[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Notices]
[Pages 83880-83882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24107]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-3993]


Postoperative 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Prevention; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled 
``Postoperative Nausea and Vomiting: Developing Drugs for Prevention.'' 
This guidance provides recommendations regarding the design of clinical 
trials for the prevention of postoperative nausea and vomiting in 
adults, including considerations for eligibility criteria, trial design 
features, efficacy evaluations, and safety assessments.

DATES: Submit either electronic or written comments on the draft 
guidance by December 17, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

[[Page 83881]]

    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2024-D-3993 for ``Postoperative 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.
    <bullet> 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, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 5350, Silver Spring, MD 20993-0002, 301-796-0260.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Postoperative Nausea and Vomiting: Developing Drugs for 
Prevention.'' Postoperative nausea and vomiting (PONV) is a serious, 
common, and distressing complication of surgery occurring within the 0- 
to 24-hour postoperative period in approximately 30 percent of the 
general surgical population and increasing to as high as 80 percent in 
high-risk cohorts. Nausea and vomiting following surgery can cause 
serious complications, including electrolyte imbalances and 
dehydration, can have a significant impact on how patients are 
functioning, and may prolong hospitalization and recovery from surgery. 
Additional complications of uncontrolled PONV can include esophageal 
tears, wound dehiscence, and decreased self-care and functional 
ability. Several risk factors have been associated with the development 
of PONV in adults. These include patient-specific risk factors (e.g., 
female sex, a history of PONV and/or motion sickness, nonsmoking 
status, and young age) as well as intraoperative risk factors (e.g., 
type of surgery and anesthesia administered) and postoperative risk 
factors (e.g., opioid administration). Volatile anesthetic agents are 
the primary cause of early PONV within the 0- to 2-hour postoperative 
period.
    Current treatment guidelines recommend that adults with at least 
one of the identified risk factors receive combination pharmacological 
PONV prophylaxis, which includes drugs from more than one 
pharmacological class that act on different receptor sites. 
Importantly, some antiemetics are commonly being administered off-label 
as part of the combination prophylaxis, as they have not been FDA-
approved for this indication. Therefore, this draft guidance, when 
finalized, will help facilitate trials that can lead to FDA approval 
for a PONV prevention indication.
    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 
``Postoperative 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. 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 relating to clinical trials associated with 
investigational new drug applications have been approved under OMB 
control

[[Page 83882]]

number 0910-0014. The collections of information in 21 CFR part 50 
relating to protection of human subjects have been approved under OMB 
control number 0910-0130.

III. Electronic Access

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

    Dated: October 9, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24107 Filed 10-17-24; 8:45 am]
BILLING CODE 4164-01-P