80_FR_61118 80 FR 60923 - Request for Information (RFI): Soliciting Input for the National Center for Advancing Translational Sciences (NCATS) Strategic Planning Process

80 FR 60923 - Request for Information (RFI): Soliciting Input for the National Center for Advancing Translational Sciences (NCATS) Strategic Planning Process

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 195 (October 8, 2015)

Page Range60923-60924
FR Document2015-24761

The National Center for Advancing Translational Sciences (NCATS) seeks input on the development of a five-year strategic plan. We invite input from any and all interested parties.

Federal Register, Volume 80 Issue 195 (Thursday, October 8, 2015)
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60923-60924]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24761]



[[Page 60923]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information (RFI): Soliciting Input for the National 
Center for Advancing Translational Sciences (NCATS) Strategic Planning 
Process

SUMMARY: The National Center for Advancing Translational Sciences 
(NCATS) seeks input on the development of a five-year strategic plan. 
We invite input from any and all interested parties.

DATES: To ensure consideration, responses must be submitted by Jan. 8, 
2016, 11:59:59 p.m. EST.

ADDRESSES: Comments must be submitted electronically using the web-
based form available at http://grants.nih.gov/grants/rfi/rfi.cfm?ID=50.

FOR FURTHER INFORMATION CONTACT: Specific questions about this notice 
should be sent via email to: NCATSstrategicplan@mail.nih.gov.

SUPPLEMENTARY INFORMATION:

Background

    Several thousand diseases affect humans of which only about 500 
have any treatment. Thanks to our growing understanding of human 
biology, along with the increased availability of innovative 
technologies, there is an unprecedented opportunity to translate 
scientific discoveries more efficiently into new, more effective and 
safer health interventions. Currently, a novel intervention can take 
about 14 years and $2 billion to develop, with a failure rate exceeding 
95 percent.
    To address the challenges, NCATS strives to develop innovations to 
reduce, remove or bypass costly and time-consuming bottlenecks in the 
translational science process in an effort to speed the delivery of 
interventions (e.g. drugs, diagnostics and medical devices) to 
patients. Rather than targeting a particular disease or fundamental 
science, NCATS focuses on what is common across diseases and the 
translational process. The Center emphasizes innovation and 
deliverables, relying on the power of data and new technologies to 
develop, demonstrate and disseminate improvements in translational 
science that bring about tangible improvements in human health. NCATS' 
current programs focus on pre-clinical innovation to drive advances in 
early stages of the translational process, from target validation to 
first-in-human studies; clinical innovation to support clinical and 
translational research, creating and sharing expertise, tools and 
training needed to develop and deploy effective treatments in people; 
and reengineering translational science through cross-cutting programs 
that address common scientific and organizational barriers to enable 
faster and more effective interventions that tangibly improve human 
health.
    For more information about NCATS, visit https://ncats.nih.gov.

Translation and Translational Science

    NCATS defines translation as the process of turning observations in 
the laboratory, clinic, and community into interventions that improve 
the health of individuals and the public--from diagnostics and 
therapeutics to medical procedures and behavioral changes. 
Translational science is defined as the field of investigation focused 
on understanding the scientific and operational principles underlying 
each step of the translational process.
    The translational science process can be envisioned as a spectrum 
(https://ncats.nih.gov/translation/spectrum) encompassing each stage of 
research along the path from the biological basis of health and disease 
to interventions that improve the health of individuals and the public. 
The spectrum is not linear or unidirectional; rather, each of the five 
stages (Basic Research, Pre-Clinical Research, Clinical Research, 
Clinical Implementation, and Public Health) builds upon and informs the 
others. Patient Involvement plays a central role in the entire process.
    Basic Research, while not typically conducted at NCATS, reveals 
fundamental mechanisms of biology, disease or behavior that inform and 
can be informed by each of the other stages. Pre-clinical Research 
connects those basic discoveries made in the laboratory or clinic to a 
new medical intervention. Clinical Research tests the safety and 
effectiveness of those interventions in human subjects, and also can 
include behavioral and observational studies, outcomes and health 
services research, and the testing and refinement of new technologies. 
Research on the adoption of medical interventions into routine clinical 
care for the general population, the evaluation of clinical trial 
results, and the identification of new clinical questions and gaps in 
care occur in the Clinical Implementation stage. The Public Health 
stage of translation includes studies on health outcomes at the 
population level to determine the effects of diseases and efforts to 
prevent, diagnose and treat them. Central to the translational science 
spectrum is Patient Involvement in which NCATS researchers collaborate 
and engage with patients and community members to better identify and 
understand public health needs and develop useful medical 
interventions. For more information, including a graphical depiction of 
the translational science spectrum, visit https://ncats.nih.gov/translation/spectrum.
    At all stages of the spectrum, NCATS develops new approaches, 
demonstrates their usefulness, disseminates the findings, and engages 
with patients and community members to better identify and understand 
public health needs.

Strategic Planning Process

    NCATS is in the process of developing its first strategic plan to 
set the goals and priorities of the Center over the next five years. We 
anticipate that the strategic plan will outline and provide a roadmap 
of translational research priorities and the most pressing scientific 
and operational opportunities and challenges in translation; emerging 
research needs; barriers to progress; and the resources, 
infrastructure, or tools needed to catalyze major scientific advances 
in translation.
    NCATS is soliciting stakeholder input through this Request for 
Information and through a series of webinars (details at https://ncats.nih.gov/strategicplan) to ensure that members of the community 
and our partners have a voice in framing the Center's future scientific 
direction.

Information Requested

    NCATS seeks input on the scientific and operational opportunities, 
challenges and research needs in translational science to help set the 
Center's strategic priorities and inform the development of a five-year 
strategic plan.
    Some examples of particular issues of interest that apply across 
the translational science spectrum include:
     Breaking down professional, cultural and scientific silos 
across the translational science spectrum
     Focusing on inter-operability of data systems (such as 
integrating patient data and electronic health records into pre-
clinical research)
     Expanding research efforts at NCATS into new therapeutic 
modalities
     Focusing on patient-driven research and patient/community 
engagement
     Forming innovative partnerships with a wide variety of 
stakeholders
     Identifying skillsets and competencies needed for training 
the next generation of translational scientists
     Utilizing modern communication and dissemination tools to 
expand awareness of translational science to a wide variety of 
stakeholders
    NCATS encourages stakeholders from all sectors to provide input on 
these and

[[Page 60924]]

any other relevant issues. Stakeholders include, but are not limited 
to: Patients and members of the health advocacy community; basic, 
translational and clinical scientists at universities and research 
institutions; health care providers; biotechnology, venture capital and 
pharmaceutical industry members; colleagues at other NIH institutes, 
centers and offices; partners at other government agencies (e.g. the 
Food and Drug Administration, other agencies of the Department of 
Health and Human Services, the Environmental Protection Agency, and the 
Department of Defense); policy makers and funders; as well as the 
general public. Organizations are encouraged to submit a single 
response that reflects the views of their organization and membership 
as a whole.
    To respond to this RFI, please go to http://grants.nih.gov/grants/rfi/rfi.cfm?ID=50. To ensure consideration, responses must be submitted 
by Jan. 8, 2016, 11:59:59 p.m. EST.

General Information

    Responses to this RFI are voluntary. Do not include any 
proprietary, classified, confidential, trade secret or sensitive 
information in your response. Respondents are advised that the U.S. 
Government is under no obligation to acknowledge receipt of the 
information provided and will not provide feedback to respondents. The 
Government will use the information submitted in response to this RFI 
at its discretion. The Government reserves the right to use any 
submitted information on public NIH Web sites, in reports, in summaries 
of the state of the science, in any possible resultant solicitation(s), 
grant(s), or cooperative agreement(s), or in the development of future 
funding opportunity announcements.
    This RFI is for information and planning purposes only and shall 
not be construed as a solicitation, grant, or cooperative agreement, or 
as an obligation on the part of the Federal Government, the NIH, or 
individual NIH Institutes and Centers. The Government will not pay for 
the preparation of any information submitted or for the Government's 
use of such information. No basis for claims against the Government 
shall arise as a result of a response to this request for information 
or from the Government's use of such information.
    NCATS looks forward to your input and encourages you to share this 
RFI document and the information about the upcoming webinars with your 
colleagues.

    Dated: September 25, 2015.
Christopher P. Austin,
Director, National Center for Advancing Translational Sciences (NCATS).
[FR Doc. 2015-24761 Filed 10-7-15; 8:45 am]
 BILLING CODE P



                                                                               Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices                                          60923

                                                  DEPARTMENT OF HEALTH AND                                training needed to develop and deploy                 better identify and understand public
                                                  HUMAN SERVICES                                          effective treatments in people; and                   health needs and develop useful
                                                                                                          reengineering translational science                   medical interventions. For more
                                                  National Institutes of Health                           through cross-cutting programs that                   information, including a graphical
                                                                                                          address common scientific and                         depiction of the translational science
                                                  Request for Information (RFI):                          organizational barriers to enable faster              spectrum, visit https://ncats.nih.gov/
                                                  Soliciting Input for the National Center                and more effective interventions that                 translation/spectrum.
                                                  for Advancing Translational Sciences                    tangibly improve human health.                           At all stages of the spectrum, NCATS
                                                  (NCATS) Strategic Planning Process                         For more information about NCATS,                  develops new approaches, demonstrates
                                                  SUMMARY:   The National Center for                      visit https://ncats.nih.gov.                          their usefulness, disseminates the
                                                  Advancing Translational Sciences                                                                              findings, and engages with patients and
                                                                                                          Translation and Translational Science
                                                  (NCATS) seeks input on the                                                                                    community members to better identify
                                                                                                             NCATS defines translation as the                   and understand public health needs.
                                                  development of a five-year strategic
                                                                                                          process of turning observations in the
                                                  plan. We invite input from any and all                                                                        Strategic Planning Process
                                                                                                          laboratory, clinic, and community into
                                                  interested parties.
                                                                                                          interventions that improve the health of                 NCATS is in the process of
                                                  DATES: To ensure consideration,
                                                                                                          individuals and the public—from                       developing its first strategic plan to set
                                                  responses must be submitted by Jan. 8,                  diagnostics and therapeutics to medical               the goals and priorities of the Center
                                                  2016, 11:59:59 p.m. EST.                                procedures and behavioral changes.                    over the next five years. We anticipate
                                                  ADDRESSES: Comments must be                             Translational science is defined as the               that the strategic plan will outline and
                                                  submitted electronically using the web-                 field of investigation focused on                     provide a roadmap of translational
                                                  based form available at http://                         understanding the scientific and                      research priorities and the most pressing
                                                  grants.nih.gov/grants/rfi/rfi.cfm?ID=50.                operational principles underlying each                scientific and operational opportunities
                                                  FOR FURTHER INFORMATION CONTACT:                        step of the translational process.                    and challenges in translation; emerging
                                                  Specific questions about this notice                       The translational science process can              research needs; barriers to progress; and
                                                  should be sent via email to:                            be envisioned as a spectrum (https://                 the resources, infrastructure, or tools
                                                  NCATSstrategicplan@mail.nih.gov.                        ncats.nih.gov/translation/spectrum)                   needed to catalyze major scientific
                                                  SUPPLEMENTARY INFORMATION:                              encompassing each stage of research                   advances in translation.
                                                                                                          along the path from the biological basis                 NCATS is soliciting stakeholder input
                                                  Background                                              of health and disease to interventions                through this Request for Information
                                                     Several thousand diseases affect                     that improve the health of individuals                and through a series of webinars (details
                                                  humans of which only about 500 have                     and the public. The spectrum is not                   at https://ncats.nih.gov/strategicplan) to
                                                  any treatment. Thanks to our growing                    linear or unidirectional; rather, each of             ensure that members of the community
                                                  understanding of human biology, along                   the five stages (Basic Research, Pre-                 and our partners have a voice in framing
                                                  with the increased availability of                      Clinical Research, Clinical Research,                 the Center’s future scientific direction.
                                                  innovative technologies, there is an                    Clinical Implementation, and Public
                                                                                                                                                                Information Requested
                                                  unprecedented opportunity to translate                  Health) builds upon and informs the
                                                  scientific discoveries more efficiently                 others. Patient Involvement plays a                      NCATS seeks input on the scientific
                                                  into new, more effective and safer                      central role in the entire process.                   and operational opportunities,
                                                  health interventions. Currently, a novel                   Basic Research, while not typically                challenges and research needs in
                                                  intervention can take about 14 years and                conducted at NCATS, reveals                           translational science to help set the
                                                  $2 billion to develop, with a failure rate              fundamental mechanisms of biology,                    Center’s strategic priorities and inform
                                                  exceeding 95 percent.                                   disease or behavior that inform and can               the development of a five-year strategic
                                                     To address the challenges, NCATS                     be informed by each of the other stages.              plan.
                                                  strives to develop innovations to reduce,               Pre-clinical Research connects those                     Some examples of particular issues of
                                                  remove or bypass costly and time-                       basic discoveries made in the laboratory              interest that apply across the
                                                  consuming bottlenecks in the                            or clinic to a new medical intervention.              translational science spectrum include:
                                                  translational science process in an effort              Clinical Research tests the safety and                   • Breaking down professional,
                                                  to speed the delivery of interventions                  effectiveness of those interventions in               cultural and scientific silos across the
                                                  (e.g. drugs, diagnostics and medical                    human subjects, and also can include                  translational science spectrum
                                                  devices) to patients. Rather than                       behavioral and observational studies,                    • Focusing on inter-operability of
                                                  targeting a particular disease or                       outcomes and health services research,                data systems (such as integrating patient
                                                  fundamental science, NCATS focuses on                   and the testing and refinement of new                 data and electronic health records into
                                                  what is common across diseases and the                  technologies. Research on the adoption                pre-clinical research)
                                                                                                                                                                   • Expanding research efforts at
                                                  translational process. The Center                       of medical interventions into routine
                                                                                                                                                                NCATS into new therapeutic modalities
                                                  emphasizes innovation and                               clinical care for the general population,                • Focusing on patient-driven research
                                                  deliverables, relying on the power of                   the evaluation of clinical trial results,             and patient/community engagement
                                                  data and new technologies to develop,                   and the identification of new clinical                   • Forming innovative partnerships
                                                  demonstrate and disseminate                             questions and gaps in care occur in the               with a wide variety of stakeholders
                                                  improvements in translational science                   Clinical Implementation stage. The                       • Identifying skillsets and
                                                  that bring about tangible improvements                  Public Health stage of translation                    competencies needed for training the
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                                                  in human health. NCATS’ current                         includes studies on health outcomes at                next generation of translational
                                                  programs focus on pre-clinical                          the population level to determine the                 scientists
                                                  innovation to drive advances in early                   effects of diseases and efforts to prevent,              • Utilizing modern communication
                                                  stages of the translational process, from               diagnose and treat them. Central to the               and dissemination tools to expand
                                                  target validation to first-in-human                     translational science spectrum is Patient             awareness of translational science to a
                                                  studies; clinical innovation to support                 Involvement in which NCATS                            wide variety of stakeholders
                                                  clinical and translational research,                    researchers collaborate and engage with                  NCATS encourages stakeholders from
                                                  creating and sharing expertise, tools and               patients and community members to                     all sectors to provide input on these and


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                                                  60924                               Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices

                                                  any other relevant issues. Stakeholders                         or from the Government’s use of such                      (IPV) and trauma for women with HIV,
                                                  include, but are not limited to: Patients                       information.                                              at risk for HIV, and at risk for substance
                                                  and members of the health advocacy                                NCATS looks forward to your input                       use disorders (SUDs). VITEL provides
                                                  community; basic, translational and                             and encourages you to share this RFI                      supplemental funding to existing
                                                  clinical scientists at universities and                         document and the information about the                    SAMHSA Targeted Capacity Expansion:
                                                  research institutions; health care                              upcoming webinars with your                               Substance Abuse Treatment for Racial/
                                                  providers; biotechnology, venture                               colleagues.                                               Ethnic Minority Women at High Risk for
                                                  capital and pharmaceutical industry                               Dated: September 25, 2015.                              HIV/AIDS (TCE–HIV: Minority Women)
                                                  members; colleagues at other NIH                                Christopher P. Austin,                                    grantees. The goals of the VITEL
                                                  institutes, centers and offices; partners                       Director, National Center for Advancing                   program are (1) reduce IPV through
                                                  at other government agencies (e.g. the                          Translational Sciences (NCATS).                           screening and referrals, (2) reduce risky
                                                  Food and Drug Administration, other                             [FR Doc. 2015–24761 Filed 10–7–15; 8:45 am]               behaviors that lead to new HIV
                                                  agencies of the Department of Health                            BILLING CODE P                                            infections and SUDs, (3) increase access
                                                  and Human Services, the Environmental
                                                                                                                                                                            to care and improve health outcomes for
                                                  Protection Agency, and the Department
                                                  of Defense); policy makers and funders;                                                                                   people living with HIV and AIDS, (4)
                                                                                                                  DEPARTMENT OF HEALTH AND                                  reduce HIV-related health disparities
                                                  as well as the general public.                                  HUMAN SERVICES
                                                  Organizations are encouraged to submit                                                                                    resultant from IPV screening tool
                                                  a single response that reflects the views                       Substance Abuse and Mental Health                         implementation, and (5) determine the
                                                  of their organization and membership as                         Services Administration                                   feasibility of integrating IPV screening
                                                  a whole.                                                                                                                  in behavioral health settings. A multi-
                                                     To respond to this RFI, please go to                         Agency Information Collection                             stage approach has been used to develop
                                                  http://grants.nih.gov/grants/rfi/                               Activities: Proposed Collection;                          the appropriate theoretical framework,
                                                  rfi.cfm?ID=50. To ensure consideration,                         Comment Request                                           conceptual model, evaluation design
                                                  responses must be submitted by Jan. 8,                            In compliance with Section                              and protocols, and data collection
                                                  2016, 11:59:59 p.m. EST.                                        3506(c)(2)(A) of the Paperwork                            instrumentation. Process and outcome
                                                  General Information                                             Reduction Act of 1995 concerning                          measures have been developed to fully
                                                                                                                  opportunity for public comment on                         capture community and contextual
                                                    Responses to this RFI are voluntary.                          proposed collections of information, the                  conditions, the scope of the VITEL
                                                  Do not include any proprietary,                                 Substance Abuse and Mental Health                         program implementation and activities,
                                                  classified, confidential, trade secret or                       Services Administration (SAMHSA)                          and client outcomes. A mixed-method
                                                  sensitive information in your response.                         will publish periodic summaries of                        approach (e.g., surveys, semi-structured
                                                  Respondents are advised that the U.S.                           proposed projects. To request more                        interviews, focus groups) will be used,
                                                  Government is under no obligation to                            information on the proposed projects or                   for example, to examine collaborative
                                                  acknowledge receipt of the information                          to obtain a copy of the information
                                                  provided and will not provide feedback                                                                                    community linkages established
                                                                                                                  collection plans, call the SAMHSA                         between grantees and other service
                                                  to respondents. The Government will                             Reports Clearance Officer on (240) 276–
                                                  use the information submitted in                                                                                          providers (e.g., primary health care,
                                                                                                                  1243.                                                     SUD recovery), determine which
                                                  response to this RFI at its discretion.                           Comments are invited on: (a) Whether
                                                  The Government reserves the right to                                                                                      program models and what type and
                                                                                                                  the proposed collections of information
                                                  use any submitted information on                                                                                          amount of client exposure to services
                                                                                                                  are necessary for the proper
                                                  public NIH Web sites, in reports, in                            performance of the functions of the                       contribute to significant changes in IPV,
                                                  summaries of the state of the science, in                       agency, including whether the                             SUD, and HIV risk behaviors of the
                                                  any possible resultant solicitation(s),                         information shall have practical utility;                 targeted populations, and determine the
                                                  grant(s), or cooperative agreement(s), or                       (b) the accuracy of the agency’s estimate                 impact of VITEL services on providers,
                                                  in the development of future funding                            of the burden of the proposed collection                  clients, and communities.
                                                  opportunity announcements.                                      of information; (c) ways to enhance the                      The data collection for this program
                                                    This RFI is for information and                               quality, utility, and clarity of the                      will be conducted quarterly (during this
                                                  planning purposes only and shall not be                         information to be collected; and (d)                      one year supplemental period) and the
                                                  construed as a solicitation, grant, or                          ways to minimize the burden of the                        client outcome data collection will be
                                                  cooperative agreement, or as an                                 collection of information on                              ongoing throughout the program and
                                                  obligation on the part of the Federal                           respondents, including through the use
                                                  Government, the NIH, or individual NIH                                                                                    will be collected at baseline, discharge
                                                                                                                  of automated collection techniques or                     and 6-months post baseline for all
                                                  Institutes and Centers. The Government                          other forms of information technology.
                                                  will not pay for the preparation of any                                                                                   treatment clients. The respondents are
                                                  information submitted or for the                                Proposed Project: Violence Intervention                   clinic-based social workers and
                                                  Government’s use of such information.                           to Enrich Lives (VITEL) Supplement—                       counselors, clinic-based administrators
                                                  No basis for claims against the                                 NEW                                                       and clinic-based clients. The estimated
                                                  Government shall arise as a result of a                           This data collection is to study the                    annualized burden is summarized
                                                  response to this request for information                        intersection of intimate partner violence                 below:
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                                                                                                                               Responses                  Total             Total                                 Total
                                                                                                              Number of                                                                        Hours per
                                                                 Instrument/activity                                               per                  response          response                               burden
                                                                                                             respondents                                                                       response
                                                                                                                               respondent               numbers           numbers                                 hours

                                                  Baseline data collection (Clients) ........                           500                    1                 500                 500                   .42       210
                                                  Discharge data collection (Clients) ......                            500                    1                 500                 500                   .42       210
                                                  6-month post Baseline data collection
                                                    (Clients) ............................................              500                    1                 500                 500                   .42       210



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Document Created: 2015-12-15 08:42:24
Document Modified: 2015-12-15 08:42:24
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
DatesTo ensure consideration, responses must be submitted by Jan. 8, 2016, 11:59:59 p.m. EST.
ContactSpecific questions about this notice should be sent via email to: [email protected]
FR Citation80 FR 60923 

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