E8-25472. Agency Information Collection Activities; Proposed Collection; Comment Request; Survey to Evaluate the Effectiveness of Mississippi Delta Fish Advisories

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 a voluntary consumer survey of fishing and fish consumption habits in the Mississippi Delta.

DATES:

Submit written or electronic comments on the collection of information by December 23, 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 Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3794.

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.

Survey to Evaluate the Effectiveness of Mississippi Delta Fish Advisories

The proposed survey will gather information about fishing and fish consumption habits in the Mississippi Delta region, as well as the respondents' awareness and understanding of the Regional Delta Advisory (RDA) issued by the Mississippi Department of Environmental Quality. Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)), FDA is authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the nation's food supply. In June 2005, the Environmental Protection Agency's (EPA) Office of Water and FDA's Center for Food Safety and Applied Nutrition finalized a Memorandum of Understanding (MOU) to enhance collaboration between FDA and EPA regarding environmental contaminants in fish and shellfish and the safety of fish and shellfish for U.S. consumers. The MOU is available at http://www.epa.gov/​waterscience/​fish/​files/​moufdaepa.pdf.

The proposed study is phase two of a two phase study designed to determine whether existing fish consumption recommendations issued by the state of Mississippi are adequately protecting sport and subsistence consumers of fish harvested from Delta waters. The final report of phase one, entitled “Recommended Study Design for a Survey to Evaluate the Effectiveness of Mississippi Delta Fish Advisories,” is available at http://www.epa.gov/​waterscience/​fish/​technical/​ms-delta.html. Based on the report cited here, FDA is conducting the proposed survey on behalf of EPA to evaluate the effectiveness of the Mississippi Delta Fish Advisories.The proposed survey will collect information on the extent to which Delta sport and subsistence fishermen and their families are aware of the RDA and its recommendations and the extent to which the respondents have changed their fish consumption behaviors as a result of the advisory. The survey will also document specific behavior changes resulting from the RDA, such as increases or decreases in the amount of locally harvested fish consumed, changes in methods of fish preparation, and consumption or avoidance of specific species of fish.

Results of the survey will provide EPA information about fishing and fish consumption habits in the Mississippi Delta region, as well as the respondents' awareness and understanding of the RDA.

The respondents will be selected from four counties in the Mississippi Delta region. Counties were selected to include a mix of rural and non-rural areas and areas with major water resources affected by the advisory. The selected counties are Coahoma, Holmes, Leflore, and Washington. Only the part of Holmes County that is within the advisory area will be included in the survey.

The total sample will include 400 on-the-banks interviews and 600 household interviews of sport and subsistence fishers who harvest noncommercial fish from the Mississippi Delta advisory area, and individuals in the Mississippi Delta area who consume wild-caught fish from the advisory area. FDA estimates that the survey will take approximately 18 minutes to complete, for a total burden of 300 hours (1,000 x 0.3 = 300).

FDA will conduct 6 cognitive interviews and 20 pretests prior to fielding the survey, for a total additional burden of 16 hours.

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

Table 1.—Estimated Annual Reporting Burden¹

Activity	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
Cognitive Interviews	6	1	6	1	6
Pretest	20	1	20	0.5	10
Survey	1,000	1	1,000	.30	300
Total					316
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA's burden estimate is based on the agency's prior experience with surveys similar to the proposed survey.

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: October 20, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.