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 


ddrumheller on DSK120RN23PROD with NOTICES1
88624 Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 

Products for Treatment or Prevention.’’ 

FDA is also announcing the withdrawal 

of the guidance entitled ‘‘COVID–19: 

Master Protocols Evaluating Drugs and 

Biological Products for Treatment or 

Prevention.’’ 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 20, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment 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 a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• 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 written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–D–5259 for ‘‘Master Protocols for 

Drug and Biological Product 

Development.’’ Received comments 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 a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments 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 comments. 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. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ 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 to 

read background documents or the 

electronic and written/paper comments 

received, 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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 3128, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Scott N. Goldie, Center for Drug 

Evaluation and Research, Office of 

Biostatistics, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 21, Rm. 3557, Silver Spring, 

MD 20993–0002, 301–796–2055; or 

Anne Taylor, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA 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 of 

this guidance is on randomized 

umbrella and platform trials that are 

intended to contribute to a 

demonstration of safety and substantial 

evidence of effectiveness. The concepts 

discussed may also be useful to consider 

for early-phase or exploratory umbrella 

and platform trials as well as those 

conducted to satisfy post-marketing 

commitments or requirements. The 

considerations in this draft guidance 

apply to a range of therapeutic areas. 

Well-designed and -conducted trials 

using master protocols can accelerate 

drug development by maximizing the 

amount of information obtained from 

the research effort. Compared with 

stand-alone trials under separate 

protocols, a master protocol may offer 

certain advantages by leveraging a 

shared control arm and other shared 

protocol elements (e.g., visit schedule, 

measurement procedures), shared 

infrastructure (e.g., network of clinical 

sites, central facilities, central 

randomization system, data 

management systems), and shared 

oversight (e.g., steering committee, data 

review committee). At the same time, 

master protocols add elements of 

complexity, which can increase startup 

time and can lead to design challenges 

such as ensuring adequate blinding to 

treatment assignment. Additionally, 

master protocols involving multiple 

stakeholders will require a high degree 

of coordination. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 88625 

FDA provided recommendations on 

master protocols for COVID–19 drug 

and biological products in the guidance 

entitled ‘‘COVID–19: Master Protocols 

Evaluating Drugs and Biological 

Products for Treatment or Prevention,’’ 

which posted May 2021 and was 

announced in the Federal Register on 

June 24, 2021 (86 FR 33309) (hereafter 

‘‘2021 COVID–19 Master Protocols 

Guidance’’). FDA issued the guidance to 

communicate its policy for the duration 

of the COVID–19 public health 

emergency (PHE) declared by the 

Secretary of Health and Human Services 

(HHS) on January 31, 2020, including 

any renewals made by the HHS 

Secretary in accordance with section 

319(a)(2) of the Public Health Service 

Act (42 U.S.C. 247d(a)(2)). Furthermore, 

in the Federal Register of March 13, 

2023 (88 FR 15417), FDA listed the 

guidance documents that will no longer 

be effective with the expiration of the 

PHE declaration, guidances that FDA 

was revising to continue in effect for 

180 days after the expiration of the PHE 

declaration to provide a period for 

stakeholder transition and then would 

no longer be in effect, and guidances 

that FDA was revising to continue in 

effect for 180 days after the expiration 

of the PHE declaration during which 

time FDA planned to further revise the 

guidances. The 2021 COVID–19 Master 

Protocols Guidance is included in the 

latter category. The 2021 COVID–19 

Master Protocols Guidance was revised 

to remain in effect for 180 days post 

expiration of the PHE declaration, and 

then revised again to remain in effect 

until March 7, 2024, so that FDA could 

further revise the 2021 guidance. 

FDA is issuing this draft guidance 

because many of the issues addressed in 

the 2021 guidance arise outside the 

context of the COVID–19 PHE. The 

recommendations in this draft guidance 

apply to a range of therapeutic areas, not 

just COVID–19. The draft guidance also 

provides a more comprehensive 

discussion of many of the design and 

analysis topics covered in the 2021 

COVID–19 Master Protocols Guidance. 

For example, the draft guidance 

provides more detailed considerations 

related to randomization, the choice of 

control group, informed consent, 

blinding to treatment assignment, 

adaptive design, multiplicity, 

comparisons between drugs, and the 

evaluation of drug safety. The draft 

guidance also expands on 

considerations for trial oversight, data 

sharing, dissemination of information, 

and submissions to support regulatory 

review. The draft guidance, when 

finalized, will represent the Agency’s 

current thinking on the use of master 

protocols in drug and biological product 

development. 

FDA is issuing this guidance to 

satisfy, in part, a mandate under section 

3607(b)(2)(C–F) of the Food and Drug 

Omnibus Reform Act of 2022 (FDORA). 

Consistent with the FDORA mandate, 

this guidance discusses 

recommendations for clinical trials to 

streamline logistics and facilitate the 

efficient collection and analysis of data, 

as well as important principles for the 

evaluation of effectiveness, 

recommendations for communication 

between sponsors and FDA, and 

considerations related to ensuring 

participant safety and data integrity in 

such trials. 

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 ‘‘Master Protocols for Drug and 

Biological Product Development.’’ 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. 

FDA is also announcing that the 2021 

COVID–19 Master Protocols Guidance 

will be withdrawn upon publication of 

this draft guidance. FDA has determined 

that the 2021 COVID–19 Master 

Protocols Guidance is no longer needed 

because this new draft is available and 

its recommendations, when finalized, 

will be applicable outside the context of 

the COVID–19 PHE. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 312 for the 

submission of investigational new drug 

applications (INDs), including 

protocols, protocol amendments, and 

information amendments, have been 

approved under OMB control number 

0910–0014. The information collections 

for new drug application (NDA) 

regulations (including abbreviated new 

drug applications (ANDAs)) (21 CFR 

part 314) and related guidances are 

approved under OMB control number 

0910–0001, and our biological licensing 

applications (BLA) regulations (21 CFR 

part 601) are approved under OMB 

control number 0910–0338. The 

collections of information in 21 CFR 

parts 50 and 56 for the protection of 

human subjects and institutional review 

boards have been approved under OMB 

control number 0910–0130. The 

collections of information related to the 

protection of human subjects under 45 

CFR part 46 and to IRB recordkeeping 

under 45 CFR 46.115 have been 

approved under OMB control number 

0990–0260. The collections of 

information in 21 CFR part 11, 

Electronic Records; Electronic 

Signatures, have been approved under 

OMB control number 0910–0303. The 

information collection requirements in 

FDA’s guidance for industry entitled 

‘‘Establishment and Operation of 

Clinical Trial Data Monitoring 

Committees’’ have been approved under 

OMB control number 0910–0581. The 

information collection requirements in 

FDA’s guidance for industry entitled 

‘‘Oversight of Clinical Investigations—A 

Risk-Based Approach to Monitoring’’ 

and FDA’s final guidance for industry 

entitled ‘‘A Risk-Based Approach to 

Monitoring of Clinical Investigations’’ 

have been approved under OMB control 

number 0910–0733. The information 

collections in FDA’s guidance for 

industry entitled ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics’’ have been approved under 

OMB control number 0910–0765. 

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/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: December 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28210 Filed 12–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–E–3017] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Emgality 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


ddrumheller on DSK120RN23PROD with NOTICES1