From: Susie.Hoeger@abbott.com
Sent: Tuesday, July 13, 2004 3:51 PM
To: fdadockets@oc.fda.gov
Subject: Comments on Docket No. 2002N-0278

Re:  Food and Drug Administration
     Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
     69 Fed. Reg. 28060 (May 18, 2004)
     Docket No. 2002N-0278

Dear Sir or Madam:

Abbott Laboratories ("Abbott") appreciates the opportunity to submit comments
to the Food and Drug Administration ("FDA") regarding the Prior Notice
requirements under the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002.  Abbott is a multinational broad-based health care
company that develops, manufactures, and markets medical products, including
pharmaceuticals, diagnostic equipment and tests, and adult and infant
nutritional products.  In 2003 Abbott's annual sales were in excess of $19
billion.  Abbott has several concerns regarding the Prior Notice requirements,
which are outlined below.

1. FDA Prior Notice and C-TPAT.  Articles subject to the FDA's Prior Notice
   requirements should be eligible for the full expedited processing and
   information transmission benefits allowed through the Customs-Trade
   Partnership Against Terrorism (C-TPAT) Program.  Participation in C-TPAT
   should be encouraged by the FDA because it furthers the goal of the FDA
   Prior Notice requirements by extending trade security efforts, past prior
   notice of arriving shipments to include logistics service providers and
   foreign suppliers.  By removing the primary benefit of the C-TPAT program,
   the FDA would create a disincentive for C-TPAT participation that would
   ultimately reduce the security of the articles covered by the Bioterrorism
   Act.

2. FDA Prior Notice/Customs Advance Manifest Coordination.  The FDA Prior
   Notice requirements and the Customs Advance Manifest requirements serve the
   common purpose of providing their respective agencies an opportunity to
   screen, identify, and review shipments before they enter the commerce of
   the United States.  Serving the same goal and applying to the same
   shipments, their prior notice timeframes should be the same for both policy
   and efficiency reasons.  Utilizing the same timeframes will not only
   minimize the complexity of the process for importers, but should make it
   easier for the two agencies to continue to harmonize their prior/advance
   notice systems and responses, increasing governmental efficiency.

3. Pharmaceutical Ingredients.  Abbott imports many articles that may be used
   as both food and pharmaceutical ingredients.  Examples of these articles
   include sugar, starches, and gelatins.  Additionally, Abbott imports
   articles (e.g., placebos) that are regulated as "drugs" by the FDA, but
   classified by U.S. Customs and Border Protection (Customs) in the
   Harmonized Tariff Schedule of the United States (HTSUS) as "food."

   The FDA recently updated its FD3 and FD4 indicators to make one of the
   HTSUS classifications that provides for placebos (subheading 2106.90.9998)
   an FD3 indicator instead of an FD4.  Depending on a placebo's ingredients,
   it may be properly classified in a classification other than the one
   identified above.  We suggest, therefore, that the FDA reconsider
   additional FD3 and FD4 codes.  All articles that have dual uses should not
   be coded FD4, and we respectfully request that the FDA code these articles
   FD3.


4. Corrections to Clerical Errors.  Many of the articles that Abbott imports
   are time sensitive and must be shipped in a temperature controlled
   environment.  As we understand the Prior Notice requirements, clerical
   errors made by a person submitting prior notice may not be corrected.
   Therefore, if an error is discovered after a Customs entry is certified,
   the entry must be cancelled.  If Customs is not available to cancel the
   entry (e.g., if the shipment arrives over the weekend), the shipment may
   sit, potentially causing the shipment to be destroyed.  We suggest that
   either Customs be required to be available 24/7, or FDA modify its system
   to allow clerical errors to be corrected.

5. Penalties for Non-Compliance.  After August 12, 2004, the penalties for
   non-compliance with the Prior Notice requirements will be refusal of the
   imported item and/or monetary penalties.  As indicated above, many of the
   items that Abbott imports are "drugs" for FDA purposes, but are classified
   by Customs as "foods."  Imports should not be denied entry or assessed
   monetary penalties where Customs and the FDA categorize the same articles
   differently.  We suggest that the final regulations allow for the immediate
   release and cancellation of monetary penalties for shipments demonstrated
   as not being "food" as defined by the FDA.

   We also suggest that the FDA consider the importer's circumstances when
   denying entry or assessing penalties.  It is reasonable to expect a Company
   whose principal business is importing food to abide by regulations
   applicable to food imports.  But companies that import food products only
   very rarely will likely have greater difficulty in complying with the
   requirements.  Though these companies should be required to comply before
   their entries are released, blanket denials of entry or assessments of a
   monetary penalties, in our view, would are not appropriate.


6. 1.277 -- What is the scope of this subpart?  Section (a) currently reads
   "This subpart applies to all food for humans and other animals that is
   imported or offered for import into the United States for use, storage or
   distribution into the United States, including food for gifts and trade and
   quality assurance/quality control samples, food for transshipment through
   the United States to another country, food for future export and food for
   use in a U.S. Foreign Trade Zone."

   Comment:   For purposes of this Interim Final Rule, "food" is defined in
   section 201(f) of The Act as articles used for food or drink for humans or
   animals, chewing gum and articles used for components of any such articles.
   However, for purposes of the Facility Registration IFR, the Agency has
   indicated that foreign facilities utilizing articles in the manufacture of
   drugs, devices or for R&D purposes be exempt from facility registration if
   they are reasonably sure that the articles will not be used in food for
   consumption. This appears to create a conflict between the Registration and
   Prior Notice Interim Final Rules where the former is based upon the
   intended use of food, or consumption, and the latter which applies to "all"
   food.

   This has caused difficulties with the import process in two ways, 1)
   requiring foreign facilities to register in order to meet the Prior
   Notification requirements and 2) requiring drug and device establishments
   to register as food facilities in order to facilitate importation of
   intra-company articles. By utilizing the Harmonized Tariff Schedule (HTS)
   codes to flag articles, the FDA's Prior Notification System and CBP's
   ABI/ACS requires (FD4) or leaves open to interpretation (FD3) prior notice
   status and ultimately facility registration for imported articles that are
   clearly not intended for consumption.

   Although the FDA's intent may be to enforce foreign facility registrations
   through the Prior Notice Interim Final Rule, it places an undo burden on
   drug or device establishments and hampers the import process for articles
   not intended for use in food as well as for food articles not intended for
   consumption.

   Recommendation:  Change the verbiage in section (a) to read  "This subpart
   applies to all food intended for consumption by humans and other animals
   that is imported or offered for import into the United States for use,
   storage or distribution into the United States, including food for gifts
   and trade and quality assurance/quality control samples, food for
   transshipment through the United States to another country, food for future
   export and food for use in a U.S. Foreign Trade Zone."

   The Harmonized Tariff Schedules codes could continue to flag articles for
   prior notice, however, both the FDA's Prior Notification System and CBP's
   ABI/ACS should be modified to allow articles flagged as FD3 or FD4 to be
   disclaimed, with rationale, depending on their intended use. If the option
   of disclaiming with rationale is not satisfactory, an alternative solution
   is provided in comment 2.

6. 1.281 -- What information must be in a prior notice?  Section (a)(6)
   currently reads:  "For an article of food that is no longer in its natural
   state, the name and address of the manufacturer and the registration number
   assigned to the facility that is associated with the article of food. A
   registration number is not required for a facility associated with an
   article of food if the article is imported or offered for import for
   transshipment, storage and export, or further manipulation and export."

   Comment:  This requirement does not allow for the importation of
   competitive product samples and for finished product samples used for
   evaluation purposes as well as articles used for R&D purposes unless the
   manufacturer's facility registration number is provided in the prior
   notice. It is unlikely that this information will be available since
   facility registration numbers should remain confidential and do not fall
   under the Freedom of Information Act. In some instances, a manufacturer's
   facility may not require registration since the article was not intended
   for consumption in the United States.

   Recommendation:  Change the verbiage in section (a)(6) to read "For an
   article that is no longer in its natural state or for final product samples
   not for commercial distribution, the name and address of the manufacturer
   or the registration number assigned to the facility that is associated with
   the article of food". Delete "A registration number is not required for a
   facility associated with an article of food if the article is imported or
   offered for import for transshipment, storage and export, further
   manipulation and export".

   The name and address of the manufacturer or the facility registration
   number, in conjunction with other required product specific information
   such as the FDA product code, common or usual name or market name and lot
   or code numbers should provide adequate traceability if needed.



Again, we thank you for the opportunity to submit comments.  Should you have
any questions concerning the contents of this document, please do not hesitate
to contact me.

Best regards,

Susie Hoeger

-----------------------------------------------------------
Susie Hoeger
Director, Customs & Trade Compliance
ABBOTT LABORATORIES
D03CC, AP6D-1
100 Abbott Park Road
Abbott Park, IL 60064-6056
Phone:  (847) 935-2355
Fax:  (847) 887-8215
E-mail:  susie.hoeger@abbott.com
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