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, 12982-12983 [2022-04786]
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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
Drug Enforcement Administration
Psilocybin .....................
Levorphanol ..................
[Docket No. DEA–961]
Importer of Controlled Substances
Application: ANI Pharmaceuticals Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
20:36 Mar 07, 2022
Drug
code
Controlled substance
DEPARTMENT OF JUSTICE
VerDate Sep<11>2014
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):
Jkt 256001
I
7437
9220
Schedule
I
I
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
Drug Enforcement
Administration, Department of Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice,
Drug Enforcement Administration
(DEA), will be submitting the following
information collection request to the
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\08MRN1.SGM
08MRN1
Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Notices
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.
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
17:25 Mar 07, 2022
Jkt 256001
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
Drug Enforcement
Administration, Department of Justice.
ACTION: 60-Day notice.
AGENCY:
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,
SUMMARY:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
12983
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
E:\FR\FM\08MRN1.SGM
08MRN1
Agencies
[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Notices]
[Pages 12982-12983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04786]
-----------------------------------------------------------------------
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.
[[Page 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