[Federal Register Volume 74, Number 36 (Wednesday, February 25, 2009)]
[Pages 8549-8550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3938]



Food and Drug Administration

[Docket No. FDA-2009-N-0050]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Importer's Entry Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on FDA's need to collect 
additional information in the Importer's Entry Notice.

DATES: Submit written or electronic comments on the collection of 
information by April 27, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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) data set. 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

[[Page 8550]]

as an extension of the prior approval of collection of this data via a 
different media, i.e., paper. There are additional data elements that 
filers can provide to FDA along with other entry-related information 
that, 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 U.S. 
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 
    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, and 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 in this document. 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.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                              Annual Frequency per
                    No. 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.

    Dated: February 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3938 Filed 2-24-09; 8:45 am]