Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Eye Institute (NEI) (http://www.nei.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov/)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
Title: Countermeasures Against Chemical Threats (CounterACT)
Research Centers of Excellence (U54)
This is a reissue of RFA-NS-08-004.
Update: The following update relating to this announcement has been issued:
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).
Program Announcement (PA) Number: PAR-10-181Catalog of Federal Domestic Assistance Number(s)
Release Date: April 29, 2010
Letters of Intent Receipt Date(s): August 14 2010; August 14, 2011; August 14, 2012
Application Receipt Date(s): September 14, 2010; September 14, 2011; September 14, 2012
Peer Review Date(s): February/March 2011; February/March 2012; February/March 2013
Council Review Date(s): May 2011; May 2012; May 2013
Earliest Anticipated Start Date: July 1, 2011; July 1, 2012; July 1, 2013
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: September 15, 2012
Dates for E.O. 12372
Additional Overview Content
Table of Contents
I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application
2. Review and Selection Process
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution Process
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Purpose and Nature of this Research Opportunity
The overall goal of the NIH CounterACT program is to reduce mortality and morbidity during and after emergency events involving the release of chemical threat agents. Chemical threat agents are toxic chemicals that could cause mass casualties after being released by a deliberate terrorist attack, or by industrial accident or natural disaster (see below for categories and examples of chemicals). The purpose of this U54 research opportunity is to foster and support the development of Food and Drug Administration (FDA)-approved therapeutics that can be used effectively to treat individuals during a chemical emergency event. This announcement requests new proposals, as well as renewal applications of existing projects within the CounterACT Network (see www.ninds.nih.gov/counteract).
The NIH has developed a comprehensive CounterACT Research Program that includes a research network of Research Centers of Excellence, individual research projects, contracts and Interagency Agreements with the Department of Defense. The network conducts basic, translational, and clinical research aimed at the discovery and/or identification of better medical countermeasures against chemical threat agents, and it supports their movement through the regulatory process. The CounterACT U54 program described in this FOA is a central component of this overall larger effort, and is designed to support research centers consisting of three or more subprojects and scientific cores that synergistically produce the highest quality research on and development of relevant therapeutics. To ensure that the research is translational in nature, CounterACT Research Centers of Excellence will be milestone-driven cooperative agreements with substantial scientific and programmatic involvement by NIH staff.
CounterACT cooperative agreement U54 Principal Investigators will become members of the CounterACT Research Network, and will be able to utilize its resources such as the CounterACT Preclinical Development Facility (CPDF) (see below). They will be expected to participate in annual meetings of the national CounterACT research network to share information and ideas. The CounterACT program at NIH is part of the larger biodefense program coordinated by the National Institute of Allergy and Infectious Diseases (NIAID) that includes biological and radiation/nuclear threats (http://www3.niaid.nih.gov/topics/BiodefenseRelated/). Also see www.medicalcountermeasures.gov which facilitates communication between federal government agencies and public stakeholders to enhance the Nation's public health emergency preparedness.
Examples of Threat Agents
The civilian chemical threat spectrum includes chemical warfare agents, and toxic industrial chemicals, pesticides, toxins and other chemicals. The following is a list of examples of chemical threat agents based on their primary target tissue and physiological effects:
Chemicals not included on this list may also be eligible. Applicants are strongly urged to contact the Program Officials listed in this FOA to determine if their proposed threat agent or countermeasure is of high enough programmatic priority to be considered for funding under the CounterACT U54 program.
Special Biosafety Certification
Many of the chemical threat agents are extremely hazardous to humans. This FOA will only consider supporting studies deemed safe for research personnel and the environment by appropriate official institutional biosafety review. This must be addressed in the application, including a description of adequate protection and safeguards if required.
Because of the special biosafety concerns with some chemical agents, applicants are encouraged to collaborate with laboratories that are certified to work with restricted chemical agents, such as the US Army Medical Research Institute of Chemical Defense and others. Applicants are strongly encouraged to contact the NINDS program official listed in this FOA for further information on working with restricted chemical agents.
Broad Spectrum Therapeutics
Antidotes that are specific to a chemical will be considered, however, applicants should also consider research on acute effects and pathologies that are common to several chemical threat agents, so that the therapeutics being developed will have a broader spectrum of activity against more than one chemical. Some of these effects include:
Scope of Research
This FOA will only support translational research. Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease. The categories of research supported under this program include but are not limited to:
The scope of research covered by this FOA is also described by Technology Rediness Levels (TRLs) for Medical Countermeasure Products listed at https://www.medicalcountermeasures.gov/Integrated_TRLs.aspx. This FOA generally covers research that would produce a medical countermeasure that would be rated at the TRL 3 through TRL 6 at the end of the project period.
Center Goals and Subprojects
There must be a unifying well-defined goal or problem area of research to which each project relates and contributes, thereby producing a synergistic research environment that allows each research effort to share the resources and creative strengths of the others. There is the expectation that support of interrelated projects and collaborating investigators would yield results beyond those achievable if each project were pursued separately without formal interaction among the participating investigators. All investigators must contribute to, and share in, the responsibilities of fulfilling the Center objectives.
Each CounterACT U54 application must include clearly stated project milestones. Milestones toward therapeutic intervention are not a description of specific aims and experiments, but rather are discreet goals that create go/no-go decision points in the project that include quantitative success criteria. For examples of acceptable milestones, see www.ninds.nih.gov/research/counterterrorism/developing_milestones.htm. Milestones for each year of each Center subproject should be listed in the Research Strategy section of each subproject. In addition, milestones for the overall Center should be listed in the Overview section (Section A) described below in Special Instructions for CounterACT Center Applications. These Center milestones should reflect the overall goals and objectives of the Center, and be supported by the milestones proposed in the subprojects. There may only be 3 or 4 Center milestones over the course of the entire project period. Annual milestones may be modified in negotiations with NIH program officials before an initial award is made, and during the review of annual non-competitive renewal applications. Unmet milestones will have a negative impact on the review and approval of these annual renewal applications.
If a specific new therapy has not yet been identified, the proposed translational research should demonstrate a clear path towards identification of a lead compound by the end of the project period. Lead compounds are biologically active compounds or hits where affinity, potency, and selectivity have been established. If the project goals are related to model development, then the model(s) should be fully developed and validated by the end of the project period. Validation includes a demonstration of the model’s predictive value for screening compounds for the desired therapeutic effect. The proposal should describe in detail how the proposed research will lead to the development of a validated model and/or lead compound, and it should present milestones related to achieving that goal.
Use of the CounterACT Preclinical Development Facility (CPDF)
In order to leverage resources already established by the CounterACT program, applicants may propose preclinical studies to be conducted at the CounterACT Preclinical Development Facility (CPDF) at no cost to the applicant. The types of studies available at this facility include, but are not limited to:
Applicants must justify inclusion of these studies as part of a logical and progressive milestone-driven drug development plan. Experimental details of the proposed studies in these categories should not be included in the application. However, each proposed study must be well-justified as an essential component of the overall study plan. The costs of these studies should not be included in the budget of the application. See http://www.ninds.nih.gov/research/counterterrorism/developing_milestones.htm for an example of a milestone that includes studies to be conducted at the CPDF (Example B, Year 5). In order to qualify for including CPDF studies in the application, the following steps must be taken at least six weeks before the application receipt date:
Alternatively, applicants may choose to conduct these studies in laboratories other than the CPDF. In this case, the costs of these studies should be included in the application budget, if needed.
Specific examples of relevant research topics include but are not limited to those listed below:
Special considerations related to the significance of proposed research:
Because of the urgency in need, and the lengthy time and expense for bringing a new compound to regulatory approval, applicants are encouraged to consider drugs that are already approved by the FDA for other indications. Some of these drugs have been shown to be effective in treating victims of chemical exposures, and in some cases, the length of time to regulatory approval for a new indication may be shorter than for a novel compound. Applicants are urged to contact the Scientific Contacts listed in this FOA for more information related to the FDA, including FDA contacts.
This FOA will only support translational research that is clearly relevant to the development of therapeutics that will enhance our medical response capabilities during an emergency. New medical countermeasures that have no practical use during a mass casualty situation will not be considered. Drugs that are only effective if given prior to chemical insult (pre-treatment), or those that must be given within a very short period (1-15 minutes) after the insult will be of low priority. Because many chemical threats have rapid modes of action, the drug should act rapidly to counter these effects. The ultimate intended use of a drug should be discussed within the application, including timing and route of administration that is consistent with its effective use in an emergency setting. For example, drugs that are only effective when administered intravenously would be of low priority since its use would be impractical in a mass casualty situation. Model development, screening activity and efficacy studies should be designed and justified with these ultimate requirements under consideration.
Special consideration will be given to research relevant to people who are particularly vulnerable, including the young, the elderly, and individuals with pre-existing medical conditions. Pregnant women, infants and children are particularly vulnerable to the effects of chemical agents. Animal models and studies that address these vulnerabilities will be of high priority.
CounterACT Center Structure
Each CounterACT Research Center of Excellence must include the following components:
Description of CounterACT Center Components:
1. Administrative Core for Center Management and Operations
The Principal Investigator (PI) or Center Director will be responsible for overall planning and management of the CounterACT Center. The PI must be the director of the Administrative Core and must commit at least 10% effort to these responsibilities, in addition to his/her own CounterACT Center research and other activities, if applicable. The PI is permitted but not required to be a subproject or core investigator.
The PI and Administrative Core staff will be responsible for managing, coordinating, and supervising the entire range of Center activities, monitoring progress, and ensuring that a strategic plan is implemented in an effective and efficient manner. This may require both an Administrative and Scientific Program Manager to assist the PI. The PI and Administrative Core staff will be responsible for ensuring that appropriate systems are in place to provide for biosafety and security of materials, data, and facilities.
2. Research and Development Projects
These projects should be scientifically linked. Examples of how these projects could be linked include:
3. Scientific Core(s)
Scientific core facilities may be proposed if they will be utilized by at least two of the subprojects. Such core facilities should provide services that are already available, fully developed, and cannot be funded through other means for the purposes proposed. The cores should be well justified within the description of the proposed core facility and also within each relevant subproject description. If subprojects are removed, replaced, or redirected during the funding period, core facility funds may be rebudgeted within the individual CounterACT Center upon approval by the NIH. Scientific core facilities may include clinical, statistical, technical, or other supportive activities. If appropriate to the particular CounterACT Center, repositories for cells, tissues, data, or reagents may be funded under this component. In this case, applications should include methods to obtain, protect, and archive relevant pathological, clinical, and family history information. In addition, appropriate informatics capability should be provided to track data and link to other data sets. A plan for distribution of data or samples should also be included, and should conform to the NIH policy on data and resource sharing (http://grants.nih.gov/grants/policy/data_sharing).
4. Training and Education Program (Core)
One goal of the CounterACT program is to increase the number and capabilities of researchers and other personnel in applied toxicological research related to chemical threats. In general, proposed training and education programs should be multidisciplinary and provide short-term education for technicians, medical or graduate students, postdoctoral fellows, and/or independent investigators, either within or beyond the CounterACT Center. Formal graduate programs are excluded from this FOA.
The proposed program should build on the strengths of the Center investigators, although outside instructors may be incorporated into the program on occasion to provide cross-disciplinary depth.
One or more of the following activities may be proposed, and applicants should clearly justify the choice of activity(s) in terms of value to the particular CounterACT Center, the CounterACT Network, and the general research community:
CounterACT Center Steering Committee:
A Steering Committee for each CounterACT Center will make strategic decisions with regard to goals and research implementation of the Center to ensure that scientific milestones are met, resources are shared, and productive collaborations are established. The Center Steering Committee will meet as frequently as possible utilizing various modes of communication, and be composed of the Principal Investigator, subproject investigators and other members with relevant scientific expertise. The NIH program official will serve on this committee.
External Advisory Committee:
Awardees will form an External Advisory Committee. This committee will provide subjective evaluation of the annual or progress of the Center, and make recommendations to the Center PI. The Committee should meet once per project year. In order to maintain the largest possible reviewer pool for this FOA, applicants should not propose specific external advisors and should not contact potential members prior to NIH review of the application. However, applicants submitting a competitive renewal application are permitted to utilize their existing External Advisory Committee, as they deem appropriate.
Competitive Renewal Applications
Competitive renewal applications must adhere to special instructions described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A competitive renewal application must be consistent with the scope of research of this FOA and clearly build upon the scientific advances made during the previous award.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This funding opportunity announcement (FOA) will use the Specialized Center Cooperative Agreement (U54) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This is a cooperative agreement award mechanism. In the
cooperative agreement mechanism, the Project Director/Principal Investigator
(PD/PI) retains the primary responsibility and dominant role for planning,
directing, and executing the proposed project, with NIH staff being
substantially involved as a partner with the Principal Investigator, as
described under the Section VI. 2. Administrative
"Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
The participating Institutes intend to commit on average $6 million per year in Fiscal Years 2011, 2012, and 2013 to fund new and/or competing renewal awards. The total number of anticipated awards is approximately 4-6.
Budgets for direct costs per year will depend upon specific project requirements, and a project duration of up to five years may be requested. For most studies within the scope of this FOA, the expected direct cost for individual awards is $1.5-2.5 million per year for a total of $7.5-12.5 million over a five-year project period.
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
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.
The following organizations/institutions are eligible to apply:
Foreign institutions are not eligible to apply but may be members of consortia headed by U.S. institutions.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution 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.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Applicants may submit a renewal application.
1. Address to Request Application
The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398.
further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).
must have a D&B Data Universal Numbering System (DUNS) number as the
universal identifier when applying for Federal grants or cooperative
agreements. The D&B number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dnb.com/us/. The D&B number should
be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
See Section IV.3.A. for details.
Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): August 14, 2010; August 14, 2011; August 14, 2012
Application Receipt Date(s): September 14, 2010; September 14, 2011; September 14, 2012
Peer Review Date(s): February/March 2011; February/March 2012; February/March, 2013
Council Review Date(s): May 2011; May 2012; May 2013
Earliest Anticipated Start Date(s): July 1, 2011; July 1, 2012; July 1, 2013
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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
review staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A.
The letter of intent should be sent to:
David A. Jett, Ph.D.
Program Director, NIH CounterACT Research
National Institutes of Health, NINDS
6001 Executive Blvd.
NSC, Room 2177, MSC 9527
Bethesda, MD 20892-9527
3.B. Sending an Application to the NIH
must be prepared using the research grant application forms found in the PHS
398 instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and five
signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
Applications must be received on or before the application receipt/ date(s) described above (Section IV.3.A.). If an application is
received after that date, it will be returned to the applicant
Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. 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. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information.
Special Instructions for CounterACT Center Applications:
For CounterACT Center applications submitted in response to this FOA, the standard PHS 398 Research instructions for application preparation are altered as follows:
In the Key Personnel table provided, list the PI for the overall CounterACT Center and the investigator responsible for each component project or core. List the investigators in the same order in which their individual components are presented. Under "Role on Project" state the investigator's role (e.g., "Investigator, Project 1", "Co-investigator, Core B", or "Consultant, Project 3").
Prepare a detailed table of contents that will enable reviewers to find specific information readily. Present the projects first and the cores last. Applicants should prepare only a single face page for the entire application, not one for each component. The title should be followed by "(U54)".
Table of Contents (PHS 398 Form Page 3): Modify Form Page 3 of the PHS 398 to replace standard sub-sections of Section 3 “Research Strategy” of the PHS 398 Research Plan with the following new sub-sections A-E:
A. Overview of the Proposed CounterACT Center and Its Area of Focus
B. Administrative Core for Center Management and Operations
C. Research and Development Projects (Numbered: Project 1, Project 2, etc.)
D. Scientific Cores (Lettered: Core A, Core B, etc.)
E. Training and Education Program (Core)
Budget (PHS 398 Form Pages 4 and 5): Follow the current PHS 398 instructions to provide a detailed budget (direct costs) for the entire application for the first 12-month period (Form page 4) and the entire proposed project period (Form page 5). Include appropriate budget pages for any sub-contractual arrangements proposed.
Use additional Form Pages 4 and 5 to provide detailed separate budget information (first year and cumulative budgets for the entire project period) for the following individual application components:
RESEARCH PLAN: The standard PHS398 Research Plan is altered as follows:
Other sections of the PHS398 Research Plan remain unmodified and should be completed following standard instructions.
A. Overview of the Proposed CounterACT Center and Its Area of Focus (up to 12 pages)
Present the overall vision for the proposed CounterACT Center including the following segments:
B. Administrative Core for Center Management and Operations (up to 12 pages).
The description must contain the following elements:
C. Research and Development Projects - three to five projects (up to 12 pages for each Project).
Describe each research project in sufficient detail to enable reviewers to judge its scientific merit.
The description must contain the following elements:
D. Scientific Cores – up to two cores (up to 6 pages/Core)
For each proposed Scientific Core include:
E. Training and Education Program (Core) (up to 6 pages)
In this section, describe the following:
Note: a minimum of $50,000 in direct costs must be allocated to the Training and Education Core activities in the budgetary request.
When appropriate, awardees will be expected to collaborate; share novel reagents, assays, and animal models; and share both positive and negative results that would help guide the research and development activities of other CounterACT awardees. These activities will be facilitated by annual meetings of CounterACT investigators. Budgets should include cost for travel to one annual meeting of CounterACT investigators, in addition to other anticipated travel associated with the research.
This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
Specific Instructions for Applications Requesting $500,000
(direct costs) or More per Year
Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;
2) Obtain agreement
from the IC staff that the IC will accept the application for consideration for
3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.
This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004.
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Only the review criteria described below will be considered in the review process.
Review and and Selection Process
submitted for this funding opportunity will be assigned on the basis of
established PHS referral guidelines to the ICs for funding consideration.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support 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 five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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?
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?
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?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Individual Research and Development Projects:
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.
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.
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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period. How significant is the contribution of the applicants’ currently funded CounterACT Research Center to scientific knowledge in the field? How well have the applicants accomplished the specific objectives and milestones proposed in the original CounterACT Research Center application?
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Additional Review Considerations
As applicable for the project proposed, reviewers will address 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. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Budget and Period 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 submitted in response to this funding opportunity will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
NIH considers the following in evaluating Center grant applications:
3. Anticipated Announcement and Award Dates
1. Award Notices
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.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
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. See Also Section IV.5. Funding Restrictions.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.
2. Administrative and National Policy Requirements
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
Annual milestones will be included in the Special Terms and Conditions of the Notice of Award. Failure to meet these annual milestones will have a negative impact on the review of Type 5 non-competitive progress reports.
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS 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.
2.A.1. Project Director/Principal Investigator (PD/PI) Rights and Responsibilities
The Principal Investigator will have the primary responsibility for defining objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.
Awardees are responsible for identifying specific milestones toward countermeasure development that will be achieved during the project period.
Awardees are responsible for establishing an external advisory committee composed of experts not otherwise associated with the activity.
Awardees agree to participate in the overall coordination of NIH CounterACT Research Network. This participation may include collaboration and consultation with other CounterACT research awardees, and the sharing of information, data, and research materials.
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 HHS, PHS, and NIH policies.
2.A.2. NIH Responsibilities
An NIH Project Scientist [or “Project Coordinator,” or “Project Collaborator,” or “Intramural Scientist”] will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
Each project will have the support of one or more Project Scientists from NIH program staff who are assigned an administrative role for the medical countermeasure(s) being studied and have expertise in the implementation of the CounterACT program.
The NIH Project Scientists will have substantial scientific-programmatic involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants.
NIH Project Scientists will be responsible for assessing the progress of the projects toward the accomplishment of specified milestones, and for recommending if further funds should be released to the project.
The NIH Project Scientists will facilitate the establishment of contacts and collaborations between awardees of the CounterACT program and other persons or organizations whose participation will assist with the accomplishment of project goals. These persons or organizations may include the FDA, disease voluntary organizations, pharmaceutical companies, or research organizations that can provide essential services on contract.
An important part of the CounterACT program is the coordination of research efforts across different funding mechanisms and research structures, and coordination among efforts aimed at different medical countermeasures. NIH Project Scientists will have the primary responsibility for this overall coordination.
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. The assigned program director may also serve as an NIH
2.A.3. Collaborative Responsibilities
A Steering Committee will make strategic decisions with regard to goals and research implementation, including the establishment of shared resources and the development of collaborations. The Steering Committee will meet at least annually.
The Steering Committee will be composed of the project PI, and other investigators who are leaders of individual projects within the award or leaders of efforts at consortium sites, if applicable, and one or more NIH Project Scientists. The project PI will serve as chairperson of the Steering Committee.
Each full member will have one vote. The NIH Project Scientists will have a single NIH vote. Awardee
members of the Steering Committee will be required to accept and implement policies approved by the
2.A.4. Dispute Resolution Process
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 in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
1. Scientific/Research Contacts:
Primary contact for questions concerning the overall CounterACT program or for questions related to the mission of NINDS and its role in the CounterACT program:
David A. Jett, Ph.D.
Program Director, NIH CounterACT Research
National Institutes of Health, NINDS
6001 Executive Blvd.
NSC, Room 2177, MSC 9527
Bethesda, MD 20892-9527
For questions related to the mission of NEI and its role in the CounterACT program:
Houmam Araj, Ph.D.
Div. of Extramural Research
National Eye Institute
5635 Fishers Lane, MSC 9300, Suite 1300
Bethesda, MD 20892-9300
For questions related to the mission of NIAID and its role in the CounterACT program:
Dr. Gennady E. Platoff, Jr
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 5407, MSC-6615
6610 Rockledge Drive
Bethesda, MD 20892-6601
For questions related to the mission of NIAMS and its role in the CounterACT program:
Hung Tseng PhD
Extracellular Matrix Biology and Disease Program
Division of Skin and Rheumatic Diseases
National Institute of Arthritis, Musculoskeletal and Skin Diseases
National Institutes of Health
One Democracy Plaza, Room 886
6701 Democracy Boulevard
Bethesda, MD 20892-4872
For questions related to the mission of NICHD and its role in the CounterACT program:
David A. Siegel, M.D.
Obstetric and Pediatric Pharmacology Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard
Bethesda, Maryland 20892
For questions related to the mission of NIEHS and its role in the CounterACT program:
Elizabeth A. Maull, Ph.D.
Program Administrator, Susceptibility and Population Health Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC21
Research Triangle Park, NC 27709
For questions related to the mission of NIGMS and its role in the CounterACT program:
Richard T. Okita, Ph.D.
Division of Pharmacology, Physiology, & Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, Room 2AS-49A
Bethesda, MD 20892-6200
2. Peer Review Contacts:
Jonathan Ivins, Ph.D.
Scientific Review Officer
Center for Scientific Review, NIH
Rockledge II, room 4186
6701 Rockledge Drive, MSC 7850
Bethesda, MD 20892-7850
(20817 for Fed-Ex)
3. Financial or Grants Management
Grants Management Specialist
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd.
Bethesda, MD 20892
Telephone: 301- 496-5707
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Access to Research Data through the Freedom of
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Inclusion of Women And Minorities in Clinical
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.
Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
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