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 Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)

Title: Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP-HTM) Competitive Revisions (U19)

Announcement Type
Announces competitive revisions for IPCP-HTM grants awarded under RFA-AI-07-001, RFA-AI-08-006, and RFA-AI-08-057.

Request For Applications (RFA) Number: RFA-AI-10-007

Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856, 93.242

Key Dates
Release Date: August 2, 2010
Letters of Intent Receipt Date: October 15, 2010
Application Receipt Date: November 17, 2010
Peer Review Date: March, 2011
Council Review Date: May, 2011
Earliest Anticipated Start Date: July, 2011
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm 
Expiration Date:  November 18, 2010

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. Dispute Resolution 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 objective of the Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP-HTM) is to advance novel single and combination safe, effective and acceptable microbicides and microbicide strategies to prevent sexual transmission of HIV to the clinical testing stage.  The IPCP-HTM supports a wide range of microbicide research, including specific product development, basic and developmental microbicide science to support the advancement of a specific microbicide or microbicide strategy, preclinical development, IND-enabling critical path development and exploratory small scale clinical trials – hereinafter referred to as pre-Phase I clinical trials.  The IPCP-HTM serves as a platform for microbicide development through support of integrated and iterative research projects and cores that host a collaborative environment to promote microbicide development.

The purpose of this FOA is to solicit competitive revision applications from eligible IPCP-HTM grantees to provide grantees an opportunity to expand the scope to accelerate, enhance and synergize their project’s progress.  Resources may be added as specific enhancements to existing project(s) and/or core(s), such as personnel, and/or research resources.  In all cases the requested competitive revision must expand upon the original scope of the proposed science and should add significantly and synergistically to the ability of the current project to achieve its objectives and milestones.  Competitive revisions may be developed that address newly recognized opportunities in the current research program and/or changes in the microbicide field.  Competitive revisions may support additional pre-Phase I clinical trials if clinical trials are ongoing.

Background

The IPCP-HTM Program has been integral in supporting the transition of topical microbicide candidates from early discovery to initial clinical testing by promoting the development of single and combination topical microbicides delivered by a variety of methods (gels, films and intravaginal rings).

Addressing the many challenges of microbicide development requires IPCP-HTM Programs to develop collaborative research and development platforms that integrate diverse scientific disciplines.  The field of microbicides is constantly changing and IPCP-HTM awards must continually make adjustments in their development to assure success.  Newly acquired biochemical and biophysical knowledge of the mechanism of HIV transmission and the in vivo parameters that specify safety, efficacy and acceptability are driving these changes.  Therefore, IPCP-HTM programs may need to adjust and/or modify strategies to meet their overarching objective of developing a microbicide or microbicide strategy.  These adjustments are guided in part by their Scientific Advisory Panels (SAP) and administrative infrastructure.  This FOA will enable awarded IPCP-HTM teams to identify and acquire additional resources to address scientific and administrative gaps that have arisen in their program through expansion of the originally proposed scope of research thus potentially enhancing the productivity and success of the IPCP-HTM Program.

Milestones are essential to the operation and success of IPCP-HTM programs.  Competitive revision applications must include milestones that are integrated with the milestones of the IPCP-HTM award.  These must identify metrics to be used to measure the success of the activities supported by the revision.  For revisions proposing new IND-enabling critical path projects, the milestones must also include go/no–go criteria that provide funding based on successful achievement of the milestones.

Applicants are encouraged to involve industrial partners as defined in the parent IPCP-HTM FOA RFA-AI-10-006, where appropriate.  Revisions should not be used to replace industrial partners or to circumvent their contribution to the awarded IPCP-HTM Program.

Research Objectives and Scope

Revisions to the IPCP-HTM program are intended to provide additional support by acknowledging the need for IPCP-HTM teams to incorporate additional resources for addressing gaps, obstacles and hurdles that may have arisen following initial award or emerging scientific advances.  The overarching goal of any request for additional resources to expand the scope of the originally proposed research  should be to increase the efficiencies of the operations of the IPCP-HTM Program.  IPCP-HTM revisions may be requested in any of the areas of microbicide science found in the most recent version of the IPCP-HTM RFA-AI-10-006. New projects and/or cores should not duplicate activities already conducted in the IPCP-HTM award; rather they must  expand upon the scope of the originally proposed research.  In the case where activities may appear similar due to the scientific theme proposed, e.g. formulation, IND-enabling studies, etc., the applicant must provide sufficient justification for additional resources.

Sufficient justification should address how the proposed activities will be completed within the remaining award period and contribute substantially to the proposed microbicide under development.  This FOA will follow the criteria for nonresponsive and responsive applications criteria of the IPCP-HTM RFA-AI-10-006.  The following additional non-responsive criteria will apply specifically to competitive revision applications.

Clinical projects may not be expanded or initiated in the last year of award.  All proposed new Pre-phase I clinical trials should address the adequacy of existing IPCP-HTM resources (existing regulatory core/project) to support multiple trials.

A clinical project may not be appended to a nonclinical 4-year IPCP-HTM award.

This FOA will NOT support Phase I, II, or III clinical trials.

A proposed IND-enabling critical path development project cannot be incorporated into an ongoing award with less than 2 years remaining. Competitive revision awards may not be used to extend the 3-year duration of a funded IND-enabling critical path project.

Revisions may include a request for equipment; however, the total cost of the equipment must be less than 10% of the requested revision.  The equipment request must be justified and demonstrated to be critical to the operation of the IPCP-HTM Program.  The gained efficiencies should be quantified in the justification.

Revisions may be used to enhance existing, or to add new animal safety or efficacy studies to the IPCP-HTM award.  Applications requesting supplemental funding for nonhuman primate (NHP) studies for determining candidate efficacy must include (1) placebo and no-treatment control arms in the study, (2) sufficient numbers of NHP for all groups to allow a statistical analysis of the endpoint, (3) a formulated product that has undergone sufficient preformulation and formulation development to establish product stability and release from the dosing vehicle, and (4) where applicable, value added studies such as pharmacokinetic and pharmacodynamic endpoints, safety measurements (colposcopy, histology, vaginal pH. microflora and/or adaptive/innate immune markers).  Studies in which unformulated microbicides are administered to NHP to screen for active or more potent candidates are strongly discouraged.  Additionally, requests to include additional animals in ongoing studies without addressing the 4 areas above are discouraged. 

IPCP-HTM Administrative Core

It is not anticipated that revisions applied to administrative cores will be used to increase the administrative core activities without a concomitant increase in research activities.  Revisions may be applicable to the Administrative core.  It is expected that these revisions will be in the form of additional administrative infrastructure (personnel and time commitments) to facilitate the addition of new cores or projects and/or to increase oversight needed for projects and cores receiving increased resources.    Descriptions of the enhanced administrative core should discuss the efficiencies of adding the requested resources and how they will facilitate the newly proposed IPCP-HTM activities.

Applications should include travel funds for any new Project Leaders, Core Leaders, other key IPCP-HTM personnel, and new SAP members to attend the required annual IPCP-HTM meeting.  Applicants proposing new or modified pre-Phase I clinical trials where new or additional travel is required to coordinate activities among clinical sites may request travel.  However, all such travel requests should be well justified.  Requests for additional travel to visit subcontractor or consortium sites for discussion and planning involved in supplying specific assays or services, such as GLP analytical services or animal testing must be specifically justified.  Applicants should provide a justification for face-to-face meetings and a rationale for why they cannot be adequately conducted via tele- or web conference.

Additional travel resources CANNOT be added without a concomitant increase in the effort of an IPCP-HTM project or core.

Revisions may not be made to administrative or regulatory cores without a concomitant increase in the overall proposed research to be conducted by the IPCP-HTM team.  If resources in the original award were inadequate, re-budgeting within the award or alternative sources of support should be located to meet these gaps.

IPCP-HTM Scientific Cores

Revision applications may include the addition of new scientific cores to the IPCP-HTM.  New cores must support 2 or more projects.  The proposed core activities should not be available in currently awarded cores or projects.  Added cores should not be used solely for coordinating consortium or subcontracting activities in support of the IPCP-HTM.  Added cores must address a specific unmet need or service that the awarded IPCP-HTM lacks.  Wherever possible applicants are encouraged to expand existing cores rather than create new cores. 

IPCP-HTM Scientific Advisory Panel (SAP) and Consultants

Revisions may necessitate the addition of new SAP members and consultants to the IPCP-HTM.  Potential new expertise needed for IPCP-HTM operations should be identified and endorsed by current SAP members.  New SAP members should be described only by the expertise they will provide to the IPCP-HTM, and not by name.  Proposed consultants should be named and their area of expertise specifically identified.  Sufficient justification should be provided to determine how their addition will enhance the IPCP-HTM program.

Because of the uncertainty of the efficacy of candidate microbicides and other prevention strategies, the need to maintain a balanced portfolio of candidates, expertise and microbicide strategies is critical toward meeting NIAID’s commitment to HIV/AIDS prevention and will be carefully considered in making funding decisions.  The Government reserves the right to make awards that incorporate significantly different concepts as a mechanism to achieve programmatic balance.

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 U19 award mechanism(s). 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 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement 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 this funding opportunity will be reissued.

2. Funds Available

NIAID anticipates awarding a total of $6 million in FY 2011 to IPCP-HTM applications under this FOA and RFA-AI-10-006, for new IPCP-HTM applications.

The requested project period may not extend beyond that of the parent grant.

It is anticipated that at least one new competitive revision award will be awarded in response to this FOA.

Competitive revision budget requests may not exceed a total Direct Cost of $1.4 million per year and may request support for multiple years.

Applicants may develop an application requesting specific additions to existing core(s) and/or project(s), addition of new core(s) and/or project(s) or any combination of the above. 

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:

Eligible institutions are current NIAID IPCP-HTM awardees.

1.B. Eligible Individuals

Eligible principal investigators (PIs) are current NIAID awardees of the IPCP-HTM program who meet the requirements for supplemental awards. 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.

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

Number of Applications. Applicants may only submit one competitive revision application to this FOA for each IPCP-HTM award.

Resubmission. Resubmission applications are not permitted in response to this FOA.

Renewal. Renewal applications are not permitted in response to the FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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.

The exceptions from the PHS 398 instructions and detailed information on the application structure and components are provided in Section IV.6 “Other Submission Requirements.”  All applicants must follow the specific instructions in that section.

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: October 15, 2010
Application Receipt Dates: November 17, 2010
Peer Review Date: March, 2011
Council Review Date: May, 2011
Earliest Anticipated Start Date: July, 2011

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:

Brenda Lange-Gustafson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3122, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
(express courier ZIP: 20817-7616)
Phone: (301) 451-3684
Fax:  (301) 480-2408
E-mail: bgustafson@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:

Brenda Lange-Gustafson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3122, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
(express courier ZIP: 20817-7616)
Phone: (301) 451-3684
Fax:  (301) 480-2408
E-mail: bgustafson@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 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 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

Supplemental Instructions for the Preparation of an IPCP-HTM Competitive Revision Application

The following section supplements the instructions found in Form PHS 398.  Additional instructions are required because the Form PHS 398 is designed primarily for individual, research project grant applications, and has no specific instructions for multi-project competitive revision applications. 

The supplemental instructions for competitive revision applications below are divided as follows:

A. General Instructions – addresses 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 and Cores – describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project or core.

A. General Instructions

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

1. Form Page 1 - Face Page

Applicants must list the parent grant title and parent grant number followed by the term “Competitive Revision” as the title of the application.

Items 1 - 10: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

2. Form Page 2

Using Page 2 of Form 398, provide a succinct but accurate description (abstract) of the OVERALL competitive revision application.  Do not exceed the space provided.

List the performance sites where the research will be conducted.

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

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 PHS Form 398 for composite budget.  Instead, using the suggested format presented below, prepare a Composite Budget for All Proposed Years of Support. (Justification for new budget elements should not be presented here but in the individual budgets of the projects and cores.) List only costs for proposed new activities to ongoing projects/cores or new projects/cores associated with the competitive revision. All other projects or cores from the parent application not requesting additional funds should be listed with a zero (0) budget.

SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support of proposed revision to Project 1 and 3 and Core B.

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Invest.

15,000

13,000

13,200

14,600

14,230

70,030

Project 2. Study

0

0

0

0

0

0

Project 3. Develop.

10,000

10,000

10,160

11,480

16,980

58,620

Core A. Admin. Core.

0

0

0

0

0

0

Core B. DNA

2,000

5,000

5,000

5,080

5,240

22,320

Totals

27,000

28,000

28,360

31,160

33,450

150,970



 

 

 

5. Form Page 5

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

6. Biographical Sketch Format Page

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

7. Resources Format Page

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

8. Program Overview (Research Objectives and Strategic Plan)

This narrative section should summarize the IPCP-HTM research plan and progress to date and is limited to (12) pages. It should also detail the role and impact of the proposed revision on the current IPCP-HTM award.  The narrative section will be essential to reviewers of the application to understand the overall goals and objectives of the funded IPCP-HTM and provide a context for how the revision will further enhance and synergize with its objectives and specific aims.  This important section provides the investigators an opportunity to describe the progress made in the current IPCP-HTM Program and how that progress has led to identification of supplemental needs that are essential to achieving the overarching goals of the IPCP-HTM program.  It also provides a section where all proposed revision activities can be summarized (if more than one) and their impact on milestones and timeline, overarching objectives and go/no-go decisions can be discussed.  Each requested element of the revision should be cited briefly as to its place in the overall scheme.  Special features (environment, resources, and infrastructure) that the revision will bring to the IPCP-HTM program and how they will enhance the IPCP-HTM program should also be addressed.  If resources are NOT to be added to the administrative, statistical and/or regulatory cores and the revision application specifies activities that will impact these cores; then, this section should also address how the existing cores will manage the new administrative and regulatory burdens brought to the IPCP-HTM program by the revision in the absence of additional funding.

9. Checklist

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

10. Appendix Materials

Refer to Section IV.6. “Appendix Materials” below, for instructions on submitting appendix materials.

For each project or core in the multi-project application, 3 publications plus other approved material are allowed.  

B. Specific Instructions for Individual Research Projects and 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 research project.

For each individual Research Project(s) or Core (s)requesting support in this revision, include:

Cover page (see special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

Research Plan

Resources

1. Cover Page (provide a cover page for all projects or cores in the parent application even if additional funds are not requested)

The Face Page of the 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-

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: (e.g., $700,000)

Applicant Organization (full address)

2-8 below should only be filled out for only new or ongoing project(s) or core(s) requesting a competitive revision.

2. Form Page 2

Provide a Description (abstract) of the research proposed in the project according to the instructions on Form Page 2 of PHS Form 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. Research Plan

Introduction (For Revision Projects or Cores within a Revision Application Only. Limited to 1 page.) 

New applications and projects should not include an Introduction. 

Specific Aims (Limited to 1 page.)

List in priority order, the broad, long-range objectives and goals of the proposed project or core. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the project's or core’s relationship to the multi-project program goals and how it relates to other projects or cores.

Research Strategy (Limited to 12 pages for Research Project and 6 pages for Cores.)

Use this section to describe how the proposed research or core activity 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.

Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.  Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.  Preliminary Studies for new projects and progress reports for renewal and revision projects as part of a renewal or revision application must be included as part of the approach section.

Each addition to the specific IPCP-HTM project or core should be described and justified.  The progress within the project or core should be related to the need for the revision and it should be clearly delineated how the additional resources will enhance the progress of the project or core toward achieving its milestones.  Each new resource to be added should be described.  The description should address how the resource: adds to the overall operations of the IPCP-HTM program (increased efficiency, synergy, etc.), impacts the operations on the project or core, impacts overall IPCP-HTM operations and consequences if the need is not met.

If a new scientific core is created, the application must indicate how it serves 2 or more projects in the IPCP-HTM.  New scientific cores should not be created solely to support newly requested projects.  This section of the application should present a clear picture of the facilities, techniques, and skills that the supplemental funding of a new core will provide to the total IPCP-HTM.

The funded IPCP–HTM award will already have an established SAP.  However, if the revision proposes research activities that require additions to the SAP, the application should describe the proposed expertise to be added to the SAP and how this expertise will be utilized to guide the IPCP-HTM within the applicable research project or core.  This section should also include a discussion of the role of the new SAP members and their integration into the operations of the IPCP-HTM.

6. Resources

Provide information on resources available for the project.  Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.)  For Early Stage Investigators, describe institutional investment in the success of the investigator.  If there are multiple performance sites, describe the resources available at each site.  Describe any special facilities used for working with biohazards or other potentially dangerous substances.

7. 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). 

8. Select Agent Research (if applicable)

As directed in the PHS 398 Instructions, provide a description of all facilities where the Select Agent(s) will be used in the project.  Describe the procedures that will be used to monitor possession, use and transfer of the Select Agent(s).  Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).  Describe the biocontainment resources available at all performance sites.

Additional information:

MILESTONES FOR NEW PROJECTS, CORES OR RESOURCES ADDED TO IPCP-HTM PROGRAMS IN IPCP-HTM COMPETIIVE REVISION APPLICATIONS.

A. INDIVIDUAL RESEARCH PROJECTS, SCIENTIFIC AND ADMINISTRATIVE CORES.  Applicants must provide well-described, quantifiable, and scientifically justified milestones that are not simply a restatement of specific aims for each individual research project, scientific, and administrative core.  Milestones should be presented via a Gantt chart or equivalent, with associated timelines and identified outcomes.  Milestones must specify the outcome(s) for each activity, i.e., synthesize “n” compounds, or, initiate pre–Phase I clinical trial.  It is recognized that milestones associated with more basic science-oriented projects may be difficult to quantify; however, in those cases, applicants should develop specific criteria, benchmarks or outcomes to be met that can be used to quantify progress.  All proposed milestones should be integrated with the overall goals of the proposed IPCP-HTM Program.  Applicants should include plans for periodically revisiting and revising milestones and timelines, if needed, as new information becomes available, challenges to the proposed development path are encountered, and research outside the IPCP-HTM modifies the science of microbicides. If new milestones are proposed that are specific to the revision’s activities they should be related to the overall objectives of the IPCP-HTM program, with their effect on existing IPCP-HTM program milestones discussed.

B. IND-ENABLING CRITICAL PATH PROJECTS.  For applications creating a new IND-enabling critical path project or for requests to add resources to an existing IND-enabling critical path project, applicants must provide quantifiable milestones and interim go/no-go decision points for all years of the project.  Applicants must describe how the new milestones and go/no-go decision points alter existing project decision points, if applicable.  The revision cannot extend the duration of the original IND-enabling critical path project beyond the original funded period.

Milestones and decision points must also be provided for individual elements of the IND-enabling critical path project, i.e. preformulation, formulation, analytical assay development, acute/chronic toxicology, etc.  The milestones and go/no-go criteria should be presented in Gantt charts with proposed timelines to clearly identify specific outcomes for each activity at each stage of the project.  For example an overarching milestone may indicate completion of specific preformulation/formulation studies, while interim milestones and go/no-go criteria may identify completion of excipient compatibility and stability studies. The milestones for IND-enabling critical path projects will be used by Program to measure progress and for determining whether the next year’s funding increment will be awarded, thus an adequate description of the impact of the revision on operations and goals of this project is essential.

Milestones and timelines should be placed at the end of the Research Plan section for each individual research project and scientific core and fall within the 12 page and 6 page limits respectively.

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

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.  An application that does not observe the required page limitations may be delayed in the review process.

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 should 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: Regardless of the amount requested, investigators 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

Review 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 mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the revision address important gaps in the current IPCP-HTM program and provide a solution to these gaps?  What is the potential for the revision to advance the proposed program and will it contribute significantly to the advancement of the microbicide by enhancing the IPCP-HTM Program’s ability to support the discovery and implementation of new technologies, single or combination microbicides or microbicide strategies? For revisions proposing new or increased resources for pre-Phase I clinical trials, have the applicants provided sufficient information to demonstrate that the proposed trial(s) has the potential to advance the field of microbicides and can be carried out within the current infrastructure of the IPCP-HTM program?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Have the PI, project and cores leaders and/or any new project or core leaders devoted adequate time and effort to the requirements of the revision?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Does the integration of the proposed revision into the current IPCP-HTM Program further support the innovative approach used to address the developmental problem(s) of creating a topical microbicide candidate or strategy established by the initial IPCP-HTM Program?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  Are the added resources not otherwise available to the IPCP-HTM Program, and do new resources synergize with existing resources?  Will the addition of the requested resources allow more efficient attainment of the IPCP-HTM objectives and timelines?  Do resources that increase the scope of the original IPCP-HTM integrate well with the original program, and will their inclusion enhance the development of the microbicide or microbicide strategy?  If a new private sector (industrial) component is proposed, is it well integrated into the proposed IPCP-HTM program?  Does the private sector involvement provide access to expertise, activities, other resources and processes that would not otherwise be available to the IPCP-HTM Program investigators without the revision?  Does the revision support the initial scientific rationale and basis for the candidate microbicide/strategy, and does the strength of the existing data support the need for a revision?  Is there a sound scientific rationale and basis for inclusion of the new project, core or resources, and does the addition advance efforts to determine microbicide product feasibility, safety and potential efficacy?  Are the proposed new project(s), core(s) and/or resources appropriate for the stage of development of the candidate microbicide/strategy?  Are any proposed new pre-Phase I clinical trials appropriately designed and integrated into the original Program?  And, if the revision adds new iterative pre-phase I clinical trials, do the proposed outcomes further the objectives of the overall program?  If new private sector (industrial) components are added are they well integrated into the proposed IPCP-HTM program?  In cases where subcontracts are proposed for carrying out specific tasks, is there evidence that the project or core leaders will have adequate oversight on these activities? If a significant modification of an existing IND-enabling critical path project or a new Project is proposed does the applicant adequately describe communication and coordination processes with potential contractors and subcontractors to be used to meet the projects milestones?  Are the milestones appropriate, adequately described, feasible, quantifiable and achievable within the proposed time frame?  Are the individual research project’s milestones integrated into the IPCP-HTM program milestones and are they applicable to the overall program?  Do the milestones given for each new core and project identify critical activities with a time line that has to be achieved to adequately support the IPCP-HTM program?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Do new research sites added under the revision contribute positively to the overall activities of the IPCP-HTM Program?  In cases where subcontracts are proposed for carrying out specific tasks, i.e. animal toxicology, are the quality/appropriateness of the personnel, facilities and procedures (laboratory methods, work plan and/or QA/QC procedures) adequate?

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

REVIEW CRITERIA FOR CORES

Administrative Core (if applicable): Reviewers will consider each of the criteria below in the determination of scientific and technical merit:  Are the changes in the administrative and organizational structure appropriate to facilitate attainment of the objective(s) of the proposed IPCP-HTM? Will the new administrative core resources synergize with existing resources and create efficiencies in achieving the administrative objectives of the IPCP-HTM program? Do any new plans to manage subcontracts and fee-for-service activities continue to be adequate to assess the quality/appropriateness of the facilities, methods and other resources to be used?

Scientific Cores (if applicable):  Reviewers will consider each of the criteria below in the determination of scientific and technical merit: Is provision of additional resources or core services for the individual research projects critical and justified?  Is the relationship of a new scientific core to the central focus of the overall program strong?  Are the quality of the relevant facilities or services provided and criteria for prioritization and usage appropriate?  Are the qualifications, competence, and commitment of the Core Leader and key personnel appropriate?  Are the added core facilities appropriate and adequate to support at least two of the individual research projects? Does the new core contribute to the central focus of the overall IPCP-HTM, and is this contribution well described and justified? Have the criteria for prioritization and usage of supplemented core facilities or services (including procedures, techniques, and quality control) been updated to remain appropriate?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Resubmission Applications. Resubmission applications are not permitted in response to this FOA.

Renewal Applications.  Renewals applications are not permitted in response to this FOA.

Revision Applications. When reviewing a Revision application (formerly called a competing revision application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations. Not Applicable to this FOA.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

The following will be considered in making funding decisions:

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 Notice of Award will be generated via email notification from the awarding component to the grantee 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 Principal Investigator will have the primary responsibility for: defining the research objectives, approaches and details of the projects and scientific cores within the guidelines of the FOA.  Specifically, awardees have primary responsibility as described below.

The Principal Investigator retains primary responsibility for the performance of the scientific activity, and understands the role of the Program Officer in the Cooperative Agreement award mechanism as described below.

The Principal Investigator will be solely responsible for:

Annual IPCP-HTM Meetings

All awardees are required to host an annual meeting attended by Project Leaders, Scientific Core Leaders, SAP members, other key IPCP-HTM staff and NIAID staff.  The PI and other IPCP-HTM members shall present: (1) an update on the results achieved for each research project and scientific core, (2) a review of progress in achieving established milestones within the specified timelines, any modifications in milestones or timelines that are proposed or have been implemented and their rationale, and a discussion of scientific, technical and other problems and obstacles, including performance, encountered and methods/approaches proposed or implemented to overcome and/or resolve obstacles and problems, and (3) future plans for achieving remaining milestones, any identified or potential problems that may impede or slow progress, and proposed methods/approaches to dealing with such problems, including contingency plans for delays, acceleration of timelines, and/or recommended modifications to established milestones and timelines.

IPCP-HTM Awards Involving Clinical Trials

Applicants are encouraged to familiarize themselves with Division of AIDS Clinical Research Policies, which specify requirements for conducting clinical research under Division of AIDS sponsorship (http://www3.niaid.nih.gov/research/resources/DAIDSClinRsrch/).  Protocols for clinical trials must be reviewed and approved by the Division of AIDS Prevention Sciences Review Committee (PSRC) prior to implementation.  In addition, awardees engaged in the conduct of clinical trials will be required to adhere to the NIAID Clinical Terms of Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf).

Monitoring Clinical Studies and Pre-Phase I Clinical Trials

When clinical studies or pre-phase I trials are a component of the research conducted, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study.  AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://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.  All clinical research activities performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for human subjects.

Intellectual Property

The successful development of high priority products as microbicide candidates will require substantial investment and support by private sector industries, and may involve collaborations with other organizations such as academic and/or non-profit research institutions not directly involved in the IPCP-HTM.  It is the intent of this initiative to encourage the formation of the appropriate public-private partnerships that are essential to meet these urgent public health needs.  NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program.  To this end, all awardees shall 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, reports to the NIAID, and other mechanisms.

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.

Publications

The Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by program participants and supported in whole or in part under this Cooperative Agreement.  The Principal Investigator and Project Leaders are requested to submit manuscripts to the NIH Project Scientist within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained.  Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the Principal Investigator and appropriate Project Leaders and will require appropriate acknowledgement of NIAID support.  Timely publication of major findings is encouraged.

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.

During performance of the IPCP-HTM award, the NIH Project Scientist will provide appropriate assistance, advice, and guidance by: participating in scheduled meetings and teleconferences that may include, but are not limited to, Steering Committee meetings and teleconferences to discuss program coordination and/or progress; participating in annual meetings and SAP deliberations; participating in the design of the activities; facilitating collaboration with other NIAID-supported research resources; and advising in project management and technical performance.  However, the role of the NIH Project Scientist will be to facilitate and not to direct the activities.  It is anticipated that the NIH Project Scientist, and other NIAID staff identified by the Principal Investigator, the Steering Committee and/or the NIH Project Scientist as having relevant expertise, may be given the opportunity to offer advisory input.  The NIH Project Scientist will facilitate liaison activities for partnerships, and provide assistance with access to NIAID-supported resources and services.

Other appropriate NIH program staff assistance will be coordinated by the NIH Project Scientist and may include Medical Officer(s), clinical operations and regulatory staff and other expertise as required.  The NIH Project Scientist, with support of the appropriate staff and expertise, will provide coordination and assistance to the awardee to meet the Division of AIDS requirements for clinical protocol content, PSRC review and pre-Phase l clinical trial initiation and conduct.  For awardees conducting pre-Phase l clinical trials, the NIAID reserves the right to terminate or curtail a clinical trial in the event of (a) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol, (b) substantive changes in the consensus protocol to which the NIAID does not agree, (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (d) human subject ethical issues that may dictate a premature termination.

The Government, via the NIH Project Scientist, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports.  NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study.  However, awardees will retain custody of and have primary rights to all data developed under these awards.

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

The assigned program director may also serve as an NIH Project Scientist.

2.A.3.  Collaborative Responsibilities

Milestones and Timelines

New or modified specific milestones and timelines agreed to by the Principal Investigator and NIAID shall be included in the terms and conditions of award.  It is recognized that milestones and timelines may require revision and renegotiation during the project period.  The Principal Investigator and NIAID must agree to all such revisions.

IPCP-HTM Scientific Advisory Panel (SAP)

If a modification of the SAP is proposed, the modified SAP should be constituted no later than 6 months following award of the revision.  The new members will be expected to attend the next IPCP-HTM annual meeting and subsequent annual meetings as needed during the award period.  The entire SAP membership is not required to attend all annual meetings, but at least 1 member of the SAP must attend each annual meeting.  Any augmented SAP will continue to perform the required duties of the parent award as outlined in the RFA.

2.A.4.  Dispute Resolution 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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter 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:

Jim A. Turpin, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 5114, MSC-7628
6700B Rockledge Drive
Bethesda, MD 20892-7628
Telephone: (301) 451-2732
Fax: (301) 496-8530
Email: jturpin@niaid.nih.gov

Roberta Black, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 5117, MSC-7628
6700B Rockledge Drive
Bethesda, MD 20892-7628
Telephone: (301)-496-8199
FAX: (301)-402-3684
Email: rblack@niaid.nih.gov

Andrew D. Forsyth, Ph.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
Room 6204, MSC-9619
6001 Executive Boulevard
Bethesda, MD 20892-9619
Telephone: (301) 443-8403
Fax: (301) 443-9719
Email: aforsyth@mail.nih.gov

2. Peer Review Contacts:

Brenda Lange-Gustafson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3122, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
(express courier ZIP: 20817-7616)
Phone: (301) 451-3684
Fax:  (301) 480-2408
E-mail: bgustafson@niaid.nih.gov

3. Financial or Grants Management Contacts:

Mollie Shea
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2234, MSC-7614
6700B Rockledge Drive
Bethesda, Maryland 20892-7614
Telephone: (301) 402-6576
FAX: (301-493-0597
Email: mshea@niaid.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (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.

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-09-116.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.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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