Part I Overview Information


Department of Health and Human Services

Issuing Organization
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)

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/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)

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

Announcement Type

This is a re-issuance with modifications, as a Request for Applications, of a previous Program Announcement, PAR-03-138, last released on June 12, 2003.

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


Request For Applications (RFA) Number: RFA-AI-06-009

Catalog of Federal Domestic Assistance Number(s)
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
No. 93.242, Mental Health Research Grants

Key Dates
Release Date: March 1, 2006
Letters of Intent Receipt Date(s): May 23, 2006
Application Receipt Dates(s): June 23, 2006
Peer Review Date(s): October, 2006
Council Review Date(s): January, 2007
Earliest Anticipated Start Date: January, 2007
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration Date: June 24, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH), National Institutes of Health (NIH), invite applications from single institutions and consortia of institutions to participate in the Novel HIV Therapies: Integrated Preclinical/Clinical Program (IPCP) for the development and evaluation of innovative therapies for HIV infection.

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 nontraditional therapeutic concepts as well as traditional drug-based therapies exploiting novel viral and cellular targets. This RFA is designed to assist researchers interested in HIV therapeutics development to assemble the diverse scientific expertise and resources needed to translate basic laboratory discoveries to applied entities. In the preclinical area, the RFA seeks research on: (1) the development/validation of new therapeutic targets; and (2) the development and evaluation of small molecule inhibitors of viral or cellular proteins or pathways critical to HIV replication and/or persistence. The inclusion of animal model studies is encouraged. In the clinical area, the focus is on iterative bench to bedside research to optimize new therapeutic approaches. Pilot clinical studies (10-30 subjects) will provide the means for demonstrating proof-of-concept.

Background

For the first 15 years of the HIV epidemic, drug discovery efforts concentrated on a relatively small number of viral targets: reverse transcriptase and protease. Basic research on virus replication and virus/host interactions is beginning, however, to yield new targets and inhibitors that can be evaluated in the clinic. For example, a number of potential targets have been identified in the HIV-1 attachment and entry process, with one fusion inhibitor now FDA-approved. Numerous pharmaceutical and biotechnology companies are evaluating inhibitors of the CCR5 co-receptor/HIV-1 interaction; both small molecules and antibodies are being pursued in a race that undoubtedly will yield an FDA-approved drug within the foreseeable future. Research on the assembly, maturation, and budding of HIV-1 has likewise provided potential targets in the viral capsid or its precursor protein (Gag). Inhibitors of these and other newly identified targets are being sought by means of high throughput screening of chemical libraries, made possible by the development of innovative assays and the application of robotics technology.

Extensive research has shown that currently available therapies do not totally eliminate HIV-1 and only partially reverse immune system damage. Thus, while advances continue to be made, there remains an urgent need for the identification/validation of new host and viral targets, novel drugs and delivery systems, immunological approaches to block HIV-1 replication, and agents/strategies to eliminate viral reservoirs, including those in the central nervous system.

Research Objectives and Scope

The objectives of the Novel HIV Therapies: Integrated Preclinical/Clinical Program (IPCP) are to support: (1) innovative preclinical studies to develop new HIV therapeutics, and (2) the translation of innovative treatment concepts from the preclinical arena to pilot clinical proof-of-concept studies. Successful programs will develop a new treatment concept that can be reduced to clinical practice and/or open a new research direction.

Applicants may propose: (1) preclinical research exclusively; (2) preclinical research that transitions to clinical research during the award period; or (3) clinical research that initiates in the first year of award. For the purpose of this RFA, the Multi-project Cooperative Agreement (U19) mechanism is being utilized. Each application must be composed of a minimum of 3 research projects. To facilitate the translation of new treatment concepts to the clinic, applications are required to include at least one component (a research project or scientific core) from 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. To be considered responsive to this requirement, the private sector partner is expected to contribute intellectually and materially to the program. The provision of selected research resources, such as reagents and novel experimental therapeutics, does not meet the requirement for private sector participation. The private sector component may budget for anticipated expenditures in all categories.

A list of projects supported under previous issuances of this initiative (PAR-97-080, PAR-00-098, PAR-03-138) 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 the NIAID Division of AIDS.

Examples of research of responsive to this RFA include, but are not limited to, the following:

NOTE: This RFA will NOT support:

Applications proposing research in any of the above areas will be deemed unresponsive and will be returned to the applicant without review.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the Multi-project Cooperative Agreement (U19) award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U19 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

It is anticipated that this funding opportunity will be re-issued in 2007.

2. Funds Available

The participating IC(s) NIAID and NIMH intend to commit approximately $3.7 and $1.9 million dollars, respectively, in FY 2007 to fund 1-2 new and/or competing continuation grants each in response to this RFA. 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 5 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. NIMH encourages investigators to propose projects at the lower end of the budget spectrum, focusing on either preclinical (in vitro and/or in vivo animal studies) or pilot clinical research.

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/cr_gcrc.asp), Institutional Clinical and Translational Science Awards (CTSA, http://www.ncrr.nih.gov/clinicaldiscipline.asp ), and Centers for AIDS Research (CFAR, http://www3.niaid.nih.gov/research/cfar/)]. 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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Foreign institutions are not eligible to apply as the primary applicant, but may enter into a consortium with a domestic institution serving as the primary applicant for one of the proposed research projects or scientific cores.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

Not applicable.

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

3. Other-Special Eligibility Criteria

Applications must include a minimum of 3 research projects; at least one component (a research project or scientific core) must be from 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.

Applicants may submit more than one application, provided they are scientifically distinct.

Applications from existing awardees are eligible to compete under this RFA provided that the total term does not exceed 9 years of continuous support for the same concept (4 years under PAR-03-138 and 5 years under this RFA).

NOTE: Applications for supplements to existing projects are not eligible to compete under this RFA.

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Multi-Project Applications

Applicants for multi-project grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. This brochure presents specific instructions for sections of the PHS 398 application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398.

Foreign Organizations

Several special provisions apply to applications that include the participation of foreign organizations:

Proposed research contribution of foreign institutions should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): May 23, 2006
Application Receipt Dates(s): June 23, 2006
Peer Review Date(s): October, 2006
Council Review Date(s): January, 2007
Earliest Anticipated Start Date: January, 2007

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Brenda Lange-Gustafson, PhD
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3122, 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) 451-3684
FAX: 301 480-2408
Email: bgustafson@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:

Brenda Lange-Gustafson, PhD
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3122, 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) 451-3684
FAX: 301 480-2408
Email:
bgustafson@niaid.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

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

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

Concurrent submission of an R01 and a component project of a multi-project application: current NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the PI and awarding institution.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

The suggested budget limit for applicants proposing exclusively preclinical research is $650,000 direct costs for the first year. Applicants proposing the use of large animals (e.g. non human primates) may budget up to $775,000 direct costs in any year(s) that such large animals will be needed. Applicants proposing clinical studies may budget up to $1.3 million direct costs in any year(s) in which clinical studies are being conducted. Applicants proposing to transition from preclinical to clinical studies during the award period should submit a budget for each phase that reflects the limits given above.

6. Other Submission Requirements

Applicants for U19 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the web at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. This brochure presents specific instructions for sections of the PHS 398 application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398.

All applications must include:

Program Overview: A clear and concise narrative that describes the interrelationships among the research groups, their relevant experience and expertise, and the contribution of each to the fulfillment of the objectives of this RFA; an organizational chart of the U19 cooperative group showing the name, institution, and scientific disciplines of the Principal Investigator (PI) and of all key scientific and technical personnel, as well as a discussion/flow chart illustrating the lines of authority and plans for the coordination of research projects; and a plan to ensure the maintenance of close cooperation and effective communication among members of the U19 group.

Administrative Core Plan: A plan, under the direction of the PI, which addresses Program oversight, daily operations, promotion of collaborations, participation in meetings, and other IPCP activities. The Administrative Core budget request should include funding for: 1) overall administration (e.g. secretarial and other administrative services), expenses for publications for collaborative efforts, and communication expenses; 2) travel funds to cover the costs associated with one IPCP Group meeting per year for the PI, the Project and Core Leaders, and the Scientific Advisory Panel (see Section VI., 2.A.1) members. No travel funds will be provided for investigators to attend other domestic or foreign scientific meetings.

Development Plan: 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. In the case of projects that will make a transition from preclinical to clinical research, the goals and milestones will be used to judge the completion of the preclinical development phase and the readiness of the Group to proceed to the clinical phase. This decision i) will be made by NIAID or NIMH and may involve the 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 Protocol Design: For purposes of the initial peer review, the application must include a design for the clinical protocol based on research findings available at the time of submission, including proposed clinical sites and names of clinical investigators to be involved.

Proprietary Rights Assurance Letter: NIAID requires that at the time of application all applicants must provide a letter ("Proprietary Rights Assurance Letter") containing the following assurances, which is signed by a representative who is duly authorized to provide such assurances on behalf of the applicant organization:

Apart from the Proprietary Rights Assurance Letter, applicants are encouraged to reach early consensus with any proposed partners regarding intellectual property 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 the NIAID or other mechanisms.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

General review criteria for multi-project grant applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" at http://www.niaid.nih.gov/ncn/grants/multibron.htm. These relate to the evaluation of the overall application, the appropriateness of the cores, the adequacy of the proposed administrative structure, and the suitability of the budget in relation to the proposed program.

The following review criteria, specific to this RFA, will also be considered in the determination of scientific merit and the priority score:

For Groups focusing on preclinical research:

For Groups proposing clinical research:

Adequacy and validity of the proposed milestones for determining the readiness of the Group to transition to clinical research; iterative research plan to develop and optimize the proposed strategy; protocol design; short- and long-term development plans; contingency plans; plans to ensure the safety of research subjects; plans to evaluate outcome even if unanticipated; and provisions to obtain the required institutional and regulatory approvals (IRB, IBC, FDA, RAC, if applicable) to conduct the clinical study.

2.A. Additional Review Criteria:

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

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

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

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

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

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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

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

2. Administrative and National Policy Requirements

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

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the 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 above.

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 or NIMH 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.

c) Compliance with NIAID or NIMH and NIH policies related to clinical research: 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. Release of funds for the clinical study will depend on compliance with the NIAID Clinical Terms of Award, including the applicable institutional and regulatory requirements (IRB, IBC, FDA, RAC, other). NIAID reserves the right to independently monitor the clinical research. Such review and monitoring may be conducted by an organization contracted by and acting on behalf of NIAID. NIH policy regarding compliance with NIH guidelines on recombinant DNA research is found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html.

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 wil 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 the NIAID or NIMH, and a complete, cumulative list of all publications authored by group members.

g) Acknowledgements of published work: All published presentations of work supported in part or in total by the IPCP cooperative agreement must acknowledge the Institute, program, and grant number, e.g. "This work was supported in whole (or in part) by the NIAID Novel HIV Therapies: Integrated Preclinical/Clinical Program, cooperative agreement number U19-AI-12345".

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.

A Scientific Coordinator (SC) will provide a liaison function between the awardee and the NIAID or NIMH. 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 or NIMH 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 appropriate assistance, advice, and guidance by: participating in the design of activities; by facilitating access to resources and information that otherwise might not be available; by advising in the management of the projects and technical performance; by 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; by providing guidance and oversight on compliance with Federal regulations related to human subjects research and NIAID or NIHM policy on clinical research, and communicating in a timely fashion information that might affect the safety of subjects in grant supported studies; and by participating in the annual site visit as a partner, to review research progress and direction and provide recommendations. However, the role of NIAID and NIMH 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 or NIMH 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, the SC 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
Not applicable.

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 NIAID or NIMH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Sandra Bridges, PhD
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

Kathy L. Kopnisky, PhD
Center for Mental Health Research on AIDS
National Institute of Mental Health
Room 6199, MSC-9619
6001 Executive Blvd
Bethesda, MD 20892-9619
Telephone: (301) 443-7726
FAX: (301) 443-9719
Email:
kkopnisk@mail.nih.gov

2.
Peer Review Contacts:

Brenda Lange-Gustafson, PhD
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3122, 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) 451-3684
FAX: 301 480-2408
Email:
bgustafson@niaid.nih.gov

3.
Financial or Grants Management Contacts:

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) 480-3780
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.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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

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

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

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

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

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Allergy, Immunology and Transplantation Research, No. 93.856, Microbiology and Infectious Diseases Research, and No. 93.242, Mental Health Research Grants, 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


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