[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Notices]
[Pages 67876-67877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33925]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0529]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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 a three-part telephone survey of tobacco
retailers, to assess the effectiveness of an advertising campaign aimed
at increasing retailers' awareness of, and motivating retailers to
comply with, new regulations that prohibit retailers from selling
cigarettes and smokeless tobacco to persons younger than 18 years of
age, and require retailers to verify, by means of photographic
identification containing the bearer's date of birth, the age of every
purchaser who is younger than 27 years old.
DATES: Submit written comments on the collection of information by
March 2, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Requests and two
copies of any comment are to be submitted except that individuals may
submit one copy comments should be identified with the docket number
found in brackets in the heading of this document. Received comments
are available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
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 listed below.
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.
National Tobacco Retailer Tracking Survey
On February 28, 1997, new Federal regulations in 21 CFR part 897
went into effect that prohibit retailers from selling cigarettes and
smokeless tobacco to persons younger than 18 years of age, and require
retailers to verify, by means of photographic identification, the age
of purchaser younger than 27 years old. To enforce these requirements,
FDA is commissioning State officials to conduct compliance checks
during which an adolescent, accompanied by a commissioned official,
will attempt to purchase cigarettes and smokeless tobacco at retail
establishments.
FDA is planning to conduct a national advertising campaign aimed at
raising retailers' awareness of the new regulations and motivating
retailers to comply. The campaign will target persons who sell
cigarettes or smokeless tobacco to consumers for their personal use,
including clerks and cashiers in grocery and convenience stores,
pharmacies and drug stores, gas stations, liquor stores, taverns and
bars, and tobacco stores. As a part of the campaign, FDA is proposing
to conduct a three-part telephone survey of tobacco retailers to
measure their awareness of, and compliance with, the new regulations
before and after exposure to the advertising campaign.
The initial overall media campaign would focus on the 10 States
with which FDA has already contracted to conduct compliance checks, and
would be expanded as additional States contract with FDA. The media
campaign would be conducted over a 12-month period in each State that
receives it. States that have contracted with FDA and are exposed to
the media campaign (test States) will be compared with States that have
not contracted with FDA (control States). Although some of the control
States may contract with FDA during the course of the data collection,
at the start of the data collection there would be 10 test States and
10 control States.
A total of 6,000 tobacco retailers would be randomly selected to
participate in a telephone interview over three phases of data
collection. Data would be collected in three phases over a 12-month
period. The first phase would occur immediately before the 10 test
States that have contracted with FDA are exposed to the media campaign.
The second phase would occur approximately 6 months later and would
allow for an assessment of retailer awareness of and compliance with
the new regulations after recent exposure to the advertising campaign
in the original 10 test States. A third phase of data collection would
be conducted approximately 6 months after the second phase. This phase
would address retailer awareness of and compliance with the new
regulations after extended exposure to the media campaign in the
original 10 test States, and would address retailer awareness of and
compliance with the new regulations after recent exposure to the
advertising campaign in those former control States that contracted
with FDA after the first phase of data collection. All interviewing
would be conducted by a single-market research firm that would
[[Page 67877]]
employ computer-aided telephone interviewing technology to expedite the
fieldwork and improve accuracy. FDA plans to use the results of the
survey to assess the effectiveness of the advertising campaign. Under
21 U.S.C. 393 (b)(2)(C), FDA is authorized to conduct surveys and other
research relating to its responsibilities under the Federal, Food,
Drug, and Cosmetic Act.
Respondents to this collection of information would be tobacco
retailers and salesclerks.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
21 CFR No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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897 6,000 1 6,000 .2 1,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 22, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-33925 Filed 12-29-97; 8:45 am]
BILLING CODE 4160-01-F