# ``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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A96-13304

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** May 28, 1996
- **Citation:** 61 FR 26473

## Text

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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A96-13304. Public record. Not legal advice.