[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availability of the draft guidance document entitled ``Guidance for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The draft guidance document, when finalized, is intended to provide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ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry: For Platelet Testing and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to the draft guidance.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