Food and Drug Administration, HHS.
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).
Submit written or electronic comments on the collection of information by December 28, 2009.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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 (http://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 http://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,Start Printed 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:
|Activity and Form FDA 3734||No. of Respondents||Annual Frequency per Response||Total Annual Responses||Minutes per Response||Total Hours|
|Reporting violations of section 907(a)(1)(A) of the FDCA||1,700||1||1,700||10||283|
Dated: October 15, 2009.
Assistant Commissioner for Policy.
[FR Doc. E9-25604 Filed 10-23-09; 8:45 am]
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