National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting, 56887 [2024-15188]

Download as PDF 56887 Federal Register / Vol. 89, No. 133 / Thursday, July 11, 2024 / Notices include inaccurate participant reports of drug use, high rates of missing data, the confounding effects of concomitant drug treatments, and the need to demonstrate the durability of the device’s treatment effect, which can necessitate prolonged observation. A notice of availability of the draft guidance appeared in the Federal Register of July 28, 2023 (88 FR 48888). FDA considered comments received and has made some minor edits for clarity. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder. It does not establish any rights for any person and is not binding on FDA or the II. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov and https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. Persons unable to download an electronic copy of ‘‘Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00019017 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new 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 the following table have been approved by OMB: OMB control No. 21 CFR part; guidance; or FDA form Topic 807, subpart E ............................................................................ 814, subparts A through E .......................................................... ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’. 860, subpart D ............................................................................ Premarket notification ................................................................ Premarket approval .................................................................... Q-submissions and Early Payor Feedback Request Programs for Medical Devices. De Novo classification process .................................................. Dated: July 5, 2024. Lauren K. Roth, Associate Commissioner for Policy. 0910–0120 0910–0231 0910–0756 0910–0844 [FR Doc. 2024–15130 Filed 7–10–24; 8:45 am] Dated: July 5, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. Dated: July 5, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4164–01–P [FR Doc. 2024–15187 Filed 7–10–24; 8:45 am] [FR Doc. 2024–15188 Filed 7–10–24; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting khammond on DSKJM1Z7X2PROD with NOTICES public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. Notice is hereby given of a change in the meeting of the National Institute of Neurological Disorders and Stroke Special Emphasis Panel, Clinical Trials and Comparative Effectiveness Research in Neurology, July 09, 2024, 09:00 a.m. to July 10, 2024, 02:00 p.m., National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 which was published in the Federal Register on June 13, 2024, FR Doc. 2024–13021, 89 FR 50347. This notice is being amended to change the dates of this two-day meeting from July 9, 2024, and July 10, 2024, to July 29, 2024, and July 30, 2024. The meeting time remains the same. The meeting is closed to the public. VerDate Sep<11>2014 19:08 Jul 10, 2024 Jkt 262001 National Institutes of Health National Institutes of Health National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Neurological Disorders and Stroke Special Emphasis Panel, Early Phase Clinical Trials in Neurology, July 10, 2024, 02:00 p.m. to July 10, 2024, 05:00 p.m., National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, which was published in the Federal Register on June 13, 2024, FR Doc. 2024–13021, 89 FR 50347. This notice is being amended to change the date of this one-day meeting from July 10, 2024, to July 30, 2024. The meeting time remains the same. The meeting is closed to the public. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Vaccine (and Other E:\FR\FM\11JYN1.SGM 11JYN1

Agencies

[Federal Register Volume 89, Number 133 (Thursday, July 11, 2024)]
[Notices]
[Page 56887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15188]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Neurological Disorders and Stroke; Amended 
Notice of Meeting

    Notice is hereby given of a change in the meeting of the National 
Institute of Neurological Disorders and Stroke Special Emphasis Panel, 
Early Phase Clinical Trials in Neurology, July 10, 2024, 02:00 p.m. to 
July 10, 2024, 05:00 p.m., National Institutes of Health, Neuroscience 
Center, 6001 Executive Boulevard, Rockville, MD 20852, which was 
published in the Federal Register on June 13, 2024, FR Doc. 2024-13021, 
89 FR 50347.
    This notice is being amended to change the date of this one-day 
meeting from July 10, 2024, to July 30, 2024. The meeting time remains 
the same. The meeting is closed to the public.

    Dated: July 5, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-15188 Filed 7-10-24; 8:45 am]
BILLING CODE 4140-01-P

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