[Federal Register Volume 64, Number 97 (Thursday, May 20, 1999)]
[Notices]
[Pages 27582-27583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-1171]


Draft ``Guidance for Industry: For Platelet Testing and 
Evaluation of Platelet Substitute Products;'' 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availability of the draft guidance document entitled ``Guidance for 
Industry: For Platelet Testing and Evaluation of Platelet Substitute 
Products.'' Recent technological advances regarding platelet physiology

[[Page 27583]]

and biochemistry have altered the way that platelets can be evaluated. 
The draft guidance document, when finalized, is intended to provide 
manufacturers with updated guidance on the evaluation of platelets and 
of their substituted products.

DATES: Written comments may be submitted at any time, however, comments 
should be submitted by July 19, 1999, to ensure their adequate 
consideration in preparation of the final document.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: For Platelet Testing and 
Evaluation of Platelet Substitute Products'' 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to the draft guidance.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, 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 is announcing the availability of a draft document entitled 
``Guidance for Industry: For Platelet Testing and Evaluation of 
Platelet Substitute Products.'' New instrumentation and information 
about platelet physiology and biochemistry have altered the way that 
platelets can be evaluated. These advances have prompted FDA's 
development of an updated draft guidance document regarding platelet 
testing. The draft guidance document provides recommendations on the 
evaluation of platelets and platelet substitute products including: In 
vitro evaluation of platelet biochemistry and function, evaluation of 
platelet survival in circulation, clinical hemostatic efficacy, and 
guidance for testing potential platelet substitutes. The draft guidance 
document, when finalized, is intended to delineate principles of 
general applicability for evaluation of platelets collected and 
processed by novel technologies and would replace the document entitled 
``Platelet Testing Guidelines'' (July 1981) published in the Federal 
Register of October 2, 1981 (46 FR 48768).
    The draft guidance document represents the agency's current 
thinking on platelet testing and evaluation of platelet substitute 
products. 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. 
The document is intended to provide information and does not set forth 
requirements.

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 regarding the draft guidance document. Written comments may be 
submitted at any time, however, comments should be submitted by July 
19, 1999, to ensure adequate consideration in preparation of the final 
document. Two copies of any comments are to be submitted, except 
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 the draft guidance 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 draft guidance 
document by using the World Wide Web (WWW). For WWW access, connect to 
CBER at ``http://www.fda.gov/cber/guidelines.htm''.

    Dated: May 10, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-12649 Filed 5-19-99; 8:45 am]
BILLING CODE 4160-01-F