Document ID: FDA-2010-N-0074-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments, etc.
Posted Date: 2010-05-07T04:00Z

[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25267-25268]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. 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, 301-796-3794, Jonnalynn.Capezzuto@fda.hhs.gov.

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

[[Page 25268]]

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