Agency Information Collection Request. 30-Day Public Comment Request, 48176-48178 [2024-12273]
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<![CDATA[
48176
Federal Register / Vol. 89, No. 109 / Wednesday, June 5, 2024 / Notices
methods including email and FDA’s
eSubmitter program (https://
www.fda.gov/industry/fda-esubmitter).
FDA issued part 810 to implement the
provisions of section 518 of the FD&C
Act. The information collected under
the mandatory recall authority
provisions is used by FDA to implement
mandatory recalls.
Description of Respondents:
Respondents for this collection of
information are firms, including
medical device manufacturers,
importers, distributors, and retailers,
that have been issued a cease
distribution and notification order or
mandatory recall order in accordance
with the provisions under part 810,
during the timeframe(s) specified in the
order.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Collection activity—21 CFR section
Number of
respondents
Number of
responses per
respondent
2
1
1
1
2
1
8
8
16
8
1
1
1
8
8
2
1
2
16
32
2
12
24
40
960
2
1
2
8
16
....................
........................
....................
....................
1,040
Submission of information to FDA about device distribution and remedial actions to be taken, as specified in the order—810.10(d) ............
Submission of a written request for regulatory hearing—810.11(a) .......
Submission of a written request to FDA asking that the order be modified or vacated—810.12(a–b) ...............................................................
Submission of a strategy for compliance with cease distribution and
notification or mandatory recall order—810.14 ....................................
Submission of periodic status reports to FDA to enable the agency to
assess progress in compliance with the order—810.16(a–b) .............
Submission of a written request to FDA to certify compliance with and
terminate the order—810.17(a) ............................................................
Total Hours .......................................................................................
1 There
Total
annual
responses
Average
burden per
response
Total
hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Collection activity—21 CFR section
Documentation of communications to appropriate person(s)—
810.15(b) ..........................................................................................
1 There
I
Number of
records per
recordkeeper
I
2
Total
annual
records
I
1
I
2
Average
burden per
recordkeeping
Total
hours
8
16
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Communications to appropriate person(s) concerning a cease distribution and notification or mandatory recall order—810.15(a)–(c)
Follow up communications to appropriate person(s) who fail to respond to the initial communication—810.15(d) ................................
Notifications provided by recipients of communications to appropriate consignees—810.15(e) ..........................................................
Total ..............................................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
Number of
disclosures
per
respondent
Number of
respondents
Collection activity—21 CFR section
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
2
1
2
12
24
2
1
2
4
8
10
1
10
1
10
....................
........................
........................
....................
42
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden per response, burden per
recordkeeping, and burden per
disclosure estimates are based on FDA’s
recent experience with voluntary recalls
under 21 CFR part 7. Based on an
analysis of cease distribution and
notification and mandatory recall order
activity over the last 3 years, FDA
expects no more than two of such
actions per year as a conservative
estimate.
Based on a review of the information
collection since our last request for
VerDate Sep<11>2014
16:50 Jun 04, 2024
Jkt 262001
OMB approval, we have made no
adjustments to our burden estimate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[Document Identifier: OS–0990–new]
[FR Doc. 2024–12346 Filed 6–4–24; 8:45 am]
Agency Information Collection
Request. 30-Day Public Comment
Request
BILLING CODE 4164–01–P
PO 00000
Office of the Secretary, HHS
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
SUMMARY:
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 109 / Wednesday, June 5, 2024 / Notices
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 July 5, 2024.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041, or PRA@HHS.GOV.
When submitting comments or
requesting information, please include
the document identifier 0990–New–30D
and project title for reference.
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: OASH
Performance Project Report for Grants
and Cooperative Agreements.
Type of Collection: New.
OMB No. 0990–NEW—Office of the
Assistant Secretary for Health
Abstract: The Office of the Assistant
Secretary for Health (OASH) is seeking
OMB approval on a new information
collection, the OASH Periodic
Performance Project Report for Grants
and Cooperative Agreements (hereafter
the OASH PPR). The purpose of this
data collection is to gather quantitative
and qualitative information common to
the assessment of recipient performance
on individual grants and cooperative
agreements (collectively, grants)
managed in OASH. OASH will collect
common data elements measuring the
performance of each recipient against
the approved grant project plan,
VerDate Sep<11>2014
16:50 Jun 04, 2024
Jkt 262001
including progress toward goals and
outcomes as required by 45 CFR
75.342(b)(2).
OASH oversees a broad range of grant
programs within the Office of the
Secretary (OS), Department of Health
and Human Services (HHS). The current
active OASH programs with
discretionary grants (with assistance
listing number) include: Public
Awareness Campaigns on Embryo
Adoption (93.007); Research on
Research Integrity (93.085); Advancing
System Improvements for Key Issues in
Women’s Health (93.088); Community
Programs to Improve Minority Health
Grant Programs (93.137); Family
Planning Services (93.217); Family
Planning Personnel Training (93.260);
Teenage Pregnancy Prevention Program
(93.297); Public Health Service
Evaluation Funds (93.343); Research,
Monitoring and Outcomes Definitions
for Vaccine Safety (93.344); Minority
HIV/AIDS Fund (93.899); Family
Planning Service Delivery Improvement
Research Grants (93.974); and National
Health Promotion (93.990). OASH
grants span a wide range of project
types, including service, demonstration
project, evaluation, research, training,
and conference projects. Within each
program, the awards are subdivided into
cohorts aligned with the notices of
funding opportunity under which
OASH competed the awards. Currently,
there are 47 cohorts of active awards
across OASH. In any given year, OASH
programs collectively monitor 450–550
active awards with another 200–300
inactive awards awaiting final reports as
a prerequisite to closing the grant.
The collection is needed to enhance
project performance information and
simplify reporting under 45 CFR 75.301.
Each recipient currently must submit a
quarterly Federal Financial Report (FFR
or SF–425)(45 CFR 75.341) and a
periodic Performance Progress Report
(PPR) for each grant (45 CFR
75.342(b)(2). PPR reporting periods in
OASH are scheduled quarterly, semiannually, or annually, depending on the
need determined by the program office
using a narrative format that can vary by
cohort. The PPR schedule is specifically
aligned with the quarterly FFRs
whenever possible to create a complete
snapshot of the project’s progress at the
end of the reporting period.
The common elements identified in
the new collection for OASH programs
PO 00000
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48177
will standardize the collection of the
required information (45 CFR
75.342(b)(2)) including: (1) a
comparison of the actual
accomplishments to the objectives of the
award for the period; (2) the reasons
why established goals were not met; and
(3) pertinent information, analysis and
explanation of cost overruns or high
unit costs. The common elements
include reporting on publications,
including data sets and other work
products, to facilitate implementation of
OSTP Memorandum Ensuring Free,
Immediate, and Equitable Access
Federally Funded Research (August 25,
2022). The new information collection
will limit the content of the report to
those activities taking place during the
reporting period (i.e., quarterly,
semiannually, or annually). The
information collection is structured to
facilitate program review across
reporting periods. This will allow
OASH to identify and improve program
outcomes, share lessons learned, and
spread the adoption of promising
practices among its grant recipients and
other HHS awarding agencies.
The content of the new collection is
structured for web-based data collection
under 7 headings: Report Header;
Project Progress; Significant Project
Accomplishments; Broader Program
Impacts; Products and Dissemination;
Collaboration and Partnering Activities;
and Project Evaluation Activities.
Information will be prepopulated based
on the login credentials for the user
submitting the report and the specific
grant being reported. Not all grants will
have reportable activities under all
headings (e.g., not all grants have an
evaluation component embedded in the
project). However, most OASH grants
will have reportable information under
most headings. Program offices with
additional reporting programmatic
information collections will eventually
transition collection of any overlapping
data elements to this OASH PPR. During
the transition, OASH will not require
grant recipients to provide the same
information twice.
Likely Respondents: Members and
staff from academia, community
organizations, local/State/Federal
government, private sector, and tribal
government and services organizations
including those who serve American
Indian and Alaska Native and/or racial
and ethnic minorities.
E:\FR\FM\05JNN1.SGM
05JNN1
48178
Federal Register / Vol. 89, No. 109 / Wednesday, June 5, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Average
burden per
response
(in hours)
Total burden
hours
OASH grant recipients .....................................................................................
800
3
1
2,400
Total ..........................................................................................................
800
3
1
2,400
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2024–12273 Filed 6–4–24; 8:45 am]
BILLING CODE 4150–34–P
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.
khammond on DSKJM1Z7X2PROD with NOTICES
Number
responses per
respondent
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Cancer Prevention Study Section.
Date: June 27–28, 2024.
Time: 9:00 a.m. to 9:00 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: Byung Min Chung, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 496–4056, justin.chung@
nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Modeling and Analysis of Biological
Systems Study Section.
Date: June 27–28, 2024.
Time: 9:30 a.m. to 7:00 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: Zarana Patel, Ph.D., MPH
Scientific Review Officer, Center for
VerDate Sep<11>2014
18:43 Jun 04, 2024
Jkt 262001
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 496–9295, zarana.patel@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–24–
045 and PAR–24–046: Tackling Acquisition
of Language in Kids (TALK) applications.
Date: June 27, 2024.
Time: 9:30 a.m. to 12:30 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: Rochelle Francine
Hentges, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 1000C, Bethesda, MD 20892, (301)
402–8720, hentgesrf@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Neuroimaging Technologies.
Date: June 27–28, 2024.
Time: 9:30 a.m. to 6:30 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: Raj K. Krishnaraju, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6190,
MSC 7804, Bethesda, MD 20892, (301) 435–
1047, kkrishna@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Genes, Genomes and Genetics.
Date: June 27–28, 2024.
Time: 10:00 a.m. to 8:00 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: Linda Wagner Jurata,
Scientific Review Officer, The Center for
Scientific Review, The National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 496–8032 linda.jurata@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
The Cellular and Molecular Biology of
Complex Brain Disorders.
Date: June 27–28, 2024.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Contact Person: Adem Can, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4190,
MSC 7850 Bethesda, MD 20892, (301) 435–
1042, cana2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Epidemiology and Population
Sciences.
Date: June 27–28, 2024.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (In Person and Virtual
Meeting).
Contact Person: Rebecca I. Tinker, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20817, (301) 435–0637, tinkerri@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cerebrovascular Disorders, Epilepsy
and Neural Injury.
Date: June 27, 2024.
Time: 10:00 a.m. to 4:30 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: Paula Elyse Schauwecker,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5201
Bethesda, MD 20892, 301–760–8207,
schauweckerpe@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Cellular Immunology,
Transplantation and Viremia.
Date: June 27, 2024.
Time: 10:00 a.m. to 3:00 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: Philip Owens, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Dr. Bethesda, MD
20892, (301) 594–7394, owensp2@csr.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Language and Communication Study
Section.
Date: June 27–28, 2024.
Time: 12:30 p.m. to 8:30 p.m.
E:\FR\FM\05JNN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 109 (Wednesday, June 5, 2024)]
[Notices]
[Pages 48176-48178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12273]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-new]
Agency Information Collection Request. 30-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
[[Page 48177]]
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 July 5, 2024.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 264-0041, or [email protected]. When submitting comments or
requesting information, please include the document identifier 0990-
New-30D and project title for reference.
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: OASH Performance Project Report for Grants
and Cooperative Agreements.
Type of Collection: New.
OMB No. 0990-NEW--Office of the Assistant Secretary for Health
Abstract: The Office of the Assistant Secretary for Health (OASH)
is seeking OMB approval on a new information collection, the OASH
Periodic Performance Project Report for Grants and Cooperative
Agreements (hereafter the OASH PPR). The purpose of this data
collection is to gather quantitative and qualitative information common
to the assessment of recipient performance on individual grants and
cooperative agreements (collectively, grants) managed in OASH. OASH
will collect common data elements measuring the performance of each
recipient against the approved grant project plan, including progress
toward goals and outcomes as required by 45 CFR 75.342(b)(2).
OASH oversees a broad range of grant programs within the Office of
the Secretary (OS), Department of Health and Human Services (HHS). The
current active OASH programs with discretionary grants (with assistance
listing number) include: Public Awareness Campaigns on Embryo Adoption
(93.007); Research on Research Integrity (93.085); Advancing System
Improvements for Key Issues in Women's Health (93.088); Community
Programs to Improve Minority Health Grant Programs (93.137); Family
Planning Services (93.217); Family Planning Personnel Training
(93.260); Teenage Pregnancy Prevention Program (93.297); Public Health
Service Evaluation Funds (93.343); Research, Monitoring and Outcomes
Definitions for Vaccine Safety (93.344); Minority HIV/AIDS Fund
(93.899); Family Planning Service Delivery Improvement Research Grants
(93.974); and National Health Promotion (93.990). OASH grants span a
wide range of project types, including service, demonstration project,
evaluation, research, training, and conference projects. Within each
program, the awards are subdivided into cohorts aligned with the
notices of funding opportunity under which OASH competed the awards.
Currently, there are 47 cohorts of active awards across OASH. In any
given year, OASH programs collectively monitor 450-550 active awards
with another 200-300 inactive awards awaiting final reports as a
prerequisite to closing the grant.
The collection is needed to enhance project performance information
and simplify reporting under 45 CFR 75.301. Each recipient currently
must submit a quarterly Federal Financial Report (FFR or SF-425)(45 CFR
75.341) and a periodic Performance Progress Report (PPR) for each grant
(45 CFR 75.342(b)(2). PPR reporting periods in OASH are scheduled
quarterly, semi-annually, or annually, depending on the need determined
by the program office using a narrative format that can vary by cohort.
The PPR schedule is specifically aligned with the quarterly FFRs
whenever possible to create a complete snapshot of the project's
progress at the end of the reporting period.
The common elements identified in the new collection for OASH
programs will standardize the collection of the required information
(45 CFR 75.342(b)(2)) including: (1) a comparison of the actual
accomplishments to the objectives of the award for the period; (2) the
reasons why established goals were not met; and (3) pertinent
information, analysis and explanation of cost overruns or high unit
costs. The common elements include reporting on publications, including
data sets and other work products, to facilitate implementation of OSTP
Memorandum Ensuring Free, Immediate, and Equitable Access Federally
Funded Research (August 25, 2022). The new information collection will
limit the content of the report to those activities taking place during
the reporting period (i.e., quarterly, semiannually, or annually). The
information collection is structured to facilitate program review
across reporting periods. This will allow OASH to identify and improve
program outcomes, share lessons learned, and spread the adoption of
promising practices among its grant recipients and other HHS awarding
agencies.
The content of the new collection is structured for web-based data
collection under 7 headings: Report Header; Project Progress;
Significant Project Accomplishments; Broader Program Impacts; Products
and Dissemination; Collaboration and Partnering Activities; and Project
Evaluation Activities. Information will be prepopulated based on the
login credentials for the user submitting the report and the specific
grant being reported. Not all grants will have reportable activities
under all headings (e.g., not all grants have an evaluation component
embedded in the project). However, most OASH grants will have
reportable information under most headings. Program offices with
additional reporting programmatic information collections will
eventually transition collection of any overlapping data elements to
this OASH PPR. During the transition, OASH will not require grant
recipients to provide the same information twice.
Likely Respondents: Members and staff from academia, community
organizations, local/State/Federal government, private sector, and
tribal government and services organizations including those who serve
American Indian and Alaska Native and/or racial and ethnic minorities.
[[Page 48178]]
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number Average burden
Type of respondent Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
OASH grant recipients........................... 800 3 1 2,400
---------------------------------------------------------------
Total....................................... 800 3 1 2,400
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-12273 Filed 6-4-24; 8:45 am]
BILLING CODE 4150-34-P
