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Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 submission of tobacco health documents under the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).


Submit written or electronic comments on the collection of information by June 21, 2010.


Submit electronic comments on the collection of information to 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.

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

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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.Start Printed Page 20604

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 Health Document Submission (OMB Control Number 0910-0654)—Extension

On June 22, 2009, the President signed the Tobacco Control Act (Public Law 111-31) into law. The Tobacco Control Act granted 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. Among its many provisions, the Tobacco Control Act added section 904(a)(4) to the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 387d(a)(4)), requiring submission of documents related to certain effects of tobacco products.

Section 904(a)(4) of the act requires each tobacco product manufacturer or importer, or agent thereof, to submit all documents developed after June 22, 2009 “that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.” Information required under section 904(a)(4) of the act must be submitted to FDA beginning December 22, 2009.

FDA issued a draft guidance document entitled, “Tobacco Health Document Submission” on December 28, 2009 (74 FR 68629) to assist persons making certain document submissions to FDA under section 904(a)(4) of the act. While electronic submission of tobacco health documents is not required, FDA designed the eSubmitter application as an alternative for mailing documents. This electronic tool allows for importation of large quantities of structured data, attachments of files (e.g., in portable document format (PDFs) and certain media files), and automatic acknowledgement of FDA's receipt of submissions. FDA also is developing a paper form (FDA Form 3743) as an alternative submission tool. Both the eSubmitter application and the paper form can be accessed at​tobacco once they are complete.

On September 1, 2009 (74 FR 45219), FDA published notice in the Federal Register announcing that a proposed collection of information had been submitted to OMB for emergency processing under the Paperwork Reduction Act of 1995. On September 15, 2009 (74 FR 47257), FDA published a notice correcting the length of the comment period, keeping it open until October 1, 2009. On October 13, 2009 (74 FR 52495), FDA published a notice reopening the comment period until October 26, 2009. On January 7, 2010, FDA received emergency approval for this information collection. Based on comments indicating that the burden estimate was too low, FDA has adjusted its original burden estimate from 1.0 hour per response to 200 hours per response. FDA also increased the annual frequency per response from 1 to 4 (quarterly). FDA is maintaining the original estimate of the number of respondents at 10. FDA is basing its estimates on the total number of tobacco firms it is aware of, its experience with document production, and comments received in response to the draft guidance document published on December 28, 2009.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden1

ActivityNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
Tobacco Health Document Submission104402008,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: April 14, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-8976 Filed 4-19-10; 8:45 am]