National Institute of Allergy and Infectious Diseases (NIAID)
New
None
93.855
The purpose of this limited competition Funding Opportunity Announcement (FOA) is to support continued care for and conduct of specialized research using a unique nonhuman primate (NHP) population. Specifically, the preservation, medical monitoring, study, treatment, and intervention in the development of late effects in NHP survivors of radiation exposure. NHPs most closely resemble human responses to radiation exposure and, as such, long-term studies on a radiation survivor cohort will permit continuous observations and treatment of this valuable population, while providing a critical understanding of the natural history of radiation exposures, including early and late injuries and disease development. The successful applicant must have facilities and staff to care for a combined minimum of 120 irradiated and unirradiated control NHPs, exposed at various ages and available for study, and must be able to accommodate receipt of additional radiation-exposed animals from other government-supported studies.
30 days prior to the application due date
May 31, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
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
Not Applicable
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose
The purpose of this limited competition Funding Opportunity Announcement (FOA) is to support continued care for and conduct of specialized research using a unique nonhuman primate (NHP) population. Specifically, the preservation, medical monitoring, study, treatment, and intervention in the development of late effects in NHP survivors of radiation exposure. NHPs most closely resemble human responses to radiation exposure and, as such, long-term studies on a radiation survivor cohort will permit continuous observations and treatment of this valuable population, while providing a critical understanding of the natural history of radiation exposures, including early and late injuries and disease development. The successful applicant must have facilities and staff to care for a combined minimum of 120 irradiated and unirradiated control NHPs, exposed at various ages and available for study, and must be able to accommodate receipt of additional radiation-exposed animals from other government-supported studies.
Background
The Department of Health and Human Services (HHS) has charged the NIH with the responsibility to identify, characterize, and develop new medical countermeasures against radiological or nuclear attacks. On October 14, 2004, the NIH convened an expert panel to review the “NIH Strategic Plan and Research Agenda for Medical Countermeasures against Radiological and Nuclear Threats” (https://www.niaid.nih.gov/sites/default/files/radnucstrategicplan.pdf). This strategic plan and research agenda outline a flexible, collaborative, and comprehensive NIH research and product development program focused on animal model development and medical therapies and diagnostics to address injuries sustained during a radiation public health emergency. On behalf of the NIH, NIAID is charged with implementing this research agenda. An updated Radiological and Nuclear Threats Program Progress Report and Future Research Directions was published in 2012 and can be found at https://www.niaid.nih.gov/sites/default/files/radnucprogressreport.pdf.
Concern about the threat of nuclear or radiological attacks has grown in recent years due to the increased activity of global terrorist organizations and documented illicit trafficking of radioactive materials. In addition, recent natural disasters, which have threatened the security of nuclear power facilities, highlight the need to stockpile countermeasures to treat radiation injuries in the civilian population. The overall goals of NIAID's program are the establishment of animal models for radiation-induced injuries, and the rapid development of safe and effective radiological/nuclear medical countermeasures for clinical use under emergency situations. To achieve these goals, it is critical to understand the natural history of radiation effects in the animal models that will be used to show efficacy of approaches to mitigate radiation-induced injuries.
Many radiation injuries that have been noted among human survivors of exposure lie in long-term effects, including organ failure, fibrosis, cardiovascular abnormalities, and cancer. A major gap exists in our understanding of how radiation exposures lead to the development of late effects in the months to years after irradiation. In particular, knowledge about the natural history of radiation injuries in nonhuman primates (NHPs) is especially important, since the NHP model is increasingly used to establish both the efficacy of candidate medical countermeasures and applicability of biodosimetry biomarkers and devices to support Food and Drug Administration licensure for use during and following a radiation incident.
For this reason, the NIAID’s Radiation and Nuclear Countermeasures Program (RNCP) has placed a strong emphasis on studying the late effects of radiation injury in a population of NHPs that have survived a prior radiation exposure.
An existing cohort of over 130 NHP (all rhesus macaques (Macaca mulatta), including unirradiated control animals and radiation survivors) is currently maintained as a Center-wide core within the RNCP’s Centers for Medical Countermeasures Against Radiation Consortium (CMCRC). Animals acquired and placed in the cohort have been exposed to single, whole-body doses of ionizing radiation in the range of 2 to 8.4 Gray (Gy). Animals receiving partial-body radiation exposures, as well as animals exposed to radiation and then treated with drugs have also been accepted into the cohort. Age-matched, non-irradiated animals have been acquired to serve as controls for normal growth, behavior and aging. Both male and female animals are being monitored. Maintenance of and studies on radiation NHP survivors has led to many important observations to date, including immune dysfunctions, development of cardiovascular, kidney, liver and lung complications, and cognitive impairments. In the current cohort, several unexpected patterns of radiation-associated disease have emerged. These findings have led to research publications documenting the development of these disease states in the monkeys. In addition, collected samples and data have been made available to more than 50 investigators in the research field.
Research Objectives and Scope
NHP cohort characteristics and research areas of interest for this FOA include, but are not limited to, the following:
NHP Cohort
Areas of Research
This FOA will support both observational (e.g. behavioral monitoring, and assessment of biomarkers of injury and animal disease status) and interventional (e.g. possible testing of treatment regimens) studies on animals in the NHP cohort. Types of studies that are of interest include, but are not limited to the following:
Milestones
The proposed research plan should encompass a milestone-based approach with explicit, detailed, and quantitative yearly milestones. These milestones will be used by NIAID program staff to assess progress and recommend continued funding on an annual basis.
Applications proposing the following will be considered non-responsive and will not be reviewed:
Applicants are advised to contact the Scientific/Research Contact with any questions they may have regarding the responsiveness of their application.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Need help determining whether you are doing a clinical trial?
NIAID intends to commit $3 million in FY 2020 to fund 1 award.
The scope of the proposed project should determine the project period. The maximum project period is 7 years.
Eligible applicant organizations are limited to those receiving grant and/or cooperative agreement funding from NIAID‘s Radiation and Nuclear Countermeasures Program (RFA-AI-14-055) at the time of application submission, and provide documented ability to access the existing NHP RSC cohort. NHP comprising the cohort must be housed at the applicant organization.
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.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
The letter of intent should be sent to:
Louis Rosenthal, Ph.D.
Telephone: 240-669-5070
Fax: 301-480-2408
Email: rosenthalla@niaid.nih.gov
All instructions in the SF424 (R&R) Application Guide must be followed. Completion of this section should describe all performance sites for all animal activities involving Nonhuman Primates (NHPs) or other live vertebrate animals.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Facilities & Other Resources: In addition to the information requested, the Facilities & Other Resources attachment should also address the following:
Availability of laboratory space and the ability to perform the following NHP studies and testing:
Provision of safe and reliable NHP transport to and from the site for accrual and evaluations in compliance with USDA AWA transportation regulations.
Applicant must demonstrate the availability of Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accredited NHP facilities with adequate housing and caging, including indoor and outdoor access.
Performance sites must maintain an exemplary program of animal care and use consistent with current Public Health Service (PHS) Policy. Basic evidence for this is accreditation by the American Association for the Accreditation of Laboratory Animal Care (AAALAC) International.
For all performance sites where animal activities involving live vertebrate animals/NHPS, please provide the Animal Welfare Assurance number and indicate if the facility is a Category 1, AAALAC accredited, or Category 2, not AAALAC accredited, institution as described in the Assurance. The organization must negotiate an Assurance with the Office of Laboratory Animal Welfare, NIH, if not previously approved. The Assurance is a commitment that the organization will adhere to the PHS Policy on the Humane Care and Use of Laboratory Animals and comply with the Guide for the Care and Use of Laboratory Animals (Guide) (National Research Council 2011) and the applicable regulations (9CFR, Subchapter A) issued by the United States Department of Agriculture (USDA) under the Animal Welfare Act (AWA).
Since the proposed work involves the use of NHPs, which are USDA-regulated species, each organization will have to register with the USDA and agree to comply with the AWA and annual inspections. If currently licensed or registered, please provide the license or registration number for each facility.
Provide verification of IACUC approval for activities at all performance sites, which may be filed before award with JIT procedures or earlier if required by the IC.All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
A biostatistician, an individual with radiation biology experience (e.g., conducting radiation diagnostic and treatment protocols), and at least one veterinarian with experience in handling irradiated NHPs should be included as key personnel.
Applicant must demonstrate the availability of Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accredited veterinary services with NHP research expertise.All instructions in the SF424 (R&R) Application Guide must be followed.
Animal care costs: Applicants should assume that up to 25 animals will be added to the cohort each year from other government-funded studies. These animals will be designated by NIAID staff, in conjunction with the PD(s)/PI(s).
Travel: Proposed budgets should include travel costs for the PD(s)/PI(s), or their representative, and one additional investigator to attend one meeting/event at the NIAID each year. Travel for up to two scientists to attend a scientific meeting each year (in order to present results from study of the cohort) may also be budgeted.
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. This could include observational studies to correlate observed late effects with radiation dose received, or the testing of different treatment protocols to address radiation-induced complications in animals in the cohort.
Research Strategy: Use this section to summarize the research strategy, including significance, innovation and approach and explain the rationale for selecting the methods to accomplish the specific aims. Applicant should assume that any diagnostics that are proposed to be carried out and/or standard, medical management and treatment(s) provided to the animals in the cohort would be consistent with treatment(s) provided to humans with similar symptoms (e.g. blood products, steroids, antibiotics, analgesics, anti-pyretics, etc.), with some exceptions, including use of cellular therapies (other than their use as part of a proposed, defined study) or other invasive/heroic measures (e.g. growth factor or other drug treatments (e.g. insulin for diabetes), cancer therapies, transplants, etc.). Detailed information should be included concerning standard clinically-relevant assessments that will be performed on animals in the cohort, and on what triggers to treat morbidities will be applied. Applicants should also discuss what samples will be archived from the animals, and what data will be preserved
Milestones: Include a synopsis and an assessment diagram/timeline detailing proposed diagnostic and/or treatment protocol(s), with clearly defined triggers to treat animals. Provide detailed, explicit and, where applicable, quantitative milestones that should be achieved each year of the project.
Letters of Support: Provide letter of support documenting access to the existing NHP radiation survivor cohort.
The following modifications also apply:
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.
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 SF424 (R&R) Application Guide must be followed.
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
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.
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.
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 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 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.
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.
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?
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 have appropriate veterinary expertise in handling irradiated NHPs? Do the investigators have appropriate expertise in biostatistics, radiation biology, pathology, and radiation dosimetry? Are AAALAC-accredited veterinary services with NHP research expertise available?
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?
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/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?
Specific to this FOA
Are the proposed approaches appropriate for NHP research? Are approaches to study underlying mechanisms and/or biomarkers appropriate? Are the milestones and timelines adequate, appropriate, and reasonably attainable?
Is the justification for the numbers of NHP to be selected for any particular observational study reasonable? Are the statistical considerations of the proposed experiments appropriate? Are the preparation of tissues or cells to be archived and the proposed methods, source, and number of NHP samplings/biopsies appropriate?
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 FOA
Are appropriate and sufficient AAALAC accredited veterinary services and NHP housing and care facilities available to carry out the proposed work? Are appropriate and sufficient NHP evaluation and treatment facilities available to carry out the work?
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.
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. 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 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.
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.
Not Applicable
Not Applicable
Not Applicable
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 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).
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 National Institute of Allergy and Infectious Diseases, 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.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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.
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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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 Part 75, 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:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
A NIAID program official will serve as the Project Scientist and will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
Areas of Joint Responsibility include:
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 Steering Committee 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.
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 instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (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: support@grants.gov
Andrea L. DiCarlo-Cohen, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3492
Email: cohena@niaid.nih.gov
Louis Rosenthal, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5070
Email: rosenthalla@niaid.nih.gov
Trevor Alford
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-747-7398
Email: Trevor.alford@nih.gov
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