0520 Prior notice of imported food SSA 2020 Ext

UNITED STATES FOOD AND DRUG ADMINISTRATION
Prior Notice of Imported Food under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
OMB Control No. 0910-0520

SUPPORTING STATEMENT – Part A: Justification:
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we) regulations
and implementation of the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 (the Bioterrorism Act). Section 801(m) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 381(m)), requires that the Food and Drug Administration (FDA or
we) receive prior notice for food, including food for animals, that is imported or offered for
import into the United States. Regulations found in 21 CFR Part 1; Subpart I govern “Prior
Notice of Imported Food.” Specifically, sections 1.278 to 1.282 (21 CFR 1.278 to 1.282) set
forth the requirements for submitting prior notice; §§ 1.283(d) and 1.285(j) (21 CFR 1.283(d)
and 1.285(j)) set forth procedures for requesting FDA review if admission of an article of food
under section 801(m)(1) of the FD&C Act has been refused or placed on hold under section
801(l) of the FD&C Act; and § 1.285(i) (21 CFR 1.285(i)) sets forth the procedure for post-hold
submissions.
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 additional information that indicates prior refusals by any country and also identifies the
country or countries, we may better identify imported food shipments that may pose safety and
security risks to U.S. consumers.
To facilitate submission of information to FDA, we developed Form FDA 3540, or the Prior
Notice System Interface (PNSI), for use with CBP systems. Section 304 of the FDA Food Safety
Modernization Act (FSMA) (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.”
Accordingly, we request extension of OMB approval of the information collection provisions
found in 21 CFR part 1; Subpart I and Form FDA 3540.
2. Purpose and Use of the Information Collection
Our regulations require that prior notice of imported food be submitted electronically using
CBP’s Automated Broker Interface of the Automated Commercial Environment (ABI/ACE)
(§1.280(a)(1)) through the FDA Prior Notice System Interface (PNSI) (Form FDA 3540)
(§1.280(a)(2)). PNSI is an electronic submission system available on the FDA Industry Systems

page at http://www.access.fda.gov/. Information collected via the prior notice submission
includes the name of the submitter and transmitter (if different from the submitter); entry type
and CBP identifier; the article of food, including complete FDA product code; the manufacturer,
for an article of food no longer in its natural state; the grower, if known, for an article of food
that is in its natural state; the FDA Country of Production; the name of any country that has
refused entry of the article of food; the shipper, except for food imported by international mail;
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; the anticipated
arrival information or, if the food is imported by international mail, the U.S. recipient; the
importer, owner, and ultimate consignee, except for food imported by international mail or
transshipped through the United States; the carrier and mode of transportation, except for food
imported by international mail; and planned shipment information, except for food imported by
international mail (§1.281).
In addition to submitting a prior notice, a submitter should cancel a prior notice and must
resubmit the information to us if information changes after we have confirmed a prior notice
submission for review (e.g., if the identity of the manufacturer changes) (§1.282). However,
changes in the estimated quantity, anticipated arrival information, or planned shipment
information do not require resubmission of prior notice after we have confirmed a prior notice
submission for review (§1.282(a)(1)(i) to 1.282(a)(1)(iii)). In the event that we refuse admission
to an article of food under section 801(m)(1) or we place it under hold under section 801(l) of the
FD&C Act, §§1.283(d) and 1.285(j) set forth the procedure for requesting our review and the
information required in a request for review. In the event that we place an article of food under
hold under section 801(l) of the FD&C Act, § 1.285(i) sets forth the procedure for, and the
information to be included in, a post-hold submission.
We use the information, with the support of CBP, to target import inspections more effectively
and to help protect the nation's food supply against terrorist acts and other public health
emergencies.
Description of Respondents: Any person with knowledge of the required information may
submit prior notice for an article of food. Thus, the respondents to this information collection
include importers, owners, ultimate consignees, shippers, and carriers with knowledge of the
required information about food, including food for animals, that is imported or offered for
import into the United States. Respondents include, unless otherwise exempt, individuals and
households, the private sector (including for-profit businesses, not-for-profit institutions and
farms), state local or tribal governments, as well as the Federal government.
3. Use of Improved Information Technology and Burden Reduction
As noted above, FDA regulations require that prior notice of imported food be submitted
electronically either through ABI/ACE or the FDA PNSI. Thus, we estimate that one hundred
percent (100%) of the respondents will use electronic means to submit the required information.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Although similar information collection
is accounted for under OMB control no. 0910-0046 in conjunction with FDA’s import program

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generally, here we are exclusively accounting for those elements described in section 801 of the
FD&C Act related to prior notice of imported foods, as discussed in this supporting statement.
5. Impact on Small Businesses or Other Small Entities
Although we estimate that ninety percent (90%) of respondents are small businesses, we do not
believe the information collection poses undue burden on small entities. At the same time, we
assist small businesses through our Regional Small Business Representatives. We also provide a
Small Business Guide on our website at https://www.fda.gov/industry/small-business-assistance.
With regard to Prior Notice specifically, we have established the following resources:
System Help Desk
800-216-7331
240-247-8804 INTL
Contact for questions regarding PNSI account creation, management, password reset, and
technical computer questions. (Mon–Fri 7:30 am - 11:00 pm EST)
Division of Food Defense Targeting
(formerly Prior Notice Center)
866-521-2297
571-468-1488 INTL
571-468-1936 Fax
prior.notice@fda.hhs.gov
Contact for questions regarding prior notice policies, procedures, and interpretations. (24/7)
Division of Import Operations & Policy
301-796-0356
Contact for import questions not related to prior notice.
6. Consequences of Collecting the Information Less Frequently
Data collection is consistent with statutory and regulatory requirements that mandate public
health protection measures be employed regarding the United States’ food supply.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment in the
Federal Register of February 6, 2020 (85 FR 6955). Because the one comment received was not
responsive to the information collection topics solicited, it was not addressed.
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide any payments or gifts to respondents.

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10. Assurance of Confidentiality Provided to Respondents
In preparing this supporting statement, we consulted our Privacy Office to ensure appropriate
handling. While FDA has minimized the PII to be collected to protect the privacy of the
individuals, the collection of information does not specifically pledge confidentiality. However,
confidential commercial information is protected from disclosure under the Freedom of
Information Act (FOIA) under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20
of the our regulations (21 CFR part 20). The information collected is also protected by Section
301(j) of the Act (21 U.S.C. 331(j).
Privacy Act
This ICR collects personally identifiable information or information of a personal nature. The
PII collected is for business contact purposes only and includes business name, business address,
business telephone numbers. The business contact information is maintained and stored at the
vendor facility.
FDA further determined that although PII is collected and stored at the vendor facility the
collection is not subject to the Privacy Act of 1974 and the particular notice and other
requirements of the Act do not apply. Specifically, FDA does not use name or any other
personal identifier to routinely retrieve records from the information collected.

11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Cost
12a. Annualized Hour Burden Estimate
Our estimate of the burden for this collection of information is as follows:
Table 1.--Estimated Annual Reporting Burden1
21 CFR Section No.
FDA
No. of
No. of
Total
Form Respondents
Responses
Annual
No.
per
Responses
Respondent
PRIOR NOTICE SUBMISSIONS:
Through ABI/ACE
1.280-1.281

N/A

Average
Burden per
Response

Total
Hours

1,900

7,895

15,000,500

0.167
(10 mins.)

2,505,084

13,000

231

3,003,000

0.384
(23 mins.)
Subtotal:

1,153,152

Through PNSI
1.280-1.281

3540

CANCELLATIONS:
Through ABI/ACE

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3,658,236

1.282

3540

25,000

1

25,000

0.25
(15 mins.)

6,250

3540

50,000

1

50,000

0.25
(15 mins.)
Subtotal:

12,500

Through PNSI
1.282, 1.283(a)(5)

18,750

REQUESTS FOR REVIEW AND POST-HOLD SUBMISSIONS:
1.283(d), 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
1
There are no capital costs or operating and maintenance costs associated with this collection of
information.

3,677,494

Table 1 reflects the annual estimated reporting burden associated with the information
collection. During the next three 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.
While we have not received any submissions under § 1.283(d) or § 1.285(j) in the last 3
years, we estimate at least one response for purposes of retaining collection authority under
this provision. Estimating it will take approximately 8 hours to prepare a submission, this
totals one annual response and 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 § 1.285(i)(2)(i), for a total
of 500 annual burden hours.
12b. Annualized Cost Burden Estimate
We estimate the annualized cost burden to respondents for this collection of
information is $253,820,635.88. We estimate that the prior notice process will involve an
employee making an average wage similar to that of a Federal government employee at the
GS-11/Step-1 rate for the Washington-Baltimore locality pay area for the year 2020
($34.51/hour). To account for overhead, this cost is increased by 100 percent, which is $69.02
per hour. Thus, the annual wage cost imposed by this collection of information is
approximately $253,820,635.88 (3,677,494 hours x $69.02 per hour).

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Table 2.--Annual Cost Burden Estimate
Activity
Total Burden
Hourly Wage
Hours
Rate
Prior Notice submissions, cancellations,
and review and
3,677,494
$69.02
post-hold submissions

Total Respondent
Costs
$253,820,635.88

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this collection.
14. Annualized Cost to the Federal Government
We estimate an annual cost of $1,000,000 to operate and maintain the Prior Notice System
Interface (PNSI).
15. Explanation for Program Changes or Adjustments
Based on our evaluation of the information collection, we have made no adjustments.
16. Plans for Tabulation and Publication and Project Time Schedule
The information from this collection will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Displaying the OMB approval date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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