Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Standard for Flavored Cigarettes, 55050-55051 [E9-25604]

Download as PDF 55050 Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices Written comments and recommendations concerning the proposed information collection should be sent by November 25, 2009 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB’s receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202–395– 5806. Dated: October 19, 2009. Elaine Parry, Director, Office of Program Services. [FR Doc. E9–25667 Filed 10–23–09; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0496] Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Standard for Flavored Cigarettes AGENCY: Food and Drug Administration, HHS. mstockstill on DSKH9S0YB1PROD with NOTICES 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 the proposed extension of an existing collection of information pertaining to the tobacco product standard for flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (FSPTCA). DATES: Submit written or electronic comments on the collection of information by December 28, 2009. 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 VerDate Nov<24>2008 15:19 Oct 23, 2009 Jkt 220001 comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3794, Jonnalynn.Capezzuto@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 extension of an existing 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. Title: Tobacco Product Standard on Flavored Cigarettes (OMB Control Number 0910–0647—Extension) On June 22, 2009, the President signed the FSPTCA (Public Law 111–31) into law. The FSPTCA amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 FDA is requesting an extension of an existing collection of information pertaining to section 907(a)(1)(A) of the FDCA, as amended by the FSPTCA, which provides a general tobacco standard special rule for cigarettes that became effective on September 22, 2009. This special rule for cigarettes states in part that: ‘‘* * * a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.’’ As part of our enforcement strategy, FDA created a Tobacco Call Center (with a toll-free number) to accept information from the public about violations of this provision, known as the cigarette flavor ban. Callers are able to report violations of the cigarette flavor ban and FDA will determine whether to conduct targeted followup investigations based on information the agency receives. Members of the public who wish to report a violation will be asked for certain information: Name and contact information, which are optional, date that the caller observed or purchased the alleged violative product, description of the tobacco product, and address of the retail outlet or Internet address where the violative product was available. FDA developed a form (FDA Form 3734) that Call Center representatives use to record this information. Additionally, this form is posted on FDA’s Internet (https:// www.accessdata.fda.gov/scripts/email/ TobaccoProducts/flavored Cigarettes.cfm), which allows the public to report violations of the cigarette flavor ban by filling out the form online. Others may simply choose to send a letter to FDA. (Information about how to contact FDA’s Center for Tobacco Products is posted at https:// www.fda.gov/TobaccoProducts/ default.htm). FDA described how to report information about possible violations in a Federal Register notice reminding regulated industry of the effective date of the ban on certain flavored cigarettes (September 25, 2009; 74 FR 48974). FDA also included this information in the following outreach materials: • Letter to our tobacco control partners announcing the cigarette flavor ban and soliciting information on possible violations, E:\FR\FM\26OCN1.SGM 26OCN1 55051 Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices • Press release announcing the effective date of the cigarette flavor ban, • Flavored tobacco products fact sheet, and • Flavored tobacco products parental advisory. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN Activity and Form FDA 3734 No. of Respondents Reporting violations of section 907(a)(1)(A) of the FDCA Annual Frequency per Response 1,700 Dated: October 15, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–25604 Filed 10–23–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects: Total Annual Responses 1 Minutes per Response 1,700 Title: Community Services Block Grant (CSBG) Program Model Plan Application. OMB No.: New collection. Description: Sections 676 and 677 of the Community Services Block Grant Act require States, including the District of Columbia and the Commonwealth of Puerto Rico, Tribes, Tribal organizations and U.S. territories applying for Community Services Block Grant (CSBG) funds to submit an application and plan (Model Application Plan). The application plan must meet statutory requirements prior to being funded with CSBG funds. Applicants have the option Total Hours 10 283 to submit a detailed application annually or biannually. Entities that submit a biannual application must provide an abbreviated application the following year if substantial changes to the initial application will occur. OMB approval is being sought. Respondents: State Governments, including the District of Columbia and the Commonwealth of Puerto Rico, Tribal Governments, Tribal Organizations, and U.S. territories. ANNUAL BURDEN ESTIMATES Number of respondents Instrument mstockstill on DSKH9S0YB1PROD with NOTICES Model State CSBG Application ....................................................................... Model Indian Tribes & Tribal Organizations CSBG Application ...................... Estimated Total Annual Burden Hours: 860 In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have VerDate Nov<24>2008 18:16 Oct 23, 2009 Jkt 220001 Dated: October 21, 2009. Robert Sargis, Reports Clearance Officer. [FR Doc. E9–25650 Filed 10–23–09; 8:45 am] PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 Average burden hours per response 1 1 10 10 56 30 practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. BILLING CODE 4184–01–P Number of responses per respondent Total burden hours 560 300 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Cross-Site Evaluation of the Children’s Bureau Grantee Cluster: Supporting Evidence-Based Home Visiting Programs to Prevent Child Maltreatment (EBHV). OMB No.: New collection. Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing this crosssite evaluation data collection activity to identify successful strategies for adopting, implementing, and sustaining high-quality home visitation programs to prevent child maltreatment. An evaluation study will address four domains: (1) Systems change to develop infrastructure, (2) fidelity to evidence- E:\FR\FM\26OCN1.SGM 26OCN1

Agencies

[Federal Register Volume 74, Number 205 (Monday, October 26, 2009)]
[Notices]
[Pages 55050-55051]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25604]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0496]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Tobacco Product Standard for Flavored Cigarettes

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 the proposed extension of an 
existing collection of information pertaining to the tobacco product 
standard for flavored cigarettes under the Family Smoking Prevention 
and Tobacco Control Act (FSPTCA).

DATES:  Submit written or electronic comments on the collection of 
information by December 28, 2009.

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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794, Jonnalynn.Capezzuto@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 extension of 
an existing 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.

Title: Tobacco Product Standard on Flavored Cigarettes (OMB Control 
Number 0910-0647--Extension)

    On June 22, 2009, the President signed the FSPTCA (Public Law 111-
31) into law. The FSPTCA amended the Federal Food, Drug, and Cosmetic 
Act (FDCA) by adding a new chapter granting FDA important new authority 
to regulate the manufacture, marketing, and distribution of tobacco 
products to protect the public health generally and to reduce tobacco 
use by minors.
    FDA is requesting an extension of an existing collection of 
information pertaining to section 907(a)(1)(A) of the FDCA, as amended 
by the FSPTCA, which provides a general tobacco standard special rule 
for cigarettes that became effective on September 22, 2009. This 
special rule for cigarettes states in part that: ``* * * a cigarette or 
any of its component parts (including the tobacco, filter, or paper) 
shall not contain, as a constituent (including a smoke constituent) or 
additive, an artificial or natural flavor (other than tobacco or 
menthol) or an herb or spice, including strawberry, grape, orange, 
clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, 
chocolate, cherry, or coffee, that is a characterizing flavor of the 
tobacco product or tobacco smoke.''
    As part of our enforcement strategy, FDA created a Tobacco Call 
Center (with a toll-free number) to accept information from the public 
about violations of this provision, known as the cigarette flavor ban. 
Callers are able to report violations of the cigarette flavor ban and 
FDA will determine whether to conduct targeted followup investigations 
based on information the agency receives. Members of the public who 
wish to report a violation will be asked for certain information: Name 
and contact information, which are optional, date that the caller 
observed or purchased the alleged violative product, description of the 
tobacco product, and address of the retail outlet or Internet address 
where the violative product was available. FDA developed a form (FDA 
Form 3734) that Call Center representatives use to record this 
information. Additionally, this form is posted on FDA's Internet 
(https://www.accessdata.fda.gov/scripts/email/TobaccoProducts/flavoredCigarettes.cfm), which allows the public to report violations 
of the cigarette flavor ban by filling out the form on-line. Others may 
simply choose to send a letter to FDA. (Information about how to 
contact FDA's Center for Tobacco Products is posted at https://www.fda.gov/TobaccoProducts/default.htm). FDA described how to report 
information about possible violations in a Federal Register notice 
reminding regulated industry of the effective date of the ban on 
certain flavored cigarettes (September 25, 2009; 74 FR 48974). FDA also 
included this information in the following outreach materials:
     Letter to our tobacco control partners announcing the 
cigarette flavor ban and soliciting information on possible violations,

[[Page 55051]]

     Press release announcing the effective date of the 
cigarette flavor ban,
     Flavored tobacco products fact sheet, and
     Flavored tobacco products parental advisory.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1.--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        No. of         Annual Frequency        Total Annual           Minutes per
           Activity and Form  FDA 3734               Respondents         per Response            Responses             Response           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting violations of section 907(a)(1)(A) of               1,700                     1                 1,700                    10                283
 the FDCA
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: October 15, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25604 Filed 10-23-09; 8:45 am]
BILLING CODE 4160-01-S
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