Proposed Rule2022-15109
Revocation of Methods of Analysis Regulation
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 15, 2022
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 Methods of analysis regulation describing an FDA policy to use certain methods of analysis for FDA enforcement programs when the method of analysis is not prescribed in a regulation. FDA is proposing this action because the existing regulation is unnecessary.
Full Text
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<title>Federal Register, Volume 87 Issue 135 (Friday, July 15, 2022)</title>
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[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Proposed Rules]
[Pages 42398-42401]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 2
[Docket No. FDA-2020-N-1383]
Revocation of Methods of Analysis Regulation
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 Methods of analysis regulation describing an
FDA policy to use certain methods of analysis for FDA enforcement
programs when the method of analysis is not prescribed in a regulation.
FDA is proposing this action because the existing regulation is
unnecessary.
DATES: Either electronic or written comments on the proposed rule must
be submitted by September 28, 2022.
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 September 28, 2022. 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-2020-N-1383 for ``Revocation of Methods of Analysis Regulation.''
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
[[Page 42399]]
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: Holli Kubicki, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Drive, Rockville,
MD 20852, 240-402-4557.
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. Background
A. Introduction
B. Need for Regulation
III. Legal Authority
IV. Description of the Proposed Rule
V. Proposed Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. Reference
I. Executive Summary
A. Purpose of the Proposed Rule
This proposed rule would revoke the Methods of analysis regulation,
Sec. 2.19 (21 CFR 2.19), describing an FDA policy to use certain
methods of analysis for FDA enforcement programs when the method of
analysis is not prescribed in a regulation. The regulation is
unnecessary.
B. Summary of the Major Provisions of the Proposed Rule
The proposed rule revokes Sec. 2.19, which states that it is FDA
policy to use the methods of analysis of the Association of Analytical
Chemists (AOAC) International as published in the 1980 edition of
``Official Methods of Analysis of the Association of Analytical
Chemists'' for FDA enforcement programs when the method of analysis is
not prescribed in a regulation.
C. Legal Authority
FDA is taking this action under the general administrative
provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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. Background
A. Introduction
FDA's regulation concerning its policy on methods of analysis in
enforcement programs dates back nearly 50 years (37 FR 16174, Aug. 11,
1972). Early versions of the regulation stated that unless a regulation
prescribed a specific method of analysis, it would be FDA's policy to
use the methods of analysis in the ``latest edition of [the AOAC's]
publication . . . and supplements thereto. . . .'' (see, e.g., 21 CFR
3.89 (1976 ed.). However, in 1982, 1 CFR 51.1 was amended to limit
incorporation by reference of a publication to the edition of the
publication that is approved, and to exclude future amendments or
revisions of the publication.
FDA has revised the methods of analysis regulation several times,
including in 1982 to meet the drafting requirements for incorporation
by reference set forth in 1 CFR part 51, and after to make several
technical amendments to update names and addresses. However, since the
1982 revision, the regulation has referred to the methods of analysis
in the 13th Edition, 1980 of AOAC's publication. FDA is now proposing
to revoke the methods of analysis regulation as specified in this
proposed rule.
B. Need for Regulation
The Agency believes that the regulation is unnecessary as a general
matter. Absent specifying a method of analysis in a regulation, FDA
believes it is more appropriate, flexible, and efficient to identify
the Agency's preferred methods of analysis in documents such as the
Office of Regulatory Affairs Laboratory Procedures Manual, FDA
compliance programs, and other resources.
III. Legal Authority
FDA is issuing this proposed rule under the following provisions of
the FD&C Act: 21 U.S.C. 321, 331, 335, 342, 343, 346a, 348, 351, 352,
355, 360b, 361, 362, 371, 372, 374.
IV. Description of the Proposed Rule
The proposed rule revokes Sec. 2.19, which states that it is FDA
policy to use the methods of analysis of the AOAC International as
published in the 1980 edition of ``Official Methods of Analysis of the
Association of Analytical Chemists'' for FDA enforcement programs when
the method of analysis is not prescribed in a regulation. Repeal of
this regulation would eliminate an unnecessary policy.
FDA is proposing this action because a general reference to the
1980 edition of the ``Official Methods of Analysis of the Association
of Analytical Chemists'' is unnecessary and because newer, updated
methods of analysis may exist. Unless a method of analysis is specified
in regulations, FDA believes it is more appropriate, flexible, and
efficient to identify the Agency's preferred methods of analysis in
documents such as the Office of Regulatory Affairs Laboratory
Procedures Manual and other resources.
FDA is proposing to remove Sec. 2.19 from the regulations.
V. 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.
VI. Economic Analysis of Impacts
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, 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 and 13563 direct us to assess all costs
and benefits 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).
This proposed rule is not a significant regulatory action as defined by
Executive Order 12866.
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 industry, 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 costs and benefits, 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
[[Page 42400]]
one year.'' The current threshold after adjustment for inflation is
$165 million, using the most current (2021) 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 largely maintain their current practices
following the removal of Sec. 2.19 Methods of analysis regulation. FDA
will also maintain its current practices, similarly generating no
quantifiable 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 Discount Period Notes
estimate estimate estimate Year rate covered
dollars (years) (%)
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Benefits:
Annualized................................ $0 $0 $0 2019 7 10 ................................
Monetized $millions/year.................. 0 0 0 2019 3 10 ................................
Annualized................................ .......... .......... .......... .......... .......... .......... ................................
Quantified................................ .......... .......... .......... .......... .......... .......... ................................
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Qualitative............................... There would no longer be any .......... .......... .......... ................................
inefficiencies due to keeping
unnecessary regulations on the
books.
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Costs:
Annualized................................ $0 $0 $0 2019 7 10 ................................
Monetized $millions/year.................. 0 0 0 2019 3 10 ................................
Annualized................................ .......... .......... .......... .......... 7 .......... ................................
Quantified................................ .......... .......... .......... .......... 3 .......... ................................
Qualitative............................... .......... .......... .......... .......... .......... .......... ................................
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Transfers:
Federal Annualized........................ .......... .......... .......... .......... 7 .......... ................................
Monetized $millions/year.................. .......... .......... .......... .......... 3 .......... ................................
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From/To................................... From:
To: ..........
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Other Annualized.......................... .......... .......... .......... .......... 7 .......... ................................
Monetized $millions/year.................. .......... .......... .......... .......... 3 .......... ................................
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From/To................................... From:
To: ..........
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Effects:
State, Local or Tribal Government: None.
Small Business: None.
Wages: None.
Growth: None.
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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 and at <a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm</a>.
VII. 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.
VIII. 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.
IX. 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 this proposed 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.
X. 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 this proposed rule does not contain policies that would
have a substantial direct effect 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.
XI. 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>. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.
[[Page 42401]]
1. FDA/Economics Staff, ``Revocation of Methods of Analysis
Regulation, 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 2
Administrative practice and procedure, Cosmetics, Drugs, Foods.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, FDA
proposes that 21 CFR part 2 be amended as follows:
PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
0
1. The authority citation for part 2 continues to read as follows:
Authority: 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342,
343, 346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42
U.S.C. 7671 et seq.
Sec. 2.19 [Removed]
0
2. Remove Sec. 2.19.
Dated: July 11, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-15109 Filed 7-14-22; 8:45 am]
BILLING CODE 4164-01-P
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