[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]
BILLING CODE 4160-01-F
