Conforming Amendment Regarding the Veterinary Medicine Mobility Act of 2014, 8538-8539 [2024-02322]

Download as PDF 8538 Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Rules and Regulations 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. DEPARTMENT OF JUSTICE FOR FURTHER INFORMATION CONTACT: Conforming Amendment Regarding the Veterinary Medicine Mobility Act of 2014 Stephen DiFranco, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2710. Under the Federal Food, Drug, and Cosmetic Act (section 721(d)(1) (21 U.S.C. 379e(d)(1))), we are giving notice that we have filed a color additive petition (CAP 4C0328), submitted by Exponent, Inc., on behalf of Sensient Colors, LLC., 1150 Connecticut Ave. NW, Suite 1100, Washington, DC 20036. The petition proposes to amend the color additive regulations in § 73.69 (21 CFR 73.69) Listing of Color Additives Exempt from Certification: Butterfly pea flower extract to expand the safe use of butterfly pea flower extract to include ready-to-eat cereals, crackers and snack mixes, and chips at levels consistent with good manufacturing practice. The petitioner claims that this action is categorically excluded under 21 CFR 25.32(k) because the substance is intended to remain in food through ingestion by consumers and is not intended to replace macronutrients in food. In addition, the petitioner states that, to their knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection. SUPPLEMENTARY INFORMATION: Dated: February 5, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–02576 Filed 2–7–24; 8:45 am] lotter on DSK11XQN23PROD with RULES1 BILLING CODE 4164–01–P Drug Enforcement Administration 21 CFR Part 1301 [Docket No. DEA–1043] RIN 1117–AB82 Drug Enforcement Administration (DEA), Department of Justice. ACTION: Final rule. AGENCY: The Veterinary Medicine Mobility Act of 2014 (VMMA), which became law on August 1, 2014, amended the Controlled Substances Act to address separate registration requirements for veterinarians. The VMMA allows a veterinarian to transport and dispense controlled substances in the usual course of veterinary practice at a site other than the veterinarian’s registered principal place of business or professional practice without obtaining a separate registration, subject to certain limitations. The Drug Enforcement Administration is amending its regulations to codify the VMMA. This rule merely conforms DEA regulations to statutory amendments of the Controlled Substances Act that have already taken effect and makes no substantive change to existing legal requirements. SUMMARY: This final rule is effective on February 8, 2024. FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 776– 3882. DATES: SUPPLEMENTARY INFORMATION: Legal Authority The Drug Enforcement Administration (DEA) implements and enforces the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act, as amended.1 The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. DEA publishes the implementing regulations for these statutes in 21 CFR parts 1300 to 1399. On August 1, 2014, the President signed the Veterinary Medicine Mobility Act of 2014 (VMMA) into law as Public Law 113–143.2 The VMMA amended section 302(e) of the CSA to address separate registration requirements for veterinarians. Specifically, the VMMA redesignated 21 U.S.C. 822(e) as 21 U.S.C. 822(e)(1) and added a new paragraph, 21 U.S.C. 822(e)(2). The newly added 21 U.S.C. 822(e)(2) provides that ‘‘. . . a registrant who is a veterinarian shall not be required to have a separate registration in order to transport and dispense controlled substances in the usual course of veterinary practice at a site other than the registrant’s registered principal place of business or professional practice, so long as the site of transporting and dispensing is located in a State where the veterinarian is licensed to practice veterinary medicine and is not a principal place of business or professional practice.’’ In this final rule, DEA is amending its regulations to conform to the change to the CSA made by the VMMA. Regulatory Analysis Administrative Procedure Act Under the Administrative Procedure Act (APA),3 agencies generally offer interested parties the opportunity to comment on proposed regulations before they become effective. However, an agency may find good cause to exempt a rule from certain provisions of the APA, including those requiring the publication of a prior notice of proposed rulemaking and the opportunity for public comment, if such actions are determined to be unnecessary, impracticable, or contrary to the public interest. DEA finds there is good cause within the meaning of the APA to issue this amendment as a final rule without opportunity for public comment and with an immediate effective date because such comment is unnecessary. This final rule amends DEA regulations simply to incorporate the provisions of the VMMA. The legal requirements articulated in this final rule are already in effect by virtue of the VMMA. This rule merely incorporates the statutory provision into DEA regulations. DEA is publishing this as a final rule because notice of proposed rulemaking and solicitation of public comment is 2 Public 1 21 VerDate Sep<11>2014 16:18 Feb 07, 2024 Jkt 262001 PO 00000 U.S.C. 801–971. Frm 00014 Fmt 4700 35 Sfmt 4700 Law 113–143, 128 Stat. 1750 (2014). U.S.C. 553. E:\FR\FM\08FER1.SGM 08FER1 Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Rules and Regulations unnecessary.4 Because the statutory change at issue has been in effect since August 1, 2014, DEA finds good cause exists to make this rule effective immediately upon publication.5 Therefore, DEA is issuing this amendment as a final rule, effective upon publication in the Federal Register. Executive Orders 12866, 13563, and 14094 (Regulatory Review) DEA has determined that this rulemaking is not a ‘‘significant regulatory action’’ under section 3(f) of Executive Order 12866, Regulatory Planning and Review. Accordingly, this final rule has not been submitted to the Office of Management and Budget (‘‘OMB’’) for review. This final rule has been drafted and reviewed in accordance with Executive Order 12866, ‘‘Regulatory Planning and Review,’’ section 1(b), Principles of Regulation; Executive Order 13563, ‘‘Improving Regulation and Regulatory Review,’’ section 1(b), General Principles of Regulation; and Executive Order 14094, ‘‘Modernizing Regulatory Review.’’ As stated above, this final rule amends DEA regulations only to the extent necessary to be consistent with current Federal law, as modified by the VMMA. DEA has no discretion with respect to this amendment. The legal requirements in this final rule have been in effect since 2014, when the VMMA became law. DEA anticipates all affected persons are operating in accordance with the VMMA and this codification will have no economic impact. Executive Order 12988, Civil Justice Reform This final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden. lotter on DSK11XQN23PROD with RULES1 Executive Order 13132, Federalism This final rule does not have federalism implications warranting the application of E.O. 13132. The final rule does not have substantial direct effects on the States, on the relationship between the National Government and 4 See 5 U.S.C. 553(b)(B) (relating to notice and comment procedures). ‘‘[W]hen regulations merely restate the statute they implement, notice-andcomment procedures are unnecessary.’’ Gray Panthers Advocacy Comm. v. Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 1991); see also Komjathy v. Nat’l Transp. Safety Bd., 832 F.2d 1294, 1296 (D.C. Cir. 1987) (per curiam) (notice-and-comment procedures are not required when a rule ‘‘does no more than repeat, virtually verbatim, the statutory grant of authority’’). 5 See 5 U.S.C. 553(d). VerDate Sep<11>2014 16:18 Feb 07, 2024 Jkt 262001 the States, or on the distribution of power and responsibilities among the various levels of government. Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This final rule does not have tribal implications warranting the application of E.O. 13175. It does not 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. Regulatory Flexibility Act The Regulatory Flexibility Act (RFA) (5 U.S.C. 601–612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As explained above, DEA determined that there is good cause to exempt this final rule from notice and comment. Consequently, the RFA does not apply to this final rule. In any event, as explained above, this rule is a conforming amendment that makes no change in the status quo. 8539 original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register. Scott Brinks, Federal Register Liaison Officer, Drug Enforcement Administration. List of Subjects 21 CFR Part 1301 Administrative practice and procedure, Drug traffic control, Exports, Imports, Security measures. For the reasons stated above, 21 CFR part 1301 is amended as follows: PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES Unfunded Mandates Reform Act of 1995 In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined that this action will not result in 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 million or more (adjusted for inflation) in any one year. Therefore, neither a Small Government Agency plan nor any other action is required under UMRA of 1995. Paperwork Reduction Act of 1995 This final rule does not involve a collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501–21. This final rule would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. Congressional Review Act This is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General. 1. The authority citation for part 1301 continues to read as follows: ■ Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965 unless otherwise noted. 2. In § 1301.12, add paragraph (c) to read as follows: ■ § 1301.12 Separate registrations for separate locations * * * * * (c) As provided in 21 U.S.C. 822(e)(2), a registrant who is a veterinarian may transport and dispense controlled substances in the usual course of veterinary practice at a site other than the registrant’s registered principal place of business or professional practice without obtaining a separate registration so long as the site of transporting and dispensing is located in a State where the veterinarian is licensed to practice veterinary medicine and is not a principal place of business or professional practice. [FR Doc. 2024–02322 Filed 2–7–24; 8:45 am] BILLING CODE 4410–09–P Signing Authority This document of the Drug Enforcement Administration was signed on January 29, 2024, by Administrator Anne Milgram. That document with the PO 00000 Frm 00015 Fmt 4700 Sfmt 9990 E:\FR\FM\08FER1.SGM 08FER1

Agencies

[Federal Register Volume 89, Number 27 (Thursday, February 8, 2024)]
[Rules and Regulations]
[Pages 8538-8539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02322]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

[Docket No. DEA-1043]
RIN 1117-AB82


Conforming Amendment Regarding the Veterinary Medicine Mobility 
Act of 2014

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Veterinary Medicine Mobility Act of 2014 (VMMA), which 
became law on August 1, 2014, amended the Controlled Substances Act to 
address separate registration requirements for veterinarians. The VMMA 
allows a veterinarian to transport and dispense controlled substances 
in the usual course of veterinary practice at a site other than the 
veterinarian's registered principal place of business or professional 
practice without obtaining a separate registration, subject to certain 
limitations. The Drug Enforcement Administration is amending its 
regulations to codify the VMMA. This rule merely conforms DEA 
regulations to statutory amendments of the Controlled Substances Act 
that have already taken effect and makes no substantive change to 
existing legal requirements.

DATES: This final rule is effective on February 8, 2024.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION:

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
the Comprehensive Drug Abuse Prevention and Control Act of 1970, often 
referred to as the Controlled Substances Act (CSA) and the Controlled 
Substances Import and Export Act, as amended.\1\ The CSA and its 
implementing regulations are designed to prevent, detect, and eliminate 
the diversion of controlled substances and listed chemicals into the 
illicit market while providing for the legitimate medical, scientific, 
research, and industrial needs of the United States. DEA publishes the 
implementing regulations for these statutes in 21 CFR parts 1300 to 
1399.
---------------------------------------------------------------------------

    \1\ 21 U.S.C. 801-971.
---------------------------------------------------------------------------

    On August 1, 2014, the President signed the Veterinary Medicine 
Mobility Act of 2014 (VMMA) into law as Public Law 113-143.\2\ The VMMA 
amended section 302(e) of the CSA to address separate registration 
requirements for veterinarians. Specifically, the VMMA redesignated 21 
U.S.C. 822(e) as 21 U.S.C. 822(e)(1) and added a new paragraph, 21 
U.S.C. 822(e)(2). The newly added 21 U.S.C. 822(e)(2) provides that ``. 
. . a registrant who is a veterinarian shall not be required to have a 
separate registration in order to transport and dispense controlled 
substances in the usual course of veterinary practice at a site other 
than the registrant's registered principal place of business or 
professional practice, so long as the site of transporting and 
dispensing is located in a State where the veterinarian is licensed to 
practice veterinary medicine and is not a principal place of business 
or professional practice.'' In this final rule, DEA is amending its 
regulations to conform to the change to the CSA made by the VMMA.
---------------------------------------------------------------------------

    \2\ Public Law 113-143, 128 Stat. 1750 (2014).
---------------------------------------------------------------------------

Regulatory Analysis

Administrative Procedure Act

    Under the Administrative Procedure Act (APA),\3\ agencies generally 
offer interested parties the opportunity to comment on proposed 
regulations before they become effective. However, an agency may find 
good cause to exempt a rule from certain provisions of the APA, 
including those requiring the publication of a prior notice of proposed 
rulemaking and the opportunity for public comment, if such actions are 
determined to be unnecessary, impracticable, or contrary to the public 
interest. DEA finds there is good cause within the meaning of the APA 
to issue this amendment as a final rule without opportunity for public 
comment and with an immediate effective date because such comment is 
unnecessary.
---------------------------------------------------------------------------

    \3\ 5 U.S.C. 553.
---------------------------------------------------------------------------

    This final rule amends DEA regulations simply to incorporate the 
provisions of the VMMA. The legal requirements articulated in this 
final rule are already in effect by virtue of the VMMA. This rule 
merely incorporates the statutory provision into DEA regulations.
    DEA is publishing this as a final rule because notice of proposed 
rulemaking and solicitation of public comment is

[[Page 8539]]

unnecessary.\4\ Because the statutory change at issue has been in 
effect since August 1, 2014, DEA finds good cause exists to make this 
rule effective immediately upon publication.\5\ Therefore, DEA is 
issuing this amendment as a final rule, effective upon publication in 
the Federal Register.
---------------------------------------------------------------------------

    \4\ See 5 U.S.C. 553(b)(B) (relating to notice and comment 
procedures). ``[W]hen regulations merely restate the statute they 
implement, notice-and-comment procedures are unnecessary.'' Gray 
Panthers Advocacy Comm. v. Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 
1991); see also Komjathy v. Nat'l Transp. Safety Bd., 832 F.2d 1294, 
1296 (D.C. Cir. 1987) (per curiam) (notice-and-comment procedures 
are not required when a rule ``does no more than repeat, virtually 
verbatim, the statutory grant of authority'').
    \5\ See 5 U.S.C. 553(d).
---------------------------------------------------------------------------

Executive Orders 12866, 13563, and 14094 (Regulatory Review)

    DEA has determined that this rulemaking is not a ``significant 
regulatory action'' under section 3(f) of Executive Order 12866, 
Regulatory Planning and Review. Accordingly, this final rule has not 
been submitted to the Office of Management and Budget (``OMB'') for 
review. This final rule has been drafted and reviewed in accordance 
with Executive Order 12866, ``Regulatory Planning and Review,'' section 
1(b), Principles of Regulation; Executive Order 13563, ``Improving 
Regulation and Regulatory Review,'' section 1(b), General Principles of 
Regulation; and Executive Order 14094, ``Modernizing Regulatory 
Review.''
    As stated above, this final rule amends DEA regulations only to the 
extent necessary to be consistent with current Federal law, as modified 
by the VMMA. DEA has no discretion with respect to this amendment. The 
legal requirements in this final rule have been in effect since 2014, 
when the VMMA became law. DEA anticipates all affected persons are 
operating in accordance with the VMMA and this codification will have 
no economic impact.

Executive Order 12988, Civil Justice Reform

    This final rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to 
eliminate ambiguity, minimize litigation, establish clear legal 
standards, and reduce burden.

Executive Order 13132, Federalism

    This final rule does not have federalism implications warranting 
the application of E.O. 13132. The final rule does not 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.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This final rule does not have tribal implications warranting the 
application of E.O. 13175. It does not 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.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA. As explained above, DEA determined that there is good cause to 
exempt this final rule from notice and comment. Consequently, the RFA 
does not apply to this final rule. In any event, as explained above, 
this rule is a conforming amendment that makes no change in the status 
quo.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined that this action will not 
result in 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 million or more (adjusted for inflation) in any 
one year. Therefore, neither a Small Government Agency plan nor any 
other action is required under UMRA of 1995.

Paperwork Reduction Act of 1995

    This final rule does not involve a collection of information 
requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-21. This 
final rule would not impose recordkeeping or reporting requirements on 
State or local governments, individuals, businesses, or organizations.

Congressional Review Act

    This is not a major rule as defined by the Congressional Review Act 
(CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a 
copy of this final rule to both Houses of Congress and to the 
Comptroller General.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
January 29, 2024, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.

List of Subjects 21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Security measures.

    For the reasons stated above, 21 CFR part 1301 is amended as 
follows:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1301 continues to read as follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.


0
2. In Sec.  1301.12, add paragraph (c) to read as follows:


Sec.  1301.12   Separate registrations for separate locations

* * * * *
    (c) As provided in 21 U.S.C. 822(e)(2), a registrant who is a 
veterinarian may transport and dispense controlled substances in the 
usual course of veterinary practice at a site other than the 
registrant's registered principal place of business or professional 
practice without obtaining a separate registration so long as the site 
of transporting and dispensing is located in a State where the 
veterinarian is licensed to practice veterinary medicine and is not a 
principal place of business or professional practice.

[FR Doc. 2024-02322 Filed 2-7-24; 8:45 am]
BILLING CODE 4410-09-P
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