[Federal Register Volume 74, Number 196 (Tuesday, October 13, 2009)]
[Notices]
[Pages 52495-52496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24543]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0406]


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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; reopening of the comment period.

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SUMMARY:  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.

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

ADDRESSES:  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 
[email protected]. 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.

FOR FURTHER INFORMATION CONTACT: 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: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of September 1, 2009 
(74 FR 45219), FDA requested emergency processing of this proposed 
collection of information under section

[[Page 52496]]

3507(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).

    Dated: October 6, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24543 Filed 10-9-09; 8:45 am]
BILLING CODE 4160-01-S