[Federal Register Volume 72, Number 61 (Friday, March 30, 2007)]
[Proposed Rules]
[Pages 15080-15081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5894]


=======================================================================
-----------------------------------------------------------------------

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: 
[email protected].
    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: [email protected].
    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: 
[email protected].
    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: [email protected].

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