Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents, 59622-59624 [2012-23833]
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59622
Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15 (a) and (d) ..................................................................
25.40 (a) and (c) ..................................................................
70
10
10
1
700
10
3
2,160
2,100
21,600
Total ..............................................................................
........................
........................
........................
........................
23,700
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for
Tobacco Products
Under sections 905, 910, and 911 of
the Federal Food, Drugs, and Cosmetic
Act, premarket tobacco applications
(PMTAs), applications for substantial
equivalence (SEs), Exemption from SEs,
and modified risk tobacco products
must contain a claim for categorical
exclusion under 25.30 or 25.34 or an EA
under 25.40. In 2011, FDA estimated it
will receive approximately 20 PMTAs
and supplements from 20 respondents,
150 reports intended to demonstrate the
SE of a new tobacco product from 150
respondents, 500 exemption from SE
requirements applications from 500
respondents, and 3 modified risk
Tobacco product applications from 3
respondents for a total of 673 responses
from 673 respondents. FDA estimates
that there were 538 claims from 538
respondents for categorical exclusions
as required under 25.15(a) and (d), and
135 EAs from 135 respondents as
required under 25.40(a) and (c).
Therefore, over the next 3 years, FDA
estimates that approximately 538
respondents will submit an average of 1
application for categorical exclusion
and 135 respondents will submit an
average of 1 EA. Based on FDA’s
experience and previous information
provided by potential sponsors, FDA
estimates that it takes approximately 12
hours to prepare a claim for a
categorical exclusion and 12 hours to
prepare an EA.
TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15 (a) and (d) ..................................................................
25.40 (a) and (c) ..................................................................
538
135
1
1
538
135
12
12
6,456
1,620
Total ..............................................................................
........................
........................
........................
........................
8,076
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 7—ESTIMATED ANNUAL TOTAL REPORTING BURDEN FOR ALL CENTERS 1
Number of
respondents
CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15 (a) and (d) ..................................................................
25.40 (a) and (c) ..................................................................
4,124
190
........................
........................
14,526
190
........................
........................
114,756
70,950
Total ..............................................................................
........................
........................
........................
........................
185,706
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–23838 Filed 9–27–12; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2012–N–0977]
BILLING CODE 4160–01–P
srobinson on DSK4SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
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.
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
regulations restricting the sale and
distribution of cigarettes and smokeless
tobacco to protect children and
adolescents.
The Food and Drug
Administration (FDA) is announcing an
SUMMARY:
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Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
Submit either electronic or
written comments on the collection of
information by November 27, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
DATES:
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless
Tobacco to Protect Children and
Adolescents—21 CFR 1140 (OMB
Control Number 0910–0312)—Renewal
This is a request for a renewal of OMB
approval of the information collection
requirements contained in FDA’s
regulations for cigarettes and smokeless
tobacco containing nicotine. The
21 CFR 1140.30 .................
Reporting ............................
21 CFR 1140.32 .................
21 CFR 1140.32 .................
Disclosure ...........................
Recordkeeping ...................
For the disclosure and recordkeeping
requirements under 1140.32, FDA has
decided to use its discretionary
enforcement and has placed
59623
regulations that are codified at 21 CFR
Part 1140 (previously codified at 21 CFR
Part 897) are authorized by section 102
of the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act) (Pub. L. 111–31). Section 102 of the
Tobacco Control Act required FDA to
publish a final rule regarding cigarettes
and smokeless tobacco identical in its
provisions to the regulation issued by
FDA in 1996 (61 FR 44396, August 28,
1996), with certain specified exceptions
including subpart C (which included
897.24) and 897.32(c) be removed from
the reissued rule (section 102(a)(2)(B)).
The reissued final rule was published in
the Federal Register on March 19, 2010
(75 FR 13225).
This collection includes reporting
information requirements for 1140.30
(formerly 897.30) which directs persons
to notify FDA if they intend to use a
form of advertising that is not addressed
in the regulations. Disclosure
requirements for 1140.32 (formerly
897.32) states that the advertising must
use black text on a white background,
but that this particular requirement does
not apply to adult newspapers,
magazines, periodicals, or other
publications. Recordkeeping
requirements under 1140.32 indicate
that competent and reliable survey
evidence is required to determine
whether a particular publication is an
‘‘adult’’ publication.
The requirements are as follows:
Directs persons to notify FDA if they intend to use a form of advertising that is not
originally described in the March 19, 2010, final rule.
Requires firms to use black text on white backgrounds in labeling and advertising.
Firms advertising in ‘‘adult’’ magazines or publications may need survey evidence
demonstrating that the publication meets the criteria for an ‘‘adult’’ publication.
placeholders of 1 burden hour for
disclosure and 1 burden hour for
reporting because FDA does not intend
to enforce the requirements for this
section for the next 3 years.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
1140.30 (Scope of permissible forms of labeling and advertising) ...........................................................................
300
1
300
1
300
........................
........................
........................
........................
300
srobinson on DSK4SPTVN1PROD with NOTICES
Total ..............................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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59624
Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of
record-keepers
Number of
records per
record-keeper
Total annual
records
Average
burden per
record-keeping
Total hours
1140.32 (Format and content requirements for labeling
and advertising) ................................................................
1
1
1
1
1
........................
........................
........................
........................
1
Total ..............................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
1140.32 ................................................................................
1
1
1
1
1
srobinson on DSK4SPTVN1PROD with NOTICES
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
industry-prepared data and information
regarding pharmaceutical advertising
and cigarette and smokeless tobacco
product advertising expenditures. The
burden collection does not include
reporting burdens associated with
providing established names on labels
and statements of intended use because
section 102 of the Tobacco Control Act
required that these provisions be struck
from the reissued final rule (previously
included in 897.24 and 897.32(c)).
Section 1140.30 (previously 897.30)
requires manufacturers, distributors,
and retailers to observe certain format
and content requirements for labeling
and advertising, and requires
manufacturers, distributors, and
retailers to notify FDA if they intend to
use an advertising medium that is not
listed in the regulations. The concept of
permitted advertising in 1140.30 is
sufficiently broad to encompass most
forms of advertising. FDA estimates that
approximately 300 respondents will
submit an annual notice of alternative
advertising, and the Agency has
estimated it should take 1 hour to
provide such notice.
For the recordkeeping and disclosure
requirements, 1140.32 (previously
897.32) requires competent and reliable
survey evidence to establish whether a
newspaper, magazine, periodical, or
other publication qualifies as an ‘‘adult’’
publication. Section 1140.32 also
requires the use of a black text on a
white background for labeling and
advertising. The respondent and hourly
burden for recordkeeping and disclosure
under this section (2 burden hours total)
reflect placeholders for the number of
manufacturers who would keep records
under this section.
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During the next 3 years, FDA does not
intend to enforce the recordkeeping and
disclosure requirements of 1140.32 and
has revised the burden to act as a
placeholder in the event FDA exercises
its authority to enforce the requirements
of this section in the future.
FDA estimates that the total time
required for this collection of
information is 302 hours.
Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
301–847–8533, email:
GIDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), or visit our Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: September 25, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–23885 Filed 9–27–12; 8:45 am]
BILLING CODE 4160–01–P
[FR Doc. 2012–23833 Filed 9–27–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Food and Drug Administration
Submission for OMB Review;
Comment Request; CareerTrac
[Docket No. FDA–2012–N–0001]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is postponing the
Gastrointestinal Drugs Advisory
Committee Meeting scheduled for
October 15, 2012. This meeting was
announced in the Federal Register of
August 16, 2012 (77 FR 49446). The
postponement is due to scheduling
issues.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Cindy Hong, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, Fax:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Fogarty
International Center (FIC), National
Institute of General Medical Science
(NIGMS), National Cancer Institute
(NCI), and National Library of Medicine
(NLM) of the National Institutes of
Health (NIH), in conjunction with the
National Institute of Environmental
Health Sciences (NIEHS), including the
Intramural Research and Training
Award (IRTA) and Superfund Research
Program (SRP) within NIEHS, has
submitted to the Office of Management
and Budget (OMB) for review and
approval. This proposed information
collection was previously published in
the Federal Register, Vol. 77, No. 106,
on June 1, 2012, pages 32648–32649 and
allowed 60 days for public comment.
One public comment was received from
the Association for Research in Vision
and Ophthalmology (ARVO). The
SUMMARY:
Gastrointestinal Drugs Advisory
Committee; Notice of Postponement of
Meeting
E:\FR\FM\28SEN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Pages 59622-59624]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23833]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0977]
Agency Information Collection Activities; Proposed Collection;
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on regulations restricting the
sale and distribution of cigarettes and smokeless tobacco to protect
children and adolescents.
[[Page 59623]]
DATES: Submit either electronic or written comments on the collection
of information by November 27, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco to Protect Children and Adolescents--21 CFR 1140 (OMB
Control Number 0910-0312)--Renewal
This is a request for a renewal of OMB approval of the information
collection requirements contained in FDA's regulations for cigarettes
and smokeless tobacco containing nicotine. The regulations that are
codified at 21 CFR Part 1140 (previously codified at 21 CFR Part 897)
are authorized by section 102 of the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31). Section 102
of the Tobacco Control Act required FDA to publish a final rule
regarding cigarettes and smokeless tobacco identical in its provisions
to the regulation issued by FDA in 1996 (61 FR 44396, August 28, 1996),
with certain specified exceptions including subpart C (which included
897.24) and 897.32(c) be removed from the reissued rule (section
102(a)(2)(B)). The reissued final rule was published in the Federal
Register on March 19, 2010 (75 FR 13225).
This collection includes reporting information requirements for
1140.30 (formerly 897.30) which directs persons to notify FDA if they
intend to use a form of advertising that is not addressed in the
regulations. Disclosure requirements for 1140.32 (formerly 897.32)
states that the advertising must use black text on a white background,
but that this particular requirement does not apply to adult
newspapers, magazines, periodicals, or other publications.
Recordkeeping requirements under 1140.32 indicate that competent and
reliable survey evidence is required to determine whether a particular
publication is an ``adult'' publication.
The requirements are as follows:
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
21 CFR 1140.30........................... Reporting............................... Directs persons to notify
FDA if they intend to use
a form of advertising that
is not originally
described in the March 19,
2010, final rule.
21 CFR 1140.32........................... Disclosure.............................. Requires firms to use black
text on white backgrounds
in labeling and
advertising.
21 CFR 1140.32........................... Recordkeeping........................... Firms advertising in
``adult'' magazines or
publications may need
survey evidence
demonstrating that the
publication meets the
criteria for an ``adult''
publication.
----------------------------------------------------------------------------------------------------------------
For the disclosure and recordkeeping requirements under 1140.32,
FDA has decided to use its discretionary enforcement and has placed
placeholders of 1 burden hour for disclosure and 1 burden hour for
reporting because FDA does not intend to enforce the requirements for
this section for the next 3 years.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.30 (Scope of permissible forms of labeling and advertising)... 300 1 300 1 300
------------------------------------------------------------------------------------
Total.......................................................... ............... ............... ............... ............... 300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 59624]]
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per record- Total hours
record-keepers record-keeper records keeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.32 (Format and content requirements for labeling and 1 1 1 1 1
advertising)......................................................
------------------------------------------------------------------------------------
Total.......................................................... ............... ............... ............... ............... 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.32............................................................ 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 industry-prepared data and information regarding
pharmaceutical advertising and cigarette and smokeless tobacco product
advertising expenditures. The burden collection does not include
reporting burdens associated with providing established names on labels
and statements of intended use because section 102 of the Tobacco
Control Act required that these provisions be struck from the reissued
final rule (previously included in 897.24 and 897.32(c)).
Section 1140.30 (previously 897.30) requires manufacturers,
distributors, and retailers to observe certain format and content
requirements for labeling and advertising, and requires manufacturers,
distributors, and retailers to notify FDA if they intend to use an
advertising medium that is not listed in the regulations. The concept
of permitted advertising in 1140.30 is sufficiently broad to encompass
most forms of advertising. FDA estimates that approximately 300
respondents will submit an annual notice of alternative advertising,
and the Agency has estimated it should take 1 hour to provide such
notice.
For the recordkeeping and disclosure requirements, 1140.32
(previously 897.32) requires competent and reliable survey evidence to
establish whether a newspaper, magazine, periodical, or other
publication qualifies as an ``adult'' publication. Section 1140.32 also
requires the use of a black text on a white background for labeling and
advertising. The respondent and hourly burden for recordkeeping and
disclosure under this section (2 burden hours total) reflect
placeholders for the number of manufacturers who would keep records
under this section.
During the next 3 years, FDA does not intend to enforce the
recordkeeping and disclosure requirements of 1140.32 and has revised
the burden to act as a placeholder in the event FDA exercises its
authority to enforce the requirements of this section in the future.
FDA estimates that the total time required for this collection of
information is 302 hours.
Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23833 Filed 9-27-12; 8:45 am]
BILLING CODE 4160-01-P
