[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77837-77838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32026]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0867]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study on the Public Display of Lists of 
Harmful and Potentially Harmful Tobacco Constituents

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 a notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the Experimental Study on the Public 
Display of the List of Harmful and Potentially Harmful Tobacco 
Constituents. This study is being conducted in support of the provision 
of the Family Smoking Prevention and Tobacco Control Act (the Tobacco 
Control Act) that requires FDA to publish in a format that is 
understandable and not misleading to a lay person and to place on 
public display the list of harmful and potentially harmful constituents 
(HPHCs) in tobacco products and tobacco smoke.

DATES: Submit either electronic or written comments on the collection 
of information by February 13, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 
[email protected].

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 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.

Experimental Study on the Public Display of the List of Harmful and 
Potentially Harmful Tobacco Constituents (OMB Control Number--0910-New)

    The Tobacco Control Act (Pub. L. 111-31) amends the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) to grant FDA authority to regulate 
the manufacture, marketing, and distribution of tobacco products to 
protect the public health and to reduce tobacco use by minors. Section 
904(d)(1) of the FD&C Act states, ``Not later than 3 years after the 
date of enactment of the Family Smoking Prevention and Tobacco Control 
Act, and annually thereafter, the Secretary shall publish in a format 
that is understandable and not misleading to a lay person, and place on 
public display (in a manner determined by the Secretary) the list [of 
harmful or potentially harmful constituents] established under [section 
904(e)]'' of the FD&C Act. Section 904(e) of the FD&C Act directs FDA 
to establish ``a list of harmful and potentially harmful constituents, 
including smoke constituents, to health in each tobacco product by 
brand, and by quantity in each brand and subbrand.'' On January 31, 
2011, FDA announced the availability of a final guidance representing 
the Agency's current thinking on the meaning of the term ``harmful and 
potentially harmful constituent'' (see 76 FR 5387). On August 12, 2011, 
FDA published a notice in the Federal Register requesting comment 
issues related to the establishment of the HPHC list (see 76 FR 50226).
    FDA intends to conduct research with consumers to help inform 
decisions about how to implement section 904(d)(1) of the FD&C Act and 
to provide information about how consumers understand information about 
HPHCs. The research goals are to evaluate the impact of different list 
formats on the public's ability to understand HPHC information, and to 
assess the potential for certain unintended consequences resulting from 
exposure to the lists. The impact of different list formats will be 
measured by evaluating respondents' understanding of the following 
concepts: (1) There are more than 4,000 chemicals in tobacco products 
and tobacco smoke; (2) the chemicals come from the tobacco leaf itself, 
how it is processed, and different parts of a tobacco product such as 
the tobacco smoke, glues, inks, paper, or additives; (3) for smokeless 
products, many of the chemicals come from the tobacco leaf itself; for 
smoked products, many of the chemicals come from burning the tobacco 
leaf; (4) Federal law requires tobacco companies to test their tobacco 
products and smoke for the chemicals on this list; (5) each tobacco 
product brand and subbrand has its own separate list of chemicals; (6) 
science has linked the chemicals on these lists to health problems or 
potential health problems; (7) these lists do not include necessarily 
all of the health problems that may be caused by the tobacco product; 
(8) these lists do not necessarily include all of the chemicals in the 
tobacco product that may be harmful; (9) the amount of a chemical 
listed for a specific tobacco product does not necessarily indicate the 
likelihood of experiencing a health problem; (10) the number of 
chemicals listed for a specific tobacco product does not necessarily 
indicate the likelihood of experiencing a health problem; (11) the 
number of possible health outcomes listed for a tobacco product does 
not necessarily indicate the likelihood of experiencing a health 
problem; (13) the number of chemicals listed for a specific health 
problem does

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not necessarily indicate the likelihood of experiencing a health 
problem; (13) when a chemical is listed without a quantity it may mean 
that a manufacturer has not yet tested its products for that chemical; 
and/or that a test was conducted but it was not sensitive enough to 
measure the amount of chemical in the product; and/or that a way to 
test for that chemical is still being developed. Unintended 
consequences will be assessed by measuring respondents' susceptibility 
to initiation of tobacco use, motivation and confidence to quit tobacco 
use, risk perceptions about tobacco use, and emotional reactivity.
    FDA proposes to conduct an experimental study with current smokers 
aged 15 years and older, former smokers aged 15 years and older, and 
nonsmokers aged between 13 and 25 years who may be susceptible to 
initiation of smoking. Data will be collected from members of an 
Internet panel. The study will include an oversampling of subjects with 
limited health literacy. Participation in the experimental study is 
voluntary. The information collected from the study is necessary to 
inform the Agency's efforts to implement the requirement of the FD&C 
Act to place on public display a list of HPHCs in tobacco products and 
tobacco smoke in a format that is understood and not misleading to a 
lay person, and is expected to provide information that may inform 
Agency communications about HPHCs. The data obtained from this study is 
one factor that will be used to inform FDA's decisionmaking regarding 
the public display of the list of HPHCs required under section 
904(d)(1) of the FD&C Act. By evaluating respondents' understanding of 
the concepts listed previously in this document we do not intend to 
imply that consumer understanding of all concepts is needed to comply 
with these requirements.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Pretest.........................              60               1              60             0.5              30
Screener........................          10,000               1          10,000          0.0167             167
Experimental Survey.............           3,000               1           3,000             0.5           1,500
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    Total.......................          13,060  ..............  ..............  ..............           1,697
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's burden estimate is based on prior experience with Internet 
panel experiments similar to the study proposed here. Sixty panel 
members will take part in a pretest of the study, estimated to last 30 
minutes (0.5 hours), for a total of 30 hours. Approximately 10,000 
respondents will complete a screener to determine eligibility for 
participation in the study, estimated to take 1 minute (0.0167 hours), 
for a total of 167 hours. Three thousand respondents will complete the 
full study, estimated to last 30 minutes (0.5 hours), for a total of 
1,500 hours. The total estimated burden is 1,697 hours.

    Dated: December 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32026 Filed 12-13-11; 8:45 am]
BILLING CODE 4160-01-P