[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] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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