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 Institutes of Allergy and Infectious Diseases (NIAID) (http://www3.niaid.nih.gov/)

Title: NIAID Partnerships with Public-Private Partnerships (U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-AI-06-033

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

Key Dates
Release Date: June 7, 2006
Letters of Intent Receipt Date(s): October 30, 2006
Application Receipt Date(s): November 30, 2006
Peer Review Date(s): March, 2007
Council Review Date(s): May, 2007
Earliest Anticipated Start Date(s): July, 2007
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration Date: December 1, 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

Background

Public-Private Partnerships have emerged in recent years as important new entities for bringing products to market.  NIH has recognized the importance of PPPs through the Program on PPPs located in the Office of Science Policy within the NIH’s Office of the Director (http://nihroadmap.nih.gov/publicprivate/).  However, therapeutic, preventive, and/or diagnostic health care products are extremely expensive to develop.  For example, it has been estimated that investment of an average of $802 million is necessary to bring one new drug through the development pipeline to regulatory approval and marketing. [DiMasi et al, J Health Econ 22(2) 151-185, Mar 2003]  Furthermore, the perceived lack of a viable market in developing countries for many interventions against neglected infectious diseases has resulted in limited interest by pharmaceutical developers. [See “The New Landscape of Neglected Disease Drug Development” at www.wellcome.ac.uk/assets/wtx026592.pdf ] Consequently, the large, private shareholder-owned pharmaceutical industry has focused almost exclusively on the development of health care products targeted to countries in which a return on this large investment can be expected.  As a result, of the 1223 new chemical entities brought to market worldwide between 1975 and 1996, only 13 were developed specifically for neglected infectious diseases.  [Pécoul B et al, JAMA 281: 361-367, Jan 1999]

This initiative seeks to support research leading to increasing the number of new products for prevention, treatment and diagnosis of these diseases.  Although the term ‘neglected infectious diseases’ is commonly used to describe certain diseases primarily, if not exclusively, affecting poor populations in developing countries, a specific definition of this term has not been universally accepted.  For the purposes of this RFA , the term ‘neglected infectious diseases’ will refer to those diseases identified as priority diseases by the WHO Special Programme for Research and Training in Tropical Diseases (WHO/TDR), as found on the TDR website (www.who.int/tdr/diseases/default.htm). 

The failure of traditional market-driven R&D for infectious diseases of the developing world has led to the creation of a variety of Public-Private Partnerships (PPPs).  For example, the Mectizan Donation Program Partnership, initially between Merck and WHO/TDR, resulted in the approval of ivermectin for the treatment of onchocerciasis (river blindness), and the subsequent announcement by Merck of an open-ended donation of ivermectin for the control of onchocerciasis in Africa.  With the active involvement of the World Bank, the WHO, the affected countries and a broad partnership of Non-Governmental Organizations, onchocerciasis has been largely eliminated as a public health problem in West Africa.  Subsequently, many public and private organizations have demonstrated a desire to create an environment in which industry can sustainably engage in R&D activities on neglected infectious diseases.

Product Development Public-Private Partnerships (PD PPPs):  Since the announcement of the Mectizan Donation Program in 1987, an increasing number of PPPs have been created to address the widening gap in product development for neglected infectious diseases.  The Initiative for Public-Private Partnerships for Health (IPPPH), an organization that tracks the growth of these PPPs, has documented that a total of 92 health-focused partnerships have been created as of December 2005; of these, 34 are specifically involved in the discovery and/or development of new drugs, vaccines, or other health products addressing neglected infectious diseases and conditions in low and middle income countries.  The study by the Wellcome Trust and the London School of Economics (www.wellcome.ac.uk/assets/wtx026592.pdf) has documented that of the 55 drugs in development or registered for neglected infectious diseases since 2000, 45 are being developed by product development (PD)-oriented PPPs. To accelerate this process, this initiative will support a collaborative relationship between NIAID and an established PD PPP.

Research Goals and Objectives

The objective of this RFA is to provide targeted resources for preclinical aspects of a product development program that is being coordinated by a PD PPP.  NIAID seeks a more active collaboration with the PD PPPs dedicated to the development of new products for neglected infectious diseases, with the goal of funding crucial tasks that are required for the advancement of a product along the development pathway.

This program is intended to support product development PPPs focused on neglected infectious diseases as defined by the WHO/TDR Special Programme for Research and Training in Tropical Diseases (http://www.who.int/tdr/diseases/default.htm):

Examples of the types of studies that could be supported under this program include, but are not limited to, various aspects of preclinical development of interventions or diagnostics, such as:

NOTE:  While clinical development strategies may be included within an overall product development plan, this RFA will NOT support Phase 1, 2, or 3 clinical trials or field trials.  Applications requesting support for clinical trials or field trials will be viewed as nonresponsive to this RFA and will be returned to the applicant without review.  However, utilization of appropriate human cell lines and human derived materials in preclinical studies in support of complying with regulatory requirements is considered responsive and is encouraged.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U01 award mechanism.  As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. 

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

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

Essential elements of the U01 include: (1) a single research project that may include consortium agreements, but does not include "Core" resources and facilities as defined for U19 applications; (2) a single Principal Investigator who will be scientifically and administratively responsible for the research project; and (3) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded.

This RFA is a one-time solicitation. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present RFA.

2. Funds Available

The NIAID intends to commit approximately $3 million in FY 2007 to fund 3-4 new cooperative agreements in response to this RFA.  An applicant may request a project period of up to 5 years.

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

Applicants may request up to a total of $50,000 for equipment to ensure that research aims can be met and biohazards can be contained; this must be well justified. Funds for equipment may not be included in the first year requested budget. Prior approval from NIH program staff must be obtained for requests for equipment that exceed this amount. Unapproved equipment requests that exceed $50,000 will not be considered for funding.

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:

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

This program does not require cost sharing or matching funds.

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

Applicants may submit more than one application, but each application must be scientifically distinct, as follows;

PPPs based in the U.S. should be registered as 501(c)(3) organizations, or must provide documentation of incorporation as a non-profit public entity that has established collaborations with the private sector.  PPPs based outside of the US should provide comparable documentation of incorporation as a non-profit public entity that has established collaborations with the private sector.   If such documentation is not in English, then a translation of the documents into English must be provided.

Eligible PPPs must be dedicated to the discovery and/or development of new drugs, vaccines, diagnostics, or other health products addressing neglected infectious diseases that are prevalent in low income countries (the lower 50% of countries rated by poverty level according to the 2006 World Development Report, found at  http://publications.worldbank.org/ecommerce/catalog/product?item_id=4849133 ).  Representative examples include those PPPs listed on the database of the Initiative on Public-Private Partnerships for Health (found at  http://www.ippph.org ).

NOTE:   Applications from applicants that do not meet the eligibility criteria will be returned without review.

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.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations (http://www.niaid.nih.gov/ncn/sop/foreign.htm): Charge back of customs and import fees is not allowed.

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.

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): October 30, 2006
Application Receipt Date(s): November 30, 2006
Peer Review Date(s): March, 2007
Council Review Date(s): May, 2007
Earliest Anticipated Start Date: July, 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:

Peter Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive,
Bethesda, MD 20892-7616 (Express mail zip: 20817-7616)
Telephone: (301) 496-8426
FAX: (301) 480-2408
Email: pjackson@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:

Peter Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive,
Bethesda, MD 20892-7616 (Express mail zip: 20817-7616)
Telephone: (301) 496-8426
FAX: (301) 480-2408
Email: pjackson@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. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

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 http://grants.nih.gov/grants/policy/policy.htm.

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

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

6. Other Submission Requirements

RESEARCH PLAN  

1.  Research Focus

This program responds to the urgent public health need to develop new and promising high-priority products for the treatment, prevention, or diagnosis of neglected infectious diseases.   Each application must outline a specific product development plan, and describe precisely how the resources available under this RFA will be utilized to advance that product through its development pathway.  This should include why the PPP was established (e.g., to address an unmet public health need), how the proposed product will address will address the rationale and public health need, and the global impact on human health of the particular disease that is the focus of the application.

All applications that pertain to a diagnostic device should include in the research plan a clear description of the capabilities of the method, technology, or assay; a clear description of how the diagnostic/technology will be used and its applicability to human clinical samples or field specimens in resource-poor settings; relevance to the target population; and plans for determining the sensitivity, specificity, and validation of the technology, assay, or diagnostic.

2.  Good Laboratory Practice

When appropriate, applicants must document in the Research Plan compliance with guidelines that govern GLP, as defined by 21 CRF (58), and cGMP, as defined by 21 CRF (211), manufacturing and/or IND, IDE enabling studies that will be performed under the project award as they would be applicable to eventual product licensure in the U.S.

3.  External Advisors

External advisors may be appointed by the Principal Investigator in consultation with NIAID Program Staff to assist in progress review. Names of suggested external advisors should not be included in the application; external advisors should be identified and appointed only after award.  Funds may be requested for external advisors.

ADDITIONAL SUBMISSION REQUIREMENTS 

Applications lacking these additional submission requirements will be considered non-responsive and will be returned to the applicant without review. Additional submission requirements do not count towards page limits for the Research Plan.

1.  Milestones and Timeline

The applicant must provide detailed project performance and timeline objectives in a section entitled “Milestones and Timeline” (may not exceed five pages).  The Milestones and Timeline section should follow the Research Plan of the application and does not count toward the page limits for the Research Plan. This section must include: 

2.   Product Development Plan

Applicants must include a section entitled “Product Development Plan” in the application (may not exceed five pages).  The Product Development Plan should follow the Milestones and Timelines section of the application and does not count towards the page limits for the Research Plan.  This section must include:

·A statement of the scientific and technical merit of the project, including lay description of key technology objectives, current competition, and advantages compared to competing products, technologies, or services.

·A clear description of the goals of the project, including one or more final product(s)  or stage(s) of product development to be completed during the award period.  A specific product profile that is defined by a licensing indication is not requested at this time.

·A clear description of plans for further development of candidate product(s) after completion of this project. For example, tests for use on human samples may consider benchmarks required for FDA approval (http://www.fda.gov/cber/devices.htm).

3.   Accomplishments of Applicant Organization  

Applicants must include a section entitled Accomplishments of Applicant Organization that delineates the track record of the PPP and the products currently in their product development pipeline (may not exceed five pages).  This section should follow the Product Development Plan section of the application and does not count towards the page limits for the Research Plan.  It must include a description of the other products currently in development by the applicant PPP, including the phase of development for each of these products, the intended use of each product (i.e. the disease targeted and the projected global market), and the partnering entities with which the PPP collaborates.

4.  Physical and/or Facility Security

Applicants must address issues related to physical or facility security and biocontainment and biosafety (http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm) pertinent to the specific pathogens of interest in a section entitled “Biosafety and Biocontainment” in the application (may not exceed 1 page). Guidelines for Institutional Biosafety Committees are available at: http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm. The Biosafety and Biocontainment section should follow the Accomplishments of Applicant Organization section of the application and does not count towards the page limits for the Research Plan.

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 may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score

Sharing Research Resources

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

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

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions on the U01 application resulting in initial awards:

Decisions for continued funding in subsequent years will be based on:

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.  More than one peer review group may be convened to review the applications received in response to this RFA.

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

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.

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 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? 

Milestones and Product Development Plan: Are defined objectives/milestones appropriate and feasible, and indicative of the feasibility of future product development, and the appropriateness and feasibility of conducting preclinical testing for safety and efficacy in animal models?.

Accomplishments of Applicant Organization:  Does the track record of the applicant PPP, demonstrate that it is actively engaged in development of diagnostic, therapeutic, and/or preventive products for neglected diseases will be assessed by the reviewers.

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 Principal Investigator will also receive a written critique called a Summary Statement.

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

A formal notification in the form of a Notice of 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 cooperative agreement (U01 single project), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:  defining the research objectives, approaches and details of the projects within the guidelines of the RFA and for performing the scientific activity.  Specifically, awardees have primary responsibility as described below.

The Principal Investigator retains primary responsibility for the performance of the scientific activity, and agrees to accept close assistance in coordination, cooperation and participation of NIAID staff in scientific and technical management of the project in accordance with the terms formally and mutually agreed upon prior to the award.  The responsibility for the planning, direction, and execution of the proposed project will be solely that of the Principal Investigator.

Intellectual Property

The successful development of high priority products and interventions for neglected infectious diseases will require substantial investment and support of private sector industries and may also involve collaborations with multiple organizations, including academic and/or non-profit research institutions.  It is the intent of this initiative to support activities of appropriate PD PPPs that are essential to meet these urgent public health needs.  NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program.  To this end, all awardees understand and acknowledge the following:

Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID or other mechanisms.

Select Agents

All U.S. awardees must be in compliance with the U.S. Select Agent Regulations (http://www.cdc.gov/od/sap/) and NIH Guidelines for Research Involving Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html).

Award to a U.S. Institution: Before using NIH funds, the awardee must complete registration with CDC (or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied.

Award to a Foreign Institution: Before using NIH funds for any work directly involving the Select Agents, the awardee must provide information to the NIAID that a process equivalent to that described in 42 CFR 73 for U.S. institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds. All foreign laboratories are inspected to determine if the site has minimum biosafety and biosecurity procedures in place for working with Select Agents. During inspections the awardee must be willing to address the following key elements appropriate for their institutions: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents. If available, the awardee will be asked to provide copies of any applicable laws, regulations and policies equivalent to 42 CFR 73.

Award to U.S. Institution with Foreign Institution Participation: Before using NIH funds for any work directly involving the Select Agent at the US institution, the awardee must complete registration with CDC (or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied. Before using NIH funds for any work directly involving the Select Agents at the foreign institution, the US awardee must provide information from the foreign institution to the NIAID that a process equivalent to that described in 42 CFR 73 for US institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds. All foreign laboratories are inspected to determine if the site has minimum biosafety and biosecurity procedures in place for working with Select Agents. During inspections the awardee must be willing to address the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, If available, the awardee will be asked to provide copies of any applicable laws, regulations and policies equivalent to 42 CFR 73.

Annual Progress Review Meetings

The Principal Investigator and one or two key personnel designated by the Principal Investigator of each grant awarded under this RFA shall participate, with NIAID Program Staff and any external advisors (when applicable), in annual meetings to review progress and aid in program development.  These annual meetings shall be held at the NIAID offices in Bethesda, Maryland, USA, one of the awardee institutions, at a scientific meeting, or at another site determined by NIAID Program Staff.  Additional meetings, which may be necessary for coordination of cooperative agreement activities, may be scheduled if necessary

Publications

The Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews co-authored by members of the grant and supported in part or in total under this Cooperative Agreement.  Manuscripts shall be submitted to the NIAID Program Officer within two weeks of acceptance for publication.  Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of NIAID support.  Timely publication of major findings is encouraged.

Data

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIH Project Scientist will serve as a liaison/facilitator between the awardee and other government agencies (e.g., FDA, USDA, CDC), and will serve as a resource of scientific and policy information related to the goals of the awardee's research. The NIH Project Scientist will also facilitate coordination of project activities during the course of the project and assist the awardee with access to other NIAID-supported resources and services, including resources for preclinical development such as animal models, screening facilities, standardized research reagents, and a genomics resource center, where available.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program official may also serve as the NIH Project Scientist.

2.A.3. Collaborative Responsibilities
The specific timelines, interim objectives and funding levels agreed to by the Principal Investigator and the NIAID shall be included in the terms and conditions of award.  Given the nature of product development, it is recognized that timelines and interim objectives may require revision and renegotiation during the course of the project period.  The Principal Investigator and NIAID must agree to all such revisions. Release of each funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon interim objective.  NIAID may ask recipients to collaborate or cooperate with other NIAID funded projects, and/or other US government agencies, for example with the CDC, FDA and/or USDA.

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

3. Reporting

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Philip E. Coyne, Jr., MD
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5093, MSC-6604
6610 Rockledge Dr.
Bethesda, MD  20892-6604
Telephone: (301) 496-2544
FAX: (301) 402-0659
Email: pcoyne@niaid.nih.gov

2. Peer Review Contacts:

Peter Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive,
Bethesda, MD 20892-7616 (Express mail zip: 20817-7616)  
Telephone: (301) 496-8426
FAX: (301) 480-2408
Email: pjackson@niaid.nih.gov

3. Financial or Grants Management Contacts:

Ms. Katie Ellis
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2240, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 451-2687
FAX: 301-480-3780
Email: kellis@niaid.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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.

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).

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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