Document ID: FDA-2013-N-0190-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Requirements Under the Comprehensive Smokeless
Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
Posted Date: 2016-02-19T05:00Z

[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8505-8507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03478]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on submission of rotational plans 
for health warning label statements for smokeless tobacco products.

DATES: Submit either electronic or written comments on the collection 
of information by April 19, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your

[[Page 8506]]

comment does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your comments, that information will be 
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0190 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Requirements Under the 
Comprehensive Smokeless Tobacco Health Education Act of 1986, as 
Amended by the Family Smoking Prevention and Tobacco Control Act.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (FD&C 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

[[Page 8507]]

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:

                                                     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.

    Dated: February 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03478 Filed 2-18-16; 8:45 am]
 BILLING CODE 4164-01-P