11722 Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 

(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 parts 50 and 56 have been 

approved under OMB control number 

0910–0130. The collections of 

information in 21 CFR part 58 for good 

laboratory practices for nonclinical 

laboratory studies have been approved 

under OMB control number 0910–0119. 

The collections of information in 

§§ 201.56 and 201.57 have been 

approved under OMB control number 

0910–0572. The collections of 

information in 21 CFR part 312 that 

support FDA’s regulations for 

investigational new drug applications 

have been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. 

The collections of information in 

biologics license applications submitted 

under 21 CFR part 601 have been 

approved under OMB control number 

0910–0338. The collections of 

information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078. 

The collections of information in the 

guidance for industry entitled 

‘‘Oversight of Clinical Investigations—A 

Risk-Based Approach to Monitoring’’ 

(available at https://www.fda.gov/ 

media/116754/download) have been 

approved under OMB control number 

0910–0733. The collections of 

information in the guidance for industry 

entitled ‘‘Expedited Programs for 

Serious Conditions—Drugs and 

Biologics’’ (available at https://

www.fda.gov/media/86377/download) 

have been approved under OMB control 

number 0910–0765. 

The collections of information in the 

International Council for Harmonisation 

guidance for industry entitled ‘‘E6(R2) 

Good Clinical Practice: Integrated 

Addendum to ICH E6(R1)’’ (available at 

https://www.fda.gov/media/93884/ 

download) have been approved under 

OMB control number 0910–0843. The 

collections of information in the 

guidance for industry entitled ‘‘Formal 

Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products’’ (available at https://

www.fda.gov/media/109951/download) 

have been approved under OMB control 

number 0910–0429. 

The collections of information 

regarding evaluation of the program for 

enhanced review transparency and 

communication for new molecular 

entity new drug applications and 

original biologics license applications in 

the Prescription Drug User Fee Act have 

been approved under OMB control 

number 0910–0746. 

The collections of information 

described in the guidance for industry 

and review staff entitled ‘‘Formal 

Dispute Resolution: Sponsor Appeals 

Above the Division Level’’ (available at 

https://www.fda.gov/media/126910/ 

download) have been approved under 

OMB control number 0910–0430. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: February 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04397 Filed 3–1–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–3292] 

Master Protocols: Efficient Clinical 

Trial Design Strategies To Expedite 

Development of Oncology Drugs and 

Biologics; 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 final 

guidance for industry entitled ‘‘Master 

Protocols: Efficient Clinical Trial Design 

Strategies to Expedite Development of 

Oncology Drugs and Biologics.’’ This 

guidance provides advice to sponsors of 

drugs and biologics for cancer treatment 

regarding the design and conduct of 

clinical trials, other than first-in-human 

trials, intended to simultaneously 

evaluate more than one investigational 

drug and/or more than one cancer type 

within the same overall trial structure 

(master protocols) in adult and pediatric 

cancers. In contrast to traditional trial 

designs, where a single drug is tested in 

a single disease population in one 

clinical trial, master protocols use a 

single infrastructure, trial design, and 

protocol to simultaneously evaluate 

multiple drugs and/or disease 

populations in multiple substudies, 

allowing for efficient and accelerated 

drug development. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on March 2, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2018–D–3292 for ‘‘Master Protocols: 

Efficient Clinical Trial Design Strategies 

to Expedite Development of Oncology 

Drugs and Biologics.’’ Received 

comments will be placed in the docket 


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Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 11723 

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 this 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 to 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: Lee 

Pai-Scherf, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2314, Silver Spring, 

MD 20993, 301–796–3400; or Stephen 

Ripley, 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 final guidance for industry entitled 

‘‘Master Protocols: Efficient Clinical 

Trial Design Strategies to Expedite 

Development of Oncology Drugs and 

Biologics.’’ 

This guidance provides 

recommendations to sponsors of drugs 

or biologics for the treatment of cancer 

regarding the design and conduct of 

clinical trials intended to 

simultaneously evaluate more than one 

investigational drug and/or more than 

one cancer type within the same overall 

trial structure (master protocols) in 

adult and pediatric cancers. In general, 

the recommended phase 2 dose should 

have been established for an 

investigational drug or drugs evaluated 

in a master protocol. It also describes 

aspects of master protocol designs and 

trial conduct and related considerations, 

such as biomarker codevelopment and 

statistical analysis considerations, and 

provides advice on the information that 

sponsors should submit to FDA and on 

how sponsors can interact with FDA to 

facilitate efficient review. 

This guidance does not address all 

issues relating to clinical trial design, 

statistical analysis, or the biomarker 

development process. Those topics are 

addressed in the International Council 

for Harmonisation (ICH) guidances for 

industry ‘‘E9 Statistical Principles for 

Clinical Trials’’ and ‘‘E10 Choice of 

Control Group and Related Issues in 

Clinical Trials’’ and the guidance for 

industry and FDA staff ‘‘In Vitro 

Companion Diagnostic Devices.’’ 

This guidance finalizes the draft 

guidance of the same name issued on 

October 1, 2018 (83 FR 49398). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. Changes from the draft to the 

final guidance include adding 

information about a dose-finding or 

safety lead-in component in basket trials 

when evaluating an investigational drug 

combination and comparison between 

experimental arms in umbrella trials 

and acceptable statistical approaches. 

Revisions were also made to various 

sections of the draft guidance to clarify 

the information to be submitted to FDA 

to support amendments to expand the 

protocol, the frequency of cumulative 

safety updates, the role of ad hoc 

institutional review board meetings, the 

role of the safety assessment committee, 

and informed consent requirements. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Master Protocols: 

Efficient Clinical Trial Design Strategies 

to Expedite Development of Oncology 

Drugs and Biologics.’’ 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. 

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 314.50(d)(5) 

(clinical data section) and (d)(6) 

(statistical section) have been approved 

under OMB control number 0910–0001; 

the collections of information in 21 CFR 

part 312, subpart B, 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. 

Sponsors may request comment and 

advice on an IND as well as request 

meetings with FDA under 21 CFR part 

312, subpart C (OMB control number 

0910–0014). 

The collections of information in 21 

CFR part 11 have been approved under 

OMB control number 0910–0303; the 

collections of information in parts 50 

and 56 for the protection of human 

subjects and institutional review boards 

have been approved under OMB control 

numbers 0910–0130; Responsibilities of 

sponsors and investigators (21 CFR part 

312, subpart D) are also covered under 

OMB control number 0910–0014; the 

collections of information in 21 CFR 

part 601 have been approved under 


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11724 Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 

OMB control number 0910–0338; the 

collections of information in §§ 201.56 

and 201.57 for the content and format 

requirements for labeling of human 

prescription drug and biological 

products have been approved under 

OMB control number 0910–0572. 

In addition, the following collections 

of information in FDA’s guidances have 

been approved by OMB (https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents): 

• Collections in FDA’s draft guidance 

for industry entitled ‘‘Formal Meetings 

Between the FDA and Sponsors and 

Applicants for PDUFA Products’’ have 

been approved under OMB control 

number 0910–0429. 

• Collections in FDA’s guidance for 

industry entitled ‘‘Special Protocol 

Assessment’’ have been approved under 

OMB control number 0910–0470. 

• Collections 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. 

• Collections in FDA’s guidance for 

industry entitled ‘‘Oversight of Clinical 

Investigations—A Risk-Based Approach 

to Monitoring’’ have been approved 

under OMB control number 0910–0733. 

• 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. 

• Collections in FDA’s guidance for 

industry entitled ‘‘E6(R2) Good Clinical 

Practice: Integrated Addendum to ICH 

E6(R1)’’ have been approved under 

OMB control number 0910–0843. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: February 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04398 Filed 3–1–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Vaccines Federal 

Implementation Plan 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health, Office of Infectious Disease and 

HIV/AIDS Policy. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services’ Office of Infectious 

Disease and HIV/AIDS Policy in the 

Office of the Assistant Secretary for 

Health announces that the draft 

Vaccines Federal Implementation Plan 

2021–2025 is available for public 

comment. The Vaccines Federal 

Implementation Plan is a companion 

document to the Vaccines National 

Strategic Plan 2021–2025 (VNSP), 

which was published in January 2021. 

The Vaccines Federal Implementation 

Plan is a compilation of federal agency 

immunization activities that collectively 

advance the goals of the VNSP. Its target 

audience is other federal agencies and 

external partners who work in the area 

of vaccination. The public will be 

interested in how the implementation 

plan documents federal agency efforts. It 

does not outline mandates or other 

COVID–19 response measures. 

DATES: The public comment period for 

the Vaccines Federal Implementation 

Plan starts on February 28, 2022 at 9 

a.m. ET and ends on March 29, 2022 at 

5 p.m. ET. All comments must be 

received by 5 p.m. ET on March 29, 

2022 to be considered. 

ADDRESSES: All comments must be 

submitted electronically to nvp.rfi@

hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

David Kim, MD, MA, Director, Division 

of Vaccines, Office of Infectious Disease 

and HIV/AIDS Policy, Office of the 

Assistant Secretary for Health, U.S. 

Department of Health and Human 

Services, Room L616, Switzer Building, 

330 C St. SW, Washington, DC 20024. 

Phone: 202–795–7697; Email: nvp.rfi@

hhs.gov. 

Dated: February 17, 2022. 

David Kim, 

Designated Federal Officer, Vaccines Federal 

Implementation Plan, Office of the Assistant 

Secretary for Health. 

[FR Doc. 2022–04327 Filed 3–1–22; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Toxicology Program Board of 

Scientific Counselors; Announcement 

of Meeting; Request for Comments 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

next meeting of the National Toxicology 

Program (NTP) Board of Scientific 

Counselors (BSC). The BSC, a federally 

chartered, external advisory group 

composed of scientists from the public 

and private sectors, will review and 

provide advice on programmatic 

activities. This meeting is a virtual 

meeting and is open to the public. 

Written comments will be accepted and 

registration is required to present oral 

comments. 

DATES: 

Meeting: Scheduled for April 19, 

2022, 12:30 p.m.–2:00 p.m. Eastern 

Standard Time (EST). Ending times are 

approximate; meeting may end earlier or 

run later. 

Written Public Comment 

Submissions: Deadline is April 12, 2022. 

Registration for Oral Comments: 

Deadline is April 12, 2022. 

ADDRESSES:

Meeting Web Page: The preliminary 

agenda, registration, and other meeting 

materials will be available at https://

ntp.niehs.nih.gov/go/165 by March 14, 

2022. 

Virtual Meeting: The URL for viewing 

the virtual meeting will be provided on 

the meeting web page the day before the 

meeting. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Mary Wolfe, Designated Federal Official 

for the BSC, Office of Policy, Review, 

and Outreach, Division of NTP, NIEHS, 

P.O. Box 12233, K2–03, Research 

Triangle Park, NC 27709. Phone: 984– 

287–3209, Fax: 301–451–5759, Email: 

wolfe@niehs.nih.gov. Hand Deliver/ 

Courier address: 530 Davis Drive, Room 

K2130, Morrisville, NC 27560. 

SUPPLEMENTARY INFORMATION: The BSC 

will provide input to the NTP on 

programmatic activities and issues. The 

preliminary agenda topics include 

presentations on a contract concept: 

Bioinformatics Support for the NIEHS. 

The preliminary agenda, roster of BSC 

members, background materials, public 

comments, and any additional 

information, when available, will be 

posted on the BSC meeting web page 

(https://ntp.niehs.nih.gov/go/165) or 


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