and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). The FOA will be administered by the National Center for Advancing Translational Sciences (NCATS) (http://www.ncats.nih.gov) on behalf of the NIH. |
|
Funding Opportunity Title |
Resource Access for the Bridging Interventional Development Gaps Program (X01) |
Activity Code |
X01 Resource Access Award |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
PAR-12-092 |
Companion FOA |
NoneNone |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.310 |
FOA Purpose |
The high cost of translating therapeutic discoveries into clinically-available agents can deter the development of promising therapeutics. When private sector resources are limited, BrIDGs in-kind services could help researchers span the gap between the preclinical and clinical stages of therapy development and continue to evaluate agents that may improve the standard of care for patients with a variety of diseases and disorders.The purpose of this Funding Opportunity Announcement (FOA) is to invite investigators to apply for access to government-funded contract resources needed for the preclinical development of therapeutic agents. |
Posted Date |
February 1, 2012 |
Open Date (Earliest Submission Date) |
March 3, 2012 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
April 3, 2012, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
June 2012 |
Advisory Council Review |
Not Applicable |
Earliest Start Date(s) |
September 2012 |
Expiration Date |
April 4, 2012 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (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.
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
Promising ideas for therapeutic interventions can encounter roadblocks in the pipeline for preclinical development. Translation can be facilitated by partnering with the private sector, but high risk ideas or therapies for uncommon disorders frequently do not attract investment. When funding for new therapies is limited or not available, resources provided by the Federal Government could bridge the gap between discovery and clinical testing, so that translation can occur.
The National Institutes of Health (NIH) established the Bridging Interventional Development Gaps (BrIDGs) program (formerly known as NIH-RAID) to make available, on a competitive basis, certain critical resources needed for the development of therapeutic agents. The program’s goal is to generate the data and clinical material that investigators need to file an IND application with the Food and Drug Administration. BrIDGs is not a grant program. Successful projects gain access to government contract resources and assistance with establishing a product development plan.
The total number of awards will depend on the number of applications received, their relative scientific merit, and the availability of NIH funds. Approved BrIDGs projects are completed using contract resources in the National Center for Advancing Translational Sciences (NCATS), the National Cancer Institute (NCI), and the National Heart, Lung, and Blood Institute (NHLBI). Other collaborating NIH Institutes and Centers may also provide funding or contract resources.
Applications are accepted for the development of the following therapeutic agents:
Potential therapies for any disease or disorder may be submitted. Vaccines, devices and diagnostic agents are ineligible for the program. Only lead agents with demonstrated pharmacological activity in an appropriate disease model will be considered for development.
Available services include:
BrIDGs is not a complete drug development program or an unconditional commitment to develop a particular compound for the clinic. The services provided will depend upon the stage of the project. In some cases the BrIDGs program will support only one or two key steps for preclinical development, while in other cases it may be possible to provide assistance with most of the development tasks needed to file an Investigational New Drug (IND) application with the Food and Drug Administration (FDA). Development will proceed sequentially in most cases and the start of one segment of the project (e.g., toxicology) may depend on satisfactory completion of preceding segments (e.g., formulation). Insurmountable difficulties in one segment may force the discontinuation of an entire project. Applicants to the program (or their collaborators) are expected to file investigator-held INDs after the project is completed. Regulatory affairs support is not offered by BrIDGs.
Projects requiring earlier-stage resources, including assay development, high-throughput screening, medicinal chemistry optimization, or in vitro/in vivo efficacy testing are not appropriate for BrIDGs. Researchers interested in these resources should consider the Molecular Libraries Program (http://mli.nih.gov/mli), the Therapeutics for Rare and Neglected Diseases program (http://nctt.nih.gov/trnd) or consult with extramural program staff at the appropriate NIH Institute or Center to discuss other funding options.
Preclinical studies in support of Phase II or later trials (including carcinogenicity and reproductive toxicity studies) and funding for clinical trials of any phase are not within the scope of BrIDGs.
The output of BrIDGs program activities will be made fully available to the awarded institution, as appropriate, in support of additional studies, an IND application, or performance of clinical trials. Data and material will be transferred to the applicant under the terms of a non-negotiable Material Transfer Agreement (MTA).
It is expected that the originating investigator institution or a collaborating partner will have acquired or be in the process of acquiring appropriate intellectual property protection prior to applying to the program. All relevant intellectual property should be fully described in the application.
As noted previously, most BrIDGs studies will be completed by NIH contractors. Normally, the NIH will not acquire intellectual property rights to inventions made by its staff under the BrIDGs program. NIH contractors, under the Bayh-Dole Act, may elect to retain rights for a contribution they make that rises to the level of invention. However, some contractors, as a term of their funding agreements, have agreed to offer a first option to the originating investigator institution for license negotiation. Certain other contractors or subcontractors may be subject to a Determination of Exceptional Circumstances (DEC) through which rights in subject inventions may be assigned to the originating investigator institution.
Funding Instrument |
Not Applicable, this is a resource access award, not a grant. |
Application Types Allowed |
New The OER Glossary and the SF 424 (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 |
Not applicable, as funds are not awarded via this FOA. |
Award Project Period |
The scope of the proposed project will determine the project period. The maximum period is 5 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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
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 theNIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 4-6 weeks prior to the application due date.
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 PD(s)/PI(s), visit the Multiple
Program Director(s)/Principal Investigator(s) Policy and submission details in
the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R)
Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
For the purposes of this FOA, resubmissions of applications previously submitted to the NIH-RAID program will be treated as new applications.
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.
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.
The forms package associated with this FOA includes all applicable components, mandatory 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.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following requirement:
11. Descriptive Title of Applicant's Project. Applicants should enter a title that describes the disease and therapeutic agent (small molecule, peptide, etc) being studied.
12. Proposed Project. Enter dates based upon the anticipated project timeline. These dates will be determined by the duration of the tasks approved by the NIH. A general suggestion for the start and ending dates are 10 months and 3 years from the application’s submission respectively
15. Estimated Project Funding. Enter zero for lines a, b and c. Since the X01 (Resource Access Award) results in the award of resources NOT funds, any non-zero value will be treated as an ERROR. No budget forms will be used in the X01 submission and applications are NOT expected to request specific funds or even estimate costs.
1. Are Human Subjects Involved? Check no.
2. Are Vertebrate Animals Used? Check no.
5. Is the research performance site designated, or eligible to be designated, as a historic place? Check no .
7. Project Summary/Abstract. The Project Summary/Abstract must state the applications broad, long-term objectives and specific aims. The abstract should state explicitly which services are being requested from the NIH-BrIDGs program.
10. Facilities & Other Resources. Not applicable. Do not include an attachment here.
11. Equipment. Not applicable. Do not include an attachment here.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
2. Specific Aims.
Do not include an attachment here.
Note: A warning will be issued about the Specific Aims Page. The Specific Aims Page is not required for this FOA. Please disregard the warning.
3. Research Strategy
The research strategy must include the following information and cannot exceed 6 pages:
1. Background
Provide a brief summary of the disease to be treated. Discuss the current standard of care for the disease, and why new therapies are needed. Explain the selection of, and level of agreement in the field regarding, the therapeutic target and its potential clinical relevance. Describe the proposed agent, its impact on the target, and the rationale for selecting the agent over similar entities. Briefly describe the competitive landscape and the effectiveness of comparator compounds, if any.
2. Available Data
As appropriate for the stage of the program, please describe data obtained in the following areas:
Chemistry
PK/PD/Toxicology
Regulatory and Clinical
Intellectual Property
Please list any patents issued or pending with respect to either the agent or to any non-commercially available technology/material required for the development of the agent. In the event that an application requires the use of non-commercially available technology/equipment that is patented by a third party, the applicant will be expected to provide appropriate documentation of the patent holder’s approval of the applicant's use of said technology during the due diligence phase of the approval process.
3. Development plans
Provide a clear statement of the tasks that are proposed for completion by BrIDGs contractors. If the investigator or a collaborator intends to conduct tasks that may impact research supported by the program, (e.g. the investigator will provide the drug material to the NIH for use in BrIDGs supported studies) then the investigator should indicate how those tasks will be conducted and funded.
Outline a potential timeline for the conduct of studies needed to file the IND application. The timeline should highlight potential milestones and go/no go decision points. A timeline chart is acceptable. Following acceptance of a project, NIH staff may modify the timeline, milestones, and go/no go decisions points based upon review recommendations and contract availability.
State all current and applied for sources of support for the project. This includes a summary of the status of past, planned, or ongoing negotiations with companies related to licensure or future development of the product. Include information on any peer-reviewed grants and/or grant applications pertaining to the project. The applicant should indicate how BrIDGs support would complement, not duplicate, other sources of support. For projects close to clinical application, the investigator should document the strategy for obtaining funding for early phase clinical testing. Include potential collaborators and institutional arrangements for oversight and IRB review, if applicable.
4. Justification
Indicate why private funding for the project is not currently available. Describe the likelihood of the adoption of the therapeutic agent once an IND is approved, and why organizations (biotechnology companies, venture capital firms, pharmaceutical companies) are presently unwilling to fund or develop this drug project as it currently stands.
Resource Sharing Plan
Not Applicable.
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:
Top projects will undergo additional due diligence prior to the final determination of an award. Applicants will be expected to respond to questions related to the development of their proposed therapeutic agent in a timely fashion. For some projects, the due diligence process will included a face to face meeting at the NIH with program staff.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Commercialization Potential
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Not Applicable.
Budget and Period of Support
Not Applicable.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCATS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NIH Office of the Director. The following will be considered in making funding decisions:
Applicants will be notified about the outcome of their submissions by NCATS staff within seven months of the receipt date.
Not Applicable.
Not Applicable. All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
The following reporting requirements apply to this FOA:
All results of the research using material or data generated by the BrIDGs program shall be provided to NIH, including all publications thirty (30) days prior to public disclosure or within thirty (30) days as requested by the NIH, which ever occurs earlier.
Applicants agree to provide to NIH copies of Annual Reports concurrently with submissions to the FDA or corresponding foreign health authority.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Tony Jackson
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-4660
Email: [email protected]
Not Applicable
Not Applicable.
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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NIH Funding Opportunities and Notices
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