[Federal Register Volume 67, Number 202 (Friday, October 18, 2002)]
[Notices]
[Page 64402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26612]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0428]


Draft ``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 draft document entitled ``Guidance for Industry: An 
Acceptable Circular of Information for the Use of Human Blood and Blood 
Components'' dated October 2002. The draft guidance document recognizes 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 those manufacturers in complying with the 
labeling requirements under FDA regulations.

DATES: Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by December 17, 2002. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance and the Circular to the Office of Communication, Training, and 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, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your requests. The documents 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for electronic access to the draft guidance document.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. 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 draft document entitled 
``Guidance for Industry: An Acceptable Circular of Information for the 
Use of Human Blood and Blood Components'' dated October 2002. The draft 
guidance document recognizes that the circular dated July 2002 meets 
the labeling requirements in Sec.  606.122 (21 CFR 606.122), and 
therefore is acceptable for use by manufacturers of blood and blood 
components intended for transfusion that are subject to U.S. statutes 
and regulations.
    The requirements under Sec.  606.122 specify that an instruction 
circular must be available for distribution with blood and blood 
components intended for transfusion, and that the information in the 
instruction circular must include adequate instructions for use. The 
circular will assist manufacturers of blood and blood components 
intended for transfusion in complying with the labeling requirements 
under Sec.  606.122. 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 in the draft guidance 
document.
    This draft guidance document is being issued in accordance with 
FDA's good guidance practices regulation (21 CFR 10.115). The draft 
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

    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 (see ADDRESSES) written or 
electronic comments regarding this draft guidance document. Submit 
written or electronic comments 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 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 www.aabb.org.

    Dated: October 10, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26612 Filed 10-17-02; 8:45 am]
BILLING CODE 4160-01-S