Agency Information Collection Request; 30-Day Public Comment Request, 40277-40278 [2023-13173]
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Federal Register / Vol. 88, No. 118 / Wednesday, June 21, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0008]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Circulatory System Devices Panel of the
Medical Devices Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public.
DATES: The meeting will take place
virtually on August 22 and 23, 2023,
from 9 a.m. to 6 p.m. Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked questions,
including information regarding special
accommodations due to a disability,
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/ucm408555.
htm.
FOR FURTHER INFORMATION CONTACT:
Jarrod Collier, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
MD 20993–0002, Jarrod.Collier@
fda.hhs.gov, 240–672–5763, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On both
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SUMMARY:
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days, the committee will discuss, make
recommendations, and vote on devices
indicated to reduce blood pressure in
patients with hypertension. On August
22, 2023, the committee will discuss,
make recommendations, and vote on
information regarding the premarket
approval application (PMA) for the
ReCor Paradise Ultrasound Renal
Denervation System by ReCor, Inc. The
proposed indication for use statement is
as follows: The ReCor Paradise
Ultrasound Renal Denervation System is
indicated to reduce blood pressure in
adult (≥ 22 years of age) patients with
uncontrolled hypertension, who may be
inadequately responsive to, or who are
intolerant to, antihypertensive
medications, which is intended to be
used in renal arteries of diameters
ranging from 3.0 to 8.0 mm.
On August 23, 2023, the committee
will discuss, make recommendations,
and vote on information regarding the
PMA for the Medtronic Symplicity
Spyral Renal Denervation System by
Medtronic, Inc. The proposed indication
for use statement is as follows: The
Symplicity Spyral multielectrode renal
denervation catheter and the Symplicity
G3 RF Generator are indicated for the
reduction of blood pressure in patients
with uncontrolled hypertension despite
the use of antihypertensive medications
or in patients in whom blood pressure
lowering therapy is poorly tolerated.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting, and the background
material will be posted on FDA’s
website after the meeting. Background
material and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down and select the
appropriate advisory committee meeting
link. The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 1, 2023. Oral
presentations from the public will be
scheduled on August 22 and 23, 2023
between approximately 1:30 p.m. and
2:30 p.m. Eastern Time. Those
individuals interested in making formal
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40277
oral presentations should notify the
contact person (see FOR FURTHER
INFORMATION CONTACT) and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before July 24, 2023. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 25, 2023.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Ann Marie
Williams at Annmarie.williams@
fda.hhs.gov or 240–507–6496 at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13136 Filed 6–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0937–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.
SUMMARY:
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40278
Federal Register / Vol. 88, No. 118 / Wednesday, June 21, 2023 / Notices
Comments on the ICR must be
received on or before July 21, 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 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. When submitting
comments or requesting information,
please include the document identifier
0937—New–30D and project title for
reference.
DATES:
Interested
persons are invited to send comments
regarding this burden estimate or any
SUPPLEMENTARY INFORMATION:
Services (HHS), requests a new
clearance for the collection of
performance measures specifically for
new FY2023Teen Pregnancy Prevention
(TPP) Program grantees. In FY2023,
OPA expects to award 5-year TPP
cooperative agreements to up to 96
organizations across three Notice of
Funding Opportunities (NOFOs).
Collection of performance measures is a
requirement of all TPP awards and is
included in the NOFOs. The semiannual
data collection will allow OPA to
comply with federal accountability and
performance requirements, inform
stakeholders of grantee progress in
meeting TPP program goals, provide
OPA with metrics for monitoring
FY2023 TPP grantees, and facilitate
individual grantees’ continuous quality
improvement efforts within their
projects. OPA requests clearance for
three years.
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: FY2023 Teen
Pregnancy Prevention Performance
Measures.
Type of Collection: New.
OMB No. 0937–NEW–OASH—Office
of Population Affairs (OPA).
Abstract: The Office of Population
Affairs (OPA), in the Office of the
Assistant Secretary for Health (OASH),
U.S. Department of Health and Human
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Average
burden per
response
(in hours)
Total burden
hours
TPP Tier 1 & Tier 2 Rigorous Impact grantees ...............................................
Tier 1 Grantees (Supportive Services Form) ..................................................
Tier 2 Innovation Network Grantees ................................................................
86
70
10
2
2
2
8
15/60
1
1,376
35
20
Total ..........................................................................................................
........................
2
........................
1,431
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2023–13173 Filed 6–20–23; 8:45 am]
BILLING CODE 4150–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
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Number
responses per
respondent
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.,
as amended. The cooperative agreement
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
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18:36 Jun 20, 2023
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unwarranted invasion of personal
privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; Translational Centers for
Microphysiological Systems Review.
Date: July 17–18, 2023.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Room
1037, Bethesda, MD 20892.
Contact Person: Victor Henriquez, Ph.D.,
Scientific Review Officer, Office of Scientific
Director, National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Room
1080, Bethesda, MD 20892–4878, 301–451–
2405, henriquv@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
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Dated: June 15, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–13184 Filed 6–20–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering Notice of
Proposed Reorganization
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute of
Biomedical Imaging and Bioengineering
(NIBIB) will host a public online forum
to enable public discussion of the
Institute’s proposal to establish the
Section on Mechanics and Tissue
Remodeling Integrating Computational
& Experimental Systems (MATRICES).
The proposed reorganization will more
accurately reflect the current structure
by which the Intramural Research
SUMMARY:
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]]>Agencies
[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Notices]
[Pages 40277-40278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13173]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0937-NEW]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
[[Page 40278]]
DATES: Comments on the ICR must be received on or before July 21, 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 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 264-0041. When submitting comments or requesting information,
please include the document identifier 0937--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: FY2023 Teen Pregnancy Prevention
Performance Measures.
Type of Collection: New.
OMB No. 0937-NEW-OASH--Office of Population Affairs (OPA).
Abstract: The Office of Population Affairs (OPA), in the Office of
the Assistant Secretary for Health (OASH), U.S. Department of Health
and Human Services (HHS), requests a new clearance for the collection
of performance measures specifically for new FY2023Teen Pregnancy
Prevention (TPP) Program grantees. In FY2023, OPA expects to award 5-
year TPP cooperative agreements to up to 96 organizations across three
Notice of Funding Opportunities (NOFOs). Collection of performance
measures is a requirement of all TPP awards and is included in the
NOFOs. The semiannual data collection will allow OPA to comply with
federal accountability and performance requirements, inform
stakeholders of grantee progress in meeting TPP program goals, provide
OPA with metrics for monitoring FY2023 TPP grantees, and facilitate
individual grantees' continuous quality improvement efforts within
their projects. OPA requests clearance for three years.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number burden per Total burden
Type of respondent respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
TPP Tier 1 & Tier 2 Rigorous Impact grantees.... 86 2 8 1,376
Tier 1 Grantees (Supportive Services Form)...... 70 2 15/60 35
Tier 2 Innovation Network Grantees.............. 10 2 1 20
---------------------------------------------------------------
Total....................................... .............. 2 .............. 1,431
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2023-13173 Filed 6-20-23; 8:45 am]
BILLING CODE 4150-34-P
