Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents, 76198-76199 [2022-27011]
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76198
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
cardiovascular-and-renal-drugsadvisory-committee/cardiovascularand-renal-drugs-advisory-committeecharter or by contacting the Designated
Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the
fact that no change has been made to the
committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27014 Filed 12–12–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 January 12,
2023.
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 0910–0312. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
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.
SUMMARY:
Regulations Restricting the Sale and
Distribution of Cigarettes and
Smokeless Tobacco To Protect Children
and Adolescents—21 CFR Part 1140
Food and Drug Administration
[Docket No. FDA–2012–N–0977]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents
AGENCY:
ACTION:
Food and Drug Administration,
HHS.
OMB Control Number 0910–0312—
Revision
This information collection supports
FDA regulatory requirements contained
in part 1140 (21 CFR part 1140)
authorized under Chapter IX of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 9) and associated Agency
guidance. Regulations in part 1140
establish permissible forms of labeling
and advertising for cigarettes or
smokeless tobacco and include
reporting requirements directing
persons to notify FDA if they intend to
use a form of advertising or labeling that
is not addressed in the regulations.
Section 1140.30(a)(2) (21 CFR
1140.30(a)(2)) requires tobacco product
manufacturers, distributors, and
retailers to notify FDA if they intend to
use advertising or labeling for cigarettes
or smokeless tobacco in a medium that
is not listed in the regulations. The
notifications must be made 30 days
prior to the use of such mediums.
We allow electronic and written
submission of these notifications.
Respondents can mail notifications as
prescribed in section 1140.30(a)(2) to
FDA. Instructions providing
clarification on how to format the
notification may be found in the
guidance document entitled
‘‘Compliance with Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents’’
(2010) (https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/compliance-regulationsrestricting-sale-and-distributioncigarettes-and-smokeless-tobaccoprotect).
In the Federal Register of June 27,
2022 (87 FR 38160), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited. Subsequent to publication of
the 60-day notice, we identified the
associated guidance as an information
collection instrument.
FDA estimates the burden of this
collection of information as follows:
lotter on DSK11XQN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section/Guidance Document Section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
1140.30(a)(2)—Notification of other advertising or labeling medium ...................
25
1
25
1
25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden hour estimates for this
collection of information were based on
submissions regarding cigarette and
VerDate Sep<11>2014
16:56 Dec 12, 2022
Jkt 259001
smokeless tobacco product advertising
expenditures.
FDA estimates that approximately 25
respondents will submit an annual
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
notice of alternative advertising or
labeling, and the Agency has estimated
it should take 1 hour to provide such
notice. Therefore, the total estimated
E:\FR\FM\13DEN1.SGM
13DEN1
76199
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
time required for this collection of
information is 25 hours. Based on a
review of the information collection and
the number of notifications received
since 2018, we have made no
adjustments to our burden estimate.
by using the search function. The OMB
control number for this information
collection is 0910–0073. Also include
the FDA docket number found in
brackets in the heading of this
document.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
[FR Doc. 2022–27011 Filed 12–12–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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:
Food and Drug Administration
[Docket No. FDA–2016–N–2544]
Medical Devices: Current Good
Manufacturing Practice Quality System
Regulation—21 CFR part 820
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Quality System
Regulation
AGENCY:
OMB Control Number 0910–0073—
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 January 12,
2023.
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
SUMMARY:
As authorized under section 520(f) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360j(f)), the
Secretary of the Department of Health
and Human Services has issued
regulations requiring that the methods
used in, and the facilities and controls
used for, the manufacture,
preproduction design validation
(including a process to assess the
performance of a device, but not
including an evaluation of the safety
and effectiveness of a device), packing,
storage, and installation of a device
conform to current good manufacturing
practice (CGMP) and assure that the
device will be safe and effective and
otherwise in compliance with the FD&C
Act.
The quality system regulation (QSR)
under part 820 (21 CFR part 820) sets
forth CGMP requirements governing the
design, manufacture, packing, labeling,
storage, installation, and servicing of all
finished medical devices intended for
human use. The requirements cover
purchasing and service controls, clarify
recordkeeping for device failure and
complaint investigations, clarify
requirements for verifying/validating
production processes and process or
product changes, and clarify
requirements for product acceptance
activities, quality data evaluations, and
corrections of nonconforming product/
quality problems. In the Federal
Register of February 23, 2022 (87 FR
10119), we proposed to incorporate by
reference International Organization for
Standardization 13485 (ISO 13485):
Medical devices—Quality Management
Systems—Requirements for Regulatory
Purposes, the 2016 edition, to the QSR
(RIN 0910–AH99), to align
implementation of requirements.
Information collection under the QSR
is intended to assist FDA in assuring the
safety of medical devices. Requirements
include documenting the establishment
of procedures and identifying required
records that assist FDA in determining
whether firms are in compliance with
CGMP. In particular, for example,
compliance with CGMP design control
requirements should decrease the
number of design-related device failures
that have resulted in deaths and serious
injuries. Records must be made
available for review or copying during
FDA inspection. The regulations in part
820 apply to approximately 29,424
respondents, based on current data
within our device registration and
listing database.
In the Federal Register of August 22,
2022 (87 FR 51433), we published a 60day notice soliciting comment on the
proposed collection of information. No
comments were received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
lotter on DSK11XQN23PROD with NOTICES1
21 CFR part 820;
required records
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Quality System Requirements—Subpart B .......................................................
Design Controls—Subpart C .............................................................................
Document Controls—Subpart D .......................................................................
Purchasing Controls—Subpart E ......................................................................
Identification and Traceability—Subpart F ........................................................
Production and Process Controls—Subpart G .................................................
Acceptance Activities—Subpart H ....................................................................
Nonconforming Product; Corrective and Preventative Action—Subparts I And
J .....................................................................................................................
Labeling and Packaging Controls—Subpart K .................................................
Handling, Storage, Distribution, and Installation—Subpart L ...........................
Records—Subpart M .........................................................................................
Servicing—Subpart N ........................................................................................
Statistical Techniques—section 820.250—Subpart O ......................................
29,424
29,424
29,424
29,424
29,424
29,424
29,424
1
1
1
1
1
1
1
29,424
29,424
29,424
29,424
29,424
29,424
29,424
83
132
11
28
2
31
6
2,442,192
3,883,968
323,664
823,872
58,848
912,144
176,544
29,424
29,424
29,424
29,424
29,424
29,424
1
1
1
1
1
1
29,424
29,424
29,424
29,424
29,424
29,424
23
3
15
10
3
1
676,752
88,272
441,360
294,240
88,272
29,424
Total ...........................................................................................................
..........................
..........................
........................
........................
10,239,552
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
16:56 Dec 12, 2022
Jkt 259001
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76198-76199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27011]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0977]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Regulations
Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco To Protect Children and Adolescents
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 January 12, 2023.
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 0910-0312. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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.
Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco To Protect Children and Adolescents--21 CFR Part 1140
OMB Control Number 0910-0312--Revision
This information collection supports FDA regulatory requirements
contained in part 1140 (21 CFR part 1140) authorized under Chapter IX
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 9) and
associated Agency guidance. Regulations in part 1140 establish
permissible forms of labeling and advertising for cigarettes or
smokeless tobacco and include reporting requirements directing persons
to notify FDA if they intend to use a form of advertising or labeling
that is not addressed in the regulations. Section 1140.30(a)(2) (21 CFR
1140.30(a)(2)) requires tobacco product manufacturers, distributors,
and retailers to notify FDA if they intend to use advertising or
labeling for cigarettes or smokeless tobacco in a medium that is not
listed in the regulations. The notifications must be made 30 days prior
to the use of such mediums.
We allow electronic and written submission of these notifications.
Respondents can mail notifications as prescribed in section
1140.30(a)(2) to FDA. Instructions providing clarification on how to
format the notification may be found in the guidance document entitled
``Compliance with Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To Protect Children and Adolescents''
(2010) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-regulations-restricting-sale-and-distribution-cigarettes-and-smokeless-tobacco-protect).
In the Federal Register of June 27, 2022 (87 FR 38160), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
Subsequent to publication of the 60-day notice, we identified the
associated guidance as an information collection instrument.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section/Guidance Document Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.30(a)(2)--Notification of other advertising or labeling medium 25 1 25 1 25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden hour estimates for this collection of information were
based on submissions regarding cigarette and smokeless tobacco product
advertising expenditures.
FDA estimates that approximately 25 respondents will submit an
annual notice of alternative advertising or labeling, and the Agency
has estimated it should take 1 hour to provide such notice. Therefore,
the total estimated
[[Page 76199]]
time required for this collection of information is 25 hours. Based on
a review of the information collection and the number of notifications
received since 2018, we have made no adjustments to our burden
estimate.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27011 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P
