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 ----------------------------------------------------------- Note: The information contained in this message may be privileged and confidential and protected from disclosure. If the reader of this message is not the intended recipient, or an employee or agent responsible for delivering this message to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, please notify us immediately by replying to this message and deleting it from your computer. Abbott Laboratories 100 Abbott Park Road, Abbott Park, IL 60064-6056.