2010-16806. Agency Information Collection Activities; Proposed Collection; Comment Request; “The Dairy Practitioner's Role in Residue Avoidance 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 “The Dairy Practitioner's Role in Residue Avoidance Survey.”

DATES:

Submit either electronic or written comments on the collection of information by September 7, 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, 350 Piccard Dr., P150-400B, 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.

“The Dairy Practitioner's Role in Residue Avoidance Survey” (OMB Control Number—0910-NEW)

The Food and Drug Administration (FDA), through its Center for Veterinary Medicine (CVM), regulates the manufacture and distribution of food additives and drugs that will be given to animals. FDA is responsible for investigating veterinary drug residue violations in meats and providing regulatory action when necessary. In connection with this mission, the CVM Office of Surveillance and Compliance (OSC) develops programs to promote veterinary drug residue awareness and avoidance in order to reduce the risk of drug residues in safeguarding the public health. Information will be collected to determine the current state of veterinary drug residue avoidance in the dairy industry.

The United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) and FDA are responsible for collecting data on tissue residues of animal drugs. Information from this survey will be analyzed and used to: (1) Identify the respondent's level of awareness of the veterinary drug residues in dairy beef; (2) assess the current level of participation in the existing residue avoidance programs i.e., the Food Animal Residue Avoidance Database and Dairy Beef Quality Assurance Program; (3) identify risk factors currently associated with drug residues in dairy tissues; and (4) identify the best way to disseminate drug residue avoidance information to dairy producers. Information from this study will be used to shape the Agency's efforts to develop educational materials and to identify ways in which the Agency can optimize resources in the area of drug residue avoidance. Further, the findings will be presented in a descriptive report and informational sheets will be disseminated to animal health officials, dairy producers, and veterinarians. Participation in this survey is voluntary. It is up to the individual dairy practitioner to determine if participation is desirable.

“The Dairy Practitioner's Role in Residue Avoidance Survey” will be comprised of a one time study that will employ a web-based self-administered survey instrument, followed by mailing of the same survey in a paper self-administered mode to increase coverage and response rate. The instrument will collect information on the respondent's knowledge of drug residues in dairy beef and experience with drug residues at their clients' dairy farms. The study will be disseminated via the American Association of Bovine Practitioners (AABP) e-mail list-serve. Mail and electronic correspondence promotional material will be disseminated throughout the process to increase response rates.

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

Table 1.—Estimated Annual Reporting Burden¹

Study	No. of respondents	Annual Frequency per response	Total Annual Responses	Hours per Response	Total Hours
Survey	2,890	1	2,890	.33	953.7
Total
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

There will be 2,890 respondents for a one-time survey total of 2,890 annual responses. The hours per response is estimated to be .33 hours. Thus the total annual burden is estimated to be 953.7 hours. A 60 percent response rate is expected.

Dated: July 1, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.