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

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

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

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Source file: Laws/federal/codes/united-states-code/title-21/section-355f-extension-of-exclusivity-period-for-new-qualified-infectious-disease-pro--6c1fa77202.md
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Source location: Title 21, Chapter 9, § 355f; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(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.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; (3) a product that does not meet the definition of a qualified infectious disease product under subsection (g) based upon its approved uses; or (4) an application pursuant to [section 262(a) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim). **(d) Designation** (1) **In general** — The manufacturer or sponsor of a drug may request the Secretary to designate a drug as a qualified infectious disease product at any time 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) or [section 262(a) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim) for such drug. The Secretary shall, not later than 60 days after the submission of such a request, determine whether the drug is a qualified infectious disease product. (2) **Limitation** — Except as provided in paragraph (3), a designation under this subsection shall not be withdrawn for any reason, including modifications to the list of qualifying pathogens under subsection (f)(2)(C). (3) **Revocation of designation** — The Secretary may revoke a designation of a drug as a qualified infectious disease product if the Secretary finds that the request for such designation contained an untrue statement of material fact. **(e) Regulations** (1) **In general** — Not later than 2 years after July 9, 2012, the Secretary shall adopt final regulations implementing this section, including developing the list of qualifying pathogens described in subsection (f). (2) **Procedure** — In promulgating a regulation implementing this section, the Secretary shall— (A) issue a notice of proposed rulemaking that includes the proposed regulation; (B) provide a period of not less than 60 days for comments on the proposed regulation; and (C) publish the final regulation not less than 30 days before the effective date of the regulation. (3) **Restrictions** — Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this section only as described in paragraph (2), except that the Secretary may issue interim guidance for sponsors seeking designation under subsection (d) prior to the promulgation of such regulations. (4) **Designation prior to regulations** — The Secretary shall designate drugs as qualified infectious disease products under subsection (d) prior to the promulgation of regulations under this subsection, if such drugs meet the definition of a qualified infectious disease product described in subsection (g). **(f) Qualifying pathogen** (1) **Definition** — In this section, the term “qualifying pathogen” means a pathogen identified and listed by the Secretary under paragraph (2) that has the potential to pose a serious threat to public health, such as— (A) resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant enterococcus; (B) multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species; (C) multi-drug resistant tuberculosis; and (D) Clostridium difficile. (2) **List of qualifying pathogens** (A) *In general* — The Secretary shall establish and maintain a list of qualifying pathogens, and shall make public the methodology for developing such list. (B) *Considerations* — In establishing and maintaining the list of pathogens described under this section, the Secretary shall— (i) consider— (I) the impact on the public health due to drug-resistant organisms in humans; (II) the rate of growth of drug-resistant organisms in humans; (III) the increase in resistance rates in humans; and (IV) the morbidity and mortality in humans; and (ii) consult with experts in infectious diseases and antibiotic resistance, including the Centers for Disease Control and Prevention, the Food and Drug Administration, medical professionals, and the clinical research community. (C) *Review* — Every 5 years, or more often as needed, the Secretary shall review, provide modifications to, and publish the list of qualifying pathogens under subparagraph (A) and shall by regulation revise the list as necessary, in accordance with subsection (e). **(g) Qualified infectious disease product** The term “qualified infectious disease product” means a drug (including a biological product), including an antibacterial or antifungal drug, for human use that— (1) acts on bacteria or fungi or on substances produced by such bacteria or fungi; and (2) is intended to treat a serious or life-threatening infection, including such an infection caused by— (A) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or (B) qualifying pathogens listed by the Secretary under subsection (f).

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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

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. § 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](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

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

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

21 U.S.C. § 360a–1 — Clinical trials

**(a) Review and revision of guidance documents** (1) **In general** — The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall review and, as appropriate, revise not fewer than 3 guidance documents per year, which shall include— (A) reviewing the guidance documents of the Food and Drug Administration for the conduct of clinical trials with respect to antibacterial and antifungal drugs; and (B) as appropriate, revising such guidance documents to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of antibacterial and antifungal drugs under chapter V of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 351](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section351&num=0&edition=prelim) et seq.). (2) **Issues for review** — At a minimum, the review under paragraph (1) shall address the appropriate animal models of infection, in vitro techniques, valid microbiological surrogate markers, the use of noninferiority versus superiority trials, trial enrollment, data requirements, and appropriate delta values for noninferiority trials. (3) **Rule of construction** — Except to the extent to which the Secretary makes revisions under paragraph (1)(B), nothing in this section shall be construed to repeal or otherwise effect the guidance documents of the Food and Drug Administration. **(b) Recommendations for investigations** (1) **Request** — The sponsor of a drug intended to be designated as a qualified infectious disease product may request that the Secretary provide written recommendations for nonclinical and clinical investigations which the Secretary believes may be necessary to be conducted with the drug

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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

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

21 U.S.C. § 355f — Extension of exclusivity period for new

Page 260 TITLE 21—FOOD AND DRUGS § 355d reports, including recommendations therein, regarding the topics addressed in the reports under this section, including with respect to— ‘‘(A) improving public access to information from pediatric studies conducted under such sections 355a and 355c of this title; and ‘‘(B) improving the timeliness of pediatric studies and pediatric study planning under such sections 355a and 355c of this title.’’ Statutory Notes and Related Subsidiaries RULE OF CONSTRUCTION Nothing in amendment by Pub. L. 115–52 to limit the authority of the Secretary of Health and Human Serv- ices to issue written requests under section 355a of this title or section 262(m) of Title 42, The Public Health and Welfare, or to negotiate or implement amendments to such requests proposed by applicants, see section 504(e) of Pub. L. 115–52, set out as a note under section 355c of this title. DEFINITION OF ‘‘SECRETARY’’ The term ‘‘Secretary’’ as used in this section means the Secretary of Health and Human Services, see sec- tion 503 of Pub. L. 112–144, set out as a note under sec- tion 355a of this title. § 355d. Internal committee for review of pedi- atric plans, assessments, deferrals, deferral extensions, and waivers The Secretary shall establish an internal com- mittee within the Food and Drug Administra- tion to carry out the activities as described in sections 355a(f) and 355c(f) of this title. Such in- ternal committee shall include employees of the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharma- cology, statistics, chemistry, legal issues, pedi- atric ethics, neonatology, and the appropriate expertise pertaining to the pediatric product under revi

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