Proposed Collection; 60-Day Comment Request; Cancer Genomics Cloud Pilots Survey (NCI), 1633-1634 [2016-00458]

Download as PDF Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Notices electronic and written/paper comments received, go to http:// 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: http://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: http:// 1 The term drug, as used in this notice, refers to human drugs including biological products. 16:59 Jan 12, 2016 Jkt 238001 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: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 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] BILLING CODE 4140–01–P PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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