[Federal Register: December 13, 2000 (Volume 65, Number 240)]
[Proposed Rules]
[Page 77838-77839]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de00-33]
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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.
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[[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