EXPLORATORY/DEVELOPMENTAL GRANTS: TECHNOLOGY APPLICATIONS TO NIAID-FUNDED RESEARCH Release Date: December 5, 2001 PA NUMBER: PAS-02-031 National Institute of Allergy and Infectious Disease (http://www.niaid.nih.gov/default.htm) Application Receipt Date: February 26, 2002 THIS PAS USES THE "MODULAR GRANT" AND JUST-IN-TIME CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT https://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Allergy and Infectious Disease (NIAID) solicits exploratory/developmental (R21) grant applications that facilitate the application of innovative/emerging technologies to currently funded research projects related to the study of infectious diseases (bacterial, viral, fungal and Parasitic), diseases caused by category A agents of bioterrorism, HIV/AIDS, basic immunology, and immune mediated conditions. This R21 mechanism is designed to capitalize on scientific opportunities that would augment the value of the project and may not have been available at the time of submission of the Parent grant. Therefore, R21 grant applications should be coupled to ongoing NIAID-funded research projects. 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 PAS 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 not-for- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, eligible agencies of Federal government, and small businesses. 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 Parent NIAID grant. MECHANISM OF SUPPORT Support of this PAS 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. This PAS is a one-time solicitation and R21 grant applications are not renewable. NIAID may repeat the announcement in future years, depending on the needs of the scientific community and the availability of funds. FUNDS AVAILABLE NIAID intends to commit approximately $3,000,000 in FY2002 to fund 10-12 applications in response to this PAS. The usual PHS 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. RESEARCH OBJECTIVES New and emerging technological advances 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 problems. Ongoing research studies frequently need to expand the project scope and involve new collaborators and facilities to take advantage of emerging technologies. This PAS supports the application of new technology to existing projects as exploratory/developmental projects that will increase the capability of the research to more directly and rapidly address central questions related to important areas of NIAID's research focus. This focus includes 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 infectious diseases, diseases caused by category A bioterrorism agents (http://www.bt.cdc.gov/agent/Agentlist.asp); HIV/AIDS; basic immunology; 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, 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 imaging technology such as new and innovative imaging modalities and/or contrast reagent, with emphasis on their potential for cellular trafficking, identification of specific immune cell populations, and molecular imaging of gene expression and protein-protein interactions. o Incorporation of bioinformatics approaches/tools such as analysis software for microarray analyses, new informatics methods appropriate for 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 than the principal investigator on the Parent NIAID grant award. In this case, the principal investigator of the Parent grant should be listed as a co-investigator on the R21 application. 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 clear and compelling 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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of the policy 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: https://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: https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PAS 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev.5/2001) at https://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 301-710-0267 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 https://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 NIH 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 parent grant, 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. Included in the application (but separate from the 10 page limit) should be a section containing the parent grant's grant number, abstract and specific aims. 5. 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. 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 that are complete and responsive to the PAS will be evaluated for scientific and technical merit by an appropriate peer review groups convened by the CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Institute of Allergy and Infectious Disease Advisory Board. 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? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, programmatic priorities, and the availability of funds. INQUIRIES 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 Irene Glowinski, Ph.D. Associate Director for Operations, Communication and Policy 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: iglowinski@niaid.nih.gov Polly Sager, Ph.D. Director, Office of Scientific Coordination Division of AIDS National Institute of Allergy and Infectious Diseases National Institutes of Health 6700-B Rockledge Drive MSC 7620 Bethesda, MD 20892-7620 Phone: (301) 402-0755 FAX: (301)480-0753 Email: psager@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 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.855, Allergy, Immunology and Transplantation and No. 93.856 Microbiology and Infectious Diseases. Awards are made under the authorization of the 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 PHS strongly encourages all grant 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, 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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