Proposed Rule2024-21559
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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Published
September 20, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 FDA is proposing this action because the existing regulations have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.
Full Text
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<title>Federal Register, Volume 89 Issue 183 (Friday, September 20, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21559]
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#a6f6c3d4cac3d5d2c788eec9cacacfc8c1d5d1c9d4d2cee6c0c2c7ceced588c1c9d0"><span class="__cf_email__" data-cfemail="5505302739302621347b1d3a39393c3b3226223a27213d153331343d3d267b323a23">[email protected]</span></a>.
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
[[Page 77063]]
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
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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 (<a href="https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra">https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra</a>). 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 (<a href="https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra">https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra</a>). 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,
[[Page 77064]]
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
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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............. .......... .......... .......... .......... .......... ..........
.......... .......... .......... .......... .......... ..........
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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 ..........
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Qualitative.......................
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Transfers:
Federal Annualized Monetized .......... .......... .......... .......... 7 ..........
millions/year. .......... .......... .......... .......... 3 ..........
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From/To........................... From:
To:
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Other Annualized Monetized .......... .......... .......... .......... 7 ..........
millions/year. .......... .......... .......... .......... 3 ..........
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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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[[Page 77065]]
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 <a href="https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria">https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm</a>.)
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
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