Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 76630 [2022-27192]
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Federal Register / Vol. 87, No. 240 / Thursday, December 15, 2022 / Notices
regimens with treatment-shortening
regimens with improved safety and
efficacy. Thus, in this revised draft
guidance more detail is provided for
nonclinical models, early phase studies
and trial design considerations,
including the demonstration of efficacy
using superiority or noninferiority (NI)
trial designs. Additionally, updates are
made to pediatric patients being
included in trials, endpoint and safety
considerations, and labeling. The
Appendix is also updated with an
example of an NI margin justification.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Pulmonary Tuberculosis:
Developing Drugs for Treatment.’’ 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 312 have
been approved under OMB control
numbers 0910–0014. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001. The collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338. The collections of
information in 21 CFR 201.56 and
201.57 have been approved under OMB
control number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27186 Filed 12–14–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–N–1048; FDA–
2012–N–0386; FDA–2019–N–0430; FDA–
2019–N–5553; FDA–2021–N–0555; FDA–
2013–N–0242; and FDA–2019–N–1517]
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Medical Devices; Humanitarian Use Devices .........................................................................................................
Tobacco Product Establishment Registration and Submission of Certain Health Information ...............................
Generic Clearance for Quick Turnaround Testing of Communication Effectiveness .............................................
Right to Try Act: Reporting Requirements ..............................................................................................................
Medical Device Labeling Regulations .....................................................................................................................
Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs .....................................
Abbreviated New Animal Drug Applications ............................................................................................................
Dated: December 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27192 Filed 12–14–22; 8:45 am]
lotter on DSK11XQN23PROD with NOTICES1
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Integrative Health; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
VerDate Sep<11>2014
16:51 Dec 14, 2022
Jkt 259001
PO 00000
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Fmt 4703
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0910–0332
0910–0650
0910–0876
0910–0893
0910–0485
0910–0667
0910–0669
Date approval
expires
10/31/2025
10/31/2025
10/31/2025
10/31/2025
11/30/2025
11/30/2025
11/30/2025
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.
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[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Notices]
[Page 76630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27192]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2014-N-1048; FDA-2012-N-0386; FDA-2019-N-0430; FDA-
2019-N-5553; FDA-2021-N-0555; FDA-2013-N-0242; and FDA-2019-N-1517]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Medical Devices; Humanitarian Use 0910-0332 10/31/2025
Devices................................
Tobacco Product Establishment 0910-0650 10/31/2025
Registration and Submission of Certain
Health Information.....................
Generic Clearance for Quick Turnaround 0910-0876 10/31/2025
Testing of Communication Effectiveness.
Right to Try Act: Reporting Requirements 0910-0893 10/31/2025
Medical Device Labeling Regulations..... 0910-0485 11/30/2025
Current Good Manufacturing Practices for 0910-0667 11/30/2025
Positron Emission Tomography (PET)
Drugs..................................
Abbreviated New Animal Drug Applications 0910-0669 11/30/2025
------------------------------------------------------------------------
Dated: December 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27192 Filed 12-14-22; 8:45 am]
BILLING CODE 4164-01-P
