[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Notices]
[Pages 36196-36197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14097]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0157]


Draft Guidance for Industry: Biologics License Applications for 
Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord 
Blood Intended for Hematopoietic and Immunologic Reconstitution in 
Patients With Disorders Affecting the Hematopoietic System; 
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: 
Biologics License Applications for Minimally Manipulated, Unrelated 
Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic 
and Immunologic Reconstitution in Patients with Disorders Affecting the 
Hematopoietic System'' dated June 2013. The draft guidance document 
provides recommendations for manufacturers, generally cord blood banks, 
to apply for licensure of minimally manipulated, unrelated allogeneic 
placental/umbilical cord blood, for hematopoietic and immunologic 
reconstitution. The guidance document is intended to assist 
manufacturers obtain a biologics license. The guidance contains 
information about the manufacture of minimally manipulated, unrelated 
allogeneic placental/umbilical cord blood and how to comply with 
applicable regulatory requirements. The draft guidance, when finalized, 
is intended to supersede the guidance entitled ``Guidance for Industry: 
Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord 
Blood Intended for Hematopoietic Reconstitution for Specified 
Indications'' dated October 2009.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 16, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-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 electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, 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: Biologics License Applications for Minimally 
Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood 
Intended for Hematopoietic and Immunologic Reconstitution in Patients 
with Disorders Affecting the Hematopoietic System'' dated June 2013. 
The draft guidance document, when finalized, will provide 
recommendations for manufacturers to apply for licensure of minimally 
manipulated, unrelated allogeneic placental/umbilical cord blood, for 
hematopoietic and immunologic reconstitution in patients with disorders 
affecting the hematopoietic system that are inherited, acquired, or 
result from myeloablative treatment. The guidance document is intended 
to assist manufacturers obtain a biologics license. The guidance 
contains information about the manufacture of minimally manipulated, 
unrelated, allogeneic placental/umbilical cord blood and how to comply 
with applicable regulatory requirements. The draft guidance, when 
finalized, is intended to supersede the document entitled ``Guidance 
for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/
Umbilical Cord Blood Intended for Hematopoietic Reconstitution for 
Specified Indications'' dated October 2009.
    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.
    Elsewhere in this issue of the Federal Register, we also are 
announcing the availability of another, related draft guidance entitled 
``Guidance for Industry and FDA Staff: Investigational New Drug 
Applications for Minimally Manipulated, Unrelated Allogeneic Placental/
Umbilical Cord Blood Intended for Hematopoietic and Immunologic 
Reconstitution in Patients with Disorders Affecting the Hematopoietic 
System.'' That draft guidance, when finalized, is intended to supersede 
the document entitled ``Guidance for Industry and FDA Staff: 
Investigational New Drug Applications (INDs) for Minimally Manipulated, 
Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for 
Hematopoietic Reconstitution for Specified Indications'' dated June 
2011.

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 number 0910-0572; 21 CFR part 211 have been approved under 
OMB control number 0910-0139; 21 CFR part 600 have been approved under 
OMB control number 0910-0308; 21 CFR parts 601, 610, and FDA Form 356h 
have been approved under OMB control number 0910-0338; 21 CFR part 1271 
have been approved under OMB control number 0910-0543; and FDA Form 
3500A has been approved under OMB control number 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 either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets

[[Page 36197]]

Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14097 Filed 6-14-13; 8:45 am]
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