[Federal Register Volume 62, Number 173 (Monday, September 8, 1997)]
[Notices]
[Pages 47212-47213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23655]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 90N-0349]


Draft ``Guidance for Industry: Efficacy Evaluation of Hemoglobin- 
and Perfluorocarbon-Based Oxygen Carriers;'' 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availability of a draft guidance document entitled ``Efficacy 
Evaluation of Hemoglobin- and Perfluorocarbon-Based Oxygen Carriers.'' 
The document is intended as general guidance for manufacturers, 
investigators, sponsors, and other parties interested in the design, 
endpoints, and efficacy criteria for clinical trials of hemoglobin- and 
perfluorocarbon-based oxygen carrier products.

DATE: Written comments may be submitted at any time, however, comments 
should be submitted by December 8, 1997, to ensure their adequate 
consideration in preparation of the final document.

ADDRESSES: Submit written requests for single copies of ``Efficacy 
Evaluation of Hemoglobin- and Perfluorocarbon-Based Oxygen Carriers'' 
to (1) 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, or (2) the Drug Information Branch, Division of 
Communications Management (HFD-210), Center for Drug Evaluation and 
Research, FDA, 5600 Fishers Lane, Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing requests. 
The document may also be obtained by mail by calling the CBER Voice 
Information System at 1-800-835-4709 or 301-827-

[[Page 47213]]

1800, or by fax by calling the FAX Information System at 1-888-CBER-FAX 
or 301-827-3844. Submit written comments on the guidance document to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

SUPPLEMENTARY INFORMATION: 

I. Background

    The draft document is intended to serve as an adjunct to FDA's 
``Points to Consider (PTC) in Safety Evaluation of Hemoglobin-Based 
Oxygen Carriers,'' which is dated August 27, 1990. That PTC was 
announced as available in the Federal Register of January 8, 1991 (56 
FR 698), and was published in the April 1991 issue of Transfusion (31: 
369-371, 1991). This draft document was developed, in part, from 
presentations and discussions at the ``Workshop on Criteria for 
Efficacy of Red Cell Substitutes,'' held in Bethesda, MD, on January 
11, 1994, and sponsored by the National Heart, Lung, and Blood 
Institute, the Department of the Army, and FDA. The draft document is 
intended as general guidance for manufacturers, investigators, 
sponsors, and other parties interested in the design, endpoints, and 
efficacy criteria for clinical trials of hemoglobin- and 
perfluorocarbon-based oxygen carrier products.
    This guidance document represents the agency's current thinking on 
hemoglobin- and perfluorocarbon-based oxygen carriers. 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 requirements 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. This document is 
intended to provide information and does not set forth requirements. 
FDA encourages manufacturers, sponsors, investigators, and other 
interested parties to prospectively discuss with FDA the design of 
clinical trials, selection of clinical trial endpoints, and development 
of efficacy criteria to prevent expenditure of time, personnel, money, 
and other resources on clinical trials that FDA may later determine are 
unacceptable.

II. Comments

    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 on the draft guidance document. Written comments may be 
submitted at any time, however, comments should be submitted by 
December 8, 1997,, to ensure adequate consideration in preparation of 
the final document. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments and requests for 
copies should be identified with the docket number found in brackets in 
the heading of this document. A copy of this 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. Electronic Access

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

    Dated: August 29, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-23655 Filed 9-5-97; 8:45 am]
BILLING CODE 4160-01-F