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42 U.S.C. § 247d–5a — Repealed. Pub. L. 114–255, div. A, title III, § 3044(b)(1), Dec. 13, 2016, 130 Stat. 1121
Federal law — U.S. Code and appendices · legal_authorities
### Statutory Notes
Section, Pub. L. 110–85, title XI, § 1111, Sept. 27, 2007, 121 Stat. 975, related to identification of clinically susceptible concentrations of antimicrobials. See [section 360a–2 of Title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360a–2&num=0&edition=prelim), Food and Drugs.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d–5a
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Source file: Laws/federal/codes/united-states-code/title-42/section-247d5a-repealed-pub-l-114255-div-a-title-iii-3044-b-1-dec-13-2016-130-stat-1121--3fe754c929.md
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Source location: Title 42, Chapter 6A, § 247d–5a; chapter-6a-public-health-service.md
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### Statutory Notes
Section, Pub. L. 110–85, title XI, § 1111, Sept. 27, 2007, 121 Stat. 975, related to identification of clinically susceptible concentrations of antimicrobials. See [section 360a–2 of Title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360a–2&num=0&edition=prelim), Food and Drugs.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Purpose; identification of criteria**
(1) **Purpose** — The purpose of this section is to clarify the Secretary’s authority to—
(A) efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health, due to, among other things, the constant evolution of microorganisms that leads to the development of resistance to drugs that have been effective in decreasing morbidity and mortality for patients, which warrants unique management of antimicrobial drugs that is inappropriate for most other drugs in order to delay or prevent the development of further resistance to existing therapies;
(B) provide for public notice of the availability of recognized interpretive criteria and interpretive criteria standards; and
(C) clear under [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim), classify under [section 360c(f)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f/2&num=0&edition=prelim), or approve under [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim), antimicrobial susceptibility testing devices utilizing updated, recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria, fungi, or other microorganisms, as applicable, to antimicrobial drugs.
(2) **Identification of criteria** — The Secretary shall identify appropriate susceptibility test interpretive criteria with respect to antimicrobial drugs—
(A) if such criteria are available on the date of approval of the drug under [section 355 of this title](https://uscode.house.gov/view.xhtml?
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360a–2
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Designation of a drug as a breakthrough therapy**
(1) **In general** — The Secretary shall, at the request of the sponsor of a drug, expedite the development and review of such drug if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. (In this section, such a drug is referred to as a “breakthrough therapy”.)
(2) **Request for designation** — The sponsor of a drug may request the Secretary to designate the drug as a breakthrough therapy. A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug 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)].
(3) **Designation**
(A) *In general* — Not later than 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a breakthrough therapy and shall take such actions as are appropriate to expedite the development and review of the application for approval of such drug.
(B) *Actions* — The actions to
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356
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