[Federal Register Volume 64, Number 78 (Friday, April 23, 1999)]
[Notices]
[Pages 20004-20005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0803]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Regulations Restricting the Sale and Distribution of 
Cigarettes and Smokeless Tobacco to Protect Children and Adolescents

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, 
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 proposed collection of 
information concerning restrictions on the sale and distribution of 
cigarettes and smokeless tobacco in order to protect children and 
adolescents under the Federal Food, Drug, and Cosmetic Act (the act).

DATES: Submit written comments on the collection of information by June 
22, 1999.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (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: Heather M. Rubino, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 15-74, Rockville, MD 20857, 301-
827-3322.

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: (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.

Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco to Protect Children and Adolescents--OMB No. 
0910-0312--Extension

    Part 897 (21 CFR part 897) reflects requirements in sections 
502(e)(2) and 520(e) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 352(e)(2) and 360j(e)).
    Section 897.24 is intended to implement section 502(e)(2) of the 
act. Under section 502(e)(2) of the act, a device is misbranded unless 
its label bears the product's established name. Section 502(e)(4) of 
the act, in turn, explains that the ``established name'' with respect 
to a device means: (1) The applicable official name of the device 
designated under section 508 of the act (21 U.S.C. 358), (2) if there 
is no such name and the device is recognized in an official compendium, 
then the official title in such compendium, or (3) if neither (1) nor 
(2) apply, then ``any common or usual name of such device.'' Here, no 
official names have been designated under section 508 of the act, and 
these products are not recognized in an official compendium. 
Consequently, FDA developed established names for these products under 
section 502(e)(4) of the act. Section 897.24 requires that each 
cigarette or smokeless tobacco product package, carton, box, or 
container of any kind that is offered for sale, sold, or otherwise 
distributed bear

[[Page 20005]]

whichever of the following established names is appropriate: 
``Cigarettes,'' ``Cigarette Tobacco,'' ``Loose Leaf Chewing Tobacco,'' 
``Plug Chewing Tobacco,'' ``Twist Chewing Tobacco,'' ``Moist Snuff,'' 
or ``Dry Snuff.''
    Section 520(e) of the act authorizes the agency to, by regulation, 
require that a device be restricted to sale, distribution, or use 
``upon such other conditions as the [agency] may prescribe in such 
regulation, if, because of its potentiality for harmful effect or the 
collateral measures necessary to its use, the [agency] determines that 
there cannot otherwise be reasonable assurance of its safety and 
effectiveness.'' In the Federal Register of August 28, 1996 (21 CFR 
44396), the agency issued regulations restricting the sale and 
distribution of cigarettes and smokeless tobacco under this authority 
(hereinafter referred to as the August 1996 final rule).
    Sections 897.30 and 897.32 are intended to help protect children 
and adolescents by reducing the appeal of cigarettes and smokeless 
tobacco to them. Section 897.30, in part, contains a comprehensive list 
of permissible forms of advertising and labeling; in the unlikely event 
that a person wishes to use a form of advertising or labeling that is 
not described in Sec. 897.30, the rule directs persons to notify FDA. 
The rule's concept of permitted advertising is sufficiently broad to 
encompass almost all known forms of advertising, but the agency has 
provided a reporting estimate of 1 hour in the remote chance that a 
firm will provide such notice to FDA.
    Section 897.32 would reduce the appeal of cigarettes and smokeless 
tobacco to children and adolescents by requiring most advertisements to 
use black text on white backgrounds, without any colors or pictures. It 
would also require advertising to include the product's established 
name and a statement of its intended use. In the August 1996 final 
rule, FDA estimated that approximately 25,000 pieces of labeling or 
advertising will be submitted to the agency under this provision. The 
agency arrived at this estimate by comparing the advertising 
expenditures by the cigarette and smokeless tobacco industries and by 
the pharmaceutical industry and the number of pieces of advertising 
that the agency receives from the pharmaceutical industry, and 
projecting that printed advertisements may increase due to the rule's 
effect on promotional activities (see 61 FR 44396 at 44597). FDA also 
estimated that the time required for such advertising is 1 hour based 
on the highest estimated time reported in industry comments on the 
proposed rule.
    The text-only requirement of Sec. 897.32 does not apply to 
advertisements in ``adult'' publications, as defined in 
Sec. 897.32(a)(2). Under that definition, firms wishing to advertise in 
``adult'' publications may need to retain records to demonstrate that 
the publication is an ``adult'' publication within the meaning of 
Sec. 897.32. In the August 1996 final rule, FDA estimated that 31 
respondents may be affected and that a total of 100,000 hours would be 
needed for such surveys (see 61 FR 44396 at 44612). The 31 respondents 
reflects the number of manufacturers as reported in a 1992 U.S. census 
of tobacco product manufacturers, and the estimated total time for 
these surveys would be 100,000 hours, assuming 100 surveys (for the 
approximately 100 magazines in which tobacco manufacturers advertise) 
at 1,000 hours per survey or approximately 3,226 hours per respondent.
    The medical device reporting requirements (21 CFR 803.19 and 
804.25) were addressed in a separate rulemaking that published in the 
Federal Register of May 12, 1998 (63 FR 26069 and 26129).
    Description of Respondents: Cigarette and smokeless tobacco 
manufacturers, distributors, and retailers.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden
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                                Annual
  21 CFR        No. of       Frequency per   Total Annual      Hours per      Total Hours    Total Capital Costs
  Section     Respondents      Response        Responses       Response
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897.24        2,000               1           2,000              40          80,000         $17 million
897.30            1               1               1               1               1                  0
897.32       25,000               1          25,000               1          25,000                  0
Total                                                                       105,001         $17 million
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                                                     Table 2.--Estimated Annual Recordkeeping Burden
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                                                     Annual
        21 CFR Section              No. of       Frequency per     Total Annual      Hours per       Total Hours      Total Capital    Total Operating &
                                Recordkeepers    Recordkeeping       Records        Recordkeeper                          Costs        Maintenance Costs
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97.32                                      31                1               31            3,226          100,000         $2 million         $1 million
Total                                                                                                     100,000         $2 million         $1 million
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    It should be noted that some information requested from respondents 
is already provided or possessed by the respondents. For example, 
Sec. 897.24 makes ``cigarettes'' the established name for cigarettes, 
and cigarette packages already use that name. Therefore, there should 
not be any significant burden on respondents to comply with 
Sec. 897.24.
    FDA also notes that, due to ongoing litigation concerning FDA's 
authority to issue regulations pertaining to cigarettes and smokeless 
tobacco, Secs.  897.24, 897.30, and 897.32 have not become effective. 
Nevertheless, FDA intends to submit the proposed collection of 
information to OMB for its review and clearance under the PRA so that 
it will continue to be able to collect the information once these 
provisions become effective.

    Dated: April 15, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-10227 Filed 4-22-99; 8:45 am]
BILLING CODE 4160-01-F