National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 49744-49745 [2019-20448]

Download as PDF 49744 Federal Register / Vol. 84, No. 184 / Monday, September 23, 2019 / Notices ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (OCOD), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993– 0002 or the Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 240–402– 8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Shruti Modi, CBER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911; or Scott Goldie, CDER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993–0002, 301–796–2055. SUPPLEMENTARY INFORMATION: jbell on DSK3GLQ082PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Interacting with the FDA on Complex Innovative Clinical Trial Designs for Drugs and Biological Products.’’ The draft guidance document provides recommendations to sponsors and applicants on interacting with the FDA on CID proposals for drugs or biological products. FDA is issuing this guidance to satisfy, in part, a mandate under section 3021 of the Cures Act. In accordance with the Cures Act mandate, the draft guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115).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 VerDate Sep<11>2014 17:55 Sep 20, 2019 Jkt 247001 on ‘‘Interacting with the FDA on Complex Innovative Clinical Trial Designs for Drugs and Biological 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520); the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; and the collections of information in the guidance for industry entitled ‘‘Special Protocol Assessment,’’ have been approved under 0910–0470. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics, https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, or https:// www.regulations.gov. Dated: September 17, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–20494 Filed 9–20–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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 Child Health and Human Development Special Emphasis Panel; Innovative Epidemiologic approaches for understanding long-term health outcomes of HIV-exposed uninfected populations. (R61/R33) Date: December 13, 2019. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Helen Huang, Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Health and Human Development, NIH, Bethesda, MD 20817, 301–435–8380, helen.huang@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: September 17, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–20449 Filed 9–20–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; 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: Heart, Lung and Blood Initial Review Group Clinical Trials Review Committee. Date: October 24–25, 2019. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\23SEN1.SGM 23SEN1 Federal Register / Vol. 84, No. 184 / Monday, September 23, 2019 / Notices Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Keary A. Cope, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7190, Bethesda, MD 20892–7924, 301–827– 7912, copeka@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: September 17, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–20448 Filed 9–20–19; 8:45 am] BILLING CODE 4140–01–P (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: September 17, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–20447 Filed 9–20–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2019–0002] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, And Blood Institute; Notice of Closed Meeting SUMMARY: AGENCY: 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 sections in 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. jbell on DSK3GLQ082PROD with NOTICES Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Clinical Ancillary Studies (R01). Date: October 30, 2019. Time: 8:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC 20015. Contact Person: YingYing Li-Smerin, MD, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7184, Bethesda, MD 20892– 7924, 301–827–7942, lismerin@nhlbi.nih.gov. Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency’s (FEMA’s) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings. DATES: The date of January 22, 2020 has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community. ADDRESSES: The FIRM, and if applicable, the FIS report containing the Community final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at https://msc.fema.gov by the date indicated above. Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646–7659, or (email) patrick.sacbibit@fema.dhs.gov; or visit the FEMA Map Information eXchange (FMIX) online at https:// www.floodmaps.fema.gov/fhm/fmx_ main.html. FOR FURTHER INFORMATION CONTACT: The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification. This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60. Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at https:// msc.fema.gov. The flood hazard determinations are made final in the watersheds and/or communities listed in the table below. SUPPLEMENTARY INFORMATION: Final Flood Hazard Determinations Federal Emergency Management Agency, DHS. ACTION: Notice. 49745 (Catalog of Federal Domestic Assistance No. 97.022, ‘‘Flood Insurance.’’) Michael M. Grimm, Assistant Administrator for Risk Management, Department of Homeland Security, Federal Emergency Management Agency. Community map repository address New Castle County, Delaware and Incorporated Areas Docket No.: FEMA–B–1701 and FEMA–B–1849 City of New Castle .................................................................................... VerDate Sep<11>2014 17:55 Sep 20, 2019 Jkt 247001 PO 00000 Frm 00041 Fmt 4703 Public Works Building, 900 Wilmington Road, New Castle, DE 19720. Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1

Agencies

[Federal Register Volume 84, Number 184 (Monday, September 23, 2019)]
[Notices]
[Pages 49744-49745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20448]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; 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: Heart, Lung and Blood Initial Review Group 
Clinical Trials Review Committee.
    Date: October 24-25, 2019.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.

[[Page 49745]]

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: Keary A. Cope, Ph.D., Scientific Review Officer, 
Office of Scientific Review/DERA, National Heart, Lung, and Blood 
Institute, 6701 Rockledge Drive, Room 7190, Bethesda, MD 20892-7924, 
301-827-7912, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.233, 
National Center for Sleep Disorders Research; 93.837, Heart and 
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, 
Blood Diseases and Resources Research, National Institutes of 
Health, HHS)

    Dated: September 17, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-20448 Filed 9-20-19; 8:45 am]
 BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.