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21 U.S.C. § 360bbb–0a — Investigational drugs for use by eligible patients

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

21 U.S.C. § 360bbb–0a — Investigational drugs for use by eligible patients

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Stable record: federal_law:legal_authorities:record_usc_5df1a43540c6ae74894742cd
Source file: Laws/federal/codes/united-states-code/title-21/section-360bbb0a-investigational-drugs-for-use-by-eligible-patients--6943212300.md
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Source location: Title 21, Chapter 9, § 360bbb–0a; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) Definitions** For purposes of this section— (1) the term “eligible patient” means a patient— (A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations)); (B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who— (i) is in good standing with the physician’s licensing organization or board; and (ii) will not be compensated directly by the manufacturer for so certifying; and (C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent; (2) the term “eligible investigational drug” means an investigational drug (as such term is used in [section 360bbb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb&num=0&edition=prelim))— (A) for which a Phase 1 clinical trial has been completed; (B) that has not been approved or licensed for any use under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)]; (C) (i) for which an application has been filed under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)]; or (ii) that is under investigation in a clinical trial that— (I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)]; and (II) is the subject of an active investigational new drug application under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim) or section 351(a)(3) of the Public Health Service Act [[42 U.S.C. 262(a)(3)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a/3&num=0&edition=prelim)], as applicable; and (D) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim); and (3) the term “phase 1 trial” means a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations). **(b) Exemptions** Eligible investigational drugs provided to eligible patients in compliance with this section are exempt from sections 352(f), 353(b)(4), 355(a), and 355(i) of this title, section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)], and parts 50, 56, and 312 of title 21, Code of Federal Regulations (or any successor regulations), provided that the sponsor of such eligible investigational drug or any person who manufactures, distributes, prescribes, dispenses, introduces or delivers for introduction into interstate commerce, or provides to an eligible patient an eligible investigational drug pursuant to this section is in compliance with the applicable requirements set forth in sections 312.6, 312.7, and 312.8(d)(1) of title 21, Code of Federal Regulations (or any successor regulations) that apply to investigational drugs. **(c) Use of clinical outcomes** (1) **In general** — Notwithstanding any other provision of this chapter, the Public Health Service Act [[42 U.S.C. 201](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section201&num=0&edition=prelim) et seq.], or any other provision of Federal law, the Secretary may not use a clinical outcome associated with the use of an eligible investigational drug pursuant to this section to delay or adversely affect the review or approval of such drug under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)] unless— (A) the Secretary makes a determination, in accordance with paragraph (2), that use of such clinical outcome is critical to determining the safety of the eligible investigational drug; or (B) the sponsor requests use of such outcomes. (2) **Limitation** — If the Secretary makes a determination under paragraph (1)(A), the Secretary shall provide written notice of such determination to the sponsor, including a public health justification for such determination, and such notice shall be made part of the administrative record. Such determination shall not be delegated below the director of the agency center that is charged with the premarket review of the eligible investigational drug. **(d) Reporting** (1) **In general** — The manufacturer or sponsor of an eligible investigational drug shall submit to the Secretary an annual summary of any use of such drug under this section. The summary shall include the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. The Secretary shall specify by regulation the deadline of submission of such annual summary and may amend section 312.33 of title 21, Code of Federal Regulations (or any successor regulations) to require the submission of such annual summary in conjunction with the annual report for an applicable investigational new drug application for such drug. (2) **Posting of information** — The Secretary shall post an annual summary report of the use of this section on the internet website of the Food and Drug Administration, including the number of drugs for which clinical outcomes associated with the use of an eligible investigational drug pursuant to this section was— (A) used in accordance with subsection (c)(1)(A); (B) used in accordance with subsection (c)(1)(B); and (C) not used in the review of an application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)].

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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

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355

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

21 U.S.C. § 360bbb — Expanded access to unapproved therapies and diagnostics

**(a) Emergency situations** The Secretary may, under appropriate conditions determined by the Secretary, authorize the shipment of investigational drugs or investigational devices for the diagnosis, monitoring, or treatment of a serious disease or condition in emergency situations. **(b) Individual patient access to investigational products intended for serious diseases** Any person, acting through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and any manufacturer or distributor may, after complying with the provisions of this subsection, provide to such physician an investigational drug or investigational device for the diagnosis, monitoring, or treatment of a serious disease or condition if— (1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition involved, and that the probable risk to the person from the investigational drug or investigational device is not greater than the probable risk from the disease or condition; (2) the Secretary determines that there is sufficient evidence of safety and effectiveness to support the use of the investigational drug or investigational device in the case described in paragraph (1); (3) the Secretary determines that provision of the investigational drug or investigational device will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval; and (4) the sponsor, or clinical investigator, of the investigational drug or investigational device submits to the Secretary a clinical protocol consistent with the provisions of section 355(i) or 360j(g) of this title, including any regulations promulgated under

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360bbb

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

42 U.S.C. § 201 — Funding

Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.

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

42 U.S.C. § 262 — Regulation of biological products

**(a) Biologics license** (1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless— (A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and (B) each package of the biological product is plainly marked with— (i) the proper name of the biological product contained in the package; (ii) the name, address, and applicable license number of the manufacturer of the biological product; and (iii) the expiration date of the biological product. (2) (A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses. (B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)]. (C) The Secretary shall approve a biologics license application— (i) on the basis of a demonstration that— (I) the biological product that is the subject of the application is safe, pure, and potent; and (II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and (ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). (D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262

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

42 U.S.C. § 18001 — Immediate access to insurance for uninsured individuals with a preexisting condition

**(a) In general** Not later than 90 days after March 23, 2010, the Secretary shall establish a temporary high risk health insurance pool program to provide health insurance coverage for eligible individuals during the period beginning on the date on which such program is established and ending on January 1, 2014. **(b) Administration** (1) **In general** — The Secretary may carry out the program under this section directly or through contracts to eligible entities. (2) **Eligible entities** — To be eligible for a contract under paragraph (1), an entity shall— (A) be a State or nonprofit private entity; (B) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; and (C) agree to utilize contract funding to establish and administer a qualified high risk pool for eligible individuals. (3) **Maintenance of effort** — To be eligible to enter into a contract with the Secretary under this subsection, a State shall agree not to reduce the annual amount the State expended for the operation of one or more State high risk pools during the year preceding the year in which such contract is entered into. **(c) Qualified high risk pool** (1) **In general** — Amounts made available under this section shall be used to establish a qualified high risk pool that meets the requirements of paragraph (2). (2) **Requirements** — A qualified high risk pool meets the requirements of this paragraph if such pool— (A) provides to all eligible individuals health insurance coverage that does not impose any preexisting condition exclusion with respect to such coverage; (B) provides health insurance coverage— (i) in which the issuer’s share of the total allowed costs of benefits provided under such co

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 18001

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

42 U.S.C. § 201 — Definitions

Page 35 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 201 1 See References in Text note below. Sec. 300jj–34. Competitive grants to States and Indian tribes for the development of loan pro- grams to facilitate the widespread adoption of certified EHR technology. 300jj–35. Demonstration program to integrate in- formation technology into clinical education. 300jj–36. Information technology professionals in health care. 300jj–37. General grant and loan provisions. 300jj–38. Authorization for appropriations. PART C—OTHER PROVISIONS 300jj–51. Health information technology enroll- ment standards and protocols. 300jj–52. Information blocking. SUBCHAPTER XXIX—DATA COLLECTION, ANALYSIS, AND QUALITY 300kk. Data collection, analysis, and quality. SUBCHAPTER XXX—COMMUNITY LIVING ASSISTANCE SERVICES AND SUPPORTS 300ll to 300ll–9. Repealed. SUBCHAPTER XXXI—WORLD TRADE CENTER HEALTH PROGRAM PART A—ESTABLISHMENT OF PROGRAM; ADVISORY COMMITTEE 300mm. Establishment of World Trade Center Health Program. 300mm–1. WTC Health Program Scientific/Tech- nical Advisory Committee; WTC Health Program Steering Committees. 300mm–2. Education and outreach. 300mm–3. Uniform data collection and analysis. 300mm–4. Clinical Centers of Excellence and Data Centers. 300mm–5. Definitions. PART B—PROGRAM OF MONITORING, INITIAL HEALTH EVALUATIONS, AND TREATMENT SUBPART 1—WTC RESPONDERS 300mm–21. Identification of WTC responders and provision of WTC-related monitoring services. 300mm–22. Treatment of enrolled WTC responders for WTC-related health conditions. 300mm–23. National arrangement for benefits for el- igible individuals outside New York. SUBPART 2—WTC SURVIVORS 300mm–31. Identification and initial health evalua- tion of screening-eligible and

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 201

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

42 U.S.C. § 262 — Regulation of biological products

Page 456 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 258a § 258a. Transferred Editorial Notes CODIFICATION Section, act July 8, 1947, ch. 210, title II, § 201, 61 Stat. 269, which related to transfer of balances in working capital fund, narcotic hospitals, to surplus fund, was transferred and is set out as a note under section 290aa of this title. §§ 259 to 261a. Repealed. Pub. L. 106–310, div. B, title XXXIV, § 3405(a), Oct. 17, 2000, 114 Stat. 1221, as amended by Pub. L. 114–198, title I, § 110(b), July 22, 2016, 130 Stat. 710 Section 259, acts July 1, 1944, ch. 373, title III, § 343, 58 Stat. 699; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240; Pub. L. 92–293, § 3, May 11, 1972, 86 Stat. 136; Pub. L. 98–473, title II, § 232(b), Oct. 12, 1984, 98 Stat. 2031, related to convict addicts or other persons with drug abuse or drug dependence problems. Section 260, acts July 1, 1944, ch. 373, title III, § 344, 58 Stat. 701; June 25, 1948, ch. 654, § 5, 62 Stat. 1018; July 24, 1956, ch. 676, title III, § 302(b), 70 Stat. 622; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240, re- lated to addicts and persons with drug abuse or drug dependence problems. Section 260a, act July 1, 1944, ch. 373, title III, § 345, as added May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended July 24, 1956, ch. 676, title III, § 302(c), 70 Stat. 622; Pub. L. 91–358, title I, § 155(c)(32), July 29, 1970, 84 Stat. 572, re- lated to admission of addicts committed from District of Columbia. Section 261, acts July 1, 1944, ch. 373, title III, § 346, formerly § 345, 58 Stat. 701; renumbered § 346, May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended Pub. L. 91–513, title I, § 2(a)(2)(A), (5), Oct. 27, 1970, 84 Stat. 1240, relate

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 262

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