Agency Information Collection Activities: Proposed Collection: Public Comment Request, Information Collection Request Title: HIV Quality Measures (HIVQM) Module, OMB No. 0906-0022-Revision, 9362-9363 [2019-04766]
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Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
S. Tissue Engineering
15–56 ......................
1 All
Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue
using Magnetic Resonance Imaging.
ASTM F3224–17.
standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA
Recognized Consensus Standards in a
searchable database that may be
accessed at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has
recognized by notice published in the
Federal Register or that FDA has
decided to recognize but for which
recognition is pending (because a
periodic notice has not yet appeared in
the Federal Register). FDA will
announce additional modifications and
revisions to the list of recognized
consensus standards, as needed, in the
Federal Register once a year, or more
often if necessary. Beginning with list
52, FDA will no longer announce in the
Federal Register updates to current
recognized standards for reapproved or
reaffirmed standards because
reapproved or reaffirmed standards have
not changed from the recognized
standard. International and national
standards developing organizations use
the designations of reapproved or
reaffirmed to indicate a standard has
been reviewed but no changes were
made to the standard at that time.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to
CDRHStandardsStaff@fda.hhs.gov. To
be considered, such recommendations
should contain, at a minimum, the
following information available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123739.htm.
Dated: March 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–04710 Filed 3–13–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request, Information
Collection Request Title: HIV Quality
Measures (HIVQM) Module, OMB No.
0906–0022—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects, HRSA announces plans to
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.
DATES: Comments on this ICR must be
received no later than May 13, 2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: 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 Lisa Wright-Solomon, the HRSA
Information Collection Clearance
Officer, at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
HIV Quality Measures (HIVQM) Module
OMB No. 0906–0022—Revision.
Abstract: HRSA 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 to lowSUMMARY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
income people living with HIV (PLWH).
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. 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 PLWH—more than
50 percent of all people living with
diagnosed HIV in the United States.
All parts of the RWHAP must follow
the legislative requirements for the
establishment of clinical quality
management programs to assess their
HIV services according to the most
recent HHS guidelines and to develop
strategies to improve access to quality
HIV services. The HIVQM Module
supports recipients and subrecipients in
their clinical quality management,
performance measurement, service
delivery, and monitoring of client health
outcomes; and supports the requirement
imposed by the Uniform Administrative
Requirements, Cost Principles, and
Audit Requirements that recipients
relate performance accomplishments of
their Federal awards. 45 CFR 75.301.
The module is accessible via the Ryan
White Services Report, an existing
online portal that RWHAP recipients
already use for required data collection
of their services. While the use of the
module is voluntary for RWHAP
recipients, its use is strongly
encouraged.
The HRSA performance measures are
comprised of 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 performance measures.
Recipients can choose the performance
measures they want to monitor and may
enter data on their measures into the
module up to 4 times a year and then
generate reports to assess their
performance. Recipients may also
compare their performance against other
recipients regionally and nationally.
Need and Proposed Use of the
Information: The HIVQM Module
provides recipients an easy-to-use and
E:\FR\FM\14MRN1.SGM
14MRN1
9363
Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices
structured platform to voluntarily and
continually monitor their performance.
The main purpose for the module is to
help recipients set goals and monitor
performance measures and quality
improvement projects. 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 module is to
qualify them for incentives and comply
with the requirements to receive
incentives from these programs.
For this revised information
collection request, HRSA is proposing to
allow recipients the option to enter data
for specific populations for a subset of
performance measures based on age,
gender, race/ethnicity, and specific risk
factors. In addition, recipients will be
able to generate reports of performance
measures, review them stratified by the
recipients or their service providers, and
compare to results at the state, regional,
and national levels. HRSA is proposing
these enhancements to increase the
functionality and overall usability of the
HIVQM Module.
Likely Respondents: HRSA Ryan
White HIV/AIDS Program Part A, Part B,
Part C, and Part D recipients and their
service providers and the AIDS Drug
Assistance Program 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.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
HIVQM Report .....................................................................
2,316
4
9,264
1
9,264
Total ..............................................................................
2,316
........................
9,264
........................
9,264
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.
development of the National Youth
Sports Strategy.
The meeting for the public to
provide oral remarks to HHS will be
held on Thursday, April 4, 2019, from
9:00 a.m. to 5:00 p.m. E.D.T.
DATES:
John R. Womack,
Acting Deputy Director, Division of the
Executive Secretariat.
Those providing public oral
remarks to HHS are required to attend
the listening session in-person at the
Hubert H. Humphrey Building,
Auditorium, 200 Independence Ave.
SW, Washington, DC 20201. Others
wanting to attend can do so in-person or
via webcast on the internet.
[FR Doc. 2019–04766 Filed 3–13–19; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4165–15–P
Katrina L. Piercy, Ph.D., R.D., Office of
Disease Prevention and Health
Promotion (ODPHP), Office of the
Assistant Secretary for Health (OASH),
HHS; 1101 Wootton Parkway, Suite LL–
100; Rockville, MD 20852; Telephone:
(240) 453–8280. Email: odphpinfo@
hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Listening Session To Inform the
Development of the National Youth
Sports Strategy
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) provides notice
of a public listening session; invites the
public to attend; and solicits request to
provide oral remarks to inform the
SUMMARY:
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17:22 Mar 13, 2019
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ADDRESSES:
Executive
Order 13824 directs the development of
a National Strategy on Youth Sports and
outlines the key pillars that the strategy
will address. The Office of Disease
Prevention and Health Promotion, in
collaboration with the President’s
Council on Sports, Fitness & Nutrition,
Centers for Disease Control and
Prevention, and National Institutes of
Health, is leading the development of
this strategy.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00076
Fmt 4703
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Key Pillars of Youth Sports Strategy
1. Increase awareness of the benefits
of participation in sports and regular
physical activity, as well as the
importance of good nutrition;
2. Promote private and public sector
strategies to increase participation in
sports, encourage regular physical
activity, and improve nutrition;
3. Develop metrics that gauge youth
sports participation and physical
activity to inform efforts that will
improve participation in sports and
regular physical activity among young
Americans; and
4. Establish a national and local
strategy to recruit volunteers who will
encourage and support youth
participation in sports and regular
physical activity, through coaching,
mentoring, teaching, or administering
athletic and nutritional programs.
Agenda: The agenda will include
opportunity for the public to provide
oral remarks to HHS and to hear an
update about this project from HHS.
Submitting a Request to Speak: HHS
requests applications from organizations
to speak at the April 4, 2019 listening
session. There are a limited number of
speaking slots available. Length of
presentation will be determined based
on interest and is anticipated to be
approximately 15 minutes per
organization, including time for
comments or questions. HHS is
interested in hearing from organizations
that have experience and expertise in
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[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9362-9363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04766]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request, Information Collection Request Title: HIV
Quality Measures (HIVQM) Module, OMB No. 0906-0022--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects, HRSA announces plans to
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.
DATES: Comments on this ICR must be received no later than May 13,
2019.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: 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 Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer, at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: HIV Quality Measures (HIVQM)
Module OMB No. 0906-0022--Revision.
Abstract: HRSA 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 to low-income people living with HIV (PLWH). 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. 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 PLWH--
more than 50 percent of all people living with diagnosed HIV in the
United States.
All parts of the RWHAP must follow the legislative requirements for
the establishment of clinical quality management programs to assess
their HIV services according to the most recent HHS guidelines and to
develop strategies to improve access to quality HIV services. The HIVQM
Module supports recipients and subrecipients in their clinical quality
management, performance measurement, service delivery, and monitoring
of client health outcomes; and supports the requirement imposed by the
Uniform Administrative Requirements, Cost Principles, and Audit
Requirements that recipients relate performance accomplishments of
their Federal awards. 45 CFR 75.301. The module is accessible via the
Ryan White Services Report, an existing online portal that RWHAP
recipients already use for required data collection of their services.
While the use of the module is voluntary for RWHAP recipients, its use
is strongly encouraged.
The HRSA performance measures are comprised of 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 performance measures. Recipients can choose the
performance measures they want to monitor and may enter data on their
measures into the module up to 4 times a year and then generate reports
to assess their performance. Recipients may also compare their
performance against other recipients regionally and nationally.
Need and Proposed Use of the Information: The HIVQM Module provides
recipients an easy-to-use and
[[Page 9363]]
structured platform to voluntarily and continually monitor their
performance. The main purpose for the module is to help recipients set
goals and monitor performance measures and quality improvement
projects. 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 module is to qualify them for incentives
and comply with the requirements to receive incentives from these
programs.
For this revised information collection request, HRSA is proposing
to allow recipients the option to enter data for specific populations
for a subset of performance measures based on age, gender, race/
ethnicity, and specific risk factors. In addition, recipients will be
able to generate reports of performance measures, review them
stratified by the recipients or their service providers, and compare to
results at the state, regional, and national levels. HRSA is proposing
these enhancements to increase the functionality and overall usability
of the HIVQM Module.
Likely Respondents: HRSA Ryan White HIV/AIDS Program Part A, Part
B, Part C, and Part D recipients and their service providers and the
AIDS Drug Assistance Program 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.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
HIVQM Report.................... 2,316 4 9,264 1 9,264
-------------------------------------------------------------------------------
Total....................... 2,316 .............. 9,264 .............. 9,264
----------------------------------------------------------------------------------------------------------------
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.
John R. Womack,
Acting Deputy Director, Division of the Executive Secretariat.
[FR Doc. 2019-04766 Filed 3-13-19; 8:45 am]
BILLING CODE 4165-15-P
