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, 77062-77065 [2024-21559]
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Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules
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.
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superseded in part by the ‘‘United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outdated, do not reflect current Agency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.
SUMMARY:
ddrumheller on DSK120RN23PROD with PROPOSALS1
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
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19:06 Sep 19, 2024
Jkt 262001
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
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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-201509-18/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
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Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules
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
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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
EC ....................
E.O ...................
FD&C Act .........
GMP .................
MRA .................
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What it means
European Community.
Executive Order.
Federal Food, Drug, and Cosmetic Act.
Good Manufacturing Practice.
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 systemrelated 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/internationalprograms/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
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77063
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/internationalarrangements/mutual-recognitionagreements-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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Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules
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
Units
Category
Benefits:
Annualized Monetized $millions/year ..................
Annualized Quantified ..........................................
Qualitative ............................................................
Primary
estimate
Low
estimate
High
estimate
$0
0
..................
..................
$0
0
..................
..................
$0
0
..................
..................
Period
covered
(years)
2024
2024
..................
..................
7
3
..................
..................
10
10
..................
..................
0
0
0
0
0
0
2024
2024
7
3
10
10
..................
..................
..................
..................
..................
..................
..................
..................
7
3
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
7
3
..................
..................
7
3
..................
..................
Qualitative ............................................................
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Transfers:
Federal Annualized Monetized millions/year .......
From/To ...............................................................
From:
Other Annualized Monetized millions/year ..........
..................
..................
From/To ...............................................................
From:
To:
..................
..................
..................
..................
..................
..................
To:
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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16:22 Sep 19, 2024
Jkt 262001
Notes
Avoid confusion created by outdated
and unnecessary regulations that do
not reflect current Agency practice
Costs:
Annualized Monetized millions/year ....................
Annualized Quantified ..........................................
Year
dollars
Discount
rate
(%)
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20SEP1
Qualified reduction in inspection reports reporting
costs per industry. Affected firms would not
incur costs to develop and
submit inspection reports.
Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules
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/regulatoryimpact-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.
ddrumheller on DSK120RN23PROD with PROPOSALS1
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
VerDate Sep<11>2014
16:22 Sep 19, 2024
Jkt 262001
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.)
77065
FOR FURTHER INFORMATION CONTACT:
Patricia Toppings, 571–372–0485.
SUPPLEMENTARY INFORMATION:
Correction
In proposed rule FR Doc. 2024–19457,
published in the Federal Register on
September 4, 2024 (89 FR 71865) make
the following correction:
On page 71865, in the first column, in
the document heading, the docket
number ‘‘Docket ID: DoD–2021–OS–
0071’’ is corrected to read ‘‘Docket ID:
DoD–2024–OS–0099’’.
Dated: September 17, 2024.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2024–21551 Filed 9–19–24; 8:45 am]
BILLING CODE 6001–FR–P
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
DEPARTMENT OF DEFENSE
32 CFR Part 3
[Docket ID: DoD–2024–OS–0099]
RIN 0790–AK98
Transactions Other Than Contracts,
Grants, or Cooperative Agreements for
Prototype Projects; Correction
Office of the Under Secretary of
Defense for Acquisition and
Sustainment (OUSD(A&S)), Department
of Defense (DoD).
ACTION: Proposed rule; correction.
AGENCY:
On September 4, 2024, the
DoD published a proposed rule titled
Transactions Other Than Contracts,
Grants, or Cooperative Agreements for
Prototype Projects. Subsequent to
publication of the proposed rule, DoD
discovered that the docket identifier in
the published proposed rule was
incorrect. All other information in the
September 4, 2024, remains the same.
DATES: This correction is effective on
September 20, 2024.
PO 00000
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47 CFR Part 64
[WC Docket Nos. 12–375, 23–62; FCC 24–
75; FR ID 237560]
Incarcerated People’s Communication
Services; Implementation of the Martha
Wright-Reed Act; Rates for Interstate
Inmate Calling Services
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
The Federal Communications
Commission (Commission) seeks
additional comment on establishing
permanent rate caps for video
incarcerated people’s communications
services (IPCS) that are just and
reasonable, and will fairly compensate
IPCS providers, including comment on
the video IPCS marketplace and the
types of data needed to support its
efforts to adopt permanent video IPCS
rate caps in the future. It also seeks
comment on the possibly of further
disaggregating the very small jail rate
tier and the types of cost or other data
that would identify any additional
distinctions within this rate tier. The
Commission seeks comment on its
authority to address quality of service
issues raised in this proceeding and
whether it should develop minimum
Federal quality of service standards. It
again seeks comment on whether to
expand the definitions of ‘‘Prison’’ and
‘‘Jail’’ to capture the full universe of
confinement facilities and specifically,
the costs providers incur in providing
service to confinement facilities that are
not correctional institutions. It also
seeks comment on whether to
SUMMARY:
Office of the Secretary
SUMMARY:
FEDERAL COMMUNICATIONS
COMMISSION
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]]>Agencies
[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.
-----------------------------------------------------------------------
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
[[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
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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,
[[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized .......... .......... .......... .......... 7 ..........
millions/year. .......... .......... .......... .......... 3 ..........
-----------------------------------------------------------------------------------------------------------------
From/To........................... From:
To:
-----------------------------------------------------------------------------------------------------------------
Other Annualized Monetized .......... .......... .......... .......... 7 ..........
millions/year. .......... .......... .......... .......... 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.........................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[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 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
