[Federal Register Volume 62, Number 16 (Friday, January 24, 1997)]
[Notices]
[Pages 3703-3704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1784]


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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