
[Federal Register: November 12, 2009 (Volume 74, Number 217)]
[Notices]               
[Page 58298-58299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12no09-67]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0508]

 
Guidance for Industry on Registration and Product Listing for 
Owners and Operators of Domestic Tobacco Product Establishments; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Registration and Product 
Listing for Owners and Operators of Domestic Tobacco Product 
Establishments.'' The guidance document is intended to assist persons 
making tobacco product establishment registration and product listing 
submissions to FDA under the Family Smoking Prevention and Tobacco 
Control Act (Tobacco Control Act).

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Registration and Product Listing for Owners and 
Operators of Domestic Tobacco Product Establishments'' to the Center 
for Tobacco Products, Food and Drug Administration, 9200 Corporate 
Blvd., Rockville, MD 20850-3229. Send one self-addressed adhesive label 
to assist that office in processing your request or include a fax 
number to which the guidance document may be sent. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance document.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Michele Mital, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 301-796-4800, Michele.Mital@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 21, 2009 (74 FR 54052), FDA 
announced the availability of a draft guidance document entitled 
``Registration and Product Listing for Owners and Operators of Domestic 
Tobacco Product Establishments.'' The agency considered received 
comments as it finalized this guidance. This guidance document is 
designed to assist domestic owners and operators with submitting 
tobacco product establishment registration and tobacco product listing 
information. Under section 905(b) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 387e(b)), added by the

[[Page 58299]]

Tobacco Control Act, every person who owns or operates any domestic 
establishments engaged in the manufacture, preparation, compounding, or 
processing of a regulated tobacco product must register with FDA by 
December 31 of each year. Moreover, all registrants must at the time of 
registration file with FDA a list of all tobacco products which are 
being manufactured, prepared, compounded, or processed by that person 
for commercial distribution, along with certain accompanying 
information, including all labeling (see section 905(i)(1) of the act, 
as added by the Tobacco Control Act).
    FDA does not intend to enforce the requirement to submit 
registration and product listing information under section 905 of the 
act by December 31, 2009, provided that the submission is received by 
FDA on or before February 28, 2010. We recognize that the forms 
developed by FDA are new to industry, and so may require additional 
time to complete accurately. While electronic submission of 
registration and listing information is not required, FDA is strongly 
encouraging electronic submission to facilitate efficiency and 
timeliness of data management and submission. FDA does recognize, 
however, that electronic submission requires several additional steps, 
such as obtaining an Electronic Submissions Gateway account and 
becoming familiar with the eSubmitter electronic application. FDA 
therefore believes that this additional time for the first submission 
of this registration and listing information should result in 
submission of higher quality information.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on ``Registration and Product Listing for 
Owners and Operators of Domestic Tobacco Product Establishments.'' It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute 
and regulations.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0650.

V. Electronic Access

    An electronic version of the guidance document is available on the 
Internet at http://www.regulations.gov and http://www.fda.gov/
TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: November 6, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27182 Filed 11-6-09; 4:15 pm]

BILLING CODE 4160-01-S
