Centers for Medical Countermeasures Against Radiation

RFA Number: RFA-AI-04-045

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 Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

Announcement Type
New

Updates: The following updates relating to this announcement have been issued:

Catalog of Federal Domestic Assistance Number(s)
93.856, 93.855

Key Dates

Release Date: November 23, 2004
Letters of Intent Receipt Date(s): January 24, 2005
Application Receipt Date(s): February 22, 2005
Peer Review Date(s): June, 2005
Council Review Date(s) : August, 2005
Earliest Anticipated Start Date: September, 2005
Expiration Date: February 23, 2005

Due Dates for E.O. 12372
Not Applicable

Executive Summary

This RFA invites applications to establish Centers for Medical Countermeasures Against Radiation (CMCR). The primary goal of the Centers will be to develop new medical products that will protect against, mitigate the effects of, and treat the short- and long-term consequences of radiation exposure due to terrorist attack. NIAID intends to commit approximately $28 million in Fiscal Year 2005 to fund six to eight CMCRs as cooperative (U19) agreements.

Eligible organizations include domestic for-profit or non-profit organizations, public or private institutions (e.g., universities, colleges, hospitals), units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to apply but may be members of consortia headed by U.S. institutions. Eligible principal investigators include any individual with the skills, knowledge, and resources necessary to carry out the proposed research. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply for NIH programs.

PUBLIC BRIEFING: 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 NIAID biodefense web site (http://www.niaid.nih.gov/biodefense/research.htm), in the NIH Guide to Grants and Contracts, and in the Federal Register. Representatives from the NIH CMCR program and the NIAID Division of Extramural Activities will provide information and answer questions pertinent to preparing applications in response to this RFA.

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001); additional instructions for application preparation are provided in Section IV of this RFA. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: Grantsinfo@nih.gov.

Telecommunications for the disabled:  TTY 301-451-5936.

Each applicant may submit only one application as a principal investigator.

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
    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
      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
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilites
        4. Arbitration Process
    3. Award Criteria
    4. 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

Background

Very few medical products exist to counter the variety of acute and long-term injuries that can result from nuclear or radiological attacks. The threat of such attacks has grown in recent years, with the increased activity of global terrorist organizations and a rise in illicit trafficking of radioactive materials. To expand the medical options available to prevent or treat radiation-induced injury, and thereby help minimize the terrorist threat as well as develop effective countermeasures, the NIAID will establish and oversee a comprehensive program of basic and translational research, with a strong emphasis on product development. The Centers for Medical Countermeasures Against Radiation (CMCR) network will form one part of this overall program.

Objectives

A network of CMCRs will be established. The network will address broad areas of research, ranging from methods to measure external or internal radiation doses post-exposure to the development of new therapeutic products to prevent short- and long-term effects. For example, there is currently no high throughput post-exposure method available to measure the radiation dose received by individuals. The development of biodosimetry devices that can rapidly and accurately distinguish individuals who need therapy from those who do not, and that can identify and measure internal and external exposure, is a high priority. Exposure may result from low-level radiation after detonation of a radiological dispersion device, or from other means of dispersal, with a relatively limited number of casualties incurred. Alternatively, exposure may result from the detonation of improvised nuclear devices, or from explosions or leaks at nuclear power plants. Low or high level, internal or external exposure might involve a variety of different radioisotopes. Injuries that range from minor to treatable to currently untreatable are all possible after a single event. Radiation injury combined with severe wounding or burns is also a likely scenario. Therefore, a variety of different products and medical approaches is needed to protect and treat the population.

The primary focus for the CMCR program is to support basic, translational, and applied research leading to new medical countermeasures against radiological and nuclear exposures due to terrorist attacks. The CMCRs will be multidisciplinary extramural research centers comprised of academic, commercial, and/or eligible government laboratories to; move candidate countermeasures through the regulatory process into the national stockpile; conduct basic and translational research to identify new countermeasures; develop and validate new animal models or in vitro assays to evaluate countermeasures or underlying biology; and provide new or expanded education resources to improve expertise in radiobiology. The CMCR network will facilitate interactions with regulatory and public health organizations, as well as facilitate progress in basic research. Consortia applicants must document commitment by all participant institutions, must explain the organizational logistics and capabilities, and must be led by a single Principal Investigator and single institution responsible for the management and scientific direction of the CMCR. The NIAID encourages participation by all types of relevant organizations, including academic laboratories, private companies, and eligible U.S. federal government groups. Each CMCR must participate as a member of the CMCR network, which will include all CMCR awardees as well as other NIAID-designated partners such as U.S. federal government laboratories or private companies. The Centers network will be governed by a CMCR Steering Committee to coordinate and facilitate research activities for the overall program.

Within the CMCR program, current candidate products with radioprotectant/prophylactic, mitigation, or treatment potential will be moved into validation and licensing studies to facilitate their inclusion in the Strategic National Stockpile (http://www.bt.cdc.gov/stockpile/index.asp).The program will support applied research and studies to advance products through needed developmental stages when proposed by applicants with these capabilities. In addition, new candidate products will be developed through basic and translational research. Past discoveries in radiation biology and epidemiology have provided an excellent foundation for expanded efforts in these areas, and a series of recent workshops and working groups convened by the White House Office of Science and Technology Policy, the Armed Forces Radiobiology Research Institute, the National Cancer Institute, and the NIAID have delineated major research gaps as well as opportunities and directions for research emphasis.

Areas of research and development interest for the CMCR program include, but are not limited to, the following:

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 CMCR network members.

Public Briefing

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 NIAID biodefense web site (http://www.niaid.nih.gov/biodefense/research.htm), in the NIH Guide to Grants and Contracts, and in the Federal Register. Representatives from the NIH CMCR program and Division of Extramural Activities will provide information and answer questions pertinent to preparing applications in response to this RFA.

Scope

The NIAID invites applications from single institutions or consortia of institutions to establish Centers for Medical Countermeasures Against Radiation (CMCR). The overall goal of this program is the development and maintenance of a strong infrastructure combined with the multidisciplinary research expertise and development capacity to generate new medical products that will protect against, mitigate the effects of, and treat the short- and long-term consequences of radiation exposure from terrorist attacks or accidental exposure. To realize this goal, the CMCR will be provided with support to: (1) conduct investigator-directed basic, translational, or applied research; (2) utilize existing core facilities that support the research and development activities of an individual CMCR; (3) develop or expand core capabilities that support the research and development activities of other participating CMCRs; (4) utilize or develop translational research capacity to test and validate radiation countermeasures for regulatory approvals; and (5) support training and education programs in radiobiology research. Diverse research and development approaches are encouraged, but all projects must be focused on medical countermeasures to prevent, mitigate, or treat human injury incurred by radiological or nuclear attack, and must describe their feasibility for human use under emergency conditions. Although clinical research is encouraged within this program where relevant, clinical trials beyond Phase 1 will not be supported. For the NIH definition of clinical research versus clinical trials, please see http://grants.nih.gov/grants/funding/phs398/phs398.html.

The CMCR program will establish a network of Centers focused on accelerating the development and production of medical countermeasures against radiological or nuclear exposure of the civilian population. Consortia of investigators at different institutions are encouraged to apply if the collaborations will strengthen the proposed scientific program. Awards will be based on scientific excellence and the need for programmatic balance to ensure the most comprehensive and efficient approach to achieving the objectives. The NIAID, in concert with a CMCR Steering Committee, will have the option to remove, replace, or redirect research or education activities within a CMCR if it is considered beneficial to the overall program.

To ensure that the CMCR program contributes maximally and effectively to the NIH medical countermeasures against radiation effort, the overall direction and scope of activities of the program and its participant Center sites will be centrally coordinated and monitored by a CMCR Steering Committee. This Committee will help optimize resources and communications within the Centers network and with other government or private organizations. This Steering Committee will be responsible for promoting synergistic interactions among the Centers and with other relevant groups; evaluating plans for removal, redirection, or replacement of ongoing projects for NIAID approval; developing a policy on publication and sharing of data obtained by the collaborative efforts of the Centers; and evaluating CMCR Training and Education Plans.

All applicants are strongly encouraged to confer with NIAID 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.

Scientific Advisory Group: Applicants may propose to establish an external Scientific Advisory Group for their CMCR. However, in order to maintain the largest possible reviewer pool for this RFA, applicants should not propose specific potential members of a Scientific Advisory Group and should not contact potential members prior to NIH review of the application.

CMCR Structure

Each CMCR must include the following components:

Overview of CMCR Components

1. Center Management and Operations

The Principal Investigator (PI) will be responsible for overall planning and management of the CMCR. The PI must be director of the Administrative Core and must commit at least 10% effort to these responsibilities, in addition to his/her own CMCR 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. The management plan for the CMCR must include procedures for periodically evaluating and selecting the most promising research, with the ultimate goal of developing clinically useful medical countermeasures against radiation. It is expected that research projects with little translational potential will be discontinued and that new projects with greater potential will be initiated as the program evolves and matures.

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 CMCR 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 CMCR 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 NIAID.

The planning and management of the Pilot Research Projects Program (see 3. below) and the Training and Education Program (see 5. below) shall be done by the Center Management and Operations (Administrative Core).

2. Research/Development Projects

The CMCR 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 could contribute to a product or medical approach that is feasible for human use and feasible to stockpile or use in emergency situations.

Projects may include studies for regulatory approvals of candidate products, such as efficacy, toxicity, and pharmacokinetic studies in animal models; translational research to support further development of a candidate countermeasure; development of standardized services, such as unique high throughput assays or animal testing for proof-of-principle and/or cGLP studies, for use by CMCR network members; applied, descriptive, or hypothesis-generating research to define new candidate products or approaches; and/or hypothesis-driven research to identify mechanisms of radiation injury, prevention, or repair useful for regulatory approval. Clinical trials beyond Phase 1 trials will not be supported by this program. Clinical research using human tissues and data is encouraged when appropriate. For the NIH definitions of clinical trials and clinical research please see http://grants.nih.gov/grants/funding/phs398/phs398.html.

All proposed projects should include sufficient preliminary data to allow a realistic assessment of the likely productivity of the research plan. Projects may focus on practical issues of product testing and licensure; on animal model or drug screening assay development; on the identification of biomarkers of radiation exposure and/or injury; on the development of biodosimetry devices; on specific organ targets of radiation damage such as bone marrow, gastrointestinal tract, lung, kidney, and cardiovascular and nervous systems; on epidemiological data that would define consequences of radiation exposure or new approaches to counter radiation damage; or on basic biological mechanisms.

3. Pilot Research Projects Program (Core)

The key purposes of this CMCR activity are to fund novel ideas not yet supported by preliminary data, to develop or incorporate new technologies as they become available, and/or to foster collaborations between members of different CMCR programs.

The Pilot Research Project Plan must describe processes for soliciting applications for Pilot Research Projects from qualified investigators either within or outside of the CMCR; for selecting the most promising projects to propose to NIAID program staff for approval, consistent with the strategic plan and the overall CMCR program goals; and for monitoring the success and productivity of the funded Pilot Projects, including terminating them or promoting Pilot Research Projects to full Research/Development Project status. Some Pilot Research Projects will begin during the first year, and others will be phased in during the life of the award. A plan for management of the funds associated with these projects must be addressed in the application. However, applicants should not include descriptions of any specific projects.

After award, each CMCR must identify and support Pilot Research Projects that take advantage of emergent technology or new research or development opportunities within the scope of the research plan. These projects may involve scientists within the CMCR or extend to appropriate scientists outside the Center.

The specific number of Pilot Research Projects to be funded is at the discretion of the applicant, but total funding for these projects may not exceed $500,000 direct costs in any one year, with no more than $100,000 annual direct costs for any one study. Furthermore, each Pilot Research Project may be supported for no more than two (2) years.

The use of Pilot Research Projects permits maximal flexibility to advance in the directions that seem most scientifically fruitful. With NIAID approval, successful Pilot Research Projects may mature and become full Research/Development Projects.

4. Scientific Core(s)

Scientific facilities to support the Research/Development Projects 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, do not need to be 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 CMCR upon approval by the NIAID. Scientific core facilities may include clinical, statistical, technical, or other supportive activities. If appropriate to the particular CMCR, 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://grants2.nih.gov/grants/policy/data_sharing/).

5. Training and Education Program (Core)

One goal of the overall CMCR program is to increase the numbers and capabilities of researchers and other personnel in radiobiology and related areas. 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 CMCR. Formal graduate programs are excluded from this RFA.

The proposed program should build on the strengths of the CMCR investigators, although outside instructors may be incorporated into the program on occasion to provide cross-disciplinary depth. The CMCR Steering Committee will periodically assess all CMCR-funded education programs and will recommend to the NIAID any suggested improvements.

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 CMCR, the CMCR network, and the radiation research community:

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U19 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 (U 19 ) 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.

2. Funds Available

The NIAID intends to commit approximately $28 million dollars in FY 2005 to fund six to eight new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $5 million dollars per year. 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 NIAID provides 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. Fiscal and administrative costs are not included in the direct cost limitation, see NOT-OD-04-040.

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:

Several special provisions apply to foreign organizations that are proposed for participation in a CMCR cooperative agreement:

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

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

3. Other-Special Eligibility Criteria
Not Applicable.

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. 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 PHS 398 research grant application instructions and forms (rev. 5/2001; 9/2004 version after May 10). Applications must have a Dun and Bradstreet (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.

See Section VI.2 Administrative Requirements for additional information.

3. Submission Dates

Applications must be mailed on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): January 24, 2005
Application Receipt Date(s): February 22, 2005
Peer Review Date(s): June, 2005
Council Review Date(s): August, 2005
Earliest Anticipated Start Date: September, 2005

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:

Dr. Kirt J. Vener
Division of Extramural Activities
National Cancer Institute
Room 8061, MSC-8329
6116 Executive Boulevard
Bethesda, MD 20892-8329
Telephone: 301-496-7173
FAX: 301-402-0742
Email: venerk@dea.nci.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

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

Dr. Kirt J. Vener
Division of Extramural Activities
National Cancer Institute
Room 8061, MSC-8329
6116 Executive Boulevard
Bethesda, MD 20892-8329
Telephone: 301-496-7173
FAX: 301-402-0742
Email: venerk@dea.nci.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 listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.

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 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 (See also Section VI.3. Award Criteria).

6. Other Submission Requirements

Applicants for U19 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the web at:  http://www.niaid.nih.gov/ncn/grants/multibron.htm. Multi-project grant applications must have two or more individual projects and may include scientific cores and an administrative core.  Scientific cores must serve at least two individual projects within the multi-project grant. Specific application details for multi-project grant applications are available at http://www.niaid.nih.gov/ncn/grants/multi/3aa.htm 

This brochure presents specific instructions for sections of the PHS 398 (rev. 5/01) application form that should be completed differently than usual.  For all other items in the application, follow the usual instructions in the PHS 398.

Special Instructions for Preparing a CMCR Application

These instructions supplement those in PHS 398; they are organized as follows:

A) CMCR application overview -- addresses the objectives and unifying theme or themes of a multi-project grant, the relationships among research projects and cores and how they will contribute to overall objectives, the administrative and organizational structure, and the overall budget.

B) Instructions for individual projects -- describes modifications to PHS 398 instructions to address the collaborative or interactive role of the project.

C) Instructions for core units -- describes modifications to PHS 398 instructions to address the collaborative or interactive role of the project.

A. Instructions for Overall CMCR Application

Form Page 1 - Face page (for the overall application)

Items 1-15: complete these items as instructed. This should be the first page of the entire application; number all succeeding pages consecutively.

Form page 2 - Description, Performance Sites, and Key Personnel (for the overall application)

Using page 2 of PHS 398, provide a succinct but accurate description, the abstract , of the overall multi-project application, addressing the major, common theme(s) of the program. Do not exceed the space provided.

Under "key personnel," list the principal investigator of the multi-project application, followed by the project leaders of the research projects and cores and other key personnel.

Form page 3 - Research Grant Table of Contents

Do not use form page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application. Given the application will be peer reviewed project by project and core by core, prepare a detailed table of contents that will let reviewers locate information pertinent to the overall application as well as to each component project and core. For each project and core, include a page reference for the associated budget. Identify each project by number (e.g., project 1), title, and project leader, and each core by letter (e.g., core A), title, and core leader.

Form page 4 - Detailed budget for initial budget period

Do not use form page 4 of PHS 398 for a composite budget for the entire multi-project application. Instead, prepare a composite budget (spreadsheet – see http://www.niaid.nih.gov/ncn/grants/multi/5a.htm) for all proposed years of support. Indicate the page location of your budget in the table of contents.

Use form page 4 for individual projects and cores and include a justification for the budget elements for each project and core (see below).

Form page 5 - Budget for Entire Project Period of Support

Complete the total direct cost entries for all requested budget periods (years) and the total direct cost for the entire period of support.

Modular Budget Format Page – do not use – modular budgets not accepted for responses to this RFA.

Biographical Sketch Format Page

Put biographical sketches of professional personnel for all components at the end of the application (before the checklist), with the principal investigator's first followed by other key personnel in alphabetical order.

Resources Format Page

Do not complete for the overall application. Give essential information in the individual research project and core sections of the application.

Research Plan

This section is limited to 20 pages and should identify and describe the overall goals and objectives of the proposed CMCR, the general organizational structure, participating institutions/organizations, and the roles of all consortium members for multi-institutional applications. Provide a strategic plan, including a chronological outline of planning and priority-setting processes. The strategic plan must include both short- and long-term goals and descriptions of objective annual milestones for the CMCR research, development, and education components, which may be used to measure progress. The following topics should be addressed:

B. Instructions for Individual Research/Development Projects

The following instructions are unique to multi-project grants. For other items in an individual project application, follow the PHS 398 instructions.

Item 1. Number and title of project

For all research/development projects, use a number (e.g., 1, 2, 3) to designate each research project and make sure each has a unique title. Give the name and title of the project leader and participating investigators. Type the number and title of a research project on the upper left-hand margin of all relevant pages, for easy cross-reference. The research plan for each project is limited to 25 pages.

Form Page 2. Provide a Description, or abstract, of the research following instructions on form page 2 of the PHS 398. The abstract should briefly describe how the research project will contribute to attaining the objectives of the overall program.

Under Key personnel, follow the PHS 398 instructions, listing all key personnel participating in the project beginning with the project leader.

Form Page 3. Prepare a Table of contents for the research project using form page 3 of the PHS 398. Do not repeat the biographical sketches of participating investigators since they will be included at the end of the overall application and in that table of contents.

Research Plan

The research plan for each project is limited to 25 pages. An important consideration is whether a Research/Development Project is likely to produce information useful for rapid development of medical countermeasures. Collectively, these projects should support the applicant's strategic plan and emphasize a synergistic approach with integration into the overall scientific theme. Applicants are encouraged to carefully consider the scope and range of the Research/Development Projects proposed, in order to construct a CMCR that is cohesive, synergistic, and consistent with available resources and personnel.

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 could contribute to a product or medical approach that is feasible for human use and feasible to stockpile or use in emergency situations.

Appendix

Do not create an appendix for an individual project.

C. Instructions for Core Units

The following instructions are unique to cores in multi-project grants. For other items in an individual project application, follow the PHS 398 instructions.

Each CMCR must include the following cores: Administrative Core (includes Center Management and Operations), Pilot Research Projects Program Core, Scientific Core(s) if needed, and a Training and Education Core.

One face page

Form Page 1. Item 1. Letter and title of core

For all cores use a letter (e.g., A, B, C) to designate each core unit and give each a unique title; type these on the upper left-hand margin of all pages in the core section for easy cross-reference.

State the name and title of the core leader and participating investigators.

Form Page 2. Provide a Description (abstract) of the core activities and services according to the instructions on form page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute to attaining the program's objectives.

Form Page 3. Prepare a Table of contents for the core using form page 3 of the PHS 398. Do not repeat the biographical sketches of participating investigators since they will be included at the end of the overall application and in that table of contents.

Research Plans

All cores. Limit research plans to 10 pages each.

Checklist for the entire application

Appendix

You can have only one appendix for the whole application, up to 5 documents or 50 pages, whichever is less. All pages in reprints and other documents count as one page. Limit the appendix to information directly relevant to the application. Place data crucial to the research plan in the application, not in the appendix. Clearly cross-reference all appended material to a project or core. Prepare five sets of the appendix including only relevant reprints, making sure that reprints are cross-referenced as well.

Supplemental Information
No supplemental information will be accepted after the application receipt date.

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 web site, 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 explaining 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). See Section VI.3. Award Criteria.

Section V. Application Review Information

1. Criteria

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants2.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAID . Incomplete and/or non-responsive applications will not be reviewed.

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 NIAID in accordance with the review criteria stated below.

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

If a large number of applications is received in response to this RFA, more than one review committee may be utilized to conduct the initial merit review.

3. Merit Review Criteria

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.

1. 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?

2. 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?

3. 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?

4. 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)?

5. 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?

The following items will be considered in the determination of scientific merit and the priority score:

Scoring and Evaluation

Overall Score: a single numerical priority score will be assigned to the whole application after consideration of all of the elements. The overall score for the application will be based on the scientific merit of the individual components as well as the overall synergy and integration of the components, the overall program organization and capability of the associated personnel, and the extent to which the proposed CMCR would contribute to the global NIH mission to develop medical countermeasures against radiological and nuclear threats to the civilian population.

If peer reviewers deem that fewer than the required three research projects have substantial and significant scientific merit, the application is recommended for “no further consideration.”

Center Management and Operations

Research/Development Projects

Administrative Core

Scientific Core(s)

Pilot Research Project Plan Core

Training and Education Core

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will 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.

3.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.

3.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.

3.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.

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 Principal Investigator 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. Award Criteria.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 Grant Award (NGA) will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

NIAID will transmit the NGA via U.S. mail for a hard copy and/or via email for an electronic copy.

2. Administrative Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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

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 (U 19 ), 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 for: Awardees will have primary responsibility for the project as a whole, including research design and conduct, data collection, data quality control, data analysis and interpretation, preparation of publications, and collaborations with other awardees.

If clinical research or clinical trials are components of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants2.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

Awardees will retain primary custody of and have primary rights to the data developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees must be committed to making the medical countermeasures, diagnostic products, and other research tools, methods, and materials that they develop available to the CMCR network and the research community.

Principal Investigators must coordinate and participate in regular, local meetings of their CMCR to discuss progress and directions of Center activities and to ensure that the necessary interdisciplinary interactions are taking place. Principal Investigators and appropriate other CMCR investigators must attend annual CMCR Meetings to be organized by the NIAID. Principal Investigators and any additional CMCR staff members designated by the CMCR Steering Committee must attend the regular meetings and teleconferences of the CMCR Steering Committee to discuss progress and directions of research and product development to ensure that overall program goals are being met.

When possible, awardees agree to participate in projects identified by the CMCR Steering Committee that include common research interests that address a specific problem of threat.

An NIH intramural scientist (IMS) may participate as a member researcher of the CMCR, but may not receive any funds from the CMCR award. The participation of an IMS is independent of and unrelated to the responsibilities of the NIAID Program Staff as described below. An IMS who is one of the Center's member scientists will have the same programmatic rights and responsibilities as other investigators.

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. NIAID staff assistance will be provided by a program officer from the Basic Immunology Branch, Division of Allergy, Immunology, and Transplantation, NIAID, who will serve as the NIAID Scientific Coordinator. The NIAID Scientific Coordinator 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. During performance of the award, the NIAID Scientific Coordinator, with assistance from scientific program staff from the National Cancer Institute and other NIH Institutes who are designated based on the research topic and their relevant expertise, may provide assistance, advice, and guidance by: participating in the design of the activities; advising in the selection of sources or resources (e.g., determining where a particular reagent can be found); coordinating or participating in the collection and/or analysis of data; advising in management and technical performance; or participating in the preparation of publications. The NIAID Scientific Coordinator will serve as a liaison/facilitator between the awardee, pharmaceutical and biotech industries, and other U.S. government agencies (e.g. Centers for Disease Control and Prevention, Department of Defense, Department of Energy) and will serve as a resource of scientific and policy information related to the goals of the awardee's research. The role of the NIAID Scientific Coordinator will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus and the NIAID staff will be given the opportunity to offer input into this process.

An NIAID Program Official will be assigned to perform normal program stewardship responsibilities for this award, including the evaluation and approval of proposed Pilot Research Projects; and approval of replacement, redirection, or removal of Research/Development or Education Projects. The Program Official may serve as the Scientific Coordinator.

NIH program staff may assist, where warranted, in data analyses and interpretation, and the dissemination of study findings to the research community, including co-authorship of the publication of results of studies conducted by the CMCR, subject to NIH publication policies.

It is anticipated that most Investigational New Drug (IND) applications or other relevant clinical applications submitted to the U.S. Food and Drug Administration (FDA) or other health authorities in conjunction with this program will be held either by the NIAID or by the pharmaceutical or biopharmaceutical company. The Chief of Regulatory Affairs, Division of Allergy, Immunology, and Transplantation, NIAID, will be responsible for providing guidance and assistance in the development, assembly, and submission of all required regulatory documents, e.g., those regarding the use of investigational drugs, to the FDA or other applicable health authorities.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

CMCR Steering Committee

A Steering Committee will be established as a governing body for the CMCR program. Voting members of this Committee will include the Principal Investigators of each of the CMCR grants and the NIAID Scientific Coordinator. Non-voting Committee members may include additional program staff from the NIAID, National Cancer Institute, and other NIH Institutes as appropriate, and other members identified by the NIAID or CMCR grantees as appropriate. The Steering Committee will meet once per year in conjunction with the annual CMCR meeting, and may meet more frequently by teleconference throughout the funding period. All Steering Committee members will be expected to participate in all meetings. The Steering Committee will be responsible for promoting synergistic interactions among the Centers and with other relevant groups; evaluating plans for removal, redirection, or replacement of ongoing projects for NIAID approval; developing a policy on publication and sharing of data obtained by the collaborative efforts of the Centers; and evaluating CMCR Education Plans. The Steering Committee may determine the need to redirect certain CMCR efforts when results and data suggest that the proposed research is no longer feasible or progressing toward desired goals. Some CMCR may develop common research interests, and research focus groups may be formed to pursue coordinated research activities identified by the Steering Committee.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies 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. Award Criteria

The following will be considered in making funding decisions:

4. 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 Contact:

Helen Quill, Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3013, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: 301-496-7551
FAX: 301-480-2381
Email: hquill@niaid.nih.gov

2. Peer Review Contact:

Dr. Kirt J. Vener
Division of Extramural Activities
National Cancer Institute
Room 8061, MSC-8329
6116 Executive Boulevard
Bethesda, MD 20892-8329
Telephone: 301-496-7173
FAX: 301-402-0742
Email: venerk@dea.nci.nih.gov

3. Financial or Grants Management Contact:

Ann Devine
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2114, MSC-7614
6700 B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: 301-402-5601
FAX: 301-480-3780
Email: adevine@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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.

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, June 12, 1998: 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.

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://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). 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.

Public Access to Research Data through the Freedom of Information Act:
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 PA 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.

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 web site (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/ in the following citations: No. 93.856, Microbiology and Infectious Diseases Research and No. 93.855, Immunology, Allergy, and Transplantation Research 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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