41486 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 Able’s 

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. Patel’s 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 

306(c)(3)(C) of the FD&C Act weigh in 

Mr. Patel’s favor in determining the 

appropriateness and period of 

debarment. 

Given the undisputed facts described 

above, and after considering the 

applicable factors listed in section 

306(c)(3) of the FD&C Act, the Chief 

Scientist finds that Mr. Patel’s 

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. Attorney’s letter, 

and he has no prior convictions. 

Particularly in light of FDA’s strong 

public policy interest in encouraging 

cooperation with authorities engaged in 

investigating wrongdoing related to the 

Agency’s regulation of drugs, as 

reflected in section 306(c)(3)(C) of the 

FD&C Act, the Chief Scientist has 

determined that a debarment period of 

only 1 year is appropriate in this case. 

IV. Findings and Order 

Therefore, the Chief Scientist, under 

section 306(b)(2)(B)(i)(II) 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 306(c)(3) of the FD&C 

Act and determined that a debarment of 

1 year is appropriate. 

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. 335a(c)(1)(B) and 

(c)(2)(A)(iii) and 21 U.S.C. 321(dd)). 

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 307(a)(6) of the 

FD&C Act (21 U.S.C. 335b(a)(6))). 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 

307(a)(7) 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 306(c)(1)(B) of the 

FD&C Act). 

Dated: July 27, 2021. 

Denise Hinton, 

Chief Scientist. 

[FR Doc. 2021–16350 Filed 7–30–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0198] 

Belen G. Ngo; Denial of Hearing; Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying Belen 

G. Ngo’s (Ms. Ngo’s) 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 

the regulation of drugs. In determining 

the appropriateness and period of Ms. 

Ngo’s 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 306(d) 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 else’s 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 (HFA–305), 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. FDA–2012–N– 

0198. Received applications will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 41487 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

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 FDA’s 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-2015- 

09-18/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, 

240–402–7500. 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, 240–402–5931. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(i)(I) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) 

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 

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 505(i) of the FD&C 

Act (21 U.S.C. 355(i)) in violation of 

sections 301(e) and 303(a)(1) (21 U.S.C. 

331(e) and 333(a)(1)). Ms. Ngo’s 

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 312.62(a) and 

by extension, section 505(i) 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, FDA’s 

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 

306(b)(2)(B)(i)(I) 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 

306(c)(3) 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 

involving matters within FDA’s 

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 Agency’s authority to 

debar her upon the basis of that 

conviction. However, Ms. Ngo argues 

that she should only be subject to a 1- 

year debarment, rather than FDA’s 

proposed 5-year debarment, based on 

the considerations for determining the 

appropriateness and period of 

debarment under section 306(c)(3) of the 

FD&C Act. Ms. Ngo also included 

specific arguments related to the 

considerations under section 306(c)(3) 

of the FD&C Act. 

Under the authority delegated by the 

Commissioner of Food and Drugs, the 

Chief Scientist has considered Ms. Ngo’s 

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 

12.24(b)). 

The Chief Scientist has considered 

Ms. Ngo’s 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 

prosecution’s 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 study’s 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 ‘‘[t]here 

is no evidence that her data affected the 


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41488 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 

‘‘[t]he 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. 

Ngo’s debarment, whether she could 

have been convicted of a felony is not 

relevant. Under section 306(c)(3) 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. Ngo’s 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, 

‘‘[t]he creation and submission of 

falsified clinical trial data undermines 

FDA’s 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. Ngo’s 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. Ngo’s 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 306(c)(3)(D) 

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 

in section 306(c)(3) 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 306(c)(3) 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 FDA’s jurisdiction under section 

306(c)(3)(F) 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 306(c)(3). 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 5- 

year period of debarment, even though 

she does not have any prior convictions 

involving matters within the Agency’s 

jurisdiction. 

III. Findings and Order 

Therefore, the Chief Scientist, under 

section 306(b)(2)(B)(i)(I) 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 306(c)(3) of the FD&C 

Act and determined that a debarment of 

5 years is appropriate. 

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. 335a(c)(1)(B) and 

(c)(2)(A)(iii) and 21 U.S.C. 321(dd)). 

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 307(a)(6) of the 

FD&C Act (21 U.S.C. 335b(a)(6))). 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 307(a)(7) 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 306(c)(1)(B) of the FD&C Act). 

Dated: July 27, 2021. 

Denise Hinton, 

Chief Scientist. 

[FR Doc. 2021–16352 Filed 7–30–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2002–N–0314] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Request for 

Samples and Protocols 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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. 


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