[Federal Register Volume 89, Number 183 (Friday, September 20, 2024)]
[Proposed Rules]
[Pages 77062-77065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21559]



[[Page 77062]]

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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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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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superseded in part by the ``United States-European Union Amended 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are outdated, do not reflect current Agency practice, and are 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, 
[email protected].

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

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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
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EC..................................  European Community.
E.O.................................  Executive Order.
FD&C Act............................  Federal Food, Drug, and Cosmetic
                                       Act.
GMP.................................  Good Manufacturing Practice.
MRA.................................  Mutual Recognition Agreement.
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III. Background

A. Introduction

    Part 26 was issued in response to the 1998 MRA between the United 
States and the European Community (EC), whereby both parties would 
recognize certain drug and device inspections/evaluation reports of the 
other, in order to more effectively allocate limited inspection 
resources (Mutual Recognition of Pharmaceutical Good Manufacturing 
Practice Inspection Reports, Medical Device Quality System Audit 
Reports, and Certain Medical Device Product Evaluation Reports Between 
the United States and the European Community, 63 FR 60122 at 60141 
(November 6, 1998)). Subparts A and B of part 26 substantially reflect 
the 1998 MRA's pharmaceutical and medical device sectoral annexes, 
respectively. Subpart C of part 26 sets forth the framework provisions 
by which subparts A and B can be implemented. Subpart A governs ``the 
exchange between the parties and normal endorsement by the receiving 
regulatory authority of official [pharmaceutical] good manufacturing 
practices (GMP) inspection reports[.]'' (21 CFR 26.2) Subpart B 
specifies ``the conditions under which a party will accept the results 
of quality system-related evaluations and inspections and premarket 
evaluations of the other party with regard to medical devices as 
conducted by listed conformity assessment bodies (CAB's) and to provide 
for other related cooperative activities.'' (21 CFR 26.31(a))
    The pharmaceutical sectoral annex to the 1998 MRA was superseded by 
the 2017 Amended Pharmaceutical Annex (https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra). The 2017 Amended Pharmaceutical Annex included new 
terms, rendering Subpart A obsolete. The medical device sectoral annex 
was not addressed in the 2017 Amended Pharmaceutical Annex, but since 
the 1998 MRA went into effect, it has never been fully implemented. As 
other mechanisms (e.g., Medical Device Single Audit Program) now exist 
for mutual recognition with Europe with respect to medical device 
inspections, Subpart B is no longer necessary.
    Moreover, we do not believe it is required or would be beneficial 
for us to issue regulations that substantially reflect the 2017 Amended 
Pharmaceutical Annex with the European Union. The 2017 Amended 
Pharmaceutical Annex is in force and has been successfully implemented 
without regulations that substantially reflect it. The same is true for 
the MRAs that FDA entered into subsequently with Switzerland and the 
United Kingdom (https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra). FDA's 
proposed revocation of part 26 should not be interpreted as FDA 
retreating from our commitment to working with our foreign 
counterparts, including through mutual recognition agreements, to 
achieve greater efficiencies and increase our inspectional reach.

B. Need for Regulation

    The Agency believes the regulations in part 26 should be revoked 
because they have been superseded in part by the 2017 Amended 
Pharmaceutical Annex, do not reflect current Agency practice, and are 
unnecessary.

IV. Legal Authority

    We are issuing this proposed rule under the drugs, medical devices, 
and general administrative provisions of the FD&C Act (21 U.S.C. 321, 
331, 351, 352, 355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h, 
360i, 360j, 360l, 360m, 371, 374, 381, 382, 383, 384e, and 393) and 
under certain provisions of the Public Health Service Act (42 U.S.C. 
216, 241, 242l, 262, 264, and 265). Under section 701(a) of the FD&C 
Act (21 U.S.C. 371(a)), FDA has the authority to issue regulations, and 
under section 809 of the FD&C Act (21 U.S.C. 384e), FDA has the 
authority to ``enter into arrangements and agreements with a foreign 
government or an agency of a foreign government to recognize the 
inspection of foreign establishments registered under section 510(i) in 
order to facilitate preapproval or risk-based inspections in accordance 
with the schedule established in paragraph (2) or (3) of section 
510(h)[.]''

V. Description of the Proposed Rule

    The proposed rule revokes part 26, which substantially reflects a 
1998 agreement between the United States and the EC created to better 
utilize the inspectional resources of each signatory by recognizing one 
another's inspection reports. Revocation would eliminate regulations 
that have been superseded in part by the 2017 Amended Pharmaceutical 
Annex, do not reflect current Agency practice, and are unnecessary.
    FDA is proposing this action because the pharmaceutical sectoral 
annex to the 1998 MRA which subpart A substantially reflects has been 
superseded by the 2017 Amended Pharmaceutical Annex, and the medical 
device sectoral annex to the 1998 MRA,

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which subpart B substantially reflects, was never fully implemented. 
Subpart C contains general provisions applicable to both subparts A and 
B that will be unnecessary once subparts A and B are revoked.

VI. Proposed Effective Date

    FDA is proposing that any final rule based on this proposed rule 
become effective 30 days after the date of its publication in the 
Federal Register.

VII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14904, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4).
    Executive Orders 12866, 13563, and 14094 direct us to assess all 
benefits, costs, and transfers of available regulatory alternatives 
and, when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). Rules are ``significant'' under Executive Order 12866 
section 3(f)(1) (as amended by Executive Order 14094) if they ``have an 
annual effect on the economy of $200 million or more (adjusted every 3 
years by the Administrator [of the Office of Information and Regulatory 
Affairs (OIRA)] for changes in gross domestic product); or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, territorial, or tribal governments or 
communities.'' OIRA has determined that this proposed rule is not a 
significant regulatory action under Executive Order 12866 section 
3(f)(1).
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this proposed rule does not add any new regulatory 
burden on the pharmaceutical or medical device industries, we propose 
to certify that the proposed rule will not have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated impacts, before proposing ``any rule that includes any 
Federal mandate that may result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $183 
million, using the most current (2023) Implicit Price Deflator for the 
Gross Domestic Product. This proposed rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    We believe industry will maintain their current practices following 
the removal of part 26. FDA will also maintain its current practices, 
similarly generating no quantifiable costs or cost savings. Therefore, 
we expect this proposed rule to be cost neutral. Table 1 summarizes the 
estimated benefits and costs of the proposed rule, if finalized.

                                     Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
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                                                                                           Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate (%)     (years)
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Benefits:
    Annualized Monetized $millions/             $0          $0          $0        2024           7          10
     year.                                       0           0           0        2024           3          10
    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
                                        ..........  ..........  ..........  ..........  ..........  ..........
                                       -----------------------------------------------------------------------------------------------------------------
    Qualitative.......................  Avoid confusion created by
                                        outdated and unnecessary
                                        regulations that do not reflect
                                        current Agency practice
 
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Costs:
    Annualized Monetized millions/year           0           0           0        2024           7          10  Qualified reduction in inspection
                                                 0           0           0        2024           3          10   reports reporting costs per industry.
                                                                                                                 Affected firms would not incur costs to
                                                                                                                 develop and submit inspection reports.
    Annualized Quantified.............  ..........  ..........  ..........  ..........           7  ..........
                                        ..........  ..........  ..........  ..........           3  ..........
                                       -----------------------------------------------------------------------------------------------------------------
    Qualitative.......................
 
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Transfers:
    Federal Annualized Monetized        ..........  ..........  ..........  ..........           7  ..........
     millions/year.                     ..........  ..........  ..........  ..........           3  ..........
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized          ..........  ..........  ..........  ..........           7  ..........
     millions/year.                     ..........  ..........  ..........  ..........           3  ..........
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
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Effects:
    State, Local or Tribal Government: No estimated effect..............................................................................................
    Small Business: No estimated effect.................................................................................................................
    Wages: No estimated effect..........................................................................................................................
    Growth: No estimated effect.........................................................................................................................
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    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
preliminary analysis of economic impacts is available in the docket for 
this proposed rule (Ref. 1) and at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have 
substantial direct effects on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. The Agency solicits comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

XII. Reference

    The following reference is on display at the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m. Monday through Friday; it is also 
available electronically at https://www.regulations.gov. Although FDA 
verified the website addresses in this document, please note that 
websites are subject to change over time.

1. FDA/Economics Staff, ``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 Preliminary Regulatory Impact Analysis, 
Preliminary Regulatory Flexibility Analysis, Unfunded Mandates 
Reform Act Analysis,'' 2020. (Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.)

List of Subjects in 21 CFR Part 26

    Animal, Animal drugs, Biologics, Drugs, Exports, Imports.

    For reasons stated in the preamble, and under the authority of 21 
U.S.C. 393 and delegated to the Commissioner of Food and Drugs, FDA 
proposes to remove 21 CFR part 26.

    Dated: September 12, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-21559 Filed 9-19-24; 8:45 am]
BILLING CODE 4164-01-P