Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices, 67045-67046 [2022-24232]
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67045
Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
FDA’s estimate of the number of
respondents in tables 1 and 2 is based
on data from the deeming rule Final
Regulatory Impact Analysis,1 which
showed there are an estimated 362,273
retail establishments that currently sell
tobacco products. The Agency reviewed
these numbers again for this notice, and
believe they are an accurate estimation.
We assume that 75 percent of tobacco
retailers already have some sort of age
and identification verification training
program in place. We expect that some
of those retailer training programs
already meet the elements in the
guidance, some retailers would update
their training program to meet the
elements in the guidance, and other
retailers would develop a training
program for the first time. Thus, we
estimate that two-thirds of tobacco
retailers would develop a training
program that meets the elements in the
guidance (66 percent of 362,273 =
239,100; then annualized to 79,700).
We have adjusted our burden estimate
and the number of respondents, which
has resulted in a decrease to the
currently approved burden and
respondent count. This adjustment is
based on available data estimating the
number of retail establishments that sell
tobacco products in the United States.
Additionally, the burden chart was
updated to reflect a change from an
estimation over the course of 3 years to
annualized burden.
Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24218 Filed 11–4–22; 8:45 am]
BILLING CODE 4164–01–P
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2013–N–0557]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Postmarket
Surveillance of Medical Devices
AGENCY:
Postmarket Surveillance of Medical
Devices—21 CFR Part 822
OMB Control Number 0910–0449—
Extension
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by December
7, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0449. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
SUMMARY:
Section 522 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360l)
authorizes FDA to require a
manufacturer to conduct postmarket
surveillance (PS) of any device that
meets the criteria set forth in the statute.
The PS regulation establishes
procedures that FDA uses to approve
and disapprove PS plans. The regulation
provides instructions to manufacturers,
so they know what information is
required in a PS plan submission. FDA
reviews PS plan submissions in
accordance with 21 CFR 822.15 through
822.19 of the regulation, which describe
the grounds for approving or
disapproving a PS plan. In addition, the
PS regulation provides instructions to
manufacturers to submit interim and
final reports in accordance with 21 CFR
822.38. Respondents to this collection of
information are those manufacturers
that require PS of their products.
In the Federal Register of May 27,
2022 (87 FR 32169), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
21 CFR part/activity
Average
burden per
response
Total annual
responses
Total hours
§§ 822.9 and 822.10; PS submission ..................................
§ 822.21; Changes to PS plan after approval .....................
§ 822.28; Changes to PS plan for a device that is no
longer marketed ...............................................................
§ 822.29; Waiver ..................................................................
§ 822.30; Exemption request ...............................................
§ 822.38; Periodic reports ....................................................
5
9
1
1
5
9
120
40
600
360
1
0
0
17
1
0
0
3
1
0
0
51
8
40
40
40
8
0
0
2,040
Total ..............................................................................
........................
........................
........................
........................
3,008
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation of Reporting Burden
Estimate: The burden captured in table
1 is based on the data from FDA’s
internal tracking system. 21 CFR 822.26,
822.27, and 822.34 do not constitute
information collection subject to review
1 Deeming Tobacco Products to be Subject to the
[Federal] Food, Drug, and Cosmetic Act, as
Amended by the Family Smoking Prevention and
Tobacco Control Act: Final Regulatory Impact
Analysis, 2016 https://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/Reports/
EconomicAnalyses/UCM500254.pdf.
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67046
Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
under the PRA because it entails no
burden other than that necessary to
identify the respondent, the date, the
respondent’s address, and the nature of
the instrument (see 5 CFR 1320.3(h)(1)).
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR part/activity
Number of
records per
recordkeeper
Total hours
§ 822.31; Manufacturer records ...........................................
§ 822.32; Investigator records ..............................................
5
15
1
1
5
15
20
5
100
75
Total ..............................................................................
........................
........................
........................
........................
175
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation of Recordkeeping Burden
Estimate: FDA expects that at least some
of the manufacturers will be able to
satisfy the PS requirement using
information or data they already have.
For purposes of calculating burden,
however, FDA has assumed that each PS
order can only be satisfied by a 3-year
clinically based surveillance plan, using
three investigators. These estimates are
based on FDA’s knowledge and
experience with PS.
We have adjusted our burden
estimate, which has resulted in a
decrease to the currently approved
burden. Our estimated burden for the
information collection reflects an
overall decrease of 4,780 hours and a
corresponding decrease of 145
responses. We believe these adjustments
more accurately reflect the current
number of requests associated with
postmarket surveillance of medical
devices.
Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24232 Filed 11–4–22; 8:45 am]
BILLING CODE 4164–01–P
document provides recommendations to
sponsors interested in studying multiple
versions of a cellular or gene therapy
product in an early phase clinical trial
for a single disease. Sponsors have
expressed interest in gathering
preliminary evidence of safety and
activity using multiple versions of a
cellular or gene therapy product in a
single clinical trial, where each version
of the product is distinct and is
generally submitted to FDA in a
separate investigational new drug
application (IND). The guidance
provides recommendations for
conducting such studies, including how
to organize and structure the INDs,
submit new information, and report
adverse events. The guidance
announced in this notice finalizes the
draft guidance of the same title dated
September 2021.
DATES: The announcement of the
guidance is published in the Federal
Register on November 7, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0776]
Studying Multiple Versions of a
Cellular or Gene Therapy Product in an
Early-Phase Clinical Trial; Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
khammond on DSKJM1Z7X2PROD with NOTICES
Average
burden per
recordkeeping
Total annual
records
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Studying Multiple
Versions of a Cellular or Gene Therapy
Product in an Early-Phase Clinical Trial;
Guidance for Industry.’’ The guidance
SUMMARY:
VerDate Sep<11>2014
16:45 Nov 04, 2022
Jkt 259001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
PO 00000
Frm 00040
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comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2021–D–0776 for ‘‘Studying Multiple
Versions of a Cellular or Gene Therapy
Product in an Early-Phase Clinical Trial;
Guidance for Industry.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
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]]>Agencies
[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67045-67046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24232]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0557]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarket
Surveillance of Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by December 7, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0449. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Postmarket Surveillance of Medical Devices--21 CFR Part 822
OMB Control Number 0910-0449--Extension
Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360l) authorizes FDA to require a manufacturer to conduct postmarket
surveillance (PS) of any device that meets the criteria set forth in
the statute. The PS regulation establishes procedures that FDA uses to
approve and disapprove PS plans. The regulation provides instructions
to manufacturers, so they know what information is required in a PS
plan submission. FDA reviews PS plan submissions in accordance with 21
CFR 822.15 through 822.19 of the regulation, which describe the grounds
for approving or disapproving a PS plan. In addition, the PS regulation
provides instructions to manufacturers to submit interim and final
reports in accordance with 21 CFR 822.38. Respondents to this
collection of information are those manufacturers that require PS of
their products.
In the Federal Register of May 27, 2022 (87 FR 32169), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR part/activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 822.9 and 822.10; 5 1 5 120 600
PS submission..................
Sec. 822.21; Changes to PS 9 1 9 40 360
plan after approval............
Sec. 822.28; Changes to PS 1 1 1 8 8
plan for a device that is no
longer marketed................
Sec. 822.29; Waiver........... 0 0 0 40 0
Sec. 822.30; Exemption request 0 0 0 40 0
Sec. 822.38; Periodic reports. 17 3 51 40 2,040
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 3,008
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Explanation of Reporting Burden Estimate: The burden captured in
table 1 is based on the data from FDA's internal tracking system. 21
CFR 822.26, 822.27, and 822.34 do not constitute information collection
subject to review
[[Page 67046]]
under the PRA because it entails no burden other than that necessary to
identify the respondent, the date, the respondent's address, and the
nature of the instrument (see 5 CFR 1320.3(h)(1)).
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR part/activity Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec. 822.31; Manufacturer 5 1 5 20 100
records........................
Sec. 822.32; Investigator 15 1 15 5 75
records........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 175
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Explanation of Recordkeeping Burden Estimate: FDA expects that at
least some of the manufacturers will be able to satisfy the PS
requirement using information or data they already have. For purposes
of calculating burden, however, FDA has assumed that each PS order can
only be satisfied by a 3-year clinically based surveillance plan, using
three investigators. These estimates are based on FDA's knowledge and
experience with PS.
We have adjusted our burden estimate, which has resulted in a
decrease to the currently approved burden. Our estimated burden for the
information collection reflects an overall decrease of 4,780 hours and
a corresponding decrease of 145 responses. We believe these adjustments
more accurately reflect the current number of requests associated with
postmarket surveillance of medical devices.
Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24232 Filed 11-4-22; 8:45 am]
BILLING CODE 4164-01-P
