[Federal Register Volume 61, Number 38 (Monday, February 26, 1996)]
[Proposed Rules]
[Pages 7087-7088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4065]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. 96N-0002]


``Draft Document Concerning the Regulation of Placental/Umbilical 
Cord Blood Stem Cell Products Intended for Transplantation or Further 
Manufacture into Injectable Products;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Availability of draft document.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Draft Document Concerning 
the Regulation of Placental/Umbilical Cord Blood Stem Cell Products 
Intended for Transplantation or Further Manufacture into Injectable 
Products (December 1995).'' This draft document is intended to identify 
an approach that FDA believes is appropriate for the regulation of 
placental/umbilical cord blood stem 

[[Page 7088]]
cell products for transplantation and to provide an opportunity for 
interested persons to submit written comments on the draft document. 
This document is in response to numerous inquiries regarding the 
agency's regulatory approach to cord blood stem cell products. The 
draft document was distributed at the public workshop held on December 
13, 1995, as announced in the Federal Register of November 24, 1995 (60 
FR 58088). FDA has since made editorial changes to the draft document 
but the content and technical information remains unchanged.

DATES: Written comments by April 26, 1996.

ADDRESSES: Submit written requests for single copies of the draft 
document entitled ``Draft Document Concerning the Regulation of 
Placental/Umbilical Cord Blood Stem Cell Products for Transplantation 
or Further Manufacture into Injectable Products'' to the Division of 
Congressional and Public Affairs (HFM-44), Office of Communication, 
Training and Manufacturers Assistance, Center for Biologics Evaluation 
and Research, Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448, or call FDA's automated information 
system at 1-800-835-4709. Send one self-addressed adhesive label to 
assist that office in processing your requests. Persons with access to 
the INTERNET may request the document be sent by return E-mail by 
sending a message to ``[email protected]''. The draft document 
may also be obtained through INTERNET via File Transfer Protocol (FTP). 
Requesters should connect to the Center for Drug Evaluation and 
Research (CDER) FTP using the FTP. The Center for Biologics Evaluation 
and Research (CBER) documents are maintained in a subdirectory called 
CBER on the server, ``CDVS2.CDER.FDA.GOV'' (150.148.24.202). The 
``READ.ME'' file in that subdirectory describes the available 
documents, which may be available as an ASCII text file (*.TXT), or 
WordPerfect 5.1 document (*.w51), or both. A sample dialogue for 
obtaining the READ.ME file with a test based FTP program would be:
FTP CDVS2.CBER.FDA.GOV
LOGIN ANONYMOUS
 <``YOUR EMAIL ADDRESS''>
BINARY
CD CBER
GET READ.ME
EXIT
    The draft document may also be obtained by calling the CBER FAX 
information system (FAX-On-Demand) at 1-800-835-4709 from a touch tone 
telephone. Submit written comments on the draft document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two copies of all comments 
are to be submitted, except that individuals may submit one copy. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document. A copy of the draft 
document and received comments are available for public examination in 
the Dockets Management Branch (address above) between 9 a.m. and 4 
p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Sharon A. Carayiannis, Center for 
Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-594-3074.

SUPPLEMENTARY INFORMATION:

I. Introduction

    -Traditional bone marrow transplantation, involving the extraction 
of bone marrow by aspiration from bone cavities and processing by 
density gradient centrifugation, is increasingly being supplanted by 
novel sources of stem cells and biotechnologic procedures to purify and 
expand hematopoietic stem cells. Human cord blood, which is enriched 
with pluripotent hematopoietic stem cells, has recently emerged as an 
alternative source of hematopoietic stem cells for patients who are 
unable to obtain stem cells from allogeneic donors. Although 
availability of cord blood stem cells may reduce some constraints on 
bone marrow transplantation, the ultimate safety and efficacy of cord 
blood stem cell transplantation has yet to be determined.
    Recently, the agency has received numerous inquiries regarding the 
regulatory approach to cord blood stem cell products. Cord blood stem 
cells for transplantation in autologous or allogeneic recipients is an 
emerging area with complex medical issues, including issues raised by 
the banking of such cells for possible future transplantation. Unlike 
bone marrow donors who are at least several years old with a medical 
history, cord blood is obtained from a newborn donor without an 
established medical history. Existing FDA statutory authorities apply 
to these new products and allow FDA to see that areas such as quality 
control, quality assurance, safety, purity, potency, and efficacy are 
appropriately addressed prior to marketing.
    -FDA is announcing the availability of a draft document that 
includes discussions of the following: (1) The applicable legal 
authorities in the Federal Food, Drug, and Cosmetic Act and the Public 
Health Service Act; (2) FDA's approach to the regulation of human cord 
blood stem cells intended for transplantation; (3) FDA's approach to 
the regulation of cord blood stem cells as source material for further 
manufacture; (4) FDA's approach to the regulation of ancillary products 
used for production of cord blood stem cells; and (5) a request for 
public comments on the regulatory approach.

II. Comments

    -FDA is providing for comment the draft document prepared by the 
Office of Blood Research and Review and the Office of Therapeutics 
Research and Review in CBER. FDA does not intend the draft document to 
be all-inclusive. This draft document does not bind FDA and does not 
create or confer any rights, privileges, or benefits on or for any 
person.
    -FDA recognizes that cord blood stem cell products used for 
hematologic transplantation constitute a new and emerging scientific 
area. FDA will review and consider written comments on the regulatory 
approach set forth in the draft document. FDA specifically invites 
public comment on the approach for regulation of cord blood stem cells 
as source material for further manufacture and for regulation of 
ancillary products used in the production of cord blood stem cells, as 
discussed in the draft document.
    Interested persons may, on or before April 26, 1996, submit to the 
Dockets Management Branch (address above) comments on the draft 
document. 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. A copy 
of the draft document and received comments are available for public 
examination in the Dockets Management Branch (address above) between 9 
a.m. and 4 p.m., Monday through Friday.
    FDA will consider any written comments received in determining 
whether amendments to, or revisions of, the document are warranted.

    Dated: February 13, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-4065 Filed 2-23-96; 8:45 am]
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