[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 Burden<SUP>1                                  
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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