Agency Information Collection Request; 60-Day Public Comment Request, 93308-93309 [2024-27598]
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93308
Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices
3965b once for each submission. We
assume the submitter could include
from 1 to 2,000 products in each Form
FDA 3965b. Entering data for up to
2,000 rows can take approximately 4
hours on average per Form FDA 3965b
for manual data entry. We reflect the
average time of 60 minutes per response
based on the assumption that we expect
to receive an average of 25 bundled
products per submission. Assuming 60
minutes per Form FDA 3965b for 1,570
applications, we estimate a total burden
of 1,570 hours for this activity.
The FDA Tobacco Product Grouping
Spreadsheet Validator (Validator) is a
free software that validates the content
of FDA product grouping spreadsheets
such as ‘‘Form FDA 3965b—SE Unique
Identification for New and Predicate
Tobacco Products.’’ The Validator is
available for voluntary use by the
tobacco industry (sponsors,
manufacturers, and importers) prior to
submitting a product grouping
spreadsheet to FDA.
The Validator allows industry users to
validate product attributes in their
product grouping spreadsheet with the
defined and accepted product data
standards and to make corrections as
needed. If there are no errors found in
a spreadsheet, the Validator will
produce a certificate of completion that
can be saved locally and included with
the applicants FDA submission
voluntarily. If errors are found during
validation, the Validator will provide
the applicants with the error at the end
of each impacted row of the
spreadsheet, allowing applicants to
make necessary changes.
The software and any output files
reside locally on an applicant’s
computer, allowing them to work on the
product grouping spreadsheet offline.
The Validator does not transmit any
data across the web to FDA. FDA does
not have the ability to access, review, or
supplement the information on local
computers through this application. We
estimate that use of the Validator will
take an average of 5 minutes per
response.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity; 21 CFR section
Recordkeeping SE Report under 1107.18–1107.58 ...........
1
471
Total annual
records
1
471
Average burden per recordkeeping
5
Total hours
2,355
There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 30 percent of SE
Reports or 471 respondents will
maintain required records related to
their SE Reports at 5 hours per record
for a total of 2,355 recordkeeping hours
(table 2). The first SE Report in a chain
must use a tobacco product
commercially marketed (other than for
test marketing) in the United States as
of February 15, 2007, as a predicate
product for the SE Report. Therefore, we
believe that manufacturers will have
records on those ‘‘original’’ predicate
tobacco products from their initial SE
Reports.
Our estimated burden for the
information collection reflects an
overall increase of 69,010 hours and a
corresponding increase of 2,905
responses/records. We attribute this to
adding a new form, providing the
validator tool, and reevaluating our
current estimates.
Dated: November 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–27654 Filed 11–25–24; 8:45 am]
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Number of
records per
recordkeeper
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18:03 Nov 25, 2024
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0008]
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 January 27, 2025.
ADDRESSES: Submit your comments to
sagal.musa@hhs.gov or by calling (202)
205–2634.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 4040–0008–60D
and project title for reference, to Sagal
Musa, email: sagal.musa@hhs.gov, or
call (202) 205–2634 the Reports
Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
SUMMARY:
PO 00000
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Fmt 4703
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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: Budget
Information for Construction Programs
(SF–424C).
Type of Collection: Extension.
OMB No.: 4040–0008.
Abstract
Budget Information for Construction
Programs (SF–424C) is used by
applicants to apply for Federal financial
assistance. The Budget Information for
Construction Programs (SF–424C) form
allows the applicants to provide budget
details as part of their grant proposals.
This form is evaluated by Federal
agencies as part of the overall grant
application. This IC expires on February
28, 2025. Grants.gov seeks a three-year
clearance of these collections.
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93309
Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices
ANNUALIZED BURDEN HOUR TABLE
Average
burden per
response
Respondents
(if necessary)
Budget Information for Construction
Programs (SF–424C).
Grant-seeking organizations ............
239
1
1
239
Total ...........................................
...........................................................
........................
1
........................
239
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2024–27598 Filed 11–25–24; 8:45 am]
BILLING CODE 4151–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0007]
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.
SUMMARY:
Number of
respondents
Number of
responses per
respondents
Forms
(if necessary)
Comments on the ICR must be
received on or before January 27, 2025.
ADDRESSES: Submit your comments to
sagal.musa@hhs.gov or by calling (202)
205–2634.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 4040–0007–60D
and project title for reference, to Sagal
Musa, email: sagal.musa@hhs.gov, or
call (202) 205–2634 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
DATES:
Total burden
hours
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: Assurances for
Non-Construction Programs (SF424B).
Type of Collection: Extension.
OMB No.: 4040–0007.
Abstract
Assurances for Non-Construction
Programs (SF–424B) is used by
applicants to apply for Federal financial
assistance. The Assurances for NonConstruction Programs (SF–424B) form
requests that the applicants certify
specified required assurances as part of
their grant proposals. This form is
evaluated by Federal agencies as part of
the overall grant application. This IC
expires on February 28, 2025.
Grants.gov seeks a three-year clearance
of these collections.
ANNUALIZED BURDEN HOUR TABLE
Assurances for Non-Construction
Programs (SF–424B).
Grant-seeking organizations ............
9,772
1
0.5
4,886
Total ...........................................
...........................................................
........................
1
........................
4,886
Health Information Technology’s public
internet website at www.HealthIT.gov/
TEFCA.
This notice fulfills an
obligation under the Public Health
Service Act (PHSA). The act requires the
National Coordinator for Health
Information Technology to publish on
the Office of the National Coordinator
for Health Information Technology’s
public internet website, and in the
Federal Register, the trusted exchange
framework and common agreement
developed under the PHSA. This notice
is for publishing an updated version of
the Common Agreement (Version 2.1).
ADDRESSES: Common Agreement
Version 2.1 is also available on the
Office of the National Coordinator for
FOR FURTHER INFORMATION CONTACT:
SUMMARY:
BILLING CODE 4151–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Notice of Publication of Common
Agreement for Nationwide Health
Information Interoperability (Common
Agreement) Version 2.1
Assistant Secretary for
Technology Policy/Office of the
National Coordinator for Health
AGENCY:
VerDate Sep<11>2014
18:03 Nov 25, 2024
Jkt 265001
Total burden
hours
Information Technology, Department of
Health and Human Services.
ACTION: Notice.
[FR Doc. 2024–27595 Filed 11–25–24; 8:45 am]
lotter on DSK11XQN23PROD with NOTICES1
Average
burden per
response
Respondents
(if necessary)
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
Number of
respondents
Number of
responses per
respondents
Forms
(if necessary)
PO 00000
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Fmt 4703
Sfmt 4703
Mark Knee, Office of the National
Coordinator for Health Information
Technology, 202–664–2058.
This
notice fulfills the obligation under
section 3001(c)(9)(C) of the Public
Health Service Act (PHSA) to publish
the trusted exchange framework and
common agreement, developed under
section 3001(c)(9)(B) of the PHSA (42
U.S.C. 300jj–11(c)(9)(B)), in the Federal
Register. This publication consists of
the following document:
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 89, Number 228 (Tuesday, November 26, 2024)]
[Notices]
[Pages 93308-93309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27598]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-4040-0008]
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 January 27,
2025.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 205-2634.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 4040-0008-60D and
project title for reference, to Sagal Musa, email: [email protected],
or call (202) 205-2634 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: Budget Information for Construction
Programs (SF-424C).
Type of Collection: Extension.
OMB No.: 4040-0008.
Abstract
Budget Information for Construction Programs (SF-424C) is used by
applicants to apply for Federal financial assistance. The Budget
Information for Construction Programs (SF-424C) form allows the
applicants to provide budget details as part of their grant proposals.
This form is evaluated by Federal agencies as part of the overall grant
application. This IC expires on February 28, 2025. Grants.gov seeks a
three-year clearance of these collections.
[[Page 93309]]
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of
Forms (if necessary) Respondents (if Number of responses per Average burden Total burden
necessary) respondents respondents per response hours
----------------------------------------------------------------------------------------------------------------
Budget Information for Grant-seeking 239 1 1 239
Construction Programs (SF- organizations.
424C).
---------------------------------------------------------------
Total..................... ................ .............. 1 .............. 239
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-27598 Filed 11-25-24; 8:45 am]
BILLING CODE 4151-AE-P
