Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Notices 62575 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10769 Satisfaction of Nursing 

Homes, Hospitals, and Outpatient 

Clinicians Working with the CMS 

Network of Quality Improvement 

and Innovation Contractors Program 

(NQIIC) 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved information collection; Title 

of Information Collection: Satisfaction 

of Nursing Homes, Hospitals, and 

Outpatient Clinicians Working with the 

CMS Network of Quality Improvement 

and Innovation Contractors Program 

(NQIIC); Use: The purpose of this 

Information Collection Request (ICR) is 

to collect data to inform the program 

evaluation of the Centers for Medicare & 

Medicaid Services (CMS) Quality 

Innovation Network-Quality 

Improvement Organization (QIN–QIO) 

and Hospital Quality Improvement 

Contractors (HQIC) programs under the 

Network of Quality Improvement and 

Innovation Contractors (NQIIC) contract 

vehicle. This is a revision package. First, 

we updated the Nursing Home and 

Hospital Surveys to cover all the quality 

improvement focus areas targeted by 

NQIIC awardees, removed some but not 

all COVID–19 Public Health Emergency 

(PHE) related questions to reflect the 

progress of federal health program (e.g., 

Agency for Healthcare Research and 

Quality Project Echo program was 

officially ended in August 2021), and 

made minor refinements based on the 

first round of survey fielding. Second, 

we added the Outpatient Clinician 

Survey in the same revision package 

since all three surveys are conducted 

under the same NQIIC contract. 

This revision package supports 

evaluation of the technical assistance 

provided by the QINQIO Program to 

nursing homes and outpatient clinicians 

in community settings, and Hospital 

Quality Improvement Contractors 

(HQIC) Program activities to support 

hospitals. This ICR is part of a larger 

evaluation of the overall impact of the 

NQIIC Program. Form Number: CMS– 

10769 (OMB control number: 0938– 

1424); Frequency: Yearly; Affected 

Public: State and Private Sector 

(Business or other for-profits); Number 

of Respondents: 1,900; Total Annual 

Responses: 1,900; Total Annual Hours: 

559. (For policy questions regarding this 

collection, contact Jeff Mokry at 214– 

767–4021.) 

Dated: September 7, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–19603 Filed 9–11–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0579] 

Mayya Tatsene: Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) permanently 

debarring Mayya Tatsene 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. Tatsene 

was convicted of a felony under Federal 

law for conduct that relates to the 

regulation of any drug product under 

the FD&C Act. Ms. Tatsene was given 

notice of the proposed permanent 

debarment and was given an 

opportunity to request a hearing to show 

why she should not be debarred. As of 

July 8, 2023 (more than 30 days after 

receipt of the notice, as prescribed by 

regulation), Ms. Tatsene has not 

responded to the notice. Ms. Tatsene’s 

failure to respond and request a hearing 

within the prescribed timeframe 

constitutes a waiver of her right to a 

hearing concerning this action. 

DATES: This order is applicable 

September 12, 2023. 

ADDRESSES: Any application by Ms. 

Tatsene for special termination of 

debarment under section 306(d)(4) of 

the FD&C Act (21 U.S.C. 335a(d)(4)) 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 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an 

application with confidential 


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62576 Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Notices 

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 

• 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–2023–N– 

0579. 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. 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: 

Jaime Espinosa, Division of Compliance 

and Enforcement, Office of Policy, 

Compliance, and Enforcement, Office of 

Regulatory Affairs, Food and Drug 

Administration, at 240–402–8743, or 

debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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

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 regulation of 

any drug product under the FD&C Act. 

On January 10, 2023, Mayya Tatsene 

was convicted in the U. S. District Court 

for the Southern District of New York 

when the court entered judgment of 

conviction against her, after her plea of 

guilty, to one count of Conspiracy to 

Commit Wire Fraud in violation of 18 

U.S.C. 1349 and one count of Wire 

Fraud in violation of 18 U.S.C. 1343. 

The underlying facts supporting the 

conviction are contained in the 

Information, entered into the docket on 

May 29, 2019, and from the transcript of 

Ms. Tatsene’s guilty plea hearing which 

occurred on May 29, 2019. Ms. Tatsene 

was an employee of AMA Laboratories 

(AMA), a consumer product testing 

company in Rockland County, New 

York. At AMA, Ms. Tatsene was 

employed as the clinical laboratory 

director and, between 2005 and 2017, 

was in charge of the Repeat Insult Patch 

Test laboratory at AMA. AMA 

purported to test the safety and efficacy 

of cosmetics, sunscreens, and other 

products on specified numbers of 

volunteer panelists in exchange for fees 

paid by consumer products companies. 

The customers who engaged AMA to 

run these tests on their products used 

the results to determine whether those 

products were safe and effective. From 

at least in or about 2005, through in or 

about April 2017, Ms. Tatsene and AMA 

personnel defrauded AMA’s customers 

in excess of $25 million by testing 

products on materially lower numbers 

of panelists than the numbers specified 

and paid for by AMA’s customers. Ms. 

Tatsene and other AMA employees 

made materially false and misleading 

statements about the results of the tests 

to AMA’s customers. Specifically, Ms. 

Tatsene and other AMA employees 

falsely represented to AMA’s customers 

that AMA had tested the products on 

the number of panelists specified by the 

laboratory’s customers. Ms. Tatsene and 

other AMA employees sent its 

customers laboratory results containing 

false information via interstate email 

and facsimile communications. 

Based on this conviction, FDA sent 

Ms. Tatsene by certified mail on May 

25, 2023, 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)(B) of the FD&C Act, that Ms. 

Tatsene was convicted, as set forth in 

section 306(l)(1) of the FD&C Act, of a 

felony under Federal law for conduct 

relating to the regulation of a drug 

product under the FD&C Act. The 

proposal also offered Ms. Tatsene 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 

file a timely request for a hearing would 

constitute an election not to use the 

opportunity for a hearing and a waiver 

of any contentions concerning this 

action. Ms. Tatsene received the 

proposal on June 8, 2023. 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)(B) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Ms. Tatsene 

has been convicted of a felony under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. 

As a result of the foregoing finding, 

Ms. Tatsene 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)(B) 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 in any capacity the services of Ms. 

Tatsene 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. Tatsene 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 


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Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Notices 62577 

1For OMUFA purposes, an OTC monograph drug 

is a nonprescription drug without an approved new 

drug application that is governed by the provisions 

of section 505G of the FD&C Act (21 U.S.C. 355h) 

(see section 744L(5) of the FD&C Act); 

2Section 744M(a)(2)(B) of the FD&C Act. 

3The Agency anticipates a greater likelihood of 

OMOR submissions in FY 2024 compared to prior 

fiscal years. 

4Under OMUFA, a Tier 1 OMOR is defined as 

any OMOR that is not a Tier 2 OMOR (see section 

744L(8) of the FD&C Act). Tier 2 OMORs are 

detailed in section 744L(9) of the FD&C Act. 5See section 744M(c)(1)(C) of the FD&C Act. 

accept or review any abbreviated new 

drug application from Ms. Tatsene 

during her period of debarment, other 

than in connection with an audit under 

section 306 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))). 

Dated: September 7, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19672 Filed 9–11–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3573] 

Over-the-Counter Monograph Drug 

User Fee Program—OTC Monograph 

Order Requests Fee Rates for Fiscal 

Year 2024 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the over-the-counter (OTC) 

monograph order request (OMOR) fee 

rates under the OTC monograph drug 

user fee program (OMUFA) for fiscal 

year (FY) 2024. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act) authorizes 

FDA to assess and collect user fees from 

qualifying manufacturers of OTC 

monograph drugs and submitters of 

OMORs. This notice publishes the 

OMOR fee rates under OMUFA for FY 

2024. FDA plans to publish the FY 2024 

OMUFA facility fee rates in a 

subsequent Federal Register notice (and 

anticipates its issuance will generally 

align with the timing of OMUFA facility 

fee rate publication for prior fiscal 

years). 

DATES: These fees are effective on 

October 1, 2023, and will remain in 

effect through September 30, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Olufunmilayo Ariyo, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

6th Floor, Beltsville, MD 20705–4304, 

240–402–4989; or the User Fees Support 

Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 744M of the FD&C Act (21 

U.S.C. 379j–72), authorizes FDA to 

assess and collect: (1) facility fees from 

qualifying owners of OTC monograph 

drug facilities and (2) fees from 

submitters of qualifying OTC 

monograph order requests. These fees 

are to support FDA’s OTC monograph 

drug activities, which are detailed in 

section 744L(6) of the FD&C Act (21 

U.S.C. 379j–71(6)) and include various 

FDA activities associated with OTC 

monograph drugs.1

For OMUFA purposes, an OTC 

monograph order request (OMOR) is a 

request for an administrative order, with 

respect to an OTC monograph drug, 

which is submitted under section 

505G(b)(5) of the FD&C Act (see section 

744L(7) of the FD&C Act). Given that 

OMOR fees are due on the date of 

submission of the OMOR,2 the Agency 

is publishing the OMOR fee rates for FY 

2024 in advance of the fiscal year to 

ensure that applicable OMOR fee rates 

are available in the event that OMORs 

are submitted early in the fiscal year.3

Under section 744M(a)(2)(A) of the 

FD&C Act, the Agency is authorized to 

assess and collect fees from submitters 

of OMORs, except for OMORs that 

request certain safety-related changes 

(as discussed below). There are two 

levels of OMOR fees, based on whether 

the OMOR at issue is a Tier 1 or Tier 

2 OMOR.4

For FY 2024, the OMUFA fee rates 

are: Tier 1 OMOR fees ($537,471), Tier 

2 OMOR fees ($107,494). These fees are 

effective for the period from October 1, 

2023, through September 30, 2024. This 

document is issued pursuant to sections 

744M(a)(4) and 744M(c)(4)(B) of the 

FD&C Act and describes the calculations 

used to set the OMUFA OMOR fees for 

FY 2024 in accordance with the 

directives in the statute. 

II. Determination of FY 2024 OMOR 

Fees 

Under OMUFA, the FY 2024 Tier 1 

OMOR fee is $537,471 and the Tier 2 

OMOR fee is $107,494, including an 

adjustment for inflation (see sections 

744M(a)(2)(A)(i) and (ii) of the FD&C 

Act, respectively). OMOR fees are not 

included in the OMUFA target revenue 

calculation, which is based on the 

facility fees (see section 744M(b) of the 

FD&C Act). 

An OMOR fee is generally assessed to 

each person who submits an OMOR (see 

section 744M(a)(2)(A) of the FD&C Act). 

OMOR fees are due on the date of the 

submission of the OMOR (see section 

744M(a)(2)(B) of the FD&C Act). The 

payor should submit the OMOR fee that 

applies to the type of OMOR they are 

submitting (i.e., Tier 1 or Tier 2). FDA 

will determine whether the appropriate 

OMOR fee has been submitted following 

receipt of the OMOR and the fee. 

An OMOR fee will not be assessed if 

the OMOR seeks to make certain safety 

changes with respect to an OTC 

monograph drug. Specifically, no fee 

will be assessed if FDA finds that the 

OMOR seeks to change the drug facts 

labeling of an OTC monograph drug in 

a way that would add to or strengthen: 

(1) a contraindication, warning, or 

precaution; (2) a statement about risk 

associated with misuse or abuse; or (3) 

an instruction about dosage and 

administration that is intended to 

increase the safe use of the OTC 

monograph drug (see section 

744M(a)(2)(C) of the FD&C Act). 

III. OMOR Fee Adjustment for Inflation 

Under OMUFA, the OMOR fee is 

adjusted for inflation for FY 2022 and 

each subsequent fiscal year (see section 

744M(c)(1)(B) of the FD&C Act). That 

provision states that the dollar amount 

of the inflation adjustment to the fee for 

OMORs is equal to the product of the 

applicable fee for the preceding fiscal 

year and the inflation adjustment 

percentage.5 For FY 2024, the inflation 

adjustment percentage is equal to the 

sum of 

• (1) the average annual percent 

change in the cost, per full-time 

equivalent position of the FDA, of all 

personnel compensation and benefits 

paid with respect to such positions for 

the first 3 years of the preceding 4 fiscal 

years, multiplied by the proportion of 

personnel compensation and benefits 

costs to total costs of OTC monograph 

drug activities for the first 3 years of the 

preceding 4 fiscal years (see section 

744M(c)(1)(C)(ii)(I) of the FD&C Act); 

and 

• (2) the average annual percent 

change that occurred in the Consumer 

Price Index for urban consumers 

(Washington-Baltimore, DC–MD–VA– 

WV; Not Seasonally Adjusted; All items; 

Annual Index) for the first 3 years of the 

preceding 4 years of available data 

multiplied by the proportion of all costs 


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