88622 Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

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 January 22, 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: Extension of a currently 

approved collection; Title of 

Information Collection: 1915(c) Home 

and Community-Based Services (HCBS) 

Waiver Application; Use: Although we 

published a Federal Register notice on 

September 11, 2023 (88 FR 62377) that 

set out revisions to what is active and 

currently approved by OMB, this 

December 2023 iteration is an extension 

that does not propose any change. The 

subsequent 30-day notice for the 

September 11, 2023, revisions is 

expected to publish in the Federal 

Register in January/February 2024. We 

use the application to review and 

adjudicate individual waiver actions. 

The application is also used by states to 

submit and revise their waiver requests. 

Form Number: CMS–8003 (OMB control 

number 0938–0449); Frequency: Yearly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

47; Total Annual Responses: 71; Total 

Annual Hours: 6,005. (For policy 

questions regarding this collection 

contact Ryan Shannahan at 410–786– 

0295.) 

Dated: December 19, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–28288 Filed 12–21–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10883, CMS– 

R–64 and CMS–10396] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the 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 must be received by 

February 20, 2024. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

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–10883 American Dental 

Association (ADA) Dental Claim Form 

CMS–R–64 Indirect Medical Education 

and Direct Graduate Medical 

Education 

CMS–10396 Medication Therapy 

Management Program 

Improvements—Standardized Format 

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 


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Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 88623 

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: New collection; Title of 

Information Collection: American 

Dental Association (ADA) Dental Claim 

Form; Use: Medicare has traditionally 

accepted the Professional (CMS–1500/ 

837P transaction) and Institutional 

(UB04/837I transaction) claims forms to 

provide payment for Medicare-covered 

services. The Centers for Medicare & 

Medicaid Services (CMS) now plans to 

allow providers to submit Medicarecovered dental services on the dental 

claim form, a similar information 

collection as the already-approved 

professional and institutional claim 

forms. The ADA Dental Claim Form will 

be used to deliver information from 

dental providers to CMS for CMS to 

reimburse for provided dental services. 

Medicare Part B MACs will use the data 

collected on the ADA dental form to 

determine the proper amount of 

reimbursement for Part B dental services 

provided to Medicare beneficiaries. 

Submission of information on the ADA 

Dental Claim Form and associated 

HIPAA-standard 837D transaction 

format permits Medicare Part B MACs to 

receive consistent data for proper 

benefit payment. Form Number: CMS– 

10883 (OMB control number: 0938- 

New); Frequency: Occasionally; 

Affected Public: Private sector, 

Businesses and other for-profits; 

Number of Respondents: 50,000; Total 

Annual Responses: 50,000; Total 

Annual Hours: 12,500. (For policy 

questions regarding this collection 

contact Charlene Parks at 410–786– 

8684.) 

2. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: Indirect 

Medical Education and Direct Graduate 

Medical Education; Use: Section 

1886(d)(5)(B) of the Social Security Act 

requires additional payments to be 

made under the Medicare Prospective 

Payment System (PPS) for the indirect 

medical educational costs a hospital 

incurs in connection with interns and 

residents (IRs) in approved teaching 

programs. In addition, title 42, part 413, 

sections 75 through 83 implement 

section 1886(d) of the Act by 

establishing the methodology for 

Medicare payment for the costs of direct 

graduate medical educational activities. 

The information collected on IRs is 

used by Part-A Medicare Administrative 

Contractors (MAC) to verify the number 

of IRs FTE used in the calculation of 

Medicare payments for IME and GME. 

The IR data submitted by the hospitals 

to the MACs is uploaded into CMS’ 

Intern and Resident Information System 

(IRIS) database to identify duplicate 

FTEs reported for any IR. 

The MACs use the information 

collected on IRs to ensure that all 

program payments for IME and GME are 

accurate and are in accordance with 

Medicare regulations. The IR data 

submitted by the hospitals to the MACs 

are used to audit the Medicare cost 

reports filed by the hospitals. Form 

Number: CMS–R–64 (OMB control 

number: 0938–0456); Frequency: 

Monthly; Affected Public: Private sector 

and Federal Government; Number of 

Respondents: 1,245; Total Annual 

Responses: 1,245; Total Annual Hours: 

2,490. (For policy questions regarding 

this collection contact Owen Osaghae at 

410–786–7550.) 

3. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Medication 

Therapy Management Program 

Improvements—Standardized Format; 

Use: Section 1860D–4(c)(2)(C)(i) of the 

Act requires plan sponsors to offer MTM 

services that include an annual CMR 

with a written summary and action plan 

provided in a standardized format 

developed in consultation with 

stakeholders. This requirement is 

codified at § 423.153(d)(1)(vii)(D), 

which requires that the standardized 

action plan and summary comply with 

requirements specified by CMS for the 

standardized format. Components of the 

CMR summary in Standardized Format 

should include a cover letter, 

personalized medication list, and action 

plan if applicable. 

Users include members in a Part D 

sponsors’ plan who are eligible are 

enrolled in the sponsors’ MTM program 

and offered a CMR. The CMR is a 

consultation between the MTM provider 

(such as a pharmacist) with the 

beneficiary to review their medications. 

The MTM provider is either an 

employee/contractor of the plan itself or 

of a downstream entity contracted by 

the plan to provide MTM services. After 

a CMR is performed, the sponsor creates 

and sends a summary of the CMR to the 

beneficiary that includes a medication 

action plan and personal medication list 

using the Standardized Format. 

Information collected by Part D MTM 

programs as required by the 

Standardized Format for the CMR 

summary is used by beneficiaries or 

their authorized representatives, 

caregivers, and their healthcare 

providers to improve medication use 

and achieve better healthcare outcomes. 

Form Number: CMS–10396 (OMB 

control number: 0938–1154); Frequency: 

Yearly; Affected Public: Private Sector 

and Business or other for-profits; 

Number of Respondents: 842; Total 

Annual Responses: 2,382,774; Total 

Annual Hours: 1,588,595. (For policy 

questions regarding this collection 

contact Victoria Dang at 410–786–3991 

or Victoria.dang@cms.hhs.gov.) 

Dated: December 19, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–28292 Filed 12–21–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–5259] 

Master Protocols for Drug and 

Biological Product Development; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Master 

Protocols for Drug and Biological 

Product Development.’’ The draft 

guidance addresses the design and 

analysis of trials conducted under a 

master protocol as well as the 

submission of documentation to support 

regulatory review. The primary focus is 

on randomized umbrella and platform 

trials that are intended to contribute to 

a demonstration of safety and 

substantial evidence of effectiveness. 

The considerations in this guidance 

apply to a range of therapeutic areas. 

The draft guidance is intended to clarify 

the Agency’s thinking on the use of 

master protocols in drug and biological 

product development, which was 

previously addressed in FDA’s guidance 

entitled ‘‘COVID–19: Master Protocols 

Evaluating Drugs and Biological 


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