**BIOTERRORISM ACT OF 2002**

**PRIOR NOTIFICATION OF IMPORTED FOOD SHIPMENTS**

**SUPPORTING STATEMENT**

**0910-0520**

A.  **Justification**

1\. Circumstances Necessitating Information Collection

The Bioterrorism Act contains a provision requiring the Secretary,
through FDA, to develop regulations mandating notification to FDA prior
to the entry of imported food shipments. The provision also requires
that the article be held at the port of entry until the notice is
submitted and examined. The Bioterrorism Act also provides that the
importing of food or offering of food for import without notice is a
prohibited act. With respect to the implementation of this provision,
the Bioterrorism Act provides that the Secretary, through FDA, must
promulgate proposed and final regulations to implement the prior notice
requirement no later than December 12, 2003. The Bioterrorism Act also
provides that if FDA fails to issue a final regulation by this deadline,
prior notice of imported food shipments still must be given to FDA.

Section 801(m) of the Federal Food, Drug, and Cosmetic Act (the Act) (21
U.S.C. 381(m)) requires prior notification to the Secretary of Health
and Human Services of an article of food that is being imported or
offered for import into the United States.

Section 801(m)(1) of the Act states that the Secretary shall require
submission of notice providing the identity of each of the following:
the article of food; the manufacturer; the shipper; the grower, if known
at the time of notification; the originating country; the shipping
country; and the anticipated port of entry. Section 801(m)(2)(A) of the
Act states that the Secretary shall by regulation prescribe the time of
submission of the notification in advance of importation or the offering
of the food for import, which period shall be no less than the minimum
amount of time necessary for the Secretary to receive, review, and
appropriately respond to such notification, but may not exceed five
days. FDA's prior notification of imported foods regulation implements
these statutory provisions.

2\. How, By Whom, Purpose of Collection

To implement this provision of the Bioterrorism Act, the final rule
requires notice to be given to the FDA of imported food shipments prior
to their arrival at a U.S. port. The rule explains 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.

The information that the prior notice is required to contain is
consistent with the statutory directive, and benefits FDA in gathering
sufficient information to protect the U.S. food supply from
bioterrorism. Information necessary to collect includes the identity of
the article, the identity of submitter and transmitter, manufacturer,
shipper, and grower (if known), the country of production, the country
from which the article is shipped, and the anticipated port of arrival.
In addition, the notification must provide the identity of the person
who submits the prior notice, the importer, the owner, the consignee,
the carrier, the CBP entry number, anticipated time and date of arrival,
anticipated shipment information, and, if the food has been refused
admission and required to be held, the location where it is held. This
information will be collected electronically.

3\. Consideration Given to Information Technology

FDA is requiring electronic submission of the prior notification. The
Bioterrorism Act requires that FDA be given notice prior to arrival of
imported food shipments beginning December 12, 2003. In order to allow
industry to meet this requirement, FDA will utilize the Custom and
Border Protection's (CBP's) Automated Commercial System (ABI/ACS) for
the filing of most prior notices. FDA has developed its own web system
to handle the prior notices that will not be filed through CBP (mostly
international mail shipments and other informal import entries). At the
present time, much of the information required to be provided to FDA by
Section 307 of the Bioterrorism Act currently is supplied
electronically, in nearly all cases, by the importer to CBP through a
broker or self-filer.

4\. Identification of Duplicative Information

Similar information to that required by Prior Notice is currently
collected by CBP upon entry of the imported food shipments at a U.S.
border. However, the FDA prior notice requirement has a unique purpose
of helping to identify a potential import shipment that represents a
credible threat to human or animal health. This new information
collection will allow FDA to possibly deter or prevent attacks to the
U.S. food supply before the imported food shipment reaches the port of
arrival.

5\. Small Businesses

There is no statutory exception for small businesses in the statute. It
is likely that there will be some small importers adversely affected by
the prior notice requirement. FDA will attempt to assist these small
businesses to comply with prior notice through the CFSAN small business
office.

6\. Less Frequent Information Collection

FDA will require this information for each imported shipment of human
and animal food and dietary supplements. Without prior notice of every
imported shipment it would not be possible to ensure the safety of the
U.S. food supply from a credible threat to the health of humans and
animals.

7\. Information Collection Circumstances

There are no special circumstances.

8\. Consultations with Persons Outside the FDA

In the Federal Register of February 3, 2003, (68 FR 5428, FDA published
a Notice of Proposed Rulemaking asking for comments. FDA has reviewed
and considered over 400 comments before issuing this final rule.
Commenters were supportive of an electronic prior notice system that
utilizes CBP's existing entry information requirements. Comments also
stated concern for the prior notice minimum time frame; concern was
especially noted among those persons importing perishable seafood and
produce from Mexico, Canada, and Central America.

9\. Payment or Gift

This information collection does not provide for payment or gifts to
respondents.

10\. Confidentiality Provisions

This information collection will only be used to assure the safety of
the U.S. food supply. Identity of the information submitter will likely
be reported as an FDA firm registration number which is only obtainable
by FDA employees authorized to use the OASIS database system.

11\. Privacy

There would be no question of a personally sensitive nature associated
with the data collected.

12\. Burden of Information Collection

FDA estimates the burden for this information collection as follows:

  -------------------- ------------- ----------- ----------- ---------- ------------- ------------- -----------
  Table 1.\--Estimated                                                                              
  Annual Reporting                                                                                  
  Burden                                                                                            

  21 CFR Part 1,       No. Of        Annual      Total       Hours per  Total Capital Operating and Total Hours
  Subpart I            Respondents   Frequency   Annual      Response   Costs         Maintenance   
                                     per         Responses                            Costs         
                                     Response                                                       

  1.279-1.285^1^       77,427        1           77,427      40         \$6,194,000   \$743,000     3,097,080

  1.279-1.285^1^       7,743         1           7,743       40         \$620,000     \$74,400      309,715

  1.280-1.281^2^       77,427        84          6,500,000   0.384      \$0           \$0           2,500,000

  1.282^2^             77,427        3.36        260,000     0.5        \$0           \$0           130,000

  1.283(a)(2)(iv),     77,427        0.168       13,000      0.25       \$0           \$0           3,250
  1.285(c)(4)^2^                                                                                    

  1.283(a)(5)(ii)^2^   77,427        1.26        97,500      1          \$0           \$0           97,500

  1.283(a)(7)^2^       77,427        0.105       8,125       0.25       \$0           \$0           2,031

  1.283(a)(6)(i-iv),   77,427        0.168       13,000      8          \$0           \$0           104,000
  1.285(f)(1-4)^2^                                                                                  

                                                                                                    

  Total one time                                                                                    3,406,795
  burden hours                                                                                      

  Total recurring                                                                                   2,836,781
  burden hours                                                                                      
  -------------------- ------------- ----------- ----------- ---------- ------------- ------------- -----------

One time burden.

^2^ Recurring burden.

## Hour Burden Estimate: 

##  

[Number of establishments affected]{.underline}:

Using 2001 fiscal year information from FDA's OASIS system (industry
codes 02 through 52, 54, and 70 through 72), FDA has determined that
there are approximately 77,427 importers and consignees who receive
shipments of food imported or offered for import into the United States.
FDA does not have specific information on who will submit prior notice
since there are no restrictions on who can submit prior notice.
Therefore, FDA estimates prior notice submission information based on
the 77,427 importers of food in the OASIS database.

### New and closing importers

In addition to the U.S. importers currently in existence, in future
years new import businesses will open and some existing import
businesses will close. These new submitters would have to become
familiar with the FDA prior notice system and possibly obtain computer
equipment and Internet access to comply with prior notice requirements.

According to the Small Business Administration Office of Advocacy, in
2001, about ten percent of all businesses were new and ten percent of
businesses closed. Using the 10 percent opening and closing business
statistic, and given that there are currently 77,427 U.S. importers, FDA
assumes that on a yearly basis 7,743 importers will leave the market and
7,743 importers will enter the market.

*Hour Burden Estimate Researching the prior notice requirement*

####### Learning the final rule

To become familiar with the requirements for this final rule, FDA
estimates that one manager and two subordinates from each importing
business will attend an 8-hour training session on the prior notice
regulation. This one-time search burden for the existing importers is
about 1,858,248 hours (3 people per firm x 8 hours x 77,427 importers).
This portion of the estimate is for 21 CFR part 1, Subpart I,
1.279-1.285 and is shown in row 1 of Table1.

In the years that follow the start-up year for prior notice, it is
reasonable to expect a certain percentage of importing firms to enter
and leave the market. In addition to the first year burden to research
prior notice, it is expected that 185,832 hours will be spent annually
researching the prior notice requirement by the anticipated 7,743 new
importers entering the market annually that must learn about prior
notice (3 people per firm x 8 hours x 7,743 new importers). This portion
of the estimate is for 21 CFR part 1, Subpart I, 1.279-1.285 and is
shown in row 2 of Table1.

[Coordinating the information]{.underline}

FDA assumes it will take about two business days (16 hours) for an
administrative employee of the prior notice-submitting firm to
coordinate with others to establish new business practices required to
receive the information needed for prior notice. We assume this set-up
time is sufficient to coordinate information for existing importing
accounts. The total hours needed to gather information for existing
accounts is 1,238,832 (77,427 importing firms x 16 hours per firm). This
portion of the estimate is for 21 CFR part 1, Subpart I, 1.279-1.285 and
is shown in row 1 of Table1. Thus, the total burden listed in row 1 is
1,858,248 hours + 1,238,832 hours = 3,097,080 one-time burden hours to
learn the rule and coordinate information.

In addition to the first year coordination burden, we expect importing
businesses to see a 10 percent turnover in their accounts. Thus, in
future years, importing firms will spend 123,883 hours to gather
information on their new accounts. This portion of the estimate is for
21 CFR part 1, Subpart I, 1.276-1.285 and is shown in row 2 of Table 1.
Thus, the total burden listed in row 2 is 185,832 hours + 123,883 hours
= 309,715 one-time burden hours for new firms to learn the rule and
coordinate information.

*Submitting prior notice*

To estimate the repetitive effort of submitting a prior notice, FDA
assumes the activity takes one hour each time an import entry is
submitted. An import entry, on average, constitutes 2.6 different
articles of food; a prior notice must be submitted for each article of
food. Therefore we estimate that submitting prior notice for each
article of food will take 23 minutes to complete (23 minutes per line =
60 minutes/2.6 lines per entry). On an annual basis, submitting prior
notice will take about 2.5 million hours (23 minutes (or 0.384 hours)
per prior notice x 6.5 million notices). This estimate is for 21 CFR
part 1, Subpart I, 1.280-1.281 and is shown in row 3 of Table 1.

FDA does not have information on how many prior notices will come from
each of the 77,427 importers. However, we assume that 6.5 million prior
notices will be submitted annually based on fiscal year 2002 OASIS
information and estimates of prior notice capacity. We divide 6.5
million lines by the 77,427 importers to get an average annual response
frequency per importer of 84 notices.

####### Changes to a confirmed prior notice

The annual total number of changes made by importers to confirmed prior
notices will vary depending on the minimum prior notice submission time
required. For example, more confirmed prior notices will likely have to
be changed if the minimum prior notice submission time is noon the
calendar day before arrival as opposed to a minimum submission time of 2
hours before arrival. FDA's final rule requires a minimum prior notice
submission time of: 2 hours before arrival for articles of food imported
by vehicle, 4 hours before arrival for articles of food imported by rail
and air, and 8 hours before arrival for articles of food imported by
vessel.

By combining the percentages by mode of transport and taking into
account the location of the exporting country, we assume that about 4
percent of all prior notices (260,000 notices) will have to be
resubmitted after confirmation is received from FDA. We assume that
changes in the prior notices will be minor adjustments; therefore, both
the cancellation of the original notice and the resubmission of the new
notice are estimated to take about 30 minutes. This estimate is for 21
CFR part 1, Subpart I, 1.282 and is shown in row 4 of Table 1.

[Refused admission]{.underline}

An imported food product will be refused admission into the U.S. under §
801(m)(1) if it arrives at the port of arrival with untimely, inaccurate
or no prior notice. FDA estimates that about 130,000 of the annual prior
notices will result in a refusal (2 percent of 6.5 million prior
notices).

If an article of food is refused under § 801(m)(1), the food must be
held at the U.S. port of arrival or at secure storage until the prior
notice has been correctly submitted or until the product is exported.
FDA must be notified of the location where the food has been or will be
moved within 24 hours of refusal.

In many cases, the location notice will be given as part of a correction
and resubmission, as described in the next section. FDA estimates that
13,000 out of the 130,000 annual refusals will give the location notice
separately and that it will take about 15 minutes per prior notice to
notify FDA of the shipment's location. Even if moved to a secure
facility, most are located at the ports and are probably familiar to the
person giving notice. This will result in about 3,250 hours (13,000
notices x 0.25 hours). This estimate is for 21 CFR part 1, Subpart I,
1.283(a)(2)(iv) and 1.285(c)(4) and is shown in row 5 of Table 1.

[Correction and resubmission of prior notice]{.underline}

FDA estimates that 97,500 out of the 130,000 annual refusals will be
because of inaccurate prior notice requiring resubmission, or because no
prior notice was submitted. FDA estimates that it will take an hour to
cancel, correct, and resubmit, or submit (in the case of no notice) each
of these 97,500 notices. This estimate is for 21 CFR part 1, Subpart I,
1.283(a)(5)(ii) and is shown in row 6 of Table 1.

[Exportation of products refused admission]{.underline}

Some importers of articles of food that have been refused admission into
the U.S. will decide to export their product rather than try to submit
or resubmit prior notice. FDA estimates that this will occur for only
about 25 percent of the 130,000 articles refused admission for
inaccurate, untimely or no prior notice. If an article of food is
refused admission under 801(m)(1) and exported, FDA requests, but does
not require, that prior notice be cancelled. FDA estimates that for
these 32,500 articles of food, prior notice will be cancelled 25 percent
of the time and that this cancellation will take 15 minutes per article.
This estimate is for 21 CFR part 1, Subpart I, 1.283(a)(7) and is shown
in row 7 of Table 1.

[FDA Review request]{.underline}

If an article of food to be imported is refused under § 801(m)(1) or
placed under hold under 801(1), a request may be submitted asking for an
FDA review. FDA estimates that of the 130,000 articles of food that are
refused admission under § 801(m)(1) or placed under hold under 801(l)
yearly, 10 percent will request an FDA review (13,000 reviews). FDA
estimates that it will take the requestor about 8 hours to prepare the
factual and legal information necessary to request a review. Thus,
importers will spend about 104,000 hours on review requests annually.
This estimate is for 21 CFR part 1, Subpart I, 1.283(a)(6)(i-iv) and
1.285(f)(1-4) and is shown in row 8 of Table 1.

13\. Total Annual Cost

Since all prior notices must be submitted electronically, we assume that
the 3,097 responsible parties without Internet access will have to
purchase the appropriate computer equipment and gain Internet access to
transmit the information. Assuming computer equipment costs each firm
\$2,000 and yearly Internet access costs each firm \$240 (\$20 per month
for 12 months), this results in a one-time computer cost for these
facilities of \$6,194,000 and a recurring Internet access cost of
\$743,000. This estimate is for 21 CFR part 1, Subpart I, 1.279-1.285
and is included in row 1 of Table 1.

For the 7,743 new firms that enter the import market each year, we
expect 310 of them to need to purchase computer equipment and obtain
Internet access. On an annual basis we expect new importers to spend
\$620,000 on computers and \$74,400 on Internet access to be able to
submit their prior notice information. This estimate is for 21 CFR part
1, Subpart I, 1.279-1.285 and is included in row 2 of Table 1.

14\. Annual Cost to Government

FDA's costs will be to develop a stand-alone computer system to receive
prior notice submissions that cannot be handled through CBP's ACS. This
system will be used until Customs' new ACE system comes online, at which
time submissions to FDA's system and to CBP's ACS will be merged and
simplified. The costs to develop a stand-alone system include design,
development, and implementation, software and security, and a network
interface. FDA estimates that this will cost a total of \$12.5 million.

15\. Reason for Change

This is a new collection.

16\. Statistical Reporting

FDA has no plans for publication from this information collection.

17\. Display of OMB Approval Date

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", of OMB Form 83I

No exception to the certification statement identified in Item 19 of the
instructions for completing OMB Form 83-I has been identified.