80 FR 23280 - Center For Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 80 (April 27, 2015)

Page Range		23280-23281
FR Document		2015-09622

Federal Register, Volume 80 Issue 80 (Monday, April 27, 2015)

[Federal Register Volume 80, Number 80 (Monday, April 27, 2015)]
[Notices]
[Pages 23280-23281]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09622]


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

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: Cell Biology Integrated Review Group; Nuclear 
and Cytoplasmic Structure/Function and Dynamics Study Section.
    Date: May 28-29, 2015.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: BW Plus Tuscan, a Kimpton Hotel, 425 North Point Street, 
San Francisco, CA 94133.
    Contact Person: David Balasundaram, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5189, MSC 7840, Bethesda, MD 
20892, 301-435-1022, [email protected].

    Name of Committee: Population Sciences and Epidemiology 
Integrated Review Group; Kidney, Nutrition, Obesity and Diabetes 
Study Section.
    Date: May 28-29, 2015.
    Time: 8:00 a.m. to 3:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hotel Nikko San Francisco, 222 Mason Street, San 
Francisco, CA 94102.
    Contact Person: Fungai Chanetsa, Ph.D., MPH, Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3135, MSC 7770, Bethesda, MD 
20892, 301-408-9436, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR Panel: High Throughput Screening.
    Date: May 28, 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: Nancy Templeton, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5168, MSC 7849, Bethesda, MD 
20892, 301-408-9694, [email protected].


[[Page 23281]]


    Name of Committee: Cell Biology Integrated Review Group; 
Cellular Signaling and Regulatory Systems Study Section.
    Date: May 28-29, 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: Elena Smirnova, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5187, MSC 7840, Bethesda, MD 
20892, 301-357-9112, [email protected].

    Name of Committee: Immunology Integrated Review Group, Cellular 
and Molecular Immunology--B Study Section.
    Date: May 28-29, 2015.
    Time: 8:30 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: Betty Hayden, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 4206, MSC 7812, Bethesda, MD 20892, 301-435-
1223, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR Panel: Academic Industrial Partnership.
    Date: May 28, 2015.
    Time: 9:00 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.
    Contact Person: Donald Scott Wright, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5108, MSC 7854, Bethesda, MD 
20892, (301) 435-8363, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR Panel: Pregnancy in Women with Disabilities.
    Date: May 28, 2015.
    Time: 10:30 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.
    Contact Person: Priscah Mujuru, RN, MPH, DRPH, COHNS, Scientific 
Review Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD 
20892, 301-594-6594, [email protected].

    Name of Committee: Healthcare Delivery and Methodologies 
Integrated Review Group; Biomedical Computing and Health Informatics 
Study Section.
    Date: May 28, 2015.
    Time: 11:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Sheraton Delfina Santa Monica Hotel, 530 West Pico 
Boulevard, Santa Monica, CA 90405.
    Contact Person: Melinda Jenkins, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3156, MSC 7770, Bethesda, MD 
20892, 301-437-7872, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Biomedical Computing and Health Informatics.
    Date: May 28, 2015.
    Time: 4:00 p.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Sheraton Delfina Santa Monica Hotel, 530 West Pico 
Boulevard, Santa Monica, CA 90405.
    Contact Person: Peter J Kozel, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3139, Bethesda, MD 20892, 301-435-1116, 
[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: April 21, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-09622 Filed 4-24-15; 8:45 am]
 BILLING CODE 4140-01P

23280 Federal Register / Vol. 80, No. 80 / Monday, April 27, 2015 / Notices

from both regulatory and industry enhancements. The M8 eCTD draft DEPARTMENT OF HEALTH AND
representatives. FDA also seeks input implementation guidance provides HUMAN SERVICES
from consumer representatives and instructions for creating the eCTD v4.0
others. ICH is concerned with RPS message for the ICH Modules 2 National Institutes of Health
harmonization of technical through 5 of the eCTD. The draft
requirements for the registration of specifications document provides Center For Scientific Review; Notice of
pharmaceutical products among three Closed Meetings
specifications for creating files for
regions: The European Union, Japan, inclusion in the eCTD. These draft Pursuant to section 10(d) of the
and the United States. The eight ICH documents facilitate implementation of Federal Advisory Committee Act, as
sponsors are the European Commission; the eCTD v4.0 standard. The draft amended (5 U.S.C. App.), notice is
the European Federation of documents are being issued as a package hereby given of the following meetings.
Pharmaceutical Industries Associations; that includes the draft ICH code list and The meetings will be closed to the
the Japanese Ministry of Health, Labour, public in accordance with the
the M8 schema files. In addition, the
and Welfare; the Japanese provisions set forth in sections
FDA regional/module 1 documents have
Pharmaceutical Manufacturers 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Association; CDER and CBER, FDA; the been developed and are available at
http://www.fda.gov/Drugs/ as amended. The grant applications and
Pharmaceutical Research and the discussions could disclose
Manufacturers of America; Health DevelopmentApprovalProcess/
FormsSubmissionRequirements/ confidential trade secrets or commercial
Canada; and Swissmedic. The ICH property such as patentable material,
Secretariat, which coordinates the ElectronicSubmissions/ucm309911.htm.
and personal information concerning
preparation of documentation, is The M8 eCTD draft implementation individuals associated with the grant
provided by the International guidance is being issued consistent with applications, the disclosure of which
Federation of Pharmaceutical FDA’s good guidance practices would constitute a clearly unwarranted
Manufacturers Associations (IFPMA). regulation (21 CFR 10.115). The draft invasion of personal privacy.
The ICH Steering Committee includes guidance, when finalized, will represent
representatives from each of the ICH Name of Committee: Cell Biology
the current thinking of FDA on this Integrated Review Group; Nuclear and
sponsors and the IFPMA, as well as topic. It does not establish any rights for
observers from the World Health Cytoplasmic Structure/Function and
any person and is not binding on FDA Dynamics Study Section.
Organization and the European Free or the public. You can use an alternative Date: May 28–29, 2015.
Trade Area. Time: 8:00 a.m. to 5:00 p.m.
The eCTD is an ICH standard based approach if it satisfies the requirements
of the applicable statutes and Agenda: To review and evaluate grant
on specifications developed by ICH and applications.
its member parties. The ICH M2 Expert regulations.
Place: BW Plus Tuscan, a Kimpton Hotel,
Working Group has previously II. Comments 425 North Point Street, San Francisco, CA
developed a list of requirements for 94133.
input in the eCTD RPS Project. The list Interested persons may submit either Contact Person: David Balasundaram,
of requirements was last updated on electronic comments regarding these Ph.D., Scientific Review Officer, Center for
November 11, 2010, and is available at documents to http:// Scientific Review, National Institutes of
http://estri.ich.org/ICH_eCTD_NMV_ Health, 6701 Rockledge Drive, Room 5189,
www.regulations.gov or written MSC 7840, Bethesda, MD 20892, 301–435–
Requirements-V4-0.pdf (FDA has comments to the Division of Dockets 1022, balasundaramd@csr.nih.gov.
verified the Web site address, but FDA Management (see ADDRESSES). It is Name of Committee: Population Sciences
is not responsible for any subsequent only necessary to send one set of and Epidemiology Integrated Review Group;
changes to the Web site after this comments. Identify comments with the Kidney, Nutrition, Obesity and Diabetes
document publishes in the Federal docket number found in brackets in the Study Section.
Register). heading of this document. Received Date: May 28–29, 2015.
The ICH M8 Expert Working Group comments may be seen in the Division Time: 8:00 a.m. to 3:30 p.m.
was formed in November 2010 to of Dockets Management between 9 a.m. Agenda: To review and evaluate grant
assume responsibility for the continued and 4 p.m., Monday through Friday, and applications.
development of the next major version Place: Hotel Nikko San Francisco, 222
will be posted to the docket at http:// Mason Street, San Francisco, CA 94102.
of the eCTD. www.regulations.gov.
In February 2015, the ICH Steering Contact Person: Fungai Chanetsa, Ph.D.,
Committee agreed that a draft guidance MPH, Scientific Review Officer, Center for
III. Electronic Access Scientific Review, National Institutes of
entitled ‘‘M8 eCTD v4.0 Draft Health, 6701 Rockledge Drive, Room 3135,
Implementation Guide v2.0’’ and the Persons with access to the Internet
MSC 7770, Bethesda, MD 20892, 301–408–
related document entitled ‘‘eCTD v4.0 may obtain the documents at http:// 9436, fungai.chanetsa@nih.hhs.gov.
Implementation Package Draft www.regulations.gov, http://
Name of Committee: Center for Scientific
Specification for Submission Formats www.fda.gov/Drugs/Guidance Review Special Emphasis Panel; PAR Panel:
v2.0’’ should be made available for ComplianceRegulatoryInformation/ High Throughput Screening.
public comment. These documents are Guidances/default.htm, or http:// Date: May 28, 2015.
the product of the M8 Expert Working www.fda.gov/BiologicsBloodVaccines/ Time: 8:00 a.m. to 6:00 p.m.
Group. Comments about these draft GuidanceComplianceRegulatory Agenda: To review and evaluate grant
documents will be considered by FDA Information/Guidances/default.htm. applications.
Rmajette on DSK2VPTVN1PROD with NOTICES

and the M8 Expert Working Group. Place: Residence Inn Bethesda, 7335
Dated: April 21, 2015. Wisconsin Avenue, Bethesda, MD 20814.
Since adoption of the eCTD standard,
Peter Lurie, Contact Person: Nancy Templeton, Ph.D.,
the ICH Steering Committee has Scientific Review Officer, Center for
endorsed using the RPS Release 2 Associate Commissioner for Public Health
Scientific Review, National Institutes of
standard. A core feature of the RPS Strategy and Analysis.
Health, 6701 Rockledge Drive, Room 5168,
standard is the flexibility the message [FR Doc. 2015–09646 Filed 4–24–15; 8:45 am] MSC 7849, Bethesda, MD 20892, 301–408–
provides to enable future eCTD BILLING CODE 4164–01–P 9694, templetonns@mail.nih.gov.

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Federal Register / Vol. 80, No. 80 / Monday, April 27, 2015 / Notices 23281

Name of Committee: Cell Biology Health, 6701 Rockledge Drive, Room 3156, Institutes of Health, 6701 Democracy
Integrated Review Group; Cellular Signaling MSC 7770, Bethesda, MD 20892, 301–437– Boulevard, Suite 703, Bethesda, MD 20892,
and Regulatory Systems Study Section. 7872, jenkinsml2@mail.nih.gov. (301) 594–0343, tamizchelvi.thyagarajan@
Date: May 28–29, 2015. Name of Committee: Center for Scientific nih.gov.
Time: 8:00 a.m. to 6:00 p.m. Review Special Emphasis Panel; Biomedical (Catalogue of Federal Domestic Assistance
Agenda: To review and evaluate grant Computing and Health Informatics. Program Nos. 93.361, Nursing Research,
applications. Date: May 28, 2015. National Institutes of Health, HHS)
Place: Embassy Suites at the Chevy Chase Time: 4:00 p.m. to 6:00 p.m.
Pavilion, 4300 Military Road NW., Dated: April 21, 2015.
Agenda: To review and evaluate grant
Washington, DC 20015. applications. Michelle Trout,
Contact Person: Elena Smirnova, Ph.D., Place: Sheraton Delfina Santa Monica Program Analyst, Office of Federal Advisory
Scientific Review Officer, Center for Hotel, 530 West Pico Boulevard, Santa Committee Policy.
Scientific Review, National Institutes of Monica, CA 90405. [FR Doc. 2015–09621 Filed 4–24–15; 8:45 am]
Health, 6701 Rockledge Drive, Room 5187, Contact Person: Peter J Kozel, Ph.D.,
MSC 7840, Bethesda, MD 20892, 301–357– BILLING CODE 4140–01–P
Scientific Review Officer, Center for
9112, smirnove@csr.nih.gov. Scientific Review, National Institutes of
Name of Committee: Immunology Health, 6701 Rockledge Drive, Room 3139,
Integrated Review Group, Cellular and Bethesda, MD 20892, 301–435–1116, kozelp@ DEPARTMENT OF HOMELAND
Molecular Immunology—B Study Section. mail.nih.gov. SECURITY
Date: May 28–29, 2015. (Catalogue of Federal Domestic Assistance
Time: 8:30 a.m. to 5:00 p.m. Program Nos. 93.306, Comparative Medicine; U.S. Customs and Border Protection
Agenda: To review and evaluate grant 93.333, Clinical Research, 93.306, 93.333,
applications. [1651–0032]
93.337, 93.393–93.396, 93.837–93.844,
Place: Residence Inn Bethesda, 7335 93.846–93.878, 93.892, 93.893, National
Wisconsin Avenue, Bethesda, MD 20814. Agency Information Collection
Institutes of Health, HHS) Activities: Importers of Merchandise
Contact Person: Betty Hayden, Ph.D.,
Scientific Review Officer, Center for Dated: April 21, 2015. Subject to Actual Use Provisions
Scientific Review, National Institutes of Michelle Trout,
Health, 6701 Rockledge Drive, Room 4206,
AGENCY: U.S. Customs and Border
Program Analyst, Office of Federal Advisory
MSC 7812, Bethesda, MD 20892, 301–435– Committee Policy.
Protection, Department of Homeland
1223, haydenb@csr.nih.gov. Security.
[FR Doc. 2015–09622 Filed 4–24–15; 8:45 am]
Name of Committee: Center for Scientific ACTION: 60-Day notice and request for
BILLING CODE 4140–01P
Review Special Emphasis Panel; PAR Panel: comments; extension of an existing
Academic Industrial Partnership. collection of information.
Date: May 28, 2015.
DEPARTMENT OF HEALTH AND SUMMARY: U.S. Customs and Border
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant HUMAN SERVICES Protection (CBP) of the Department of
applications. Homeland Security will be submitting
Place: National Institutes of Health, 6701 National Institutes of Health
the following information collection
Rockledge Drive, Bethesda, MD 20892. request to the Office of Management and
Contact Person: Donald Scott Wright, National Institute of Nursing Research;
Notice of Closed Meeting Budget (OMB) for review and approval
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of in accordance with the Paperwork
Pursuant to section 10(d) of the Reduction Act: Importers of
Health, 6701 Rockledge Drive, Room 5108,
Federal Advisory Committee Act, as Merchandise Subject to Actual Use
MSC 7854, Bethesda, MD 20892, (301) 435–
8363, wrightds@csr.nih.gov. amended (5 U.S.C. App.), notice is Provisions. CBP is proposing that this
hereby given of the following meeting. information collection be extended with
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
The meeting will be closed to the no change to the burden hours. This
Pregnancy in Women with Disabilities. public in accordance with the document is published to obtain
Date: May 28, 2015. provisions set forth in sections comments from the public and affected
Time: 10:30 a.m. to 5:00 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., agencies.
Agenda: To review and evaluate grant as amended. The grant applications and
DATES: Written comments should be
applications. the discussions could disclose
Place: National Institutes of Health, 6701 received on or before June 26, 2015 to
confidential trade secrets or commercial
Rockledge Drive, Bethesda, MD 20892. be assured of consideration.
property such as patentable material,
Contact Person: Priscah Mujuru, RN, MPH, and personal information concerning ADDRESSES: Direct all written comments
DRPH, COHNS, Scientific Review Officer, to U.S. Customs and Border Protection,
Center for Scientific Review, National
individuals associated with the grant
applications, the disclosure of which Attn: Tracey Denning, Regulations and
Institutes of Health, 6701 Rockledge Drive, Rulings, Office of International Trade,
Room 3139, MSC 7770, Bethesda, MD 20892, would constitute a clearly unwarranted
invasion of personal privacy. 90 K Street NE., 10th Floor, Washington,
301–594–6594, mujurup@mail.nih.gov.
DC 20229–1177.
Name of Committee: Healthcare Delivery Name of Committee: National Institute of
and Methodologies Integrated Review Group; FOR FURTHER INFORMATION CONTACT:
Nursing Research Special Emphasis Panel;
Biomedical Computing and Health Fellowship and Career Development. Requests for additional information
Informatics Study Section. Date: June 4, 2015. should be directed to Tracey Denning,
Date: May 28, 2015. Time: 11:00 a.m. to 1:00 p.m. U.S. Customs and Border Protection,
Time: 11:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant Regulations and Rulings, Office of
Rmajette on DSK2VPTVN1PROD with NOTICES

Agenda: To review and evaluate grant applications. International Trade, 90 K Street NE.,
applications. Place: National Institutes of Health, One 10th Floor, Washington, DC 20229–
Place: Sheraton Delfina Santa Monica Democracy Plaza, 6701 Democracy 1177, at 202–325–0265.
Hotel, 530 West Pico Boulevard, Santa Boulevard, Suite 703, Bethesda, MD 20892
Monica, CA 90405. (Telephone Conference Call). SUPPLEMENTARY INFORMATION: CBP
Contact Person: Melinda Jenkins, Ph.D., Contact Person: Tamizchelvi Thyagarajan, invites the general public and other
Scientific Review Officer, Center for Ph.D., Scientific Review Officer, National Federal agencies to comment on
Scientific Review, National Institutes of Institute of Nursing Research, National proposed and/or continuing information

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Document Created: 2015-12-16 08:29:48
Document Modified: 2015-12-16 08:29:48

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		May 28-29, 2015.
FR Citation		80 FR 23280

80 FR 23280 - Center For Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 80 (April 27, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health