[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