[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25267-25268]
[FR Doc No: 2010-10781]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0074]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration and
Product Listing for Owners and Operators of Domestic Tobacco Product
Establishments and Listing of Ingredients in Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by June 7,
2010.

ADDRESSES:  To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0650.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments and Listing of Ingredients in Tobacco
Products--(OMB Control Number 0910-0650)--Extension

    On June 22, 2009, the President signed The Family Smoking
Prevention and Tobacco Control Act (the Tobacco Control Act) (Public
Law 111-31) into law. The Tobacco Control Act amended the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.) by, among
other things, adding a new chapter granting 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. Section 905(b) of the act (21 U.S.C. 395(b)), as amended
by the Tobacco Control Act, requires that ``every person who owns or
operates any establishment in any State engaged in the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products * * *'' register with FDA the name, places of business, and
all establishments owned or operated by that person. Every person must
register by December 31 of each year. Section 905(i)(1) of the act, as
amended by the Tobacco Control Act, requires that all registrants
``shall, at the time of registration under any such subsection, 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 consumer information,
such as all labeling and a representative sampling of advertisements.
Section 904(a)(1) of the act, as amended by the Tobacco Control Act,
requires each tobacco product manufacturer or importer, or agent
thereof, to submit ``a listing of all ingredients, including tobacco,
substances, compounds, and additives that are * * * added by the
manufacturer to the tobacco, paper, filter, or other part of each
tobacco product by brand and by quantity in each brand and subbrand.''
Since the Tobacco Control Act was enacted on June 22, 2009, the
information required under section 904(a)(1) of the act must be
submitted to FDA by December 22, 2009, and include the ingredients
added as of the date of submission. Section 904(c) of the act also
requires submission of information whenever additives, or the
quantities of additives, are changed.
    FDA issued guidance documents on both (1) Registration and Product
Listing for Owners and Operators of Domestic Tobacco Product
Establishments (November 12, 2009, 74 FR 58298) and (2) Listing of
Ingredients in Tobacco Products (December 1, 2009, 74 FR 62795) to
assist persons making such submissions to FDA under the Tobacco Control
Act. While electronic submission of registration and product listing
information and ingredient listing information are not required, FDA is
strongly encouraging electronic submission to facilitate efficiency and
timeliness of data management and collection. To that end, FDA designed
the eSubmitter application to streamline the data entry process for
registration and product listing and for ingredient listing. This 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 developed paper forms (FDA Form 3742--
Registration and Listing for Owners and Operators of Domestic Tobacco
Product Establishments and FDA Form 3743--Listing of Ingredients in
Tobacco Products) as an alternative submission tool. Both the
eSubmitter application and the paper forms can be accessed at http://www.fda.gov/tobacco.
    In the Federal Register of September 1, 2009 (74 FR 45219), FDA
published a notice announcing that a proposed collection of information
had been submitted to OMB for emergency processing under the PRA. In
the Federal Register of September 15, 2009 (74 FR 47257), FDA published
a notice correcting the length of the comment period, keeping it open
until October 1, 2009. In the Federal Register of October 13, 2009 (74
FR 52495), FDA published a notice reopening the comment period until
October 26, 2009. Based on comments indicating that the burden
estimates were too low, FDA has adjusted its original burden estimates.
FDA has adjusted its burden estimate for registration and product
listing for owners and operators of domestic establishments under
section 905 of the act from 0.75 hours per response to 3.75 hours per
response. FDA has adjusted its burden estimate for listing of
ingredients under section 904 of the act from 0.75 hours per response
to 3.0 hours per response. FDA also decreased

the number of respondents for listing of ingredients under section 904
of the act from 100,000 to 11,000 in response to comments that this
estimate was too high. FDA also added the activity of applying for a
Dun and Bradstreet D-U-N-S number to the burden of this information
collection for those who chose to use eSubmitter.
    In the Federal Register of February 18, 2010 (75 FR 7269), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but was outside the
scope of the PRA requirements.
    FDA estimates the burden of this collection of information as
follows:

                                                       Table 1.--Estimated Annual Reporting Burden
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                                                                        Annual Frequency      Total Annual
                  Activity                     Number of  Respondents     per Response        Respondents       Hours per  Response      Total Hours
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Registration and Product Listing for Owners                   100,000                  1              100,000                  3.75              375,000
 and Operators of Domestic Establishments
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Listing of Ingredients                                         11,000                  1               11,000                  3.0                33,000
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Obtaining a Dun and Bradstreet D-U-N-S                          1,550                  1                1,550                  0.5                   775
 Number
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Total                                                         112,550  .................              112,550  ....................              408,775
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    Dated: May 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10781 Filed 5-6-10; 8:45 am]
BILLING CODE 4160-01-S


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