Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), ( http://www.nih.gov/)

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

Title: Novel HIV Therapies: Integrated Preclinical/Clinical Program (IPCP)(U19)

Announcement Type
This is a modification of RFA-AI-07-019 which was previously released March 13, 2007.

Request For Applications (RFA) Number: RFA-AI-08-018

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

Key Dates
Release Date: April 22, 2008
Letters of Intent Receipt Date: June 11, 2008
Application Receipt Date: July 11, 2008
Peer Review Date: November, 2008
Council Review Date: January, 2009
Earliest Anticipated Start Date: March, 2009
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/  
Expiration Date: July 12, 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 and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements 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), National Institutes of Health (NIH), invites applications from consortia of institutions/organizations to participate in the Novel HIV Therapies: Integrated Preclinical/Clinical Program (IPCP).  This program is designed to move new therapeutic concepts from the laboratory bench to the clinic for initial testing.  The multi-project cooperative agreement (U19) mechanism is being used to encourage multidisciplinary, collaborative research efforts involving NIAID, academia, the private sector, and external scientific advisors.

Research advances in recent years have yielded a wealth of information on HIV molecular biology, the pathogenesis of HIV disease, and the impact of disease progression on immune function.  Concomitantly, important methodological advances have been made.  Together this scientific and technological progress has made possible the exploration of a wide range of non-traditional therapeutic concepts, as well as traditional drug-based therapies exploiting novel viral and cellular targets.  In the preclinical area this RFA seeks research on: new therapeutic targets, novel inhibitors of viral or cellular proteins or pathways critical to HIV replication and/or persistence, and immunological approaches to complement antiretroviral-based therapies.  Animal model studies are encouraged.  In the clinical area the focus is on iterative bench-to-bedside research to pilot new therapeutic approaches.  Phase I or I/II clinical studies (10-30 subjects) may be included to demonstrate proof-of-concept.

Background

Since the mid-1980’s NIAID has encouraged investigators from academia and the private sector to work together to find new therapies for HIV infection through such programs as the National Cooperative Drug Discovery Groups (NCDDG), the Strategic Program for Innovative Research on AIDS Treatment (SPIRAT), and the current IPCP.  Such partnerships have explored a number of novel targets and discovered entities/strategies that have been evaluated in HIV-infected subjects.  A list of projects supported under previous issuances of the IPCP can be found at:  http://www.niaid.nih.gov/daids/pdatguide/ipcp.htm.  This site also contains examples of accomplishments attributable to the IPCP and similar multi-project programs supported by NIAID, Division of AIDS (DAIDS).

In an era of complex antiretroviral treatment regimens, the development of resistance, toxicities, and drug interactions will continue to be problematic as new agents are introduced.  Moreover, extensive research has shown that combination antiretroviral therapy cannot totally eliminate HIV-1 and only partially reverses immune system damage.  Thus, while efforts to develop effective prevention and treatment modalities for HIV infection continue, there remains a need for the identification/validation of new host and viral targets, novel drugs and delivery systems, immunological approaches to contain HIV infection, and agents/strategies to eliminate viral reservoirs.

Research Objectives and Scope

The objectives of the IPCP are to support: (1) innovative preclinical studies to identify new HIV therapies, and (2) the translation of innovative treatment concepts to the clinic for proof-of-concept studies.  Applicants are expected to have an identified strategy based on a solid scientific rationale and supported by preliminary data.  Applications may propose:  (1) preclinical research exclusively, or (2) iterative bench-to-bedside research that involves one or more pilot scale clinical studies (10 - 30 subjects). 

Examples of research topics of interest for this RFA:

NOTE:  For applications focused on small molecule inhibitors, sufficient information about the chemical structure, physical/chemical, and pharmacologic properties should be provided so that potential toxicities and drug-like characteristics of the proposed molecules can be potentially predicted at the review stage.

Applications proposing any of the following will be deemed non-responsive and will not be reviewed.

Partnerships 

A key component of this initiative is the formation of partnerships between academia and the private sector.  For the purpose of this RFA, the term “private sector” comprises large and small, domestic and foreign, for-profit and non-profit pharmaceutical, biotechnology, bioengineering, and chemical companies.  Each application must be composed of a minimum of three interrelated research projects and an Administrative Core; one or more Scientific Cores may be proposed.  At least one research project must be contributed by the private sector partner if the applicant institution is from academia; conversely, at least one research project must be contributed by an academic partner if the applicant institution is from the private sector.  Applications not meeting the above described requirements, with regard to number and types of projects/cores, will be considered non-responsive and the application will not be reviewed.

The private sector partner must propose a research plan that contributes materially and intellectually to the overall goals and objectives of the program.  The requirement for a private sector component is not met by entities providing only research resources for the project, such as reagents and novel experimental therapeutics, or service-type activities as described below under Scientific Cores.  Projects from a private sector partner proposing to provide only resources or services, even if unique, will be deemed non-responsive, and the application will not be reviewed.

Applicants are encouraged to reach early consensus with any proposed partners regarding intellectual property, data sharing, and other legal matters that may arise during the project.  In addition, applicants are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goals of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit.  Finally, applicants are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to NIAID or other mechanisms (see Section VI.2.A.1. for Principal Investigator (PI) responsibilities related to Intellectual Property and Section IV.6. for requirements related to sharing research data and resources).

Scientific Cores

One or more scientific cores may be proposed.  A scientific core is a resource to the multi-project grant as a whole and must support at least two of the proposed research projects.  The application must indicate the specific projects to be served by the scientific core(s).  Typically a core performs a service-type activity rather than hypothesis-driven research.  Examples of services that could be provided by such cores include: routine in vitro assays, cell processing and preparation, standard pharmacology and toxicology tests.  The placing of clinical trials or other significant clinical activity in a core is not appropriate; applications structured in this manner will be deemed non responsive and not reviewed.

Scientific Advisory Panel

The PI will constitute a Scientific Advisory Panel (SAP) of 2-3 investigators not affiliated with any of the institutions comprising the group within six months of the award.  The SAP will attend the awardee’s annual meeting to review program activities and evaluate progress, adherence to the milestones and timelines, and the continued relevance of each project and core to the overall goals.  The SAP will recommend new directions as appropriate and will provide the PI and NIAID with a comprehensive written evaluation of the group’s activities following each annual meeting.

NOTE:  The SAP may NOT be constituted prior to award and names of potential members are NOT to be provided in the application.

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 the “Just-in-Time” information concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

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."

2. Funds Available

The estimated amount of funds available for support of 1-2 projects awarded as a result of this announcement is $2.8 Million for fiscal year 2009.  Future year amounts will depend on annual appropriations.

An applicant may request a project period of up to five years and a budget for direct costs that respects the following limits: for applicants proposing exclusively preclinical research throughout the five year term, $650,000 direct costs for the first year; for applicants proposing the use of large animals (e.g. non-human primates), up to $775,000 direct costs in any year(s) that such large animals will be needed; and for applicants proposing clinical studies, up to $1.3 million direct costs in any year(s) in which clinical studies are being conducted.  Applications not adhering to the stated budget limits will not be reviewed.

Applicants are encouraged to develop plans to use existing infrastructure and organizational support to complement the award, including NIH-sponsored General Clinical Research Centers (GCRC, http://www.ncrr.nih.gov/clinical%5Fresearch%5Fresources/resource%5Fdirectory/general%5Fclinical%5Fresearch%5Fcenters/ , Institutional Clinical and Translational Science Awards (CTSA, http://www.ncrr.nih.gov/clinicaldiscipline.asp), Centers for AIDS Research (CFAR, http://www3.niaid.nih.gov/research/cfar/), and existing government funded clinical trials networks. These plans, and supporting documentation, should be included in the application.

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

3. Other-Special Eligibility Criteria

PIs, Project Leaders, and Core Leaders are requested to commit substantial time and effort to ensure success of the multi-project program.  It is recommended that these individuals devote a minimum of 2.4 calendar months annual effort.  This level of commitment can be all in one project or core or a total effort across several projects/cores within a single application. 

Applications for supplements to existing projects are not eligible to compete under this FOA.

Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewal applications are not permitted in response to this FOA.

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number for the primary applicant institution 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.

Supplemental Instructions for the Preparation of Multi-Project Applications

The following section supplements the instructions found in the PHS Form 398 for preparing the multi-project grant application. Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research grant (R01) 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 – 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 – describes 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 – Cores must provide services or resources to support at least two research projects. Instructions 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.

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 Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, 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 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 5

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry.

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 Principal Investigator first, followed by those of other key personnel in alphabetical order.

7.  Other Support Format Page

Do not complete. (Any required information will be requested from successful applicants prior to grant award.)

8.  Resources Format Page

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

9.  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.

10. Checklist

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

11. Resource Sharing Plan

One Resource Sharing Plan, placed at the end of the application, is to be submitted for the entire application.

B. Specific Instructions for Individual Research Projects

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)
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: (mmddyyyy - e.g., 07/01/2007)
To: (mmddyyyy - 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 Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key 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. 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).

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

6.     Appendix. Do not create an appendix for an individual project.

7.    Resource Sharing Plan. Do not create a resource sharing plan for an individual project.

For all other items in the individual research project application, follow the usual PHS 398 instructions.

C.  Specific Instructions for Cores

All Cores

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., 5/14/2006, or Pending)
(and)
Federal Wide Assurance (FWA) number

Vertebrate Animals (Yes or No)
If Yes, IACUC Approval Date (e.g., 4/15/2007, or Pending)
(and) Animal welfare assurance number

Proposed Period of Support
From: (mmddyyyy, e.g., 07/01/2007)
To: (mmddyyyy, 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)

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 research will be conducted.

Under "Key Personnel", list the Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key personnel, and then other significant contributors.

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

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).

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

Appendix. Do not create an appendix for a core.

Resource Sharing Plan. Do not create a resource sharing plan for a core.

For all other items in the individual core application, follow the usual PHS 398 instructions.

Foreign Organizations

Foreign institutions/organizations are not eligible to apply as the primary applicant, but may enter into a consortium with a domestic [U.S.] institution/organization and participate as a component (project or scientific core).

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.

Foreign components of domestic applications must:

In addition, for foreign components of applications:

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

Applications with Multiple PDs/PIs

Not Applicable.

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: June 11, 2008
Application Receipt Date: July 11, 2008
Peer Review Date: November, 2008
Council Review Date: January, 2009
Earliest Anticipated Start Date: March, 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 at the beginning of this document.

The letter of intent should be sent to:

Clayton Huntley, Ph.D .
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3124, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)


Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 496-2550
FAX: (301)  480-2408
Email: chuntley@niaid.nih.gov

3.B. Sending an Application to the NIH

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

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

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

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

Clayton Huntley, Ph.D .
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3124, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)

Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 496-2550
FAX: (301)  480-2408
Email: chuntley@niaid.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIAID.  Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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

4. Intergovernmental Review


This initiative is not subject to intergovernmental review.

5. Funding Restrictions


All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at 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/archive/grants/policy/nihgps_2003/index.htm).

The release of funds for any clinical study will be contingent upon compliance with NIH, NIAID, and DAIDS policies and procedures for clinical research  and those of applicable institutional and regulatory bodies [Institutional Review Board (IRB), Institutional Biohazard Committee (IBC), Food and Drug Administration (FDA), Recombinant DNA Advisory Committee (RAC), other].  See Section VI. 2.A.1.c.

6. Other Submission Requirements and Information

Research Plan Page Limitations

Standard page limitations apply; items 2-5 of the project or core research plan may not exceed 25 pages.

Applications must include the following, which are to be placed in the appropriate sections as indicated:

Development Plan (Place in Overview):  A plan articulating a set of goals and milestones to be completed during the term of the project, and a time table for achieving them. For projects that have a clinical component, the goals and milestones will be used to judge the readiness of the Group to proceed to the clinical phase. This decision i) will be made by NIAID and may involve the applicant’s Scientific Advisory Panel and/or other outside experts, and ii) will be based on a review of the preclinical data generated to support the clinical study, the clinical protocol, and the status of the budget.

Clinical study plan, if applicable (Place in appropriate research project):  Applicants must address the following elements: study design, rationale for the design, study objectives, study population, statistical design and analysis, management and quality control of data, receipt and storage of human samples, proposed clinical sites and investigators.  Recognizing that the details of the study will change as a result of scientific progress and as a function of review by various institutional and Governmental bodies, a formal protocol is not requested. However, applicants must address all NIH-required human subjects issues, including protection against research risks and gender, minority, and child representation in the human subjects section of the application as described in the PHS 398 application instructions.

Applications that do not include a development plan and a clinical study plan (if applicable) will be deemed non-responsive and will not be reviewed.

Additional requirements for the applicants are stated below (Section VI, 2.A. Cooperative Agreement Terms and Conditions of Award). 

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

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: 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/.

NIAID recognizes that the data and information generated through the IPCP Program will be extremely valuable to other researchers and that the rapid sharing of these data will be essential in advancing research to facilitate the development of therapeutics, vaccines and diagnostics.  Sharing of data and information with the broad scientific community relies upon the awardees making such data and information available by depositing them into publicly accessible data repositories.  NIAID has established data release guidelines for other programs, including the Centers of Excellence for Influenza Research and Surveillance http://www3.niaid.nih.gov/research/resources/ceirs/ and the Microbial Sequencing Centers http://www.niaid.nih.gov/dmid/genomes/mscs/default.htm.

Genomic sequences data sets generated with IPCP funding are required to follow the NIAID Data Release and Usage Plan (http://www.niaid.nih.gov/dmid/genomes/mscs/data_release.htm), which provides for releasing sequence data within 45 calendar days of being generated to Genbank, a publicly searchable, international database of genetic sequences provided by the NIH National Center for Biotechnology and Information.

Other genome-wide or proteome-wide data sets including, but not limited to, functional genomics, proteomics, metabolomics, glycomics data sets should be made available through a publicly accessible web site(s), such as one of the NIAID Bioinformatics Resource Center or other relevant sites as determined by the NIAID Program Officers; this must be done within 2 months of publication or within 1 year of generation, whichever comes first. Examples of genomics or proteomics data sets that should be made available to the broad scientific community include annotation and functional characterization of genes and their products, gene and protein expression data, mass spectrometry data, siRNA data, SNPs and other genetic variation data, genotype and phenotype associations.

All applicants must include a plan for sharing genomics, proteomics and other types of research data in their application.  Those responding to this funding opportunity announcement must include a description of how such research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Final details of the data release plan must be negotiated between NIAID and each awardee to assure that the planned data releases are consistent with the guiding principles stated above. Final approval for the data release plans will be given by NIAID prior to award. Updates to the Plan will have to be submitted to NIAID as part of the Annual Progress Report.  The NIAID Program Staff will review the updated Plan for approval with modifications as needed.

It is recognized that each scientific project may pose specific opportunities or challenges with respect to public data release.  Therefore efforts will be made to tailor the data release guidelines to accommodate specific situations and needs as plans are negotiated between awardees and NIAID program staff.

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 the NIAID 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 high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Review Criteria for the Overall Application

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

Overall score: a single numerical priority score will be assigned to the whole application after consideration of all of the elements.  The overall score for the application will be based primarily on the scientific merit of the individual components, with additional consideration of the overall synergy and integration of the components, the overall program organization, and the capabilities of the associated personnel.

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 preventive 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?  Is a novel therapeutic target identified or validated?

Investigators: Are the investigators appropriately trained and well suited to carry out this work?  Is the work proposed appropriate to the experience level of the principal investigator and other researchers?  Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success?  Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Review Criteria for the 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 appropriately trained and well suited to carry out this work?  Is the work proposed appropriate to their level of experience?  Does the investigative team bring complementary and integrated expertise to the project (if applicable)?  If from the same academic institution or company as the PI or other Project Leaders, has the Project Leader demonstrated the ability to direct an independent research program?

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

Scientific Research Cores

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

Private sector partner.  Did the private sector partner propose a research plan that contributes materially and intellectually to the overall goals and objectives of the program?  Is it committed to the development of the proposed therapeutic entity or modality?  Will it provide expertise and/or resources not generally available in academia? 

Groups proposing exclusively preclinical research.  Is it likely that the proposed target/strategy can be advanced toward clinical evaluation during the award period?

Groups proposing clinical research.  Is the timeline for initiating the clinical studies realistic?  Has the group provided milestones that can be used to assess their readiness to begin human studies?  Have they provided a short and long term development plan?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

2.C. 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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award


The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the Multi-project Cooperative Agreement (U19), 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:

a)  Annual Meeting: The Principal Investigator (PI) will be responsible for scheduling the time and place of an annual meeting of the group (PI, Project and Core Leaders), the Scientific Advisory Panel, and NIAID Scientific Coordinator (SC) to review progress, plan and design research activities, and establish priorities.

b)  Scientific Advisory Panel:  The PI will constitute a Scientific Advisory Panel of 2-3 investigators, not affiliated with any of the institutions comprising the Group, within six months of the award.  The Panel will review progress and make recommendations as appropriate.  The Panel will provide the PI with a comprehensive written evaluation of the group's activities after each meeting; a copy of the Panel's report will be sent by the PI to the SC within thirty (30) days of each annual meeting.  For awards involving a clinical study, the Panel, at the discretion of NIAID, may be called upon to help determine the readiness of the group to initiate the study.

c)  Compliance with NIH policies on human subjects research, NIAID clinical terms of award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf), DAIDS policies and procedures for clinical research (http://www3.niaid.nih.gov/research/resources/DAIDSClinRsrch/Default.htm) and those of applicable institutional and regulatory bodies (IRB, IBC, FDA, RAC, other). 

d)  Communication: The PI will communicate with the SC on a regular basis regarding the status of the ongoing research.  Importantly, the PI will communicate with the SC regarding the conduct of any clinical activity (enrollment, adverse events, interactions with the FDA, problems and resolutions of the same, changes of personnel, protocol amendments, etc.).

e)  Intellectual Property:

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.

f)  Annual progress report: The PI will submit an annual progress report including results of the activities of all components of the grant (projects and cores); a summary outlining interactions among group members and with NIAID; and a complete, cumulative list of all publications authored by group members.

g)  Presentations or publications:  The PI is responsible for the timely presentation/publication of work supported in part or in whole by this Cooperative agreement.  Appropriate acknowledgement of NIAID support under the IPCP is required.

2.A.2. NIH Responsibilities

An NIAID Scientific Coordinator (SC) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

A SC will provide a liaison function between the awardee and the NIAID.  Ordinarily a single extramural SC will be the contact for all facets of the scientific interaction with the awardee. As required for the coordination of activities and to expedite progress, the SC may designate additional NIAID staff to provide advice or assistance to the awardee on specific scientific, medical, technical, or management issues.  The SC shall retain overall programmatic oversight for the award and will clearly specify to the awardee the name(s) and role(s) of any such additional individuals and the lines of reporting authority.

During performance of the award, the SC may provide assistance, advice, and guidance by: participating in the design of activities; facilitating access to resources and information that otherwise might not be available; advising in the management of the projects and technical performance; facilitating interactions between the awardee and other groups of importance to the awardee, for example the AIDS Clinical Trials Network, the FDA, pharmaceutical and/or biotechnology companies, and other investigators with similar interests; providing guidance and oversight on compliance with Federal regulations related to human subjects research and NIAID policy on clinical research, and communicating in a timely fashion information that might affect the safety of subjects in grant supported studies; and participating in the annual site visit as a partner, to review research progress and direction and provide recommendations.  However, the role of NIAID will be to facilitate and not direct the activities.  It is anticipated that decisions in all activities will be reached by consensus and that NIAID program staff will be given the opportunity to offer input into this process.  The manner of reaching consensus and the final decision-making authority will rest with the PI.

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

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 awarded group, 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 Contact:

Sandra Bridges, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4154, MSC-7626
6700B Rockledge Drive
Bethesda, MD 20892-7626
Telephone: (301) 496-8198
FAX: (301) 402-3211
Email: sbridges@niaid.nih.gov 

2. Peer Review Contact:

Clayton Huntley, Ph.D .
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3124, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)

Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 496-2550
FAX: (301)  480-2408
Email: chuntley@niaid.nih.gov

3. Financial or Grants Management Contact:

Jackie Johnson
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2127, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-5936
FAX: (301) 480-2599
Email: jjohnson@mail.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 public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy 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 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.