E7-18033. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information From United States Processors That Export to the European Community

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by October 12, 2007.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: [phone], or e-mailed to [e-mail]. All comments should be identified with the OMB control number 0910-0320. Also include the FDA 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:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Information From U.S. Processors That Export to the European Community—(OMB Control Number 0910-0320)—Extension

The European Community (EC) is a group of 27 European countries that have agreed to harmonize their commodity requirements to facilitate commerce among member states. EC legislation for intra-EC trade has been extended to trade with non-EC countries, including the United States. For certain food products, including those listed in this document, EC legislation requires assurances from the responsible authority of the country of origin that the processor of the food is in compliance with applicable regulatory requirements.

FDA requests information from processors that export certain animal-derived products (e.g., shell eggs, dairy products, game meat, game meat products, animal casings, and gelatin) to the EC. FDA uses the information to maintain lists of processors that have demonstrated current compliance with U.S. requirements and provides the lists to the EC quarterly. Inclusion on the list is voluntary. EC member countries refer to the lists at ports of entry to verify that products offered for importation to the EC from the United States are from processors that meet U.S. regulatory requirements. Products processed by firms not on the lists are subject to detention and possible refusal at the port. FDA requests the following information from each processor seeking to be included on the lists:

1. Business name and address;

2. Name and telephone number of person designated as business contact;

3. Lists of products presently being shipped to the EC and those intended to be shipped in the next 6 months;

4. Name and address of manufacturing plants for each product; and

5. Names and affiliations of any Federal, State, or local governmental agencies that inspect the plant, government-assigned plant identifier such as plant number, and last date of inspection.

In the Federal Register of June 21, 2007 (72 FR 34256), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

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

Table 1.—Estimated Annual Reporting Burden¹

Products	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
Shell Eggs	10	1	10	.25	3
Dairy	120	1	120	.25	30
Game Meat and Meat Products	5	1	5	.25	1
Animal Casings	5	1	5	.25	1
Gelatin	3	1	3	.25	1
Collagen	3	1	3	.25	1
Total					37
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA bases its estimate on the responses received over the past 3 years. We estimate that the annual reporting burden would be approximately 37 hours. The time to respond to the questions should take approximately 15 minutes using any of the technologies available to transmit the information. All of the information asked for should be readily available. No record retention is required. In previous years, FDA estimated that the agency's communication with trade associations and states resulted in a reporting burden of 520 hours. FDA no longer receives information from trade associations and states under this program. Accordingly, the proposed annual burden for this information collection has been reduced by 520 hours. Therefore, the proposed annual burden for this information collection is 37 hours.

Dated: September 6, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.