80_FR_64211 80 FR 64007 - Center for Scientific Review; Notice of Closed Meetings

80 FR 64007 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 204 (October 22, 2015)

Page Range64007-64007
FR Document2015-26774

Federal Register, Volume 80 Issue 204 (Thursday, October 22, 2015) 
[Federal Register Volume 80, Number 204 (Thursday, October 22, 2015)]
[Notices]
[Page 64007]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26774]


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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: Center for Scientific Review Special Emphasis 
Panel; Program Project: Molecular structure, dynamics, and mechanism 
of key membrane transporters and enzymes in cellular metabolism.
    Date: November 17-18, 2015.
    Time: 7:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Virtual Meeting).
    Contact Person: Kathryn M. Koeller, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4166, MSC 7806, Bethesda, MD 
20892, 301-435-2681, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR13-189: Imaging and Biomarkers for Early Cancer Detection.
    Date: November 17, 2015.
    Time: 10:00 a.m. to 2:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Virtual Meeting).
    Contact Person: Chiayeng Wang, Ph.D., Scientific Review Officer. 
Center for Scientific Review. 6701 Rockledge Drive, Room 5213, MSC 
7852, Bethesda, MD 20892, 301-435-2397, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR-14-092: Bioengineering Research Partnerships (BRP).
    Date: November 17, 2015.
    Time: 11:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Virtual Meeting).
    Contact Person: Mehrdad Mohseni, MD, Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 5211, MSC 7854, Bethesda, MD 20892, 301-435-
0484, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; AREA grant applications: Toxicology and Digestive, Kidney and 
Urological Systems.
    Date: November 17, 2015.
    Time: 11:30 a.m. to 2:00 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: Patricia Greenwel, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 2178, MSC 7818, Bethesda, MD 
20892, 301-435-1169, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Small Business: Skeletal Muscle.
    Date: November 17, 2015.
    Time: 1:00 p.m. to 4:00 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: Richard Ingraham, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4116, MSC 7814, Bethesda, MD 
20892, 301-496-8551, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Program Projects: New Modalities for the Treatment of Pain 
and Drug Abuse.
    Date: November 17, 2015.
    Time: 1:00 p.m. to 4:00 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: Geoffrey G. Schofield, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4040-A, MSC 7850, Bethesda, MD 
20892, 301-435-1235, [email protected].

(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: October 16, 2015.
Anna Snouffer,
 Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-26774 Filed 10-21-15; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 204 / Thursday, October 22, 2015 / Notices 64007 This draft guidance is being issued Dated: October 16, 2015. Agenda: To review and evaluate grant consistent with FDA’s good guidance Leslie Kux, applications. practices regulation (21 CFR 10.115). Associate Commissioner for Policy. Place: National Institutes of Health, 6701 The draft guidance, when finalized, will Rockledge Drive, Bethesda, MD 20892, [FR Doc. 2015–26849 Filed 10–21–15; 8:45 am] (Virtual Meeting). represent the current thinking of FDA BILLING CODE 4164–01–P Contact Person: Mehrdad Mohseni, MD, on ‘‘Selection of the Appropriate Scientific Review Officer, Center for Package Type Terms and Scientific Review, National Institutes of Recommendations for Labeling DEPARTMENT OF HEALTH AND Health, 6701 Rockledge Drive, Room 5211, Injectable Medical Products Packaged in HUMAN SERVICES MSC 7854, Bethesda, MD 20892, 301–435– Multiple-Dose, Single-Dose, and Single- 0484, mohsenim@csr.nih.gov. Patient-Use Containers for Human Use.’’ National Institutes of Health Name of Committee: Center for Scientific It does not establish any rights for any Review Special Emphasis Panel; AREA grant person and is not binding on FDA or the Center for Scientific Review; Notice of applications: Toxicology and Digestive, public. You can use an alternative Closed Meetings Kidney and Urological Systems. approach if it satisfies the requirements Date: November 17, 2015. Pursuant to section 10(d) of the Time: 11:30 a.m. to 2:00 p.m. of the applicable statutes and Federal Advisory Committee Act, as Agenda: To review and evaluate grant regulations. amended (5 U.S.C. App.), notice is applications. II. Electronic Access hereby given of the following meetings. Place: National Institutes of Health, 6701 Persons with access to the Internet The meetings will be closed to the Rockledge Drive, Bethesda, MD 20892, public in accordance with the (Telephone Conference Call). may obtain the draft guidance at either provisions set forth in sections Contact Person: Patricia Greenwel, Ph.D., http://www.fda.gov/Drugs/ Scientific Review Officer, Center for GuidanceComplianceRegulatory 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Scientific Review, National Institutes of Information/Guidances/default.htm or as amended. The grant applications and Health, 6701 Rockledge Drive, Room 2178, http://www.regulations.gov. the discussions could disclose MSC 7818, Bethesda, MD 20892, 301–435– confidential trade secrets or commercial 1169, greenwep@csr.nih.gov. III. The Paperwork Reduction Act of property such as patentable material, 1995 Name of Committee: Center for Scientific and personal information concerning Review Special Emphasis Panel; Small This guidance refers to previously individuals associated with the grant Business: Skeletal Muscle. approved collections of information that applications, the disclosure of which Date: November 17, 2015. are subject to review by the Office of would constitute a clearly unwarranted Time: 1:00 p.m. to 4:00 p.m. Management and Budget (OMB) under invasion of personal privacy. Agenda: To review and evaluate grant the Paperwork Reduction Act of 1995 applications. Name of Committee: Center for Scientific (44 U.S.C. 3501–3520). The collections Place: National Institutes of Health, 6701 Review Special Emphasis Panel; Program of information discussed in this draft Rockledge Drive, Bethesda, MD 20892, Project: Molecular structure, dynamics, and guidance have been approved under (Telephone Conference Call). mechanism of key membrane transporters Contact Person: Richard Ingraham, Ph.D., OMB under the following control and enzymes in cellular metabolism. Scientific Review Officer, Center for numbers: OMB control number 0910– Date: November 17–18, 2015. Scientific Review, National Institutes of 0001 for NDAs, ANDAs, supplements to Time: 7:00 a.m. to 5:00 p.m. Health, 6701 Rockledge Drive, Room 4116, NDAs and ANDAs, and annual reports; Agenda: To review and evaluate grant applications. MSC 7814, Bethesda, MD 20892, 301–496– OMB control number 0910–0572 for 8551, ingrahamrh@mail.nih.gov. Place: National Institutes of Health, 6701 prescription drug product labeling; Name of Committee: Center for Scientific Rockledge Drive, Bethesda, MD 20892, OMB control number 0910–0338 for (Virtual Meeting). Review Special Emphasis Panel; Program BLA, BLA supplements and annual Contact Person: Kathryn M. Koeller, Ph.D., Projects: New Modalities for the Treatment of reports; OMB control number 0910– Scientific Review Officer, Center for Pain and Drug Abuse. 0120 for premarket notifications Scientific Review, National Institutes of Date: November 17, 2015. (510(k)s); OMB control number 0910– Health, 6701 Rockledge Drive, Room 4166, Time: 1:00 p.m. to 4:00 p.m. 0231 for premarket approval MSC 7806, Bethesda, MD 20892, 301–435– Agenda: To review and evaluate grant applications (PMAs); OMB control 2681, koellerk@csr.nih.gov. applications. Name of Committee: Center for Scientific Place: National Institutes of Health, 6701 number 0910–0485 for medical device Review Special Emphasis Panel; PAR13–189: Rockledge Drive, Bethesda, MD 20892, labeling; and OMB control number (Telephone Conference Call). 0910–0577 for prominent and Imaging and Biomarkers for Early Cancer Detection. Contact Person: Geoffrey G. Schofield, conspicuous mark of manufacturers on Ph.D., Scientific Review Officer, Center for Date: November 17, 2015. single-use devices. Relevant to this Time: 10:00 a.m. to 2:00 p.m. Scientific Review, National Institutes of collection of information, FDA Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 4040–A, published its proposed rule on the applications. MSC 7850, Bethesda, MD 20892, 301–435– electronic distribution of prescribing Place: National Institutes of Health, 6701 1235, geoffreys@csr.nih.gov. information for human prescription Rockledge Drive, Bethesda, MD 20892, (Catalogue of Federal Domestic Assistance drugs, including biological products in (Virtual Meeting). Program Nos. 93.306, Comparative Medicine; the Federal Register of December 18, Contact Person: Chiayeng Wang, Ph.D., 93.333, Clinical Research, 93.306, 93.333, Scientific Review Officer. Center for 93.337, 93.393–93.396, 93.837–93.844, 2014 (79 FR 75506). In Section VII, Scientific Review. 6701 Rockledge Drive, 93.846-93.878, 93.892, 93.893, National ‘‘Paperwork Reduction Act of 1995,’’ Institutes of Health, HHS). Room 5213, MSC 7852, Bethesda, MD 20892, tkelley on DSK3SPTVN1PROD with NOTICES FDA estimated the burden to design, 301–435–2397, chiayeng.wang@nih.gov. test, and produce the label for a drug Dated: October 16, 2015. Name of Committee: Center for Scientific Anna Snouffer, product’s immediate container and Review Special Emphasis Panel; PAR–14– outer container or package, as set forth Deputy Director, Office of Federal Advisory 092: Bioengineering Research Partnerships in 21 CFR part 201, including Committee Policy. (BRP). § 201.100(b) and other sections in Date: November 17, 2015. [FR Doc. 2015–26774 Filed 10–21–15; 8:45 am] subpart A and subpart B. Time: 11:00 a.m. to 5:00 p.m. BILLING CODE 4140–01–P VerDate Sep<11>2014 18:05 Oct 21, 2015 Jkt 238001 PO 00000 Frm 00051 Fmt 4703 Sfmt 9990 E:\FR\FM\22OCN1.SGM 22OCN1


Document Created: 2015-12-14 15:34:18
Document Modified: 2015-12-14 15:34:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesNovember 17-18, 2015.
FR Citation80 FR 64007 
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