4950 Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by February 26, 2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain . Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

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 Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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 (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to publish a 30-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 that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved Information Collection; Title 

of Information Collection: CMS Plan 

Benefit Package (PBP) and Formulary 

CY 2025; Use: Under the Medicare 

Modernization Act (MMA), Medicare 

Advantage (MA) and Prescription Drug 

Plan (PDP) organizations are required to 

submit plan benefit packages for all 

Medicare beneficiaries residing in their 

service area. The plan benefit package 

submission consists of the Plan Benefit 

Package (PBP) software, formulary file, 

and supporting documentation, as 

necessary. MA and PDP organizations 

use the PBP software to describe their 

organization’s plan benefit packages, 

including information on premiums, 

cost sharing, authorization rules, and 

supplemental benefits. They also 

generate a formulary to describe their 

list of drugs, including information on 

prior authorization, step therapy, 

tiering, and quantity limits. 

CMS requires that MA and PDP 

organizations submit a completed PBP 

and formulary as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to CMS 

for review and approval. CMS uses this 

data to review and approve the benefit 

packages that the plans will offer to 

Medicare beneficiaries. This allows 

CMS to review the benefit packages in 

a consistent way across all submitted 

bids during with incredibly tight 

timeframes. This data is also used to 

populate data on Medicare Plan Finder, 

which allows beneficiaries to access and 

compare Medicare Advantage and 

Prescription Drug plans. Form Number: 

CMS–R–262 (OMB control number: 

0938–0763); Frequency: Yearly; 

Affected Public: Private Sector, Business 

or other for-profits and Not-for-profit 

institutions; Number of Respondents: 

825; Total Annual Responses: 8,770; 

Total Annual Hours: 55,782 (For policy 

questions regarding this collection 

contact Kristy Holtje at 410–786–2209.) 

2. 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: January 19, 2024. 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–01383 Filed 1–24–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5706] 

Voluntary Quality Management 

Maturity Prototype Assessment 

Protocol Evaluation Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for a limited 

number of establishments to participate 

in a voluntary Quality Management 

Maturity Prototype Assessment Protocol 

Evaluation Program involving the use of 

a prototype assessment protocol to 

evaluate quality management maturity 

(QMM). The Center for Drug Evaluation 

and Research (CDER) is implementing 

this voluntary program for 

manufacturers of CDER-regulated drug 

products to gain experience with the 

prototype assessment protocol and to 

evaluate whether use of the protocol, as 

designed, will enable a meaningful 

assessment of the establishment’s 


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Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 4951 

1FDA has solicited comments to inform the 

development of this program. See 88 FR 63587, 

September 15, 2023. 

2For additional information, see CDER’s Quality 

Management Maturity (QMM) Program: Practice 

Areas and Prototype Assessment Protocol 

Development (2023), available at https://

www.fda.gov/media/171705/download?attachment. 

3 Inspections conducted by FDA or by Mutual 

Recognition Agreement (MRA) partners and 

classified by FDA would fulfill this criterion. See 

Mutual Recognition Agreements (MRA) for more 

information. 

quality management practices while 

providing useful feedback for the 

establishment. This notice outlines the 

types of establishments FDA is seeking 

for participation and the process for 

submitting a request to participate in the 

program. 

DATES: FDA intends to accept requests 

to participate in the voluntary QMM 

Prototype Assessment Protocol 

Evaluation Program through March 25, 

2024. See the ‘‘Participation’’ section of 

this document for instructions on 

submitting a request to participate and 

the selection process. 

FOR FURTHER INFORMATION CONTACT: For 

questions about the voluntary QMM 

Prototype Assessment Protocol 

Evaluation Program: Djamila Harouaka, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 4160, Silver Spring, 

MD 20993–0002, 240–402–0224, CDERQMM@fda.hhs.gov. 

To submit a request to participate in 

the program: Conchetta Newton, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4144, 

240–402–6551, CDER-QMM@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

QMM refers to the extent to which 

drug manufacturing establishments 

implement quality management 

practices that prioritize patients, drive 

continual improvement, and enhance 

supply chain reliability through the 

strategic integration of business 

decisions and manufacturing operations 

with quality practices and technological 

advancements. CDER is in the process of 

developing a voluntary program to 

promote QMM at drug manufacturing 

establishments, which would encourage 

drug manufacturers to implement 

quality management practices that go 

beyond current good manufacturing 

practice (CGMP) requirements.1

As part of the QMM program 

initiative, CDER is developing a QMM 

Assessment Tool (including both a 

protocol and rubric) to evaluate how 

effectively establishments monitor and 

manage quality and quality systems.2 In 

FY 2024, CDER intends to launch the 

voluntary Quality Management Maturity 

Prototype Assessment Protocol 

Evaluation Program to gain experience 

with use of a prototype of the 

assessment protocol to evaluate whether 

use of the protocol, as currently 

designed, will enable a meaningful 

assessment of the establishment’s 

quality management practices and 

actionable feedback for the 

establishment. The outcomes from this 

prototype evaluation program will help 

to inform the development of the QMM 

Assessment Tool to be used in the 

eventual QMM program. This notice 

announces FDA’s intent to launch the 

QMM Prototype Assessment Protocol 

Evaluation Program, outlines the types 

of establishments FDA is seeking for 

participation, and describes the process 

for submitting a request to participate in 

the program. 

Between October 2020 and March 

2022, CDER conducted under contract 

two pilot programs to assess the QMM 

of drug manufacturing establishments. 

The first pilot program evaluated the 

maturity of seven domestic 

manufacturers of finished dosage forms 

for the U.S. market (Ref. 1). The second 

pilot program evaluated the maturity of 

eight foreign manufacturers of active 

pharmaceutical ingredients (APIs) (Ref. 

2). Each pilot program was conducted 

by a different contractor. These pilot 

programs provided valuable insights to 

CDER for developing a protocol to 

assess establishments’ QMM, 

understanding assessor behaviors 

during interviews of establishment 

personnel, and gathering participant 

feedback on assessment questions, 

reports, and outcomes (Ref. 3). 

Using findings from these two pilot 

programs, a review of the quality 

management maturity literature, 

evaluations of existing external 

programs assessing elements of quality 

culture or pharmaceutical quality, 

surveys of external stakeholders, and 

feedback from partner offices and 

centers within FDA, CDER has 

developed a prototype assessment 

protocol to evaluate an establishment’s 

QMM. The prototype assessment 

protocol includes a series of questions 

in five practice areas: leadership, 

business continuity, technical 

excellence, advanced pharmaceutical 

quality system, and employee 

empowerment and engagement. Within 

each practice area, the prototype 

assessment protocol explores key 

elements of the establishment’s QMM. 

Examples of some topics that may be 

covered under the practice areas 

include: management review and 

resource management (management 

commitment to quality), supply 

planning and demand forecasting 

(business continuity), corrective action 

and preventive action process 

(advanced pharmaceutical quality 

system), data governance and process 

optimization (technical excellence), and 

rewards and recognition (employee 

engagement and empowerment). CDER 

will use the standardized prototype 

assessment protocol to collect 

information on an establishment’s 

executed practices, behaviors, and 

responses to specific questions, and will 

evaluate this information using an 

objective rubric to help identify areas of 

strength and potential areas with 

opportunities for improvement. 

Prototype assessment protocols will 

be conducted by trained assessors who 

will engage directly with 

establishments, either onsite or in a 

hybrid (both virtual and onsite) 

environment. Assessments are 

anticipated to take up to five business 

days and are distinct from FDA’s 

regulatory inspections. 

II. Participation 

A. Establishment Characteristics 

CDER will consider the following 

establishment characteristics when 

identifying potential participants for 

this QMM Prototype Assessment 

Protocol Evaluation Program: 

• The potential participant is an 

establishment as defined in 21 CFR 

207.1 that registers with FDA under 

section 510 (21 U.S.C. 360) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) and manufactures, prepares, 

propagates, compounds, or processes 

drugs, or APIs used in such drugs, 

subject to approval or licensure under 

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

Act or section 351 of the Public Health 

Service Act (42 U.S.C. 262), or that are 

marketed pursuant to section 505G of 

the FD&C Act without an approved 

application under section 505 of the 

FD&C Act (often referred to as over-thecounter (OTC) monograph drug 

products). 

• The establishment received at least 

one human drug surveillance 

inspection 3 in the prior 5 years. 

• The current inspection 

classification for the establishment at 

the time of the request to participate is 

No Action Indicated or Voluntary 

Action Indicated. 

• The establishment manufactures, 

prepares, propagates, compounds, or 

processes at least one CDER-regulated 

drug (API or finished drug product) that 


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4952 Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 

is currently in commercial distribution 

in the United States. 

• The establishment is willing to 

participate in an onsite or hybrid 

assessment. 

B. Requests To Participate 

Drug product manufacturers that are 

eligible and interested in participating 

in the voluntary QMM Prototype 

Assessment Protocol Evaluation 

Program should submit a request 

directly to Conchetta Newton (see FOR

FURTHER INFORMATION CONTACT). To be 

considered for this program, a request 

should include all the following 

information: (1) a contact person (name 

and email); (2) manufacturing 

establishment address; (3) FDA 

Establishment Identifier and Data 

Universal Numbering System Numbers; 

(4) a brief description of the business 

operations (e.g., manufacturing, testing, 

re/packaging, re/labeling, sterilizing, 

storing, distributing, or salvaging) 

conducted at the establishment; and (5) 

confirmation that the establishment 

features the characteristics discussed in 

section II.A of this notice. 

C. Selection Process 

FDA intends to select participants 

that reasonably reflect the diversity of 

the industry. FDA intends to notify each 

establishment of FDA’s decision on 

their request to participate in the 

voluntary QMM Prototype Assessment 

Protocol Evaluation Program within 90 

days of receipt. FDA intends to select up 

to nine volunteer participants for this 

program. 

D. FDA-Participant Interactions 

FDA intends to notify selected 

participants of their selection and 

confirm participation. This notification 

will include more information about 

engagement with the Agency, including 

an orientation and a pre-assessment 

questionnaire to assist the establishment 

in preparing for the assessment, 

logistical information such as options 

for dates and times to schedule the 

assessment, and recommendations for 

establishment personnel that should be 

available during the assessment. Teams 

of three assessors will conduct the 

prototype assessment protocol over a 

period that is expected to be up to five 

business days. Each team will be 

composed of CDER staff, or a 

combination of CDER staff and 

contractors. Following completion of 

the assessment, each participating 

establishment will receive a report 

summarizing areas of strength and 

growth opportunities. In addition, 

approximately 6 months after the 

assessment, FDA will followup with a 

virtual meeting to get feedback on the 

prototype assessment protocol, the 

report, and any limitations encountered. 

This will help the Agency evaluate use 

of the protocol, including whether it 

enables meaningful assessment of the 

establishment’s quality management 

practices and if feedback for the 

establishment is actionable. 

III. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

* 1. Quality Management Maturity for 

Finished Dosage Forms Pilot Program for 

Domestic Drug Product Manufacturers; 

Program Announcement,’’ 85 FR 65824, 

October 16, 2020, https://www.federal

register.gov/d/2020-22976. 

* 2. ‘‘Quality Management Maturity for 

Active Pharmaceutical Ingredients Pilot 

Program for Foreign Facilities; Program 

Announcement,’’ 85 FR 65828, October 16, 

2020, https://www.federalregister.gov/d/ 

2020-22977. 

3. J. Maguire, A. Fisher, D. Harouaka, N. 

Rakala, et al., 2023, ‘‘Lessons from CDER’s 

Quality Management Maturity Pilot 

Programs,’’ AAPS Journal, 25(14), January 10, 

2023, https://doi.org/10.1208/s12248-022- 

00777-z. 

Dated: January 22, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01423 Filed 1–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1584] 

Authorization of Emergency Use of 

Certain Medical Devices During 

COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the issuance of Emergency 

Use Authorizations (EUAs) (the 

Authorizations) for certain medical 

devices related to Coronavirus Disease 

2019 (COVID–19). FDA has issued the 

Authorizations listed in this document 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). These 

Authorizations contain, among other 

things, conditions on the emergency use 

of the authorized products. The 

Authorization follows the February 4, 

2020, determination by the Secretary of 

Health and Human Services (HHS), as 

amended on March 15, 2023, that there 

is a public health emergency, or a 

significant potential for a public health 

emergency, that affects, or has a 

significant potential to affect, national 

security or the health and security of 

U.S. citizens living abroad and that 

involves the virus that causes COVID– 

19, and the subsequent declarations on 

February 4, 2020, March 2, 2020, and 

March 24, 2020, that circumstances 

exist justifying the authorization of 

emergency use of in vitro diagnostics for 

detection and/or diagnosis of the virus 

that causes COVID–19, personal 

respiratory protective devices, and 

medical devices, including alternative 

products used as medical devices, 

respectively, subject to the terms of any 

authorization issued under the FD&C 

Act. These Authorizations, which 

include an explanation of the reasons 

for issuance, are listed in this document, 

and can be accessed on FDA’s website 

from the links indicated. 

DATES: These Authorizations are 

effective on their date of issuance. 

ADDRESSES: Submit written requests for 

single copies of an EUA to the Office of 

Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a fax number to which the 

Authorization may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the Authorization. 

FOR FURTHER INFORMATION CONTACT: Kim 

Sapsford-Medintz, Office of Product 

Evaluation and Quality, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 3216, 

Silver Spring, MD 20993–0002, 301– 

796–0311 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 


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