
[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51326-51328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16568]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0465]


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, Agency, or we) 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 September 5, 2023.

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.

[[Page 51327]]


FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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--Extension

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (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 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 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 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 Environment (ABI/ACE) (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/ACE 
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/ACE 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 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.
    In the Federal Register of February 27, 2023 (88 FR 12366), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate 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                FDA form No.      Number of     responses per   Total annual     Average burden per response     Total hours
                                                            respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Submissions:
    Through ABI/ACE.....................
    1.280 through 1.281.................             N/A           1,900           7,895      15,000,500  0.167 (10 minutes)............   \2\ 2,505,084
    Through PNSI........................

[[Page 51328]]

 
    1.280 through 1.281.................        \3\ 3540          13,000             231       3,003,000  0.384 (23 minutes)............       1,153,152
        Subtotal........................  ..............  ..............  ..............  ..............  ..............................       3,658,236
Cancellations:
    Through ABI/ACE.....................
    1.282...............................             N/A          25,000               1          25,000  0.25 (15 minutes).............           6,250
    Through PNSI........................
    1.282 and 1.283(a)(5)...............            3540          50,000               1          50,000  0.25 (15 minutes).............          12,500
        Subtotal........................  ..............  ..............  ..............  ..............  ..............................          18,750
Requests for Review and Post-hold
 Submissions:
    1.283(d) and 1.285(j)...............             N/A               1               1               1  8.............................               8
    1.285(i)............................             N/A             500               1             500  1.............................             500
        Subtotal:.......................  ..............  ..............  ..............  ..............  ..............................             508
                                         ---------------------------------------------------------------------------------------------------------------
            Total.......................  ..............  ..............  ..............      18,079,001  ..............................       3,677,494
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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 the 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.

    Table 1 reflects the annual estimated reporting burden associated 
with the information collection. During the next 3 years, we estimate 
each respondent will need approximately 10 minutes per submission for a 
total of 15,000,500 annual submissions and 2,505,083.5 rounded up to 
2,505,084 annual hours of burden. Similarly, we estimate 13,000 users 
submitting an average of 231 notices annually, requiring approximately 
23 minutes per submission. Cumulatively, this totals 3,003,000 annual 
responses and 1,153,152 annual hours of burden.
    Regarding cancellations of prior notices, we estimate 25,000 
respondents averaging 1 cancellation annually and requiring 15 minutes 
to do so. Cumulatively, this totals 25,000 annual submissions and 6,250 
annual hours of burden. Similarly, we estimate 50,000 registered users 
submitting an average of 1 cancellation annually and requiring 15 
minutes to do so. Cumulatively, this totals 50,000 annual responses and 
12,500 annual hours of burden.
    We estimate that we will receive one submission annually under 
Sec.  1.283(d) or Sec.  1.285(j) over the next 3 years. It takes 
approximately 8 hours to prepare a submission, which results in 8 hours 
of burden.
    Finally, for an average of 500 post-hold submissions annually, we 
estimate it will take respondents 1 hour to prepare the written 
notification described in Sec.  1.285(i)(2)(i), for a total of 500 
annual burden hours.
    Based on our experience and the average number of prior notice 
submissions, cancellations, and requests for review received in the 
past 3 years, we are adjusting our burden estimate for this information 
collection by increasing the number of responses and total burden. The 
number of responses has increased by 3,146,589 responses (from 
14,932,412 to 18,079,001). The total burden has increased by 769,918 
hours (from 2,907,576 to 3,677,494). We attribute the adjustment to an 
increase in the number of responses.

    Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16568 Filed 8-2-23; 8:45 am]
BILLING CODE 4164-01-P


