[Federal Register Volume 65, Number 109 (Tuesday, June 6, 2000)]
[Notices]
[Pages 35944-35945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14211]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0965]


``Guidance for Industry: Recognition and Use of a Standard for 
the Uniform Labeling of 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 guidance document entitled ``Guidance for Industry: 
Recognition and Use of a Standard for the Uniform Labeling of Blood and 
Blood Components.'' The guidance document describes a system for the 
uniform labeling of blood and blood components for transfusion, Source 
Plasma, and other components for use in further manufacturing. The 
guidance will assist manufacturers in complying with the labeling 
requirements under FDA's regulations.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Guidance for Industry: Recognition and Use of a Standard for 
the Uniform Labeling of Blood and Blood Components'' to the Office of 
Communication, Training, and Manufacturers Assistance (HFM-40), Center 
for Biologics Evaluation and Research, 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 
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 
guidance document.
    Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: For information about this notice: 
Sharon A. Carayiannis, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448, 301-827-6210.
    For technical information: Kenneth A. Zemann, Center for Biologics 
Evaluation and Research (HFM-375), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-3543, or FAX 301-827-
3534.

SUPPLEMENTARY INFORMATION:

I. Background

    The International Council for Commonality in Blood Banking 
Automation (ICCBBA) prepared and submitted to FDA a draft document 
entitled ``United States Industry Consensus Standard for the Uniform 
Labeling of Blood and Blood Components Using ISBT 128,'' Version 1.2.0 
(draft Standard). The ICCBBA requested that ISBT 128 replace the 
current ``ABC Codabar'' system as an approved machine readable barcode 
for labeling blood and blood components. On November 21, 1998, FDA made 
the draft Standard available on its website for public comment. In the 
Federal Register of November 27, 1998 (63 FR 65600), FDA announced the 
availability of the draft Standard and requested public comment on both 
the use of ISBT 128 and timeframes for implementation. The ICCBBA 
revised the draft Standard in response to public comment and submitted 
to FDA the revised document entitled ``United States Industry Consensus 
Standard for the Uniform Labeling of Blood and Blood Components Using 
ISBT 128,'' Version 1.2.0, dated November 1999 (the Version 1.2.0 
Standard).
    FDA has reviewed the draft Standard, the comments received, and the 
Version 1.2.0 Standard. FDA believes that conformance to the Version 
1.2.0 Standard, prepared and revised by ICCBBA, will help facilitate 
the use of a uniform container label for blood and blood components. 
FDA is announcing the availability of a guidance entitled ``Guidance 
for Industry: Recognition and Use of a Standard for the Uniform 
Labeling of Blood and Blood Components'' that recognizes as acceptable 
the Version 1.2.0 Standard prepared by ICCBBA, and the implementation 
of the ISBT 128 uniform labeling system, except where inconsistent with 
FDA's regulations under 21 CFR 606.121. Although FDA finds use of the 
Version 1.2.0 Standard acceptable, FDA has identified inconsistencies 
between the Version 1.2.0 Standard and Federal regulations. FDA intends 
to revise the regulations to remove these inconsistencies. The guidance 
provides recommendations to follow where discrepancies exist between 
the Version 1.2.0 Standard and the current regulations, pending 
completion of rulemaking to remove these discrepancies.
    This guidance document represents the agency's current thinking 
with regard to use of the Version 1.2.0 Standard for use in labeling 
blood, blood components for transfusion, Source Plasma, and other 
components for further manufacturing use. 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 statute, regulations, or both. As 
with other guidance documents, FDA does not intend this document to be 
all-inclusive and cautions that not all information may be applicable 
to all situations. The document is intended to provide information and 
does not set forth requirements.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this guidance document at 
any time. 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 the 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. Paperwork Reduction Act of 1995

    The labeling regulations on which the guidance is based are 
reported under the Office of Management and Budget (OMB) control number 
0910-0116. FDA tentatively concludes that this guidance contains no new 
collections of information. Therefore, clearance by OMB under the 
Paperwork Reduction Act of 1995 is not required.

[[Page 35945]]

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document and the Version 1.2.0 Standard at http://www.fda.gov/cber/guidelines.htm.

    Dated: May 25, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-14211 Filed 6-2-00; 11:16 am]
BILLING CODE 4160-01-F