[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
