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: Partnerships to Develop Tools to Evaluate Women's Health

Announcement Type
New

Request For Applications (RFA) Number: RFA-AI-05-029

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

Key Dates
Release Date: May 26, 2005
Letters of Intent Receipt Date(s): September 16, 2005
Application Receipt Dates(s): October 17, 2005
Peer Review Date(s): February, 2006
Council Review Date(s): May, 2006
Earliest Anticipated Start Date: July, 2006
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/QA/rfa-05-029.htm
Expiration Date: October 18, 2005

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, 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 understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. NIAID supports 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.

This RFA will support translational and applied research for the evaluation and improvement of women's health by advancing the development of tools and methods to: assess vaginal ecology; measure immune responses in the vagina; and/or assess the influence of reproductive hormones on the vaginal ecosystem and the immune responses. The research could include investigating a variety of aspects of the reproductive tract in normal and altered physiological conditions.

Partnerships

The partnerships series of grant programs was started in FY 2002 to stimulate industry participation in the development of vaccines, drugs and diagnostics for human infectious diseases of public health importance and products for controlling arthropod vectors that transmit infectious agents. The development of vaccines, drugs and diagnostics for biodefense was also added in FY 2002. For FY 2003, the non-biodefense partnerships initiative was focused on the development of novel therapies for Hepatitis B virus and strategies for control of arthropod vector-borne diseases. In FY 2004, the non-biodefense partnerships initiative was focused on vaccines for Helicobacter pylori and vaccines and diagnostics for Group A streptococcus (GAS) and Group B streptococcus (GBS). In FY 2005, the non-biodefense partnerships will be focused on the development of diagnostics for common blood stream pathogens encountered in the hospital setting (leading to sepsis) and the common causes of community acquired pneumonia, and development of new topical microbicides for preventing sexually transmitted infections. NIAID is also using this approach to solicit applications related to biodefense.

A key component of this initiative is the development of partnerships between the government and industry. 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 technologies and candidate products, this RFA will also support partnerships between industry and collaborator(s) as necessary from academic and non-profit research organizations. The involvement of an academic or non-profit research organization is NOT a requirement; therefore, industry does not need a collaborator to submit an application to this program.

All projects must demonstrate substantive involvement by the industry partner. For the purpose of this RFA, "substantive involvement" is defined as the commitment of any one or more of the following resources: funds; personnel; or in-kind contributions of materials and/or reagents including, but not limited to, recombinant protein production, provision of animal or other laboratory models, and assays, subcontracts, data management resources or regulatory support. The Principal Investigator of the project may be affiliated with either industry or academic organizations (if academia is part of a partnership with industry). See information under Eligible Institutions below.

Applicants are encouraged to reach early consensus with their proposed partners regarding intellectual property and other legal matters that may arise during the project.

Background

The NIH and other agencies in the Department of Health and Human Services (DHHS) are currently supporting extramural and intramural women's health research. An increased understanding of the pathogenesis and epidemiology of infectious diseases (including sexually transmitted infections and group B streptococcal infections) has led to a broader understanding of the reproductive tract, the role of vaginal flora, and the influence of the immune response in the vagina. However, the development of tools to conduct comprehensive evaluations of the vaginal ecosystem have not kept pace with this increased understanding. Many of these infections not only affect women, but also have a significant impact on outcomes of pregnancy and subsequent neonatal health. This initiative will stimulate and provide support of research to develop tools to assess women's reproductive health.

Control and prevention of infections in the female reproductive tract are critical global and national health priorities because of the devastating impact on women and infants, and the inter-relationships with HIV/AIDS. Each year an estimated 15 million Americans suffer the effects of Sexually Transmitted Infections (STIs) at a cost exceeding $16 billion. STIs and HIV are linked both by biological interactions and by infections occurring in the same populations. Recent studies indicate that the more prevalent STIs that cause non-ulcerative diseases (Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis , and organisms associated with bacterial vaginosis), as well as the STIs that cause ulcerative diseases (Herpes simplex virus type 2, Treponema pallidum and Haemophilus ducreyi) increase the risk of HIV transmission by at least two-to five-fold.

Because some infectious agents (e.g., Chlamydia), can ascend to the upper female genital tract, the long-term consequences of infection are also more severe for women and may result in pelvic inflammatory disease (PID), infertility, or tubal/ectopic pregnancy. The harmful effects on babies born to infected mothers may include stillbirth, premature birth, and perinatal and congenital infections. Moreover, many infections are often asymptomatic in women, resulting in a delay or lack of treatment. Women and their children bear a disproportionate burden of the harm caused by STIs. Group B streptococci also cause infections in mothers during pregnancy and in the neonate. During pregnancy, women can be afflicted with amnionitis, endometritis, sepsis, or rarely, meningitis. Intrauterine infections from GBS can lead to stillbirth or sepsis. In addition, infants can also be infected with GBS during passage through the birth canal resulting in sepsis, pneumonia and/or meningitis.

Infections in the female reproductive tract are an area of significant health disparity. African Americans are hardest hit with rates more than thirty times greater than white Americans for some STIs. Although intrapartum administration of antibiotics during delivery has decreased the incidence of neonatal GBS disease, racial disparities persist with higher rates recorded for African Americans than whites. This is likely due to higher GBS colonization rates and more common preterm delivery which increase risk for neonatal GBS disease.

Research Objectives and Scope

This RFA is specifically focused on applied and translational research to advance the development of tools and methods to:

Women are infected with microbial pathogens throughout their life. The objective of this RFA is to support research that will advance the development and evaluation of a variety of tools and methods that will help define the complex ecosystem of vaginal flora and pathogens in the context of the immune response of the female reproductive tract. Research may include, but is not limited to, target identification (e.g., compound screening, epitope identification); the adaptation of platform technologies or products to women's health applications; optimization of products; process development, early validation and testing; and preclinical evaluation. It is essential to have robust methods to measure components of vaginal fluid (e.g., microbial and/or cellular products such as enzymes, cytokines, immunoglobulins) in order to understand the impact of their role in prevention from infection. For example, sialidases produced by bacterial species found in the vagina have been shown to impair mucosal immune defenses by chemical degradation of IgA and IgM molecules in vaginal fluid. This knowledge will facilitate development of a variety of interventions to improve the overall status of women's sexual and reproductive health, as well as to improve the well-being of neonates. Clinical evaluation of the technologies/products developed through this Partnership Program may subsequently be supported through other mechanisms.

It is likely that a comprehensive team and multidisciplinary effort will be needed to advance promising tools for evaluation and improvement of women's health. Research projects funded under this RFA will be implemented in accordance with the defined project goals, interim objectives/development milestones, and the timeline for the achievement of goals and milestones. When appropriate, research projects funded under this RFA will incorporate measures that are consistent with the guidelines that govern GLP (as defined by 21 CFR(58)) and cGMP (as defined by 21 CFR(211)).

Note: Research to advance the development of tools and methods could be positioned at any point in the product development pipeline, ranging from the initial transition from basic to translational research through later stages close to final product evaluation. Research leading to the improvement of an existing tool/technology/method will be responsive to this RFA. Basic research will NOT be supported.

Note: The utilization of archived or prospectively collected human samples in the early phases of development as well as in the evaluation of proposed tools in preclinical and clinical studies is considered responsive and is encouraged. While clinical development strategies may be included within an overall product development plan, this RFA will NOT support Phase I, II, and III clinical trials or field trials. Applications requesting support for clinical trials will be viewed as unresponsive to this RFA and will be returned to the applicant without review.

Tools and Methods to Assess Vaginal Ecology

Epidemiological studies have been conducted to define parameters that are associated with colonization/infections of the female genital tract. Risk factors that have been studied include demographics, socio-economic factors, smoking, alcohol use and sexual behavior. However, to date, comprehensive studies have not been conducted in minority and adolescent populations. Relevant and reliable tools are needed to be able to assess a more global view of the vaginal ecology in relation to its role in susceptibility to infection. A better understanding of the relevant parameters and risk factors may guide the development of strategies for the control and prevention of infections of the reproductive tract and/or for the safety assessments of vaginal products to prevent these infections.

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

Note: Epidemiological studies that do not support the development of a tool or its evaluation will not be considered responsive to this RFA.

Tools and Methods to Measure the Immune Response in the Vagina

Despite the interest in the mechanisms of immune protection for sexually transmitted infections, little is known about the immune system in the genital tract. The mucosal and regional immunology of the vagina has unique features that can influence the outcome of vaginal challenge with microbial pathogens in animal models. Studies are required in humans to comprehend the cellular and molecular mechanisms involved in inducing effective immune responses that will be effective in the reproductive tract. The roles of vaginal cells and secretions and their interactions need to be more clearly defined in order to better understand microbial pathogenesis and to prevent infections in women. In addition, the use of vaginal products, such as douches, may impact the immune response in the vagina.

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

Note: Basic research to develop animal models will not be supported.

Note: Studies on vaginal immune response that do not support the development of a tool or method, or are not carried out in conjunction with the development of a tool or method, will not be supported.

Tools and Methods to Assess the Influence of Reproductive Hormones on the Vaginal Ecosystem and Immune Responses

The development of tools to incorporate the hormonal influences on the assessment of vaginal ecology and the immune response is needed. Some studies have demonstrated the effects of hormones on antigen presentation, innate immunity, regulation of immunoglobulin secretions and genital infections. Additional studies are needed to understand more thoroughly how hormonal changes regulate immune responses and the subsequent impact on susceptibility to infection. Topics to be investigated include specific hormones, individually and in combination, as well as the absolute amounts during various phases of life (e.g., menarche, menopause and/or post menopause as well as pregnancy and the post-partum period). This includes sources that are endogenous and exogenous (e.g., hormonal contraception, treatment of genital disorders, treatment of menopause, en vironmental exposure through herbal/natural products).

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

Note: Research to advance development of a tool or method to measure hormone levels in the absence of female ecology or female genital infections will not be responsive to this RFA, e.g., hormonal blood levels in isolation from any other data.

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.

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".

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 $2 million dollars in FY 2006 to fund 2-4 new and/or competitive 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 no greater than $500,000 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 RFA 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.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria
Not Applicable

Section IV. Application Submission Instructions

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 most 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 a unique research opportunity not available in the U.S.

3. Submission Dates and Time
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): September 16, 2005
Application Receipt Dates(s): October 17, 2005
Peer Review Date(s): February, 2006
Council Review Date(s): May, 2006
Earliest Anticipated Start Date: July, 2006

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

The letter of intent should be sent to:

Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20892 (for express/courier service; non-USPS service)
Telephone: 301-435-8537
FAX: 301-480-2310
E-mail: eschroder@niaid.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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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

Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20892 (for express/courier service; non-USPS service)
Telephone: 301-435-8537
FAX: 301-480-2310
E-mail: eschroder@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 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.

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

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

1. Research Plan

1A. Project Description:

The proposed research plan must include:

1B. Good Laboratory Practice/current Good Manufacturing Practice

When appropriate, applicants must document in the Research Plan compliance with guidelines that govern GLP, as defined by 21 CRF (58), and cGMP, as defined by 21 CRF (211).

2. Mandatory Meetings

Requested budgets must include funds for travel by the Principal Investigator and key personnel to participate in 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. 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 must not be included in the application; external advisors must be identified and appointed only after award.

Additional Submission Requirements (Do not count towards page limits for Research Plan)

1. Milestones and Timeline

Applicants must provide detailed project performance objectives and timelines 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

If appropriate, applicants may 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:

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 NIAID in accordance with the review criteria stated below.

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 comments, 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? Is this project likely to significantly advance the development of a tool for the evaluation and/or improvement of women's health?

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? Is the likelihood of successful project completion high given the current state of research and development and the technical approach?

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? Many aspects of product development are not inherently innovative (e.g., GLP or cGMP production). However, each project will be judged on whether the proposed research leverages multi-disciplinary involvement to accelerate product development. In addition, the approach should represent the best use of current or emerging technologies and appropriate collaborations to achieve the research objectives.

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?

2.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 398 research grant application instructions will be assessed.

Timelines, Milestones and Product Development Plan: The appropriateness and feasibility of proposed timelines and interim milestones will be evaluated by reviewers. The feasibility of future product development, if appropriate, also will be assessed by the reviewers.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

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

Program staff will be responsible for the administrative review of the plan for sharing research 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 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 NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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 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 (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 and for performing the scientific activity. Specifically, awardees have primary responsibility as described below.

The Principal Investigator retains primary responsibility for the performance of the scientific activity, and agrees to accept close assistance in coordination, cooperation and participation of NIAID staff in scientific and technical management of 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 be solely that of the Principal Investigator.

Intellectual Property

The successful development of tools for the evaluation of women's health will require substantial investment and support of private sector industries and may also involve collaborations with multiple organizations, including 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 critical 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.

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 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.

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.

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

The specific timelines, milestones and funding levels agreed to by the awardee 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. In order to advance the development of a tool or method to evaluate women's health, NIAID may ask awardees to collaborate or cooperate with other NIAID-funded projects and/or U.S. government agencies, for example CDC, FDA, and/or USDA.

External Advisors

External advisors may be appointed by the Principal Investigator in consultation with NIAID Program Staff to assist in progress review. External advisors will be identified and appointed only after award.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

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

M. Elizabeth Rogers
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5026, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
(Express mail zip code is 20817)
Telephone: 301-451-3742
Fax: 301-480-3617
E-mail: erogers@niaid.nih.gov

Direct your questions about scientific/research issues on group B streptococci to:

Fran A. Rubin, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5055, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
(For express mail, use zip code 20817)
Telephone: (301) 435-2863
Fax: (301) 496-8030
E-mail: frubin@niaid.nih.gov

2. Peer Review Contacts:

Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20892 (for express/courier service; non-USPS service)
Telephone: 301-435-8537
FAX: 301-480-2310
E-mail: eschroder@niaid.nih.gov

3. Financial or Grants Management Contacts:

Michael A. Wright
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2249, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: 301-451-2688
FAX: 301-493-0597
Email: mawright@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 (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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.

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 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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