[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Notices]
[Pages 65670-65672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-25974]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0179]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Prior Notice of Imported Food Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 the information collection 
provisions of our regulations requiring that the Agency receive prior 
notice before food is imported or offered for import into the United 
States.

DATES: Submit either electronic or written comments on the collection 
of information by December 31, 2013.

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, 301-796-3793, [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, we are publishing this notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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.

Prior Notice of Imported Food Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.278 to 
1.285 (OMB Control Number 0910-0520)--Revision

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act) added section 801(m) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)), 
which requires that we receive prior notice for food, including food 
for animals, that is imported or offered for import into the United 
States. Sections 1.278 to 1.282 of our regulations (21 CFR 1.278 to 
1.282) set forth the requirements for submitting prior notice; 
Sec. Sec.  1.283(d) and 1.285(j) (21 CFR 1.283(d) and 1.285(j)) set 
forth the procedure for requesting our review after we have refused 
admission of an article of food under section 801(m)(1) of the FD&C Act 
or placed an article of food under hold under section 801(l) of

[[Page 65671]]

the FD&C Act; and Sec.  1.285(i) sets forth the procedure for post-hold 
submissions.
    Section 304 of the FDA Food Safety Modernization Act (FSMA) (Pub. 
L. 111-353) amended section 801(m) of the FD&C Act to require a person 
submitting prior notice of imported food, including food for animals, 
to report, in addition to other information already required, ``any 
country to which the article has been refused entry.'' In the Federal 
Register of May 5, 2011 (76 FR 25542), we issued an interim final rule 
(IFR) entitled ``Information Required in Prior Notice of Imported 
Food'' (2011 IFR) that implemented section 304 of FSMA and requested 
public comments. OMB approved the collection of information 
requirements of the 2011 IFR under OMB control number 0910-0683. On May 
30, 2013 (78 FR 32359), we published a final rule that adopts, without 
change, the regulatory requirements established in the 2011 IFR, 
specifically that a person submitting prior notice of imported food, 
including food for animals, must report the name of any country that 
has refused entry of that product. In this request for extension of OMB 
approval under the PRA, we are combining the burden hours associated 
with OMB control number 0910-0683 (collection entitled ``Information 
Required in Prior Notice of Imported Food'') with the burden hours 
approved under OMB control number 0910-0520 (collection entitled 
``Prior Notice of Imported Food Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002''). If approved, we 
will discontinue the information collection in OMB control number 0910-
0683, having incorporated the burden into OMB control number 0910-0520.
    Advance notice of imported food allows us, with the support of the 
U.S. Customs and Border Protection (CBP), to target import inspections 
more effectively and help protect the nation's food supply against 
terrorist acts and other public health emergencies. By requiring that a 
prior notice contain additional information that indicates prior 
refusals by any country and also identifies the country or countries, 
we may better identify imported food shipments that may pose safety and 
security risks to U.S. consumers. This additional knowledge can further 
help us to make better informed decisions in managing the potential 
risks of imported food shipments into the United States.
    Any person with knowledge of the required information may submit 
prior notice for an article of food. Thus, the respondents to this 
information collection may include importers, owners, ultimate 
consignees, shippers, and carriers.
    Our regulations require that prior notice of imported food be 
submitted electronically using CBP's Automated Broker Interface of the 
Automated Commercial System (ABI/ACS) (Sec.  1.280(a)(1)) or the FDA 
Prior Notice System Interface (PNSI) (Form FDA 3540) (Sec.  
1.280(a)(2)). PNSI is an electronic submission system available on the 
FDA Industry Systems page at http://www.access.fda.gov/. Information we 
collect in the prior notice submission includes: The submitter and 
transmitter (if different from the submitter); entry type and CBP 
identifier; the article of food, including complete FDA product code; 
the manufacturer, for an article of food no longer in its natural 
state; the grower, if known, for an article of food that is in its 
natural state; the FDA Country of Production; the name of any country 
that has refused entry of the article of food; the shipper, except for 
food imported by international mail; the country from which the article 
of food is shipped or, if the food is imported by international mail, 
the anticipated date of mailing and country from which the food is 
mailed; the anticipated arrival information or, if the food is imported 
by international mail, the U.S. recipient; the importer, owner, and 
ultimate consignee, except for food imported by international mail or 
transshipped through the United States; the carrier and mode of 
transportation, except for food imported by international mail; and 
planned shipment information, except for food imported by international 
mail (Sec.  1.281).
    Much of the information collected for prior notice is identical to 
the information collected for our importer's entry notice, which has 
been approved under OMB control number 0910-0046. The information in an 
importer's entry notice is collected electronically via CBP's ABI/ACS 
at the same time the respondent files an entry for import with CBP. To 
avoid double-counting the burden hours already counted in the 
importer's entry notice information collection, the burden hour 
analysis in table 1 of this document reflects our estimate of the 
reduced burden for prior notice submitted through ABI/ACS in column 6, 
entitled ``Average Burden per Response.''
    In addition to submitting a prior notice, a submitter should cancel 
a prior notice and must resubmit the information to us if information 
changes after we have confirmed a prior notice submission for review 
(e.g., if the identity of the manufacturer changes) (Sec.  1.282). 
However, changes in the estimated quantity, anticipated arrival 
information, or planned shipment information do not require 
resubmission of prior notice after we have confirmed a prior notice 
submission for review (Sec.  1.282(a)(1)(i) to (a)(1)(iii)). In the 
event that we refuse admission to an article of food under section 
801(m)(1) of the FD&C Act or we place it under hold under section 
801(l), Sec. Sec.  1.283(d) and 1.285(j) set forth the procedure for 
requesting our review and the information required in a request for 
review. In the event that we place an article of food under hold under 
section 801(l) of the (FD&C Act), Sec.  1.285(i) sets forth the 
procedure for, and the information to be included in, a post-hold 
submission.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                    FDA                      Number of
                         21 CFR Section                            Form      Number of     responses per   Total annual   Average burden    Total hours
                                                                    No.     respondents     respondent       responses     per response
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                                                                Prior Notice Submissions
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Prior Notice submitted through ABI/ACS:
    1.280, 1.281................................................   (\4\)          15,000             608       9,120,000           0.167   \2\ 1,523,040
Prior Notice submitted through PNSI:
    1.280, 1.281................................................     \3\          26,667              58       1,546,686           0.384         593,927
                                                                    3540
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        New Prior Notice Submissions Subtotal...................  ......  ..............  ..............  ..............  ..............       2,116,967
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[[Page 65672]]

 
                                                               Prior Notice Cancellations
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Prior Notice cancelled through ABI/ACS:
    1.282.......................................................    3540           4,098               1           4,098           0.25            1,025
Prior Notice cancelled through PNSI:
    1.282, 1.283(a)(5)..........................................    3540          33,096               1          33,096           0.25            8,274
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        Prior Notice Cancellations Subtotal.....................  ......  ..............  ..............  ..............  ..............           9,299
Prior Notice Requests for Review and Post-hold Submissions:
    1.283(d), 1.285(j)..........................................   (\4\)               1               1               1           8                   8
    1.285(i)....................................................   (\4\)               1               1               1           1                   1
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        Prior Notice Requests for Review and Post-hold            ......  ..............  ..............  ..............  ..............               9
         Submissions Subtotal...................................
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            Total Hours Annually................................  ......  ..............  ..............  ..............  ..............       2,126,275
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ To avoid double-counting, an estimated 396,416 burden hours already accounted for in the Importer's Entry Notice information collection approved
  under OMB Control No. 0910-0046 are not included in this total.
\3\ The term ``Form FDA 3540'' refers to the electronic submission system known as the Prior Notice System Interface (PNSI), which is available at http://www.access.fda.gov.
\4\ None.

    This estimate is based on our experience and the average number of 
prior notice submissions, cancellations, and requests for review 
received in the past 3 years.
    As discussed, on May 30, 2013, we published a final rule that 
adopts, without change, the regulatory requirements established in the 
2011 IFR, specifically that a person submitting prior notice of 
imported food, including food for animals, must report the name of any 
country that has refused entry of that product. We estimate that it 
would take on average about one additional minute (0.016 hours) per 
entry for each respondent to submit prior notice with this additional 
piece of information. Accordingly, we have increased our estimate of 
the hours per response for prior notices received through ABI/ACS from 
9 minutes, or 0.15 hours, per notice, to 10 minutes, or 0.167 hours, 
per notice. We have also increased our estimate of the hours per 
response for prior notices received through PNSI from 22 minutes, or 
0.366 hours (rounded to 0.37 hours), per notice, to 23 minutes, or 
0.384 hours, per notice.
    We received 8,570,504 prior notices through ABI/ACS during 2010; 
9,054,187 during 2011; and 9,716,147 during 2012. Based on this 
experience, we estimate that approximately 15,000 users of ABI/ACS will 
submit an average of 608 prior notices annually, for a total of 
9,120,000 prior notices received annually through ABI/ACS. FDA 
estimates the reporting burden for a prior notice submitted through 
ABI/ACS to be 10 minutes, or 0.167 hours, per notice, for a total 
burden of 1,523,040 hours. This estimate takes into consideration the 
burden hours already counted in the information collection approval for 
our importer's entry notice (OMB Control No. 0910-0683), as previously 
discussed in this document.
    We received 1,566,029 prior notices through PNSI during 2010; 
1,498,609 during 2011; and 1,524,901 during 2012. Based on this 
experience, we estimate that approximately 26,667 registered users of 
PNSI will submit an average of 58 prior notices annually, for a total 
of 1,546,686 prior notices received annually. We estimate the reporting 
burden for a prior notice submitted through PNSI to be 23 minutes, or 
0.384 hours, per notice, for a total burden of 593,927 hours.
    We received 4,488 cancellations of prior notices through ABI/ACS 
during 2010; 3,993 during 2011; and 3,812 during 2012. Based on this 
experience, we estimate that approximately 4,098 users of ABI/ACS will 
submit an average of 1 cancellation annually, for a total of 4,098 
cancellations received annually through ABI/ACS. We estimate the 
reporting burden for a cancellation submitted through ABI/ACS to be 15 
minutes, or 0.25 hours, per cancellation, for a total burden of 1,024.5 
hours, rounded to 1,025 hours.
    We received 33,353 cancellations of prior notices through PNSI 
during 2010; 33,343 during 2011; and 32,592 during 2012. Based on this 
experience, we estimate that approximately 33,096 registered users of 
PNSI will submit an average of 1 cancellation annually, for a total of 
33,096 cancellations received annually. We estimate the reporting 
burden for a cancellation submitted through PNSI to be 15 minutes, or 
0.25 hours, per cancellation, for a total burden of 8,274 hours.
    We have not received any requests for review under Sec.  1.283(d) 
or Sec.  1.285(j) in the last 3 years (2010, 2011, and 2012); 
therefore, we estimate that one or fewer requests for review will be 
submitted annually. We estimate that it will take a requestor about 8 
hours to prepare the factual and legal information necessary to prepare 
a request for review. Thus, we have estimated a total reporting burden 
of 8 hours.
    We have not received any post-hold submissions under Sec.  1.285(i) 
in the last 3 years (2010, 2011, and 2012); therefore, we estimate that 
one or fewer post-hold submissions will be submitted annually. We 
estimate that it will take about 1 hour to prepare the written 
notification described in Sec.  1.285(i)(2)(i). Thus, we have estimated 
a total reporting burden of 1 hour.

    Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25974 Filed 10-31-13; 8:45 am]
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