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21 U.S.C. § 360bbb–4b — Medical countermeasure master files

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21 U.S.C. § 360bbb–4b — Medical countermeasure master files

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Stable record: federal_law:legal_authorities:record_usc_9dd17afcc0b3a80cadda90e3
Source file: Laws/federal/codes/united-states-code/title-21/section-360bbb4b-medical-countermeasure-master-files--dd1c437717.md
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Source location: Title 21, Chapter 9, § 360bbb–4b; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) Applicability of reference** (1) **In general** — A person may submit data and information in a master file to the Secretary with the intent to reference, or to authorize, in writing, another person to reference, such data or information to support a medical countermeasure submission (including a supplement or amendment to any such submission), without requiring the master file holder to disclose the data and information to any such persons authorized to reference the master file. Such data and information shall be available for reference by the master file holder or by a person authorized by the master file holder, in accordance with applicable privacy and confidentiality protocols and regulations. (2) **Reference of certain master files** — In the case that data or information within a medical countermeasure master file is used only to support the conditional approval of an application filed under [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim), such master file may be relied upon to support the effectiveness of a product that is the subject of a subsequent medical countermeasure submission only if such application is supplemented by additional data or information to support review and approval in a manner consistent with the standards applicable to such review and approval for such countermeasure, qualified countermeasure, or qualified pandemic or epidemic product. **(b) Medical countermeasure master file content** (1) **In general** — A master file under this section may include data or information to support— (A) the development of medical countermeasure submissions to support the approval, licensure, classification, clearance, conditional approval, or authorization of one or more security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products; and (B) the manufacture of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products. (2) **Required updates** — The Secretary may require, as appropriate, that the master file holder ensure that the contents of such master file are updated during the time such master file is referenced for a medical countermeasure submission. **(c) Sponsor reference** (1) **In general** — Each incorporation of data or information within a medical countermeasure master file shall describe the incorporated material in a manner in which the Secretary determines appropriate and that permits the review of such information within such master file without necessitating resubmission of such data or information. Master files shall be submitted in an electronic format in accordance with sections 360b(b)(4), 360ccc(a)(4), and 379k–1 of this title, as applicable, and as specified in applicable guidance. (2) **Reference by a master file holder** — A master file holder that is the sponsor of a medical countermeasure submission shall notify the Secretary in writing of the intent to reference the medical countermeasure master file as a part of the submission. (3) **Reference by an authorized person** — A person submitting an application for review may, where the Secretary determines appropriate, incorporate by reference all or part of the contents of a medical countermeasure master file, if the master file holder authorizes the incorporation in writing. **(d) Acknowledgment of and reliance upon a master file by the Secretary** (1) **In general** — The Secretary shall provide the master file holder with a written notification indicating that the Secretary has reviewed and relied upon specified data or information within a master file and the purposes for which such data or information was incorporated by reference if the Secretary has reviewed and relied upon such specified data or information to support the approval, classification, conditional approval, clearance, licensure, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product. The Secretary may rely upon the data and information within the medical countermeasure master file for which such written notification was provided in additional applications, as applicable and appropriate and upon the request of the master file holder so notified in writing or by an authorized person of such holder. (2) **Certain applications** — If the Secretary has reviewed and relied upon specified data or information within a medical countermeasure master file to support the conditional approval of an application under [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim) to subsequently support the approval, clearance, licensure, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product, the Secretary shall provide a brief written description to the master file holder regarding the elements of the application fulfilled by the data or information within the master file and how such data or information contained in such application meets the standards of evidence under subsection (c) or (d) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), subsection (d) of [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&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)] (as applicable), which shall not include any trade secret or confidential commercial information. **(e) Rules of construction** Nothing in this section shall be construed to— (1) limit the authority of the Secretary to approve, license, clear, conditionally approve, or authorize drugs, biological products, or devices pursuant to, as applicable, this Act [this chapter] 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)] (as such applicable Act is in effect on the day before June 24, 2019), including the standards of evidence, and applicable conditions, for approval under the applicable Act; (2) alter the standards of evidence with respect to approval, licensure, or clearance, as applicable, of drugs, biological products, or devices under this Act [this chapter] 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)], including, as applicable, the substantial evidence standards under sections 355(d) and 360b(d) of this title and 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 (3) alter the authority of the Secretary under this Act [this chapter] or 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.] to determine the types of data or information previously submitted by a sponsor or any other person that may be incorporated by reference in an application, request, or notification for a drug, biological product, or device submitted under sections 355(i), 355(b), 355(j), 360b(b)(1), 360b(b)(2), 360b(j), 360bbb–3, 360ccc, 360j(g), 360e(c), 360c(f)(2), or 360(k) of this title, or subsection (a) or (k) of 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)], including a supplement or amendment to any such submission, and the requirements associated with such reference. **(f) Definitions** In this section: (1) The term “master file holder” means a person who submits data and information to the Secretary with the intent to reference or authorize another person to reference such data or information to support a medical countermeasure submission, as described in subsection (a). (2) The term “medical countermeasure submission” means an 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), a new drug 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 an abbreviated new drug application under [section 355(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j&num=0&edition=prelim), a biological product license application under 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 a biosimilar biological product license application under section 351(k) of the Public Health Service Act [[42 U.S.C. 262(k)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/k&num=0&edition=prelim)], a new animal drug application under [section 360b(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/b/1&num=0&edition=prelim) or abbreviated new animal drug application under [section 360b(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/b/2&num=0&edition=prelim), an application for conditional approval of a new animal drug under [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim), an investigational device application under [section 360j(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g&num=0&edition=prelim), an application with respect to a device under [section 360e(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/c&num=0&edition=prelim), a request for classification of a device 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), a notification with respect to a device under [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim), or a request for an emergency use authorization under [section 360bbb–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-3&num=0&edition=prelim) to support— (A) the approval, licensure, classification, clearance, conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product; or (B) a new indication to an approved security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product. (3) The terms “qualified countermeasure”, “security countermeasure”, and “qualified pandemic or epidemic product” have the meanings given such terms in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [[42 U.S.C. 247d–6a](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6a&num=0&edition=prelim), 247d–6b, 247d–6d].

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

21 U.S.C. § 360ccc — Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs

**(a) Application requirements** (1) (A) Except as provided in paragraph (3), any person may file with the Secretary an application for conditional approval of— (i) a new animal drug intended for a minor use or a minor species; or (ii) a new animal drug not intended for a minor use or minor species— (I) that is intended to treat a serious or life-threatening disease or condition or addresses an unmet animal or human health need; and (II) for which the Secretary determines that a demonstration of effectiveness would require a complex or particularly difficult study or studies. (B) The Secretary shall, not later than September 30, 2019, issue guidance or regulations further clarifying the criteria specified in subparagraph (A)(ii). (C) An application under this paragraph shall comply in all respects with the provisions of [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&num=0&edition=prelim) except for subsections (a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), (e), (h), and (n) of such section unless otherwise stated in this section, and any additional provisions of this section. (D) New animal drugs for which conditional approval is sought under this section are subject to the same safety standards that would be applied to new animal drugs under [section 360b(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/d&num=0&edition=prelim) (including, for antimicrobial new animal drugs, with respect to antimicrobial resistance). (2) The applicant shall submit to the Secretary as part of an application for the conditional approval of a new animal drug— (A) all information necessary to meet the requirements of [section 360b(b)(1) o

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

21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

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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. § 360b — New animal drugs

**(a) Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research; import tolerances** (1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for purposes of [section 351(a)(5) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section351/a/5&num=0&edition=prelim) and [section 342(a)(2)(C)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/2/C/ii&num=0&edition=prelim) unless— (A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such approved application; (B) there is in effect a conditional approval of an application filed pursuant to [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such conditionally approved application; (C) there is in effect an index listing pursuant to [section 360ccc–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc-1&num=0&edition=prelim) with respect to such use or intended use of such drug in a minor species, and such drug, its labeling, and such use conform to such index listing; or (D) there is in effect an authorization pursuant to [section 360bbb–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-3&num=0&edition=prelim) with respect to such use or intended use of such drug, and such drug, its labeling, and su

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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. § 247d–6a — Authority for use of certain procedures regarding qualified countermeasure research and development activities

**(a) In general** (1) **Authority** — In conducting and supporting research and development activities regarding countermeasures under [section 247d–6(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6/e&num=0&edition=prelim), the Secretary may conduct and support such activities in accordance with this section and, in consultation with the Director of the National Institutes of Health, as part of the program under [section 285f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section285f&num=0&edition=prelim), if the activities concern qualified countermeasures. (2) **Definitions** — In this section: (A) *Qualified countermeasure* — The term “qualified countermeasure” means a drug (as that term is defined by [section 321(g)(1) of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/g/1&num=0&edition=prelim)), biological product (as that term is defined by [section 262(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/i&num=0&edition=prelim)), or device (as that term is defined by [section 321(h) of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/h&num=0&edition=prelim)), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)— (i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; (ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d–6a

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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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