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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Product Standard on Flavored Cigarettes

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.

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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.


Fax written comments on the collection of information by March 22, 2010.


To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or e-mailed to All comments should be identified with the OMB control number 0910-0647. Also include the FDA docket number found in brackets in the heading of this document.

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Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3794,

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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

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

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the act) 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 act (21 U.S.C. 397(a)(1)(A), as amended by the Tobacco Control Act, 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 Tobacco Call Center representatives use to record this information. Additionally, this form is posted on FDA's Internet at​scripts/​email/​TobaccoProducts/​flavoredCigarettes.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​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 (74 FR 48974, September 25, 2009). 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,
  • Press release announcing the effective date of the cigarette flavor ban,
  • Flavored tobacco products fact sheet, and
  • Flavored tobacco products parental advisory.

In the Federal Register of October 26, 2009 (74 FR 55050), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment in response to the 60-day notice soliciting public comment on the extension of OMB approval for this information collection generally supporting “the extension of this collection of information regarding the enforcement of the cigarette flavor ban and submits that the extension of data collection is critical to the ‘proper performance of FDA's functions’ and that it will have great ‘practical utility’.” Although FDA did not receive comment on the estimated number of respondents, FDA is adjusting this estimate based on current reporting experience to 170 respondents.

Table 1.—Estimated Annual Reporting Burden1

Activity and Form FDA 3734No. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesMinutes Per ResponseTotal Hours
Reporting violations of section 907(a)(1)(A) of the act170117010 (0.167 hours)28
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: February 12, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-3036 Filed 2-17-10; 8:45 am]