Document ID: FDA-2006-D-0157-0003
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications; Availability
Posted Date: 2009-10-20T04:00Z

[Federal Register: October 20, 2009 (Volume 74, Number 201)]
[Notices]               
[Page 53753-53754]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc09-68]                         

[[Page 53753]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0157] (Formerly Docket No. 2006D-0514)

 
Guidance for Industry: Minimally Manipulated, Unrelated 
Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic 
Reconstitution for Specified Indications; 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 guidance document entitled ``Guidance for Industry: 
Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord 
Blood Intended for Hematopoietic Reconstitution for Specified 
Indications,'' dated October 2009. In this guidance, we refer to these 
products for hematopoietic reconstitution for specified indications as 
hematopoietic progenitor cells, cord (HPC-C). This guidance (HPC-C 
licensure guidance) provides recommendations to manufacturers applying 
for licensure of minimally manipulated, unrelated allogeneic placental/
umbilical cord blood, for specified indications. Elsewhere in this 
issue of the Federal Register, FDA is publishing a draft guidance 
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.'' FDA is also announcing the 
end of the phased-in implementation period for IND and biologics 
license application (BLA) requirements for minimally manipulated 
unrelated allogeneic hematopoietic stem/progenitor cell products. The 
HPC-C licensure guidance announced in this notice finalizes the draft 
guidance entitled ``Guidance for Industry: Minimally Manipulated, 
Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for 
Hematopoietic Reconstitution in Patients with Hematological 
Malignancies,'' dated December 2006.

DATES:  Submit electronic or written comments on agency guidances at 
any time. FDA no longer intends to exercise enforcement discretion with 
respect to IND and BLA requirements for minimally manipulated, 
unrelated allogeneic hematopoietic stem/progenitor cell products and 
the phase in implementation period for IND and BLA requirements will 
end after October 20, 2011.

ADDRESSES:  Submit written requests for single copies of the 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 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 guidance document.
    Submit electronic comments on the 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:  Tami Belouin, 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 guidance document entitled 
``Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic 
Placental/Umbilical Cord Blood Intended for Hematopoietic 
Reconstitution for Specified Indications,'' dated October 2009. This 
guidance provides recommendations to manufacturers applying for 
licensure of minimally manipulated, unrelated allogeneic placental/
umbilical cord blood, for specified indications. Elsewhere in this 
issue of the Federal Register, FDA is publishing an IND draft guidance 
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.'' FDA is also announcing that 
it no longer intends to exercise enforcement discretion with respect to 
IND and BLA requirements for minimally manipulated unrelated allogeneic 
hematopoietic stem/progenitor cell products and the phase-in 
implementation period for IND and license application requirements for 
these products will end (see DATES for ending date). We encourage 
sponsors to send in applications as soon as possible to allow 
sufficient time for review, comment, and re-submission as needed to 
complete all actions by the end of this 2-year period.
    In the Federal Register notice of January 20, 1998 (63 FR 2985), 
FDA requested submission of comments proposing establishment controls, 
process controls, and product standards designed to ensure the safety 
and effectiveness of minimally manipulated unrelated allogeneic 
hematopoietic stem/progenitor cell products derived from peripheral and 
cord blood for hematopoietic reconstitution. Also, in the January 20, 
1998, notice, FDA announced its intention to phase in implementation of 
IND and license application requirements for minimally manipulated 
unrelated allogeneic hematopoietic stem/progenitor cell products to 
permit the development of licensing standards for those products where 
possible.
    In the Federal Register notice of January 17, 2007 (72 FR 1999), 
FDA announced the availability of the draft guidance entitled 
``Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic 
Placental/Umbilical Cord Blood Intended for Hematopoietic 
Reconstitution in Patients with Hematological Malignancies,'' dated 
December 2006. FDA received comments on the December 2006 draft 
guidance and those comments were considered as the guidance was 
finalized. The HPC-C licensure guidance announced in this notice 
finalizes the December 2006 draft guidance. Some of the comments 
received by FDA expressed the importance of access and availability of 
HPC-C products that not do meet standards for licensure and therefore 
cannot be licensed. FDA recognizes the importance of these products and 
is publishing a draft IND guidance addressing IND submissions for such 
products.
    This guidance is consistent with FDA's good guidance practices 
regulation (21 CFR 10.115). The guidance represents FDA's current 
thinking on these topics. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. 
Alternative approaches may be used if such approaches satisfy the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These

[[Page 53754]]

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

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) electronic or written comments 
regarding the 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 brackets in the heading of this document. A copy of the 
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 guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: October 14, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25135 Filed 10-19-09; 8:45 am]

BILLING CODE 4160-01-S