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Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community

89 Fed. Reg. 77062 (Sep. 20, 2024)

Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community

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Federal RegisterSep 20, 2024
89 Fed. Reg. 77062 (Sep. 20, 2024)
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  • the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
  • the agency docket number / agency internal file number
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    Department of Health and Human Services Food and Drug Administration
  • 21 CFR Part 26
  • [Docket No. FDA-2024-N-4016]
  • RIN 0910-AI92

    • AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Food and Drug Administration (FDA, Agency, or we) is proposing to revoke the regulations entitled “Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community.” FDA is proposing this action because the existing regulations have been superseded in part by the “United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)” that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.

    DATES:

    Either electronic or written comments on the proposed rule must be submitted by November 19, 2024.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 19, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov .
    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2024-N-4016 for “Revocation of Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov . Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf .

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

    FOR FURTHER INFORMATION CONTACT:

    Perlesta Hollingsworth, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 240-402-5874, Perlesta.Hollingsworth@fdahhs.gov.

    SUPPLEMENTARY INFORMATION:

    Table of Contents

    I. Executive Summary

    A. Purpose of the Proposed Rule

    B. Summary of the Major Provisions of the Proposed Rule

    C. Legal Authority

    D. Costs and Benefits

    II. Table of Abbreviations/Acronyms

    III. Background

    A. Introduction

    B. Need for Regulation

    IV. Legal Authority

    V. Description of the Proposed Rule

    VI. Proposed Effective Date

    VII. Preliminary Economic Analysis of Impacts

    VIII. Analysis of Environmental Impact

    IX. Paperwork Reduction Act of 1995

    X. Federalism

    XI. Consultation and Coordination With Indian Tribal Governments

    XII. References

    I. Executive Summary

    A. Purpose of the Proposed Rule

    FDA proposes to revoke the regulations at part 26 (21 CFR part 26), which substantially reflect certain provisions of the “Agreement on Mutual Recognition Between the United States of America and the European Community” that was signed in 1998 (1998 MRA). These regulations have been superseded in part by the 2017 Amended Pharmaceutical Annex, do not reflect current Agency practice, and are unnecessary.

    B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule would revoke part 26—Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community. This part substantially reflects the 1998 MRA between the United States and the European Community that was created to better utilize the inspectional resources of each signatory by recognizing one another's inspection reports. Part 26 consists of 3 subparts: Subpart A—Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices (which substantially reflects the 1998 MRA's “pharmaceutical sectoral annex”), Subpart B—Specific Sector Provisions for Medical Devices (which substantially reflects the 1998 MRA's “medical device sectoral annex”), and Subpart C—“Framework” Provisions (which substantially reflects the 1998 MRA's “umbrella” agreement that contained general provisions applicable to the operation of all of the sectoral annexes).

    C. Legal Authority

    FDA is taking this action under the general administrative provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). We discuss our legal authority in greater detail in part III.

    D. Costs and Benefits

    Because this proposed rule would not impose any additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.

    II. Table of Abbreviations/Acronyms

    Abbreviation/ acronym What it means
    EC European Community.
    E.O Executive Order.
    FD&C Act Federal Food, Drug, and Cosmetic Act.
    GMP Good Manufacturing Practice.
    MRA Mutual Recognition Agreement.

    Table 1—Summary of Benefits, Costs and Distributional Effects of Proposed Rule

    Category Primary estimate Low estimate High estimate Units Notes
    Year dollars Discount rate (%) Period covered (years)
    Benefits:
    Annualized Monetized $millions/year $0 0 $0 0 $0 0 2024 2024 7 3 10 10
    Annualized Quantified
    Qualitative Avoid confusion created by outdated and unnecessary regulations that do not reflect current Agency practice  
    Costs:
    Annualized Monetized millions/year 0 0 0 0 0 0 2024 2024 7 3 10 10 Qualified reduction in inspection reports reporting costs per industry. Affected firms would not incur costs to develop and submit inspection reports.
    Annualized Quantified 7 3
    Qualitative    
    Transfers:
    Federal Annualized Monetized millions/year 7 3
    From/To From: To:
    Other Annualized Monetized millions/year 7 3
    From/To From: To:
    Effects:
    State, Local or Tribal Government: No estimated effect. Small Business: No estimated effect. Wages: No estimated effect. Growth: No estimated effect.