[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
