Commercial Information Circulars

24-hour hotline : 23 922 922

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

Ref : EIC 111/2/19

27 February 2012

Dear Sirs,

Commercial Information Circular No. 152/2012

US : Establishment, Maintenance, and Availability of Records: FDA's Amendment to Record Availability Requirements

The US Food and Drug Administration (FDA) issued in the Federal Register (FR) of 23 February 2012 an interim final rule (IFR) amending its regulations on establishment, maintenance and availability of records. Interested parties may submit comments on the IFR by 23 May 2012. The FR notice is available at: http://www.gpo.gov/fdsys/pkg/FR-2012-02-23/pdf/2012-4165.pdf.

DETAILS

2.The IFR implements amendments to the Federal Food, Drug, and Cosmetic Act made by the FDA Food Safety Modernization Act (FSMA). The relevant FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to records relating to any other article of food that the Secretary of Health and Human Services (the Secretary) reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which the Secretary believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. 
 

3.The IFR is effective 1 March 2012. FDA will consider modifications to the IFR based on comments made during the comment period, and intends to finalize the rule one year from the close of the comment period.

ENQUIRIES

4.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 :

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