Inspections, Compliance, Enforcement, and Criminal Investigations

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]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0061]
Gary D. Mays; Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.


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:

  1. 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.

  2. 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

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