Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: HRSA Ryan White HIV/AIDS Program Part F Regional AIDS Education and Training Center Program Activities, OMB No. 0915-XXX New, 58744-58745 [2024-15957]
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Federal Register / Vol. 89, No. 139 / Friday, July 19, 2024 / Notices
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
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received, go to https://
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heading of this document, into the
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Submit written requests for single
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402–4276.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Pediatric Inflammatory Bowel Disease:
Developing Drugs for Treatment.’’ The
draft guidance was prepared by the
Division of Gastroenterology in the
Center for Drug Evaluation and Research
at FDA.
The purpose of the draft guidance is
to help sponsors in the clinical
development of drugs to treat pediatric
patients with inflammatory bowel
disease. Specifically, the draft guidance
provides FDA’s recommendations about
the necessary attributes of clinical
studies for drugs being developed for
the treatment of pediatric ulcerative
colitis or pediatric Crohn’s disease,
including study population, study
design, efficacy considerations, and
safety assessments.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Pediatric Inflammatory Bowel
Disease: Developing Drugs for
Treatment.’’ It does not establish any
rights for any person and is not binding
VerDate Sep<11>2014
18:53 Jul 18, 2024
Jkt 262001
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR 314.50(d)(5) have
been approved under OMB control
number 0910–0001. The collections in
21 CFR 601.2 have been approved under
OMB control number 0910–0338. The
collections of information in 21 CFR
201.56 and 201.57 pertaining to the
content and format of labeling have
been approved under OMB control
number 0910–0572. The collections of
information in 21 CFR parts 50 and 56
pertaining to the protection of human
subjects in clinical trials and
institutional review board
considerations have been approved
under OMB control number 0910–0130.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: July 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–15942 Filed 7–18–24; 8:45 am]
BILLING CODE 4164–01–P
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 Part F
Regional AIDS Education and Training
Center Program Activities, OMB No.
0915–XXX New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
ACTION:
Notice.
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 September 17,
2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 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 Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
HRSA Ryan White HIV/AIDS Program
Part F Regional AIDS Education and
Training Center Program Activities,
OMB No. 0906–xxxx—New.
Abstract: The Ryan White HIV/AIDS
Program’s (RWHAP) AIDS Education
and Training Center (AETC) Program,
authorized under Title XXVI of the
Public Health Service Act, supports a
network of regional centers that conduct
targeted, multi-disciplinary education
and training programs for health care
providers treating people with HIV. The
RWHAP Regional AETC Program’s
purpose is to increase the number of
health care providers who are
effectively educated and motivated to
counsel, diagnose, treat, and medically
manage people with HIV. The RWHAP
Regional AETC Program recipients are
required to report data on the training
activities and trainees to HRSA once a
year. HRSA is requesting the approval of
new AETC data collection forms to
accurately capture data relating to
Regional AETC activities, participants,
and site information for both Practice
Transformation (PT) and
Interprofessional Education (IPE) sites
as well as involvement in the HIV care
and treatment workforce (1-year postparticipation), knowledge gained
through participating in an activity, and
SUMMARY:
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58745
Federal Register / Vol. 89, No. 139 / Friday, July 19, 2024 / Notices
satisfaction with the activity. The
RWHAP Regional AETC Program
recipients will gather data on the
training activities they conduct using
six data collection instruments. The
Individual Participant Record is
completed at least once every reporting
period by participants actively engaging
in Regional AETC activities. This form
includes Regional AETC participant
demographic, workplace, and clientserved data for the participant’s
respective provider sites. The Training
Activity Record is a form completed at
the end of each Regional AETC activity
that takes place during the reporting
period and is completed by the regional
recipients. This form describes the
activity in hours, modality, and topic(s).
The PT Site Characteristics/Outcomes
form collects site characteristics
information for PT recipient sites only,
like clinic activities and procedures,
and aggregate counts of clients. PT sites
provide clinical services and differ from
IPE sites that support students, thus
necessitating a different form. The IPE
Site Characteristics/Outcomes form
collects site characteristics information
for IPE recipient sites only. The
Participant Post-Activity Immediate
Survey collects information from
participants immediately after an
activity, specifically, their satisfaction
and potential increased knowledge due
to participating in said activity. The IPE
Long-Term form collects 1-year postparticipation information from
participant students who engaged in an
IPE program to gauge involvement in
the field of HIV care and treatment.
Need and Proposed Use of the
Information: HRSA uses the data
collected when conducting RWHAP
AETC programmatic assessments to
determine future program needs. These
data allow HRSA to identify where gaps
exist in training HIV professionals as
well as to measure whether training
activities are meeting the goals of the
National HIV/AIDS Strategy and the
RWHAP statute.
Likely Respondents: RWHAP Regional
AETC participants complete the
Individual Participant Record at least
once a reporting period. Regional AETC
recipients complete a Training Activity
Record for each training activity they
conduct during the reporting period. All
Regional AETC participants will take
the Participant Post-Activity Survey
immediately after any attended activity.
The IPE Long-Term form will only be
completed by participants who engaged
in an IPE program, 1-year postparticipation in the IPE program.
Finally, PT recipients will complete the
PT Site Characteristics/Outcomes form
at least once per reporting period, and
IPE recipients will complete the IPE Site
Characteristics/Outcomes form at least
once per reporting period.
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
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Individual Participant Record ................................................................................
Training Activity Record ........................................................................................
PT, Site Characteristics and Outcomes ................................................................
IPE, Site Characteristics and Outcomes ..............................................................
Participant Post-Activity Immediate Survey ..........................................................
IPE, Long-Term .....................................................................................................
Combined Data Set ...............................................................................................
59,576
12,226
128
86
59,576
4,403
8
1
1
1
1
3
1
1
59,576
12,226
128
86
178,728
4,403
8
0.27
0.21
0.31
0.09
0.06
0.07
64
16,085.52
2,567.46
39.68
7.74
10,723.68
308.21
512.00
Total ...............................................................................................................
136,003
........................
255,155
........................
30,244.29
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.
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Form name
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–15957 Filed 7–18–24; 8:45 am]
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18:53 Jul 18, 2024
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on HIV/AIDS
Office of the Secretary, Office
of the Assistant Secretary for Health,
Department of Health and Human
Services.
AGENCY:
ACTION:
Notice of a virtual meeting.
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Service is hereby giving notice that the
Presidential Advisory Council on HIV/
AIDS (PACHA or the Council) will
convene the 82nd full council meeting
on Wednesday, August 28–Thursday,
August 29, 2024. The meeting will
include panels on the U.S. government’s
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
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global HIV response; the science and
impact of ‘‘Undetectable =
Untransmittable’’, or U = U; Affordable
Care Act risk adjustment model to
expand access and uptake of PrEP. It
will be open to the public and there will
be a public comment session during the
meeting; pre-registration is required to
provide public comment. To pre-register
to provide public comment, please send
an email to PACHA@hhs.gov and
include your name, organization, and
title by close of business Wednesday,
August 21, 2024. If you decide you
would like to provide public comment
but do not pre-register, you may submit
your written statement by emailing
PACHA@hhs.gov by close of business
Thursday, September 5, 2024. The
meeting agenda will be posted on the
PACHA page on HIV.gov at https://
E:\FR\FM\19JYN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 139 (Friday, July 19, 2024)]
[Notices]
[Pages 58744-58745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15957]
-----------------------------------------------------------------------
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 Part F Regional AIDS Education and Training
Center Program Activities, OMB No. 0915-XXX New
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 September
17, 2024.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 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 [email protected] or call Joella Roland, the
HRSA Information Collection Clearance Officer, at (301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: HRSA Ryan White HIV/AIDS
Program Part F Regional AIDS Education and Training Center Program
Activities, OMB No. 0906-xxxx--New.
Abstract: The Ryan White HIV/AIDS Program's (RWHAP) AIDS Education
and Training Center (AETC) Program, authorized under Title XXVI of the
Public Health Service Act, supports a network of regional centers that
conduct targeted, multi-disciplinary education and training programs
for health care providers treating people with HIV. The RWHAP Regional
AETC Program's purpose is to increase the number of health care
providers who are effectively educated and motivated to counsel,
diagnose, treat, and medically manage people with HIV. The RWHAP
Regional AETC Program recipients are required to report data on the
training activities and trainees to HRSA once a year. HRSA is
requesting the approval of new AETC data collection forms to accurately
capture data relating to Regional AETC activities, participants, and
site information for both Practice Transformation (PT) and
Interprofessional Education (IPE) sites as well as involvement in the
HIV care and treatment workforce (1-year post-participation), knowledge
gained through participating in an activity, and
[[Page 58745]]
satisfaction with the activity. The RWHAP Regional AETC Program
recipients will gather data on the training activities they conduct
using six data collection instruments. The Individual Participant
Record is completed at least once every reporting period by
participants actively engaging in Regional AETC activities. This form
includes Regional AETC participant demographic, workplace, and client-
served data for the participant's respective provider sites. The
Training Activity Record is a form completed at the end of each
Regional AETC activity that takes place during the reporting period and
is completed by the regional recipients. This form describes the
activity in hours, modality, and topic(s). The PT Site Characteristics/
Outcomes form collects site characteristics information for PT
recipient sites only, like clinic activities and procedures, and
aggregate counts of clients. PT sites provide clinical services and
differ from IPE sites that support students, thus necessitating a
different form. The IPE Site Characteristics/Outcomes form collects
site characteristics information for IPE recipient sites only. The
Participant Post-Activity Immediate Survey collects information from
participants immediately after an activity, specifically, their
satisfaction and potential increased knowledge due to participating in
said activity. The IPE Long-Term form collects 1-year post-
participation information from participant students who engaged in an
IPE program to gauge involvement in the field of HIV care and
treatment.
Need and Proposed Use of the Information: HRSA uses the data
collected when conducting RWHAP AETC programmatic assessments to
determine future program needs. These data allow HRSA to identify where
gaps exist in training HIV professionals as well as to measure whether
training activities are meeting the goals of the National HIV/AIDS
Strategy and the RWHAP statute.
Likely Respondents: RWHAP Regional AETC participants complete the
Individual Participant Record at least once a reporting period.
Regional AETC recipients complete a Training Activity Record for each
training activity they conduct during the reporting period. All
Regional AETC participants will take the Participant Post-Activity
Survey immediately after any attended activity. The IPE Long-Term form
will only be completed by participants who engaged in an IPE program,
1-year post-participation in the IPE program. Finally, PT recipients
will complete the PT Site Characteristics/Outcomes form at least once
per reporting period, and IPE recipients will complete the IPE Site
Characteristics/Outcomes form at least once per reporting period.
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
----------------------------------------------------------------------------------------------------------------
Individual Participant Record... 59,576 1 59,576 0.27 16,085.52
Training Activity Record........ 12,226 1 12,226 0.21 2,567.46
PT, Site Characteristics and 128 1 128 0.31 39.68
Outcomes.......................
IPE, Site Characteristics and 86 1 86 0.09 7.74
Outcomes.......................
Participant Post-Activity 59,576 3 178,728 0.06 10,723.68
Immediate Survey...............
IPE, Long-Term.................. 4,403 1 4,403 0.07 308.21
Combined Data Set............... 8 1 8 64 512.00
-------------------------------------------------------------------------------
Total....................... 136,003 .............. 255,155 .............. 30,244.29
----------------------------------------------------------------------------------------------------------------
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. 2024-15957 Filed 7-18-24; 8:45 am]
BILLING CODE 4165-15-P
