03-1020. Delfina Hernandez; Rescission of Debarment Order

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is rescinding an order issued under the Federal Food, Drug, and Cosmetic Act (the act) debarring Ms. Delfina Hernandez for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA is issuing this rescission because service of a notice proposing to debar Ms. Hernandez and offering her an opportunity for a hearing on the proposal was sent to the wrong person.

DATES:

This notice is effective November 6, 2002.

FOR FURTHER INFORMATION CONTACT:

Mary Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

In the Federal Register of November 6, 2002 (67 FR 67629), FDA issued an order debarring Ms. Delfina Hernandez for 5 years from providing services in any capacity to a person that has an approved or pending drug product application under sections 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382) or under section 351 of the Public Health Service Act (42 U.S.C. 262) (see sections 306(c)(1)(B) and (c)(2)(A)(iii) and 201(dd) of the act (21 U.S.C. 321(dd))).

The debarment order stated that FDA had served Ms. Hernandez by certified mail on May 13, 2002, a notice proposing to debar her and offering her an opportunity for a hearing on the proposal. The debarment order further stated that Ms. Hernandez had failed to request a hearing and thereby waived her opportunity for a hearing and waived any contentions concerning her debarment.

FDA has learned that the notice proposing to debar Ms. Hernandez and offering her an opportunity for a hearing was sent to an incorrect address and was apparently signed for by a person with the same name as Ms. Hernandez, but who was not the intended subject of the notice. Accordingly, FDA is rescinding the November 6, 2002, order.

This notice is issued under the Federal Food, Drug, and Cosmetic Act (section 306 (21 U.S.C. 335a)) and under authority delegated to the Director of the Center for Drug Evaluation and Research (21 CFR 5.34).

Dated: January 2, 2003.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.