Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Communities Opioid Response Program Performance Measures, 38163-38164 [2024-09888]
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Federal Register / Vol. 89, No. 89 / Tuesday, May 7, 2024 / Notices
validating assumptions, incorporating
new information, and refining the
program.
This draft guidance is being issued to
fulfill the performance goals (available
at https://www.fda.gov/industry/
prescription-drug-user-fee-amendments/
pdufa-vii-fiscal-years-2023-2027) under
the sixth reauthorization of the
Prescription Drug User Fee Act (PDUFA
VII). This REMS logic model guidance is
the first in a series of planned guidances
for industry and FDA staff to optimize
REMS design and improve the way a
REMS is assessed.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘REMS Logic Model: A Framework
to Link Program Design With
Assessment.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
khammond on DSKJM1Z7X2PROD with 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. 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 for the
submission of investigational new drug
applications have been approved under
OMB control number 0910–0014. The
collections of information in 21 CFR
part 314 for the submission of new drug
applications and abbreviated new drug
applications have been approved under
OMB control number 0910–0001. The
collections of information in 21 CFR
part 601 for the submission of biologics
license applications have been approved
under OMB control number 0910–0338.
The collections of information in 21
CFR part 208 pertaining to Medication
Guides for prescription drug and
biological products have been approved
under OMB control number 0910–0393.
The collections of information in 21
CFR 201.56 and 201.57 for the content
and format requirements for labeling of
drugs and biologics have been approved
under OMB control number 0910–0572.
The collections of information in 21
CFR part 316 regarding orphan drug
product development are approved
under OMB control number 0910–0167.
The collections of information
pertaining to Prescription Drug User Fee
VerDate Sep<11>2014
15:55 May 06, 2024
Jkt 262001
Program have been approved under
OMB control number 0910–0297.
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/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: May 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–09928 Filed 5–6–24; 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: Rural
Communities Opioid Response
Program Performance Measures
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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 July 8, 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
SUMMARY:
PO 00000
Frm 00146
Fmt 4703
Sfmt 4703
38163
information, please include the ICR title
for reference.
Information Collection Request Title:
Rural Communities Opioid Response
Program (RCORP) Performance
Measures, OMB No. 0906–0044—
Revision
Abstract: HRSA administers RCORP,
which is authorized by section 711(b)(5)
of the Social Security Act (42 U.S.C.
912(b)(5)) and is a multi-initiative
program that aims to: (1) support
treatment for and prevention of
substance use disorder (SUD), including
opioid use disorder (OUD); and (2)
reduce morbidity and mortality
associated with SUD, including OUD,
by improving access to and delivering
prevention, treatment, and recovery
support services to high-risk rural
communities. To support this purpose,
RCORP grant initiatives include:
• RCORP—Implementation grants
fund established networks and consortia
to deliver SUD/OUD prevention,
treatment, and recovery activities in
high-risk rural communities.
• RCORP—Psychostimulant Support
grants aim to strengthen and expand
access to prevention, treatment, and
recovery services for individuals in
rural areas who misuse
psychostimulants, to enhance their
ability to access treatment and move
toward recovery.
• RCORP—Medication Assisted
Treatment Access grants aim to
establish new access points in rural
facilities where none currently exist.
• RCORP—Behavioral Health Care
support grants aim to expand access to
and quality of behavioral health care
services at the individual-, provider-,
and community-levels.
• RCORP Overdose Response
recipients address immediate needs in
rural areas through improving access to,
capacity for, and sustainability of
prevention, treatment, and recovery
services for SUD.
• RCORP Child and Adolescent
Behavioral Health grants aim to
establish and expand sustainable
behavioral health care services for
children and adolescents aged 5–17
years who live in rural communities.
• RCORP-Neonatal Abstinence
Syndrome grants aim to reduce the
incidence and impact of Neonatal
Abstinence Syndrome in rural
communities by improving systems of
care, family supports, and social
determinants of health.
• Note that additional grant
initiatives may be added pending fiscal
year 2025 and future fiscal year
appropriations.
HRSA currently collects information
about RCORP grants using approved
E:\FR\FM\07MYN1.SGM
07MYN1
38164
Federal Register / Vol. 89, No. 89 / Tuesday, May 7, 2024 / Notices
performance measures. HRSA
developed separate performance
measures for RCORP’s new Overdose
Response, Behavioral Health, and
Neonatal Abstinence Syndrome grants
and seeks OMB approval for the new
performance measures.
Need and Proposed Use of the
Information: Due to the growth in the
number of grant initiatives included
within RCORP, as well as emerging SUD
and other behavioral health trends in
rural communities, HRSA is submitting
a revised ICR that includes measures for
RCORP’s new Overdose Response, Child
and Adolescent Behavioral Health, and
Neonatal Abstinence Syndrome grants.
For this program, performance
measures were developed to provide
data on each RCORP initiative and to
enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993. These measures
cover the principal topic areas of
interest to HRSA’s Federal Office of
Rural Health Policy, including: (a)
provision of, and referral to, rural
behavioral health care services,
including SUD prevention, treatment
and recovery support services; (b)
behavioral health care, including SUD
prevention, treatment, and recovery,
process and outcomes; (c) education of
health care providers and community
members; (d) emerging trends in rural
behavioral health care needs and areas
of concern; and (e) consortium strength
and sustainability. All measures will
speak to the progress on meeting the set
goals of the Federal Office of Rural
Health Policy.
Likely Respondents: The respondents
will be the recipients of the RCORP
grants.
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
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
RCORP—Implementation .....................................................................................
RCORP—Psychostimulant Support ......................................................................
RCORP—Medication Assisted Treatment Access ...............................................
RCORP—Behavioral Health Care Support ..........................................................
Rural Communities Opioid Response—Overdose Response (NEW) ..................
RCORP—Child and Adolescent Behavioral Health (NEW) ..................................
RCORP—Neonatal Abstinence Syndrome (NEW) ...............................................
290
15
11
58
47
9
41
2
1
1
1
3
2
4
580
15
11
58
141
18
164
1.24
1.30
1.95
2.02
0.56
0.48
2.31
719.20
19.50
21.45
117.16
78.96
8.64
378.84
Total ...............................................................................................................
471
..........................
987
........................
1,343.75
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. 2024–09888 Filed 5–6–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
VerDate Sep<11>2014
15:55 May 06, 2024
Jkt 262001
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Heart, Lung, and
Blood Initial Review Group; NHLBI
Mentored Clinical and Basic Science Study
Section.
Date: June 27–28, 2024.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Bethesdan Hotel, Tapestry
Collection by Hilton, 8120 Wisconsin Ave,
Bethesda, MD 20814 (Hybrid Meeting).
Contact Person: Manoj Kumar
Valiyaveettil, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA,
National Heart, Lung, and Blood Institute,
National Institutes of Health, 6705 Rockledge
Drive, Room 208–R, Bethesda, MD 20817,
(301) 402–1616, manoj.valiyaveettil@nih.gov.
PO 00000
Frm 00147
Fmt 4703
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: May 1, 2024.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–09896 Filed 5–6–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental and
Craniofacial Research; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, National Institute of Dental
and Craniofacial Research.
E:\FR\FM\07MYN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 89 (Tuesday, May 7, 2024)]
[Notices]
[Pages 38163-38164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09888]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Rural
Communities Opioid Response Program Performance Measures
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 July 8,
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: Rural Communities Opioid
Response Program (RCORP) Performance Measures, OMB No. 0906-0044--
Revision
Abstract: HRSA administers RCORP, which is authorized by section
711(b)(5) of the Social Security Act (42 U.S.C. 912(b)(5)) and is a
multi-initiative program that aims to: (1) support treatment for and
prevention of substance use disorder (SUD), including opioid use
disorder (OUD); and (2) reduce morbidity and mortality associated with
SUD, including OUD, by improving access to and delivering prevention,
treatment, and recovery support services to high-risk rural
communities. To support this purpose, RCORP grant initiatives include:
RCORP--Implementation grants fund established networks and
consortia to deliver SUD/OUD prevention, treatment, and recovery
activities in high-risk rural communities.
RCORP--Psychostimulant Support grants aim to strengthen
and expand access to prevention, treatment, and recovery services for
individuals in rural areas who misuse psychostimulants, to enhance
their ability to access treatment and move toward recovery.
RCORP--Medication Assisted Treatment Access grants aim to
establish new access points in rural facilities where none currently
exist.
RCORP--Behavioral Health Care support grants aim to expand
access to and quality of behavioral health care services at the
individual-, provider-, and community-levels.
RCORP Overdose Response recipients address immediate needs
in rural areas through improving access to, capacity for, and
sustainability of prevention, treatment, and recovery services for SUD.
RCORP Child and Adolescent Behavioral Health grants aim to
establish and expand sustainable behavioral health care services for
children and adolescents aged 5-17 years who live in rural communities.
RCORP-Neonatal Abstinence Syndrome grants aim to reduce
the incidence and impact of Neonatal Abstinence Syndrome in rural
communities by improving systems of care, family supports, and social
determinants of health.
Note that additional grant initiatives may be added
pending fiscal year 2025 and future fiscal year appropriations.
HRSA currently collects information about RCORP grants using
approved
[[Page 38164]]
performance measures. HRSA developed separate performance measures for
RCORP's new Overdose Response, Behavioral Health, and Neonatal
Abstinence Syndrome grants and seeks OMB approval for the new
performance measures.
Need and Proposed Use of the Information: Due to the growth in the
number of grant initiatives included within RCORP, as well as emerging
SUD and other behavioral health trends in rural communities, HRSA is
submitting a revised ICR that includes measures for RCORP's new
Overdose Response, Child and Adolescent Behavioral Health, and Neonatal
Abstinence Syndrome grants.
For this program, performance measures were developed to provide
data on each RCORP initiative and to enable HRSA to provide aggregate
program data required by Congress under the Government Performance and
Results Act of 1993. These measures cover the principal topic areas of
interest to HRSA's Federal Office of Rural Health Policy, including:
(a) provision of, and referral to, rural behavioral health care
services, including SUD prevention, treatment and recovery support
services; (b) behavioral health care, including SUD prevention,
treatment, and recovery, process and outcomes; (c) education of health
care providers and community members; (d) emerging trends in rural
behavioral health care needs and areas of concern; and (e) consortium
strength and sustainability. All measures will speak to the progress on
meeting the set goals of the Federal Office of Rural Health Policy.
Likely Respondents: The respondents will be the recipients of the
RCORP grants.
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
----------------------------------------------------------------------------------------------------------------
RCORP--Implementation............ 290 2 580 1.24 719.20
RCORP--Psychostimulant Support... 15 1 15 1.30 19.50
RCORP--Medication Assisted 11 1 11 1.95 21.45
Treatment Access................
RCORP--Behavioral Health Care 58 1 58 2.02 117.16
Support.........................
Rural Communities Opioid 47 3 141 0.56 78.96
Response--Overdose Response
(NEW)...........................
RCORP--Child and Adolescent 9 2 18 0.48 8.64
Behavioral Health (NEW).........
RCORP--Neonatal Abstinence 41 4 164 2.31 378.84
Syndrome (NEW)..................
------------------------------------------------------------------------------
Total........................ 471 ............... 987 .............. 1,343.75
----------------------------------------------------------------------------------------------------------------
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. 2024-09888 Filed 5-6-24; 8:45 am]
BILLING CODE 4165-15-P
