[Federal Register Volume 77, Number 186 (Tuesday, September 25, 2012)]
[Notices]
[Pages 59000-59001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23542]


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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)]


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 document entitled ``Guidance for Industry: Pre-
Storage Leukocyte Reduction of Whole Blood and Blood Components 
Intended for Transfusion'' dated September 2012. The 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 guidance 
announced in this notice finalizes the draft guidance of the same title 
dated January 2011 and supersedes the FDA memorandum issued on May 29, 
1996, entitled ``Recommendations and Licensure Requirements for 
Leukocyte-Reduced Blood Products.''

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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

[[Page 59001]]

Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood 
and Blood Components Intended for Transfusion'' dated September 2012. 
The 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 guidance also provides information to assist 
licensed blood establishments for submitting biologics license 
application supplements to include leukocytes reduced components.
    In the Federal Register of January 31, 2011 (76 FR 5386), FDA 
announced the availability of the draft guidance of the same title 
dated January 2011. FDA received several comments on the draft guidance 
and those comments were considered as the guidance was finalized. A 
summary of changes includes the following: Removing the recommendation 
for use of a mixing device during collection, modifying definitions, 
and clarifying performance qualification criteria. In addition, 
editorial changes were made to improve clarity. The guidance announced 
in this notice finalizes the draft guidance dated January 2011 and 
supersedes the FDA memorandum issued on May 29, 1996, entitled 
``Recommendations and Licensure Requirements for Leukocyte-Reduced 
Blood Products.''
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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

    The 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 and Form FDA 2830 have 
been approved under OMB control number 0910-0052; the collections of 
information in 21 CFR 606.100(b), 606.100(c), 606.121, and 606.122 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 and Form FDA 356h have been approved under OMB 
control number 0910-0338.

III. Comments

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

    Dated: September 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23542 Filed 9-24-12; 8:45 am]
BILLING CODE 4160-01-P