Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Enhancing HIV Care of Women, Infants, Children and Youth Building Capacity Through Communities of Practice, 30767-30768 [2023-10192]
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Federal Register / Vol. 88, No. 92 / Friday, May 12, 2023 / Notices
II. Paperwork Reduction Act of 1995
While this guidance contains no
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 21 CFR 601.12 have been
approved under OMB control number
0910–0338; the collections of
information in 21 CFR 606.121 and
parts 610 and 630 have been approved
under OMB control number 0910–0116;
and the collections of information for
consignee notification have been
approved under OMB control number
0910–0681.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: May 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–10252 Filed 5–11–23; 8:45 am]
BILLING CODE 4164–01–P
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; Enhancing HIV Care of
Women, Infants, Children and Youth
Building Capacity Through
Communities of Practice
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:11 May 11, 2023
Jkt 259001
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
Comments on this ICR should be
received no later than June 12, 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, Samantha
Miller, the HRSA Information Collection
Clearance Officer, at paperwork@
hrsa.gov or call (301) 594–4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Enhancing HIV Care of Women, Infants,
Children and Youth Building Capacity
through Communities of Practice, OMB
No. 0915–xxxx—New.
Abstract: HRSA aims to increase
delivery of evidence-based interventions
that enhance client outcomes, increase
the skill level of the HIV workforce
providing care and treatment to Women,
Infants, Children and Youth, and
involve partnerships for dissemination
of best practices to Ryan White HIV/
AIDS Program (RWHAP) Part D
participants. To that end, HRSA seeks to
implement a Communities of Practice
(CoP) platform for RWHAP Part D
recipients. A CoP engages recipient
teams in improvement learning sessions
using subject matter experts along with
application experts who help recipient
teams select, test, and implement
changes on the front line of care.
Through organizational selfassessments, didactic learning on
specific care topics, goals setting, and
work plan development, each team can
strategically benefit their organization.
CoPs afford participants the opportunity
to work in a group to solve a recognized
challenge related to a CoP domain and
support dialogue among participants
and the consultant/subject matter
experts. Recipient teams commit to
working over a period of 12 months,
alternating between Learning Sessions
in which teams come together to learn
about the chosen topic and to plan
changes, and Action Periods in which
the teams return to their respective
organizations and test those changes in
their clinic settings. The domains for the
proposed CoPs are trauma informed
care, pre-conception counseling, and
DATES:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
30767
youth transitioning into adult HIV care
services.
A 60-day notice published in the
Federal Register on February 27, 2023,
vol. 88, No. 38; pp. 12386–12387. The
one comment received was outside the
scope of the ICR, and therefore no
changes to the information collection
were made as a result of this comment.
Need and Proposed Use of the
Information: Process and outcome
evaluations are a critical part of
ensuring that CoP initiatives were
implemented as planned and met their
intended outcome. Evaluation of
technical assistance (TA) depends on
establishing clear goals and plans from
the beginning of the process. This
includes specifying the intended impact
of the TA with concrete, measurable
objectives. To judge performance against
goals, HRSA will administer TA
evaluation surveys following TA and
training, webinars, teleconferences, and
meetings. Findings will drive quality
improvement activities and reports.
The evaluation plan focuses on
process and impact evaluation of all
CoP Teams (Pre-Conception Counseling
and Sexual Health, Trauma-Informed
Care, and Transitioning Adolescents to
Adult Care) over the duration of the 4year period of performance. The
evaluation plan components will be
operationalized to include TA
satisfaction measures (reaction), change
in knowledge after the TA (learning),
and change in behavior or practice after
the introduction of evidence-based
interventions (behavior). More
specifically, the evaluation plan
includes (1) post TA satisfaction
measures, (2) pre-post measures of CoP
staff knowledge about effective
practices, (3) retrospective measures to
gather measures of CoP staff knowledge
for the first community of practice only,
and (4) measures of TA usefulness and
impact on CoP performance.
Likely Respondents: Up to 90 RWHAP
Part D Women, Infants, Children and
Youth recipients will participate in the
CoPs. Each recipient may have up to six
staff members who may complete the
survey.
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
E:\FR\FM\12MYN1.SGM
12MYN1
30768
Federal Register / Vol. 88, No. 92 / Friday, May 12, 2023 / Notices
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
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Pre-conception Counseling Community of Practice Retrospective Pretest-Post Assessment ...................................
Community of Practice Pre-Assessment .............................
Community of Practice Post-Assessment ...........................
Community of Practice Session Assessment ......................
Targeted and Intensive TA Assessment .............................
Foundational TA Assessment ..............................................
90
180
180
270
120
150
1
1
1
6
1
1
90
180
180
1,620
120
150
.4733
.2900
.3767
.0767
.0833
.0616
42.6
52.2
67.8
124.3
10.0
9.2
Total ..............................................................................
990
........................
2,340
........................
306.1
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–10192 Filed 5–11–23; 8:45 am]
BILLING CODE 4165–15–P
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; Delta States Rural
Development Network Grant Program,
OMB No. 0915–0386—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,
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. 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 June 12, 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/
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
VerDate Sep<11>2014
19:11 May 11, 2023
Jkt 259001
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) 594–
4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Delta States Rural Development
Network Grant Program—OMB No.
0915–0386—Revision.
Abstract: The Delta States Rural
Development Network Grant (Delta)
Program is authorized by the Public
Health Service Act, section 330A(f) (42
U.S.C. 254c(f)). The Delta Program
supports projects that demonstrate
evidence based and/or promising
approaches around cardiovascular
disease, diabetes, acute ischemic stroke,
or obesity in order to improve health
status in rural communities throughout
the Delta Region. Key features of Delta
Program-supported projects are
collaboration, adoption of an evidencebased approach, demonstration of
health outcomes, program replicability,
and sustainability. HRSA collects
information from Delta Program award
recipients using an OMB-approved set
of performance measures and seeks to
extend that approved information
collection.
A 60-day notice published in the
Federal Register on February 02, 2023,
vol. 88, No. 22; pp. 7095–96. There were
no public comments. Since the
publication of the 60-day notice, HRSA
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
has updated the estimated average
burden per response from 1.66 hours to
2 hours, with a corresponding increase
in the estimated total annual burden for
this ICR.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data useful to the program and
to enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993 (Pub. L. 103–62).
These measures cover the principal
topic areas of interest to HRSA
including the following: (a) access to
care, (b) population demographics, (c)
staffing, (d) sustainability, (e) project
specific domains, and (f) health related
clinical measures. These measures
encompass HRSA’s progress toward
meeting the goals set.
Likely Respondents: Grant recipients
of the Delta Program.
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.
E:\FR\FM\12MYN1.SGM
12MYN1
]]>Agencies
[Federal Register Volume 88, Number 92 (Friday, May 12, 2023)]
[Notices]
[Pages 30767-30768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10192]
-----------------------------------------------------------------------
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; Enhancing HIV Care of
Women, Infants, Children and Youth Building Capacity Through
Communities of Practice
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, 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. 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 June 12,
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, Samantha Miller, the HRSA
Information Collection Clearance Officer, at [email protected] or call
(301) 594-4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Enhancing HIV Care of Women,
Infants, Children and Youth Building Capacity through Communities of
Practice, OMB No. 0915-xxxx--New.
Abstract: HRSA aims to increase delivery of evidence-based
interventions that enhance client outcomes, increase the skill level of
the HIV workforce providing care and treatment to Women, Infants,
Children and Youth, and involve partnerships for dissemination of best
practices to Ryan White HIV/AIDS Program (RWHAP) Part D participants.
To that end, HRSA seeks to implement a Communities of Practice (CoP)
platform for RWHAP Part D recipients. A CoP engages recipient teams in
improvement learning sessions using subject matter experts along with
application experts who help recipient teams select, test, and
implement changes on the front line of care. Through organizational
self-assessments, didactic learning on specific care topics, goals
setting, and work plan development, each team can strategically benefit
their organization. CoPs afford participants the opportunity to work in
a group to solve a recognized challenge related to a CoP domain and
support dialogue among participants and the consultant/subject matter
experts. Recipient teams commit to working over a period of 12 months,
alternating between Learning Sessions in which teams come together to
learn about the chosen topic and to plan changes, and Action Periods in
which the teams return to their respective organizations and test those
changes in their clinic settings. The domains for the proposed CoPs are
trauma informed care, pre-conception counseling, and youth
transitioning into adult HIV care services.
A 60-day notice published in the Federal Register on February 27,
2023, vol. 88, No. 38; pp. 12386-12387. The one comment received was
outside the scope of the ICR, and therefore no changes to the
information collection were made as a result of this comment.
Need and Proposed Use of the Information: Process and outcome
evaluations are a critical part of ensuring that CoP initiatives were
implemented as planned and met their intended outcome. Evaluation of
technical assistance (TA) depends on establishing clear goals and plans
from the beginning of the process. This includes specifying the
intended impact of the TA with concrete, measurable objectives. To
judge performance against goals, HRSA will administer TA evaluation
surveys following TA and training, webinars, teleconferences, and
meetings. Findings will drive quality improvement activities and
reports.
The evaluation plan focuses on process and impact evaluation of all
CoP Teams (Pre-Conception Counseling and Sexual Health, Trauma-Informed
Care, and Transitioning Adolescents to Adult Care) over the duration of
the 4-year period of performance. The evaluation plan components will
be operationalized to include TA satisfaction measures (reaction),
change in knowledge after the TA (learning), and change in behavior or
practice after the introduction of evidence-based interventions
(behavior). More specifically, the evaluation plan includes (1) post TA
satisfaction measures, (2) pre-post measures of CoP staff knowledge
about effective practices, (3) retrospective measures to gather
measures of CoP staff knowledge for the first community of practice
only, and (4) measures of TA usefulness and impact on CoP performance.
Likely Respondents: Up to 90 RWHAP Part D Women, Infants, Children
and Youth recipients will participate in the CoPs. Each recipient may
have up to six staff members who may complete the survey.
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
[[Page 30768]]
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-conception Counseling 90 1 90 .4733 42.6
Community of Practice
Retrospective Pretest-Post
Assessment.....................
Community of Practice Pre- 180 1 180 .2900 52.2
Assessment.....................
Community of Practice Post- 180 1 180 .3767 67.8
Assessment.....................
Community of Practice Session 270 6 1,620 .0767 124.3
Assessment.....................
Targeted and Intensive TA 120 1 120 .0833 10.0
Assessment.....................
Foundational TA Assessment...... 150 1 150 .0616 9.2
-------------------------------------------------------------------------------
Total....................... 990 .............. 2,340 .............. 306.1
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-10192 Filed 5-11-23; 8:45 am]
BILLING CODE 4165-15-P
