Background

The possibility of a radiation accident and/or the threat of radiological or nuclear terrorism has prompted NIH-sponsored research to develop medical countermeasures suitable for civilian populations. The threats that could result in radiation exposure, which might then lead to acute and delayed injuries, include detonation of conventional explosives combined with radioactive materials, e.g. dirty bombs ; placement of radioactive sources in public locations, contamination of food and water supplies; accidents or attacks on nuclear reactors or sites where radioactive materials are stored; and the detonation of a nuclear device. Among the casualties of a nuclear detonation would be tens or hundreds of thousands of persons exposed to acute irradiation while thousands more might experience radioactive fallout downwind from the explosion. These individuals will need to be assessed to determine if they have been exposed to potentially-lethal doses of radiation. Such victims might not initially show overt symptoms of radiation toxicity, even if exposed to substantial doses of radiation. In addition, there is considerable person-to-person variability in early and delayed radiation damage to organs and tissues in response to a given radiation dose, due to factors such as genetic pre-disposition, age, body size, partial shielding, underlying illnesses, and immune status. Therefore, estimates of radiation exposure dose alone will not necessarily predict the extent of radiation injury to organs and tissues. Hence, there is a need for rapid, accurate and sensitive assays/techniques and diagnostic platforms that can confirm exposure and predict acute and delayed radiation injury to different organs and tissues in victims of radiation incidents.

In 2004, the US Department of Health and Human Services (HHS) tasked the National Institute of Allergy and Infectious Diseases (NIAID) with the responsibility to identify, characterize and develop products to diagnose and treat acute and delayed radiation injuries. NIAID’s Radiation and Nuclear Countermeasures Program (RNCP) has instituted a robust research and development program that has provided many promising leads for the development of new diagnostic tools, and medical countermeasures (MCMs) to mitigate and/or treat acute radiation syndrome (ARS) and delayed effects of acute radiation exposure (DEARE). As a result of RNCP efforts, in 2015, two medical countermeasures, Neupogen and Neulasta (Amgen) were granted label extension by the FDA to "increase survival in patients acutely exposed to myelosuppressive doses of radiation". However, thus far no biodosimetry approach has been cleared by the FDA for use in triage or as a diagnostic tool for the irradiated population.

In radiation exposure scenarios, injury to different physiological systems, organs, cells, and tissues can result from external exposure (the severity of which is dependent on radiation dose, dose-rate, and radiation type (e.g. high or low linear energy transfer (LET)) and/or internal exposure due to the uptake of radioactive materials by inhalation, ingestion, skin absorption, or wound contamination. The manifestation of clinically-relevant injury, however, is highly variable and depends on many factors. Clinical symptoms of radiation injury to different organs and tissues can appear days, weeks and months after exposure, and this could lead to a delay in the utilization of effective treatment options. Moreover, inter-individual differences in radiation sensitivity may contribute to variability in the manifestations of radiation injury.

Adding to the complexity of injury to individual organs and tissues is the heterogeneity of exposure (partial- versus total-body) as well as the source of exposure (external radiation exposure versus internal contamination). Existing biodosimetry techniques and devices, and others in development, cannot assess such variability. Furthermore, these techniques and devices do not predict the severity of injury sustained by specific organs and tissues. Therefore, in addition to radiation dose assessment through biodosimetry techniques and tools, there is a critical need to develop radiation-specific biomarkers and devices that will predict the acute and/or delayed damage to specific organs and tissues (e.g. predictive biodosimetry), to facilitate precise and timely medical interventions.

Research Objectives and Scope

The goal of this Funding Opportunity Announcement (FOA) is to invite applications that support basic, applied or translational research on discovery of biomarkers of radiation injury. This FOA will support approaches addressing one or more of the following research gaps: 1. Distinguish between the worried well and the exposed population, 2. Determine the radiation dose in the affected group, 3. Predict the acute and delayed radiation injuries to major organs/physiological systems by discovering biomarkers that can be used for triage and treatment decisions in the event of a large scale radiological incident. Biodosimetry biomarkers/devices to be studied under this FOA address the unmet need to distinguish between the exposed and unexposed populations and has a sample to answer time of 30 min or less.

The goals of the FOA include the development and validation of rapid, reliable, inexpensive and easy-to-use techniques/assays and devices for use in all segments of the civilian population including geriatric, pediatric, and immune-compromised individuals. The FOA encourages exploration of biokinetics for promising biomarkers at times earlier than 24 h post-exposure to establish trends in response; however, the signature should be quantifiable at 24 h post-exposure or later post-exposure (i.e. days to weeks and months post- exposure) to allow repeated assays over time and should be able to accurately predict acute and delayed radiation injury to one or more organs and/or tissues of physiological systems. The ideal radiation biomarker will be measurable in a non-invasive or minimally invasive way (e.g., finger stick, urine, saliva, or skin scraping as opposed to spinal fluid or complex imaging), will allow for repeated assays over time, is sensitive to incremental differences in radiation exposure, is specific over a wide range of radiation doses and dose-rates and has utility for different qualities of radiation (high and low LET).

Studies using human tissue samples or data from radiotherapy patients may be included if the results are likely to be relevant to exposure scenarios due to terrorist or accidental radiological or nuclear attack; however, the use of samples from radiotherapy patients that have been exposed to fractionated radiation doses should be carefully justified as to their relevance to injuries that might be sustained following a radiological or nuclear incident.

Applications could include, but not be limited to the following areas:

• Identification, evaluation and characterization of radiation injury biomarkers based on radiation-induced gene expression, protein expression, DNA or protein modifications, metabolomic, lipidomic, immunomodulatory, cytogenetic, inflammatory, biochemical and/or physico-chemical changes predictive of early and delayed injury.

• Development of rapid, reliable, inexpensive and easy-to-use techniques/assays and devices.

• Discovery and development of biomarkers of radiation injury, assays/techniques and devices in geriatric, pediatric, and immune-compromised populations.

Scientific Meetings: All PIs or designated representatives will attend an initial meeting or teleconference, arranged by the NIAID Project Scientist, to be held shortly after award. All PIs or designated representatives will also attend face-to-face, one-day scientific meetings to be held annually thereafter, where the PIs and/or their designated representatives will give oral presentations on current progress and planned activities and projects.

Applications including the following areas of study will be considered non-responsive and will not be reviewed:

• Applications proposing HIV/AIDS studies.

• Epidemiological studies.

• Projects focused exclusively on quantitation of radiation dose received (e.g., radiation biodosimetry) that do not assess or predict individual radiosensitivity, specific organ or tissue injury, or other relevant clinical outcomes.

• Characterization and development of biomarkers of carcinogenesis.

• Projects not specifically addressing radiation injury biomarkers.

• Projects that are focused on medical countermeasures against radiation exposure.

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Applicant organizations

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity
  

The letter of intent should be sent to:

Thomas Conway, PhD
Telephone: 240-669-5075
Fax: 301-480-2408
Email: [email protected]

All instructions in the SF424 (R&R) Application Guide must be followed.

Specific Aims: List in priority order the broad, long-range objectives and goals of the proposed project. Concisely describe the hypothesis or hypotheses to be tested.

Research Strategy: Applicants are required to provide preliminary data for intended use (point of care, high throughput or predictive approaches) and a description of how the proposed study will lead to future FDA clearance.

Applicants are required to address one or more of the three research gaps mentioned before: 1. Distinguish between the worried well and the exposed population, 2. Determine the radiation dose in the affected group, 3. Predict the consequences of acute and delayed radiation injuries to major organs/physiological systems by discovering biomarkers that can be used for triage and treatment decisions in the event of a large-scale radiological incident.

Biodosimetry biomarkers/devices to be studied under this FOA must distinguish between the exposed and unexposed populations and should be inexpensive, field-deployable, with a sample to answer time of 30 min or less. Research focusing on diagnosis of the absorbed dose must measure the extent and intensity of radiation injuries to aid in determining the type of medical intervention that are needed within at time-window of 7 days post-exposure. Research in late effects must identify, evaluate and characterize markers of radiation injury to major organs and tissues to allow for timely and appropriate administration of treatments before the onset of overt radiation subsyndromes. Biomarkers should be linked to relevant clinical outcomes such as organ failure, and other major morbidities and/or mortality.

Include studies in animal models to identify and characterize the biomarkers of radiation injury to specific organs and tissues or physiological systems.

Include plans for the coordination of staff to accomplish the goals described in the research strategy; the investigator and/or Key personnel must include a radiation biologist, a dosimetrist, a veterinarian and a statistician.

Briefly describe for all years of the award specific, quantitative milestones that will be achieved in each year of the Project. Milestones should address the following:

• A clear description of all interim objectives (research and/or developmental milestones) to be achieved during the course of the project. Applicants also must identify any impediments that could require a revision in the work plan or milestones with a discussion of alternative approaches.

• Detailed, quantitative criteria by which yearly milestone/s achievement will be assessed.

• A detailed schedule or timeline for the anticipated attainment of each milestone and the overall goal(s).

Describe specifics on the dosimetry methodology used at the institution where radiation will be utilized. Dosimetry methodology must describe: radiation source and geometry of exposure, dose level, dose rate, shielding (if applicable), dosimetry calibration method (indicate if it follows standards set forth by the National Institute for Standards and Technology (NIST)); and plans for initial dosimetry calibration (e.g. devices used and phantoms) and in-run evaluation of radiation dose delivered. Also, if applicable, include description of irradiation chambers/jigs, geometry of jigs, orientation to the plane of exposure, anesthesia methods.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. 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

4. Submission Dates and Times

Part I. Overview Information 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 Policy on Late Application Submission.

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 SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. Additional information may be found in the SF424 (R&R) 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.

1. Criteria

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.

Significance

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?

Investigator(s)

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 FOA:

Do the investigators/key personnel have the appropriate radiation biology, dosimetry, veterinary and statistical expertise? Are there plans for coordination of staff to accomplish the goals described in the research strategy?

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? 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?

Specific to this FOA:

Are the timelines and milestones provided well-justified quantifiable, reasonably attainable and appropriate for the scope of the project? Is dosimetry methodology adequately described and are plans for dosimetry calibration appropriate? Given the critical nature of the milestones to measure the success of the program, are the proposed milestones suitable for advancing the biodosimetry signature/device to meet FDA clearance requirement.

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/gender, 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?

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?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

Applications from Foreign Organizations

Not Applicable

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

• 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.

• Will receive a written critique.

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Research design and protocol development, data collection, final data analysis and interpretation, preparation of publications, as well as collaboration with other awardees, and with assistance from the NIAID Project Scientist.
• Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID, or other mechanisms.
• Publications: The PI will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Agreement. The PI is requested to submit manuscripts to the Project Scientist right after acceptance for publication so that an up-to-date summary of program accomplishments can be maintained, and press conferences and press releases prepared. Publications or oral presentations of work performed under this Agreement are the responsibility of the PI and will require appropriate acknowledgement of NIAID support.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• A program official from the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) will serve as the NIH Project Scientist for this program. In conjunction with other NIAID scientific program staff the NIH Project Scientist will provide advice and guidance on technical issues, such as reviewing progress or recommending changes. The NIH Project Scientist may also: provide input into the design of activities; advise in the selection of sources or resources (e.g., determining where a particular reagent may be found); coordinate or participate in the collection and/or analysis of data; or advice in the management and technical performance.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Milestones: It is recognized that Milestones may require revision and re-negotiation prior to award and during the course of the project period. The NIH Program Official will negotiate the Milestones with the PD/PI(s) and provide approvals. Release of each yearly funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon Milestones.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Study Team chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Merriline Satyamitra, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5432
Email: [email protected]

Thomas Conway, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5075
Email: [email protected]

David Madoo
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6446
Email: [email protected]