Skip to Content


Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Label Comprehension Study

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Food and Drug Administration, HHS.




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.


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


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.

Start Further Info


Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food Start Printed Page 33233and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

End Further Info End Preamble Start Supplemental 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FDA issued the “Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex” on November 14, 2005 (70 FR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understandability of the condom labeling language currently on the market and the labeling language proposed in this draft guidance, as well as a future revised version of the labeling, FDA plans to evaluate readers' comprehension of three versions of condom labeling through a label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 Burden1

ActivityNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
Screening Tool3,30013,300.05165
Stage 1: Part A - REALM test; Informed Consent; Read Labeling; Questionnaire4001400.45180
Stage 1: Part B - REALM test; Informed Consent; Read Labeling; Questionnaire4001400.45180
Stage 2 - REALM test; Informed Consent; Read Labeling; Questionnaire4001400.45180
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.

Start Signature

Dated: June 8, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. E7-11528 Filed 6-14-07; 8:45 am]