[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Pages 46441-46443]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18975]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0386]


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.

-----------------------------------------------------------------------

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.

DATES: Fax written comments on the collection of information by 
September 4, 2012.

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 emailed to oira_submission@omb.eop.gov. All

[[Page 46442]]

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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
daniel.gittleson@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 Tobacco Control Act 
(Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) by, 
among other things, adding a new chapter granting FDA important 
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 FD&C Act (21 U.S.C. 387e(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(c) of the FD&C Act 
requires that first-time persons ``engaging in the manufacture, 
preparation, compounding, or processing of a tobacco product or tobacco 
products shall register with the Secretary the name, places of 
business, and all such establishments of that person.'' Section 905(d) 
states that persons required to register under sections 905(b) or 
905(c) shall register any additional establishment that they own or 
operate in any state which begins the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco products. 
Section 905(h) addresses foreign establishment registration 
requirements, which will go into effect when regulations are 
promulgated by the Secretary. Section 905(i)(1) of the FD&C 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 FD&C Act (21 U.S.C. 387d(a)(1)), 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 or 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) 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 FD&C 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, 
attachment 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 (Form FDA 3742--
Registration and Listing for Owners and Operators of Domestic Tobacco 
Product Establishments and Form FDA 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 May 3, 2012 (77 FR 26281), FDA published 
a 60-day notice requesting public comment on the proposed collection of 
information. One comment beyond the scope of this collection was 
received that discussed the importance of extending this collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
  FDA form/activity/tobacco       Number of     responses per    Total annual    Average  burden    Total hours
     control act section         respondents      respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
Form FDA 3742/Registration                125              1.6             200  3.75                         750
 and Product Listing for
 Owners and Operators of
 Domestic Establishments
 (Electronic and Paper
 submission)/Sections 905(b),
 905(c), 905(d) 905(h), or
 905(i).
Form FDA 3743/Listing of                  125              1.6             200  3                            600
 Ingredients (Electronic and
 Paper Submissions)/Sections
 904(a)(1) or 904(c).
Obtaining a DUNS Number (10%                8              1                 8  0.50 (30                       4
 of total respondents).                                                          minutes)
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ...............  ..............  ................           1,354
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 46443]]

    Since this collection of information was last approved by OMB on 
December 2, 2010, its burden has decreased by 407,421 hours, from 
408,775 to 1,354 reporting hours. This adjustment is a result of FDA 
experience over the past 2 years in the regulation of tobacco products 
and is based on the actual number of establishment registration and 
product ingredient submissions received during this time period. In 
2010, when this collection was first published for public comment in 
the Federal Register, FDA attempted to determine the actual number of 
tobacco manufacturers by using the Security and Exchange Commission's 
Standard Industrial Classification (SIC) codes, which are identifying 
codes that appear in a company's EDGAR filings to show the company's 
type of business. When preparing the collection of information package 
for publication in 2010, the tobacco industry codes indicated that over 
10,000 tobacco manufacturers existed under the SIC codes for tobacco 
products and cigarettes. However, upon further examination of these 
codes, it appears that the number of tobacco manufacturers was greatly 
inflated, as the SIC codes included tobacco retail in addition to 
tobacco manufacturers. In addition, no comments were received from the 
2010 initial 60-day Federal Register notice regarding either the number 
of respondents or the number of reporting burden hours listed in the 
notice, so FDA used the collection's SIC-researched manufacturer 
numbers for this collection of information. Actual FDA registration and 
product listing report submissions and FDA experience indicate in the 
past 2 years, the number of tobacco manufacturers required to register 
and list their products and ingredient listings is approximately 125, a 
substantial decrease from the number of potential respondents listed in 
2010. By applying the revised number of manufacturers to the burden 
chart, the total burden for registration and listing now is currently 
estimated to be 1,354 reporting burden hours, much less than the 
408,775 OMB-approved reporting burden hours stated in 2010.
    Based on the actual number of registration and product ingredient 
listing reports received by FDA over the past 2 years, the number of 
expected annual responses is projected to decrease from 100,000 
registration responses to 200 annual responses, and from 11,000 annual 
product ingredient listing responses to 200 annual product ingredient 
responses. The Agency bases its estimate on the actual number of 
registration and listing and product ingredient listing reports 
received, its experience with the submission of registration and 
listing requirements applicable to other FDA regulated products, and 
ongoing interactions with industry. FDA estimates that the submission 
of registration information as required by section 905 of the FD&C Act 
will remain at 3.75 hours per establishment. Based on the actual number 
of registration information submitted in the past 2 years and its 
experience, the Agency estimates that approximately 200 registrations 
will be submitted from 125 tobacco product establishments annually, for 
a total 750 hour burden (125 respondents x 1.6 responses per respondent 
x 3.75 hours per response).
    FDA estimates that the submission of ingredient listing information 
as required by section 904 of the FD&C Act will remain at 3.0 hours per 
tobacco product. Based on the actual number of product ingredient 
listings submitted over the past 2 years and its experience, the Agency 
estimates that approximately 200 ingredient listings will be submitted 
from 125 tobacco establishments, for a total 600 burden hours (125 
respondents x 1.6 responses per respondent x 3.0 hours per response).
    FDA estimates that obtaining a Dun and Bradstreet (DUNS) number 
will take 0.5 hours, and that 8 respondents (1 percent (1.25) of 
establishments required to register under section 905 and 5 percent 
(6.25) of submitters required to list ingredients under section 904) 
will not already have a DUNS number. The total burden, therefore, will 
be 4 hours (8 respondents x 1 response per respondent x 0.5 hours per 
response).
    Total burden hours for this collection, therefore is 1,354 hours 
(750 + 600 + 4 hours).

    Dated: July 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18975 Filed 8-2-12; 8:45 am]
BILLING CODE 4160-01-P