FR DATE: 01/13/2003

[Federal Register: January 13, 2003 (Volume 68, Number 8)]

[Notices]               

[Page 1619-1620]

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

[DOCID:fr13ja03-63]                         





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DEPARTMENT OF HEALTH AND HUMAN SERVICES





Food and Drug Administration





[Docket No. 01N-0565]





 

Harry W. Snyder, Jr.; Debarment Order





AGENCY: Food and Drug Administration, HHS.





ACTION: Notice.





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SUMMARY: The Food and Drug Administration (FDA) is issuing an order 

under the Federal Food, Drug, and Cosmetic Act (the act) permanently 

debarring Harry W. Snyder, Jr., from providing services in any capacity 

to a person that has an approved or pending drug product application. 

FDA bases this order on a finding that Mr. Snyder was convicted of a 

felony under Federal law for conduct relating to the development or 

approval, including the process for development or approval, of a drug 

product. Mr. Snyder failed to request a hearing and, therefore, has 

waived his opportunity for a hearing concerning this action.





DATES: This order is effective January 13, 2003.





ADDRESSES: Submit applications for termination of debarment to the 

Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 20852.





FOR FURTHER INFORMATION CONTACT: Nicole K. Mueller, Center for Drug 

Evaluation and Research (HFD-7), Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 301-594-2041.





SUPPLEMENTARY INFORMATION:





I. Background





    On August 31, 2000, the U.S. District Court for the Northern 

District of Alabama entered judgment against Mr. Snyder for two counts 

of making false statements to an agency of the United States, two 

counts of mail fraud, and one count of conspiracy to commit





[[Page 1620]]





offenses against the United States, Federal felony offenses under 18 

U.S.C. 2, 1001, 1341, and 371, respectively. These offenses were 

committed as part of the development of a new drug for which Mr. Snyder 

was conducting efficacy trials.

    As a result of this conviction, FDA served Mr. Snyder by certified 

mail on May 8, 2002, a notice proposing to permanently debar Mr. Snyder 

from providing services in any capacity to a person that has an 

approved or pending drug product application. The proposal also offered 

Mr. Snyder an opportunity for a hearing on the proposal. The proposal 

was based on a finding, under section 306(a)(2)(A) of the act (21 

U.S.C. 335a(a)(2)(A)), that Mr. Snyder was convicted of a felony under 

Federal law for conduct relating to the development or approval, 

including the process for development or approval, of a drug product. 

Mr. Snyder was provided 30 days to file objections and request a 

hearing. Mr. Snyder did not request a hearing. His failure to request a 

hearing constitutes a waiver of his opportunity for a hearing and a 

waiver of any contentions concerning his debarment.





II. Findings and Order





    Therefore, the Director, Center for Drug Evaluation and Research, 

under section 306(a)(2)(A) of the act, and under authority delegated to 

her (21 CFR 5.34), finds that Mr. Harry W. Snyder, Jr., has been 

convicted of a felony under Federal law for conduct relating to the 

development or approval, including the process for development or 

approval, of a drug product.

    As a result of the foregoing finding, Mr. Harry W. Snyder, Jr., is 

permanently debarred from providing services in any capacity to a 

person with an approved or pending drug product application under 

section 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)(ii) and 201(dd) of the act (21 

U.S.C. 321(dd))). Any person with an approved or pending drug product 

application who knowingly uses the services of Mr. Snyder, in any 

capacity, during his period of debarment, will be subject to civil 

money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). 

If Mr. Snyder, during his period of debarment, provides services in any 

capacity to a person with an approved or pending drug product 

application, he will be subject to civil money penalties (section 

307(a)(7) of the act). In addition, FDA will not accept or review any 

abbreviated new drug applications submitted by or with the assistance 

of Mr. Snyder during his period of debarment.

    Any application by Mr. Snyder for termination of debarment under 

section 306(d)(4) of the act should be identified with Docket No. 01N-

0565 and sent to the Dockets Management Branch (see ADDRESSES). All 

such submissions are to be filed in four copies. The public 

availability of information in these submissions is governed by 21 CFR 

10.20(j). Publicly available submissions may be seen in the Dockets 

Management Branch between 9 a.m. and 4 p.m., Monday through Friday.





    Dated: December 23, 2002.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

[FR Doc. 03-661 Filed 1-10-03; 8:45 am]



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