Daily Rules, Proposed Rules, and Notices of the Federal Government
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
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.
Resistance of parasites to one or more of the major classes of FDA approved antiparasitic drugs is a documented problem in cattle, horses, sheep, and goats in the United States. The results from this survey will provide FDA information that can be used to make decisions about future approaches to antiparasitic drugs. FDA will make the results of the survey publicly available.
FDA plans to survey members of veterinary professional organizations using an Internet-based survey instrument. The questions in the survey are designed to elicit professional opinions regarding the use of antiparasitic drugs and the awareness of antiparasitic drug resistance. The survey will query subjects on topics including: (1) Awareness of the issues related to antiparasitic resistance, (2) methods currently being used to detect and/or monitor for antiparasitic resistance, (3) management practices being used or recommended to manage or reduce antiparasitic resistance, and (4) labeling and marketing considerations for antiparasitic drugs.
FDA published a 60-day notice in the
FDA estimates the burden of this collection of information as follows:
FDA will conduct a pre-test of the survey with five respondents, and it is estimated that it will take 30 minutes (0.5 hour) to complete the pretest, for a total of 2.5 hours. We estimate that 650 respondents will complete the survey. It is estimated that it will take a respondent 30 minutes (0.5 hour) for a total of 325 hours. Thus, the total estimated annual reporting burden is 327.5 hours. FDA's burden estimate is based on prior experience with consumer surveys that are similar.