Document ID: FDA-2001-D-0254-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry; Availability: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion
Posted Date: 2011-01-31T05:00Z

[Federal Register Volume 76, Number 20 (Monday, January 31, 2011)]
[Notices]
[Pages 5386-5387]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1989]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0254; formerly Docket No. 2001D-0037]

Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of 
Whole Blood and Blood Components Intended for Transfusion; 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: Pre-
Storage Leukocyte Reduction of Whole Blood and Blood Components 
Intended for Transfusion'' dated January 2011. The draft guidance 
document provides blood establishments with recommendations for pre-
storage leukocyte reduction of Whole Blood and blood components 
intended for transfusion, including recommendations for validation and 
quality control monitoring of the leukocyte reduction process. This 
second draft guidance document incorporates revisions after reviewing 
comments on the January 2001 draft. This draft guidance replaces the 
draft guidance of the same title dated January 2001. This draft 
guidance, when

[[Page 5387]]

finalized, will supersede the FDA memorandum issued on May 29, 1996, 
entitled ``Recommendations and Licensure Requirements for Leukocyte-
Reduced Blood Products.''

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 2, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-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: Lori Jo Churchyard, 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 revised, second draft 
document entitled ``Guidance for Industry: Pre-Storage Leukocyte 
Reduction of Whole Blood and Blood Components Intended for 
Transfusion'' dated January 2011. The draft guidance document provides 
blood establishments with recommendations for pre-storage leukocyte 
reduction of Whole Blood and blood components intended for transfusion, 
including recommendations for validation and quality control monitoring 
of the leukocyte reduction process. The draft guidance provides 
information to assist licensed blood establishments for submitting 
biologics license application supplements to include leukocytes reduced 
components. This second draft guidance document incorporates revisions 
after reviewing comments on the January 2001 draft, and in 
consideration of additional public discussions held at the June and 
December 2001 meetings of the Blood Products Advisory Committee and the 
July 2005 public workshop entitled ``Update on Leukocyte Reduction of 
Blood and Blood Components.'' This draft guidance replaces the draft 
guidance of the same title dated January 2001 (January 31, 2001, 66 FR 
8410). The draft guidance, when finalized, will supersede the FDA 
memorandum issued on May 29, 1996, entitled ``Recommendations and 
Licensure Requirements for Leukocyte-Reduced Blood Products.''
    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 607 have been approved under 
OMB control number 0910-0052; the collections of information in 21 CFR 
606.100(b), 606.100(c), and 606.121 have been approved under OMB 
control number 0910-0116; the collections of information in 21 CFR 
211.192 and 211.198 have been approved under OMB control number 0910-
0139; and the collections of information in 21 CFR 601.12 and 610.60 
have been approved under OMB control number 0910-0338.

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) either 
electronic or written comments regarding this document. It is only 
necessary to send one set of comments. It is no longer necessary to 
send two copies of mailed 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.

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: January 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1989 Filed 1-28-11; 8:45 am]
BILLING CODE 4160-01-P