FDA Reopens Comment Period for Proposed Rule to Bar Certain Cattle Material from Medical Products, Etc.
The Food and Drug Administration (FDA) has issued a notice reopening the comment period until May 14, 2007 on its proposed rule to prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs (prescription, over-the-counter, and homeopathic), biologics (such as vaccines), and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (like cattle and sheep).
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FDA has previously stated that it is also proposing to limit the materials used in these medical products in order to keep them free of the agent thought to cause mad cow disease, also known as bovine spongiform encephalopathy (BSE).
FDA has also proposed new recordkeeping requirements for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle, in order to ensure that companies comply with the prohibitions.
According to the FDA, the proposed requirements would only apply to medical products for humans and drugs for ruminants. They would not apply to any other product regulated by FDA.
(The previous comment period for this proposed rule ended on March 13, 2007. See ITT's Online Archives or 01/26/07 news, 07012625, for BP summary of the proposed rule.)
Comment Period Extended by 45 Days to Allow Industry to Generate Information
According to the FDA, it received a request to extend the comment period, and it believes that extending the comment period by 45 days is appropriate to allow industry to generate information on products that might be affected by the rule. Therefore, FDA is extending the comment period until May 14, 2007.
- written or electronic comments now due by May 14, 2007
| Audrey Thomas (Drug Evaluation and Research) | (301) 443-5533 |
| Stephen Ripley (Biologics Evaluation and Research) | (301) 827-6210 |
| Scott McNamee (Devices and Radiological Health) | (240) 276-0105 |
| Michael Popek (Veterinary Medicine) | (301) 827-6462 |
FDA notice (D/N 2005N-0373, FR Pub 03/30/07) available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-5894.pdf