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Revised FDA Import Alerts on Oct 25
October 26, 2011 by Jewel Hoffman|FDA and EPA

On October 25, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Considers Changes to 2004 Bar Code Rule for Drugs, Biological Products
October 26, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration is announcing a review and comment request on its 2004 “Bar Code Final Rule,” which requires certain human drug products and biological products to have a bar code. The review is part of FDA's regulatory review process established by Executive Order 13563, "Improving Regulation and Regulatory Review.” Information submitted can help FDA to reassess the costs and benefits of the rule and to identify any relevant changes in technology that have occurred since it went into effect, including alternative identification technologies for drugs and biological products. FDA will use the information received to assess whether the Bar Code Final Rule is achieving its intended benefits as effectively as possible or should be modified. Comments are due by approximately Jan. 9, 2011. Reply comments are due by approximately Feb. 23, 2011.

Revised FDA Import Alerts on Oct 24
October 25, 2011 by Jewel Hoffman|FDA and EPA

On October 24, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Issues Small Business Guide on Cigarette Package Warnings
October 25, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration announced the availability of a guidance for industry entitled "Required Warnings for Cigarette Packages and Advertisements - Small Entity Compliance Guide". This compliance guide is intended to set forth in plain language the requirements of FDA's June 2011 final rule regarding required warnings for use on cigarette packages and in cigarette advertisements to help small businesses understand and comply with the regulation.

FDA Says FURLS, LACF, PNSI Experienced System Time Outs on Oct 22
October 25, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration reported that on October 22, 2011 users of the following systems and their subcomponents experienced intermittent time outs from 3:00 AM to 10:00 AM ET on October 22, 2011: FDA Unified Registration and Listing System (FURLS), Low Acid Canned Food System (LACF), and Prior Notice System Interface (PNSI).

Revised FDA Import Alerts on Oct 21
October 24, 2011 by Jewel Hoffman|FDA and EPA

On October 21, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Collaborates with Canada on Norovirus Risks in Shellfish
October 24, 2011 by Marie Rapport|FDA and EPA

The Food and Drug Administration is undertaking a collaboration with Health Canada, the Canadian Food Inspection Agency, Environment Canada, and Fisheries and Oceans Canada, to conduct a quantitative food safety risk assessment on norovirus in bivalve molluscan shellfish, specifically, oysters, clams, and mussels. Comments and data that would assist in the development of the risk assessment. are due by January 18, 2012.

EPA Proposes 2012 Critical Use Exemptions for Methyl Bromide
October 21, 2011 by Barbara Chaves|FDA and EPA

The Environmental Protection Agency has issued a proposed rule on uses that qualify for the 2012 critical use exemption for methyl bromide as well as the amount of methyl bromide that may be produced, imported, or supplied from existing pre-phaseout inventory for those uses in 2012. Comments are due by November 21, 2011.