[Federal Register Volume 61, Number 103 (Tuesday, May 28, 1996)]
[Proposed Rules]
[Pages 26473-26474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13304]



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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; Extension of 
Comment Period

Agency: Food and Drug Administration, HHS.

Action: Availability of draft document; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to July 
26, 1996, the comment period for the 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,'' which appeared in the Federal Register of 
February 26, 1996 (61 FR 7087). The purpose of the draft document is to 
identify a draft regulatory approach that FDA believes is appropriate 
for the regulation of placental/umbilical cord blood stem cell products 
for transplantation. FDA published the draft document in response to 
numerous inquiries regarding the agency's regulatory approach to cord 
blood stem cell products and to provide an opportunity for interested 
persons to submit written comments on the draft document prior to fully 
implementing this approach. FDA is taking this action in response to 
requests to allow additional time for public comments.

DATES: Written comments by July 26, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Sharon A. Carayiannis, Center for 
Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 26, 1996 
(61 FR 7087), FDA requested public comment from interested persons on 
the draft document which included 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; and (4) FDA's approach to the 
regulation of ancillary products used for production of cord blood stem 
cells. Interested persons were given until April 26, 1996, to submit 
written comments on the draft document.
    The agency received four letters from companies and research 
institutions involved in the collection and storage of cord blood 
requesting an extension of the comment period. The letters requested up 
to 90 additional days for comment on the basis that FDA's proposed 
regulatory approach would significantly alter the current cord blood 
collection and storage practices used by companies and research 
institutions. In addition, the requests cited the need for additional 
time to adequately review

[[Page 26474]]

and analyze the draft document so as to formulate and submit 
meaningful, substantive comments to the agency. In a letter of April 
26, 1996, FDA responded by offering an additional 29 days for comment, 
while the agency considered the requests for a 90-day extension. After 
careful consideration, the agency has concluded that it is in the 
public interest to allow additional time for interested persons to 
submit comments. Accordingly, FDA is extending the original comment 
period by 90 days, to July 26, 1996.
    Interested persons may, on or before July 26, 1996, submit written 
comments to the Dockets Management Branch (address above). 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.

    Dated: May 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-13304 Filed 5-22-96; 4:03 pm]
BILLING CODE 4160-01-F