[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