[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Notices]
[Pages 24131-24133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10712]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 
26, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0520. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

    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 (the 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); 
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 https://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

[[Page 24132]]

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 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), 
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 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.
    In the Federal Register of January 5, 2017 (82 FR 1349), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments.
    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           7,647      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
                                                                                                                                         ---------------
    New Prior Notice Submissions Subtotal.  ..............  ..............  ..............  ..............  ............................       2,896,743
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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)...........           1,760
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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
                                                                                                                                         ---------------
    Prior Notice Cancellations Subtotal...  ..............  ..............  ..............  ..............  ............................          10,562
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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
1.285(i)..................................            None             263               1             263  1...........................             263
                                                                                                                                         ---------------
    Prior Notice Requests for Review and    ..............  ..............  ..............  ..............  ............................             271
     Post-Hold Submissions Subtotal.
                                                                                                                                         ---------------
        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 https://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.

[[Page 24133]]

    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.
    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: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10712 Filed 5-24-17; 8:45 am]
 BILLING CODE 4164-01-P