Part I Overview Information


Department of Health and Human Services

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

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

Title: Cooperative Research into Therapeutics and Diagnostics for Category B Bacteria, Viruses, and Parasites (U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-AI-06-029

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 5, 2006
Letters of Intent Receipt Date(s): October 27, 2006
Application Receipt Date(s): November 27, 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: November 28, 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

Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), strives to diagnose, understand, treat and ultimately prevent the myriad infectious, immunological, and allergic diseases that impact millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) and the Division of Allergy, Immunology and Transplantation (DAIT) support extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic biomedical research, such as studies of microbial physiology and antigenic structure; immunity; applied research, including the development of diagnostic tests; and clinical trials to evaluate experimental drugs and vaccines.

Through this RFA, the NIAID invites research grant applications that will lead to the development of new therapeutics and diagnostics addressing NIAID Category B priority pathogens (http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm). The objective of this program is to support translational research and advanced product development, i.e. beyond basic research. Projects may include, but not be limited to, identification of diagnostic or therapeutic targets; the adaptation of technologies or products to Category B biodefense applications; optimization of products; process development, early validation and testing; preclinical evaluation; scale-up, and production of materials sufficient for preclinical regulatory requirements and clinical Phase I testing or field trials.

NOTE: While clinical development strategies may be included within an overall product development plan, this RFA will NOT support clinical trials, as defined in http://www.niaid.nih.gov/ncn/glossary/default2.htm#clintrial. Applications requesting support for clinical trials will be viewed as unresponsive to this RFA and will be returned to the applicant without review. Collection and utilization of human derived material required for therapeutic or diagnostic development, or for compliance with regulatory requirements is considered responsive. Collection of all specimens must comply with the requirements and policies of DMID (http://www.niaid.nih.gov/dmid/clinresearch/) and 45 CFR 46.

NOTE: Applications proposing the development of a therapeutic or diagnostic that does not focus on a NIAID Category B priority pathogen will be deemed unresponsive and will be returned to the applicant without review.

NOTE: Applications addressing the Category B Toxins (Shiga, Shiga-like, ricin, Clostridium perfringens epsilon toxin, and the staphylococcal enterotoxins) are not responsive to this RFA, and should be directed to the companion solicitation, RFA-AI-06-035.

Partnerships

A key component of this initiative is the development of partnerships. All awardees will be required to partner with an NIH project scientist who will be assigned to the project post-award. In addition, cooperative applications between researchers in academia and/or industry that bring together expertise in different aspects of research and product development are strongly encouraged, but not required.

For the purpose of this RFA, "industry" is defined as large and small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and other relevant for-profit entities. Since academic organizations are often the source of new candidate products, this RFA will also support a partnership between industry and collaborator(s) from academic and non-profit research organizations as necessary. Such partnerships are strongly encouraged, but not required.

The Principal Investigator of the project may be affiliated with any of the eligible institutions listed in Section III below.  It is expected that in the application the Principal Investigator will detail the relevant product development expertise and track record available within the team.

The NIH project scientist assigned to the project post-award will ensure that issues are addressed and milestones met during product development. It is recognized that early research and development steps may not be successful, and may need to be modified or reworked. NIAID staff, through the cooperative agreement grant mechanism, will be actively involved in evaluating progress toward project milestones and determining whether continued investment is warranted. To receive consideration for funding of each successive year, the annual progress report and an updated product development plan must be received 2 months prior to the end of the current funding period, demonstrating that the milestones defined for that funding year have been met.

Background

The NIH and other agencies in the Department of Health and Human Services (DHHS) are currently supporting extramural and intramural projects to develop new products to protect the public from the health consequences resulting from the use of biological agents in acts of terrorism or war. The biological agents deemed to pose the greatest threat to civilian populations are prioritized in the NIAID Category A, B and C priority pathogens and toxins list, which is available at: http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm. The NIAID convened three Blue Ribbon Panels to address the research priorities for Category A pathogens and toxins, Category B and C pathogens and toxins, and immunology research. The research agendas that resulted from these three meetings are published at: http://www.niaid.nih.gov/biodefense/research/biotresearchagenda.pdf, http://www.niaid.nih.gov/biodefense/research/categorybandc.pdf and http://www.niaid.nih.gov/publications/pdf/biodimmunpan.pdf. In addition to the NIAID research agendas, the DHHS has identified the highest priority products for bioterrorism preparedness (http://www.niaid.nih.gov/biodefense/research/high_priority.htm).

To meet the objectives outlined by the Blue Ribbon Panels, it is imperative that promising findings are translated rapidly into product development. The involvement of diverse disciplines within academia and industry in basic science, translational research, and product development is needed to bring sufficient expertise to bear on the development of well-designed therapeutics and medical diagnostics.

Research Goals and Objectives

Applicants should propose projects that will advance the development of a therapeutic or diagnostic that is specific for one or more NIAID Category B pathogens.  Research is not required to result in a "final" product since clinical trials are not supported; however, proposals to make significant progress along the pre-clinical research and product development pathway are expected. Diagnostic development will likely target demonstrable needs and should consider evaluation and validation with appropriate clinical specimens. Therapeutics development may extend to the point where the R34 Clinical Trial Planning Grants and U01 Clinical Trial Implementation Cooperative Agreements (http://www.niaid.nih.gov/ncn/clinical/R34.htm) offer the logical next step. Research and product development projects that address multiple agents such as broad spectrum therapeutics, novel drug families, and multiplex diagnostics are particularly encouraged, especially when a clearly demonstrable need is shown, and a pathway to clinical or field use is presented.

All applicants must define the proposed project goal, describe the proposed final product, and provide a schedule or timeline for goal attainment with measurable interim objectives (essential milestones). A specific product profile defined by licensing indication is not requested. When appropriate, research plans should include an awareness of the guidelines that govern GLP (as defined by 21 CFR(58)) and GMP (as defined by 21 CFR(211)) manufacturing, and/or IND enabling studies that will be performed under this award as they would be applied to eventual product licensure in the U.S.

The NIAID recognizes that critical aspects of the product development pathway such as GLP, cGMP production, or diagnostic validations are inherently not amenable to innovation; however innovation is encouraged where it is appropriate to reducing project risk and the efficient accomplishment of goals.

Phase I, II, and III clinical trials and field trials are not supported by this RFA. However, in the case of diagnostics, it is expected that appropriate human specimens will be used to show that performance specifications can be met, to demonstrate a level of utility that exceeds existing systems, and to clearly place the proposed product on a pathway to FDA review. Collection of all specimens must comply with the requirements and policies of 45 CFR 46, and DMID (http://www.niaid.nih.gov/dmid/clinresearch/).

Therapeutics for Biodefense

Developing biodefense therapeutics against NIAID Category B threats is a key national priority. Applications are invited that will lead to the development of drugs against any of the Category B priority pathogens or the physiological insults that they cause. Projects including one or more of the following areas are particularly encouraged but not limited to:

NOTE:  For applications for development of therapeutics, of particular interest are projects that incorporate formulation strategies that optimize the properties of the resulting product.

NOTE:  Applications proposing the development of a therapeutic that does not focus on a NIAID Category B priority pathogen will be deemed unresponsive and will be returned to the applicant without review.

NOTE:  Applications addressing the Category B Toxins (Shiga, Shiga-like, ricin, Clostridium perfringens epsilon toxin, and the staphylococcal enterotoxins) are not responsive to this RFA, and should be directed to the companion solicitation RFA-AI-06-035.

Diagnostics for Biodefense

There is an urgent need for easy to use, rapid, and cost-effective medical diagnostics for public health laboratories, hospital-based clinical laboratories, field, and point-of-care use to diagnose individuals exposed to and/or infected with NIAID Category B priority pathogens. NIAID goals include supporting the development of diagnostics that identify infectious agents and instruct appropriate therapy for individuals who are pre- symptomatic, symptomatic, non-responding to treatment, or have non-specific symptoms. Medical diagnostics that determine drug sensitivities, perform differential diagnoses, or identify co-infections are also of high priority. The development of medical diagnostics that use multiplex, platform technologies is encouraged and can include pathogens in addition to those in NIAID Category B, but must be focused on rapidly distinguishing whether an individual is infected by a NIAID Category B agent or by a common infection with similar, generalized symptoms. Projects including one or more of the following areas are particularly encouraged but not limited to:

 NOTE: Applications proposing the development of a diagnostic that do not focus on a NIAID Category B priority pathogen will be deemed unresponsive and will be returned to the applicant without review.

NOTE: This program will NOT support research on the development or deployment of devices for the detection of agents in foods, fomites, or environmental specimens. Such applications will be deemed unresponsive and returned to the applicant without peer review.

NOTE:  Applications addressing the Category B Toxins (Shiga, Shiga-like, ricin, Clostridium perfringens epsilon toxin, and the staphylococcal enterotoxins) are not responsive to this RFA, and should be directed to the companion solicitation RFA-AI-06-035.

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

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

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:

Institutions must be in compliance with U.S. laws and regulations and DHHS and NIH policies in effect at the time of grant award and during the period of performance of the research.

Collaborators at foreign institutions are allowed and encouraged, particularly when a diagnostic or therapeutic is targeting a disease that has a low incidence/prevalence in the USA and a high incidence/prevalence at a foreign setting where future product development activities may be planned.

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 support.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

None

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:

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 27, 2006
Application Receipt Date(s): November 27, 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:

Dr. Gregory Jarosik
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3134, MSC 7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (Express mail zip: 20817-7616)
Telephone: (301) 496-0695
FAX: 301-480-2408
Email: gjarosik@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:

Dr. Gregory Jarosik
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3134, MSC 7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (Express mail zip: 20817-7616)
Telephone: (301) 496-0695
FAX: 301-480-2408
Email: gjarosik@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/grants/policy/nihgps_2003/NIHGPS_Part6.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 biodefense by supporting partnerships between the research community and the Federal Government. Each application must propose a research and development project whose goal is to advance a therapeutic or diagnostic countermeasure specific to an NIAID Category B priority pathogen through the product development process. It is not necessary to propose to complete the product development process up to the point of readiness for clinical trials within the time frame of this project. Applications that would significantly advance a specific product toward clinical or field usefulness are responsive.

NOTE: All applications for research projects must include in the Research Plan:

2. Mandatory Meetings

Requested budgets must include funds for travel by the Principal Investigator and key personnel to an annual meeting in Bethesda, Maryland, as determined by NIAID Program staff. See Section VI.2.A.1. Award Administration Information below.

3. Good Laboratory Practice

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

4. 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 must NOT be included in the application; external advisors must be identified and appointed only after award.

Additional Submission Requirements (Do not count towards page limits for Research Plan) Applications lacking these additional submission requirements will be considered non-responsive.

1. Milestones and Timeline

Applicants must provide detailed project performance and timeline objectives in a section entitled “Milestones and Timeline” (may not exceed 5 pages). The Milestones and Timeline section should follow the Research Plan of the application and does not count towards 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 5 pages). The Product Development Plan should follow the Milestones and Timeline section of the application and does not count towards the page limits for the Research Plan. This section must include:

3. 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 Product Development Plan 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 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/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.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 one or more 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:

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: Do the milestones and product development plan assess the feasibility of the objectives, milestones, and plans for future product development, including the approach to obtaining the data required for pre-market approval? (if applicable) 

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. Are plans related to physical or facility security and biocontainment and biosafety adequately  assessed and addressed.

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/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 PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.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/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement U01, 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 awardees will retain primary responsibility for the performance of the scientific activity. The Principal Investigator agrees to accept consultation, coordination, cooperation and participation of NIAID staff in 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 remain solely with the Principal Investigator.

Intellectual Property

The successful development of high priority products for biodefense will require substantial investment and support by private sector industries, and may also involve collaborations with other organizations such as academic and/or non-profit research institutions. It is the intent of this initiative to support the formation of the appropriate public-private partnerships that are essential to meet these urgent public health needs. NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees 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, at 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.

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

2.A.3. Collaborative Responsibilities  
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 Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the 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:

Direct enquiries regarding general scientific and programmatic issues, and questions concerning therapeutics and diagnostics for Category B Bacteria to:

Robert H. Hall, Ph.D
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 4013, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 451-5074
FAX: (301) 402 1456
Email: rhall@niaid.nih.gov

Direct your questions about therapeutics and diagnostics for Category B Viruses to:

Cristina Cassetti, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 4044, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 451-3745
FAX: (301) 480-1594
Email: ccassetti@niaid.nih.gov

Direct your questions about therapeutics and diagnostics for Category B Parasites to:

Philip Coyne, M.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5103, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 496-2544
FAX: (301) 402-0659
Email: pcoyne@niaid.nih.gov

2. Peer Review Contacts:

Dr. Gregory Jarosik
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3134, MSC 7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (Express mail zip: 20817-7616)
Telephone: (301) 496-0695
FAX: 301-480-2408
Email: gjarosik@niaid.nih.gov 

3. Financial or Grants Management Contacts:

Ms. Mollie Shea
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2234R, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614

Telephone: (301) 402-6576
FAX: 301-480-3780
Email: mshea@niaid.nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45 CFR 46) 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/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, 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.


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