Expired PA-14-156: Extended Development, Hardening and Dissemination of Technologies in Biomedical Computing, Informatics and Big Data Science (R01)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of General Medical Sciences (NIGMS) National Human Genome Research Institute (NHGRI) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS) National Institute of Nursing Research (NINR) Office of Behavioral and Social Sciences Research (OBSSR) National Cancer Institute (NCI)
Funding Opportunity Title	Extended Development, Hardening and Dissemination of Technologies in Biomedical Computing, Informatics and Big Data Science (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) July 30, 2014 - Notice of Modification of Allowable Budgets for Data Deposition in PA-14-156. See Notice NOT-GM-14-125. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. March 24, 2014 - See Notice NOT-CA-14-041. Notice of National Cancer Institute (NCI) Participation.
Funding Opportunity Announcement (FOA) Number	PA-14-156
Companion Funding Opportunity	PAR-15-288, R44 Small Business Innovation Research (SBIR) Grant - Phase II only PA-14-155, R01 Research Project Grant PA-14-154, R43/R44- Small Business Innovation Research - Phase I, Phase II, and Fast Track PA-14-157, R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.859, 93.273, 93.361, 97.853, 93.286, 93.865, , 93.846, 93.172, 93.113, 93.242, 93.279, 93.393, 93.394, 93.395, 93.396, 93.399
Funding Opportunity Purpose	The goal of this program announcement is to support the extended development, maintenance, testing, evaluation, hardening and dissemination of existing biomedical software. The NIH is interested in promoting a broad base of research and development of technologies in biomedical computing, informatics, and Big Data Science that will support rapid progress in areas of scientific opportunity in biomedical research. It is expected that this research and development is conducted in the context of important biomedical and behavioral research problems and that domain researchers are consulted to make sure that the software is relevant to users. As such, applications are intended to develop enabling technologies that could apply to the interests of most NIH Institutes and Centers and range from basic biomedicine and including research to all relevant organ systems and diseases. Major themes of research include collaborative environments; data integration; analysis and modeling methodologies; and novel computer science and statistical approaches. New opportunities are also emerging as large and complex data sets are becoming increasingly available to the research community. The proposed work should apply best practices and proven methods for software design, construction, and implementation to extend the applicability of existing technologies in biomedical computing, informatics and big data science to a broader biomedical research community.

Key Dates

Posted Date	March 14, 2014
Open Date (Earliest Submission Date)	May 5, 2014
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Standard AIDS dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	May 8, 2017
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) is aimed at satisfying one of the needs created by the parallel achievements and increased interdependence of the biomedical, computational, and big data science communities. This interdependence offers an unprecedented opportunity for sophisticated approaches to computer-enabled research in the biomedical sciences. The purpose of this FOA is to ensure the availability, continued usefulness (through extended development), and software hardening of existing technologies in biomedical computing, informatics and big data science. This FOA is coordinated by the NIH Big Data Initiative (BD2K) and the Biomedical Information Science and Technology Initiative (BISTI) committees. Through this and related opportunities, Institutes and Centers at the NIH offer support for: fundamental research (e.g., methodologies and approaches) in biomedical computing, informatics, and Big Data science; continued development, maintenance and hardening of software, tools and related resources; and applications of computational technologies to a particular domain area(s) in biomedical research. Information on these programs and related funding opportunities from participating Institutes and Centers of NIH can be found at http://www.bd2k.nih.gov and http://www.bisti.nih.gov/. Note that in this document, the term biomedical will be used in the broadest sense to include biological, biomedical, behavioral, social, environmental, and clinical studies that relate to understanding health and disease. Applicants are reminded to carefully check that the proposed research lies in the mission of the participant Institutes and Centers of the initiative.

In addition to applications for funding continued development and maintenance of software that have been accepted under previous BISTI funding opportunity announcements, this announcement acknowledges new opportunities are also emerging as large and complex data sets are becoming increasingly available to the research community. While the biomedical research enterprise is producing increasingly large amounts of digital data, it has not yet fully capitalized on the transformative opportunities that these data provide. As stated by the Data and Informatics Working Group (DIWG) of the Advisory Committee to the NIH Director, "Colossal changes in biomedical research technologies and methods have shifted the bottleneck in scientific productivity from data production to data management, communication, and interpretation." (http://acd.od.nih.gov/Data%20and%20Informatics%20Working%20Group%20Report.pdf). In this context, the term "Big Data Science" is meant to capture the opportunities and address the challenges facing all biomedical researchers in releasing, accessing, managing, analyzing, and integrating datasets of diverse data types. Such data types may include imaging, phenotypic, molecular (including omics), physiological, anatomical, clinical, behavioral, environmental, and many other types of biological and biomedical data. They may also include data generated for other purposes (e.g., social media, search histories, and cell phone data).

Applications under this program announcement can seek support to continue development and maintenance of Big Data Science software. A number of features of the improved software are listed below. Any of these improvements should benefit the existing user community and/or have potential for attracting more users.

First, contemporary software must be easy to modify and extend, and must be fully documented. Users who experience problems with software should be able to correct the problem with minimal effort and a mechanism must exist for incorporating these corrections into the software. As the needs of a community of users change, the software that supports their research efforts must be adaptable as well. The ability of software to be repaired and to evolve is particularly important because the scientific discovery process is open-ended and ever-changing.

Second, interoperability among different software packages or among software and existing databases is a major challenge. Applications with the goal of extending interoperability are welcomed under this program announcement. Portability to different types of hardware is a related area of challenge. Applications with the goal of improving software so that it operates on a variety of platforms employing different operating systems are also encouraged.

Finally, an important goal of the BD2K and BISTI Initiatives is to promote a culture where a large body of annotated and shareable data is available online to the broad biomedical research community. The development and use of data and metadata standards are critical for achieving this goal. The NIH has a number of efforts to stimulate the creation and support of community-based approaches to develop such standards. Investigators may participate in the development of data standards, and may serve as early testers and adopters of community-developed standards. The application should include a plan for how the proposed R01 will manage data and metadata standards and formats. Applicants should, as appropriate, i) engage with community-based standard and format development activities, and ii) apply community-based standards and formats to the data and metadata that the R01 is using for its research.

In the context of the research and development to extend, harden and disseminate established software, investigators may target one or multiple of the following four themes of biomedical computing, informatics, and Big Data science that will enable progress in biomedical research.

1. Collaborative environments and technologies: An applicant continues the development and maintenance of environments and technologies for Big Data science and gaining access to and using Big Data and tools. Examples include, but are not limited to:

Knowledge environments
Research commons
Scalable, extensible, and maintainable methods of data and metadata curation
Data security and privacy, and technical areas related to other ethical, legal, and social implications of Big Data

2. Data integration: An applicant may propose to continue the development and maintenance of efficient and effective ways to create connections across data types (i.e., unimodal or multimodal data integration). Examples of data types that could be addressed include, but are not limited to:

Omics data (e.g., genomics, proteomics, metabolomics, etc.)
Image and physiological data (e.g., CT, PET/SPECT, sMRI, fMRI, rMRI, DTI, EEG, MEG, ultrasound, cellular level imaging, multi-electrode recording, etc.)
Behavioral, social, and environmental data
Clinical data (e.g., lab tests, pathology, imaging, diagnosis, electronic health records, etc.)
Data from nontraditional sources (e.g., social media, mobile devices, etc.)
Multiscale data (genomic, epigenomic, subcellular, cellular, network, organ, systems, organism, population levels)
Multiplatform data (desktop, cloud-based storage, etc.)
Data from multiple research areas and diseases (e.g., common inflammation pathways in cancer, obesity, immune diseases, and neurodegenerative diseases)
Data with special considerations (e.g., sparse data, heterogeneous data, or very large or very small datasets)
Human-computer interfaces and visualization

3. Analysis and modeling methodologies: An applicant may propose to continue the development and maintenance of approaches for modeling, simulation, or analysis to produce useful biomedical information in ways that current methods cannot provide. Examples include, but are not limited to:

Processing of data to allow more efficient analyses
Multidimensional statistical and computational methods for analyzing, inspecting, displaying, representing, parsing, and searching high-dimensional data
Intensive longitudinal data analyses
Spatio-temporal dynamical modeling and adaptive dynamical modeling (e.g., parameter fitting and optimization of complex time series data)
Mechanistic modeling
Agent-based, Ordinary Differential Equation (ODE), Partial Differential Equation (PDE), and stochastic methods
Clinical decision-making
Individualized therapies
Multi-scale modeling
Organ-based or whole-body-based modeling
Population-based modeling

The research and development to extend, harden and disseminate established software should take place in the context of biomedical and behavioral research that is of interest across most NIH Institutes and Centers from basic biomedicine to research in all relevant organ systems and diseases. These projects do not require substantial innovation as the main purpose of this initiative is to support existing software and make it more useful to the user community. Therefore, it is important to obtain testimonials from the user community, e.g., letters of support, as to the potential for the project, along with other preliminary results provided by the applicants. The applicant should address the intended use of the technology, identify the technology development needs that s/he proposes to address, and how these needs are related to important biomedical, translational, or clinical research problems. Applicants will be expected to demonstrate appropriate understanding and adequate expertise in the relevant areas of both biomedical research and computational science and technology.

Through separate funding opportunity announcements of similar scientific scope, participating Institutes and Centers invite applications for early stage development in biomedical computing, informatics, and Big Data science (R01) PA-14-155, as well as small business innovation research (SBIR) PA-14-154 and small business technology transfer research (STTR) PA-14-157 . Some NIH Institutes and Centers may have other grant mechanisms that could apply to biomedical computing projects. Applicants are encouraged to visit the BD2K and BISTI web sites for these and other relevant funding opportunities: http://www.bd2k.nih.gov/opportunities, and http://www.bisti.nih.gov/bistic_funding.cfm.

Section II. Award Information

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period	Project periods are limited to five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover