[Federal Register Volume 68, Number 163 (Friday, August 22, 2003)]
[Notices]
[Page 50804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21477]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999D-4577]


Guidance for Industry: Application of Current Statutory Authority 
to Nucleic Acid Testing of Pooled Plasma; Withdrawal of Draft Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of a draft guidance entitled ``Guidance for Industry: 
Application of Current Statutory Authority to Nucleic Acid Testing of 
Pooled Plasma'' dated November 1999, that was announced in the Federal 
Register on November 26, 1999. In the draft guidance, FDA sought public 
comment on the development and implementation of nucleic acid testing 
(NAT) for infectious diseases.

DATES: Effective September 22, 2003.

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, 301-827-6210.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of November 26, 1999 (64 FR 66481), FDA announced the 
availability of a draft guidance entitled ``Guidance for Industry: 
Application of Current Statutory Authority to Nucleic Acid Testing of 
Pooled Plasma'' dated November 1999. This draft guidance responded to 
industry's request for guidance in the development and implementation 
of NAT of pooled plasma in further improving the safety of the nation's 
blood products. No NAT test kit manufacturers were licensed at that 
time. A number of manufacturers have subsequently been licensed for 
NAT, making the request for guidance in the development of NAT testing 
of pooled plasma for infectious agents now moot. This draft guidance is 
therefore being withdrawn as of September 22, 2003, because it is 
obsolete.

    Dated: August 14, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-21477 Filed 8-21-03; 8:45 am]
BILLING CODE 4160-01-S