Commercial Information Circulars

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e-mail address : enquiry@tid.gov.hk

Ref : EIC 111/2

16 April 2004

Dear Sirs,

Commercial Information Circular No. 97/2004

US:FDA Seeks Additional Comments on Implementation of the Bioterrorism Act

Further to Commercial Information Circular (CIC) No. 77/2004 dated 19 March 2004, the US Food and Drug Administration (FDA) published three notices in the Federal Register (FR) of 14 April 2004 on the following :-

1. Reopening of comment period for FDA's interim final rule (IFR) on prior notice of imported food;
2. Reopening of comment period for FDA's IFR on registration of food facilities; and
3. Seeking of comments on the Joint FDA-Customs and Border Protection (CBP) plan for increasing integration and assessing the co-ordination of prior notice timeframes.

Copies of the three FR notices are at Annexes A - C. Highlights of which are set out in the following paragraphs.

DETAILS

(A) Reopening of Comment Period for the Two FDA's Interim Final Rules (IFRs)

2. As promulgated in CIC No. 258/2003 dated 14 October 2003, FDA provided a 75-day comment period when the two IFRs on prior notice requirement and registration of food facilities were published in October 2003. FDA further stated that it intended to re-open the comment period in March 2004 to ensure that those commenting the IFRs would have had the benefit of FDA's outreach and education efforts as well as some experience with the systems, timeframes, and data elements of the interim rules. Accordingly, FDA is now re-opening the comment period on the two IFRs with respect to the following :-

1. Prior Notice Requirement - FDA would like to explore flexible alternatives for submission of prior notice for foods or firms covered by programs of other agencies like CBP's Customs-Trade Partnership Against Terrorism (C-TPAT) and the Free and Secure Trade (FAST) program, or food imported by other government agencies.
2. Registration of Food Facilities - FDA is inviting comments and submission of data/information pertaining to the costs to foreign facilities of hiring and retaining an US agent as well as the effects on domestic small businesses, if any, if some foreign facilities cease exporting to the US due to the US agent requirement for registration.

(B) Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes

3. FDA is seeking public comments on its joint plan with CBP for increasing integration and assessing the co-ordination of prior notice timeframes. The plan includes an assessment schedule and describes the process by which FDA and CBP intend to increase integration. It also examines whether FDA could amend the timeframe requirement in FDA's prior notice IFR to have the same advanced notice timeframes for cargo arriving by land via road or rail, or by air that are currently in CBP's advance electronic information rule. The full text of the FDA-CBP joint plan is at Annex D (pdf format).

(C) Submission of Written Comments

4. Written comments on the three FR notices must reach FDA by 14 May 2004. Interested parties may wish to submit their comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD?20852, USA or by email to http://www.fda.gov/dockets/ecomments.

ENQUIRIES

5. For enquiries concerning the content of this circular, please contact the undersigned at 2398 5403.

Yours faithfully,

(Ms. Shirley TSE)

for Director-General of Trade and Industry

Annex A, B, C and D (pdf format)

Note : While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.