[Federal Register Volume 66, Number 21 (Wednesday, January 31, 2001)]
[Notices]
[Pages 8410-8411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2584]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-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.'' The draft guidance document provides 
recommendations on manufacturing and quality assurance applicable to 
pre-storage leukocyte reduction of blood components intended for 
transfusion. This draft guidance document describes manufacturing 
procedures and controls that should be in place and would supersede the 
FDA memorandum issued on May 29, 1996, entitled ``Recommendations and 
Licensure Requirements for Leukocyte-Reduced Blood Products.''

DATES: Submit written comments on the draft guidance at any time, 
however, comments should be submitted by May 1, 2001, to ensure their 
adequate consideration in preparation of the final guidance document.

ADDRESSES: Submit written requests for single copies of ``Guidance for 
Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood 
Components Intended for Transfusion'' to the Office of Communication, 
Training, and Manufacturers Assistance (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

[[Page 8411]]

requests. The document may also be obtained by mail by calling the CBER 
Voice Information System at 1-800-835-4709 or 301-827-1800, or by fax 
by calling the FAX Information System at 1-888-CBER-FAX or 301-827-
3844. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance document.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Requests and comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, 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: Pre-Storage Leukocyte Reduction of Whole Blood 
and Blood Components Intended for Transfusion.'' The draft guidance 
document provides FDA recommendations regarding leukocyte reduction and 
provides information to assist licensed facilities in filing 
supplements to their biologics licenses to include leukocyte reduced 
products.
    This draft guidance document describes the manufacturing procedures 
and controls applicable to pre-storage leukocyte reduced blood 
components for transfusion. Additionally, the agency would streamline 
the licensing procedure for leukocyte reduced products in order to 
assist blood establishments in making pre-storage leukocyte reduced 
products more widely available.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). This draft guidance document represents the agency's current 
thinking on the leukocyte reduction of blood components intended for 
transfusion. 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 statute and regulations. As with other guidance documents, 
FDA does not intend this document to be all-inclusive and cautions that 
not all information may be applicable to all situations. The document 
is intended to provide information and does not set forth requirements.

II. Comments

    This draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (address above) written 
comments regarding this draft guidance document. Written comments may 
be submitted at any time, however, comments should be submitted by May 
1, 2001, to ensure adequate consideration in preparation of the final 
document. Two copies of any comments are to be submitted, except 
individuals may submit one copy. Comments should be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the document and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document at http://www.fda.gov/cder/guidance/index.htm or at http://www.fda.gov/cber/guidelines.htm.

    Dated: January 22, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-2584 Filed 1-30-01; 8:45 am]
BILLING CODE 4160-01-F