[Federal Register Volume 63, Number 179 (Wednesday, September 16, 1998)]
[Notices]
[Pages 49582-49583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0748]


Agency Emergency Processing Request Under OMB Review; Attitudinal 
and Behavorial Efffects of Direct-To-Consumer Advertising of 
Prescription Drugs

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). This notice solicits 
comments on a survey of the public to examine the impact of direct-to-
consumer (DTC) advertising.

DATES: Submit written comments on the collection of information by 
September 28, 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. 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-26, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the 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. FDA has 
requested emergency processing of this proposed collection of 
information under section 3507(j) of the PRA and 5 CFR 1320.13 by 
September 28, 1998, because this information is essential to the 
agency's mission. The agency cannot reasonably comply with the 
provisions of the PRA because the use of normal clearance procedures 
would prevent this collection of information from being carried out in 
a timely manner. FDA needs information about consumers' reactions to 
and behaviors that stem from DTC prescription drug advertising in order 
to develop policy on appropriate requirements for disclosure of risk 
and efficacy information about the drugs. In August 1997, when the 
agency issued its draft guidance on consumer-directed broadcast 
advertisements, FDA announced its intention to evaluate the effects of 
the guidance and of DTC promotion in general within 2 years of 
finalizing the guidance. FDA is currently in the process of finalizing 
this guidance. In addition, the amount of prescription drug DTC 
advertising is growing so quickly that rapid assessment of the public 
is required in order to assess public response before such advertising 
increases further. The information to be collected on consumer exposure 
and response to prescription drug DTC advertising is needed: (1) As a 
baseline measurement against which the effects of the final guidance 
will be evaluated and (2) as a timely and immediate assessment of 
consumers' initial response to the already high and rapidly increasing 
level of prescription drug DTC advertising.
    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.

Attitudinal and Behavioral Effects of Direct-To-Consumer (DTC) 
Advertising of Prescription Drugs

    Under the Food, Drug, and Cosmetic Act (the act), FDA has 
responsibility to ensure that the labeling and advertising of 
prescription drugs is truthful and not misleading. Section 502(n) of 
the act (21 U.S.C. 352(n)) prohibits the advertising of prescription 
drugs that is false or misleading or that fails to provide a ``brief 
summary'' of products' risks. Although advertising of prescription 
drugs was once restricted to health professionals, consumers 
increasingly have become a primary target audience, and DTC advertising 
has dramatically increased in the past few years. However, DTC 
advertising raises many questions and issues. While bringing new 
information to consumers, it also may confuse consumers, and no 
rigorous research has been done about the effects of DTC on health 
professional-patient relationships, compliance, or the health-care 
system, despite a request by FDA at a public hearing on DTC in October 
1995. This data collection by FDA will serve as a baseline prior to 
increased advertising of prescription drugs expected in the near 
future.
    A national randomized telephone survey will be conducted with 1,000 
adults 18 years of age and over who recently visited a physician. 
Respondents will be asked their views about any prescription drug they 
may have received and prescription drugs in general, and their 
attitudes and behavior in relation to DTC advertising, including any 
visits to a health professional. In a followup mail survey, respondents 
will be sent a questionnaire with a variety of print DTC ads. They will 
be asked to rate their familiarity with the advertisements. The 
information from this data collection is needed to help FDA make policy 
decisions about disclosure requirements for promoting prescription 
drugs DTC.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 49583]]



                                  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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11,000 (screener)                                       1          11,000                .017         183.3     
1,000 (survey)                                          1           1,000                .317         317.0     
1,000 (mail followup)                                   1           1,000                .167         167.0     
Total Burden                                                                                          667.3     
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 10, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-24796 Filed 9-15-98; 8:45 am]
BILLING CODE 4160-01-F