03-21477. 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for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma; Withdrawal of Draft Guidance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.

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The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance entitled “Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma” dated November 1999, that was announced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 In the draft guidance, FDA sought public comment on the development and implementation of nucleic acid testing (NAT) for infectious diseases.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In a notice published in the Federal Register of November 26, 1999 (64 FR 66481), FDA announced the availability of a draft guidance entitled “Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma” dated November 1999. This draft guidance responded to industry's request for guidance in the development and implementation of NAT of pooled plasma in further improving the safety of the nation's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 This draft guidance is therefore being withdrawn as of September 22, 2003, because it is obsolete.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.