and Human Services (HHS)
EXPIRED
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: Genomics of Transplantation Cooperative Research Program
Announcement Type
This is a re-issuance and a modification of RFA-AI-04-002, which was previously released on December 11, 2003.
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-AI-05-022
Catalog of Federal Domestic Assistance Number(s)
93.855
Key Dates
Release Date: March 18, 2005
Letters Of Intent Receipt Date(s): August 16, 2005
Application Receipt Dates(s): September 16, 2005
Peer Review Date(s): January, 2006
Council Review Date(s): May, 2006
Earliest Anticipated Start Date: July, 2006
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/QA/rfa-05-022.htm
Expiration Date: September 17, 2005
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
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 Announcement1. Research Objectives
Purpose
The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) invites applicants to participate in the expansion of the Genomics of Transplantation Cooperative Research Program for large-scale, broad-scope genomic studies in clinical transplantation, including solid organ, tissue, and cell transplantation. The goals of this program are to identify and characterize gene polymorphisms and gene expression patterns that: (1) correlate with and/or predict transplantation outcomes; (2) delineate immune responses relating to the onset and severity of acute and chronic graft rejection; (3) predict responses to immunosuppressive therapeutics to allow tailoring of therapy; and (4) elucidate the genetic basis of variability in graft survival between populations. The long-term goal of the program is to understand the genetic basis of immune-mediated graft rejection and differences in transplant outcomes, and thereby provide a rational basis for the development of more effective treatment and prevention strategies to improve long-term graft survival and quality of life for transplant recipients.
Background
Transplantation is the preferred therapy for the majority of end-stage organ diseases. Over the last ten years, 20,000 to 25,000 organ transplants have been performed each year in the United States. One-year graft and patient survival rates have improved dramatically during the past 15 years, approaching 90% for many organs. A major factor contributing to this short-term improvement is the development of more efficacious immunosuppressive agents that prevent or treat acute rejection. However, long-term graft survival has not improved appreciably since the early 1980s due, in large part, to a poor understanding of the mechanisms of chronic graft failure.
Improving transplantation outcomes requires a greater understanding of the genetic basis of the immune response to organ and tissue allografts. Decades of research focused on the extraordinary genetic polymorphism of the major histocompatibility complex (MHC) and its role in graft survival have provided valuable insights into the relative risk for graft failure of MHC gene disparities between donors and recipients. In recent years, investigators have also demonstrated intriguing associations between transplant outcomes and polymorphisms in a variety of genes encoding cytokines (TNF-alpha, TGF-beta, IFN-gamma, IL-1, IL-4, IL-6 and IL-10), adhesion molecules (ICAM-1), and co-stimulatory/regulatory molecules (CTLA-4). Similarly, the efficacy and toxicity of immunosuppressive agents such as steroids and Tacrolimus in some transplant patients have correlated with polymorphisms in the multi-drug resistance gene (MDR1). Genetic variations between genders and races may also influence transplantation outcomes. A recent review of transplants performed worldwide indicated that recipients of solid organs from female donors have poorer outcomes than recipients of organs from male donors. Similarly, while one-year graft survival is equivalent for African Americans and Caucasians, the three-year graft survival rate is significantly lower for African Americans. In the few studies addressing this health disparity, adverse transplantation outcomes among African Americans were correlated with certain gene polymorphisms which lead to higher production of inflammatory cytokines and increased expression of costimulatory molecules compared to Caucasians. Overall, studies delineating the contributions of gene polymorphisms or gene expression variation in transplantation outcomes have been relatively few and limited in scope. Larger-scale, broad-scope studies of gene polymorphisms and expression in donor organs and recipients will help elucidate the genetic basis of immune response differences and risk factors, such as gender and race, which result in acute and chronic graft rejection. In addition, these studies should lead to the development of safer and more efficacious immunosuppressive therapies.
During the past decade, genomic research has benefited from significant technological advances in measuring and identifying gene expression, and in determining genotypes, single nucleotide polymorphisms (SNPs), microsatellite polymorphisms, and haplotypes. In addition, the sequencing of the human genome has created new opportunities and challenges to apply these technologies to decipher the biological significance of genes, gene expression, and polymorphisms as they relate to human diseases, including the clinical outcomes of organ, tissue, and cell transplantation. Furthermore, knowledge gained through the International HapMap Project (http://www.genome.gov/10001688), which is charting genetic variations within the human genome that contribute to many diseases, will inform efforts in transplantation genomics. Recently, researchers have also made tremendous advances in SNP and microsatellite polymorphism discovery within immune response genes, underscoring the timeliness of undertaking larger, targeted efforts in transplantation genomics.
In May 2003, NIAID convened a multidisciplinary Expert Panel on the genomics of transplantation to discuss the state-of-the-science in complex-trait disease genomics, identify areas of research emphasis, and identify gaps in knowledge and scientific opportunities to fill these gaps. Based, in part, on the Expert Panel's recommendations, an RFA was published in December 2003, and one cooperative research program was funded in 2004. The goal of the program is to apply genomics research to critical scientific questions in organ, tissue, and/or cell transplantation. This RFA is a re-issuance of the previous RFA to expand the breadth of the cooperative research program in transplantation genomics. Understanding the genetic basis of graft rejection and responses to therapy should allow prediction of outcomes and thus have a major impact on the development of new immunosuppressive therapeutics and tailoring of existing therapeutic strategies. In addition, these studies should facilitate identification of genetic markers to be used as diagnostic and prognostic tools.
Research Objectives
This RFA will support collaborative multidisciplinary teams with expertise in various disciplines, including transplantation medicine, genetics, immunology, molecular biology, pharmacogenomics, biostatistics, and bioinformatics. This RFA calls for the use of recipient and donor samples, as well as clinical data, for hypothesis-driven or discovery-based and hypothesis-generating, large-scale, broad-scope, prospective and/or retrospective genomic studies in clinical transplantation. The research focus may address: (1) the identification of unique immune response genes or gene expression patterns during acute and chronic graft rejection; (2) the identification of genetic variation in response to immunosuppressive therapeutics; and/or (3) the identification of SNPs, haplotypes, or microsatellite polymorphisms that correlate with and/or predict differences in transplant outcomes in individuals due to race or gender. The primary research focus must be transplantation genomics. However, a minor proteomics component, if an integral part of the proposed genomics studies, may be included. Application of rigorous statistical tools is expected to: (1) analyze multi-dimensional genomic data with clinical data; and (2) evaluate multigenic and varied therapeutic effects, particularly given the challenges due to the limited numbers and heterogeneous character of the patients and patient groups. Clinical trials of interventional agents or strategies, or interventional or observational clinical studies associated with the proposed genomic studies must have independent financial support and will not be supported under this RFA. Proposed mechanistic studies associated with clinical trials supported by industry are particularly encouraged; however, all clinical trials, regardless of sources of funding, are eligible sources of clinical samples or data for proposed genomic studies.
Examples of relevant research include, but are not limited to, the following areas:
This RFA will not support:
A Steering Committee will serve as the governing board of the cooperative research program. Voting membership will include, at a minimum, each U01/U19 Principal Investigator, one sub-project investigator from each U19 award, the NIAID Project Scientist, and selected scientists other than the awardees when additional expertise is required for Committee breadth and balance. Specific responsibilities of the Steering Committee include the following:
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity will use the U01 single-project and U19 multi-project cooperative agreement award mechanism(s). 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/U19 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
The NIAID intends to commit approximately $3 million dollars in FY 2006 to fund 2-3 new grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $700,000 per year for a U01 or $1.5 million per year for a U19. 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 provides 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.
Section III. Eligibility Information1. 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.
Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
2. Cost Sharing or Matching
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
A Principal Investigator may submit only one application. However, participation of a Principal Investigator as a project leader in multi-project applications (U19 mechanism) is allowed if there is no scientific overlap with the application submitted by the Principal Investigator.
The primary research focus must be transplantation genomics. However, a minor proteomics component, if an integral part of the proposed genomics studies, may be included as an aim or sub-aim of a project or as a project in a U19 multi-project application.
Section IV. Application and Submission Information1. 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) 710-0267, Email: [email protected].
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.
Applicants for U19 cooperative agreements must follow special application guidelines as described in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available from NIAID listed under INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. This brochure presents specific instructions for sections of the PHS 398 application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398.
Essential elements of the multi-project cooperative agreement mechanism (U19) include: 1) a minimum of two interrelated individual research projects organized around a central theme; 2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal; 3) a single Principal Investigator who will be scientifically and administratively responsible for the group effort; 4) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded; and 5) where necessary, support for core resources or facilities, each of which shall be utilized by at least two research projects in order to facilitate the research effort.
See the OTHER SUBMISSION REQUIREMENTS below (Section IV.6) for additional application requirements and instructions.
Potential applicants are strongly encouraged to consult the appropriate NIAID program contact during the early stages of preparation of the application.
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
Letter of Intent Receipt Date: August 16, 2005
Application Receipt Dates(s): September 16, 2005
Peer Review Date(s): January, 2006
Council Review Date(s): May, 2006
Earliest Anticipated Start Date: July, 2006
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:
Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: 301-435-8537
FAX: 301-480-2310
E-mail: [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)
At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:
Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: 301-435-8537
FAX: 301-480-2310
E-mail: [email protected]
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. Personal deliveries of applications are no longer permitted.
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.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
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 (see also Section VI.3. Reporting).
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
Applicants are strongly encouraged to contact NIAID Program staff well in advance of the application submission date to discuss the proposed research program. This contact allows staff to assess responsiveness to this RFA and provide appropriate guidance as needed.
1. Description of Research Projects
The primary research focus must be transplantation genomics. However, a minor proteomics component, if an integral part of the proposed genomics studies, may be included as an aim or sub-aim of a project or as a project in a U19 multi-project application.
All applications must propose clear research plan(s) and project goal(s) to be completed during the award period. The applicant must clearly state the interim objectives to be achieved during the project, identify impediments or critical decision points that could require a revision in the work plan, and provide a detailed timeline for the attainment of each goal. The application must also demonstrate the scientific and technical expertise required to carry out studies responsive to this RFA.
2. Development of a Productive Collaborative Program
All applications must provide a clear and concise research plan demonstrating a multi-disciplinary approach including, but not necessarily limited to, expertise in transplantation research, genomics, and biostatistics/bioinformatics.
All applications must demonstrate the organization's ability to participate effectively in the NIAID Genomics of Transplantation Cooperative Research Program. The application must include a written commitment to: participate in the NIAID Genomics of Transplantation Cooperative Research Program; serve on the Steering Committee; adhere to the decisions reached by the Steering Committee; and accept the participation and assistance of NIH staff in accordance with the guidelines outlined below (Section VI.2.A.2 Cooperative Agreement Terms and Conditions of Award: NIH Responsibilities).
Applicants for U19 cooperative agreements must follow special application guidelines as described in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available from NIAID listed under INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. This brochure presents specific instructions for sections of the PHS 398 application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398.
Essential elements of the multi-project cooperative agreement mechanism (U19) include: 1) a minimum of two interrelated individual research projects organized around a central theme; 2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal; 3) a single Principal Investigator who will be scientifically and administratively responsible for the group effort; 4) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded; and 5) where necessary, support for core resources or facilities, each of which shall be utilized by at least two research projects in order to facilitate the research effort.
U19 applications must provide: a clear and concise plan, in narrative and diagrammatic form, that depicts the interrelationships among the research groups, their relevant experience/expertise, and the contribution of each to fulfillment of the objectives of this RFA, and an organizational chart of the U19 cooperative group showing the name, organization, and scientific discipline of the PI and of all key scientific and technical personnel. If the application is from a consortium of institutions, the applicant must provide a plan to assure the maintenance of close cooperation and effective communication among members of the U19 cooperative group.
3. Studies with Human Samples
Although clinical trials will not be supported under this RFA, human samples and clinical data will be utilized in the research supported by this program. Research samples may be derived from ongoing clinical trials or completed clinical trials in which samples were maintained for the expressed purpose of future genetic research. Support for clinical procedures to obtain samples that are not part of an associated clinical trial or study (e.g., additional biopsies) must be clearly described and justified. Applications should address plans for human subjects, including definition(s) of the population(s); plans for recruitment and retention; informed consent forms (including descriptions of plans for subject confidentiality, deposition of information into a database, and follow-up with participants); plans for stored or shared samples (and the prior informed consents permitting this); or use of any established sample sets. It is highly recommended that proposed consent forms for the genomics studies have clear language that (1) distinguishes mechanistic studies from the clinical trials with which they may be linked; (2) clarifies and ensures that subjects can refuse to participate in the mechanistic genomics study and still participate in the clinical trial; and (3) stipulates that there will be no charges to the subjects for the additional studies. Any incentives provided to subjects to participate in the mechanistic studies (if in addition to those under the clinical trial or study) should be clearly described and justified in the application.
Applications must include documentation of the ability to acquire human samples and clinical data for the proposed studies. The NIH OER Human Subjects Website may also be of use to applicants (http://grants.nih.gov/grants/policy/hs/index.htm). OHRP guidance on Repositories, Tissue Storage Activities and Data Banks should also be considered (http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm).
IRB approval of the consent form(s) is not required at the time of submission of the application. However, at a minimum, a draft of the consent form to be used for the genomics studies must be included in the application, as well as the consent form for the associated clinical trial, if different.
4. Data Management Plans
Applications must include proposed plans for data management including: data access by investigators participating in the project; data analysis; statistical/bioinformatics support; and where applicable, establishment of a database(s). Timely release of data to the NIH-supported and/or public databases is expected in accordance with the guidelines set by the Steering Committee and the NIH data sharing policy available at: http://grants.nih.gov/grants/policy/data_sharing/.
5. Statistical Considerations
All applications must include a description of the proposed methods of data analysis and power calculations, as well as a justification for the required sample size. A restatement of the sample size calculations from an associated clinical trial is insufficient. Applications must describe the statistical procedures that will be used to analyze the data. If appropriate to your application, discuss whether it is necessary to perform the genomic studies on all subjects enrolled in the associated trial or whether a sample of such subjects would be sufficient. A statistician must be a part of the research team, and actively involved in preparation of the proposal. Documentation of the appropriate statistical expertise should also be included in the application.
6. Studies with Associated Clinical Trials
The complete clinical protocol and informed consent form(s) for the associated clinical trial must be included with the application as an appendix. While drafts of the consent forms at participating sites are not required, it would be useful to include them if they are available. NIH will treat as confidential any scientific, pre-clinical, clinical, or formulation data and information that the sponsor deems to be proprietary and confidential.
In order to ensure coordination between the genomic studies and the associated clinical trial, the Principal Investigator and his or her academic institution, the sponsor(s) of the clinical trial (including drug companies, if applicable), and the IND sponsor, if not one of the above, must provide written agreements for the conduct of the proposed studies as presented in the application.
7. Steering Committee
The Steering Committee will meet at least twice during the first year of the project period and annually thereafter. At least one of the meetings in the first year and the annual meetings will be held in Bethesda, MD. Proposed budgets should include funds to cover travel costs for these meetings. Each Steering Committee member will be expected to participate in all meetings and activities, e.g., conference calls and special subcommittees as required.
8. Memorandum of Understanding
Prior to award, the applicant must provide to the NIAID a memorandum of understanding signed by the applicant, an appropriate representative of the applicant institution, the Principal Investigator of the associated clinical trial, and an appropriate representative of the financial sponsor of the associated clinical trial, and IND holder if different. This memorandum will indicate agreement and will outline the specifics of the agreement for the following areas: 1) data from the genomic studies (including ownership, analysis, access, and release), 2) access to the data from the associated clinical trial (how/when) that are needed for the genomic studies, including procedures for prevention of unblinding of the parent trial, 3) documentation of quality assurance procedures for both the parent trial and the genomic studies, and documentation of Data Safety Monitoring procedures for the parent trial, especially for efficacy trials, and 4) publication of the results of the genomic studies.
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 Information1. Criteria
Only the review criteria described below will be considered in the review process.
The following will be considered in making funding decisions:
2. Review and Selection Process
Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAID. Incomplete and/or 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.
Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
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.
1. 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? Scientific merit of hypothesis-driven or discovery-based, hypothesis-generating genomic studies will be considered.
2. 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? Is the multidisciplinary approach synergistic and adequate to achieve the goals of the Genomics of Transplantation Cooperative Research Program? Are the plans to conduct studies with human samples technically and administratively feasible? Adequacy of proposed methods of data analysis and power calculations, and proposed plans for data management and statistical/bioinformatics support will also be evaluated.
3. 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?
4. 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)?
5. 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?
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).
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.
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
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/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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.
NIAID will transmit the NGA via U.S. mail for a hard copy and/or via email for an electronic copy.
2. Administrative and National Policy Requirements
Monitoring Clinical Studies
When clinical studies or trials are a component of the research proposed, the NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.
Studies with Human Samples
Although clinical trials will not be supported under this RFA, human samples and clinical data will be utilized in the research supported by this program. The NIAID Program Director will facilitate compliance with NIH policies for monitoring activities commensurate with the degree of potential risk to human subjects. The NIAID policy including terms and conditions of award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.
Data Sharing
Timely release of data to the NIH-supported and/or public databases is expected in accordance with the guidelines set by the Steering Committee and the NIH data sharing policy available at: http://grants.nih.gov/grants/policy/data_sharing/.
Organizational Changes
Certain organizational changes require the prior written approval of the NIAID Project Scientist. These changes include the addition or replacement of an investigator, component, or research base that is associated with the studies. A change in the PI, or in any key personnel identified on the Notice of Award, must have the prior written approval of the NIAID Grants Management Specialist in consultation with the NIAID Project Scientist.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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 single project cooperative agreement ( U01) or multi-project cooperative agreement (U19) , an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for: defining the research objectives, approaches and details of the projects within the guidelines of the RFA and for performing the scientific activity. Specifically, the Principal Investigators have primary responsibility as described below:
The Principal Investigators will: determine and coordinate the scientific and administrative activities of the project(s); set project goals and timelines to achieve the goals; accept and implement common guidelines approved by the Steering Committee; submit data to NIH-supported and/or public databases in accordance with policies agreed upon and established by the Steering Committee and the NIH data sharing policy available at: http://grants.nih.gov/grants/policy/data_sharing/; attend Steering Committee meetings and serve as a voting member of the Steering Committee; and participate in the cooperative nature of the group.
Awardees will implement the approved memorandum of understanding that will indicate agreement and will outline the specifics of the agreement for the following areas: 1) data from the genomic studies (including ownership, analysis, access, and release), 2) access to the data from the associated clinical trial (how/when) that are needed to analyze the genomic studies, including procedures for prevention of unblinding of the parent trial, 3) documentation of quality assurance procedures for both the parent trial and the genomic studies, and documentation of Data Safety Monitoring procedures for the parent trial, especially for efficacy trials, and 4) publication of the results of the genomic studies.
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.
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
The NIAID Project Scientist will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, and will serve as a voting member of the Steering Committee.
During performance of the award, the NIAID Project Scientist, with assistance from other scientific program staff who are designated based on the research topic and their relevant expertise, may provide appropriate assistance, advice, and guidance by: participating in the design of the activities; advising in the selection of sources or resources; coordinating or participating in the collection and/or analysis of data; advising in management and technical performance; and participating in the preparation of publications. However, the role of NIAID will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus and the NIAID staff will be given the opportunity to offer input into this process. The manner of reaching this consensus and the final decision-making authority will rest with the Principal Investigator and the Steering Committee.
Cooperation with Other NIH-Sponsored Programs: In order to most efficiently utilize research resources and rapidly exchange scientific information to promote transplantation genomics objectives, NIAID anticipates the opportunities to collaborate with other NIAID programs, such as the Cooperative Clinical Trial in Pediatric Transplantation and Clinical Trials in Organ Transplantation. These future interactions will be coordinated and facilitated by the NIAID Project Scientist.
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 NIAID Program Official may serve as the NIAID Project Scientist.
The NIAID Program Official will approve changes in proposed research objectives and redirection of research projects. The NIAID reserves the right to terminate or curtail a study or any individual award in the event of (a) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol; (b) substantive changes in the consensus protocol to which the NIAID does not agree; (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance; or (d) human subject ethical issues that may dictate a premature termination.
NIAID recognizes that specific goals may require revision and re-negotiation during the course of the project period. Release of each funding increment by NIAID will be based on an NIAID review of progress towards achieving the previously agreed upon research goals.
2.A.3. Collaborative Responsibilities
Steering Committee
The Steering Committee serves as the governing body of the Genomics of Transplantation Cooperative Research Program. At a minimum, voting membership of the Steering Committee will include the NIAID Project Scientist, each U01/U19 Principal Investigator, one sub-project investigator from each U19 award, and selected scientists other than the awardees when additional expertise is required for committee breadth and balance. The Steering Committee will appoint additional members by majority vote. In addition, the NIAID may appoint up to two members of an NIAID scientific advisory group to the Steering Committee as non-voting members. Each member will have one vote, and Federal votes cannot exceed 25%. Awardee members of the Steering Committee will be required to accept and implement common guidelines and procedures approved by the Steering Committee.
The NIAID Project Scientist will schedule the meetings of the Steering Committee and actively assist the Chair in developing the meeting agendas. The Committee will meet at least twice during the first year of the project period and annually thereafter. At least one of the meetings in the first year and the annual meetings will be in Bethesda, MD. Subcommittees may be established by the Steering Committee as necessary. The NIAID Project Scientist will ensure coordination of the Steering Committee's activities and implementation of the group's recommendations.
The Steering Committee will:
The Steering Committee or a designated subcommittee will prepare an annual report containing the following information: progress of ongoing and newly-initiated projects; manuscripts published, in press, and in preparation; presentations at regional, national, and international meetings; other activities of the group; data submitted to databases; and evaluation of overall goals and achievements and future plans of the cooperative group. The first such report will be submitted to the NIAID Project Scientist not later than 13 months after the initial notice of award and yearly thereafter. This Program Annual Report does not replace the PHS 2590 Progress Report required for individual projects.
NIAID intends to support the peer-reviewed studies proposed in the awarded grant applications. However, under special circumstances (e.g. duplicative or overlapping specific aims between two or more awardees), the Steering Committee will establish guidelines and review procedures, and will evaluate and determine opportunities for collaboration, redirection or modification of the peer-reviewed or new projects. This policy is in keeping with the terms and conditions of the cooperative agreement mechanism.
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.
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:
Crystal Y. Koh, Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases Room 3026, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-5598
FAX: (301) 480-0693
Email: [email protected]
2. Peer Review Contacts:
Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 496-2550
FAX: (301) 480-2310
E-mail: [email protected]
3. Financial or Grants Management Contacts:
Ann Devine
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2114, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 496-7075
FAX: (301) 480-3780
Email: [email protected]
Required Federal Citations
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
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.
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.
Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA 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.
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 citation: No. 93.855, Immunology, Allergy and Transplantation 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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NIH Funding Opportunities and Notices
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