E6-5970. Vaccine Adverse Event Reporting; Revised Form VAERS-2; Withdrawal of Proposed Revised Form

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; withdrawal.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the withdrawal of a proposed revised form that was issued in the Federal Register on November 20, 2001.

DATES:

April 21, 2006.

FOR FURTHER INFORMATION CONTACT:

Joseph L. Okrasinski, Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

In a notice published in the Federal Register of November 20, 2001 (66 FR 58153), FDA announced the availability of a proposed revised form entitled “Vaccine Adverse Event Reporting System” (Form VAERS-2) dated July 2001. This proposed revised form is being withdrawn because FDA is no longer pursuing changes to the form.

Dated: April 12, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.