Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Communities Opioid Response Program Performance Measures, OMB No 0906-0044, Revision, 57419-57421 [2024-15441]
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Federal Register / Vol. 89, No. 135 / Monday, July 15, 2024 / Notices
On October 19, 2023, FDA met with
Takeda to discuss the voluntary
withdrawal of EXKIVITY (mobocertinib
succinate) capsule, EQ 40 mg base,
according to § 314.150(d) (21 CFR
314.150(d)). On October 25, 2023, FDA
recommended the applicant voluntarily
request withdrawal of approval of
EXKIVITY (mobocertinib succinate)
capsule, EQ 40 mg base, for EGFR exon
20 insertion-mutated NSCLC according
to § 314.150(d) because the
postmarketing trial did not verify
clinical benefit. FDA also requested
Takeda waive its opportunity for a
hearing.
On March 15, 2024, Takeda submitted
a letter asking FDA to withdraw
approval of NDA 215310 for EXKIVITY
(mobocertinib succinate) capsule, EQ 40
mg base, according to § 314.150(d) and
waiving its opportunity for a hearing.
For the reasons discussed above, and
in accordance with the applicant’s
request, approval of NDA 215310 for
EXKIVITY (mobocertinib succinate)
capsule, EQ 40 mg base, and all
amendments and supplements thereto,
is withdrawn under § 314.150(d).
Distribution of EXKIVITY (mobocertinib
succinate) capsule, EQ 40 mg base, into
interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)).
Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–15371 Filed 7–12–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Council on Blood Stem Cell
Transplantation (ACBSCT or Advisory
Council) has scheduled public meetings.
Information about the Advisory Council
and the agenda for these meetings can
be found on the ACBSCT website at
https://bloodstemcell.hrsa.gov/about/
advisory-council.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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Thursday, August 22, 2024, 2:00
p.m.–6:00 p.m. Eastern Standard Time;
and Thursday, October 24, 2024, 2:00
p.m.–6:00 p.m. Eastern Standard Time.
ADDRESSES: Both meetings will be held
virtually by webinar. A link to register
and join each meeting will be posted at
least 10 days prior to the meeting date
at: https://bloodstemcell.hrsa.gov/
about/advisory-council.
FOR FURTHER INFORMATION CONTACT:
Shelley Tims Grant, Designated Federal
Official, HRSA Health Systems Bureau,
Division of Transplantation, 5600
Fishers Lane, 8W–67, Rockville,
Maryland 20857; 301–443–8036; or
ACBSCTHRSA@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACBSCT
provides advice and recommendations
to the Secretary of Health and Human
Services on policy, program
development, and other matters of
significance concerning the activities
under the authority of 42 U.S.C. 274k
(Section 379 of the Public Health
Service Act), as amended, and Public
Law 109–129, as amended. The
Advisory Council may transmit its
recommendations through the HRSA
Administrator on matters related to the
activities of the C.W. Bill Young Cell
Transplantation Program and National
Cord Blood Inventory.
The agenda for the August 22, 2024,
meeting is being finalized and may
include the following topics: criteria for
defining a high-quality cord blood unit
for banking specifications; the unmet
needs in blood stem cell transplantation
and cellular therapy; updates on
transplant outcomes by different donor
sources; strategies to improve rates of
donation for adult blood stem cell
donors; and other areas to increase
blood stem cell donation and
transplantation. The agenda for the
October 24, 2024, meeting will be
determined based on discussion,
priorities, and/or action items from the
August 22, 2024, meeting. All agenda
items will be posted on the Advisory
Council’s website no later than 10 days
prior to the respective meeting dates.
Agenda items are subject to change as
priorities dictate. Interested individuals
are encouraged to monitor the Advisory
Council’s website for any updated
information concerning the meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meetings; oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to ACBSCT
should be sent to Shelley Tims Grant,
DATES:
PO 00000
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57419
using the contact information above, at
least 3 business days prior to the
meeting.
Individuals who plan to attend and
need special assistance or other
reasonable accommodations should
notify Advisory Council at the address
and phone number listed above at least
10 business days prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–15391 Filed 7–12–24; 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; Rural Communities Opioid
Response Program Performance
Measures, OMB No 0906–0044,
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 August 14, 2024.
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
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
SUMMARY:
E:\FR\FM\15JYN1.SGM
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57420
Federal Register / Vol. 89, No. 135 / Monday, July 15, 2024 / Notices
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;
and
• 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
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.
A 60-day notice published in the
Federal Register on May 7, 2024, vol.
89, No. 89; pp. 38163–64. There were no
public comments.
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
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Form name
Number of
responses per
respondent
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
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Federal Register / Vol. 89, No. 135 / Monday, July 15, 2024 / Notices
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–15441 Filed 7–12–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before August 14, 2024.
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 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041, or PRA@HHS.GOV.
When submitting comments or
requesting information, please include
the document identifier 0990-New-30D
and project title for reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (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.
Title of the Collection: OASH
Performance Project Report for Grants
and Cooperative Agreements.
Type of Collection: New.
OMB No. 0990–NEW—Office of the
Assistant Secretary for Health.
Abstract: The Office of the Assistant
Secretary for Health (OASH) is seeking
OMB approval on a new information
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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collection, the OASH Periodic
Performance Project Report for Grants
and Cooperative Agreements (hereafter
the OASH PPR). The purpose of this
data collection is to gather quantitative
and qualitative information common to
the assessment of recipient performance
on individual grants and cooperative
agreements (collectively, grants)
managed in OASH. OASH will collect
common data elements measuring the
performance of each recipient against
the approved grant project plan,
including progress toward goals and
outcomes as required by 45 CFR
75.342(b)(2).
OASH oversees a broad range of grant
programs within the Office of the
Secretary (OS), Department of Health
and Human Services (HHS). The current
active OASH programs with
discretionary grants (with assistance
listing number) include: Public
Awareness Campaigns on Embryo
Adoption (93.007); Research on
Research Integrity (93.085); Advancing
System Improvements for Key Issues in
Women’s Health (93.088); Community
Programs to Improve Minority Health
Grant Programs (93.137); Family
Planning Services (93.217); Family
Planning Personnel Training (93.260);
Teenage Pregnancy Prevention Program
(93.297); Public Health Service
Evaluation Funds (93.343); Research,
Monitoring and Outcomes Definitions
for Vaccine Safety (93.344); Minority
HIV/AIDS Fund (93.899); Family
Planning Service Delivery Improvement
Research Grants (93.974); and National
Health Promotion (93.990). OASH
grants span a wide range of project
types, including service, demonstration
project, evaluation, research, training,
and conference projects. Within each
program, the awards are subdivided into
cohorts aligned with the notices of
funding opportunity under which
OASH competed the awards. Currently,
there are 47 cohorts of active awards
across OASH. In any given year, OASH
programs collectively monitor 450–550
active awards with another 200–300
inactive awards awaiting final reports as
a prerequisite to closing the grant.
The collection is needed to enhance
project performance information and
simplify reporting under 45 CFR 75.301.
Each recipient currently must submit a
quarterly Federal Financial Report (FFR
or SF–425)(45 CFR 75.341) and a
periodic Performance Progress Report
(PPR) for each grant (45 CFR
75.342(b)(2). PPR reporting periods in
OASH are scheduled quarterly, semiannually, or annually, depending on the
need determined by the program office
using a narrative format that can vary by
cohort. The PPR schedule is specifically
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57421
aligned with the quarterly FFRs
whenever possible to create a complete
snapshot of the project’s progress at the
end of the reporting period.
The common elements identified in
the new collection for OASH programs
will standardize the collection of the
required information (45 CFR
75.342(b)(2)) including: (1) a
comparison of the actual
accomplishments to the objectives of the
award for the period; (2) the reasons
why established goals were not met; and
(3) pertinent information, analysis and
explanation of cost overruns or high
unit costs. The common elements
include reporting on publications,
including data sets and other work
products, to facilitate implementation of
OSTP Memorandum Ensuring Free,
Immediate, and Equitable Access
Federally Funded Research (August 25,
2022). The new information collection
will limit the content of the report to
those activities taking place during the
reporting period (i.e., quarterly,
semiannually, or annually). The
information collection is structured to
facilitate program review across
reporting periods. This will allow
OASH to identify and improve program
outcomes, share lessons learned, and
spread the adoption of promising
practices among its grant recipients and
other HHS awarding agencies.
The content of the new collection is
structured for web-based data collection
under 7 headings: Report Header;
Project Progress; Significant Project
Accomplishments; Broader Program
Impacts; Products and Dissemination;
Collaboration and Partnering Activities;
and Project Evaluation Activities.
Information will be prepopulated based
on the login credentials for the user
submitting the report and the specific
grant being reported. Not all grants will
have reportable activities under all
headings (e.g., not all grants have an
evaluation component embedded in the
project). However, most OASH grants
will have reportable information under
most headings. Program offices with
additional reporting programmatic
information collections will eventually
transition collection of any overlapping
data elements to this OASH PPR. During
the transition, OASH will not require
grant recipients to provide the same
information twice.
Likely Respondents: Members and
staff from academia, community
organizations, local/state/federal
government, private sector, and tribal
government and services organizations
including those who serve American
Indian and Alaska Native and/or racial
and ethnic minorities.
E:\FR\FM\15JYN1.SGM
15JYN1
]]>Agencies
[Federal Register Volume 89, Number 135 (Monday, July 15, 2024)]
[Notices]
[Pages 57419-57421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15441]
-----------------------------------------------------------------------
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; Rural Communities Opioid
Response Program Performance Measures, OMB No 0906-0044, Revision
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 August 14,
2024.
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:
[[Page 57420]]
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;
and
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 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.
A 60-day notice published in the Federal Register on May 7, 2024,
vol. 89, No. 89; pp. 38163-64. There were no public comments.
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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total
Form name respondents responses per responses response burden
respondent (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 Treatment Access.. 11 1 11 1.95 21.45
RCORP--Behavioral Health Care Support........ 58 1 58 2.02 117.16
Rural Communities Opioid Response--Overdose 47 3 141 0.56 78.96
Response (NEW)..............................
RCORP--Child and Adolescent Behavioral Health 9 2 18 0.48 8.64
(NEW).......................................
RCORP--Neonatal Abstinence Syndrome (NEW).... 41 4 164 2.31 378.84
------------------------------------------------------------------
Total.................................... 471 ............... 987 ........... 1,343.75
----------------------------------------------------------------------------------------------------------------
[[Page 57421]]
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-15441 Filed 7-12-24; 8:45 am]
BILLING CODE 4165-15-P
