Center For Scientific Review; Notice of Closed Meetings, 23280-23281 [2015-09622]
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Federal Register / Vol. 80, No. 80 / Monday, April 27, 2015 / Notices
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The eight ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; the
Pharmaceutical Research and
Manufacturers of America; Health
Canada; and Swissmedic. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization and the European Free
Trade Area.
The eCTD is an ICH standard based
on specifications developed by ICH and
its member parties. The ICH M2 Expert
Working Group has previously
developed a list of requirements for
input in the eCTD RPS Project. The list
of requirements was last updated on
November 11, 2010, and is available at
https://estri.ich.org/ICH_eCTD_NMV_
Requirements-V4-0.pdf (FDA has
verified the Web site address, but FDA
is not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register).
The ICH M8 Expert Working Group
was formed in November 2010 to
assume responsibility for the continued
development of the next major version
of the eCTD.
In February 2015, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘M8 eCTD v4.0 Draft
Implementation Guide v2.0’’ and the
related document entitled ‘‘eCTD v4.0
Implementation Package Draft
Specification for Submission Formats
v2.0’’ should be made available for
public comment. These documents are
the product of the M8 Expert Working
Group. Comments about these draft
documents will be considered by FDA
and the M8 Expert Working Group.
Since adoption of the eCTD standard,
the ICH Steering Committee has
endorsed using the RPS Release 2
standard. A core feature of the RPS
standard is the flexibility the message
provides to enable future eCTD
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enhancements. The M8 eCTD draft
implementation guidance provides
instructions for creating the eCTD v4.0
RPS message for the ICH Modules 2
through 5 of the eCTD. The draft
specifications document provides
specifications for creating files for
inclusion in the eCTD. These draft
documents facilitate implementation of
the eCTD v4.0 standard. The draft
documents are being issued as a package
that includes the draft ICH code list and
the M8 schema files. In addition, the
FDA regional/module 1 documents have
been developed and are available at
https://www.fda.gov/Drugs/
DevelopmentApprovalProcess/
FormsSubmissionRequirements/
ElectronicSubmissions/ucm309911.htm.
The M8 eCTD draft implementation
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 on this
topic. 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.
II. Comments
Interested persons may submit either
electronic comments regarding these
documents to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (see ADDRESSES). It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: April 21, 2015.
Peter Lurie,
Associate Commissioner for Public Health
Strategy and Analysis.
[FR Doc. 2015–09646 Filed 4–24–15; 8:45 am]
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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: 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, balasundaramd@csr.nih.gov.
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, fungai.chanetsa@nih.hhs.gov.
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, templetonns@mail.nih.gov.
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Rmajette on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 80 / Monday, April 27, 2015 / Notices
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, smirnove@csr.nih.gov.
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, haydenb@csr.nih.gov.
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, wrightds@csr.nih.gov.
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, mujurup@mail.nih.gov.
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
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Health, 6701 Rockledge Drive, Room 3156,
MSC 7770, Bethesda, MD 20892, 301–437–
7872, jenkinsml2@mail.nih.gov.
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, kozelp@
mail.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: April 21, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–09622 Filed 4–24–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
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
Nursing Research Special Emphasis Panel;
Fellowship and Career Development.
Date: June 4, 2015.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Suite 703, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Tamizchelvi Thyagarajan,
Ph.D., Scientific Review Officer, National
Institute of Nursing Research, National
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Institutes of Health, 6701 Democracy
Boulevard, Suite 703, Bethesda, MD 20892,
(301) 594–0343, tamizchelvi.thyagarajan@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
Dated: April 21, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–09621 Filed 4–24–15; 8:45 am]
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SECURITY
U.S. Customs and Border Protection
[1651–0032]
Agency Information Collection
Activities: Importers of Merchandise
Subject to Actual Use Provisions
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 60-Day notice and request for
comments; extension of an existing
collection of information.
AGENCY:
U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security will be submitting
the following information collection
request to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act: Importers of
Merchandise Subject to Actual Use
Provisions. CBP is proposing that this
information collection be extended with
no change to the burden hours. This
document is published to obtain
comments from the public and affected
agencies.
DATES: Written comments should be
received on or before June 26, 2015 to
be assured of consideration.
ADDRESSES: Direct all written comments
to U.S. Customs and Border Protection,
Attn: Tracey Denning, Regulations and
Rulings, Office of International Trade,
90 K Street NE., 10th Floor, Washington,
DC 20229–1177.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of
International Trade, 90 K Street NE.,
10th Floor, Washington, DC 20229–
1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
SUMMARY:
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[Federal Register Volume 80, Number 80 (Monday, April 27, 2015)]
[Notices]
[Pages 23280-23281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09622]
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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: 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, balasundaramd@csr.nih.gov.
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, fungai.chanetsa@nih.hhs.gov.
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, templetonns@mail.nih.gov.
[[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, smirnove@csr.nih.gov.
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, haydenb@csr.nih.gov.
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, wrightds@csr.nih.gov.
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, mujurup@mail.nih.gov.
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, jenkinsml2@mail.nih.gov.
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,
kozelp@mail.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: 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
