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) (www.niaid.nih.gov)

Title:Sexually Transmitted Infections Cooperative Research Centers (U19)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-AI-03-042.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-AI-08-004

Catalog of Federal Domestic Assistance Number(s)
93.856

Key Dates
Release Date: July 16, 2008
Letters of Intent Receipt Date: September 30, 2008
Application Receipt Date: October 30, 2008
Peer Review Date: February 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration Date: October 31, 2008

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
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

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

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) invites applications to participate in a multidisciplinary research program to enhance understanding and further knowledge of sexually transmitted infections (STIs), associated syndromes and other reproductive tract infections, such as bacterial vaginosis (BV), pelvic inflammatory disease (PID) and non-gonococcal urethritis (NGU). The objective of the Sexually Transmitted Infections Cooperative Research Centers (STI CRC) program is to create a group of research centers dedicated to studies that increase knowledge needed to inform strategies for the control and prevention of STIs, the organisms that cause STIs, and syndromes and conditions associated with STIs. The scientific knowledge to be achieved through this FOA will build on the information that is presently available in the STI community as well as discover new ways of preventing, diagnosing and treating STIs.

Background

STIs are critical global and national health priorities because of their disproportionate impact on women and infants. Many of these women are uninsured and come from lower socioeconomic areas without regular access to health care. In the U.S. alone there are an estimated 19 million new infections each year. Half of these new infections occur among young people ages 15 to 24. Healthcare costs associated with STIs in the U.S. are estimated at $14.7 billion annually. Several STIs can increase the risk of HIV acquisition and transmission, as well as alter the course of AIDS progression. Preventative strategies for several STIs, including vaccination, the use of simple and accurate diagnostics, and behavioral interventions have been developed and introduced into the public. However, there is a clear need to continue basic and translational research on many STIs where effective preventative strategies do not exist.

Research Scope and Objectives

STIs, associated syndromes and other reproductive tract infections of considerable U.S. and global public heath importance which are within the scope of this FOA, include, but are not limited to, the following:

Chlamydia infection, caused by the bacterium Chlamydia trachomatis (CT), is the most common bacteria-mediated STI in the U.S. with over 1 million cases reported in 2006. However, it is estimated that a large number of chlamydia infections are asymptomatic and therefore underdiagnosed. Prolonged and/or repeat infection of the female genital tract by CT may induce detrimental sequelae such as Pelvic Inflammatory Disease (PID) and infertility.

Gonorrhea, caused by the bacterium Neisseria gonorrhoeae (GC), is the second most commonly reported bacterial STI with over 500,000 cases per year in the U.S. In 2006 the infection rate exceeded 2005 by 5.5%. Like chlamydia, gonorrhea is likely substantially underdiagnosed and underreported. Untreated cases can lead to PID in women and epididymitis in men. A recent increase in the prevalence of antibiotic resistance in GC has led to a change in the Centers for Disease Control (CDC) Sexually Transmitted Diseases (STD) Treatment Guidelines for gonorrhea (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5614a3.htm).

Trichomoniasis, caused by the parasite Trichomonas vaginalis (TV), is the most common non viral STI affecting humans. Trichomoniasis is associated with PID, adverse pregnancy outcomes, and is a co-factor in HIV transmission.

Syphilis, caused by the bacterium Treponema pallidum, has been increasing in the U.S. since 2000. Between 2005 and 2006 the national rate of syphilis infections increased by 13.8%. Increases in the rate of congenital syphilis, a particularly devastating neonatal infection, have also been reported.

Chancroid, a genital ulcer disease, is caused by the bacterium Haemophilus ducreyi. Chancroid is endemic in developing countries of Africa, Asia, and the Caribbean. Chancroid has also been reported as a co-factor in HIV transmission.

Mycoplasma genitalium (MG) was initially implicated as a cause of non-gonococcal urethritis (NGU) in men in 1980. Since that time it has become clear that MG is a common cause of urethritis in men and both urethritis and cervicitis in women. There is concern that MG may also be a causative agent of PID, endometritis and preterm birth.

Genital herpes, caused by the herpes simplex virus (HSV 1 and HSV 2), is one of the most common STIs in the U.S. with over 1 million infections per year. More than one in five Americans 45 million people are infected with HSV-2. Presently there is no cure for HSV. Genital herpes is also a co-factor in HIV transmission.

Genital and cervical warts are caused by the human papilloma virus (HPV). Over 6 million cases of HPV occur annually in the U.S. HPV infection is extremely common in young adults between the ages of 15 and 24. Several types of HPV cause cervical cancer, which is the second most common cause of cancer deaths in women world-wide. In 2006 the first vaccine developed to prevent cervical cancer and genital warts in women was licensed and introduced to the public.

Pelvic Inflammatory Disease (PID) is a common and serious complication of some STIs, especially Chlamydia and gonorrhea. PID can damage the fallopian tubes and tissues in and near the uterus and ovaries. PID can lead to serious consequences, including infertility, ectopic pregnancy (a pregnancy in the fallopian tube or elsewhere outside of the womb), abscess formation, and chronic pelvic pain. Each year in the U.S., it is estimated that more than 1 million women experience an episode of acute PID, and more than 100,000 women become infertile each year as a result of PID.

Bacterial vaginosis (BV) is the most common vaginal infection in women of childbearing age. The condition appears to involve the disruption of normal vaginal ecology. BV increases susceptibility to other STIs, and when present during pregnancy, may increase the risk of complications such as pre-term delivery.

Specific areas of interest for STIs, associated syndromes and other reproductive tract infections include, but are not limited to:

1. Development and assessment of prevention strategies for STIs, including vaccines, microbicides and behavioral interventions.

2. Development of control and treatment strategies for STIs such as identification of targets that could be developed as therapeutic agents.

3. Research leading to the development of in vitro diagnostic tools to aid in the early diagnosis of STIs.

4. Research that provides a better understanding of vaginal ecology, including interactions between vaginal flora and STI-causing organisms.

5. Research on the pathogenesis of organisms that cause STIs and associated syndromes or conditions.

6. Research on the innate and adaptive immune responses of the male and female genital tract in relation to STIs, associated syndromes and other reproductive tract infections.

7. Research on STI organisms in relation to their interactions with each other and/or HIV; the impact of STIs in the acquisition and progression of HIV infection and the role of HIV in alterations of the natural history, diagnosis, or response to treatment of STIs.

8. Development of models of infection for pathogenesis studies as well as pre-clinical testing of vaccines, topical microbicides and therapeutics.

9. Discovery and testing of topical microbicides effective against one or more STIs, including pre-clinical and clinical research to measure and assess vaginal and cervical inflammation.

This FOA will NOT support:

Applications proposing such studies will be considered unresponsive and will not be reviewed.

STI CRC STRUCTURE

Each STI CRC MUST encompass and include all of the following:

Each STI CRC MAY encompass:

Administrative Core (required)

The Administrative Core is responsible for coordinating the Center’s efforts and may sponsor activities to advance the Center’s integration. The administrative responsibilities of the Center Director(s) include:

The Administrative Core budget must request funds for the Center Director(s) (see below) to attend the Annual STI CRC Meeting. These meetings will be held in Bethesda, Maryland or at another site approved by the NIAID. Travel costs for Project Leaders and Core Leaders may be included in the Administrative Core or individual projects or cores.

Shared Resource Cores (optional)

Shared Resource Cores provide scientific and/or clinical services or resources to at least two research projects. Cores must be well justified and clearly non-duplicative of other services or facilities available to STI CRC investigators. Examples of services provided by a shared scientific core are monoclonal antibody production, peptide synthesis, microbiology laboratory services, and statistical support. Shared clinical cores could provide a source of patients and healthy volunteers, patient specimens or represent a facility for procedures that require health care personnel supervision. Each Core must be headed by a Core Leader. Applications proposing Shared Resource Cores must give a clear description of the facilities, techniques, and skills that the Core will provide to research projects, and the role of the Core Leader and key personnel. A budget must be provided for each Core. The apportionment of dollars, or percentage of dollars, that will be required to support each research project should also be presented.

Developmental Awards Program (DAP) Core (optional)

The purpose of the DAP is to provide specific funds to encourage and train researchers new to the field of STI research. This award may be used to support a specific research project or a training activity to take place at one or more of the STI CRCs. One STI CRC will be selected from among the pool of successful STI CRC applicants who proposed acceptable DAP Cores, to serve as the administrator of the DAP Core. The Administrator may be the Center Director(s) or his/her designee.

Applicants interested in serving as the administrator for the DAP must include a DAP Core with a detailed plan to support the responsibilities associated with the disbursement, administration and reporting on the use of the funds. This Core is optional and will not be considered in the overall evaluation of the application. Applicants proposing to administer the DAP must include, as part of their application, a plan for the DAP describing: (1) proposed administrative structure; (2) methods/procedures to support the EC in the solicitation and review process including criteria for selecting Award recipients, and for reviewing the progress of projects and awardees; (3) proposed procedures, format and timing for reporting on the status of DAP use; and (4) proposed budget. The DAP Core will be evaluated by the peer review panel, but will not influence the overall score of the application.

a. Candidates for a developmental award must be nominated by a Center Director(s) and can be internal or external to the nominating STI CRC.

b. The EC will review applications for developmental awards and will select awardees without regard to institutional association.

c. At any time, there may be none, one, or multiple awardees at one or more of the STI CRCs.

d. Developmental awards may be requested for a specific research project to take place at one or more of the STI CRCs or for a training activity (e.g., a course, workshop or training to transfer a technology from one STI CRC laboratory to another).

e. The annual amount available for the DAP Core for all developmental awards is $340,000 in direct costs. Each individual award may not exceed $85,000 per year in direct costs.

f. The duration of support for each developmental award can be for up to three years. The EC will review progress on a regular basis.

g. Recipients of a developmental award may not receive subsequent developmental awards. If the awardee achieves independent funding through a traditional research grant (for example: R01, R21, R03) prior to the end of the developmental award, and there is scientific overlap between the awards, the developmental award must be terminated and unexpended funds must be returned to the central DAP fund.

h. A progress report on the DAP Core activities must be included in the annual progress report of the STI CRC chosen to administer the program.

STI CRC Executive Committee (EC)

A STI CRC Executive Committee (EC) will be established to direct the collaborative work of the Centers and approve use of DAP funds. Center Directors from each STI CRC and a Project Scientist from the NIAID Division of Microbiology and Infectious Diseases STD Branch (see Section VI.2.A.2. NIH Responsibilities) will form a central EC. The EC will select one member to serve as Chair of the Committee. The EC must meet face-to-face within two months of award at a location to be determined by NIAID Program staff. The EC will meet at least annually, in conjunction with the Annual STI CRC Meeting, and will hold conference calls to facilitate interaction and collaboration across STI CRCs and with NIAID Program staff. Meetings may also be used, for example, to address common training needs, develop cross-Center initiatives or host invited speakers.

Annual STI CRC Meetings

The NIAID will hold an annual 1-2 day meeting to share recent findings and encourage collaborations. All key personnel are expected to attend and participate. Funds for travel and accommodations should be included in the budget request for the Administrative Core for Center Directors. Travel costs for Project Leaders and Core Leaders may be included in the Administrative Core or individual projects or cores. The research aims and status of projects from the Centers will be presented in brief talks. Highlights from each Center’s recent findings may also be presented, with Project and Core Leaders from each STI CRC summarizing their scientific activities. All annual STI CRC meetings will be held in the Bethesda, Maryland area or another NIAID-approved site. The initial meeting will be held within 2 months of award.

Note: If included in a Center application, the DAP Core will be evaluated by the peer review committee, but will not influence the overall score of the application.

Note: Advisory Groups are not required. If an application proposes to include an Advisory Group, it should be constituted after the grant award has been made so as not to name individual members in the application. Applicants should not contact nor identify individuals who might be invited to serve on the Advisory Group for their Center. For renewal applications, if an Advisory Group already exists, the names of current advisory group members should be provided in the application so that conflicts may be efficiently managed. Applications proposing an Advisory Group should include plans that indicate how such groups will be included in and contribute to, the success of the STI CRC. Funds to support an Advisory Group may be included in the Administrative Core budget.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH multi-project Cooperative Agreement (U19) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use a cooperative award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present FOA.

2. Funds Available

NIAID intends to commit $10.2 million in total costs for fiscal year 2009 to fund 4-6 new and/or competing renewal grants in response to this FOA. Budgets for direct costs are expected to range between $1 million and $2 million per year. Of the $10.2 million total, approximately $340,000 in direct costs will be available annually in a Development Awards Program fund to support investigators new to the STI field. Future year amounts will depend on annual appropriations.

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.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions are not eligible to apply as the primary applicant. However, applications may include foreign research components or collaborative sites.

1.B. Eligible Individuals

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

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

Note that multiple Project Leaders or Core Leaders are not allowed for individual Research Projects or Shared Resource Cores. The Core Leader(s) of the Administrative Core will be the Center Director(s) of the overall application.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

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) 710-0267, 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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project (see below under Supplemental Instructions for the Preparation of Multi-project Applications).

Additional information is available in the PHS 398 grant application instructions.

Supplemental Instructions for the Preparation of Multi-Project Applications

The following section supplements the instructions found in the PHS Form 398 for preparing multi-project grant applications that will be submitted in paper format. Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.

The supplemental instructions below are divided as follows:

A. General Instructions address collaborative efforts among research projects, the administrative and organizational structure, as well as the overall facilities and environment, and the overall budget.

B. Specific Instructions for Individual Projects describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

C. Specific Instructions for Core Units describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

A. General Instructions

All applications must be submitted on PHS Form 398. The multi-project grant application should be assembled and paginated as one complete document.

1. Form Page 1 - Face Page

Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

When multiple PDs/PIs are proposed, use the Face Page-Continued page to provide items 3a-3h for all PDs/PIs. The Contact PI should be listed on block 3 of Form Page 1-Face Page, with additional PDs/PIs listed on the Face Page-Continued.

2. Form Page 2

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

List the performance sites where the research will be conducted.

Under "Key Personnel", list the PD/PI(s) of the multi-project application, followed by the Project and Core Leaders of the component research projects and cores, other key personnel, and then other significant contributors.

When multiple PDs/PIs are proposed, list the Contact PI first, then all additional PDs/PIs in alphabetical order. Then list all Key Personnel, giving name and organization.

3. Form Page 3 - Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core. A page reference should be included for the budget for each project and each core. Further, each research project should be identified by number (e.g., Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g., Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."

4. Composite Budget

Do not use Form Page 4 of the PHS 398. Instead, using the suggested format presented below, prepare a composite budget for all proposed years of support. (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)

SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Invest.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2. Study

125,000

130,000

135,200

140,608

146,232

677,040

Project 3. Develop.

100,000

104,000

108,160

112,486

116,985

541,631

Core A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core B. DNA

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850











5. Form Page

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. Detailed budgets are required within the descriptions of each project and core (see below).

6. Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed at the end of the application with the PD/PI(s) first, followed by those of other key personnel in alphabetical order.

5. Resources Format Page

Do not complete. Essential information is to be presented in the individual research project and core sections of the application.

6. Program Overview (Research Objectives and Strategic Plan)

This narrative section summarizes the overall research plan for the multi-project application and is limited to 25 pages. The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.

If the application is a competing renewal, this section should also highlight past performance and the major accomplishments from the prior funding period. In addition to discussing results from individual projects, describe the synergy and collaborations that occurred. For individual research projects that will be continued, additional details should be provided in the Progress Report section of the Research Plan within the application for the Research Project (see below Section IV.2.C.7.).

7. Leadership Plan for Multiple PDs/PIs (required, if applicable)

For applications designating multiple PD/PIs, a leadership plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PD/PIs, including responsibilities for human or live vertebrate animal subject studies as appropriate.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PD/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

8. Checklist

One Checklist, placed at the end of the application, is to be submitted for the entire application.

9. Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

For each project or core in the multi-project application, 3 publications (see below) plus other approved material are allowed. The Appendix may not be used to circumvent the page limitations of the Research Plan. The Appendix material should be collated as one body of material and submitted on CD only, as indicated below. Each document file must include header information clearly indicating the project or core to which it applies.

Do not include unpublished theses, or abstracts/manuscripts submitted (but not yet accepted) for publication.

Note: Include the URL or PMC submission identification numbers along with the full reference in the Literature Cited section, the Progress Report for Competing Renewals section, and/or the Biographical Sketch section.

B. Specific Instructions for Individual Research Projects

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each research project.

Each individual Research Project must include:

1. Cover Page

The Face Page of the PHS 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project. This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):

Project Number and Title: (e.g., 1. Preclinical Evaluation of HIV Microbicides)

Name of Project Leader: (e.g., Jones, Roberta A.)

Human Subjects: (Yes or No)

If Yes, exemption number:

(or)

Institutional Review Board (IRB) Approval Date: (e.g., 12/13/2006,or "Pending")

(and)

Federalwide Assurance (FWA) number:

Vertebrate Animals: (Yes or No)

If Yes, IACUC Approval Date: (e.g., 11/17/2006, or Pending)

(and)

Animal welfare assurance number:

Proposed Period of Support:

From: (mmddyy - e.g., 07/01/2007)

To: (mmddyy - e.g., 06/30/2112)

Costs Requested for Initial Budget Period: (e.g. 07/01/2007-06/30/2008)

Direct Costs: (e.g., $ 150,000)

Total Costs: (e.g., $162,000)

Costs Requested for the Entire Budget Period: (e.g., 07/01/2007-06/30/2112)

Direct Costs: $700,000

Applicant Organization:

(full address)

2. Form Page 2

Provide a Description (abstract) of the research proposed in the project according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the research project will contribute towards attainment of the multi-project program objectives.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.

3. Form Page 3

Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.

5. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

6. Resources Format Page

Provide information on resources available for the project.

7. Research Plan (Items 2-5 cannot exceed 25 pages)

Item 2 -- Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the project's relationship to the multi-project program goals and how it relates to other projects or cores. This section is typically one page.

Item 3 -- Background and Significance: Use this section to describe how the proposed research will contribute to meeting the program's goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application.

8. Appendix

All appendix material should be collated as one body of material and submitted on CD as described above.

C. Specific Instructions for Cores

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.

Each Core must include:

1. Cover Page

The Face Page of the PHS 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page:

Core Letter and Core Title: (e.g., A. Monoclonal Antibody Production Core)

Name of Core Leader: (e.g., Smith, Robert A.)

Human Subjects (Yes or No)

If Yes, Exemption Number

(or)

IRB Approval Date (e.g., 5/14/06, or Pending)

(and)

Federalwide Assurance (FWA) number

Vertebrate Animals (Yes or No)

If Yes, IACUC Approval Date (e.g., 4/15/07, or Pending)

(and) Animal welfare assurance number

Proposed Period of Support

From: (mmddyy, e.g., 07/01/2007)

To: (mmddyy, e.g., 06/30/2012)

Costs Requested for Initial Budget Period

(e.g., Direct Costs: $50,000)

(e.g., Total Costs: $70,000)

Costs Requested for the Entire Budget Period

(e.g., Direct Costs: $212,323)

(e.g., Total Costs: $297,252)

Applicant Organization

(full address)

2. Form Page 2

Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the multi-project program objectives.

List the performance sites where the core activities and services will be conducted.

Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.

3. Form Page 3

Prepare a Table of Contents for the core using Form Page 3 of the PHS 398.

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.

5. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be located at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

6. Resources Format Page

Provide information on resources available for the core.

7. Core Research Plan (Items 2-5 cannot exceed 5 pages for the Administrative Core, 10 pages for each Shared Resources Core, and 10 pages for the [optional] DAP Core)

8. Appendix

All appendix materials should be collated as one body of material and submitted on CD as described above.

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: September 30, 2008
Application Receipt Date: October 30, 2008
Peer Review Date: February 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009

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 in Section IV.3.A.

The letter of intent should be sent to:

Michelle Timmerman, Ph.D.
Division of Extramural Activities
Scientific Review Program
National Institute of Allergy and Infectious Diseases
Room 3147, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892 (express mail zip 20817)
Telephone: 301-451-4573
Fax: 301-480-2310
Email: timmermanm@niaid.nih.gov

3.B. Sending an Application to the NIH

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

Michelle Timmerman, Ph.D.
Division of Extramural Activities
Scientific Review Program
National Institute of Allergy and Infectious Diseases
Room 3147, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892 (express mail zip 20817)
Telephone: 301-451-4573
Fax: 301-480-2310
Email: timmermanm@niaid.nih.gov

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, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or 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 NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

Requested budgets must include funds for travel by the Center Director(s), Project Leaders and Core Leaders to participate in an Annual STI CRC Meeting in Bethesda, Maryland or another location as determined by NIAID staff.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Applications proposing clinical research or early phase clinical trials must present the concept of the proposed research or trial to include the hypothesis, the study objectives, the target population, and potential clinical sites. The application should provide sufficient detail to allow the reviewers to judge significance, approach, innovation , investigators and environment. Submission of a detailed, final clinical protocol is neither required nor encouraged at this time.

Research Plan Page Limitations

See Section IV.2. Content and Form of Application Submission for Research Plan page limitations for the individual STI CRC components.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

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 meritorious 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.

Review Criteria for Individual Research Projects

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 and other key personnel 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 (e.g., experience in multidisciplinary research or experience in conducting clinical research and/or clinical trials)?

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?

Review Criteria for Cores

Administrative Core

Shared Resource Cores (if applicable)

Review Criteria for Evaluating the Overall Application

The following items will be considered in the determination of the overall scientific and technical merit and priority score for the entire application:

NIH considers the following in evaluating Center grant applications:

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 rating:

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 on Human Subjects in the PHS 398 instructions).

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 on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan 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.

Developmental Awards Program (DAP) Core (if applicable)

The plan for the Development Awards Program administration is optional and will not be factored into determining the overall priority score. The review panel will consider the following criteria:

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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.

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/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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 an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The PD/PI, or Center Director, will have the primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the FOA and for performing the scientific activity. Specifically, the Center Director has the primary responsibility as described below.

The Center Director will have ultimate responsibility for the coordination of efforts within the STI CRC and ensuring that results obtained are analyzed and published in a timely manner. It will be the responsibility of the Project and Core Leaders to plan and conduct the activities described in the application. Timely publication of major findings is encouraged. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgement of the STI CRCs and NIAID support. NIAID may periodically review and generate internal reports from data and progress reports developed under this cooperative agreement. The data obtained will, however, be the property of the awardee.

The Center Director will be a voting member of the Executive Committee (see below), will participate in all Executive Committee activities, and will follow the policies and procedures developed by the Executive Committee.

The Center Director agrees to accept close coordination, cooperation, and participation of NIAID staff in all aspects of scientific and technical management of the project as stated below under NIH Responsibilities.

Under the Cooperative Agreement, a partnership relationship exists between the recipient of the award and NIAID in which successful applicants are responsive to the guidelines and conditions set forth in the FOA. At the same time, Center Directors are expected to define research objectives and approaches in accord with their own interests and perceptions of novel and exploitable approaches to the research which ultimately is likely to result in improved prevention and control of STIs, associated syndromes and other reproductive tract infections..

The multi-disciplinary and collaborative nature of the STI CRCs creates an extraordinary opportunity for information exchange and scientific advancement in STI research. STI CRC investigators are expected to take advantage of this opportunity by participation in both formal events established expressly for this purpose and informal investigator-initiated dialogues.

Monitoring Clinical Studies

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

Federally Mandated Regulatory Requirements for Clinical Trials

Each institution participating in a clinical trial is required to meet DHHS regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. At a minimum, these include:

Intellectual Property

The awardee is solely responsible for the timely acquisition of all appropriate propriety rights, including intellectual property rights, and all materials needed for the awardee to perform the project.

Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any propriety rights, including intellectual property rights, or any materials needed by the awardee to perform the project.

The awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).

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.

Developmental Awards Program (DAP) Administration

Developmental awards funds will be awarded to one STI CRC institution that will be responsible for managing and administering the DAP. This institution must agree to take responsibility for managing the funds, including the disbursement, administration, and reporting on the use of developmental awards funds as approved by the Executive Committee. Developmental awards fund expenditures will be restricted until a process for the prioritization, solicitation, review and evaluation of projects and the disbursement of funds is established and agreed upon in writing by the Executive Committee. Once this process is established, funds will be available for distribution.

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 role of NIAID/NIH Project Scientist in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD/PI. The NIAID Project Scientist will work closely with the PDs/PIs and other STI CRC member scientists to facilitate collaborations and to leverage the resources available to the Program.

The NIAID Project Scientist will monitor the progress of the STI CRCs, help coordinate research approaches among Centers, and contribute to the shaping of research projects or approaches as warranted. The NIAID Project Scientist will support and facilitate this process but not direct it.

The NIAID Project Scientist will keep the STI CRCs informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in infectious diseases research. The NIAID Project Scientist will coordinate access for the STI CRCs to other NIAID resources, as well as assist the research efforts of the STI CRCs by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.

The NIAID Project Scientist will serve as a non-voting member of the Executive Committee.

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 NIAID STD Branch will provide overall coordination of the STI CRC Program. The NIAID Project Scientist will coordinate with the PDs/PIs and hold regular program-wide discussions to facilitate program goals. Some STI CRCs may develop common research interests; research focus groups may be formed to pursue coordinated research activities.

In addition, Center Directors and the NIAID Project Scientist will participate in a central STI CRC Executive Committee (EC) to direct the collaborative work of the Centers. The EC will meet at least annually, in conjunction with the Annual STI CRC Meeting, and will hold conference calls to facilitate interaction and collaboration across STI CRCs and with NIAID program staff. Meetings may also be used, for example, to address common training needs, develop cross-Center initiatives, or host invited speakers.

A major activity of the EC will be to determine use of the Development Awards Program funds for investigators new to the field of STIs. The EC will solicit, review, and select awardees for the DAP fund. Each full member will have one vote. The NIAID Project Scientist will serve as a non-voting member.

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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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:

M. Elizabeth Rogers
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Disease
Room 5035, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 451-3742
FAX: 301-480-3617
Email: erogers@niaid.nih.gov

2. Peer Review Contacts:

Michelle Timmerman, Ph.D.
Division of Extramural Activities
Scientific Review Program
National Institute of Allergy and Infectious Diseases
Room 3147, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892 (express mail zip 20817)
Telephone: 301-451-4573
Fax: 301-480-2310
Email: timmermanm@niaid.nih.gov

3. Financial or Grants Management Contacts:

Kim Coats
Division of Extramural Activities
Grants Management Program
Room 2243, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 451-4576
FAX: (301) 493-0597
Email: kcoats@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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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/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 Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable 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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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