Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC, 83577-83578 [2023-26343]
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Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices
DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NRSS–NPS0036715
PPWONRADE1 PPMRSNR1Y:NM0000
211P103601; OMB Control Number 1024–
NEW]
Agency Information Collection
Activities; NPS Preservation Values for
Individual Animals
National Park Service, Interior.
Notice of Information
Collections; request for comment.
AGENCY:
ACTION:
In accordance with the
Paperwork Reduction Act of 1995 we,
the National Park Service (NPS), are
proposing a new information collection.
DATES: Interested persons are invited to
submit comments on or before January
2, 2024.
ADDRESSES: Written comments and
suggestions on the information
collection requirements should be
submitted by the date specified above in
DATES to https://www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function. Please provide a copy
of your comments to Phadrea Ponds,
NPS Information Collection Clearance
Officer (ADIR–ICCO), National Park
Service, 13461 Sunrise Valley Drive,
Mail Stop 244 Reston, VA 20192 (mail);
or phadrea_ponds@nps.gov (email).
Please include 1024–NEW (PVIA) in the
subject line of your comments.
FOR FURTHER INFORMATION CONTACT: To
request additional information about
this Information Collection Request
(ICR), contact Leslie Richardson,
Economist, NPS Social Science Branch
at leslie_a_richardson@nps.gov (email)
or at 970–821–5352 (telephone), or
contact Chris Neher by email at
bioecon@montana.com. Please reference
OMB Control Number 1024–NEW
(PVIA) in the subject line of your
comments. Individuals in the United
States who are deaf, deafblind, hard of
hearing, or have a speech disability may
dial 711 (TTY, TDD, or TeleBraille) to
access telecommunications relay
services. Individuals outside the United
States should use the relay services
offered within their country to make
international calls to the point of
contact in the United States. You may
also view the ICR at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION: In
accordance with the Paperwork
Reduction Act of 1995 (PRA, 44 U.S.C.
3501 et seq.) and 5 CFR 1320.8(d)(1), we
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SUMMARY:
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17:22 Nov 29, 2023
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provide the public and other Federal
agencies with an opportunity to
comment on new, proposed, revised,
and continuing collections of
information. This helps us assess the
impact of our information collection
requirements and minimize the public’s
reporting burden. It also helps the
public understand our information
collection requirements and provide the
requested data in the desired format.
A Federal Register notice with a 60day public comment period soliciting
comments on this collection of
information was published (87 FR
43054) on July 19, 2022. No comments
were received.
As part of our continuing effort to
reduce paperwork and respondent
burdens, we are again soliciting
comments from the public and other
Federal agencies on the proposed ICR
that is described below. We are
especially interested in public comment
addressing the following:
(1) Whether or not the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether or not the
information will have practical utility;
(2) The accuracy of our estimate of the
burden for this collection of
information, including the validity of
the methodology and assumptions used;
(3) Ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(4) How might the agency 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 response.
Comments that you submit in
response to this notice are a matter of
public record. We will include or
summarize each comment in our request
to OMB to approve this ICR. Before
including your address, phone number,
email address, or other personal
identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
Abstract: The National Park Service
(NPS) is authorized by the System Unit
Resource Protection Act (54 U.S.C.
100721) to collect information that can
be used to assess the economic value of
lost resources that cannot be restored or
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83577
replaced. The NPS Environmental
Quality Division will request approval
to conduct a survey to determine the
economic value associated with the
preservation (avoided loss) of individual
members of a wildlife species
population. The survey will provide
estimates of the full value of protecting
individual animals from intentional or
accidental loss. These value estimates
are not currently available to the NPS
and are necessary for park management
decisions.
Title of Collection: NPS Preservation
Values for Individual Animals.
OMB Control Number: 1024–NEW.
Form Number: None.
Type of Review: New.
Respondents/Affected Public: General
Public.
Total Estimated Number of Annual
Respondents: 8,876 (On-site Survey:
5,600; Non-response Survey: 1,260; Mail
back Survey: 2,016).
Estimated Completion Time per
Response: On-site Survey: 5 minutes;
Non-response Survey: 2 minutes; Mail
back Survey: 15 minutes.
Total Estimated Number of Annual
Burden Hours: 1,014.
Respondent’s Obligation: Voluntary.
Frequency of Collection: Once.
Total Estimated Annual Nonhour
Burden Cost: None.
An agency may not conduct, or
sponsor nor is a person required to
respond to a collection of information
unless it displays a currently valid OMB
control number.
The authority for this action is the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Phadrea Ponds,
Information Collections Clearance Officer,
National Park Service.
[FR Doc. 2023–26308 Filed 11–29–23; 8:45 am]
BILLING CODE 4312–52–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1299]
Bulk Manufacturer of Controlled
Substances Application: Pharmaron
Manufacturing Services (US) LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Pharmaron Manufacturing
Services (US) LLC has applied to be
registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
SUMMARY:
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83578
Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices
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 January 29, 2024. Such
persons may also file a written request
for a hearing on the application on or
before January 29, 2024.
ADDRESSES: The Drug Enforcement
Administration 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on October 23, 2023,
Pharmaron Manufacturing Services (US)
LLC, 498 Washington Street, Coventry,
Rhode Island 02816, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
DATES:
Drug
code
Controlled substance
Dimethyltryptamine ........
I
7435
Schedule
II
The company plans to bulk
manufacture the listed controlled
substance for the purpose of producing
material for clinical trials. No other
activities for this drug code are
authorized for this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–26343 Filed 11–29–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
khammond on DSKJM1Z7X2PROD with NOTICES
Drug Enforcement Administration
Pharmaron Manufacturing
Services (US) LLC 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.
SUMMARY:
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 January 2, 2024. Such
persons may also file a written request
for a hearing on the application on or
before January 2, 2024.
ADDRESSES: The Drug Enforcement
Administration 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 October 30, 2023,
Pharmaron Manufacturing Services (US)
LLC, 498 Washington Street, Conventry,
Rhode Island 02816, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
DATES:
[Docket No. DEA–1298]
Drug
code
Controlled substance
Schedule
Importer of Controlled Substances
Application: Pharmaron Manufacturing
Services (US) LLC
Dimethyltryptamine ..........
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
The company purpose of importing
Dimethyltryptamine (7435) is to
conduct process and analytical
technology transfer, further process, and
AGENCY:
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17:22 Nov 29, 2023
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I
7435
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II
analytical development as needed and
subsequently manufacture/produce an
Active Pharmaceutical Ingredient under
Good Manufacturing Practices at the US
Pharmaron site (Pharmaron
Manufacturing Services (US) LLC in
Coventry, Rhode Island. 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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–26342 Filed 11–29–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1110–0057]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Uniform Crime
Reporting (UCR) Instrument Pretesting
and Burden Estimation Generic
Clearance
Federal Bureau of
Investigation, Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Federal Bureau of
Investigation (FBI), Department of
Justice (DOJ), will be submitting the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The proposed
information collection was previously
published in the Federal Register on
September 15, 2023, allowing a 60-day
comment period.
DATES: Comments are encouraged and
will be accepted for 30 days until
January 2, 2024.
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: Edward L. Abraham, Crime and
Law Enforcement Statistics Unit Chief,
FBI, CJIS Division, Module D–1, 1000
Custer Hollow Road, Clarksburg, West
Virginia 26306; telephone number: 304–
625–4830, email: elabraham@fbi.gov.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
SUMMARY:
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Agencies
[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83577-83578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26343]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1299]
Bulk Manufacturer of Controlled Substances Application: Pharmaron
Manufacturing Services (US) LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Pharmaron Manufacturing Services (US) LLC has applied to be
registered as a bulk manufacturer of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for
further drug information.
[[Page 83578]]
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
January 29, 2024. Such persons may also file a written request for a
hearing on the application on or before January 29, 2024.
ADDRESSES: The Drug Enforcement Administration 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on October 23, 2023, Pharmaron Manufacturing Services
(US) LLC, 498 Washington Street, Coventry, Rhode Island 02816, applied
to be registered as a bulk manufacturer of the following basic
class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Dimethyltryptamine..................... 7435 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substance for the purpose of producing material for clinical trials. No
other activities for this drug code are authorized for this
registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-26343 Filed 11-29-23; 8:45 am]
BILLING CODE 4410-09-P