E8-9373. Agency Information Collection Activities; Proposed Collection; Comment Request; Submission for Office of Management and Budget Review; Health and Diet Survey; Pet Food Labeling 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 for public comment in response to the notice. This notice solicits comments on FDA's Pet Food Labeling Survey.

DATES:

Submit written or electronic comments on the collection of information by [May 30, 2008.

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:

Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 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.

Health and Diet Survey; Pet Food Labeling Survey—(OMB Control Number 0910-0545)

On September 28, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 1002(a) of FDAAA requires, among other things, that FDA establish “by regulation,” standards for labeling of pet food, including nutritional and ingredient information. The Center for Veterinary Medicine (CVM), FDA, seeks to establish baseline information about consumer use and understanding of pet food labels. The survey module would be repeated after the new pet food label regulations are implemented to estimate changes in consumer beliefs and behavior about pet food labels.

FDA is required to implement the pet food labeling regulations by September 2009. Due to the short time frame, CVM seeks to have adequate time to collect the data to inform future research on standardized pet food labels. The Center for Food Safety and Applied Nutrition's (CFSAN) Health and Diet Survey (HDS) (0910-0545) could serve as a vehicle for accomplishing this goal. CVM and CFSAN would like to modify the existing information collection request, currently at OMB for renewal, to include a new module.

The proposed plan is to sample a subset of those responding to the HDS that are also pet owners. We estimate that about 14 questions will be asked to approximately 1,000 respondents. CVM does not believe that there will be an additional burden because consumers would be asked the questions about pet food labels in lieu of other questions currently in the HDS. FDA believes that adding the pet food labeling questions to the HDS is the most cost effective way of collecting this information and precludes the need for a separate pet food labeling survey, thus reducing the overall burden to the public.

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

Table 1.—Estimated Annual Reporting Burden¹

Statutory Authority	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
Public Law 110-85 Sec. 1002(a)(3)	1,000	1	1,000	0.08	80
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

This burden estimate does not represent a new estimate of burden hours. Instead, it represents the estimated number of respondents and burden hours that will be used from the current approval for 0910-0545 to conduct the pet food labeling questions. The total estimated burden for 0910-0545 is 1,300 hours. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.

Dated: April 24, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.