Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Standardized Work Plan Form for Use With Applications to the Bureau of Health Workforce Research and Training Grants and Cooperative Agreements OMB No. 0906-0049-Extension, 58284-58285 [2023-18360]
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Federal Register / Vol. 88, No. 164 / Friday, August 25, 2023 / Notices
withdrawal of approval is warranted
because the required post-approval
confirmatory trial failed to verify
clinical benefit and because available
evidence demonstrates PEPAXTO is not
shown to be safe or effective under its
conditions of use. The Oncologic Drugs
Advisory Committee (ODAC) convened
on September 22, 2022, to discuss issues
related to this proposed withdrawal.
The ODAC voted 14 to 2 that the
benefit-risk profile of melphalan
flufenamide was not favorable for the
currently indicated patient population.
For additional background, please refer
to CDER’s letter to Oncopeptides Re:
Section 506(c)(3)(B) Notice of Proposed
Withdrawal of Approval; PEPAXTO
(melphalan flufenamide) for injection;
NDA 214383 (‘‘Notice to Oncopeptides
of Proposed Withdrawal of PEPAXTO’’)
and CDER’s Proposed Withdrawal of
PEPAXTO Decisional Memorandum,
available at Docket No. FDA–2023–N–
3167, https://www.regulations.gov.
ddrumheller on DSK120RN23PROD with NOTICES1
II. Legal Standard for Withdrawal of
Approval
Section 506(c) of the FD&C Act, as
amended most recently by the
Consolidated Appropriations Act of
2023 (Pub. L. 117–328), describes the
accelerated approval of new drug
applications and the procedures and
authority governing expedited
withdrawal of approval. FDA has the
legal authority to use the expedited
procedures to withdraw approval of a
product that has received accelerated
approval if, among other reasons, ‘‘a
study required to verify and describe the
predicted effect on irreversible
morbidity or mortality or other clinical
benefit of the product fails to verify and
describe such effect or benefit’’ (section
506(c)(3)(A)(ii) of the FD&C Act) or
‘‘other evidence demonstrates that the
product is not shown to be safe or
effective under the conditions of use.’’
(section 506(c)(3)(A)(iii) of the FD&C
Act.)
III. Explanation for the Proposed
Withdrawal
CDER proposes to withdraw approval
of PEPAXTO because the required
confirmatory study, Trial OP–103, also
known as OCEAN, failed to verify
clinical benefit and because available
evidence demonstrates PEPAXTO is not
shown to be safe or effective under its
conditions of use. More specifically, the
results failed to show that PEPAXTO
had a significant effect on the primary
endpoint of progression-free survival.
Furthermore, the observed median
Act of 2023 (Pub. L. 117–328); see also 21 CFR
314.510.
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18:23 Aug 24, 2023
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overall survival was 5.3 months shorter
in the PEPAXTO arm compared to the
control arm. After considering all the
available data and the discussion at the
ODAC held in September 2022, CDER
recommends withdrawing the
accelerated approval for PEPAXTO.
Please refer to CDER’s ‘‘Notice to
Oncopeptides of Proposed Withdrawal
of PEPAXTO’’ and ‘‘Proposed
Withdrawal of PEPAXTO Decisional
Memorandum’’ for additional
explanation.
IV. Opportunity for Public Comment on
CDER’s Proposal To Withdraw
Approval of PEPAXTO
In accordance with the expedited
withdrawal of approval procedures
described in section 506(c)(3)(B)(ii) and
(iii) of the FD&C Act, CDER is providing
an opportunity for public comment on
its proposal to withdraw approval of
NDA 214383 (PEPAXTO) through the
issuance of a Federal Register Notice.
FDA will consider any such public
comments it receives in making its
decision on CDER’s proposal to
withdraw approval of NDA 214383
(PEPAXTO) and make available on its
website and in the public docket a
summary of such comments and FDA’s
response to them.
Dated: August 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–18320 Filed 8–24–23; 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: Standardized
Work Plan Form for Use With
Applications to the Bureau of Health
Workforce Research and Training
Grants and Cooperative Agreements
OMB No. 0906–0049—Extension
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
SUMMARY:
PO 00000
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Fmt 4703
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(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 October 24, 2023.
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:
Standardized Work Plan (SWP) Form for
Use with Applications to the Bureau of
Health Workforce (BHW) Research and
Training Grants and Cooperative
Agreements OMB No. 0906–0049—
Extension.
Abstract: BHW requires applicants for
training and research grants and
cooperative agreements to submit work
plans via the SWP form. Information in
the SWP describes the timeframes and
progress required during the grant
period of performance to address each
of the needs detailed in the Purpose and
Need section of the application, as
required in the Notice of Funding
Opportunity announcement. Applicants
use the SWP form when they submit
their proposals, and award recipients
and Project Officers use the SWP
information to assist in monitoring
progress once HRSA makes the awards.
After awards are made, recipients
complete a Quarterly Progress Update
(QPU) to provide information to BHW
on a quarterly basis on each activity
listed in the SWP.
Need and Proposed Use of the
Information: Information collected by
the SWP form and QPUs standardizes
and streamlines the data used by HRSA
in reviewing applications and
monitoring awardees. The form asks
applicants to provide a description of
the activities or steps the applicant will
take to achieve each of the objectives
proposed during the entire period of
performance. The current standardized
format and data submission by
applicants increases efficiency in
reviewing, awarding, and monitoring
each project.
The QPU is completed via HRSA’s
Electronic Handbook system and
E:\FR\FM\25AUN1.SGM
25AUN1
58285
Federal Register / Vol. 88, No. 164 / Friday, August 25, 2023 / Notices
prompts recipients to report on progress
of activities that were submitted using
the SWP in the original application. The
QPU automatically populates activities
from the recipient’s SWP form on a
quarterly basis. For each activity listed
in the submitted SWP for any particular
quarter within the project period,
recipients select and submit a single
selection response for each activity
status from a pull-down menu with five
options: Activity is on Schedule,
Activity is Complete, Timing is off
track, Activity will be missed if action
is not taken, and Activity cannot be
achieved. Information provided is
utilized by the program staff to regularly
assess overall progress of program
requirements and analyze data in order
to monitor award recipient compliance
and track progress against proposed
targets and goals. Information gathered
allows an improved and more efficient
method for identifying whether projects’
goals are being advanced or achieved, as
set forth in 45 CFR 75.342. Program staff
also use information provided over the
period of performance to see emerging
trends and to assess whether an award
recipient requires technical assistance to
address challenges that the award
recipient may be experiencing with the
implementation of the project. Seeking
OMB extension approval comports with
the regulatory requirement imposed by
45 CFR 75.206(a), Paperwork clearances.
Likely Respondents: Respondents are
applicants for, and recipients of, BHW’s
research and training grants and
cooperative agreements.
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
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total annual
burden hours
Standardized Work Plan (SWP) ..........................................
Quarterly Progress Update (QPU) Form .............................
1,000
1,000
1
4
1,000
4,000
1.00
.10
1,000
400
Total ..............................................................................
1 1,000
........................
5,000
........................
1,400
1 The
1,000 Standardized Work Plan (SWP) respondents reflects the number of new grant applications submitted annually. The 1,000 Quarterly Progress Update (QPU) respondents reflects the current volume of funded, active grants.
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. 2023–18360 Filed 8–24–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 1009 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.,
VerDate Sep<11>2014
18:23 Aug 24, 2023
Jkt 259001
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: National Institute on
Aging Initial Review Group; Career
Development for Established Investigators
and Conference Grants Study Section.
Date: October 26–27, 2023.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Rajasri Roy, Ph.D., M.P.H.,
Scientific Review Officer, Scientific Review
Branch, National Institutes of Health,
National Institute on Aging, 7201 Wisconsin
Avenue, RM: 2W200, Bethesda, MD 20892,
301–496–6477, rajasri.roy@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 21, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–18380 Filed 8–24–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; 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 on
Alcohol Abuse and Alcoholism.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), title 5 U.S.C., as amended for
the review, discussion, and evaluation
of individual intramural programs and
projects conducted by the National
Institute on Alcohol Abuse and
Alcoholism, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, National Institute on Alcohol
Abuse and Alcoholism.
Date: September 13–14, 2023.
Time: 9:00 a.m. to 5:00 p.m.
E:\FR\FM\25AUN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 164 (Friday, August 25, 2023)]
[Notices]
[Pages 58284-58285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18360]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title:
Standardized Work Plan Form for Use With Applications to the Bureau of
Health Workforce Research and Training Grants and Cooperative
Agreements OMB No. 0906-0049--Extension
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 October
24, 2023.
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: Standardized Work Plan (SWP)
Form for Use with Applications to the Bureau of Health Workforce (BHW)
Research and Training Grants and Cooperative Agreements OMB No. 0906-
0049--Extension.
Abstract: BHW requires applicants for training and research grants
and cooperative agreements to submit work plans via the SWP form.
Information in the SWP describes the timeframes and progress required
during the grant period of performance to address each of the needs
detailed in the Purpose and Need section of the application, as
required in the Notice of Funding Opportunity announcement. Applicants
use the SWP form when they submit their proposals, and award recipients
and Project Officers use the SWP information to assist in monitoring
progress once HRSA makes the awards. After awards are made, recipients
complete a Quarterly Progress Update (QPU) to provide information to
BHW on a quarterly basis on each activity listed in the SWP.
Need and Proposed Use of the Information: Information collected by
the SWP form and QPUs standardizes and streamlines the data used by
HRSA in reviewing applications and monitoring awardees. The form asks
applicants to provide a description of the activities or steps the
applicant will take to achieve each of the objectives proposed during
the entire period of performance. The current standardized format and
data submission by applicants increases efficiency in reviewing,
awarding, and monitoring each project.
The QPU is completed via HRSA's Electronic Handbook system and
[[Page 58285]]
prompts recipients to report on progress of activities that were
submitted using the SWP in the original application. The QPU
automatically populates activities from the recipient's SWP form on a
quarterly basis. For each activity listed in the submitted SWP for any
particular quarter within the project period, recipients select and
submit a single selection response for each activity status from a
pull-down menu with five options: Activity is on Schedule, Activity is
Complete, Timing is off track, Activity will be missed if action is not
taken, and Activity cannot be achieved. Information provided is
utilized by the program staff to regularly assess overall progress of
program requirements and analyze data in order to monitor award
recipient compliance and track progress against proposed targets and
goals. Information gathered allows an improved and more efficient
method for identifying whether projects' goals are being advanced or
achieved, as set forth in 45 CFR 75.342. Program staff also use
information provided over the period of performance to see emerging
trends and to assess whether an award recipient requires technical
assistance to address challenges that the award recipient may be
experiencing with the implementation of the project. Seeking OMB
extension approval comports with the regulatory requirement imposed by
45 CFR 75.206(a), Paperwork clearances.
Likely Respondents: Respondents are applicants for, and recipients
of, BHW's research and training grants and cooperative agreements.
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 annual
respondents respondent responses (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Standardized Work Plan (SWP).... 1,000 1 1,000 1.00 1,000
Quarterly Progress Update (QPU) 1,000 4 4,000 .10 400
Form...........................
-------------------------------------------------------------------------------
Total....................... \1\ 1,000 .............. 5,000 .............. 1,400
----------------------------------------------------------------------------------------------------------------
\1\ The 1,000 Standardized Work Plan (SWP) respondents reflects the number of new grant applications submitted
annually. The 1,000 Quarterly Progress Update (QPU) respondents reflects the current volume of funded, active
grants.
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. 2023-18360 Filed 8-24-23; 8:45 am]
BILLING CODE 4165-15-P
