
[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48813-48814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17569]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0190]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Requirements Under 
the Comprehensive Smokeless Tobacco Health Education Act of 1986, as 
Amended by the Family Smoking Prevention and Tobacco Control Act

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 August 
25, 2016.

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 
comments should be identified with the OMB control number 0910-0671. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@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.

Requirements Under the Comprehensive Smokeless Tobacco Health Education 
Act of 1986, as Amended by the Family Smoking Prevention and Tobacco 
Control Act (OMB Control Number 0910-0671)--Extension

    The Family Smoking Prevention and Tobacco Control Act (the Tobacco 
Control Act) was enacted on June 22, 2009, amending the Federal Food, 
Drug, and Cosmetic Act and providing FDA with the authority to regulate 
tobacco products (Pub. L. 111-31; 123 Stat. 1776). Section 3 of the 
Comprehensive Smokeless Tobacco Health Education Act of 1986 (the 
Smokeless Tobacco Act) (15 U.S.C. 4402), as amended by section 204 of 
the Tobacco Control Act, requires, among other things, that all 
smokeless tobacco product packages and advertisements bear one of four 
required warning statements. Section 3(b)(3)(A) of the Smokeless 
Tobacco Act requires that the warnings be displayed on packaging and 
advertising for each brand of smokeless tobacco ``in accordance with a 
plan submitted by the tobacco product manufacturer, importer, 
distributor, or retailer'' to, and approved by, FDA.
    This information collection-the submission to FDA of warning plans 
for smokeless tobacco products is statutorily mandated. The warning 
plans will be reviewed by FDA, as required by the Smokeless Tobacco 
Act, to determine whether the companies' plans for the equal 
distribution and display of warning statements on packaging and the 
quarterly rotation of warning statements in advertising for each brand 
of smokeless tobacco products comply with section 3 of the Smokeless 
Tobacco Act, as amended.
    Based on the Federal Trade Commission's (FTC's) previous experience 
with the submission of warning plans and FDA's experience, FDA 
estimates that there are 52 companies affected by this information 
collection. To account for the entry of new smokeless tobacco companies 
that may be affected by this information collection, FDA is 
conservatively estimating the total number of annual respondents to 
this collection of information to be 100.
    When the FTC requested an extension of their approved warning plan 
information collection in 2007, based on over 20 years implementing the 
warning plan requirements and taking into account increased 
computerization and improvements in electronic communication, the FTC 
estimated submitting an initial plan would take 60 hours. Based on 
FDA's experience over the past several years, FDA believes the estimate 
of 60 hours to complete an initial rotational plan continues to be 
reasonable.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 48814]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Numbers of
                      Activity                          Numbers of     responses per     Total annual    Average burden    Total hours     Total capital
                                                       respondents       respondent       responses       per response                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of rotational plans for health warning               100                1              100               60            6,000           $1,200
 statements........................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    FDA estimates a total of 100 respondents will respond to this 
collection of information and take 60 hours to complete a rotational 
warning plan for a total of 6,000 burden hours. In addition, capital 
costs are based on 100 respondents mailing in their submission at a 
postage rate of $12 for a 5-pound parcel (business parcel post mail 
delivered from the furthest delivery zone). Therefore, FDA estimates 
that the total postage cost for mailing the rotational warning plans to 
FDA to be $1,200.
    In the Federal Register of February, 19, 2016 (81 FR 8505), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was PRA related comment was 
received.
    (Comment) The comment believes that warning plans should not be 
renewed every year, but should remain in force as long as necessary 
after their approval
    (Response) FDA does not require that a previously FDA-approved 
warning plan be resubmitted. FDA reviews and approves warning plans 
only once, unless a submitter seeks to change the distribution or 
display of warnings on packages or rotation of warnings in 
advertisements, in which case the submission would be considered a 
supplement. The purpose of FDA's proposed extension is to account for 
the entry of new smokeless tobacco product brands and advertising onto 
the market place.

    Dated: July 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17569 Filed 7-25-16; 8:45 am]
BILLING CODE 4164-01-P


