Agency Information Collection Request; 60-Day Public Comment Request, 66461-66462 [2023-21098]
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Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–N–0487 for ‘‘Discussion Paper:
Artificial Intelligence in Drug
Manufacturing, Notice; Request for
Information and Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
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18:44 Sep 26, 2023
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second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4162,
Silver Spring, MD 20993, 240–402–
7930, Elizabeth.Giaquinto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 1, 2023 (88
FR 12943), FDA established a public
docket to solicit comments on the
‘‘Discussion Paper: Artificial
Intelligence in Drug Manufacturing.’’
The discussion paper presents areas for
consideration and policy development
identified by the Center for Drug
Evaluation and Research (CDER)
scientific and policy experts associated
with application of artificial intelligence
to pharmaceutical manufacturing. The
discussion paper includes a series of
questions to stimulate feedback from the
public, including CDER and the Center
for Biologics Evaluation and Research
stakeholders.
Interested persons were originally
given until May 1, 2023, to comment on
the content of the discussion paper.
Following publication of the March 1,
2023, notice, FDA has decided to reopen
the public docket to allow interested
persons additional time to comment on
the discussion paper. We note that there
is also a public workshop organized by
FDA and the Product Quality Research
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66461
Institute entitled ‘‘Regulatory
Framework for the Utilization of
Artificial Intelligence in Pharmaceutical
Manufacturing: An Opportunity for
Stakeholder Engagement,’’ which is
scheduled for September 26 and 27,
2023 (https://pqri.org/fda-pqriaiworkshop/).
Dated: September 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20902 Filed 9–26–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0324]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before November 27,
2023.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0324–60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Report of
Dental Examination of Applicants to the
Public Health Service Commissioned
Corps.
SUMMARY:
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66462
Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices
Type of Collection: Reinstatement
without change.
OMB No.: 0990–0324.
Abstract: Pursuant to the Paperwork
Reduction Act of 1995, the
Commissioned Corps Headquarters
(CCHQ), Office of the Secretary,
Department of Health and Human
Services (HHS), requests that the Office
of Management and Budget (OMB)
renew the form PHS–6355 Report of
Dental Examination of Applicants to the
Commissioned Corps of the Public
Health Service for use in determining
the medical qualifications of applicants
to the Commissioned Corps of the U.S.
Public Health Service (Corps).
Applicants to the Corps must meet the
Corps’ medical standards for
appointment.
This is a 3-year request for OMB
approval.
Likely Respondents: U.S. citizens
applying to the United States Public
Health Service.
ANNUALIZED BURDEN HOUR TABLE
Total
burden
hours
PHS–6355 .........................................
Applicants .........................................
1,000
1
1
1,000
Total ...........................................
...........................................................
........................
........................
........................
1,000
[FR Doc. 2023–21098 Filed 9–26–23; 8:45 am]
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[FR Doc. 2023–20978 Filed 9–26–23; 8:45 am]
National Institutes of Health
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National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Allergy, Immunology,
and Transplantation Research Committee.
Date: October 17–18, 2023.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G51A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Thomas F. Conway, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G51A, Bethesda, MD
20892, 240–507–9685, thomas.conway@
nih.gov.
VerDate Sep<11>2014
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 21, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ddrumheller on DSK120RN23PROD with NOTICES1
Average
burden per
response
Respondents
(if necessary)
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
Number of
respondents
Number of
responses per
respondents
Forms
(if necessary)
Jkt 259001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Social Sciences and Population Studies, A
Study Section.
Date: October 17–18, 2023.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Plaza Hotel, 10 Thomas
Circle NW, Washington, DC 20005.
Contact Person: Suzanne Ryan, Ph.D.,
Scientific Review Officer, Center for
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Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 435–
1712, ryansj@csr.nih.gov.
Name of Committee: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group; Imaging Guided
Interventions and Surgery Study Section.
Date: October 19–20, 2023.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Gaithersburg Marriott
Washingtonian Center, 9751 Washingtonian
Blvd., Gaithersburg, MD 20878.
Contact Person: Ella Fung Jones, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 496–0777, ella.jones@nih.gov.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Cellular and Molecular
Biology of Glia Study Section.
Date: October 19–20, 2023.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Sung-Wook Jang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 812P,
Bethesda, MD 20892, (301) 435–1042,
jangs2@csr.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Lung Injury, Repair, and Remodeling
Study Section.
Date: October 19–20, 2023.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Ghenima Dirami, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4122,
MSC 7814, Bethesda, MD 20892, 240–498–
7546, diramig@csr.nih.gov.
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[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Pages 66461-66462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0324]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before November 27,
2023.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 264-0041 and [email protected].
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0324-60D and
project title for reference, to Sherrette A. Funn, email:
[email protected], [email protected] or call (202) 264-0041 the Reports
Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Report of Dental Examination of Applicants
to the Public Health Service Commissioned Corps.
[[Page 66462]]
Type of Collection: Reinstatement without change.
OMB No.: 0990-0324.
Abstract: Pursuant to the Paperwork Reduction Act of 1995, the
Commissioned Corps Headquarters (CCHQ), Office of the Secretary,
Department of Health and Human Services (HHS), requests that the Office
of Management and Budget (OMB) renew the form PHS-6355 Report of Dental
Examination of Applicants to the Commissioned Corps of the Public
Health Service for use in determining the medical qualifications of
applicants to the Commissioned Corps of the U.S. Public Health Service
(Corps). Applicants to the Corps must meet the Corps' medical standards
for appointment.
This is a 3-year request for OMB approval.
Likely Respondents: U.S. citizens applying to the United States
Public Health Service.
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of
Forms (if necessary) Respondents (if Number of responses per Average burden Total burden
necessary) respondents respondents per response hours
----------------------------------------------------------------------------------------------------------------
PHS-6355...................... Applicants...... 1,000 1 1 1,000
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 1,000
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2023-21098 Filed 9-26-23; 8:45 am]
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