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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of availability.

# 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Postoperative Nausea and Vomiting: Developing Drugs for Prevention.”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Submit either electronic or written comments on the draft guidance by December 17, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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:                          ( print 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                           ( print 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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