``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

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.

-----------------------------------------------------------------------

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