[Federal Register Volume 62, Number 100 (Friday, May 23, 1997)]
[Notices]
[Pages 28482-28483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13601]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0201]
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 pursuant to the Paperwork Reduction Act of
1995 (the PRA). This notice solicits comments on a data collection
effort consisting of four consumer surveys regarding preferences for,
and comprehension of information contained in different formats and
methods for communication in over-the-counter (OTC) drug labels. For
two of these studies (studies A and B), the agency has requested
emergency processing of the proposed collection by the Office of
Management and Budget (OMB).
DATES: Submit written comments on the collection of information for
studies A and B by June 2, 1997. Submit written comments on the
collection of information for studies C and D by July 22, 1997.
ADDRESSES: Submit written comments on the collection of information for
studies A and B 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. Submit written
comments on the collection of information for studies C and D to the
Dockets Management Branch (HFA-305), ATTN: OTC Drug Labeling Data
Collection, Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from 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
collections to OMB for approval. Section 3507(j) of the P.A. and 5 CFR
1320.12 provides for emergency processing of proposed collection of
information.
FDA intends to conduct four separate studies related to the
labeling of OTC drug products. For studies A and B, the agency is
requesting emergency processing because the information is necessary
for the agency's deliberations on a proposed rule related to providing
easier to read and easier to understand labeling on OTC drug products.
(See 62 FR 9024.) The agency has determined that there is a public
health need for revised OTC labeling, which is essential to the
agency's mission, and if normal clearance procedures were followed, it
would take longer to conclude the related OTC labeling rulemaking.
To comply with the PRA requirements, FDA is publishing notice of
the proposed collections of information listed below.
With respect to the following collections of information, FDA
invites comments on: (1) Whether the proposed collections of
information are necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimates of the burdens of the
proposed collections 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 burdens of the collections of information on
respondents, including through the use of automated collection
[[Page 28483]]
techniques, when appropriate, and other forms of information
technology.
1. Evaluation of Proposed OTC Label Formats and OTC Label Format
Preference
Under sections 201(n) and 502 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C 321(n) and 352), FDA has the authority
to ensure that approved drugs are properly labeled. Section 201(n) of
the act defines a drug as misbranded if its labeling or advertising is
misleading; this includes the failure to reveal material facts. Under
section 903 of the act (21 U.S.C. 393), FDA may conduct research
related to drugs and conduct educational and public information
programs relating to the responsibilities of the FDA. FDA will evaluate
proposed OTC label formats and study the effect of various label
formats on consumers' preference. The agency will conduct two studies:
In study A (Evaluation of Proposed OTC Label Formats), consumers
will be shown the label of an OTC drug using either the proposed or the
traditional format. Based on the different labels and different reading
conditions, consumers' knowledge, attitudes, and decisions about proper
drug use will be investigated.
In study B (OTC Label Format Preference), consumers will be asked
to view examples and variations of current OTC label designs.
Respondents will be asked to indicate their preference for various
designs, as well as demonstrate memory retention of labeling
information. Also, consumers will be asked to evaluate labeling
terminology and graphics to investigate how they interpret various ways
of communicating drug safety and effectiveness.
2. Evaluation of Statement of Identity Comprehension and of Alcohol
Warning Statement Comprehension
Under sections 201(n) and 502 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C 321(n) and 352), FDA has the authority
to ensure that approved drugs are properly labeled. Section 201(n) of
the act defines a drug as misbranded if its labeling or advertising is
misleading; this includes the failure to reveal material facts. Under
section 903 of the act (21 U.S.C. 393), FDA may conduct research
related to drugs and conduct educational and public information
programs relating to the responsibilities of the FDA. FDA will study
the comprehension of the statement of identity and warning information
on labeling for OTC drug products. FDA will conduct two studies:
In study C (Statement of Identity Comprehension), consumers will be
asked to view examples and variations of the placement of OTC statement
of identity information. Respondents will be asked to demonstrate their
perceptions and reactions to placement of active ingredient(s),
pharmacologic category, and/or intended action information on the front
and/or back portion of the product package.
In study D (Alcohol Warning Statement Comprehension), consumers
will be asked to rate the clarity or understandability of the warning
message. Respondents will be asked to rate various methods of conveying
the alcohol warning that systematically vary the specificity,
permissiveness, frequency, and quantity descriptors in the alcohol
warning messages.
In each of the four studies, participants will examine materials
varied by one or more format or content variables. Central location
intercept sites that are geographically dispersed will be used to
recruit and question respondents.
FDA estimates the burden of these collections of information as
follows:
Estimated Annual Reporting Burden
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Annual
Study No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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A & B 2,100 1 2,100 .5 1,050
C & D 480 1 480 .5 240
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There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 19, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-13601 Filed 5-22-97; 8:45 am]
BILLING CODE 4160-01-F
