SUPPLEMENTARY INFORMATION:

I. Background

A. FDA Prior Notice Interim Final Rule

On October 10, 2003, FDA issued an IFR (the prior notice IFR) (68 FR 58974) to implement new section 801(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(m)), added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. 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 requires that prior notice be submitted to FDA electronically via either CBP's Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PN System Interface) (21 CFR 1.280). Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held (21 CFR 1.283).

Under section 801(m)(2)(A) of the FD&C Act, FDA is to choose timeframes that “shall be no less than the minimum amount of time necessary for the Secretary [of Health and Human Services] to receive, review, and appropriately respond to such notification * * *.” Using this standard, the prior notice IFR requires that the information must be submitted and confirmed electronically as facially complete by FDA for review no more than 5 days and no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival (21 CFR 1.279). However, when we issued the prior notice IFR, FDA was committed to exploring ways to increase integration of advance electronic notification processes with CBP and reduce prior notice timeframes further. Indeed, we stated in the preamble of the prior notice IFR (68 FR 58974 at 58995) that, by March 12, 2004, FDA and CBP would publish a plan, including an implementation schedule, to achieve the goal of a uniform, integrated system, and to coordinate timeframes for import prior notice information while fulfilling the Bioterrorism Act mandates for air and truck modes of transportation with timeframes finalized by CBP when they finalize their rule entitled “Required Advance Electronic Presentation of Cargo Information” (the Advance Electronic Information Rule).

For this reason, as well as to obtain comments on other aspects of the prior notice rulemaking, we issued the IFR with an opportunity for public comment for 75 days. Moreover, to ensure that those who comment on the prior notice IFR would have had the benefit of our experience with the systems, timeframes, and data elements, FDA also stated that it intended to reopen the comment period for an additional 30 days in March 2004, coinciding with the issuance of the plan by FDA and CBP relating to timeframes.

B. CBP Advance Electronic Information Rule

On December 5, 2003, CBP issued the Advance Electronic Information Rule (68 FR 68140), which requires CBP to receive, by way of a CBP-approved electronic data interchange system, information pertaining to cargo before the cargo is either brought into or sent from the United States by any mode of commercial transportation (sea, air, rail, or truck). The cargo information required is that which is reasonably necessary to enable high-risk shipments to be identified for purposes of ensuring cargo safety and security and preventing smuggling under the laws enforced and administered by CBP. The Advance Electronic Information Rule implements the provisions of section 343(a) of the Trade Act of 2002, as amended by the Maritime Transportation Security Act of 2002.

The relevant timeframes provided in the Advance Electronic Information Rule are as follows:

• For arrival by land via road at ports that are fully equipped to accommodate CBP's Advance Electronic Information Rule, no later than 1 hour prior to the arrival of the truck at the border, or for ( printed page 19766) Free and Secure Trade/Customs-Trade Partnership Against Terrorism (FAST/C-TPAT) participants, 30 minutes;
• For arrival by land via rail at ports that are fully equipped to accommodate CBP's Advance Electronic Information Rule, no later than 2 hours prior to the arrival of the train at the border;
• For arrival by air, no later than the departure time (“wheels up”) of the aircraft from any foreign port or place in North America, including locations in Mexico, Central America, South America (from north of the Equator only), the Caribbean, and Bermuda, and from other areas into ports that are fully equipped to accommodate CBP's Advance Electronic Information Rule no later than 4 hours prior to the arrival of the aircraft in the United States.

II. Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes

After consultation, FDA and CBP have developed a plan to increase integration and assess whether FDA can adopt reduced timeframes. As set out in the plan, the agencies intend to assess whether FDA can meet its statutory mandate under section 801(m)(2)(A) of the FD&C Act if prior notice is received and confirmed electronically by FDA for review with reduced timeframes, including those adopted by CBP by mode of transportation listed in the following paragraphs, no fewer than:

• 1 hour before arrival by land by road, or 30 minutes for participants in FAST/C-TPAT;
• 2 hours before arrival by land by rail;
• 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.

As noted previously, section 801(m)(2)(A) of the FD&C Act states that FDA shall by regulation prescribe the time of submission of the notification in advance of importation or the offering of the food for import, which period shall be no less than the minimum amount of time necessary for the Secretary to receive, review, and appropriately respond to such notification, and any timeframe FDA adopts in the final rule must be justified under this standard.

III. Comments

Elsewhere in this issue of the Federal Register , we are reopening the comment period on the prior notice IFR. To be considered part of the rulemaking record, interested persons must submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the plan as indicated in the DATES section of this document. Two copies of any mailed comments are to be submitted by commenting entities; individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The plan and comments FDA has received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Interested persons who wish to submit general comments on the prior notice IFR should consult the document reopening the comment period that is published elsewhere in this issue of the Federal Register .

IV. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/​oc/​bioterrorism/​bioact.html.