[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33309-33310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13394]



[[Page 33309]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0409]


COVID-19: Master Protocols Evaluating Drugs and Biological 
Products for Treatment or Prevention; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``COVID-19: 
Master Protocols Evaluating Drugs and Biological Products for Treatment 
or Prevention.'' FDA is issuing this guidance to assist sponsors 
developing master protocols for trials evaluating drugs and biological 
products for the treatment or prevention of COVID-19. This guidance 
primarily focuses on the trial design and conduct as well as 
statistical considerations for master protocols intended to generate 
substantial evidence of effectiveness and adequate characterization of 
safety for COVID-19. Additionally, this guidance provides 
administrative and procedural recommendations to sponsors of master 
protocols for COVID-19. Given the public health emergency presented by 
COVID-19, this guidance document is being implemented without prior 
public comment because FDA has determined that prior public 
participation is not feasible or appropriate, but it remains subject to 
comment in accordance with the Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal 
Register on June 24, 2021. The guidance document is immediately in 
effect, but it remains subject to comment in accordance with the 
Agency's good guidance practices.

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-2021-D-0409 for ``COVID-19: Master Protocols Evaluating Drugs and 
Biological Products for Treatment or Prevention.'' 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 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 Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research, 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: Ei Thu Lwin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6236, Silver Spring, MD 20993-0002, 301-
796-0728; 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

[[Page 33310]]

``COVID-19: Master Protocols Evaluating Drugs and Biological Products 
for Treatment or Prevention.'' This guidance describes FDA's current 
recommendations regarding master protocols for trials evaluating drugs 
and biological products for the treatment or prevention of COVID-19. 
Well-designed and -conducted master protocols can accelerate drug 
development by maximizing the amount of information obtained from the 
research effort. These efficiencies are of particular importance in the 
setting of a public health emergency such as the current COVID-19 
pandemic, where the burden of disease is high and there is a critical 
need for the development of therapies. This guidance focuses on the 
trial design and conduct as well as statistical considerations for 
master protocols intended to generate substantial evidence of 
effectiveness and adequate characterization of safety for COVID-19. 
Additionally, this guidance provides administrative and procedural 
recommendations to sponsors of master protocols for COVID-19.
    In light of the public health emergency related to COVID-19 
declared by the Secretary of the Department of Health and Human 
Services (HHS), FDA has determined that prior public participation for 
this guidance is not feasible or appropriate and is issuing this 
guidance without prior public comment (see section 701(h)(1)(C)(i) of 
the FD&C Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR 10.115(g)(2)). This 
guidance document is being implemented immediately, but it remains 
subject to comment in accordance with the Agency's good guidance 
practice statute and regulation.
    This guidance is intended to remain in effect for the duration of 
the public health emergency related to COVID-19 declared by HHS, 
including any renewals made by the Secretary in accordance with section 
319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). 
However, the recommendations and processes described in the guidance 
are expected to assist the Agency more broadly in its continued efforts 
to assist sponsors in the clinical development of drugs for the 
treatment or prevention of COVID-19 beyond the termination of the 
COVID-19 public health emergency and reflect the Agency's current 
thinking on this issue. Therefore, within 60 days following the 
termination of the public health emergency, FDA intends to revise and 
replace this guidance with any appropriate changes based on comments 
received on this guidance and the Agency's experience with 
implementation.
    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 ``COVID-19: Master Protocols Evaluating 
Drugs and Biological Products for Treatment or Prevention.'' 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 part 312, Investigational New Drug 
Application, have been approved under OMB control number 0910-0014 and 
the collections of information required for institutional review boards 
and informed consent are approved under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, 
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or https://www.regulations.gov.

    Dated: June 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13394 Filed 6-23-21; 8:45 am]
BILLING CODE 4164-01-P