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21 U.S.C. § 360bbb — Expanded access to unapproved therapies and diagnostics
Federal law — U.S. Code and appendices · legal_authorities
**(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
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Source file: Laws/federal/codes/united-states-code/title-21/section-360bbb-expanded-access-to-unapproved-therapies-and-diagnostics--1ab8a50b9b.md
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Source location: Title 21, Chapter 9, § 360bbb; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(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 section 355(i) or 360j(g) of this title, describing the use of the investigational drug or investigational device in a single patient or a small group of patients.
**(c) Treatment investigational new drug applications and treatment investigational device exemptions** Upon submission by a sponsor or a physician of a protocol intended to provide widespread access to an investigational drug or investigational device for eligible patients (referred to in this subsection as an “expanded access protocol”), the Secretary shall permit such investigational drug or investigational device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if the Secretary determines that—
(1) under the treatment investigational new drug application or treatment investigational device exemption, the investigational drug or investigational device is intended for use in the diagnosis, monitoring, or treatment of a serious or immediately life-threatening disease or condition;
(2) there is no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat that stage of disease or condition in the population of patients to which the investigational drug or investigational device is intended to be administered;
(3)
(A) the investigational drug or investigational device is under investigation in a controlled clinical trial for the use described in paragraph (1) under an investigational drug application in effect 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 investigational device exemption in effect under [section 360j(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g&num=0&edition=prelim); or
(B) all clinical trials necessary for approval of that use of the investigational drug or investigational device have been completed;
(4) the sponsor of the controlled clinical trials is actively pursuing marketing approval of the investigational drug or investigational device for the use described in paragraph (1) with due diligence;
(5) in the case of an investigational drug or investigational device described in paragraph (3)(A), the provision of the investigational drug or investigational device will not interfere with the enrollment of patients in ongoing clinical investigations under section 355(i) or 360j(g) of this title;
(6) in the case of serious diseases, there is sufficient evidence of safety and effectiveness to support the use described in paragraph (1); and
(7) in the case of immediately life-threatening diseases, the available scientific evidence, taken as a whole, provides a reasonable basis to conclude that the investigational drug or investigational device may be effective for its intended use and would not expose patients to an unreasonable and significant risk of illness or injury.
A protocol submitted under this subsection shall be subject to the provisions of section 355(i) or 360j(g) of this title, including regulations promulgated under section 355(i) or 360j(g) of this title. The Secretary may inform national, State, and local medical associations and societies, voluntary health associations, and other appropriate persons about the availability of an investigational drug or investigational device under expanded access protocols submitted under this subsection. The information provided by the Secretary, in accordance with the preceding sentence, shall be the same type of information that is required by [section 282(i)(3) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section282/i/3&num=0&edition=prelim).
**(d) Termination** The Secretary may, at any time, with respect to a sponsor, physician, manufacturer, or distributor described in this section, terminate expanded access provided under this section for an investigational drug or investigational device if the requirements under this section are no longer met.
**(e) Definitions** In this section, the terms “investigational drug”, “investigational device”, “treatment investigational new drug application”, and “treatment investigational device exemption” shall have the meanings given the terms in regulations prescribed by the Secretary.
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Relation to Public Health Service** The National Institutes of Health is an agency of the Service.
**(b) National research institutes and national centers** The following agencies of the National Institutes of Health are national research institutes or national centers:
(1) The National Cancer Institute.
(2) The National Heart, Lung, and Blood Institute.
(3) The National Institute of Diabetes and Digestive and Kidney Diseases.
(4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases.
(5) The National Institute on Aging.
(6) The National Institute of Allergy and Infectious Diseases.
(7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.
(8) The National Institute of Dental and Craniofacial Research.
(9) The National Eye Institute.
(10) The National Institute of Neurological Disorders and Stroke.
(11) The National Institute on Deafness and Other Communication Disorders.
(12) The National Institute on Alcohol Abuse and Alcoholism.
(13) The National Institute on Drug Abuse.
(14) The National Institute of Mental Health.
(15) The National Institute of General Medical Sciences.
(16) The National Institute of Environmental Health Sciences.
(17) The National Institute of Nursing Research.
(18) The National Institute of Biomedical Imaging and Bioengineering.
(19) The National Human Genome Research Institute.
(20) The National Library of Medicine.
(21) The National Center for Advancing Translational Sciences.
(22) The John E. Fogarty International Center for Advanced Study in the Health Sciences.
(23) The National Center for Complementary and Integrative Health.
(24) The National Institute on Minority Health and Health Disparities.
(25) Any other national center that, as an agency separate from
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 281
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Federal law — U.S. Code and appendices · legal_authorities
**(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
**(a) Submission of proposed strategy**
(1) **Initial approval** — If the Secretary, in consultation with the office responsible for reviewing the drug and the office responsible for postapproval safety with respect to the drug, determines that a risk evaluation and mitigation strategy is necessary to ensure that the benefits of the drug outweigh the risks of the drug, and informs the person who submits such application of such determination, then such person shall submit to the Secretary as part of such application a proposed risk evaluation and mitigation strategy. In making such a determination, the Secretary shall consider the following factors:
(A) The estimated size of the population likely to use the drug involved.
(B) The seriousness of the disease or condition that is to be treated with the drug.
(C) The expected benefit of the drug with respect to such disease or condition.
(D) The expected or actual duration of treatment with the drug.
(E) The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug.
(F) Whether the drug is a new molecular entity.
(2) **Postapproval requirement**
(A) *In general* — If the Secretary has approved a covered application (including an application approved before the effective date of this section) and did not when approving the application require a risk evaluation and mitigation strategy under paragraph (1), the Secretary, in consultation with the offices described in paragraph (1), may subsequently require such a strategy for the drug involved (including when acting on a supplemental application seeking approval of a new indication for use of the drug) if the Secretary becomes aware of new safet
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355–1
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Federal law — U.S. Code and appendices · legal_authorities
**(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)](htt
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360bbb–0a
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Authority of Secretary** The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in (1) defraying the costs of developing drugs for rare diseases or conditions, including qualified testing expenses, (2) defraying the costs of developing medical devices for rare diseases or conditions, (3) defraying the costs of developing medical foods for rare diseases or conditions, and (4) developing regulatory science pertaining to the chemistry, manufacturing, and controls of individualized medical products to treat individuals with rare diseases or conditions.
**(b) Definitions** For purposes of subsection (a):
(1) The term “qualified testing” means—
(A) human clinical testing—
(i) which is carried out under an exemption for a drug for a rare disease or condition 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 regulations issued under such section); and
(ii) which occurs before the date on which an application with respect to such drug is submitted under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim);
(B) preclinical testing involving a drug for a rare disease or condition which occurs after the date such drug is designated under [section 360bb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim) and before the date on which an application with respect to such drug is submitted under [section 355(b) of this title](ht
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360ee
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Federal law — U.S. Code and appendices · legal_authorities
**(a) General rule** Any requirement authorized by or under section 351, 352, 360, or 360i of this title applicable to a device intended for human use shall apply to such device until the applicability of the requirement to the device has been changed by action taken under section 360c, 360d, or 360e of this title or under subsection (g) of this section, and any requirement established by or under section 351, 352, 360, or 360i of this title which is inconsistent with a requirement imposed on such device under section 360d or 360e of this title or under subsection (g) of this section shall not apply to such device.
**(b) Custom devices**
(1) **In general** — The requirements of sections 360d and 360e of this title shall not apply to a device that—
(A) is created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing);
(B) in order to comply with an order described in subparagraph (A), necessarily deviates from an otherwise applicable performance standard under [section 360d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360d&num=0&edition=prelim) or requirement under [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim);
(C) is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution;
(D) is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;
(E)
(i) is intended to meet the special need
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360j
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Drugs and biologics**
(1) **In general** — Beginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or subsection (a) or (k) of [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) shall be submitted in such electronic format as specified by the Secretary in such guidance.
(2) **Guidance contents** — In the guidance under paragraph (1), the Secretary may—
(A) provide a timetable for establishment by the Secretary of further standards for electronic submission as required by such paragraph; and
(B) set forth criteria for waivers of and exemptions from the requirements of this subsection.
(3) **Exception** — This subsection shall not apply to submissions described in [section 360bbb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb&num=0&edition=prelim).
**(b) Devices**
(1) **In general** — Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under section 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb–3 of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), and any supplements to such presubmissions or submissions, shall include an electronic copy of such presubmissions or submissions.
(2) **Guidance contents** — In the guidance under paragraph (1), the Secretary may—
(A) provide standards for the
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379k–1
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment** Not later than one year after December 23, 2021, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall establish and implement a Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the Food and Drug Administration, and one or more eligible entities (to be known and referred to in this section as the “Partnership”) through cooperative agreements, contracts, or other appropriate mechanisms with such eligible entities, for the purpose of advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amytrophic lateral sclerosis and other rare neurodegenerative diseases. The Partnership shall—
(1) establish partnerships and consortia with other public and private entities and individuals with expertise in amyotrophic lateral sclerosis and other rare neurodegenerative diseases for the purposes described in this subsection;
(2) focus on advancing regulatory science and scientific research that will support and accelerate the development and review of drugs for patients with amyotrophic lateral sclerosis and other rare neurodegenerative diseases; and
(3) foster the development of effective drugs that improve the lives of people that suffer from amyotrophic lateral sclerosis and other rare neurodegenerative diseases.
**(b) Eligible entity** In this section, the term “eligible entity” means an entity that—
(1) is—
(A) an institution of higher education (as such term is defined in section 1001 11 See References in Text note below. of title 20) or a consortium of such institutions; or
(B) an organization described in [section 501(c)(3) of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title2
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 280g–7b
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Appointment** The National Institutes of Health shall be headed by the Director of NIH who shall be appointed by the President by and with the advice and consent of the Senate. The Director of NIH shall perform functions as provided under subsection (b) and as the Secretary may otherwise prescribe.
**(b) Duties and authority** In carrying out the purposes of [section 241 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section241&num=0&edition=prelim), the Secretary, acting through the Director of NIH—
(1) shall carry out this subchapter, including being responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;
(2) shall coordinate and oversee the operation of the national research institutes, national centers, and administrative entities within the National Institutes of Health;
(3) shall, in consultation with the heads of the national research institutes and national centers, be responsible for program coordination across the national research institutes and national centers, including conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research;
(4) shall assemble accurate data to be used to assess research priorities, including—
(A) information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities; and
(B) data on study populations of clinical research, funded by or conducted at each national research institute and
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 282
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