[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Notices]
[Pages 9023-9024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3466]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0543]


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.

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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: 202-395-7285, or e-mailed to [email protected]. 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, [email protected].

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

[[Page 9024]]

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\
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                                                      Annual
      FDA imported products          Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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Non-Tobacco (approved by OMB 09/           3,406           1,089       3,709,134             .14         519,279
 01/2009).......................
Tobacco (new estimated burden)..             200              68          13,600             .14           1,904
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    Total.......................  ..............  ..............  ..............  ..............         521,183
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\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.
[FR Doc. 2011-3466 Filed 2-15-11; 8:45 am]
BILLING CODE 4160-01-P