Agency Information Collection Request; 60-Day Public Comment Request, 16275 [2023-05345]
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Federal Register / Vol. 88, No. 51 / Thursday, March 16, 2023 / Notices
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that LAMZEDE
(velmanase alfa-tycv), manufactured by
Chiesi Farmaceutici S.p.A., meets the
criteria for a priority review voucher.
LAMZEDE (velmanase alfa-tycv)
injection is for the treatment of noncentral nervous system manifestations
of alpha-mannosidosis.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDisease
PriorityVoucherProgram/default.htm.
For further information about
LAMZEDE (velmanase alfa-tycv), go to
the ‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05355 Filed 3–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Request; 60-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 May 15, 2023.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0473–60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.gov, or call (202) 795–7714 the
Reports Clearance Officer.
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
SUMMARY:
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: HHS Subpart C
Certification Form.
Type of Collection: Revision.
OMB No.: 0990–0473.
Abstract: The Office for Human
Research Protections (OHRP) is
requesting a three-year approval on a
0revision of OMB No. 0990–0473, the
HHS Subpart C Certification Form. The
purpose of this form is to provide a
simplified, standardized procedure for
institutions to submit subpart C research
certifications to OHRP in order to obtain
authorization to include prisoners in
HHS-conducted or supported human
subjects research. The form also
simplifies the internal process used by
OHRP to review and record such
certifications, resulting in faster
processing while reducing unnecessary
and burdensome staff time.
Likely Respondents: Institutions or
Organizations operating Institutional
Review Boards (IRBs) that have enrolled
or are planning to enroll prisoners in
human subjects research conducted or
supported by HHS.
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
Form name
Average burden
per response
(in hours)
Total burden
hours
Subpart C Certification Form .......................................................................
Subpart C Certification Form .......................................................................
25
5
2
3
1.0
1.0
50
15
Total ......................................................................................................
........................
........................
............................
65
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2023–05345 Filed 3–15–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
VerDate Sep<11>2014
19:10 Mar 15, 2023
Jkt 259001
meeting of the Sleep Disorders Research
Advisory Board.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Sleep Disorders
Research Advisory Board Sleep Disorders
Research Advisory Board.
Date: April 6–7, 2023.
Open: April 06, 2023, 1:00 p.m. to 5:00
p.m.
Agenda: The purpose of this meeting is to
update the Advisory Board and public
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
stakeholders on the progress of sleep and
circadian research activities across NIH, and
the activities of Federal stakeholders and
interested organizations.
Place: Virtual-Teleconference, ZoomGov
and In-Person.
Virtual: The event is free and open to the
public, however, registration is required.
Please use this link to register: https://
nih.zoomgov.com/webinar/register/WN_
NjI6hGOLQgmEGTNOe2zTzA.
In Person: Two Rockledge Centre,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20817.
Open: April 07, 2023, 9:00 a.m. to 2:00
p.m.
Agenda: The purpose of this meeting is to
update the Advisory Board and public
stakeholders on the progress of sleep and
circadian research activities across NIH, and
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Page 16275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05345]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency Information Collection Request; 60-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.
DATES: Comments on the ICR must be received on or before May 15, 2023.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0473-60D and
project title for reference, to Sherrette A. Funn, email:
[email protected], [email protected], or call (202) 795-7714 the Reports
Clearance Officer.
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: HHS Subpart C Certification Form.
Type of Collection: Revision.
OMB No.: 0990-0473.
Abstract: The Office for Human Research Protections (OHRP) is
requesting a three-year approval on a 0revision of OMB No. 0990-0473,
the HHS Subpart C Certification Form. The purpose of this form is to
provide a simplified, standardized procedure for institutions to submit
subpart C research certifications to OHRP in order to obtain
authorization to include prisoners in HHS-conducted or supported human
subjects research. The form also simplifies the internal process used
by OHRP to review and record such certifications, resulting in faster
processing while reducing unnecessary and burdensome staff time.
Likely Respondents: Institutions or Organizations operating
Institutional Review Boards (IRBs) that have enrolled or are planning
to enroll prisoners in human subjects research conducted or supported
by HHS.
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per per response (in Total burden
respondents respondent hours) hours
----------------------------------------------------------------------------------------------------------------
Subpart C Certification Form.................. 25 2 1.0 50
Subpart C Certification Form.................. 5 3 1.0 15
-----------------------------------------------------------------
Total..................................... .............. .............. ................ 65
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2023-05345 Filed 3-15-23; 8:45 am]
BILLING CODE 4150-36-P
