Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Ryan White HIV/AIDS Program (RWHAP) Compilation of Best Practice Strategies and Interventions, OMB No. 0906-xxxx-NEW, 54615-54616 [2019-22162]
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Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Notices
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 809 have
been approved under OMB control
number 0910–0485. The collections of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0755. The collections of
information in 21 CFR 56.115 have been
approved under OMB control number
0910–0130. The collections of
information in 21 CFR 50.23 have been
approved under OMB control number
0910–0586. The collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078. The collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073. The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; and the collections
of information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001. The collections of
information in the guidance document
entitled ‘‘Requests for Feedback and
Meetings for Medical Device
Submissions: The Q-Submission
Program’’ (available at https://
www.fda.gov/media/114034/download)
have been approved under OMB control
number 0910–0756.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, or https://
www.regulations.gov.
Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22117 Filed 10–9–19; 8:45 am]
BILLING CODE 4164–01–P
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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; Information Collection
Request Title: Ryan White HIV/AIDS
Program (RWHAP) Compilation of Best
Practice Strategies and Interventions,
OMB No. 0906–xxxx–NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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.
DATES: Comments on this ICR should be
received no later than November 12,
2019.
SUMMARY:
Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Ryan White HIV/AIDS Program
(RWHAP) Compilation of Best Practice
Strategies and Interventions, OMB No.
0906–xxxx–New
Abstract: HRSA’s RWHAP funds and
coordinates with cities, states, and local
clinics/community-based organizations
to deliver efficient and effective HIV
care, treatment, and support to lowincome people with HIV (PWH). Nearly
two-thirds of clients (patients) live at or
below 100 percent of the Federal
poverty level and approximately threequarters 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 people living with
ADDRESSES:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
54615
HIV (PLWH)—more than 50 percent of
all people living with diagnosed HIV in
the United States. HRSA is developing
a comprehensive, web-based
compilation of RWHAP recipient and
subrecipient best practice strategies and
interventions. When completed, the
online recipient compilation will be
housed on TargetHIV.org (HRSA’s
technical assistance site for recipients
and subrecipients) and structured to
allow programs to easily search and
identify RWHAP best practice strategies
and interventions for implementation.
Recipients and subrecipients may
voluntarily complete a submission form,
also housed on TargetHIV.org, when
they have a best practice strategy or
intervention to share. Strategies and
interventions that meet certain criteria
will be incorporated into the online
compilation.
The project team has developed a
draft submission form and criteria for
the types of strategies and interventions
to be included in the compilation based
on: (1) The quality and relevance of the
approach to the RWHAP; (2) the level of
feasibility, replicability, and
sustainability; and (3) the quality of
evidence that supports the approach’s
results.
Specifically, this information
collection request involves three forms
of data collection as described below.
1. Pre-Submission Screening Form:
Through extensive outreach, the project
team expects up to 70 recipients and
subrecipients to express interest in
submission. They will be asked four
screening questions to determine
whether they are eligible for inclusion
in the compilation.
2. Submission Form: Recipients and
subrecipients that screen eligible will
then complete a submission form
describing their strategy or intervention,
including service delivery model, target
population, expected or achieved
outcomes, and resource requirements.
The project team will score the
submissions based on the established
criteria.
3. Site Visit Discussion Guide: The
project team will conduct up to 30 site
visits to test the criteria and gather
feedback on the submission form and
compilation. The half-day site visits will
involve individual or small group
discussions with program staff involved
in implementation (e.g., program
managers, direct service providers, and
evaluators). The project team will then
revise the submission form, criteria, and
compilation template based on
feedback.
A 60-day Federal Register Notice was
published in the Federal Register on
E:\FR\FM\10OCN1.SGM
10OCN1
54616
Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Notices
June 19, 2019, vol. 84, No. 118; pp.
28561. There were no public comments.
Need and Proposed Use of the
Information: The purpose of this data
collection effort is for HRSA contractors
to assess the review criteria being used
to systematically identify and select
RWHAP-funded best practice
intervention strategies that demonstrate
impact across the HIV care continuum
for the online compilation.
Assessing the review criteria will
allow HRSA to obtain important
information from recipients and
determine if the intervention strategies
shared via the submission form are
effective in improving outcomes across
the HIV care continuum. Intervention
strategies that meet the review criteria
verified by HRSA contractors and
approved by HRSA program staff
through this data collection will be
considered best practices and made
available through the online
compilation for consideration,
adaptation, and replication by other HIV
programs. In addition, the best practices
will support peer exchange to resolve
problems impacting HIV care and
treatment and eliminating disparities in
health outcomes.
Likely Respondents: RWHAP
recipients and subrecipients that
voluntarily submit a best practice
strategy or intervention will participate
in the data collection. The project team
expects that up to 70 recipients and
subrecipients will complete the
screening form and 50 will screen
eligible and complete the full
submission form. For the site visits, the
project team will strategically select 30
sites from the universe of submitted
eligible initiatives, ensuring a range of
scores and representativeness of factors
such as Census region, proposed
strategy/intervention outcome, priority
population, and the type of agency or
provider implementing the strategy or
intervention.
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
Total
responses
Average
burden
per response
(in hours)
Total
burden
hours
Pre-Submission Screening Form .........................................
Submission Form .................................................................
Site Visit Discussion Guide ..................................................
Program Manager Interview .........................................
Direct Service Provider Interview .................................
Evaluator Interview .......................................................
70
50
120
30
60
30
1
1
1
1
1
1
70
50
120
30
60
30
0.08
3.00
0.75
1.50
0.50
0.50
5.60
150.00
* 90.00
45.00
30.00
15.00
Total .......................................................................
* * 240
........................
240
........................
245.60
* For a total of 90 hours, each of the 30 site visits will include 1.5-hour interviews with a program manager (45 hours), up to two 0.5-hour interviews with direct service providers (30 hours), and an 0.5-hour interview with an evaluator (15 hours).’
** The total number of respondents is 240 as comprised by the number of respondents for the pre-submission screening form (70), the submission form (50), and the site visit discussion guide (120).
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019–22162 Filed 10–9–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Public Comment
Request; Hospital Campaign for Organ
Donation Scorecard, OMB No. 0915–
0373, Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
SUMMARY:
VerDate Sep<11>2014
19:50 Oct 09, 2019
Jkt 250001
HRSA 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.
DATES: Comments on this ICR should be
received no later than November 12,
2019.
Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
ADDRESSES:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Hospital Campaign for Organ Donation
Scorecard OMB No. 0915–0373,
Revision
Abstract: HRSA’s Hospital Campaign
for Organ Donation enlists healthcare
organizations nationwide to increase the
number of registered organ, eye, and
tissue donors by hosting education and
donor registration events in their
facilities and communities. A scorecard
identifies activities that participants can
implement and assigns points to each
activity. Participants that earn a certain
number of points annually are
recognized by HRSA and the campaign’s
national partners.
For this information collection
request, the proposed change to the
Scorecard is the addition of the 2020
date. HRSA also intends to create a new
electronic version of the Scorecard for
future campaigns that will ultimately
reduce the level of burden for
E:\FR\FM\10OCN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54615-54616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22162]
-----------------------------------------------------------------------
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; Information Collection
Request Title: Ryan White HIV/AIDS Program (RWHAP) Compilation of Best
Practice Strategies and Interventions, OMB No. 0906-xxxx-NEW
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.
DATES: Comments on this ICR should be received no later than November
12, 2019.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION: Information Collection Request Title: Ryan
White HIV/AIDS Program (RWHAP) Compilation of Best Practice Strategies
and Interventions, OMB No. 0906-xxxx-New
Abstract: HRSA's 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
with HIV (PWH). 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 people living with HIV (PLWH)--more than 50 percent of
all people living with diagnosed HIV in the United States. HRSA is
developing a comprehensive, web-based compilation of RWHAP recipient
and subrecipient best practice strategies and interventions. When
completed, the online recipient compilation will be housed on
TargetHIV.org (HRSA's technical assistance site for recipients and
subrecipients) and structured to allow programs to easily search and
identify RWHAP best practice strategies and interventions for
implementation. Recipients and subrecipients may voluntarily complete a
submission form, also housed on TargetHIV.org, when they have a best
practice strategy or intervention to share. Strategies and
interventions that meet certain criteria will be incorporated into the
online compilation.
The project team has developed a draft submission form and criteria
for the types of strategies and interventions to be included in the
compilation based on: (1) The quality and relevance of the approach to
the RWHAP; (2) the level of feasibility, replicability, and
sustainability; and (3) the quality of evidence that supports the
approach's results.
Specifically, this information collection request involves three
forms of data collection as described below.
1. Pre-Submission Screening Form: Through extensive outreach, the
project team expects up to 70 recipients and subrecipients to express
interest in submission. They will be asked four screening questions to
determine whether they are eligible for inclusion in the compilation.
2. Submission Form: Recipients and subrecipients that screen
eligible will then complete a submission form describing their strategy
or intervention, including service delivery model, target population,
expected or achieved outcomes, and resource requirements. The project
team will score the submissions based on the established criteria.
3. Site Visit Discussion Guide: The project team will conduct up to
30 site visits to test the criteria and gather feedback on the
submission form and compilation. The half-day site visits will involve
individual or small group discussions with program staff involved in
implementation (e.g., program managers, direct service providers, and
evaluators). The project team will then revise the submission form,
criteria, and compilation template based on feedback.
A 60-day Federal Register Notice was published in the Federal
Register on
[[Page 54616]]
June 19, 2019, vol. 84, No. 118; pp. 28561. There were no public
comments.
Need and Proposed Use of the Information: The purpose of this data
collection effort is for HRSA contractors to assess the review criteria
being used to systematically identify and select RWHAP-funded best
practice intervention strategies that demonstrate impact across the HIV
care continuum for the online compilation.
Assessing the review criteria will allow HRSA to obtain important
information from recipients and determine if the intervention
strategies shared via the submission form are effective in improving
outcomes across the HIV care continuum. Intervention strategies that
meet the review criteria verified by HRSA contractors and approved by
HRSA program staff through this data collection will be considered best
practices and made available through the online compilation for
consideration, adaptation, and replication by other HIV programs. In
addition, the best practices will support peer exchange to resolve
problems impacting HIV care and treatment and eliminating disparities
in health outcomes.
Likely Respondents: RWHAP recipients and subrecipients that
voluntarily submit a best practice strategy or intervention will
participate in the data collection. The project team expects that up to
70 recipients and subrecipients will complete the screening form and 50
will screen eligible and complete the full submission form. For the
site visits, the project team will strategically select 30 sites from
the universe of submitted eligible initiatives, ensuring a range of
scores and representativeness of factors such as Census region,
proposed strategy/intervention outcome, priority population, and the
type of agency or provider implementing the strategy or intervention.
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
----------------------------------------------------------------------------------------------------------------
Pre-Submission Screening Form... 70 1 70 0.08 5.60
Submission Form................. 50 1 50 3.00 150.00
Site Visit Discussion Guide..... 120 1 120 0.75 * 90.00
Program Manager Interview... 30 1 30 1.50 45.00
Direct Service Provider 60 1 60 0.50 30.00
Interview..................
Evaluator Interview......... 30 1 30 0.50 15.00
-------------------------------------------------------------------------------
Total................... * * 240 .............. 240 .............. 245.60
----------------------------------------------------------------------------------------------------------------
* For a total of 90 hours, each of the 30 site visits will include 1.5-hour interviews with a program manager
(45 hours), up to two 0.5-hour interviews with direct service providers (30 hours), and an 0.5-hour interview
with an evaluator (15 hours).'
** The total number of respondents is 240 as comprised by the number of respondents for the pre-submission
screening form (70), the submission form (50), and the site visit discussion guide (120).
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-22162 Filed 10-9-19; 8:45 am]
BILLING CODE 4165-15-P
