[Federal Register Volume 85, Number 25 (Thursday, February 6, 2020)]
[Notices]
[Pages 6955-6957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02371]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the 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: Submit either electronic or written comments on the collection 
of information by April 6, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 6, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is 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-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, 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.
     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.

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: 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

[[Page 6956]]

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 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 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 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.
    We estimate the burden of this collection of information as 
follows:

[[Page 6957]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               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/ACS
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.280 through 1.281.......................             N/A           1,700           7,647      12,999,900  0.167 (10 minutes)..........   \2\ 2,170,983
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Through PNSI
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.280 through 1.281.......................        3540 \3\          27,000              70       1,890,000  0.384 (23 minutes)..........         725,760
                                           -------------------------------------------------------------------------------------------------------------
    Subtotal..............................  ..............  ..............  ..............  ..............  ............................       2,896,743
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Cancellations: Through ABI/ACS
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.282.....................................            3540           7,040               1           7,040  0.25 (15 minutes)...........           1,760
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Through PNSI
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.282 and 1.283(a)(5).....................            3540          35,208               1          35,208  0.25 (15 minutes)...........           8,802
                                           -------------------------------------------------------------------------------------------------------------
    Subtotal..............................  ..............  ..............  ..............  ..............  ............................          10,562
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      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             263               1             263  1...........................             263
                                           -------------------------------------------------------------------------------------------------------------
    Subtotal..............................  ..............  ..............  ..............  ..............  ............................             271
                                           -------------------------------------------------------------------------------------------------------------
        Total.............................  ..............  ..............  ..............      14,932,412  ............................       2,907,576
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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)(i), for 
a total reporting burden of 263 hours.

    Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02371 Filed 2-5-20; 8:45 am]
 BILLING CODE 4164-01-P


