National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.
RM1 Research Project with Complex Structure
See Section III. 3. Additional Information on Eligibility.
This Notice of Funding Opportunity (NOFO) encourages applications for NIGMS Biomedical Technology Optimization and Dissemination (BTOD) Centers to support late-stage technology optimization and sustainable dissemination of the technologies to the wider biomedical research community. A BTOD Center should be at the leading edge of its field with respect to both technology optimization and engagement with relevant research communities.
BTOD projects must address biomedical research areas within the NIGMS mission. Potential applicants are strongly encouraged to consult with NIGMS staff about adherence of their proposed research strategy to the Institute's goals and mission and its responsiveness to this NOFO.
The National Institute of General Medical Sciences (NIGMS) supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS also supports research in specific clinical areas that affect multiple organ systems: anesthesiology and peri-operative pain; clinical pharmacology common to multiple drugs and treatments; and injury, critical illness, sepsis, and wound healing. NIGMS-funded scientists investigate how living systems work at a range of levels–from molecules and cells to tissues and organs–in research organisms, humans, and populations. Additionally, to ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in supporting the training of future scientists and developing research capacity throughout the country.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| September 29, 2026 | September 29, 2026 | Not Applicable | March 2027 | May 2027 | July 2027 |
| January 28, 2027 | January 28, 2027 | Not Applicable | July 2027 | October 2027 | December 2027 |
| May 28, 2027 | May 28, 2027 | Not Applicable | November 2027 | January 2028 | April 2028 |
| January 28, 2028 | January 28, 2028 | Not Applicable | July 2028 | October 2028 | December 2028 |
| May 26, 2028 | May 26, 2028 | Not Applicable | November 2028 | January 2029 | April 2029 |
| January 29, 2029 | January 29, 2029 | Not Applicable | July 2029 | October 2029 | December 2029 |
All applications are due 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.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
This Notice of Funding Opportunity Announcement (NOFO) encourages applications for support of Biomedical Technology Optimization and Dissemination (BTOD) Centers in any of the basic or clinical research areas within the NIGMS mission. This program supports optimization of late-stage technologies that have demonstrated laboratory feasibility and dissemination of the optimized technologies to the broad biomedical research community. A BTOD Center may focus on a specific technology, or it may integrate multiple technologies to create a transformative approach to solving a class of research problems.
The NIGMS technology research and development pipeline supports technology development from its earliest stages to broad dissemination of products to the research community. The Technology Development R21/R01 Program supports early-stage proof of concept and prototype development. The BTOD Center program supports the optimization of late-stage technologies, defined as functional technologies that, while readily employed by investigators with specialized expertise, require further optimization and dissemination for use by the general research community.
Technologies of interest include, but are not limited to: analytical biochemistry and chemical biology tools, high throughput biochemical methods, chemistry, advanced spatial omics, structural biology and imaging methods, molecular biology, cell manipulation, computational methods, and modeling of molecular and biological systems.
BTOD Centers are comprised of three integrated components: Technology Optimization Projects (TOPs), Driving Biomedical Projects (DBPs), and Community Engagement (CE). The Center optimizes technologies through synergistic collaborations between TOPs and DBPs and disseminates them through CE activities. The latter promote and distribute the technologies to the wider research community using multiple strategies including training, commercialization, and public outreach.
Technology Optimization Projects (TOPs): TOPs are the central focus of the BTOD Center and serve as the foundation for all other Center activities.
TOPs Characteristics:
Technology Partnership Projects (TPPs) : BTOD centers have the option to collaborate with industrial partners to accelerate technology optimization over a short time window (1-2 yrs), however, no funds from this project can support the activity.
If applicable, applicants should describe TPPs in the application. TPPs may also be initiated at any time during the grant period at the discretion of the PD(s)/PI(s).
Driving Biomedical Projects (DBPs): DBPs are biomedical research projects that the Center pursues in collaboration with outside investigators to serve as test beds for refinement of its technologies. This collection of projects and their collaboration with TOPs are core components of a BTOD Center and should represent a significant investment of its time and effort.
DBPs Characteristics:
Community Engagement (CE): A BTOD Center should develop a plan to engage with a variety of biomedical research community segments to facilitate adoption of its technologies.
CE Characteristics:
Acknowledgment of NIGMS grant support and citation of NIGMS grant number are required (see Communicating and Acknowledging Federal Funding).
Academic courses, research, and training activities that are not available to the biomedical research community external to the Center's institution are not considered community engagement.
External Advisory Committee: Each BTOD Center must have an External Advisory Committee (EAC) that meets at least annually and prepares a written report of its recommendations.
The following types of BTOD Center applications are non-responsive to this NOFO and will not be reviewed:
Applications that propose technologies of limited utility to the biomedical research community will be low priority for funding.
See Section VIII. Other Information for award authorities and regulations.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
The number of awards is contingent upon NIH appropriations and the number of meritorious applications.
The maximum budget that may be requested is $850,000 in direct costs per year, excluding equipment and consortium F&A costs. Applications requesting more than this amount will not be reviewed. Because of the technology-intensive nature of these Centers, there may be a need to acquire specialized equipment. Equipment requests are expected to vary with the nature of the technology optimization projects proposed. Funds for such specialized equipment may be requested in excess of the $850,000 operating limit but should be well justified.
The scope of the proposed project should determine the project period. The maximum project period is 5 years. NIGMS will not support a BTOD Center for more than 15 total years (2 renewals), including support for previous P41 BTRR and RM1 BTDD Centers.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.
Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information
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.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
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 their organization to develop an application for 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 How to Apply - Application Guide.
PD(s)/PI(s) must each provide a minimum of 3 person months effort to the Center project.
PDs/PIs with a Maximizing Investigators' Research Award (MIRA, Early Stage or Established Investigator) are eligible to apply, but must maintain the minimum required research effort toward their MIRA, and 3 person months effort toward the BTOD Center. While a MIRA can support a PD/PI's laboratory for early-stage technology development, a BTOD Center can only support late-stage technology optimization and dissemination efforts.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.
The Research Strategy section must consist of the following subsections, with each adhering to the following page limits:
| Subsection | Page Limits |
| Overview | 12 |
| Administration and Management | 6 |
| Technology Optimization Projects (TOPs) (3 maximum) | 12 each |
| Driving Biomedical Projects (DBPs) (10 maximum) | 12 total |
| Community Engagement (CE) | 12 total |
The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Facilities & Other Resources: For projects with more than one performance site, provide any plans to mitigate adverse effects of geographic separation of Center activities.
Other Attachments: For renewal applications, applications from existing Centers, or applications transitioning from a BTRR to a BTOD Center, the following attachments are required.
Attachment 1. Title "EAC Report": Include the most recent report as an attachment in this section.
Attachment 2: Title: "Indirectly Supported Publications": List the publications indirectly resulting from Center efforts.
All instructions in the How to Apply - Application Guide must be followed.
Include TOP and CE lead investigators as key personnel.
Biographical Sketch: PD(s)/PI(s) and other key personnel should describe the following in the Personal Statement of the NIH Biographical Sketch Supplement:
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Specific Aims: Describe the overall aims of the proposed Center.
Research Strategy: The Research Strategy must consist of the following subsections, in the order listed below, and uploaded as a single PDF attachment. See page limits above.
Note: A BTOD Center may not be supported beyond a combined total of 15 years as a BTRR, BTDD, or BTOD if the same technology for optimization and dissemination is proposed. Applicants submitting for the final project period should be aware that BTOD Center funding will not be extended beyond the final project period and should propose a Research Strategy and a sustainable technology dissemination plan that takes this limit into account.
Overview
Annotated Timeline: Include an annotated timeline that indicates the interconnection between TOPs, DBPs (and TPPs if applicable), and target dates that illustrate the proposed project's milestones.
Existing Center or BTRR transition (if applicable):
Administration and Management
Under Administration and Management, include the following sections with headings:
Organizational Structure and Staff Responsibilities:
Center Operating Procedures:
External Advisory Committee (EAC):
Technology Dissemination Plan:
Resiliency Plan:
Technology Optimization Projects (TOPs)
Include the following under the specific subheadings in the TOP subsection:
Driving Biomedical Projects (DBPs)
All applications must provide the following (suggested page limits provided as guidance): table of proposed DBPs (1 page), summary of DBPs (1 page), and descriptions of a maximum of 10 DBPs (1 page per DBP including references).
Table of Proposed DBPs: Provide a 1-page table of up to 10 DBPs. Format the table to include the following columns:
Summary of DBPs: Provide a 1-page summary of all DBPs with a succinct description of the overall goals. Provide a description of criteria used for including new DBPs and rotating existing DBPs out of the BTOD Center during the award period.
Descriptions of a maximum of 10 DBPs (1 page per DBP including references). Begin each on a new page with the following information:
Community Engagement (CE)
Technology Training for the Scientific Community:
Technology Dissemination:
Website:
Outline plans to maintain an effective and current website and describe how the Center will monitor its impact.
Websites should include:
Multiple PD/PI Leadership Plan: If multiple PD(s)/PI(s) are proposed, describe in general the structural and procedural elements that will ensure their integration and prevent fragmentation of the Center, ensuring that it is not simply a collection of individual projects with a common technological theme. Refer to the Multiple PD/PI (MPI) Leadership Plan for additional details, where details may be fully elaborated.
Letters of Support: Provide a table of contents for Letters of Support. Include the names of signatories and their institutions. Letters expressing institutional support should be presented first. Letters of support from investigators specifically collaborating with Center investigators on any TOP, DBP, or other projects described specifically in the application should be included next. The purpose of collaborative letters of support is to describe the nature of the collaborative relationship, including its scope, and any special circumstances (e.g., materials or technology transfer, or intellectual property agreements). If students or trainees are involved in BTOD Center operations, institutional letters documenting that these activities are integral to their overall training goals must be included. Do not include letters of support from users whose interactions are limited to activities described in the CE component.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date 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 How to Apply – 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.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The objectives of the BTOD Centers program are to: (1) optimize technologies that, while readily employed by investigators with specialized expertise, require further optimization; and (2) disseminate these technologies for use by the biomedical research community. The technologies described in the Technology Optimization Projects (TOPs) should potentially be of broad utility for biomedical research. Their optimization through iterative interactions with the Driving Biomedical Projects (DBPs) should yield technologies that are readily usable by both experts and non-experts. Sustainable dissemination of the optimized technologies through Community Engagement (CE) strategies should eliminate the need for continuous funding of the Center. Therefore, Center support is limited to a total of 15 years, inclusive of previous BTRRs and BTDD Center funding.
Reviewers will provide an overall impact 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.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?
Specific to this NOFO:
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?
Specific to this NOFO:
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?
Specific to this NOFO:
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this NOFO:
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?
Specific to this NOFO:
As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Each TOP will receive merit descriptors (Exceptional, Excellent, Good, Fair or Marginal) based upon the following criteria:
Quality of Research:
Technology Integration:
DBP/TOP Interaction:
For existing Center or BTRR transition applications:
Technology Partnership Projects (if applicable):
Community Engagement
The Community Engagement component will receive merit descriptors (Exceptional, Excellent, Good, Fair or Marginal) based upon the following criteria:
Current Centers:
For Centers developing software:
For Center website:
Technology Training for the Scientific Community:
For research that involves human subjects but does not involve one of the 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 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 Guidelines for the Review of Human Subjects.
This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
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.
For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals (as applicable), the committee will consider the progress made in the last funding period.
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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 score.
Not applicable.
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).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned to the National Institute of General Medical Sciences (NIGMS). Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. The following will be considered in making funding decisions, consistent with applicable law:
NIGMS will give priority to areas of technology development not already supported in current NIGMS-funded Centers.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.
Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy."
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Cybersecurity plans and procedures must at minimum include the following:
All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.
For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.
For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on MAT/MOUD.
Not Applicable
A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.
A reporting plan tailored to evaluate the progress in technology optimization and dissemination is required in the RPPR. Report data on an annual basis to track optimization, demand, utilization, training, and dissemination of Center technologies under TOPs, DBPs, and CEs. Sample data may include the following.
The report of recommendations prepared by the EAC must be included under G.1 of the annual RPPR.
A final RPPR, 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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
In carrying out stewardship of grant programs, NIGMS will periodically evaluate the BTOD program, employing representative measures identified below. In assessing the effectiveness of technology development investments, NIGMS may use information from progress reports and public databases, PDs/PIs, and from participants themselves. Where necessary, PDs/PIs and participants may be appropriately contacted after completion of the grant period for updates on participants' subsequent outcomes. The overall program evaluation will be based on metrics that include, but are not limited to, the following:
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
NIGMS BTOD Mailbox
National Institute of General Medical Sciences (NIGMS)
Email: NIGMS_BTODMailbox@nigms.nih.gov
Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov
NIGMS BBCB GAB NOFO
National Institute of General Medical Sciences (NIGMS)
Email: NIGMSBBCBGABNOFO@nih.gov
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 2 CFR Part 200.