[Federal Register Volume 74, Number 217 (Thursday, November 12, 2009)]
[Notices]
[Pages 58298-58299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27182]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, [email protected].
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announced the availability of a draft guidance document entitled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