E9-12317. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importer's Entry Notice

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 June 29, 2009.

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 0910-0046. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Berbakos, Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3792.

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.

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

In order to make an admissibility decision for each entry, FDA needs four additional pieces of information that are not available in the U.S. Customs and Border Protection's (CBP's) dataset. These data elements are the FDA Product Code, FDA country of production, FDA manufacturer/shipper, and ultimate consignee. It is the “automated” collection of these four data elements for which OMB approval is requested. FDA construes this request as an extension of the prior approval of collection of this data via a different media, i.e., paper. There are additional data elements which filers can provide to FDA along with other entry-related information which, by doing so, may result in their receiving an FDA admissibility decision more expeditiously, e.g., the quantity, value, and Affirmation(s) of Compliance with Qualifier(s).

At each U.S. port of entry (seaport, landport, and airport) where foreign-origin FDA-regulated products are offered for import, FDA is notified, through CBP's Automated Commercial System (ACS) by the importer (or his agent) of the arrival of each entry. Following such notification, FDA reviews relevant data to ensure the imported product meets the standards as are required for domestic products, makes an admissibility decision, and informs the importer and CBP of its decision. A single entry frequently contains multiple lines of different products. FDA may authorize specific lines to enter the United States unimpeded, while others in the same entry are to be held pending further FDA review/action.

An important feature developed and programmed into FDA's automated system is that all entry data passes through a screening criteria program. FDA's electronic screening criteria module makes the initial screening decision on every entry of foreign-origin FDA-regulated product. Virtually instantaneously after the entry is filed, the filer receives FDA's admissibility decision covering each entry, i.e., “MAY PROCEED” or “FDA REVIEW.”

Examples of FDA's need to further review an entry include: Products originating from a specific country or manufacturer known to have a history of problems, FDA has no previous knowledge of the foreign manufacturer and/or product, or an import alert covering the product has been issued, etc. The system assists FDA entry reviewers by notifying them of information, such as the issuance of import alerts, thus averting the chance that such information will be missed.

With the inception of the interface with CBP's ACS, FDA's electronic screening criteria program is applied nationwide. This virtually eliminates problems such as “port shopping,” e.g., attempts to intentionally slip products through one FDA port when refused by another, or to file entries at a port known to receive a high volume of entries. Every electronically submitted entry line of foreign-origin FDA-regulated product undergoes automated screening described previously. The screening criteria can be set to be as specific or as broad as applicable; changes are virtually immediately effective. This capability is of tremendous value in protecting the public in the event there is a need to immediately halt a specific product from entering the United States.

In the Federal Register of February 25, 2009 (74 FR 8549), FDA published a 60-day notice requesting comments on the information collection requirements for FDA regulated products. Two comments were received.

One comment was submitted by the American Association of Exporters and Importers. General comments expressed support for the automation of the data elements sought by FDA. A second comment encouraged FDA to pursue risk management methodologies which will reduce FDA's dependence on transaction data for admissibility decisions. The comments encouraged FDA to develop risk management methodologies using account management techniques assessing the internal controls of foreign manufacturers and U.S. importers will provide FDA with better insight into admissibility decisions before entry of the merchandise.

FDA agrees that risk management methodologies are key to effective and efficient oversight of FDA regulated commodities. However, different commodities may have different risk factors and being able to identify the commodity, where it was manufactured, and who shipped the commodity are essential for FDA to determine the risk factors that should be applied when the product is offered for entry. These data elements are key for FDA in order to apply the appropriate risk strategy.

A second comment was submitted by Organon Schering-Plough. No specific comments were provided about the collection of the additional FDA data elements. The submission suggested that FDA develop a process similar to the “binding ruling” process that is maintained by CBP because of the impact on the filers compliance-score rating. However, the development of a “binding ruling” process is outside the scope of this announcement.

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

Table 1—Estimated Annual Reporting Burden¹

Number of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
3,727	1,070	3,988,371	.263	1,048,447
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: May 20, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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