§360bbb–4b — Title 21 Food and Drugs | U.S. Code

Summary

Lets people send a "master file" of data to the Secretary so others can rely on it in their medical countermeasure applications without getting the file's raw data. The person who sends the file (the master file holder) can give written permission for another person to reference the file. The holder or people the holder authorizes can access the file under privacy and confidentiality rules. If the file was only used to get a conditional approval, it can only help a later full approval if extra data are added so the product meets the normal approval standards. A master file can include information for developing or making security, qualified, or pandemic/epidemic countermeasures. The Secretary can require the holder to keep the file updated while others use it. Files must be submitted electronically in the formats required by the agency. Each time someone incorporates a part of a master file, the included material must be described so the Secretary can review it without asking for the raw data again. A sponsor who will reference a master file must tell the Secretary in writing. An applicant can incorporate master file material by reference only if the holder gives written authorization. When the Secretary uses specific master file data to support approval, licensing, clearance, conditional approval, or authorization, the Secretary must give the holder a written notice saying which data were relied on and for what purpose. The Secretary may then use that same master file data in other applications if the holder asks. If master file data used for a conditional approval later help a full approval, the Secretary must send the holder a short written explanation of what parts of the approval were met by the master file data, without including trade secrets or confidential business information. Nothing here changes the Secretary’s existing authority or the legal evidence standards for approvals (including rules in effect the day before June 24, 2019). Definitions in one line each: “master file holder” — the person who submits the master file; “medical countermeasure submission” — an application or request to approve or authorize drugs, biologics, or devices for countermeasures; the terms “qualified countermeasure,” “security countermeasure,” and “qualified pandemic or epidemic product” — have the meanings given in other public health laws.

Title 21, §360bbb–4b

Food and Drugs — Source: USLM XML via OLRC

(a)(1)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)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, 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)(1)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)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)(1)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 section 360b(b)(4), 360ccc(a)(4), and 379k–1 of this title, as applicable, and as specified in applicable guidance.

(2)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)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)(1)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)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 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, subsection (d) of section 360b of this title, or section 351 of the Public Health Service Act [42 U.S.C. 262] (as applicable), which shall not include any trade secret or confidential commercial information.

(e)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] (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], including, as applicable, the substantial evidence standards under section 355(d) and 360b(d) of this title and section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]; or

(3)alter the authority of the Secretary under this Act [this chapter] or the Public Health Service Act [42 U.S.C. 201 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 section 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], including a supplement or amendment to any such submission, and the requirements associated with such reference.

(f)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, a new drug application under section 355(b) of this title, or an abbreviated new drug application under section 355(j) of this title, a biological product license application under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] or a biosimilar biological product license application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)], a new animal drug application under section 360b(b)(1) of this title or abbreviated new animal drug application under section 360b(b)(2) of this title, an application for conditional approval of a new animal drug under section 360ccc of this title, an investigational device application under section 360j(g) of this title, an application with respect to a device under section 360e(c) of this title, a request for classification of a device under section 360c(f)(2) of this title, a notification with respect to a device under section 360(k) of this title, or a request for an emergency use authorization under section 360bbb–3 of this title 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 section 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [42 U.S.C. 247d–6a, 247d–6b, 247d–6d].

Notes & Related Subsidiaries

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: “(a) 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. “(b) Medical Countermeasure Master Files.— [Enacted this section.] “(c) 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). “(d) 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.”

§360bbb–4b Medical countermeasure master files