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)
National Institutes of Health
Federal Register Volume 80, Issue 195 (October 8, 2015)
| Page Range | 60923-60924 | |
| FR Document | 2015-24761 |
[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]] ----------------------------------------------------------------------- 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
![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:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
| 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 | |
| Dates | To ensure consideration, responses must be submitted by Jan. 8, 2016, 11:59:59 p.m. EST. | |
| Contact | Specific questions about this notice should be sent via email to: [email protected] | |
| FR Citation | 80 FR 60923 |
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