Postoperative Nausea and Vomiting: Developing Drugs for Prevention; Draft Guidance for Industry; Availability, 83880-83882 [2024-24107]

Download as PDF 83880 Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices GENERAL SERVICES ADMINISTRATION [Notice–P–2024–15; Docket No. 2024–0002; Sequence No. 49] Notice of Availability for the Record of Decision on the Final Environmental Impact Statement for the Alcan Land Port of Entry Expansion and Modernization in Alcan, Alaska Public Buildings Service (PBS), U.S. General Services Administration (GSA). ACTION: Notice of availability (NOA). AGENCY: GSA issued a Record of Decision (ROD) on the Final Environmental Impact Statement (EIS) for the Alcan Land Port of Entry Expansion and Modernization in Alcan, Alaska on October 18, 2024. The ROD was prepared in accordance with the National Environmental Policy Act (NEPA) of 1969, the Council on Environmental Quality Regulations, and the GSA PBS NEPA Desk Guide. DATES: Applicable: Friday, October 18, 2024. SUMMARY: The ROD may be found online at the following website: www.gsa.gov/alcan. FOR FURTHER INFORMATION CONTACT: Aaron Evanson, Capital Project Manager, AlcanLPOE@gsa.gov or 206– 445–5876. SUPPLEMENTARY INFORMATION: ADDRESSES: khammond on DSKJM1Z7X2PROD with NOTICES Background The Alcan LPOE is located at Milepost 1221.8 on the Alaska Highway, 0.43 miles from the U.S./Canada Border. The existing Alcan LPOE is owned and managed by GSA and is operated by the U.S. Department of Homeland Security’s Customs and Border Protection (CBP). The Alcan LPOE is the only 24-hour port serving privately-owned vehicles (POVs) and commercial traffic between the Yukon Territory, Canada, and mainland Alaska. GSA is the lead agency for the Final EIS and the Native Village of Northway is a cooperating agency. GSA proposes to build an expanded and modernized LPOE and new housing units at Alcan, Alaska, to replace the existing facilities. The Final EIS describes the purpose and need for the proposed project, the alternatives considered, the existing environment that could be affected, the potential impacts resulting from each of the alternatives, and proposed best management practices and mitigation measures. On April 7, 2023, GSA published a Notice of Intent for the EIS and VerDate Sep<11>2014 16:48 Oct 17, 2024 Jkt 265001 underwent a 40-day scoping period. A Draft EIS was issued over a 45-day public comment period on February 26, 2024. Comments received, along with GSA’s responses, during the Final EIS 30-day waiting period, which ended on October 7, 2024, are provided in Appendix A of the ROD. Preferred Alternative As noted in the ROD, GSA has chosen to implement Alternative 1: Expansion and Modernization in Place as defined in the Final EIS. This decision is based on the Final EIS issued in September 2024; associated technical reports; comments from federal and state agencies, stakeholders, members of the public, and elected officials; and other resources contained in the administrative record. Alternative 1 consists of expanding and modernizing the Alcan LPOE and will include: site preparation and grading; construction of a new Main LPOE Building, enclosed inspection vehicle spaces, new housing units with improved security measures, an indoor firing range, and a helicopter landing zone; and demolition of the existing LPOE structures. GSA will need authorization for use of up to 6.5 acres extending into the Tetlin NWR for the proposed helicopter landing zone. All facility and infrastructure improvements proposed under Alternative 1 will incorporate a sustainable, climate-resilient, cybersecure, and operationally efficient design. GSA will seek to meet or exceed energy and sustainability goals established by federal guidelines and policies, along with industry standard building codes and best practices. There will be approximately 15 acres of temporary ground disturbance and 5 acres of permanent ground disturbance under Alternative 1. Approximately 5 acres will be used as a staging area during construction. There are currently 8 acres of impermeable surfaces at the LPOE; expansion and modernization will add approximately 4 acres of impervious surfaces. Given the seasonal constraints of construction work in Alaska, Alternative 1 will likely follow a six-year implementation timeline, which will be phased to avoid disruption to LPOE operations. GSA intends to implement and comply with all mitigation measures as detailed in the ROD. Anamarie Crawley, Director, R10 Facilities Management Division, Northwest/Arctic Region 10, U.S. General Services Administration. [FR Doc. 2024–23879 Filed 10–17–24; 8:45 am] BILLING CODE 6820–DL–P PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 GOVERNMENT PUBLISHING OFFICE Depository Library Council Meeting AGENCY: U.S. Government Publishing Office. ACTION: Notice of meeting. The Depository Library Council (DLC) will meet virtually in conjunction with the Federal Depository Library Conference from Monday, October 21, 2024, through Wednesday, October 23, 2024. The meetings will take place online, and anyone may register to attend at https:// www.fdlp.gov/2024-fdl-conference. Closed captioning will also be provided. The purpose is to discuss matters affecting the Federal Depository Library Program. All sessions are open to the public. SUMMARY: DATES: October 21–23, 2024. Hugh Nathanial Halpern, Director, U.S. Government Publishing Office. [FR Doc. 2024–24114 Filed 10–17–24; 8:45 am] BILLING CODE 1520–01–P 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. 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: SUMMARY: Electronic Submissions Submit electronic comments in the following way: E:\FR\FM\18OCN1.SGM 18OCN1 Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices khammond on DSKJM1Z7X2PROD with NOTICES • 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 VerDate Sep<11>2014 16:48 Oct 17, 2024 Jkt 265001 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-201509-18/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 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 83881 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 patientspecific 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 E:\FR\FM\18OCN1.SGM 18OCN1 83882 Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 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/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–E–0199] Determination of Regulatory Review Period for Purposes of Patent Extension; EXXUA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXXUA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by December 17, 2024. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 16, 2025. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:48 Oct 17, 2024 Jkt 265001 11:59 p.m. Eastern Time at the end of December 17, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. 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– 2024–E–0199 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; EXXUA.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 • 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 § 10.20 (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-201509-18/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. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to E:\FR\FM\18OCN1.SGM 18OCN1

Agencies

[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.

-----------------------------------------------------------------------

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]
BILLING CODE 4164-01-P
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