Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 63786 [2022-22762]
Download as PDF
<![CDATA[
63786
Federal Register / Vol. 87, No. 202 / Thursday, October 20, 2022 / Notices
Food and Drug Administration
[Docket Nos. FDA–2013–N–0375, FDA–
2013–N–1147, FDA–2010–N–0083, FDA–
2013–N–0115, FDA–2013–N–1588, and FDA–
2016–N–1593]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
SUPPLEMENTARY INFORMATION:
Notice.
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
No.
Title of collection
Agreement for Shipments of Devices for Sterilization ............................................................................................
Environmental Impact Considerations .....................................................................................................................
Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed ..........
Manufactured Food Regulatory Program Standards ..............................................................................................
Tobacco Products, Exemptions From Substantial Equivalence Requirements ......................................................
Medical Device Accessories ....................................................................................................................................
Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2022–22762 Filed 10–19–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2455]
Advancing Real-World Evidence
Program
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
I. Background
The Food and Drug
Administration (FDA or Agency) is
announcing the Advancing Real-World
Evidence (RWE) Program to fulfill
FDA’s commitment under the seventh
iteration of the Prescription Drug User
Fee Amendments (PDUFA VII),
incorporated as part of the FDA User
Fee Reauthorization Act of 2022.
DATES: The Advancing RWE Program
will proceed from the date of this notice
through September 30, 2027. Sponsors
may submit meeting requests for the
program through March 31, 2027.
ADDRESSES: For additional information
about the Program, please refer to FDA’s
web page at https://www.fda.gov/drugs/
development-resources/advancing-realworld-evidence-program.
In connection with the seventh
iteration of the Prescription Drug User
Fee Amendments (PDUFA VII),
incorporated as part of the FDA User
Fee Reauthorization Act of 2022, FDA
committed to establishing the
‘‘Advancing Real-World Evidence
(RWE) Program,’’ which seeks to
identify approaches for generating RWE
that meet regulatory requirements in
support of labeling for effectiveness
(e.g., new indications, populations,
dosing information) or for meeting postapproval study requirements. FDA is
establishing and publicly
communicating the Advancing RWE
Program to satisfy this commitment. The
Advancing RWE Program provides
sponsors who are selected into the
Program the opportunity to meet with
AGENCY:
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Nahleen Lopez, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6360,
Silver Spring, MD 20993–0002, 240–
402–2659, Nahleen.Lopez@fda.hhs.gov,
with the subject line ‘‘Advancing RWE
Program’’; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911, Stephen.Ripley@
fda.hhs.gov, with the subject line
‘‘Advancing RWE Program.’’
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:50 Oct 19, 2022
Jkt 259001
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
0910–0131
0910–0322
0910–0339
0910–0601
0910–0684
0910–0823
Date approval
expires
9/30/2025
9/30/2025
9/30/2025
9/30/2025
9/30/2025
9/30/2025
Agency staff—before protocol
development or study initiation—to
discuss the use of RWE in medical
product development. The Advancing
RWE Program is an optional pathway
for sponsors submitting RWE proposals;
established procedures to engage with
the Agency will continue to be
available.
Meetings under the Advancing RWE
Program will be conducted by FDA’s
Center for Drug Evaluation and Research
(CDER) or Center for Biologics
Evaluation and Research (CBER) during
fiscal years 2023 to 2027. Oncology
applications will include participation
from the Oncology Center of Excellence.
FDA will grant up to four meetings
between CDER or CBER and a sponsor
selected into the Advancing RWE
Program to discuss approaches for
generating RWE that can meet
regulatory requirements. To promote
awareness of characteristics of RWE that
can support regulatory decisions, study
designs discussed through the program
may be presented by FDA in a public
forum (e.g., in a guidance or public
workshop).
The Advancing RWE Program website
includes current program eligibility
criteria; format, content, and
instructions for submission of initial
and followup meeting requests; and
information regarding a required
disclosure agreement. The Program’s
website address is https://www.fda.gov/
drugs/development-resources/
E:\FR\FM\20OCN1.SGM
20OCN1
]]>Agencies
[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Page 63786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22762]
[[Page 63786]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-0375, FDA-2013-N-1147, FDA-2010-N-0083, FDA-
2013-N-0115, FDA-2013-N-1588, and FDA-2016-N-1593]
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
------------------------------------------------------------------------
Agreement for Shipments of Devices for 0910-0131 9/30/2025
Sterilization..........................
Environmental Impact Considerations..... 0910-0322 9/30/2025
Substances Prohibited from Use in Animal 0910-0339 9/30/2025
Food or Feed; Animal Proteins
Prohibited in Ruminant Feed............
Manufactured Food Regulatory Program 0910-0601 9/30/2025
Standards..............................
Tobacco Products, Exemptions From 0910-0684 9/30/2025
Substantial Equivalence Requirements...
Medical Device Accessories.............. 0910-0823 9/30/2025
------------------------------------------------------------------------
Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22762 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P
