[Federal Register Volume 85, Number 98 (Wednesday, May 20, 2020)]
[Notices]
[Pages 30713-30715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10825]


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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

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: Submit written comments (including recommendations) on the 
collection of information by June 19, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0520. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA

[[Page 30714]]

has submitted the following proposed collection of information to OMB 
for review and clearance.

Prior Notice of Imported Food--21 CFR 1.278 to 1.285

OMB Control Number 0910-0520--Extension

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 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 
receive prior notice for food, including food for animals, that is 
imported or offered for import into the United States. Sections 1.278 
through 1.282 of FDA regulations (21 CFR 1.278 through 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 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 (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 specific information that indicates prior refusals by any 
country and 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 information collection enables 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 
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) of 
the FD&C Act, Sec. Sec.  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 February 6, 2020 (85 FR 6955), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received but was not 
responsive to the four information collection topics solicited and 
therefore is not addressed.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                         Number of
           21 CFR section              FDA Form No.      Number of     responses per   Total annual       Average burden per response       Total hours
                                                        respondents     respondent       responses
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                                                                Prior Notice Submissions:
                                                                     Through ABI/ACS
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1.280 through 1.281.................             N/A           1,700           7,647      12,999,900  0.167 (10 minutes)................   \2\ 2,170,983
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                                                                      Through PNSI
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1.280 through 1.281.................        \3\ 3540          27,000              70       1,890,000  0.384 (23 minutes)................         725,760
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[[Page 30715]]

 
    Subtotal........................  ..............  ..............  ..............  ..............  ..................................       2,896,743
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                                                                     Cancellations:
                                                                     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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                                                                      Through PNSI
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1.282 and 1.283(a)(5)...............            3540          35,208               1          35,208  0.25 (15 minutes).................           8,802
                                     -------------------------------------------------------------------------------------------------------------------
    Subtotal........................  ..............  ..............  ..............  ..............  ..................................          10,562
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                                                      Requests for Review and Post-hold Submissions
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1.283(d) and 1.285(j),..............             N/A               1               1               1  8.................................               8
1.285(i)............................             N/A             263               1             263  1.................................             263
                                     -------------------------------------------------------------------------------------------------------------------
    Subtotal........................  ..............  ..............  ..............  ..............  ..................................             271
                                     -------------------------------------------------------------------------------------------------------------------
        Total.......................  ..............  ..............  ..............      14,932,412  ..................................       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.

    Based on our experience and the average number of prior notice 
submissions, cancellations, and requests for review received in the 
past 3 years, we have made no adjustments in our burden estimate for 
the information collection. We estimate that 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 through ABI/ACS. We assume the 
reporting burden for a prior notice submitted through ABI/ACS to be 10 
minutes, or 0.167 hour, per notice, for a total annual 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.
    We estimate that 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. We assume 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.
    We estimate that 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. We assume 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.
    We estimate that 35,208 registered users of PNSI will submit an 
average of 1 cancellation annually, for a total of 35,208 cancellations 
received annually. We assume 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.
    We estimate that one or fewer requests for review under Sec.  
1.283(d) or Sec.  1.285(j) will be submitted annually. We assume that 
it will take respondents 8 hours to prepare the factual and legal 
information necessary to prepare a request for review. Thus, we 
estimate a total reporting burden of 8 hours.
    We estimate that 263 post-hold submissions under Sec.  1.285(i) 
will be submitted annually. We assume that it will take about 1 hour to 
prepare the written notification described in Sec.  1.285(i)(2), for a 
total reporting burden of 263 hours.

    Dated: May 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10825 Filed 5-19-20; 8:45 am]
 BILLING CODE 4164-01-P


