EXPIRED
RAPID RESPONSE GRANT PROGRAM ON BIOTERRORISM-RELATED RESEARCH (RRGP-BTRR) Release Date: December 5, 2001 RFA: RFA-AI-02-002 National Institute of Allergy and Infectious Diseases (http://www.niaid.nih.gov) National Institute of Biomedical Imaging and Bioengineering (http://www.nibib.nih.gov/) Letter of Intent Receipt Date: January 15, 2002 Application Receipt Date: February 15, 2002 THE APPLICATIONS IN RESPONSE TO THIS RFA SHOULD USE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (VER 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health (NIH), announces a new Rapid Response Grant Program on Bioterrorism-Related Research (RRGP-BTRR). The RRGP-BTRR will support innovative research targeted at the design and development of specific diagnostics, therapies, and prevention strategies for Category A biological diseases as defined by the CDC (http://www.bt.cdc.gov/Agent/Agentlist.asp), which includes: Bacillus anthracis (anthrax), Clostridium botulinum (botulism), Yersinia pestis (plague), pox viruses, Francisella tularensis (tularemia), and viral hemorrhagic fevers. Specifically, this initiative encourages research to develop: o new prevention strategies for those at risk of exposure, o novel targets and therapeutics for effective treatments for those infected, o rapid, accurate diagnostics for natural and bioengineered microbes and/or toxins, and o more complete understanding of the pathogenesis, physiology, and host immune interactions with these organisms. Research that builds on recent advances in genomics and proteomics of these organisms is especially encouraged. Applications are especially welcome from young investigators and those not currently active in the field of bioterrorism research. 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 Request for Applications (RFA), Title of 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. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Please note that special terms of award will be added to any awards made to foreign institutions. In addition, all work must be performed in compliance with Federal regulations regarding biohazards. MECHANISM OF SUPPORT The mechanism of support will be 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. 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. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. It is hoped that successful grantees funded through this program will seek continuing support for research further through the R01 grant mechanism. Applications will request direct costs in $25,000 modules. A typical modular grant application requests the same number of modules in each year. Applicants may request up to two years of support and up to $150,000 per annum in direct costs, although with compelling justification exceptions can be made if specific costly reagents, animals, specimens or laboratory modifications are needed to perform these studies. Contact the program staff listed under INQUIRIES for further information. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/01). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. A notice of modification and update (OD-00-046) regarding modular grants was released on 7/24/00 and can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-046.html. This RFA is a one-time solicitation. Future unsolicited competing renewal applications will compete with all investigator-initiated applications and will be reviewed according to customary referral and peer review procedures. The anticipated award date is July, 2002. FUNDS AVAILABLE The estimated total funds [direct and facilities and administrative (F&A) costs] available for the first year of support for all awards made under this RFA will be $3 million. In Fiscal Year 2002 the NIAID plans to fund approximately 8-12 awards. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of high scientific merit. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES The RRGP-BTRR will support all pertinent areas of investigation that will contribute toward development of specific diagnostics, therapies, and prevention strategies for Category A biological diseases (http://www.bt.cdc.gov/Agent/Agentlist.asp), as well as studies leading to a more complete understanding of the pathogenesis, physiology, and host immune interactions with these organisms. Research topics might include but are not limited to the following: Therapeutics 1. Design, synthesis and evaluation of therapeutic strategies for diseases caused by poxviruses and hemorrhagic fever viruses. 2. Novel therapeutic approaches for anthrax, botulism, plague, and tularemia to: o Prevent the germination of anthrax spores in vivo, o Inhibit the synthesis or neutralize the lethal effects of toxins generated in vivo during the course of infection, and o Inactivate or block the attachment and entry of toxins to host target cells during the course of infection or after the deliberate release of bacterial exotoxins (e.g. botulinum toxin) into the environment (air, food, or water). Vaccines and other Prevention Strategies 1. Design and development of a replacement for Variella Immune Globulin (VIG). 2. Design, development, and evaluation (preclinically and clinically) of the next generation vaccines for smallpox that can be safely administered to the entire population. 3. Perform basic, preclinical and clinical research on vaccines for hemorrhagic fever viruses. 4. Application of new approaches for the expression and delivery of protective antigens as new, more effective vaccines against anthrax, botulism, plague and tularemia. Diagnostics 1. Application of genomics/proteomics data to identify targets suitable for use as rapid diagnostics. 2. Design and development rapid diagnostics applicable in a variety of environments. Basic Research 1. Evaluate immune-evasive responses associated with spore formation and/or latency. 2. Evaluate the role of general antimicrobial peptides (e.g. defensins) in activating innate immune response. 3. Identify mechanisms of pathogenesis, virulence, resistance, and host responses. Approaches involving the use of antibiotics to limit or inhibit bacterial growth in vivo will not be considered responsive to this announcement since such approaches are supported by other mechanisms. In addition, applications that propose research on organisms other than those associated with the diseases listed in CDC Category A will not be considered responsive. TERMS AND CONDITIONS OF AWARD 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. This award provides support for one or more NIH-defined Phase III clinical trials. The NIH Policy for research supported as an NIH Phase III Clinical Trial has been updated in Section III.B. of the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research", updated August 1, 2000 (URL listed below under STUDY POPULATIONS). A description of plans to conduct analyses, as appropriate, by sex/gender and/or racial/ethnic groups must be included in clinical trial protocols and the results of the subset analyses must be reported to NIH in Progress Reports, Competitive Renewal Applications, and in the required Final Progress Report, as stated in Section III.B. of the Guidelines. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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 the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 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. LETTER OF INTENT Prospective applicants are asked to submit, by January 15, 2002, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of a subsequent application, the information that it contains allows NIAID staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Edward Schroder at the address(s) listed under INQUIRIES. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/01) at http://grants.nih.gov/grants/forms.htm must be used in applying for these grants and will be accepted at the receipt date stated at the top of this RFA. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: [email protected]. For purposes of identification and processing the application, mark "YES" in item 2 on the face page and enter: "RFA AI-02-002 Rapid Response Grant Program for Bioterrorism-Related Research". The research plan will be strictly limited to 10 pages total. Applications that exceed the page limit will be returned without review. An appendix may be included in the application, however, the appendix is not to be used to circumvent the page limit of the research plan. Explicit instructions concerning what may be included in an appendix can be found in Section 1B "General Instructions" for the PHS 398 Grant Application. Late or incomplete applications will not be accepted. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. 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. Submit a signed, typewritten original of the application 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 appendix material must be sent to: Dr. Edward W. Schroder Scientific Review Administrator Division of Extramural Activities National Institute of Allergy and Infectious Diseases National Institutes of Health Room 2151, MSC 7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (for FedEx use zip code 20817) The Center for Scientific Review (CSR) will not accept any application in response to this announcement 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. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIAID in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique. Only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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 the application 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 the 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. Review Criteria (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? 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? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator 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 (if any)? (5) Environment: Does the scientific environment in which the 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o 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. Schedule Letter of Intent Receipt Date: January 15, 2002 Application Receipt Date: February 15, 2002 Scientific Peer Review Date: May, 2002 National Advisory Council Date: June, 2002 Earliest Anticipated Award Date: July, 2002 AWARD CRITERIA The following will be considered in making funding decisions: the scientific and technical merit of the proposed project as determined by peer review, and the availability of funds. In the final selection of applications to be funded, consideration will be given to developing a portfolio that most directly addresses issues of public health and bioterrorism. INQUIRIES Inquiries are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. The Division of Microbiology and Infectious Diseases has a website for bioterrorism-related research: http://www.niaid.nih.gov/publications/bioterrorism.htm. The website has information describing the various programs targeting bioterrorism-related research and listings of currently active bioterrorism-related program announcements and contracts and their associated deadlines. Direct inquiries regarding programmatic issues to: Dr. Barbara Mulach Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 3266, MSC-7630 6700-B Rockledge Drive Bethesda, MD 20892-7630 Telephone: (301) 496-1884 FAX: (301) 480-4528 Email: [email protected] Joan T. Harmon, Ph.D. Division of Bioengineering National Institute of Biomedical Imaging and Bioengineering Room 1B37, MSC 2077 31 Center Drive Bethesda, MD 20892-2077 Telephone: (301) 451-6772 FAX: (301) 480-4515 Email: [email protected] Direct inquiries regarding review issues to: Dr. Edward W. Schroder Scientific Review Administrator Division of Extramural Activities National Institute of Allergy and Infectious Diseases National Institutes of Health Room 2151, MSC 7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (for FedEx use zip code 20817) Telephone: (301) 435-8537 FAX: (301) 402-2638 Email: [email protected] Direct inquiries regarding fiscal matters to: Theresa Mercogliano Grants Management Specialist Grants Management Branch National Institute of Allergy and Infectious Diseases National Institutes of Health 6700-B Rockledge Drive, MSC 7610 Bethesda, MD 20892-7610 Phone: (301) 402-5512 Fax: (301) 480-3780 Email: [email protected] Annette Hanopole, CRA Grants Management Officer National Institute of Biomedical Imaging and Bioengineering Room 1B37, MSC 2077 31 Center Drive Bethesda, MD 20892-2077 Telephone: (301) 451-6768 FAX: (301) 480-4515 Email: [email protected] 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 and No. 93.020, Bio-engineering 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 and contract recipients to provide a smoke-free workplace and promote the non-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, and 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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