
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1349-1352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-32030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0118]


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 the Agency) 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 FDA regulations requiring that the 
Agency receives 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 March 6, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0118 for ``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.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the

[[Page 1350]]

claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

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.
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 FDA receives 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 FDA 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 the Agency review after FDA has 
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 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.''
    Advance notice of imported food allows FDA, 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, 
the Agency may better identify imported food shipments that may pose 
safety and security risks to U.S. consumers. This additional knowledge 
can further help FDA 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.
    FDA 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 
the Agency collects in the prior notice submission includes: (1) The 
submitter and transmitter (if different from the submitter); (2) entry 
type and CBP identifier; (3) the article of food, including complete 
FDA product code; (4) the manufacturer, for an article of food no 
longer in its natural state; (5) the grower, if known, for an article 
of food that is in its natural state; (6) the FDA Country of 
Production; (7) the name of any country that has refused entry of the 
article of food; (8) the shipper, except for food imported by 
international mail; (9) 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; 
(10) the anticipated arrival information or, if the food is imported by 
international mail, the U.S. recipient; (11) the importer, owner, and 
ultimate consignee, except for food imported by international mail or 
transshipped through the United States; (12) the carrier and mode of 
transportation, except for food imported by international mail; and 
(13) 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 FDA 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 reflects FDA's estimate of the reduced burden for 
prior

[[Page 1351]]

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 FDA if information 
changes after the Agency has 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 the Agency has confirmed a prior 
notice submission for review (Sec.  1.282(a)(1)(i) to (iii)). In the 
event that FDA refuses admission to an article of food under section 
801(m)(1) or the Agency places it under hold under section 801(l) of 
the FD&C Act, Sec. Sec.  1.283(d) and 1.285(j) (21 CFR 1.283(d) and 
1.285(j)) set forth the procedure for requesting FDA's review and the 
information required in a request for review. In the event that the 
Agency places an article of food under hold under Sec.  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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                         Number of
         21 CFR section No.            FDA Form No.      Number of     responses per   Total annual       Average burden per response       Total hours
                                                        respondents     respondent       responses                  (hours)
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                                                                Prior Notice Submissions
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                                                         Prior Notice Submitted Through ABI/ACS
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1.280-1.281.........................            None           1,700            7647      12,999,900  0.167 (10 minutes)................   \2\ 2,170,983
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                                                           Prior Notice Submitted Through PNSI
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1.280-1.281.........................        \3\ 3540          27,000              70       1,890,000  0.384 (23 minutes)................         725,760
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    New Prior Notice Submissions      ..............  ..............  ..............  ..............  ..................................       2,896,743
     Subtotal.
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                                                               Prior Notice Cancellations
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                                                         Prior Notice Cancelled Through ABI/ACS
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1.282...............................            3540           7,040               1           7,040  0.25 (15 minutes).................            1760
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                                                           Prior Notice Cancelled Through PNSI
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1.282, 1.283(a)(5)..................            3540          35,208               1          35,208  0.25 (15 minutes).................           8,802
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    Prior Notice Cancellations        ..............  ..............  ..............  ..............  ..................................          10,562
     Subtotal.
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                                               Prior Notice Requests for Review and Post-Hold Submissions
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1.283(d), 1.285(j),.................            None               1               1               1  8.................................               8
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1.285(i)............................            None             263               1             263  1.................................             263
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    Prior Notice Requests for Review  ..............  ..............  ..............  ..............  ..................................             271
     and Post-Hold Submissions
     Subtotal.
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    Total...............................................................................................................................       2,907,576
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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 number 0910-0046 are not included in this total.
\3\ The term ``Form FDA 3540'' refers to the electronic submission system known as PNSI, which is available at http://www.access.fda.gov.

    This estimate is based on FDA's experience and the average number 
of prior notice submissions, cancellations, and requests for review 
received in the past 3 years.
    FDA received 10,450,824 prior notices through ABI/ACS during 2014; 
11,282,015 during 2015; and 12,153,880 during 2016. Based on this 
experience, the Agency estimates that approximately 1,700 users of ABI/
ACS will submit an average of 7,647 prior notices annually, for a total 
of 12,999,900 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 hour, per notice, for a total burden 
of 2,170,983 hours. This estimate takes into consideration the burden 
hours already counted in the information collection approval for FDA 
importer's entry notice (OMB control number 0910-0046), as previously 
discussed.
    FDA received 1,529,110 prior notices through PNSI during 2014; 
1,633,567 during 2015; and 1,768,790 during 2016. Based on this 
experience, the Agency estimates that approximately 27,000 registered 
users of PNSI will submit an average of 70 prior notices annually, for 
a total of 1,890,000 prior notices received annually. FDA estimates the 
reporting burden for a prior notice submitted through PNSI to be 23 
minutes, or 0.384 hour, per notice, for a total burden of 725,760 
hours.

[[Page 1352]]

    FDA received 7,265 cancellations of prior notices through ABI/ACS 
during 2014; 7,910 during 2015; and 5,948 during 2016. Based on this 
experience, the Agency estimates that approximately 7,040 users of ABI/
ACS will submit an average of 1 cancellation annually, for a total of 
7,040 cancellations received annually through ABI/ACS. FDA estimates 
the reporting burden for a cancellation submitted through ABI/ACS to be 
15 minutes, or 0.25 hour, per cancellation, for a total burden of 1,760 
hours.
    FDA received 36,324 cancellations of prior notices through PNSI 
during 2014; 39,553 during 2015; and 29,743 during 2016. Based on this 
experience, the Agency estimates that approximately 35,208 registered 
users of PNSI will submit an average of 1 cancellation annually, for a 
total of 35,208 cancellations received annually. FDA estimates the 
reporting burden for a cancellation submitted through PNSI to be 15 
minutes, or 0.25 hour, per cancellation, for a total burden of 8,802 
hours.
    FDA has not received any requests for review under Sec.  1.283(d) 
or Sec.  1.285(j) in the last 3 years; therefore, the Agency estimates 
that one or fewer requests for review will be submitted annually. FDA 
estimates that it will take a requestor about 8 hours to prepare the 
factual and legal information necessary to prepare a request for 
review. Thus, the Agency has estimated a total reporting burden of 8 
hours.
    FDA received 235 post-hold submissions under Sec.  1.285(i) during 
2014; 218 during 2015; and 337 during 2016. Based on this experience, 
the Agency estimates that 263 post-hold submissions under Sec.  
1.285(i) will be submitted annually. FDA estimates that it will take 
about 1 hour to prepare the written notification described in Sec.  
1.285(i)(2)(i). Thus, the Agency estimates a total reporting burden of 
263 hours.

    Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-32030 Filed 1-4-17; 8:45 am]
 BILLING CODE 4164-01-P


