16 August 2004 Source: http://www.access.gpo.gov/su_docs/aces/fr-cont.html ----------------------------------------------------------------------- [Federal Register: August 16, 2004 (Volume 69, Number 157)] [Notices] [Page 50388-50389] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr16au04-74] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D-0361] Guidance for Industry: Prior Notice of Imported Food Contingency Plan for System Outages; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a contingency plan that provides guidance on submitting prior notice of imported food during system outages affecting the applicable FDA and Customs and Border Protection (CBP) program systems. Section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and its implementing regulations require prior notice to FDA of all food imported or offered for import into the United States. DATES: This guidance is final upon the date of publication. However, you may submit written or electronic comments at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance may be sent. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Domenic Veneziano, Office of Regulatory Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 703-621-7809. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of October 10, 2003 (68 FR 58974), FDA issued an interim final rule (IFR) to implement section 307 of the Bioterrorism Act. The prior notice IFR requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The prior notice IFR provides that if a customs broker's or self-filer's system is not working or if the Automated Broker Interface of the Automated Commercial System is not working, prior notice must be submitted through the Prior Notice System Interface (PNSI); and that if PNSI or the Operational and Administrative System for Import Support is not operating, prior notice information must be submitted by e-mail or by fax to FDA. We stated in the prior notice IFR that FDA does not plan to exempt any specific categories of food articles from prior notice if system(s) are not working, and that FDA and CBP are working together to develop contingency plans for when the applicable FDA and CBP program systems are not working (68 FR 58974 at 58997). FDA with concurrence from CBP is announcing the availability of a contingency plan that provides guidance on submitting prior notice of imported food during system outages affecting the applicable FDA and CBP program systems. The contingency plan identifies seven potential system downtime scenarios that could impact transmission, confirmation, and processing of prior notice submissions and explains recommended submission options for each of the identified scenarios. In any of the scenarios described in the contingency plan, where the alternate submission options include both e-mail and fax (telephonic facsimile) transmissions, e-mail transmission is strongly encouraged as the more efficient means. FDA is issuing this document as a level 1 guidance consistent with FDA's good guidance practices regulation (Sec. 10.115 (21 CFR 10.115)). The contingency plan is being implemented immediately without prior public comment, under Sec. 10.115(g)(2), because the agency has determined that prior public participation is not feasible or appropriate. Under section 307 of the Bioterrorism Act, the prior notice requirements were effective December 12, 2003, and FDA and CBP's systems for processing prior notice submissions are up and running, making it urgent that the agencies explain how submitters can fulfill the prior notice requirements in the event of system outages. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the guidance document. Submit two copies of written comments, except that individuals may submit one [[Page 50389]] copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/oc/bioterrorism/bioact.html. Dated: August 11, 2004. John Marzilli, Acting Associate Commissioner for Regulatory Affairs. [FR Doc. 04-18741 Filed 8-12-04; 10:56 am] BILLING CODE 4160-01-S ----------------------------------------------------------------------- [Federal Register: August 16, 2004 (Volume 69, Number 157)] [Notices] [Page 50389-50390] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr16au04-75] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D-0554] Revised Compliance Policy Guide Regarding Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Revised Joint Food and Drug Administration-Customs and Border Protection Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a revised compliance policy guide (CPG) Sec. 110.310 entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides written guidance to FDA's and Customs and Border Protection's (CBP's) staff on enforcement of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulations, which require prior notice for all food imported or offered for import into the United States. This document also describes certain date changes to the Joint Food and Drug Administration-Customs and Border Protection Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes (revised joint plan) that was announced in the Federal Register of April 14, 2004 (69 FR 19765). DATES: The revised CPG and the revised joint plan are final upon the date of publication. However, you may submit written or electronic comments on the revised CPG at any time. ADDRESSES: Submit written requests for single copies of the revised CPG to the Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the revised CPG may be sent. Submit written comments on the revised CPG to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments . Submit written requests for single copies of the revised joint plan to the Office of Regional Operations (HFC-100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self- addressed adhesive label to assist that office in processing your request or include a fax number to which it may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revised CPG and the revised joint plan. FOR FURTHER INFORMATION CONTACT: Domenic Veneziano, Office of Regulatory Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 703-621-7809. SUPPLEMENTARY INFORMATION: I. Background A. Revisions to the CPG FDA is announcing the availability of revised CPG Sec. 110.310 entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' This revised CPG is issued with CBP concurrence and explains to FDA and CBP staff the new FDA and CBP policies on enforcement of section 307 of the Bioterrorism Act and its implementing regulations, which require prior notice to FDA of all food imported or offered for import into the United States (68 FR 58974, October 10, 2003), (codified at 21 CFR 1.276 through 1.285)). The original CPG was issued in December 2003 and was revised in June 2004 to include additional guidance regarding food imported or offered for import for noncommercial purposes with a noncommercial shipper. Since the prior notice interim final rule (IFR) became effective in December 2003, FDA and CBP have been reviewing the data quality of prior notice submissions. This review has revealed practical implementation problems with certain data elements, such as registration number, bill of lading number, and ultimate consignee. In part, these problems result from a lack of standardization. The problems also arose due to the practical difficulties faced by submitters in obtaining required information in complex commercial settings. Therefore, the CPG is being revised concerning the following violations: The registration number submitted for the manufacturing facility is inaccurate or is invalid; The registration number for the shipper is not provided; The airway bill number or bill of lading number is not provided or is invalid; and The name and address of the ultimate consignee is inaccurate because it contains the name and address of the express consignment operator or consolidator instead of the ultimate consignee. For the violations listed previously in this document, FDA and CBP should typically consider not taking any regulatory action until November 1, 2004.\1\ If, however, the violation reflects a history of repeated conduct of a similar nature by a person who had been notified of such violations, then the action FDA and CBP staff typically should consider taking is assessment of CBP Civil Monetary Penalties. --------------------------------------------------------------------------- \1\ In the original CPG issued in December 2003, the transition period was to end August 12, 2004; CBP and FDA informally referred to this time period as ``Phase IV.'' The two agencies now will refer to the time period of August 13, 2004, until November 1, 2004, as ``Phase IV (revised)'' and the time period on or after November 1, 2004, as ``Phase V.'' --------------------------------------------------------------------------- Another change relates to food imported or offered for import for quality assurance, research or analysis purposes only, not for human or animal consumption and not for resale. If prior notice does not include a required manufacturing facility registration number, FDA and CBP should typically not take any regulatory action. FDA is issuing this revised CPG as level 1 guidance consistent with FDA's good guidance practices regulation (Sec. 10.115 (21 CFR 10.115)). The revised CPG Sec. 110.310 is being implemented immediately without prior public comment, under Sec. 10.115(g)(2), because the agency has determined that prior public participation is not feasible or appropriate. This document revises policies that were due to take effect on August 13, 2004, so it is urgent that the [[Page 50390]] agencies explain their new enforcement policies before that date. B. Revisions to the Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes On April 14, 2004, FDA and CBP (we) announced the availability of a joint plan entitled ``Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes.'' The joint plan describes the process by which FDA and CBP intend to increase integration and examine whether we could amend the timeframe requirements in FDA's prior notice IFR to have the same advanced notice timeframes for arrivals by land via road or rail or arrival via air that are currently in CBP's advance electronic information rule (69 FR 19765). Due to the revisions in the CPG described previously that extend the transition period of the prior notice IFR to November 1, 2004, certain dates outlined in the joint FDA-CBP are revised as follows: We intend to implement the plan in November 2004. From November 1, 2004, to January 3, 2005, we plan to assess existing procedures and staffing needed to receive, review, and respond to the prior notices submitted in accordance with the prior notice IFR (i.e., 2 hours before arrival by land by road; 4 hours before arrival by air or by land by rail; and 8 hours before arrival by water). From January 4, 2005, to February 3, 2005, we intend to identify what changes to work practices and staffing would be necessary to determine if FDA could continue to receive, review, and respond to all prior notice submissions with reduced timeframes (e.g., 1 hour or 30 minutes before arrival by land by road; 2 hours before arrival by land by rail; and by ``wheels up'' for flights originating in North and Central America, South America (north of the Equator only), the Caribbean, and Bermuda; otherwise 4 hours before arrival by air). From February 4, 2005, to May 3, 2005, we plan to implement necessary changes and make appropriate adjustments to ensure we could receive, review, and respond to all prior notice submissions with reduced timeframes. In June 2005, we intend to issue a prior notice final rule that responds to the comments we received on the prior notice IFR, including this revised joint plan, during the two open comment periods. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the revised CPG. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The revised CPG and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access An electronic version of the revised CPG is available on the Internet at http://www.fda.gov/ora under ``Compliance Reference.'' An electronic version of the revised joint plan is available on the Internet at http://www.fda.gov/oc/bioterrorism/bioact.html. Dated: August 11, 2004. John Marzilli, Acting Associate Commissioner for Regulatory Affairs. [FR Doc. 04-18742 Filed 8-12-04; 10:56 am] BILLING CODE 4160-01-S