[Federal Register Volume 65, Number 138 (Tuesday, July 18, 2000)]
[Proposed Rules]
[Pages 44485-44486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17942]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER) and Center for Devices and Radiological 
Health (CDRH), is announcing a public meeting entitled ``Human Bone 
Allograft: Manipulation and Homologous Use in Spine and Other 
Orthopedic Reconstruction and Repair.'' The purpose of the meeting is 
to provide a public forum for gathering scientific information and 
views from the public to help FDA in clarifying the regulation of human 
bone allograft.

DATES: The public meeting will be held on Wednesday, August 2, 2000, 
from 8:30 a.m. to 5 p.m. Submit registration information by July 24, 
2000. Submit written comments by September 1, 2000.

ADDRESSES: The public meeting will be held at the National Institutes 
of Health (NIH), NIH Clinical Center, Bldg. 10, Jack Masur Auditorium, 
9000 Rockville Pike, Bethesda, MD. Submit written comments to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Submit registration information to Kathy A. Eberhart 
(address below).

FOR FURTHER INFORMATION CONTACT: For registration and meeting 
information: Kathy A. Eberhart, Center for Biologics Evaluation and 
Research (HFM-49), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-1317, FAX 301-827-3079, 
e-mail: [email protected].
    For information about presentations: Martha A. Wells, Center for 
Biologics Evaluation and Research (HFM-305), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6106.
    For information about this notice: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA began regulating tissue establishments in 1993 when it issued 
an interim rule entitled ``Human Tissue Intended for Transplantation'' 
that was codified in 21 CFR 1270 (58 FR 65514, December 14, 1993). In 
1997 the agency replaced the interim rule with a final rule entitled 
``Human Tissue Intended

[[Page 44486]]

for Transplantation'' (62 FR 40429, July 29, 1997). FDA announced a 
plan for a new approach to regulate cells and tissue-based products in 
February 1997 with two documents: ``Reinventing the Regulation of Human 
Tissue'' and ``A Proposed Approach to the Regulation of Cellular and 
Tissue-Based Products.'' FDA requested written comments on the proposed 
approach and on March 17, 1997, held a public meeting to solicit 
information and views from the interested public (62 FR 9721, March 4, 
1997). FDA is implementing its regulatory plan for human cellular and 
tissue-based products with publication of a series of proposed 
regulations. On May 14, 1998, FDA published a proposed regulation 
entitled ``Establishment Registration and Listing for Manufacturers of 
Human Cellular and Tissue-Based Products'' (63 FR 26744). On September 
30, 1999, FDA published a proposed rule entitled ``Suitability 
Determination for Donors of Human Cellular and Tissue-Based Products'' 
(64 FR 52696). The comment period for the 1999 proposed rule was 
reopened on April 18, 2000 (65 FR 20774), and will close on July 17, 
2000.
    The proposed rule for establishment registration and listing also 
proposed criteria that human cellular and tissue-based products must 
meet for regulation solely under section 361 of the Public Health 
Service Act. One of the criteria is that these products be ``minimally 
manipulated.'' ``Minimal manipulation'' is defined in proposed 
Sec. 1271.3(g) for structural tissue, as processing that does not alter 
the original relevant characteristics of the tissue relating to the 
tissue's utility for reconstruction, repair, or replacement. Another 
criterion, ``homologous use,'' is defined in proposed Sec. 1271.3(d). 
``Homologous use'' means the use of a cellular or tissue-based product 
for replacement or supplementation or for structural tissue-based 
products, used for the same basic function that it fulfills in its 
native state, in a location where such structural function normally 
occurs. FDA has received numerous comments to the dockets of both 
proposed rules (Docket Nos. 97N-484R and 97N-484S) about the 
application of the definitions for minimal manipulation and homologous 
use in the regulation of human allograft bone products. Many of these 
comments request that FDA clarify how these definitions will be applied 
to bone products that are preshaped for use in spinal fixation. Other 
comments cite the long history of safe use of bone products.
    This public meeting is being organized by CBER and CDRH to provide 
stakeholders with the opportunity to provide additional information to 
the agency. The agency is requesting information concerning the 
characteristics of various bone products as they relate to the agency's 
proposed definitions for ``minimal manipulation'' and ``homologous 
use.'' Such information will be considered for future guidance to 
industry in conjunction with the regulations discussed above. 
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?

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments by September 1, 2000. Two copies of 
any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the appropriate docket 
number found in brackets in the heading of this document. FDA is 
requesting that those persons making oral presentations at the public 
meeting also submit in writing comments based on their statements by 
September 1, 2000, to ensure their adequate consideration. Received 
comments may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

III. Registration and Requests for Oral Presentations

    Those persons interested in attending the public meeting should fax 
or e-mail their registration information (including name, title, firm 
name, address, and telephone and fax numbers), a summary of their 
presentation, and a notice of intent to make an oral presentation, to 
Kathy Eberhart (address above) by Monday, July 24, 2000. Registration 
is not required for attendees not making a presentation. However, all 
interested persons are encouraged to preregister because space is 
limited. An announcement of the public meeting and the notice of intent 
to participate may be accessed at http://www.fda.gov/cber/scireg/htm. 
FDA will post a draft agenda on this web site about a week before the 
meeting.
    If time permits, those who did not submit a notice of participation 
will be given an opportunity to speak at the end of the meeting.
    If you need special accommodations due to a disability, please 
contact Kathy Eberhart at least 7 days in advance.

IV. Transcripts

    Transcripts of the meeting may be requested in writing from the 
Freedom of Information Office (HFI-35), Food and Drug Administration, 
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 
working days after the meeting at a cost of 10 cents per page. The 
transcript will also be available at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: July 10, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-17942 Filed 7-17-00; 8:45 am]
BILLING CODE 4160-01-F