21 U.S.C. § 335a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter III: PROHIBITED ACTS AND PENALTIES / Section 335a: Debarment, temporary denial of approval, and suspension
Debarment, temporary denial of approval, and suspension
Status: in_force

(a) Mandatory debarment; certain drug applications

(1) Corporations, partnerships, and associations

If the Secretary finds that a person other than an individual has been convicted, after May 13, 1992, of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any abbreviated drug application, the Secretary shall debar such person from submitting, or assisting in the submission of, any such application.

(2) Individuals

If the Secretary finds that an individual has been convicted of a felony under Federal law for conduct—

(A) relating to the development or approval, including the process for development or approval, of any drug product, or

(B) otherwise relating to the regulation of any drug product under this chapter,

the Secretary shall debar such individual from providing services in any capacity to a person that has an approved or pending drug product application.

(b) Permissive debarment; certain drug applications; food imports

(1) In general

The Secretary, on the Secretary's own initiative or in response to a petition, may, in accordance with paragraph (2) or (3), debar—

(A) a person other than an individual from submitting or assisting in the submission of any abbreviated drug application;

(B) an individual from providing services in any capacity to a person that has an approved or pending drug product application;

(C) a person from importing an article of food or offering such an article for import into the United States; or

(D) a person from importing or offering for import into the United States a drug.

(2) Persons subject to permissive debarment; certain drug applications

The following persons are subject to debarment under subparagraph (A) or (B) of paragraph (1):

(A) Corporations, partnerships, and associations

Any person other than an individual that the Secretary finds has been convicted—

(i) for conduct that—

(I) relates to the development or approval, including the process for the development or approval, of any abbreviated drug application; and

(II) is a felony under Federal law (if the person was convicted before May 13, 1992), a misdemeanor under Federal law, or a felony under State law, or

(ii) of a conspiracy to commit, or aiding or abetting, a criminal offense described in clause (i) or a felony described in subsection (a)(1),

if the Secretary finds that the type of conduct which served as the basis for such conviction undermines the process for the regulation of drugs.

(B) Individuals

(i) Any individual whom the Secretary finds has been convicted of—

(I) a misdemeanor under Federal law or a felony under State law for conduct relating to the development or approval, including the process for development or approval, of any drug product or otherwise relating to the regulation of drug products under this chapter, or

(II) a conspiracy to commit, or aiding or abetting, such criminal offense or a felony described in subsection (a)(2),

if the Secretary finds that the type of conduct which served as the basis for such conviction undermines the process for the regulation of drugs.

(ii) Any individual whom the Secretary finds has been convicted of—

(I) a felony which is not described in subsection (a)(2) or clause (i) of this subparagraph and which involves bribery, payment of illegal gratuities, fraud, perjury, false statement, racketeering, blackmail, extortion, falsification or destruction of records, or interference with, obstruction of an investigation into, or prosecution of, any criminal offense, or

(II) a conspiracy to commit, or aiding or abetting, such felony,

if the Secretary finds, on the basis of the conviction of such individual and other information, that such individual has demonstrated a pattern of conduct sufficient to find that there is reason to believe that such individual may violate requirements under this chapter relating to drug products.

(iii) Any individual whom the Secretary finds materially participated in acts that were the basis for a conviction for an offense described in subsection (a) or in clause (i) or (ii) for which a conviction was obtained, if the Secretary finds, on the basis of such participation and other information, that such individual has demonstrated a pattern of conduct sufficient to find that there is reason to believe that such individual may violate requirements under this chapter relating to drug products.

(iv) Any high managerial agent whom the Secretary finds—

(I) worked for, or worked as a consultant for, the same person as another individual during the period in which such other individual took actions for which a felony conviction was obtained and which resulted in the debarment under subsection (a)(2), or clause (i), of such other individual,

(II) had actual knowledge of the actions described in subclause (I) of such other individual, or took action to avoid such actual knowledge, or failed to take action for the purpose of avoiding such actual knowledge,

(III) knew that the actions described in subclause (I) were violative of law, and

(IV) did not report such actions, or did not cause such actions to be reported, to an officer, employee, or agent of the Department or to an appropriate law enforcement officer, or failed to take other appropriate action that would have ensured that the process for the regulation of drugs was not undermined, within a reasonable time after such agent first knew of such actions,

if the Secretary finds that the type of conduct which served as the basis for such other individual's conviction undermines the process for the regulation of drugs.

(3) Persons subject to permissive debarment; food or drug importation

A person is subject to debarment under paragraph (1)(C) if—

(A) the person has been convicted of a felony for conduct relating to the importation into the United States of any food;

(B) the person has engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences or death to humans or animals;

(C) the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 802 of this title);

(D) the person has engaged in a pattern of importing or offering for import—

(i) controlled substances that are prohibited from importation under section 1401(m) of title 19; or

(ii) adulterated or misbranded drugs that are—

(I) not designated in an authorized electronic data interchange system as a product that is regulated by the Secretary; or

(II) knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary.

(4) Stay of certain orders

An order of the Secretary under clause (iii) or (iv) of paragraph (2)(B) shall not take effect until 30 days after the order has been issued.

(5) Definition

For purposes of paragraph (3)(D), the term "pattern of importing or offering for import" means importing or offering for import a drug described in clause (i) or (ii) of paragraph (3)(D) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.

(c) Debarment period and considerations

(1) Effect of debarment

The Secretary—

(A) shall not accept or review (other than in connection with an audit under this section) any abbreviated drug application submitted by or with the assistance of a person debarred under subsection (a)(1) or (b)(2)(A) during the period such person is debarred,

(B) shall, during the period of a debarment under subsection (a)(2) or (b)(2)(B), debar an individual from providing services in any capacity to a person that has an approved or pending drug product application and shall not accept or review (other than in connection with an audit under this section) an abbreviated drug application from such individual, and

(C) shall, if the Secretary makes the finding described in paragraph (6) or (7) of section 335b(a) of this title, assess a civil penalty in accordance with section 335b of this title.

(2) Debarment periods

(A) In general

The Secretary shall debar a person under subsection (a) or (b) for the following periods:

(i) The period of debarment of a person (other than an individual) under subsection (a)(1) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under subsection (a) occurs within 10 years after such person has been debarred under subsection (a)(1), the period of debarment shall be permanent.

(ii) The debarment of an individual under subsection (a)(2) shall be permanent.

(iii) The period of debarment of any person under paragraph (2) or (3) of subsection (b) shall not be more than 5 years.

The Secretary may determine whether debarment periods shall run concurrently or consecutively in the case of a person debarred for multiple offenses.

(B) Notification

Upon a conviction for an offense described in subsection (a) or (b) or upon execution of an agreement with the United States to plead guilty to such an offense, the person involved may notify the Secretary that the person acquiesces to debarment and such person's debarment shall commence upon such notification.

(3) Considerations

In determining the appropriateness and the period of a debarment of a person under subsection (b) and any period of debarment beyond the minimum specified in subparagraph (A)(i) of paragraph (2), the Secretary shall consider where applicable—

(A) the nature and seriousness of any offense involved,

(B) the nature and extent of management participation in any offense involved, whether corporate policies and practices encouraged the offense, including whether inadequate institutional controls contributed to the offense,

(C) the nature and extent of voluntary steps to mitigate the impact on the public of any offense involved, including the recall or the discontinuation of the distribution of suspect drugs, full cooperation with any investigations (including the extent of disclosure to appropriate authorities of all wrongdoing), the relinquishing of profits on drug approvals fraudulently obtained, and any other actions taken to substantially limit potential or actual adverse effects on the public health,

(D) whether the extent to which changes in ownership, management, or operations have corrected the causes of any offense involved and provide reasonable assurances that the offense will not occur in the future,

(E) whether the person to be debarred is able to present adequate evidence that current production of drugs subject to abbreviated drug applications and all pending abbreviated drug applications are free of fraud or material false statements, and

(F) prior convictions under this chapter or under other Acts involving matters within the jurisdiction of the Food and Drug Administration.

(d) Termination of debarment

(1) Application

Any person that is debarred under subsection (a) (other than a person permanently debarred) or any person that is debarred under subsection (b) may apply to the Secretary for termination of the debarment under this subsection. Any information submitted to the Secretary under this paragraph does not constitute an amendment or supplement to pending or approved abbreviated drug applications.

(2) Deadline

The Secretary shall grant or deny any application respecting a debarment which is submitted under paragraph (1) within 180 days of the date the application is submitted.

(3) Action by the Secretary

(A) Corporations

(i) Conviction reversal

If the conviction which served as the basis for the debarment of a person under subsection (a)(1) or paragraph (2)(A) or (3) of subsection (b) is reversed, the Secretary shall withdraw the order of debarment.

(ii) Application

Upon application submitted under paragraph (1), the Secretary shall terminate the debarment of a person if the Secretary finds that—

(I) changes in ownership, management, or operations have fully corrected the causes of the offense involved and provide reasonable assurances that the offense will not occur in the future, and

(II) in applicable cases, sufficient audits, conducted by the Food and Drug Administration or by independent experts acceptable to the Food and Drug Administration, demonstrate that pending applications and the development of drugs being tested before the submission of an application are free of fraud or material false statements.

 In the case of persons debarred under subsection (a)(1), such termination shall take effect no earlier than the expiration of one year from the date of the debarment.

(B) Individuals

(i) Conviction reversal

If the conviction which served as the basis for the debarment of an individual under subsection (a)(2) or clause (i), (ii), (iii), or (iv) of subsection (b)(2)(B) or subsection (b)(3) is reversed, the Secretary shall withdraw the order of debarment.

(ii) Application

Upon application submitted under paragraph (1), the Secretary shall terminate the debarment of an individual who has been debarred under subsection (b)(2)(B) or subsection (b)(3) if such termination serves the interests of justice and adequately protects the integrity of the drug approval process or the food importation process, as the case may be.

(4) Special termination

(A) Application

Any person that is debarred under subsection (a)(1) (other than a person permanently debarred under subsection (c)(2)(A)(i)) or any individual who is debarred under subsection (a)(2) may apply to the Secretary for special termination of debarment under this subsection. Any information submitted to the Secretary under this subparagraph does not constitute an amendment or supplement to pending or approved abbreviated drug applications.

(B) Corporations

Upon an application submitted under subparagraph (A), the Secretary may take the action described in subparagraph (D) if the Secretary, after an informal hearing, finds that—

(i) the person making the application under subparagraph (A) has demonstrated that the felony conviction which was the basis for such person's debarment involved the commission of an offense which was not authorized, requested, commanded, performed, or recklessly tolerated by the board of directors or by a high managerial agent acting on behalf of the person within the scope of the board's or agent's office or employment,

(ii) all individuals who were involved in the commission of the offense or who knew or should have known of the offense have been removed from employment involving the development or approval of any drug subject to sections 1 355 of this title,

(iii) the person fully cooperated with all investigations and promptly disclosed all wrongdoing to the appropriate authorities, and

(iv) the person acted to mitigate any impact on the public of any offense involved, including the recall, or the discontinuation of the distribution, of any drug with respect to which the Secretary requested a recall or discontinuation of distribution due to concerns about the safety or efficacy of the drug.

(C) Individuals

Upon an application submitted under subparagraph (A), the Secretary may take the action described in subparagraph (D) if the Secretary, after an informal hearing, finds that such individual has provided substantial assistance in the investigations or prosecutions of offenses which are described in subsection (a) or (b) or which relate to any matter under the jurisdiction of the Food and Drug Administration.

(D) Secretarial action

The action referred to in subparagraphs (B) and (C) is—

(i) in the case of a person other than an individual—

(I) terminating the debarment immediately, or

(II) limiting the period of debarment to less than one year, and

(ii) in the case of an individual, limiting the period of debarment to less than permanent but to no less than 1 year,

whichever best serves the interest of justice and protects the integrity of the drug approval process.

(e) Publication and list of debarred persons

The Secretary shall publish in the Federal Register the name of any person debarred under subsection (a) or (b), the effective date of the debarment, and the period of the debarment. The Secretary shall also maintain and make available to the public a list, updated no less often than quarterly, of such persons, of the effective dates and minimum periods of such debarments, and of the termination of debarments.

(f) Temporary denial of approval

(1) In general

The Secretary, on the Secretary's own initiative or in response to a petition, may, in accordance with paragraph (3), refuse by order, for the period prescribed by paragraph (2), to approve any abbreviated drug application submitted by any person—

(A) if such person is under an active Federal criminal investigation in connection with an action described in subparagraph (B),

(B) if the Secretary finds that such person—

(i) has bribed or attempted to bribe, has paid or attempted to pay an illegal gratuity, or has induced or attempted to induce another person to bribe or pay an illegal gratuity to any officer, employee, or agent of the Department of Health and Human Services or to any other Federal, State, or local official in connection with any abbreviated drug application, or has conspired to commit, or aided or abetted, such actions, or

(ii) has knowingly made or caused to be made a pattern or practice of false statements or misrepresentations with respect to material facts relating to any abbreviated drug application, or the production of any drug subject to an abbreviated drug application, to any officer, employee, or agent of the Department of Health and Human Services, or has conspired to commit, or aided or abetted, such actions, and

(C) if a significant question has been raised regarding—

(i) the integrity of the approval process with respect to such abbreviated drug application, or

(ii) the reliability of data in or concerning such person's abbreviated drug application.

Such an order may be modified or terminated at any time.

(2) Applicable period

(A) In general

Except as provided in subparagraph (B), a denial of approval of an application of a person under paragraph (1) shall be in effect for a period determined by the Secretary but not to exceed 18 months beginning on the date the Secretary finds that the conditions described in subparagraphs (A), (B), and (C) of paragraph (1) exist. The Secretary shall terminate such denial—

(i) if the investigation with respect to which the finding was made does not result in a criminal charge against such person, if criminal charges have been brought and the charges have been dismissed, or if a judgment of acquittal has been entered, or

(ii) if the Secretary determines that such finding was in error.

(B) Extension

If, at the end of the period described in subparagraph (A), the Secretary determines that a person has been criminally charged for an action described in subparagraph (B) of paragraph (1), the Secretary may extend the period of denial of approval of an application for a period not to exceed 18 months. The Secretary shall terminate such extension if the charges have been dismissed, if a judgment of acquittal has been entered, or if the Secretary determines that the finding described in subparagraph (A) was in error.

(3) Informal hearing

Within 10 days of the date an order is issued under paragraph (1), the Secretary shall provide such person with an opportunity for an informal hearing, to be held within such 10 days, on the decision of the Secretary to refuse approval of an abbreviated drug application. Within 60 days of the date on which such hearing is held, the Secretary shall notify the person given such hearing whether the Secretary's refusal of approval will be continued, terminated, or otherwise modified. Such notification shall be final agency action.

(g) Suspension authority

(1) In general

If—

(A) the Secretary finds—

(i) that a person has engaged in conduct described in subparagraph (B) of subsection (f)(1) in connection with 2 or more drugs under abbreviated drug applications, or

(ii) that a person has engaged in flagrant and repeated, material violations of good manufacturing practice or good laboratory practice in connection with the development, manufacturing, or distribution of one or more drugs approved under an abbreviated drug application during a 2-year period, and—

(I) such violations may undermine the safety and efficacy of such drugs, and

(II) the causes of such violations have not been corrected within a reasonable period of time following notice of such violations by the Secretary, and

(B) such person is under an active investigation by a Federal authority in connection with a civil or criminal action involving conduct described in subparagraph (A),

the Secretary shall issue an order suspending the distribution of all drugs the development or approval of which was related to such conduct described in subparagraph (A) or suspending the distribution of all drugs approved under abbreviated drug applications of such person if the Secretary finds that such conduct may have affected the development or approval of a significant number of drugs which the Secretary is unable to identify. The Secretary shall exclude a drug from such order if the Secretary determines that such conduct was not likely to have influenced the safety or efficacy of such drug.

(2) Public health waiver

The Secretary shall, on the Secretary's own initiative or in response to a petition, waive the suspension under paragraph (1) (involving an action described in paragraph (1)(A)(i)) with respect to any drug if the Secretary finds that such waiver is necessary to protect the public health because sufficient quantities of the drug would not otherwise be available. The Secretary shall act on any petition seeking action under this paragraph within 180 days of the date the petition is submitted to the Secretary.

(h) Termination of suspension

The Secretary shall withdraw an order of suspension of the distribution of a drug under subsection (g) if the person with respect to whom the order was issued demonstrates in a petition to the Secretary—

(1)(A) on the basis of an audit by the Food and Drug Administration or by experts acceptable to the Food and Drug Administration, or on the basis of other information, that the development, approval, manufacturing, and distribution of such drug is in substantial compliance with the applicable requirements of this chapter, and

(B) changes in ownership, management, or operations—

(i) fully remedy the patterns or practices with respect to which the order was issued, and

(ii) provide reasonable assurances that such actions will not occur in the future, or

(2) the initial determination was in error.

The Secretary shall act on a submission of a petition under this subsection within 180 days of the date of its submission and the Secretary may consider the petition concurrently with the suspension proceeding. Any information submitted to the Secretary under this subsection does not constitute an amendment or supplement to a pending or approved abbreviated drug application.

(i) Procedure

The Secretary may not take any action under subsection (a), (b), (c), (d)(3), (g), or (h) with respect to any person unless the Secretary has issued an order for such action made on the record after opportunity for an agency hearing on disputed issues of material fact. In the course of any investigation or hearing under this subsection, the Secretary may administer oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation.

(j) Judicial review

(1) In general

Except as provided in paragraph (2), any person that is the subject of an adverse decision under subsection (a), (b), (c), (d), (f), (g), or (h) may obtain a review of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the person resides, by filing in such court (within 60 days following the date the person is notified of the Secretary's decision) a petition requesting that the decision be modified or set aside.

(2) Exception

Any person that is the subject of an adverse decision under clause (iii) or (iv) of subsection (b)(2)(B) may obtain a review of such decision by the United States District Court for the District of Columbia or a district court of the United States for the district in which the person resides, by filing in such court (within 30 days following the date the person is notified of the Secretary's decision) a complaint requesting that the decision be modified or set aside. In such an action, the court shall determine the matter de novo.

(k) Certification

Any application for approval of a drug product shall include—

(1) a certification that the applicant did not and will not use in any capacity the services of any person debarred under subsection (a) or (b), in connection with such application, and

(2) if such application is an abbreviated drug application, a list of all convictions, described in subsections (a) and (b) which occurred within the previous 5 years, of the applicant and affiliated persons responsible for the development or submission of such application.

(l) Applicability

(1) Conviction

For purposes of this section, a person is considered to have been convicted of a criminal offense—

(A) when a judgment of conviction has been entered against the person by a Federal or State court, regardless of whether there is an appeal pending,

(B) when a plea of guilty or nolo contendere by the person has been accepted by a Federal or State court, or

(C) when the person has entered into participation in a first offender, deferred adjudication, or other similar arrangement or program where judgment of conviction has been withheld.

(2) Effective dates

Subsection (a), subparagraph (A) of subsection (b)(2), clauses (i) and (ii) of subsection (b)(2)(B), and subsection (b)(3)(A) shall not apply to a conviction which occurred more than 5 years before the initiation of an agency action proposed to be taken under subsection (a) or (b). Clauses (iii) and (iv) of subsection (b)(2)(B), subsection (b)(3)(B), and subsections (f) and (g) shall not apply to an act or action which occurred more than 5 years before the initiation of an agency action proposed to be taken under subsection (b), (f), or (g). Clause (iv) of subsection (b)(2)(B) shall not apply to an action which occurred before June 1, 1992. Subsection (k) shall not apply to applications submitted to the Secretary before June 1, 1992.

(m) Devices; mandatory debarment regarding third-party inspections and reviews

(1) In general

If the Secretary finds that a person has been convicted of a felony under section 331(gg) of this title, the Secretary shall debar such person from being accredited under section 360m(b) or 374(g)(2) of this title and from carrying out activities under an agreement described in section 383(b) of this title.

(2) Debarment period

The Secretary shall debar a person under paragraph (1) for the following periods:

(A) The period of debarment of a person (other than an individual) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under such paragraph occurs within 10 years after such person has been debarred under such paragraph, the period of debarment shall be permanent.

(B) The debarment of an individual shall be permanent.

(3) Termination of debarment; judicial review; other matters

Subsections (c)(3), (d), (e), (i), (j), and (l)(1) apply with respect to a person (other than an individual) or an individual who is debarred under paragraph (1) to the same extent and in the same manner as such subsections apply with respect to a person who is debarred under subsection (a)(1), or an individual who is debarred under subsection (a)(2), respectively.

(June 25, 1938, ch. 675, §306, as added Pub. L. 102–282, §2, May 13, 1992, 106 Stat. 150; amended Pub. L. 105–115, title I, §125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 107–188, title III, §304(a)–(c), June 12, 2002, 116 Stat. 665, 666; Pub. L. 107–250, title II, §203, Oct. 26, 2002, 116 Stat. 1610; Pub. L. 115–271, title III, §3022(b)(2), Oct. 24, 2018, 132 Stat. 3938.)

Editorial Notes

Prior Provisions

A prior section 306 of act June 25, 1938, was renumbered section 309 and is classified to section 336 of this title.

Amendments

2018—Subsec. (b)(1). Pub. L. 115–271, §3022(b)(2)(A)(i), inserted "or (3)" after "paragraph (2)" in introductory provisions.

Subsec. (b)(1)(D). Pub. L. 115–271, §3022(b)(2)(A)(ii)–(v), added subpar. (D).

Subsec. (b)(3). Pub. L. 115–271, §3022(b)(2)(B)(i), inserted "or drug" after "food" in heading.

Subsec. (b)(3)(C), (D). Pub. L. 115–271, §3022(b)(2)(B)(ii)–(iv), added subpars. (C) and (D).

Subsec. (b)(5). Pub. L. 115–271, §3022(b)(2)(C), added par. (5).

2002—Subsec. (a). Pub. L. 107–188, §304(b)(1), substituted "Mandatory debarment; certain drug applications" for "Mandatory debarment" in heading.

Subsec. (b). Pub. L. 107–188, §304(b)(2)(A), substituted "Permissive debarment; certain drug applications; food imports" for "Permissive debarment" in heading.

Subsec. (b)(1)(C). Pub. L. 107–188, §304(a)(1), added subpar. (C).

Subsec. (b)(2). Pub. L. 107–188, §304(b)(2)(B), substituted "permissive debarment; certain drug applications" for "permissive debarment" in heading.

Pub. L. 107–188, §304(a)(2)(A), inserted "subparagraph (A) or (B) of" before "paragraph (1)" in introductory provisions.

Subsec. (b)(3), (4). Pub. L. 107–188, §304(a)(2)(B), (C), added par. (3) and redesignated former par. (3) as (4).

Subsec. (c)(2)(A)(iii). Pub. L. 107–188, §304(b)(3), substituted "paragraph (2) or (3) of subsection (b)" for "subsection (b)(2)".

Subsec. (d)(3)(A)(i). Pub. L. 107–188, §304(b)(4)(A), substituted "subsection (a)(1) or paragraph (2)(A) or (3) of subsection (b)" for "subsection (a)(1) or (b)(2)(A)".

Subsec. (d)(3)(A)(ii)(II). Pub. L. 107–188, §304(b)(4)(B), inserted "in applicable cases," before "sufficient audits".

Subsec. (d)(3)(B)(i). Pub. L. 107–188, §304(b)(4)(C), inserted "or subsection (b)(3)" after "subsection (b)(2)(B)".

Subsec. (d)(3)(B)(ii). Pub. L. 107–188, §304(b)(4)(C), (D), inserted "or subsection (b)(3)" after "subsection (b)(2)(B)" and "or the food importation process, as the case may be" before period.

Subsec. (l)(2). Pub. L. 107–188, §304(c), in first sentence struck out "and" after "subsection (b)(2)," and inserted ", and subsection (b)(3)(A)" after "subsection (b)(2)(B)" and in second sentence inserted ", subsection (b)(3)(B)," after "subsection (b)(2)(B)".

Subsec. (m). Pub. L. 107–250 added subsec. (m).

1997—Subsec. (d)(4)(B)(ii). Pub. L. 105–115 struck out "or 357" after "355".

Statutory Notes and Related Subsidiaries

Construction

Pub. L. 102–282, §7, May 13, 1992, 106 Stat. 162, provided that: "No amendment made by this Act [enacting this section and sections 335b and 335c of this title and amending sections 321, 336, 337, and 355 of this title] shall preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by this Act."

Congressional Findings

Pub. L. 102–282, §1(c), May 13, 1992, 106 Stat. 149, provided that: "The Congress finds that—

"(1) there is substantial evidence that significant corruption occurred in the Food and Drug Administration's process of approving drugs under abbreviated drug applications,

"(2) there is a need to establish procedures designed to restore and to ensure the integrity of the abbreviated drug application approval process and to protect the public health, and

"(3) there is a need to establish procedures to bar individuals who have been convicted of crimes pertaining to the regulation of drug products from working for companies that manufacture or distribute such products."

1 So in original. Probably should be "section".
21 U.S.C. § 1705 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1705: Development, submission, implementation, and assessment of National Drug Control Strategy
Development, submission, implementation, and assessment of National Drug Control Strategy
Status: in_force

(a) In general

(1) Statement of drug policy priorities

The Director shall release a statement of drug control policy priorities in the calendar year of a Presidential inauguration following the inauguration, but not later than April 1.

(2) National Drug Control Strategy submitted by the President

Not later than the first Monday in February following the year in which the term of the President commences, and every 2 years thereafter, the President shall submit to Congress a National Drug Control Strategy.

(b) Development of the National Drug Control Strategy

(1) Promulgation

The Director shall promulgate the National Drug Control Strategy, which shall set forth a comprehensive plan to reduce illicit drug use and the consequences of such illicit drug use in the United States by limiting the availability of and reducing the demand for illegal drugs and promoting prevention, early intervention, treatment, and recovery support for individuals with substance use disorders.

(2) State and local commitment

The Director shall seek the support and commitment of State, local, and Tribal officials in the formulation and implementation of the National Drug Control Strategy.

(3) Strategy based on evidence

The Director shall ensure the National Drug Control Strategy is based on the best available evidence regarding the policies that are most effective in reducing the demand for and supply of illegal drugs.

(4) Process for development and submission of National Drug Control Strategy

In developing and effectively implementing the National Drug Control Strategy, the Director—

(A) shall consult with—

(i) the heads of the National Drug Control Program agencies;

(ii) each Coordinator listed in section 1703 of this title;

(iii) the Interdiction Committee and the Emerging Threats Committee;

(iv) the appropriate congressional committees and any other committee of jurisdiction;

(v) State, local, and Tribal officials;

(vi) private citizens and organizations, including community and faith-based organizations, with experience and expertise in demand reduction;

(vii) private citizens and organizations with experience and expertise in supply reduction; and

(viii) appropriate representatives of foreign governments; and

(B) in satisfying the requirements of subparagraph (A), shall ensure, to the maximum extent possible, that State, local, and Tribal officials and relevant private organizations commit to support and take steps to achieve the goals and objectives of the National Drug Control Strategy.

(c) Contents of the National Drug Control Strategy

(1) In general

The National Drug Control Strategy submitted under subsection (a)(2) shall include the following:

(A) A mission statement detailing the major functions of the National Drug Control Program.

(B) Comprehensive, research-based, long-range, quantifiable goals for reducing illicit drug use, and the consequences of illicit drug use in the United States.

(C) Annual quantifiable and measurable objectives and specific targets to accomplish long-term quantifiable goals that the Director determines may be achieved during each year beginning on the date on which the National Drug Control Strategy is submitted.

(D) A 5-year projection for the National Drug Control Program and budget priorities.

(E) A review of international, State, local, and private sector drug control activities to ensure that the United States pursues coordinated and effective drug control at all levels of government.

(F) A description of how each goal established under subparagraph (B) will be achieved, including for each goal—

(i) a list of each relevant National Drug Control Program agency and each such agency's related programs, activities, and available assets and the role of each such program, activity, and asset in achieving such goal;

(ii) a list of relevant stakeholders and each such stakeholder's role in achieving such goal;

(iii) an estimate of Federal funding and other resources needed to achieve such goal;

(iv) a list of each existing or new coordinating mechanism needed to achieve such goal; and

(v) a description of the Office's role in facilitating the achievement of such goal.

(G) For each year covered by the Strategy, a performance evaluation plan for each goal established under subparagraph (B) for each National Drug Control Program agency, including—

(i) specific performance measures for each National Drug Control Program agency;

(ii) annual and, to the extent practicable, quarterly objectives and targets for each performance measure; and

(iii) an estimate of Federal funding and other resources needed to achieve each performance objective and target.

(H) A list identifying existing data sources or a description of data collection needed to evaluate performance, including a description of how the Director will obtain such data.

(I) A list of any anticipated challenges to achieving the National Drug Control Strategy goals and planned actions to address such challenges.

(J) A description of how each goal established under subparagraph (B) was determined, including—

(i) a description of each required consultation and a description of how such consultation was incorporated; and

(ii) data, research, or other information used to inform the determination to establish the goal.

(K) A description of the current prevalence of illicit drug use in the United States, including both the availability of illicit drugs and the prevalence of substance use disorders.

(L) Such other statistical data and information as the Director considers appropriate to demonstrate and assess trends relating to illicit drug use, the effects and consequences of illicit drug use (including the effects on children), supply reduction, demand reduction, drug-related law enforcement, and the implementation of the National Drug Control Strategy.

(M) A systematic plan for increasing data collection to enable real time surveillance of drug control threats, developing analysis and monitoring capabilities, and identifying and addressing policy questions related to the National Drug Control Strategy and Program, which shall include—

(i) a list of policy-relevant questions for which the Director and each National Drug Control Program agency intends to develop evidence to support the National Drug Control Program and Strategy;

(ii) a list of data the Director and each National Drug Control Program agency intends to collect, use, or acquire to facilitate the use of evidence in drug control policymaking and monitoring;

(iii) a list of methods and analytical approaches that may be used to develop evidence to support the National Drug Control Program and Strategy and related policy;

(iv) a list of any challenges to developing evidence to support policymaking, including any barriers to accessing, collecting, or using relevant data;

(v) a description of the steps the Director and the head of each National Drug Control Program agency will take to effectuate the plan; and

(vi) any other relevant information as determined by the Director.

(N) A plan to expand treatment of substance use disorders, which shall—

(i) identify unmet needs for treatment for substance use disorders and a strategy for closing the gap between available and needed treatment;

(ii) describe the specific roles and responsibilities of the relevant National Drug Control Program agencies for implementing the plan;

(iii) identify the specific resources required to enable the relevant National Drug Control Program agencies to implement that strategy; and

(iv) identify the resources, including private sources, required to eliminate the unmet need for evidence-based substance use disorder treatment.

(2) Consultation

In developing the plan required under paragraph (1)(M), the Director shall consult with the following:

(A) The public.

(B) Any evaluation or analysis units and personnel of the Office.

(C) Office officials responsible for implementing privacy policy.

(D) Office officials responsible for data governance.

(E) The appropriate congressional committees.

(F) Any other individual or entity as determined by the Director.

(3) Additional strategies

(A) In general

The Director shall include in the National Drug Control Strategy the additional strategies described under this paragraph and shall comply with the following:

(i) Provide a copy of the additional strategies to the appropriate congressional committees and to the Committee on Armed Services and the Committee on Homeland Security of the House of Representatives, and the Committee on Homeland Security and Governmental Affairs and the Committee on Armed Services of the Senate.

(ii) Issue the additional strategies in consultation with the head of each relevant National Drug Control Program agency, any relevant official of a State, local, or Tribal government, and the government of other relevant countries.

(iii) Not change any existing agency authority or construe any strategy described under this paragraph to amend or modify any law governing interagency relationship but may include recommendations about changes to such authority or law.

(iv) Present separately from the rest of any strategy described under this paragraph any information classified under criteria established by an Executive order, or whose public disclosure, as determined by the Director or the head of any relevant National Drug Control Program agency, would be detrimental to the law enforcement or national security activities of any Federal, State, local, or Tribal agency.

(B) Requirement for Southwest Border Counternarcotics Strategy

(i) Purposes

The Southwest Border Counternarcotics Strategy shall—

(I) set forth the Government's strategy for preventing the illegal trafficking of drugs across the international border between the United States and Mexico, including through ports of entry and between ports of entry on that border;

(II) state the specific roles and responsibilities of the relevant National Drug Control Program agencies for implementing that strategy; and

(III) identify the specific resources required to enable the relevant National Drug Control Program agencies to implement that strategy.

(ii) Specific content related to drug tunnels between the United States and Mexico

The Southwest Border Counternarcotics Strategy shall include—

(I) a strategy to end the construction and use of tunnels and subterranean passages that cross the international border between the United States and Mexico for the purpose of illegal trafficking of drugs across such border; and

(II) recommendations for criminal penalties for persons who construct or use such a tunnel or subterranean passage for such a purpose.

(C) Requirement for Northern Border Counternarcotics Strategy

(i) Purposes

The Northern Border Counternarcotics Strategy shall—

(I) set forth the strategy of the Federal Government for preventing the illegal trafficking of drugs across the international border between the United States and Canada, including through ports of entry and between ports of entry on the border;

(II) state the specific roles and responsibilities of each relevant National Drug Control Program agency for implementing the strategy;

(III) identify the specific resources required to enable the relevant National Drug Control Program agencies to implement the strategy;

(IV) be designed to promote, and not hinder, legitimate trade and travel; and

(V) reflect the unique nature of small communities along the international border between the United States and Canada, ongoing cooperation and coordination with Canadian law,1 enforcement authorities, and variations in the volumes of vehicles and pedestrians crossing through ports of entry along the international border between the United States and Canada.

(ii) Specific content related to cross-border Indian reservations

The Northern Border Counternarcotics Strategy shall include—

(I) a strategy to end the illegal trafficking of drugs to or through Indian reservations on or near the international border between the United States and Canada; and

(II) recommendations for additional assistance, if any, needed by Tribal law enforcement agencies relating to the strategy, including an evaluation of Federal technical and financial assistance, infrastructure capacity building, and interoperability deficiencies.

(4) Classified information

Any contents of the National Drug Control Strategy that involve information properly classified under criteria established by an Executive order shall be presented to Congress separately from the rest of the National Drug Control Strategy.

(5) Selection of data and information

In selecting data and information for inclusion in the Strategy, the Director shall ensure—

(A) the inclusion of data and information that will permit analysis of current trends against previously compiled data and information where the Director believes such analysis enhances long-term assessment of the National Drug Control Strategy; and

(B) the inclusion of data and information to permit a standardized and uniform assessment of the effectiveness of drug treatment programs in the United States.

(d) Submission of revised Strategy

The President may submit to Congress a revised National Drug Control Strategy that meets the requirements of this section—

(1) at any time, upon a determination of the President, in consultation with the Director, that the National Drug Control Strategy in effect is not sufficiently effective; or

(2) if a new President or Director takes office.

(e) Failure of Director to Submit National Drug Control Strategy

If the Director does not submit a National Drug Control Strategy to Congress in accordance with subsection (a)(2), not later than five days after the first Monday in February following the year in which the term of the President commences, the Director shall send a notification to the appropriate congressional committees—

(1) explaining why the Strategy was not submitted; and

(2) specifying the date by which the Strategy will be submitted.

(f) Drug Control Data Dashboard

(1) In general

The Director shall collect and disseminate, as appropriate, such information as the Director determines is appropriate, but not less than the information described in this subsection. The data shall be publicly available in a machine-readable format on the online portal of the Office, and to the extent practicable on the Drug Control Data Dashboard.

(2) Establishment

The Director shall publish to the online portal of the Office in a machine-readable, sortable, and searchable format, or to the extent practicable, establish and maintain a data dashboard on the online portal of the Office to be known as the "Drug Control Data Dashboard". To the extent practicable, when establishing the Drug Control Dashboard, the Director shall ensure the user interface of the dashboard is constructed with modern design standards. To the extent practicable, the data made available on the dashboard shall be publicly available in a machine-readable format and searchable by year, agency, drug, and location.

(3) Data

The data included in the Drug Control Data Dashboard shall be updated quarterly to the extent practicable, but not less frequently than annually and shall include, at a minimum, the following:

(A) For each substance identified by the Director as having a significant impact on the prevalence of illicit drug use—

(i) data sufficient to show the quantities of such substance available in the United States, including—

(I) the total amount seized and disrupted in the calendar year and each of the previous 3 calendar years, including to the extent practicable the amount seized by State, local, and Tribal governments;

(II) the known and estimated flows into the United States from all sources in the calendar year and each of the previous 3 calendar years;

(III) the total amount of known flows that could not be interdicted or disrupted in the calendar year and each of the previous 3 calendar years;

(IV) the known and estimated levels of domestic production in the calendar year and each of the previous three calendar years, including the levels of domestic production if the drug is a prescription drug, as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], for which a listing is in effect under section 812 of this title;

(V) the average street price for the calendar year and the highest known street price during the preceding 10-year period; and

(VI) to the extent practicable, related prosecutions by State, local, and Tribal governments; 2

(ii) data sufficient to show the frequency of use of such substance, including—

(I) use of such substance in the workplace and productivity lost by such use;

(II) use of such substance by arrestees, probationers, and parolees;

(III) crime and criminal activity related to such substance; and

(IV) to the extent practicable, related prosecutions by State, local, and Tribal governments.

(B) For the calendar year and each of the previous three years data sufficient to show, disaggregated by State and, to the extent feasible, by region within a State, county, or city, the following:

(i) The number of fatal and non-fatal overdoses caused by each drug identified under subparagraph (A)(i).

(ii) The prevalence of substance use disorders.

(iii) The number of individuals who have received substance use disorder treatment, including medication assisted treatment, for a substance use disorder, including treatment provided through publicly-financed health care programs.

(iv) The extent of the unmet need for substance use disorder treatment, including the unmet need for medication-assisted treatment.

(C) Data sufficient to show the extent of prescription drug diversion, trafficking, and misuse in the calendar year and each of the previous 3 calendar years.

(D) Any quantifiable measures the Director determines to be appropriate to detail progress toward the achievement of the goals of the National Drug Control Strategy.

(g) Development of an annual national drug control assessment

(1) Timing

Not later than the first Monday in February of each year, the Director shall submit to the President, Congress, and the appropriate congressional committees, a report assessing the progress of each National Drug Control Program agency toward achieving each goal, objective, and target contained in the National Drug Control Strategy applicable to the prior fiscal year.

(2) Process for development of the annual assessment

Not later than November 1 of each year, the head of each National Drug Control Program agency shall submit, in accordance with guidance issued by the Director, to the Director an evaluation of progress by the agency with respect to the National Drug Control Strategy goals using the performance measures for the agency developed under this chapter, including progress with respect to—

(A) success in achieving the goals of the National Drug Control Strategy;

(B) success in reducing domestic and foreign sources of illegal drugs;

(C) success in expanding access to and increasing the effectiveness of substance use disorder treatment;

(D) success in protecting the borders of the United States (and in particular the Southwestern border of the United States) from penetration by illegal narcotics;

(E) success in reducing crime associated with drug use in the United States;

(F) success in reducing the negative health and social consequences of drug use in the United States;

(G) implementation of evidence-based substance use disorder treatment and prevention programs in the United States and improvements in the adequacy and effectiveness of such programs; and

(H) success in increasing the prevention of illicit drug use.

(3) Contents of the annual assessment

The Director shall include in the annual assessment required under paragraph (1)—

(A) a summary of each evaluation received by the Director under paragraph (2);

(B) a summary of the progress of each National Drug Control Program agency toward the National Drug Control Strategy goals of the agency using the performance measures for the agency developed under this chapter;

(C) an assessment of the effectiveness of each National Drug Control Program agency and program in achieving the National Drug Control Strategy for the previous year, including a specific evaluation of whether the applicable goals, measures, objectives, and targets for the previous year were met; and

(D) the assessments required under this subsection shall be based on the Performance Measurement System.3

(h) Performance measurement system

Not later than February 1 of each year, the Director shall submit to Congress as part of the National Drug Control Strategy, a description of a national drug control performance measurement system, that—

(1) develops 2-year and 5-year performance measures and targets for each National Drug Control Strategy goal and objective established for reducing drug use, availability, and the consequences of drug use;

(2) describes the sources of information and data that will be used for each performance measure incorporated into the performance measurement system;

(3) identifies major programs and activities of the National Drug Control Program agencies that support the goals and annual objectives of the National Drug Control Strategy;

(4) evaluates the contribution of demand reduction and supply reduction activities as defined in section 1701 of this title implemented by each National Drug Control Program agency in support of the National Drug Control Strategy;

(5) monitors consistency between the drug-related goals and objectives of the National Drug Control Program agencies and ensures that each agency's goals and budgets support and are fully consistent with the National Drug Control Strategy;

(6) coordinates the development and implementation of national drug control data collection and reporting systems to support policy formulation and performance measurement, including an assessment of—

(A) the quality of current drug use measurement instruments and techniques to measure supply reduction and demand reduction activities;

(B) the adequacy of the coverage of existing national drug use measurement instruments and techniques to measure the illicit drug user population, and groups that are at risk for illicit drug use;

(C) the adequacy of the coverage of existing national treatment outcome monitoring systems to measure the effectiveness of drug abuse treatment in reducing illicit drug use and criminal behavior during and after the completion of substance abuse treatment; and

(D) the actions the Director shall take to correct any deficiencies and limitations identified pursuant to subparagraphs (A) and (B) of this subsection; and

(7) develops performance measures and targets for the National Drug Control Strategy for supplemental strategies (the Southwest Border, Northern Border, and Caribbean Border Counternarcotics Strategies) to effectively evaluate region-specific goals, to the extent the performance measurement system does not adequately measure the effectiveness of the strategies, as determined by the Director, such strategies may evaluate interdiction efforts at and between ports of entry, interdiction technology, intelligence sharing, diplomacy, and other appropriate metrics, specific to each supplemental strategies region, as determined by the Director.

(i) Modifications

A description of any modifications made during the preceding year to the national drug performance measurement system described in subsection (c) 4 shall be included in each report submitted under subsection (b).5

(Pub. L. 105–277, div. C, title VII, §§706, 715, Oct. 21, 1998, 112 Stat. 2681–681, 2681–693; Pub. L. 109–469, title II, §§201, 202, title VI, §602, Dec. 29, 2006, 120 Stat. 3513, 3517, 3533; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8221(a), Oct. 24, 2018, 132 Stat. 4110, 4134; Pub. L. 116–74, §2(a)(1), (2), (c)(1)(B), (d), Nov. 27, 2019, 133 Stat. 1155, 1158; Pub. L. 117–263, div. E, title LIII, §5302, Dec. 23, 2022, 136 Stat. 3249.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (f)(3)(A)(i)(IV), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

This chapter, referred to in subsec. (g)(2), (3)(B), was in the original "this title", meaning title VII of div. C of Pub. L. 105–277, Oct. 21, 1998, 112 Stat. 2681–670, which is classified principally to this chapter. For complete classification of title VII to the Code, see Short Title note set out under section 1701 of this title and Tables.

Amendments

2022—Subsec. (h)(7). Pub. L. 117–263 added par. (7).

2019—Pub. L. 116–74, §2(c)(1)(B), amended directory language of Pub. L. 115–271, §8221(a). See 2018 Amendment note below.

Pub. L. 116–74, §2(a)(2), substituted "National Drug Control Program agencies" for "National Drug Control Program Agencies" wherever appearing.

Pub. L. 116–74, §2(a)(1), substituted "National Drug Control Program agency" for "National Drug Control Program Agency" wherever appearing.

Subsec. (c)(1)(N)(ii). Pub. L. 116–74, §2(d)(1)(A), substituted "Program agencies" for "Programs".

Subsec. (c)(1)(N)(iii). Pub. L. 116–74, §2(d)(1)(B), substituted "Program agencies" for "Agencies".

Subsec. (c)(2). Pub. L. 116–74, §2(d)(2), substituted "paragraph (1)(M)" for "paragraph (1)" in introductory provisions.

Subsec. (f)(2). Pub. L. 116–74, §2(d)(3)(A), substituted "Office" for "office".

Subsec. (f)(3)(A)(ii)(III). Pub. L. 116–74, §2(d)(3)(B)(i), substituted "substance; and" for "substance;".

Subsec. (f)(3)(A)(ii)(IV). Pub. L. 116–74, §2(d)(3)(B)(ii), substituted "governments." for "governments;".

Subsec. (g)(3)(B). Pub. L. 116–74, §2(d)(4), made technical amendment to reference in original act which appears in text as reference to this chapter.

2018—Pub. L. 115–271, §8221(a), as amended by Pub. L. 116–74, §2(c)(1)(B)(ii), added subsecs. (a) to (g), redesignated former subsecs. (c) and (d) as (h) and (i), respectively, and struck out former subsecs. (a) and (b) which related to submission of the National Drug Control Strategy and submission of a revised strategy.

Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Pub. L. 109–469, §201, amended section generally. Prior to amendment, section related to development, submission, implementation, and assessment of National Drug Control Strategy.

Subsecs. (c), (d). Pub. L. 109–469, §202, added subsecs. (c) and (d).

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by section 2(c)(1)(B) of Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out as a note under section 1522 of this title.

Requirement for Southwest Border Counternarcotics Strategy

Pub. L. 109–469, title XI, §1110, Dec. 29, 2006, 120 Stat. 3543, which directed the Director of National Drug Control Policy to submit to Congress every two years a Southwest Border Counternarcotics Strategy, was repealed by Pub. L. 115–271, title VIII, §8221(b)(2), Oct. 24, 2018, 132 Stat. 4142. See subsection (c)(3)(B) of this section.

Requirement for Northern Border Counternarcotics Strategy

Pub. L. 109–469, title XI, §1110A, as added by Pub. L. 111–356, §2, Jan. 4, 2011, 124 Stat. 3976, which directed the Director of National Drug Control Policy to develop, in consultation with the head of each relevant National Drug Control Program Agency, and to submit to Congress every two years, a Northern Border Counternarcotics Strategy, was repealed by Pub. L. 115–271, title VIII, §8221(b)(2), Oct. 24, 2018, 132 Stat. 4142. See subsection (c)(3)(C) of this section.

1 So in original. The comma probably should not appear.

2 So in original. Probably should be followed by "and".

3 So in original.

4 Probably should be "(h)".

5 Probably should be "(d)".
21 U.S.C. § 356 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 356: Expedited approval of drugs for serious or life-threatening diseases or conditions
Expedited approval of drugs for serious or life-threatening diseases or conditions
Status: in_force

(a) Designation of a drug as a breakthrough therapy

(1) In general

The Secretary shall, at the request of the sponsor of a drug, expedite the development and review of such drug if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. (In this section, such a drug is referred to as a "breakthrough therapy".)

(2) Request for designation

The sponsor of a drug may request the Secretary to designate the drug as a breakthrough therapy. A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].

(3) Designation

(A) In general

Not later than 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a breakthrough therapy and shall take such actions as are appropriate to expedite the development and review of the application for approval of such drug.

(B) Actions

The actions to expedite the development and review of an application under subparagraph (A) may include, as appropriate—

(i) holding meetings with the sponsor and the review team throughout the development of the drug;

(ii) providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable;

(iii) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review;

(iv) assigning a cross-disciplinary project lead for the Food and Drug Administration review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor; and

(v) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment.

(b) Designation of drug as fast track product

(1) In general

The Secretary shall, at the request of the sponsor of a new drug, facilitate the development and expedite the review of such drug if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition, or if the Secretary designates the drug as a qualified infectious disease product under section 355f(d) of this title. (In this section, such a drug is referred to as a "fast track product".)

(2) Request for designation

The sponsor of a new drug may request the Secretary to designate the drug as a fast track product. A request for the designation may be made concurrently with, or at any time after, submission of an application for the investigation of the drug under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].

(3) Designation

Within 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a fast track product and shall take such actions as are appropriate to expedite the development and review of the application for approval of such product.

(c) Accelerated approval of a drug for a serious or life-threatening disease or condition, including a fast track product

(1) In general

(A) Accelerated approval

The Secretary may approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, under section 355(c) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. The approval described in the preceding sentence is referred to in this section as "accelerated approval".

(B) Evidence

The evidence to support that an endpoint is reasonably likely to predict clinical benefit under subparagraph (A) may include epidemiological, pathophysiological, therapeutic, pharmacologic, or other evidence developed using biomarkers, for example, or other scientific methods or tools.

(2) Limitation

(A) In general

Approval of a product under this subsection may be subject to 1 or both of the following requirements:

(i) That the sponsor conduct an appropriate postapproval study or studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit.

(ii) That the sponsor submit copies of all promotional materials related to the product during the preapproval review period and, following approval and for such period thereafter as the Secretary determines to be appropriate, at least 30 days prior to dissemination of the materials.

(B) Studies not required

If the Secretary does not require that the sponsor of a product approved under accelerated approval conduct a postapproval study under this paragraph, the Secretary shall publish on the website of the Food and Drug Administration the rationale for why such study is not appropriate or necessary.

(C) Postapproval study conditions

Not later than the date of approval of a product under accelerated approval, the Secretary shall specify the conditions for a postapproval study or studies required to be conducted under this paragraph with respect to such product, which may include enrollment targets, the study protocol, and milestones, including the target date of study completion.

(D) Studies begun before approval

The Secretary may require, as appropriate, a study or studies to be underway prior to approval, or within a specified time period after the date of approval, of the applicable product.

(3) Expedited withdrawal of approval

(A) In general

The Secretary may withdraw approval of a product approved under accelerated approval using expedited procedures described in subparagraph (B) if—

(i) the sponsor fails to conduct any required postapproval study of the product with due diligence, including with respect to conditions specified by the Secretary under paragraph (2)(C);

(ii) a study required to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit of the product fails to verify and describe such effect or benefit;

(iii) other evidence demonstrates that the product is not shown to be safe or effective under the conditions of use; or

(iv) the sponsor disseminates false or misleading promotional materials with respect to the product.

(B) Expedited procedures described

Expedited procedures described in this subparagraph shall consist of, prior to the withdrawal of accelerated approval—

(i) providing the sponsor with—

(I) due notice;

(II) an explanation for the proposed withdrawal;

(III) an opportunity for a meeting with the Commissioner or the Commissioner's designee; and

(IV) an opportunity for written appeal to—

(aa) the Commissioner; or

(bb) a designee of the Commissioner who has not participated in the proposed withdrawal of approval (other than a meeting pursuant to subclause (III)) and is not subordinate of an individual (other than the Commissioner) who participated in such proposed withdrawal;

(ii) providing an opportunity for public comment on the proposal to withdraw approval;

(iii) the publication of a summary of the public comments received, and the Secretary's response to such comments, on the website of the Food and Drug Administration; and

(iv) convening and consulting an advisory committee on issues related to the proposed withdrawal, if requested by the sponsor and if no such advisory committee has previously advised the Secretary on such issues with respect to the withdrawal of the product prior to the sponsor's request.

(d) Review of incomplete applications for approval of a fast track product

(1) In general

If the Secretary determines, after preliminary evaluation of clinical data submitted by the sponsor, that a fast track product may be effective, the Secretary shall evaluate for filing, and may commence review of portions of, an application for the approval of the product before the sponsor submits a complete application. The Secretary shall commence such review only if the applicant—

(A) provides a schedule for submission of information necessary to make the application complete; and

(B) pays any fee that may be required under section 379h of this title.

(2) Exception

Any time period for review of human drug applications that has been agreed to by the Secretary and that has been set forth in goals identified in letters of the Secretary (relating to the use of fees collected under section 379h of this title to expedite the drug development process and the review of human drug applications) shall not apply to an application submitted under paragraph (1) until the date on which the application is complete.

(e) Construction

(1) Purpose

The amendments made by the Food and Drug Administration Safety and Innovation Act and the 21st Century Cures Act to this section are intended to encourage the Secretary to utilize innovative and flexible approaches to the assessment of products under accelerated approval for treatments for patients with serious or life-threatening diseases or conditions and unmet medical needs.

(2) Construction

Nothing in this section shall be construed to alter the standards of evidence under subsection (c) or (d) of section 355 of this title (including the substantial evidence standard in section 355(d) of this title) or under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]. Such sections and standards of evidence apply to the review and approval of products under this section, including whether a product is safe and effective. Nothing in this section alters the ability of the Secretary to rely on evidence that does not come from adequate and well-controlled investigations for the purpose of determining whether an endpoint is reasonably likely to predict clinical benefit as described in subsection (b)(1)(B).

(f) Awareness efforts

The Secretary shall—

(1) develop and disseminate to physicians, patient organizations, pharmaceutical and biotechnology companies, and other appropriate persons a description of the provisions of this section applicable to breakthrough therapies, accelerated approval, and and 1 fast track products; and

(2) establish a program to encourage the development of surrogate and clinical endpoints, including biomarkers, and other scientific methods and tools that can assist the Secretary in determining whether the evidence submitted in an application is reasonably likely to predict clinical benefit for serious or life-threatening conditions for which significant unmet medical needs exist.

(g) Regenerative advanced therapy

(1) In general

The Secretary, at the request of the sponsor of a drug, shall facilitate an efficient development program for, and expedite review of, such drug if the drug qualifies as a regenerative advanced therapy under the criteria described in paragraph (2).

(2) Criteria

A drug is eligible for designation as a regenerative advanced therapy under this subsection if—

(A) the drug is a regenerative medicine therapy (as defined in paragraph (8));

(B) the drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and

(C) preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition.

(3) Request for designation

The sponsor of a drug may request the Secretary to designate the drug as a regenerative advanced therapy concurrently with, or at any time after, submission of an application for the investigation of the drug under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].

(4) Designation

Not later than 60 calendar days after the receipt of a request under paragraph (3), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (2). If the Secretary determines that the drug meets the criteria, the Secretary shall designate the drug as a regenerative advanced therapy and shall take such actions as are appropriate under paragraph (1). If the Secretary determines that a drug does not meet the criteria for such designation, the Secretary shall include with the determination a written description of the rationale for such determination.

(5) Actions

The sponsor of a regenerative advanced therapy shall be eligible for the actions to expedite development and review of such therapy under subsection (a)(3)(B), including early interactions to discuss any potential surrogate or intermediate endpoint to be used to support the accelerated approval of an application for the product under subsection (c).

(6) Access to expedited approval pathways

An application for a regenerative advanced therapy under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] may be—

(A) eligible for priority review, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012; and

(B) eligible for accelerated approval under subsection (c), as agreed upon pursuant to subsection (a)(3)(B), through, as appropriate—

(i) surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit; or

(ii) reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate.

(7) Postapproval requirements

The sponsor of a regenerative advanced therapy that is granted accelerated approval and is subject to the postapproval requirements under subsection (c) may, as appropriate, fulfill such requirements, as the Secretary may require, through—

(A) the submission of clinical evidence, clinical studies, patient registries, or other sources of real world evidence, such as electronic health records;

(B) the collection of larger confirmatory data sets, as agreed upon pursuant to subsection (a)(3)(B); or

(C) postapproval monitoring of all patients treated with such therapy prior to approval of the therapy.

(8) Definition

For purposes of this section, the term "regenerative medicine therapy" includes cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act [42 U.S.C. 264] and part 1271 of title 21, Code of Federal Regulations.

(h) Limited population pathway for antibacterial and antifungal drugs

(1) In general

The Secretary may approve an antibacterial or antifungal drug, alone or in combination with one or more other drugs, as a limited population drug pursuant to this subsection only if—

(A) the drug is intended to treat a serious or life-threatening infection in a limited population of patients with unmet needs;

(B) the standards for approval under section 355(c) and (d) of this title, or the standards for licensure under section 351 of the Public Health Service Act [42 U.S.C. 262], as applicable, are met; and

(C) the Secretary receives a written request from the sponsor to approve the drug as a limited population drug pursuant to this subsection.

(2) Benefit-risk consideration

The Secretary's determination of safety and effectiveness of an antibacterial or antifungal drug shall reflect the benefit-risk profile of such drug in the intended limited population, taking into account the severity, rarity, or prevalence of the infection the drug is intended to treat and the availability or lack of alternative treatment in such limited population. Such drug may be approved under this subsection notwithstanding a lack of evidence to fully establish a favorable benefit-risk profile in a population that is broader than the intended limited population.

(3) Additional requirements

A drug approved under this subsection shall be subject to the following requirements, in addition to any other applicable requirements of this chapter:

(A) Labeling

To indicate that the safety and effectiveness of a drug approved under this subsection has been demonstrated only with respect to a limited population—

(i) all labeling and advertising of an antibacterial or antifungal drug approved under this subsection shall contain the statement "Limited Population" in a prominent manner and adjacent to, and not more prominent than—

(I) the proprietary name of such drug, if any; or

(II) if there is no proprietary name, the established name of the drug, if any, as defined in section 353(e)(3) of this title, or, in the case of a drug that is a biological product, the proper name, as defined by regulation; and

(ii) the prescribing information for the drug required by section 201.57 of title 21, Code of Federal Regulations (or any successor regulation) shall also include the following statement: "This drug is indicated for use in a limited and specific population of patients.".

(B) Promotional material

The sponsor of an antibacterial or antifungal drug subject to this subsection shall submit to the Secretary copies of all promotional materials related to such drug at least 30 calendar days prior to dissemination of the materials.

(4) Other programs

A sponsor of a drug that seeks approval of a drug under this subsection may also seek designation or approval, as applicable, of such drug under other applicable sections or subsections of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.].

(5) Guidance

Not later than 18 months after December 13, 2016, the Secretary shall issue draft guidance describing criteria, processes, and other general considerations for demonstrating the safety and effectiveness of limited population antibacterial and antifungal drugs. The Secretary shall publish final guidance within 18 months of the close of the public comment period on such draft guidance. The Secretary may approve antibacterial and antifungal drugs under this subsection prior to issuing guidance under this paragraph.

(6) Advice

The Secretary shall provide prompt advice to the sponsor of a drug for which the sponsor seeks approval under this subsection to enable the sponsor to plan a development program to obtain the necessary data for such approval, and to conduct any additional studies that would be required to gain approval of such drug for use in a broader population.

(7) Termination of limitations

If, after approval of a drug under this subsection, the Secretary approves a broader indication for such drug under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], the Secretary may remove any postmarketing conditions, including requirements with respect to labeling and review of promotional materials under paragraph (3), applicable to the approval of the drug under this subsection.

(8) Rules of construction

Nothing in this subsection shall be construed to alter the authority of the Secretary to approve drugs pursuant to this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262], including the standards of evidence and applicable conditions for approval under such chapter or Act, the standards of approval of a drug under such chapter or Act, or to alter the authority of the Secretary to monitor drugs pursuant to such chapter or Act.

(9) Reporting and accountability

(A) Biennial reporting

The Secretary shall report to Congress not less often than once every 2 years on the number of requests for approval, and the number of approvals, of an antibacterial or antifungal drug under this subsection.

(B) GAO report

Not later than December 2021, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on the coordination of activities required under section 319E of the Public Health Service Act [42 U.S.C. 247d–5]. Such report shall include a review of such activities, and the extent to which the use of the pathway established under this subsection has streamlined premarket approval for antibacterial or antifungal drugs for limited populations, if such pathway has functioned as intended, if such pathway has helped provide for safe and effective treatment for patients, if such premarket approval would be appropriate for other categories of drugs, and if the authorities under this subsection have affected antibacterial or antifungal resistance.

(June 25, 1938, ch. 675, §506, as added Pub. L. 105–115, title I, §112(a), Nov. 21, 1997, 111 Stat. 2309; amended Pub. L. 112–144, title VIII, §803, title IX, §§901(b), 902(a), July 9, 2012, 126 Stat. 1079, 1083, 1086; Pub. L. 114–255, div. A, title III, §§3033(a), (c), 3042, Dec. 13, 2016, 130 Stat. 1101, 1103, 1112; Pub. L. 117–328, div. FF, title III, §3210(a), Dec. 29, 2022, 136 Stat. 5822.)

Editorial Notes

References in Text

The Food and Drug Administration Safety and Innovation Act, referred to in subsec. (e)(1), is Pub. L. 112–144. For the amendments made to this section by the Act, see 2012 Amendment notes below.

The 21st Century Cures Act, referred to in subsec. (e)(1), is Pub. L. 114–255. For the amendments made to this section by the Act, see 2016 Amendment notes below.

Section 101(b) of the Prescription Drug User Fee Amendments of 2012, referred to in subsec. (g)(6)(A), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title.

The Public Health Service Act, referred to in subsec. (h)(4), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Prior Provisions

A prior section 356, act June 25, 1938, ch. 675, §506, as added Dec. 22, 1941, ch. 613, §3, 55 Stat. 851; amended Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §3(o), Aug. 13, 1993, 107 Stat. 777, related to certification of drugs containing insulin, prior to repeal by Pub. L. 105–115, title I, §125(a)(1), Nov. 21, 1997, 111 Stat. 2325.

Amendments

2022—Subsec. (c)(2). Pub. L. 117–328, §3210(a)(1)(A), (B), (D), designated existing provisions as subpar. (A), inserted heading, redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A) and realigned margins, and added subpars. (B) to (D).

Subsec. (c)(2)(A)(i). Pub. L. 117–328, §3210(a)(1)(C), substituted "an appropriate postapproval study or studies" for "appropriate postapproval studies".

Subsec. (c)(3). Pub. L. 117–328, §3210(a)(2)(B), (C), (F), designated existing provisions as subpar. (A), inserted heading, redesignated former subpars. (A) to (D) as cls. (i) to (iv), respectively, of subpar. (A) and realigned margins, and added subpar. (B).

Pub. L. 117–328, §3210(a)(2)(A), substituted "described in subparagraph (B)" for "(as prescribed by the Secretary in regulations which shall include an opportunity for an informal hearing)" in introductory provisions.

Subsec. (c)(3)(A)(i). Pub. L. 117–328, §3210(a)(2)(D), substituted "product with due diligence, including with respect to conditions specified by the Secretary under paragraph (2)(C)" for "drug with due diligence".

Subsec. (c)(3)(A)(iii). Pub. L. 117–328, §3210(a)(2)(E), inserted "shown to be" after "product is not".

2016—Subsec. (e). Pub. L. 114–255, §3033(a)(1), transferred subsec. (e) to appear before subsec. (f).

Subsec. (e)(1). Pub. L. 114–255, §3033(c), inserted "and the 21st Century Cures Act" after "Food and Drug Administration Safety and Innovation Act".

Subsec. (g). Pub. L. 114–255, §3033(a)(2), added subsec. (g).

Subsec. (h). Pub. L. 114–255, §3042, added subsec. (h).

2012—Pub. L. 112–144, §901(b), amended section generally. Prior to amendment, section consisted of subsecs. (a) to (d) relating to designation of drugs as fast track products, approval of applications for fast track products, review of incomplete applications for approval of fast track products, and awareness efforts, respectively.

Subsec. (a). Pub. L. 112–144, §902(a)(3), added subsec. (a). Former subsec. (a) redesignated (b).

Subsec. (a)(1). Pub. L. 112–144, §803, amended subsec. (a)(1), as amended by Pub. L. 112–144, §901(b), by inserting ", or if the Secretary designates the drug as a qualified infectious disease product under section 355f(d) of this title" after "such a disease or condition".

Subsecs. (b) to (d). Pub. L. 112–144, §902(a)(1), redesignated subsecs. (a) to (c) as (b) to (d), respectively. Former subsec. (d) relating to awareness efforts redesignated (f).

Subsec. (f). Pub. L. 112–144, §902(a)(2), which directed the redesignation of subsec. (d) as (f), was executed by redesignating the subsec. (d) relating to awareness efforts as (f), to reflect the probable intent of Congress and the subsequent amendment by Pub. L. 114–255, §3033(a)(1), which transferred subsec. (e) to appear before subsec. (f) "relating to awareness efforts".

Subsec. (f)(1). Pub. L. 112–144, §902(a)(4), substituted "applicable to breakthrough therapies, accelerated approval, and" for "applicable to accelerated approval".

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Construction of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3210(f), Dec. 29, 2022, 136 Stat. 5825, provided that: "Nothing in this section [enacting section 356–2 of this title, amending this section and sections 331 and 356b of this title, and enacting provisions set out as a note under this section] (including the amendments made by this section) shall be construed to affect ongoing withdrawal proceedings for products approved pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) for which a notice of proposed withdrawal has been published in the Federal Register prior to the date of enactment of this Act [Dec. 29, 2022]. Such proceedings may continue under procedures in effect prior to the date of enactment of this Act."

Construction of 2016 Amendments

Pub. L. 114–255, div. A, title III, §3033(b), Dec. 13, 2016, 130 Stat. 1103, provided that: "Nothing in this section [amending this section] and the amendments made by this section shall be construed to alter the authority of the Secretary of Health and Human Services—

"(1) to approve drugs pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 of the Public Health Service Act (42 U.S.C. 262) as authorized prior to the date of enactment of the 21st Century Cures Act [Dec. 13, 2016], including the standards of evidence, and applicable conditions, for approval under such Acts; or

"(2) to alter the authority of the Secretary to require postapproval studies pursuant to such Acts, as authorized prior to the date of enactment of the 21st Century Cures Act."

Pub. L. 114–255, div. A, title III, §3043, Dec. 13, 2016, 130 Stat. 1114, provided that: "Nothing in this subtitle [subtitle E (§§3041–3044) of title III of div. A of Pub. L. 114–255, enacting section 360a–2 of this title, amending this section, sections 352 and 360d of this title, and section 247d–5 of Title 42, The Public Health and Welfare, repealing section 247d–5a of Title 42, and enacting provisions set out as notes under section 360a–2 of this title and section 247d–5 of Title 42], or an amendment made by this subtitle, shall be construed to restrict the prescribing of antimicrobial drugs or other products, including drugs approved under subsection (h) of section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356[(h)]) (as added by section 3042), by health care professionals, or to limit the practice of health care."

Guidance

Pub. L. 117–328, div. FF, title III, §3210(d), Dec. 29, 2022, 136 Stat. 5824, provided that:

"(1) In general.—The Secretary [of Health and Human Services] shall issue guidance describing—

"(A) how sponsor questions related to the identification of novel surrogate or intermediate clinical endpoints may be addressed in early-stage development meetings with the Food and Drug Administration;

"(B) the use of novel clinical trial designs that may be used to conduct appropriate postapproval studies as may be required under section 506(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)(2)(A)), as amended by subsection (a);

"(C) the expedited procedures described in section 506(c)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)(3)(B)); and

"(D) considerations related to the use of surrogate or intermediate clinical endpoints that may support the accelerated approval of an application under 506(c)(1)(A) of such Act (21 U.S.C. 356(c)(1)(A)), including considerations in evaluating the evidence related to any such endpoints.

"(2) Final guidance.—The Secretary shall issue—

"(A) draft guidance under paragraph (1) not later than 18 months after the date of enactment of this Act [Dec. 29, 2022]; and

"(B) final guidance not later than 1 year after the close of the public comment period on such draft guidance."

Report on Regenerative Advanced Therapies

Pub. L. 114–255, div. A, title III, §3035, Dec. 13, 2016, 130 Stat. 1103, provided that:

"(a) Report to Congress.—Before March 1 of each calendar year, the Secretary of Health and Human Services shall, with respect to the previous calendar year, submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on—

"(1) the number and type of applications for approval of regenerative advanced therapies filed, approved or licensed as applicable, withdrawn, or denied; and

"(2) how many of such applications or therapies, as applicable, were granted accelerated approval or priority review.

"(b) Regenerative Advanced Therapy.—In this section, the term 'regenerative advanced therapy' has the meaning given such term in section 506(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356(g)], as added by section 3033 of this Act."

Findings and Sense of Congress on Enhancement of Accelerated Patient Access to New Medical Treatments

Pub. L. 112–144, title IX, §901(a), July 9, 2012, 126 Stat. 1082, as amended by Pub. L. 114–255, div. A, title III, §3101(b)(1), Dec. 13, 2016, 130 Stat. 1156, provided that:

"(1) Findings.—Congress finds as follows:

"(A) The Food and Drug Administration (referred to in this section as the 'FDA') serves a critical role in helping to assure that new medicines are safe and effective. Regulatory innovation is 1 element of the Nation's strategy to address serious or life-threatening diseases or conditions by promoting investment in and development of innovative treatments for unmet medical needs.

"(B) During the 2 decades following the establishment of the accelerated approval mechanism, advances in medical sciences, including genomics, molecular biology, and bioinformatics, have provided an unprecedented understanding of the underlying biological mechanism and pathogenesis of disease. A new generation of modern, targeted medicines is under development to treat serious and life-threatening diseases, some applying drug development strategies based on biomarkers or pharmacogenomics, predictive toxicology, clinical trial enrichment techniques, and novel clinical trial designs, such as adaptive clinical trials.

"(C) As a result of these remarkable scientific and medical advances, the FDA should be encouraged to implement more broadly effective processes for the expedited development and review of innovative new medicines intended to address unmet medical needs for serious or life-threatening diseases or conditions, including those for rare diseases or conditions, using a broad range of surrogate or clinical endpoints and modern scientific tools earlier in the drug development cycle when appropriate. This may result in fewer, smaller, or shorter clinical trials for the intended patient population or targeted subpopulation without compromising or altering the high standards of the FDA for the approval of drugs.

"(D) Patients benefit from expedited access to safe and effective innovative therapies to treat unmet medical needs for serious or life-threatening diseases or conditions.

"(E) For these reasons, the statutory authority in effect on the day before the date of enactment of this Act [July 9, 2012] governing expedited approval of drugs for serious or life-threatening diseases or conditions should be amended in order to enhance the authority of the FDA to consider appropriate scientific data, methods, and tools, and to expedite development and access to novel treatments for patients with a broad range of serious or life-threatening diseases or conditions.

"(2) Sense of congress.—It is the sense of Congress that the Food and Drug Administration should apply the accelerated approval and fast track provisions set forth in section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356), as amended by this section, to help expedite the development and availability to patients of treatments for serious or life-threatening diseases or conditions while maintaining safety and effectiveness standards for such treatments."

Guidance; Amended Regulations

Pub. L. 112–144, title IX, §901(c), July 9, 2012, 126 Stat. 1085, provided that:

"(1) Draft guidance.—Not later than 1 year after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall issue draft guidance to implement the amendments made by this section [amending this section]. In developing such guidance, the Secretary shall specifically consider issues arising under the accelerated approval and fast track processes under section 506 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356], as amended by subsection (b), for drugs designated for a rare disease or condition under section 526 of such Act (21 U.S.C. 360bb) and shall also consider any unique issues associated with very rare diseases.

"(2) Final guidance.—Not later than 1 year after the issuance of draft guidance under paragraph (1), and after an opportunity for public comment, the Secretary shall—

"(A) issue final guidance; and

"(B) amend the regulations governing accelerated approval in parts 314 and 601 of title 21, Code of Federal Regulations, as necessary to conform such regulations with the amendment made by subsection (b).

"(3) Consideration.—In developing the guidance under paragraphs (1) and (2)(A) and the amendments under paragraph (2)(B), the Secretary shall consider how to incorporate novel approaches to the review of surrogate endpoints based on pathophysiologic and pharmacologic evidence in such guidance, especially in instances where the low prevalence of a disease renders the existence or collection of other types of data unlikely or impractical.

"(4) Conforming changes.—The Secretary shall issue, as necessary, conforming amendments to the applicable regulations under title 21, Code of Federal Regulations, governing accelerated approval.

"(5) No effect of inaction on requests.—The issuance (or nonissuance) of guidance or conforming regulations implementing the amendment made by subsection (b) shall not preclude the review of, or action on, a request for designation or an application for approval submitted pursuant to section 506 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356], as amended by subsection (b)."

Pub. L. 112–144, title IX, §902(b), July 9, 2012, 126 Stat. 1087, provided that:

"(1) In general.—

"(A) Guidance.—Not later than 18 months after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall issue draft guidance on implementing the requirements with respect to breakthrough therapies, as set forth in section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)), as amended by this section. The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.

"(B) Amended regulations.—

"(i) In general.—If the Secretary determines that it is necessary to amend the regulations under title 21, Code of Federal Regulations in order to implement the amendments made by this section to section 506(a) of the Federal Food, Drug, and Cosmetic Act, the Secretary shall amend such regulations not later than 2 years after the date of enactment of this Act.

"(ii) Procedure.—In amending regulations under clause (i), the Secretary shall—

"(I) issue a notice of proposed rulemaking that includes the proposed regulation;

"(II) provide a period of not less than 60 days for comments on the proposed regulation; and

"(III) publish the final regulation not less than 30 days before the effective date of the regulation.

"(iii) Restrictions.—Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing the amendments made by this section only as described in clause (ii).

"(2) Requirements.—Guidance issued under this section shall—

"(A) specify the process and criteria by which the Secretary makes a designation under section 506(a)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356(a)(3)]; and

"(B) specify the actions the Secretary shall take to expedite the development and review of a breakthrough therapy pursuant to such designation under such section 506(a)(3), including updating good review management practices to reflect breakthrough therapies."

Pub. L. 105–115, title I, §112(b), Nov. 21, 1997, 111 Stat. 2310, provided that: "Within 1 year after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall issue guidance for fast track products (as defined in [former] section 506(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356(a)(1)]) that describes the policies and procedures that pertain to section 506 of such Act."

1 So in original.
21 U.S.C. § 133 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter III: PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION / Section 133: Repealed. July 13, 1949, ch. 307, 63 Stat. 410
Repealed. July 13, 1949, ch. 307, 63 Stat. 410
Status: repealed

Section, act July 24, 1946, ch. 592, 60 Stat. 633, related to establishment of a quarantine station on Swan Island.
21 U.S.C. § 824 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 824: Denial, revocation, or suspension of registration
Denial, revocation, or suspension of registration
Status: in_force

(a) Grounds

A registration pursuant to section 823 of this title to manufacture, distribute, or dispense a controlled substance or a list I chemical may be suspended or revoked by the Attorney General upon a finding that the registrant—

(1) has materially falsified any application filed pursuant to or required by this subchapter or subchapter II;

(2) has been convicted of a felony under this subchapter or subchapter II or any other law of the United States, or of any State, relating to any substance defined in this subchapter as a controlled substance or a list I chemical;

(3) has had his State license or registration suspended, revoked, or denied by competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances or list I chemicals or has had the suspension, revocation, or denial of his registration recommended by competent State authority;

(4) has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section; or

(5) has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a–7(a) of title 42.

A registration pursuant to section 823(h)(1) 1 of this title to dispense a narcotic drug for maintenance treatment or detoxification treatment may be suspended or revoked by the Attorney General upon a finding that the registrant has failed to comply with any standard referred to in section 823(h)(1) 1 of this title.

(b) Limits of revocation or suspension

The Attorney General may limit revocation or suspension of a registration to the particular controlled substance or list I chemical with respect to which grounds for revocation or suspension exist.

(c) Service of show cause order; proceedings

(1) Before taking action pursuant to this section, or pursuant to a denial of registration under section 823 of this title, the Attorney General shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked, or suspended.

(2) An order to show cause under paragraph (1) shall—

(A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant;

(B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and

(C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance.

(3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan.

(4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the United States.

(5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d).

(d) Suspension of registration in cases of imminent danger

(1) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety. A failure to comply with a standard referred to in section 823(h)(1) 1 of this title may be treated under this subsection as grounds for immediate suspension of a registration granted under such section. A suspension under this subsection shall continue in effect until the conclusion of such proceedings, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction.

(2) In this subsection, the phrase "imminent danger to the public health or safety" means that, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under this subchapter or subchapter II, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.

(e) Suspension and revocation of quotas

The suspension or revocation of a registration under this section shall operate to suspend or revoke any quota applicable under section 826 of this title.

(f) Disposition of controlled substances or list I chemicals

In the event the Attorney General suspends or revokes a registration granted under section 823 of this title, all controlled substances or list I chemicals owned or possessed by the registrant pursuant to such registration at the time of suspension or the effective date of the revocation order, as the case may be, may, in the discretion of the Attorney General, be placed under seal. No disposition may be made of any controlled substances or list I chemicals under seal until the time for taking an appeal has elapsed or until all appeals have been concluded except that a court, upon application therefor, may at any time order the sale of perishable controlled substances or list I chemicals. Any such order shall require the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all such controlled substances or list I chemicals (or proceeds of sale deposited in court) shall be forfeited to the United States; and the Attorney General shall dispose of such controlled substances or list I chemicals in accordance with section 881(e) of this title. All right, title, and interest in such controlled substances or list I chemicals shall vest in the United States upon a revocation order becoming final.

(g) Seizure or placement under seal of controlled substances or list I chemicals

The Attorney General may, in his discretion, seize or place under seal any controlled substances or list I chemicals owned or possessed by a registrant whose registration has expired or who has ceased to practice or do business in the manner contemplated by his registration. Such controlled substances or list I chemicals shall be held for the benefit of the registrant, or his successor in interest. The Attorney General shall notify a registrant, or his successor in interest, who has any controlled substance or list I chemical seized or placed under seal of the procedures to be followed to secure the return of the controlled substance or list I chemical and the conditions under which it will be returned. The Attorney General may not dispose of any controlled substance or list I chemical seized or placed under seal under this subsection until the expiration of one hundred and eighty days from the date such substance or chemical was seized or placed under seal.

(h) Order to prohibit registration based on prior history

The Attorney General may issue an order to prohibit, conditionally or unconditionally, and permanently or for such period as the Attorney General may determine, any person from being registered under this subchapter to manufacture, distribute, or dispense a controlled substance or a list I chemical, if the Attorney General finds that—

(1) such person meets or has met any of the conditions for suspension or revocation of registration under subsection (a); and

(2) such person has a history of prior suspensions or revocations of registration.

(Pub. L. 91–513, title II, §304, Oct. 27, 1970, 84 Stat. 1255; Pub. L. 93–281, §4, May 14, 1974, 88 Stat. 125; Pub. L. 98–473, title II, §§304, 512, 513, Oct. 12, 1984, 98 Stat. 2050, 2073; Pub. L. 100–93, §8(j), Aug. 18, 1987, 101 Stat. 695; Pub. L. 103–200, §3(d), Dec. 17, 1993, 107 Stat. 2337; Pub. L. 103–322, title XXXIII, §330024(e), Sept. 13, 1994, 108 Stat. 2151; Pub. L. 106–310, div. B, title XXXV, §3502(b), Oct. 17, 2000, 114 Stat. 1227; Pub. L. 114–145, §2(a)(2), (b), Apr. 19, 2016, 130 Stat. 354; Pub. L. 117–36, §2, Aug. 6, 2021, 135 Stat. 328; Pub. L. 117–215, title I, §103(b)(1)(C), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, §1262(b)(1), Dec. 29, 2022, 136 Stat. 5682.)

Editorial Notes

References in Text

Section 823(h) of this title, referred to in subsecs. (a) and (d)(1), originally consisted of pars. (1) and (2). Par. (1) was redesignated as the entire subsec. (h), with its subpars. (A) to (C) redesignated pars. (1) to (3), and former par. (2) was struck out by Pub. L. 117–328, div. FF, title I, §1262(a), Dec. 29, 2022, 136 Stat. 5681.

This subchapter, referred to in subsecs. (a)(1), (2), (c)(4), (d)(2), and (h), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

Subchapter II, referred to in subsecs. (a)(1), (2) and (d)(2), was in the original "title III", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

Amendments

2022—Subsec. (a). Pub. L. 117–328, §1262(b)(1), which directed substitution of "823(g)" for "823(g)(1)" in two places in concluding provisions, could not be executed because of the intervening amendment by Pub. L. 117–215, §103(b)(1)(C). See Amendment note below.

Pub. L. 117–215, in concluding provisions, substituted "823(h)(1)" for "823(g)(1)" in two places.

Subsec. (d)(1). Pub. L. 117–328, §1262(b)(1), which directed substitution of "823(g)" for "823(g)(1)", could not be executed because of the intervening amendment by Pub. L. 117–215, §103(b)(1)(C). See Amendment note below.

Pub. L. 117–215 substituted "823(h)(1)" for "823(g)(1)".

2021—Subsec. (h). Pub. L. 117–36 added subsec. (h).

2016—Subsec. (c). Pub. L. 114–145, §2(b), struck out "The order to show cause shall contain a statement of the basis thereof and shall call upon the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but in no event less than thirty days after the date of receipt of the order. Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the United States." after "denied, revoked, or suspended.", designated existing provisions as par. (1), and added pars. (2) to (5).

Subsec. (d). Pub. L. 114–145, §2(a)(2), designated existing provisions as par. (1) and added par. (2).

2000—Subsec. (a). Pub. L. 106–310, §3502(b)(1), substituted "section 823(g)(1) of this title" for "section 823(g) of this title" in two places in concluding provisions.

Subsec. (d). Pub. L. 106–310, §3502(b)(2), substituted "section 823(g)(1) of this title" for "section 823(g) of this title".

1994—Subsec. (g). Pub. L. 103–322 inserted "or chemical" after "such substance" in last sentence.

1993—Subsec. (a). Pub. L. 103–200, §3(d)(1), inserted "or a list I chemical" after "controlled substance" in introductory provisions and par. (2) and inserted "or list I chemicals" after "controlled substances" in par. (3).

Subsec. (b). Pub. L. 103–200, §3(d)(2), inserted "or list I chemical" after "controlled substance".

Subsec. (f). Pub. L. 103–200, §3(d)(3), inserted "or list I chemicals" after "controlled substances" wherever appearing.

Subsec. (g). Pub. L. 103–200, §3(d)(4), inserted "or list I chemicals" after "controlled substances" in two places and "or list I chemical" after "controlled substance" wherever appearing.

1987—Subsec. (a)(5). Pub. L. 100–93 added par. (5).

1984—Subsec. (a)(3). Pub. L. 98–473, §512(1), inserted provisions relating to suspension, etc., recommended by competent State authority.

Subsec. (a)(4). Pub. L. 98–473, §512(2), added par. (4).

Subsec. (f). Pub. L. 98–473, §304, inserted provisions relating to vesting of right, title, and interest in the United States.

Subsec. (g). Pub. L. 98–473, §513, added subsec. (g).

1974—Subsec. (a). Pub. L. 93–281, §4(a), provided for revocation or suspension of a registration pursuant to section 823(g) of this title for failure of a registrant to comply with standards referred to in such section 823(g).

Subsec. (d). Pub. L. 93–281, §4(b), substituted "A suspension under this subsection" for "Such suspension" in third sentence.

Statutory Notes and Related Subsidiaries

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–322 effective 120 days after Dec. 17, 1993, see section 330024(f) of Pub. L. 103–322, set out as a note under section 802 of this title.

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date of 1987 Amendment

Amendment by Pub. L. 100–93 effective at end of fourteen-day period beginning Aug. 18, 1987, and inapplicable to administrative proceedings commenced before end of such period, see section 15(a) of Pub. L. 100–93, set out as a note under section 1320a–7 of Title 42, The Public Health and Welfare.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Provisional Registration

Applicability of this section to provisional registrations, see section 703 of Pub. L. 91–513, set out as a note under section 822 of this title.

1 See References in Text note below.
21 U.S.C. § 344 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 344: Emergency permit control
Emergency permit control
Status: in_force

(a) Conditions on manufacturing, processing, etc., as health measure

Whenever the Secretary finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with micro-organisms during the manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he then, and in such case only, shall promulgate regulations providing for the issuance, to manufacturers, processors, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health; and after the effective date of such regulations, and during such temporary period, no person shall introduce or deliver for introduction into interstate commerce any such food manufactured, processed, or packed by any such manufacturer, processor, or packer unless such manufacturer, processor, or packer holds a permit issued by the Secretary as provided by such regulations.

(b) Violation of permit; suspension and reinstatement

The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated. The holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of such permit, and the Secretary shall, immediately after prompt hearing and an inspection of the establishment, reinstate such permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued or as amended.

(c) Inspection of permit-holding establishments

Any officer or employee duly designated by the Secretary shall have access to any factory or establishment, the operator of which holds a permit from the Secretary, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator.

(June 25, 1938, ch. 675, §404, 52 Stat. 1048.)

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
21 U.S.C. § 2001 (2024) — Title 21: FOOD AND DRUGS / Chapter 25: MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS / Subchapter I: ANTI-DOPING AGENCY / Section 2001: Designation of United States Anti-Doping Agency
Designation of United States Anti-Doping Agency
Status: in_force

(a) Definitions

In this subchapter:

(1) United States Olympic Committee

The term "United States Olympic Committee" means the organization established by the "Ted Stevens Olympic and Amateur Sports Act" (36 U.S.C. 220501 et seq.).

(2) Amateur athletic competition

The term "amateur athletic competition" means a contest, game, meet, match, tournament, regatta, or other event in which amateur athletes compete (36 U.S.C. 220501(b)(2)).

(3) Amateur athlete

The term "amateur athlete" means an athlete who meets the eligibility standards established by the national governing body or paralympic sports organization for the sport in which the athlete competes (36 U.S.C. 22501(b)(1)).1

(b) In general

The United States Anti-Doping Agency shall—

(1)(A) serve as the independent anti-doping organization for the amateur athletic competitions recognized by the United States Olympic and Paralympic Committee;

(B) be responsible for certifying in advance any testing conducted by international organizations under the World Anti-Doping Code for international amateur athletes and athletic competitions occurring within the jurisdiction of the United States; and

(C) be recognized worldwide as the independent national anti-doping organization for the United States;

(2) ensure that athletes participating in amateur athletic activities recognized by the United States Olympic Committee are prevented from using performance-enhancing drugs or prohibited performance-enhancing methods adopted by the Agency;

(3) implement anti-doping education, research, testing, and adjudication programs to prevent United States Amateur Athletes participating in any activity recognized by the United States Olympic Committee from using performance-enhancing drugs or prohibited performance-enhancing methods adopted by the Agency;

(4) serve as the United States representative responsible for coordination with other anti-doping organizations coordinating amateur athletic competitions recognized by the United States Olympic Committee to ensure the integrity of athletic competition, the health of the athletes, and the prevention of use by United States amateur athletes of performance-enhancing drugs or prohibited performance-enhancing methods adopted by the Agency; and

(5) promote a positive youth sport experience by using a portion of the funding of the United States Anti-Doping Agency to provide educational materials on sportsmanship, character building, and healthy performance for the athletes, parents, and coaches who participate in youth sports.

(c) Due process in arbitration proceedings

Any action taken by the United States Anti-Doping Agency to enforce a policy, procedure, or requirement of the United States Anti-Doping Agency against a person with respect to a violation of Federal law, including an investigation, a disciplinary action, a sanction, or any other administrative action, shall be carried out in a manner that provides due process protection to the person.

(Pub. L. 109–469, title VII, §701, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 113–280, §2, Dec. 18, 2014, 128 Stat. 3020; Pub. L. 117–103, div. Q, title III, §303, Mar. 15, 2022, 136 Stat. 817.)

Editorial Notes

References in Text

The Ted Stevens Olympic and Amateur Sports Act, referred to in subsec. (a)(1), is chapter 2205 of Title 36, Patriotic and National Observances, Ceremonies, and Organizations.

Amendments

2022—Subsec. (b)(1). Pub. L. 117–103, §303(1)(A), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "serve as the independent anti-doping organization for the amateur athletic competitions recognized by the United States Olympic Committee and be recognized worldwide as the independent national anti-doping organization for the United States;".

Subsec. (b)(5). Pub. L. 117–103, §303(1)(B), (C), added par. (5).

Subsec. (c). Pub. L. 117–103, §303(2), added subsec. (c).

2014—Subsec. (a)(4). Pub. L. 113–280, §2(1), struck out par. (4). Text read as follows: "The term 'gene doping' means the nontherapeutic use of cells, genes, genetic elements, or of the modulation of gene expression, having the capacity to enhance athletic performance."

Subsec. (b)(1). Pub. L. 113–280, §2(2)(A), inserted "and be recognized worldwide as the independent national anti-doping organization for the United States" after "Committee".

Subsec. (b)(2). Pub. L. 113–280, §2(2)(B), substituted "or prohibited performance-enhancing methods adopted by the Agency" for ", or performance-enhancing genetic modifications accomplished through gene-doping".

Subsec. (b)(3). Pub. L. 113–280, §2(2)(C), substituted "or prohibited performance-enhancing methods adopted by the Agency" for ", or performance-enhancing genetic modifications accomplished through gene-doping".

Subsec. (b)(4). Pub. L. 113–280, §2(2)(D), substituted ", and the prevention of use by United States amateur athletes of performance-enhancing drugs or prohibited performance-enhancing methods adopted by the Agency." for "and the prevention of use of performance-enhancing drugs, or performance-enhancing genetic modifications accomplished through gene-doping by United States amateur athletes; and".

Subsec. (b)(5). Pub. L. 113–280, §2(2)(E), struck out par. (5) which read as follows: "permanently include 'gene doping' among any list of prohibited substances adopted by the Agency."

Statutory Notes and Related Subsidiaries

Change of Name

References to the United States Olympic Committee deemed to refer to the United States Olympic and Paralympic Committee, see section 220502(c) of Title 36, Patriotic and National Observances, Ceremonies, and Organizations.

Short Title of 2022 Amendment

Pub. L. 117–103, div. Q, title III, §301, Mar. 15, 2022, 136 Stat. 816, provided that: "This title [enacting section 2004 of this title, amending this section and section 2003 of this title, and enacting provisions set out as a note below] may be cited as the 'United States Anti-Doping Agency Reauthorization Act of 2022'."

Short Title of 2014 Amendment

Pub. L. 113–280, §1, Dec. 18, 2014, 128 Stat. 3020, provided that: "This Act [amending this section and section 2003 of this title] may be cited as the 'United States Anti-Doping Agency Reauthorization Act'."

Short Title

Pub. L. 109–469, title X, §1001, Dec. 29, 2006, 120 Stat. 3537, provided that: "This title [enacting subchapter II of this chapter] may be cited as the 'National Methamphetamine Information Clearinghouse Act of 2006'."

Findings

Pub. L. 117–103, div. Q, title III, §302, Mar. 15, 2022, 136 Stat. 816, provided that: "Congress makes the following findings:

"(1) The United States Anti-Doping Agency—

"(A) is the independent national anti-doping organization of the United States; and

"(B) manages the anti-doping program, results management processes, drug reference resources, and athlete education for all United States Olympic Committee-recognized national governing bodies and the athletes and events of such national governing bodies.

"(2) The United States Anti-Doping Agency contributes to the advancement of clean sport through scientific research, anti-doping education, and outreach programs, and the mission of the United States Anti-Doping Agency is to preserve the integrity of competition and protect the rights of athletes.

"(3) Participation in youth sports has the potential to equip young athletes with important skills and values necessary for success in life, and it is essential that the culture of youth sports emphasizes such skills and values.

"(4) The TrueSport program of the United States Anti-Doping Agency partners with youth sport organizations across the United States to promote sportsmanship, character building, and healthy performance through the use of targeted educational materials designed to promote a positive youth sport experience.

"(5) In modifying the authority of the United States Anti-Doping Agency to include the promotion of the positive values of youth sport, Congress sends a strong signal that the goals of youth sport should include instilling in young athletes the values of integrity, respect, teamwork, courage, and responsibility.

"(6) Due to the unique leadership position of the United States in the global community, adequate funding of the anti-doping and clean sport programs of the United States Anti-Doping Agency is imperative to the preparation for the 2028 Summer Olympic Games, which will be held in Los Angeles, California.

"(7) Increased appropriations for fiscal years 2023 through 2031 would enable the United States Anti-Doping Agency to directly affect the integrity and well-being of sport, both domestically and internationally."

1 So in original. Probably should be "220501(b)(1))."
21 U.S.C. § 844 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 844: Penalties for simple possession
Penalties for simple possession
Status: in_force

(a) Unlawful acts; penalties

It shall be unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by this subchapter or subchapter II. It shall be unlawful for any person knowingly or intentionally to possess any list I chemical obtained pursuant to or under authority of a registration issued to that person under section 823 of this title or section 958 of this title if that registration has been revoked or suspended, if that registration has expired, or if the registrant has ceased to do business in the manner contemplated by his registration. It shall be unlawful for any person to knowingly or intentionally purchase at retail during a 30 day period more than 9 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product, except that, of such 9 grams, not more than 7.5 grams may be imported by means of shipping through any private or commercial carrier or the Postal Service. Any person who violates this subsection may be sentenced to a term of imprisonment of not more than 1 year, and shall be fined a minimum of $1,000, or both, except that if he commits such offense after a prior conviction under this subchapter or subchapter II, or a prior conviction for any drug, narcotic, or chemical offense chargeable under the law of any State, has become final, he shall be sentenced to a term of imprisonment for not less than 15 days but not more than 2 years, and shall be fined a minimum of $2,500, except, further, that if he commits such offense after two or more prior convictions under this subchapter or subchapter II, or two or more prior convictions for any drug, narcotic, or chemical offense chargeable under the law of any State, or a combination of two or more such offenses have become final, he shall be sentenced to a term of imprisonment for not less than 90 days but not more than 3 years, and shall be fined a minimum of $5,000. Notwithstanding any penalty provided in this subsection, any person convicted under this subsection for the possession of flunitrazepam shall be imprisoned for not more than 3 years, shall be fined as otherwise provided in this section, or both. The imposition or execution of a minimum sentence required to be imposed under this subsection shall not be suspended or deferred. Further, upon conviction, a person who violates this subsection shall be fined the reasonable costs of the investigation and prosecution of the offense, including the costs of prosecution of an offense as defined in sections 1918 and 1920 of title 28, except that this sentence shall not apply and a fine under this section need not be imposed if the court determines under the provision of title 18 that the defendant lacks the ability to pay.

(b) Repealed. Pub. L. 98–473, title II, §219(a), Oct. 12, 1984, 98 Stat. 2027

(c) "Drug, narcotic, or chemical offense" defined

As used in this section, the term "drug, narcotic, or chemical offense" means any offense which proscribes the possession, distribution, manufacture, cultivation, sale, transfer, or the attempt or conspiracy to possess, distribute, manufacture, cultivate, sell or transfer any substance the possession of which is prohibited under this subchapter.

(Pub. L. 91–513, title II, §404, Oct. 27, 1970, 84 Stat. 1264; Pub. L. 98–473, title II, §219, Oct. 12, 1984, 98 Stat. 2027; Pub. L. 99–570, title I, §1052, Oct. 27, 1986, 100 Stat. 3207–8; Pub. L. 100–690, title VI, §§6371, 6480, Nov. 18, 1988, 102 Stat. 4370, 4382; Pub. L. 101–647, title XII, §1201, title XIX, §1907, Nov. 29, 1990, 104 Stat. 4829, 4854; Pub. L. 104–237, title II, §201(a), Oct. 3, 1996, 110 Stat. 3101; Pub. L. 104–305, §2(c), Oct. 13, 1996, 110 Stat. 3808; Pub. L. 109–177, title VII, §711(e)(1), Mar. 9, 2006, 120 Stat. 262; Pub. L. 111–220, §3, Aug. 3, 2010, 124 Stat. 2372.)

Editorial Notes

Amendments

2010—Subsec. (a). Pub. L. 111–220 struck out "Notwithstanding the preceding sentence, a person convicted under this subsection for the possession of a mixture or substance which contains cocaine base shall be imprisoned not less than 5 years and not more than 20 years, and fined a minimum of $1,000, if the conviction is a first conviction under this subsection and the amount of the mixture or substance exceeds 5 grams, if the conviction is after a prior conviction for the possession of such a mixture or substance under this subsection becomes final and the amount of the mixture or substance exceeds 3 grams, or if the conviction is after 2 or more prior convictions for the possession of such a mixture or substance under this subsection become final and the amount of the mixture or substance exceeds 1 gram." after "$5,000."

2006—Subsec. (a). Pub. L. 109–177 inserted after second sentence "It shall be unlawful for any person to knowingly or intentionally purchase at retail during a 30 day period more than 9 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product, except that, of such 9 grams, not more than 7.5 grams may be imported by means of shipping through any private or commercial carrier or the Postal Service."

1996—Subsec. (a). Pub. L. 104–305 inserted "Notwithstanding any penalty provided in this subsection, any person convicted under this subsection for the possession of flunitrazepam shall be imprisoned for not more than 3 years, shall be fined as otherwise provided in this section, or both." after "mixture or substance exceeds 1 gram."

Pub. L. 104–237, §201(a)(1), inserted after first sentence "It shall be unlawful for any person knowingly or intentionally to possess any list I chemical obtained pursuant to or under authority of a registration issued to that person under section 823 of this title or section 958 of this title if that registration has been revoked or suspended, if that registration has expired, or if the registrant has ceased to do business in the manner contemplated by his registration." and substituted "drug, narcotic, or chemical" for "drug or narcotic" in two places.

Subsec. (c). Pub. L. 104–237, §201(a)(2), substituted "drug, narcotic, or chemical" for "drug or narcotic".

1990—Subsec. (a). Pub. L. 101–647, §1907, inserted subsec. (a) designation.

Pub. L. 101–647, §1201, substituted "shall be imprisoned not less than 5 years and not more than 20 years, and fined a minimum of $1,000" for "shall be fined under title 18 or imprisoned not less than 5 years and not more than 20 years, or both".

1988—Subsec. (a). Pub. L. 100–690, §6480(1)(A)–(C), struck out "but not more than $5,000" after "$1,000", "but not more than $10,000" after "$2,500", and "but not more than $25,000" after "$5,000" in second sentence.

Pub. L. 100–690, §6371, inserted provisions relating to increased penalties in cases of certain serious crack possession offenses, making offenders subject to fines under title 18 or imprisonment to terms not less than 5 years nor more than 20 years, or both.

1986—Subsec. (a). Pub. L. 99–570 amended subsec. (a) generally. Prior to amendment, subsec. (a) read as follows: "It shall be unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by this subchapter or subchapter II of this chapter. Any person who violates this subsection shall be sentenced to a term of imprisonment of not more than one year, a fine of not more than $5,000, or both, except that if he commits such offense after a prior conviction or convictions under this subsection have become final, he shall be sentenced to a term of imprisonment of not more than 2 years, a fine of not more than $10,000 or both."

Subsec. (b). Pub. L. 99–570, in amending subsec. (b) generally, substituted "Upon the discharge of such person and dismissal of the proceedings" for "Upon the dismissal of such person and discharge of the proceedings" in par. (2).

Subsec. (c). Pub. L. 99–570, in amending section generally, added subsec. (c).

1984—Pub. L. 98–473 struck out subsec. (a) designation and struck out subsec. (b) which related to probation before judgment and expunging of records for first offense.

Statutory Notes and Related Subsidiaries

Effective Date of 2006 Amendment

Pub. L. 109–177, title VII, §711(e)(2), Mar. 9, 2006, 120 Stat. 262, provided that: "The amendment made by paragraph (1) [amending this section] applies on and after the expiration of the 30-day period beginning on the date of the enactment of this Act [Mar. 9, 2006]."

Effective Date of 1984 Amendment

Amendment by Pub. L. 98–473 effective Nov. 1, 1987, and applicable only to offenses committed after the taking effect of such amendment, see section 235(a)(1) of Pub. L. 98–473, set out as an Effective Date note under section 3551 of Title 18, Crimes and Criminal Procedure.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Executive Documents

Proc. No. 10467. Granting Pardon for the Offense of Simple Possession of Marijuana

Proc. No. 10467, Oct. 6, 2022, 87 F.R. 61441, provided:

Acting pursuant to the grant of authority in Article II, Section 2, of the Constitution of the United States, I, Joseph R. Biden Jr., do hereby grant a full, complete, and unconditional pardon to (1) all current United States citizens and lawful permanent residents who committed the offense of simple possession of marijuana in violation of the Controlled Substances Act, as currently codified at 21 U.S.C. 844 and as previously codified elsewhere in the United States Code, or in violation of D.C. Code 48–904.01(d)(1), on or before the date of this proclamation [Oct. 6, 2022], regardless of whether they have been charged with or prosecuted for this offense on or before the date of this proclamation; and (2) all current United States citizens and lawful permanent residents who have been convicted of the offense of simple possession of marijuana in violation of the Controlled Substances Act, as currently codified at 21 U.S.C. 844 and as previously codified elsewhere in the United States Code, or in violation of D.C. Code 48–904.01(d)(1); which pardon shall restore to them full political, civil, and other rights.

My intent by this proclamation is to pardon only the offense of simple possession of marijuana in violation of Federal law or in violation of D.C. Code 48–904.01(d)(1), and not any other offenses related to marijuana or other controlled substances. No language herein shall be construed to pardon any person for any other offense, including possession of other controlled substances, whether committed prior, subsequent, or contemporaneous to the pardoned offense of simple possession of marijuana. This pardon does not apply to individuals who were non-citizens not lawfully present in the United States at the time of their offense.

Pursuant to this proclamation, the Attorney General, acting through the Pardon Attorney, shall administer and effectuate the issuance of certificates of pardon to eligible applicants who have been charged or convicted for the offense of simple possession of marijuana in violation of the Controlled Substances Act, as currently codified at 21 U.S.C. 844 and as previously codified elsewhere in the United States Code, or in violation of D.C. Code 48–904.01(d)(1). The Attorney General, acting through the Pardon Attorney, is directed to develop and announce application procedures for certificates of pardon and to begin accepting applications in accordance with such procedures as soon as reasonably practicable. The Attorney General, acting through the Pardon Attorney, shall review all properly submitted applications and shall issue certificates of pardon to eligible applicants in due course.

IN WITNESS WHEREOF, I have hereunto set my hand this sixth day of October, in the year of our Lord two thousand twenty-two, and of the Independence of the United States of America the two hundred and forty-seventh.

J.R. Biden, Jr.      

Proc. No. 10688. Granting Pardon for the Offense of Simple Possession of Marijuana, Attempted Simple Possession of Marijuana, or Use of Marijuana

Proc. No. 10688, Dec. 22, 2023, 88 F.R. 90083, provided:

In Proclamation 10467 of October 6, 2022 (Granting Pardon for the Offense of Simple Possession of Marijuana) [set out above], I exercised my authority under the Constitution to pardon individuals who committed or were convicted of the offense of simple possession of marijuana in violation of the Controlled Substances Act [21 U.S.C. 801 et seq.] and section 48–904.01(d)(1) of the Code of the District of Columbia (D.C. Code). As I have said before, convictions for simple possession of marijuana have imposed needless barriers to employment, housing, and educational opportunities. Through this proclamation, consistent with the grant of Proclamation 10467, I am pardoning additional individuals who may continue to experience the unnecessary collateral consequences of a conviction for simple possession of marijuana, attempted simple possession of marijuana, or use of marijuana. Therefore, acting pursuant to the grant of authority in Article II, Section 2, of the Constitution of the United States, I, Joseph R. Biden Jr., do hereby grant a full, complete, and unconditional pardon to all current United States citizens and lawful permanent residents who, on or before the date of this proclamation [Dec. 22, 2023], committed or were convicted of the offense of simple possession of marijuana, attempted simple possession of marijuana, or use of marijuana, regardless of whether they have been charged with or prosecuted for these offenses on or before the date of this proclamation, in violation of:

(1) section 844 of title 21, United States Code, section 846 of title 21, United States Code, and previous provisions in the United States Code that prohibited simple possession of marijuana or attempted simple possession of marijuana;

(2) section 48–904.01(d)(1) of the D.C. Code and previous provisions in the D.C. Code that prohibited simple possession of marijuana;

(3) section 48–904.09 of the D.C. Code and previous provisions in the D.C. Code that prohibited attempted simple possession of marijuana; and

(4) provisions in the Code of Federal Regulations, including as enforced under the United States Code, that prohibit only the simple possession or use of marijuana on Federal properties or installations, or in other locales, as currently or previously codified, including but not limited to 25 C.F.R. 11.452(a); 32 C.F.R. 1903.12(b)(2); 36 C.F.R. 2.35(b)(2); 36 C.F.R. 1002.35(b)(2); 36 C.F.R. 1280.16(a)(1); 36 C.F.R. 702.6(b); 41 C.F.R. 102–74.400(a); 43 C.F.R. 8365.1–4(b)(2); and 50 C.F.R. 27.82(b)(2).

My intent by this proclamation is to pardon only the offenses of simple possession of marijuana, attempted simple possession of marijuana, or use of marijuana in violation of the Federal and D.C. laws set forth in paragraphs (1) through (3) of this proclamation, as well as the provisions in the Code of Federal Regulations consistent with paragraph (4) of this proclamation, and not any other offenses involving other controlled substances or activity beyond simple possession of marijuana, attempted simple possession of marijuana, or use of marijuana, such as possession of marijuana with intent to distribute or driving offenses committed while under the influence of marijuana. This pardon does not apply to individuals who were non-citizens not lawfully present in the United States at the time of their offense.

Pursuant to the procedures in Proclamation 10467, the Attorney General, acting through the Pardon Attorney, shall review all properly submitted applications for certificates of pardon and shall issue such certificates of pardon to eligible applicants in due course.

IN WITNESS WHEREOF, I have hereunto set my hand this twenty-second day of December, in the year of our Lord two thousand twenty-three, and of the Independence of the United States of America the two hundred and forty-eighth.

J.R. Biden, Jr.
21 U.S.C. § 1701 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1701: Definitions
Definitions
Status: in_force

In this chapter:

(1) Agency

The term "agency" has the meaning given the term "executive agency" in section 102 of title 31.

(2) Appropriate congressional committees

(A) In general

The term "appropriate congressional committees" means—

(i) the Committee on the Judiciary, the Committee on Appropriations, and the Committee on Health, Education, Labor, and Pensions of the Senate; and

(ii) the Committee on Oversight and Government Reform, the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives.

(B) Submission to Congress

Any submission to Congress shall mean submission to the appropriate congressional committees.

(3) Demand reduction

The term "demand reduction" means any activity conducted by a National Drug Control Program agency, other than an enforcement activity, that is intended to reduce or prevent the use of drugs or support, expand, or provide treatment and recovery efforts, including—

(A) education about the dangers of illicit drug use;

(B) services, programs, or strategies to prevent substance use disorder, including evidence-based education campaigns, community-based prevention programs, collection and disposal of unused prescription drugs, and services to at-risk populations to prevent or delay initial use of an illicit drug;

(C) substance use disorder treatment;

(D) support for long-term recovery from substance use disorders;

(E) drug-free workplace programs;

(F) drug testing, including the testing of employees;

(G) interventions for illicit drug use and dependence;

(H) expanding availability of access to health care services for the treatment of substance use disorders;

(I) international drug control coordination and cooperation with respect to activities described in this paragraph;

(J) pre- and post-arrest criminal justice interventions such as diversion programs, drug courts, and the provision of evidence-based treatment to individuals with substance use disorders who are arrested or under some form of criminal justice supervision, including medication assisted treatment;

(K) other coordinated and joint initiatives among Federal, State, local, and Tribal agencies to promote comprehensive drug control strategies designed to reduce the demand for, and the availability of, illegal drugs;

(L) international illicit drug use education, prevention, treatment, recovery, research, rehabilitation activities, and interventions for illicit drug use and dependence; and

(M) research related to illicit drug use and any of the activities described in this paragraph.

(4) Director

The term "Director" means the Director of National Drug Control Policy.

(5) Drug

The term "drug" has the meaning given the term "controlled substance" in section 802(6) of this title.

(6) Drug control

The term "drug control" means any activity conducted by a National Drug Control Program agency involving supply reduction or demand reduction.

(7) Emerging drug threat

The term "emerging drug threat" means the occurrence of a new and growing trend in the use of an illicit drug or class of drugs, including rapid expansion in the supply of or demand for such drug.

(8) Illicit drug use; illicit drugs; illegal drugs

The terms "illicit drug use", "illicit drugs", and "illegal drugs" include the illegal or illicit use of prescription drugs.

(9) Law enforcement

The term "law enforcement" or "drug law enforcement" means all efforts by a Federal, State, local, or Tribal government agency to enforce the drug laws of the United States or any State, including investigation, arrest, prosecution, and incarceration or other punishments or penalties.

(10) National Drug Control Program

The term "National Drug Control Program" means programs, policies, and activities undertaken by National Drug Control Program agencies pursuant to the responsibilities of such agencies under the National Drug Control Strategy, including any activities involving supply reduction, demand reduction, or State, local, and tribal 1 affairs.

(11) National Drug Control Program agency

The term "National Drug Control Program agency" means any agency (or bureau, office, independent agency, board, division, commission, subdivision, unit, or other component thereof) that is responsible for implementing any aspect of the National Drug Control Strategy, including any agency that receives Federal funds to implement any aspect of the National Drug Control Strategy, but does not include any agency that receives funds for drug control activity solely under the National Intelligence Program or the Joint Military Intelligence Program.

(12) National Drug Control Strategy

The term "National Drug Control Strategy" or "Strategy" means the strategy developed and submitted to Congress under section 1705 of this title, including any report, plan, or strategy required to be incorporated into or issued concurrently with such strategy.

(13) Nonprofit organization

The term "nonprofit organization" means an organization that is described in section 501(c)(3) of title 26 and exempt from tax under section 501(a) of such title.

(14) Office

The term "Office" means the Office of National Drug Control Policy established under section 1702(a) of this title.

(15) State, local, and Tribal affairs

The term "State, local, and Tribal affairs" means domestic activities conducted by a National Drug Control Program agency that are intended to reduce the availability and use of illegal drugs, including—

(A) coordination and enhancement of Federal, State, local, and Tribal law enforcement drug control efforts;

(B) coordination and enhancement of efforts among National Drug Control Program agencies and State, local, and Tribal demand reduction and supply reduction agencies;

(C) coordination and enhancement of Federal, State, local, and Tribal law enforcement initiatives to gather, analyze, and disseminate information and law enforcement intelligence relating to drug control among domestic law enforcement agencies; and

(D) other coordinated and joint initiatives among Federal, State, local, and Tribal agencies to promote comprehensive drug control strategies designed to reduce the demand for, and the availability of, illegal drugs.

(16) Substance use disorder treatment

The term "substance use disorder treatment" means an evidence-based, professionally directed, deliberate, and planned regimen including evaluation, observation, medical monitoring, and rehabilitative services and interventions such as pharmacotherapy, behavioral therapy, and individual and group counseling, on an inpatient or outpatient basis, to help patients with substance use disorder reach recovery.

(17) Supply reduction

The term "supply reduction" means any activity or program conducted by a National Drug Control Program agency that is intended to reduce the availability or use of illegal drugs in the United States or abroad, including—

(A) law enforcement outside the United States;

(B) domestic law enforcement;

(C) source country programs, including economic development programs primarily intended to reduce the production or trafficking of illicit drugs;

(D) activities to control international trafficking in, and availability of, illegal drugs, including—

(i) accurate assessment and monitoring of international drug production and interdiction programs and policies; and

(ii) coordination and promotion of compliance with international treaties relating to the production, transportation, or interdiction of illegal drugs;

(E) activities to conduct and promote international law enforcement programs and policies to reduce the supply of drugs;

(F) activities to facilitate and enhance the sharing of domestic and foreign intelligence information among National Drug Control Program agencies, relating to the production and trafficking of drugs in the United States and in foreign countries;

(G) activities to prevent the diversion of drugs for their illicit use; and

(H) research related to any of the activities described in this paragraph.

(Pub. L. 105–277, div. C, title VII, §§702, 715, Oct. 21, 1998, 112 Stat. 2681–670, 2681–693; Pub. L. 109–469, title I, §101, title VI, §602, Dec. 29, 2006, 120 Stat. 3503, 3533; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8216, Oct. 24, 2018, 132 Stat. 4110, 4117; Pub. L. 116–74, §2(a)(1), (3), Nov. 27, 2019, 133 Stat. 1155.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this title", meaning title VII of div. C of Pub. L. 105–277, Oct. 21, 1998, 112 Stat. 2681–670, which is classified principally to this chapter. For complete classification of title VII to the Code, see Short Title note set out below and Tables.

Amendments

2019—Pars. (3), (11). Pub. L. 116–74, §2(a)(1), substituted "National Drug Control Program agency" for "National Drug Control Program Agency".

Par. (15). Pub. L. 116–74, §2(a)(3), substituted "Tribal" for "tribal" wherever appearing.

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out below.

Pars. (1), (2). Pub. L. 115–271, §8216(6), added pars. (1) and (2). Former pars. (1) and (2) redesignated (3) and (4), respectively.

Par. (3). Pub. L. 115–271, §8216(5), (7), redesignated par. (1) as (3) and amended it generally. Prior to amendment, par. defined demand reduction.

Par. (4). Pub. L. 115–271, §8216(5), redesignated par. (2) as (4). Former par. (4) redesignated (6).

Par. (5). Pub. L. 115–271, §8216(1), (5), redesignated par. (3) as (5) and struck out former par. (5) which defined the term "Fund" as the fund established under section 1702(d) of this title.

Par. (6). Pub. L. 115–271, §8216(5), redesignated par. (4) as (6). Former par. (6) redesignated (10).

Pars. (7) to (9). Pub. L. 115–271, §8216(8), added pars. (7) to (9). Former pars. (7), (8), and (9) redesignated (11), (12), and (14), respectively.

Par. (10). Pub. L. 115–271, §8216(4), redesignated par. (6) as (10). Former par. (10) redesignated (15).

Par. (11). Pub. L. 115–271, §8216(4), (9), redesignated par. (7) as (11) and amended it generally. Prior to amendment, text read as follows: "The term 'National Drug Control Program agency' means any agency that is responsible for implementing any aspect of the National Drug Control Strategy, including any agency that receives Federal funds to implement any aspect of the National Drug Control Strategy, but does not include any agency that receives funds for drug control activity solely under the National Intelligence Program, the Joint Military Intelligence Program or Tactical Intelligence and Related Activities, or (for purposes of section 1703(d) of this title) an agency that is described in section 530C(a) of title 28, unless such agency has been designated—

"(A) by the President; or

"(B) jointly by the Director and the head of the agency."

Par. (12). Pub. L. 115–271, §8216(10), inserted "or 'Strategy' " before "means" and ", including any report, plan, or strategy required to be incorporated into or issued concurrently with such strategy" before period at end.

Pub. L. 115–271, §8216(1), (4), redesignated par. (8) as (12) and struck out former par. (12). Prior to amendment, text of par. (12) read as follows: "Except where otherwise provided, the term 'appropriate congressional committees' means the Committee on the Judiciary, the Committee on Appropriations, and the Caucus on International Narcotics Control of the Senate and the Committee on Government Reform, the Committee on the Judiciary, and the Committee on Appropriations of the House of Representatives."

Par. (13). Pub. L. 115–271, §8216(1), (11), added par. (13) and struck out former par. (13). Prior to amendment, text read as follows: "The term 'law enforcement' or 'drug law enforcement' means all efforts by a Federal, State, local, or tribal government agency to enforce the drug laws of the United States or any State, including investigation, arrest, prosecution, and incarceration or other punishments or penalties."

Par. (14). Pub. L. 115–271, §8216(3), (12), redesignated par. (9) as (14) and substituted "The" for "Unless the context clearly indicates otherwise, the".

Par. (15). Pub. L. 115–271, §8216(3), redesignated par. (10) as (15).

Par. (16). Pub. L. 115–271, §8216(13), added par. (16).

Par. (17). Pub. L. 115–271, §8216(2), redesignated par. (11) as (17).

Par. (17)(B) to (H). Pub. L. 115–271, §8216(14), added subpar. (B), redesignated former subpars. (B) to (E) as (C) to (F), respectively, and added subpars. (G) and (H).

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Par. (1)(G). Pub. L. 109–469, §101(a)(2), substituted ", including the testing of employees;" for period at end.

Par. (1)(H) to (J). Pub. L. 109–469, §101(a)(1), (3), added subpars. (H) to (J).

Par. (6). Pub. L. 109–469, §101(b), inserted ", including any activities involving supply reduction, demand reduction, or State, local, and tribal affairs" before period at end.

Par. (7). Pub. L. 109–469, §101(c), in introductory provisions, substituted "National Intelligence Program," for "National Foreign Intelligence Program," and inserted "or (for purposes of section 1703(d) of this title) an agency that is described in section 530C(a) of title 28," after "Related Activities,".

Par. (9). Pub. L. 109–469, §101(d), substituted "indicates" for "implicates".

Par. (10). Pub. L. 109–469, §101(e), amended par. (10) generally. Prior to amendment, text defined the term "State and local affairs".

Par. (11). Pub. L. 109–469, §101(f), amended par. (11) generally. Prior to amendment, text defined the term "supply reduction".

Pars. (12), (13). Pub. L. 109–469, §101(g), added pars. (12) and (13).

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Oversight and Government Reform of House of Representatives changed to Committee on Oversight and Reform of House of Representatives by House Resolution No. 6, One Hundred Sixteenth Congress, Jan. 9, 2019. Committee on Oversight and Reform of House of Representatives changed to Committee on Oversight and Accountability of House of Representatives by House Resolution No. 5, One Hundred Eighteenth Congress, Jan. 9, 2023.

Short Title of 2019 Amendment

Pub. L. 116–74, §1, Nov. 27, 2019, 133 Stat. 1155, provided that: "This Act [see Tables for classification] may be cited as the 'ONDCP Technical Corrections Act of 2019'."

Short Title of 2018 Amendment

Pub. L. 115–271, title VIII, §8201, Oct. 24, 2018, 132 Stat. 4110, provided that: "This subtitle [subtitle K (§§8201–8222) of title VIII of Pub. L. 115–271, see Tables for classification] may be cited as the 'Substance Abuse Prevention Act of 2018'."

Short Title of 2010 Amendment

Pub. L. 111–356, §1, Jan. 4, 2011, 124 Stat. 3976, provided that: "This Act [amending provisions set out as a note under section 1705 of this title] may be cited as the 'Northern Border Counternarcotics Strategy Act of 2010'."

Short Title of 2006 Amendment

Pub. L. 109–469, §1(a), Dec. 29, 2006, 120 Stat. 3502, provided that: "This Act [enacting sections 1708a, 1714, 2001 to 2003, and 2011 to 2014 of this title, amending this section, sections 823, 1524, 1532, 1702 to 1708, 1710 to 1712 of this title, and section 458 of Title 6, Domestic Security, repealing sections 1509, 1709, and 1801 to 1804 of this title, enacting provisions set out as notes under this section, sections 1532, 1705, 1706, and 2001 of this title, and section 112 of Title 32, National Guard, amending provisions set out as a note under section 1521 of this title, and repealing provisions set out as a note under section 1801 of this title] may be cited as the 'Office of National Drug Control Policy Reauthorization Act of 2006'."

Pub. L. 109–469, title III, §302(a), Dec. 29, 2006, 120 Stat. 3524, provided that: "This section [amending section 1706 of this title and enacting provisions set out as a note under section 1706 of this title] may be cited as the 'Dawson Family Community Protection Act'."

Short Title

Pub. L. 105–277, div. C, title VII, §§701, 715, Oct. 21, 1998, 112 Stat. 2681–670, 2681–693, as amended by Pub. L. 109–469, title VI, §602, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 115–271, title VIII, §8202(a), (b)(2), Oct. 24, 2018, 132 Stat. 4110, provided that: "This title [enacting this chapter and amending section 1509 of this title, sections 5312 to 5314 of Title 5, Government Organization and Employees, section 1105 of Title 31, Money and Finance, and section 402 of Title 50, War and National Defense] may be cited as the 'Office of National Drug Control Policy Reauthorization Act of 1998'."

Reauthorization of the Office of National Drug Control Policy and Revival of Office of National Drug Control Policy Reauthorization Act of 1998

Pub. L. 115–271, title VIII, §8202(a), Oct. 24, 2018, 132 Stat. 4110, provided that:

"(1) In general.—The Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1701 et seq.) [title VII of div. C of Pub. L. 105–277, see Short Title note set out above], as in effect on September 29, 2003, and as amended by the laws described in paragraph (2), is revived and restored.

"(2) Laws described.—The laws described in this paragraph are:

"(A) The Office of National Drug Control Policy Reauthorization Act of 2006 (Public Law 109–469; 120 Stat. 3502) [see Short Title of 2006 Amendment note set out above].

"(B) The Presidential Appointment Efficiency and Streamlining Act of 2011 (Public Law 112–166; 126 Stat. 1283) [see Short Title of 2012 Amendment note set out under section 101 of Title 5, Government Organization and Employees]."

Model Acts

Pub. L. 109–469, title XI, §1105, Dec. 29, 2006, 120 Stat. 3541, which directed the Director of the Office of National Drug Control Policy to enter into an agreement with a non-profit corporation to advise States on establishing laws and policies to address alcohol and other drug issues based on the model State drug laws developed by the President's Commission on Model State Drug Laws in 1993, was repealed by Pub. L. 115–271, title VIII, §8217(h), Oct. 24, 2018, 132 Stat. 4125. See section 1703(i) of this title.

Executive Documents

Ex. Ord. No. 13165. White House Task Force on Drug Use in Sports and United States Representative on the Board of the World Anti-Doping Agency

Ex. Ord. No. 13165, Aug. 9, 2000, 65 F.R. 49469, as amended by Ex. Ord. No. 13286, §11, Feb. 28, 2003, 68 F.R. 10622, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, including the Office of National Drug Control [Policy] Reauthorization Act of 1998, (21 U.S.C. 1701 et seq.), and in order to develop recommendations for Federal agency actions to address the use of drugs in sports, in particular among young people, it is hereby ordered as follows:

Section 1. Policy. The use of drugs in sports has reached a level that endangers not just the legitimacy of athletic competition but also the lives and health of athletes—from the elite ranks to youth leagues. The National Household Survey on Drug Abuse issued in 1999 found that in just 1 year's time the rate of steroid use among young people rose roughly 50 percent among both sexes and across all age groups. It is the policy of my Administration to take the steps needed to help eliminate illicit or otherwise banned drug use and doping in sports at the State, national, and international level.

Sec. 2. Establishment of a White House Task Force on Drug Use in Sports. (a) There is established a White House Task Force on Drug Use in Sports (Task Force). The Task Force shall comprise the co-vice chairs of the White House Olympic Task Force (the "Olympic Task Force Vice Chairs"), and representatives designated by the Office of National Drug Control Policy, the Department of Health and Human Services, the Department of Labor, the President's Council on Physical Fitness and Sports [now President's Council on Fitness, Sports, and Nutrition], the Office of Management and Budget, the National Security Council, the Department of State, the Department of the Treasury, the Department of Education, the Department of Justice, the Department of Transportation, the Department of Homeland Security, the National Institute on Drug Abuse, and the Substance Abuse and Mental Health Services Administration.

(b) The Task Force shall develop recommendations for the President on further executive and legislative actions that can be undertaken to address the problem of doping and drug use in sports. In developing the recommendations, the Task Force shall consider, among other things: (i) the health and safety of America's athletes, in particular our Nation's young people; (ii) the integrity of honest athletic competition; and (iii) the views and recommendations of State and local governments, the private sector, citizens, community groups, and nonprofit organizations, on actions to address this threat. The Task Force, through its Chairs, shall submit its recommendations to the President.

(c) The Director of the Office of National Drug Control Policy (the Director), the Secretary of the Department of Health and Human Services, and the Olympic Task Force Vice Chairs or their designees shall serve as the Task Force Chairs.

(d) To the extent permitted by law and at the request of the Chairs, agencies shall cooperate with and provide information to the Task Force.

Sec. 3. Participation in the World Anti-Doping Agency. (a) As part of my Administration's efforts to address the problem of drug use in sports, the United States has played a leading role in the formation of a World Anti-Doping Agency (WADA) by the Olympic and sports community and the nations of the world. Through these efforts, the United States has been selected to serve as a governmental representative on the board of the WADA. This order will authorize the Director to serve as the United States Government's representative on the WADA board.

(b) Pursuant to 21 U.S.C. 1701 et seq., the Director, or in his absence his designee, is hereby authorized to take all necessary and proper actions to execute his responsibilities as United States representative to the WADA.

(c) To assist the Director in carrying out these responsibilities as the United States Government representative to the WADA and to the extent permitted by law, Federal employees may serve in their official capacity, inter alia, on WADA Committees or WADA advisory committees, serving as experts to the WADA.

1 So in original. Probably should be "Tribal".
21 U.S.C. § 1706 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1706: High Intensity Drug Trafficking Areas Program
High Intensity Drug Trafficking Areas Program
Status: in_force

(a) Establishment

(1) In general

There is established in the Office a program to be known as the High Intensity Drug Trafficking Areas Program (in this section referred to as the "Program").

(2) Purpose

The purpose of the Program is to reduce drug trafficking and drug production in the United States by—

(A) facilitating cooperation among Federal, State, local, and tribal law enforcement agencies to share information and implement coordinated enforcement activities;

(B) enhancing law enforcement intelligence sharing among Federal, State, local, and tribal law enforcement agencies;

(C) providing reliable law enforcement intelligence to law enforcement agencies needed to design effective enforcement strategies and operations; and

(D) supporting coordinated law enforcement strategies which maximize use of available resources to reduce the supply of illegal drugs in designated areas and in the United States as a whole.

(b) Designation

(1) In general

The Director, in consultation with the Attorney General, the Secretary of the Treasury, the Secretary of Homeland Security, heads of the National Drug Control Program agencies, and the Governor of each applicable State, may designate any specified area of the United States as a high intensity drug trafficking area.

(2) Activities

After making a designation under paragraph (1) and in order to provide Federal assistance to the area so designated, the Director may—

(A) obligate such sums as are appropriated for the Program;

(B) direct the temporary reassignment of Federal personnel to such area, subject to the approval of the head of the department or agency that employs such personnel;

(C) take any other action authorized under section 1703 of this title to provide increased Federal assistance to those areas; and

(D) coordinate activities under this section (specifically administrative, recordkeeping, and funds management activities) with State, local, and tribal officials.

(c) Petitions for designation

The Director shall establish regulations under which a coalition of interested law enforcement agencies from an area may petition for designation as a high intensity drug trafficking area. Such regulations shall provide for a regular review by the Director of the petition, including a recommendation regarding the merit of the petition to the Director by a panel of qualified, independent experts.

(d) Factors for consideration

In considering whether to designate an area under this section as a high intensity drug trafficking area, the Director shall consider, in addition to such other criteria as the Director considers to be appropriate, the extent to which—

(1) the area is a significant center of illegal drug production, manufacturing, importation, or distribution;

(2) State, local, and tribal law enforcement agencies have committed resources to respond to the drug trafficking problem in the area, thereby indicating a determination to respond aggressively to the problem;

(3) drug-related activities in the area are having a significant harmful impact in the area, and in other areas of the country; and

(4) a significant increase in allocation of Federal resources is necessary to respond adequately to drug-related activities in the area.

(e) Organization of high intensity drug trafficking areas

(1) Executive Board and officers

To be eligible for funds appropriated under this section, each high intensity drug trafficking area shall be governed by an Executive Board. The Executive Board shall designate a chairman, vice chairman, and any other officers to the Executive Board that it determines are necessary.

(2) Responsibilities

The Executive Board of a high intensity drug trafficking area shall be responsible for—

(A) providing direction and oversight in establishing and achieving the goals of the high intensity drug trafficking area;

(B) managing the funds of the high intensity drug trafficking area;

(C) reviewing and approving all funding proposals consistent with the overall objective of the high intensity drug trafficking area; and

(D) reviewing and approving all reports to the Director on the activities of the high intensity drug trafficking area.

(3) Board representation

None of the funds appropriated under this section may be expended for any high intensity drug trafficking area, or for a partnership or region of a high intensity drug trafficking area, if the Executive Board for such area, region, or partnership, does not apportion an equal number of votes between representatives of participating Federal agencies and representatives of participating State, local, and tribal agencies. Where it is impractical for an equal number of representatives of Federal agencies and State, local, and tribal agencies to attend a meeting of an Executive Board in person, the Executive Board may use a system of proxy votes or weighted votes to achieve the voting balance required by this paragraph.

(4) No agency relationship

The eligibility requirements of this section are intended to ensure the responsible use of Federal funds. Nothing in this section is intended to create an agency relationship between individual high intensity drug trafficking areas and the Federal Government.

(f) Use of funds

The Director shall ensure that not more than a total of 5 percent of Federal funds appropriated for the Program are expended for substance use disorder treatment programs and drug prevention programs.

(g) Counterterrorism activities

(1) Assistance authorized

The Director may authorize use of resources available for the Program to assist Federal, State, local, and tribal law enforcement agencies in investigations and activities related to terrorism and prevention of terrorism, especially but not exclusively with respect to such investigations and activities that are also related to drug trafficking.

(2) Limitation

The Director shall ensure—

(A) that assistance provided under paragraph (1) remains incidental to the purpose of the Program to reduce drug availability and carry out drug-related law enforcement activities; and

(B) that significant resources of the Program are not redirected to activities exclusively related to terrorism, except on a temporary basis under extraordinary circumstances, as determined by the Director.

(h) Role of Drug Enforcement Administration

The Director, in consultation with the Attorney General, shall ensure that a representative of the Drug Enforcement Administration is included in the Intelligence Support Center for each high intensity drug trafficking area.

(i) Annual HIDTA Program budget submissions

As part of the documentation that supports the President's annual budget request for the Office, the Director shall submit to Congress a budget justification that includes—

(1) the amount proposed for each high intensity drug trafficking area, conditional upon a review by the Office of the request submitted by the HIDTA and the performance of the HIDTA, with supporting narrative descriptions and rationale for each request;

(2) a detailed justification that explains—

(A) the reasons for the proposed funding level; how such funding level was determined based on a current assessment of the drug trafficking threat in each high intensity drug trafficking area;

(B) how such funding will ensure that the goals and objectives of each such area will be achieved; and

(C) how such funding supports the National Drug Control Strategy; and

(3) the amount of HIDTA funds used to investigate and prosecute organizations and individuals trafficking in methamphetamine in the prior calendar year, and a description of how those funds were used.

(j) Emerging threat response fund

(1) In general

Subject to the availability of appropriations, the Director may expend up to 10 percent of the amounts appropriated under this section on a discretionary basis, to respond to any emerging drug trafficking threat in an existing high intensity drug trafficking area, or to establish a new high intensity drug trafficking area or expand an existing high intensity drug trafficking area, in accordance with the criteria established under paragraph (2).

(2) Consideration of impact

In allocating funds under this subsection, the Director shall consider—

(A) the impact of activities funded on reducing overall drug traffic in the United States, or minimizing the probability that an emerging drug trafficking threat will spread to other areas of the United States; and

(B) such other criteria as the Director considers appropriate.

(k) Evaluation

(1) Initial report

Not later than 90 days after December 29, 2006, the Director shall, after consulting with the Executive Boards of each designated high intensity drug trafficking area, submit a report to Congress that describes, for each designated high intensity drug trafficking area—

(A) the specific purposes for the high intensity drug trafficking area;

(B) the specific long-term and short-term goals and objectives for the high intensity drug trafficking area;

(C) the measurements that will be used to evaluate the performance of the high intensity drug trafficking area in achieving the long-term and short-term goals; and

(D) the reporting requirements needed to evaluate the performance of the high intensity drug trafficking area in achieving the long-term and short-term goals.

(2) Evaluation of HIDTA Program as part of National Drug Control Strategy

For each designated high intensity drug trafficking area, the Director shall submit, as part of the annual National Drug Control Strategy report, a report that—

(A) describes—

(i) the specific purposes for the high intensity drug trafficking area; and

(ii) the specific long-term and short-term goals and objectives for the high intensity drug trafficking area; and

(B) includes an evaluation of the performance of the high intensity drug trafficking area in accomplishing the specific long-term and short-term goals and objectives identified under paragraph (1)(B).

(l) Assessment of drug enforcement task forces in high intensity drug trafficking areas

Not later than 1 year after December 29, 2006, and as part of each subsequent annual National Drug Control Strategy report, the Director shall submit to Congress a report—

(1) assessing the number and operation of all federally funded drug enforcement task forces within each high intensity drug trafficking area; and

(2) describing—

(A) each Federal, State, local, and tribal drug enforcement task force operating in the high intensity drug trafficking area;

(B) how such task forces coordinate with each other, with any high intensity drug trafficking area task force, and with investigations receiving funds from the Organized Crime and Drug Enforcement Task Force;

(C) what steps, if any, each such task force takes to share information regarding drug trafficking and drug production with other federally funded drug enforcement task forces in the high intensity drug trafficking area;

(D) the role of the high intensity drug trafficking area in coordinating the sharing of such information among task forces;

(E) the nature and extent of cooperation by each Federal, State, local, and tribal participant in ensuring that such information is shared among law enforcement agencies and with the high intensity drug trafficking area;

(F) the nature and extent to which information sharing and enforcement activities are coordinated with joint terrorism task forces in the high intensity drug trafficking area; and

(G) any recommendations for measures needed to ensure that task force resources are utilized efficiently and effectively to reduce the availability of illegal drugs in the high intensity drug trafficking areas.

(m) Assessment of law enforcement intelligence sharing in High Intensity Drug Trafficking Areas Program

Not later than 180 days after December 29, 2006, and as part of each subsequent annual National Drug Control Strategy report, the Director, in consultation with the Director of National Intelligence, shall submit to Congress a report—

(1) evaluating existing and planned law enforcement intelligence systems supported by each high intensity drug trafficking area, or utilized by task forces receiving any funding under the Program, including the extent to which such systems ensure access and availability of law enforcement intelligence to Federal, State, local, and tribal law enforcement agencies within the high intensity drug trafficking area and outside of it;

(2) the extent to which Federal, State, local, and tribal law enforcement agencies participating in each high intensity drug trafficking area are sharing law enforcement intelligence information to assess current drug trafficking threats and design appropriate enforcement strategies; and

(3) the measures needed to improve effective sharing of information and law enforcement intelligence regarding drug trafficking and drug production among Federal, State, local, and tribal law enforcement participating in a high intensity drug trafficking area, and between such agencies and similar agencies outside the high intensity drug trafficking area.

(n) Coordination of Law enforcement intelligence sharing with Organized Crime Drug Enforcement Task Force program

The Director, in consultation with the Attorney General, shall ensure that any drug enforcement intelligence obtained by the Intelligence Support Center for each high intensity drug trafficking area is shared, on a timely basis, with the drug intelligence fusion center operated by the Organized Crime Drug Enforcement Task Force of the Department of Justice.

(o) Use of funds to combat methamphetamine trafficking

(1) Requirement

As part of the documentation that supports the President's annual budget request for the Office, the Director shall submit to Congress a report describing the use of HIDTA funds to investigate and prosecute organizations and individuals trafficking in methamphetamine in the prior calendar year.

(2) Contents

The report shall include—

(A) the number of methamphetamine manufacturing facilities discovered through HIDTA-funded initiatives in the previous fiscal year;

(B) the amounts of methamphetamine or listed chemicals (as that term is defined in section 802(33) of this title) seized by HIDTA-funded initiatives in the area during the previous year; and

(C) law enforcement intelligence and predictive data from the Drug Enforcement Administration showing patterns and trends in abuse, trafficking, and transportation in methamphetamine and listed chemicals.

(3) Certification

Before the Director awards any funds to a high intensity drug trafficking area, the Director shall certify that the law enforcement entities participating in that HIDTA are providing laboratory seizure data to the national clandestine laboratory database at the El Paso Intelligence Center.

(p) Authorization of appropriations

There is authorized to be appropriated to the Office of National Drug Control Policy to carry out this section—

(1) $240,000,000 for fiscal year 2007;

(2) $250,000,000 for fiscal year 2008;

(3) $260,000,000 for fiscal year 2009;

(4) $270,000,000 for fiscal year 2010;

(5) $280,000,000 for each of 1 fiscal year 2011; and

(6) $280,000,000 for each of fiscal years 2018 through 2023.

(q) Specific purposes

(1) In general

The Director shall ensure that, of the amounts appropriated for a fiscal year for the Program, at least $7,000,000 is used in high intensity drug trafficking areas with severe neighborhood safety and illegal drug distribution problems.

(2) Required uses

The funds used under paragraph (1) shall be used to ensure the safety of neighborhoods and the protection of communities, including the prevention of the intimidation of witnesses of illegal drug distribution and related activities and the establishment of, or support for, programs that provide protection or assistance to witnesses in court proceedings.

(3) Best practice models

The Director shall work with HIDTAs to develop and maintain best practice models to assist State, local, and Tribal governments in addressing witness safety, relocation, financial and housing assistance, or any other services related to witness protection or assistance in cases of illegal drug distribution and related activities. The Director shall ensure dissemination of the best practice models to each HIDTA.

(r) Drug overdose response strategy implementation

The Director may use funds appropriated to carry out this section to implement a drug overdose response strategy in high intensity drug trafficking areas on a nationwide basis by—

(1) coordinating multi-disciplinary efforts to prevent, reduce, and respond to drug overdoses, including the uniform reporting of fatal and non-fatal overdoses to public health and safety officials;

(2) increasing data sharing among public safety and public health officials concerning drug-related abuse trends, including new psychoactive substances, and related crime; and

(3) enabling collaborative deployment of prevention, intervention, and enforcement resources to address substance use addiction and narcotics trafficking.

(s) Supplemental grants

The Director is authorized to use not more than $10,000,000 of the amounts otherwise appropriated to carry out this section to provide supplemental competitive grants to high intensity drug trafficking areas that have experienced high seizures of fentanyl and new psychoactive substances for the purposes of—

(1) purchasing portable equipment to test for fentanyl and other substances;

(2) training law enforcement officers and other first responders on best practices for handling fentanyl and other substances; and

(3) purchasing protective equipment, including overdose reversal drugs.

(Pub. L. 105–277, div. C, title VII, §§707, 715, Oct. 21, 1998, 112 Stat. 2681–686, 2681–693; Pub. L. 109–469, title III, §§301, §302(c), title VI, §602, Dec. 29, 2006, 120 Stat. 3518, 3525, 3533; Pub. L. 115–271, title VIII, §§8202(a), 8202(b)(2), 8205, 8208, 8209, Oct. 24, 2018, 132 Stat. 4110, 4113, 4114; Pub. L. 116–74, §2(a)(7), Nov. 27, 2019, 133 Stat. 1157.)

Editorial Notes

References in Text

December 29, 2006, referred to in subsecs. (k)(1), (l), and (m) was in the original "the date of the enactment of this section", which was translated as meaning the date of enactment of Pub. L. 109–469, which amended this section generally, to reflect the probable intent of Congress.

Amendments

2019—Subsec. (o)(2)(B). Pub. L. 116–74 substituted "802(33) of this title)" for "802(33) of this title".

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

Subsec. (f). Pub. L. 115–271, §8205(1), substituted "not more than a total of 5 percent of Federal funds appropriated for the Program are expended for substance use disorder treatment programs and drug prevention programs." for "no Federal funds appropriated for the Program are expended for the establishment or expansion of drug treatment programs, and shall ensure that not more than 5 percent of the Federal funds appropriated for the Program are expended for the establishment of drug prevention programs."

Subsec. (p)(6). Pub. L. 115–271, §8205(2), added par. (6).

Subsec. (q)(2). Pub. L. 115–271, §8205(3)(A), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: "The funds used under paragraph (1) shall be used—

"(A) to ensure the safety of neighborhoods and the protection of communities, including the prevention of the intimidation of potential witnesses of illegal drug distribution and related activities; and

"(B) to combat illegal drug trafficking through such methods as the Director considers appropriate, such as establishing or operating (or both) a toll-free telephone hotline for use by the public to provide information about illegal drug-related activities."

Subsec. (q)(3). Pub. L. 115–271, §8205(3)(B), added par. (3).

Subsec. (r). Pub. L. 115–271, §8208, added subsec. (r).

Subsec. (s). Pub. L. 115–271, §8209, added subsec. (s).

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Pub. L. 109–469, §301, amended section generally. Prior to amendment, section related to the High Intensity Drug Trafficking Areas Program.

Subsec. (q). Pub. L. 109–469, §302(c), added subsec. (q).

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Findings

Pub. L. 109–469, title III, §302(b), Dec. 29, 2006, 120 Stat. 3524, provided that: "Congress finds the following:

"(1) In the early morning hours of October 16, 2002, the home of Carnell and Angela Dawson was firebombed in apparent retaliation for Mrs. Dawson's notification to police about persistent drug distribution activity in their East Baltimore City neighborhood.

"(2) The arson claimed the lives of Mr. and Mrs. Dawson and their 5 young children, aged 9 to 14.

"(3) The horrific murder of the Dawson family is a stark example of domestic narco-terrorism.

"(4) In all phases of counternarcotics law enforcement—from prevention to investigation to prosecution to reentry—the voluntary cooperation of ordinary citizens is a critical component.

"(5) Voluntary cooperation is difficult for law enforcement officials to obtain when citizens feel that cooperation carries the risk of violent retaliation by illegal drug trafficking organizations and their affiliates.

"(6) Public confidence that law enforcement is doing all it can to make communities safe is a prerequisite for voluntary cooperation among people who may be subject to intimidation or reprisal (or both).

"(7) Witness protection programs are insufficient on their own to provide security because many individuals and families who strive every day to make distressed neighborhoods livable for their children, other relatives, and neighbors will resist or refuse offers of relocation by local, State, and Federal prosecutorial agencies and because, moreover, the continued presence of strong individuals and families is critical to preserving and strengthening the social fabric in such communities.

"(8) Where (as in certain sections of Baltimore City) interstate trafficking of illegal drugs has severe ancillary local consequences within areas designated as high intensity drug trafficking areas, it is important that supplementary High Intensity Drug Trafficking Areas Program funds be committed to support initiatives aimed at making the affected communities safe for the residents of those communities and encouraging their cooperation with tribal, local, State, and Federal law enforcement efforts to combat illegal drug trafficking."

Combating Methamphetamine and Amphetamine in High Intensity Drug Trafficking Areas

Pub. L. 106–310, div. B, title XXXVI, §3624, Oct. 17, 2000, 114 Stat. 1232, provided that:

"(a) In General.—

"(1) In general.—The Director of National Drug Control Policy shall use amounts available under this section to combat the trafficking of methamphetamine and amphetamine in areas designated by the Director as high intensity drug trafficking areas.

"(2) Activities.—In meeting the requirement in paragraph (1), the Director shall transfer funds to appropriate Federal, State, and local governmental agencies for employing additional Federal law enforcement personnel, or facilitating the employment of additional State and local law enforcement personnel, including agents, investigators, prosecutors, laboratory technicians, chemists, investigative assistants, and drug-prevention specialists.

"(b) Authorization of Appropriations.—There is authorized to be appropriated to carry out this section—

"(1) $15,000,000 for fiscal year 2000; and

"(2) such sums as may be necessary for each of fiscal years 2001 through 2004.

"(c) Apportionment of Funds.—

"(1) Factors in apportionment.—The Director shall apportion amounts appropriated for a fiscal year pursuant to the authorization of appropriations in subsection (b) for activities under subsection (a) among and within areas designated by the Director as high intensity drug trafficking areas based on the following factors:

"(A) The number of methamphetamine manufacturing facilities and amphetamine manufacturing facilities discovered by Federal, State, or local law enforcement officials in the previous fiscal year.

"(B) The number of methamphetamine prosecutions and amphetamine prosecutions in Federal, State, or local courts in the previous fiscal year.

"(C) The number of methamphetamine arrests and amphetamine arrests by Federal, State, or local law enforcement officials in the previous fiscal year.

"(D) The amounts of methamphetamine, amphetamine, or listed chemicals (as that term is defined in section 102(33) of the Controlled Substances Act (21 U.S.C. 802(33)) seized by Federal, State, or local law enforcement officials in the previous fiscal year.

"(E) Intelligence and predictive data from the Drug Enforcement Administration and the Department of Health and Human Services showing patterns and trends in abuse, trafficking, and transportation in methamphetamine, amphetamine, and listed chemicals (as that term is so defined).

"(2) Certification.—Before the Director apportions any funds under this subsection to a high intensity drug trafficking area, the Director shall certify that the law enforcement entities responsible for clandestine methamphetamine and amphetamine laboratory seizures in that area are providing laboratory seizure data to the national clandestine laboratory database at the El Paso Intelligence Center.

"(d) Limitation on Administrative Costs.—Not more than 5 percent of the amount appropriated in a fiscal year pursuant to the authorization of appropriations for that fiscal year in subsection (b) may be available in that fiscal year for administrative costs associated with activities under subsection (a)."

Funding for High Intensity Drug Trafficking Areas Program

Pub. L. 106–58, title III, Sept. 29, 1999, 113 Stat. 448, provided in part: "That, hereafter, of the amount appropriated for fiscal year 2000 or any succeeding fiscal year for the High Intensity Drug Trafficking Areas Program, the funds to be obligated or expended during such fiscal year for programs addressing the treatment or prevention of drug use as part of the approved strategy for a designated High Intensity Drug Trafficking Area (HIDTA) shall not be less than the funds obligated or expended for such programs during fiscal year 1999 for each designated HIDTA without the prior approval of the Committees on Appropriations".

1 So in original.