22218 Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 

1See section 505(j)(2)(A) of the FD&C Act (setting 

forth the required contents of an ANDA). 

2Section 505(j)(4)(H) of the FD&C Act. 

3 21 CFR 314.127(a)(8)(ii); 54 FR 28871 at 28903 

(July 10, 1989). 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1611, 

Silver Spring, MD 20993–0002, 301– 

796–2747. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Considerations for Waiver Requests for 

pH Adjusters in Generic Drug Products 

Intended for Parenteral, Ophthalmic, or 

Otic Use.’’ This draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on ‘‘Considerations for 

Waiver Requests for pH Adjusters in 

Generic Drug Products Intended for 

Parenteral, Ophthalmic, or Otic Use.’’ It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) does not require an 

ANDA to have the same inactive 

ingredients as the RLD.1 Section 

505(j)(4)(H) of the FD&C Act (21 U.S.C. 

355(j)(4)(H)) does, however, state that an 

ANDA shall not be approved if 

information submitted in the 

application (or other information 

available) shows (1) the inactive 

ingredients of the drug are unsafe for 

use under the conditions prescribed, 

recommended, or suggested in the 

labeling proposed for the drug, or (2) the 

type or quantity of inactive ingredients 

included or the manner in which the 

inactive ingredients are included is 

unsafe under such conditions.2

The Agency has interpreted section 

505(j)(4)(H) of the FD&C Act as 

permitting the Agency to deny approval 

of an ANDA ‘‘if there is a reasonable 

basis to conclude that its inactive 

ingredients or composition raise serious 

questions about the drug’s safety.’’ 3

The regulations at § 314.94(a)(9)(iii) 

and (iv) (21 CFR 314.94(a)(9)(iii) and 

(iv)), with parallel provisions in the 

approval regulations at 

§ 314.127(a)(8)(ii)(B) and (C) (21 CFR 

314.127(a)(8)(ii)(B) and (C)), specify that 

FDA will consider an inactive 

ingredient in, or the composition of, a 

generic drug product intended for 

parenteral, ophthalmic, or otic use to be 

unsafe and will refuse to approve the 

ANDA unless the generic drug product 

contains the same inactive ingredients 

(with certain listed exceptions) in the 

same concentration as the RLD. These 

regulations also identify permissible 

differences in certain inactive 

ingredients for drug products intended 

for parenteral, ophthalmic, or otic use, 

commonly referred to as ‘‘exception 

excipients,’’ if the ANDA contains 

sufficient information to demonstrate 

that any such differences do not affect 

the safety or efficacy of the drug. The 

regulations do not, however, expressly 

identify pH adjusters as one of these 

‘‘exception excipients,’’ and, as such, 

the inactive ingredient requirements in 

§ 314.94(a)(9)(iii) and (iv) apply to pH 

adjusters. 

Under § 314.99(b) (21 CFR 314.99(b)), 

however, an applicant may ask FDA to 

waive any requirement that applies to 

the applicant under §§ 314.92 through 

314.99 (21 CFR 314.92 through 314.99). 

Such a request under § 314.99(b) must 

comply with the requirements at 21 CFR 

314.90. FDA may grant a § 314.99(b) 

waiver if the Agency finds one of the 

following: (1) The applicant’s 

compliance with the requirement is 

unnecessary for the Agency to evaluate 

the ANDA or compliance cannot be 

achieved; (2) the applicant’s alternative 

submission satisfies the requirement; or 

(3) the applicant’s submission otherwise 

justifies a waiver. Even if FDA grants a 

waiver of a requirement in §§ 314.92 

through 314.99 in a particular 

application, the application still must 

meet all applicable statutory 

requirements for approval. If FDA grants 

the applicant’s waiver request with 

respect to a requirement under 

§§ 314.92 through 314.99, the waived 

requirement will not constitute a basis 

for refusal to approve an ANDA under 

§ 314.127. Thus, an ANDA applicant for 

a drug product intended for parenteral, 

ophthalmic, or otic use who seeks to use 

a pH adjuster(s) that is Q1 or Q2 

different from the RLD may ask the 

Agency to waive the inactive ingredient 

requirements at § 314.94(a)(9)(iii) or (iv) 

for the pH adjuster(s). This draft 

guidance document provides 

recommendations on (1) the type of 

information that applicants should 

consider submitting with a § 314.99(b) 

waiver request when an ANDA 

applicant asks the Agency to waive the 

inactive ingredient requirements for pH 

adjusters and (2) the format and process 

for submitting such waiver requests. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR part 320 been 

approved under OMB control numbers 

0910–0014 and 0910–0291; and the 

collections of information for the 

submission of controlled 

correspondence related to generic drug 

development and FDA approval have 

been approved under OMB control 

number 0910–0797. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08012 Filed 4–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0313] 

Lisett Raventos: Final Debarment 

Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) permanently debarring Lisett 

Raventos 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 Lisett Raventos was 

convicted of a felony under Federal law 

for conduct that relates to the 

development or approval, including the 

process of development or approval, of 

a drug product under the FD&C Act. Ms. 

Raventos was given notice of the 

proposed permanent debarment and 

was given an opportunity to request a 

hearing to show why she should not be 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 22219 

debarred. As of December 29, 2021 (30 

days after receipt of the notice), Ms. 

Raventos had not responded. Ms. 

Raventos’s failure to respond and 

request a hearing constitutes a waiver of 

her right to a hearing concerning this 

action. 

DATES: This order is applicable April 14, 

2022. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, or at https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, Division of Enforcement 

(ELEM–4029), Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, 240–402–8743, or 

at debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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

(21 U.S.C. 335a(a)(2)(A)) requires 

debarment of an individual from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application if FDA finds 

that the individual 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. On March 

5, 2021, Ms. Raventos was convicted as 

defined in section 306(l)(1) of the FD&C 

Act when judgment was entered against 

her in the U.S. District Court for the 

Southern District of Florida, after her 

plea of guilty to one count of Conspiracy 

to Commit Wire Fraud in violation of 18 

U.S.C. 1349. 

The factual basis for this conviction is 

as follows: Ms. Raventos was a clinical 

study coordinator at Unlimited Medical 

Research, LLC. From about September 

2013 through June 2016, Ms. Raventos 

conspired with others to unlawfully 

enrich herself by making materially 

false representations about clinical 

trials; fabricating data and the 

participation of subjects in those 

clinical trials; concealing from FDA, 

sponsors, and contract research 

organizations the fact that the data and 

participation of subjects had been 

fabricated; and inducing sponsors and 

contract research organizations to pay 

money for Ms. Raventos and her coconspirators’ own benefit. Specifically, 

one of Ms. Raventos’s co-conspirators 

entered into a contract with a Contract 

Research Organization (CRO), retained 

by a drug manufacturer (Sponsor) to 

hire clinical investigators and to manage 

clinical trials. Ms. Raventos’s coconspirator entered into a contract with 

the CRO to conduct a clinical trial at 

Unlimited Medical Research site in 

return for payment. The clinical trial 

was for an investigational drug intended 

to treat pediatric asthma in children 

between the ages of 4 and 11 years. 

Ms. Raventos represented herself to be 

the Site Director, Director of Clinical 

Operations, and the Study Coordinator 

for this clinical trial. In those roles, Ms. 

Raventos was responsible for complying 

with the study protocol, including 

administering the study drug to subjects 

in the study and preparing written 

records, known as case histories, which 

documented the participation of 

subjects in the clinical trial. Ms. 

Raventos participated in a scheme to 

defraud the Sponsor by fabricating the 

data and participation of subjects in the 

clinical trial in a variety of ways: Ms. 

Raventos and her co-conspirators 

falsified medical records to portray 

persons as legitimate study subjects 

when they were not. In addition, Ms. 

Raventos and her co-conspirators made 

it appear as though pediatric subjects 

made scheduled visits to Unlimited 

Medical Research when they had not, 

made it appear as though subjects had 

taken the study’s drugs as required 

when they had not, and made it appear 

that the study subjects had received 

checks as payment when they had not. 

As a result of this conviction, FDA 

sent Ms. Raventos by certified mail on 

November 19, 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. 

Raventos 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. Raventos 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. 

Raventos received the proposal on 

November 29, 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. Raventos 

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. Raventos is permanently debarred 

from providing services in any capacity 

to a person with an approved or 

pending drug product application, 

effective (see DATES) (see section 

306(a)(2)(A) and (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. 

Raventos, 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. 

Raventos 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. Raventos 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 

section 306 of the FD&C Act, a ‘‘drug 

product’’ is defined as a drug subject to 

regulation under section 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) (section 201(dd) of the FD&C Act 

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

Any application by Ms. Raventos for 

special termination of debarment under 

section 306(d)(4) of the FD&C Act 

should be identified with Docket No. 

FDA–2021–N–0313 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. 


lotter on DSK11XQN23PROD with NOTICES1
22220 Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08025 Filed 4–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0008] 

Patient Engagement Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the CDRH Patient 

Engagement Advisory Committee. The 

general function of the committee is to 

provide advice to the Commissioner of 

Food and Drugs, or designee, on 

complex scientific issues relating to 

medical devices, the regulation of 

devices, and their use by patients. The 

meeting will be open to the public. 

DATES: The meeting will take place 

virtually on July 12, 2022, from 10 a.m. 

to 4 p.m. Eastern Time and on July 13, 

2022, from 10 a.m. to 2 p.m. Eastern 

Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. Information on how to 

access the webcast will be made 

available no later than 2 business days 

prior to the meeting at https://

www.fdalive.com/peac. 

FOR FURTHER INFORMATION CONTACT: 

Letise Williams, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5441, Silver Spring, 

MD 20993–0002, letise.williams@

fda.hhs.gov, 301–796–8398, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/advisory-committees and 

scroll down to the appropriate advisory 

committee meeting link or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On July 12 

and 13, 2022, the committee will 

discuss and make recommendations on 

the topic of ‘‘Augmented Reality (AR) 

and Virtual Reality (VR) Medical 

Devices.’’ AR/VR devices are 

increasingly applied to healthcare 

settings across the patients’ care 

continuum. From diagnostics to clinical 

decision making, to surgical support, 

and to directly treating patients, AR/VR 

devices are used across multiple 

medical specialties. These devices have 

novel attributes and considerations for 

the end users that impact FDA’s 

evaluation of the device’s safety and 

effectiveness. The novel attributes of 

digital health visualization, tracking 

techniques, embedded software among 

other factors present unique challenges 

for pre- and postmarked evaluation. The 

recommendations provided by the 

committee will address factors FDA and 

industry should consider when 

evaluating the benefits, risks, and the 

extent of uncertainty in the benefit-risk 

information for AR/VR medical devices. 

The committee will also consider 

specific challenges related to specific 

populations (e.g., pediatric or 

cognitively impaired) who may use this 

technology. Additionally, the committee 

will discuss ways patient perspectives 

could be incorporated in FDA and 

industry benefit-risk decision making, 

as well as the healthcare provider 

decision-making process related to 

using or prescribing the technology. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

materials will be available at https://

www.fda.gov/advisory-committees/ 

committees-and-meeting-materials/ 

patient-engagement-advisorycommittee. Select the link for the 2022 

Meeting Materials. The meeting will 

include slide presentations with audio 

components to allow the presentation of 

materials in a manner that most closely 

resembles an in-person advisory 

committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Oral presentations 

from the public will be scheduled on 

July 12, 2022, between approximately 

2:30 p.m. Eastern Time to 3:30 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person (see FOR FURTHER INFORMATION

CONTACT). The notification should 

include a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before June 10, 2022. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by June 14, 2022. 

Individuals who do not wish to speak at 

the open public hearing session but 

would like their comments to be heard 

by the committee may send written 

submissions to the contact person on or 

before June 20, 2022. 

Virtual Breakout Session: Individuals 

interested in participating in the virtual 

breakout scenario discussions will need 

to sign up to participate on or before 

June 28, 2022. The signup sheet, as well 

as additional information pertaining to 

the virtual scenario discussions, will be 

available at https://www.fdalive.com/ 

peac. Everyone who signs up in advance 

and provides a valid email address will 

receive an email at least 2 days prior to 

the meeting with information on how to 

access the virtual platform that will host 

the virtual breakout scenario 

discussions. Please note that due to 

limited technology capacity, 

participation in the virtual breakout 

scenario discussions will be limited to 

150 participants. Once capacity reaches 

150 participants, the breakout session 

will be closed to additional participants. 

Additional information regarding the 

virtual breakout scenario discussions 

will be provided at https://

www.fdalive.com/peac. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 


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