COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry; Availability
| Published date | 19 May 2020 |
| Record Number | 2020-10635 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 97 (Tuesday, May 19, 2020)
[Federal Register Volume 85, Number 97 (Tuesday, May 19, 2020)]
[Notices]
[Pages 29949-29951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10635]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1370]
COVID-19: Developing 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:
Developing Drugs and Biological Products for Treatment or Prevention.''
This guidance describes FDA's current recommendations regarding phase 2
or phase 3 trials for drugs or biological products under development
for the treatment or prevention of 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 May 19, 2020. 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 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,
[[Page 29950]]
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-2020-D-1370 for ``COVID-19: Developing 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.
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.
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 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: Eithu 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 guidance for industry
entitled ``COVID-19: Developing Drugs and Biological Products for
Treatment or Prevention.'' There is currently an outbreak of
respiratory disease caused by a novel coronavirus. The virus has been
named SARS-CoV-2, and the disease it causes has been named Coronavirus
Disease 2019 (COVID-19). On January 31, 2020, the Department of Health
and Human Services (HHS) issued a declaration of a public health
emergency related to COVID-19 and mobilized the Operating Divisions of
HHS. The public health emergency declaration was renewed on April 21,
2020. In addition, on March 13, 2020, the President declared a national
emergency in response to COVID-19.
This guidance describes FDA's current recommendations regarding
phase 2 or phase 3 trials for drugs under development to treat or
prevent COVID-19. This guidance focuses on the patient population,
trial design, efficacy endpoints, safety considerations, and
statistical considerations for such trials. Drugs should have undergone
sufficient development before their evaluation in phase 2 or phase 3.
This guidance focuses on the development of drugs with direct
antiviral activity or immunomodulatory activity. However, the
recommendations in this guidance may be applicable to development plans
for drugs for COVID-19 with other mechanisms of action. The mechanism
of action of the drug may impact key study design elements (e.g.,
population, endpoints, safety assessments, duration of followup, etc.).
Preventative vaccines are not within the scope of this guidance.
Nor does this guidance provide general recommendations on early drug
development in COVID-19, such as use of animal models.
In light of the public health emergency related to COVID-19
declared by the Secretary of 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.
[[Page 29951]]
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 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: Developing 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
The guidance contains information collection provisions that 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). Under
the PRA, Federal Agencies must obtain approval from OMB for each
collection of information they conduct or sponsor. ``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.
This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
OMB under the PRA. The collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; the collections
of information in 21 CFR parts 312 and 320 have been approved under OMB
control number 0910-0014; the collections of information in 21 CFR part
58 regarding good laboratory practice for nonclinical laboratory
studies have been approved under OMB control number 0910-0119; 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 320 have been approved under OMB control number 0910-0291;
the collections of information in 21 CFR part 601 have been approved
under OMB control number 0910-0338; the collections of information in
FDA's draft guidance for industry entitled ``Formal Meetings Between
FDA and Sponsors and Applicants of Prescription Drug User Fee Act
Products'' have been approved under OMB control number 0910-0429; the
collections of information in FDA's final guidance for clinical trial
sponsors entitled ``Establishment and Operation of Clinical Trial Data
Monitoring Committees'' have been approved under OMB control number
0910-0581; and the collections of information in FDA's final guidance
for industry entitled ``Oversight of Clinical Investigations--A Risk-
Based Approach to Monitoring'' have been approved under OMB control
number 0910-0733.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
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/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or
https://www.regulations.gov.
Dated: May 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10635 Filed 5-18-20; 8:45 am]
BILLING CODE 4164-01-P
