Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rapid Uptake of Disseminated Interventions Evaluation, OMB No. 0906-xxxx, 72085-72086 [2023-23108]
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Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices
Agency ‘‘continues to assess the needs
and circumstances related to the
policies in our COVID–19-related
guidances, and we may alter our
approach for individual guidances listed
in this notice.’’ (88 FR 15417 at 15418).
Following the expiration of the COVID–
19 PHE declaration on May 11, 2023,
FDA has reviewed the Notifying FDA
Guidance and the Potency Assay
Guidance and determined that these two
guidances are no longer needed because
new draft guidances are available.
In March 2023 (88 FR 13126), the
Agency issued the draft guidance
document entitled ‘‘Potency Assay
Considerations for Monoclonal
Antibodies and Other Therapeutic
Proteins Targeting Viral Pathogens,’’
which provides information to assist in
the development of mAbs and other
therapeutic proteins directly targeting
viral proteins or host cell proteins
mediating pathogenic mechanisms of
infection. The draft guidance also
provides detailed recommendations for
drug developers with the goal of helping
to ensure that drug developers provide
adequate information to assess potency
at each stage of a product’s life cycle.
FDA believes that many of the
recommendations set forth in the 2021
Potency Assay Guidance are applicable
outside the context of the COVID–19
PHE and are applicable to mAbs and
other therapeutic protein directly
targeting any viral surfaces (glycol)
proteins mediating pathogenic
mechanisms of infection, not just those
that directly target SARS–CoV–2. In
preparing the draft guidance, FDA
considered comments received
regarding the 2021 Potency Assay
Guidance as well as the Agency’s
experience with SARS–CoV–2 and other
viruses.
In April 2023 (88 FR 20526), the
Agency issued the draft guidance for
industry entitled ‘‘Notification of a
Permanent Discontinuance or
Interruption in Manufacturing Under
Section 506C of the FD&C Act’’ to assist
applicants and manufacturers in
providing FDA timely, informative
notifications about changes in the
production of certain finished drugs and
biological products as well as certain
active pharmaceutical ingredients (API)
that may, in turn, help the Agency in its
effort to prevent and mitigate shortages.
The draft guidance discusses the
notification requirements under section
506C of the Federal Food, Drug and
Cosmetic Act (FD&C Act) (21 U.S.C.
356c), including requirements added by
the Coronavirus Aid, Relief, and
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17:48 Oct 18, 2023
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Economic Security Act (CARES Act) 2
related to notifying FDA about finished
product and API manufacturing
discontinuances and interruptions. The
draft guidance provides
recommendations for applicants and
manufacturers to provide additional
details and follow additional procedures
to ensure FDA has the specific
information it needs to help prevent or
mitigate shortages. In addition, the draft
guidance explains how FDA
communicates information about
products in shortage to the public. In
preparing the draft guidance, FDA
considered comments received on the
2020 Notifying FDA Guidance.
For the reasons discussed above, FDA
is announcing the guidance entitled
‘‘Notifying FDA of Permanent
Discontinuance or Interruption in
Manufacturing Under Section 506C of
the FD&C Act’’ (March 2020) and the
guidance entitled ‘‘COVID–19: Potency
Assay Consideration for Monoclonal
Antibodies and Other Therapeutic
Proteins Targeting SARS–CoV–2
Infectivity’’ (January 2021) will expire
on November 7, 2023.
II. Expiration Date
The expiration date for the guidance
documents in this document is
November 7, 2023.
Dated: October 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–23071 Filed 10–18–23; 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; Rapid Uptake of
Disseminated Interventions Evaluation,
OMB No. 0906-xxxx
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
SUMMARY:
2 The CARES Act (Pub. L. 116–136) was enacted
on March 27, 2020. The CARES Act amendments
to section 506C of the FD&C Act took effect on
September 23, 2020. See section 3112(g) of the
CARES Act.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
72085
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.
Comments on this ICR should be
received no later than November 20,
2023.
DATES:
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
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Rapid Uptake of Disseminated
Interventions (RUDI) Evaluation, OMB
No. 0906-xxxx—New.
Abstract: HRSA dedicated significant
resources and effort to developing novel
intervention strategies aimed at
eliminating disparities and improving
HIV-related health outcomes for people
with HIV. HRSA encourages and
supports Ryan White HIV/AIDS
Program (RWHAP) providers to
implement interventions developed
through its RWHAP Part F Special
Projects of National Significance
program and technical assistance
initiatives that have been found to be
effective, with adaptations for priority
populations served as applicable. HRSA
disseminates its RWHAP Part F Special
Projects of National Significance and
technical assistance initiative resources
and products across a variety of
dissemination channels, hoping to reach
a maximum number of RWHAP
recipients and subrecipients for whom
these resources may meet an important
need. This mixed-methods RUDI
evaluation will use a web-based survey
and virtual site visits to collect
information from RWHAP recipients
and subrecipients on the uptake, utility,
and efficacy of the resources and
products HRSA disseminates; the
effectiveness of its dissemination
processes; and the reach of its
dissemination channels. HRSA will use
ADDRESSES:
E:\FR\FM\19OCN1.SGM
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72086
Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices
the information to identify
opportunities for strengthening its
dissemination channels and resources to
improve care and health outcomes for
program participants. A 60-day notice
was published in the Federal Register
on July 12, 2023, Vol. 88, No. 132, pp.
44371–44373 (88 FR 44371). HRSA
received no comments.
Need and Proposed Use of the
Information: Currently, HRSA does not
systematically gather information about
the resources accessed by RWHAP
providers, RWHAP recipients, or AIDS
Education and Training Center (AETC)
staff and the extent to which they use
those resources to inform
implementation of interventions.
The mixed-methods RUDI evaluation
will help HRSA systematically assess
and understand (1) how, where, and
why recipients of RWHAP funding
access and use its disseminated
resources and products; and (2) the
utility and effectiveness of the
disseminated resources and products in
caring for and treating people with HIV.
HRSA will use the findings from the
RUDI evaluation to develop strategies to
maximize the uptake and impact of its
disseminated resources and products,
contributing to ending the HIV epidemic
in the United States.
Likely Respondents: The mixedmethods RUDI evaluation includes a
web-based survey of all RWHAP
recipients and subrecipients nationally,
individual and small group interviews
with a sample of RWHAP recipients,
virtual site visits with a sample of
RWHAP providers, and individual
interviews with all AETCs. The RUDI
web-based survey design includes two
versions of the survey that will be
administered to non-overlapping
respondents—the RUDI Recipients
Survey for RWHAP Part A and B
recipient administrative entities—and
the RUDI Providers Survey for Part A
and B subrecipients and Part C, D, and
F recipients who provide direct care.
Both versions ask about respondents’
use of HRSA-disseminated resources,
how they were helpful, what could be
improved, and reasons for non-use
where applicable. In addition, the RUDI
Recipients Survey asks about the
recipients’ role in guiding their
subrecipients to needed resources, and
the RUDI Providers Survey asks about
the providers’ experience implementing
interventions for which they used the
resources. Both surveys are designed to
be followed up with additional sets of
interviews with a sample of the survey
respondents to provide deeper
understanding of their experience to
support development of actionable
recommendations pertaining to
dissemination. Virtual site visits to
RWHAP providers include interviews
with an average of three staff within
each provider organization that were
part of an intervention implementation
with assistance from HRSA resources.
Individual interviews for Part A and B
recipient administrative entities and
AETCs will generate a complete picture
of how those organizations use HRSA
resources and how the resources or their
dissemination could be improved for
the future, especially when considered
together with the survey responses and
virtual site visit data from the RWHAP
providers.
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
(RWHAP
sites)
Respondent
Data collection
RWHAP recipients ..............
RWHAP provider .................
RWHAP recipients ..............
RWHAP provider .................
AETC providers ...................
RUDI—Recipient Survey ....
RUDI—Provider Survey .....
Interviews ...........................
Virtual site visit interviews ..
Interviews ...........................
Number of
responses
per
respondent
56
1,066
20
40
8
Total
responses
1
1
3
3
1
56
1,066
60
120
8
1,190
Maria G. Button,
Director, Executive Secretariat.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2023–23108 Filed 10–18–23; 8:45 am]
BILLING CODE 4165–15–P
lotter on DSK11XQN23PROD with NOTICES1
1,310
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Bureau of
Health Workforce Performance Data
Collection, OMB No. 0915–0061—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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17:48 Oct 18, 2023
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Frm 00046
Fmt 4703
Sfmt 4703
Average
burden per
response
(in hours)
0.33
0.33
0.75
1.00
1.00
Total burden
hours
18.48
351.78
45.00
120.00
8.00
543.26
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
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 should be
received no later than December 18,
2023.
SUMMARY:
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
ADDRESSES:
E:\FR\FM\19OCN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72085-72086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23108]
-----------------------------------------------------------------------
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; Rapid Uptake of
Disseminated Interventions Evaluation, OMB No. 0906-xxxx
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 November
20, 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 Joella Roland, the HRSA
Information Collection Clearance Officer, at [email protected] or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Rapid Uptake of Disseminated
Interventions (RUDI) Evaluation, OMB No. 0906-xxxx--New.
Abstract: HRSA dedicated significant resources and effort to
developing novel intervention strategies aimed at eliminating
disparities and improving HIV-related health outcomes for people with
HIV. HRSA encourages and supports Ryan White HIV/AIDS Program (RWHAP)
providers to implement interventions developed through its RWHAP Part F
Special Projects of National Significance program and technical
assistance initiatives that have been found to be effective, with
adaptations for priority populations served as applicable. HRSA
disseminates its RWHAP Part F Special Projects of National Significance
and technical assistance initiative resources and products across a
variety of dissemination channels, hoping to reach a maximum number of
RWHAP recipients and subrecipients for whom these resources may meet an
important need. This mixed-methods RUDI evaluation will use a web-based
survey and virtual site visits to collect information from RWHAP
recipients and subrecipients on the uptake, utility, and efficacy of
the resources and products HRSA disseminates; the effectiveness of its
dissemination processes; and the reach of its dissemination channels.
HRSA will use
[[Page 72086]]
the information to identify opportunities for strengthening its
dissemination channels and resources to improve care and health
outcomes for program participants. A 60-day notice was published in the
Federal Register on July 12, 2023, Vol. 88, No. 132, pp. 44371-44373
(88 FR 44371). HRSA received no comments.
Need and Proposed Use of the Information: Currently, HRSA does not
systematically gather information about the resources accessed by RWHAP
providers, RWHAP recipients, or AIDS Education and Training Center
(AETC) staff and the extent to which they use those resources to inform
implementation of interventions.
The mixed-methods RUDI evaluation will help HRSA systematically
assess and understand (1) how, where, and why recipients of RWHAP
funding access and use its disseminated resources and products; and (2)
the utility and effectiveness of the disseminated resources and
products in caring for and treating people with HIV. HRSA will use the
findings from the RUDI evaluation to develop strategies to maximize the
uptake and impact of its disseminated resources and products,
contributing to ending the HIV epidemic in the United States.
Likely Respondents: The mixed-methods RUDI evaluation includes a
web-based survey of all RWHAP recipients and subrecipients nationally,
individual and small group interviews with a sample of RWHAP
recipients, virtual site visits with a sample of RWHAP providers, and
individual interviews with all AETCs. The RUDI web-based survey design
includes two versions of the survey that will be administered to non-
overlapping respondents--the RUDI Recipients Survey for RWHAP Part A
and B recipient administrative entities--and the RUDI Providers Survey
for Part A and B subrecipients and Part C, D, and F recipients who
provide direct care. Both versions ask about respondents' use of HRSA-
disseminated resources, how they were helpful, what could be improved,
and reasons for non-use where applicable. In addition, the RUDI
Recipients Survey asks about the recipients' role in guiding their
subrecipients to needed resources, and the RUDI Providers Survey asks
about the providers' experience implementing interventions for which
they used the resources. Both surveys are designed to be followed up
with additional sets of interviews with a sample of the survey
respondents to provide deeper understanding of their experience to
support development of actionable recommendations pertaining to
dissemination. Virtual site visits to RWHAP providers include
interviews with an average of three staff within each provider
organization that were part of an intervention implementation with
assistance from HRSA resources. Individual interviews for Part A and B
recipient administrative entities and AETCs will generate a complete
picture of how those organizations use HRSA resources and how the
resources or their dissemination could be improved for the future,
especially when considered together with the survey responses and
virtual site visit data from the RWHAP providers.
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
Respondent Data collection respondents responses per responses response (in hours
(RWHAP sites) respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
RWHAP recipients.......................... RUDI--Recipient Survey...... 56 1 56 0.33 18.48
RWHAP provider............................ RUDI--Provider Survey....... 1,066 1 1,066 0.33 351.78
RWHAP recipients.......................... Interviews.................. 20 3 60 0.75 45.00
RWHAP provider............................ Virtual site visit 40 3 120 1.00 120.00
interviews.
AETC providers............................ Interviews.................. 8 1 8 1.00 8.00
-------------------------------------------------------------------------------
1,190 1,310 543.26
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-23108 Filed 10-18-23; 8:45 am]
BILLING CODE 4165-15-P
