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From: TSS ()
Subject: Re: Docket No. 2005N-0373 RIN number 0910-AF54 TSS SUBMISSION
Date: March 30, 2007 at 10:57 am PST

In Reply to: Docket No. 2005N-0373 RIN number 0910-AF54 TSS SUBMISSION posted by TSS on January 25, 2007 at 8:35 am:

[Federal Register: March 30, 2007 (Volume 72, Number 61)]
[Proposed Rules]
[Page 15080-15081]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr07-24]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 211, 226, 300, 500, 530, 600, 895, and 1271

[Docket No. 2005N-0373]
RIN 0910-AF54


Use of Materials Derived From Cattle in Medical Products Intended
for Use in Humans and Drugs Intended for Use in Ruminants; Reopening of
the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening until May
14, 2007, the comment period for the proposed rule published in the
Federal Register of January 12, 2007 (72 FR 1582). The proposed rule
would prohibit the use of certain cattle material in, or in the
manufacture (including processing) of, drugs, biologics, 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
(drugs for ruminants) and would also require new recordkeeping
provisions for medical products for humans and drugs for ruminants that
are manufactured from or otherwise contain material from cattle. The
agency is reopening the comment period in response to a request for
more time to enable industry to generate more information on products
that might be affected by the rule.

DATES: Submit written or electronic comments on the proposed rule by
May 14, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 2005N-0373
and RIN number 0910-AF54, by any of the following methods:

Electronic Submissions

Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.

Follow the instructions for submitting comments on the agency Web site.

Written Submissions

Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously in
the ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.fda.gov/ohrms/dockets/default.htm, including any personal

information provided. For additional information on submitting
comments, see section II ``Comments'' in the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm

and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
For information concerning products regulated by the Center for
Drug Evaluation and Research: Audrey A. Thomas, Center for Drug
Evaluation and Research (HFD-007), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5533, e-mail:
audrey.thomas@fda.hhs.gov.

For information concerning products regulated by the Center for
Biologics Evaluation and Research: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210, e-mail: stephen.ripley@fda.hhs.gov.
For information concerning products regulated by the Center for
Devices and Radiological Health: Scott G. McNamee, Center for Devices
and Radiological Health, Food and Drug Administration, 2094 Gaither
Rd., rm. 230, Rockville, MD 20850, 240-276-0105, e-mail:
scott.mcnamee@fda.hhs.gov.

For information concerning products regulated by the Center for
Veterinary Medicine: Michael J. Popek, Center for Veterinary Medicine
(HFV-144), Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 301-827-6462, e-mail: michael.popek@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 12, 2007 (72 FR 1582), FDA
published a proposed rule that, if finalized, would prohibit the use of
certain cattle material in, or in the manufacture (including
processing) of, medical products for humans and drugs for ruminants.
FDA also proposed new recordkeeping requirements for medical products
for humans and drugs for ruminants that are manufactured from or
otherwise contain material from cattle.
Interested persons were given until March 13, 2007, to submit
written or electronic comments to the agency on the proposal. On
February 12, 2007,

[[Page 15081]]

FDA received a request to extend the comment period. FDA 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. This extension will provide the public with a total of 105 days
to submit comments.

II. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the proposed rule.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the Docket No. 2005N-0373. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.

Dated: March 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5894 Filed 3-29-07; 8:45 am]

BILLING CODE 4160-01-S


http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E7-5894.htm
http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-5894.pdf


TSS



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