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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
studies or resulted in the production of the drugs affected by the fraud and that the drugs produced were free of fraud and material false statements. Ms. Ngo then asserts that her lack of financial motive for conducting her offense weighs in her favor because the maximum period of debarment should be reserved for those who profit.
In determining the period of Ms.
Ngos debarment, whether she could have been convicted of a felony is not relevant. Under section 306c3 of the FD&C act, FDA considers the nature and seriousness of the offense. Ms. Ngo admitted to knowingly and repeatedly falsifying clinical trial records.
Additionally, the inclusion of a provision in Ms. Ngos plea agreement that prevents her from engaging in clinical research during any term of probation or supervised release evinces concern by the prosecution that she would continue to violate the law if involved in clinical research.
As set forth in the proposal to debar, the creation and submission of falsified clinical trial data undermines FDAs determination of safety, effectiveness, and quality of the drugs the studies were designed to assess.
Although the scope of conduct to which Ms. Ngo admitted during the criminal proceedings may have been limited to a few patients, submitting any false or fabricated data to the FDA is a serious offense that compromises the public health. Further, it is irrelevant that Eli Lilly ultimately did not use any of her information in a detrimental way.
Had Ms. Ngos conduct gone undetected and Eli Lilly submitted a new drug application containing the falsified data, FDA might have relied on her fabricated information to approve a new drug product, which reliance could have compromised the public health.
Additionally, Ms. Ngos lack of financial gain from her conduct does not diminish the nature and seriousness of her offense. Accordingly, Ms. Ngo has failed to create a genuine and material factual dispute with respect to the nature and seriousness of her offense.
Ms. Ngo next argues that, because she has not been involved in clinical trials since entering her guilty plea, there are reasonable assurances that the offense will not happen again. Ms. Ngo appears to be referencing the consideration under section 306c3D
of the FD&C Act, where FDA must consider, where applicable, whether the extent to which changes in ownership, management, or operations have corrected the causes of any offense involved and provide reasonable assurances that the offense will not occur in the future. The considerations
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in section 306c3 of the FD&C Act are not only for individuals but also for corporations, partnerships, and associations subject to permissive debarment. The consideration at issue does not typically apply to individuals because individuals are incapable of changes in ownership or management and could only alter the current operations of a business enterprise in which they are currently engaged. Even assuming for the sake of argument that an individual could point to changes in his or her current business practices as an applicable consideration under section 306c3 of the FD&C Act, Ms.
Ngo offers no actual facts to support her assertion that there are reasonable assurances that the offense will not occur again in the future; therefore, her unsubstantiated contention that, because she has not been involved in clinical trials since entering her guilty plea provides reasonable assurances that she will not commit the offense again, fails to create a genuine and substantial issue of fact that warrants a hearing.
Finally, Ms. Ngo argues that the maximum period of debarment is inappropriate for first-time offenders.
While the Agency does consider prior convictions involving matters within the FDAs jurisdiction under section 306c3F of the FD&C Act, that consideration is only one of several that FDA considers in determining the appropriateness and period of debarment under section 306c3. Ms.
Ngo knowingly and repeatedly falsified clinical data records. FDA has determined that the conduct underlying her offense, combined with her failure to take any voluntary steps to mitigate the effect of her offense on the public, is sufficiently serious to warrant a 5year period of debarment, even though she does not have any prior convictions involving matters within the Agencys jurisdiction.

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FR Doc. 202116352 Filed 73021; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2002N0314

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Request for Samples and Protocols AGENCY:
ACTION:

Therefore, the Chief Scientist, under section 306b2BiI of the FD&C
Act and under the authority delegated to her by the Commissioner of Food and Drugs, finds: 1 That Ms. Ngo has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act and 2 that the conduct underlying the conviction undermines the process for the regulation of drugs.
FDA has considered the relevant factors listed in section 306c3 of the FD&C
Act and determined that a debarment of 5 years is appropriate.

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Dated: July 27, 2021.
Denise Hinton, Chief Scientist.

Food and Drug Administration,
HHS.

III. Findings and Order
PO 00000

As a result of the foregoing findings, Ms. Ngo is debarred for 5 years from providing services in any capacity to a person with an approved or pending drug product application under section 505, 512, or 802 of the FD&C Act 21
U.S.C. 335, 360b, or 382, or under section 351 of the Public Health Service Act 42 U.S.C. 262, effective August 2, 2021 see 21 U.S.C. 335ac1B and c2Aiii and 21 U.S.C. 321dd.
Any person with an approved or pending drug product application, who knowingly uses the services of Ms. Ngo, in any capacity during her period of debarment, will be subject to civil money penalties section 307a6 of the FD&C Act 21 U.S.C. 335ba6. If Ms.
Ngo, during her period of debarment, provides services in any capacity to a person with an approved or pending drug product application, that person will be subject to civil money penalties section 307a7 of the FD&C Act. In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Ms. Ngo during her period of debarment section 306c1B of the FD&C Act.

Notice.

The Food and Drug Administration FDA or we is announcing that a proposed collection of information has been submitted to the Office of Management and Budget OMB for review and clearance under the Paperwork Reduction Act of 1995.
DATES: Submit written comments including recommendations on the collection of information by September 1, 2021.
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https
www.reginfo.gov/public/do/PRAMain.
SUMMARY:

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