Prior Notice of Imported Food under the Public Health
SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
The
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (the Bioterrorism Act) added section 801(m) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381(m)) (Attachment
A), 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's regulations (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 FDA review after an
article of food has been refused admission under section 801(m)(1) of
the act or placed under hold under section 801(l) of the act; and §
1.285(i) (21 CFR 1.285(i)) sets forth the procedure for post-hold
submissions (Attachment B). Advance notice of imported food allows
FDA, with the support of the Bureau of 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.
We request the extension of OMB approval for the following collection of information requirements and form:
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
FDA's
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 (PN) System Interface Form (FDA 3540). Information
collected by FDA in the prior notice submission includes: 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 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 if information changes after FDA has 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 FDA has confirmed a prior notice submission for review (§ 1.282(a)(1)(i) to 1.282(a)(1)(iii)). In the event that an article of food has been refused admission under section 801(m)(1) or placed under hold under section 801(l) of the act, §§ 1.283(d) and 1.285(j) set forth the procedure for requesting FDA review and the information required to be included in a request for review. In the event that an article of food has been placed under hold under section 801(l) of the 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: Respondents to this collection of information
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
Much
of the information collected for prior notice is identical to the
information collected for FDA's importer's entry notice, which has
been approved under OMB control number 0910-0046. The information in
FDA's 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 of this document reflects the reduced burden
for prior notice submitted through ABI/ACS in the column labeled
“Hours per Response.”
The
ABI/ACS information cannot substitute for the submission of prior
notice because it does not meet the requirements of the Bioterrorism
Act, such as providing FDA with certain specified information before
the food arrives in the United States. Entry may be made up to 15
days after
a food arrives in the U.S. and does not contain all of the
information required in a prior notice, such as the country from
which the article is shipped. The information in a prior notice is
necessary for FDA to determine whether it should examine the food at
the U.S. port of arrival.
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.
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
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 associated with 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), in the FEDERAL REGISTER of March 16,
2010 (75 FR 12549), FDA published a 60-day notice requesting public
comment on the proposed extension of this collection of information.
FDA received one letter, containing multiple comments, in response
to the notice. These comments were outside the scope of the four
collection of information topics on which the notice solicits
comments.
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 Burden
21 CFR Section No. |
FDA Form No. |
No. of Respondents |
Annual Frequency per Respondent |
Total Annual Responses |
Hours per Response |
Total Hours |
Prior Notice Submissions |
||||||
Prior Notice submitted through ABI/ACS |
||||||
1.280-1.281 |
None |
6,500 |
1,290 |
8,385,000 |
0.15 |
1,257,7502 |
Prior Notice submitted through PN System Interface |
||||||
1.280-1.281 |
FDA 35403 |
21,500 |
73 |
1,569,500 |
0.37 |
580,715 |
New Prior Notice Submissions Subtotal |
1,838,465 |
|||||
Prior Notice Cancellations |
||||||
Prior Notice cancelled through ABI/ACS |
||||||
1.282 |
FDA 3540 |
6,500 |
3 |
19,500 |
0.25 |
4,875 |
Prior Notice cancelled through PN System Interface |
||||||
1.282, 1.283(a)(5) |
FDA 3540 |
21,500 |
3 |
64,500 |
0.25 |
16,125 |
Prior Notice Cancellations Subtotal |
21,000 |
|||||
Prior Notice Requests for Review and Post-hold Submissions |
|
|||||
1.283(d), 1.285(j), |
None |
1 |
1 |
1 |
8 |
8 |
1.285(i) |
None |
1 |
1 |
1 |
1 |
1 |
Prior Notice Requests for Review and Post-hold Submissions Subtotal |
9 |
|||||
Total Hours Annually |
1,859,474 |
|||||
1To avoid double-counting, an estimated 396,416 burden hours already accounted for in the Importer’s Entry Notice information collection approved under OMB Control No. 0910-0046 are not included in this total.
2The term “Form FDA 3540” refers to the electronic system known as the FDA PN System Interface, which is available at http://www.access.fda.gov.
This estimate is based on FDA's experience and the average number of prior notice submissions, cancellations, and requests for review received in the past 3 years.
In the Federal Register of November 7, 2008 (73 FR 66294), FDA and CBP issued the prior notice final rule, which finalized the prior notice interim final rule (IFR) (October 10, 2003, 68 FR 58974). From the IFR to the final rule, FDA removed a few of the required prior notice data elements. Specifically, submitters no longer need to include the fax number of the submitter and transmitter, the anticipated border crossing, the country of the carrier, or the 6–digit HTS code in their prior notices. Other changes include the addition of the registration number of the transshipper for articles of food for transshipment, storage and export, or manipulation and export; flexibility in submitting the registration number and the city and country of the manufacturer and shipper instead of full addresses of these entities; and the option of submitting the tracking number for articles of food arriving by express consignment instead of anticipated arrival information when the prior notice is submitted through the PN System Interface (73 FR 66293, at 66402). In the final rule, FDA estimated that the changes in the filing requirements would not affect the time needed to file prior notice (73 FR 66293, at 66402). Based on its experience during the last two years, FDA now estimates that the hours per response were reduced by the changes. Accordingly, FDA has reduced its estimate of the hours per response for prior notices received through ABI/ACS from 10 minutes, or 0.167 hours, per notice, to 9 minutes, or 0.15 hours, per notice. FDA has also reduced its estimate of the hours per response for prior notices received through the PN System Interface from 23 minutes, or 0.384 hours, per notice, to 22 minutes, or 0.366 hours (rounded to 0.37 hours), per notice.
FDA received 8,144,419 prior notices through ABI/ACS during 2007; 8,266,200 during 2008; and 5,221,549 as of August 26, 2009. Based on this experience, FDA estimates that approximately 6,500 users of ABI/ACS will submit an average of 1,290 prior notices annually, for a total of 8,385,000 prior notices received annually through ABI/ACS. FDA estimates the reporting burden for a prior notice submitted through ABI/ACS to be 9 minutes, or 0.15 hours, per notice, for a total burden of 1,257,750 hours. This estimate takes into consideration the burden hours already counted in the information collection approval for FDA’s importer’s entry notice, as previously discussed in this document.
FDA received 1,744,287 prior notices through the PN System Interface during 2007; 1,662,033 during 2008; and 989,708 as of August 26, 2009. Based on this experience, FDA estimates that approximately 21,500 registered users of the PN System Interface will submit an average of 73 prior notices annually, for a total of 1,569,500 prior notices received annually through the PN System Interface. FDA estimates the reporting burden for a prior notice submitted through the PN System Interface to be 22 minutes, or 0.366 hours (rounded to 0.37 hours), per notice 22 minutes, or 0.366 hours (rounded to 0.37 hours), per notice, for a total burden of 580,715 hours.
FDA received 16,215 cancellations of prior notices through ABI/ACS during 2007; 16,673 during 2008; and 16,045 as of August 26, 2009. Based on this experience, FDA estimates that approximately 6,500 users of ABI/ACS will submit an average of 2.64 (rounded to 3) cancellations annually, for a total of 19,500 cancellations received annually through ABI/ACS. FDA estimates the reporting burden for a cancellation submitted through ABI/ACS to be 15 minutes, or 0.25 hours, per cancellation, for a total burden of 4,875 hours.
FDA received 58,345 cancellations of prior notices through the PN System Interface during 2007; 63,779 during 2008; and 55,019 as of August 26, 2009. Based on this experience, FDA estimates that approximately 21,500 registered users of the PN System Interface will submit an average of 3.24 (rounded to 3) cancellations annually, for a total of 64,500 cancellations received annually through the PN System Interface. FDA estimates the reporting burden for a cancellation submitted through the PN System Interface to be 15 minutes, or 0.25 hours, per cancellation, for a total burden of 16,125 hours.
FDA has not received any requests for review under §§ 1.283(d) or 1.285(j) in the last 3 years (2007 through August 26, 2009); therefore, the agency estimates that one or fewer requests for review will be submitted annually. FDA estimates that it will take a requestor about 8 hours to prepare the factual and legal information necessary to prepare a request for review. Thus, FDA has estimated a total reporting burden of 8 hours.
FDA has not received any post-hold submissions under § 1.285(i) in the last 3 years (2007 through August 26, 2009); therefore, the agency estimates that one or fewer post-hold submissions will be submitted annually. FDA estimates that it will take about 1 hour to prepare the written notification described in § 1.285(i)(2)(i). Thus, FDA has estimated a total reporting burden of 1 hour.
12 b. Annualized Cost Burden Estimate
FDA estimates the annualized burden hour cost to respondents for this collection of information to be approximately $111,308,113.64. FDA estimates that the prior notice process will involve an employee making an average wage similar that of a Federal government employee at the GS-11/Step-1 rate for the Washington-Baltimore locality pay area for the year 2010, which is $29.93 per hour. To account for overhead, this cost is increased by 100 percent, which is $59.86 per hour. Thus, the annual wage cost imposed by this collection of information is approximately $111,308,113.64 (1,859,474 hours x $59.86 per hour).
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.
14. Annualized
Cost to the
Federal Government
FDA’s
costs to develop the PN
System Interface
include design, development, and implementation, software and
security, and a network interface. FDA estimates that these costs
will total $12.5 million.
15. Explanation
for Program Changes or Adjustments
The
burden hours increased from 1,749,913 to 1,859,474 hours, a
difference of 109,561 hours. This is due to two factors. There was
a large increase in the total number of prior notices submitted, an
increase of 1,992,624 responses. The total number of responses is now
10,038,502. The second factor is a slight decrease in the estimated
time required for each respondent to complete these forms. Based on
experience in the field, FDA now estimates some required responses
have a slightly decreased burden. The net effect of these changes is
a burden increase of 109,561 hours.
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
There
are no reasons why display of the expiration date for OMB approval of
the information collection would be inappropriate.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
There
are no exceptions to the certification.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | omb |
| File Modified | 2010-11-05 |
| File Created | 2010-11-05 |