[Federal Register Volume 72, Number 32 (Friday, February 16, 2007)]
[Notices]
[Pages 7661-7662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2716]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0050]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Label Comprehension Study

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 notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on a questionnaire to evaluate 
reader's comprehension of three versions of condom labeling through a 
label comprehension study.

DATES: Submit written or electronic comments on the collection of 
information by April 17, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

Label Comprehension Study (U.S.C. 393 (d)(2)(C))

    FDA issued the ``Draft Guidance for Industry and FDA Staff: Class 
II Special Controls Guidance Document: Labeling for Male Condoms Made 
of Natural Rubber Latex'' on November 14, 2005 (70 FR 69156). Section 
21 U.S.C. 393(d)(2)(C) of the Federal Food, Drug and Cosmetic Act (the 
act) states that the Secretary, through the Commissioner, shall be 
responsible to conduct research relating to devices in carrying out 
this chapter. In order to evaluate the understandability of the condom 
labeling language currently on the market and the labeling language 
proposed in this draft guidance, as well as a future revised version of 
the labeling, FDA plans to evaluate readers' comprehension of three 
versions of condom labeling through a label comprehension study.
    The proposed label comprehension study will measure current and 
potential condom consumers' understanding of the current market 
labeling and the proposed condom labeling in the draft guidance of the 
retail package, foil and package insert of condom labeling, as well as 
a future revised version of the labeling. The label comprehension study 
will follow a sequential design, first testing both the current market 
labeling (Part A) and the draft labeling in the guidance (Part B) in 
Stage 1, and then a revised version of the labeling in Stage 2.
    FDA will conduct a label comprehension study via a mall intercept/
central location intercept methodology with pre-screened participants. 
FDA will administer a screening instrument, the REALM (Rapid Estimate 
of Adult Literacy in Medicine) test, an informed consent, and a 
questionnaire with approximately 20 questions related to the condom 
labeling language to a total of 1,200 participants: 400 participants 
for Part A of Stage 1, 400 participants for Part B of Stage 1, and 400 
participants for Stage 2 of the study. Results of the study will be 
considered in FDA's condom labeling recommendations to provide 
important risk/benefit and use information associated with condoms in 
an easily understood language.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 7662]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                No. of       Annual Frequency     Total Annual       Hours per
         Activity             Respondents      per Response        Responses         Response       Total Hours
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Screening Tool                       3,300                  1              3,300             .05             165
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Stage 1: Part A--REALM                 400                  1                400             .45             180
 test; Informed Consent;
 Read Labeling;
 Questionnaire
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Stage 1: Part B--REALM                 400                  1                400             .45             180
 test; Informed Consent;
 Read Labeling;
 Questionnaire
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Stage 2--REALM test;                   400                  1                400             .45             180
 Informed Consent; Read
 Labeling; Questionnaire
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Total                       ..............  .................  .................  ..............            705
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    This was based on similar types of FDA studies conducted in the 
past. FDA has conducted both focus group studies and label 
comprehension studies, where similar participant activities, such as 
reading the labeling, taking the REALM test, signing the informed 
consent, and answering questions on a self-administered questionnaire 
took place. In order to achieve the 1,200 participants for the condom 
label comprehension study, FDA estimates screening 3,300 to achieve 
1,200 interviews.

    Dated: February 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2716 Filed 2-15-07; 8:45 am]
BILLING CODE 4160-01-S