Commercial Information Circulars

24-hour hotline : 23 922 922

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

Ref : EIC 111/2/19

11 October 2011

Dear Sirs,

Commercial Information Circular No. 613/2011

US : Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act

The trade was informed via Commercial Information Circular No. 462/2011 of 2 August 2011 that the US Food and Drug Administration (FDA) issued in the Federal Register (FR) of 1 August 2011 a notice to establish fee rates for fiscal year (FY) 2012 for domestic and foreign food facility reinspections, recall orders, and import reinspections, which will take effect from 1 October 2011. The FDA is announcing the availability of a guidance for industry entitled "Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act". This guidance provides answers to common questions that might arise about the new fee provisions and FDA's plans for their implementation in FY 2012. The FR notice is available at: http://www.gpo.gov/fdsys/pkg/FR-2011-10-06/pdf/2011-25831.pdf and the guidance is available at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm.

ENQUIRIES

2. For enquiries about the content of this circular, please contact Miss S Y TANG at telephone number 2398 5403.

Yours faithfully,

(Ms Cindy CHENG)
for Director-General of Trade and Industry