[Federal Register Volume 72, Number 115 (Friday, June 15, 2007)]
[Notices]
[Pages 33232-33233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0050]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
16, 2007.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974. All comments should be identified with the OMB 
control number 0910-NEW and title ``Label Comprehension Study.'' Also 
include the FDA 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

[[Page 33233]]

and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-1472.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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    FDA issued the ``Draft Guidance for Industry and FDA Staff: Class 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language proposed in this draft guidance, as well as a future revised 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. 
The FDA will administer a screening instrument, the Rapid Estimate of 
Adult Literacy in Medicine (REALM) 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.
    In the Federal Register of February 16, 2007 (72 FR 7661), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden for this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                               No. of        Annual Frequency  per
                Activity                    Respondents             Response         Total Annual  Responses    Hours per  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 test; Informed                 400                        1                      400                      .45                180
 Consent; Read Labeling; Questionnaire
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Stage 1: Part B - REALM test; Informed                 400                        1                      400                      .45                180
 Consent; Read Labeling; Questionnaire
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Stage 2 - REALM test; Informed Consent;                400                        1                      400                      .45                180
 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: June 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11528 Filed 6-14-07; 8:45 am]
BILLING CODE 4160-01-S