[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60923-60924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24761]



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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: [email protected].

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

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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]
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