Notice2023-03991
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
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Published
February 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 38 (Monday, February 27, 2023)</title>
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[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12366-12368]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#95c5c7d4c6e1f4f3f3d5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="78282a392b0c191e1e381e1c195610100b561f170e">[email protected]</span></a>.
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 <a href="https://www.access.fda.gov/">https://www.access.fda.gov/</a>. 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
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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 <a href="https://www.access.fda.gov/">https://www.access.fda.gov/</a>.
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]
BILLING CODE 4164-01-P
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