Bulk Manufacturer of Controlled Substances Application: Benuvia Therapeutics Inc., 19505 [2020-07279]
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Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 / Notices
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 March 6, 2020, Almac
Clinical Services Incorp, (ACSI) 25 Fretz
Road, Souderton, Pennsylvania, 18964,
applied to be registered as an importer
of the following basic class(es) of
controlled substances:
Controlled substance
Psilocybin .................
Oxycodone ...............
Hydromorphone ........
Morphine ...................
Tapentadol ................
Fentanyl ....................
Drug
code
Schedule
7437
9143
9150
9300
9780
9801
I
II
II
II
II
II
The company plans to import the
listed controlled substances in dosage
form to conduct clinical trials.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under to 21 U.S.C.
952(a)(2). Authorization will not extend
to the import of FDA-approved or nonapproved finished dosage forms for
commercial sale.
BILLING CODE 4410–09–P
Drug Enforcement Administration
[Docket No. DEA–620]
Bulk Manufacturer of Controlled
Substances Application: Benuvia
Therapeutics Inc.
Notice of application.
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 June 8, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
khammond on DSKJM1Z7X2PROD with NOTICES
Drug
code
Schedule
7360
7370
I
I
The company plans to manufacture
the above-listed controlled substances
in bulk to produce finished dosage
forms and conduct research to develop
new drug products and for clinical
studies. In reference to drug codes 7360
(Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–07279 Filed 4–6–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Employment and Training
Administration
Notice.
The Department of Labor’s
(DOL) Employment and Training
Administration (ETA) is soliciting
comments concerning a proposed
extension for the authority to conduct
the information collection request (ICR)
titled, ‘‘Disaster Unemployment
Assistance Activities Report’’. This
comment request is part of continuing
Departmental efforts to reduce
paperwork and respondent burden in
accordance with the Paperwork
Reduction Act of 1995 (PRA).
DATES: Consideration will be given to all
written comments received by June 8,
2020.
SUMMARY:
DEPARTMENT OF JUSTICE
In
accordance with 21 CFR 1301.33(a), this
SUPPLEMENTARY INFORMATION:
18:22 Apr 06, 2020
Marihuana .......................
Tetrahydrocannabinols ...
ACTION:
[FR Doc. 2020–07273 Filed 4–6–20; 8:45 am]
VerDate Sep<11>2014
Controlled substance
Agency Information Collection
Activities; Comment Request
William T. McDermott,
Assistant Administrator.
ACTION:
is notice that on December 4, 2019,
Benuvia Therapeutics Inc., 2700
Oakmont Drive, Round Rock, Texas
78665 applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Jkt 250001
A copy of this ICR with
applicable supporting documentation,
including a description of the likely
respondents, proposed frequency of
response, and estimated total burden,
may be obtained free by contacting
David King by telephone at (202) 693–
2698 (this is not a toll-free number),
TTY 1–877–889–5627 (this is not a tollfree number), or by email at
king.david.h@dol.gov.
ADDRESSES:
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
19505
Submit written comments about, or
requests for a copy of, this ICR by mail
or courier to the U.S. Department of
Labor, ETA, Office of Unemployment
Insurance, DUA Program, Room S–4520,
202 Constitution Ave. NW, Washington,
DC 20210; by email: king.david.h@
dol.gov; or by fax (202) 693–3975.
FOR FURTHER INFORMATION CONTACT:
David King by telephone at (202) 693–
2698 (this is not a toll-free number) or
by email at king.david.h@dol.gov.
SUPPLEMENTARY INFORMATION: DOL, as
part of continuing efforts to reduce
paperwork and respondent burden,
conducts a pre-clearance consultation
program to provide the general public
and Federal agencies an opportunity to
comment on proposed and/or
continuing collections of information
before submitting them to the Office of
Management and Budget (OMB) for final
approval. This program helps to ensure
requested data can be provided in the
desired format, reporting burden (time
and financial resources) is minimized,
collection instruments are clearly
understood, and the impact of collection
requirements can be properly assessed.
This ICR seeks to extend PRA
authority for the Disaster
Unemployment Assistance Activities
Report information collection. Sections
410 and 423 of the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act provide for Disaster
Unemployment Assistance (DUA) to
eligible applicants who are unemployed
as a direct result of a major disaster.
State Workforce Agencies, through
individual agreements with the
Secretary of Labor, act as agents of the
Federal government in providing DUA.
Form ETA 902 is a monthly report that
a State submits on DUA program
activities once the President declares a
disaster. The Social Security Act section
303(a)(6) authorizes this information
collection. See 42 U.S.C. 503(a)(6).
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
generally not required to respond to an
information collection, unless it is
approved by OMB under the PRA and
displays a currently valid OMB Control
Number. In addition, notwithstanding
any other provisions of law, no person
shall generally be subject to penalty for
failing to comply with a collection of
information that does not display a
valid Control Number. See 5 CFR
1320.5(a) and 1320.6.
Interested parties are encouraged to
provide comments to the contact shown
in the ADDRESSES section. Comments
must be written to receive
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07APN1
]]>Agencies
[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Page 19505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07279]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-620]
Bulk Manufacturer of Controlled Substances Application: Benuvia
Therapeutics Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
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 June 8, 2020.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on December 4, 2019, Benuvia Therapeutics Inc., 2700
Oakmont Drive, Round Rock, Texas 78665 applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances in bulk to produce finished dosage forms and conduct
research to develop new drug products and for clinical studies. In
reference to drug codes 7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture these
drugs as synthetic. No other activities for these drug codes are
authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-07279 Filed 4-6-20; 8:45 am]
BILLING CODE 4410-09-P
