[Federal Register Volume 63, Number 58 (Thursday, March 26, 1998)]
[Notices]
[Pages 14716-14717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7832]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0376]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing

[[Page 14717]]

that the proposed collection of information listed below has been 
submitted to the Office of Management and Budget (OMB) for review and 
clearance under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
April 27, 1998.
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.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

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 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 
section 903(b)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 393 (b)(2)(C)), FDA is authorized to conduct surveys and other 
research relating to its responsibilities.
    In the Federal Register of December 30, 1997 (62 FR 67876), the 
agency requested comments on the proposed collection of information. No 
comments were received.
    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                                                    
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours 
                                                     Response        Responses       Response                   
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6,000                                                   1           6,000               0.2         1,200       
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 20, 1998.
William K. Hubbard,
Associate Commisioner for Policy Coordination.
[FR Doc. 98-7832 Filed 3-25-98; 8:45 am]
BILLING CODE 4160-01-F