Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Network Development Planning Program, 14172-14173 [2023-04585]
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Federal Register / Vol. 88, No. 44 / Tuesday, March 7, 2023 / Notices
Ave., Bldg. 51, Rm. 6226, Silver Spring,
MD 20993, 301–796–3137,
Kimberly.Lehrfeld@fda.hhs.gov.
On June
30, 1999, FDA approved ANDA 075286
for pemoline tablets, 18.75 mg, 37.5 mg,
and 75 mg, for the conditions of use in
the labeling of new drug application
(NDA) 016832, the reference listed drug
on which it relied. On October 24, 2005,
the Agency issued a Postmarket Drug
Safety Information for Patients and
Providers communication entitled
‘‘Information for Healthcare
Professionals: Pemoline Tablets and
Chewable Tablets (Marketed as
CYLERT)’’ which concluded the overall
liver toxicity risk of CYLERT (pemoline)
(NDAs 016832 and 017703) and generic
pemoline products outweighed the
benefits of these products (https://
wayback.archive-it.org/7993/
20171114124349/https://www.fda.gov/
Drugs/DrugSafety/
PostmarketDrugSafety
InformationforPatientsandProviders/
ucm126461.htm).
All holders of approved applications
for pemoline products, including Fosun,
ceased marketing the products at that
time. On April 22, 2019, Fosun
requested that FDA withdraw approval
of ANDA 075286, pursuant to
§ 314.150(d) (21 CFR 314.150(d)) and
waived its opportunity for a hearing.
For the reasons discussed above, and
in accordance with the applicant’s
request, approval of ANDA 075286 for
pemoline tablets, 18.75 mg, 37.5 mg,
and 75 mg, and all amendments and
supplements thereto, is withdrawn
under § 314.150(d). Distribution of
pemoline tablets, 18.75 mg, 37.5 mg,
and 75 mg, 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))).
SUPPLEMENTARY INFORMATION:
Dated: March 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–04564 Filed 3–6–23; 8:45 am]
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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 Health Network
Development Planning Program
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 April 6, 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
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 594–
4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The Rural Health Network Development
Planning Performance Improvement and
Measurement System Database OMB
No. 0915–0384—Revision.
Abstract: The purpose of the Rural
Health Network Development Planning
Program (Network Planning Program) is
to promote the planning and
development of integrated health care
networks to address the following
legislative aims: (i) achieve efficiencies;
(ii) expand access to, coordinate, and
improve the quality of basic health care
services and associated health
SUMMARY:
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outcomes; and (iii) strengthen the rural
health care system. This program
supports 1 year of planning and brings
together key parts of a rural health care
delivery system, particularly those
entities that may not have collaborated
in the past, to establish and/or improve
local capacity in order to strengthen
rural community health interventions
and enhance care coordination. HRSA
collects information from the Network
Planning Program award recipients
using approved performance measures.
HRSA seeks to revise its approved
information collection by increasing the
total estimated annual burden hours,
due to an increase in the number of
program award recipients.
A 60-day notice was published in the
Federal Register on December 9, 2022,
vol. 87, No. 236; pp. 75638–39. There
were no public comments.
Need and Proposed Use of the
Information: Performance measures for
the Network Planning Program serve the
purpose of quantifying awardee-level
data that conveys the successes and
challenges associated with the grant
award. These measures and aggregate
data substantiate and inform the focus
and objectives of the grant program. The
approved measures encompass the
following principal topic areas: network
infrastructure, network collaboration,
sustainability, and network assessment.
The burden is increasing by 2 hours
from the previously approved collection
due to an increase in the number of
award recipients from 21 to 23.
Likely Respondents: The respondents
for these measures are Rural Health
Network Development Planning
Program award recipients.
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:
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14173
Federal Register / Vol. 88, No. 44 / Tuesday, March 7, 2023 / Notices
Number of
respondents
Form name
Number of
responses per
respondent
Total burden
hours
Rural Health Network Development Planning Program
Performance Improvement Measurement System ..........
23
1
23
1
23
Total ..............................................................................
23
........................
23
........................
23
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.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: March 2, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–04621 Filed 3–6–23; 8:45 am]
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Maria G. Button,
Director, Executive Secretariat.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2023–04585 Filed 3–6–23; 8:45 am]
BILLING CODE 4165–15–P
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
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.
ddrumheller on DSK120RN23PROD with NOTICES1
Average
burden per
response (in
hours)
Total
responses
Name of Committee: National Institute on
Aging Special Emphasis Panel; Dementia
Care.
Date: March 28, 2023.
Time: 9:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Dario Dieguez, Ph.D.,
Scientific Review Officer, National Institutes
of Health, National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892, (301) 827–3101,
dario.dieguez@nih.gov.
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Submission for OMB Review; 30-Day
Comment Request; NCI Genomic Data
Commons (GDC) Data Submission
Request Form (National Cancer
Institute)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30 days of the date of this
publication.
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 using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Jean Claude
Zenklusen, Ph.D., Scientific Program
Director, Center for Cancer Genomics
SUMMARY:
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(CCG), National Cancer Institute,
Building 31 Room 3A20, 31 Center
Drive, Bethesda MD 20814 or call the
non-toll-free number 301–781–3409 or
Email your request, including your
address to: Jean.Zenklusen@nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on November 7, 2022, page
67049 (Vol. 87 No. 215 FR 67049 and
allowed 60 days for public comment. No
public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: NCI Genomic
Data Commons (GDC) Data Submission
Request Form, 0925–0752, Expiration
Date 3/31/2023, EXTENSION, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The purpose of the NCI
Genomic Data Commons (GDC) Data
Submission Request Form is to provide
a vehicle for investigators to request the
submission of their cancer genomic data
into the GDC in support of data sharing.
The purpose is also to provide a
mechanism for the GDC Data
Submission Review Committee to
review and assess the data submission
request for applicability to the GDC
mission. The scope of the form involves
obtaining information from investigators
that: (1) would like to submit data about
their study into the GDC, (2) are
affiliated with studies that adhere to
GDC data submission conditions. The
benefits of the collection are that it
provides the needed information for
investigators to understand the types of
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[Federal Register Volume 88, Number 44 (Tuesday, March 7, 2023)]
[Notices]
[Pages 14172-14173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04585]
-----------------------------------------------------------------------
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 Health Network
Development Planning Program
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 April 6,
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 Samantha Miller, the HRSA
Information Collection Clearance Officer, at [email protected] or call
(301) 594-4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: The Rural Health Network
Development Planning Performance Improvement and Measurement System
Database OMB No. 0915-0384--Revision.
Abstract: The purpose of the Rural Health Network Development
Planning Program (Network Planning Program) is to promote the planning
and development of integrated health care networks to address the
following legislative aims: (i) achieve efficiencies; (ii) expand
access to, coordinate, and improve the quality of basic health care
services and associated health outcomes; and (iii) strengthen the rural
health care system. This program supports 1 year of planning and brings
together key parts of a rural health care delivery system, particularly
those entities that may not have collaborated in the past, to establish
and/or improve local capacity in order to strengthen rural community
health interventions and enhance care coordination. HRSA collects
information from the Network Planning Program award recipients using
approved performance measures. HRSA seeks to revise its approved
information collection by increasing the total estimated annual burden
hours, due to an increase in the number of program award recipients.
A 60-day notice was published in the Federal Register on December
9, 2022, vol. 87, No. 236; pp. 75638-39. There were no public comments.
Need and Proposed Use of the Information: Performance measures for
the Network Planning Program serve the purpose of quantifying awardee-
level data that conveys the successes and challenges associated with
the grant award. These measures and aggregate data substantiate and
inform the focus and objectives of the grant program. The approved
measures encompass the following principal topic areas: network
infrastructure, network collaboration, sustainability, and network
assessment. The burden is increasing by 2 hours from the previously
approved collection due to an increase in the number of award
recipients from 21 to 23.
Likely Respondents: The respondents for these measures are Rural
Health Network Development Planning Program award recipients.
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:
[[Page 14173]]
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Rural Health Network Development 23 1 23 1 23
Planning Program Performance
Improvement Measurement System.
-------------------------------------------------------------------------------
Total....................... 23 .............. 23 .............. 23
----------------------------------------------------------------------------------------------------------------
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. 2023-04585 Filed 3-6-23; 8:45 am]
BILLING CODE 4165-15-P
