal Register and on the Internet website of the Food and Drug Administration not later than 30 calendar days after the occurrence of each of the following:
(1) The Secretary issues a priority review voucher under this section.
(2) The Secretary approves a drug pursuant to an application submitted under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)] for which the sponsor of the application used a priority review voucher issued under this section.
**(e) Eligibility for other programs** Nothing in this section precludes a sponsor who seeks a priority review voucher under this section from participating in any other incentive program, including under this chapter, except that no sponsor of a material threat medical countermeasure application may receive more than one priority review voucher issued under any section of this chapter with respect to such drug.
**(f) Relation to other provisions** The provisions of this section shall supplement, not supplant, any other provisions of this chapter or the Public Health Service Act [[42 U.S.C. 201](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section201&num=0&edition=prelim) et seq.] that encourage the development of medical countermeasures.
**(g) Sunset** The Secretary may not award any priority review vouchers under subsection (b) after October 1, 2023.
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Federal law — U.S. Code and appendices · legal_authorities
For purposes of this subpart:
(1) The term “human drug application” means an application for—
(A) approval of a new drug submitted under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim), or
(B) licensure of a biological product under subsection (a) of [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim).
Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to an in vitro diagnostic biologic product licensed under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distribute
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379g
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Federal law — U.S. Code and appendices · legal_authorities
Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 201
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Biologics license**
(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—
(A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and
(B) each package of the biological product is plainly marked with—
(i) the proper name of the biological product contained in the package;
(ii) the name, address, and applicable license number of the manufacturer of the biological product; and
(iii) the expiration date of the biological product.
(2)
(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.
(B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)].
(C) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and
(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).
(D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section:
(1) **BARDA** — The term “BARDA” means the Biomedical Advanced Research and Development Authority.
(2) **Fund** — The term “Fund” means the Biodefense Medical Countermeasure Development Fund established under subsection (d).
(3) **Other transactions** — The term “other transactions” means transactions, other than procurement contracts, grants, and cooperative agreements.
(4) **Qualified countermeasure** — The term “qualified countermeasure” has the meaning given such term in [section 247d–6a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-6a&num=0&edition=prelim).
(5) **Qualified pandemic or epidemic product** — The term “qualified pandemic or epidemic product” has the meaning given the term in [section 247d–6d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-6d&num=0&edition=prelim).
(6) **Advanced research and development**
(A) *In general* — The term “advanced research and development” means, with respect to a product that is or may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly—
(i) are conducted after basic research and preclinical development of the product; and
(ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.] or under [section 262 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim).
(B) *Activities included* — The term under subparagraph (A)
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d–7e
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Federal law — U.S. Code and appendices · legal_authorities
Page 35
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 201
1 See References in Text note below.
Sec.
300jj–34.
Competitive grants to States and Indian
tribes for the development of loan pro-
grams to facilitate the widespread
adoption of certified EHR technology.
300jj–35.
Demonstration program to integrate in-
formation
technology
into
clinical
education.
300jj–36.
Information technology professionals in
health care.
300jj–37.
General grant and loan provisions.
300jj–38.
Authorization for appropriations.
PART C—OTHER PROVISIONS
300jj–51.
Health information technology enroll-
ment standards and protocols.
300jj–52.
Information blocking.
SUBCHAPTER XXIX—DATA COLLECTION,
ANALYSIS, AND QUALITY
300kk.
Data collection, analysis, and quality.
SUBCHAPTER XXX—COMMUNITY LIVING
ASSISTANCE SERVICES AND SUPPORTS
300ll to 300ll–9. Repealed.
SUBCHAPTER XXXI—WORLD TRADE CENTER
HEALTH PROGRAM
PART A—ESTABLISHMENT OF PROGRAM; ADVISORY
COMMITTEE
300mm.
Establishment of World Trade Center
Health Program.
300mm–1.
WTC Health Program Scientific/Tech-
nical
Advisory
Committee;
WTC
Health Program Steering Committees.
300mm–2.
Education and outreach.
300mm–3.
Uniform data collection and analysis.
300mm–4.
Clinical Centers of Excellence and Data
Centers.
300mm–5.
Definitions.
PART B—PROGRAM OF MONITORING, INITIAL HEALTH
EVALUATIONS, AND TREATMENT
SUBPART 1—WTC RESPONDERS
300mm–21.
Identification of WTC responders and
provision of WTC-related monitoring
services.
300mm–22.
Treatment of enrolled WTC responders
for WTC-related health conditions.
300mm–23.
National arrangement for benefits for el-
igible individuals outside New York.
SUBPART 2—WTC SURVIVORS
300mm–31.
Identification and initial health evalua-
tion of screening-eligible and
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 201
Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 201. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Emergencies** If the Secretary determines, after consultation with such public health officials as may be necessary, that—
(1) a disease or disorder presents a public health emergency; or
(2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists,
the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.
**(b) Public Health Emergency Fund**
(1) **In general** — There is established in the Treasury a fund to be designated as the “Public Health Emergency Fund” to be made available to the Secretary without fiscal year limitation to carry out subsection (a) only if a public health emergency has been declared by the Secretary under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Se
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d
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Federal law — U.S. Code and appendices · legal_authorities
Page 228
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 247c–2
which the delivery of services under sub-
section (a) may be improved. The Secretary
may make such grants only to grantees under
such subsection and to public and nonprofit
private entities that are carrying out pro-
grams substantially similar to programs car-
ried out under such subsection.
(2) Authorization of appropriations
For the purpose of carrying out paragraph
(1), there are authorized to be appropriated
such sums as may be necessary for each of the
fiscal years 1993 through 1998.
(July 1, 1944, ch. 373, title III, § 318A, as added
Pub. L. 102–531, title III, § 304, Oct. 27, 1992, 106
Stat. 3490; amended Pub. L. 103–43, title XX,
§ 2008(i)(1)(B)(ii), June 10, 1993, 107 Stat. 212; Pub.
L. 103–183, title IV, § 402, Dec. 14, 1993, 107 Stat.
2236; Pub. L. 107–251, title VI, § 601(a), Oct. 26,
2002, 116 Stat. 1664; Pub. L. 108–163, § 2(m)(1), Dec.
6, 2003, 117 Stat. 2023.)
Editorial Notes
REFERENCES IN TEXT
The reference to section 254b of this title the first
place appearing, referred to in subsec. (e), was in the
original a reference to section 329, meaning section 329
of act July 1, 1944, which was omitted in the general
amendment of subpart I (§ 254b et seq.) of part D of this
subchapter by Pub. L. 104–299, § 2, Oct. 11, 1996, 110 Stat.
3626.
Section 256a of this title, referred to in subsec. (e),
was repealed by Pub. L. 104–299, § 4(a)(3), Oct. 11, 1996,
110 Stat. 3645.
AMENDMENTS
2003—Subsec. (e). Pub. L. 108–163 substituted ‘‘254b’’
for ‘‘254c, 254b(h)’’ before ‘‘, 256a’’.
2002—Subsec. (e). Pub. L. 107–251 substituted ‘‘254b(h)’’
for ‘‘256’’.
1993—Pub. L. 103–43 made technical amendment to di-
rectory language of Pub. L. 102–531, § 304, which enacted
this section.
Subs
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 247d
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Federal law — U.S. Code and appendices · legal_authorities
Page 456
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 258a
§ 258a. Transferred
Editorial Notes
CODIFICATION
Section, act July 8, 1947, ch. 210, title II, § 201, 61 Stat.
269, which related to transfer of balances in working
capital fund, narcotic hospitals, to surplus fund, was
transferred and is set out as a note under section 290aa
of this title.
§§ 259 to 261a. Repealed. Pub. L. 106–310, div. B,
title XXXIV, § 3405(a), Oct. 17, 2000, 114 Stat.
1221, as amended by Pub. L. 114–198, title I,
§ 110(b), July 22, 2016, 130 Stat. 710
Section 259, acts July 1, 1944, ch. 373, title III, § 343, 58
Stat. 699; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct.
27, 1970, 84 Stat. 1240; Pub. L. 92–293, § 3, May 11, 1972, 86
Stat. 136; Pub. L. 98–473, title II, § 232(b), Oct. 12, 1984, 98
Stat. 2031, related to convict addicts or other persons
with drug abuse or drug dependence problems.
Section 260, acts July 1, 1944, ch. 373, title III, § 344, 58
Stat. 701; June 25, 1948, ch. 654, § 5, 62 Stat. 1018; July 24,
1956, ch. 676, title III, § 302(b), 70 Stat. 622; Pub. L. 91–513,
title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240, re-
lated to addicts and persons with drug abuse or drug
dependence problems.
Section 260a, act July 1, 1944, ch. 373, title III, § 345, as
added May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended July
24, 1956, ch. 676, title III, § 302(c), 70 Stat. 622; Pub. L.
91–358, title I, § 155(c)(32), July 29, 1970, 84 Stat. 572, re-
lated to admission of addicts committed from District
of Columbia.
Section 261, acts July 1, 1944, ch. 373, title III, § 346,
formerly § 345, 58 Stat. 701; renumbered § 346, May 8,
1954, ch. 195, § 2, 68 Stat. 79; amended Pub. L. 91–513,
title I, § 2(a)(2)(A), (5), Oct. 27, 1970, 84 Stat. 1240, relate
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 262
Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 262. This identifies an authority to review, not proof of applicability.