Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 41483 

C. Complete the Information Online To 

Update Your Establishment’s Annual 

Registration for FY 2022, or To Register 

a New Establishment for FY 2022 

Go to the Center for Devices and 

Radiological Health’s website at https:// 

www.fda.gov/medical-devices/howstudy-and-market-your-device/deviceregistration-and-listing and click the 

‘‘Access Electronic Registration’’ link on 

the left side of the page. This opens up 

a new page with important information 

about the FDA Unified Registration and 

Listing System (FURLS). After reading 

this information, click on the ‘‘Access 

Electronic Registration’’ link in the 

middle of the page. This link takes you 

to an FDA Industry Systems page with 

tutorials that demonstrate how to create 

a new FURLS user account, if your 

establishment did not create an account 

in FY 2021. Manufacturers of licensed 

biologics should register in the BER 

system at https://www.fda.gov/vaccinesblood-biologics/guidance-complianceregulatory-information-biologics/ 

biologics-establishment-registration. 

Enter your existing account ID and 

password to log into FURLS. From the 

FURLS/FDA Industry Systems menu, 

click on the Device Registration and 

Listing Module (DRLM) of FURLS 

button. New establishments will need to 

register and existing establishments will 

update their annual registration using 

choices on the DRLM menu. When you 

choose to register or update your annual 

registration, the system will prompt you 

through the entry of information about 

your establishment and your devices. If 

you have any problems with this 

process, email: reglist@cdrh.fda.gov or 

call 301–796–7400 for assistance. (Note: 

This email address and this telephone 

number are for assistance with 

establishment registration only; they are 

not to be used for questions related to 

other aspects of medical device user 

fees.) Problems with the BER system 

should be directed to https://

www.accessdata.fda.gov/scripts/email/ 

cber/bldregcontact.cfm or call 240–402– 

8360. 

D. Enter Your DFUF Order PIN and PCN 

After completing your annual or 

initial registration and device listing, 

you will be prompted to enter your 

DFUF order PIN and PCN, when 

applicable. This process does not apply 

to establishments engaged only in the 

manufacture, preparation, propagation, 

compounding, or processing of licensed 

biologic devices. CBER will send 

invoices for payment of the 

establishment registration fee to such 

establishments. 

Dated: July 28, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16408 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–2011–N–0658] 

Vithal K. Patel; Denial of Hearing; Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying a 

request for a hearing submitted by 

Vithal K. Patel (Mr. Patel) and issuing 

an order under the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) debarring 

Mr. Patel for 1 year 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 Mr. Patel was 

convicted of conspiracy to commit a 

felony under Federal law for conduct 

relating to the regulation of drug 

products under the FD&C Act and that 

the type of conduct underlying the 

conviction undermined the process for 

the regulation of drugs. In determining 

the appropriateness and period of Mr. 

Patel’s debarment, FDA considered the 

relevant factors listed in the FD&C Act. 

Mr. Patel has 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 Mr. Patel 

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–2011–N– 

0658. Received applications will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
41484 Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 

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)(II) of the FD&C 

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

permits FDA to debar an individual if it 

finds: (1) That the individual has been 

convicted of a conspiracy to commit a 

felony under Federal law for conduct 

relating to the regulation of any drug 

product under the FD&C Act and (2) 

that the type of conduct serving as the 

basis of the conviction undermines the 

process for the regulation of drugs. 

On August 7, 2007, Mr. Patel pled 

guilty to a felony count of conspiracy to 

distribute misbranded and adulterated 

drugs in violation of 18 U.S.C. 371. On 

December 16, 2010, the U.S. District 

Court for the District of New Jersey 

entered the conviction, sentenced Mr. 

Patel to 2 years of probation, and 

imposed a $3,000 fine. Mr. Patel’s 

conviction stemmed from his 

employment at Able Laboratories, Inc. 

(Able), where he was a Research and 

Development Manager and later the 

Associate Director for Technical 

Service. Mr. Patel and others conspired 

to cause the introduction of misbranded 

and adulterated drugs into interstate 

commerce with the intent to defraud 

and mislead the United States, in 

violation of sections 301(a) and 

303(a)(2) of the FD&C Act (21 U.S.C. 

331(a) and 333(a)(2)). According to the 

criminal information to which he pled 

guilty under a plea agreement, Mr. Patel 

and his coconspirators agreed to violate 

FDA’s regulations regarding good 

manufacturing practice for drugs by, 

among other things, manipulating and 

falsifying testing data and information. 

Mr. Patel specifically admitted to an 

overt act in furtherance of the 

conspiracy, namely supervising the 

manipulation of the process for 

manufacturing promethazine, a 

prescription antihistamine medication. 

By letter dated January 6, 2012, FDA’s 

Office of Regulatory Affairs (ORA) 

notified Mr. Patel of an opportunity for 

a hearing on a proposal to debar him for 

5 years from providing services in any 

capacity to a person having an approved 

or pending drug product application. In 

its proposal, ORA concluded that Mr. 

Patel should be debarred for 5 years 

based on four applicable considerations 

in section 306(c)(3) of the FD&C Act: (1) 

The nature and seriousness of his 

offense, (2) the nature and extent of 

management participation in the 

offense, (3) the nature and extent of 

voluntary steps taken to mitigate the 

impact on the public, and (4) prior 

convictions involving matters within 

FDA’s jurisdiction. ORA found that the 

first three of those considerations weigh 

in favor of debarment and noted, as to 

the fourth consideration, that FDA is 

unaware of any prior convictions. 

In a letter dated March 8, 2012, Mr. 

Patel requested a hearing on the 

proposal and submitted materials and 

arguments in support of his request. In 

his submission, Mr. Patel acknowledges 

his conviction of a conspiracy to 

commit a felony under Federal law and 

does not dispute that the conduct 

underlying that conviction related to the 

regulation of a drug product or that 

conduct of that type undermines the 

process for the regulation of drugs. He 

argues, however, that with respect to the 

considerations for determining the 

appropriateness and period of 

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

FD&C Act, there are genuine and 

substantial issues of fact for resolution 

at a hearing. 

II. Statutory and Regulatory 

Framework Regarding Part 12 Hearings 

Under the authority delegated by the 

Commissioner of Food and Drugs, the 

Chief Scientist has considered Mr. 

Patel’s submission. Under § 12.24(a)(2) 

(21 CFR 12.24(a)(2)), the Agency 

reviews a hearing request to determine 

whether a hearing is justified. FDA has 

the authority to deny a hearing when it 

appears from the hearing request that 

there are no material disputes of fact. 

See Costle v. Pacific Legal Found., 445 

U.S. 198, 214 (1980) (a party seeking a 

hearing is required to meet a ‘‘threshold 

burden of tendering evidence suggesting 

the need for a hearing’’), reh’g denied, 

446 U.S. 947 (1980), citing Weinberger 

v. Hynson, Westcott & Dunning, Inc., 

412 U.S. 609, 620–21 (1973); Pineapple 

Growers Ass’n v. FDA, 673 F.2d 1083, 

1085–86 (9th Cir. 1982) (holding that no 

hearing is necessary unless ‘‘material 

issues of fact’’ have been raised). 

In determining whether there are 

material issues of fact suitable for a 

hearing, FDA considers the specific 

criteria set out in § 12.24(b) and grants 

a hearing only if the material submitted 

in support of the request shows the 

following: (1) There is a genuine and 

substantial factual issue for resolution at 

a hearing; a hearing will not be granted 

on issues of policy or law; (2) the factual 

issue can be resolved by available and 

specifically identified reliable evidence; 

a hearing will not be granted on the 

basis of mere allegations or denials or 

general descriptions of positions and 

contentions; (3) the data and 

information submitted, if established at 

a hearing, would be adequate to justify 

resolution of the factual issue in the way 

sought by the requestor; a hearing will 

be denied if the Agency concludes that 

the data and information submitted are 

insufficient to justify the factual 

determination urged, even if accurate; 

(4) resolution of the factual issue in the 

way sought by the person is adequate to 

justify the action requested; a hearing 

will not be granted on factual issues that 

are not determinative with respect to the 

action requested (e.g., if the Agency 

concludes that the action would be the 

same even if the factual issue were 

resolved in the way sought); (5) the 

action requested is not inconsistent with 

any provision in the FD&C Act or any 

FDA regulation; and (6) the 

requirements in other applicable 

regulations, e.g., 21 CFR 10.20, 12.21, 

and 12.22, and in the notice of an 

opportunity for hearing are met. 

III. Arguments 

In his request for a hearing, Mr. Patel 

challenges ORA’s findings with respect 

to the three considerations that it 

concluded weighed in favor of his 

debarment. Mr. Patel also contends that 

there are two additional considerations 

under section 306(c)(3) of the FD&C Act 

that were not considered by ORA and 

should weigh in his favor against 

debarment. Section 306(c)(3) of the 

FD&C Act explicitly requires that FDA 

consider, ‘‘where applicable,’’ certain 

factors ‘‘[i]n determining the 

appropriateness and the period of 

debarment’’ for any permissive 

debarment. 

A. Nature and Seriousness of the 

Offense 

Regarding the nature and seriousness 

of his offense, Mr. Patel contends that, 

in reaching its conclusion regarding the 

nature and seriousness of his felony 


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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 41485 

offense, ORA failed to consider certain 

important facts. Specifically, Mr. Patel 

argues that the overt act underlying his 

conspiracy conviction—namely 

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. 

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 

ORA’s analysis overlooks the nature and 

extent of Mr. Patel’s 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 

Attorney’s 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 

Able’s SOPs, including protocols for 

investigating, logging, and archiving any 

aberrant, deviant, or failing analytical 

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 ORA’s 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 

306(c)(3)(D) 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 306(c)(3) 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 

306(c)(3) of the FD&C Act, Mr. Patel’s 

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. 

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 306(c)(3)(E) 

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 306(c)(3)(C) 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. Patel’s ‘‘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 

306(c)(3)(C) 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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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