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)

Title:  Cooperative Research Partnerships into Therapeutics and Diagnostics for Biodefense Toxins (U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-AI-06-035

Catalog of Federal Domestic Assistance Number(s)
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research

Key Dates
Release Date: June 21, 2006
Letters of Intent Receipt Date(s): October 27, 2006
Application Receipt Date(s): November 27, 2006
Peer Review Date(s): March, 2007
Council Review Date(s): May, 2007
Earliest Anticipated Start Date(s): July, 2007
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration Date: November 28, 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

Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), strives to diagnose, understand, treat and ultimately prevent the myriad infectious, immunological, and allergic diseases that impact millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) and the Division of Allergy, Immunology and Transplantation (DAIT) support extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic biomedical research, such as studies of microbial physiology and antigenic structure; immunity; applied research, including the development of diagnostic tests; and clinical trials to evaluate experimental drugs and vaccines.

Through this RFA, the NIAID invites research grant applications that will support the discovery, design, and/or development of novel therapeutics and/or post-exposure prophylactics and rapid and sensitive diagnostics for certain biodefense toxins: Shiga toxins, ricin toxin, the Staphylococcus enterotoxin B (SEB), Clostridium perfringens epsilon toxin and the botulinum neurotoxins (http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm). Translational research to support, or which might lead to, the development of therapeutics or diagnostics for biodefense toxins, as well as advanced product development, are encouraged. Projects may include, but are not limited to, target identification (e.g., compound screenings, epitope identification); the adaptation of platform technologies or products to biodefense applications; development of high throughput screening assays; novel approaches to delivering drugs to specific cell types; approaches that link drug delivery to drug discovery; discovery and evaluation of candidate inhibitors; selection, evaluation, and characterization of lead inhibitors; optimization of products; process development, early validation and testing; preclinical evaluation; scale-up, and production of quantities sufficient for preclinical regulatory requirements and clinical Phase I testing or field trials.  Applications that include collaborations between researchers from different disciplines and/or with industry (e.g., pharmaceutical, chemical or biotechnological companies) are strongly encouraged.  This RFA will not support basic research.

For some biodefense toxins, models for the testing of candidate therapeutics may be lacking, therefore, the development of new or improved animal models, as well as alternatives to animal models, will be responsive.  However, the investigator must present strong evidence that an adequate model is lacking and that this will inhibit the testing of candidate therapeutics.  The investigator must also present compelling justification that the proposed new or improved model is needed to facilitate the testing of candidate therapeutics, and is feasible and appropriate.

NOTE: While clinical development strategies may be included within an overall product development plan, this RFA will NOT support clinical trials, as defined in http://www.niaid.nih.gov/ncn/glossary/default2.htm#clintrial. Applications requesting support for clinical trials will be viewed as unresponsive to this RFA and will be returned to the applicant without review. Collection and utilization of human derived material required for therapeutic or diagnostic development, or for compliance with regulatory requirements is considered responsive. Collection of all specimens must comply with the requirements and policies of the NIAID, DMID (http://www.niaid.nih.gov/dmid/clinresearch/) and 45 CFR Part 46.

NOTE:  Applications proposing the development of a therapeutic or diagnostic that does not focus on one or more of the biodefense toxins specified above (Shiga toxins, ricin toxin, the Staphylococcus enterotoxin B (SEB), Clostridium perfringens epsilon toxin and the botulinum neurotoxins) will be deemed unresponsive and will be returned to the applicant without review. 

NOTE:  Applications addressing therapeutics or diagnostics for the NIAID Category B bacteria that produce Shiga toxins (diarrheagenic E. coli and Shigella) are not responsive to this RFA, and should be directed to the companion solicitation (RFA AI-06-029, http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-06-029.html)

NOTE:  This RFA will NOT support research on environmental or workplace detection technologies or targets. Diagnostics applications must focus on the goal of detection and identification of toxins in human clinical samples.

Partnerships

A key component of this initiative is the development of partnerships between researchers from different disciplines and/or with industry. Cooperative research that brings together expertise in different aspects of research and product development is strongly encouraged.

For the purpose of this RFA, "industry" is defined as large and small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and chemical companies. Since academic organizations are often the source of new candidate products, this RFA will also support a partnership between industry and collaborator(s) as necessary from academic and non-profit research organizations. Such partnerships are strongly encouraged, but not required.

The Principal Investigator of the project may be affiliated with any of the eligible institutions listed in Section III below.  It is expected that in the application the Principal Investigator will describe in detail the relevant product development expertise and track record available within the team.

The NIH project scientist assigned to the project post-award will ensure that issues are addressed and milestones met during product development. It is recognized that early research and development steps may not be successful, and may need to be modified or reworked. NIAID staff, through the cooperative agreement grant mechanism, will be actively involved in evaluating progress toward project milestones and determining whether continued investment is warranted. To receive consideration for funding of each successive year, the annual progress report and an updated product development plan must be received 2 months prior to the end of the current funding period, demonstrating that the milestones defined for that funding year have been met.

Background

The NIH and other agencies in the Department of Health and Human Services (DHHS) are currently supporting extramural and intramural projects to develop new products to protect the public from the health consequences resulting from the use of biological agents in acts of terrorism or war. The biological agents deemed to pose the greatest threat to civilian populations are prioritized in the NIAID Category A, B and C priority pathogens and toxins list, which is available at: http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm. The NIAID convened three Blue Ribbon Panels to address the research priorities for Category A pathogens and toxins, Category B and C pathogens and toxins, and immunology research. The research agendas that resulted from these three meetings are published at: http://www.niaid.nih.gov/biodefense/research/biotresearchagenda.pdf, http://www.niaid.nih.gov/biodefense/research/categorybandc.pdf and http://www.niaid.nih.gov/publications/pdf/biodimmunpan.pdf.  

In addition to the NIAID research agendas, the DHHS has identified the highest priority products for bioterror preparedness (http://www.niaid.nih.gov/biodefense/research/high_priority.htm).

Several expert panel meetings were also convened to address research needs for developing therapeutics or diagnostics for the botulinum neurotoxins, ricin, and Shiga toxins  (http://www3.niaid.nih.gov/Biodefense/PDF/bot_toxins.pdf;   http://www3.niaid.nih.gov/Biodefense/PDF/bot+toxins+mtg.pdfhttp://www3.niaid.nih.gov/Biodefense/PDF/Report+BoNT.pdfhttp://www3.niaid.nih.gov/Biodefense/ricin_meeting.pdfhttp://www.niaid.nih.gov/dmid/enteric/hus_prevent.htm).

To meet the objectives outlined by the Blue Ribbon Panels, it is imperative that promising findings are translated rapidly into product development. The involvement of diverse disciplines within academia and industry in basic science, translational research and product development is needed to bring sufficient expertise to bear on the development of well-designed therapeutics and medical diagnostics.

Research Goals and Objectives

The objective of this RFA is to support scientifically sound, original and innovative research that will advance the development of a therapeutic or diagnostic that is specific for one or more of the following toxins: Shiga toxins, ricin toxin, the Staphylococcus enterotoxin B (SEB), Clostridium perfringens epsilon toxin or the botulinum neurotoxins.  Projects are not required to result in a "final" product since clinical trials are not supported; however proposals to make significant progress along the pre-clinical research and product development pathway are expected.  Therapeutics development may extend to the point where the R34 Clinical Trial Planning Grants and U01 Clinical Trial Implementation Cooperative Agreements (http://www.niaid.nih.gov/ncn/clinical/R34.htm) offer the logical next step. Diagnostic development should target demonstrable needs and should consider evaluation and validation with appropriate clinical specimens.  Research and product development projects that address multiple agents such as broad spectrum therapeutics, novel drug families, and multiplex diagnostics are particularly encouraged, especially when a clearly demonstrable need is shown, and a pathway to clinical or field use is presented. 

All applications should define the proposed project goal, describe the proposed final product, and provide a schedule or timeline for goal attainment with measurable interim objectives (essential milestones). A specific product profile defined by licensing indication is not requested. When appropriate, research plans should demonstrate an awareness of the guidelines that govern GLP (as defined by 21 CFR Part 58) and GMP (as defined by 21 CFR Part 211) manufacturing, and/or IND/IDE enabling studies that will be performed under this award as they would be applied to eventual product/device licensure in the U.S.

The NIAID recognizes that critical aspects of the product development pathway such as GLP, cGMP production, or diagnostic validations are not inherently innovative; however, innovation is encouraged where it is appropriate to reduce project risk or to facilitate the efficient accomplishment of goals.

Phase I, II, and III clinical trials and field trials are not supported by this RFA. However, in the case of diagnostics, it is expected that appropriate human specimens will be used to establish proof of principle, show that performance specifications can be met, to demonstrate a level of utility that exceeds existing systems, and to clearly place the proposed product on a pathway to FDA review. Collection of all specimens must comply with the requirements and policies of 45 CFR Part 46, and the NIAID, DMID (http://www.niaid.nih.gov/dmid/clinresearch/).

Therapeutics for Biodefense

Development of biodefense therapeutics is a key national priority. Applications are invited that will lead to the development of therapies against Shiga toxins, ricin toxin, the Staphylococcus enterotoxin B (SEB), Clostridium perfringens epsilon toxin and the botulinum neurotoxins or the physiological insults that they cause. The NIAID encourages the multidisciplinary collaboration and expertise of toxin researchers, medicinal chemists, clinicians, and structural biologists needed to address discovery, development, evaluation, and delivery of therapies.

Some of the challenges of developing post-exposure treatments for these toxins include the following: toxin is free in the circulation for only a brief period of time (hours to days); the therapeutic window for conventional anti-toxins (e.g., antibodies) that target free toxin or block the binding of toxin to cellular receptors is short; and the patient is asymptomatic prior to the intracellular internalization of the toxin.  The greatest clinical benefit would be derived from therapies capable of blocking or reversing either the action of the toxin following cellular internalization or the host responses to the toxin that result in disease.

Projects may include, but are not limited to, one or more of the following areas:

NOTE:  Interventions that can block or reverse the effects of intoxication after the toxins have reached their intracellular site(s) of action are of particular interest.

NOTE:  For therapeutics development applications, of particular interest are projects that incorporate formulation strategies that optimize the properties of the resulting product.

NOTE:  Applications that do not address the development of a therapeutic or diagnostic for Shiga toxins, ricin toxin, the Staphylococcus enterotoxin B (SEB), Clostridium perfringens epsilon toxin or the botulinum neurotoxins will be deemed unresponsive and will be returned to the applicant without review.

NOTE:  Applications addressing therapeutics or diagnostics for the NIAID Category B bacteria that produce Shiga toxins (diarrheagenic E. coli and Shigella) are not responsive to this RFA, and should be directed to the companion solicitation (RFA AI-06-029, http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-06-029.html).

NOTE:  Clinical trials will NOT be supported.

Diagnostics for Biodefense

There is an urgent need for easy to use, rapid, and cost-effective medical diagnostics for public health laboratories, hospital-based clinical laboratories, field, and point-of-care use to diagnose individuals exposed to and/or intoxicated with Shiga toxins, ricin toxin, the Staphylococcus enterotoxin B (SEB), Clostridium perfringens epsilon toxin and the botulinum neurotoxins. NIAID goals include supporting the development of diagnostics that identify these toxins and instruct appropriate therapy for individuals who are pre- symptomatic, symptomatic, non-responding to treatment, or have non-specific symptoms.  The design and development of diagnostics should be focused on the steps critical to product development and with an understanding of the clinical needs and the appropriate sensitivity required for each toxin.  Medical diagnostics that perform differential diagnoses are of high priority. The development of medical diagnostics that use multiplex, platform technologies is encouraged and can include other agents in addition to Shiga toxins, ricin toxin, the Staphylococcus enterotoxin B (SEB), Clostridium perfringens epsilon toxin or the botulinum neurotoxins, but must be focused on rapidly distinguishing whether an individual is intoxicated with one of these toxins or by a common disorder with similar, generalized symptoms. Projects may include, but are not limited to, one or more of the following areas:

NOTE:  Applications proposing the development of a diagnostic or therapeutic that do not include Shiga toxins, ricin toxin, the Staphylococcus enterotoxin B (SEB), Clostridium perfringens epsilon toxin or the botulinum neurotoxins will be deemed unresponsive and will be returned to the applicant without review. 

NOTE:  This program will NOT support research on the development or deployment of devices for the detection of agents in foods, fomites, or environmental specimens. Such applications will be deemed unresponsive and returned to the applicant without peer review.

NOTE:  Applications addressing therapeutics or diagnostics for the NIAID Category B bacteria that produce Shiga toxins (diarrheagenic E. coli and Shigella) are not responsive to this RFA, and should be directed to the companion solicitation (RFA AI-06-029, http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-06-029.html).

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 U01 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 (U01) 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".

Essential elements of the U01 include: (1) a single research project that may include consortium agreements, but does not include "Core" resources and facilities as defined for U19 applications; (2) a single Principal Investigator who will be scientifically and administratively responsible for the research project; and (3) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded.

This RFA is a one-time solicitation. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present RFA.  

2. Funds Available

The NIAID intends to commit approximately $10 million dollars in FY 2007 to fund 10-15 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 $500,000 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 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:

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.

Collaborators at foreign institutions are allowed and encouraged, particularly when a diagnostic or therapeutic is targeting a disease that has a low incidence/prevalence in the USA and a high incidence/prevalence at a foreign settings where future product development activities may be planned.

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 support.

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

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. 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.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.


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

Letters of Intent Receipt Date(s): October 27, 2006
Application Receipt Date(s): November 27, 2006
Peer Review Date(s): March, 2007
Council Review Date(s): May, 2007
Earliest Anticipated Start Date: July, 2007

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:

Lucy A. Ward, DVM, Ph.D.
Division of Extramural Activities
National Institute of Allergy & Infectious Diseases
Room 3117, MSC-7616
6700-B Rockledge Drive
Bethesda, MD  20892-7616 (express mail zip code 20817)
phone: (301) 594-6635
fax: (301) 480-7614
email: lward@niaid.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 five copies of the appendix material must be sent to:

Lucy A. Ward, DVM, Ph.D.
Division of Extramural Activities
National Institute of Allergy & Infectious Diseases
Room 3117, MSC-7616
6700-B Rockledge Drive
Bethesda, MD  20892-7616 (express mail zip code 20817)
phone: (301) 594-6635
fax: (301) 480-7614
email: lward@niaid.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 NIAID. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial 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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. 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

Essential elements of the U01 include: (1) a single research project that may include consortium agreements, but does not include "Core" resources and facilities as defined for U19 applications; (2) a single Principal Investigator who will be scientifically and administratively responsible for research project; and (3) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded.

Research Plan

1. Research Focus

This program responds to the urgent public health need to develop new and promising high-priority products for biodefense by supporting partnerships between the research community and the Federal Government. Each application must propose a research and development project whose goal is to advance a therapeutic or diagnostic countermeasure specific to Shiga toxins, ricin toxin, the Staphylococcus enterotoxin B (SEB), Clostridium perfringens epsilon toxin or the botulinum neurotoxins through the product development process. It is not necessary to propose to complete the product development process up to the point of readiness for clinical trials within the time frame of this project. Applications that would significantly advance a specific product toward clinical or field usefulness are responsive, as are applications that develop the tools that are lacking to test candidate therapeutics (e.g., new or improved animal models).

NOTE: All applications for research projects should include in the Research Plan:

2. Mandatory Meetings

Requested budgets must include funds for travel by the Principal Investigator and key personnel to an annual meeting in Bethesda, Maryland, or at a relevant scientific meeting, as determined by NIAID Program staff. See Section VI.2.A.1. Award Administration Information (below).

3. Good Laboratory Practice/Good Manufacturing Practice

When appropriate, applicants must document in the Research Plan compliance with guidelines that govern GLP, as defined by 21 CFR Part 58, and cGMP, as defined by 21 CFR Part 211, manufacturing and/or IND/IDE enabling studies that will be performed under the project award as they would be applicable to eventual product/device licensure in the U.S.

4. External Advisors

External advisors may be appointed by the Principal Investigator in consultation with NIAID Program Staff to assist in progress review. Names of suggested external advisors should NOT be included in the application; external advisors should be identified and appointed only after award.

Additional Submission Requirements

(Do not count towards page limits for Research Plan) Applications lacking these additional submission requirements will be considered non-responsive.

1. Milestones and Timeline

ALL applicants must provide detailed project performance and timeline objectives in a section entitled “Milestones and Timeline” (may not exceed 5 pages). The Milestones and Timeline section should follow the Research Plan of the application and does not count towards the page limits for the Research Plan. This section must include:

2. Product Development Plan

ALL applicants must include a section entitled “Product Development Plan” in the application (may not exceed 5 pages). The Product Development Plan should follow the Milestones and Timeline section of the application and does not count towards the page limits for the Research Plan. This section must include:

3. Physical and/or Facility Security

ALL applicants must address issues related to physical or facility security and biocontainment and biosafety (http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm) pertinent to the specific agents of interest in a section entitled “Biosafety and Biocontainment” in the application (may not exceed 1 page). Guidelines for Institutional Biosafety Committees are available at: http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm. The Biosafety and Biocontainment section should follow the Product Development Plan section of the application and does not count towards the page limits for the Research Plan.
 
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 the NIAID 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?

Milestones and Product Development Plan:  Do the milestones and product development plan assess the feasibility of the objectives, milestones, and plans for future product development, including the appropriateness and feasibility of conducting preclinical testing for safety and efficacy in animal models?

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.

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 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA 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

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 (U01), 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: defining the research objectives, approaches and details of the projects within the guidelines of the RFA AI-06-035, and awardees will retain primary responsibility for the performance of the scientific activity. The Principal Investigator agrees to accept consultation, coordination, cooperation and participation of NIAID staff in the project in accordance with the terms formally and mutually agreed upon prior to the award. The responsibility for the planning, direction, and execution of the proposed project will remain solely with the Principal Investigator.

Intellectual Property

The successful development of high priority products for biodefense will require substantial investment and support by private sector industries, and may also involve collaborations with other organizations such as academic and/or non-profit research institutions. It is the intent of this initiative to support the formation of the appropriate public-private partnerships that are essential to meet these urgent public health needs. NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees understand and acknowledge the following:

Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID or other mechanisms.

Select Agents

All U.S. awardees must be in compliance with the U.S. Select Agent Regulations (http://www.cdc.gov/od/sap/) and NIH Guidelines for Research Involving Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html)

Note: The CDC has published maximum amounts of toxins excluded from the U.S. Select Agent Regulations (http://www.cdc.gov/od/sap/sap/toxinamt.htm).  The PI should clearly address whether the aggregate amount of toxin under their control will exceed the maximum permissible amount, and thus be subject to the U.S. Select Agent Regulations.

Award to a U.S. Institution: Before using NIH funds, the awardee must complete registration with CDC (or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied.

Award to a Foreign Institution: Before using NIH funds for any work directly involving the Select Agents, the awardee must provide information to the NIAID that a process equivalent to that described in 42 CFR Part 73 for U.S. institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds. All foreign laboratories are inspected to determine if the site has minimum biosafety and biosecurity procedures in place for working with Select Agents. During inspections the awardee must be willing to address the following key elements appropriate for their institutions: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents. If available, the awardee will be asked to provide copies of any applicable laws, regulations and policies equivalent to 42 CFR Part 73.

Award to U.S. Institution with Foreign Institution Participation: Before using NIH funds for any work directly involving the Select Agent at the US institution, the awardee must complete registration with CDC (or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied. Before using NIH funds for any work directly involving the Select Agents at the foreign institution, the US awardee must provide information from the foreign institution to the NIAID that a process equivalent to that described in 42 CFR Part 73 for US institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds. All foreign laboratories are inspected to determine if the site has minimum biosafety and biosecurity procedures in place for working with Select Agents. During inspections the awardee must be willing to address the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, If available, the awardee will be asked to provide copies of any applicable laws, regulations and policies equivalent to 42 CFR Part 73.

Annual Progress Review Meetings

The Principal Investigator and one or two key personnel designated by the Principal Investigator of each grant awarded under this RFA AI-06-035 shall participate, with NIAID Program staff and any external advisors (when applicable), in annual meetings to review progress and aid in program development. These annual meetings shall be held at the NIAID offices in Bethesda, Maryland, at one of the awardee institutions, at a scientific meeting, or at another site determined by NIAID Program staff. Additional meetings, which may be necessary for coordination of cooperative agreement activities, may be scheduled if necessary.

Publications

The Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Cooperative Agreement. Manuscripts shall be submitted to the NIAID Program Officer within two weeks of acceptance for publication. Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of NIAID support. Timely publication of major findings is encouraged.  

Data

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.

The NIH Project Scientist will serve as a liaison/facilitator between the awardee, pharmaceutical and  biotechnology industries, and other government agencies (e.g., FDA, USDA, CDC), and will serve as a resource of scientific and policy information related to the goals of the awardee's research. The NIH Project Scientist will also facilitate coordination of project activities during the course of the project and assist the awardee with access to other NIAID-supported resources and services, including resources for preclinical development such as animal models, screening facilities, standardized research reagents, and a genomics resource center, where available.

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. The assigned program official may also serve as the NIH Project Scientist.

2.A.3. Collaborative Responsibilities  

The specific timelines, interim objectives (milestones) and funding levels agreed to by the Principal Investigator and the NIAID shall be included in the terms and conditions of award.  Given the nature of product development, it is recognized that timelines and interim objectives may require revision and renegotiation during the course of the project period.  The Principal Investigator and NIAID must agree to all such revisions. Release of each funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon interim objective.  NIAID may ask recipients to collaborate or cooperate with other NIAID funded projects, and/or other US government agencies, for example with the CDC, FDA and/or USDA.

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 awardee, 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:

Direct inquires regarding general scientific, technical, and programmatic issues to:

Clare K. Schmitt, PhD
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 4005, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 451-5075
FAX: (301) 402-1456
Email: CSchmitt@niaid.nih.gov

Direct your questions about scientific/research issues on THERAPEUTICS & IMMUNOTHERAPEUTICS to:

Lillian Van De Verg, Ph.D
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 4010, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 451-3754
FAX: (301) 402 1456
Email: LVanDeVerg@niaid.nih.gov

Direct your questions about scientific/research issues on DIAGNOSTICS to:

Robert H. Hall, Ph.D
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 4013, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 451-5074
FAX: (301) 402 1456
Email: RHall@niaid.nih.gov

 2. Peer Review Contacts:

Lucy A. Ward, DVM, Ph.D.
Division of Extramural Activities
National Institute of Allergy & Infectious Diseases
Room 3117, MSC-7616
6700-B Rockledge Drive
Bethesda, MD  20892-7616 (express mail zip code 20817)
phone: (301) 594-6635
fax: (301) 480-7614
email: lward@niaid.nih.gov

3. Financial or Grants Management Contacts:

Ms. Mollie Shea
Division of Extramural Activities
National Institute of Allergy & Infectious Diseases
Room 2234, MSC-7614
6700-B Rockledge Drive
Bethesda, MD  20892-7614
phone: (301) 402-6576
FAX: 301-480-3780
Email: mshea@niaid.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 (45 CFR Part 46) 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).

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:
The Office of Management and Budget (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://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/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/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases 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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