Agency Information Collection Request. 30-Day Public Comment Request, 77620-77621 [2022-27463]
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tkelley on DSK125TN23PROD with NOTICE
77620
Federal Register / Vol. 87, No. 242 / Monday, December 19, 2022 / Notices
antimicrobial drugs. To address the
human health risks surrounding the use
of antimicrobial new animal drugs, in
2003, FDA issued Guidance for Industry
(GFI) #152, entitled ‘‘Evaluating the
Safety of Antimicrobial New Animal
Drugs with Regard to their
Microbiological Effects on Bacteria of
Human Health Concern.’’
GFI #152 outlines a qualitative risk
assessment methodology as a process for
evaluating foodborne antimicrobial
resistance concerns related to the use of
antimicrobial drugs in food-producing
animals. GFI #152 also contains an
appendix, commonly referred to as
‘‘Appendix A,’’ in which FDA ranks
antimicrobial drugs according to their
relative importance to human medicine:
‘‘critically important,’’ ‘‘highly
important,’’ or ‘‘important.’’
The current list of medically
important antimicrobial drugs in
Appendix A reflects FDA’s thinking at
the time of publication, in 2003. It was
envisioned at the time of publication of
GFI #152 that the Agency would
reassess the rankings provided in
Appendix A periodically to confirm that
the rankings are consistent with
contemporary practices and needs. As
noted in GFI #152, the development of
new antimicrobial drugs for human
therapy, the emergence or re-emergence
of diseases in humans, and changes in
prescribing practices, are some factors
that may cause the human medical
importance rankings to change over
time.
Given the considerable advances in
science that have taken place since
2003, new relevant information has
become available. In light of those
advances and the new information now
available, FDA published a notice in the
Federal Register of October 13, 2020 (85
FR 64481), announcing a public meeting
and requesting comments on a concept
paper entitled ‘‘Potential Approach for
Ranking of Antimicrobial Drugs
According to Their Importance in
Human Medicine: A Risk Management
Tool for Antimicrobial New Animal
Drugs.’’
FDA received more than 60 comment
submissions from pharmaceutical
companies, academia, organizations,
and private citizens on this concept
paper. FDA has considered all
comments and is issuing this draft
guidance document, which contains
revised sections in the risk assessment
framework, including updated tables
and figures, and a revised Appendix A
based on new ranking criteria of
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antimicrobials according to their
importance in human medicine.
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on ‘‘Evaluating the
Safety of Antimicrobial New Animal
Drugs with Regard to their
Microbiological Effects on Bacteria of
Human Health Concern.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27415 Filed 12–16–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0005]
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
SUMMARY:
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
Comments on the ICR must be
received on or before January 18, 2023.
DATES:
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Sagal Musa, sagal.musa@hhs.gov or
(202) 205–2634. When submitting
comments or requesting information,
please include the document identifier
4040–0005–30D and project title for
reference.
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 Collections: Application
for Federal Domestic Assistance—
Individual.
Type of Collection: Renewal.
OMB No.: 4040–0005.
Abstract: The Application for Federal
Assistance—Individual form provides
the Federal grant-making agencies an
alternative to the Standard Form 424
data set and form. Agencies may use
Application for Federal Assistance—
Individual form for grant programs not
required to collect all the data that is
required on the SF–424 core data set
and form.
Type of respondent: The Application
for Federal Assistance—Individual form
is used by organizations to apply for
Federal financial assistance in the form
of grants. This form is submitted to the
Federal grant-making agencies for
evaluation and review. This IC expires
on January 31, 2023. Grants.gov seeks a
three-year clearance of these collections.
SUPPLEMENTARY INFORMATION:
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77621
Federal Register / Vol. 87, No. 242 / Monday, December 19, 2022 / Notices
ANNUALIZED BURDEN HOUR TABLE
Forms
(if necessary)
Respondents
(if necessary)
Number of
respondents
Application for Federal Assistance—
Individual.
Grant Applicants ...............................
Total ...........................................
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2022–27463 Filed 12–16–22; 8:45 am]
BILLING CODE 4151–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0020]
ACTION:
Office of the Secretary, HHS.
Notice.
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 18, 2023.
SUMMARY:
Total burden
hours
1
1
100
100
1
1
100
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.
ADDRESSES:
Sagal Musa, sagal.musa@hhs.gov or
(202) 205–2634. When submitting
comments or requesting information,
please include the document identifier
4040–0020–30D and project title for
reference.
AGENCY:
Average
burden per
response
100
FOR FURTHER INFORMATION CONTACT:
Agency Information Collection
Request. 30-Day Public Comment
Request
Number of
responses per
respondents
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
SUPPLEMENTARY INFORMATION:
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 Collections: SF–424
Mandatory Form.
Type of Collection: Renewal.
OMB No.: 4040–0020.
Abstract: The Standard 424
Mandatory form provides the Federal
grant-making agencies an alternative to
the Standard Form 424 data set and
form. Agencies may use SF–424
Mandatory Form for grant programs not
required to collect all the data that is
required on the SF–424 core data set
and form.
Type of respondent: The SF–424
Mandatory form is used by
organizations to apply for Federal
financial assistance in the form of
grants. This form is submitted to the
Federal grant-making agencies for
evaluation and review. This IC expires
on January 31, 2023. Grants.gov seeks a
three-year clearance of these collections.
ANNUALIZED BURDEN HOUR TABLE
Forms
(if necessary)
Respondents
(if necessary)
Number of
respondents
SF424 Mandatory Form ....................
Grant Applicants ...............................
Total ...........................................
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2022–27464 Filed 12–16–22; 8:45 am]
BILLING CODE 4151–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK125TN23PROD with NOTICE
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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Total burden
hours
1
1
5,761
5,761
1
1
5,761
Name of Committee: National Center for
Advancing Translational Sciences Special
Frm 00075
Average
burden per
response
5,761
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 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.
PO 00000
Number of
responses per
respondents
Emphasis Panel; NCATS CTSA Training
Grants Review Meeting.
Date: January 25, 2023.
Time: 10:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Room
1037, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Nakia C. Brown, Ph.D.,
Scientific Review Officer, Office of Grants
Management and Scientific Review, National
Center for Advancing Translational Sciences,
6701 Democracy Boulevard, Room 1037,
Bethesda, MD 20892, 301–827–4905,
brownnac@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
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]]>Agencies
[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77620-77621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27463]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-4040-0005]
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.
DATES: Comments on the ICR must be received on or before January 18,
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: Sagal Musa, [email protected] or
(202) 205-2634. When submitting comments or requesting information,
please include the document identifier 4040-0005-30D 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 Collections: Application for Federal Domestic
Assistance--Individual.
Type of Collection: Renewal.
OMB No.: 4040-0005.
Abstract: The Application for Federal Assistance--Individual form
provides the Federal grant-making agencies an alternative to the
Standard Form 424 data set and form. Agencies may use Application for
Federal Assistance--Individual form for grant programs not required to
collect all the data that is required on the SF-424 core data set and
form.
Type of respondent: The Application for Federal Assistance--
Individual form is used by organizations to apply for Federal financial
assistance in the form of grants. This form is submitted to the Federal
grant-making agencies for evaluation and review. This IC expires on
January 31, 2023. Grants.gov seeks a three-year clearance of these
collections.
[[Page 77621]]
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of Average
Forms (if necessary) Respondents (if Number of responses per burden per Total burden
necessary) respondents respondents response hours
----------------------------------------------------------------------------------------------------------------
Application for Federal Grant Applicants 100 1 1 100
Assistance--Individual.
---------------------------------------------------------------
Total..................... 100 1 1 100
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2022-27463 Filed 12-16-22; 8:45 am]
BILLING CODE 4151-AE-P
