21 U.S.C. § 1536 — Community-based coalition enhancement

Page 948 TITLE 21—FOOD AND DRUGS § 1536 initial grant under this subsection, and renewal grants under subsection (f), to any coalition awarded a grant under section 1532 of this title that meets the criteria specified in subsection (d) in order to fund coalition mentoring activi- ties by such coalition in support of the program. (b) Treatment with other grants (1) Supplement A grant awarded to a coalition under this section is in addition to any grant awarded to the coalition under section 1532 of this title. (2) Requirement for basic grant A coalition may not be awarded a grant under this section for a fiscal year unless the coalition was awarded a grant or renewal grant under section 1532(b) of this title for that fiscal year. (c) Application A coalition seeking a grant under this section shall submit to the Administrator an applica- tion for the grant in such form and manner as the Administrator may require. (d) Criteria A coalition meets the criteria specified in this subsection if the coalition— (1) has been in existence for at least 5 years; (2) has achieved, by or through its own ef- forts, measurable results in the prevention and treatment of substance use and misuse among youth; (3) has staff or members willing to serve as mentors for persons seeking to start or expand the activities of other coalitions in the pre- vention and treatment of substance use and misuse; (4) has demonstrable support from some members of the community in which the coali- tion mentoring activities to be supported by the grant under this section are to be carried out; and (5) submits to the Administrator a detailed plan for the coalition mentoring activities to be supported by the grant under this section. (e) Use of grant funds A coalition awarded a grant under this section shall use the grant amount for mentoring activi- ties to support and encourage the development of new, self-supporting community coalitions that are focused on the prevention and treat- ment of substance use and misuse in such new coalitions’ communities. The mentoring coali- tion shall encourage such development in ac- cordance with the plan submitted by the men- toring coalition under subsection (d)(5). (f) Renewal grants The Administrator may make a renewal grant to any coalition awarded a grant under sub- section (a), or a previous renewal grant under this subsection, if the coalition, at the time of application for such renewal grant— (1) continues to meet the criteria specified in subsection (d); and (2) has made demonstrable progress in the development of one or more new, self-sup- porting community coalitions that are focused on the prevention and treatment of substance use and misuse. (g) Grant amounts (1) In general Subject to paragraphs (2) and (3), the total amount of grants awarded to a coalition under this section for a fiscal year may not exceed the amount of non-Federal funds raised by the coalition, including in-kind contributions, for that fiscal year. Funds appropriated for the substance use and misuse activities of a coali- tion that includes a representative of the Bu- reau of Indian Affairs, the Indian Health Serv- ice, or a tribal government agency with exper- tise in the field of substance use and misuse may be counted as non-Federal funds raised by the coalition. (2) Initial grants The amount of the initial grant awarded to a coalition under subsection (a) may not ex- ceed $75,000. (3) Renewal grants The total amount of renewal grants awarded to a coalition under subsection (f) for any fis- cal year may not exceed $75,000. (h) Fiscal year limitation on amount available for grants The total amount available for grants under this section, including renewal grants under sub- section (f), in any fiscal year may not exceed the amount equal to five percent of the amount au- thorized to be appropriated by section 1524(a) of this title for that fiscal year. (i) Priority in awarding initial grants In awarding initial grants under this section, priority shall be given to a coalition that ex- pressly proposes to provide mentorship to a coa- lition or aspiring coalition serving economically disadvantaged areas. (Pub. L. 100–690, title I, § 1035, as added Pub. L. 107–82, § 2, Dec. 14, 2001, 115 Stat. 819; amended Pub. L. 115–271, title VIII, § 8203(b)(4)(A), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116–74, § 2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157.) Editorial Notes AMENDMENTS 2019—Pub. L. 116–74, § 2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, § 8203(b)(4)(A). See 2018 Amendment note below. 2018—Pub. L. 115–271, § 8203(b)(4)(A), as amended by Pub. L. 116–74, § 2(c)(1)(A)(ii)(II), substituted ‘‘substance use and misuse’’ for ‘‘substance abuse’’ wherever ap- pearing. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2019 AMENDMENT Amendment by 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. § 1536. Community-based coalition enhancement grants to address local drug crises (a) Definitions In this section: (1) Administrator The term ‘‘Administrator’’ means the Ad- ministrator of the Substance Abuse and Men- tal Health Services Administration. Page 949 TITLE 21—FOOD AND DRUGS § 1536 (2) Director The term ‘‘Director’’ means the Director of the Office of National Drug Control Policy. (3) Drug-Free Communities Act of 1997 The term ‘‘Drug-Free Communities Act of 1997’’ means chapter 2 of the National Nar- cotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.). (4) Eligible entity The term ‘‘eligible entity’’ means an organi- zation that— (A) on or before the date of submitting an application for a grant under this section, receives or has received a grant under the Drug-Free Communities Act of 1997; and (B) has documented, using local data, rates of abuse of opioids or methamphetamines at levels that are— (i) significantly higher than the national average as determined by the Secretary (including appropriate consideration of the results of the Monitoring the Future Sur- vey published by the National Institute on Drug Abuse and the National Survey on Drug Use and Health published by the Sub- stance Abuse and Mental Health Services Administration); or (ii) higher than the national average, as determined by the Secretary (including ap- propriate consideration of the results of the surveys described in clause (i)), over a sustained period of time. (5) Emerging drug abuse issue The term ‘‘emerging drug abuse issue’’ means a substance use disorder within an area involving— (A) a sudden increase in demand for par- ticular drug abuse treatment services rel- ative to previous demand; and (B) a lack of resources in the area to ad- dress the emerging problem. (6) Local drug crisis The term ‘‘local drug crisis’’ means, with re- spect to the area served by an eligible entity— (A) a sudden increase in the abuse of opioids or methamphetamines, as docu- mented by local data; (B) the abuse of prescription medications, specifically opioids or methamphetamines, that is significantly higher than the na- tional average, over a sustained period of time, as documented by local data; or (C) a sudden increase in opioid-related deaths, as documented by local data. (7) Opioid The term ‘‘opioid’’ means any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addic- tion-forming or addiction-sustaining liability. (b) Program authorized The Director, in coordination with the Admin- istrator, may make grants to eligible entities to implement comprehensive community-wide strategies that address local drug crises and emerging drug abuse issues within the area served by the eligible entity. (c) Application (1) In general An eligible entity seeking a grant under this section shall submit an application to the Di- rector at such time, in such manner, and ac- companied by such information as the Direc- tor may require. (2) Criteria As part of an application for a grant under this section, the Director shall require an eli- gible entity to submit a detailed, comprehen- sive, multisector plan for addressing the local drug crisis or emerging drug abuse issue with- in the area served by the eligible entity. (d) Use of funds An eligible entity shall use a grant received under this section— (1) for programs designed to implement com- prehensive community-wide prevention strate- gies to address the local drug crisis in the area served by the eligible entity, in accordance with the plan submitted under subsection (c)(2); (2) to obtain specialized training and tech- nical assistance from the organization funded under section 4 of Public Law 107–82 (21 U.S.C. 1521 note); and (3) for programs designed to implement com- prehensive community-wide strategies to ad- dress emerging drug abuse issues in the com- munity. (e) Supplement not supplant An eligible entity shall use Federal funds re- ceived under this section only to supplement the funds that would, in the absence of those Fed- eral funds, be made available from other Federal and non-Federal sources for the activities de- scribed in this section, and not to supplant those funds. (f) Evaluation A grant under this section shall be subject to the same evaluation requirements and proce- dures as the evaluation requirements and proce- dures imposed on the recipient of a grant under the Drug-Free Communities Act of 1997, and may also include an evaluation of the effective- ness at reducing abuse of opioids or methamphetamines. (g) Limitation on administrative expenses Not more than 8 percent of the amounts made available to carry out this section for a fiscal year may be used to pay for administrative ex- penses. (h) Delegation authority The Director may enter into an interagency agreement with the Administrator to delegate authority for the execution of grants and for such other activities as may be necessary to carry out this section. (i) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2017 through 2021. (Pub. L. 114–198, title I, § 103, July 22, 2016, 130 Stat. 699.) Page 950 TITLE 21—FOOD AND DRUGS §§ 1541 to 1548 Editorial Notes REFERENCES IN TEXT The Drug-Free Communities Act of 1997, referred to in subsec. (a)(3), is Pub. L. 105–20, June 27, 1997, 111 Stat. 224, section 2(a)(2) of which enacted chapter 2 of the National Narcotics Leadership Act of 1988, which is classified to this subchapter. For complete classifica- tion of the Drug-Free Communities Act of 1997 to the Code, see Short Title of 1997 Amendment note set out under section 1501 of this title and Tables. CODIFICATION Section was enacted as part of the Comprehensive Addiction and Recovery Act of 2016, and not as part of the National Narcotics Leadership Act of 1988 which comprises this chapter. PART B—ADVISORY COMMISSION §§ 1541 to 1548. Repealed. Pub. L. 115–271, title VIII, § 8203(b)(5), Oct. 24, 2018, 132 Stat. 4112; Pub. L. 116–74, § 2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157 Section 1541, Pub. L. 100–690, title I, § 1041, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 231, es- tablished Advisory Commission on Drug-Free Commu- nities. Section 1542, Pub. L. 100–690, title I, § 1042, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 231, re- lated to duties of the Commission. Section 1543, Pub. L. 100–690, title I, § 1043, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 232, re- lated to membership of the Commission. Section 1544, Pub. L. 100–690, title I, § 1044, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 232, re- lated to compensation. Section 1545, Pub. L. 100–690, title I, § 1045, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 233, re- lated to terms of office. Section 1546, Pub. L. 100–690, title I, § 1046, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 233, re- lated to Commission meetings. Section 1547, Pub. L. 100–690, title I, § 1047, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 233, re- lated to Commission staff. Section 1548, Pub. L. 100–690, title I, § 1048, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 234; amended Pub. L. 107–82, § 3, Dec. 14, 2001, 115 Stat. 820, terminated the Commission at the end of fiscal year 2007. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2019 AMENDMENT Amendment by 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 a note under section 1522 of this title. CHAPTER 21—BIOMATERIALS ACCESS ASSURANCE Sec. 1601. Findings. 1602. Definitions. 1603. General requirements; applicability; preemp- tion. 1604. Liability of biomaterials suppliers. 1605. Procedures for dismissal of civil actions against biomaterials suppliers. 1606. Subsequent impleader of dismissed biomate- rials supplier. § 1601. Findings The Congress finds that— (1) each year millions of citizens of the United States depend on the availability of lifesaving or life-enhancing medical devices, many of which are permanently implantable within the human body; (2) a continued supply of raw materials and component parts is necessary for the inven- tion, development, improvement, and mainte- nance of the supply of the devices; (3) most of the medical devices are made with raw materials and component parts that— (A) move in interstate commerce; (B) are not designed or manufactured spe- cifically for use in medical devices; and (C) come in contact with internal human tissue; (4) the raw materials and component parts also are used in a variety of nonmedical prod- ucts; (5) because small quantities of the raw mate- rials and component parts are used for medical devices, sales of raw materials and component parts for medical devices constitute an ex- tremely small portion of the overall market for the raw materials and component parts; (6) under the Federal Food, Drug, and Cos- metic Act (21 U.S.C. 301 et seq.) manufacturers of medical devices are required to demonstrate that the medical devices are safe and effective, including demonstrating that the products are properly designed and have adequate warnings or instructions; (7) notwithstanding the fact that raw mate- rials and component parts suppliers do not de- sign, produce, or test a final medical device, the suppliers have been the subject of actions alleging inadequate— (A) design and testing of medical devices manufactured with materials or parts sup- plied by the suppliers; or (B) warnings related to the use of such medical devices; (8) even though suppliers of raw materials and component parts have very rarely been held liable in such actions, such suppliers have ceased supplying certain raw materials and component parts for use in medical devices for a number of reasons, including concerns about the costs of such litigation; (9) unless alternate sources of supply can be found, the unavailability of raw materials and component parts for medical devices will lead to unavailability of lifesaving and life-enhanc- ing medical devices; (10) because other suppliers of the raw mate- rials and component parts in foreign nations are refusing to sell raw materials or compo- nent parts for use in manufacturing certain medical devices in the United States, the pros- pects for development of new sources of supply for the full range of threatened raw materials and component parts for medical devices are remote; (11) it is unlikely that the small market for such raw materials and component parts in the United States could support the large in- vestment needed to develop new suppliers of such raw materials and component parts; (12) attempts to develop such new suppliers would raise the cost of medical devices; (13) courts that have considered the duties of the suppliers of the raw materials and compo-