---
kind: "section"
citation: "21 U.S.C. § 360bbb–4b"
title: "21"
title_heading: "Food and Drugs"
number: "360bbb–4b"
heading: "Medical countermeasure master files"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bbb-4b"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part E — General Provisions Relating to Drugs and Devices"
---

# §360bbb–4b. Medical countermeasure master files

- (a) **Applicability of reference—**
  - (1) **In general—** A [person](/usc/21/321.md?p=e) may submit data and information in a master file to the [Secretary](/usc/21/321.md?p=d) with the intent to reference, or to authorize, in writing, another [person](/usc/21/321.md?p=e) 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](/usc/21/321.md?p=e) [authorized](/usc/21/360eee.md?p=2) to reference the master file. Such data and information shall be available for reference by the master file holder or by a [person](/usc/21/321.md?p=e) [authorized](/usc/21/360eee.md?p=2) 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](/usc/21/360ccc.md), such master file may be relied upon to support the effectiveness of a [product](/usc/21/360eee.md?p=13) 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](/usc/21/360eee.md?p=13).
- (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](/usc/21/360eee.md?p=13); and
    - (B) the manufacture of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic [products](/usc/21/360eee.md?p=13).
  - (2) **Required updates—** The [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=d) 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)](/usc/21/360b.md?p=b-4), [360ccc(a)(4)](/usc/21/360ccc.md?p=a-4), and [379k–1](/usc/21/379k–1.md) 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](/usc/21/360fff.md?p=8) of a medical countermeasure submission shall notify the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=e) submitting an application for review may, where the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=d) shall provide the master file holder with a written notification indicating that the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=d) 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](/usc/21/360eee.md?p=13). The [Secretary](/usc/21/321.md?p=d) 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](/usc/21/360eee.md?p=2) [person](/usc/21/321.md?p=e) of such holder.
  - (2) **Certain applications—** If the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/360ccc.md) to subsequently support the approval, clearance, licensure, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic [product](/usc/21/360eee.md?p=13), the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/355.md), subsection (d) of [section 360b of this title](/usc/21/360b.md), or section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)] (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](/usc/21/321.md?p=d) to approve, license, clear, conditionally approve, or authorize [drugs](/usc/21/321.md?p=g-1), biological [products](/usc/21/360eee.md?p=13), or [devices](/usc/21/321.md?p=h-1) pursuant to, as applicable, this Act [this chapter] or section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)] (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](/usc/21/321.md?p=g-1), biological [products](/usc/21/360eee.md?p=13), or [devices](/usc/21/321.md?p=h-1) under this Act [this chapter] or section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)], including, as applicable, the substantial evidence standards under sections [355(d)](/usc/21/355.md?p=d) and [360b(d)](/usc/21/360b.md?p=d) of this title and section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](/usc/42/262.md?p=a)]; or
  - (3) alter the authority of the [Secretary](/usc/21/321.md?p=d) under this Act [this chapter] or the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.] to determine the types of data or information previously submitted by a [sponsor](/usc/21/360fff.md?p=8) or any other [person](/usc/21/321.md?p=e) that may be incorporated by reference in an application, request, or notification for a [drug](/usc/21/321.md?p=g-1), biological [product](/usc/21/360eee.md?p=13), or [device](/usc/21/321.md?p=h-1) submitted under sections [355(i)](/usc/21/355.md?p=i), [355(b)](/usc/21/355.md?p=b), [355(j)](/usc/21/355.md?p=j), [360b(b)(1)](/usc/21/360b.md?p=b-1), [360b(b)(2)](/usc/21/360b.md?p=b-2), [360b(j)](/usc/21/360b.md?p=j), [360bbb–3](/usc/21/360bbb–3.md), [360ccc](/usc/21/360ccc.md), [360j(g)](/usc/21/360j.md?p=g), [360e(c)](/usc/21/360e.md?p=c), [360c(f)(2)](/usc/21/360c.md?p=f-2), or [360(k)](/usc/21/360.md?p=k) of this title, or subsection [(a)](/usc/21/351.md?p=a) or [(k)](/usc/21/351.md) of section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)], 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](/usc/21/321.md?p=e) who submits data and information to the [Secretary](/usc/21/321.md?p=d) with the intent to reference or authorize another [person](/usc/21/321.md?p=e) to reference such data or information to support a medical countermeasure submission, as described in [subsection (a)](#a).
  - (2) The term “medical countermeasure submission” means an investigational [new drug](/usc/21/321.md?p=p) application under [section 355(i) of this title](/usc/21/355.md?p=i), a [new drug](/usc/21/321.md?p=p) application under [section 355(b) of this title](/usc/21/355.md?p=b), or an abbreviated [new drug](/usc/21/321.md?p=p) application under [section 355(j) of this title](/usc/21/355.md?p=j), a biological [product](/usc/21/360eee.md?p=13) license application under section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](/usc/42/262.md?p=a)] or a biosimilar biological [product](/usc/21/360eee.md?p=13) license application under section 351(k) of the Public Health Service Act [[42 U.S.C. 262(k)](/usc/42/262.md?p=k)], a [new animal drug](/usc/21/321.md?p=v) application under [section 360b(b)(1) of this title](/usc/21/360b.md?p=b-1) or abbreviated [new animal drug](/usc/21/321.md?p=v) application under [section 360b(b)(2) of this title](/usc/21/360b.md?p=b-2), an application for conditional approval of a [new animal drug](/usc/21/321.md?p=v) under [section 360ccc of this title](/usc/21/360ccc.md), an investigational [device](/usc/21/321.md?p=h-1) application under [section 360j(g) of this title](/usc/21/360j.md?p=g), an application with respect to a [device](/usc/21/321.md?p=h-1) under [section 360e(c) of this title](/usc/21/360e.md?p=c), a request for classification of a [device](/usc/21/321.md?p=h-1) under [section 360c(f)(2) of this title](/usc/21/360c.md?p=f-2), a notification with respect to a [device](/usc/21/321.md?p=h-1) under [section 360(k) of this title](/usc/21/360.md?p=k), or a request for an emergency use authorization under [section 360bbb–3 of this title](/usc/21/360bbb–3.md) to support—
    - (A) the approval, licensure, classification, clearance, conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic [product](/usc/21/360eee.md?p=13); or
    - (B) a new indication to an approved security countermeasure, qualified countermeasure, or qualified pandemic or epidemic [product](/usc/21/360eee.md?p=13).
  - (3) The terms “qualified countermeasure”, “security countermeasure”, and “qualified pandemic or epidemic [product](/usc/21/360eee.md?p=13)” 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](/usc/42/247d–6a.md), 247d–6b, 247d–6d].

## Source credit

(June 25, 1938, ch. 675, § 565B, as added Pub. L. 116–22, title VI, § 603(b), June 24, 2019, 133 Stat. 953.)

## Notes

### Editorial Notes

### References in Text

This Act, referred to in subsec. (e), is the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter (§ 301 et seq.). For complete classification of this Act to the Code, see section 301 of this title and Tables.

The Public Health Service Act, referred to in subsec. (e)(3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

### Statutory Notes and Related Subsidiaries

### Medical Countermeasure Master Files

Pub. L. 116–22, title VI, § 603, June 24, 2019, 133 Stat. 953, provided that: In General.—The purpose of this section (including section 565B of the Federal Food, Drug, and Cosmetic Act [this section], as added by subsection (b)) is to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products by facilitating and encouraging submission of data and information to support the development of such products, and through clarifying the authority to cross-reference to data and information previously submitted to the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’), including data and information submitted to medical countermeasure master files or other master files. Medical Countermeasure Master Files.— Stakeholder Input.—Not later than 18 months after the date of enactment of this Act [June 24, 2019], the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Assistant Secretary for Preparedness and Response, shall solicit input from stakeholders, including stakeholders developing security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products, and stakeholders developing technologies to assist in the development of such countermeasures with respect to how the Food and Drug Administration can advance the use of tools and technologies to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products, including through reliance on cross-referenced data and information contained within master files and submissions previously submitted to the Secretary as set forth in section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b). Guidance.—Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall publish draft guidance about how reliance on cross-referenced data and information contained within master files under section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b) or submissions otherwise submitted to the Secretary may be used for specific tools or technologies (including platform technologies) that have the potential to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products. The Secretary, acting through the Commissioner of Food and Drugs, shall publish the final guidance not later than 3 years after the enactment of this Act.”