Proposed Collection; 60-Day Comment Request; Cancer Genomics Cloud Pilots Survey (NCI), 1633-1634 [2016-00458]
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Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Notices
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Nikunj B. Patel, Clinical Outcome
Assessments Staff (formerly Study
Endpoints and Labeling Development
(SEALD)), Office of New Drugs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6369,
Silver Spring, MD 20993–0002, 240–
402–6502, email: COACompendium@
fda.hhs.gov.
I. Background
Capturing outcomes that are
important to patients in clinical trials is
a high priority for FDA. The pilot COA
Compendium is part of FDA’s efforts to
foster patient-focused drug
development.1 The COA Compendium
is intended to facilitate communication
and to provide clarity and transparency
to drug developers and the research
community by collating and
summarizing clinical outcome
assessment information for many
different diseases and conditions into a
single resource. It can be used as a
starting point when considering how
certain clinical outcome assessments
might be utilized in clinical trials and
will likely be most informative in early
drug development. The public is
referred to the following FDA Web site
for additional background information,
along with the pilot COA Compendium:
https://www.fda.gov/COACompendium.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
II. Establishment of a Docket and
Request for Comments
To help FDA determine the utility of
the COA Compendium, develop future
iterations of the COA Compendium, and
identify best methods for conveying
COA Compendium information on
FDA’s Web site, FDA is launching the
pilot COA Compendium and soliciting
public suggestions, recommendations,
and comments for each aspect of the
COA Compendium mentioned on the
following FDA Web site: https://
1 The term drug, as used in this notice, refers to
human drugs including biological products.
16:59 Jan 12, 2016
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Dated: January 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–00529 Filed 1–12–16; 8:45 am]
BILLING CODE 4164–01–P
of having their full effect if received
within 60 days of the date of this
publication.
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Anthony Kerlavage, NCI CBIIT,
Program Manager, 9609 Medical Center
Drive, Room 1W–436, Rockville, MD
20850 or call non-toll-free number 240–
276–5190 or email your request,
including your address to:
anthony.kerlavage@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
www.fda.gov/COACompendium.
Specifically, FDA welcomes your
comments concerning: (1) The utility of
the COA Compendium; (2) the best
approach for developing future
iterations of it, including any suggested
expansions of its scope; and (3) COA
Compendium-related questions you
would like FDA to address in its future
communications. FDA will consider all
comments submitted but will generally
not respond directly to the person or
organization submitting the comment.
1633
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Cancer Genomics Cloud
Pilots Survey (NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute, the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
following points: Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
The quality, utility, and clarity of the
information to be collected; and
Minimize the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
DATES: Comments regarding this
information collection are best assured
SUMMARY:
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Proposed Collection: Cancer
Genomics Cloud Pilots Survey, 0925–
NEW, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The Center for Biomedical
Informatics and Information Technology
(CBIIT), in collaboration with the Center
for Cancer Genomics at the National
Cancer Instititues (NCI) in the National
Institutes of Health (NIH), is
coordinating a program to develop three
Cancer Genomics Cloud Pilots to help
meet the research community’s needs to
access and analyze high quality, largescale cancer genomic data and
associated clinical information. The goal
of this effort is to develop an innovative,
cost-effective model for computational
analysis of biological data and provide
broader yet secure access to genomic
data that NCI generates. Cloud
computing will be a valuable tool to
support studies related to the
mechanisms of cancer. This capability
will be equally valuable to other NCI
scientific areas, including clinical trials
and other types of patient-focused
research. In order to understand the
utility and value of the tools being
developed, the NCI has developed a
survey instrument to capture feedback
from the cancer research community.
The information collected as part of this
survey process will be used exclusively
by the NCI to determine future funding
of cloud technology projects.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
375.
E:\FR\FM\13JAN1.SGM
13JAN1
1634
Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Type of
respondent
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hour
Cloud Pilot Survey ............................
Principal Investigator ........................
1500
1
15/60
375
Dated: January 6, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer
Institute, NIH.
[FR Doc. 2016–00458 Filed 1–12–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute: Notice of
Closed Meetings
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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/
contract proposals 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/
contract proposals, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Purification of Cancer Cell Extracellular
Vesicles.
Date: February 10, 2016.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Rockville,
MD 20850 (Telephone Conference Call).
Contact Person: Jeffrey E. DeClue, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W238, Bethesda, MD 20892–
9750, 240–276–6371, decluej@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Quantification of Redox.
Date: February 11, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
VerDate Sep<11>2014
16:59 Jan 12, 2016
Jkt 238001
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Rockville,
MD 20850 (Telephone Conference Call).
Contact Person: Nadeem Khan, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W260, Bethesda, MD 20892–
9750, 240–276–5856, nkhann3@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Biomarker
Immunoassay Signal Amplification.
Date: February 16–17, 2016.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Rockville,
MD 20850 (Telephone Conference Call).
Contact Person: Jeffrey E. DeClue, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W238, Bethesda, MD 20892–
9750, 240–276–6371, decluej@mail.nih.gov.
Name of Committee: National Cancer
Institute Initial Review Group; Subcommittee
F—Institutional Training and Education.
Date: February 22–23, 2016.
Time: 7:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road
Bethesda, MD 20852.
Contact Person: Timothy C. Meeker, MD,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
7W624, Bethesda, MD 20892–9750, 240–276–
6464, meekert@mail.nih.gov.
(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: January 7, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–00459 Filed 1–12–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
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: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel; P50
Clinical Research Center Vocal Disorders
Review Meeting.
Date: January 28, 2016.
Time: 11:30 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Kausik Ray, Ph.D.,
Scientific Review Officer, National Institute
on Deafness and Other Communication
Disorders, National Institutes of Health,
Rockville, MD 20850, 301–402–3587, rayk@
nidcd.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel; Clinical
Trial Review.
Date: February 2, 2016.
Time: 2:45 p.m. to 4:45 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Kausik Ray, Ph.D.,
Scientific Review Officer, National Institute
E:\FR\FM\13JAN1.SGM
13JAN1
Agencies
[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)]
[Notices]
[Pages 1633-1634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00458]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Cancer Genomics
Cloud Pilots Survey (NCI)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute,
the National Institutes of Health (NIH) will publish periodic summaries
of proposed projects to be submitted to the Office of Management and
Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited to address one or more of the following points:
Whether the proposed collection of information is necessary for the
proper performance of the function of the agency, including whether the
information will have practical utility; The accuracy of the agency's
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; The
quality, utility, and clarity of the information to be collected; and
Minimize the burden of the collection of information on those who are
to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Anthony
Kerlavage, NCI CBIIT, Program Manager, 9609 Medical Center Drive, Room
1W-436, Rockville, MD 20850 or call non-toll-free number 240-276-5190
or email your request, including your address to:
anthony.kerlavage@nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
SUPPLEMENTARY INFORMATION:
Proposed Collection: Cancer Genomics Cloud Pilots Survey, 0925-NEW,
National Cancer Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Center for Biomedical
Informatics and Information Technology (CBIIT), in collaboration with
the Center for Cancer Genomics at the National Cancer Instititues (NCI)
in the National Institutes of Health (NIH), is coordinating a program
to develop three Cancer Genomics Cloud Pilots to help meet the research
community's needs to access and analyze high quality, large-scale
cancer genomic data and associated clinical information. The goal of
this effort is to develop an innovative, cost-effective model for
computational analysis of biological data and provide broader yet
secure access to genomic data that NCI generates. Cloud computing will
be a valuable tool to support studies related to the mechanisms of
cancer. This capability will be equally valuable to other NCI
scientific areas, including clinical trials and other types of patient-
focused research. In order to understand the utility and value of the
tools being developed, the NCI has developed a survey instrument to
capture feedback from the cancer research community. The information
collected as part of this survey process will be used exclusively by
the NCI to determine future funding of cloud technology projects.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 375.
[[Page 1634]]
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cloud Pilot Survey.............................. Principal Investigator............ 1500 1 15/60 375
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: January 6, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-00458 Filed 1-12-16; 8:45 am]
BILLING CODE 4140-01-P