[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57444-57445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23250]


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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.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 
November 25, 2019.

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: 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: 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. 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

[[Page 57445]]

estimates it will take half the time per response (30 hours).
    In the Federal Register of June 13, 2019 (84 FR 27638), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                            Numbers of                        Average
                        Activity                            Numbers of     responses per   Total annual     burden per      Total hours    Total capital
                                                            respondents     respondent       responses       response                          costs
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Submission of Initial rotational plans for health                      4               1               4              60             240             $48
 warning statements.....................................
Supplement to approved plan.............................              10               1              10              30             300             120
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............             540             168
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\1\ There are no operating and maintenance costs associated with this collection of information.

    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 to 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: October 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23250 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P


