Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment; Biographical Sketch Form for Use With Applications to the Maternal and Child Health Bureau Research Grants OMB No. 0906-Reinstatement, 56025-56026 [2023-17636]
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Federal Register / Vol. 88, No. 158 / Thursday, August 17, 2023 / Notices
I. Background
In the United States, approximately
5.5 million pregnancies occur each year
(Ref. 1). Half of individuals who are
pregnant use at least one drug or
biological product to treat chronic (e.g.,
diabetes, seizure disorders, or asthma),
acute (e.g., infection) or serious medical
conditions (Ref. 2). Typically at the time
of initial market approval, there are
limited to no human data on the safety
of drug or biological products used
during pregnancy. As a result, for most
products, human pregnancy safety data
are collected after a product is available
on the market (i.e., postapproval).
In May 2019, FDA published a draft
Guidance for Industry entitled
‘‘Postapproval Pregnancy Safety
Studies’’ (available at https://
www.fda.gov/media/124746/download),
which discusses the strengths and
limitations of postapproval study types
including studies based on registry data
and cohort studies using electronic
health records or claims data. However,
more research is needed to better
understand the key considerations for
determining the optimal postapproval
study designs to obtain timely evidence
to ensure the safe use of drug and
biological products in pregnant
individuals. The public workshop is a
preliminary discussion with
stakeholders to inform FDA’s further
development of a framework and also
meets a performance goal under the
FDA User Fee Reauthorization Act of
2022, in accordance with the
Prescription Drug User Fee Act
(PDUFA) Reauthorization Performance
Goals and Procedures Fiscal Years 2023
Through 2027 letter (PDUFA VII
Commitment Letter), which is available
at https://www.fda.gov/media/151712/
download. Specifically, the PDUFA VII
Commitment Letter outlines the
commitment of a public workshop to
discuss postapproval pregnancy safety
studies to facilitate determination of
ideal study designs.
ddrumheller on DSK120RN23PROD with NOTICES1
II. Topics for Discussion at the Public
Workshop
The public workshop will include the
following topics for discussion:
1. FDA’s considerations for
constructing a framework describing
how data from different types of postmarket pregnancy safety studies might
optimally be used.
2. Stakeholders’ perspectives on
opportunities to optimize postapproval
pregnancy safety study types and
designs.
3. Design considerations and potential
approaches to bridge knowledge gaps in
developing the framework, including
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21:36 Aug 16, 2023
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understanding how the Sentinel
Initiative (i.e., Sentinel System and
Biologics Effectiveness and Safety
(BEST)) may address these gaps.
4. Stakeholders’ perspectives on
considerations for FDA’s proposed
framework.
Meeting updates, the agenda, and
background materials (if any) will be
made available at https://duke.is/nj5kg
prior to the workshop.
III. Participating in the Public
Workshop
Registration: To register for this
hybrid public workshop, please visit the
following website: https://duke.is/nj5kg.
Please provide complete contact
information for each attendee, including
attendance format (in-person or virtual),
name, title, affiliation, and email.
Registration is free and based on space
availability, with priority given to early
registrants. Persons interested in
attending this public workshop must
register by 10 a.m. Eastern Daylight
Time, September 18, 2023. Early
registration is recommended due to
limited seating; therefore, FDA may
limit the number of participants from
each organization. Registrants will
receive a confirmation email when they
have been registered.
If you need special accommodations
due to a disability, please contact Luke
Durocher, Duke-Margolis Center for
Health Policy, 202–621–2800,
margolisevents@duke.edu, no later than
5 p.m. Eastern Time, September 5, 2023.
Requests for Oral Comments: During
online registration, you may indicate if
you wish to speak during a public
comment session. We will do our best
to accommodate requests to make public
comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
comments and request a time for joint
commentary. All requests to make oral
comments must be received by 11:59
p.m. Eastern Time on September 5,
2023. FDA will determine the amount of
time allotted to each commenter and the
approximate time each comment is to
begin and will select and notify
participants by September 11, 2023.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
by the Dockets Management Staff.
IV. References
The following references marked with
an asterisk (*) have been placed on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
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56025
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. FDA
has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
*1. Centers for Disease Control and
Prevention, National Center for Health
Statistics. ‘‘U.S. Pregnancy Rates Drop
During Last Decade.’’ Hyattsville (MD);
2023 April 12, Available from: https://
www.cdc.gov/nchs/pressroom/nchs_
press_releases/2023/20230412.htm.
2. Mitchell, A.A, S.M. Gilboa, M.M. Werler,
et al. ‘‘Medication Use During
Pregnancy, with Particular Focus on
Prescription Drugs: 1976–2008.’’
American Journal of Obstetrics &
Gynecology 2011;205:51.e1–8.
Dated: August 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17718 Filed 8–16–23; 8:45 am]
BILLING CODE 4164–01–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; Biographical Sketch Form
for Use With Applications to the
Maternal and Child Health Bureau
Research Grants OMB No. 0906—
Reinstatement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
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.
SUMMARY:
E:\FR\FM\17AUN1.SGM
17AUN1
56026
Federal Register / Vol. 88, No. 158 / Thursday, August 17, 2023 / Notices
Comments on this ICR should be
received no later than September 18,
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 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 Samantha Miller, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Forms for Use with Applications to the
Maternal and Child Health Bureau
Research Grants, OMB 0906—
Reinstatement
Abstract: HRSA is requesting
reinstatement of the Biographical Sketch
Form for use with applications to the
Maternal and Child Health Bureau
Research Grants (Biographical Sketch)
for HRSA’s SF424 Research & Related
application package. These grants are
funded by a number of authorities such
as 42 U.S.C. 701(a)(2) (title V, 501(a)(2)
DATES:
of the Social Security Act) and by 42
U.S.C. 280i–1(f) (title III, section
399BB(f) of the Public Health Service
Act. The purpose of these grants is to
advance the health and well-being of
Maternal and Child Health populations
and children and adolescents with
autism spectrum disorder by supporting
innovative, applied, and translational
intervention research studies on critical
issues affecting these populations.
A 60-day notice published in the
Federal Register on March 1, 2023, vol.
88, No. 40; pp. 12953–54. There were no
public comments.
Need and Proposed Use of the
Information: HRSA plans to use the
Biographical Sketch as a required
element of the SF424 Research &
Related application package. The
applicants use the Biographical Sketch
form to summarize the qualifications of
each key personnel on their proposed
research team, including education/
training, positions and honors,
contributions to science, and related
experience. The grant reviewers will use
this information to assess the
capabilities of the research team to carry
out the planned research project. The
Biographical Sketch form also collects
demographic data for the Principal
Investigator and key program staff.
HRSA is considering several changes for
the Biographical Sketch:
• Clarifying instructions: Provides the
applicant more information on what
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
Biographical Sketch Form ....................................................
200
5
1,000
1.75
1,750
Total ..............................................................................
200
5
1,000
1.75
1,750
Amy P. McNulty,
Deputy Director, Executive Secretariat.
treatments of diabetes and Alzheimer’s
disease and serve as blood-based
biomarkers for Alzheimer’s disease.
This technology was discovered and is
being developed by the National
Institute on Aging (NIA). The NIA is
currently seeking a licensee and/or
collaborator to further develop this
technology.
[FR Doc. 2023–17636 Filed 8–16–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
FOR FURTHER INFORMATION CONTACT:
Notice; Licensing and Collaboration
Opportunity
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
should and should not be included on
the biographical sketch.
• Removal of Section D: Section D:
Related Experience has been removed.
• Removal of Section E: Section E:
Additional Information: Research
Support and/or Scholastic Performance
Awards has been removed.
• ‘‘Some Other Race’’ Category: At
the request of our applicants, this
category was added.
Likely Respondents: Respondents are
applicants to HRSA’s Maternal and
Child Health Bureau research programs.
Burden Statement: Burden includes
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, disclosing and
providing information. It also accounts
for time to train personnel, respond to
a collection of information, search data
sources; complete and review the
collection of information, and 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:
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
directed to potential peptidyl
therapeutics that counteract with
amyloid forming IAPP and amyloid-b in
SUMMARY:
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21:36 Aug 16, 2023
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Inquiries related to this licensing and
collaboration opportunity should be
directed to: Zarpheen Jinnah,
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, RM 1E530 MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702 Telephone: (240) 276–5530;
Facsimile: (240) 276–5504 Email:
zarpheen.jinnah@nih.gov. A signed
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Confidential Disclosure Agreement will
be required to receive copies of
unpublished information related to this
invention.
SUPPLEMENTARY INFORMATION: The
following patent application is available
for licensing and/or collaboration under
a Cooperative Research and
Development Agreement (CRADA):
U.S. Provisional Application No. 63/
417,582.
Achieving expeditious
commercialization of federally funded
research and development is consistent
with the goals of the Bayh-Dole Act,
codified as 35 U.S.C. 200–212.
Background and Description of
Technology: Over 34 million Americans
are living with diabetes and an
estimated 6.5 million Americans are
living with Alzheimer’s disease (AD). A
E:\FR\FM\17AUN1.SGM
17AUN1
]]>Agencies
[Federal Register Volume 88, Number 158 (Thursday, August 17, 2023)]
[Notices]
[Pages 56025-56026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17636]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment; Biographical Sketch Form for Use
With Applications to the Maternal and Child Health Bureau Research
Grants OMB No. 0906--Reinstatement
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.
[[Page 56026]]
DATES: Comments on this ICR should be received no later than September
18, 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 more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Samantha Miller,
the HRSA Information Collection Clearance Officer, at (301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Forms for Use with
Applications to the Maternal and Child Health Bureau Research Grants,
OMB 0906--Reinstatement
Abstract: HRSA is requesting reinstatement of the Biographical
Sketch Form for use with applications to the Maternal and Child Health
Bureau Research Grants (Biographical Sketch) for HRSA's SF424 Research
& Related application package. These grants are funded by a number of
authorities such as 42 U.S.C. 701(a)(2) (title V, 501(a)(2) of the
Social Security Act) and by 42 U.S.C. 280i-1(f) (title III, section
399BB(f) of the Public Health Service Act. The purpose of these grants
is to advance the health and well-being of Maternal and Child Health
populations and children and adolescents with autism spectrum disorder
by supporting innovative, applied, and translational intervention
research studies on critical issues affecting these populations.
A 60-day notice published in the Federal Register on March 1, 2023,
vol. 88, No. 40; pp. 12953-54. There were no public comments.
Need and Proposed Use of the Information: HRSA plans to use the
Biographical Sketch as a required element of the SF424 Research &
Related application package. The applicants use the Biographical Sketch
form to summarize the qualifications of each key personnel on their
proposed research team, including education/training, positions and
honors, contributions to science, and related experience. The grant
reviewers will use this information to assess the capabilities of the
research team to carry out the planned research project. The
Biographical Sketch form also collects demographic data for the
Principal Investigator and key program staff. HRSA is considering
several changes for the Biographical Sketch:
Clarifying instructions: Provides the applicant more
information on what should and should not be included on the
biographical sketch.
Removal of Section D: Section D: Related Experience has
been removed.
Removal of Section E: Section E: Additional Information:
Research Support and/or Scholastic Performance Awards has been removed.
``Some Other Race'' Category: At the request of our
applicants, this category was added.
Likely Respondents: Respondents are applicants to HRSA's Maternal
and Child Health Bureau research programs.
Burden Statement: Burden includes 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, disclosing and providing information. It
also accounts for time to train personnel, respond to a collection of
information, search data sources; complete and review the collection of
information, and 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 burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Biographical Sketch Form........ 200 5 1,000 1.75 1,750
-------------------------------------------------------------------------------
Total....................... 200 5 1,000 1.75 1,750
----------------------------------------------------------------------------------------------------------------
Amy P. McNulty,
Deputy Director, Executive Secretariat.
[FR Doc. 2023-17636 Filed 8-16-23; 8:45 am]
BILLING CODE 4165-15-P
