[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Annual
FDA imported products Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total....................... 3,606 .............. 3,722,734 .28 521,183
----------------------------------------------------------------------------------------------------------------
\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