Patient Engagement Advisory Committee; Notice of Meeting-Patient-Centered Informed Consent in Clinical Study, 68908-68909 [2024-19323]

Download as PDF 68908 Federal Register / Vol. 89, No. 167 / Wednesday, August 28, 2024 / Notices Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 14 days of this publication. Authority: 42 U.S.C. 671(a)(6), 42 U.S.C. 671(a)(7), 42 U.S.C. 673(a)(8)(B) and 42 U.S.C. 674(a) and (b) Mary C. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2024–19253 Filed 8–27–24; 8:45 am] BILLING CODE 4184–73–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–0008] Patient Engagement Advisory Committee; Notice of Meeting— Patient-Centered Informed Consent in Clinical Study AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on October 30, 2024, from 10 a.m. to 5 p.m. Eastern Time. ADDRESSES: All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm408555.htm. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:13 Aug 27, 2024 Jkt 262001 FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5407, Silver Spring, MD 20993–0002, Letise.Williams@ fda.hhs.gov, 301–796–8398, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last-minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting. SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. On October 30, 2024, the Committee will discuss and make recommendations on ‘‘PatientCentered Informed Consent in Clinical Study of FDA-Regulated Medical Products.’’ The individuals who volunteer to participate in clinical research play an integral role in advancing scientific knowledge and supporting the development of potentially life-saving therapies for patients in need. Informed consent is a key element in clinical studies and can be one of a patient’s first interactions with the clinical community. Too often, however, informed consent forms are lengthy and difficult for potential research participants to understand. FDA has worked to improve informed consent over the years, including several recent activities such as developing a draft guidance in identifying key information in informed consent. The Committee will provide recommendations on the informed consent process and the areas of focus of the informed consent. The Committee will also provide recommendations on factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material and the link to the online teleconference and/or video conference meeting will be available at https:// www.fda.gov/AdvisoryCommittees/ Calendar/default.htm. Scroll down and select the appropriate advisory committee meeting link. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. Written submissions may be made to the contact person (see FOR FURTHER INFORMATION CONTACT) on or before October 3, 2024. Oral presentations from the public will be scheduled between approximately 2 p.m. and 3 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT) and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 25, 2024. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. If the number of registrants requesting to speak during the open public hearing is greater than can be reasonably accommodated during the scheduled open hearing portion of the advisory committee meeting, FDA may conduct a lottery to determine the speakers who will be invited to participate. The contact person will notify interested persons regarding their request to speak by September 26, 2024. Virtual Breakout Session: Individuals interested in participating in the virtual breakout scenario discussions will need to sign up to participate on or before October 16, 2024. The signup sheet, as well as additional information pertaining to the virtual scenario discussions, will be available at https:// www.fdalive.com/peac. Everyone who signs up in advance and provides a valid email address will receive an E:\FR\FM\28AUN1.SGM 28AUN1 Federal Register / Vol. 89, No. 167 / Wednesday, August 28, 2024 / Notices email at least 2 days prior to the meeting with information on how to access the virtual platform that will host the virtual breakout scenario discussions. Please note due to limited technology capacity, participation in the virtual breakout scenario discussions will be limited to 150 participants. Once capacity reaches 150 participants, the breakout session will be closed to additional participants. Additional information regarding the virtual breakout scenario discussions will be provided at https://www.fdalive.com/ peac. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams at Annmarie.Williams@ fda.hhs.gov, or 240–507–6496 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform. This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. The conditions for issuance of a waiver under 21 CFR 10.19 are met. Dated: August 23, 2024. Lauren K. Roth, Associate Commissioner for Policy. khammond on DSKJM1Z7X2PROD with NOTICES [FR Doc. 2024–19323 Filed 8–27–24; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:13 Aug 27, 2024 Jkt 262001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0026] Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LIVMARLI (maralixibat) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that LIVMARLI (maralixibat), manufactured by Mirum Pharmaceuticals, Inc., meets the criteria for a priority review voucher. LIVMARLI (maralixibat) oral solution is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsforRareDiseases Conditions/RarePediatricDisease PriorityVoucherProgram/default.htm. For further information about LIVMARLI (maralixibat), go to the ‘‘Drugs@FDA’’ website at https:// SUPPLEMENTARY INFORMATION: Frm 00061 Fmt 4703 www.accessdata.fda.gov/scripts/cder/ daf/. Dated: August 23, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–19334 Filed 8–27–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that LIVMARLI (maralixibat), approved on September 29, 2021, manufactured by Mirum Pharmaceuticals, Inc., meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–1394, Cathryn.Lee@ fda.hhs.gov. SUMMARY: PO 00000 68909 Sfmt 4703 [Docket No. FDA–2024–P–0805] Determination That FENTANYL CITRATE Injections, Equivalent to 2.5 Milligram Base/50 Milliliter and Equivalent to 5 Milligram Base/100 Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that FENTANYL CITRATE Injections, equivalent to 2.5 milligram (mg) base/50 milliliter (mL) (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for FENTANYL CITRATE Injections, EQ 2.5 mg base/50 mL (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Swati Rawani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993–0002, 240– 402–9917, Swati.Rawani@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved; and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain SUMMARY: E:\FR\FM\28AUN1.SGM 28AUN1

Agencies

[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Pages 68908-68909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19323]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0008]


Patient Engagement Advisory Committee; Notice of Meeting--
Patient-Centered Informed Consent in Clinical Study

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) announces a 
forthcoming public advisory committee meeting of the Patient Engagement 
Advisory Committee (the Committee). The general function of the 
Committee is to provide advice and recommendations to the Agency on 
FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will be held on October 30, 2024, from 10 a.m. to 5 
p.m. Eastern Time.

ADDRESSES: All meeting participants will be heard, viewed, captioned, 
and recorded for this advisory committee meeting via an online 
teleconferencing and/or video conferencing platform.
    Answers to commonly asked questions about FDA advisory committee 
meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5407, Silver Spring, MD 20993-0002, 
[email protected], 301-796-8398, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last-minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before the 
meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing and/or video 
conferencing platform. On October 30, 2024, the Committee will discuss 
and make recommendations on ``Patient-Centered Informed Consent in 
Clinical Study of FDA-Regulated Medical Products.'' The individuals who 
volunteer to participate in clinical research play an integral role in 
advancing scientific knowledge and supporting the development of 
potentially life-saving therapies for patients in need. Informed 
consent is a key element in clinical studies and can be one of a 
patient's first interactions with the clinical community. Too often, 
however, informed consent forms are lengthy and difficult for potential 
research participants to understand. FDA has worked to improve informed 
consent over the years, including several recent activities such as 
developing a draft guidance in identifying key information in informed 
consent.
    The Committee will provide recommendations on the informed consent 
process and the areas of focus of the informed consent. The Committee 
will also provide recommendations on factors to consider when 
communicating informed consent to clinical study participants to 
increase the likelihood of participants understanding the key elements 
of research.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available on FDA's website at 
the time of the advisory committee meeting, and the background material 
will be posted on FDA's website after the meeting. Background material 
and the link to the online teleconference and/or video conference 
meeting will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down and select the appropriate advisory 
committee meeting link. The meeting will include slide presentations 
with audio and video components to allow the presentation of materials 
in a manner that most closely resembles an in-person advisory committee 
meeting.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the Committee. 
Written submissions may be made to the contact person (see FOR FURTHER 
INFORMATION CONTACT) on or before October 3, 2024. Oral presentations 
from the public will be scheduled between approximately 2 p.m. and 3 
p.m. Eastern Time. Those individuals interested in making formal oral 
presentations should notify the contact person (see FOR FURTHER 
INFORMATION CONTACT) and submit a brief statement of the general nature 
of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
September 25, 2024. Time allotted for each presentation may be limited. 
If the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. If the number of registrants 
requesting to speak during the open public hearing is greater than can 
be reasonably accommodated during the scheduled open hearing portion of 
the advisory committee meeting, FDA may conduct a lottery to determine 
the speakers who will be invited to participate. The contact person 
will notify interested persons regarding their request to speak by 
September 26, 2024.
    Virtual Breakout Session: Individuals interested in participating 
in the virtual breakout scenario discussions will need to sign up to 
participate on or before October 16, 2024. The signup sheet, as well as 
additional information pertaining to the virtual scenario discussions, 
will be available at https://www.fdalive.com/peac. Everyone who signs 
up in advance and provides a valid email address will receive an

[[Page 68909]]

email at least 2 days prior to the meeting with information on how to 
access the virtual platform that will host the virtual breakout 
scenario discussions. Please note due to limited technology capacity, 
participation in the virtual breakout scenario discussions will be 
limited to 150 participants. Once capacity reaches 150 participants, 
the breakout session will be closed to additional participants. 
Additional information regarding the virtual breakout scenario 
discussions will be provided at https://www.fdalive.com/peac.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact AnnMarie Williams at [email protected], or 240-507-
6496 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves 
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 
14.22(b), (f), and (g) relating to the location of advisory committee 
meetings are hereby waived to allow for this meeting to take place 
using an online meeting platform. This waiver is in the interest of 
allowing greater transparency and opportunities for public 
participation, in addition to convenience for advisory committee 
members, speakers, and guest speakers. The conditions for issuance of a 
waiver under 21 CFR 10.19 are met.

    Dated: August 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19323 Filed 8-27-24; 8:45 am]
BILLING CODE 4164-01-P

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