Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
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/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
 
Title: Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54)

Announcement Type
New

Request For Applications (RFA) Number: RFA-NS-06-005

Catalog of Federal Domestic Assistance Number(s)
93.867, 93.856, 93.846, 93.113, 93.859, 93.853

Key Dates
Release Date: January 3, 2006
Letters of Intent Receipt Date(s): March 10, 2006
Application Receipt Dates(s): April 11, 2006
Peer Review Date(s): July-August 2006 
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 15, 2006
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: April, 12, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary  

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) 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

Section IV. 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 Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  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. Arbitration Process
  3. Reporting

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

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The purpose of this research program is to support specialized center cooperative agreements (U54s) to conduct interdisciplinary and collaborative research on the development of safe and effective medical countermeasures against chemical threats.  Chemical threat agents are toxic chemicals that could be used in a terrorist attack against civilians, or chemicals that could be released at toxic levels by accident or natural disaster.  Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence are being solicited in this RFA.

Background

The increased risk of a terrorist attack in the United States involving chemical agents has created new challenges for many departments and agencies across the federal government.  Within the Department of Health and Human Services (DHHS), the NIH is taking a leadership role in pursuing the development of new and improved medical countermeasures designed to prevent, diagnose, and treat the conditions caused by potential and existing chemical agents of terrorism.  In addition, many of the same chemicals posing a threat as terrorist agents may also be released from transportation and storage facilities by industrial accidents or during a natural disaster.  The NIH is developing a comprehensive CounterACT Research Network that includes CounterACT Research Centers of Excellence, individual research projects (U01s), SBIRs, contracts and other programs (see http://www.ninds.nih.gov/funding/research/counterterrorism/index.htm).  The network will conduct basic, translational, and clinical research aimed at the discovery and/or identification of better therapeutic and diagnostic medical countermeasures against chemical threat agents.  The overarching goal of this research program is to enhance our diagnostic and treatment response capabilities during an emergency.   The CounterACT Research Centers of Excellence initiative described in this RFA is part of this overall larger effort, and is designed to support research centers that consist of three or more subprojects and scientific cores that synergistically produce the highest quality research on the development of medical countermeasures against chemical threats.    To ensure that research is focused on the development of new and improved countermeasures and their movement through the regulatory process, CounterACT Centers will be funded as specialized center cooperative agreements (U54s) with substantial involvement by NIH staff.  Each CounterACT Center will be part of the CounterACT Research Network which will facilitate interactions with regulatory and public health organizations.  The CounterACT Center principal investigator and the sub-project and core investigators will be members of the research network. This program will be similar to the program already underway for the NIH/NIAID Radiation/Nuclear program launched in FY05.   A series of workshops has been held at NIH to identify research gaps in our knowledge of effective medical countermeasures against chemical threat agents.  The NINDS and NIEHS have previously supported research on countermeasures against chemical threat agents through an administrative supplement program.   The chemical threats program at NIH is part of the larger biodefense program coordinated by the National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/) that includes biological and radiation/nuclear threats.

Objectives

The primary objective of the CounterACT Research Centers of Excellence initiative is to develop medical countermeasures against chemical threat agents.  Highest priority will be given to research that is clearly aimed at rapid advancement of candidate therapeutics or diagnostic techniques through the regulatory process, so that they can be used to enhance the medical response capabilities of the United States. 

Higher Priority Chemical Threats

The civilian chemical threat spectrum now includes chemical warfare agents, toxic industrial chemicals, toxins and other chemicals.  Categories of higher priority chemical threats that will be supported by the CounterACT Centers program include:

Applicants are urged to contact the program officials listed in this RFA to determine whether their proposed threat agent or countermeasure is of high enough programmatic priority to be considered for funding under the CounterACT Centers program.

Scope of Research

The CounterACT program will only support basic or translational research that is clearly relevant to the development of new or improved therapeutic drugs or diagnostic techniques 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 under this program. The categories of research supported under this program include:

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.  Clinical research, including trials, will be supported but will depend on the nature and scope of the proposed project and the potential for advanced development.  All applicants are strongly encouraged to confer with NIH staff and with staff at the U.S. Food and Drug Administration (FDA) as soon as an appropriate product candidate or medical approach is identified. Information on FDA processes, requirements, and contacts can be found at the following web sites: http://www.fda.gov/cder/about/smallbiz/default.htm; http://www.fda.gov/cber/manufacturer.htm; and http://www.fda.gov/cdrh/devadvice.

Some examples of research projects that could be supported within CounterACT Centers are listed below.  This list only presents some examples of research that could be supported by this RFA.  Investigators are encouraged to contact the program officials listed in this RFA to determine if their proposed research will be responsive.  Research may include but is not limited to:

Special Biosafety Certification

Special biosafety certifications may be required to conduct research with some chemical threat agents, e.g. nerve agents.  Therefore when applicable, applicants will be encouraged to collaborate with laboratories that are certified to work with restricted chemical agents, such as the NIH-supported facility at the US Army’s Institute of Chemical Defense.  Applicants are encouraged to contact the NINDS program official listed in this RFA for further information on working with restricted chemical agents.

CounterACT Center Structure

Each CounterACT Research Center of Excellence must include the following components:

Overview of CounterACT Center Components:

1. Center Management and Operations

The Principal Investigator (PI) 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.

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.  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.  Institutions must be in compliance with U.S. laws and regulations and DHHS and NIH policies in effect at the time of grant award and during the period of performance of the research.

Proposed Alteration and Renovation (A&R) must be included in the administrative core budget. A&R funds can be used for U.S. institutions only.  Alteration and renovation (A&R) is defined as work required to change the interior arrangements or other physical characteristics of an existing facility or of installed equipment so that it may be more effectively used for its proposed designated purpose or adapted to an alternative use to meet a CounterACT Center programmatic requirement. The budget for A&R is restricted to one-time maximum funds of $300,000 total costs (direct plus indirect costs). The applicant must identify the proposed Research/Development or Scientific Core Facility project(s) that will benefit from the availability of the improved facilities, and describe how the A&R funds will be used to enhance the research activities within the scope of the proposed Center projects. Plans for other research uses of the A&R-improved resources should also be described so that the full benefit of the request can be assessed by both the reviewers and the NIH.

The planning and management of the Training and Education Program (see 4. below) shall be done by the Center Management and Operations (Administrative Core).

2. Research/Development Projects

The CounterACT Center must include at least three (3) R01-type Research/Development Projects. The Research/Development Projects must be focused on product development as an ultimate goal, even if development of licensed products will not be completed within the funding period.  Basic discovery or mechanistic research is allowed, but it must be made clear in the application that the results will identify targets for therapeutic development or contribute significantly to a medical approach that is feasible for human use and feasible to stockpile or use in emergency situations (see Scope of Research above). Each project should include sufficient preliminary data to allow a realistic assessment of the likely productivity of the research plan.

All proposed projects should be linked to the extent that each project contributes to a synergistic research and development effort toward a specified goal of developing a single or group of medical countermeasures.  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 Research/Development Projects. Such core facilities should provide services that are already available, fully developed, and cannot be funded through other means for the purposes proposed. They should be well justified within the description of the proposed core facility and also within each relevant Research/Development Project description. If Research/Development Projects 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 RFA.

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:

Program Oversight

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 at least annually, and be composed of the Principal Investigator, Sub-project investigators and other members with relevant scientific expertise. The NIH program official will serve on this committee.  Applicants may propose external advisors as well, however, in order to maintain the largest possible reviewer pool for this RFA, applicants should not propose specific external advisors and should not contact potential members prior to NIH review of the application.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U54 Specialized Center Cooperative Agreement award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U54 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator 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 Requirements, "Cooperative Agreement Terms and Conditions of Award". 

2. Funds Available

The participating IC(s) NEI, NIAID, NIAMS, NIEHS, NIGMS, NINDS intends to commit approximately $15 million dollars in FY 06 to fund 3-5 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs up to $2.5 million dollars per year. The budget for each U54 must be clearly justified.    

Because 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 and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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 programs.

2. Cost Sharing or Matching

Cost sharing is not required.
 
The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Milestones

This RFA supports basic and translational research (see Section 1).  Since the need for new and improved medical countermeasures is time-sensitive, priority will be given to those projects that are translational in nature, with a new therapy or diagnostic technique that has already been identified, and one that needs further development.  Each CounterACT Center application must include a clearly stated project timeline that includes practical achievable goals and project milestones.  Milestones toward therapeutic intervention are goals that create go/no-go decision points in the project, including quantitative success criteria.  Some awards may be contingent upon pre-award negotiations between the applicant and the NIH whereby milestones are reviewed and refined. Progress towards proposed milestones will be a major factor in the review and approval/disapproval of Type 5 non-competing annual applications.

If a specific new therapy or diagnostic technique has not yet been identified, basic research should clearly be relevant to the discovery of a new countermeasure.  The proposal should describe in detail how the proposed research will lead to the development of a medical countermeasure, and present milestones related to achieving that goal, some of which may be future plans outside the scope of the current research proposal.

Any collaborators, consultants, or subcontractors should be identified, no matter when during the conduct of the activity the proposed interaction occurs. It is not required that an IND or IDE is achieved during the first project period, but the plan to complete pre-clinical development should be presented in the application. Since translational research is intrinsically interdisciplinary, this plan will often involve cooperation among basic researchers and clinicians, and may include the participation of private-sector companies and voluntary organizations.

Pre-application Technical Assistance Workshop

An informational session will be held for investigators representing groups considering submission of applications in response to this RFA. Details of this meeting will be announced on the NINDS Counterterrorism web site (see http://www.ninds.nih.gov/funding/research/counterterrorism/index.htm).   Representatives from the NIH CounterACT program and NINDS Division of Extramural Activities will provide information and answer questions pertinent to preparing applications in response to this RFA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The 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. For 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

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications 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 on line 2 of the face page of the application form and the YES box must be checked.

Special Instructions for the CounterACT Center Application

Since the PHS 398 application form is designed primarily for the traditional research project grant (R01) application, several sections have to be modified and expanded so that the form can be used to provide the information needed for a CounterACT Center multi-component research project application.

Prepare a detailed table of contents that will enable reviewers to find specific information readily. Present the projects first and the cores last. Identify each component by title, and assign each project a number and each core a capital letter that reflects the order in which the projects and cores are presented in the application, and provide the name of the investigator responsible for each component.

Applicants should prepare only a single face page for the entire application, not one for each component. The title should be followed by "(U54)".

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").

For the entire CounterACT Center, as well as for each project and core, prepare the standard "Detailed Budget for Initial Budget Period" and the "Budget for Entire Proposed Project Period." Identify each budget page (e.g., "Composite", "Project 1", etc.). Place the composite budget pages first, followed by the projects and cores. All budgets (composite, projects, and cores) will be in this one section. Individual project budgets should not be included with the project research plans.

Put the biographical sketch for the PI of the CounterACT Center first, followed by the other biographical sketches in alphabetical order. Put all of the biographical sketches together in one section immediately after the budget section. Biographical sketches are required for all key personnel and consultants who participate in the research projects and cores.

Present all Resources pages in one section.

The Research Plan of each research project or core should consist of a title page, Description (use form page 2 of form PHS 398 for this), and sections on Specific Aims, Background and Significance, Preliminary Studies/Progress Report, Research Design and Methods, Human Subjects Research, Vertebrate Animals, Literature Cited, Consortium/Contractual Arrangements (as appropriate), Resource Sharing, and Letters of Support from Consultants, as described in the PHS 398 instructions. The section containing the Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods sub-sections for each research project or core should not exceed 25 pages.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: March 10, 2006
Application Receipt Date(s): April 11, 2006
Peer Review Date: July-August 2006
Council Review Date: September 2006
Earliest Anticipated Start Date: September 15, 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

David A. Jett, Ph.D.
Technology Development
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
NSC, Room 2177, MSC 9527
Bethesda, MD 20892
Telephone: (301) 496-6035
FAX: (301) 402-1501
Email: jettd@ninds.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three 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).

At the time of submission, two additional copies of the application and all six copies of the appendix material must be sent to:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
NSC, Room 3201, MSC 9529
Bethesda, MD 20892
Telephone: (301) 496-9223
FAX: (301) 402-0182
Email: nindsreview.nih.gov@mail.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

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 without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the appropriate IC. Incomplete and non-responsive applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
 
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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation 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/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

The overall program is designed for optimal research flexibility, synergy, and efficiency with the goal of rapidly developing effective countermeasures for clinical use. When appropriate, and in accordance with NIH policies (http://grants.nih.gov/grants/policy/data_sharing and http://www.ott.nih.gov/policy/rt_guide_final.html), 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.

Plan for Sharing Research Data
 
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
 
Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NINDS in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Individual Projects:

Core Resources:

Overall Program Organization:

A single priority score will be assigned to the CounterACT Center application as a whole after discussing all of the review elements. The score will be based on the overall quality of the research projects, the overall effectiveness and adequacy of core resources, and the overall program organization and capability.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

Program staff will be responsible for the administrative review of the plan for sharing research data.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not Applicable

Section VI. Award Administration Information

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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 (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

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.

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

The 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

U54 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 (U54), 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 above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility to define 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.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIH Project 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.

The program director will be responsible for normal stewardship of the award, and may also serve as a Project Scientist.

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 and the project or consortium site leaders will each have one vote, and the NIH Project Scientists will have a single NIH vote. The project PI will serve as chairperson of the Steering Committee.

Awardees will be required to accept and implement the procedures approved by the Steering Committee.

2.A.4. Arbitration 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 arbitration. An Arbitration 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 arbitration 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.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.  

Section VII. Agency Contacts

We 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 management issues:

1. Scientific/Research Contacts:

Primary contact for questions concerning the overall CounterACT program, or questions related to the mission of NINDS and its role in the CounterACT program:

David A. Jett, Ph.D.
Technology Development
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
NSC, Room 2177, MSC 9527
Bethesda, MD 20892
Telephone: (301) 496-6035
FAX: (301) 402-1501
Email: jettd@ninds.nih.gov

For questions related to the mission of NEI and its role in the CounterACT program:

Michael D. Oberdorfer, Ph.D.
Div. of Extramural Research
National Eye Institute
5635 Fishers LN., MSC 9300
Suite 1300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
Email: oberdorfer@nei.nih.gov

For questions related to the mission of NIAID and its role in the CounterACT program:

Ernest T. Takafuji, M.D., M.P.H.
Asst. Director for Biodefense Research
National Institute of Allergy and Infectious Diseases
6610 Rockledge Dr.
Rm. 4091
Bethesda, MD 20892
Telephone: (301) 451-4416
FAX: (301) 480-1432
Email: ETakafuji@niaid.nih.gov

For questions related to the mission of NIAMS and its role in the CounterACT program:

Alan N. Moshell, M.D.
Director, Skin Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, Maryland 20892-4872
Telephone: (301) 594-5017
FAX: (301) 480-4543
Email: moshella@ep.niams.nih.gov

For questions related to the mission of NIEHS and its role in the CounterACT program:

Dennis Lang, Ph.D.
Deputy Director Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC20
Research Triangle Park, NC 27709
Telephone: (919) 541-7729
FAX: (919) 541-2843
Email: DL73v@nih.gov

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
Telephone: (301) 594-3827
FAX: (301) 480-2802
Email: okitar@nigms.nih.gov

2. Peer Review Contacts:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
NSC, Room 3201, MSC 9529
Bethesda, MD 20892
Telephone: (301) 496-9223
FAX: (301) 402-0182
Email: nindsreview.nih.gov@mail.nih.gov

3. Financial or Grants Management Contacts:

Denise Chatman
Grants Management Specialist
National Institute of Neurological Disorders and Stroke
NSC 3257
6001 Executive Blvd.
Bethesda, MD 20892
Telephone: (301) 496-5707
FAX: (301) 402-0219
Email: chatmand@ninds.nih.gov

Section VIII. Other Information

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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
OMB Circular A-110 has been revised to provide 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.

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/archive/archive/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.

Inclusion of Women And Minorities in Clinical Research:
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 Research:
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 Participants:
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-02-005.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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA 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 or Health Systems Agency review. 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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NIH Funding Opportunities and Notices


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