INNOVATIVE APPROACHES FOR COMBATING ANTIMICROBIAL RESISTANCE RELEASE DATE: May 16, 2002 RFA: AI-02-009 National Institute of Allergy and Infectious Diseases (http://www.niaid.nih.gov) LETTER OF INTENT RECEIPT DATE: September 10, 2002 APPLICATION RECEIPT DATE: October 10, 2002 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 Disease (NIAID) solicits exploratory/developmental (R21) and small research grant (R03) applications for novel and innovative research, including high risk and high payoff studies in nontraditional fields to enhance the understanding of the factors affecting the development of resistant pathogens and spread of resistance genes, in order to direct actions to diagnose, control and treat antimicrobial resistance. Research conducted through this program may fall along a broad spectrum of activities and scientific areas described below. BACKGROUND Antimicrobial resistance (AR) is growing and spreading worldwide, impacting upon our ability to successfully treat respiratory, diarrheal, sexually transmitted, healthcare-associated, and a great variety of infections caused by viruses, bacteria, fungi, and parasites. From the first availability of penicillin, microbes have developed mechanisms of resistance that thwart or block the action of the antimicrobial drug. There are many examples of the transfer of resistance determinants among the same species of microbes, among different genera of organisms, from commensals to pathogens, and from animal to human pathogens. It is not always possible to predict when and why this transfer will occur. AR results in difficult to treat infections, increased hospital stays and costs, and the need to use more toxic drugs. Novel and innovative approaches are needed to advance the basic field of study, providing a basis of knowledge for the development of new diagnostic, therapeutic or preventive approaches. In July of 1999 a public meeting was held under the auspices of the Interagency Task Force on Antimicrobial Resistance, with expert consultants from academia, industry, state and local health agencies, professional societies, healthcare delivery organizations, agricultural groups, and consumer advocacy groups to address what actions the federal government should undertake to combat this growing problem. The Research Working Group identified gaps in the understanding of microbial physiology, ecology, genetics and mechanisms of antimicrobial resistance. The outcome of these discussions was "A Public Health Action Plan To Combat Antimicrobial Resistance Part 1: Domestic Issues" (http://www.cdc.gov/drugresistance/actionplan/). In addition, at the NIAID"s Summit on Development of Infectious Disease Therapeutics, (http://www.niaid.nih.gov/dmid/drug/summit.htm) pharmaceutical and biotechnology representatives and academicians supported the need for more basic microbial physiology research and research directed at antimicrobial resistance mechanisms, as an important underpinning of pharmaceutical development. RESEARCH OBJECTIVES Additional novel and innovative research, including high risk and high payoff studies in nontraditional fields, is needed to enhance the understanding of: mechanisms of AR, its emergence, acquisition, spread, persistence, and decline including mathematical modeling of these processes, effect of resistance mutations on microbial fitness, and microbial ecology, co-infection, and the role of normal flora as a repository of resistance factors, as well as the use of susceptible bacterial populations in control strategies. Studies are also needed leading to the development of: innovative molecular diagnostics for identifying and characterizing drug resistant pathogen variants, and resistance reversing agents and approaches including, combination therapies, strategies for chronic treatment, and variations in antimicrobial use patterns (e.g., drug cycling, duration and dosage, among others) that minimize the emergence and spread of resistance, while optimizing treatment outcome. Responsive research proposals will address the above basic and developmental research areas and be applicable to the full spectrum of microbes including bacteria, parasites, fungi or viruses, other than HIV. Applicants should note that the significance of the organism, or model system to public health will be evaluated. MECHANISM OF SUPPORT This RFA will use the NIH Small (Pilot) Research Project Grant, (R03) and/or Exploratory/Developmental Research Project Grant, (R21) award. The total requested project period for an application submitted in response to this RFA may not exceed two years for an R21 and three years for an R03. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. 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. The anticipated award date is June 2, 2003. NIAID uses R03 grants to support small, highly innovative or pilot projects. Applicants for R03 grants may request up to $50,000 annual direct costs for a period not to exceed three (3) years. Funds and time requested should be appropriate for the research proposed. Applicants may not request travel or large equipment. R03 awards are not renewable. NIAID uses R21 grants to provide short-duration support for preliminary studies of a highly speculative nature, which are expected to yield, within this time frame, sufficient information upon which to base a well-planned and rigorous series of further investigations. Applicants for R21 grants may request up to $150,000 annual direct costs for a period not to exceed two years. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. FUNDS AVAILABLE The NIAID intends to commit approximately $ 3M in FY 03 to fund 12 to 25 new grants in response to this RFA. 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. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your 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 or foreign 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 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. Terms and Conditions of Award will be included with awards. NIAID policy was announced in the NIH Guide on February 24, 2000 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html. The full policy including terms and conditions of award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf 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 your questions about scientific/research issues to: Marissa A. Miller, DVM, MPH Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 3112, MSC-7630 6700-B Rockledge Drive Bethesda, MD 20892-7630 Telephone: (301) (496-7728) FAX: (301) (402-2508) E-Mail: mm459k@nih.gov o Direct your questions about peer review issues, address the letter of intent, mail two copies of the application and all five sets of appendices to: Madelon Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2215 MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) (402-2636) FAX: (301) (402-2638) E-Mail: mhalula@nih.gov o Direct your questions about financial or grants management matters to: Lesia A. Norwood Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2117, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) (402-7146) Fax: (301) (480-3780) E-mail: ln5t@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Title and brief description 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: Madelon Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2215 MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) (402-2636) FAX: (301) (402-2638) E-Mail: mhalula@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS FOR R21 APPLICATIONS: To apply, please follow NIH guidelines for submission of an R21 application as listed below: 1. The description (abstract) must include a brief explanation of the proposed activity, and how it is consistent with the exploratory/development nature of the R21 mechanism as described in this notice. 2. Although preliminary data are neither expected nor required for an R21 application, they may be included. 3. Sections a-d of the Research Plan may not exceed 10 pages, including tables and figures. 4. Appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism, and should not be used to circumvent the page limit for the research plan. Copies of appendix material will only be provided to the primary reviewers of the application and will not be reproduced for wider distribution. The following materials may be included in the appendix: o Up to five publications, including manuscripts (submitted or accepted for publication), abstracts, patents, or other printed materials directly relevant to the project. These may be stapled as sets. o Surveys, questionnaires, data collection instruments, and clinical protocols. These may be stapled as sets. o Original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 10-page limit of items a-d of the research plan. Include five collated sets of all appendix material, in the same package with the application, following all copies of the application. Identify each item with the name of the principal investigator. SUPPLEMENTAL INSTRUCTIONS FOR R03 APPLICATIONS: For the NIH Small Grant (R03), Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $50,000 for up to three years. o Research Plan Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 10 pages. Please note that a Progress Report is not needed, competing continuation applications will be not accepted for an R03. o Appendix Appendix material may only include color and/or glossy pictures with descriptions. SUPPLEMENTAL INSTRUCTIONS: Responsive applicants will budget for participating in one scientific meeting to occur at some point during the award period. Provision must be made in the budget for the PI to travel to Bethesda, Maryland, and prepare a presentation of his/her research findings and outcomes with the group of recipients of this RFA. The NIAID will organize this meeting and contact PI"s concerning timing and details of attendance. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. 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: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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: Madelon Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2215 MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) (402-2636) FAX: (301) (402-2638) E-Mail: mhalula@nih.gov 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAID. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR 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 the 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 goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? What is the significance of the organism, the resistance pattern, or the proposed approach to public health and medicine? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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 included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o 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 10, 2002 Application Receipt Date: October 10, 2002 Scientific Peer Review Date: February 3, 2003 Advisory Council Review: May 1, 2003 Earliest Anticipated Start Date: June 2, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities and balance. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND 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: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are 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 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 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 proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. 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 http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance 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 http://grants.nih.gov/grants/policy/policy.htm. 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. 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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