Agency Information Collection Request; 30-Day Public Comment Request, 88787-88788 [2024-26057]
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Federal Register / Vol. 89, No. 217 / Friday, November 8, 2024 / Notices
• There are many different types of
establishment listing and certification
procedures for establishments that
produce human food products. Please
share your experience with other
countries’ establishment listing,
certification, and registration
requirements.
• FDA requires those on export lists
to reapply regularly if they wish to
remain listed. Do reapplicants
experience any challenges with the
renewal process? If you have
experienced challenges, how were those
challenges resolved?
• For those included on export lists,
please describe any challenges you have
experienced with exporting human food
products included on the export lists.
• FDA is authorized to collect up to
$175 per certification for each company
and its human food products that FDA
certifies through inclusion on an export
list. For those that would be charged a
fee, do you have any specific
suggestions about how FDA should
approach the implementation of fees?
Please provide details relating to any
suggestions you might have.
Dated: November 4, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–26040 Filed 11–7–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4734]
Amending Over-the-Counter
Monograph M012: Cold, Cough,
Allergy, Bronchodilator, and
Antiasthmatic Drug Products for Overthe-Counter Human Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability on its website of the
proposed administrative order
(proposed order) (OTC000036) entitled
‘‘Amending Over-the-Counter
Monograph M012: Cold, Cough, Allergy,
Bronchodilator, and Antiasthmatic Drug
Products for Over-the-Counter Human
Use.’’ This proposed order, if finalized,
will amend Final Administrative Order
OTC000026, to remove orally
administered phenylephrine
hydrochloride and phenylephrine
bitartrate in an effervescent dosage as
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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nasal decongestant active ingredients
because they are not effective.
DATES: Submit electronic comments on
the proposed administrative order by
May 7, 2025.
ADDRESSES: The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 7, 2025. Please note that late,
untimely filed comments will not be
considered. Instructions for submitting
comments are contained in the
proposed order OTC000036, which can
be viewed in the OTC Monographs@
FDA portal at https://dps.fda.gov/omuf.
Comments must be submitted
electronically.
FOR FURTHER INFORMATION CONTACT: Dan
Brum, Center for Drug Evaluation and
Research (HFD–600), Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–0578.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this proposed order
OTC000036 to amend the requirements
for cold, cough, allergy, bronchodilator,
and antiasthmatic drug products for
over-the-counter (OTC) human use, as
currently described in Over-the-Counter
Monograph M012: Cold, Cough, Allergy,
Bronchodilator, and Antiasthmatic Drug
Products for Over-the-Counter Human
Use (OTC Monograph M012), as set
forth in the Final Administrative Order
OTC000026. FDA is issuing the
proposed order pursuant to section
505G(b)(1) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355h(b)(1)).
OTC Monograph M012 describes the
conditions under which OTC cold,
cough, allergy, bronchodilator, and
antiasthmatic drug products are
generally recognized as safe and
effective. OTC Monograph M012 is set
forth in Final Administrative Order
OTC000026, which was deemed
established by section 505G(b)(8) of the
FD&C Act, and was effective upon
enactment of the Coronavirus Aid,
Relief, and Economic Security Act (Pub.
L. 116–136) on March 27, 2020. The
conditions described in OTC
Monograph M012, as set forth in final
order(s), may be amended, revoked, or
otherwise modified in accordance with
the procedures of section 505G(b) of the
FD&C Act.
The proposed order, if finalized, will
amend the conditions described in OTC
Monograph M012 as set forth in the
Final Administrative Order OTC000026
to remove orally administered
phenylephrine hydrochloride and
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88787
phenylephrine bitartrate in an
effervescent dosage from OTC
Monograph M012 as nasal decongestant
active ingredients because they are not
effective. This proposed order also
includes minor stylistic and formatting
changes to improve the readability and
presentation of OTC Monograph M012,
including removing references to
historical Federal Register documents
because OTC monographs are no longer
modified through notice and comment
rulemaking.
The proposed order can be viewed in
the OTC Monographs@FDA portal at
https://dps.fda.gov/omuf. The proposed
order contains instructions for
commenting on the proposed order.
Comments to the proposed order must
be submitted electronically to the
Federal eRulemaking Portal at https://
www.regulations.gov.
OTC Monographs@FDA provides a
resource for the public to view
Administrative Orders (Proposed, Final,
and Interim Final Orders) for OTC
Monograph Drugs and view OTC
Monographs. In the future, OTC
Monographs@FDA will facilitate the
public’s ability to submit, search, and
view comments and data for Proposed
and Interim Final Orders.
II. Paperwork Reduction Act of 1995
The proposed order is issued under
section 505G(b)(1) of the FD&C Act.
Under section 505G(o) of the FD&C Act,
the Paperwork Reduction Act of 1995
(PRA) (Chapter 35 of title 44, United
States Code) does not apply to
collections of information made under
section 505G of the FD&C Act.
Therefore, clearance by the Office of
Management and Budget under the PRA
is not required for collections of
information, if any, in a final order
issued under section 505G of the FD&C
Act that results from this proposed
order.
Dated: October 31, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–25910 Filed 11–7–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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88788
Federal Register / Vol. 89, No. 217 / Friday, November 8, 2024 / Notices
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 December 9, 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, 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
SUMMARY:
collection of performance-oriented data
tied to OMH-wide performance
reporting needs. The ability to monitor
and evaluate performance in this
manner, and to work towards
continuous program improvement are
basic functions that OMH must be able
to accomplish to carry out its mandate
with the most effective and appropriate
use of resources.
This information collection includes
two new web-based data collection
tools:
• OMH Performance Progress Report
• Disparity Impact Statement
The OMH Performance Progress
Report is a supplement to the Office of
the Assistant Secretary for Health
(OASH) periodic Performance Progress
Report, and recipients will submit
reports on a quarterly basis. Recipients
will submit the Disparity Impact
Statement once during the period of
performance.
Likely Respondents: Members and
staff from academia, community
organizations, private non-profit
organizations, local/state/federal
government, and tribal government and
services organizations including those
who serve American Indian and Alaska
Native and/or racial and ethnic
minorities.
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: Performance
and Evaluation Measurement System
(PEMS).
Type of Collection: New Data
Collection.
OMB No. 0990–NEW.
Abstract: The U.S. Department of
Health and Human Services (HHS)
Office of Minority Health (OMH) is
requesting OMB approval on a new
information collection, Performance and
Evaluation Measurement System
(PEMS). The proposed information
collection activity will allow OMH to
collect grant management and
performance data and disparity impact
information for all OMH-funded
projects. The clearance is needed to
support data collection using Grant
Solutions, a system that enables OMH to
comply with Federal reporting
requirements and monitor and evaluate
performance by enabling the efficient
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
responses per
respondent
OMH grant recipients—Disparity Impact Statement ........................................
OMH grant recipients—OMH Performance Progress Report .........................
125
125
1
4
1
1.5
125
750
Total ..........................................................................................................
250
5
2.5
875
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2024–26057 Filed 11–7–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
Average
burden per
response
(in hours)
Number
of respondents
Type of respondent
National Institute of Allergy and
Infectious Diseases; 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
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17:38 Nov 07, 2024
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552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
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 of
Allergy and Infectious Diseases Special
Emphasis Panel; Limited Interaction Targeted
Epidemiology: Epidemiology of Transmission
and Treatment of HIV Among People Who
Are at Increased Risk for HIV Infection in
Latin America (LITE–LA) (UG3/UH3 Clinical
Trial Optional).
Date: December 3, 2024.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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Total burden
hours
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F40,
Rockville, MD 20892 (Video Assisted
Meeting).
Contact Person: Robert C. Unfer, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F40, Rockville, MD
20892 240–669–5035, unferrc@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: November 4, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–25936 Filed 11–7–24; 8:45 am]
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]]>Agencies
[Federal Register Volume 89, Number 217 (Friday, November 8, 2024)]
[Notices]
[Pages 88787-88788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26057]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-new]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 88788]]
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 December 9,
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: Performance and Evaluation Measurement
System (PEMS).
Type of Collection: New Data Collection.
OMB No. 0990-NEW.
Abstract: The U.S. Department of Health and Human Services (HHS)
Office of Minority Health (OMH) is requesting OMB approval on a new
information collection, Performance and Evaluation Measurement System
(PEMS). The proposed information collection activity will allow OMH to
collect grant management and performance data and disparity impact
information for all OMH-funded projects. The clearance is needed to
support data collection using Grant Solutions, a system that enables
OMH to comply with Federal reporting requirements and monitor and
evaluate performance by enabling the efficient collection of
performance-oriented data tied to OMH-wide performance reporting needs.
The ability to monitor and evaluate performance in this manner, and to
work towards continuous program improvement are basic functions that
OMH must be able to accomplish to carry out its mandate with the most
effective and appropriate use of resources.
This information collection includes two new web-based data
collection tools:
OMH Performance Progress Report
Disparity Impact Statement
The OMH Performance Progress Report is a supplement to the Office
of the Assistant Secretary for Health (OASH) periodic Performance
Progress Report, and recipients will submit reports on a quarterly
basis. Recipients will submit the Disparity Impact Statement once
during the period of performance.
Likely Respondents: Members and staff from academia, community
organizations, private non-profit organizations, local/state/federal
government, and tribal government and services organizations including
those who serve American Indian and Alaska Native and/or racial and
ethnic minorities.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
OMH grant recipients--Disparity Impact Statement 125 1 1 125
OMH grant recipients--OMH Performance Progress 125 4 1.5 750
Report.........................................
---------------------------------------------------------------
Total....................................... 250 5 2.5 875
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-26057 Filed 11-7-24; 8:45 am]
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