81_FR_1641 81 FR 1633 - Proposed Collection; 60-Day Comment Request; Cancer Genomics Cloud Pilots Survey (NCI)

81 FR 1633 - Proposed Collection; 60-Day Comment Request; Cancer Genomics Cloud Pilots Survey (NCI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 8 (January 13, 2016)

Page Range1633-1634
FR Document2016-00458

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.

Federal Register, Volume 81 Issue 8 (Wednesday, January 13, 2016) 
[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)]
[Notices]
[Pages 1633-1634]
From the Federal Register Online  [www.thefederalregister.org]
[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: 
[email protected]. 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

Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Notices 1633 electronic and written/paper comments www.fda.gov/COACompendium. of having their full effect if received received, go to http:// Specifically, FDA welcomes your within 60 days of the date of this www.regulations.gov and insert the comments concerning: (1) The utility of publication. docket number, found in brackets in the the COA Compendium; (2) the best heading of this document, into the approach for developing future FOR FURTHER INFORMATION CONTACT: To ‘‘Search’’ box and follow the prompts iterations of it, including any suggested obtain a copy of the data collection and/or go to the Division of Dockets expansions of its scope; and (3) COA plans and instruments, submit Management, 5630 Fishers Lane, Rm. Compendium-related questions you comments in writing, or request more 1061, Rockville, MD 20852. would like FDA to address in its future information on the proposed project, communications. FDA will consider all contact: Anthony Kerlavage, NCI CBIIT, FOR FURTHER INFORMATION CONTACT: comments submitted but will generally Program Manager, 9609 Medical Center Nikunj B. Patel, Clinical Outcome Drive, Room 1W–436, Rockville, MD Assessments Staff (formerly Study not respond directly to the person or organization submitting the comment. 20850 or call non-toll-free number 240– Endpoints and Labeling Development 276–5190 or email your request, (SEALD)), Office of New Drugs, Center Dated: January 7, 2016. including your address to: for Drug Evaluation and Research, Food Leslie Kux, anthony.kerlavage@nih.gov. Formal and Drug Administration, 10903 New Associate Commissioner for Policy. requests for additional plans and Hampshire Ave., Bldg. 22, Rm. 6369, [FR Doc. 2016–00529 Filed 1–12–16; 8:45 am] instruments must be requested in Silver Spring, MD 20993–0002, 240– BILLING CODE 4164–01–P writing. 402–6502, email: COACompendium@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND Proposed Collection: Cancer HUMAN SERVICES Genomics Cloud Pilots Survey, 0925– I. Background NEW, National Cancer Institute (NCI), Capturing outcomes that are National Institutes of Health National Institutes of Health (NIH). important to patients in clinical trials is Proposed Collection; 60-Day Comment Need and Use of Information a high priority for FDA. The pilot COA Request; Cancer Genomics Cloud Collection: The Center for Biomedical Compendium is part of FDA’s efforts to Pilots Survey (NCI) Informatics and Information Technology foster patient-focused drug (CBIIT), in collaboration with the Center development.1 The COA Compendium SUMMARY: In compliance with the for Cancer Genomics at the National is intended to facilitate communication requirement of Section 3506(c)(2)(A) of Cancer Instititues (NCI) in the National and to provide clarity and transparency the Paperwork Reduction Act of 1995, Institutes of Health (NIH), is to drug developers and the research for opportunity for public comment on coordinating a program to develop three community by collating and proposed data collection projects, the Cancer Genomics Cloud Pilots to help summarizing clinical outcome National Cancer Institute, the National meet the research community’s needs to assessment information for many Institutes of Health (NIH) will publish access and analyze high quality, large- different diseases and conditions into a periodic summaries of proposed scale cancer genomic data and single resource. It can be used as a projects to be submitted to the Office of associated clinical information. The goal starting point when considering how Management and Budget (OMB) for of this effort is to develop an innovative, certain clinical outcome assessments review and approval. cost-effective model for computational might be utilized in clinical trials and Written comments and/or suggestions analysis of biological data and provide will likely be most informative in early from the public and affected agencies are invited to address one or more of the broader yet secure access to genomic drug development. The public is data that NCI generates. Cloud referred to the following FDA Web site following points: Whether the proposed collection of information is necessary computing will be a valuable tool to for additional background information, support studies related to the along with the pilot COA Compendium: for the proper performance of the function of the agency, including mechanisms of cancer. This capability http://www.fda.gov/COACompendium. will be equally valuable to other NCI whether the information will have II. Establishment of a Docket and practical utility; The accuracy of the scientific areas, including clinical trials Request for Comments agency’s estimate of the burden of the and other types of patient-focused proposed collection of information, research. In order to understand the To help FDA determine the utility of utility and value of the tools being the COA Compendium, develop future including the validity of the methodology and assumptions used; developed, the NCI has developed a iterations of the COA Compendium, and survey instrument to capture feedback identify best methods for conveying The quality, utility, and clarity of the information to be collected; and from the cancer research community. COA Compendium information on The information collected as part of this FDA’s Web site, FDA is launching the Minimize the burden of the collection of information on those who are to survey process will be used exclusively pilot COA Compendium and soliciting by the NCI to determine future funding public suggestions, recommendations, respond, including the use of appropriate automated, electronic, of cloud technology projects. and comments for each aspect of the mechanical, or other technological OMB approval is requested for 3 COA Compendium mentioned on the collection techniques or other forms of years. There are no costs to respondents asabaliauskas on DSK5VPTVN1PROD with NOTICES following FDA Web site: http:// information technology. other than their time. The total 1 The term drug, as used in this notice, refers to DATES: Comments regarding this estimated annualized burden hours are human drugs including biological products. information collection are best assured 375. VerDate Sep<11>2014 16:59 Jan 12, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\13JAN1.SGM 13JAN1

1634 Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Type of Number of burden per Total annual Form name responses per respondent respondents response burden hour respondent (in hours) Cloud Pilot Survey ............................ Principal Investigator ........................ 1500 1 15/60 375 Dated: January 6, 2016. Place: National Cancer Institute Shady DEPARTMENT OF HEALTH AND Karla Bailey, Grove, 9609 Medical Center Drive, Rockville, HUMAN SERVICES Project Clearance Liaison, National Cancer MD 20850 (Telephone Conference Call). Institute, NIH. Contact Person: Nadeem Khan, Ph.D., National Institutes of Health [FR Doc. 2016–00458 Filed 1–12–16; 8:45 am] Scientific Review Officer, Research Technology and Contract Review Branch, National Institute on Deafness and BILLING CODE 4140–01–P Division of Extramural Activities, National Other Communication Disorders; Cancer Institute, NIH, 9609 Medical Center Notice of Closed Meetings Drive, Room 7W260, Bethesda, MD 20892– DEPARTMENT OF HEALTH AND Pursuant to section 10(d) of the 9750, 240–276–5856, nkhann3@nih.gov. HUMAN SERVICES Federal Advisory Committee Act, as Name of Committee: National Cancer amended (5 U.S.C. App.), notice is National Institutes of Health Institute Special Emphasis Panel; Biomarker hereby given of the following meetings. Immunoassay Signal Amplification. The meetings will be closed to the National Cancer Institute: Notice of Date: February 16–17, 2016. public in accordance with the Closed Meetings Time: 11:00 a.m. to 4:00 p.m. Agenda: To review and evaluate contract provisions set forth in sections proposals. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Pursuant to section 10(d) of the as amended. The grant applications and Federal Advisory Committee Act, as Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Rockville, the discussions could disclose amended (5 U.S.C. App.), notice is confidential trade secrets or commercial hereby given of the following meetings. MD 20850 (Telephone Conference Call). Contact Person: Jeffrey E. DeClue, Ph.D., property such as patentable material, The meetings will be closed to the Scientific Review Officer, Research and personal information concerning public in accordance with the Technology and Contract Review Branch, individuals associated with the grant provisions set forth in sections Division of Extramural Activities, National applications, the disclosure of which 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Cancer Institute, NIH, 9609 Medical Center would constitute a clearly unwarranted as amended. The grant applications/ Drive, Room 7W238, Bethesda, MD 20892– invasion of personal privacy. contract proposals and the discussions 9750, 240–276–6371, decluej@mail.nih.gov. Name of Committee: National Institute on could disclose confidential trade secrets Name of Committee: National Cancer Deafness and Other Communication or commercial property such as Institute Initial Review Group; Subcommittee Disorders Special Emphasis Panel; P50 patentable material, and personal F—Institutional Training and Education. Clinical Research Center Vocal Disorders information concerning individuals Date: February 22–23, 2016. Review Meeting. associated with the grant applications/ Time: 7:30 p.m. to 5:00 p.m. Date: January 28, 2016. contract proposals, the disclosure of Agenda: To review and evaluate grant Time: 11:30 a.m. to 2:30 p.m. applications. Agenda: To review and evaluate grant which would constitute a clearly applications. unwarranted invasion of personal Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road Place: National Institutes of Health, privacy. Neuroscience Center, 6001 Executive Bethesda, MD 20852. Name of Committee: National Cancer Boulevard, Rockville, MD 20852 (Telephone Contact Person: Timothy C. Meeker, MD, Conference Call). Institute Special Emphasis Panel; Scientific Review Officer, Resources and Purification of Cancer Cell Extracellular Contact Person: Kausik Ray, Ph.D., Training Review Branch, Division of Scientific Review Officer, National Institute Vesicles. Extramural Activities, National Cancer on Deafness and Other Communication Date: February 10, 2016. Institute, NIH, 9609 Medical Center Drive, Disorders, National Institutes of Health, Time: 11:00 a.m. to 4:00 p.m. 7W624, Bethesda, MD 20892–9750, 240–276– Rockville, MD 20850, 301–402–3587, rayk@ Agenda: To review and evaluate contract 6464, meekert@mail.nih.gov. nidcd.nih.gov. proposals. Place: National Cancer Institute Shady (Catalogue of Federal Domestic Assistance This notice is being published less than 15 Program Nos. 93.392, Cancer Construction; days prior to the meeting due to the timing Grove, 9609 Medical Center Drive, Rockville, 93.393, Cancer Cause and Prevention limitations imposed by the review and MD 20850 (Telephone Conference Call). Research; 93.394, Cancer Detection and funding cycle. Contact Person: Jeffrey E. DeClue, Ph.D., Scientific Review Officer, Research Diagnosis Research; 93.395, Cancer Name of Committee: National Institute on Technology and Contract Review Branch, Treatment Research; 93.396, Cancer Biology Deafness and Other Communication Research; 93.397, Cancer Centers Support; Disorders Special Emphasis Panel; Clinical Division of Extramural Activities, National 93.398, Cancer Research Manpower; 93.399, Trial Review. Cancer Institute, NIH, 9609 Medical Center Date: February 2, 2016. asabaliauskas on DSK5VPTVN1PROD with NOTICES Drive, Room 7W238, Bethesda, MD 20892– Cancer Control, National Institutes of Health, HHS) Time: 2:45 p.m. to 4:45 p.m. 9750, 240–276–6371, decluej@mail.nih.gov. Agenda: To review and evaluate grant Name of Committee: National Cancer Dated: January 7, 2016. applications. Institute Special Emphasis Panel; Melanie J. Gray, Place: National Institutes of Health, Quantification of Redox. Neuroscience Center, 6001 Executive Program Analyst, Office of Federal Advisory Date: February 11, 2016. Boulevard, Rockville, MD 20852 (Telephone Committee Policy. Time: 1:00 p.m. to 4:00 p.m. Conference Call). Agenda: To review and evaluate contract [FR Doc. 2016–00459 Filed 1–12–16; 8:45 am] Contact Person: Kausik Ray, Ph.D., proposals. BILLING CODE 4140–01–P Scientific Review Officer, National Institute VerDate Sep<11>2014 16:59 Jan 12, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\13JAN1.SGM 13JAN1


Document Created: 2016-01-13 01:00:43
Document Modified: 2016-01-13 01:00:43
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
DatesComments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
ContactTo 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
FR Citation81 FR 1633 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR