Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC, 83577-83578 [2023-26343]

Download as PDF 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 khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:22 Nov 29, 2023 Jkt 262001 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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: E:\FR\FM\30NON1.SGM 30NON1 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: VerDate Sep<11>2014 17:22 Nov 29, 2023 Jkt 262001 PO 00000 Frm 00048 Fmt 4703 I 7435 Sfmt 4703 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: E:\FR\FM\30NON1.SGM 30NON1

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]


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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.

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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
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