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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices offense, ORA failed to consider certain important facts. Specifically, Mr. Patel argues that the overt act underlying his conspiracy convictionnamely supervising manipulation of the process for manufacturing promethazine involved merely failing to document or follow proper procedures for a nitrogen flush and posed no danger to the end users, the public at large, or coworkers at Able. He reasons that, as an inert gas, nitrogen could not possibly interact with the promethazine hydrochloride in any way. Mr. Patel maintains that this factor should therefore not have weighed in favor of his debarment.
However, as part of his guilty plea, Mr.
Patel admitted to conspiring to cause the introduction of misbranded and adulterated products into interstate commerce, with the intent to defraud and mislead the United States.
Therefore, even assuming that Mr. Patel did not intend for his conduct to harm anyone, the offense to which Mr. Patel pled guilty remains serious and weighs in favor of debarment.

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B. Nature and Extent of Management Participation in the Offense As to the consideration addressing the nature and extent of management participation, Mr. Patel argues that ORAs analysis overlooks the nature and extent of Mr. Patels management participation in the offense and reaches the conclusion that this factor is unfavorable simply because Mr. Patel was not an entry level worker. In fact, Mr. Patel insists that he never participated in the production of commercial products at Able Labs and, as such, exercised no management authority in connection with the nitrogen flush and had no input into or control over Able Labs corporate policies and practices or institutional controls with respect to production processes. To the contrary, Mr. Patel emphasizes that both the United States Attorneys Office and the court confirmed that Mr. Patel was acting on the order of his superior managers to observe the nitrogen flush and was in fear the he would be terminated if he refused.
In the proposal to debar, ORA stated:
As a Research and Development Manager and Associate Director of Technical Service, you were responsible for supervising numerous chemists and technicians who manufactured test batches to ensure product safety and effectiveness. Your management position also entailed monitoring the chemists compliance with GMPs, as required by FDA, and SOPs established by the company and ensuring compliance with Ables SOPs, including protocols for investigating, logging, and archiving any aberrant, deviant, or failing analytical
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laboratory results. As supervisor, you held a position of authority in which your conduct served as an example to other employees.
Accordingly, the Agency will consider this an unfavorable factor.

Mr. Patel does not dispute that he was in a supervisory position at Able. Even assuming Mr. Patel reasonably feared termination related to the conspiracy he joined, Mr. Patel does not contest that he worked in a position of authority at Able and had the responsibilities outlined in ORAs proposal to debar him for 5 years. Therefore, Mr. Patel has failed to create an issue for hearing with respect to whether the nature and extent of his management participation in the offense should weigh against debarment.
C. Changes in Ownership, Management, or Operations Next, Mr. Patel argues that ORA
incorrectly failed to consider 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, under section 306c3D of the FD&C Act. Mr. Patel states that an offense will not occur here in the future because Able Labs is now defunct and he voluntarily left the pharmaceutical industry in 2007.
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 in section 306c3 of the FD&C Act are not only for individuals but also for corporations, partnerships, and associations subject to permissive debarment. This consideration 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, Mr. Patels contention that, because he voluntarily left the pharmaceutical industry he has provided reasonable assurances that he will not commit the offense again given the opportunity, fails to create a genuine and substantial issue of fact that warrants a hearing. Furthermore, given that this debarment proceeding focuses on Mr. Patel rather than Able, it is immaterial that Able Labs is no longer in business.

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D. Abbreviated New Drug Applications ANDAs Mr. Patel argues that whether the person to be debarred is able to present adequate evidence that current production of drugs subject to abbreviated drug applications and all pending abbreviated drug applications are free of fraud or material false statements under section 306c3E
of the FD&C Act should be considered in his favor because the improper manufacturing procedures for which Mr. Patel was convicted had no relation to a drug application in any way. This factor is only relevant for persons that have an ANDA. Mr. Patel has not presented any evidence that he has any existing abbreviated drug applications for consideration in his own name, and thus, this factor is not relevant in determining the appropriateness and length of debarment and fails to create a genuine and substantial issue of fact that warrants a hearing.
E. Nature and Extent of Voluntary Steps To Mitigate Lastly, under section 306c3C of the FD&C Act, in determining the appropriateness and period of debarment, FDA must consider, where applicable, the nature and extent of voluntary steps to mitigate the effect on the public, including whether the person took specified corrective actions after the criminal violation or fully cooperated with any investigations. In the proposal to debar, ORA concluded that Mr. Patels failure to take voluntary steps to mitigate the offense he committed rendered this an unfavorable factor. ORA based this conclusion on the fact that FDA has no information demonstrating that Mr.
Patel took any voluntary steps to mitigate the impact of his actions on the public.
In his hearing request, Mr. Patel maintains that he did, in fact, take voluntary steps to mitigate the effect of his offense on the public, including full cooperation with any investigations under section 306c3C of the FD&C Act. In support, Mr. Patel submits a letter from an Assistant U.S. Attorney who participated in his prosecution and a transcript of his sentencing. Quoting this letter, Mr. Patel maintains that his cooperation enabled the Government to expand its investigation to other individuals and to develop a better understanding of the misbranding conspiracy at Able Labs and permitted the government to vet the information . . . received from other
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