0520 ss 6-15-2017

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

Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
This information collection helps support the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Bioterrorism Act), which added section
801(m) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)),
requiring 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 the procedure for requesting our review after we have 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 § 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. This additional
knowledge can further help us to make better informed decisions in managing the
potential risks of imported food shipments into the United States.
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 OMB approval of the information collection provisions found in
21 CFR Part 1; Subpart I and discussed below.

21 CFR 1.280 - 1.281 -- Reporting
Requires submission of a prior notice to FDA, sets forth the information that the prior
notice is required to contain, the method of submission of the notice, and the minimum
and maximum period of advance notice required.
21 CFR 1.282, 1.283(a)(5) -- Reporting
Requests cancellation of a prior notice in the event that certain information changes after
confirmation of a prior notice has been received by FDA.
21 CFR 1.283(d), 1.285(i), and 1.285(j)-- Reporting
Establishes procedures for submitting a request for FDA review after the agency has
refused admission of an article of food under 801(m)(1) of the act.
21 CFR 1.285(j)-- Reporting
Establishes procedures for submitting a request for FDA review after the agency has
placed an article of food under hold under 801(l) of the act.
Form FDA 3540
The term “Form FDA 3540” refers to the electronic system known as the FDA Prior
Notice (PN) System Interface, which is available at http://www.access.fda.gov.
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 System
(ABI/ACS) (§1.280(a)(1)) or 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 we collect in 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).

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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.
FDA uses 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's regulations require that prior notice of imported food be
submitted electronically either through ABI/ACS or the FDA PN System Interface.
Thus, FDA estimates 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
Because much of the information being collected under this request is similar to
information that may be collected under OMB Control No. 0910–0046 (Importer’s Entry
Notice), we have confined our burden estimate to only those elements described in
section 801 of the FFDCA exclusively related to prior notice of imported foods (versus
FDA-regulated products more generally) and discussed in this supporting statement.
Information collection burden that may be associated with other regulations governing
the import of FDA-regulated products is approved under OMB Control No. 0910-0046
and discussed in the agency’s supporting statement.

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5. Impact on Small Businesses or Other Small Entities
FDA estimates that approximately ninety percent (90%) of the respondents are small
businesses. The reporting requirements of this regulation are those mandated by the
Bioterrorism Act and there is no statutory exception for small businesses in that Act.
However, FDA aids small businesses in complying with its requirements through the
Agency’s Regional Small Business Representatives and through the scientific and
administrative staffs within the Agency. FDA has provided a Small Business Guide on
the Agency’s website at http://www.fda.gov/oc/industry/. In addition, FDA’s Prior
Notice Center can answer questions about Prior Notice policies, procedures and
interpretations, and will attempt to assist small businesses to comply with prior notice.
The Prior Notice Center staff is available is available 24 hours a day, 365 days a year.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. Respondents will submit the required information
on an occasional basis, as required by section 801(m) of the act. If the collection is not
conducted or is conducted less frequently, the importers, owners, ultimate consignees,
shippers, and/or carriers will not be in compliance with section 801(m) of the Act.
Without prior notice of every imported shipment it would not be possible to protect the
nation's food supply against terrorist acts and other public health emergencies.
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), FDA published a 60 day notice for public comment
in the Federal Register of January 5, 2017 (82 FR 1349). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
The regulation does not specify 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 Agency’s
regulations (21 CFR part 20). The information also is safeguarded by Section 301(j) of
the act (21 U.S.C. 331(j).

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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 Costs
12 a. Annualized Hour Burden Estimate
FDA estimates the burden for this collection of information as follows:
Table 1- Estimated Annual Reporting Burden1
21 CFR Section No.

FDA
Form
No.

No. of
Respondents

No. of
Responses
per
Respondent

Total
Annual
Responses

Average
Burden per
Response

Total
Hours

PRIOR NOTICE SUBMISSIONS:
Through ABI/ACS
1.280-1.281

N/A

1,700

7,647

12,999,900

0.167
(10 mins.)

2,170,983

27,000

70

1,890,000

0.384
(23 mins.)
Subtotal:

725,760

Through PNSI
1.280-1.281

3540

2,896,743

CANCELLATIONS:
Through ABI/ACS
1.282

3540

7,040

1

7,040

0.25
(15 mins.)

1,760

3540

35,208

1

35,208

0.25
(15 mins.)
Subtotal:

8,802
10,562

Through PNSI
1.282, 1.283(a)(5)

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

263

1

263

1

263

Subtotal:

271

TOTAL:
1

14,932,412

2,907,576

There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 1 reflects the annual estimated reporting burden associated with the information
collection. During calendar years 2014, 2015, and 2016 we received 10,450,824,
11,282,015, and 12,153,880 prior notice submissions respectively from approximately
1,700 users of ABI/ACS. During the next three years, we estimate each respondent
needed approximately 10 minutes per submission for a total of 12,999,900 annual
submissions and 2,170,983 annual hours of burden. Similarly, during the same period
(2014-2016) we received 1,529,110, 1,633,567, 1,768,790 submissions through PNSI

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where we counted 27,000 users submitting an average of 70 notices annually, requiring
approximately 23 minutes per submission. Cumulatively this totals 1,890,000 annual
responses and 725,760 annual hours of burden.
Regarding cancellations of prior notices, during 2014, 2015, and 2016 we received 7,265,
7,910, and 5,948 submissions respectively through ABI/ACS, where we counted 7,040
respondents averaging 1 cancellation annually and requiring 15 minutes to do so.
Cumulatively this totals 7,040 annual submissions and 1,760 annual hours of burden.
Similarly, during the same period (2014-2016) we received 36,324, 39,553, and 29,743
cancellations through PNSI where we counted 35,208 registered users submitting an
average of 1 cancellation annually and requiring 15 minutes to do so. Cumulatively this
totals 35,208 annual responses and 8,802 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, during calendar years 2014, 2015, and 2016 we received 235, 218, and 337 posthold submissions respectively. For an average of 263 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 263 annual burden hours.
12b. Annualized Cost Burden Estimate
FDA estimates the annualized cost burden to respondents for this collection of
information is $127,278,821.50. FDA estimates 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 2017
($31.87/hour). To account for overhead, this cost is increased by 100 percent, which is
$63.74 per hour. Thus, the annual wage cost imposed by this collection of information is
approximately $185,328,894 (2,907,576 hours x $63.74 per hour).
Table 2. Annual Cost Burden Estimate
Activity
Prior Notice submissions,
cancellations, and review and
post hold submissions

Total Burden
Hours
2,907,576

Hourly Wage
Rate
$63.74

Total Respondent
Costs
$185,328,894

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating or maintenance costs associated with this
collection.

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14. Annualized Cost to the Federal Government
FDA incurs costs to operate and maintain the PN System Interface and estimates those
costs to be approximately $1 million annually.
15. Explanation for Program Changes or Adjustments
This information collection includes adjustments. Based on our review, the collection
reflects a continued increase in submissions. As a result we have increased our annual
estimate by 4,228,530 responses and 781,301 burden hours. Burden associated with the
individual ICs and our corresponding calculations are discussed more fully under Q12 of
this supporting statement.
16. Plans for Tabulation and Publication and Project Time Schedule
The information from this collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA has no reason for not displaying the OMB approval date.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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