[Federal Register Volume 72, Number 10 (Wednesday, January 17, 2007)]
[Notices]
[Pages 1999-2000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-549]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0514]


Draft Guidance for Industry: Minimally Manipulated, Unrelated, 
Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic 
Reconstitution in Patients with Hematological Malignancies; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord 
Blood Intended for Hematopoietic Reconstitution in Patients with 
Hematological Malignancies'' dated December 2006. The draft guidance 
document provides recommendations that would allow the manufacturer, 
generally a cord blood bank, to apply for licensure of minimally 
manipulated, unrelated, allogeneic placental/umbilical cord blood, for 
specified indications. The document also contains information about the 
manufacture of minimally manipulated, unrelated, allogeneic placental/
umbilical cord blood and how to comply with applicable regulatory 
requirements.

DATES: Submit written or electronic comments on the draft guidance by 
April 17, 2007 to ensure their adequate consideration in preparation of 
the final guidance. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your requests. The draft guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Kathleen E. Swisher, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic 
Placental/Umbilical Cord Blood Intended for Hematopoietic 
Reconstitution in Patients with Hematological Malignancies'' dated 
December 2006. The draft guidance document provides recommendations 
that would allow the manufacturer, generally a cord blood bank, to 
apply for licensure of minimally manipulated, unrelated, allogeneic 
placental/umbilical cord blood, for specified indications. The

[[Page 2000]]

guidance document provides recommendations for the submission of a 
biologics license application for placental/umbilical cord blood 
products that are: (1) Manipulated minimally; (2) used for 
hematopoietic reconstitution in patients with hematological 
malignancies; and (3) used in recipients unrelated to the donor. The 
document also contains information about the manufacture of minimally 
manipulated, unrelated, allogeneic placental/umbilical cord blood and 
how to comply with applicable regulatory requirements. For the 
manufacture of peripheral blood or cord hematopoietic stem/progenitor 
cells other than those described, the manufacturer may need to submit 
an investigational new drug application or other premarketing 
application for that product.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on this topic. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 201 have been approved under 
OMB Control No. 0910-0572; 21 CFR part 211 have been approved under OMB 
Control No. 0910-0139; 21 CFR part 600 have been approved under OMB 
Control No. 0910-0308; 21 CFR parts 601, 610, and FDA Form 356(h) have 
been approved under OMB Control No. 0910-0338; 21 CFR part 1271 have 
been approved under OMB Control Nos. 0910-0559, 0910-0469, and 0910-
0543; and FDA Form 3500A has been approved under OMB Control No. 0910-
0291.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft guidance. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in the brackets in 
the heading of this document. A copy of the draft guidance and received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: January 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-549 Filed 1-16-07; 8:45 am]
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