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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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01/24/1997

[Federal Register: January 24, 1997 (Volume 62, Number 16)]

[Notices]              

[Page 3703-3704]

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

[DOCID:fr24ja97-80]

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 96N-0061]

 

Gary D. Mays; 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) debarring Mr.

Gary D. Mays, 5304 John Thomas Dr. NE., Albuquerque, NM 87111, for a

period of 5 years from providing services in any capacity to a person

that has an approved or pending drug product application including, but

not limited to, a biological product license application or an

establishment license application. FDA bases this order on a finding

that Mr. Mays was convicted of conspiracy to commit a felony under

Federal law for conduct relating to the regulation of a drug product

under the act while he was employed as responsible head of El Paseo

Plasma, Inc., located at 1595 El Paseo, Las Cruces, NM. After being

given notice of his proposed debarment and opportunity to request a

hearing, Mr. Mays has failed to request a hearing. Therefore, Mr. Mays

has waived his opportunity for a hearing concerning this action.

 

EFFECTIVE DATE: January 24, 1997

 

ADDRESSES: Application for termination of debarment to the Dockets

Management Branch (HFA-305), Food and Drug Administration, 12420

Parklawn Dr., rm. 1-23, Rockville, MD 20857.

 

FOR FURTHER INFORMATION CONTACT: Gloria Hicks, Center for Biologics

Evaluation and Research (HFM-630), Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

 

SUPPLEMENTARY INFORMATION:

 

I. Background

    

On December 14, 1989, the United States District Court for the

District of New Mexico accepted a plea of guilty and entered judgment

against Mr. Gary D. Mays for one count of a conspiracy to provide false

statements in a matter within the jurisdiction of a Federal agency, a

Federal felony offense under 18 U.S.C. 371. The basis for this

conviction was Mr. Mays' act of falsification of whole blood logs,

donor record files, quality control logs, destruction logs, records

concerning the infusion of red blood cells to the wrong donor, and

concealing and covering up by false statements at least two incidents

of misconnecting for infusion, but not infusing, one donor with the red

blood cells of another donor.

 

In order for FDA to regulate the blood plasma supply adequately and

effectively, FDA requires that blood plasma facilities maintain

accurate and complete records containing information regarding whole

blood logs, donor record files, quality control logs, and destruction

logs. Such records are crucial for FDA to assure that plasma products

are safe, pure, and potent, and that the health of donors is protected

in order to assure a continued healthy donor population. Because of Mr.

Mays' omissions and falsifications in such records, FDA was prevented

from obtaining accurate and complete information necessary to regulate

the human blood plasma supply, and, therefore, FDA's process for the

regulation of drug products was undermined.

 

As a result of his conviction, FDA delivered a letter, dated

December 5, 1994, to Mr. Mays which provided notice of FDA's proposal

to debar him for a period of 5 years from providing services in any

capacity to a person that has an approved or pending drug product

application including, but not limited to, a biological product license

application or an establishment license application, and offered him an

opportunity for a hearing on the proposal in accordance with 21 U.S.C.

335a and 21 CFR part 12. FDA based the proposal on its finding under

section 306(b)(2)(B)(i)(II) of the act (21 U.S.C. 335a(b)(2)(B)(i)(II))

that Mr. Mays was convicted of conspiracy to commit a felony under

Federal law for conduct relating to the regulation of a drug product

under the act. Mr. Mays 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 Deputy Commissioner for Operations, under section

306(b) of the act, and under authority delegated

 

[[Page 3704]]

 

by 21 CFR 5.20, finds that Mr. Gary D. Mays has been convicted of

conspiracy to commit a felony under Federal law for conduct relating to

the regulation of a drug product under the act and that the type of

conduct which served as the basis for his conviction undermines the

process for the regulation of drugs (21 U.S.C. 335a(b)(2)(B)(i)(II)).

 

As a result of the foregoing finding, and due to the nature and

seriousness of his offense, Mr. Gary D. Mays is debarred for a period

of 5 years from providing services in any capacity to a person that has

an approved or pending drug product application under sections 505,

507, 512, or 802 of the act (21 U.S.C. 355, 357, 360b, or 382), or

biological product license application or establishment license

application under section 351 of the Public Health Service Act (42

U.S.C. 262), effective January 24, 1997 (21 U.S.C. 335a(c)(1)(B) and

(c)(2)(A)(iii)). In addition, FDA will not accept or review any

abbreviated new drug application or abbreviated antibiotic drug

application from Mr. Mays during his period of debarment (21 U.S.C.

335a(c)(1)(B)). Any person with an approved or pending drug product

application including, but not limited to, a biological product license

application or an establishment license application, who knowingly uses

the services of Mr. Mays in any capacity during his period of debarment

will be subject to civil money penalties (21 U.S.C. 335b(a)(6)). If Mr.

Mays during his period of debarment provides services in any capacity

to a person with an approved or pending drug product application

including, but not limited to, a biological product license application

or an establishment license application, he will be subject to civil

money penalties (21 U.S.C. 335b(a)(7)).

 

Any application by Mr. Mays for termination of debarment under

section 306(d)(4) of the act should be identified with the docket

number found in brackets in the heading of this notice and sent to the

Dockets Management Branch (address above). 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: January 7, 1997.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and Research.

[FR Doc. 97-1784 Filed 1-23-97; 8:45 am]

BILLING CODE 4160-01-F