Commercial Information Circulars

24-hour hotline : 23 922 922

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

Ref : EIC 111/2/19

2 August 2012

Dear Sirs,

Commercial Information Circular No. 602/2012

US : Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2013

The US Food and Drug Administration (FDA) published in the Federal Register (FR) of 1 August 2012 a notice announcing the fiscal year (FY) 2013 fee schedule for certain domestic and foreign facility reinspections, importer reinspections, and failure to comply with recall orders. The FR notice is available at: http://www.gpo.gov/fdsys/pkg/FR-2012-08-01/pdf/2012-18678.pdf.

DETAILS

2.The FDA is authorised by the US' Federal Food, Drug, and Cosmetic Act, as amended by the Food Safety Modernization Act to assess and collect fees for the above-mentioned activities. The FY 2013 fee rates are as follows: US$221 per hour if no foreign travel is required and US$289 per hour if foreign travel is required. The fees are effective 1 October 2012 through 30 September 2013. Interested parties may submit comment to the FDA by 31 October 2012.

3.In addition, FDA is considering various issues associated with the assessment and collection of importer reinspection fees, and will not assess such fees until it has reached a decision. However, the FY 2013 fee rates set forth above will be used to determine the importer reinspection fees once FDA begins to assess such fees.

4.FDA is also developing a guidance document to outline the process through which small businesses may request a reduction of certain fees. It does not intend to issue invoices for reinspection or recall order fees until publication of the guidance document.

5.Traders may wish to refer to the "Frequently Asked Questions" at the FDA's website for more information on the fees:
http://www.fda.gov/Food/FoodSafety/FSMA/ucm257982.htm.

ENQUIRIES

6.For enquiries concerning this circular, please contact the undersigned at telephone number 2398 5682.

Yours faithfully,

(Miss Cindy LAU)
for Director-General of Trade and Industry




　

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.