Importer of Controlled Substances Application: Lyndra Therapeutics, 10823 [2022-04061]
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10823
Federal Register / Vol. 87, No. 38 / Friday, February 25, 2022 / Notices
Controlled substance
Drug code
Anileridine ..........................................................................................................................................................................
Cocaine ..............................................................................................................................................................................
Diphenoxylate ....................................................................................................................................................................
Ecgonine ............................................................................................................................................................................
Levorphanol .......................................................................................................................................................................
Meperidine .........................................................................................................................................................................
Meperidine Intermediate-A ................................................................................................................................................
Meperidine Intermediate-B ................................................................................................................................................
Meperidine Intermediate-C ................................................................................................................................................
Dextropropoxyphene .........................................................................................................................................................
Morphine ............................................................................................................................................................................
Levo-alphacetylmethadol ...................................................................................................................................................
Alfentanil ............................................................................................................................................................................
Remifentanil .......................................................................................................................................................................
Sufentanil ...........................................................................................................................................................................
Carfentanil .........................................................................................................................................................................
Tapentadol .........................................................................................................................................................................
Fentanyl .............................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances as analytical materials,
proficiency test materials, and academic
research materials for distribution to its
customers. No other activities for these
drug codes are authorized for this
registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04057 Filed 2–24–22; 8:45 am]
BILLING CODE P
In
accordance with 21 CFR 1301.34(a), this
is notice that on January 13, 2022,
Lyndra Therapeutics, 65 Grove Street,
Suite 301, Watertown, Massachusetts
02472, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–965]
Importer of Controlled Substances
Application: Lyndra Therapeutics
lotter on DSK11XQN23PROD with NOTICES1
Methadone ....................
Lyndra Therapeutics has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTAL
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before March 28, 2022. Such persons
may also file a written request for a
hearing on the application on or before
March 28, 2022.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
SUMMARY:
16:44 Feb 24, 2022
Jkt 256001
Drug
code
Controlled substance
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
VerDate Sep<11>2014
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also 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.
I
9250
Schedule
I II
The company plans to develop the
formulation and process, and then
manufacture the finished oral dosage
form for use in preclinical and human
clinical trials and analysis. No other
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. 2022–04061 Filed 2–24–22; 8:45 am]
BILLING CODE 4410–09–P
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9801
Schedule
II
II
II
II
II
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II
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DEPARTMENT OF LABOR
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Miner’s
Claim for Benefits and Employment
History
Notice of availability; request
for comments.
ACTION:
The Department of Labor
(DOL) is submitting this Office of
Workers’ Compensation Programs
(OWCP)-sponsored information
collection request (ICR) to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995
(PRA). Public comments on the ICR are
invited.
DATES: The OMB will consider all
written comments that the agency
receives on or before March 28, 2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to 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.
Comments are invited on: (1) Whether
the collection of information is
necessary for the proper performance of
the functions of the Department,
including whether the information will
have practical utility; (2) if the
information will be processed and used
in a timely manner; (3) the accuracy of
the agency’s estimates of the burden and
cost of the collection of information,
including the validity of the
methodology and assumptions used; (4)
ways to enhance the quality, utility and
clarity of the information collection; and
SUMMARY:
E:\FR\FM\25FEN1.SGM
25FEN1
]]>Agencies
[Federal Register Volume 87, Number 38 (Friday, February 25, 2022)]
[Notices]
[Page 10823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04061]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-965]
Importer of Controlled Substances Application: Lyndra
Therapeutics
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Lyndra Therapeutics has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
Supplemental Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before March 28, 2022.
Such persons may also file a written request for a hearing on the
application on or before March 28, 2022.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a hearing should also 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on January 13, 2022, Lyndra Therapeutics, 65 Grove
Street, Suite 301, Watertown, Massachusetts 02472, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methadone.............................. 9250 II
------------------------------------------------------------------------
The company plans to develop the formulation and process, and then
manufacture the finished oral dosage form for use in preclinical and
human clinical trials and analysis. No other 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 non-approved finished
dosage forms for commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04061 Filed 2-24-22; 8:45 am]
BILLING CODE 4410-09-P
