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. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 41489 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0206. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Request for Samples and Protocols 

OMB Control Number 0910–0206— 

Extension 

This information collection supports 

Agency regulations. Under section 351 

of the Public Health Service Act (42 

U.S.C. 262), FDA has the responsibility 

to issue regulations that prescribe 

standards designed to ensure the safety, 

purity, and potency of biological 

products and to ensure that the 

biologics licenses for such products are 

only issued when a product meets the 

prescribed standards. Under § 610.2 (21 

CFR 610.2), the Center for Biologics 

Evaluation and Research (CBER) or the 

Center for Drug Evaluation and Research 

may at any time require manufacturers 

of licensed biological products to 

submit to FDA samples of any lot, along 

with the protocols showing the results 

of applicable tests, prior to distributing 

the lot of the product. In addition to 

§ 610.2, there are other regulations that 

require the submission of samples and 

protocols for specific licensed biological 

products: §§ 660.6, 660.36, and 660.46 

(21 CFR 660.6, 660.36, and 660.46). 

Section 660.6(a) provides 

requirements for the frequency of 

submission of samples from each lot of 

Antibody to Hepatitis B Surface Antigen 

product, and § 660.6(b) provides the 

requirements for the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.6 products subject to official 

release by CBER, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

of manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After official release is no longer 

required, one sample along with a 

protocol is required to be submitted at 

90-day intervals. In addition, samples, 

which must be accompanied by a 

protocol, may at any time be required to 

be submitted to CBER if continued 

evaluation is deemed necessary. 

Section 660.36(a) requires, after each 

routine establishment inspection by 

FDA, the submission of samples from a 

lot of final Reagent Red Blood Cell 

product along with a protocol 

containing specific information. Section 

660.36(a)(2) requires that a protocol 

contain information, including, but not 

limited to, manufacturing records, 

certain test records, and identity test 

results. Section 660.36(b) requires a 

copy of the antigenic constitution 

matrix specifying the antigens present 

or absent to be submitted to the CBER 

Director at the time of initial 

distribution of each lot. 

Section 660.46(a) contains 

requirements as to the frequency of 

submission of samples from each lot of 

Hepatitis B Surface Antigen product, 

and § 660.46(b) contains the 

requirements as to the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.46 products subject to official 

release by CBER, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

or manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After notification of official 

release is received, one sample along 

with a protocol is required to be 

submitted at 90-day intervals. In 

addition, samples, which must be 

accompanied by a protocol, may at any 

time be required to be submitted to 

CBER if continued evaluation is deemed 

necessary. 

Samples and protocols are required by 

FDA to help ensure the safety, purity, or 

potency of the product because of the 

potential lot-to-lot variability of a 

product produced from living 

organisms. In cases of certain biological 

products (e.g., Albumin, Plasma Protein 

Fraction, and therapeutic biological 

products) that are known to have lot-tolot consistency, official lot release is not 

normally required. However, 

submissions of samples and protocols of 

these products may still be required for 

surveillance, licensing, and export 

purposes, or in the event that FDA 

obtains information that the 

manufacturing process may not result in 

consistent quality of the product. 

The following burden estimate is for 

the protocols required to be submitted 

with each sample. The collection of 

samples is not a collection of 

information under 5 CFR 1320.3(h)(2). 

Respondents to the collection of 

information under § 610.2 are 

manufacturers of licensed biological 

products. Respondents to the collection 

of information under §§ 660.6(b), 

660.36(a)(2) and (b), and 660.46(b) are 

manufacturers of the specific products 

referenced previously in this document. 

The estimated number of respondents 

for each regulation is based on the 

annual number of manufacturers that 

submitted samples and protocols for 

biological products, including 

submissions for lot release, surveillance, 

licensing, or export. Based on 

information obtained from FDA’s 

database system, approximately 75 

manufacturers submitted samples and 

protocols in fiscal year (FY) 2020 under 

the regulations cited previously in this 

document. FDA estimates that 

approximately 72 manufacturers 

submitted protocols under § 610.2, and 

3 manufacturers submitted protocols 

under the regulation (§ 660.6) for the 

other specific product. FDA received no 

submissions under §§ 660.36 or 660.46; 

however, FDA is using the estimate of 

one protocol submission under each 

regulation in the event that protocols are 

submitted in the future. 

The estimated total annual responses 

are based on FDA’s final actions 

completed in FY 2020 for the various 

submission requirements of samples 

and protocols for the licensed biological 

products. The average burden per 

response is based on information 

provided by industry. The burden 

estimates provided by industry ranged 

from 1 hour to 5.5 hours. Under § 610.2, 

the hours per response are based on the 

average of these estimates and rounded 

to 3 hours. Under the remaining 

regulations, the average burden per 

response is based on the higher end of 

the estimate (rounded to 5 or 6 hours) 

because more information is generally 

required to be submitted in the other 

protocols than under § 610.2. 

In the Federal Register of March 16, 

2021 (86 FR 14448), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 


khammond on DSKJM1Z7X2PROD with NOTICES
41490 Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section/activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

610.2, Requests for Samples and Protocols; Official Release ................................................................................. 72 82.972 5,974 3 17,922 

660.6(b), Protocols ............................................................... 3 4 12 5 60 

660.36(a)(2) and (b), Samples and Protocols ..................... 1 1 1 6 6 

660.46(b), Protocols ............................................................. 1 1 1 5 5 

Total .............................................................................. 77 ........................ 5,988 ........................ 17,993 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 1,463 hours and a 

corresponding decrease of 491 

responses. We attribute this adjustment 

to a decrease in the number of 

submissions we received over the last 

few years. 

Dated: July 27, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16384 Filed 7–30–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of HHS-Certified 

Laboratories and Instrumented Initial 

Testing Facilities Which Meet Minimum 

Standards To Engage in Urine and Oral 

Fluid Drug Testing for Federal 

Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories and 

Instrumented Initial Testing Facilities 

(IITFs) currently certified to meet the 

standards of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs using Urine or Oral Fluid 

(Mandatory Guidelines). 

FOR FURTHER INFORMATION CONTACT: 

Anastasia Donovan, Division of 

Workplace Programs, SAMHSA/CSAP, 

5600 Fishers Lane, Room 16N06B, 

Rockville, Maryland 20857; 240–276– 

2600 (voice); Anastasia.Donovan@

samhsa.hhs.gov (email). 

SUPPLEMENTARY INFORMATION: In 

accordance with Section 9.19 of the 

Mandatory Guidelines, a notice listing 

all currently HHS-certified laboratories 

and IITFs is published in the Federal 

Register during the first week of each 

month. If any laboratory or IITF 

certification is suspended or revoked, 

the laboratory or IITF will be omitted 

from subsequent lists until such time as 

it is restored to full certification under 

the Mandatory Guidelines. 

If any laboratory or IITF has 

withdrawn from the HHS National 

Laboratory Certification Program (NLCP) 

during the past month, it will be listed 

at the end and will be omitted from the 

monthly listing thereafter. 

This notice is also available on the 

internet at https://www.samhsa.gov/ 

workplace/resources/drug-testing/ 

certified-lab-list. 

The Department of Health and Human 

Services (HHS) notifies federal agencies 

of the laboratories and Instrumented 

Initial Testing Facilities (IITFs) 

currently certified to meet the standards 

of the Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Mandatory Guidelines) using Urine and 

of the laboratories currently certified to 

meet the standards of the Mandatory 

Guidelines using Oral Fluid. 

The Mandatory Guidelines using 

Urine were first published in the 

Federal Register on April 11, 1988 (53 

FR 11970), and subsequently revised in 

the Federal Register on June 9, 1994 (59 

FR 29908); September 30, 1997 (62 FR 

51118); April 13, 2004 (69 FR 19644); 

November 25, 2008 (73 FR 71858); 

December 10, 2008 (73 FR 75122); April 

30, 2010 (75 FR 22809); and on January 

23, 2017 (82 FR 7920). 

The Mandatory Guidelines using Oral 

Fluid were first published in the 

Federal Register on October 25, 2019 

(84 FR 57554) with an effective date of 

January 1, 2020. 

The Mandatory Guidelines were 

initially developed in accordance with 

Executive Order 12564 and section 503 

of Pubic Law 100–71 and allowed urine 

drug testing only. The Mandatory 

Guidelines using Urine have since been 

revised, and new Mandatory Guidelines 

allowing for oral fluid drug testing have 

been published. The Mandatory 

Guidelines require strict standards that 

laboratories and IITFs must meet in 

order to conduct drug and specimen 

validity tests on specimens for federal 

agencies. HHS does not allow IITFs to 

conduct oral fluid testing. 

To become certified, an applicant 

laboratory or IITF must undergo three 

rounds of performance testing plus an 

on-site inspection. To maintain that 

certification, a laboratory or IITF must 

participate in a quarterly performance 

testing program plus undergo periodic, 

on-site inspections. 

Laboratories and IITFs in the 

applicant stage of certification are not to 

be considered as meeting the minimum 

requirements described in the HHS 

Mandatory Guidelines using Urine and/ 

or Oral Fluid. An HHS-certified 

laboratory or IITF must have its letter of 

certification from HHS/SAMHSA 

(formerly: HHS/NIDA), which attests 

that the test facility has met minimum 

standards. HHS does not allow IITFs to 

conduct oral fluid testing. 

HHS-Certified Laboratories Approved 

To Conduct Oral Fluid Drug Testing 

In accordance with the Mandatory 

Guidelines using Oral Fluid dated 

October 25, 2019 (84 FR 57554), the 

following HHS-certified laboratories 

meet the minimum standards to conduct 

drug and specimen validity tests on oral 

fluid specimens: At this time, there are 

no laboratories certified to conduct drug 

and specimen validity tests on oral fluid 

specimens. 

HHS-Certified Instrumented Initial 

Testing Facilities Approved To Conduct 

Urine Drug Testing 

In accordance with the Mandatory 

Guidelines using Urine dated January 

23, 2017 (82 FR 7920), the following 

HHS-certified IITFs meet the minimum 

standards to conduct drug and specimen 

validity tests on urine specimens: 

Dynacare, 6628 50th Street NW, 

Edmonton, AB Canada T6B 2N7, 780– 

784–1190 (Formerly: GammaDynacare Medical Laboratories) 


khammond on DSKJM1Z7X2PROD with NOTICES