8538 Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Rules and Regulations 

1 21 U.S.C. 801–971. 

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

3 5 U.S.C. 553. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Stephen DiFranco, Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2710. 

SUPPLEMENTARY INFORMATION: 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. 

Dated: February 5, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02576 Filed 2–7–24; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Rules and Regulations 8539 

4See 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’’). 

5See 5 U.S.C. 553(d). 

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. 

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 

■ 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 


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