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21 U.S.C. § 360cc — Protection for drugs for rare diseases or conditions

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21 U.S.C. § 360cc — Protection for drugs for rare diseases or conditions

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Source location: Title 21, Chapter 9, § 360cc; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) Exclusive approval, certification, or license** Except as provided in subsection (b), if the Secretary— (1) approves an application filed pursuant to [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or (2) issues a license under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for a drug designated under [section 360bb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim) for a rare disease or condition, the Secretary may not approve another application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or issue another license under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for the same drug for the same disease or condition for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 355(c)(2) 11 See References in Text note below. of this title does not apply to the refusal to approve an application under the preceding sentence. **(b) Exceptions** During the 7-year period described in subsection (a) for an approved application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or license under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if— (1) the Secretary finds, after providing the holder of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or (2) the holder provides the Secretary in writing the consent of such holder for the approval of other applications or the issuance of other licenses before the expiration of such seven-year period. **(c) Condition of clinical superiority** (1) **In general** — If a sponsor of a drug that 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 is otherwise the same, as determined by the Secretary, as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection (a) for the same rare disease or condition as the already approved drug, the Secretary shall require such sponsor, as a condition of such exclusive approval or licensure, to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug. (2) **Definition** — For purposes of paragraph (1), the term “clinically superior” with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care. (3) **Applicability** — This subsection applies to any drug designated under [section 360bb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim) for which an application was approved under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or licensed under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) after August 18, 2017, regardless of the date on which such drug was designated under [section 360bb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim). **(d) Regulations** The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on August 18, 2017, until such time as the Secretary promulgates regulations in accordance with this subsection, the Secretary may apply any definitions set forth in regulations that were promulgated prior to such date, to the extent such definitions are not inconsistent with the terms of this section, as amended by such Act. **(e) Demonstration of clinical superiority standard** To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary— (1) upon the designation of any drug under [section 360bb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim), shall notify the sponsor of such drug in writing of the basis for the designation, including, as applicable, any plausible hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously approved drug; and (2) upon granting exclusive approval or licensure under subsection (a) on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary of the clinical superiority findings.

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

21 U.S.C. § 360aa — Recommendations for investigations of drugs for rare diseases or conditions

**(a) Request by sponsor; response by Secretary** The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before— (1) it may be approved for such disease or condition under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or (2) if the drug is a biological product, it may be licensed for such disease or condition under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the non-clinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such drug for such disease or condition under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or licensing of such drug for such disease or condition under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). **(b) Regulations** The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).

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

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

21 U.S.C. § 360bb — Designation of drugs for rare diseases or conditions

**(a) Request by sponsor; preconditions; “rare disease or condition” defined** (1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. A request for designation of a drug shall be made before the submission of an application under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) for the drug, or the submission of an application for licensing of the drug under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and— (A) if an application for such drug is approved under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or (B) if a license for such drug is issued under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), the approval, certification, or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b) 11 See References in Text note below. respecting the designation of the drug. (2) For purposes of paragraph (1), the term “rare disease or condition” means any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,0

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

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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. § 357 — Qualification of drug development tools

**(a) Process for qualification** (1) **In general** — The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which— (A) (i) a requestor initiates such process by submitting a letter of intent to the Secretary; and (ii) the Secretary accepts or declines to accept such letter of intent; (B) (i) if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and (ii) the Secretary accepts or declines to accept the qualification plan; and (C) (i) if the Secretary accepts the qualification plan, the requestor submits to the Secretary a full qualification package; (ii) the Secretary determines whether to accept such qualification package for review; and (iii) if the Secretary accepts such qualification package for review, the Secretary conducts such review in accordance with this section. (2) **Acceptance and review of submissions** (A) *In general* — Subparagraphs (B), (C), and (D) shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full qualification package submitted under paragraph (1) (referred to in this paragraph as “qualification submissions”). (B) *Acceptance factors; nonacceptance* — The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use. (C) *Prioritization of qualification review* — The Secretary may prioritize the review of

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 357

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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

21 U.S.C. § 355a — Pediatric studies of drugs

**(a) Definitions** As used in this section, the term “pediatric studies” or “studies” means at least one clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies. **(b) Market exclusivity for new drugs** (1) **In general** — Except as provided in paragraph (2), if, prior to approval of an application that is submitted under [section 355(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b/1&num=0&edition=prelim), the Secretary determines that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with subsection (d)(4)— (A) (i) (I) the period referred to in subsection (c)(3)(E)(ii) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), and in subsection (j)(5)(F)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively

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

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

21 U.S.C. § 355f — Extension of exclusivity period for new qualified infectious disease products

**(a) Extension** If the Secretary approves an application pursuant to [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) for a drug that has been designated as a qualified infectious disease product under subsection (d), the 4- and 5-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or the 7-year period described in [section 360cc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc&num=0&edition=prelim), as applicable, shall be extended by 5 years. **(b) Relation to pediatric exclusivity** Any extension under subsection (a) of a period shall be in addition to any extension of the period under [section 355a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355a&num=0&edition=prelim) with respect to the drug. **(c) Limitations** Subsection (a) does not apply to the approval of— (1) a supplement to an application under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) for any qualified infectious disease product for which an extension described in subsection (a) is in effect or has expired; (2) a subsequent application filed with respect to a product approved under [section 355 of this title](https://uscode.house

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

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

21 U.S.C. § 360ddd–1 — Regulation of medical gases

**(a) Certification of designated medical gases** (1) **Submission** — Beginning 180 days after July 9, 2012, any person who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce may file with the Secretary a request for certification of a medical gas as a designated medical gas. Any such request shall contain the following information: (A) A description of the medical gas. (B) The name and address of the sponsor. (C) The name and address of the facility or facilities where the medical gas is or will be manufactured. (D) Any other information deemed appropriate by the Secretary to determine whether the medical gas is a designated medical gas. (2) **Grant of certification** — The certification requested under paragraph (1) is deemed to be granted unless, within 60 days of the filing of such request, the Secretary finds that— (A) the medical gas subject to the certification is not a designated medical gas; (B) the request does not contain the information required under paragraph (1) or otherwise lacks sufficient information to permit the Secretary to determine that the medical gas is a designated medical gas; or (C) denying the request is necessary to protect the public health. (3) **Effect of certification** (A) *In general* (i) *Approved uses* — A designated medical gas for which a certification is granted under paragraph (2) is deemed, alone or in combination, as medically appropriate, with another designated medical gas or gases for which a certification or certifications have been granted, to have in effect an approved application under section 355 or 360b of this title, subject to all applicable postapproval requirements, for the following indications for use: (I) In the case

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360ddd–1

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

42 U.S.C. § 284m — Program for pediatric studies of drugs

**(a) List of priority issues in pediatric therapeutics** (1) **In general** — Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop and publish a priority list of needs in pediatric therapeutics, including drugs, biological products, or indications that require study. The list shall be revised every three years. (2) **Consideration of available information** — In developing and prioritizing the list under paragraph (1), the Secretary— (A) shall consider— (i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials; (ii) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, and identification of biomarkers for such diseases, disorders, or conditions, may be beneficial in pediatric populations; and (iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and (B) may consider the availability of qualified countermeasures (as defined in [section 247d–6a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-6a&num=0&edition=prelim)), security countermeasures (as defined in [section 247d–6b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-6b&num=0&edition=prelim)), and qualified pandemic or epidemic products (as defined in [section 247d–6d of this title]

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 284m

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

21 U.S.C. § 360cc — Protection for drugs for rare diseases or

Page 395 TITLE 21—FOOD AND DRUGS § 360cc 1 See References in Text note below. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1985 AMENDMENT Amendment by Pub. L. 99–91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99–91, set out as a note under section 360aa of this title. § 360cc. Protection for drugs for rare diseases or conditions (a) Exclusive approval, certification, or license Except as provided in subsection (b), if the Secretary— (1) approves an application filed pursuant to section 355 of this title, or (2) issues a license under section 262 of title 42 for a drug designated under section 360bb of this title for a rare disease or condition, the Sec- retary may not approve another application under section 355 of this title or issue another li- cense under section 262 of title 42 for the same drug for the same disease or condition for a per- son who is not the holder of such approved appli- cation or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the li- cense. Section 355(c)(2) 1 of this title does not apply to the refusal to approve an application under the preceding sentence. (b) Exceptions During the 7-year period described in sub- section (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an ap- plication or issue a license for a drug that is otherwise the same, as determined by the Sec- retary, as the already approved drug for the same rare disease or condition if— (1) the Secretary finds, after providing the holder of exclusive approval or licensure no- tice and opportunity for the submission of views, that during such period the holder of the excl

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 360cc

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