Federal Register / Vol. 87, No. 75 / Tuesday, April 19, 2022 / Notices 23185 

fabricated; and inducing sponsors and 

contract research organizations to pay 

money for Ms. Villaman-Bencosme and 

her co-conspirators’ own benefit. On or 

about October 25, 2013, Ms. VillamanBencosme entered into a contract with 

a Contract Research Organization 

retained by a drug manufacturer 

(Sponsor) to serve as a clinical 

investigator for a clinical trial initiated 

by the Sponsor. The study was for an 

investigational drug intended to treat 

pediatric asthma in children between 

the ages of 4 and 11 years. As the 

clinical investigator Ms. VillamanBencosme was responsible for all 

aspects of the study to include ensuring 

that subjects provided informed consent 

and understood the risks of 

participating in the study, reporting 

adverse events to the Sponsor, and 

maintaining honest and accurate records 

known as ‘‘case histories.’’ Instead, Ms. 

Villaman-Bencosme used personal 

identification information from 

pediatric patient medical records 

maintained at her private medical 

practice to falsify case histories. This 

included a number of false details. Ms. 

Villaman-Bencosme made it appear that: 

The study subjects satisfied the 

eligibility criteria to participate in the 

study; the subjects received a physical 

examination from her; the patients 

received the study drug at the study site; 

the patients returned the study drug to 

the study site; and the patients received 

payment for visits to the study site. 

As a result of this conviction, FDA 

sent Ms. Villaman-Bencosme by 

certified mail on November 3, 2021, a 

notice proposing to permanently debar 

her from providing services in any 

capacity to a person that has an 

approved or pending drug product 

application. The proposal was based on 

a finding, under section 306(a)(2)(A) of 

the FD&C Act, that Ms. VillamanBencosme was convicted of a felony 

under Federal law for conduct relating 

to the development or approval, 

including the process of development or 

approval, of any drug product under the 

FD&C Act. The proposal also offered 

Ms. Villaman-Bencosme an opportunity 

to request a hearing, providing her 30 

days from the date of receipt of the letter 

in which to file the request, and advised 

her that failure to request a hearing 

constituted an election not to use the 

opportunity for a hearing and a waiver 

of any contentions concerning this 

action. Ms. Villaman-Bencosme 

received the proposal on November 13, 

2021. She did not request a hearing 

within the timeframe prescribed by 

regulation and has, therefore, waived 

her opportunity for a hearing and any 

contentions concerning her debarment 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(a)(2)(A) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Ms. VillamanBencosme has been convicted of a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process of development or 

approval, of any drug product under the 

FD&C Act. 

As a result of the foregoing finding, 

Ms. Villaman-Bencosme, is permanently 

debarred from providing services in any 

capacity to a person with an approved 

or pending drug product application, 

effective (see DATES) (see sections 

306(a)(2)(A) and 306(c)(2)(A)(ii) of the 

FD&C Act). Any person with an 

approved or pending drug product 

application who knowingly employs or 

retains as a consultant or contractor, or 

otherwise uses the services of Ms. 

Villaman-Bencosme, in any capacity 

during her 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. Villaman-Bencosme provides 

services in any capacity to a person with 

an approved or pending drug product 

application during her period of 

debarment, she 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 application from Ms. VillamanBencosme during her period of 

debarment, other than in connection 

with an audit under section 306 of the 

FD&C Act (section 306(c)(1)(B) of the 

FD&C Act). Note that, for purposes of 

sections 306 and 307 of the FD&C Act, 

a ‘‘drug product’’ is defined as a ‘‘drug 

subject to regulation under section 505, 

512, or 802 of this Act [(21 U.S.C. 355, 

360b, 382)] or under section 351 of the 

Public Health Service Act [(42 U.S.C. 

262)]’’ (section 201(dd) of the FD&C Act 

(21 U.S.C. 321(dd)). 

Any application by Ms. VillamanBencosme for special termination of 

debarment under section 306(d)(4) of 

the FD&C Act should be identified with 

Docket No. FDA–2021–N–0317 and sent 

to the Dockets Management Staff (see 

ADDRESSES). The public availability of 

information in these submissions is 

governed by 21 CFR 10.20. 

Publicly available submissions will be 

placed in the docket and will be 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Dated: April 12, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08302 Filed 4–18–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of the President’s 

Advisory Commission on Asian 

Americans, Native Hawaiians, and 

Pacific Islanders Meeting 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office for Civil Rights, White House 

Initiative on Asian Americans, Native 

Hawaiians, and Pacific Islanders 

ACTION: Notice of meeting. 

SUMMARY: As required by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the President’s Advisory 

Commission on Asian Americans, 

Native Hawaiians, and Pacific Islanders 

will hold a meeting on May 12, 2022. 

The meeting is the second in a series of 

federal advisory committee meetings 

regarding the development of 

recommendations to promote equity, 

justice, and opportunity for Asian 

American, Native Hawaiian, and Pacific 

Islander (AA and NHPI) communities. 

The meeting is open to the public and 

will be live streamed. Registration is 

required through the following link: 

https://www.eventbrite.com/e/meetingof-the-presidents-advisory-commissionon-aa-and-nhpis-registration311578077417. The Commission, cochaired by HHS Secretary Xavier 

Becerra and the U.S. Trade 

Representative Ambassador Katherine 

Tai, will advise the President on: (i) The 

development, monitoring, and 

coordination of executive branch efforts 

to advance equity, justice, and 

opportunity for AA and NHPI 

communities in the United States, 

including efforts to close gaps in health, 

socioeconomic, employment, and 

educational outcomes; (ii) policies to 

address and end anti-Asian bias, 

xenophobia, racism, and nativism, and 

opportunities for the executive branch 

to advance inclusion, belonging, and 

public awareness of the diversity and 

accomplishments of AA and NHPI 

people, cultures, and histories; (iii) 

policies, programs, and initiatives to 

prevent, report, respond to, and track 

anti-Asian hate crimes and hate 

incidents; (iv) ways in which the 

Federal Government can build on the 

capacity and contributions of AA and 


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23186 Federal Register / Vol. 87, No. 75 / Tuesday, April 19, 2022 / Notices 

NHPI communities through equitable 

Federal funding, grantmaking, and 

employment opportunities; (v) policies 

and practices to improve research and 

equitable data disaggregation regarding 

AA and NHPI communities; (vi) policies 

and practices to improve language 

access services to ensure AA and NHPI 

communities can access Federal 

programs and services; and (vii) 

strategies to increase public-and privatesector collaboration, and community 

involvement in improving the safety 

and socioeconomic, health, educational, 

occupational, and environmental wellbeing of AA and NHPI communities. 

DATES: The Commission will meet on 

May 12, 2022 from 12:30 p.m. to 

approximately 5:30 p.m. Eastern Time 

(ET). The confirmed time and agenda 

will be posted on the website for the 

President’s Advisory Commission on 

Asian Americans, Native Hawaiians, 

and Pacific Islanders: https://

www.hhs.gov/about/whiaanhpi/ 

commission/index.html when this 

information becomes available. 

LOCATION: The meeting will be live 

streamed. Registration is required 

through the following link: https://

www.eventbrite.com/e/meeting-of-thepresidents-advisory-commission-on-aaand-nhpis-registration-311578077417. 

FOR FURTHER INFORMATION CONTACT: 

Larissa Bungo, Designated Federal 

Officer, President’s Advisory 

Commission on Asian Americans, 

Native Hawaiians, and Pacific Islanders, 

U.S. Department of Health and Human 

Services, Office of the Secretary, Office 

for Civil Rights, Hubert H. Humphrey 

Building, Room 515F, 200 

Independence Ave. SW, Washington, 

DC 20201; email: whiaanhpi@hhs.gov; 

telephone: (202) 619–0403, fax: (202) 

619–3818. 

SUPPLEMENTARY INFORMATION: 

Information is available on the 

President’s Advisory Commission on 

Asian Americans, Native Hawaiians, 

and Pacific Islanders website at https:// 

www.hhs.gov/about/whiaanhpi/ 

commission/index.html. The names of 

the 25 members of the President’s 

Advisory Commission on Asian 

Americans, Native Hawaiians, and 

Pacific Islanders are available at https:// 

www.hhs.gov/about/whiaanhpi/ 

commission/commissioners/index.html. 

Purpose of Meeting: The President’s 

Advisory Commission on Asian 

Americans, Native Hawaiians, and 

Pacific Islanders, authorized by 

Executive Order 14031, will meet to 

discuss full and draft recommendations 

by the Commission’s six Subcommittees 

on ways to advance equity, justice, and 

opportunity for Asian American, Native 

Hawaiian, and Pacific Islander 

communities. The Subcommittees are: 

Belonging, Inclusion, Anti-Asian Hate, 

Anti-Discrimination; Data 

Disaggregation; Language Access; 

Economic Equity; Health Equity; and 

Immigration and Citizenship Status. 

Background: Asian American, Native 

Hawaiian, and Pacific Islander 

individuals and communities have 

molded the American experience, and 

the contributions and achievements of 

AA and NHPI communities make the 

United States stronger and more vibrant. 

The richness of America’s multicultural 

democracy is strengthened by the 

diversity of AA and NHPI communities 

and the many cultures and languages of 

AA and NHPI individuals in the United 

States, who collectively constitute the 

fastest growing racial group in the 

Nation and make rich contributions to 

our society, our economy, and our 

culture. 

Systemic barriers to equity, justice, 

and opportunity put the American 

dream out of reach of many AA and 

NHPI communities. Many AA and NHPI 

individuals face persistent disparities in 

socioeconomic, health, and educational 

outcomes. Linguistic isolation and lack 

of access to language-assistance services 

continue to lock many AA and NHPI 

individuals out of opportunities. Data 

collection practices fail to measure and 

reflect the diversity of AA and NHPI 

populations. Failure to disaggregate data 

contributes to enduring stereotypes 

about Asian Americans as a ‘‘model 

minority’’ and obscures disparities 

within AA and NHPI communities. 

Tragic acts of anti-Asian violence 

have increased during the COVID–19 

pandemic, casting a shadow of fear and 

grief over many AA and NHPI 

communities, in particular East Asian 

communities. Long before this 

pandemic, AA and NHPI communities 

in the United States, including South 

Asian and Southeast Asian 

communities, have faced persistent 

xenophobia, religious discrimination, 

racism, and violence. At the same time, 

AA and NHPI communities are 

overrepresented in the pandemic’s 

essential workforce in healthcare, food 

supply, education, and childcare, with 

more than four million AA and NHPIs 

manning the frontlines throughout the 

pandemic. Additionally, while they 

make up just four percent of registered 

nurses in the U.S., Filipino nurses 

accounted for 32 percent of nurse lives 

lost to COVID–19 in 2020. 

Many AA and NHPI communities, 

and in particular Native Hawaiian and 

Pacific Islander communities, have also 

been disproportionately burdened by 

the COVID–19 public health crisis. 

Evidence suggests that Native 

Hawaiians and Pacific Islanders are 

three times more likely to contract 

COVID–19 compared to white people 

and nearly twice as likely to die from 

the disease. On top of these health 

inequities, many AA and NHPI workers, 

families, and small businesses have 

faced devastating economic losses 

during this crisis, which must be 

addressed. 

Public Participation at Meeting: 

Members of the public are invited to 

view the Commission meeting. 

Registration is required through the 

following link: https://

www.eventbrite.com/e/meeting-of-thepresidents-advisory-commission-on-aaand-nhpis-registration-311578077417. 

Please note that there will be no 

opportunity for oral public comments 

during the meeting of the Commission. 

However, written comments are 

welcomed throughout the development 

of the Commission’s recommendations 

to promote equity, justice, and 

opportunity for Asian Americans, 

Native Hawaiians, and Pacific Islanders 

and may be emailed to 

AANHPICommission@hhs.gov. 

Authority: Executive Order 14031. 

The President’s Advisory Commission 

on Asian Americans, Native Hawaiians, 

and Pacific Islanders (Commission) is 

governed by provisions of the Federal 

Advisory Committee Act (FACA), Public 

Law 92–463, as amended (5 U.S.C. 

app.), which sets forth standards for the 

formation and use of federal advisory 

committees. 

Krystal Ka‘ai, 

Executive Director, White House Initiative on 

Asian Americans, Native Hawaiians, and 

Pacific Islanders and President’s Advisory 

Commission on Asian Americans, Native 

Hawaiians, and Pacific Islanders. 

[FR Doc. 2022–08118 Filed 4–18–22; 8:45 am] 

BILLING CODE 4153–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 


lotter on DSK11XQN23PROD with NOTICES1