and Human Services (HHS)
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Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
Funding Opportunity Title |
Predictive Biodosimetry: Discovery and Development of Biomarkers for Acute and Delayed Radiation Injuries (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-AI-11-033 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.855; 93.856 |
FOA Purpose |
The National Institute of Allergy and Infectious Diseases (NIAID) invites applications from institutions/organizations that propose to develop/discover biomarkers to predict acute and delayed radiation injuries to physiological systems/organs/tissues that can be used for triage and prompt treatment decisions in all segments of the civilian population after a radiological/nuclear terrorist incident. Radiation injury can take days or weeks to present clinical manifestations and some of the delayed radiation injuries (such as fibrosis) may not develop for months or years after exposure. This latency in symptoms may lead to delays in treatment decisions, thus resulting in increased morbidity and loss of lives. Moreover, individuals may differ in their sensitivity to radiation for a variety of reasons and precise treatment decisions may not be possible based on the radiation dose received by the individual. Therefore, there is a critical need to develop radiation injury biomarkers that will predict the acute and/or delayed injury to specific organs and tissues as well as devices to assay those biomarkers, to facilitate precise and timely medical intervention. This FOA will support identification, evaluation and characterization of organ/tissue-specific biomarkers to predict the acute and delayed radiation injury, including development of rapid, reliable, inexpensive and easy-to-use assays, techniques and/or devices for use in all segments of the civilian population. |
Posted Date |
May 25, 2011 |
Open Date (Earliest Submission Date) |
October 2, 2011 |
Letter of Intent Due Date |
October 3, 2011 |
Application Due Date(s) |
November 2, 2011, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
March, 2012 |
Advisory Council Review |
May, 2012 |
Earliest Start Date(s) |
July, 2012 |
Expiration Date |
November 3, 2011 |
Due Dates for E.O. 12372 |
Not Applicable. |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
National security experts have expressed increasing concern in recent years about the threat of radiological and nuclear terrorism. Scenarios of concern include the surreptitious or overt dispersion of radioactive materials, attacks on nuclear power plants, and the detonation of stolen or improvised nuclear weapons. Among the casualties of a nuclear detonation would be tens or hundreds of thousands of persons exposed to radioactive fallout downwind from the explosion. Such victims might not initially show clear signs and symptoms of radiation toxicity even if exposed to substantial doses of radiation. Similarly, persons exposed to a radiological dispersion device might also present with minimal evidence of exposure. 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, 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. There is thus 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.
Background
The Department of Health and Human Services (DHHS) has assigned the NIH the responsibility to identify, characterize, and develop new medical countermeasures against radiological or nuclear attacks. A robust research and development program in this area has already provided promising leads for new diagnostic tools, radioprotectors and mitigators and therapeutic agents to facilitate an effective response against radiological injury. 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 (http://www3.niaid.nih.gov/research/topics/radnuc/default.htm). This strategic plan and research agenda outlined a flexible, collaborative, and comprehensive NIH research and product development program focused on medical therapies and diagnostics to counter radiation injury. On behalf of the NIH, the NIAID is charged with implementing this research agenda.
In all terrorist radiation exposure scenarios, radiation induced injury to different physiological systems and tissues results from external exposure (the severity of which is dependent on radiation dose, dose-rate, and type of radiation exposure (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 a wide range of factors. Also impacting the severity 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). The extent of injury could also conceivably be modulated by the bystander effect and the host’s adaptive response to prior radiation exposure. 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 availability of effective treatment options. Moreover, inter-individual differences in radiation sensitivity may contribute to variability in the manifestations of radiation injury. 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, and thus do not allow for the prompt organ- and tissue-directed medical treatment that might be provided by any available radiation medical countermeasures. 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, in order to facilitate precise and timely medical intervention, reduce morbidity, and save lives.
Purpose
The goal of this Funding Opportunity Announcement (FOA) is to invite applications that support basic, applied or translational research on biomarkers of radiation injury. Specifically, the goal is to identify, evaluate and characterize markers of radiation injury to specific organs and tissues of physiological systems, in order to allow for timely and appropriate administration of medical countermeasures and/or other medical treatments to radiation victims. Ideal biomarkers are those that arise and are measurable prior to expression of tissue injury and thereby provide a time window for use of medical countermeasures that can mitigate injury. Useful biomarkers should be linked to relevant clinical outcomes such as organ failure, other major morbidity and/or mortality. It is important to develop methods to demonstrate that the change in the biomarker is related to the radiation exposure and not to other non-specific response to other health status, environmental and/or physiological factors. This goal includes 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, immune-compromised and genetically-susceptible individuals. The biomarker signal should be stable at 24 hr post-exposure and over a relatively long period of time (i.e. days to weeks and months, and not seconds to minutes and less than 24 hr 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 is measurable in a non-invasive or minimally invasive way, allows for repeated assays over time, is sensitive to incremental changes in radiation exposure, is specific over a wide range of radiation doses and dose-rates, and is equally-reliable for different qualities of radiation (high and low LET). Studies in animal models will be required to identify and characterize the biomarkers of radiation injury to specific organs and tissues of physiological systems. Clinical research studies (not including clinical trials) 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.
This FOA includes, but is not limited to the following areas:
This program will not support the following:
Applications that do not follow above instructions will be considered nonresponsive and will not be reviewed.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
NIAID intends to commit an estimated $4 million in FY 2012 to fund nine to eleven awards. |
Award Budget |
Budgets for direct costs of up to $250,000 per year may be requested for a maximum of $1,250,000 direct costs over a 5-year project period. |
Award Project Period |
Applicants may propose a project period up to 5 years. . |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organizations) are
not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity
The letter of intent should be sent to:
Priti Mehrotra, M. Sc., Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
(NIAID)
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
For Express Couriers: 20817-1824
Telephone: 301-435-9369, 301-496-2550
Fax: 301-480-2408
Email:pm158b@NIH.GOV
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
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 SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIAID, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is it likely that the proposed studies will result in the discovery and development of biomarkers to predict acute and/or delayed radiation injuries to tissues and/or organs of physiological systems?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed? Are there sufficient preliminary data to support the proposed
research?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR Part
46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable.
Renewals
Not Applicable.
Revisions
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
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) Genome Wide Association Studies (GWAS).
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.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NIAID, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
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 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 the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov
Narayani Ramakrishnan,
Ph.D.
Division of Allergy,
Immunology and Transplantation
National Institute of
Allergy and Infectious Diseases (NIAID)
Room 5306, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: 301-451-3101
Fax: 301-480-6597
Email: nramakrishnan@niaid.nih.gov
Priti Mehrotra, M. Sc., Ph.D.
Division of Extramural Activities
National Institute of
Allergy and Infectious Diseases (NIAID)
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
For Express Couriers: 20817-1824
Telephone: 301-435-9369, 301-496-2550
Fax: 301-480-2408
Email:pm158b@NIH.GOV
Lesia Norwood
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
(NIAID)
Room 2116, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: 301-402-7146
Email: lnorwood@niaid.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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