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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0295]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES: Submit written comments on the collection of information by November 7, 2003.
ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
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.

Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile (OMB Control Number 0910-0509)—Extension

Section 701(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)) authorizes the Secretary of Health and Human Services (the Secretary) to develop guidance documents with public participation presenting the views of the Secretary on matters under the jurisdiction of FDA.

In theFederal Registerof May 23, 2003 (68 FR 28237), FDA announced the availability of a guidance entitled “Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile.” The guidance provided voluntary recommendations on the process for firms that wish to export dairy products to Chile. FDA is taking this action in response to discussions with Chile that have been adjunct to the negotiations of the United States-Chile Free Trade Agreement. As a result of those discussions, Chile recognized FDA as the competent food safety authority in the United States to identify U.S. dairy product manufacturers and processors eligible to export to Chile and concluded that it will not conduct individual inspections of U.S. firms identified by FDA as eligible to export to Chile.

Therefore, FDA intends to establish and maintain a list identifying U.S. manufacturers/processors that have expressed interest to FDA in exporting dairy products to Chile, are subject to FDA jurisdiction, and are not the subject of a pending judicial enforcement action (i.e. an injunction or seizure) or an unresolved warning letter. Under this guidance, FDA recommends that U.S. firms that want to be placed on the list send information to FDA (i.e., name and address of the firm and the manufacturing plant; name, telephone number, and e-mail address (if available) of contact person; list of products presently shipped and expected to be shipped in the next 3 years; identities of agencies that inspect the plant and date of last inspection plant number and copy of last inspection notice; and, if other than an FDA inspection, copy of last inspection report. The term “dairy products,” for purposes of this list, is not intended to cover the raw agricultural commodity raw milk. The guidance can be found athttp://www.cfsan.fda.gov/guidance.html.

The burden estimates presented in the following paragraphs considered the number of U.S. firms that FDA believes produce dairy products and that will be interested in exporting to Chile, which is estimated to total 75. After the first year, FDA believes that approximately eight new firms each year will be interested in exporting dairy products to Chile, and thus, being placed on the list. In theFederal Registerof April 10, 2003 (68 FR 17655), FDA published an emergency notice requesting public comment on the information collection provisions that had been submitted to OMB for emergency processing under the PRA. Four comments were received from trade associations and private industry.

Those comments were answered in the 60-day notice.

In theFederal Registerof July 10, 2003 (68 FR 41157), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

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

Table 1.—Estimated Annual Reporting Burden1 Type of Survey No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Mail questionnaire 1,000 1 1,000 3 3,000 Phone Survey 1,000 1 1,000 .5 500 Internet or Cable Survey 3,000 1 3,000 1 3,000 Total 6,500 1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimate of the number of firms is based on the actual number of U.S. firms that applied to be placed on the list as a result of theFederal Registerof May 23, 2003 (68 FR 28237), publication of the availability of a guidance entitled “Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile.” The estimate of the number of hours that it will take a firm to gather the information needed to be placed on the list is based on FDA's experience with firms submitting similar requests. FDA believes that the information to be submitted will be readily available to the firms. We (FDA) estimate that for the first year a firm will require 1.5 hours to read theFederal Register, gather the information needed, and to prepare a communication to FDA that contains the information and requests that the firm be placed on the list. We estimate the recurring burden in subsequent years to be 1.5 hours for a new firm to be placed on the list and 0.5 hours for reporting changes to FDA for firms already on the list.

Dated: September 30, 2003. Jeffrey Shuren, Assistant Commissioner for Policy.