Agency Information Collection Revision 30-Day Public Comment Request, 58167 [2024-15655]
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58167
Federal Register / Vol. 89, No. 137 / Wednesday, July 17, 2024 / Notices
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the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
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received, go to https://
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docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
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FOR FURTHER INFORMATION CONTACT:
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Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4162,
Silver Spring, MD 20993, 240–402–
8912; or James Myers, Center for
Biologics Evaluation and Research,
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New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 29, 2024, FDA
published a notice with a 60-day
comment period to request comments
on the draft guidance for industry
entitled ‘‘Platform Technology
Designation Program for Drug
Development.’’ The Agency has
received a request for a 30-day
extension of the comment period. The
request conveyed concern that the
current 60-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response to
the draft guidance.
FDA has considered the request and
is extending the comment period for 30
days, until August 28, 2024. The Agency
believes that a 30-day extension allows
adequate time for interested persons to
submit comments on this draft
guidance.
Dated: July 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–15696 Filed 7–16–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0477]
Agency Information Collection
Revision 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 reinstatement for public
comment.
SUMMARY:
Comments on the ICR must be
received on or before August 16, 2024.
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.
DATES:
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041, or PRA@HHS.GOV.
When submitting comments or
requesting information, please include
the document identifier 0990–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: Incident Report
Form.
Type of Collection: Reinstatement
with Change.
OMB No.: 0990–0477.
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
Research Protections (OHRP), is
requesting reinstatement of the OMB
No. 0990–0477, Incident Report Form,
with two new information elements on
the Incident Report form: IORG # for
Reviewing IRB; and, Revising research
policies and procedures as a corrective
action plan category, if it applies. The
purpose of the Incident Report form is
to facilitate organizations or institutions
prompt reporting of specific human
subject protection incidents to OHRP, in
a simplified standardized format, as
required by HHS protection of human
subjects regulations at 45 CFR part 46.
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
ddrumheller on DSK120RN23PROD with NOTICES1
Forms name
Number of
responses per
respondents
Average
burden per
response
Total
burden
hours
Incident Report ......................................................................................................
Incident Report ......................................................................................................
Incident Report ......................................................................................................
25
25
200
1
3
5
30/60
30/60
30/60
12.5
37.5
500
Total ................................................................................................................
........................
..........................
....................
550
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2024–15655 Filed 7–16–24; 8:45 am]
National Institutes of Health
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National Institute of Allergy and
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Pursuant to section 1009 of the
Federal Advisory Committee Act, as
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Individuals who plan to attend inperson or view the virtual meeting and
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[Federal Register Volume 89, Number 137 (Wednesday, July 17, 2024)]
[Notices]
[Page 58167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15655]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0477]
Agency Information Collection Revision 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 reinstatement for public comment.
DATES: Comments on the ICR must be received on or before August 16,
2024.
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, or [email protected]. When submitting comments or
requesting information, please include the document identifier 0990-
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: Incident Report Form.
Type of Collection: Reinstatement with Change.
OMB No.: 0990-0477.
Abstract: The Office of the Assistant Secretary for Health, Office
for Human Research Protections (OHRP), is requesting reinstatement of
the OMB No. 0990-0477, Incident Report Form, with two new information
elements on the Incident Report form: IORG # for Reviewing IRB; and,
Revising research policies and procedures as a corrective action plan
category, if it applies. The purpose of the Incident Report form is to
facilitate organizations or institutions prompt reporting of specific
human subject protection incidents to OHRP, in a simplified
standardized format, as required by HHS protection of human subjects
regulations at 45 CFR part 46.
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of Average Total
Forms name Number of responses per burden per burden
respondents respondents response hours
----------------------------------------------------------------------------------------------------------------
Incident Report...................................... 25 1 30/60 12.5
Incident Report...................................... 25 3 30/60 37.5
Incident Report...................................... 200 5 30/60 500
----------------------------------------------------------
Total............................................ .............. ............... ........... 550
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-15655 Filed 7-16-24; 8:45 am]
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