time, the timeframes for submission of prior notice will remain the
same in the final rule as issued under the IFR (see Sec.  1.279).
3. Phase-In of FDA and CBP Timeframes
    When FDA reopened the comment period for the IFR on April 14, 2004
(see 69 FR 19763), FDA asked Flexible Alternative Question 6: ``If FDA
adopts reduced timeframes in the prior notice final rule, should FDA
phase in the shorter timeframes as CBP phases in the advance electronic
information rule?''
    (Comments) Most comments recommend integration of the phase-in of
reduced timeframes in association with CBP's schedule to promote
consistency between the programs, reduce errors, and minimize
disruption of supply chains through conflicting requirements. However,
one comment, in addition to recommending adherence to CBP's phase-in
schedule, also notes that they would not want FDA to delay adopting a
reduced timeframe for submitting prior notice merely because CBP is not
yet ready to implement the counterpart provisions of its advance notice
programs. In addition, they state that the deadlines are minimum
periods, and any shipper can provide more notice of imports, to FDA,
CBP or both, than the minimum timeframes in either regulation. They
recommend that FDA should shorten its lead times to match those in the
CBP regulations, even if the CBP requirements are not yet in place.
Another comment states that the phase-in plan, which is a port-by-port
implementation according to a time schedule, would be very problematic
to industry. The comment further explains that systems and operations
do not necessarily have the flexibility to switch on by individual site
or location and the current plan would introduce complication and
confuse the trade community. The comment recommends further discussion
with CBP and FDA as to development of a more viable and achievable
implementation plan.
    (Response) This issue is moot, as the final rule retains the
timeframes

established in the IFR, for the previously stated reasons.
4. Prior Notice Confirmation Number
    (Comments) One comment asks for clarification regarding when the
prior notice confirmation number is required to accompany the food.
    (Response) The prior notice confirmation number must accompany any
article of food arriving by international mail, when the food is
carried by or otherwise accompanying an individual, or when the prior
notice was submitted via FDA's PNSI.
    Under Sec.  1.279(e), the prior notice confirmation number must
accompany any article of food arriving by international mail. Under
Sec.  1.279(f), a copy of the confirmation (with the prior notice
confirmation number) must accompany any article of food carried by or
otherwise accompanying an individual (unless excluded under Sec.  1.277
(b)(1)), and be provided to CBP or FDA upon arrival. Additionally,
under Sec.  1.279(g) the prior notice confirmation number must
accompany any article of food for which the prior notice was submitted
through the FDA PNSI when arriving in the United States and must be
provided to CBP and FDA upon arrival.
    (Comments) One comment asked FDA to confirm whether it is
sufficient for an ocean carrier to have the prior notice confirmation
number on arrival or whether they are required to have the actual prior
notice confirmation also.
    (Response) Under Sec.  1.279(e), the prior notice confirmation
number must accompany any article of food arriving by international
mail. Additionally, under Sec.  1.279(g) the prior notice confirmation
number must accompany any article of food for which the prior notice
was submitted through the FDA PNSI when arriving in the United States
and must be provided to CBP and FDA upon arrival. Therefore, although a
prior notice confirmation number is required, the final rule does not
require that the actual prior notice confirmation has to be supplied
for food arriving by ocean carrier.
    (Comments) One comment states that when food arrives in the United
States, the carrier should present a copy of the prior notice
confirmation and the food to CBP. The comment asks if the submitter
should send the prior notice confirmation to the carrier company or to
the vessel that transported the food to the United States.
    (Response) As stated previously, Sec.  1.279(e) requires the prior
notice confirmation number to accompany any article of food arriving by
international mail. Additionally, under Sec.  1.279(g) the prior notice
confirmation number must accompany any article of food for which the
prior notice was submitted through the FDA PNSI when arriving in the
United States and must be provided to CBP and FDA upon arrival. How
persons importing or offering for import food into the United States
choose to comply with this requirement is a private matter (e.g.,
persons may decide to specify these obligations in the contract between
the exporting company and the carriers to ensure that the logistics are
worked out in advance).
    (Comments) Comments stated that the data requirements should be
reassessed to simplify and make the requirements more manageable. The
comment states that one data element should link all information
secured by prior notice, which would be beneficial for locating
shipments in the event of a possible crisis. The comments suggest that
FDA use bill of lading numbers as a single reference point because all
shipments that are moved are repeatedly covered by this number. This
would render the prior notice confirmation number currently used
redundant.
    (Response) FDA does not agree that the waybill/Bill of Lading can
be used as a single reference point for all shipments instead of the
prior notice confirmation number. A Bill of Lading number is not always
assigned to a shipment at the time of prior notice submission. For
certain shipments, such as those sent by international mail, no Bill of
Lading may exist. Thus, FDA has determined that it is better to use a
unique confirmation number provided by the FDA system to transmitters.
    (Comments) One comment notes that a separate prior notice is
required for each distinct food product and a prior notice confirmation
number is returned for each prior notice. Therefore, if a shipment
consists of multiple food products, the carrier would have multiple
prior notice confirmations upon arrival. The comment states multiple
prior notice confirmations do not align well with the commercial
realities of international trade, where the focus is on the entire
shipment, not the individual components. The comment recommends that
FDA provide a prior notice confirmation number that encompasses the
entire shipment.
    (Response) FDA disagrees. The carrier could be carrying articles of
food for different submitters or recipients. If it was necessary to
hold an article of food, the entire shipment would be held under the
above scenario suggested by the comment. Under the final rule, the
article of food that is subject to a hold can be offloaded and the rest
of the shipment allowed to proceed. This would not be the case if there
was only one prior notice confirmation number for the entire shipment.
5. 5-Day Maximum Pre-Arrival Limitation
    (Comments) Many comments requested that prior notice be allowed to
be submitted more than 5 days before arrival. This would allow
exporters to complete their documentation at the same time the bill of
lading and health certification is usually completed in the case of
food shipped by water. One comment contends that the 5 day limit does
not reflect the variable and unpredictable nature of transport and does
not reflect a risk-based approach to a potential bioterrorism threat.
Another comment contends that the limitation of the timeframe to 5 days
is problematic and is due to a misinterpretation of the statute. The
comment asserts that the statutory language does not preclude a party
from voluntarily providing prior notice more than 5 days in advance.
The comment also maintains that 10 days prior to arrival would provide
the necessary flexibility for their industry. A foreign government,
apparently assuming that prior notice must be submitted by the foreign
shipper or exporter, recommends that the time should be extended
because it may take the shipment 2 weeks to reach a U.S. port.
    (Response) In response to the concerns raised by the comments, we
have revised Sec.  1.279(b) to allow submission of prior notice more
than 5 days before arrival (except for articles of food imported or
offered for import by international mail). Specifically, this provision
permits prior notice submissions to be submitted no more than 30
calendar days before the anticipated date of arrival for submissions
made through ABI/ACS and no more than 15 calendar days before the
anticipated date of arrival for submissions made through PNSI. Due to
system limitations, the timeframes between ABI/ACS and PNSI are not
identical. Also, because of the way ABI/ACS is programmed, when prior
notice is submitted through ABI/ACS, the prior notice confirmation
number cannot be provided more than 5 calendar days before the
anticipated date of arrival.
    Please note that if any of the prior notice information, except the
anticipated arrival information, the estimated quantity, or the planned
shipment information, changes after FDA has confirmed the prior notice
submission for review, the prior notice must be resubmitted, as
provided by Sec.  1.282(a). The resubmission must be

confirmed by FDA for review no less than 2, 4, or 8 hours before
arriving at the port of arrival, with the minimum time depending on the
mode of transportation (Sec.  1.279(a)). If prior notice is
resubmitted, the previous prior notice should be cancelled (Sec.
1.282(b), (c)).
6. International Mail
    (Comments) There were no comments received regarding the timeframes
established for prior notice covering food arriving by international
mail.
    (Response) FDA retained the timeframes for submission of prior
notice for food arriving by international mail that are in the IFR.
    (Final rule) The final rule at Sec.  1.279(a) requires that you
must submit prior notice to FDA and the prior notice submission must be
confirmed by FDA for review as follows: If the article of food is
arriving by land by road, no less than 2 hours before arriving at the
port of arrival; if the article of food is arriving by land by rail, no
less than 4 hours before arriving at the port of arrival; if the
article of food is arriving by air, no less than 4 hours before
arriving at the port of arrival; or if the article of food is arriving
by water, no less than 8 hours before arriving at the port of arrival.
    Under Sec.  1.279(b), except in the case of an article of food
imported or offered for import by international mail, prior notice may
be submitted no more than 30 calendar days before the anticipated date
of arrival for submissions made through ABI/ACS and no more than 15
calendar days before the anticipated date of arrival for submissions
made through PNSI.
    Under Sec.  1.279(c), if the article of food is arriving by
international mail, the prior notice must be submitted before the
article of food is sent to the United States.
    Under Sec.  1.279(d), FDA will provide notification that the prior
notice has been confirmed for review with a reply message that contains
a prior notice confirmation number. The prior notice will be considered
submitted and the prior notice review time will start when FDA has
confirmed the prior notice for review.
    Under Sec.  1.279(e), the prior notice confirmation number must
accompany any article of food arriving by international mail. The prior
notice confirmation number must appear on the Customs Declaration that
accompanies the package. We provide CN22 or CN23 or a U.S. equivalent
as examples of the Customs Declaration.
    Under Sec.  1.279(f), a copy of the confirmation, including the
prior notice confirmation number, must accompany any article of food
that is subject to this subpart when it is carried by or otherwise
accompanies an individual when arriving in the United States. The copy
of the confirmation must be provided to CBP or FDA upon arrival.
    Under Sec.  1.279(g), the prior notice confirmation number must
accompany any article of food for which the prior notice was submitted
through the FDA PNSI when the article arrives in the United States and
must be provided to CBP or FDA upon arrival.

G. How Must You Submit the Prior Notice? (Sec.  1.280)

    Section 1.280 of the IFR required that prior notice must be
submitted electronically to FDA in the English language, except that an
individual's name, the name of a company, and the name of a street may
be submitted in a foreign language. All information, including these
items, must be submitted using the Latin (Roman) alphabet. The IFR
provided for two methods of electronic submission of prior notice: (1)
The CBP ABI/ACS; or (2) FDA PNSI at http://www.access.fda.gov.
    The IFR required submission of prior notice via FDA's PNSI for
articles of food imported or offered for import by international mail,
other transaction types that cannot be made through ABI/ACS, and
articles of food that have been refused under section 801(m)(1) of the
act and 21 CFR part 1, subpart I.
    The IFR also provided for contingencies if certain systems were not
working, e.g., a custom broker's or self-filer's system, ABI/ACS, PNSI,
or OASIS. The IFR required that prior notice must be submitted through
PNSI if a custom broker's or self-filer's system or if the ABI/ACS
interface is not working. The IFR also required that prior notice must
be submitted via e-mail or fax if PNSI or OASIS is not working. The IFR
did not exempt any specific categories of food articles from prior
notice if systems are not performing.
    In August 2004, FDA and CBP published guidance covering a
Contingency Plan for System Outages. This guidance can be accessed at
http://www.cfsan.fda.gov/~pn/pndguid.html. Comments addressing
contingencies will be discussed later in this section.
    Comments regarding how to submit prior notice are addressed
according to issue: General comments; comments about the ABI/ACS and
PNSI systems, including technical issues and security of the systems;
and comments about contingencies.
1. General Comments
    (Comments) One comment suggests that FDA should have CBP collect
and review all prior notices with one prior notice submission timeframe
for all agencies.
    (Response) FDA disagrees. The Bioterrorism Act, while providing for
the ability to commission other agencies to help implement the
provisions of the Bioterrorism Act, specifies that the Secretary is to
receive prior notice for all food imported or offered for import into
the United States. FDA personnel are trained and knowledgeable about
the risks and hazards involving food products under its jurisdiction
and have the expertise to review the prior notice submissions. The
integration of prior notice submission timeframes is discussed earlier
in this document under the discussion for Sec.  1.279.
    (Comments) Several comments suggest allowing the option of
submitting prior notice by fax or mail because not everyone has
Internet capability, access to a computer, or proficiency in English.
One comment asks that they be allowed to continue sending prior notice
by fax (as is allowed during certain contingency situations). Several
other comments suggest that international mail shippers are at a
disadvantage because many mail customers have no access to the
Internet, the pre-notification system is not customer-friendly, entries
take a long time, and the data requirements are too complex and
difficult for customers to determine.
    (Response) FDA does not agree that a process for manual
transmission is needed, except on a contingency basis. FDA believes
that persons engaged in international commerce have, or can get, access
to the Internet. If the Internet is not accessible by the submitter, he
or she can use a customs broker to submit prior notice through ABI/ACS
or another person to transmit prior notice through the FDA PNSI.
Allowing manual transmission would not give adequate time for FDA
personnel to receive, review, and respond, unless the timeframes for
prior notice in the final rule were greatly extended. Thus, manual
transmission will be used only as a contingency alternative.
    FDA also notes that the data quality of manual systems is usually
less than satisfactory, because no automated data validation takes
place during data entry. The U.S. Government has a strong commitment to
reducing paper-based processes and moving toward e-commerce for all
business transactions. Accordingly, under the final rule, paper-

based submissions will not be allowed, except on a contingency basis.
    In response to the comment that international mail shippers are
disadvantaged, FDA also notes that it has compliance policies to
address this situation. Its compliance policy under the IFR had been
that ``FDA and CBP should typically consider not taking any regulatory
action when an article of food is imported or offered for import for
non-commercial purposes with a non-commercial shipper'' without prior
notice. This applied to all such food subject to prior notice,
including food shipped by international mail. The Prior Notice Final
Rule Draft CPG, announced elsewhere in this issue of the Federal
Register, would continue that enforcement policy.
    (Comments) One comment suggests that instead of submitting prior
notice via PNSI, mail shippers be allowed to complete an alternate form
requiring minimal information that is similar to the Customs
Declaration form in the native language to be completed at the post
office. This comment argues that the current requirements are too
cumbersome for the average consumer. Similarly, another comment
suggests that FDA accept Customs Declaration Forms CN22 and CN23 in
lieu of submitting prior notice via PNSI for mail shippers. This
comment argues that such forms are much easier to complete and are
official documents prescribed by the Universal Postal Convention and
are used around the world. In the alternative, this comment suggests
that FDA accept data submitted by mail shippers via PNSI in a condensed
form determined by the foreign government's postal agency.
    (Response) FDA disagrees. Section 801(m) of the act requires the
prior notice submission to contain certain data elements, such as the
identity of the article of food, manufacturer and shipper of the
article, grower, country from which the article originates, country
from which the article is shipped, and the anticipated port of entry of
the article. Customs Declaration Forms are not adequate substitutes for
providing this information to FDA since such forms do not typically
require this kind of comprehensive information. Likewise, allowing a
foreign government's postal agency to determine which information to
submit to FDA also does not guarantee that we will receive the
information required by section 801(m) of the act. Therefore, FDA has
not provided an alternative form of prior notice submission for food
arriving by mail for commercial purposes.
    FDA again notes that it has compliance policies that address some
of the concerns raised by the comments. Its compliance policy under the
IFR had been that ``FDA and CBP should typically consider not taking
any regulatory action when an article of food is imported or offered
for import for non-commercial purposes with a non-commercial shipper''
without prior notice. This applied to all such food subject to prior
notice, including food shipped by international mail. The Prior Notice
Final Rule Draft CPG, announced elsewhere in this issue of the Federal
Register, would continue that enforcement policy. FDA believes that
this proposed compliance policy should not be extended to food that is
imported or offered for import for commercial purposes or with a
noncommercial shipper without prior notice. Mail shipments associated
with a commercial purpose pose a higher risk with respect to ability to
reach a greater number of people, and most commercial entities already
are familiar with submitting information to FDA and CBP.
    (Comments) One comment proposes a two-step process for filing prior
notice, whereby FDA would accept the same data submitted for CBP ABI to
satisfy the prior notice requirements at the first port of arrival.
Then, after accepting ABI data at the port of arrival, complete prior
notice data would be filed at the port of entry as step two of the
process. The comment contends that utilizing ABI data for prior notice
at the port of arrival would allow faster processing, which is a
significant issue considering FDA's concern about timely processing of
prior notice under a shorter time schedule. This more complete data
would be filed concurrent with the CBP clearance entry, and therefore
provide FDA with the level of data desired, while removing the issue of
time constraints under a reduced schedule measured against the port of
arrival.
    (Response) FDA disagrees. The purpose of section 801(m) of the
Bioterrorism Act is to ensure that FDA has sufficient information
before arrival so it can determine what foods to inspect at the border.
Therefore, all information required for prior notice must be submitted
prior to arrival, not just a portion of the information.
    Additional information may be required after arrival and for entry
admissibility decisions. That process is completed after arrival for
those foods offered for consumption in the United States. (See 68 FR
58974 at 58976 in the preamble to the IFR for additional discussion
about the relationship and differences between the prior notice
determination and the admissibility determination.)
    (Comments) One comment suggests the agencies should synchronize the
different filing systems so as to ensure that all notices can be made
via Automated Manifest System (AMS). Other comments request FDA to
coordinate prior notice with CBP's AMS to eliminate duplication of data
submissions.
    (Response) FDA disagrees. No interface currently exists between AMS
and the existing interface with FDA's OASIS through the ABI/ACS entry
processes, which means FDA does not have access to AMS data. FDA and
CBP have discussed interfacing with AMS for manifest data and
determined that the general cargo data in AMS are not suitable to
accommodate the detailed information requirements of section 801(m) of
the act. For example, AMS does not collect the country of origin. In
addition, its collection of the identities of the article of food and
its manufacturer differs from the way those are collected under the
prior notice interim final and final rules in such a way that the data
would not meet our needs in carrying out the purpose of section 801(m)
of the act.
    (Comments) One comment urges FDA to upgrade its systems to coincide
with normal commercial flow times and recommends that FDA consider the
approach used by the Census Bureau, i.e., providing a range of
automated filing options for meeting electronic filing requirements by
offering an Internet application, a direct link for certified filers,
and a personal computer (PC)-based application.
    (Response) FDA provides two methods for submitting prior notice:
One via ABI/ACS (a PC-based link for certified filers) and another via
PNSI (an Internet-based application). Prior notice is not required to
be filed at a specific time or during specific hours of the day, but
may be submitted 24 hours/day, 365 days of the year. The rule requires
FDA to receive the prior notice before the food arrives in the United
States, and the time frame is based on the mode of transportation (see
Sec.  1.279).
    (Comments) One comment suggests that FDA participate in the
International Trade Data System (ITDS), which provides for one-window
filing of trade-related information by motor carriers and other parties
through CBP's ACE system, to more effectively execute its Bioterrorism
Act mission.
    (Response) FDA is actively participating in the development of
CBP's ACE system and has long been a participant in the ITDS. However,
ACE is not yet a complete reality and prior

notice requirements have been in effect since December 12, 2003. FDA is
working with CBP and others in the international trade community to
ensure that the prior notice requirements are reflected in ACE once ACE
is fully operational.
    (Comments) One comment notes that exporters use different kinds of
transmission formats to send prior notice-related information to
importers or brokers in the United States. The comment further states
that since none of its member companies have received any notice from
FDA requesting changes in content or formatting of the transmitted
information, they assume that FDA is satisfied with their industry's
approach to regulatory compliance. In the event that FDA requires a
change to format or content of the reporting now conducted, the comment
requests that FDA notify companies well in advance of any such
requested change.
    (Response) FDA receives prior notice information via ABI/ACS or
PNSI. FDA expects that the transmitted information discussed in the
comment is submitted to FDA via one of these two methods in the proper
format. If the information is inaccurate, the food is subject to
refusal. Customs brokers are notified using typical procedures
regarding any changes relating to the rule that require an IT change to
ABI/ACS, including a 90-day lead time before implementation of the IT
change. FDA also provides tutorials on its Web site that explain
changes to PNSI (see http://www.cfsan.fda.gov/~pnts/pnsitut.html).
2. English Language
    (Comments) Many comments suggest that FDA program PNSI in other
languages, such as Japanese, Korean, German, and Spanish. These
comments state that ``mail users'' must rely on PNSI to submit prior
notice, and in many cases, English may not be the native language for
many of these users and puts them at a disadvantage, e.g., foreign
filers experience higher burdens and are frequently being timed out of
PNSI because it takes them longer to complete a prior notice. One
comment argues that a reason for noncompliance of prior notice
requirements is the inability to understand English well enough to
submit prior notice via PNSI.
    (Response) FDA agrees that a system available in multiple languages
would be advantageous for some users. However, the agency has assessed
the feasibility of providing and maintaining PNSI in multiple
languages, and has determined that the cost of developing translations
into one or more additional languages cannot be accommodated at this
time. The cost of updating the translations as new versions of the
system are developed would also be substantial. In addition, FDA notes
that other import documents required by FDA and by CBP must be filed in
English. Therefore, FDA does not plan to program PNSI in other
languages and the final rule will continue to require submission of
prior notice in the English language.
    FDA and CBP nonetheless have taken into account many of the
concerns referenced in the comments. For example, the final rule does
not apply to homemade foods shipped from an individual to an individual
in the United States (see Sec.  1.277, Scope, discussed supra). In
addition, the agencies' compliance policy under the IFR had been that
``FDA and CBP should typically consider not taking any regulatory
action when an article of food is imported or offered for import for
non-commercial purposes with a non-commercial shipper'' without prior
notice. This applied to all such food subject to prior notice,
including food shipped by international mail. The Prior Notice Final
Rule Draft CPG, announced elsewhere in this issue of the Federal
Register, would continue that enforcement policy.
    (Comments) One comment requests that other pieces of the prior
notice system also be available in other languages, such as the
tutorials for determining the FDA product code. Another comment
suggests that FDA provide foreign governments and trade organizations
with a detailed outline of the ``prior notice form'' with explanations
of the individual requirements so that they could be translated into a
foreign language and provided to affected companies.
    (Response) While many of the documents regarding prior notice
requirements have been translated into other languages, the PNSI
tutorials (available at http://www.cfsan.fda.gov/~pnts/pnsitut.html)
and the FDA Harmonized Tariff Schedule Codes guidance (available at
http://www.cfsan.fda.gov/~dms/htsguid3.html) have not been translated.
FDA intends to continue translating these and other prior notice
documents as resources permit. Documents that are available in other
languages are posted at http://www.cfsan.fda.gov/~mow/internat.html.
Foreign governments and trade organizations are welcome to translate
these documents and provide them to affected companies.
3. Technical Issues Concerning Both Systems
    (Comments) One comment suggests that both systems provide a link to
HTS codes.
    (Response) FDA agrees. Both PNSI and ABI/ACS provide a link to HTS
codes. FDA also has provided guidance regarding HTS codes and a
companion list of HTS codes flagged with prior notice indicators. The
guidance is posted at http://www.cfsan.fda.gov/~dms/htsguid3.html and
the updated list is posted at http://www.cfsan.fda.gov/~pn/
htscodes.html.
    (Comments) One comment states that railroads will not load cargo
until a prior notice confirmation number is provided, and a prior
notice confirmation number cannot be provided without complete planned
shipment information, including a railcar number.
    (Response) FDA notes that, while this situation seemed to be an
issue early in the implementation of the prior notice IFR, it is our
understanding and experience that the rail industry has now changed
business practices to address this concern. FDA received only one
comment on this issue and has not received any other feedback to
suggest this matter is still of concern. A check with a large rail
shipping company revealed that the restrictions for loading cargo are
not at issue; i.e. rail cars can be physically loaded with shipments
containing food prior to obtaining prior notice (Ref. 1). Therefore,
the prior notice filer does have the ability to obtain the rail car
number in order to file prior notice. The rail company did however
indicate that rail cars are not connected/added/attached to the U.S.
in-bound train until the rail company receives documentation that prior
notice has been filed.
    (Comments) One comment states that the FDA Help Desk, and other
methods now established for resolution of operational issues, simply
are not yielding a workable ``fix'' to the ``kinks'' in the new PNSI/
ABI system. Another comment recommends the establishment of a system
for swift resolution of technical and operational problems for both
systems.
    (Response) FDA agrees and has established an FDA Help Desk to deal
with technical issues involving PNSI. Questions and concerns about
operational, rather than technical, problems involving prior notice
should be directed to FDA's PNC. While the FDA PNC is available 24
hours a day, 7 days a week to respond to operational issues, it is not
equipped to resolve technical issues involving PNSI or ABI.

However, the PNC has a process in place to handle calls involving
technical issues and will forward those calls to the Help Desk. CBP
also has a well-established system of client representatives to deal
with technical problems involving ABI/ACS. CBP client representatives
are available to assist users with ABI issues. ABI operational issues
are the sole responsibility of CBP.
    (Comments) One comment states that the systems go down from time to
time, and all the time-consuming entry-work has to be repeated.
    (Response) PNSI has been enhanced to allow copying and saving of
prior notices within a Web entry and copying of a Web entry, with or
without the associated prior notices. Copying allows you to avoid
repetitive data entry for similar Web Entries and associated Prior
Notices. You also may cancel a Web Entry and then copy it, to correct
errors in a Web Entry you have already completed. Instructions for
copying a Web entry prior notice are available on FDA's Web site at
http://www.cfsan.fda.gov/~pn/pnstep2.html#copywe. ABI users are
responsible for their own software and its capability to save and/or
copy information that has not been transmitted.
    (Comments) One comment urges FDA to harmonize their efforts with
CBP with respect to the prior notification of food articles and to work
with CBP to integrate its joint administration and enforcement of prior
notice for both CBP and FDA. One comment recommends that both the FDA
and CBP systems be simplified to allow for both a decrease in data
entry time and a more efficient method for multiple data entries.
    (Response) FDA agrees and is continuously working with CBP to make
the administration and enforcement of prior notice as integrated and
efficient as possible. Both agencies recognize that ACE, when
initiated, will allow for a more harmonized process.
    With respect to multiple data entries, PNSI does offer several
features that make prior notice data entry faster and reduce the amount
of redundant data entry, such as the Copy Web Entry feature, Copy Prior
Notice feature, and other shortcuts. Please refer to Time Saving Tips
from the FDA PNC for PNSI (http://www.cfsan.fda.gov/~pn/pntips.html)
for a description of these features. Many private ABI software programs
also have features that provide a means for multiple data entries.
    (Comments) Several comments express concern about the timeliness of
receipt of the prior notice confirmation number. One comment states
that it can take an hour or more to receive the prior notice
confirmation number that is needed to move the cargo. Another comment
states that there have been several instances when the confirmation
response has been delayed and asks FDA to improve the timeliness of
this response.
    (Response) Generally, for prior notice submission via PNSI, the
user should receive their confirmation number immediately upon
submission of the correctly completed form. For those prior notices
submitted via ABI on the anticipated date of arrival, users can expect
to receive a response message (confirmation number or rejection) within
15 minutes of submission. For ABI submissions submitted prior to the
anticipated date of arrival, users can expect to receive their response
message no later than midnight (Eastern Time) on the anticipated date
of arrival.
    (Comments) One comment states that there are glitches in the
software that has been released. The comment notes that perfume is a
nonfood product that is subject to FDA's 801(a) jurisdiction, but it
does not require prior notice. However, in a procedures memorandum from
CBP, it appears that if you disclaim FDA in FD3, it is disclaimed for
all purposes. Similarly, if you acknowledge FDA jurisdiction in FD3,
then prior notice must be submitted whether or not the importation
involves food.
    (Response) We have provided instructions describing how to disclaim
an article for prior notice, while still sending information required
for FDA 801(a) admissibility. The instructions were included in at
least four separate ABI Administrative Messages issued by CBP beginning
in March 2004 (e.g., Administrative Message 04-0586, dated March 24,
2004). If merchandise marked FD3 in the Tariff Record is subject to
prior notice and 801(a) reporting requirements, the required prior
notice and 801(a) information should be transmitted. In cases where
801(a) information is required, and prior notice information is not
required, filers should transmit the ``PN disclaimer'' (PND) and the
information required for 801(a). In this case, the PND Affirmation of
Compliance (AofC) code must be the first AofC code recorded (FD01
Record-Positions 20-22) in the ABI transmission. The PND affirmation
does not require a qualifier. If the merchandise marked FD3 represents
an article exempt from all FDA reporting requirements, the line should
be disclaimed using the FD0 marker in the OA Record,\5\ as has always
been done for FDA disclaims.
---------------------------------------------------------------------------

    \5\ This is a ``Conditional Other Government Agency
Declaration'' input record that provides a code indicating that
there are/are not other government agency review requirements.
---------------------------------------------------------------------------

    (Comments) One comment believes there is a problem with the in-bond
system. The comment states that if it is assumed that a shipment
arrives in Los Angeles, but is destined for in-bond travel to New York,
the shipment is subject to prior notice upon arrival. In order to
properly comply with CBP requirements, the arrival date is entered
based upon the expected arrival date in New York. The data exchange
between CBP and FDA is then triggered by the New York arrival date
rather than the Los Angeles arrival date. The comment is concerned that
prior notice could be transmitted in a timely manner to CBP, but be
held up due to computer programming, making the prior notice untimely.
The brokers have fixed this problem in the short term by inputting the
Los Angeles arrival date in both places for prior notice purposes and
then changing it after prior notice has concluded.
    (Response) The anticipated arrival date is a requirement of prior
notice and is independent of CBP entry requirements. The Bioterrorism
Act requires submission of prior notice before the food arrives in the
United States, and not upon arrival as stated in the comment.
Therefore, in the example provided, prior notice is required before the
article of food arrives in Los Angeles notwithstanding any other CBP
entry requirements.
    For ABI entries requiring prior notice, the filer must enter
separate dates for purposes of entry and prior notice. The filer enters
an anticipated arrival date at the entry header level for CBP. For
purposes of prior notice, the filer also enters the anticipated arrival
date as an affirmation of compliance code ``ADA.'' Therefore, there
should not be a problem with choosing which date to submit as raised by
the comment.
    (Comments) One comment suggests that the systems provide a drop
down list of reasons that provide an explanation for the absence of the
registration number.
    (Response) FDA agrees. In the November 2004 revision of the CPG
that explained how FDA intended to enforce the prior notice IFR, a list
of reasons was provided as Appendix 1, Reason Codes for Registration
Number of Manufacturer Not Provided. This list of reasons is available
in both PNSI and ABI/ACS, and the reasons are available as a drop down
menu in PNSI. ACS is

programmed in ``batch mode'' which does not lend itself to drop down
menus. CBP also has issued Administrative Messages to ABI filers in
December 2004 and March 2005 concerning these reason codes. The Prior
Notice Final Rule Draft CPG that is announced elsewhere in this issue
of the Federal Register provides an updated list of reasons to be used
in certain limited situations when the manufacturer's facility
registration number is not provided in a prior notice submission.
    (Comments) One comment recommends that the required data elements
be identified so that shippers will know which elements are mandatory
and which are not.
    (Response) In the preamble to the IFR, FDA provided a table of the
data elements for reference describing in which situations the
information is mandatory (68 FR 58974 at 58980). The preamble of this
final rule also contains table 2 which describes the information
requirements. FDA also notes that PNSI is programmed such that if a
data element does not apply, the data element is not requested during
the prior notice submission process.
    (Comments) One comment states that when a prior notice confirmation
number is submitted to CBP and FDA, it is sometimes returned with a
different prior notice confirmation number. The comment asks why this
is and what happens to the original prior notice confirmation number.
    (Response) FDA acknowledges that this problem occurred in the early
stages of prior notice; however, we have rectified the situation. When
we received a report concerning this prior notice confirmation number
problem, we immediately modified our software to prevent the reported
problem from reoccurring.
4. ABI/ACS Interface
    (Comments) One comment states that the ABI system has been proven
to be the most efficient means for meeting the prior notice time
requirements.
    (Response) FDA agrees that for many submitters, the ABI interface
is the most efficient means for providing prior notice, as it allows
the data to be saved and used for entry purposes. FDA also acknowledges
that not all submitters have a custom broker, nor does ABI accommodate
all transactions subject to prior notice (e.g., food imported by
international mail or inside personal baggage not for personal use).
Accordingly, the final rule continues to provide for electronic
submission of prior notice via either ABI/ACS or PNSI.
    (Comments) One comment points out that some problems with
electronic submission of prior notice are being encountered by virtue
of the fact that not all brokers interact with FDA in a completely
electronic environment. ABI allows for the fully electronic
transmission of CBP and FDA data, but ``dual mode'' brokers must also
submit information to FDA in paper form. The comment recommends that
FDA encourage all brokers to participate in paperless electronic
processing.
    (Response) ``Dual mode'' filers are those who must submit paper
entries when transmitting entry information for FDA admissibility
consideration. However, for prior notice, any customs broker or self-
filer, including ``dual mode'' filers, may transmit using ABI/ACS or
PNSI.
    (Comments) One comment urges that for rail intermodal shipments
between points in Canada where the transportation transits the United
States, FDA should agree that data submitted to the CBP via AMS
constitutes advance notice under the FDA regulations.
    (Response) FDA disagrees. Under section 801(m) of the act, FDA, not
CBP, must receive prior notice. Furthermore, no interface currently
exists between AMS and the existing interface with FDA's OASIS through
the ABI/ACS entry processes, which means FDA does not have access to
AMS data. FDA and CBP have discussed interfacing with AMS for manifest
data and determined that the general cargo data in AMS are not suitable
to accommodate the detailed information requirements of the prior
notice rule. For example, AMS does not collect the country of origin.
In addition, its collection of the identities of the article of food
and its manufacturer differs from the way those data points are
collected under the prior notice final rule in such a way that the data
would not meet our needs in carrying out the purpose of section 801(m)
of the act.
    (Comments) One comment reports that foreign exporters are obliged
to use FDA's PNSI as they cannot register as users of CBP's ABI. The
comment contends that these exporters, not being able to combine prior
notice and a customs declaration for import in one operation, will be
in a disadvantaged position compared to U.S. importers because the
foreign exporter, after having completed his prior notice, will receive
a prior notice confirmation number, which he then has to transmit to
his U.S. importer or customs broker.
    (Response) FDA disagrees. Prior notice may be submitted
electronically through either ABI/ACS or PNSI. Typically, ABI/ACS is
used by a person who contracts with a filer who is licensed and
approved by CBP to use ABI/ACS. The submitter provides the filer with
the information necessary to transmit a complete prior notice through
ABI/ACS to FDA. This process is often used to combine the prior notice
and entry processes and many importers and foreign exporters find this
to be the most advantageous process. FDA and CBP provided the ability
to use ABI/ACS in response to comments to the proposed rule. As
expected, the ABI/ACS process is used in around 83 percent of prior
notice transmissions. PNSI was developed for those submissions that
cannot be accommodated by ABI/ACS, and for those who choose not to use
a customs broker for prior notice submissions, and these transmissions
represent about 17 percent of the total prior notice submissions.
    (Comments) One comment asks that the customs broker be allowed
access to all pertinent information by electronic means in order to
reduce the amount of paperwork required by the prior notice process.
    (Response) The means by which the submitter provides the
transmitter with the required information is a matter of communication
between the submitter and transmitter. The final rule neither requires
nor precludes processes the parties select to handle these
communications.
    (Comments) Several comments request that the agencies change the
process for resubmission of prior notice after the original prior
notice or entry has been cancelled and when prior notice is submitted
after the food is already in the United States. One comment asks that
the system interface be modified so that the resubmission automatically
cancels the original. Another comment suggests that in the case where
the foods are already in the United States and the CBP entry has had to
be cancelled and resubmitted, it should not be necessary to repeat the
prior notice filing; filing entry should be sufficient. Another
suggests that when the second entry is made, CBP allow for submission
of the previous prior notice confirmation number rather than the
creation of a new prior notice with an accompanying new prior notice
confirmation number. Other comments suggest that ABI submission of
prior notice be allowed for food in the United States. An additional
comment states that CBP entry can be made for articles of food that are
already in the United States without adequate prior notice. Another
comment recommends that FDA consider allowing the submission of prior
notice through the ABI interface even when that prior notice will not
be

timely. Finally, one comment suggests that a new prior notice should
not be required when errors are made and that an easier way should be
created to provide for corrections.
    (Response) In the case of a prior notice submitted after the food
has arrived, the prior notice is inadequate because of no prior notice
and the food may be refused. The post-refusal prior notice (i.e., the
prior notice submitted after arrival) may only be submitted via PNSI
until such time as ACS or its successor system can accommodate such
transactions. The changes to the system requested by the comments
cannot be accommodated since such revisions would require programming
changes to ACS, which CBP is currently only maintaining, and not
enhancing since its replacement system (ACE) is being developed.
    (Comments) One comment suggests that because errors in the ABI
system need to be corrected in a timely manner to facilitate
transmission of prior notice, CBP should be required to be available 24
hours a day, 7 days a week to allow for correction of these clerical
errors.
    (Response) Inasmuch as the filer has submitted a certified summary
that the filer wishes to change, the cancellation of the entry is more
than just a simple correction to an ABI transmission. This change
requires review because it affects the integrity of cargo release.
Accordingly, any corrections to certified entry information must be
done during normal business hours.
    (Comments) Several comments suggest that PNSI, in its validation
processes, should include a check to see if other notices are already
on file for the same article and that a warning message should be
established to indicate a duplicate prior notice is being filed.
    (Response) FDA disagrees. The prior notice submission process
allows for transmission through either ABI/ACS or PNSI. The prior
notice confirmation number is unique to a transmission through either
system but cannot be matched against other transmissions at this time.
Programming PNSI to locate duplicate prior notices would require a
considerable amount of resources, which would yield minimal benefit
since the submitter would know about the duplicate submission after
transmitting the prior notice.
    (Comments) Several comments request resolution of a PN/ABI system
interface obstacle that requires that CBP entry and prior notice be
made at the same time. The comment contends that prior notice must be
submitted before entry can be made (e.g., for quota class merchandise
subject to CBP ``live entry'' requirements) and current system
configurations can make it impossible to comply with both CBP and prior
notice requirements. The comment recommends that CBP and FDA create a
procedure in ABI/ACS that allows the CBP entry to be generated, but not
filed, at the time a prior notice is submitted.
    Another comment states that filers are insisting on submitting the
entry information to CBP via ABI at the same time that they are
submitting the prior notice information to the FDA. This apparently
creates situations where the food is loaded and ready for shipment
before there is a form of electronic release and this situation negates
CBP's Customs-Trade Partnership Against Terrorism (C-TPAT) and the Free
and Secure Trade (FAST) program requirements. The proximity of certain
border points means that although the timeframe has been met with CBP
for electronic release via CBP's PAPS, it is difficult to meet the
present timeframes of the prior notice as the filer takes a longer time
to submit both entries via ABI.
    (Response) We disagree. Prior notice and entry need not be made at
the same time. Prior notice is a precondition of entry and must be made
first but may be done independently of the entry by use of FDA's PNSI
or CBP's ``WP'' transaction in ABI. These systems allow for an
independent submission of prior notice even if no entry has been filed.
The entry filer may then provide the prior notice confirmation number
to CBP as part of the entry. The entry will be validated in the CBP/FDA
interface and will be allowed if the prior notice has been completed.
The importer and filer may make a business decision to file the prior
notice with the entry, and FDA and CBP's systems can accommodate this
practice.
    Because the entry and prior notice submissions may be completed
independently, the timeframes are dependent on how the parties at
interest choose to file entry and prior notice: The one-step (prior
notice with entry) or two-step (independent prior notice followed by
entry) process. This allows them to meet both timeframes, which
represent two agencies, two processes, and two different sets of
requirements.
    (Comments) One comment contends that the lack of uniformity between
the PNSI and CBP requirements for transmission of carrier information
causes confusion to filers and FDA/CBP staff. The comment contends that
providing the Standard Carrier Abbreviated Code (SCAC) code for the
carrier in lieu of the carrier's name and country is only available
when transmitting via PNSI because the CBP system, which is how the
majority of prior notices are being transmitted, requires the name and
country and does not provide the SCAC option.
    (Response) FDA disagrees. The SCAC or International Air
Transportation Association (IATA) codes can be transmitted via ABI/ACS
via an Affirmation of Compliance. The CBP requirement to provide the
name and country of the carrier is for purposes other than prior
notice.
    (Comments) Several comments recommend an interface between the CBP
manufacturer identity (MID) codes and the FDA food facility
registration numbers. Specific recommendations include that: (1) CBP
allow the MID system to be updated via prior notice submissions; (2)
FDA develop an interface with CBP that allows for validation and
coordination of data between these two systems; (3) ABI provide a
notification to the filer if the information from the MID does not
match the facility registration information on file with FDA; and (4)
the agencies permit incorrect and duplicate MID information to be
corrected though a secure CBP system. Another comment recommends the
establishment of a system that validates data and resolves any conflict
between CBP and FDA data.
    (Response) With respect to correcting and updating MIDs, CBP does
not believe it is possible to eliminate all differences between MIDs
and related FDA manufacturing facility registration numbers. The same
manufacturer may have numerous MIDs, and conversely, a MID may identify
more than one manufacturer due to the nature of the algorithm that is
employed.
    With respect to the comment that asks that FDA develop an interface
with CBP to allow for validation and coordination of data, FDA and CBP
currently exchange facility data electronically as part of the prior
notice and 801(a) processes. CBP sends FDA the MID and facility
information (including registration number, when applicable). FDA
performs edits to ensure that the MID matches the firm represented by
the registration number. In certain cases, FDA will reject a prior
notice submission that does not match a MID submission. Filers will
receive an ABI rejection communication identifying the mismatch when
this occurs. Once the facility and all other required information has
been received and validated, FDA will confirm the prior notice
submission.
    (Comments) Several comments suggest that when a prior notice is
transmitted via ABI/ACS and confirmed for review by FDA, the data
should be

moved from ACS to OASIS regardless of the estimated time of arrival
(ETA) date.
    (Response) The ABI/ACS system is not configured to certify
information nor transfer information to FDA in real-time as PNSI does.
ACS is programmed to collect data in batch mode and does not transmit
the data to FDA instantaneously. Therefore, prior notices submitted via
PNSI will continue to receive a real-time system response when the
prior notice is confirmed for review by FDA. However, prior notices
submitted via ABI/ACS will continue to be transmitted in a batch mode
and to receive systematic confirmation responses in the pre-arranged
timeframes developed by CBP. For those prior notices submitted via ABI
on the anticipated date of arrival, users can expect to receive a
response message (confirmation number or rejection) within 15 minutes
of submission. For ABI submissions submitted prior to the anticipated
date of arrival, users can expect to receive a response message no
later than midnight (Eastern Time) on the anticipated date of arrival,
i.e., the message generally is sent before 11:59 p.m. on the day before
the anticipated date of arrival.
    (Comments) Several comments state that although PNSI is designed to
not require changes in the location of the anticipated port of arrival
(thus allowing a shipment to be diverted to a port other than the
intended port of arrival transmitted in the prior notice), the CBP ABI
system precludes the CBP entry from being accepted at other than the
reported port of entry. When this occurs, the CBP entry and original
prior notice must be deleted and a new entry must be submitted with a
new prior notice creating a new timeframe. The comments recommend that
the requirement be consistently applied and that the ABI/ACS system be
revised to allow for changes to the port of entry without causing
cancellation of the CBP entry.
    (Response) FDA disagrees. The prior notice rule does not require a
new prior notice when the anticipated port of arrival changes after the
prior notice has been confirmed for review by FDA. CBP does require
cancellation of entry documentation for entry purposes when the port of
entry changes. The cancellation of an electronic ABI entry for CBP
results in the cancellation of any associated prior notices filed with
the entry in ABI. Amending ABI/ACS to allow amendments, such as when
the port of entry changes, would entail substantial and costly
revisions to the system; such technical changes are not cost-effective
or a good use of limited resources given the development of the
Automated Commercial Environment, which will replace ACS.
    (Comments) One comment recommends that for a short trial period,
the full prior notice edits, with warning messages, should be turned on
without rejection of CBP entry processing. The comment reasons that
this would be a method of alerting ABI/ACS transmitters to errors
without jeopardizing the movement of the food. Another comment suggests
that a significant reason for a high rate of noncompliance on data
submissions is the lack of the automated systems' capability to advise
filers of data inadequacies.
    (Response) The systems provide for error messages to be transmitted
to filers that identify the reasons for errors in prior notice
submissions that can be determined during the data entry process (e.g.,
certain required data elements are missing or product code submitted is
invalid). Over time, the agencies have seen the prior notice rejection
rate go down. Both agencies have been providing industry with
information regarding error messages.
    (Comments) One comment points out that the PNSI Web portal has
changed to allow multiple containers to be reported against a single
prior notice line but that CBP has not changed their specifications to
allow more than a single container to be reported on a prior notice
line in ABI. The comment recommends that this change to the FDA Web
portal be communicated to CBP so they may change their ABI
specifications.
    (Response) ABI currently allows filers to submit multiple container
numbers per FDA line by sending multiple FD05 records containing
affirmation of compliance code ``CNO.'' The first affirmation goes in
the FD01 record, with subsequent affirmations in the FD05 record which
can be repeated as often as necessary. Filers are able to submit
multiple records using the affirmation of compliance code ``CNO'' and
provide a different container number in each record.
5. PNSI
    (Comments) One comment suggests that to more effectively screen
shipments entering the United States, FDA must work to integrate OASIS
with the prior notice system.
    (Response) FDA's OASIS has always been an integral part of the
prior notice process as OASIS provides for internal systematic
screening of prior notice submissions in order to assist the agency in
making a determination regarding inspection of the food at the border.
OASIS also provides for systematic screening to assist FDA in making
admissibility decisions.
    (Comments) Several comments request extension of the time one is
permitted to be logged into a session using PNSI. Comments state that
it is difficult to complete entering data before the system times out.
Several comments suggest that completing the process in time was
difficult for many persons whose native language is not English.
    (Response) For security reasons, PNSI is currently configured with
a 30-minute time-out. FDA notes that Internet commerce systems are
typically configured with a similar, or more stringent, time-out
setting. FDA also notes that the time-out setting applies only to a
period of user inactivity; no limit is set on the total amount of time
the user may be logged into a particular session, nor is there a limit
to the amount of time taken to prepare and save or submit a specific
Web entry or prior notice. Users are ``timed-out'' only if their
session remains inactive for longer than the time-out setting.
    Users may also save their entry while it is partially completed.
The data are retained and will be available when the user logs back
into the system.
    (Comments) Several comments express concern about the capacity of
the FDA computer systems to process the volume of submissions. These
comments suggest that the system needs additional capacity to meet the
loads expected when full enforcement is instituted. Several comments
also believe that performance issues (e.g., slow response) are
hampering their usage of the system.
    (Response) FDA recognizes these concerns and is committed to
providing systems that will meet user needs. FDA designed the prior
notice systems to process a volume of users far in excess of the
projected usage. Prior to implementation, FDA thoroughly tested the
performance of its system against loads in excess of that anticipated.
These tests have shown the system capable of maintaining acceptable
response even at these loads. Currently, FDA handles approximately
167,000 prior notices each week and could handle a much higher volume
without a capacity problem.
    Many factors influence the responsiveness of an Internet based
system, including factors beyond the FDA's control, such as the user's
computer system (hardware, software, and Internet connection) and
traffic on the Internet as a whole. Since prior notice was implemented
in December 2003, FDA has carefully monitored both PNSI and OASIS
system usage and

performance. During this period, no issues related to load on these
systems have been identified. FDA has worked to resolve specific
issues, such as hardware failures, which have hampered system
performance and availability for short periods.
    FDA and CBP also have increased the capacity of the communications
link between their systems to ensure that additional bandwidth is
available for future increases in load. FDA continues to monitor its
system and to test for performance as the system is upgraded and
enhanced. Users may obtain current system status information for PNSI
at the FDA Industry Systems home page (http://www.access.fda.gov) and
are requested to contact the Help Desk if they encounter any
performance issues currently not identified on the system status page.
    (Comments) Several comments recommend that FDA develop an alternate
system that supports batch submission of prior notices. The comments
suggest that a batch system would save submitters a vast amount of
input time and allow the agency faster processing capability. The
comments also assert that a batch system would reduce the costs
incurred due to double entry between the user's existing systems, e.g.,
for order entry and filing with FDA. One comment proposes that they be
given a defined quantity of registration numbers at their disposal for
printing onto their dispatch labels (presumably by registration number
they are referring to the prior notice confirmation number). The
comment says they would like a fully automated process, where all data
relevant for prior notice would be created and then transmitted
electronically to CBP and FDA, instead of the current procedure of
manual input of all details.
    (Response) FDA agrees that a mechanism to facilitate batch/fully
automated filing would provide some advantage to certain filers.
However, FDA believes that the existing systems (PNSI and ABI)
currently provide substantial capabilities in this area. PNSI offers
several features that make prior notice data entry faster and reduces
the amount of redundant data entry such as the Copy Web Entry feature,
Copy Prior Notice feature and other shortcuts. Please refer to Time
Saving Tips from FDA's PNC for PNSI (http://www.cfsan.fda.gov/~pn/
pntips.html) for a description of these features. ABI software can
often provide similar copying features, depending on the ABI software
package used by the transmitter.
    FDA also recognizes that the resources to develop and maintain an
additional system would be significant. Therefore, FDA is not prepared
to undertake the development of a batch system at this time; following
completion of any system upgrades that will be released in conjunction
with implementation of the final rule, FDA will reassess the need for
and feasibility of developing a batch submission system. FDA notes that
some submitters have created their own internal programs that are
designed to organize data in ``batch'' mode, which in turn submits
their prior notices to PNSI in rapid succession.
    (Comments) One comment states that they frequently ship the same
article of food in multiple containers. The comment believes that since
there is only one article of food, only one prior notice should be
required. The comment notes that the FDA Web Portal only allows the
input of one container per prior notice; therefore, they have to submit
multiple prior notices instead of only one. The comment requests that
the FDA Web Portal be changed to allow for the input of multiple
containers per article of food.
    (Response) FDA agrees. The FDA Web Portal has been changed to allow
multiple containers to be reported against a single prior notice line
in the above situation.
    (Comments) One comment states that most of their orders contain
multiple food items in one box and the process of filing prior notice
in PNSI for each item is very time consuming because one can only enter
one item at a time. The comment suggests updating PNSI to allow users
to enter multiple items on one screen (i.e., the user creates a Web
entry for each shipment and the system then allows them to specify all
items in that shipment on one screen).
    (Response) A prior notice contains information on not just the
article of food being imported, but also the facilities related to that
article such as the manufacturer, shipper, owner and ultimate
consignee. Since this information can be unique for each article, it
must be provided for each article individually. PNSI does offer several
features that make prior notice data entry faster and reduce the amount
of redundant data entry such as the Copy Web Entry feature, Copy Prior
Notice feature and other shortcuts. Please refer to Time Saving Tips
from FDA's PNC for PNSI (http://www.cfsan.fda.gov/~pn/pntips.html) for
a description of these features.
    (Comments) One comment states that FDA's Web Portal does not accept
the input of CBP entry numbers. The comment further states that there
are times when an entry number is not required for an article of food
that requires prior notice. The comment questions why the FDA Web
Portal does not accept an entry number when a CBP entry is required and
known at the time of filing prior notice. Another comment recommends
that the Web Portal software be redesigned in order for filers to
receive the relevant entry identifier information with the prior notice
confirmation number.
    (Response) FDA disagrees. PNSI does accept the CBP entry number. If
there is no entry number or other entry identifier, PNSI will provide a
system-generated entry identifier to the prior notice submission. We
also posted guidance on FDA's Web site at http://www.cfsan.fda.gov/~pn/
pnentgui.html that describes the entry types and the entry identifiers.
(See also discussion infra on the CBP entry identifier in section
III.H.5 of this document.)
    (Comments) Several comments express concern about system outages
for PNSI and/or ABI. These comments suggest that one or both systems
had not been available for extended periods in the past or were
frequently unavailable. Comments also recommend that FDA provide an
alternate method, such as facsimile, for submission during periods when
the systems are not available. One comment notes that PNSI has not been
functioning properly. The comment states that the System Status update
pages indicates that the system is operating as ``normal,'' but the
system is really down.
    (Response) FDA recognizes that system outages could have the
potential to disrupt trade. To minimize outages, FDA has built
redundancy into these computer systems (e.g., multiple servers and
backup systems) and, to the extent possible, combined planned
maintenance activities to be accomplished during a single outage.
Planned outages are scheduled for a timeframe with the minimum possible
impact to users and notice is provided as far in advance as possible,
allowing users to plan their access to the system. System status
information, including planned outages, is posted at http://
www.access.fda.gov and at http://www.cfsan.fda.gov/~furls/fisstat.html.
Users are requested to contact the Help Desk if any performance issues
not identified on the system status page are encountered.
    FDA also provides alternate options for users to file prior notice
during system outages. Filers who use CBP's ABI/ACS system can utilize
PNSI when ABI, ACS, and/or OASIS are unavailable. In addition, FDA has
provided a method for filing via facsimile or e-mail when PNSI is

unavailable for an extended period (see the Contingency Plan for System
Outages at http://www.cfsan.fda.gov/~pn/pndguid.html). These
contingency plans are designed to ensure that the flow of trade is not
interrupted when system outages cannot be avoided (see also the
discussion on contingency plans below).
    (Comments) One comment notes that companies continue to report
technical difficulties when using PNSI, including the inability to
access reliable technical advice through the hot-line. Another comment
indicates that the waiting time for the helpline is very long, with a
minimum wait time of 15 minutes.
    (Response) FDA has made a number of enhancements and has fixed
several issues with earlier releases of PNSI. FDA also continues to
work to provide the best possible service addressing technical issues
through the Help Desk. Users are encouraged to continue to contact the
Help Desk for technical assistance. The Help Desk is available Monday
through Friday from 7:30 a.m. to 11 p.m. Eastern Time. Users may leave
a message or send e-mail at other times, which will be addressed on the
next business day.
    (Comments) Several comments address the complexity of PNSI. The
comments state that the system requires the complete re-creation of all
data for each prior notice even when shipments are repetitive with
minimal variables in information; that the full address should not be
necessary for registered facilities; and that PNSI should allow
submitters to save and store data for replication or provide for self-
populating fields. One comment, however, notes that their users have
had relatively little problem using PNSI.
    (Response) FDA continues to provide, to the extent possible, a
``user-friendly'' PNSI application. Several features have been added
since the initial release (PNSI 1.0) to assist users, including a
feature that allows users to copy individual prior notices and Web
Entries, with or without the associated prior notices. Where possible,
lists of standard values (e.g., entry types, SCAC & IATA Codes, firm
types, quantity and packaging descriptions) are provided to facilitate
entry of these values. These enhancements minimize the need for users
to enter repetitive information. Similar to the IFR, the prior notice
final rule does not require the full address in all cases. When a
registration number is provided, name, city and country can usually be
provided instead of the name and full address (e.g., Sec.
1.281(a)(6)). FDA continues to work to enhance the system, in response
to user comments, as well as to changing business requirements.
    (Comments) One comment asks if PNSI will provide guidance on
formatting of the information for identification of the submitter,
transmitter, and manufacturer. The comment is concerned that PNSI may
only accept certain formatting, without providing guidance to the
submitter, thereby, causing problems with PNSI accepting and processing
prior notice.
    (Response) PNSI is supported by several tutorials and help screens
which lead the user through correct inputting of data.
    (Comments) Several comments address specific issues with the PNSI
software (potential ``bugs'') or suggestions for enhanced capabilities.
Examples include questions about the completeness of the lists of
values (drop-down lists), issues with browser settings and
compatibility, and suggestions for additional bar code printouts.
    (Response) FDA welcomes user suggestions for improvements to the
PNSI system. Discrepancy reports are investigated thoroughly to ensure
the system meets both FDA's requirements and user needs to the extent
possible. Suggested improvements are also prioritized and reviewed by a
Change Control Board who continue to determine appropriate and feasible
improvements to the system. FDA encourages users to continue to contact
the Help Desk with any technical questions, issues, or suggestions.
    (Comments) One comment suggests that PNSI should be revised to
create a view screen similar to the printed confirmation with all the
information in one place before submission. The comment also suggests
that when creating a prior notice for different commodities, the system
should not have all commodities default onto prior notice, but should
allow the user to use a check box to choose a commodity, rather than to
cancel the commodity.
    (Response) FDA agrees. The PNSI software has been enhanced to
provide a screen that includes all of the information about the prior
notice prior to a transmitter completing the submission step. PNSI also
has been enhanced to allow copying of prior notices within a Web Entry
and copying of a Web Entry, with or without the associated prior
notices. A user thus can copy a Web Entry with all associated prior
notices, then use the cancel function to remove any prior notices not
required for the new entry.
    FDA welcomes any additional comments or suggestions on how to
improve PNSI; these can be submitted to the Help Desk using the
telephone number or e-mail provided at http://www.cfsan.fda.gov/~furls/
helpf.html.
6. Security of the Systems
    (Comments) One comment suggests that FDA create a mechanism whereby
interested parties may assert protection from public disclosure under
FOIA for information contained in prior notices that they believe is
confidential business information.
    (Response) We believe that there is no need to create such a
mechanism because the agencies would review the prior notice
information to determine if it is protected by a FOIA exemption before
disclosure to the public.
    (Comments) One comment states that in order to complete the PNSI
submission, several security settings on their respective computers had
to be disabled.
    (Response) PNSI is designed to work with the browsers listed at
http://www.access.fda.gov/, using standard settings. PNSI requires that
the browser be set to accept cookies. FDA does not believe that these
settings present a security risk to users. Users are encouraged to
contact the Help Desk for assistance with specific issues regarding
access and system settings.
7. Contingency Plans
    In Sec.  1.280(b), (c), (d), and (e) of the IFR, FDA requires that
if a custom broker's or self-filer's system is not working or if the
ABI/ACS interface is not working, prior notice must be submitted
through PNSI. It further states that if the PNSI is not working and/or
OASIS is not working, FDA will issue an Internet notification, and
submission of prior notice must be by e-mail or by facsimile to FDA.
FDA posts the e-mail or facsimile information on its Web site. The
prior notice information will only be accepted at the posted e-mail or
facsimile locations if FDA determines that PNSI or OASIS is not
working.
    On August 12, 2004, FDA and CBP published guidance covering a
Contingency Plan for System Outages (see http://www.cfsan.fda.gov/~pn/
pndguid.html/). FDA and CBP identified seven potential system downtime
scenarios that could impact transmission, confirmation, and processing
of prior notice submissions and developed alternative submission
options for each of the identified scenarios.
    (Comments) One comment states that FDA and CBP need to formulate
and communicate a realistic contingency plan for commercial
importations that takes into account CBP ABI downtime, FDA OASIS
downtime, and broker

downtime. Two comments express concern that contingency plans include a
dependency on PNSI and their experience has shown that PNSI was
intended for the casual importer and never intended for commercial
operations. The comment states that significant delays will be
experienced if 80 percent of the transactions are suddenly routed from
the ABI/ACS system to the PNSI system.
    (Response) FDA is committed to providing systems that will meet
user needs. FDA designed PNSI to process a volume of users far in
excess of the projected usage, and tested performance at these volumes.
As noted previously, FDA and CBP published guidance covering a
Contingency Plan for System Outages (see http://www.cfsan.fda.gov/~pn/
pndguid.html/) and anyone may submit comment on it.
    (Comments) One comment suggests that FDA and CBP provide guidance
that defines an appropriate timeframe to wait for prior notice
confirmation before assuming the system is down and/or that
resubmission is required.
    (Response) Generally, for prior notice submissions via PNSI, the
user should receive a confirmation number immediately upon submission
of the correctly completed form. For those prior notices submitted via
ABI on the anticipated date of arrival, users can expect to receive a
response message (confirmation number or rejection) within 15 minutes
of submission. For ABI submissions submitted prior to the anticipated
date of arrival, users can expect to receive a response message no
later than midnight (Eastern Time) on the anticipated date of arrival,
i.e., the message generally is sent before 11:59 p.m. on the day before
the anticipated date of arrival.
    The FDA/CBP Contingency Plan states that ``notice advising of any
available downtime specifics will be posted at http://
www.access.fda.gov, http://www.fda.gov, http://www.cfsan.fda.gov/
~furls/fisstat.html, and http://www.cfsan.fda.gov/~pn/pnoview.html, and
through messages in ABI/ACS (see 21 CFR 1.280(d)).'' Section 1.280(c),
(d), and (e) of the IFR also lists three of these four Web sites to
advise of system downtimes, and specifies in what form prior notice
should be submitted during certain system outages (i.e., e-mail or
fax). In order to simplify the Web addresses for these notifications
and the instructions for submitting prior notice when PNSI or OASIS is
not working, the final rule has been revised by providing the outage
notification at one Web address (http://www.fda.gov). In order to
provide more flexibility to respond to various contingencies, the final
rule has also been revised by stating that FDA will accept prior notice
submissions in the format it deems appropriate during the system(s)
outage.
    FDA has posted information on the Systems Status Web site located
at http://www.cfsan.fda.gov/~furls/fisstat.html regarding system
downtime that states ``Most problems will be temporary. Try accessing
the system again in 15 minutes.'' This site also provides information
about scheduled maintenance, which states that ``Periodically FDA
Industry Systems will need to undergo maintenance and upgrades. All
scheduled maintenance will take place on Saturdays 3 a.m. to 8 a.m.
Eastern Time (Saturday 8 a.m. to 1 p.m. GMT). If you are having trouble
accessing FDA Industry Systems during that time, please try again after
8 a.m. Eastern Time on Saturday (1 p.m. GMT).'' This site also provides
a status history of the system.
    (Comments) One comment suggests that FDA should develop and publish
a form that could be used if it were ever necessary to file prior
notice by fax. The comment asserts that a form also would assist
importers in gathering the information necessary to file a prior notice
and also would clear up the confusion that currently exists in foreign
countries. The comment believes that it was obvious that FDA
contemplated issuing a form when it first proposed the prior notice
regulations and complains that no explanation has been given by FDA for
not producing the form.
    (Response) FDA disagrees. A form to be used during contingencies is
posted on FDA's Web site only when an applicable system outage is
encountered. During a system outage when fax submissions are being
accepted, FDA will publish the fax telephone number for the PNC at
http://www.access.fda.gov, http://www.fda.gov, http://
www.cfsan.fda.gov/~furls/fisstat.html, and http://www.cfsan.fda.gov/
~pn/pnoview.html, as well as through messages in ABI/ACS. Fax
transmission is not allowed except when posted and submitted during
PNSI downtimes or specified emergencies. FDA believes that if the form
was available and posted even as a reference, there is the potential
for misuse or confusion. Our experience with use of the fax form is
that submitters will continue to fax the form even after they have been
instructed that the form will not be accepted.
    (Comments) Some comments express concern that submission of all
prior notices relies on electronic systems (even the fax). The comments
suggest that the usual flow of goods should be allowed to continue
unhindered, with the paperwork sorted out afterwards. One comment
further suggests that rather than providing for PNSI as a contingency
system when ABI is down, prior notice submissions should function
according to all other submissions processed through ABI when CBP
declares either a ``national snow day'' or ``power outage.'' The
comment recommends that if ABI is not working, the shipment should be
allowed to proceed, pending later issuance of a prior notice
confirmation via ABI.
    (Response) FDA does not agree that if ABI is not working the
shipment should be allowed to proceed. In that instance, prior notice
can, and therefore should, be submitted via PNSI.
    In all contingency situations, except for power failure, some
electronic means of prior notice submission is required, either by
PNSI, e-mail, or fax. However, in the case of a localized or regional
power failure, the Contingency Plan guidance recommends that filers
should submit the required prior notice information to FDA at the port
of arrival, or if there is no FDA officer at a given port, to CBP via a
paper copy of the prior notice e-mail contingency form (FDA 3540) at
the time of cargo release.
    (Comments) One comment explains that various companies are
organizing contingency plans whereby the prior notice confirmation
number will be included in the delivery order, which then will be faxed
to the office of the steamship line at the port of entry so that the
requisite paperwork is in hand when the product is offloaded from the
carrier. The comment further explains that this contingency plan takes
into account the unique circumstances posed by transporting goods by
steamship line insofar as the customs broker or purchaser may not
always be able to send the prior notice confirmation number to the
carrier prior to the carrier's arrival. The comment asserts that the
procedure satisfies FDA's requirements that the prior notice
confirmation number must accompany the food when it ``arrives in the
United States'' and be provided to CBP or FDA ``upon arrival.'' The
comment further urges FDA to include this course of action in its
guidance documents.
    (Response) FDA agrees that the described scenario satisfies the
requirement under Sec.  1.279(g) that the prior notice confirmation
number must accompany any article of food for which the prior notice
was submitted through PNSI when the article arrives in the United
States and must be provided to

CBP or FDA upon arrival. FDA does not believe, however, that it is
necessary to include this specific business practice in its guidance
documents, as there are various means that private entities may choose
to use to comply with the regulation.
    As described in the contingency plan guidance, if prior notice
already has been submitted via ABI/ACS prior to an interface outage,
and confirmation from FDA already has been received, then the submitter
may proceed with prior notice using the standard process under the
following scenarios:
     ACS, OASIS, and PNSI are all operational, but the link
between ACS and OASIS is down on FDA's or CBP's side of the system
interface;
     ACS, PNSI, and the link between ACS and OASIS are
operational, but OASIS is non-operational;
     ACS and the link between ACS and OASIS are operational,
but OASIS is non-operational and PNSI is non-operational or unavailable
due to Internet service interruptions;
     OASIS, PNSI and the link between ACS and OASIS are
operational but ACS is non-operational; or
     ACS is non-operational, PNSI is non-operational or
unavailable due to Internet service interruptions, and OASIS and the
link between ACS and OASIS are either operational or non-operational.
    The standard process does not include presentation of the prior
notice confirmation number to FDA or CBP upon arrival if the prior
notice was submitted by ABI/ACS.
    If prior notice already has been submitted via ABI/ACS and
confirmation from FDA has not been received prior to the interface
outage, FDA and CBP recommend that rather than resubmitting via PNSI,
submitters should provide to CBP officers, at the time of cargo
release, an endorsed (signed) copy of the ABI transmission or some
other evidence adequate to show that prior notice has been submitted
via ABI/ACS.
    If prior notice has been submitted via PNSI prior to the system
outage and a confirmation number already has been received, the
confirmation number must accompany the article of food (Sec.
1.279(g)). In addition, FDA and CBP recommend that the submitter also
provide the PNSI confirmation page, including the prior notice
confirmation number and time stamp, to CBP officers for cargo release.
If the prior notice confirmation page is not provided, this may delay
cargo release while the CBP officer contacts FDA for verification of
the prior notice confirmation number(s) and time of submission.
    (Final rule) The final rule in Sec.  1.280(a) requires that prior
notice must be submitted electronically to FDA in the English language,
except that an individual's name, the name of a company, and the name
of a street may be submitted in a foreign language. All information,
including these items, must be submitted using the Latin (Roman)
alphabet.
    Section 1.280(a)(1) and (a)(2) of the final rule provides for two
methods of electronic submission of prior notice: (1) The CBP Automated
Broker Interface of the Automated Commercial System (ABI/ACS); or (2)
The FDA PN System Interface (PNSI) at http://www.access.fda.gov. We
corrected a reference in paragraph (a) to state that unless Sec.
1.280(c) applies, prior notice must be submitted through either ABI/ACS
or PNSI.
    The final rule requires submission of prior notice via PNSI for
articles of food imported or offered for import by international mail,
and other transaction types that cannot be made through ABI/ACS. Prior
notice for articles of food that have been refused under section
801(m)(1) of the act must be submitted through PNSI until such time as
ACS or its successor system can accommodate such transactions.
    The final rule also provides for contingencies if involved systems
were not working, e.g., a custom broker's or self-filer's system, ABI/
ACS, PNSI, or OASIS. The final rule requires that prior notice must be
submitted through PNSI if a customhouse broker's or self-filer's system
or if the ABI/ACS interface is not working. The final rule states that
if PNSI or OASIS is not working, FDA will post prominent notification
and instructions at http://www.fda.gov. FDA will accept prior notice
submissions in the format it deems appropriate during the system(s)
outage. The final rule does not exempt any specific categories of food
articles from prior notice if systems are not performing.

H. What Information Must Be in a Prior Notice? (Sec.  1.281)

    The Bioterrorism Act requires the submission to the Secretary of a
notice providing the identity of each of the following: The article;
the manufacturer and shipper of the article; if known within the
specified period of time that notice is required to be provided, the
grower of the article; the country from which the article originates;
the country from which the article is shipped; and the anticipated port
of entry for the article.
    The IFR requires in Sec.  1.281(a), (b), and (c) that specific
information be submitted in prior notice: Section 1.281(a) covers
general information requirements which apply to all shipments except
those arriving by international mail; section 1.281(b) covers limited
information requirements for food arriving by international mail; and
section Sec.  1.281(c) covers information requirements for food refused
under section 801(m) of the act (e.g., food that has already arrived in
the United States).
    The preamble to the IFR discusses the term, ``an article of food,''
and states that ``the description of an `article' of food is not the
same as the definition of `food' in Sec.  1.276(b)(5). An `article'
refers to a single food that is associated with the same complete FDA
Product Code, the same package size, and the same manufacturer or
grower. These requirements are found in the information required in the
IFR in Sec.  1.281(a)(5), (a)(6), or (a)(7) and again in Sec.  1.281(b)
and (c)'' (68 FR 58974 at 59003).
    The comments are discussed in order of the information requirement
in the IFR, beginning with comments generally addressing the
information requirements.
1. General Comments
    (Comments) Several comments express concern that the IFR requires
significantly more information than the Bioterrorism Act requires and
ask that FDA reduce the number of data elements. One comment notes that
the Bioterrorism Act names only six or seven specific items that must
be provided. One comment indicates that the information required for
prior notice is far in excess of that required in the Codex Committee
on Food Import and Export Inspection and Certification Systems
Guidelines for Generic Official Certificate Formats and the Production
and Issuance of Certificates (CAC/GL 38-2001). One comment adds that
the required information far exceeds what is necessary to enable FDA to
identify articles of food that need to be inspected. Another comment
suggests that some of the information required for a prior notice is
already ``covered'' by the registration requirement of section 305 of
the Bioterrorism Act (see the Registration of Food Facilities Under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 interim final rule, 21 CFR part 1, subpart H, confirmed 70 FR
57505, October 3, 2005), so FDA will already have this information.
Another comment suggests that the prior notice could be simplified,
thus reducing the possibility of errors and potential trade
disruptions, by quoting the registration number and only adding
information

specific to a particular shipment. One comment notes that CBP's data
fulfill FDA's needs; therefore, the IFR's duplicate system is a waste
of resources, and FDA should use CBP's system.
    (Response) FDA disagrees with the comments that ask for a reduction
in the number of required data elements. FDA has selected those data
elements that will allow FDA to meet its statutory obligation to
receive, review, and respond to prior notices efficiently and
effectively. In addition to the Bioterrorism Act's requirements of the
identities of the article of food, the manufacturer and shipper, the
grower, if known, the country from which the article originates, the
country from which the article is shipped, and the anticipated port of
entry for the article, FDA determined that certain additional
information is required for efficient enforcement of the Bioterrorism
Act, primarily for the means of identifying the article of food and
effective enforcement of refusals. For example, the identification of
the individual and the firm, if applicable, submitting the prior notice
is needed so that FDA knows who is responsible for the information in
the prior notice and can communicate with them when necessary via mail,
phone, or e-mail. The information also is necessary to follow up when
audits, inspections, or enforcement are necessary. Therefore, FDA does
not agree with one of the comment's assertions that the prior notice
rule should only require the registration number and other information
specific to a particular shipment.
    The goals of the Bioterrorism Act and the Codex Committee differ,
and thus, the requirements of the prior notice rule will differ from
that of the Codex Committee on Food Import and Export Inspection and
Certification Systems. The purpose of prior notice is to enable FDA to
conduct inspections of imported foods at U.S. ports upon arrival and
target foods that may pose a significant risk to public health, based
on the information submitted. The Codex Committee on Food Import and
Export Certification and Inspection Systems is charged with developing
principles and guidelines for food import and export certification and
inspection systems.
    We also do not agree with the comment's assertion that FDA should
use CBP's data to fulfill FDA's needs under the Bioterrorism Act.
Information that is submitted at the time of CBP entry processing is
not useful for prior notice as this information can be submitted or
changed after the food has already arrived in the United States and
thus does not fulfill the express intent of the Bioterrorism Act that
FDA receive information about a shipment before it arrives in the
United States.
    FDA also does not agree that some of the prior notice information
is already ``covered'' by the food facility registration requirement.
For example, facilities typically provide general product categories as
part of the registration process. This generalized information would
not provide the identity of the article being imported or offered for
import and, therefore, would not meet the prior notice requirements as
defined in section 801(m) of the act. Therefore, we do not agree that
some of the registration information could be used to meet the prior
notice information needs. Moreover, a facility's registration contains
all of the general food product categories the facility manufactures,
processes, packs or holds; and would not allow FDA to know specifically
which article of food is the subject of the prior notice, which
precludes an effective assessment of risk.
    (Comments) Several comments recommend that the limited information
requirements associated with food arriving by international mail in
Sec.  1.281(b) be applied to all importations. One comment suggests
that by eliminating such data as the entry type and identifier, the
port of entry, the FDA Product code, and the HTS code, all prior
notices could be submitted via FDA's PNSI at an earlier time. The
comment further asserts that the requirement for these types of data is
the primary reason that 80 to 90 percent of prior notices are submitted
via ABI/ACS rather than PNSI. Another comment reasons that as the
manufacturer and facility identification numbers are not provided for
homemade food or postal shipments, the necessity of providing this
information for other types and modes should be examined. Another
comment recommends that the notification procedure should be
simplified, and that the data elements should be limited to the
minimum, such as the shipper's name and its contact point, the food
facility registration number, and food product codes.
    (Response) FDA disagrees. The type of information required for
prior notice submissions of food arriving by international mail are
limited because of the process by which international mail enters the
United States. For international mail shipments, the IFR and the final
rule requires the identification of the U.S. recipient rather than the
importer, owner, or ultimate consignee because mail is sent only to a
U.S. recipient rather than the multiple entities that may be involved
in a traditional commercial importation. The final rule does not
require an entry identifier because international mail will always
receive a system-generated identifier, as international mail shipments
cannot be submitted via ABI/ACS. Because the port of entry and time and
date of entry are completely subject to the international mail process,
the IFR requires only that the submitter identify the date of shipment,
i.e., the date the food is shipped, which provides the most information
possible to satisfy the anticipated port of entry. Moreover, since
international mail is always in the custody of CBP until it is released
for delivery to the recipient, no additional shipment information is
necessary for communication between FDA and CBP.
    FDA also disagrees that information, such as the entry type and
identifier, the port of entry, and the FDA Product Code should be
eliminated from the prior notice requirements. The anticipated port of
entry is specifically required by the statute and FDA has determined
that the best possible method of determining product identity is the
FDA Product Code. We have eliminated the HTS code in the final rule
because it has not been a necessary factor for enhancing communication
between FDA and CBP for the purpose of inspection at the port of
arrival. However, the entry type and identifier are critical elements
in communications between FDA and CBP so that the appropriate food is
either held at the port of arrival as appropriate, or allowed to
proceed.
    FDA also disagrees with the suggestion that the manufacturer and
facility registration numbers are not provided for homemade food or
postal shipments and, therefore, should not be required for other types
of shipments. The IFR excludes homemade food from prior notice
requirements entirely, and this exclusion also is in the final rule.
Both the IFR and the final rule require submission of the identity of
the manufacturer and the manufacturer's registration number in the
prior notice for food arriving by international mail.
    FDA agrees with the comments that prior notice requirements should
be limited to the minimum, and has selected those data elements that
will allow FDA to expeditiously meet its statutory obligation to
receive, review, and respond to prior notices. FDA, however, does not
agree with the comments that the shipper's name and its contact point,
the registration number of food facility, and food product codes are
the only data elements FDA needs to fulfill this mandate. In addition
to the Bioterrorism

Act requirements of the identities of the article of food, the
manufacturer and shipper, the grower, if known, the country from which
the article originates, the country from which the article is shipped,
and the anticipated port of entry for the article, FDA determined that
certain additional information is required for efficient enforcement of
the Bioterrorism Act, primarily for the means of identifying the
article of food and effective enforcement of refusals.
    FDA also notes that it is not surprising that 80 to 90 percent of
prior notices are submitted via ABI/ACS. Numerous comments on the
proposed rule urged FDA to use the existing ACS-OASIS interface between
CBP and FDA to accept prior notice information. As stated in the IFR,
FDA and CBP agreed with the recommendation that the agencies provide a
single point of data entry for CBP and FDA for as many kinds of entries
as possible, and modified our systems to allow prior notice to be filed
by either CBP's ABI/ACS or FDA's PNSI beginning with the December 12,
2003, effective date of the IFR. FDA also noted at that time that it
expected approximately 90 percent of prior notice submissions for all
importations of foods to be transmitted by a customs broker or self-
filer through the ABI/ACS interface to FDA. (See 68 FR 58974 at 58976,
October 10, 2003.) Since implementation, this estimate has proven true,
as approximately 83 percent of all prior notices are filed through the
ABI/ACS interface.
    (Comments) Several comments suggest that all prior notice
information requirements that are duplicative of information
requirements for CBP via AMS for Advanced Electronic Information or in
ABI/ACS for Entry should be eliminated. One comment recommends that
prior notice be aligned with CBP ``ACI'' rules, for both timing and
data elements. The comment believes that this could lead to a possible
reduction in data elements.
    (Response) FDA disagrees. Information that is submitted for CBP
entry processing is not useful for prior notice as this information can
be submitted or changed after the food already has arrived in the
United States and prior notice is required before the food arrives.
    Moreover, no interface currently exists between AMS and the
existing interface with FDA's OASIS through the ABI/ACS entry
processes, which means FDA does not have access to AMS data. FDA and
CBP have discussed interfacing with AMS for manifest data and
determined that the general cargo data in AMS are not suitable to
accommodate the detailed information requirements of section 801(m) of
the act. For example, its collection of the identities of the article
of food and its manufacturer differs from the way those are collected
under the prior notice interim final and final rules in such a way that
the data would not meet our needs in carrying out the purpose of
section 801(m) of the act.
    (Comments) Many comments suggest that submitters consolidate
similar prior notices into one prior notice based on a variety of
reasons, e.g., one prior notice per consignee with all food products
consolidated; one prior notice per shipment with all information
consolidated; one prior notice per commodity regardless of the
quantity, size, color or species; one prior notice per bill of lading;
one prior notice per truck or conveyance and one prior notice for the
same food type regardless of brand.
    (Response) The Bioterrorism Act requires notice for each article of
food and requires in that notice, for each article of food, certain
information. As stated in the IFR, an ``article'' refers to a single
food that is associated with the same complete FDA Product Code, the
same package size, and the same manufacturer or grower (68 FR 58974 at
59003). This is consistent with how entry is filed with CBP. An article
of food is a unique item related to a specific manufacturer or grower
and a specific process or size. All of these pieces of information are
critical for a risk-based assessment of the food. The ABI/ACS system
provides the capability to submit information for multiple food items
as lines in a single entry, when entry level information is consistent
for a number of articles in a shipment. For example, shipment level
information, such as estimated time of arrival, can be captured once
for all articles within a shipment. The ability to minimize data entry
by copying specific information from one article, or line, to another
depends upon the sophistication of the software being used by the
submitter to create the submission to CBP. The FDA PNSI allows for
simplified submission of similar articles of food by allowing the
submitter to easily repeat common information (e.g., FDA product code,
manufacturer, etc.) while entering different quantities (e.g., amount
and package size). Both systems thus significantly reduce the amount of
repetitive entry. The prior notice requirements in the IFR or the final
rule do not require the submission of the brand for the article of
food.
    (Comments) One comment suggests that different programs should not
require different information requirements. The comment particularly
focuses on FAST and C-TPAT and recommends that prior notice submissions
for those participating in these programs should be subject to fewer
information requirements.
    (Response) FDA disagrees. All of the information required in a
prior notice is necessary for determining what articles to inspect upon
arrival and otherwise carrying out section 801(m) of the act. The
information is initially screened electronically in order to expedite
the PNC's review. If less information is provided, regardless of
whether the food is covered by some other program, then the result of
that screening would be less reliable. This issue is discussed further
in section III.D.6.a of this document (``Additional Exclusions
Requested--Special Programs (C-TPAT/FAST) and Flexible Alternatives--
General Comments'')
    (Comments) Two comments refer to submission of ``blanket'' prior
notices; one referencing repetitive shipments of analytical samples and
the other suggesting a summary of daily shipments.
    (Response) FDA disagrees that it should change its approach from
the IFR. As stated in the preamble to the IFR (see 68 FR at 59003), an
article of food is a unique item related to a specific manufacturer or
grower and a specific process or size. All of these pieces of
information are critical for a risk-based assessment of the food. FDA
currently receives most of this information from customs brokers or
self-filers via ABI/ACS. The ABI/ACS system also provides the
capability to submit information for multiple food items as lines in a
single entry, when entry level information is consistent for a number
of articles in a shipment. For example, shipment level information,
such as estimated time of arrival, can be captured once for all
articles within a shipment. The ability to minimize data entry by
copying specific information from one article, or line, to another
depends upon the sophistication of the software being used to create
the submission to CBP. The FDA PNSI is designed to allow for simplified
submission of similar articles of food by allowing the submitter to
easily repeat common information (e.g., FDA product code, manufacturer,
etc.) while entering different quantities (e.g., amount and package
size). Both systems will thus significantly reduce the amount of
repetitive entry of information while preserving the identity of each
article of food. Moreover, the purpose of prior notice is for FDA to
receive, prior to arrival, information about each article of food being
imported or offered for

import for the purpose of enabling such article to be inspected at
ports of entry into the United States. Receiving blanket prior notices
would not provide the necessary information nor would a daily summary,
which by definition would be after-the-fact, not prior to arrival.
2. The Submitter
    In Sec.  1.281(a)(1), (b)(1), and (c)(1), the IFR requires
submission of the name of the individual submitting the prior notice
and his/her business address, telephone number, fax number, e-mail
address, and the name and address of the submitting firm, if
applicable. If a registration number is provided, city and country may
be provided instead of the full address.
    (Comments) Several comments assert that it is duplicative and
unnecessary to require not only the corporate name and address of the
submitter but an individual's name, telephone number, fax number and e-
mail address as well. The comments contend that this information
already should exist in the FDA registration database and that the name
of the submitting firm should be sufficient. The comments assert that
in today's job market, individuals change jobs more frequently, thereby
making the maintenance of this level of specificity in a database time
consuming with minimal benefit.
    However, another comment states that the regulatory provisions in
the prior notice IFR are silent regarding which person(s) will be
contacted by FDA and/or CBP when an issue or problem arises regarding a
prior notice and urge FDA to clarify that in refusal circumstances, the
agency will contact the person who submitted the prior notice (i.e.,
the submitter or the transmitter.) The comment further states that by
reason of his or her knowledge and/or access to the necessary
information, as well as having the implicit authority and
responsibility to properly file the prior notice, the submitter or
transmitter typically will be in the best position to take corrective
action as expeditiously as possible.
    (Response) FDA has determined that a fax number is not necessary
for communication with the submitter. However, the identification of
the individual and the firm, if applicable, submitting the prior notice
is needed so that FDA knows who is responsible for the information in
the prior notice and can communicate with them when necessary via mail,
phone, or e-mail. The information submitted must provide sufficient
information to enable FDA to communicate questions, concerns, or
enforcement information with the submitter. See section III.J.1 of this
document regarding inadequate prior notice (Sec.  1.283(a)(1)) for a
discussion of communication of refusals.
    (Comments) One comment suggests that there should be an option to
identify whether or not the submitter is C-TPAT certified.
    (Response) As we previously explained in the discussion under our
assessment of timeframes (see section III.F of this document), C-TPAT
participation will not affect timeframes, the amount of information
required to be submitted under prior notice, or decisions made during
the prior notice review process. Thus, the costs to submitters and the
government of submitting such information would not provide benefits.
FDA will continue to coordinate with CBP for administration of C-TPAT
as it applies to FDA-regulated products, particularly as it relates to
admissibility decisions under section 801(a) of the act. However, the
prior notice final rule will not require that the submitter self-
declare as C-TPAT certified or not C-TPAT certified.
    (Comments) One comment asks if it is possible for a submitter to
have his/her legal residence in the country of origin.
    (Response) Neither the IFR nor the final rule limits the residence
or location of the submitter. Section 1.278 of the final rule states
that any person with the knowledge of the required information may
submit a prior notice.
    (Final rule) The final rule requires in Sec.  1.281(a)(1), (b)(1),
and (c)(1) the submission of the name of the individual submitting the
prior notice and his/her business address, telephone number, and e-mail
address, and the name and address of the submitting firm, if
applicable. We reworded the last sentence of these paragraphs for
clarity to state that if the business address of the individual
submitting the prior notice is a registered facility, then the
facility's registration number, city, and country may be provided
instead of the facility's full address.
3. The Transmitter
    Section 1.281(a)(2), (b)(2), and (c)(2) of the IFR requires the
submission of the identity of the transmitter, if different from the
submitter. The IFR requires the name of the individual and firm, if
applicable, transmitting the prior notice on behalf of the submitter
and his/her business address, and phone number, fax number, and e-mail
address. If a registration number is provided, city and country may be
provided instead of the full address.
    (Comments) A comment states that the regulatory provisions in the
prior notice IFR are silent regarding which person(s) will be contacted
by FDA and/or CBP when an issue or problem arises regarding a prior
notice and urges FDA to clarify that in refusal circumstances, the
agency will contact the person who submitted the prior notice (i.e.,
the submitter or the transmitter.) The comment further states that due
to his or her knowledge and/or access to the necessary information, as
well as the implicit authority and responsibility for properly filing
the prior notice, the submitter or transmitter typically will be in the
best position to take corrective action as expeditiously as possible.
    (Response) FDA agrees. The identification of the individual or the
firm, if applicable, transmitting the prior notice is needed so that
FDA knows who is responsible for transmitting the information in the
prior notice and can communicate with them when necessary via mail,
phone, fax, or e-mail. Moreover, the information submitted must provide
sufficient information to enable FDA to communicate questions,
concerns, or enforcement information with the transmitter. See section
III.J.1 of this document regarding inadequate prior notice (Sec.
1.283(a)(1)) for a discussion of communication of refusals.
    (Comments) Some comments ask if FDA would clarify what
distinguishes the submitter from a transmitter and if it is possible
for an authorized transmitter to have his/her legal residence in the
USA.
    (Response) The submitter is any person with knowledge of the
required information. The transmitter is the person who transmits the
required information on behalf of the submitter. The submitter and
transmitter may be the same person. (See Sec.  1.278) The final rule
does not limit the residence or location of the transmitter.
    (Final rule) If the prior notice is transmitted by a person other
than the submitter, the final rule in Sec.  1.281(a)(2), (b)(2), and
(c)(2) requires the name of the individual and firm, if applicable,
transmitting the prior notice on behalf of the submitter and his/her
business address, telephone number, fax number, and e-mail address. We
reworded the last sentence of these paragraphs for clarity to state
that if the business address of the individual transmitting the prior
notice is a registered facility, then the facility's registration
number, city, and country may be provided instead of the facility's
full address.
4. The CBP Entry Type
    Section 1.281(a)(3), (b)(3), and (c)(3) of the IFR require
submission of the

[[Continued on page 66343]]

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[[Continued from page 66342]]

entry type, which for Sec.  1.281(b)(3) will be a mail entry.
    (Comments) Two comments ask for clarification of the CBP entry type
data element and request a list of all of the options for entry type.
    (Response) FDA needs this information both for screening to
identify the appropriate articles for inspection and for communication
between the FDA and CBP staff at the port. Also, the entry type
determines which entry identifiers should be used (entry number, in-
bond number) to identify the shipment. In addition, the CBP entry type
tells us if the article of food is for consumption in the United States
or is for export or other uses.
    Some examples of CBP entry types are: consumption entries,
warehouse entries, and temporary importation bond entries. Each of
these types has a designated CBP code. For prior notice submissions
made through ABI/ACS, the entry type will consist of the CBP entry code
specific for that type of entry; e.g., ``01'' for a consumption entry,
``21'' for a warehouse entry, ``23'' for a temporary importation bond
entry, etc. These codes are ones customs brokers and self-filers
provide to CBP at entry.
    For prior notice submissions made through the FDA PNSI, applicable
entry types will be provided for selection in a drop-down menu; e.g.,
consumption, IT, T&E, mail, FTZ, etc. Explanations of the different
entry types are available on PNSI to help the transmitter choose the
right one. There also is guidance posted on FDA's Web site located at
http://www.cfsan.fda.gov/~pn/pnentgui.html that describes the entry
types and the entry identifiers (Sec.  1.281(a)(4) and (c)(3))
associated with those entry types.
    (Final Rule) The final rule in Sec.  1.281(a)(3), (b)(3), and
(c)(3) requires submission of the entry type. For articles arriving by
international mail (Sec.  1.281(b)(3)), the entry type will always be a
mail entry.
5. The CBP Entry Identifier (e.g., the Customs ACS Entry Number or In-
Bond Number)
    Sections 1.281(a)(4) and (c)(4) of the IFR require the submission
of the CBP entry identifier (e.g., CBP entry number or in-bond number),
if available. This requirement does not apply to articles arriving by
international mail, nor to those carried by or accompanying an
individual, unless entry is otherwise required by CBP and an associated
CBP entry identifier has been assigned. In these cases, the FDA PNSI
will apply a system-generated entry identifier.
    (Comments) One comment suggests that PNSI should be modified to
allow for use of the house air waybill as a CBP identifier.
    (Response) FDA disagrees. The CBP entry identifier information is
necessary for proper identification of the information in a prior
notice with the appropriate articles for inspection. The submission of
the entry identifier also is critical for matching the prior notice to
the corresponding CBP entry, which is necessary to assess the adequacy
of the prior notice when shipments arrive and are presented for review.
    For in-bond entries and FTZ admissions, and for prior notices
submitted through the FDA PNSI, an entry identifier is critical for
matching the prior notice to the corresponding CBP entry if a
consumption entry is submitted so FDA and CBP can ensure that prior
notice requirements were satisfied. FDA does not agree that the
waybill/Bill of Lading can be used as a CBP identifier, nor do we
believe that there is a problem with obtaining a CBP identifier. If the
submitter does not have a CBP identifier, a system-generated entry
identifier can be provided upon request. The Airway Bill number and
Bill of Lading number is a separate data element found in the planned
shipment information (Sec.  1.281(a)(17)(i)). A Bill of Lading number
is not always assigned to a shipment at the time of prior notice
submission. For certain shipments, such as those sent by international
mail, no Bill of Lading may exist. Thus, FDA has determined that we
cannot allow for the use of the house air waybill number as a CBP
identifier.
    (Comments) Two comments request clarification of the CBP entry
identifier data element and where it can be located.
    (Response) For transmitters submitting prior notice with CBP entry
information through the ABI/ACS interface, the CBP entry number
assigned by CBP is also the entry identifier. For customs brokers or
self-filers submitting prior notice for a food entering the United
States as an IT entry, a T&E entry, or FTZ admission, the CBP in-bond
number or FTZ admission number assigned by CBP also is the entry
identifier. If prior notice is being submitted through PNSI, the entry
identifier will depend on the entry type and the reason for the Web
submission. If available to the transmitter (e.g., the prior notice is
for a CBP entry but the ABI/ACS interface is not available), the CBP
entry number must be used. When appropriate, the in-bond number must be
used as the entry identifier. If one of the entry identifiers described
above does not exist, the transmitter can request a system-generated
entry identifier.
    There is guidance posted on FDA's Web site at http://
www.cfsan.fda.gov/~pn/pnentgui.html that describes the entry types and
the entry identifiers (Sec.  1.281(a)(4) and (c)(4)) associated with
those entry types.
    (Final rule) The final rule requires in Sec.  1.281(a)(4) and
(c)(4) the CBP entry identifier (e.g., CBP entry number or in-bond
number), if available.
6. The Product Identity
    Section 801(m)(1) of the Bioterrorism Act requires that a prior
notice must contain the identity of the article of food being imported
or offered for import. Section 1.281 (a)(5), (b)(4), and (c)(5) of the
IFR requires the identity of the article of food being imported or
offered for import, as follows: the complete FDA product code; the
common or usual name or market name; the estimated quantity of food
that will be shipped, described from largest container to smallest
package size; and the lot or code numbers or other identifier of the
food if required by the act or FDA regulations; e.g., low-acid canned
foods, at Sec.  113.60(c) (21 CFR 113.60(c)); acidified foods, at Sec.
114.80(b) (21 CFR 114.80(b)); and infant formula, at Sec.  106.90 (21
CFR 106.90).
    (Comments) One comment suggests that the definition of ``article of
food'' should be amended to eliminate quantity and product code as
distinguishing factors that require a separate prior notice and that
separate prior notices should be based on the uniformity of entry level
food data. The comment further asserts that the integrity, or lack
thereof, of the food product will not be compromised based on the
product type, size and/or quantity.
    (Response) FDA disagrees. FDA continues to believe that estimated
quantity, including base units and total quantity, is a necessary
component of product identity. This information is important for
communications with FDA and CBP staff at the border and for
examinations to determine whether the amount ordered matches the amount
received. For example, as discussed in the preamble to the IFR, if more
was received than was ordered, FDA guidance recommends an investigation
to determine the cause of the discrepancy as additional and unwanted
articles may have been added to intentionally contaminate the shipment
(68 FR 58974 at 59005). If less product is received than ordered or
than shipped, some of the product may have been intentionally diverted.
Moreover, the agency's risk-based decisions are based upon the food
type and size of that product as many foods are

processed differently and the health-based problems result from these
differences. For example, a manufacturer may have two different low
acid canned food (LACF) production lines that are used for filling and
sealing different size cans. A problem with pulling a vacuum on one
LACF line may cause the food in those size cans to become adulterated;
this would not apply to the cans sealed on the other LACF line. FDA
would be able to target shipments from this manufacturer for the size
cans that may similarly be adulterated. As stated previously, the PNSI
system also allows for automatic repeating of like information (e.g.,
identity of the manufacturer), which decreases repetitive entry of
information that is the same for multiple articles of food within a
shipment. This also can be accomplished with submission via ABI/ACS,
dependent on the filer's own software.
    (Comments) One comment requests clarification of the interpretation
pertaining to gift packs. The comment asserts that CBP currently
processes gift packs according to the description of the entire gift
pack as an entity. The comment asks if prior notice is required on the
individual items within the gift pack. Another comment recommends that
FDA show flexibility and further develop policies that do not create
excessive costs for exporters who are shipping multiple food products
in the same package.
    (Response) A gift pack may contain various articles of food subject
to prior notice requirements. In addition, a gift pack may also contain
various nonfood articles that are not subject to prior notice
requirements. A package with multiple food products, though not a gift
pack, is another example of various articles of food. A prior notice is
required for each article of food, even when multiple articles of food
are designated as a gift pack or are otherwise packaged together.
    There is no CBP rule or regulation nor is there a General Rule of
Interpretation (GRI) under which gift packs are classified for tariff
purposes. In the case of ``gift packs'' that contain multiple products,
for entry purposes, CBP will try to classify the gift pack using the
concept of a set. That is, if the products included in a gift pack are
part of a common activity, the gift pack may be classified under the
HTS code that is most applicable. However, CBP does not consider eating
to be a common activity even when all items in a gift pack are to be
consumed. Therefore, unless there has been an applicable CBP ruling,
entries of gift packs should be declared to CBP using the HTS code for
each item included with the gift pack. This would apply even when there
are food and nonfood items in the pack; e.g. a soup mug and a can of
soup, as well as for make-your-own gift packs; e.g., if you created a
gift pack by selecting individual items from a list of available
products.
    The final rule requires a prior notice submission for each article
of food. As we explained in the preamble to the IFR, an ``article''
refers to a single food that is associated with the same complete FDA
Product Code, the same package size, and the same manufacturer or
grower (68 FR 58974 at 59003). Moreover, the ``packer'' of a gift pack
is not the facility that manufactured/processed the food pack.
Therefore, each article of food in a gift pack must be covered by a
separate prior notice. However, the Prior Notice Final Rule Draft CPG,
published elsewhere in this issue of the Federal Register, describes
our proposed enforcement policy for gift packs purchased or otherwise
acquired by an individual and imported or offered for import for
nonbusiness purposes. This draft guidance states that for these types
of gift packs FDA and CBP staff should typically consider not taking
regulatory action if there is a prior notice violation because a single
prior notice is submitted for a gift pack and the identity of the
facility that packed the gift pack is submitted in lieu of the identity
of the manufacturer(s) and/or grower(s) for each article of food within
the gift pack.
    (Comments) One comment states that the regulations should require a
separate prior notice for each HTS number in the container and that a
detailed description of the product is not necessary.
    (Response) FDA disagrees. For prior notice to accomplish its
intended purpose and help FDA protect American consumers, a more
precise description of the product is necessary than that provided by
the HTS number. As we explained in the preamble to the IFR, although
the HTS codes are currently utilized by CBP and FDA to identify
generally which imports are subject to an FDA admissibility review,