2010-16971. Agency Information Collection Activities; Proposed Collection; Comment Request; “Antiparasitic Drug Survey”

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's “Antiparasitic Drug Survey.”

DATES:

Submit either electronic or written comments on the collection of information by September 13, 2010.

ADDRESSES:

Submit electronic comments on the collection of information to http://www.regulations.gov. 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.

FOR FURTHER INFORMATION CONTACT:

Denver Presley Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3793.

SUPPLEMENTARY 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.

“Antiparasitic Drug Survey” (OMB Control Number 0910-NEW)

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. Further, FDA is aware that there are differing scientific opinions on the impact of the use of multiple antiparasitic drugs at the same time on the development of resistance to these drugs. The results from this survey will assist FDA in regulating antiparasitic drugs. FDA will also share their results with the veterinary parasitology community.

FDA plans to survey scientists and veterinarians with expertise in veterinary parasitology using a web-based tool. The questions in the survey are designed to elicit expert opinions and clarify areas of agreement and disagreement within the veterinary parasitology community. The survey will query subjects on topics such as: (1) Concurrent use of multiple antiparasitic drug products, (2) recommended tests to detect and monitor for antiparasitic resistance, (3) characteristics of combination antiparasitic drug products that may either slow or enhance the selection for multi-drug resistant parasites, and (4) regulatory considerations regarding combination antiparasitic drugs.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

Portion of Study	No. of respondents	Annual Frequency per response	Total Annual Responses	Hours per Response	Total Hours
Pre-test	5	1	5	.33	1.65
Survey	100	1	100	.33	.33
Total					34.65
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA will conduct a pre-test of the survey with five respondents, and it is estimated that it will take a respondent 20 minutes (0.33 hours) to complete the pre-test, for a total of 1.65 hours. One hundred respondents will complete the survey. It is estimated that it will take a respondent 20 minutes (0.33 hours) to complete the survey, for a total of 33 hours. Thus, the total estimated annual reporting burden is 34.65 hours. FDA's burden estimate is based on prior experience with consumer surveys that are similar.

Dated: July 7, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.