Agency Information Collection Activities: Proposed Collection; Comment Request

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

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 ---------------------------------------------------------------------------------------------------------------- Annual Study No. of Frequency per Total Annual Hours per Total Hours Respondents Response Responses Response ---------------------------------------------------------------------------------------------------------------- A & B 2,100 1 2,100 .5 1,050 C & D 480 1 480 .5 240 ---------------------------------------------------------------------------------------------------------------- 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