2011-3466. 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 March 18, 2011.

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:

Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3794, [e-mail].

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)—Revision

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.

Section 801 of the FD&C Act, as amended by the Tobacco Control Act, charges the Secretary of Health and Human Services (HHS), through FDA, with the responsibility of assuring foreign origin FDA regulated foods, drugs, cosmetics, medical devices, radiological health, and tobacco products offered for import into the United States meet the same requirements of the FD&C Act as do domestic products, and for preventing products from entering the country if they are not in compliance. The discharge of this responsibility involves close coordination and cooperation between FDA (headquarters and field inspectional personnel) and the U.S. Customs Service (USCS), as the USCS is responsible for enforcing the revenue laws covering the very same products.

This collection of information was approved by OMB on August 10, 2009, and received an expiration date of August 31, 2012 (ICR Reference Number 200905-0910-006). However, because tobacco products had only recently been added to FDA's listing of regulated products when this collection of information was approved, the approved collection did not reflect information regarding tobacco products offered for import into and for prevention from them from entering the United States if they did not meet the same requirements of the FD&C Act as domestic products. The revision to this collection of information expands the universe of respondents being regulated under the FD&C Act, as amended, to include importers of tobacco products.

In the most recent OMB approval of this information collection package, FDA noted that in order to make an admissibility decision for each entry, the Agency needed four additional pieces of information that were not available from USCS's system. These data elements were the FDA Product Code, FDA country of production, manufacturer/shipper, and ultimate consignee. It was the “automated” collection of these four data elements for which OMB approval was being requested. When this package was sent to OMB for approval, FDA construed this request as an extension of the prior approval of collection of this data via a different media, i.e., paper. FDA noted that there were additional data elements which filers could provide to FDA along with other entry-related information. Doing so could 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 Custom'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 USCS of its decision. A single entry frequently contains multiple lines of different products. FDA may authorize products listed on specific lines to enter the United States unimpeded, while other products 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 module, which makes the initial screening decision on every entry of foreign-origin FDA-regulated product. Almost instantaneously after the entry is filed, the filer receives FDA's admissibility decision covering each entry line, i.e., “MAY PROCEED” or “FDA REVIEW.”

Examples of FDA's need to further review an entry may result from some products originating from a specific country or manufacturer known to have a history of problems, FDA having no previous knowledge of the foreign manufacturer and/or product, or a product import alert may have 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 in their review.

Since the inception of the interface with ACS, FDA's electronic screening criteria program is applied nationwide. This eliminates problems such as “port shopping,” e.g., attempts to intentionally slip products through one FDA port when refused by another, or filing 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. The screening criteria can be set to be as specific or as broad as applicable; changes are 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 November 4, 2010 (75 FR 67981), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Table 1—Estimated Annual Reporting Burden ¹

FDA imported products	Number of respondents	Annual frequency per response	Total annual responses	Hours per response	Total hours
Non-Tobacco (approved by OMB 09/01/2009)	3,406	1,089	3,709,134	.14	519,279
Tobacco (new estimated burden)	200	68	13,600	.14	1,904
Total					521,183
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: February 9, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.