[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 [www.gpo.gov]
[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 https://www.regulations.gov 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: 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.
    <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 https://www.regulations.gov 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 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

[[Page 42399]]

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: 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
                                                                                   ------------------------------------
                   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................................  ..........  ..........  ..........  ..........  ..........  ..........  ................................
                                               ------------------------------------
    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...............................  ..........  ..........  ..........  ..........  ..........  ..........  ................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized........................  ..........  ..........  ..........  ..........           7  ..........  ................................
    Monetized $millions/year..................  ..........  ..........  ..........  ..........           3  ..........  ................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
    From/To...................................  From:
                                                To:                                 ..........
                                               ---------------------------------------------------------------------------------------------------------
    Other Annualized..........................  ..........  ..........  ..........  ..........           7  ..........  ................................
    Monetized $millions/year..................  ..........  ..........  ..........  ..........           3  ..........  ................................
                                               ---------------------------------------------------------------------------------------------------------
    From/To...................................  From:
                                                To:                                 ..........
                                               ---------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: None.
    Small Business: None.
    Wages: None.
    Growth: None.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

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 https://www.regulations.gov. 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: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.)

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