[Federal Register Volume 86, Number 95 (Wednesday, May 19, 2021)]
[Notices]
[Pages 27090-27091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0351]


Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for 
Prevention; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled 
``Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for 
Prevention.'' This guidance addresses FDA's current thinking regarding 
clinical trials for drugs for the prevention of chemotherapy-induced 
nausea and vomiting (CINV) in adults, including recommendations for 
trial population, trial design, efficacy considerations, and clinical 
outcome assessments. This guidance details a recent change in our 
recommendations regarding the necessary evidence and recommended 
endpoint assessments needed to support a determination of efficacy for 
the indication of the prevention of CINV. Previously, drug development 
programs seeking an indication for the prevention of CINV typically 
selected a primary efficacy endpoint of complete response, defined as 
no vomiting and no use of rescue antiemetic medication, with additional 
direct evaluation of nausea frequency and severity positioned as 
exploratory assessments. To promote consistency and interpretability in 
the assessment of nausea both within and across development programs, 
FDA now recommends sponsors analyze a primary endpoint of complete 
response (i.e., a binary endpoint defined as no vomiting and no use of 
rescue antiemetic medication) and a secondary endpoint of the absence 
of nausea (i.e., a binary endpoint defined as no reported nausea and no 
use of rescue antiemetic medication) by evaluating the difference in 
the proportions of responders across treatment arms to establish 
efficacy for the prevention of CINV.

DATES: Submit either electronic or written comments on the draft 
guidance by July 19, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

[[Page 27091]]

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-0351 for ``Chemotherapy-Induced Nausea and Vomiting: 
Developing Drugs for 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 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. 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: Mary Chung, Center for Drug Evaluation 
and Research (HFD-580), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5350, Silver Spring, MD 20993-002, (301) 
796-0260.

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Chemotherapy-Induced Nausea and Vomiting: Developing Drugs 
for Prevention.'' This draft guidance addresses FDA's current thinking 
regarding clinical trials for the prevention of CINV in adults, 
including recommendations for trial population, trial design, efficacy 
considerations, and clinical outcome assessments.
    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 
``Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for 
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 support of submission and review of data for 
applications for FDA review and approval of new drugs or therapeutic 
biologics under section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) or section 351 of the Public Health Service Act (42 
U.S.C. 262) have been approved under OMB control numbers 0910-0014, 
0910-0001, and 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10573 Filed 5-18-21; 8:45 am]
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