Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Rules and Regulations 60117 

1 21 U.S.C. 826(b). 

2 21 U.S.C. 826(d). 

OFFICE OF THE UNITED STATES 

TRADE REPRESENTATIVE 

15 CFR Part 2004 

RIN 0350–AA13 

Technical Amendment: Freedom of 

Information Act Policies and 

Procedures 

AGENCY: Office of the United States 

Trade Representative (USTR). 

ACTION: Adoption of interim rule as 

final. 

SUMMARY: This final rule adopts, 

without change, an interim final rule 

with a request for comments published 

in the Federal Register on July 25, 2023, 

that made a minor technical change to 

the USTR Freedom of Information Act 

(FOIA) regulation. 

DATES: Effective October 2, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Janice Kaye or Monique Ricker at 

FOIA@ustr.eop.gov or 202–395–3150. 

SUPPLEMENTARY INFORMATION: 

I. Technical Change 

On July 25, 2023, USTR published an 

interim final rule that made a technical 

change to § 2004.6 of the USTR FOIA 

regulation to align it with the statute 

and Office of Information Policy 

guidance about the compelling 

circumstances under which an agency 

must grant expedited processing. See 88 

FR 47772. Although the interim final 

rule was effective upon publication, 

USTR provided a 30-day comment 

period, which ended on August 24, 

2023. USTR did not receive any 

comments and is adopting the interim 

final rule without any changes. 

II. Regulatory Flexibility Act 

USTR considered the impact of this 

rule and determined that it will not 

have a significant economic impact on 

a substantial number of small business 

entities because it applies only to 

USTR’s internal operations and legal 

obligations. 5 U.S.C. 605(b). 

III. Paperwork Reduction Act 

The final rule does not contain any 

information collection requirement that 

requires the approval of the Office of 

Management and Budget under the 

Paperwork Reduction Act (44 U.S.C. 

3501 et seq.). 

IV. Administrative Procedure Act 

(APA) 

On July 25, 2023, USTR published an 

interim final rule (88 FR 47772) and 

determined that there was a basis under 

the Administrative Procedure Act for 

issuing the interim final rule with 

immediate effect. USTR provided a 30- 

day comment period, which ended on 

August 24, 2023. USTR did not receive 

any comments and is adopting the 

provisions of the interim final rule as a 

final rule with no changes. 

List of Subjects in 15 CFR Part 2004 

Administrative practice and 

procedure, Courts, Disclosure, 

Exemptions, Freedom of information, 

Government employees, Privacy, 

Records, Subpoenas, Testimony. 

PART 2004—DISCLOSURE OF 

RECORDS AND INFORMATION 

■ Accordingly, the interim final rule 

published in the Federal Register on 

July 25, 2023, at 88 FR 47772, amending 

15 CFR part 2004, is adopted as a final 

rule without change. 

Janice Kaye, 

Chief FOIA Officer, Office of the United States 

Trade Representative. 

[FR Doc. 2023–18866 Filed 8–30–23; 8:45 am] 

BILLING CODE 3290–F3–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1303 and 1315 

[Docket No. DEA–455] 

RIN 1117–AB49 

Management of Quotas for Controlled 

Substances and List I Chemicals 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is publishing this 

final rule to manage the quotas for 

controlled substances and the list I 

chemicals, ephedrine, pseudoephedrine, 

and phenylpropanolamine, held by 

DEA-registered manufacturers. This 

final rule will define the types of quotas, 

update the method to abandon quota, 

clarify the current language to ensure 

that both manufacturers and distributors 

are required to obtain certification of a 

buyer’s quota, reduce overall 

inventories, formalize the existing 

practice of use-specific subcategories for 

individual manufacturing and 

procurement quotas, and modify 

existing deadlines to fix/issue quotas. 

This final rule will also amend certain 

regulations to implement updates to the 

Controlled Substances Act made by the 

Substance Use-Disorder Prevention that 

Promotes Opioid Recovery Treatment 

for Patients and Communities Act. 

DATES: This final rule is effective 

November 29, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Scott A. Brinks, Regulatory Drafting & 

Policy Support Section (DPW), 

Diversion Control Division, Drug 

Enforcement Administration; Mailing 

Address: 8701 Morrissette Drive, 

Springfield, Virginia 22152; Telephone: 

(571) 362–3261. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The Controlled Substances Act (CSA) 

authorizes the Administrator of the Drug 

Enforcement Administration (DEA) (by 

delegation from the Attorney General) to 

promulgate rules and regulations that he 

deems necessary and appropriate for the 

efficient execution of his functions 

under subchapter I (Control and 

Enforcement) and subchapter II (Import 

and Export). 21 U.S.C. 871(b) and 958(f). 

Subchapter I includes provisions which 

require the Administrator to establish 

the aggregate production quota for each 

basic class of controlled substance listed 

in schedules I and II and the assessment 

of annual needs for the ephedrine, 

pseudoephedrine, and 

phenylpropanolamine to be 

manufactured in the United States each 

calendar year to provide for the 

estimated medical, scientific, research, 

and industrial needs of the United 

States, lawful export requirements, and 

the establishment and maintenance of 

reserve stocks. 21 U.S.C. 826. The 

Administrator shall take the following 

quota actions for a basic class of 

controlled substance listed in schedules 

I and II and ephedrine, 

pseudoephedrine, and 

phenylpropanolamine pursuant to 

stipulated conditions: limit or reduce 

individual production quotas for each 

registered manufacturer,1 and fix 

individual manufacturing quotas for 

registrants.2

On October 24, 2018, Congress 

revised the CSA through the Substance 

Use-Disorder Prevention that Promotes 

Opioid Recovery Treatment for Patients 

and Communities (SUPPORT) Act. 

These revisions will be noted and 

included in these proposed regulations, 

where applicable. Through this Act, the 

Administrator, by way of delegation 

from the Attorney General, may now set 

quota in terms of the pharmaceutical 

dosage-form. 


ddrumheller on DSK120RN23PROD with RULES1