[Federal Register Volume 75, Number 213 (Thursday, November 4, 2010)]
[Notices]
[Pages 67981-67983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27850]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 revision of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the revision of an approved 
Office of Management and Budget (OMB) collection of information for 
FDA's Importer's Entry Notice. This revision reflects additional burden 
recognized as a result of including tobacco products to the list of 
FDA-regulated products under the Family Smoking Prevention and Tobacco 
Control Act (the Tobacco Control Act).

DATES: Submit either electronic or written comments on the collection 
of information by January 3, 2011.

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: 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from 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 
revision 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.

Information Request Regarding Importer's Entry Notice--(OMB Control 
Number 0910-0046)--Revision

    On June 22, 2009, the President signed 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

[[Page 67982]]

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 the 
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 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.
    FDA estimates the revised reporting burden for this collection of 
information is 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.......................           3,606  ..............       3,722,734             .28         521,183
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 67983]]

    Dated: October 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-27850 Filed 11-3-10; 8:45 am]
BILLING CODE 4160-01-P