BILLING CODE 4160–01–F DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
نویسنده
چکیده
period of 5 years. Any person with an approved or pending drug product application who knowingly uses the services of Mr. Feuer in any in any capacity during his period of debarment will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Mr. Feuer, 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 (section 307(a)(7) of the act). In addition, FDA will not accept or review any abbreviated new drug applications or abbreviated antibiotic drug applications submitted by or with the assistance of Mr. Feuer during his period of debarment. Any application by Mr. Feuer for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 98N–0131 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.
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