[Federal Register Volume 68, Number 237 (Wednesday, December 10, 2003)]
[Notices]
[Pages 68931-68932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30644]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0428]


Guidance for Industry: An Acceptable Circular of Information for 
the Use of Human Blood and Blood Components; 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: An 
Acceptable Circular of Information for the Use of Human Blood and Blood 
Components'' dated December 2003. The guidance document recognizes the 
``Circular of Information for the Use of Human Blood and Blood 
Components'' (the circular) dated July 2002 as acceptable for use by 
manufacturers of blood and blood components intended for transfusion. 
The circular will assist manufacturers in complying with the labeling 
requirements under FDA regulations. The guidance announced in this 
notice finalizes the draft guidance of the same title dated October 
2002.

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

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40),

[[Page 68932]]

Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, 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 the CBER 
Voice Information System at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: An Acceptable Circular of Information for the 
Use of Human Blood and Blood Components'' dated December 2003. The 
guidance recognizes that the circular dated July 2002 meets the 
labeling requirements in Sec.  606.122 (21 CFR 606.122) and is 
acceptable for use by manufacturers of blood and blood components 
intended for transfusion that are subject to U.S. statutes and 
regulations. The circular was prepared jointly by the American 
Association of Blood Banks, America's Blood Centers, and the American 
National Red Cross. A copy of the circular is included as an attachment 
in the guidance document. The guidance announced in this notice 
finalizes the draft guidance of the same title, dated October 2002 (67 
FR 64402, October 18, 2002).
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance document represents 
the agency'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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this guidance. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except individuals may submit one paper copy. Comments 
should 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.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance and the 
circular at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm. The circular may also be 
obtained at http://www.aabb.org. (FDA has verified the Web site 
address, but we are not responsible for subsequent changes to the Web 
site after this document publishes in the Federal Register.)

    Dated: December 1, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-30644 Filed 12-9-03; 8:45 am]
BILLING CODE 4160-01-S