[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
    FDA Imported Products         Number of      responses per    Total annual   Average  burden    Total hours
                                 respondents      respondent        responses      per response
----------------------------------------------------------------------------------------------------------------
Non-Tobacco..................           3,406             1,089       3,709,134  .14............         519,279
                                                                                 (8 minutes)....
Tobacco......................             330                68          22,440  .14............            3142
                                                                                 (8 minutes)....
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ................  ..............  ...............         522,421
----------------------------------------------------------------------------------------------------------------
\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