Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices https www.regulations.gov or at the Dockets Management Staff between 9
a.m. and 4 p.m., Monday through Friday, 2404027500.
Confidential SubmissionsTo submit an application with confidential information that you do not wish to be made publicly available, submit your application only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION. The Agency will review this copy, including the claimed confidential information, in its consideration of your application.
The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your application and you must identify this information as confidential. Any information marked as confidential will not be disclosed except in accordance with 21 CFR 10.20
and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to https www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 between 9 a.m.
and 4 p.m., Monday through Friday, 2404027500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT:
Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 2404025931.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES

I. Background Section 306b2BiI of the FD&C
Act 21 U.S.C. 335ab2BiI
permits FDA to debar an individual if it finds that: 1 The individual was convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating to the
VerDate Sep<11>2014

17:21 Jul 30, 2021

Jkt 253001

regulation of a drug product under the FD&C Act and 2 that the type of conduct underlying the conviction undermines the process for the regulation of drugs.
On September 6, 2011, in the U.S.
District Court for the Eastern District of Virginia, Ms. Ngo pled guilty to a misdemeanor violation of the FD&C Act, namely failing to maintain records required by section 505i of the FD&C
Act 21 U.S.C. 355i in violation of sections 301e and 303a1 21 U.S.C.
331e and 333a1. Ms. Ngos conviction stemmed from her actions as a clinical research coordinator for the Norfolk Diagnostic Center, doing business as Sentara Medical Group Sentara. Eli Lilly Corp. Eli Lilly initiated a clinical study to investigate the effectiveness of lispro insulin for the purpose of applying for FDA approval to market lispro insulin for the treatment of Type 2 diabetes. Eli Lilly entered into an agreement with Sentara to conduct the ispro insulin study, and Sentara agreed to maintain records in accordance with 21 CFR 312.62a and by extension, section 505i of the FD&C
Act. Ms. Ngo was a clinical research coordinator for the lispro insulin study and responsible for maintaining and completing case report forms CRFs, which are the official records that document volunteers participation in the study and contain vital medical information related to the performance of the study drug. Ms. Ngo knowingly and repeatedly falsified CRFs.
By letter dated April 27, 2012, FDAs Office of Regulatory Affairs ORA
notified Ms. Ngo of its proposal to debar her for 5 years from providing services in any capacity to a person having an approved or pending drug product application. The proposal explained that the proposed debarment period was based on her misdemeanor conviction and that the maximum debarment period is 5 years. ORA explained that her conduct relating to the clinical trial relates to the development and approval, including the process for development and approval, of drug products; therefore, she was subject to debarment under section 306b2BiI of the FD&C Act.
The proposal outlined findings regarding the three applicable factors ORA considered in determining the appropriateness and period of debarment, as provided in section 306c3 of the FD&C Act. ORA
consider the nature and seriousness of the offense and the nature and extent of voluntary steps to mitigate the effect on the public as unfavorable factors for Ms.
Ngo and weighed these factors against the absence of prior convictions
PO 00000

Frm 00055

Fmt 4703

Sfmt 4703

41487

involving matters within FDAs jurisdiction. ORA concluded, Weighing all the factors, the Agency has determined that the unfavorable factors far outweigh the favorable factor, and therefore warrant the imposition of a five-year period of debarment in this case, the maximum possible period of debarment.
By letters dated May 22 and 23, 2012, through counsel, Ms. Ngo requested a hearing on the proposal. In her request for a hearing, Ms. Ngo acknowledges her conviction under Federal law and does not question the Agencys authority to debar her upon the basis of that conviction. However, Ms. Ngo argues that she should only be subject to a 1year debarment, rather than FDAs proposed 5-year debarment, based on the considerations for determining the appropriateness and period of debarment under section 306c3 of the FD&C Act. Ms. Ngo also included specific arguments related to the considerations under section 306c3
of the FD&C Act.
Under the authority delegated by the Commissioner of Food and Drugs, the Chief Scientist has considered Ms. Ngos request for a hearing. Hearings are granted only if there is a genuine and substantial issue of fact. Hearings will not be granted on issues of policy or law, on mere allegations, denials, or general descriptions of positions and contentions, or on data and information insufficient to justify the factual determination urged see 21 CFR
12.24b.
The Chief Scientist has considered Ms. Ngos arguments and concluded that they are unpersuasive and fail to raise a genuine and substantial issue of fact requiring a hearing.
II. Arguments In support of her hearing request, Ms.
Ngo makes many statements seemingly related to the nature and seriousness of her offense. Ms. Ngo first argues that the prosecutions failure to pursue a felony conviction reflects its judgment that a misdemeanor conviction and the terms of her probation or supervised release, which included an agreement not to engage in clinical research during that period, are sufficient to protect the public health. Ms. Ngo next argues that her role was too small to have a significant effect on the studys results and that, because of her minimal role in providing data, the maximum debarment period is not appropriate.
Ms. Ngo states that her study was discontinued and Eli Lilly did not use any of her information in a detrimental way. Ms. Ngo also alleges that there is no evidence that her data affected the
E:FRFM02AUN1.SGM

02AUN1