[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