[Federal Register Volume 65, Number 240 (Wednesday, December 13, 2000)]
[Proposed Rules]
[Pages 77838-77839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31653]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. 00N-1380]


Human Bone Allograft: Manipulation and Homologous Use in Spine 
and Other Orthopedic Reconstruction and Repair; Public Meeting; 
Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; reopening of comment period.

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

[[Page 77839]]

SUMMARY: The Food and Drug Administration (FDA) is reopening for 60 
days the comment period for a public meeting entitled ``Human Bone 
Allograft: Manipulation and Homologous Use in Spine and Other 
Orthopedic Reconstruction and Repair'' that was held on August 2, 2000. 
The agency is taking this action in response to requests for an 
extension to allow interested persons additional time to submit 
comments to FDA on the issues discussed at the public meeting.

DATES: Submit written comments by February 12, 2001.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 18, 2000 (65 
FR 44485), FDA published a notice of public meeting that would give the 
public an opportunity to provide additional information to the agency 
about the characteristics of various bone products as they relate to 
the agency's proposed definitions for ``minimal manipulation'' and 
``homologous use.'' Such information would be considered for future 
guidance to industry in conjunction with regulations that have been 
proposed. Interested persons were given until September 1, 2000, to 
submit written comments. The agency received several requests for an 
extension of the comment period to allow interested parties additional 
time to address the complex issues concerning FDA's proposed regulatory 
framework for bone allografts used for reconstruction and repair, to 
provide adequate time to review the transcript of the meeting, and to 
conduct research into the issues discussed at the meeting in 
formulating comments to submit to FDA. FDA finds these requests are 
reasonable, and, therefore, is reopening the comment period for an 
additional 60 days. Stakeholders are encouraged to provide information 
about the following issues:
      1. Which processing procedures applied to human bone allograft 
fall within, or outside of, FDA's proposed definition for ``minimal 
manipulation?''
      2. Which uses of human bone allograft fall within, or outside of, 
FDA's proposed definition for ``homologous use?''
      3. What risks to health have been identified and characterized 
for human bone allograft products?
      4. What controls have been identified to adequately address the 
risk to health of human bone allograft products?
      5. What industry standards for bone allograft products are 
available, and what standards will be needed in the future?
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the issues discussed at the public 
meeting by February 12, 2001. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 28, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-31653 Filed 12-12-00; 8:45 am]
BILLING CODE 4160-01-F