[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
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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........................
[[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
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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 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]
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