[Federal Register: January 17, 2007 (Volume 72, Number 10)]
[Notices]
[Page 1999-2000]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17ja07-52]
-----------------------------------------------------------------------
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Draft Guidance for Industry: Minimally Manipulated, Unrelated,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.
-----------------------------------------------------------------------
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 The draft guidance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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may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to the draft guidance document.
Submit written comments on the draft guidance to the Division of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/[fxsp0]cber/guidelines.htm or http://www
.fda.gov/[fxsp0]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]
BILLING CODE 4160-01-S