[Federal Register: October 28, 2004 (Volume 69, Number 208)]
[Notices]               
[Page 62903-62904]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc04-69]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0462]

 
Draft Guidance for Industry: Criteria for Safety and Efficacy 
Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes; 
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 
entitled Criteria for Safety and Efficacy Evaluation of Oxygen 
Therapeutics as Red Blood Cell Substitutes'' dated October 2004. The 
draft guidance provides sponsors or investigators, with criteria for 
testing the efficacy and safety of oxygen therapeutics as substitutes 
for red blood cells, and guidance on the design of clinical trials to 
assess risk/benefit ratio of such use. The draft guidance, when 
finalized, would supercede the ``Points to Consider on the Safety 
Evaluation of Hemoglobin-Based Oxygen Carriers,'' dated August 27, 
1990, and replaces the draft ``Guidance for Industry: Efficacy 
Evaluation of Hemoglobin- and Perfluorocarbon-Based Oxygen Carriers'' 
dated September 1997.

DATES: Submit written or electronic comments on the draft guidance by 
January 26, 2005 to ensure their adequate consideration in preparation 
of the final guidance. General comments on agency guidance documents 
are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may also be 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electronic access to the draft guidance.
    Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.


FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for 
Biologics

[[Page 62904]]

Evaluation and Research (HFM-17), Food and Drug Administration, suite 
200N, 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 entitled Criteria for Safety and Efficacy 
Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes'' dated 
October 2004. The draft guidance, when finalized, would supercede the 
``Points to Consider on the Safety Evaluation of Hemoglobin-Based 
Oxygen Carriers,'' dated August 27, 1990, and replaces the draft 
``Guidance for Industry: Efficacy Evaluation of Hemoglobin- and 
Perfluorocarbon-Based Oxygen Carriers'' dated September 1997. The draft 
guidance provides you, as a sponsor or investigator, with criteria for 
testing the efficacy and safety of oxygen therapeutics as substitutes 
for red blood cells, and guidance on the design of clinical trials to 
assess risk/benefit ratio of such use. While the draft guidance is 
restricted to use of oxygen therapeutics as substitutes for red blood 
cells, this may not be the only indication being evaluated for these 
investigational new drugs. The draft guidance should not discourage 
innovation in the development of appropriate endpoints for and the 
design of clinical trials for other uses of oxygen therapeutics.
    The draft guidance was revised based on, in part, presentations and 
discussions obtained at a workshop entitled ``Criteria for Safety and 
Efficacy Evaluation of Oxygen Therapeutics as Red Cell Substitutes'' 
held on September 27 and 28, 1999, and public comments received on the 
September 1997 draft guidance. The workshop was sponsored by CBER, FDA, 
and co-sponsored by the National Heart, Lung, and Blood Institute, 
National Institute of Health, the Department of Defense, U.S. Army 
Medical and Material Command, and the Armed Services Blood Program 
Office.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding this draft guidance. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in the brackets in 
the heading of this document. A copy of the draft guidance and received 
comments are available for public examination in the Division of 
Dockets Management 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 
at either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
    Dated: October 20, 2004.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24066 Filed 10-27-04; 8:45 am]

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