APPLICATION OF EXPLORATORY/DEVELOPMENTAL TECHNOLOGIES TO NIAID-FUNDED RESEARCH RELEASE DATE: August 29, 2002 PA NUMBER: PAS-02-160 Application Receipt Dates: Standard new research project grant receipt dates for AIDS and non-AIDS grants through May 1, 2003 (see http://grants.nih.gov/grants/funding/submissionschedule.htm). EXPIRATION DATE: May 1, 2003, unless reissued. National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Allergy and Infectious Disease (NIAID) solicits exploratory/developmental (R21) grant applications that facilitate the application of innovative/emerging technologies or established state-of-the-art technologies to augment NIAID funded research projects related to the study of infectious diseases (bacterial, viral, fungal and parasitic), HIV/AIDS, basic immunology, and immune mediated conditions (autoimmunity, asthma, allergy, organ/tissue transplant rejection). Studies focused on biodefense research are not eligible for this announcement. Funding opportunities for biodefense research are identified at http://www2.niaid.nih.gov/Biodefense/Research/funding.htm#B R21 grant applications must be scientifically and administratively linked to ongoing NIAID-funded research project (R01 and R37) grants. RESEARCH OBJECTIVES The use of emerging technologies and the application of existing state- of-the art technologies have great potential to expand the analytical power and scope of research studies that may lead to new approaches for the diagnosis, treatment, and prevention of infectious diseases and to manipulate immune responses by vaccination and immunotherapeutic strategies. Recent advances in genomics, gene expression and function analyses, proteomics, new imaging technology, and bioinformatics have proven the applicability of these technologies to many different types of biological research questions. Frequently, ongoing research studies could benefit from expansion of the project scope involving new collaborators and advanced technologies. This program will facilitate research to more directly and rapidly address central questions related to important areas of NIAID"s research focus including diseases that are a current or emerging threat to public health as well as investigations into normal and pathogenic immune responses. Specific areas of research interest include study of infectious diseases from biology of the microbe to host responses and pathogenesis, HIV/AIDS, basic immunology and immunity to infectious agents, and immune-mediated conditions such as asthma, allergy, autoimmune diseases and transplant rejection. Research technologies to be supported by the R21 mechanism include, but are not limited to: o Application of novel or established genomic and/or molecular genetic approaches such as comparative genomics studies to facilitate gene identification and/or function, microarray technology, and in vitro/in vivo systems for genetic manipulations that may include more facile transfection technologies, novel gene knockout technologies, inducible gene expression systems, RNA interference, PCR technologies, detection methods for single nucleotide polymorphisms (SNPs) and other genetic alterations or mutations, and genome-wide mutagenesis. o Application of innovative proteomics approaches such as techniques that increase the sensitivity or capacity of existing approaches with regard to throughput, quantitation, temporal resolution, reliability, new methods for defining protein properties related to their cellular functions, novel approaches for characterization of protein-protein, protein-DNA, or other protein-molecule interactions, novel applications of proteomic methodologies to the study of specific cellular processes, and use of proteomic approaches in the development and proof-of-concept testing of therapeutics. o Incorporation of studies involving human embryonic stem cells (http://stemcells.nih.gov/index.asp). o Application of established technologies such as unique animal models, flow cytometry, X-ray crystallography, mass spectrometry, 2-dimensional gel electrophoresis, and differential display to augment existing research programs. o Incorporation of imaging technologies such as new and innovative imaging modalities and/or contrast reagents, with emphasis on their potential for visualization of cellular trafficking, identification of specific immune cell populations, and molecular imaging of gene expression and protein-protein interactions. o Incorporation of bioinformatics software and computational tools for emerging DNA sequencing data (e.g. for assembling and finishing genomes and annotation of genomes), microarray analyses, specific proteomics applications (e.g. for management of time-series proteomics data obtained in basic research and clinical trials), and collation and dissemination of biological information to the scientific community (e.g., database development). Requests may include purchase of equipment needed for the specific technology application or enhancement. They may also include support for personnel who may collaborate with the principal investigator on experimental design, technology implementation, or data analysis. The principal investigator of the R21 application may be different from the principal investigator on the R01 or R37 grant award. In this case, the principal investigator of the R01 or R37 grant should be listed as a co-investigator on the R21 application and should provide a letter of support to the R21 applicant. MECHANISM OF SUPPORT Support will be through the National Institutes of Health exploratory/developmental grant (R21) award mechanism. R21 grants are non-renewable and limited to 2 years for up to $150,000 in direct costs per year. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. FUNDS AVAILABLE NIAID intends to commit approximately $3,000,000 in FY2003 to fund 10- 12 applications in response to this PAS. The usual NIH policies governing grants administration and management will apply. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this PAS are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of high scientific merit. ELIGIBILITY REQUIREMENTS Investigators currently supported by the following NIAID funding mechanisms are eligible to apply: Research Project Grant (R01) and MERIT awards (R37). Grantees are eligible for funding of one R21 award for each NIAID R01 or R37 grant. R21 applicants must have at least 12 months remaining on the R01 or R37 grant at the anticipated time of award. No-cost extensions do not apply towards the 12 month requirement. You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organization o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Domestic o Units of State and local governments o Eligible agencies of the Federal government 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. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants2.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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research and financial or grants management issues: Direct inquiries regarding programmatic issues to: Alison Deckhut, Ph.D. Program Officer Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases National Institutes of Health 6700-B Rockledge Drive MSC 7640 Bethesda, MD 20892-7640 Phone: (301) 496-7551 FAX: (301) 402-2571 Email: adeckhut@niaid.nih.gov Maria Giovanni, Ph.D. Assistant Director for Microbial Genomics Division of Microbiology and Infectious Disease National Institute of Allergy and Infectious Diseases National Institutes of Health 6700-B Rockledge Drive MSC 7630 Bethesda, MD 20892-7630 Phone: (301) 496-1884 FAX: (301) 480-4528 Email: mgiovanni@niaid.nih.gov Nabila M. Wassef, Ph.D. PBRB, Division of AIDS, NIAID, NIH Rockledge Building, Room 4135 6700-B Rockledge Drive, MSC 7626 Bethesda, MD 20892-7626 (overnight mail-20817) Tel: (301) 435-3751 Fax: (301) 402-3211 Email: nwassef@niaid.nih.gov Direct inquiries regarding fiscal matters to: Ms. Linda Shaw Grants Managements Specialist Grants Management Branch Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, MSC 7614 Bethesda, MD 20892-7614 Telephone: 301-402-6611 FAX: 301-480-3780 Email: lshaw@niaid.nih.gov SUBMITTING AN APPLICATION The PHS 398 research grant application instructions and forms (rev.5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo by telephone 301-435-0714 or email: GrantsInfo@nih.gov. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" concepts, with direct costs requested in $25,000 modules, up to $150,000 total direct costs per year. 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. Submit a signed, typewritten original of the application, including the Checklist, and five 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) SPECIFIC INSTRUCTIONS FOR R21 APPLICATIONS To apply, please follow NIAID guidelines for submission of an R21 application as listed below: 1. The Description (abstract) must include a brief explanation of the proposed activity, how it is related to the R01 or R37 grant, and how it is consistent with the exploratory/development nature of the R21 mechanism as described in this notice. The grant assignment number (e.g. 2 R01 AI123456-07) must be included in the Description section. 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. Included in the application (just before section a, and separate from the 10 page limit) should be a section containing the grant number, abstract and specific aims of the R01 or R37 to which this R21 application is linked. 5. If the principal investigator (PI) of the R21 application is different from the PI of the R01 or R37 NIAID award, a letter of support from the PI of the parent award must be included at the end of Research Plan. 6. 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 two publications, including manuscripts (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. INSTRUCTIONS SPECIFIC TO APPLICATIONS FOR SUPPORT OF TECHNOLOGY RESEARCH, DEVELOPMENT OR ENHANCEMENT Applications submitted in response to this program announcement may be design-driven or hypothesis-driven. Thus, the application should state the hypotheses and/or designs that will drive the proposed research. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR. Incomplete applications will be returned to the applicant without further consideration. Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. 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. The reviewers will comment on the following aspects of the application in their written critiques 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 by the reviewers 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 a 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 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? Will the application of the technology enhance research conducted under the parent grant award? 3. Innovation: Does the project employ novel concepts, approaches or method? Are the aims innovative? Will the proposed project have a significant impact on the field? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: 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. 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) DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities 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. 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 (see http://escr.nih.gov). It is the responsibility of the applicant to provide 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. 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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