[Federal Register Volume 84, Number 114 (Thursday, June 13, 2019)]
[Notices]
[Pages 27638-27640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12472]


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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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 the information collection ``Requirements Under 
the Comprehensive Smokeless Tobacco Health Education Act of 1986, as 
Amended by the Family Smoking Prevention and Tobacco Control Act.''

DATES: Submit either electronic or written comments on the collection 
of information by August 12, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 12, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 ``Requirements Under

[[Page 27639]]

the Comprehensive Smokeless Tobacco Health Education Act of 1986, as 
Amended by the Family Smoking Prevention and Tobacco Control Act.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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 (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). 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. Additionally, FDA considers a submission to be 
a supplement if the submitter is seeking approval of a change to an 
FDA-approved warning plan.
    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 accurate. If a supplement to an approved plan is 
submitted, FDA estimates it will take half the time per response (30 
hours).
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
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                                                  Number of
                                     Number of    responses      Total       Average                    Total
             Activity               respondents      per         annual     burden per  Total hours    capital
                                                  respondent   responses     response                   costs
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Submission of Initial rotational              4            1            4           60          240          $48
 plans for health warning
 statements.......................

[[Page 27640]]

 
Supplement to approved plan.......           10            1           10           30          300          120
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    Total.........................  ...........  ...........  ...........  ...........          540          168
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    FDA estimates a total of 4 respondents will submit a new original 
warning plan and take 60 hours to complete a rotational warning plan 
for a total of 240 burden hours. In addition, 10 respondents will 
submit a supplement to an approved warning plan at 30 hours per 
response for a total of 300 hours. The total burden for this collection 
is estimated to be 540 hours.
    Capital costs are based on 14 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 FDA to be $168.
    We have adjusted our burden estimate, which has resulted in a 
decrease of 5,460 hours and 86 respondents to the currently approved 
burden. We received a total number of 44 original smokeless warning 
plans, and a total of 17 supplements. After receiving the initial 
influx of original warnings plans, FDA does not expect to receive as 
many original warning plans annually. We expect that a few supplements 
will continue to be received as new products are marketed or as warning 
plans are revised. We anticipate a total number of 10 supplements 
submitted annually and 4 original smokeless warning plans.

    Dated: June 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12472 Filed 6-12-19; 8:45 am]
 BILLING CODE 4164-01-P


