June 11, 2010
Greetings! We hope that you are having a dynamic and effective week! This edition includes new FDA Web site providing entry to three key FDA safety reporting systems, the newest eNews newsletter, and the establishment of the Pine Mountain-Mayacmas viticultural area.
In the TTB Newsletter, we compile the top TTB news of the week and other helpful information about the Bureau and the Federal alcohol and tobacco laws and regulations we enforce. Please send any questions and/or comments to Executive Liaison for Industry Matters (industryliaison@ttb.gov) and/or State Liaison (stateliaison@ttb.gov). |
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NEW FDA WEB SITE PROVIDES ENTRY TO THREE KEY FDA SAFETY REPORTING SYSTEMS
TTB passes along for informational purposes this FDA notice regarding a new Web site to be used, in part, for reporting information about food articles that might pose a serious health risk. The FDA's Reportable Food Registry (RFR) reporting requirements, pursuant to 21 U.S.C. 350f, do apply to alcohol beverage industry members that are required to register with FDA for this purpose (generally, domestic or foreign facilities that manufacture, process, pack or hold alcohol beverages for consumption in the United States). For information about who is required to register a facility with the FDA and use the new Web site, please see FDA regulations at 21 CFR 1.225 through 1.227 or contact the FDA.
Source: FDA
May 24, 2010
New Web site provides entry to three key FDA safety reporting systems
The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) today launched a new Web site for industry to report food safety problems or adverse events involving FDA-regulated foods and animal feeds, pet foods and pet treats, animal drugs, and human gene transfer research. The new site, called the Safety Reporting Portal (SRP), is the next step in FDA's effort to expand online reporting options.
"The portal will be a key detection tool in improving the country's nationwide surveillance system and will strengthen our ability to protect the Nation's health," said Margaret A. Hamburg, Commissioner of Food and Drugs. "We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public."
The SRP, which opened today at www.safetyreporting.hhs.gov, includes:
- Reportable Food reports for food industry facilities and public health officials when they have determined that there is a reasonable probability that an article of food or animal feed will cause serious adverse health consequences or death to humans or animals;
- A Pet Food report where consumers and veterinary personnel can report adverse events or product problems with pet foods and pet treats;
- An Animal Drug Adverse Event report where animal drug makers and distributors can rapidly report to FDA about issues that may affect animal safety; and,
- An Adverse Event report for biomedical researchers involved in human gene transfer clinical trials.
The SRP provides new more user-friendly conveniences that reporters to the RFR did not have with the former RFR portal: if submitters establish a free account, they will be able to save draft, partially completed, or submitted reports; have new reports pre-populated with their contact information and amended reports pre-populated with all the information from their original submission; and view any previous submissions they have made to the SRP. These changes respond to concerns industry has raised since the original RFR opened last September.
COLAS ONLINE Enews JUNE EDITION IS NOW AVAILABLE
COLAs Online eNews June edition is now available
PROPOSAL TO ESTABLISH PINE MOUNTAIN-MAYACMAS VITICULTURAL AREA
We have published a notice of proposed rulemaking in the Federal Register proposing to establish the 4,600-acre "Pine Mountain-Mayacmas'' American viticultural area in portions of Mendocino and Sonoma Counties, California. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.
Written comments must be received on or before July 26, 2010. You may send comments on this notice to one of the following addresses:
- http://www.regulations.gov: Use the comment form for this notice as posted within Docket No. TTB-2010-0003 on "Regulations.gov," the Federal e-rulemaking portal, to submit comments via the Internet;
- Mail: Director, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044- 4412; or
- Hand Delivery/Courier in Lieu of Mail: Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street, NW., Suite 200-E, Washington, DC 20005