12982 Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Notices 

activity for this drug code is 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. 

Matthew J. Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2022–04806 Filed 3–7–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–961] 

Importer of Controlled Substances 

Application: ANI Pharmaceuticals Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: ANI Pharmaceuticals Inc. 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 April 7, 2022. Such persons 

may also file a written request for a 

hearing on the application on or before 

April 7, 2022. 

ADDRESSES: The DEA 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 January 6, 2022, ANI 

Pharmaceuticals Inc., 70 Lake Drive, 

East Windsor, New Jersey 08520, 

applied to be registered as an importer 

of the following basic class(es) of 

controlled substance(s): 

Controlled substance Drug 

code Schedule 

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

Levorphanol .................. 9220 II 

The substance Levorphanol (9220) 

will be used to manufacture the Food 

and Drug Administration-approved 

dosage forms for distribution in the 

United States. The substance Psilocybin 

(7437) will be used to support 

formulation development and clinical 

trial research. No other activity 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 Drug Administrationapproved or non-approved finished 

dosage forms for commercial sale. 

Matthew J. Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2022–04803 Filed 3–7–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

[OMB Number 1117–0006] 

Agency Information Collection 

Activities; Proposed eCollection, 

eComments Requested; Extension 

Without Change of a Previously 

Approved Collection; Application for 

Individual Manufacturing Quota for a 

Basic Class of Controlled Substance 

and for Ephedrine, Pseudoephedrine, 

and Phenylpropanolamine; DEA Form 

189 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: 60-Day notice. 

SUMMARY: The Department of Justice, 

Drug Enforcement Administration 

(DEA), will be submitting the following 

information collection request to the 

Office of Management and Budget for 

review and approval in accordance with 

the Paperwork Reduction Act of 1995. 

This information collection is also 

associated with the proposed 

rulemaking ‘‘Management of Quotas for 

Controlled Substances and List I 

Chemicals.’’ It is likely that the final 

rule will not be published before this 

information collection expires on June 

30, 2022. If the final rule does publish 

prior to the expiration, it will be 

published as the 30-Day Notice. 

DATES: Comments are encouraged and 

will be accepted for 60 days until May 

9, 2022. 

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 Scott A. Brinks, Regulatory 

Drafting and Policy Support Section 

(DPW), Diversion Control Division, Drug 

Enforcement Administration; Mailing 

Address: 8701 Morrissette Drive, 

Springfield, Virginia 22152; Telephone: 

(571) 776–2265. 

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; 

—Evaluate whether and if so how the 

quality, utility, and clarity of the 

information proposed to be collected 

can be enhanced; and 

—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. 

Overview of This Information 

Collection 

1. Type of Information Collection: 

Extension of a currently approved 

collection. 


lotter on DSK11XQN23PROD with NOTICES1

I I 
Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Notices 12983 

2. Title of the Form/Collection: 

Application for Individual 

Manufacturing Quota for a Basic Class 

of Controlled Substance and for 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine. 

3. The agency form number, if any, 

and the applicable component of the 

Department sponsoring the collection: 

DEA Form 189. The applicable 

component within the Department of 

Justice is the Drug Enforcement 

Administration, Diversion Control 

Division. 

4. Affected public who will be asked 

or required to respond, as well as a brief 

abstract: 

Affected public (Primary): Business or 

other for-profit. 

Affected public (Other): None. 

Abstract: Pursuant to 21 U.S.C. 826(c) 

and 21 CFR 1303.22 and 1315.22, any 

person who is registered to manufacture 

any basic class of controlled substances 

listed in Schedule I or II, or the List I 

chemicals ephedrine, pseudoephedrine, 

or phenylpropanolamine, and who 

desires to manufacture a quantity of 

such class or such List I chemical, must 

apply on DEA Form 189 for a 

manufacturing quota for such quantity 

of such class or List I chemical. 

5. An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: The DEA estimates 33 

respondents complete 859 DEA Form 

189 applications annually, and that each 

form takes 0.5 hours to complete. 

6. An estimate of the total public 

burden (in hours) associated with the 

proposed collection: The DEA estimates 

this collection takes a total of 430 

annual burden hours. 

If additional information is required, 

please contact: Melody Braswell, 

Department Clearance Officer, United 

States Department of Justice, Justice 

Management Division, Policy and 

Planning Staff, Two Constitution 

Square, 145 N Street NE, Suite 3E.405B, 

Washington, DC 20530. 

Dated: March 2, 2022. 

Melody Braswell, 

Department Clearance Officer for PRA, U.S. 

Department of Justice. 

[FR Doc. 2022–04786 Filed 3–7–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

[OMB Number 1117–0008] 

Agency Information Collection 

Activities; Proposed eCollection, 

eComments Requested; Extension 

Without Change of a Previously 

Approved Collection; Application for 

Procurement Quota for Controlled 

Substance and for Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine; DEA Form 250 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: 60-Day notice. 

SUMMARY: The Department of Justice, 

Drug Enforcement Administration 

(DEA), will be submitting the following 

information collection request to the 

Office of Management and Budget for 

review and approval in accordance with 

the Paperwork Reduction Act of 1995. 

This information collection is also 

associated with the proposed 

rulemaking ‘‘Management of Quotas for 

Controlled Substances and List I 

Chemicals,’’ published in the Federal 

Register. It is likely that the final rule 

will not be published before this 

information collection expires on June 

30, 2022. If the final rule does publish 

prior to the expiration, it will be 

published as the 30-Day Notice. 

DATES: Comments are encouraged and 

will be accepted for 60 days until May 

9, 2022. 

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 Scott A. Brinks, Regulatory 

Drafting and Policy Support Section 

(DPW), Diversion Control Division, Drug 

Enforcement Administration; Mailing 

Address: 8701 Morrissette Drive, 

Springfield, Virginia 22152; Telephone: 

(571) 776–2265. 

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; 

—Evaluate whether and if so how the 

quality, utility, and clarity of the 

information proposed to be collected 

can be enhanced; and 

—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. 

Overview of This information 

Collection 

1. Type of Information Collection: 

Extension of a currently approved 

collection. 

2. Title of the Form/Collection: 

Application for Procurement Quota for 

Controlled Substance and for 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine. 

3. The agency form number, if any, 

and the applicable component of the 

Department sponsoring the collection: 

DEA Form 250. The applicable 

component within the Department of 

Justice is the Drug Enforcement 

Administration, Diversion Control 

Division. 

4. Affected public who will be asked 

or required to respond, as well as a brief 

abstract: 

Affected public (Primary): Business or 

other for-profit. 

Affected public (Other): None. 

Abstract: Pursuant to 21 U.S.C. 826 

and 21 CFR 1303.12(b) and 1315.32, any 

person who desires to use, during the 

next calendar year, any basic class of 

controlled substances listed in 

schedules I or II, or the List I chemicals 

ephedrine, pseudoephedrine, or 

phenylpropanolamine for purposes of 

manufacturing must apply on DEA 

Form 250 for a procurement quota for 

such class or List I chemical. 

5. An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: The DEA estimates 344 

respondents complete 3,066 DEA Form 

250 applications annually, and that each 

form requires 0.5 hours to complete. 

6. An estimate of the total public 

burden (in hours) associated with the 

proposed collection: The DEA estimates 

this collection takes a total of 1,533 

annual burden hours. 

If additional information is required, 

please contact: Melody Braswell, 

Department Clearance Officer, United 

States Department of Justice, Justice 

Management Division, Policy and 

Planning Staff, Two Constitution 


lotter on DSK11XQN23PROD with NOTICES1