Food and Drug Administration, HHS.
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.
Submit written or electronic comments on the collection of information by April 17, 2007.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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: Start Printed Page 7662
|Activity||No. of Respondents||Annual Frequency per Response||Total Annual Responses||Hours per Response||Total Hours|
|Stage 1: Part A—REALM test; Informed Consent; Read Labeling; Questionnaire||400||1||400||.45||180|
|Stage 1: Part B—REALM test; Informed Consent; Read Labeling; Questionnaire||400||1||400||.45||180|
|Stage 2—REALM test; Informed Consent; Read Labeling; Questionnaire||400||1||400||.45||180|
|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: February 9, 2007.
Assistant Commissioner for Policy.
[FR Doc. E7-2716 Filed 2-15-07; 8:45 am]
BILLING CODE 4160-01-S