National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 512-513 [2014-30881]

Download as PDF 512 Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices Request for Comments NIH encourages the public to provide comments on any aspect of the draft policy outlined below. Comments should be submitted electronically by January 29, 2015, to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email at SingleIRBpolicy@mail.nih.gov; mail to 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892; or fax at 301–496– 9839. Submitted comments are considered public information; private or confidential information should not be submitted. Comments may be posted along with the submitter’s name and affiliation on the OCRBP Web site after the public comment period closes. Draft NIH Policy on the Use of a Single Institutional Review Board for MultiSite Research tkelley on DSK3SPTVN1PROD with NOTICES Purpose. The purpose of this Policy is to increase the use of single Institutional Review Boards (IRB) for multi-site studies funded by the National Institutes of Health (NIH). Its goal is to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed efficiently without compromising ethical principles and protections. Scope. NIH generally expects all domestic sites of multi-site NIH-funded studies to use a single IRB of record. The Policy applies to all domestic sites participating in NIH conducted or supported multi-site studies, whether supported through grants, contracts, or the NIH intramural program. While foreign sites in multi-site studies will not be expected to follow this Policy, they may elect to do so. Responsibilities. All sites participating in a multi-site study will be expected to rely on a single IRB to carry out the functions that are required for institutional compliance with IRB review set forth in the HHS regulations for the Protection of Human Subjects. The single IRB will be the IRB of record for the other participating sites. The single IRB will be accountable for compliance with regulatory requirements for IRBs specified under the HHS regulations at 45 CFR part 46, such as providing initial and continuing review of the research.12 All the use of a single IRB could lead to increased liability and diminished accountability for participating sites, and decreased consideration of local context. See https://www.gpo.gov/fdsys/pkg/ FR–2011–07–26/html/2011–18792.htm 12 On March 5, 2009, OHRP published an ANPRM requesting public comments on whether OHRP should pursue rulemaking to hold institutional review boards and institutions or organizations operating them directly accountable for compliance with the provisions of 45 CFR part 46 that relate VerDate Sep<11>2014 19:38 Jan 05, 2015 Jkt 235001 participating sites will be responsible for meeting other regulatory obligations, such as obtaining informed consent, overseeing the implementation of approved protocols, and, reporting unanticipated problems and adverse events to the single IRB of record. Agreements between the single IRB of record and other participating sites will be needed in accordance with 45 CFR part 46. IRB Authorization Agreements will document the delegation of responsibilities of IRB review to the designated IRB of record and that IRB site’s acceptance of the responsibilities. The agreement will set forth the specific responsibilities of each participating site. Participating sites will then rely on the IRB of record to satisfy the regulatory requirements relevant to the IRB review. The awardee or lead site for an NIH-funded, multi-site study will be responsible for maintaining authorization agreements and should be prepared to provide copies of the authorization agreements and other necessary documentation to the NIH funding Institute or Center upon request. As necessary, mechanisms should be established to enable the single IRB of record to consider local context issues during its deliberations. A duplicate IRB review at a participating site would be counter to the intent and goal of the Policy, but the Policy does not prohibit any participating site from carrying out its own IRB review. If this approach is taken, the participating site should expect to bear the cost of the additional review. Identification of the IRB that will serve as the single IRB of record will be the responsibility of the extramural applicant or offerer, or the intramural principal investigator. The funding NIH Institute or Center has final decisional authority for approving the selected single IRB. Use of the designated single IRB will be a term and condition of award. If the agreed-upon single IRB is a fee-based IRB, these costs will be included in the Notice of Award as a direct cost. Compliance with this Policy will be a term and condition in the Notice of Award and a contract requirement in the Contract Award. Exceptions. Exceptions to the expectation to use a single IRB may be to IRB responsibilities. In the ANPRM, OHRP identified: Responsibilities that may be unique to IRBs and the institutions operating them; responsibilities that may be unique to institutions engaged in human subjects research; and, responsibilities that may be fulfilled by either IRBs/ IORGs or institutions engaged in human subjects research. See https://www.gpo.gov/fdsys/pkg/FR– 2009–03–05/pdf/E9–4628.pdf. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 made with appropriate justification. Exceptions will be allowed only if the designated single IRB is unable to meet the needs of specific populations or where local IRB review is required by federal, tribal, or state laws or regulations.13 Effective Date. The Policy applies to all new grant applications (Type 1 and 2) and contract proposals with receipt dates after [date to be determined]. It will also apply to intramural multi-site studies submitted for initial review after that date.14 Dated: December 24, 2014. Lawrence Tabak, Principal Deputy Director, [FR Doc. 2014–30964 Filed 1–5–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, January 29, 2015 10:30 a.m. to January 30, 2015, 04:00 p.m., National Cancer Institute Shady Grove, 9609 Medical Center Drive, Rockville, MD 20850 which was published in the Federal Register on November 26, 2014, 79FR70537. The meeting notice is amended to change the date and start time to be held on January 29, 2015 at 10:00 a.m. The meeting is closed to the public. Dated: December 30, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–30883 Filed 1–5–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as 13 For example, FDA-regulated research involving a device is required to have local IRB review under 21 U.S.C. 360j(g)(3)(A)). 14 When a final policy is issued, NIH will also provide more specific procedural guidance to facilitate implementation. E:\FR\FM\06JAN1.SGM 06JAN1 Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings 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 Investigator Initiated Program Project Applications (P01). Date: January 27–28, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3G50, 5601 Fisher Lane, Rockville, MD 20582 (Telephone Conference Call). Contact Person: B. Duane Price, Ph.D., Scientific Review Officer, Scientific Review Program, DHHS/NIH/NIAID, 5601 Fisher Lane, Rockville, MD 20582, 240–669–5074, pricebd@niaid.nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Clinical Trial Implementation Cooperative Agreement (U01) and Clinical Trial Planning Grant (R34). Date: February 2, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3G50, 5601 Fisher Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: B. Duane Price, Ph.D., Scientific Review Officer, Scientific Review Program, DHHS/NIH/NIAID, 6700B Rockledge Drive, MSC 7616, Room 3139, Bethesda, MD 20892, (301) 451–2592, pricebd@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) tkelley on DSK3SPTVN1PROD with NOTICES Dated: December 30, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–30881 Filed 1–5–15; 8:45 am] 19:38 Jan 05, 2015 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 (5 U.S.C. App.), 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 Initial Review Group; Neurological Sciences and Disorders C. Date: February 26–27, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites Alexandria, 1900 Diagonal Road, Alexandria, Virginia 22314. Contact Person: William C. Benzing, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–496– 0660, benzingw@mail.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) Jkt 235001 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 Cancer Institute Special Emphasis Panel; Quantitative Imaging for Evaluation of Response to Cancer Therapies-Renewal. Date: January 30, 2015. Time: 10:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 1E030, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Gerald G. Lovinger, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W266, Bethesda, MD 20892–9750, 240–276–6385, lovingeg@mail.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// deainfo.nci.nih.gov/advisory/sep/sep.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: December 30, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. Dated: December 30, 2014. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–30880 Filed 1–5–15; 8:45 am] [FR Doc. 2014–30876 Filed 1–5–15; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–P BILLING CODE 4140–01–P National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the BILLING CODE 4140–01–P VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES 513 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings 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 E:\FR\FM\06JAN1.SGM 06JAN1

Agencies

[Federal Register Volume 80, Number 3 (Tuesday, January 6, 2015)]
[Notices]
[Pages 512-513]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Allergy and Infectious Diseases; Notice of 
Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as

[[Page 513]]

amended (5 U.S.C. App.), notice is hereby given of the following 
meetings.
    The meetings 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 Investigator Initiated 
Program Project Applications (P01).
    Date: January 27-28, 2015.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Room 3G50, 5601 Fisher 
Lane, Rockville, MD 20582 (Telephone Conference Call).
    Contact Person: B. Duane Price, Ph.D., Scientific Review 
Officer, Scientific Review Program, DHHS/NIH/NIAID, 5601 Fisher 
Lane, Rockville, MD 20582, 240-669-5074, pricebd@niaid.nih.gov.

    Name of Committee: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel, Clinical Trial Implementation 
Cooperative Agreement (U01) and Clinical Trial Planning Grant (R34).
    Date: February 2, 2015.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Room 3G50, 5601 Fisher 
Lane, Rockville, MD 20892, (Telephone Conference Call).
    Contact Person: B. Duane Price, Ph.D., Scientific Review 
Officer, Scientific Review Program, DHHS/NIH/NIAID, 6700B Rockledge 
Drive, MSC 7616, Room 3139, Bethesda, MD 20892, (301) 451-2592, 
pricebd@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: December 30, 2014.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-30881 Filed 1-5-15; 8:45 am]
BILLING CODE 4140-01-P
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