[Federal Register Volume 63, Number 228 (Friday, November 27, 1998)]
[Notices]
[Pages 65600-65601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0965]


United States Industry Consensus Standard for the Uniform 
Labeling of Blood and Blood Components Using ISBT 128; 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 ``United States Industry 
Consensus Standard for the Uniform Labeling of Blood and Blood 
Components Using ISBT 128,'' December 1997. The International Council 
for Commonality in Blood Banking Automation (ICCBBA) has submitted the 
draft document to FDA with a recommendation that it serve as the basis 
for current FDA guidance on the labeling of blood and blood components. 
The ICCBBA recommends that the bar coding system described in the draft 
document, ``ISBT 128,'' replace the coding system ``ABC Codabar'' 
currently in use for blood and blood components. FDA is considering 
updating its guidance on blood labeling and is issuing this notice to 
invite public comment on the ICCBBA's draft document and the ``ISBT 
128'' coding system, as well as issues related to the possible 
transition from the labeling of blood and blood components using the 
``ABC Codabar'' to a new coding system.

DATES: Written comments may be submitted at any time, however, to 
ensure comments are adequately considered in the preparation of 
guidance, comments should be submitted by February 25, 1999.
ADDRESSES: Submit written requests for single copies of the draft 
document ``United States Industry Consensus Standard for the Uniform 
Labeling of Blood and Blood Components Using ISBT 128'' 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 that office in processing your 
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 document.
    Submit written comments on the draft document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gloria J. Hicks, 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 published in the Federal Register of August 30, 1985 (50 FR 
35472), a notice of availability of a document entitled ``Guideline for 
the Uniform Labeling of Blood and Blood Components,'' which described 
the uniform container label for blood and blood components. The 
standard labels recommended in the guideline for blood and blood 
components incorporated bar code symbology known as ABC Codabar.
    The International Society for Blood Transfusion (ISBT) was 
organized to bring together professionals involved in blood transfusion 
medicine. One of the Society's goals is to promote and to maintain a 
high level of ethical, medical, and scientific standards in blood 
transfusion medicine and science throughout the world. In August 1989, 
an ISBT Working Party on Blood Banking Automation recognized that 
Codabar was becoming outdated and initiated the design of a totally new 
system named ISBT 128 using the bar code symbology known as Code 128. 
The ISBT 128 Technical Specification document was accepted by the ISBT 
Council in July 1994.
    In November 1994, the ISBT turned over to the ICCBBA the 
responsibility for worldwide management and distribution of the ISBT 
128 Technical Specification and associated databases. ICCBBA is a 
nonprofit group organized to oversee, maintain, and distribute the ISBT 
128 system. ICCBBA submitted a draft document to FDA that proposes that 
ISBT 128 replace the current ABC Codabar system used on blood and blood 
component labels in the United States. On March 23, 1995, FDA asked the 
Blood Products Advisory Committee

[[Page 65601]]

(BPAC) whether FDA should support conversion from the ABC Codabar 
system to the ISBT 128 system. BPAC voted in favor of FDA supporting 
the transition to the new coding system. The change to ISBT 128 is also 
supported by the American Association of Blood Banks (AABB), American 
Red Cross (ARC), America's Blood Centers (ABC), and the Department of 
Defense (DoD).
    In December 1996, ICCBBA held an ISBT 128 Consensus Conference in 
Washington, DC, to provide an opportunity for dialogue among the 
affected industry groups and FDA. Although consensus was obtained for 
use of ISBT 128 as proposed in the draft document, concerns were 
expressed regarding implementation timeframes and costs of 
implementation to hospital transfusion services. The ICCBBA submitted a 
draft of the industry consensus document to FDA with the recommendation 
that it serve as the basis for current FDA guidance on blood and blood 
component labeling. The agency is making this draft document describing 
the use of ISBT 128 in the labeling of blood and blood components 
available for public comment to assist the agency in determining 
whether to update its guidance on blood labeling.
    Under FDA's ``Good Guidance Practices'' (GGP's), published in the 
Federal Register on February 27, 1997 (62 FR 8961), this draft document 
is being made available for public comment. The GGP's provide that 
members of the public may comment on and suggest areas for guidance 
development or revision and submit draft guidance for possible adoption 
by the agency. In its discretion, FDA may choose to publish for comment 
such a draft document as the agency considers whether or not to develop 
or revise guidance. In this instance, FDA believes it would be helpful 
to obtain public comment on the ISBT 128 coding system as the agency 
considers updating its guidance on blood labeling.

II. Request for Comments

    FDA is making available for comment this draft document entitled 
``United States Industry Consensus Standard for the Uniform Labeling of 
Blood and Blood Components Using ISBT 128.'' In addition to comments 
about the adoption of ISBT 128 as a blood coding system and the 
proposed label format, FDA specifically requests comments on the 
following: (1) The proposed ``rule-based'' system for naming blood 
components since adoption of ISBT 128 would entail changing some of the 
currently accepted names of blood components, e.g., Platelets, Pheresis 
would become Apheresis Platelets; and (2) timeframes and procedures for 
the transition and full implementation of ISBT 128. FDA notes that its 
intent would be to initiate changes to language in order to permit the 
use of the new system if FDA determines the ISBT 128 is an acceptable 
coding system. Thus, in a future document FDA may consider changes to 
accommodate the new system of blood component bar coding, 
identification, and naming.
    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 document. Written comments may be 
submitted at any time, however, comments should be submitted by 
February 25, 1999, to ensure adequate consideration in the preparation 
of guidance. Received comments will be considered in determining 
whether to issue guidance. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. A copy of the draft document and received comments 
are available for public examination in the office above between 9 a.m. 
and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the draft document 
using the World Wide Web (WWW). For WWW access, connect to CBER at 
``http://www.fda.gov/cber/guidelines.htm''.

    Dated: November 18, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-31571 Filed 11-25-98; 8:45 am]
BILLING CODE 4160-01-F