63622 Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1266] 

Importer of Controlled Substances 

Application: Benuvia Operations, LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Benuvia Operations, LLC has 

applied to be registered as an importer 

of basic class(es) of controlled 

substance(s). Refer to SUPPLEMENTARY

INFORMATION listed below for further 

drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before October 16, 2023. Such 

persons may also file a written request 

for a hearing on the application on or 

before October 16, 2023. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. All 

requests for a hearing must be sent to: 

(1) Drug Enforcement Administration, 

Attn: Hearing Clerk/OALJ, 8701 

Morrissette Drive, Springfield, Virginia 

22152; and (2) Drug Enforcement 

Administration, Attn: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for a hearing should 

also be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on August 10, 2023, 

Benuvia Operations, LLC, 3950 North 

Mays Street, Round Rock, Texas 78665– 

2729, applied to be registered as an 

importer of the following basic class(es) 

of controlled substance(s): 

Controlled substance Drug code Schedule 

Ibogaine ........................................................................................................................................................................... 7260 I 

Tetrahydrocannabinols .................................................................................................................................................... 7370 I 

Mescaline ......................................................................................................................................................................... 7381 I 

3,4-Methylenedioxyamphetamine .................................................................................................................................... 7400 I 

3,4-Methylenedioxymethamphetamine ............................................................................................................................ 7405 I 

5-Methoxy-N,N-dimethyltryptamine ................................................................................................................................. 7431 I 

Dimethyltryptamine .......................................................................................................................................................... 7435 I 

Psilocybin ......................................................................................................................................................................... 7437 I 

Psilocyn ........................................................................................................................................................................... 7438 I 

5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................. 7439 I 

Dronabinol in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration 7365 II 

The company plans to import the 

listed controlled substances for clinical 

trial manufacturing and analytical 

purposes. No other activities for these 

drug codes are authorized for this 

registration. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 

is authorized under 21 U.S.C. 952(a)(2). 

Authorization will not extend to the 

import of Food and Drug 

Administration-approved or nonapproved finished dosage forms for 

commercial sale. 

Claude Redd, 

Acting Deputy Assistant Administrator. 

[FR Doc. 2023–19998 Filed 9–14–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1248] 

Bulk Manufacturer of Controlled 

Substances Application: PCI Synthesis 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: PCI Synthesis has applied to 

be registered as a bulk manufacturer of 

basic class(es) of controlled 

substance(s). Refer to SUPPLEMENTARY

INFORMATION listed below for further 

drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before November 14, 2023. Such 

persons may also file a written request 

for a hearing on the application on or 

before November 14, 2023. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on March 30, 2023, PCI 

Synthesis, 9 Opportunity Way, 

Newburyport, Massachusetts 01950– 

0195, applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Amphetamine ............... 1100 II 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 63623 

Controlled substance Drug 

code Schedule 

Methamphetamine ........ 1105 II 

The company plans to develop 

manufacturing processes, conduct 

analytical method validation and 

conduct bulk product stability studies. 

No other activities for these drug codes 

are authorized for this registration. 

Claude Redd, 

Acting Deputy Assistant Administrator. 

[FR Doc. 2023–19989 Filed 9–14–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

[OMB Number 1140–0017] 

Agency Information Collection 

Activities; Proposed eCollection 

eComments Requested; Annual 

Firearms Manufacturing and 

Exportation Report (AFMER) 

AGENCY: Bureau of Alcohol, Tobacco, 

Firearms and Explosives, Department of 

Justice. 

ACTION: 30-Day notice. 

SUMMARY: The Bureau of Alcohol, 

Tobacco, Firearms and Explosives 

(ATF), Department of Justice (DOJ), will 

be submitting the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and approval in accordance with 

the Paperwork Reduction Act of 1995. 

The proposed information collection 

was previously published in the Federal 

Register, on July 6, 2023, allowing a 60- 

day comment period. 

DATES: Comments are encouraged and 

will be accepted for 30 days until 

October 16, 2023. 

FOR FURTHER INFORMATION CONTACT: If 

you have comments especially on the 

estimated public burden or associated 

response time, suggestions, or need a 

copy of the proposed information 

collection instrument with instructions 

or additional information, please 

contact: Leslie Anderson, by email at 

Leslie.anderson@atf.gov, or by 

telephone at 301–616–4634. 

SUPPLEMENTARY INFORMATION: Written 

comments and suggestions from the 

public and affected agencies concerning 

the proposed collection of information 

are encouraged. Your comments should 

address one or more of the following 

four points: 

—Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

—Evaluate the accuracy of the agency’s 

estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

—Enhance the quality, utility, and 

clarity of the information to be 

collected; and/or 

—Minimize the burden of the collection 

of information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms 

of information technology, e.g., 

permitting electronic submission of 

responses. 

Written comments and 

recommendations for this information 

collection should be submitted within 

30 days of the publication of this notice 

on the following website 

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

30-day Review—Open for Public 

Comments’’ or by using the search 

function and entering either the title of 

the information collection or the OMB 

Control Number 1140–0017. This 

information collection request may be 

viewed at www.reginfo.gov. Follow the 

instructions to view Department of 

Justice, information collections 

currently under review by OMB. 

DOJ seeks PRA authorization for this 

information collection for three (3) 

years. OMB authorization for an ICR 

cannot be for more than three (3) years 

without renewal. The DOJ notes that 

information collection requirements 

submitted to the OMB for existing ICRs 

receive a month-to-month extension 

while they undergo review. 

Overview of This Information 

Collection 

1. Type of Information Collection: 

Revision of a previously approved 

collection. 

2. Title of the Form/Collection: 

Annual Firearms Manufacturing and 

Exportation Report (AFMER). 

3. Agency form number, if any, and 

the applicable component of the 

Department of Justice sponsoring the 

collection: ATF Form 5300.11. 

Component: Bureau of Alcohol, 

Tobacco, Firearms and Explosives, U.S. 

Department of Justice. 

4. Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Private Sector—Businesses or 

other for-profit. 

Abstract: The information collected is 

used to compile statistics on the 

manufacture and exportation of 

firearms. The furnishing of this 

information is mandatory under 18 

U.S.C. 923(g)(5)(A). This form must be 

submitted annually for every Type 07 

and Type 10 Federal Firearms Licensees 

(FFLs), even if no firearms were 

exported or distributed into commerce. 

The information collection (IC) OMB 

#1140–0017 is being revised due to 

material and non-material changes to 

the form, such as added instructions, 

definitions, formatting changes (to 

adjust form length), bolded lines (to 

fillable boxes), grammatical changes 

(sentence rephrasing/statement 

modification), and instruction 

clarification. 

5. Obligation to Respond: Mandatory. 

The statutory requirements are 

implemented under 18 U.S.C. chapter 

44. 

6. Total Estimated Number of 

Respondents: 19,200 respondents. 

7. Estimated Time per Respondent: 20 

minutes. 

8. Frequency: Once annually. 

9. Total Estimated Annual Time 

Burden: 6,400 hours. 

10. Total Estimated Annual Other 

Costs Burden: No new cost is associated 

with this collection. All respondents 

can electronically submit the AFMER to 

ATF free of charge, however, it is 

estimated that half the respondents 

submit the form to the Federal Firearms 

Licensing Center by mail. The annual 

cost has increased due to a change in 

the postal rate from $0.55 during the last 

renewal in 2020, to $0.63 in 2023. 

Consequently, the new public cost 

burden will be reported as $6,048.00, 

which is equal to $0.63 (mailing cost per 

respondent) * 19,200 (# of respondents) 

* 50% (percentage of responses 

submitted by mail). 

If additional information is required, 

contact: Darwin Arceo, Department 

Clearance Officer, Policy and Planning 

Staff, Justice Management Division, 

United States Department of Justice, 

Two Constitution Square, 145 N Street 

NE, 4W–218 Washington, DC 20530. 

Dated: September 11, 2023. 

Darwin Arceo, 

Department Clearance Officer for PRA, U.S. 

Department of Justice. 

[FR Doc. 2023–19941 Filed 9–14–23; 8:45 am] 

BILLING CODE 4410–14–P 


ddrumheller on DSK120RN23PROD with NOTICES1