Center for Scientific Review; Notice of Closed Meetings, 29013-29014 [2015-12242]

Download as PDF 29013 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0275. Also include the FDA docket number found in brackets in the heading of this document. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd.; COLE–14526, Silver Spring, MD 20993–0002 PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA SUPPLEMENTARY INFORMATION: has submitted the following proposed collection of information to OMB for review and clearance. State Enforcement Notifications—21 CFR 100.2(d) OMB Control Number 0910–0275— Extension Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 337(b)) authorizes a State to enforce certain sections of the FD&C Act in their own name and within their own jurisdiction. However, before doing so, a State must provide notice to FDA according to 21 CFR 100.2. The information required in a letter of notification under § 100.2(d) enables us to identify the food against which a State intends to take action and to advise that State whether Federal enforcement action against the food has been taken or is in process. With certain narrow exceptions, Federal enforcement action precludes State action under the FD&C Act. In the Federal Register of March 13, 2015 (80 FR 13392), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR section Number of respondents Number of responses per respondents Total annual responses Average burden per response Total hours 100.2(d) ................................................................................ 1 1 1 10 10 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated reporting burden for § 100.2(d) is minimal because enforcement notifications are seldom used by States. During the last 3 years, we have not received any new enforcement notifications; therefore, we estimate that one or fewer notifications will be submitted annually. Although we have not received any new enforcement notifications in the last 3 years, we believe these information collection provisions should be extended to provide for the potential future need of a State government to submit enforcement notifications informing us when it intends to take enforcement action under the FD&C Act against a particular food located in the State. Dated: May 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–12236 Filed 5–19–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES National Institutes of Health National Institute of Neurological Disorders and Stroke; 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 VerDate Sep<11>2014 23:50 May 19, 2015 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 Institute of Neurological Disorders and Stroke, Initial Review Group, Neurological Sciences and Disorders B. Date: June 25–26, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Wyndam Grand Chicago Riverfront Hotel, 71 E. Wacker Drive, Chicago, IL 60601. Contact Person: Birgit Neuhuber, 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– 3562, neuhuber@ninds.nih.gov. Name of Committee: Neurological Sciences Training Initial Review Group, NST–2 Subcommittee. Date: June 29–30, 2015. Time: 8:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC, 2401 M Street NW., Washington, DC 20037. Contact Person: Elizabeth A. Webber, 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, 301–496–1917, webbere@mail.nih.gov. PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 (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: May 14, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–12125 Filed 5–19–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; 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 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: Oncology 2— Translational Clinical Integrated Review E:\FR\FM\20MYN1.SGM 20MYN1 mstockstill on DSK4VPTVN1PROD with NOTICES 29014 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices Group; Radiation Therapeutics and Biology Study Section. Date: June 15–16, 2015. Time: 8:00 a.m. to 4:00 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: Bo Hong, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301–996–6208, hongb@csr.nih.gov. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Motor Function, Speech and Rehabilitation Study Section. Date: June 15, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: St. Gregory Hotel, 2033 M Street NW., Washington, DC 20036. Contact Person: Biao Tian, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, MSC 7848, Bethesda, MD 20892, 301–402–4411, tianbi@csr.nih.gov. Name of Committee:Oncology 2— Translational Clinical Integrated Review Group; Cancer Biomarkers Study Section. Date: June 17, 2015. Time: 8:00 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: Lawrence Ka-Yun Ng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6152, MSC 7804, Bethesda, MD 20892, 301–357– 9318, ngkl@csr.nih.gov. Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Cellular Aspects of Diabetes and Obesity Study Section. Date: June 18, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Bethesda (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Alexander D Politis, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD 20892, (301) 435– 1150, politisa@csr.nih.gov. Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Molecular and Cellular Endocrinology Study Section. Date: June 18, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: John Bleasdale, Ph.D., Scientific Review Officer, Center for VerDate Sep<11>2014 23:50 May 19, 2015 Jkt 235001 Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6170, MSC 7892, Bethesda, MD 20892, 301–435– 4514, bleasdaleje@csr.nih.gov. Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Synapses, Cytoskeleton and Trafficking Study Section. Date: June 18–19, 2015. Time: 8:30 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Monaco Alexandria, 480 King Street, Alexandria, VA 22314. Contact Person: Christine A Piggee, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4186, MSC 7850, Bethesda, MD 20892, 301–435– 0657, christine.piggee@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Traumatic Brain Injury and Cerebrovascular Disorders. Date: June 19, 2015. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Alexander Yakovlev, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5206, MSC 7846, Bethesda, MD 20892–7846, 301– 435–1254, yakovleva@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: May 15, 2015. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2015–12242 Filed 5–19–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage SUMMARY: PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301– 496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: Technology descriptions follow. A Novel Therapeutic Vector for Hemoglobin Disorders Description of Technology: Investigators at the National Heart, Lung, and Blood Institute have designed a novel lentiviral vector as a potential gene therapy for sickle cell anemia and beta-thalassemia. The novel lentiviral vector encodes the beta-globin gene in a forward orientation and can produce 5– 10 fold higher viral titer and 4–10 fold higher gene transfer efficiency to hematopoietic stem cells than reverseoriented lentiviral vectors. In vivo studies conducted in rhesus macaques show beta-globin production after transplantation with this novel lentiviral vector. This technology could provide an alternative therapy for patients suffering from blood disorders associated with beta-globin gene mutations. Potential Commercial Applications: Gene therapy. Competitive Advantages: • Increased viral titers • Increased transduction efficiency • Large scale vector production Development Stage: • Early-stage • In vitro data available • In vivo data available (animal) Inventors: Naoya Uchida and John F. Tisdale (NHLBI). Intellectual Property: HHS Reference No. E–165–2014/0—U.S. Provisional Application No. 62/048,881 filed September 11, 2014. Licensing Contact: Cristina Thalhammer-Reyero, Ph.D.; 301–495– 4507; thalhamc@mail.nih.gov. Collaborative Research Opportunity: The National Heart, Lung and Blood Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize this technology. For collaboration opportunities, please contact Denise Crooks at crooksd@ mail.nih.gov. E:\FR\FM\20MYN1.SGM 20MYN1

Agencies

[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Notices]
[Pages 29013-29014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12242]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; 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 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: Oncology 2--Translational Clinical Integrated 
Review

[[Page 29014]]

Group; Radiation Therapeutics and Biology Study Section.
    Date: June 15-16, 2015.
    Time: 8:00 a.m. to 4:00 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: Bo Hong, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301-996-
6208, hongb@csr.nih.gov.

    Name of Committee: Biobehavioral and Behavioral Processes 
Integrated Review Group; Motor Function, Speech and Rehabilitation 
Study Section.
    Date: June 15, 2015.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: St. Gregory Hotel, 2033 M Street NW., Washington, DC 
20036.
    Contact Person: Biao Tian, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3166, MSC 7848, Bethesda, MD 20892, 301-402-
4411, tianbi@csr.nih.gov.

    Name of Committee:Oncology 2--Translational Clinical Integrated 
Review Group; Cancer Biomarkers Study Section.
    Date: June 17, 2015.
    Time: 8:00 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: Lawrence Ka-Yun Ng, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 6152, MSC 7804, Bethesda, MD 
20892, 301-357-9318, ngkl@csr.nih.gov.

    Name of Committee: Endocrinology, Metabolism, Nutrition and 
Reproductive Sciences Integrated Review Group; Cellular Aspects of 
Diabetes and Obesity Study Section.
    Date: June 18, 2015.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Doubletree Hotel Bethesda (Formerly Holiday Inn Select), 
8120 Wisconsin Avenue, Bethesda, MD 20814.
    Contact Person: Alexander D Politis, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD 
20892, (301) 435-1150, politisa@csr.nih.gov.

    Name of Committee: Endocrinology, Metabolism, Nutrition and 
Reproductive Sciences Integrated Review Group; Molecular and 
Cellular Endocrinology Study Section.
    Date: June 18, 2015.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: John Bleasdale, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 6170, MSC 7892, Bethesda, MD 
20892, 301-435-4514, bleasdaleje@csr.nih.gov.

    Name of Committee: Molecular, Cellular and Developmental 
Neuroscience Integrated Review Group; Synapses, Cytoskeleton and 
Trafficking Study Section.
    Date: June 18-19, 2015.
    Time: 8:30 a.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hotel Monaco Alexandria, 480 King Street, Alexandria, VA 
22314.
    Contact Person: Christine A Piggee, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4186, MSC 7850, Bethesda, MD 
20892, 301-435-0657, christine.piggee@nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Traumatic Brain Injury and Cerebrovascular Disorders.
    Date: June 19, 2015.
    Time: 1:00 p.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Alexander Yakovlev, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5206, MSC 7846, Bethesda, MD 
20892-7846, 301-435-1254, yakovleva@csr.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.306, 
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)

    Dated: May 15, 2015.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-12242 Filed 5-19-15; 8:45 am]
BILLING CODE 4140-01-P
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