National Institute Of Allergy And Infectious Diseases; Notice of Closed Meeting, 68584 [2020-23965]

Download as PDF 68584 Federal Register / Vol. 85, No. 210 / Thursday, October 29, 2020 / Notices pharmacokinetic information (e.g., Cmax, Tmax, area under the curve) from the proposed drug product • An example of how systemic toxicity could be addressed by a nonclinical toxicity study conducted with a noninhalation route of exposure • Clarification that local effects in oral or respiratory tract tissues are best addressed with a nonclinical inhalation study 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 ‘‘Nonclinical Testing of Orally Inhaled NicotineContaining Drug Products.’’ 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. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (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 21 CFR part 312 have been approved under OMB control number 0910–0014. The collections of information resulting from special protocol assessments have been approved under OMB control number 0910–0470. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. Dated: October 23, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–23999 Filed 10–28–20; 8:45 am] jbell on DSKJLSW7X2PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute Of Allergy And Infectious Diseases; 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 Allergy and Infectious Diseases Special Emphasis Panel NIAID Emergency Awards: Rapid Investigation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV–2) and Coronavirus Disease 2019 (COVID–19) (R01, R21 Clinical Trial Not Allowed). Date: November 20, 2020. Time: 11:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G62, Rockville, MD 20892, (Virtual Meeting). Contact Person: Lynn Rust, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G62, Bethesda, MD 20892, (240) 669–5069. lrust@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: October 23, 2020. Tyeshia M. Roberson, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–23965 Filed 10–28–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of The Director, National Institutes of Health Notice of Meeting amended, notice is hereby given of a meeting of the Council of Councils. The meeting will be held as a virtual meeting and will be open to the public. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting, should notify the Contact Person listed below in advance of the meeting. The meeting will be videocast and can be accessed from the NIH Videocasting and Podcasting website (https://videocast.nih.gov/). Name of Committee: Council of Councils. Open: November 13, 2020. Time: 2:00 p.m. to 3:00 p.m. Agenda: Presentation and discussion of the draft NIH-Wide Strategic Plan (2021–2025). Place: National Institutes of Health, Building 1, One Center Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive Secretary, Council of Councils, Director, Office of Research Infrastructure Programs, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, 6701 Democracy Boulevard, Room 948, Bethesda, MD 20892, GriederF@mail.nih.gov, 301–435– 0744. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Council of Council’s home page at https:// dpcpsi.nih.gov/council/ where an agenda will be posted before the meeting date. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: October 26, 2020. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–23996 Filed 10–28–20; 8:45 am] BILLING CODE 4140–01–P Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Sep<11>2014 18:03 Oct 28, 2020 Jkt 253001 PO 00000 Frm 00030 Fmt 4703 Sfmt 9990 E:\FR\FM\29OCN1.SGM 29OCN1

Agencies

[Federal Register Volume 85, Number 210 (Thursday, October 29, 2020)]
[Notices]
[Page 68584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute Of Allergy And Infectious Diseases; 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 Allergy and Infectious 
Diseases Special Emphasis Panel NIAID Emergency Awards: Rapid 
Investigation of Severe Acute Respiratory Syndrome Coronavirus 2 
(SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) (R01, R21 
Clinical Trial Not Allowed).
    Date: November 20, 2020.
    Time: 11:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institute of Allergy and Infectious Diseases, 
National Institutes of Health, 5601 Fishers Lane, Room 3G62, 
Rockville, MD 20892, (Virtual Meeting).
    Contact Person: Lynn Rust, Ph.D., Scientific Review Officer, 
Scientific Review Program, Division of Extramural Activities, 
National Institute of Allergy and Infectious Diseases, National 
Institutes of Health, 5601 Fishers Lane, Room 3G62, Bethesda, MD 
20892, (240) 669-5069. [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.855, 
Allergy, Immunology, and Transplantation Research; 93.856, 
Microbiology and Infectious Diseases Research, National Institutes 
of Health, HHS)

    Dated: October 23, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-23965 Filed 10-28-20; 8:45 am]
BILLING CODE 4140-01-P
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