Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Research Domain Criteria (RDoC) Initiative (National Institute of Mental Health), 16378-16379 [2018-07859]

Download as PDF srobinson on DSK3G9T082PROD with NOTICES 16378 Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices assemble into nanoparticles with influenza antigenic proteins displayed on the nanoparticle surface (Nature 499, 102–106 (2013)). Further engineering these recombinant fusion proteins, the scientists have developed nanoparticles that simultaneously display multiple strains of influenza viral protein antigens (the receptor-binding domain of hemagglutinin) on their surface. Due to the heterogeneity of the antigenic protein derived from multiple strains, these nanoparticles are referred to as mosaic nanoparticles. Upon immunization of mice with mosaic nanoparticles displaying antigens from eight different H1N1 strains, the elicited antibodies neutralized a panel of H1N1 strains from 1918 through 2009 including the strains that had not been displayed on the mosaic nanoparticle. However, mice immunized with a mixture of the eight types of nanoparticles, each displaying a single antigenic protein, did not elicit a similar breadth of neutralizing antibody response. NIAID is continuing development of these vaccine candidates through animal studies and moving toward clinical evaluation. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration. Potential Commercial Applications: • Vaccine platform for seasonal influenza with broader protection coverage Competitive Advantages: • Nucleic acid or recombinant protein-based vaccine • Increased ease of production compared to current seasonal influenza vaccines Development Stage: • In vivo (animal studies) Inventors: Barney S. Graham, Hadi Yassine, Masaru Kanekiyo (all from NIAID). Publications: Kanekiyo, M, et al. Manuscript under revision. Intellectual Property: HHS Reference Number E–060–2015 includes U.S. Patent Application No. 15/540,898 filed June 29, 2017 (Pending); Canada Patent Application No. 2,974,346 filed December 31, 2015 (Pending); China Patent Application No. 201580076324.6 filed December 31, 2015 (Pending); Europe Patent Application No. 15825772.5 filed July 7, 2017 (Pending); India Patent Application No 201717026077 filed July 21, 2017 (Pending); Australia Patent Application No. 2015373928 filed July 21, 2017; Brazil Patent Application No. VerDate Sep<11>2014 19:42 Apr 13, 2018 Jkt 244001 BR112017014219–8 filed June 29, 2017; Israel Patent Application No. 253187 filed December 31, 2015; Japan Patent Application No. 2017–534796 filed June 28, 2017; South Korean Patent Application No. 10–2017–7021112 filed July 27, 2017; Singapore Patent Application No. 11201705264W filed June 23, 2017. Related Intellectual Property: HHS Reference Number E–293–2011 Licensing Contact: Dr. Amy Petrik, 240–627–3721; amy.petrik@nih.gov. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize influenza monoclonal antibody technologies. For collaboration opportunities, please contact Dr. Amy Petrik, 240–627–3721; amy.petrik@ nih.gov. Dated: April 5, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2018–07821 Filed 4–13–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Research Domain Criteria (RDoC) Initiative (National Institute of Mental Health) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. SUMMARY: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by ADDRESSES: PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 fax to 202–395–6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Melba Rojas, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, Office of Science Policy, Planning and Communications, NIMH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Bethesda, Maryland 20892, call 301–443–4335, or email your request, including your mailing address, to nimhprapubliccomments@mail.nih.gov. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on January 29, 2018, pages 4062–4063 (83 FR 4062) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: Generic Clearance for the Research Domain Criteria (RDoC) Initiative, 0925–NEW, National Institute of Mental Health (NIMH), National Institutes of Health (NIH). Need and Use of Information Collection: This request serves as notice that the National Institute of Mental Health (NIMH) is seeking OMB approval of a generic plan to conduct information collections to interface with the scientific community and promote the RDoC Initiative. As the lead Federal agency for research on mental illnesses, NIMH’s mission is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. To this end, NIMH launched the RDoC Initiative in 2009 to implement Strategy 1.4 of the 2008 NIMH Strategic Plan: ‘‘Develop new ways of classifying disorders based on dimensions of observable behaviors and brain functions.’’ The aim of RDoC is to E:\FR\FM\16APN1.SGM 16APN1 16379 Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices guide research that begins with disruptions in neurobiological and behavioral mechanisms, and then works across systems to clarify connections among such disruptions and clinical symptoms. The information collected as OMB approval is requested for 3 years. There are no costs to respondents’ other than their time. The total estimated annualized burden hours are 490. part of this generic clearance will allow NIMH to determine success of the RDoC Initiative, develop future directions and endeavors, and to help guide programmatic priorities for RDoC and the agency. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Instrument type Number of responses per respondent Average burden per response (in hours) Total annual burden hours Workshops ....................................................................................................... Interviews ......................................................................................................... Surveys ............................................................................................................ Focus Groups .................................................................................................. Evaluation Forms ............................................................................................. 50 10 100 10 100 1 1 1 1 1 8 30/60 30/60 1 15/60 400 5 50 10 25 Total .......................................................................................................... 270 270 ........................ 490 Dated: April 4, 2018. Melba O. Rojas, Project Clearance Liaison, NIMH, NIH. [FR Doc. 2018–07859 Filed 4–13–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF THE INTERIOR U.S. Geological Survey [GX18DJ00COM0050] Federal Interagency Collaborative on Environmental Modeling and Monitoring U.S. Geological Survey (USGS), Interior. ACTION: Notice of public meeting. AGENCY: The annual public meeting of the Federal Interagency Collaborative for Environmental Modeling and Monitoring (ICEMM) will convene to discuss developments in environmental modeling applications, tools and frameworks, as well as new operational initiatives among the participating agencies. The meeting this year will focus on the theme of ‘‘Monitoring and Model Data Fusion.’’ DATES: The meeting will be held on April 24–25, 2018, from 9:00 a.m. to 5:00 p.m. ADDRESSES: The meeting will be held at U.S. Nuclear Regulatory Commission, Office of Nuclear Regulatory Research, 11555 Rockville Pike, Rockville, MD 20852. srobinson on DSK3G9T082PROD with NOTICES SUMMARY: FOR FURTHER INFORMATION CONTACT: Brenda Rashleigh, Assistant Laboratory Director for Water, U.S. Environmental VerDate Sep<11>2014 19:42 Apr 13, 2018 Jkt 244001 Protection Agency by email at Rashleigh.Brenda@epa.gov, or by telephone at (401) 782–3014; or Pierre Glynn, Chief, Water Cycle Branch, U.S. Geological Survey, by email at pglynn@ usgs.gov, or by telephone at (703) 648– 5823. SUPPLEMENTARY INFORMATION: Background: Federal agencies have been cooperating since 2001 under a Memorandum of Understanding (MOU) on the research and development of multimedia environmental models. (please see: https://my.usgs.gov/ confluence/display/cdi/Interagency+ Collaborative+for+Environmental+ Modeling+and+Monitoring). The MOU, revised and reaffirmed in 2016, establishes a framework for facilitating cooperation and coordination among six agencies (the specific research organization within the agency is in parentheses): • National Science Foundation; • U.S. Army Corps of Engineers (Engineer Research and Development Center); • U.S. Department of Energy (Office of Biological and Environmental Research); • U.S. Environmental Protection Agency (Office of Research and Development); • U.S. Geological Survey; and • U.S. Nuclear Regulatory Commission (Office of Nuclear Regulatory Research). These agencies are cooperating and coordinating in the research and development of multimedia environmental models, software, and related databases. Model development and simulation supports interagency PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 interests in human and environmental health risk assessment, uncertainty analyses, water supply issues, and contaminant transport. Purpose of the Public Meeting: The MOU calls for an annual public meeting to provide an opportunity for other Federal and State agencies, the scientific community, and the public to be briefed on ICEMM activities and initiatives and to discuss technological advancements in multimedia environmental modeling. Proposed Agenda: This year’s ICEMM public meeting will be a workshop focusing on modeling and monitoring data fusion. The ICEMM Chair will open the meeting with an overview of the goals of the MOU and current activities of ICEMM, followed by a series of presentations on collaborative modeling and monitoring efforts by ICEMM and invited speakers. During the morning of the second day, the ICEMM agencies will discuss their programs addressing modeling and monitoring data fusion. During the afternoon of the second day, the chairs of the ICEMM Workgroups will discuss their activities and plans for fiscal years 2018 and 2019. Meeting Access: The meeting will be available for onsite attendance or remotely through Web Meeting Services. To obtain onsite or web access, all interested attendees must pre-register by providing their full contact information and affiliation. (See FOR FURTHER INFORMATION CONTACT). Pierre Glynn, U.S. Geological Survey. [FR Doc. 2018–07764 Filed 4–13–18; 8:45 am] BILLING CODE 4338–11–P E:\FR\FM\16APN1.SGM 16APN1

Agencies

[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16378-16379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07859]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Generic 
Clearance for the Research Domain Criteria (RDoC) Initiative (National 
Institute of Mental Health)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30 days of the date of 
this publication.

ADDRESSES: Written comments and/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden and associated response time, should be directed to the: Office 
of Management and Budget, Office of Regulatory Affairs, 
[email protected] or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Melba Rojas, NIMH Project Clearance Liaison, 
Science Policy and Evaluation Branch, Office of Science Policy, 
Planning and Communications, NIMH, Neuroscience Center, 6001 Executive 
Boulevard, MSC 9667, Bethesda, Maryland 20892, call 301-443-4335, or 
email your request, including your mailing address, to 
[email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on January 29, 2018, pages 
4062-4063 (83 FR 4062) and allowed 60 days for public comment. No 
public comments were received. The purpose of this notice is to allow 
an additional 30 days for public comment. The National Institute of 
Mental Health (NIMH), National Institutes of Health, may not conduct or 
sponsor, and the respondent is not required to respond to, an 
information collection that has been extended, revised, or implemented 
on or after October 1, 1995, unless it displays a currently valid OMB 
control number.
    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, the National Institutes of Health (NIH) has submitted to 
the Office of Management and Budget (OMB) a request for review and 
approval of the information collection listed below.
    Proposed Collection: Generic Clearance for the Research Domain 
Criteria (RDoC) Initiative, 0925-NEW, National Institute of Mental 
Health (NIMH), National Institutes of Health (NIH).
    Need and Use of Information Collection: This request serves as 
notice that the National Institute of Mental Health (NIMH) is seeking 
OMB approval of a generic plan to conduct information collections to 
interface with the scientific community and promote the RDoC 
Initiative. As the lead Federal agency for research on mental 
illnesses, NIMH's mission is to transform the understanding and 
treatment of mental illnesses through basic and clinical research, 
paving the way for prevention, recovery, and cure. To this end, NIMH 
launched the RDoC Initiative in 2009 to implement Strategy 1.4 of the 
2008 NIMH Strategic Plan: ``Develop new ways of classifying disorders 
based on dimensions of observable behaviors and brain functions.'' The 
aim of RDoC is to

[[Page 16379]]

guide research that begins with disruptions in neurobiological and 
behavioral mechanisms, and then works across systems to clarify 
connections among such disruptions and clinical symptoms. The 
information collected as part of this generic clearance will allow NIMH 
to determine success of the RDoC Initiative, develop future directions 
and endeavors, and to help guide programmatic priorities for RDoC and 
the agency.
    OMB approval is requested for 3 years. There are no costs to 
respondents' other than their time. The total estimated annualized 
burden hours are 490.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                 Instrument type                     Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Workshops.......................................              50               1               8             400
Interviews......................................              10               1           30/60               5
Surveys.........................................             100               1           30/60              50
Focus Groups....................................              10               1               1              10
Evaluation Forms................................             100               1           15/60              25
                                                 ---------------------------------------------------------------
    Total.......................................             270             270  ..............             490
----------------------------------------------------------------------------------------------------------------


    Dated: April 4, 2018.
Melba O. Rojas,
Project Clearance Liaison, NIMH, NIH.
[FR Doc. 2018-07859 Filed 4-13-18; 8:45 am]
 BILLING CODE 4140-01-P