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42 U.S.C. § 290dd–3 — Grants for reducing overdose deaths

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 290dd–3 — Grants for reducing overdose deaths

**(a) Establishment** (1) **In general** — The Secretary shall award grants to eligible entities to expand access to drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.] for emergency treatment of known or suspected opioid overdose. (2) **Eligible entity** — For purposes of this section, the term “eligible entity” means a State, Territory, locality, or Indian Tribe or Tribal organization (as those terms are defined in [section 5304 of title 25](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section5304&num=0&edition=prelim)). (3) **Subgrants** — For the purposes for which a grant is awarded under this section, the eligible entity receiving the grant may award subgrants to a Federally qualified health center (as defined in [section 1395x(aa) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x/aa&num=0&edition=prelim)), an opioid treatment program (as defined in section 8.2 of title 42, Code of Federal Regulations (or any successor regulations)), any practitioner dispensing narcotic drugs for the purpose of maintenance or detoxification treatment, or any nonprofit organization that the Secretary deems appropriate, which may include Urban Indian organizations (as defined in [section 1603 of title 25](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section1603&num=0&edition=prelim)). (4) **Prescribing** — For purposes of this section, the term “prescribing” means, with respect to a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emer

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Source file: Laws/federal/codes/united-states-code/title-42/section-290dd3-grants-for-reducing-overdose-deaths--d222c7934e.md
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Source location: Title 42, Chapter 6A, § 290dd–3; chapter-6a-public-health-service.md

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**(a) Establishment** (1) **In general** — The Secretary shall award grants to eligible entities to expand access to drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.] for emergency treatment of known or suspected opioid overdose. (2) **Eligible entity** — For purposes of this section, the term “eligible entity” means a State, Territory, locality, or Indian Tribe or Tribal organization (as those terms are defined in [section 5304 of title 25](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section5304&num=0&edition=prelim)). (3) **Subgrants** — For the purposes for which a grant is awarded under this section, the eligible entity receiving the grant may award subgrants to a Federally qualified health center (as defined in [section 1395x(aa) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x/aa&num=0&edition=prelim)), an opioid treatment program (as defined in section 8.2 of title 42, Code of Federal Regulations (or any successor regulations)), any practitioner dispensing narcotic drugs for the purpose of maintenance or detoxification treatment, or any nonprofit organization that the Secretary deems appropriate, which may include Urban Indian organizations (as defined in [section 1603 of title 25](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section1603&num=0&edition=prelim)). (4) **Prescribing** — For purposes of this section, the term “prescribing” means, with respect to a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, the practice of prescribing such drug or device— (A) in conjunction with an opioid prescription for patients at an elevated risk of overdose, including patients prescribed both an opioid and a benzodiazepine; (B) in conjunction with an opioid agonist approved under section 505 of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim)] for the treatment of opioid use disorder; (C) to the caregiver or a close relative of patients at an elevated risk of overdose from opioids; or (D) in other circumstances in which a provider identifies a patient is at an elevated risk for an intentional or unintentional overdose from heroin or prescription opioid therapies. **(b) Application** To be eligible to receive a grant under this section, an eligible entity shall submit to the Secretary, in such form and manner as specified by the Secretary, an application that describes— (1) the extent to which the area to which the entity will furnish services through use of the grant is experiencing significant morbidity and mortality caused by opioid abuse; (2) the criteria that will be used to identify eligible patients to participate in such program; and (3) a plan for sustaining the program after Federal support for the program has ended. **(c) Use of funds** An eligible entity receiving a grant under this section may use amounts under the grant for any of the following activities, but may use not more than 20 percent of the grant funds for activities described in paragraphs (3) and (4): (1) To establish a program for prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.] for emergency treatment of known or suspected opioid overdose. (2) To train and provide resources for health care providers and pharmacists on the prescribing of drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose. (3) To purchase drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, for distribution under the program described in paragraph (1). (4) To offset the co-payments and other cost sharing associated with drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose. (5) To establish protocols to connect patients who have experienced an overdose with appropriate treatment, including overdose reversal medications, medication assisted treatment, and appropriate counseling and behavioral therapies. **(d) Improving access to overdose treatment** (1) **Information on best practices** (A) *Health and Human Services* — The Secretary of Health and Human Services may provide information to States, localities, Indian Tribes, Tribal organizations, and Urban Indian organizations on best practices for prescribing or co-prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.] for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders. (B) *Defense* — The Secretary of Health and Human Services may, as appropriate, consult with the Secretary of Defense regarding the provision of information to prescribers within Department of Defense medical facilities on best practices for prescribing or co-prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders. (C) *Veterans Affairs* — The Secretary of Health and Human Services may, as appropriate, consult with the Secretary of Veterans Affairs regarding the provision of information to prescribers within Department of Veterans Affairs medical facilities on best practices for prescribing or co-prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders. (2) **Rule of construction** — Nothing in this subsection shall be construed as establishing or contributing to a medical standard of care. **(e) Evaluations by recipients** As a condition of receipt of a grant under this section, an eligible entity shall, for each year for which the grant is received, submit to the Secretary an evaluation of activities funded by the grant which contains such information as the Secretary may reasonably require. **(f) Reports by the Secretary** Not later than 5 years after the date on which the first grant under this section is awarded, the Secretary shall submit to the appropriate committees of the House of Representatives and of the Senate a report aggregating the information received from the grant recipients for such year under subsection (e) and evaluating the outcomes achieved by the programs funded by grants awarded under this section. **(g) Authorization of appropriations** There is authorized to be appropriated to carry out this section, $5,000,000 for the period of fiscal years 2023 through 2027.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355 — New drugs

**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug. **(b) Filing application; contents** (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as components of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the articles used as components thereof as the Secretary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and (viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approv

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Federal law — U.S. Code and appendices · legal_authorities

25 U.S.C. § 5304 — Authorization of appropriations

**(a) In general** There are authorized to be appropriated such sums as may be necessary to carry out this subchapter. **(b) Availability of appropriations** Notwithstanding any other provision of this chapter, the provision of funds under this chapter shall be subject to the availability of appropriations and the Secretary is not required to reduce funding for programs, projects, or activities serving a tribe in order to make funds available to another tribe or tribal organization under this chapter.

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Federal law — U.S. Code and appendices · legal_authorities

25 U.S.C. § 1603 — Service of traditional foods in public facilities

**(a) Purposes** The purposes of this section are— (1) to provide access to traditional foods in food service programs; (2) to encourage increased consumption of traditional foods to decrease health disparities among Indians, particularly Alaska Natives; and (3) to provide alternative food options for food service programs. **(b) Definitions** In this section: (1) **Alaska Native** — The term “Alaska Native” means a person who is a member of any Native village, Village Corporation, or Regional Corporation (as those terms are defined in [section 1602 of title 43](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title43-section1602&num=0&edition=prelim)). (2) **Commissioner** — The term “Commissioner” means the Commissioner of Food and Drugs. (3) **Food service program** — The term “food service program” includes— (A) food service at residential child care facilities that have a license from an appropriate State agency; (B) any child nutrition program (as that term is defined in [section 1769f(b) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1769f/b&num=0&edition=prelim)); (C) food service at hospitals, clinics, and long-term care facilities; and (D) senior meal programs. (4) **Indian; Indian tribe** — The terms “Indian” and “Indian tribe” have the meanings given those terms in section 4 of the Indian Self-Determination and Education Assistance Act ([25 U.S.C. 450b](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section450b&num=0&edition=prelim)).11 See References in Text note below. (5) **Traditional food** (A) *In general* — The term “traditional food” means food that has traditionally been prepared and consumed by an Indian tribe. (B) *Inclusions* — The term “traditi

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Federal law — U.S. Code and appendices · legal_authorities

5 U.S.C. § 7362 — Alcohol abuse and alcoholism

**(a)** The Office of Personnel Management shall be responsible for developing, in cooperation with the Secretary of Health and Human Services and with other agencies, and in accordance with applicable provisions of this subpart, appropriate prevention, treatment, and rehabilitation programs and services for alcohol abuse and alcoholism among employees. Such agencies are encouraged to extend, to the extent feasible, such programs and services to the families of alcoholic employees and to employees who have family members who are alcoholics. Such programs and services shall make optimal use of existing governmental facilities, services, and skills. **(b)** Section 523 11 See References in Text note below. of the Public Health Service Act ([42 U.S.C. 290dd–3](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section290dd–3&num=0&edition=prelim)), relating to confidentiality of records, and any regulations prescribed thereunder, shall apply with respect to records maintained for the purpose of carrying out this section. **(c)** Each agency shall, with respect to any programs or services provided by such agency, submit such written reports as the Office may require in connection with any report required under [section 7363 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section7363&num=0&edition=prelim). **(d)** For the purpose of this section, the term “agency” means an Executive agency.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 301 — Short title

Page 30 TITLE 21—FOOD AND DRUGS § 301 Sec. 398. Notices to States regarding imported food. 399. Grants to enhance food safety. 399a. Office of the Chief Scientist. 399b. Office of Women’s Health. 399c. Improving the training of State, local, terri- torial, and tribal food safety officials. 399d. Employee protections. 399e. Nanotechnology. 399f. Ensuring adequate information regarding pharmaceuticals for all populations, par- ticularly underrepresented subpopulations, including racial subgroups. 399g. Food and Drug Administration Intercenter Institutes. 399h. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufac- turing. 399i. Food and Drug Administration Working Cap- ital Fund. SUBCHAPTER I—SHORT TITLE § 301. Short title This chapter may be cited as the Federal Food, Drug, and Cosmetic Act. (June 25, 1938, ch. 675, § 1, 52 Stat. 1040.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, pro- vided that: ‘‘[SEC. 1] (a) The effective date of the following provi- sions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k) of this title]; 501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this title]. ‘‘(b) The Secretary of Agriculture shall promulgate regulations further postponing to July 1, 1940[,] the ef- fective date of the provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355 — New drugs

Page 186 TITLE 21—FOOD AND DRUGS § 355 § 355. New drugs (a) Necessity of effective approval of application No person shall introduce or deliver for intro- duction into interstate commerce any new drug, unless an approval of an application filed pursu- ant to subsection (b) or (j) is effective with re- spect to such drug. (b) Filing application; contents (1)(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the ap- plication— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as compo- nents of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the arti- cles used as components thereof as the Sec- retary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under section 355c of this title; and (viii) the patent number and expiration date of each patent for which a claim of patent in- fringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug sub- stance (active ingredient) patent or a drug product (formulation or composition) pat- ent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application. (B) If an a

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