National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting, 39051 [2021-15744]

Download as PDF Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39051 TABLE 2—CDER GUIDANCES AND COLLECTIONS—Continued COVID–19 guidance title CFR cite referenced in COVID–19 guidance Another guidance title referenced in COVID–19 guidance OMB control Nos. —SUPAC–SS: Nonsterile Semisolid Dosage Forms; ScaleUp and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation. —SUPAC–MR: Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. —SUPAC: Manufacturing Equipment Addendum. —Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID–19 Public Health Emergency. B. CBER Guidance While this guidance contains no collection of information, it does refer to previously approved FDA collections of information (listed in table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501–3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table: TABLE 3—CBER GUIDANCES AND COLLECTIONS COVID–19 guidance title CFR cite referenced in COVID–19 guidance Emergency Use Authorization for Vaccines to Prevent COVID–19 (Updated May 2021). 21 21 21 21 21 IV. Electronic Access Persons with access to the internet may obtain COVID–19-related guidances at: • FDA web page entitled ‘‘COVID–19Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders,’’ available at https:// www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders. • FDA web page entitled ‘‘Search for FDA Guidance Documents’’ available at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or • https://www.regulations.gov. khammond on DSKJM1Z7X2PROD with NOTICES Dated: July 16, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–15649 Filed 7–22–21; 8:45 am] 16:49 Jul 22, 2021 314.420 ...................................... part 312 ..................................... parts 210, 211, and 610 ............ part 600 ..................................... part 601 ..................................... Emergency Use Authorization of Medical Products and Related Authorities. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting Pursuant to section 10(d) 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 grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Special BILLING CODE 4164–01–P VerDate Sep<11>2014 CFR CFR CFR CFR CFR Another guidance title referenced in COVID–19 guidance Jkt 253001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 OMB control Nos. 0910–0001 0910–0014 0910–0139 0910–0308 0910–0338 0910–0595 Emphasis Panel; NINDS BRAIN Review Meeting (U01 and R01 Applications). Date: August 12–13, 2021. Time: 10:00 a.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Mir Ahamed Hossain, Ph.D., Scientific Review Officer, Scientific Review Branch, NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Rockville, MD 20852, (301) 496–9223, mirahamed.hossain@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: July 20, 2021. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–15744 Filed 7–22–21; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\23JYN1.SGM 23JYN1

Agencies

[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Page 39051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15744]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

    Pursuant to section 10(d) 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 grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Neurological Disorders 
and Stroke Special Emphasis Panel; NINDS BRAIN Review Meeting (U01 
and R01 Applications).
    Date: August 12-13, 2021.
    Time: 10:00 a.m. to 4:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).
    Contact Person: Mir Ahamed Hossain, Ph.D., Scientific Review 
Officer, Scientific Review Branch, NINDS/NIH/DHHS, Neuroscience 
Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Rockville, MD 
20852, (301) 496-9223, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.853, 
Clinical Research Related to Neurological Disorders; 93.854, 
Biological Basis Research in the Neurosciences, National Institutes 
of Health, HHS)

    Dated: July 20, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-15744 Filed 7-22-21; 8:45 am]
BILLING CODE 4140-01-P
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