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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importer's Entry Notice

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Food and Drug Administration, HHS.




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.


Fax written comments on the collection of information by December 16, 2005.


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 comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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Peggy Robbins, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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

Importer's Entry Notice—(OMB Control Number 0910-0046)—Extension

Section 801 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381) charges FDA with the following responsibilities: (1) Ensuring that foreign-origin FDA-regulated foods, drugs, cosmetics, medical devices, and radiological health products offered for import into the United States meet the same requirements of the act as do domestic products; and (2) preventing shipments from entering the country if they are not in compliance.

The information collected by FDA consists of the following: (1) Product code, an alpha-numeric series of characters that identifies each product FDA regulates; (2) FDA country of origin, the country where the FDA-registered or FDA-responsible firm is located; (3) FDA manufacturer, the party who manufactured, grew, assembled, or otherwise processed the goods (if more than one, the last party who substantially transformed the product); (4) shipper, the party responsible for packing, consolidating, or arranging the shipment of goods to their final destinations; (5) quantity and value of the shipment; and (6) if appropriate, affirmation of compliance, a code that conveys specific FDA information, such as registration number, foreign government certification, etc. This information is collected electronically by the entry filer via the U.S. Customs Service's Automated Commercial System at the same time that person files an entry for import with the U.S. Custom Service. FDA uses this information to make admissibility decisions about FDA-regulated products offered for import into the United States.

The annual reporting burden is derived from the basic processes and procedures used in fiscal year (FY) 1995. The total number of entries submitted to the automated system in FY 2004 was 6,626,827. The total number of entries less the disclaimer entries will represent the total FDA products entered into the automated system. A total of 53 percent of all entries entered into the automated system were entries dealing with FDA-regulated products. The number of respondents is a count of filers who submit entry data for foreign-origin FDA-regulated products. The estimated reporting burden is based on information obtained by FDA while contacting potential respondents. Disclaimer entries are not FDA commodities.

In the Federal Register of August 3, 2005 (70 FR 44656), FDA published a 60-day notice requesting public comment on the information collection provisions. One comment was received.

The Government of Canada is concerned that the methodology used does not take into consideration the additional burden of FDA's interim final prior notice and regulation rules which came into effect December 2003. They urged FDA to amend the methodology used to take into consideration the additional burden associated with all requirements for providing information concerning foreign-origin FDA-regulated foods. Of particular concern is the burden resulting from the implementation of the prior notice and regulation rules under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

The burden for the prior notice and regulation rules is reported and approved under OMB Control Number 0910-0520; expiration date October 31, 2006.

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

Table 1.—Estimated Annual Reporting Burden1

21 U.S.C. SectionNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: November 8, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 05-22671 Filed 11-15-05; 8:45 am]