FINDINGS AND ORDER. 1. The Stipulation of the Parties is appropriate.
FINDINGS AND ORDER. The Court finds that the Settlement Agreement is fair, reasonable, and adequate and warrants final approval under the applicable Rule 23 and Fourth Circuit factors.
FINDINGS AND ORDER. Grant request for a Fermented Malt Beverage (3.2% Beer) License for We Are ONE, Inc. and 7- Eleven, Inc. (Xxxxx Xxxxxx - County Attorney's Office) LIQUOR LICENSES Approval and Issuance
FINDINGS AND ORDER. Therefore, the Interim Deputy Commissioner for Operations, under section 306(a) of the act, and under authority delegated to her (21 CFR 5.20), finds that Mr. Xxxxx Xxxxx has been convicted of a felony under Federal law for conduct: (1) Relating to the development or approval, including the process for development or approval, of a drug product (21 U.S.C. 335a(a)(2)(A)); and (2) relating to the regulation of a drug product (21 U.S.C. 335a(a)(2)(B)). As a result of the foregoing findings, Mr. Xxxxx Xxxxx is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under section 505, 507, 512, or 802 of the act (21 U.S.C. 355, 357, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective November 8,1994 (21 U.S.C. 335a(c)(l)(B) and (c)(2)(A)(ii) ànd 21 U.S.C. 321(ee)). Any person with an approved or pending drug product application who knowingly uses the services of Xx. Xxxxx in any capacity, during his period of debarment, will be.subject to civil money penalties (21 U.S;C. 335b(a)(6)). If Xx. Xxxxx, 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 (21 U.S.C. 335b(a)(7)). In addition, FDA will not accept or review any abbreviated new drug application or abbreviated antibiotic drug application submitted by or with Xx. Xxxxx’x assistance during his period of debarment. Xx. Xxxxx may file an application to attempt to terminate his debarment, pursuant to section 306(d)(4)(A) of the act. Any such application would be reviewed under the criteria and processes set forth in section 306(d)(4)(C) and (d)(4)(D) of the act. Such an application should be identified with Docket No. 92N-0417 Federal Register / Vol. 59, Xx. 000 / Xxxxxxx., Xxxxxxxx 0, 0000 / Xxxxxxx 00000 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: October 28t 1994. Xxxxx X . Xxxxxx ,
