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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
individuals and to follow new leads.
Furthermore, he adds that he provided valuable details about events and discussions demonstrating that Able Labs management had made changes to drug protocols. He relies on these submissions to demonstrate not only that he cooperated with the government and contributed to the successful prosecution of others, including Ables top manager, but also that the government argued at his sentencing that he provided substantial assistance in those investigations and moved for a more lenient sentence on that basis. Mr. Patels account of his cooperation and substantial assistance in the investigation is undisputed and supported by the transcript of his sentencing. Therefore, the nature and extent of the voluntary steps Mr. Patel took to mitigate the impact of his offense on the public under section 306c3C of the FD&C Act weigh in Mr. Patels favor in determining the appropriateness and period of debarment.
Given the undisputed facts described above, and after considering the applicable factors listed in section 306c3 of the FD&C Act, the Chief Scientist finds that Mr. Patels conviction warrants a 1-year debarment period. It is undisputed that Mr. Patel pled guilty to a serious offense and that he participated in the offense as a supervisor. However, Mr. Patel took significant steps to mitigate the effect of his offense on the public, as described in the Assistant U.S. Attorneys letter, and he has no prior convictions.
Particularly in light of FDAs strong public policy interest in encouraging cooperation with authorities engaged in investigating wrongdoing related to the Agencys regulation of drugs, as reflected in section 306c3C of the FD&C Act, the Chief Scientist has determined that a debarment period of only 1 year is appropriate in this case.

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Therefore, the Chief Scientist, under section 306b2BiII of the FD&C
Act and under authority delegated to her by the Commissioner of Food and Drugs, finds that: 1 Mr. Patel has been convicted of a conspiracy to commit a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and 2
that the conduct which served as the basis for the conviction undermines the process for the regulation of drugs. FDA
has considered the applicable factors listed in section 306c3 of the FD&C
Act and determined that a debarment of 1 year is appropriate.

17:21 Jul 30, 2021

Dated: July 27, 2021.
Denise Hinton, Chief Scientist.
FR Doc. 202116350 Filed 73021; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2012N0198

Belen G. Ngo; Denial of Hearing; Final Debarment Order AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA is denying Belen G. Ngos Ms. Ngos request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act FD&C Act debarring Ms. Ngo for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Ngo 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 regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for
SUMMARY:

IV. Findings and Order
VerDate Sep<11>2014

As a result of the foregoing findings, Mr. Patel is debarred for 1 year from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act 21
U.S.C. 355, 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 Mr.
Patel, in any capacity during his period of debarment, will be subject to civil money penalties section 307a6 of the FD&C Act 21 U.S.C. 335ba6. If Mr.
Patel, 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 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 Mr. Patel during his period of debarment section 306c1B of the FD&C Act.

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the regulation of drugs. In determining the appropriateness and period of Ms.
Ngos debarment, FDA considered the relevant factors listed in the FD&C Act.
Ms. Ngo failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
DATES: This order is applicable August 2, 2021.
ADDRESSES: Any application for termination of debarment by Ms. Ngo under section 306d of the FD&C Act application may be submitted as follows:
Electronic Submissions Federal eRulemaking Portal:
https www.regulations.gov. Follow the instructions for submitting comments.
An application submitted electronically, including attachments, to https
www.regulations.gov will be posted to the docket unchanged. Because your application will be made public, you are solely responsible for ensuring that your application does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone elses Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your application, that information will be posted on https www.regulations.gov.
If you want to submit an application with confidential information that you do not wish to be made available to the public, submit the application as a written/paper submission and in the manner detailed see Written/Paper Submissions and Instructions.
Written/Paper Submissions Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier for written/paper submissions: Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For a written/paper application submitted to the Dockets Management Staff, FDA will post your application, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in Instructions.
Instructions: All applications must include the Docket No. FDA2012N
0198. Received applications will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at
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