Agency Information Collection Request; 60-Day Public Comment Request, 24429-24430 [2023-08339]
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24429
Federal Register / Vol. 88, No. 76 / Thursday, April 20, 2023 / Notices
information in 21 CFR part 58
pertaining to good laboratory practices
have been approved under OMB control
number 0910–0119. The collections of
information for general records and
postmarket adverse experience reporting
pertaining to biological products have
been approved under OMB control
number 0910–0308. The collections of
information pertaining to postmarketing
adverse drug experience reporting have
been approved under OMB control
number 0910–0230. The collections of
information resulting from special
protocol assessments have been
approved under OMB control number
0910–0470. The collection of
information pertaining to current good
manufacturing practices have been
approved under OMB control number
0910–0139. The collections of
information in 21 CFR part 601
pertaining to biologics license
applications have been approved under
OMB control number 0910–0338. The
collections of information in FDA’s
guidance entitled ‘‘Emergency Use
Authorization of Medical Products and
Related Authorities’’ have been
approved under OMB control number
0910–0595. The collections of
information pertaining to expedited
review programs for serious conditions
and under section 506 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
356) (as amended by the Food and Drug
Administration Safety and Innovation
Act) have been approved under OMB
control number 0910–0765. The
collections of information for the
content and format of prescription drug
labeling in 21 CFR 201.56 and 201.57
have been approved under OMB control
number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fda-
guidance-documents, or https://
www.regulations.gov.
Dated: April 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08331 Filed 4–19–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–0419]
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 June 20, 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–New–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
SUMMARY:
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.
Type of Collection: Extension.
OMB No.: 0990–0419.
Abstract: The Department of Health
and Human Services; Office of the
Assistant Secretary for Financial
Resources, Office of Acquisitions,
Acquisition Policy Division is
requesting an approval by OMB for an
extension of a previously approved
information collection request,
Acquisition Regulation Clause Patent
Rights and Rights in Data. HHS found
that systematically, over a period of
several years, when Determination of
Exceptional Circumstances (DEC) were
executed, additional legal protection for
the patent and data rights of third
parties beyond those covered by FAR
27.306 were necessary. A DEC is
executed consistent with the policy and
objectives of the Bayh-Dole Act, 35
U.S.C. 200, et seq., to ensure that subject
inventions made under contracts and
subcontracts (at all tiers) are used in a
manner to promote free competition and
enterprise without unduly encumbering
future research and discovery; to
encourage maximum participation of
small business firms in federally
supported research and development
efforts; to promote collaboration
between commercial concerns and
nonprofit organizations including
universities; to ensure that the
Government obtains sufficient rights in
federally supported inventions to meet
its needs; to protect the public against
nonuse or unreasonable use of
inventions; and in the case of fulfilling
the mission of the U.S. Department of
Health and Human Services, to
ultimately to benefit the public health.
Likely Respondents: administrative,
technical, legal and management
personnel.
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
ddrumheller on DSK120RN23PROD with NOTICES1
Type of respondent and hours for each
Technical (4), Legal (2), Management (2) .......................................................
Technical (8), Legal (2), Management (2) .......................................................
Technical (8), Legal (3), Management (1) .......................................................
Technical (8), Legal (4), Management (2) .......................................................
Technical (6), Legal (2), Management (2) .......................................................
Technical (4), Legal (2), Management (2) .......................................................
Administrative (8) .............................................................................................
Administrative (2), Management (1) ................................................................
Technical (4), Legal (2), Management (2) .......................................................
VerDate Sep<11>2014
20:01 Apr 19, 2023
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Frm 00048
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
63
63
63
63
63
63
63
63
63
E:\FR\FM\20APN1.SGM
1
1
3
3
1
1
3
3
3
20APN1
Average
burden per
response
(hours)
8
12
12
14
10
8
8
3
8
Total
burden hours
504
756
2,268
2,646
630
504
1,512
567
1,512
24430
Federal Register / Vol. 88, No. 76 / Thursday, April 20, 2023 / Notices
ANNUALIZED BURDEN HOUR TABLE—Continued
Type of respondent and hours for each
Total ..........................................................................................................
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(hours)
........................
........................
........................
[FR Doc. 2023–08339 Filed 4–19–23; 8:45 am]
Dated: April 14, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4150–04–P
[FR Doc. 2023–08289 Filed 4–19–23; 8:45 am]
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
Center for Scientific Review; Notice of
Closed Meeting
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) 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.
Pursuant to section 10(d) 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: Center for Scientific
Review Special Emphasis Panel; Topics in
Immunology and Infectious Disease.
Date: May 8, 2023.
Time: 11:00 a.m. to 5:00 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: Dayadevi Jirage, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4422,
Bethesda, MD 20892, (301) 867–5309,
jiragedb@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Name of Committee: National Institute on
Aging Initial Review Group; Career
Development Facilitating the Transition to
Independence Study Section.
Date: May 31–June 1, 2023.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Joshua Jin-Hyouk Park,
Ph.D., Scientific Review Officer, National
Institutes of Health, National Institute on
Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
(301) 496–6208, joshua.park4@nih.gov.
Name of Committee: National Institute on
Aging, Initial Review Group; Career
Development for Established Investigators
and Conference Grants Study Section.
Date: June 12–13, 2023.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Even Hotel Rockville, Previously
Holiday Inn, 1775 Rockville Pike, Rockville,
MD 20852.
VerDate Sep<11>2014
20:01 Apr 19, 2023
Jkt 259001
PO 00000
Frm 00049
Fmt 4703
Sfmt 9990
Total
burden hours
10,899
Contact Person: Greg Bissonette, Ph.D.,
Scientific Review Officer, National Institute
on Aging, National Institutes of Health,
Gateway Building, Suite 2W200, 7201
Wisconsin Avenue, Bethesda, MD 20892,
301–402–1622, bissonettegb@mail.nih.gov.
Name of Committee: National Institute on
Aging Initial Review Group; Career
Development for Clinicians/Health
Professionals Study Section Career
development for clinicians and health
professional awards.
Date: June 12–13, 2023.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Maurizio Grimaldi, M.D.,
Ph.D., Scientific Review Branch, National
Institute on Aging, National Institutes of
Health, 7201 Wisconsin Avenue, Suite 2C–
212, Bethesda, MD 20892, 301–496–9374,
grimaldim2@mail.nih.gov.
Name of Committee: National Institute on
Aging Initial Review Group; Career
Development for Early Career Investigators
Study Section.
Date: June 26–27, 2023.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Carmen Moten, Ph.D.,
Scientific Review Officer, National Institutes
of Health, National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892, 301–496–8589,
cmoten@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: April 14, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–08295 Filed 4–19–23; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 88, Number 76 (Thursday, April 20, 2023)]
[Notices]
[Pages 24429-24430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08339]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0990-0419]
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 June 20, 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-New-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.
Type of Collection: Extension.
OMB No.: 0990-0419.
Abstract: The Department of Health and Human Services; Office of
the Assistant Secretary for Financial Resources, Office of
Acquisitions, Acquisition Policy Division is requesting an approval by
OMB for an extension of a previously approved information collection
request, Acquisition Regulation Clause Patent Rights and Rights in
Data. HHS found that systematically, over a period of several years,
when Determination of Exceptional Circumstances (DEC) were executed,
additional legal protection for the patent and data rights of third
parties beyond those covered by FAR 27.306 were necessary. A DEC is
executed consistent with the policy and objectives of the Bayh-Dole
Act, 35 U.S.C. 200, et seq., to ensure that subject inventions made
under contracts and subcontracts (at all tiers) are used in a manner to
promote free competition and enterprise without unduly encumbering
future research and discovery; to encourage maximum participation of
small business firms in federally supported research and development
efforts; to promote collaboration between commercial concerns and
nonprofit organizations including universities; to ensure that the
Government obtains sufficient rights in federally supported inventions
to meet its needs; to protect the public against nonuse or unreasonable
use of inventions; and in the case of fulfilling the mission of the
U.S. Department of Health and Human Services, to ultimately to benefit
the public health.
Likely Respondents: administrative, technical, legal and management
personnel.
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent and hours for each Number of responses per per response Total burden
respondents respondent (hours) hours
----------------------------------------------------------------------------------------------------------------
Technical (4), Legal (2), Management (2)........ 63 1 8 504
Technical (8), Legal (2), Management (2)........ 63 1 12 756
Technical (8), Legal (3), Management (1)........ 63 3 12 2,268
Technical (8), Legal (4), Management (2)........ 63 3 14 2,646
Technical (6), Legal (2), Management (2)........ 63 1 10 630
Technical (4), Legal (2), Management (2)........ 63 1 8 504
Administrative (8).............................. 63 3 8 1,512
Administrative (2), Management (1).............. 63 3 3 567
Technical (4), Legal (2), Management (2)........ 63 3 8 1,512
---------------------------------------------------------------
[[Page 24430]]
Total....................................... .............. .............. .............. 10,899
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2023-08339 Filed 4-19-23; 8:45 am]
BILLING CODE 4150-04-P
