[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12366-12368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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, Agency, 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 (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: Either electronic or written comments on the collection of 
information must be submitted by April 28, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 28, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-

[[Page 12367]]

2023-N-0465 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, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), 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--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

[[Page 12368]]

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) (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) (21 CFR 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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                                                                          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/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
    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: February 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03991 Filed 2-24-23; 8:45 am]
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