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Agency Emergency Processing Under Office of Management and Budget Review; Tobacco Product Establishment Registration and Submission of Certain Health Information; Reopening of the Comment Period

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.


Notice; reopening of the comment period.


The Food and Drug Administration (FDA) is reopening until October 26, 2009, the comment period for the notice published in the Federal Register of September 1, 2009 (74 FR 45219). The document announced the proposed collection of information concerning the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and health related documents, as required by The Family Smoking Prevention and Tobacco Control Act (FSPTCA). The agency is reopening the comment period because FDA has reevaluated the expected launch date of the electronic portal and to allow interested persons additional time to review the proposed collection of information and submit comments.


Fax written comments on the collection of information by October 26, 2009. FDA is requesting approval of this emergency processing by November 2, 2009.


To ensure that comments on the information collection are received, the Office of Management and Budget (OMB) recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-5806, or e-mailed to All comments should be identified with the OMB control number 0910-NEW. Also include the FDA docket number found in brackets in the heading of this document.

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Jonna Capezzuto, Office of the Chief Information Officer (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3794, e-mail:

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In the Federal Register of September 1, 2009 (74 FR 45219), FDA requested emergency processing of this proposed collection of information under section Start Printed Page 524963507(j) of the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3507(j) and 5 CFR 1320.13). On June 22, 2009, the President signed FSPTCA into law (Public Law 111-31). Section 101 of FSPTCA amends the Federal Food, Drug, and Cosmetic Act (the act) by adding, among other things, new sections 904 (21 U.S.C. 394) and 905 (21 U.S.C. 395).

FDA originally identified its plan to collect the information submission requirements of sections 905, 904(a)(1), and 904(a)(4) through a single electronic portal. In addition to the electronic portal, FDA also plans to provide a paper based form to collect this information for those individuals who choose not to use the electronic portal. FDA originally planned to launch the electronic portal for the collection of this information on October 1, 2009. FDA now plans to launch the electronic portal for the collection of this information on November 2, 2009. If FDA were to use the normal PRA clearance procedures, the availability of the electronic portal and the submission of information by respondents could not begin with adequate time to meet the respective statutory deadlines (December 22, 2009, for section 904, and December 31, 2009, for section 905).

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Dated: October 6, 2009.

David Horowitz,

Assistant Commissioner for Policy.

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[FR Doc. E9-24543 Filed 10-9-09; 8:45 am]