[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Notices]
[Pages 70951-70953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28438]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1423]
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 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 Importer's Entry Notice.
DATES: Submit either electronic or written comments on the collection
of information by January 27, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, [email protected].
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.
Information Request Regarding Importer's Entry Notice--(OMB Control
Number 0910-0046)--Extension
Section 801 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (U.S.C. 381) 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
[[Page 70952]]
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 gathers data for FDA-regulated
products being imported into the United States and is being used by FDA
to review and prevent imported products from entering the United States
if the products do not meet the same requirements of the FD&C Act as
domestic products.
Until October 1995, importers were required to file manual entries
on OMB-approved forms which were accompanied by related documents. FDA
did away with use of the paper forms effective October 1, 1995, to
eliminate duplicity of information and to reduce the paperwork burden
both on the import community and FDA. FDA then implemented an automated
nationwide entry processing system which enabled FDA to more
efficiently obtain and process the information it requires to fulfill
its regulatory responsibility.
Most of the information FDA requires to carry out its regulatory
responsibilities under section 801 is already provided electronically
by filers to USCS. Because USCS relays this data to FDA using an
electronic interface, the majority of data submitted by the entry filer
need be completed only once.
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 USCS's Automated Commercial System (ACS) by the
importer (or his/her agent) of the arrival of each entry. Following
such notification, FDA reviews relevant data to ensure the imported
product meets the standards as required for domestic products, decides
on the admissibility of the imported product, 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 listed in the same entry may be held pending further FDA
review/action.
All entry data pass through a screening criteria program resident
on a USCS computer. This screening program was developed and is
maintained by FDA. This electronic screening criteria module 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 for each entry, i.e., ``MAY
PROCEED'' or ``FDA REVIEW.''
In addition to the information collected by USCS, FDA requires four
additional pieces of information that were not available from USCS's
system in order to make an admissibility decision for each entry. These
data elements include the FDA Product Code, FDA country of production,
manufacturer/shipper, and ultimate consignee. OMB has previously
approved the automated collection of these four data elements for
tobacco products that filers could provide to FDA along with other
entry-related information. Providing this information to FDA results in
importers receiving an FDA admissibility decision more expeditiously,
e.g., the quantity, value, and Affirmation(s) of Compliance with
Qualifier(s).
Since the inception of the interface with ACS, FDA's electronic
screening criteria program has been applied nationwide. This eliminates
issues such as ``port shopping'' (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 and 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 if there is a need to immediately halt specific
product from entering the United States.
If the data in this collection of information is not collected, FDA
could not adequately meet its statutory responsibilities to regulate
imported products, nor control potentially dangerous products from
entering the U.S. marketplace.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
FDA Imported Products Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Non-Tobacco.................. 3,406 1,089 3,709,134 .14............ 519,279
(8 minutes)....
Tobacco...................... 330 68 22,440 .14............ 3142
(8 minutes)....
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Total.................... .............. ................ .............. ............... 522,421
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The hourly burden for this information collection is based on FDA's
averaging of data obtained during a survey of nine representative
filers nationwide and FDA's experience. For purposes of comparison of
hourly burden, the filers also were requested to provide the same
information with regard to filing entries manually. FDA felt that the
average time for completing either electronic or manual entries was
very similar.
Based on data collected by FDA's survey of nine filers and its
experience, the total annual burden to the import community to submit
information electronically for 3,731,574 average annual responses was
522,421 hours. The previously OMB-approved hours per response (0.14
hours) are expected to remain the same.
This burden includes the time FDA estimates it will take
respondents to compile and provide documents to FDA for those entries
where FDA cannot make an admissibility decision based on the electronic
data alone. Based on the survey of nine filers and FDA's past
experience, FDA estimates that there will be no additional costs to
provide import data electronically to FDA, as filers already have
equipment and software in place to enable them to provide data to USCS
via the automated system. Therefore, no additional software or hardware
need be developed or purchased to enable filers to file the FDA data
elements at the same time they file entries electronically with USCS.
[[Page 70953]]
Dated: November 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28438 Filed 11-26-13; 8:45 am]
BILLING CODE 4160-01-P