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]

Download as PDF 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: VerDate Mar<15>2010 17:28 Sep 27, 2012 Jkt 226001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1 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 http:// 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. VerDate Mar<15>2010 18:20 Sep 27, 2012 Jkt 226001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1 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. VerDate Mar<15>2010 18:20 Sep 27, 2012 Jkt 226001 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 http://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 28SEN1

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 http://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