Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI), 19504-19505 [2020-07273]
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khammond on DSKJM1Z7X2PROD with NOTICES
19504
Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 / Notices
based filings or paper copies of any
electronic filings will be accepted until
further notice.
Written submissions.— Parties that
have requested to participate in the
written proceedings held in lieu of an
in-person staff conference may submit
opening remarks limited to five pages
and witness testimony (in the form of
certified affidavits) limited to 50 pages
no later than April 17, 2020. As
provided in sections 201.8 and 207.15 of
the Commission’s rules, any person may
submit to the Commission on or before
April 27, 2020, a written brief
containing information and arguments
pertinent to the subject matter of the
investigations, including responses to
staff questions. All written submissions
must conform with the provisions of
section 201.8 of the Commission’s rules;
any submissions that contain BPI must
also conform with the requirements of
sections 201.6, 207.3, and 207.7 of the
Commission’s rules. The Commission’s
Handbook on Filing Procedures,
available on the Commission’s website
at https://www.usitc.gov/documents/
handbook_on_filing_procedures.pdf,
elaborates upon the Commission’s
procedures with respect to filings.
Please note the Secretary’s Office will
accept only electronic filings during this
time. Filings must be made through the
Commission’s Electronic Document
Information System (EDIS, https://
edis.usitc.gov). No in-person paperbased filings or paper copies of any
electronic filings will be accepted until
further notice.
In accordance with sections 201.16(c)
and 207.3 of the rules, each document
filed by a party to the investigations
must be served on all other parties to
the investigations (as identified by
either the public or BPI service list), and
a certificate of service must be timely
filed. The Secretary will not accept a
document for filing without a certificate
of service.
Certification.—Pursuant to section
207.3 of the Commission’s rules, any
person submitting information to the
Commission in connection with these
investigations must certify that the
information is accurate and complete to
the best of the submitter’s knowledge. In
making the certification, the submitter
will acknowledge that any information
that it submits to the Commission
during these investigations may be
disclosed to and used: (i) By the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of these or related investigations or
reviews, or (b) in internal investigations,
audits, reviews, and evaluations relating
to the programs, personnel, and
VerDate Sep<11>2014
18:22 Apr 06, 2020
Jkt 250001
operations of the Commission including
under 5 U.S.C. Appendix 3; or (ii) by
U.S. government employees and
contract personnel, solely for
cybersecurity purposes. All contract
personnel will sign appropriate
nondisclosure agreements.
Authority: These investigations are
being conducted under authority of title
VII of the Tariff Act of 1930; this notice
is published pursuant to section 207.12
of the Commission’s rules.
By order of the Commission.
Issued: April 1, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020–07207 Filed 4–6–20; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–619]
Bulk Manufacturer of Controlled
Substances Application: American
Radiolabeled Chem
ACTION:
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:
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 7, 2020,
American Radiolabeled Chem, 101 Arc
Drive, Saint Louis, Missouri 63146,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Gamma Hydroxybutyric Acid.
Ibogaine ....................
Lysergic acid
diethylamide.
Tetrahydrocannabinols.
Dimethyltryptamine ...
1-[1-(2-Thienyl)cyclo
hexyl]piperidine.
Dihydromorphine ......
Heroin .......................
Normorphine .............
Amphetamine ...........
PO 00000
Frm 00083
Fmt 4703
Drug
code
Schedule
2010
I
7260
7315
I
I
7370
I
7435
7470
I
I
9145
9200
9313
1100
I
I
I
II
Sfmt 4703
Controlled substance
Methamphetamine ....
Amobarbital ..............
Phencyclidine ...........
Phenylacetone ..........
Cocaine ....................
Codeine ....................
Dihydrocodeine .........
Oxycodone ...............
Hydromorphone ........
Ecgonine ...................
Hydrocodone ............
Meperidine ................
Metazocine ...............
Methadone ................
Dextropropoxyphene,
bulk (non-dosage
forms).
Morphine ...................
Oripavine ..................
Thebaine ...................
Oxymorphone ...........
Phenazocine .............
Carfentanil ................
Fentanyl ....................
Drug
code
Schedule
1105
2125
7471
8501
9041
9050
9120
9143
9150
9180
9193
9230
9240
9250
9273
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
9300
9330
9333
9652
9715
9743
9801
II
II
II
II
II
II
II
The company plans to manufacture
small quantities of the above-listed
controlled substances as radiolabeled
compounds for biochemical research.
No other activities for these drug codes
are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–07277 Filed 4–6–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–618]
Importer of Controlled Substances
Application: Almac Clinical Services
Incorp (ACSI)
ACTION:
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 May 7, 2020. Such persons
may also file a written request for a
hearing on the application on or before
May 7, 2020.
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 request for a hearing
should also be sent to: (1) Drug
DATES:
E:\FR\FM\07APN1.SGM
07APN1
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
E:\FR\FM\07APN1.SGM
07APN1
]]>Agencies
[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19504-19505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07273]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-618]
Importer of Controlled Substances Application: Almac Clinical
Services Incorp (ACSI)
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 May 7, 2020.
Such persons may also file a written request for a hearing on the
application on or before May 7, 2020.
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
request for a hearing should also be sent to: (1) Drug
[[Page 19505]]
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:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin............................ 7437 I
Oxycodone............................. 9143 II
Hydromorphone......................... 9150 II
Morphine.............................. 9300 II
Tapentadol............................ 9780 II
Fentanyl.............................. 9801 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 non-approved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-07273 Filed 4-6-20; 8:45 am]
BILLING CODE 4410-09-P
