[Federal Register Volume 62, Number 227 (Tuesday, November 25, 1997)]
[Notices]
[Page 62775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30912]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0376]
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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). The purpose of the proposed
collection of information, a two-part telephone survey of tobacco
retailers, is 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. The first phase of the
survey must be completed by December 31, 1997.
DATES: Submit written comments on the collection of information by
December 5, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, rm. 16B-18, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: 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.
Tobacco Retailer Tracking Survey
On February 28, 1997, new Federal regulations at 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 purchasers younger than 27 years old. FDA is planning to conduct a
pilot advertising will campaign, in one State, 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 part of the pilot, FDA is proposing to conduct a two-part
telephone survey of tobacco retailers to measure their awareness of,
and self-reported compliance with, the new regulations before and after
exposure to the advertising campaign in the test State. FDA also would
study levels of awareness and self-reported compliance among tobacco
retailers in a control State matched demographically with the test
State. Retailers in the control State would not be exposed to the media
campaign, and FDA would not be actively conducting compliance checks
before awareness and self-reported levels of compliance are measured.
A random sample of 1,350 tobacco retailers in the test State (675
for each phase) and 300 tobacco retailers in the control State would be
selected for a telephone interview. All interviewing would be conducted
by a single market research firm that would employ computer-aided
telephone interviewing technology to expedite the fieldwork and ensure
accuracy. FDA plans to use the results of the survey in designing a
nationwide advertising campaign that would help to reduce youth access
to cigarettes and smokeless tobacco. 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
No. of Respondents Frequency per Total Annual Hours per Total Hours
Response Responses Response
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1,650 survey 1 1,650 .2 330
Total 1,650 330
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA has requested emergency processing of this proposed collection
of information under section 3507(j) of the PRA and 5 CFR 1320.13. This
information is needed by December 31, 1997, and is essential to the
agency's mission. The use of normal PRA clearance procedures would be
likely to result in the prevention or disruption of this collection of
information.
Dated: November 19, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-30912 Filed 11-24-97; 8:45 am]
BILLING CODE 4160-01-F
