The Human BioMolecular Atlas Program (HuBMAP)
The Human BioMolecular Atlas Program (HuBMAP)
Other Transactions (OTs)
The Human Biomolecular Atlas Program (HuBMAP) employs an active and collaborative program management strategy using primarily Other Transactions (OTs), which are not contracts, grants, or cooperative agreements (see the HuBMAP Other Transactions Policy Guide).
HuBMAP leverages OTs to manage projects in which time-critical developments and nimble integration of ideas and expertise from various disciplines are essential to achieve a programmatic goal. The cutting-edge research supported by HuBMAP requires multidisciplinary teams of scientists. HuBMAP’s use of OTs facilitates engagement of nontraditional partners (e.g., large corporations and unaffiliated individuals) as well as sharing of devices between industry partners, academics and clinicians to rapidly develop therapeutic advances.
HuBMAP relies on use of OT awards to adapt as new knowledge and technologies emerge. The HuBMAP Program Manager (PM), in collaboration with the HuBMAP Agreement Officer (AO), adds or aggregates the necessary expertise and combines projects as needed. Components of HuBMAP may be expanded, modified or discontinued based on project feasibility and emerging methods, technologies, or approaches that are more useful. In addition, HuBMAP awardees collaborate and cooperate with the HuBMAP PM, NIH program staff and one another to incorporate relevant breakthroughs and discoveries, and engage pioneers. This strategy is designed to mitigate the inherent risk of such a program. The HuBMAP PM uses a rapid review process and a highly responsive post-award management process to take advantage of advances emerging from diverse scientific fields and parallel programs.
The various guidelines, polices, laws, and regulations to which HuBMAP and HuBMAP OT awardees must adhere as a member of the HuBMAP consortium are provided in the HuBMAP Other Transactions Policy Guide. Please see HuBMAP Other Transactions Frequently Asked Questions (coming soon) for additional information, including key features of the HuBMAP that differ from traditional methods and procedures associated with grants, cooperative agreements and contracts.
OTs Public Policy Requirements
NIH intends to uphold high ethical, health, and safety standards in both the conduct of the research it funds and the expenditure of public funds by its recipients. The public policy requirements specified in this section set many of those standards. The signature of the Authorized Organizational Representative (AOR) on the application certifies that the organization complies, or intends to comply, with all applicable policies, certifications and assurances referenced (and, in some cases, included) in the application instructions. The policies, certifications and assurances listed may or may not be applicable to the project, program, or type of applicant organization. This list is not intended to be comprehensive and other laws may be determined to apply generally to all NIH OT awards, or specifically to a particular award depending on the terms of the OTA.
- Animal Welfare Requirements (PHS Policy on Humane Care and Use of Laboratory Animals)
- ClinicalTrials.gov Requirement
- Comptroller General Access
- Debarment and Suspension
- Dissemination of False or Deliberately Misleading Information
- Federal Information Security Act
- Financial Conflict of Interest
- Fly American Act
- Gun Control
- Human Embryo Research and Cloning Ban
- Human Fetal Tissue Research
- Human Subjects Protection
- Human Stem Cell Research (NIH Guidelines)
- Lobbying Prohibition
- Metric System
- National Environmental Policy Act (1969)
- Pro Children Act of 1994
- Prohibition on Promotion or Legalization of Controlled Substance
- Research Involving Recombinant or Synthetic Nucleic Acid Molecules
- Research on Transplantation of Human Fetal Tissue
- Restriction of Abortion Funding (appropriation Act for the NIH, with exceptions)
- Restriction on Distribution of Sterile Needles • Restriction of Pornography on Computer Networks
- Salary Cap/Salary Limitation (appropriation Act for the NIH)
- Select Agents and Toxins
- Research Misconduct
- Select Agents
- Trafficking in Persons
- USA Patriot Act
OTs Frequently Asked Questions
- 1. What is an Other Transaction (OT) award?
- The term OT award refers to a transaction other than a contract, grant or cooperative agreement under section 402(b)(7) or 402(b)(12) of the Public Health Service Act.
- 2. What is the difference between an OT award, a grant, cooperative agreement, and a contract?
- Requirements for a grant or cooperative agreement funded by NIH are described by the NIH Grants Policy Statement. Contracts are governed by Federal Acquisition Regulation . An Other Transaction is a funding mechanism which targets non-traditional sources and allows a high degree of flexibility in how the agreement is awarded. Typical government procurement and grant laws, regulations and policies do not apply to OT awards. The NIH Other Transaction Award Policy Guide for HuBMAP details the policies that are applicable to OT awards made as part of HuBMAP. To distinguish the processes and administration of other transaction awards from grants, cooperative agreements and contracts, different terminology is used: (1) OT initiatives are called Funding Opportunity Announcements (FOAs), and (2) applications are reviewed using Objective Review.
- 3. What is an “OT2” mechanism?
- For HuBMAP, OT2 is a single component award that describes in detail an applicant’s planned approach, capabilities and projected budget. The OT2 mechanism will be used to make awards for discrete, specified, circumscribed research projects that will be actively managed by NIH staff. The specific features of an OT2 application will are described in each specific Research Opportunity Announcement.
- 4. What is the difference between OT1, OT2, and OT3?
- The NIH uses three-digit Activity Codes to describe the various activities we fund. OT1, OT2, and OT3 are three specific activity codes that relate to Other Transactions. OT1 is a pre-application, OT2 is a research project award, and OT3 is a multiple-component research award.
- 5. Who is eligible to apply for an Other Transaction Award?
- Specific details of eligibility are listed in the “Eligible Applicants” section of each FOA. Other Transaction Authority permits awards to be made to institutions and individuals, including Higher Education Institutions, Nonprofits Other Than Institutions of Higher Education and For-Profit Organizations. Foreign Institutions are eligible, though foreign individuals are not eligible.
- 6. Is partnering permitted among eligible applicants?
- Yes, partnering is allowed among eligible applicants. See the “Eligible Applicants” section of the funding opportunity.
7. Does the NIH have a forum for large and small organizations to discover one another?
No. We suggest that organizations work with their professional networks to identify potential partners.
8. Where are Other Transaction (OT) Funding Opportunity Announcements (FOAs) posted?
HuBMAP OT FOAs will appear in Grants.gov, the NIH Guide and other sources to make sure the information is widely available to the entire pool of potential applicants. Announcements will also be advertised on the HuBMAP Funding Opportunities website and via the HuBMAP listserv.
Applications will be received through Grants.gov and will use an electronic Standard Form 424. The SF424 is implemented as both a fillable electronic and as a web-based form, giving potential applicants the ability to make maximal use of available resources. Additional submission requirements and instructions will be specified in the HuBMAP OT FOA.
All OT awardee organizations and unaffiliated individuals must have a DUNS number as the Universal Identifier when applying for HuBMAP OT awards. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An Authorized Organizational Representative (AOR) should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Individual PD/PI(s) do not need to register for a DUNS number unless they are unaffiliated with an institution. If a HuBMAP OT award is issued, the recipient must notify potential subrecipient organizations or unaffiliated individuals that they may not receive a subaward under the OT award unless they have provided their DUNS number to the recipient.
11. Is a System for Award Management (SAM) registration required?
All OT awardee organizations and unaffiliated individuals must register in the SAM (formerly the Central Contractor Registry (CCR)) and maintain the registration with current information for the entire duration that the application is under consideration for funding by NIH. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient.
HIn order to participate in the HuBMAP program, an OT awardee organization, PD/PI(s) and unaffiliated individuals must complete a one-time registration in the Commons. Organizations registering in the eRA Commons for the first time should allow 2-4 weeks to complete the registration process. Organizations may verify their current registration status by accessing the “List of Recipient Organizations Registered in eRA Commons”.
PD/PI(s) should only have one eRA Commons user account. If the PD/PI has been registered in eRA Commons by an organization other than the organization submitting an application, the submitting organization must take steps to affiliate the PD/PI(s) with its organization so that the PD/PI(s) can view and access data records for those applications.
Individual applicants not affiliated with an organization or who want to submit an application independently must complete all the required registrations as though they are an organization (https://grants.nih.gov/grants/ElectronicReceipt/UnaffiliatedUserRegistra...). In eRA Commons, they will be registered as “independent scholars” and will also act as the Signing Official, with the same authority in eRA Commons that the Authorized Organizational Representative(s) has in Grants.gov.
13. Do I need a signing official to submit an OT application?
Applications must be submitted by an Authorized Organizational Representative.
The receipt date(s) will be specified in each “Invitation to Submit an OT2 application” sent out in response to a successful Letter of Intent. The date provided in the Invitation to Submit will supersede any date provided in the Research Opportunity Announcement.
15. Will there be a required Letter of Intent (LOI) for OT applications?
Yes, prospective applicants are required to submit a Letter of Intent. Applications will not be accepted for review unless a Letter of Intent has been submitted, accepted, and a formal invitation to apply from NIH has been issued. Information about what is recommended for inclusion in the Letter of Intent can be found in each FOA.
NIH staff will invite meritorious Letters of Intent (LOIs) to develop and submit OT2 applications via an “Invitation to Submit” letter. This document will include information regarding associated OT2 application receipt dates and may specify recommended project changes that can be discussed with the applicant following the review of Letters of Intent (LOI). An LOI will not result in awards; they are meant to limit the number of full applications (invite only) to concepts we are strongly considering for funding. If you submit an LOI that is not of interest to the program, you will not be invited to submit a full application. You should be able to get a sense of our interest in your LOI by discussing it with HuBMAP program staff. We can provide feedback to applicants at all stages of the application process, including right now. Contact us at: [email protected].
17. Can HuBMAP select only certain portions described in an LOI?
Yes. NIH staff may choose to invite portions of your LOI submission to the OT2 application.
18. Can I be involved in more than one team/can I submit more than one LOI?
Yes.
19. How long will it take to hear about my letter of intent (LOI)?
All relevant dates are provided in the funding announcement. Applicants who submit LOIs will be notified regarding their invitation to submit a full OT application within 8 weeks.
No. LOI applicants will be notified within 8 weeks if their LOIs have been accepted, but will not be provided with feedback. Successful LOIs may receive feedback if only certain portions are invited as part of a full proposal.
Lack of quantitative metrics. We’ll be happy to suggest metrics you might be able to use to assess your progress (benchmarks) or the overall success of your project (deliverables). We are looking for applicants to provide quantified estimates of both progress at regular milestones as well as what successful will look like by the end of the project. These quantitative estimates will give us a clear sense of what to expect if we decide to fund a proposal.
22. Can I apply to both the OT award and grant announcements?
Yes, you may apply to both OT and grant / cooperative agreement announcements as part of the HuBMAP.
23. Are application due dates firm or is there a possibility that these dates may be extended?
The application due dates are non-negotiable. Late applications will not be considered.
Benchmarks are metric-driven, quantifiable and verifiable, minimum-success criteria for each year of an OT project. The adequacy of the proposed project benchmarks and the feasibility of achieving them will be considered by reviewers in determining the scientific and technical merit of the application. In addition, benchmarks will be used to determine whether support for a study will continue after the end of each year, or if funding will be substantially reduced (i.e., expand/continue/reduce funding or project scope).
As required by 402(b)(7) and 402(b)(12) of the Public Health Service (PHS) Act, objective review is an assessment of scientific or technical merit of applications by individuals with knowledge and expertise equivalent (peer) to that of the individuals whose applications of support they are reviewing, i.e., reviewers who are the professional equals of the principal investigator (PI) or program/project director (PD) for the proposed project and who often are engaged or were previously engaged in comparable activities.
Objective review is essential to ensuring selection of applications that best meet the needs of the program, consistent with established criteria, and providing assurance to the public that the evaluation and selection process was impartial and fair. To achieve this result, NIH conducts reviews under the highest ethical standards. Any circumstance that might introduce any conflict of interest, or appearance thereof, prejudices, biases, or predispositions into the process must be avoided. The review process and criteria will be specified in each HuBMAP OT Funding Opportunity Announcement (FOA). Only the review criteria described in the FOA will be considered in the review process. All applications submitted in response to the FOA will be evaluated by an appropriate review group.
The HuBMAP program plans to use LOIs followed by an OT application and review process in order to expedite and refine the selection of applications for HuBMAP awards, emphasizing programmatic priorities. NIH staff will invite meritorious LOIs to develop and submit an application that will be reviewed for scientific and programmatic merit prior to award. This invitation is predicated on the outcome of the LOI. Successful OT2 applicants will be those whose projects demonstrate the greatest potential to meet the goals of the FOA and HuBMAP. This decision is informed by the OT2 review results and input from the HuBMAP Agreement Officer regarding applicant’s business capabilities.
No, individual reviewer critiques will not be provided and applications that are not discussed at the objective review meeting will not receive written feedback. NIH staff will provide a summary of review for applications discussed during the objective review process. This may include information regarding major project changes that applicants may discuss during post-review communication(s) with the NIH staff. These changes may include recommendations to integrate ideas from separate applications, expand specific components proposed in an application, and/or eliminate specific components proposed in an application.
Yes, an overall impact score will be released for applications that are discussed during objective review.
Yes, reviewer rosters will be released with summaries of review.
30. May I appeal the results of the LOI review or objective review?
No, there is no appeal process.
The review criteria that will be considered for HuBMAP OT2 FOAs include the following: Scientific and Technical Merit; Personnel Qualifications; Institutional Commitment. Only these review criteria as described in the OT2 FOA will be considered in the review process. All applications submitted in response to the FOA will be evaluated by an appropriate review group.
OT FOAs are not being reviewed according to typical NIH grant or cooperative agreement review processes. Please read the FOA sections “Application Review Information” or "Objective Review Process" very closely as these specify the respective review processes.
While HuBMAP welcomes innovative tools and technologies, innovation is not a scored review criterion. Applicants are encouraged to instead focus on the utility of their technology in terms of addressing the HuBMAP mission.
This is a tool and technology-driven program, and we are not looking for hypothesis-driven Specific Aims. Please contact us if you still have questions: [email protected].
To promote long-term sustainability and extensibility of the HIVE, we strongly encourage applicants to propose an open-source approach (using a software license such as GPL), although we will consider other sustainability strategies as well. Our goal is for long-term sustainability of the HIVE (beyond the HuBMAP funding period). It is expected that the HIVE developers will provide access to the software and/or the framework and pseudocode of the HIVE to any team taking over from them, such that the product survives independent of the developing team. Additional information is available in the announcement.
This depends on many factors, but we anticipate issuing Other Transaction Awards approximately 6 months after the LOI receipt date. This may be accelerated or delayed depending on program needs.
Once a HuBMAP OT2 application has been selected, the HuBMAP Agreement Officer (AO) will contact the applicant to update Other Support information or any other information necessary for the OT award. The HuBMAP PM and HuBMAP AO will negotiate agreements with the applicants to support selected projects. The negotiated benchmarks will be the basis for continuation or termination of the OT award.
HuBMAP OT awards will be made via a Notice of Award (NoA) once a negotiation with the prospective awardee has been completed. The NoA will specify the terms and conditions for those awards including frequency of formal reporting, benchmarks and applicable policies.
An initial period of performance will be defined upon selection and award negotiation, and based on agreed goals and milestones for the project.
40. What are the Terms & Conditions (T&C) of the Other Transaction (OT) award?
Terms and conditions for HuBMAP OT awards including frequency of formal reporting, benchmarks and applicable policies will be specified in each HuBMAP OT FOA and included in each applicant’s Notice of Award (NoA). An outline of the general HuBMAP OT award terms and conditions may be viewed in the NIH Other Transaction Award Policy Guide for HuBMAP and in the relevant research opportunity announcement.
41. How long is the project period under an Other Transaction (OT) award?
The project period for an OT award will be specified in each OT Research Opportunity Announcement. Once an OT award has been issued, budget periods will be renewed at the end of each budget period and following successful and timely completion of negotiated benchmarks.
42. Will a Project Officer be assigned to oversee my Other Transaction (OT) award?
Yes, the HuBMAP PM or a designated HuBMAP Project Manager will serve as the Project Officer for all HuBMAP OT awards.
The HuBMAP PM will be a scientist familiar with the program area, the corresponding scientific communities, and the steps necessary to achieve the identified scientific goals. The HuBMAP PM will be responsible for the programmatic, scientific, and technical aspects of assigned applications and OT awards. This includes, but is not limited to, development of research programs to meet HuBMAP’s mission; oversight of the objective review process; and post-award administration, including review of progress reports, participation in site visits, and other activities complementary to those of the HuBMAP Agreement Officer. More information about the HuBMAP PM’s role post-award is available under Post-Award Management Information.
The HuBMAP PM oversees the review applications for completeness and conformity to requirements, ensures that adequate numbers of reviewers with appropriate expertise are available for application review, assigns applications to individual reviewers as discussion leaders and for preparation of written critiques, moderates the review meetings, prepares and sends review outcomes for all applications reviewed, and serves as the scientific point of contact with applicants during the initial phase of the peer review process.
The HuBMAP AO comprehensively understands how to develop agreements with external organizations. The HuBMAP AO advises the HuBMAP PM about the capability of individuals or organizations selected for award and works with the HuBMAP PM to establish, modify and terminate OT awards. These activities include, but are not limited to, evaluating OT applications for administrative content and compliance with statutes and guidelines; negotiating OT awards; providing consultation and technical assistance to applicants and recipients, including interpretation of OT administration policies and provisions; and administering and closing out OT awards.
The HuBMAP AO is the focal point for receiving and acting on administrative requests (e.g., for changes in the terms and conditions of award, see Sections 1.2.3-1.3 of the NIH Other Transaction Award Policy Guide for HuBMAP. The HuBMAP AO is also the only NIH official authorized to obligate NIH to the expenditure of Federal funds or to change the funding, duration, or other terms and conditions of award.
The HuBMAP PM and HuBMAP Agreement Officer (AO), with appropriate supplemental personnel, will monitor and administer each HuBMAP OT award on an ongoing basis. Awardees should make every effort to achieve the benchmarks. If a recipient fails to materially comply with the terms and conditions of award, s/he should communicate this in a timely manner to the HuBMAP PM and HuBMAP AO who will provide course correction strategies (e.g. adjust benchmarks). This also applies to necessary changes that arise based on programmatic need and the availability of funds for a project. Opportunities for supplemental funding may become available in response to evolving programmatic needs and emerging scientific advances. Additional activities that may qualify for funding adjustments include, but are not limited to, HuBMAP awardees entering into a collaboration, developments that overcome an unforeseen scientific roadblock, and sharing resources. Additional information on post-award changes is available in the NIH Other Transaction Award Policy Guide for the HuBMAP.
The HuBMAP PM will determine post-award unilateral changes, suspensions and terminations taking into account input from the Project Manager, Project Scientist, Working Group, Steering Committee and external evaluators’ advice. The HuBMAP PM will convey to the DPCPSI Director the decision to unilaterally change, suspend and/or terminate a project. Unilateral terminations are subject to approval by the DPCPSI Director.
No. There is no appeal or dispute process.
48. Does receiving an OT award affect my Early Stage Investigator or New Investigator status?
No, receiving an award will not remove your status.
The HIVE is expected to serve as the primary data repository for the program and later in the program to be an invaluable open resource to the research community. The HIVE is not expected to accept or archive all tiers of data generated by the Consortium projects. Individual projects are expected to provide their own data storage resources and to generate standardized scorecards for their datasets which will determine whether submission to the HIVE is appropriate and how the data should be archived and analyzed. For example, individual projects will be expected to archive and analyze their own calibration, validation and test datasets, whereas the HIVE is expected to archive production-level datasets and datasets from Consortium projects. The HIVE will keep the Consortium informed of data submissions and datasets generated to meet project milestones will only be recognized once they have been successfully submitted to the HIVE.
50. HIVE: What Consortium-building and community-engagement activities are encouraged?
The goal for the Collaboration Component of the HIVE is to enhance the collaborations and exchange of information among Consortium members and between HuBMAP and the wider research community. Activities that this component may be involved with include: maintaining the infrastructure to make the Consortium run smoothly; (e.g. Wiki, website, calendar, dashboard etc.); organizing and facilitating Consortium meetings; engaging with related programs and the global research community; facilitating cross-fertilization within the Consortium through supporting cross-training, pilot projects, workshops, training sessions and jamborees; and managing HuBMAP and the HIVE's web and social media presence.
51. HIVE: For the Tools Component, is the focus on new tool development or integration of tools?
The focus for the Tools Component is assembling a portfolio of tools for different data users to be able to easily and securely access and use HuBMAP data. This portfolio of tools should include a range of approaches for browsing, searching and visualizing the data, from simple direct download of data through to web-based or virtual-reality-based visualization of multi-scale, multiplexed data. The focus of these tools is on responsive, dynamic access to raw and derived data sets within the archive. This toolkit of approaches will be best assembled from a combination of working with other researchers to import and modify existing tools, developing new tools and working closely with other members of the Consortium. The Tools Component has some shared interests in particular with both the Mapping Component and the Tissue Mapping Centers. One area of shared interest with the Mapping Component is visualization – the Mapping Center is more concerned with multi-scale visualization of the human body and integration of anatomical data with HuBMAP data and telling stories around the consortium’s data releases, however there is a shared interest in making the program’s data accessible. Likewise, the Data Analysis Cores of the Tissue Mapping Centers are likely to develop new tools for analyzing their data that will be of broader interest to the Consortium and the community, and the Tools Component can work closely with them to integrate into their toolkit sitting on top of the archive.
Making data, metadata, software and other digital objects open, findable, accessible, interoperable, and reusable (FAIR) is key to the success of the HuBMAP. Applicants are strongly encouraged to optimize or adapt existing standards and approaches and to create new ones only when required. During the setup phase of HuBMAP (FY18), the HIVE will focus on developing and implementing the principles of data sharing, data and metadata standards including provenance (using relevant ontologies as needed and appropriate). The Consortium Component will take the lead on discussing and adopting standards within the Consortium. We recognize in some cases there are no existing standards and in these cases the Consortium Component will also take a lead on working with Consortium members and the wider research community to develop relevant standards to promote FAIR data and tools.
53. HIVE: What is the scope of the data to be archived in the HIVE?
The HIVE will be responsible for archiving production/publication quality data generated by the projects in the Consortium. This will be data generated from non-diseased human tissue and will involve multiple data types, including imaging data, omics data and associated metadata. To build a multiscale view of the human body incorporating anatomical and molecular data in a common coordinate framework, the HIVE is also expected to have the capacity to deal with multiple derived datasets, such as different types of maps, and to support both reliable, fast, secure access to the data through the tools developed by the Tools Component and the Mapping Component. The data is likely to include personally identifiable information as well as de-identified datasets and the HIVE should be prepared for managing human subject data and being compliant with the NIH Genome Data Sharing Policy as well as others indicated in the RFA. The expected size of the archive by the end of the program is tens of petabytes. The HIVE will also facilitate interactions within the Consortium, such as providing sharing of protocols, software and information of upcoming activities, as well as acting as the portal for the wider research community.
Details of eligibility are included in Section III Part 1. Eligibility includes institutions of higher education, for-profit and non-profit organizations, and other entities including foreign institutions and FFRDCs.
Assuming meritorious applications and the availability of funds, approximately one award will be made for each component of the HIVE. To ensure that these awards meet the needs of the program, applicants may be asked to include other teams as part of their award either during the pre-award negotiations or as part of post-award management.
AO Agreement Officer
D&B Dun and Bradstreet
DUNS Data Universal Numbering System
HIVE HuBMAP Integration, Visualization, and Engagement
LOI Letter of Intent
NoA Notice of Award
OT Other Transaction
PM Program Manager
ROA Research Opportunity Announcement
SAM System for Award Management
T&C Terms & Conditions
