[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Prevention; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled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DATES: Submit either electronic or written comments on the draft
guidance by December 17, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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]]
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-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.
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]
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