Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: HRSA Ryan White HIV/AIDS Program HIV Quality Measures Module, OMB No. 0906-0022-Extension, 57912-57914 [2022-20572]
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57912
Federal Register / Vol. 87, No. 183 / Thursday, September 22, 2022 / Notices
Resource (eSTAR) is the only electronic
submission template available to
prepare a complete 510(k) electronic
submission using the guided prompts
for the collection of structured and
unstructured data.
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original submissions for Traditional,
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the date on which the 510(k) electronic
submission requirements will take
effect.
A notice of availability of the draft
guidance appeared in the Federal
Register of September 29, 2021 (86 FR
53965). FDA considered comments
received and revised the guidance as
appropriate in response to the
comments, including updated criteria
for exemptions; clarification of the
technical screening hold; and
description of the transition period and
effective date on which 510(k)
electronic submissions will be required.
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authorization to FDA to specify in
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of the FD&C Act (i.e., standards,
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exemptions), indicated by the use of the
mandatory words, such as must or
required, this document is not subject to
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the requirement that guidances not
establish legally enforceable
responsibilities. (See § 10.115(d).)
To the extent that this final guidance
describes recommendations that are not
standards, timetable, criteria for waivers
of, or exemptions under section
745A(b)(3) of the FD&C Act, it is being
issued in accordance with FDA’s good
guidance practices regulation (§ 10.115).
This guidance represents the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
final guidance contains both binding
and nonbinding provisions.
II. Electronic Access
Persons interested in obtaining a copy
of the 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
21 CFR part or FDA form
[FR Doc. 2022–20512 Filed 9–21–22; 8:45 am]
Medical Device Labeling Regulations ........................................
0910–0485
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
jspears on DSK121TN23PROD with NOTICES
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
Jkt 256001
OMB control
No.
0910–0120
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: HRSA Ryan
White HIV/AIDS Program HIV Quality
Measures Module, OMB No. 0906–
0022—Extension
17:32 Sep 21, 2022
While this guidance contains no new
collection of information, it does refer to
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 and forms have been
approved by OMB as listed in the
following table:
Premarket Notification Submission, including submissions via
eSTAR.
BILLING CODE 4164–01–P
VerDate Sep<11>2014
III. Paperwork Reduction Act of 1995
Topic
807 subpart E, including forms FDA 4062 eSTAR and FDA
4078 eSTAR (for In Vitro Diagnostic (IVD) 510(k) submissions).
800, 801, and 809 .......................................................................
Dated: September 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics.
Persons unable to download an
electronic copy of ‘‘Electronic
Submission Template for Medical
Device 510(k) 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 19006 and complete
title to identify the guidance you are
requesting.
PO 00000
Notice.
Frm 00049
Fmt 4703
Sfmt 4703
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 October 24, 2022.
ADDRESSES: Written comments and
recommendations for the proposed
SUMMARY:
E:\FR\FM\22SEN1.SGM
22SEN1
Federal Register / Vol. 87, No. 183 / Thursday, September 22, 2022 / Notices
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
paperwork@hrsa.gov, or call (301) 443–
9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
HIV Quality Measures (HIVQM) Module
OMB No. 0906–0022—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
diagnosed with HIV in the United
States. Nearly two-thirds of clients live
at or below 100 percent of the federal
poverty level and approximately threequarters of RWHAP clients are racial/
ethnic minorities.1
RWHAP Parts A, B, C and D
recipients and subrecipients must
follow the legislative requirements for
the establishment of clinical quality
management programs to assess the
extent to which their HIV services are
consistent with the most recent HHS
Clinical Treatment guidelines. In
support of these requirements, HRSA
created the RWHAP HIVQM Module as
an online tool to assist recipients in
meeting the clinical quality
management program requirement by
allowing recipients to input data for the
HRSA performance measures. HRSA
maintains over 40 performance
measures across the following
categories: (1) core, (2) all ages, (3)
adolescent/adult, (4) HIV-infected
children, (5) HIV-exposed children, (6)
medical case management, (7) oral
health, (8) AIDS drug assistance
program, and (9) systems-level. The
RWHAP HIVQM Module also supports
the requirement imposed by the
Uniform Administrative Requirements,
Cost Principles, and Audit
Requirements for HHS Award (45 CFR
75.301) that recipients relate
performance accomplishments of their
federal awards. The RWHAP HIVQM
Module helps recipients set goals and
monitor performance measures and
quality improvement projects. The use
of the RWHAP HIVQM Module is
voluntary for RWHAP recipients but
strongly encouraged.
A 60-day notice published in the
Federal Register, 87 FR 34887–88 (June
8, 2022). There were were no public
comments.
Need and Proposed Use of the
Information: The RWHAP HIVQM
Module supports recipients and subrecipients in their clinical quality
management programs, performance
measurement, service delivery, and
monitoring of client health outcomes
and quality HIV services. The RWHAP
HIVQM Module is accessible via the
RWHAP Services Report, an existing
online portal that RWHAP recipients
use for required data collection of their
services. Recipients may enter
performance measures data into the
RWHAP HIVQM Module four times a
year and then generate reports to assess
57913
their performance. Recipients have the
option to enter data for specific
populations for a subset of performance
measures based on age, gender, race/
ethnicity, and risk factor. Recipients
may also compare their performance
against other recipients in their state,
regionally, and nationally. Additionally,
recipients can choose the performance
measures they want to monitor and
enter data accordingly. For recipients
and sub-recipients participating in the
Centers for Medicare & Medicaid
Incentive Programs, such as the
Medicare Promoting Interoperability
Program and the Merit-based Incentive
Payment System, the RWHAP HIVQM
Module may be used to monitor the
HRSA measures that qualify and comply
with the requirements to receive
incentives from these programs.
Likely Respondents: RWHAP Part A,
Part B, Part C, and Part D recipients and
their sub-recipients.
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. There is
a decrease in burden due to improved
burden calculation obtained through
conducting a pilot program.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Total
burden
hours
HIVQM Report .....................................................................
2,063
4
8,252
* .216/60
1,788
Total ..............................................................................
2,063
........................
8,252
........................
1,788
* Exact number is .216674745.
jspears on DSK121TN23PROD with NOTICES
Average
burden per
response
(in hours)
1 HRSA. Ryan White HIV/AIDS Program Data
Report (RSR) 2020.
VerDate Sep<11>2014
17:32 Sep 21, 2022
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Federal Register / Vol. 87, No. 183 / Thursday, September 22, 2022 / Notices
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. 2022–20572 Filed 9–21–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the CDC/HRSA Advisory
Committee on HIV, Viral Hepatitis and
STD Prevention and Treatment
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
Centers for Disease Control and
Prevention (CDC)/HRSA Advisory
Committee on HIV, Viral Hepatitis and
STD Prevention and Treatment (CHAC)
has scheduled a public meeting.
Information about CHAC and the agenda
for this meeting can be found on the
CHAC website at https://www.cdc.gov/
maso/facm/facmCHACHSPT.html and
the meeting website at https://
targethiv.org/ta-org/chac.
DATES:
• November 1, 2022, 12:30 p.m.–5:00
p.m. Eastern Time (ET);
• November 2, 2022, 12:30 p.m.–5:30
p.m. ET; and
• November 3, 2022, 12:30 p.m.–4:00
p.m. ET.
ADDRESSES: This meeting will be held
virtually. Advance registration is
required to attend. Please visit the
meeting website to register. The
registration deadline is Friday, October
28, 2022, at 12:00 p.m. ET. Prior to the
meeting, each individual registrant will
receive a registration confirmation along
with an access link to the virtual
meeting location.
• Meeting website link: https://
targethiv.org/ta-org/chac.
FOR FURTHER INFORMATION CONTACT:
Theresa Jumento, Senior Public Health
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:32 Sep 21, 2022
Jkt 256001
Advisor, HIV/AIDS Bureau, HRSA, 301–
443–5807; or CHACAdvisoryComm@
hrsa.gov.
CHAC
provides advice and recommendations
to the Secretary of HHS (Secretary) on
policy, program development, and other
matters of significance concerning the
activities under Section 222 of the
Public Health Service Act, 42 U.S.C.
217a.
The purpose of the CHAC is to advise
the Secretary of HHS, the Director of
CDC, and the HRSA Administrator
regarding objectives, strategies, policies,
and priorities for the prevention and
treatment of HIV, viral hepatitis, and
other STDs, including: surveillance,
epidemiologic, behavioral, health
services, and laboratory research,
identification of policy issues related to
professional eduction, patient
healthcare delivery, and prevention
services; Agency policies regarding
health care delivery, research and
training; strategic issues influencing the
ability of CDC and HRSA to fulfill their
missions programmatic efforts to
prevent and treat HIV, viral hepatitis,
and other STDs; and support to the CDC
and HRSA in their development of
responses to emerging health needs
related to these issues.
During the November 1–3, 2022,
meeting, CHAC will discuss issues
related to HIV and the workforce,
including non-traditional partnerships
to address people with HIV who are out
of care, AIDS Education and Training
Center program and integrating
innovative programs to address HIV
workforce challenges into the Ryan
White HIV/AIDS Program, and how to
more effectively use community health
workers and disease intervention
specialists in HIV and STD prevention,
care, and treatment, along with a federal
update on Monkeypox. Agenda items
are subject to change as priorities
dictate. Refer to the CHAC meeting
information page for any updated
information concerning the meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may also submit
written statements as further described
below. Oral comments will be honored
in the order they are requested and may
be limited as time allows. Requests to
submit a written statement or make oral
comments to CHAC should be sent via
the meeting website at https://
targethiv.org/ta-org/chac. Requests for
oral comment must be received by
October 25, 2022, at 5 p.m. ET to be
considered. Written comments may be
submitted to Theresa Jumento at the
email address and/or phone number
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
listed above prior to and up to ten
business days after the meeting. Visit
the meeting information page for
additional details: https://targethiv.org/
ta-org/chac.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Theresa Jumento at the email
address and/or phone number listed
above at least 10 business days prior to
the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–20528 Filed 9–21–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0004]
Agency Information Collection
Request. 30-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 October 24, 2022
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:
Sagal Musa, sagal.musa@hhs.gov or
(202) 205–2634. When submitting
comments or requesting information,
please include the document identifier
4040–0004–30D and project title for
reference.
SUMMARY:
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22SEN1.SGM
22SEN1
]]>Agencies
[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Notices]
[Pages 57912-57914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20572]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: HRSA Ryan
White HIV/AIDS Program HIV Quality Measures Module, OMB No. 0906-0022--
Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
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 October
24, 2022.
ADDRESSES: Written comments and recommendations for the proposed
[[Page 57913]]
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) 443-9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: HIV Quality Measures (HIVQM)
Module OMB No. 0906-0022--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
diagnosed with HIV in the United States. Nearly two-thirds of clients
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 (RSR) 2020.
---------------------------------------------------------------------------
RWHAP Parts A, B, C and D recipients and subrecipients must follow
the legislative requirements for the establishment of clinical quality
management programs to assess the extent to which their HIV services
are consistent with the most recent HHS Clinical Treatment guidelines.
In support of these requirements, HRSA created the RWHAP HIVQM Module
as an online tool to assist recipients in meeting the clinical quality
management program requirement by allowing recipients to input data for
the HRSA performance measures. HRSA maintains over 40 performance
measures across the following categories: (1) core, (2) all ages, (3)
adolescent/adult, (4) HIV-infected children, (5) HIV-exposed children,
(6) medical case management, (7) oral health, (8) AIDS drug assistance
program, and (9) systems-level. The RWHAP HIVQM Module also supports
the requirement imposed by the Uniform Administrative Requirements,
Cost Principles, and Audit Requirements for HHS Award (45 CFR 75.301)
that recipients relate performance accomplishments of their federal
awards. The RWHAP HIVQM Module helps recipients set goals and monitor
performance measures and quality improvement projects. The use of the
RWHAP HIVQM Module is voluntary for RWHAP recipients but strongly
encouraged.
A 60-day notice published in the Federal Register, 87 FR 34887-88
(June 8, 2022). There were were no public comments.
Need and Proposed Use of the Information: The RWHAP HIVQM Module
supports recipients and sub-recipients in their clinical quality
management programs, performance measurement, service delivery, and
monitoring of client health outcomes and quality HIV services. The
RWHAP HIVQM Module is accessible via the RWHAP Services Report, an
existing online portal that RWHAP recipients use for required data
collection of their services. Recipients may enter performance measures
data into the RWHAP HIVQM Module four times a year and then generate
reports to assess their performance. Recipients have the option to
enter data for specific populations for a subset of performance
measures based on age, gender, race/ethnicity, and risk factor.
Recipients may also compare their performance against other recipients
in their state, regionally, and nationally. Additionally, recipients
can choose the performance measures they want to monitor and enter data
accordingly. For recipients and sub-recipients participating in the
Centers for Medicare & Medicaid Incentive Programs, such as the
Medicare Promoting Interoperability Program and the Merit-based
Incentive Payment System, the RWHAP HIVQM Module may be used to monitor
the HRSA measures that qualify and comply with the requirements to
receive incentives from these programs.
Likely Respondents: RWHAP Part A, Part B, Part C, and Part D
recipients and their sub-recipients.
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. There is a decrease in
burden due to improved burden calculation obtained through conducting a
pilot program.
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)
----------------------------------------------------------------------------------------------------------------
HIVQM Report.................... 2,063 4 8,252 * .216/60 1,788
-------------------------------------------------------------------------------
Total....................... 2,063 .............. 8,252 .............. 1,788
----------------------------------------------------------------------------------------------------------------
* Exact number is .216674745.
[[Page 57914]]
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. 2022-20572 Filed 9-21-22; 8:45 am]
BILLING CODE 4165-15-P
