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

Federal Register: May 28, 2009 (Volume 74, Number 101)            
                  Page 25554-25556

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: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. 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.

[[Page 25555]]


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 Burden\1\

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Annual Frequency  per
                   Number of Respondents                            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.



[[Page 25556]]

    Dated: May 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.>
[FR Doc. E9-12317 Filed 5-27-09; 8:45 am]

BILLING CODE 4160-01-S