MYCOLOGY RESEARCH UNITS RELEASE DATE: June 11, 2003 RFA: AI-03-021 National Institute of Allergy and Infectious Diseases (NIAID) ( CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research LETTER OF INTENT RECEIPT DATE: September 23, 2003 APPLICATION RECEIPT DATE: October 23, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for program project (P01) grants to conduct interdisciplinary research to increase understanding of the biology and host-pathogen interactions of the medically important fungi. This fundamental knowledge will be applied to the development of new and improved strategies for the prevention, diagnosis, and therapy of the mycoses. Therefore, the proposed research must be focused on the identification and validation of targets for the development of diagnostics, vaccines or therapeutics directed against systemic mycotic infections, leading to but not including clinical trials. RESEARCH OBJECTIVES Nature of the problem Fungal infections are recognized with increasing frequency as an important cause of both morbidity and mortality in immunocompromised and immunocompetent hosts. This increase is in part due to expanded use of immunosuppressive therapies in the treatment of patients with malignant disease or organ transplants as well as medical intensive care procedures and complicated surgeries. Antifungal therapy remains less than optimal. Of particular concern is evidence that resistance to available drugs is developing. A lack of rapid diagnostic tests for early detection of fungal infection results in increased prophylactic antifungal use in high risk populations which in turn accelerates development of drug resistance. Background Despite the focus on altered immune status as a risk factor, only 45% of invasive fungal infections due to Candida, Aspergillus, Cryptococcus, or Histoplasma are associated with HIV/AIDS, neoplasms, or transplants (Wilson, et. al., 2002. The direct cost and incidence of systemic fungal infection. Value in Health, 5(1):26-33). While these populations provide a relatively well defined group for clinical studies, the other 55% of these fungal infections provide additional impetus for expanding efforts to improve diagnosis, prevention and therapy. Invasive candidiasis and aspergillosis are exemplary of some common issues surrounding the opportunistic systemic mycoses. The determination of real incidence, attributable cost and limitations in treatment are confounded by limitations in diagnosis. Blood cultures are usually negative in disseminated aspergillosis and often negative in systemic candidiasis. Clinical trials evaluating new antimicrobials or new regimens of existing antimicrobials in high risk groups often must be constructed around empiric treatment before a microbiologic diagnosis is proven, and measurement of successful outcome can involve interpretation of a complex including signs and symptoms of disease, and indirect evidence of infection. Through a series of NIAID-sponsored workshops, participants indicated a need for more rapid translation of basic research observations into clinical application such as better diagnostic tests for invasive candidiasis and aspergillosis; better therapeutic agents; and vaccines against systemic mycoses and opportunistic mycoses like cryptococcosis and candidiasis. The program project mechanism provides an opportunity to extend beyond the capabilities of single project grants in order to accelerate translational research. The mycology program in the Division of Microbiology and Infectious Diseases, NIAID, focuses on the biology (molecular biology, immunology, biochemistry and cell biology) of the medically important fungi. The Bacteriology and Mycology Study Group provides a contract-supported infrastructure dedicated to clinical trials of antifungal agents in invasive mycoses. The Division of AIDS, NIAID, also supports pre-clinical and clinical research on AIDS-associated pathogenic fungi (Pneumocystis carinii, Candida albicans, Cryptococcus neoformans) with an emphasis on drug development. Research Objectives and Scope The NIAID wishes to develop multidisciplinary mycology research units to serve as foci for innovative new research in fungal diseases. These units will be funded as program project grants. To achieve medical and public health relevance, studies should involve the use of clinical isolates and, where appropriate, clinical materials, including human cells. With the pending completion of the whole genome sequence of A. fumigatus, the community is poised to apply genomic and proteomic advances in discovery of novel targets for diagnosis, prevention and treatment. Further, it is anticipated that a contract will be awarded this year to improve and standardize animal models of invasive aspergillosis. This contract will provide the community access to standardized animal models to validate targets. Accordingly, the NIAID is particularly interested in applications focused on Aspergillus fumigatus including but not limited to methods applying immunological, nucleic acid, physiological, or metabolic methods or markers to target discovery and validation. Studies of diagnostics, prevention and therapy for additional fungi of medical importance including, but not limited to, A. flavus, Blastomyces dermatitidis, Candida spp., Coccidioides immitis, C. posadasii, Cryptococcus neoformans, Histoplasma capsulatum, Pneumocystis carinii, Pseudallescheria boydii, Sporothrix schenckii, and Trichosporon beigelii are also acceptable. Note: Applications focused on Pneumocystis will only be responsive if the emphasis is on vaccine development. For projects to be deemed responsive, a biological process or entity must be identified as a potential target for prevention, diagnosis, or treatment. Processes or entities that could yield potential targets may include but are not limited to: cellular and molecular biology (cell biology, genetics, genome structure, gene expression, gene manipulation; genomics); virulence factors and mechanisms of pathogenesis; host-pathogen interactions (including the role of the immune system in resistance, pathogenesis, and recovery); and fungal physiology, biochemistry and metabolism. While drawing on the preceding disciplines the central focus of proposed research must be on the identification and validation of targets for the development of diagnostics, vaccines or therapeutics for systemic mycotic infections. Evaluations must utilize appropriate in vitro assays or in vivo model systems that demonstrate clinical relevance. o Diagnostics. Targets could include fungal antigens or metabolites for a systemic fungal pathogen or related group of pathogens. Specific research aims should include methods for qualitative and quantitative analysis of the target in an in vitro system. Clinical relevance should be demonstrated by an appropriate preclinical model or by application to patient samples. Ideally, the target would serve not only to identify a specific infection at an early stage, but also to track the course of infection in response to treatment. Multiple foci of basic research could be integrated and applied to culminate in a specific aim that validates the entity or target as a legitimate diagnostic candidate. o Prevention. Research to identify antigens that are immunoprotective or immunotherapeutic for the systemic mycoses is appropriate. Multiple approaches are encouraged, but the one(s) selected for study must contain a validation step whereby acquisition of infection or modification of the course of disease is demonstrated in an appropriate preclinical model for assessment. Studies to address new methods or new models of evaluating vaccine efficacy for the systemic mycoses are also acceptable. o Therapeutics. Areas of interest include, but are not restricted to: immune based therapy, including antibody; novel approaches to enhancing antifungal efficacy; and novel approaches to enhancing antifungal delivery. Novel antimicrobial compounds may be a component of study if emphasis is to validate new chemical entities or therapeutic approaches; drug development and drug screening are not areas of interest for the purposes of this RFA. Project directors are encouraged to address or document how the research approaches are unique or underexploited and are not duplicative of approaches under extensive industrial development. A given program project could be of either organism-specific, multi- disciplinary focus on a single fungus of medical importance; or theme specific, with different medically important fungi serving as models to address closely related areas of research emphasis. For example, a program project focused on development of approaches to fungal vaccines would have a common goal, would allow for interdisciplinary projects to draw upon discipline-specific strengths, requires key components from the above research areas, and has the potential to demonstrate true synergy where the project sum is greater than the addition of individual project components. Program projects may involve collaboration among investigators at several institutions. Information on the NIH policy regarding consortium agreements is available at MECHANISM OF SUPPORT This RFA will use the NIH program project (P01) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project. This type of award supports broadly based multidisciplinary research programs that have a well-defined central research focus or objective. An important feature is that the interrelationships among the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project was pursued individually. The program project grant consists of a minimum of three interrelated individual research projects that contribute to the program objective. The award also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the award. This RFA is a one-time solicitation. Future unsolicited, competing- continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The NIAID intends to commit approximately $2.5 million in FY 2004 to fund 3 to 4 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five (5) years and a budget for direct costs of up to $600,000 per year. 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 NIAID provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS The applicant may submit (an) application(s) if the institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic Foreign Institutions are not eligible to apply INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS 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. SPECIAL REQUIREMENTS A budget for travel should be included for the purpose of attending an annual one day progress review meeting of the Project Directors at a site to be designated (either in Bethesda or in association with a relevant national meeting). When clinical studies or trials are a component of the research proposed, 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: 032.html. The full policy, including terms and conditions of award, is available at: WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: o Direct questions about scientific/research issues to: Rory A. Duncan, MS Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room Number 4109, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone: (301) 402-8613 FAX: (301) 402-2508 Email: o Direct questions about peer review issues to: Edward W. Schroder, Ph.D. Chief, Microbiology and Immunology Review Branch Scientific Review Program, DEA, NIAID, NIH, DHHS 6700-B Rockledge Drive MSC 7616, Room 2217 Bethesda, MD 20892-7616 Zip code for express couriers: 20817 Phone: 301-496-2550 FAX: 301-402-2638 e-mail: o Direct questions about financial or grants management matters to: Maryellen M. Connell Grants Management Specialist NIH/NIAID/DEA/GMB 6700B Rockledge Drive Room 2123, MSC 7614 Bethesda, Maryland 20892-7614 LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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. Chief, Microbiology and Immunology Review Branch Scientific Review Program, DEA, NIAID, NIH, DHHS 6700-B Rockledge Drive MSC 7616, Room 2217 Bethesda, MD 20892-7616 Zip code for express couriers: 20817 Phone: 301-496-2550 FAX: 301-402-2638 e-mail: SUBMITTING AN APPLICATION Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the WWW at: Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: SUPPLEMENTAL INSTRUCTIONS: USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form 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: SENDING AN APPLICATION TO THE NIH: 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 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to: Edward W. Schroder, Ph.D. Chief, Microbiology and Immunology Review Branch Scientific Review Program, DEA, NIAID, NIH, DHHS 6700-B Rockledge Drive MSC 7616, Room 2217 Bethesda, MD 20892-7616 Zip code for express couriers: 20817 Phone: 301-496-2550 FAX: 301-402-2638 e-mail: Applications must be received on or before October 23, 2003. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/01) Application Kit will be judged non-responsive and will be returned to the applicant. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. It is highly recommended that the appropriate NIAID program contact be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See program contact under INQUIRIES). SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA: Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the WWW at: The brochure presents specific instructions for sections of the PHS 398 (rev. 5/01) application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. Concurrent submission of an R01 and a Component Project of a Multi-project Application: Current NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIAID. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Institute of Allergy and Infectious Diseases Council REVIEW CRITERIA The general review criteria for P01 grant applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" at 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 criteria included in the section on Federal Citations, below) 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). 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 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: September 23, 2003 Application Receipt Date: October 23, 2003 Scientific Peer Review Date: February, 2004 Advisory Council Review: March, 2004 Earliest Anticipated Start Date: April 1, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Programmatic priorities. 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. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 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 AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 ( files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at 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 RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 that is available at 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 proposals for research involving human subjects. This policy announcement is in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at 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 Applicants may wish to place data collected under this RFA 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). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( 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 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance at in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH Grants Policy Statement is available at This document includes general information about the grant application and review process; information on the terms and conditions that apply to NIH Grants and cooperative agreements; and a listing of pertinent offices and officials at the NIH. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. 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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