[Federal Register Volume 76, Number 20 (Monday, January 31, 2011)]
[Notices]
[Pages 5386-5387]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of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 The draft guidance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second draft guidance document incorporates revisions after reviewing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 This draft guidance replaces the
draft guidance of the same title dated January 2001. This draft
guidance, when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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 2, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development (HFM-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 The draft guidance may also be obtained by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SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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]
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