[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 Burden<SUP>1                                  
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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