83 FR 16378 - Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Research Domain Criteria (RDoC) Initiative (National Institute of Mental Health)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 73 (April 16, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 73 (April 16, 2018)
| Page Range | 16378-16379 | |
| FR Document | 2018-07859 |
[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)] [Notices] [Pages 16378-16379] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07859] ----------------------------------------------------------------------- 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
![16378 Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
assemble into nanoparticles with BR112017014219–8 filed June 29, 2017; fax to 202–395–6974, Attention: Desk
influenza antigenic proteins displayed Israel Patent Application No. 253187 Officer for NIH.
on the nanoparticle surface (Nature 499, filed December 31, 2015; Japan Patent FOR FURTHER INFORMATION CONTACT: To
102–106 (2013)). Further engineering Application No. 2017–534796 filed June request more information on the
these recombinant fusion proteins, the 28, 2017; South Korean Patent proposed project or to obtain a copy of
scientists have developed nanoparticles Application No. 10–2017–7021112 filed the data collection plans and
that simultaneously display multiple July 27, 2017; Singapore Patent instruments, contact: Melba Rojas,
strains of influenza viral protein Application No. 11201705264W filed NIMH Project Clearance Liaison,
antigens (the receptor-binding domain June 23, 2017. Science Policy and Evaluation Branch,
of hemagglutinin) on their surface. Due Related Intellectual Property: HHS Office of Science Policy, Planning and
to the heterogeneity of the antigenic Reference Number E–293–2011 Communications, NIMH, Neuroscience
protein derived from multiple strains, Licensing Contact: Dr. Amy Petrik, Center, 6001 Executive Boulevard, MSC
these nanoparticles are referred to as 240–627–3721; amy.petrik@nih.gov. 9667, Bethesda, Maryland 20892, call
mosaic nanoparticles. Collaborative Research Opportunity: 301–443–4335, or email your request,
Upon immunization of mice with The National Institute of Allergy and including your mailing address, to
mosaic nanoparticles displaying Infectious Diseases is seeking statements nimhprapubliccomments@mail.nih.gov.
antigens from eight different H1N1 of capability or interest from parties SUPPLEMENTARY INFORMATION: This
strains, the elicited antibodies interested in collaborative research to proposed information collection was
neutralized a panel of H1N1 strains further develop, evaluate or previously published in the Federal
from 1918 through 2009 including the commercialize influenza monoclonal Register on January 29, 2018, pages
strains that had not been displayed on antibody technologies. For collaboration 4062–4063 (83 FR 4062) and allowed 60
the mosaic nanoparticle. However, mice opportunities, please contact Dr. Amy days for public comment. No public
immunized with a mixture of the eight Petrik, 240–627–3721; amy.petrik@ comments were received. The purpose
types of nanoparticles, each displaying nih.gov. of this notice is to allow an additional
a single antigenic protein, did not elicit Dated: April 5, 2018. 30 days for public comment. The
a similar breadth of neutralizing National Institute of Mental Health
Suzanne M. Frisbie,
antibody response. (NIMH), National Institutes of Health,
NIAID is continuing development of Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute may not conduct or sponsor, and the
these vaccine candidates through
of Allergy and Infectious Diseases. respondent is not required to respond
animal studies and moving toward
[FR Doc. 2018–07821 Filed 4–13–18; 8:45 am] to, an information collection that has
clinical evaluation.
BILLING CODE 4140–01–P been extended, revised, or implemented
This technology is available for
on or after October 1, 1995, unless it
licensing for commercial development
displays a currently valid OMB control
in accordance with 35 U.S.C. 209 and 37
DEPARTMENT OF HEALTH AND number.
CFR part 404, as well as for further
HUMAN SERVICES In compliance with Section
development and evaluation under a
3507(a)(1)(D) of the Paperwork
research collaboration. National Institutes of Health Reduction Act of 1995, the National
Potential Commercial Applications:
• Vaccine platform for seasonal Institutes of Health (NIH) has submitted
Submission for OMB Review; 30-Day to the Office of Management and Budget
influenza with broader protection Comment Request; Generic Clearance
coverage (OMB) a request for review and
for the Research Domain Criteria approval of the information collection
Competitive Advantages: (RDoC) Initiative (National Institute of
• Nucleic acid or recombinant listed below.
Mental Health) Proposed Collection: Generic
protein-based vaccine
• Increased ease of production AGENCY: National Institutes of Health, Clearance for the Research Domain
compared to current seasonal influenza HHS. Criteria (RDoC) Initiative, 0925–NEW,
vaccines National Institute of Mental Health
ACTION: Notice. (NIMH), National Institutes of Health
Development Stage:
• In vivo (animal studies) SUMMARY: In compliance with the (NIH).
Inventors: Barney S. Graham, Hadi Paperwork Reduction Act of 1995, the Need and Use of Information
Yassine, Masaru Kanekiyo (all from National Institutes of Health (NIH) has Collection: This request serves as notice
NIAID). submitted to the Office of Management that the National Institute of Mental
Publications: Kanekiyo, M, et al. and Budget (OMB) a request for review Health (NIMH) is seeking OMB approval
Manuscript under revision. and approval of the information of a generic plan to conduct information
Intellectual Property: HHS Reference collection listed below. collections to interface with the
Number E–060–2015 includes U.S. scientific community and promote the
DATES: Comments regarding this
Patent Application No. 15/540,898 filed RDoC Initiative. As the lead Federal
June 29, 2017 (Pending); Canada Patent information collection are best assured agency for research on mental illnesses,
Application No. 2,974,346 filed of having their full effect if received NIMH’s mission is to transform the
December 31, 2015 (Pending); China within 30 days of the date of this understanding and treatment of mental
Patent Application No. 201580076324.6 publication. illnesses through basic and clinical
filed December 31, 2015 (Pending); ADDRESSES: Written comments and/or research, paving the way for prevention,
srobinson on DSK3G9T082PROD with NOTICES
Europe Patent Application No. suggestions regarding the item(s) recovery, and cure. To this end, NIMH
15825772.5 filed July 7, 2017 (Pending); contained in this notice, especially launched the RDoC Initiative in 2009 to
India Patent Application No regarding the estimated public burden implement Strategy 1.4 of the 2008
201717026077 filed July 21, 2017 and associated response time, should be NIMH Strategic Plan: ‘‘Develop new
(Pending); Australia Patent Application directed to the: Office of Management ways of classifying disorders based on
No. 2015373928 filed July 21, 2017; and Budget, Office of Regulatory Affairs, dimensions of observable behaviors and
Brazil Patent Application No. OIRA_submission@omb.eop.gov or by brain functions.’’ The aim of RDoC is to
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![Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices 16379
guide research that begins with part of this generic clearance will allow OMB approval is requested for 3
disruptions in neurobiological and NIMH to determine success of the RDoC years. There are no costs to respondents’
behavioral mechanisms, and then works Initiative, develop future directions and other than their time. The total
across systems to clarify connections endeavors, and to help guide estimated annualized burden hours are
among such disruptions and clinical programmatic priorities for RDoC and 490.
symptoms. The information collected as the agency.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total annual
Instrument type responses per
respondents response burden hours
respondent (in 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. Protection Agency by email at interests in human and environmental
Melba O. Rojas, Rashleigh.Brenda@epa.gov, or by health risk assessment, uncertainty
Project Clearance Liaison, NIMH, NIH. telephone at (401) 782–3014; or Pierre analyses, water supply issues, and
[FR Doc. 2018–07859 Filed 4–13–18; 8:45 am] Glynn, Chief, Water Cycle Branch, U.S. contaminant transport.
BILLING CODE 4140–01–P
Geological Survey, by email at pglynn@ Purpose of the Public Meeting: The
usgs.gov, or by telephone at (703) 648– MOU calls for an annual public meeting
5823. to provide an opportunity for other
SUPPLEMENTARY INFORMATION: Federal and State agencies, the scientific
DEPARTMENT OF THE INTERIOR
Background: Federal agencies have community, and the public to be briefed
U.S. Geological Survey been cooperating since 2001 under a on ICEMM activities and initiatives and
Memorandum of Understanding (MOU) to discuss technological advancements
[GX18DJ00COM0050] on the research and development of in multimedia environmental modeling.
multimedia environmental models. Proposed Agenda: This year’s ICEMM
Federal Interagency Collaborative on (please see: https://my.usgs.gov/
Environmental Modeling and public meeting will be a workshop
confluence/display/cdi/Interagency+ focusing on modeling and monitoring
Monitoring Collaborative+for+Environmental+ data fusion. The ICEMM Chair will open
AGENCY: U.S. Geological Survey (USGS), Modeling+and+Monitoring). The MOU, the meeting with an overview of the
Interior. revised and reaffirmed in 2016, goals of the MOU and current activities
establishes a framework for facilitating of ICEMM, followed by a series of
ACTION: Notice of public meeting. cooperation and coordination among six presentations on collaborative modeling
agencies (the specific research and monitoring efforts by ICEMM and
SUMMARY: The annual public meeting of
organization within the agency is in invited speakers. During the morning of
the Federal Interagency Collaborative
parentheses): the second day, the ICEMM agencies
for Environmental Modeling and
Monitoring (ICEMM) will convene to • National Science Foundation; will discuss their programs addressing
discuss developments in environmental • U.S. Army Corps of Engineers modeling and monitoring data fusion.
modeling applications, tools and (Engineer Research and Development During the afternoon of the second day,
frameworks, as well as new operational Center); the chairs of the ICEMM Workgroups
initiatives among the participating • U.S. Department of Energy (Office will discuss their activities and plans
agencies. The meeting this year will of Biological and Environmental for fiscal years 2018 and 2019.
focus on the theme of ‘‘Monitoring and Research); Meeting Access: The meeting will be
Model Data Fusion.’’ • U.S. Environmental Protection available for onsite attendance or
Agency (Office of Research and remotely through Web Meeting Services.
DATES: The meeting will be held on
Development); To obtain onsite or web access, all
April 24–25, 2018, from 9:00 a.m. to
5:00 p.m. • U.S. Geological Survey; and interested attendees must pre-register by
• U.S. Nuclear Regulatory providing their full contact information
ADDRESSES: The meeting will be held at
Commission (Office of Nuclear and affiliation. (See FOR FURTHER
U.S. Nuclear Regulatory Commission, Regulatory Research).
Office of Nuclear Regulatory Research, INFORMATION CONTACT).
These agencies are cooperating and
srobinson on DSK3G9T082PROD with NOTICES
11555 Rockville Pike, Rockville, MD Pierre Glynn,
coordinating in the research and
20852. U.S. Geological Survey.
development of multimedia
FOR FURTHER INFORMATION CONTACT: environmental models, software, and [FR Doc. 2018–07764 Filed 4–13–18; 8:45 am]
Brenda Rashleigh, Assistant Laboratory related databases. Model development BILLING CODE 4338–11–P
Director for Water, U.S. Environmental and simulation supports interagency
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Document Created: 2018-04-14 02:19:19
Document Modified: 2018-04-14 02:19:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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 | |
| FR Citation | 83 FR 16378 |
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