Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ending the HIV Epidemic Initiative Triannual Report, OMB No. 0915-0051-Extension, 75637-75638 [2022-26779]
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Federal Register / Vol. 87, No. 236 / Friday, December 9, 2022 / Notices
II. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This draft
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
III. Paperwork Reduction Act of 1995
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations have been approved by OMB
as listed in the following table:
While this guidance contains no new
collection of information, it does refer to
OMB control
No.
21 CFR part; guidance; or FDA form
Topic
807, subpart E ..........................................
814, subparts A through E .......................
814, subpart H ..........................................
860, subpart D ..........................................
800, 801, and 809 ....................................
820 ............................................................
Premarket notification ..................................................................................................
Premarket approval ......................................................................................................
Humanitarian Device Exemption ..................................................................................
De Novo classification process ....................................................................................
Medical Device Labeling Regulations ..........................................................................
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation .....
Dated: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
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 Review—Open for
Public Comments’’ or by using the
search function.
ADDRESSES:
[FR Doc. 2022–26767 Filed 12–8–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than January 9, 2023.
DATES:
VerDate Sep<11>2014
17:50 Dec 08, 2022
Jkt 259001
To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 594–
4394.
FOR FURTHER INFORMATION CONTACT:
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Ending the HIV Epidemic
Initiative Triannual Report, OMB No.
0915–0051—Extension
lotter on DSK11XQN23PROD with NOTICES1
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘Content of Human
Factors Information in Medical Device
Marketing Submissions’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1500052 and
complete title to identify the guidance
you are requesting.
75637
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Ending the HIV Epidemic (EHE)
Initiative Triannual Report OMB No.
0915–0051—Extension.
Abstract: HRSA’s Ryan White HIV/
AIDS Program (RWHAP) funds and
coordinates with cities, states, and local
clinics/community-based organizations
to deliver efficient and effective HIV
care, treatment, and support services to
low-income people with HIV. Since
1990, the RWHAP has developed a
comprehensive system of safety net
providers who deliver high quality
direct health care and support services
to over half a million people with HIV—
more than 50 percent of all people with
diagnosed HIV in the United States.
Nearly two-thirds of clients (patients)
live at or below 100 percent of the
Federal poverty level and approximately
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
0910–0120
0910–0231
0910–0332
0910–0844
0910–0485
0910–0073
three-quarters of RWHAP clients are
racial/ethnic minorities.1
The Federal Ending the HIV Epidemic
in the U.S. (EHE) initiative focuses on
reducing the number of new HIV
infections in the United States by at
least 90 percent by 2030, which would
be fewer than 3,000 per year.2
Authorized by section 311(c) and title
XXVI of the Public Health Service Act,
this 10-year initiative beginning in fiscal
year (FY) 2020 focuses on 48 counties;
Washington, DC; San Juan, Puerto Rico;
and seven states that have a substantial
rural HIV burden. EHE initiative efforts
focus on the following four key
strategies that together can end the HIV
epidemic in the United States:
1. Diagnose all people with HIV as
early as possible.
2. Treat people with HIV rapidly and
effectively to reach sustained viral
suppression.
3. Prevent new HIV transmissions by
using proven interventions, including
pre-exposure prophylaxis and syringe
services programs.
4. Respond quickly to potential HIV
outbreaks to get needed prevention and
treatment services to people who need
them.
The EHE initiative is a collaborative
effort among key Department of Health
and Human Services agencies, primarily
HRSA, the Centers for Disease Control
and Prevention, the National Institutes
of Health, the Indian Health Service,
1 HRSA. Ryan White HIV/AIDS Program Data
Report, 2020.
2 HRSA. Ending the HIV Epidemic in the U.S.
https://www.hrsa.gov/ending-hiv-epidemic.
Accessed July 12, 2022.
E:\FR\FM\09DEN1.SGM
09DEN1
75638
Federal Register / Vol. 87, No. 236 / Friday, December 9, 2022 / Notices
and the Substance Abuse and Mental
Health Services Administration.
Through HRSA’s RWHAP and Health
Center Program, the agency has a
leading role in helping diagnose, treat,
prevent, and respond to end the HIV
epidemic in the United States.
In June 2022, HRSA awarded nearly
$115 million to RWHAP recipients to
help implement the EHE initiative to
support innovative strategies that help
people with HIV access care, support,
and treatment services to live longer,
healthier lives. EHE initiative funding
was awarded to 39 metropolitan areas
(RWHAP part A) and eight states
(RWHAP part B) to implement strategies
and interventions for the provision of
core medical and supportive services to
reduce new HIV infections.3
In September 2022, HRSA published
a Notice seeking public comment on
this ICR in the Federal Register, 87 FR
59443–44 (September 30, 2022). There
were no public comments.
Need and Proposed Use of the
Information: To support Federal
requirements to monitor and report on
funds distributed through the EHE
Initiative, HRSA created a reporting
module, the EHE Triannual Report, an
aggregate data report submitted three
times a year by EHE recipients and
providers of services. EHE-funded
providers report aggregate information
on the number of clients receiving
specific services and the number of
clients who were prescribed
antiretroviral medications in the 4month reporting period. This module
will provide HRSA with frequent and
timely data on EHE Initiative progress
by providing information on the number
of clients who are reached through the
EHE Initiative. In addition, HRSA can
calculate the number of clients who did
not receive services in the previous year
by subtracting the number of clients
who received services in the previous
year and the number of new clients from
the total number of clients. This will
provide valuable information on the
scope of outreach to new clients and
clients who have had a lapse in service,
which could be an indication of
reengagement in care. This module will
support project officer monitoring and
HRSA’s understanding of service
provision. Finally, the information
collected in the EHE Triannual Report
will complement the annual
information collected through the
RWHAP Services Report and other
reporting mechanisms and support
HRSA in its ability to monitor EHE
initiative activities and assess progress
toward meeting national goals for
ending the HIV epidemic.
Likely Respondents: RWHAP part A
and part B recipients and subrecipients
funded by the EHE initiative.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
EHE Module .........................................................................
HRSA specifically requests comments
on (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.
Maria G. Button,
Director, Executive Secretariat.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: The Rural
Health Network Development Planning
Performance Improvement and
Measurement System Database, OMB
No. 0915–0384—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
BILLING CODE 4165–15–P
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
SUMMARY:
3 FY 2022 EHE Awards. https://
ryanwhite.hrsa.gov/about/parts-and-initiatives/fy-
VerDate Sep<11>2014
17:50 Dec 08, 2022
Jkt 259001
Total
responses
3
........................
AGENCY:
[FR Doc. 2022–26779 Filed 12–8–22; 8:45 am]
lotter on DSK11XQN23PROD with NOTICES1
47
47
Number of
responses per
respondent
141
141
Frm 00053
Fmt 4703
Sfmt 4703
Total
burden
hours
2
........................
282
282
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
Comments on this ICR should be
received no later than February 7, 2023.
DATES:
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
ADDRESSES:
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the HRSA
Information Collection Clearance Officer
at (301) 594–4394.
FOR FURTHER INFORMATION CONTACT:
2022-ending-hiv-epidemic-awards. Accessed
August 19, 2022.
PO 00000
Average
burden per
response
(in hours)
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[Federal Register Volume 87, Number 236 (Friday, December 9, 2022)]
[Notices]
[Pages 75637-75638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26779]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Ending the HIV Epidemic
Initiative Triannual Report, OMB No. 0915-0051--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period. OMB may act on HRSA's ICR only after the
30-day comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than January 9,
2023.
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 Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the HRSA
Information Collection Clearance Officer at [email protected] or call
(301) 594-4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Ending the HIV Epidemic (EHE)
Initiative Triannual Report OMB No. 0915-0051--Extension.
Abstract: HRSA's Ryan White HIV/AIDS Program (RWHAP) funds and
coordinates with cities, states, and local clinics/community-based
organizations to deliver efficient and effective HIV care, treatment,
and support services to low-income people with HIV. Since 1990, the
RWHAP has developed a comprehensive system of safety net providers who
deliver high quality direct health care and support services to over
half a million people with HIV--more than 50 percent of all people with
diagnosed HIV in the United States. Nearly two-thirds of clients
(patients) live at or below 100 percent of the Federal poverty level
and approximately three-quarters of RWHAP clients are racial/ethnic
minorities.\1\
---------------------------------------------------------------------------
\1\ HRSA. Ryan White HIV/AIDS Program Data Report, 2020.
---------------------------------------------------------------------------
The Federal Ending the HIV Epidemic in the U.S. (EHE) initiative
focuses on reducing the number of new HIV infections in the United
States by at least 90 percent by 2030, which would be fewer than 3,000
per year.\2\ Authorized by section 311(c) and title XXVI of the Public
Health Service Act, this 10-year initiative beginning in fiscal year
(FY) 2020 focuses on 48 counties; Washington, DC; San Juan, Puerto
Rico; and seven states that have a substantial rural HIV burden. EHE
initiative efforts focus on the following four key strategies that
together can end the HIV epidemic in the United States:
---------------------------------------------------------------------------
\2\ HRSA. Ending the HIV Epidemic in the U.S. https://www.hrsa.gov/ending-hiv-epidemic. Accessed July 12, 2022.
---------------------------------------------------------------------------
1. Diagnose all people with HIV as early as possible.
2. Treat people with HIV rapidly and effectively to reach sustained
viral suppression.
3. Prevent new HIV transmissions by using proven interventions,
including pre-exposure prophylaxis and syringe services programs.
4. Respond quickly to potential HIV outbreaks to get needed
prevention and treatment services to people who need them.
The EHE initiative is a collaborative effort among key Department
of Health and Human Services agencies, primarily HRSA, the Centers for
Disease Control and Prevention, the National Institutes of Health, the
Indian Health Service,
[[Page 75638]]
and the Substance Abuse and Mental Health Services Administration.
Through HRSA's RWHAP and Health Center Program, the agency has a
leading role in helping diagnose, treat, prevent, and respond to end
the HIV epidemic in the United States.
In June 2022, HRSA awarded nearly $115 million to RWHAP recipients
to help implement the EHE initiative to support innovative strategies
that help people with HIV access care, support, and treatment services
to live longer, healthier lives. EHE initiative funding was awarded to
39 metropolitan areas (RWHAP part A) and eight states (RWHAP part B) to
implement strategies and interventions for the provision of core
medical and supportive services to reduce new HIV infections.\3\
---------------------------------------------------------------------------
\3\ FY 2022 EHE Awards. https://ryanwhite.hrsa.gov/about/parts-and-initiatives/fy-2022-ending-hiv-epidemic-awards. Accessed August
19, 2022.
---------------------------------------------------------------------------
In September 2022, HRSA published a Notice seeking public comment
on this ICR in the Federal Register, 87 FR 59443-44 (September 30,
2022). There were no public comments.
Need and Proposed Use of the Information: To support Federal
requirements to monitor and report on funds distributed through the EHE
Initiative, HRSA created a reporting module, the EHE Triannual Report,
an aggregate data report submitted three times a year by EHE recipients
and providers of services. EHE-funded providers report aggregate
information on the number of clients receiving specific services and
the number of clients who were prescribed antiretroviral medications in
the 4-month reporting period. This module will provide HRSA with
frequent and timely data on EHE Initiative progress by providing
information on the number of clients who are reached through the EHE
Initiative. In addition, HRSA can calculate the number of clients who
did not receive services in the previous year by subtracting the number
of clients who received services in the previous year and the number of
new clients from the total number of clients. This will provide
valuable information on the scope of outreach to new clients and
clients who have had a lapse in service, which could be an indication
of reengagement in care. This module will support project officer
monitoring and HRSA's understanding of service provision. Finally, the
information collected in the EHE Triannual Report will complement the
annual information collected through the RWHAP Services Report and
other reporting mechanisms and support HRSA in its ability to monitor
EHE initiative activities and assess progress toward meeting national
goals for ending the HIV epidemic.
Likely Respondents: RWHAP part A and part B recipients and
subrecipients funded by the EHE initiative.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
EHE Module...................... 47 3 141 2 282
47 .............. 141 .............. 282
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-26779 Filed 12-8-22; 8:45 am]
BILLING CODE 4165-15-P
