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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FR DATE:11/06/2002

[Federal Register: January 16, 2003 (Volume 68, Number 11)]

[Notices]               

[Page 2339]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16ja03-74]                         





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DEPARTMENT OF HEALTH AND HUMAN SERVICES





Food and Drug Administration





[Docket No. 00N-1528]





 

Delfina Hernandez; Rescission of Debarment Order





AGENCY: Food and Drug Administration, HHS.





ACTION: Notice.





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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.

[FR Doc. 03-1020 Filed 1-15-03; 8:45 am]



BILLING CODE 4160-01-S