and Human Services (HHS)
EXPIRED
TECHNOLOGY DEVELOPMENT FOR BIOMEDICAL APPLICATIONS: PHASED INNOVATION AWARD (R21/R33) Release Date: February 27, 2001 PA NUMBER: PAR-01-057 (see replacement PAR-02-091) National Center for Research Resources Application Receipt Dates: June 1, and October 1 annually PURPOSE The National Center for Research Resources invites innovative applications for (1) the development of new and improved instruments or devices, (2) the development of new methodologies, or (3) the development of software to be used in biomedical research. Current technology development applications to NCRR from individual investigators generally use either the R01 or the R21 mechanisms. Investigators with substantial preliminary data for a technology development application should continue to use the R01 mechanism. This program announcement replaces PAR 98-047. PAR 98-047 used only the R21 mechanism. Although this program announcement uses the R21/R33 phased innovation mechanism, applications using only the R21 mechanism are welcome. The proposed research may involve conceptualization, design, fabrication, and/or testing of new instruments or devices. Applications to develop new experimental techniques and protocols using existing instrumentation as well as applications to develop software are invited. It is expected that these technique development applications will have broad application to biomedical research. The overall objective of these applications for new instruments, techniques, or software is the development of more powerful and more precise technology for biomedical research. Areas of emphasis are biomedical engineering and technologies for the study of structure and function of biological systems at all levels of complexity. This program announcement (PA), Technology Development for Biomedical Applications, will utilize the Phased Innovation Award Mechanism (R21/R33). Specific features of this mechanism include: o Single submission and evaluation of both a feasibility/pilot phase (R21) and an expanded development phase (R33) as one application. o Expedited transition of the R21 feasibility phase to a R33 development phase for combined applications. o Flexible budgets. o Flexible staging of feasibility and development phases. It is anticipated that the majority of applications under this program announcement will use the combined R21/R33 mechanism. Applications using the R21 mechanism alone will be considered, but applications using just the R33 mechanism will not be considered. Applicants are strongly encouraged to contact program staff before submitting an R21 application alone. Refer to the INQUIRIES sections of this program announcement for program staff contacts. ELIGIBILITY REQUIREMENTS The technology development to be supported under this program must be applicable to a variety of NIH research areas. Applications to develop technologies that apply to one categorical NIH institute of a specific disease, generally do not meet the guidelines for this program. Such applications will be considered only if the applicant clearly demonstrates the long-term potential of the technology for having a broad impact on biomedical research. Applications may be submitted by domestic and foreign, for-profit and non-profit, and public and private organizations 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. MECHANISM OF SUPPORT Support for this program will be through the National Institutes of Health (NIH) Exploratory/Developmental Research Grant (R21) and the Exploratory/Developmental Research Grant Phase 2 (R33). The R33 is a recently established NIH grant mechanism to provide a second phase for the support of innovative exploratory and development research initiated under the R21 mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The applicant can choose to submit an independent R21 application, or a combined R21/R33 application. The advantage of the combined R21/R33 mechanism is that it offers a seamless transition between the exploratory phase and the development phase of a project. Transition of the R21 to the R33 is dependent on completion of negotiated milestones. Once these milestones have been achieved, the investigator must submit a progress report to the program. Upon determination that the milestones have been accomplished, the R33 phase can begin. This expedited transition between phases is a major advantage over the current protocol of an independent R21 award followed by a standard research project (R01). Submission of an independent R21 application is appropriate in cases where the R33 phase cannot be described without the preliminary knowledge gained during the R21 phase. It is anticipated that the R21 technology development applications will be reviewed by the same scientific review group that considers the combined R21/R33 applications. However, after completion of the R21 portion of the project, an investigator will have to submit an independent R01 application. Requests for supplements under this program announcement are discouraged because of the flexibility of the timeline and the budgets. Proposals using either the R21 or R21/R33 mechanisms will not be eligible for renewal. BACKGROUND The National Center for Research Resources strives to provide the crucial tools, technologies, and research resources that will allow scientists to achieve the biomedical breakthroughs of tomorrow. This program announcement is similar in spirit to the "Instrument Development for Biological Research" program in the Directorate for Biological Sciences at the National Science Foundation (http://www.nsf.gov/cgi-bin/getpub?nsf98119). The major difference between the two programs is that instrumentation for the conduct of disease-oriented research is specifically excluded from the NSF program. It is clear that some instrument development proposals could be considered either under this program announcement or by NSF. Applicants are encouraged to contact program staff at either NSF or NIH to discuss which program is more appropriate (see INQUIRIES section). RESEARCH GOALS AND OBJECTIVES The primary intent of this PA is to stimulate the development of new techniques for biomedical research. High risk applications are encouraged, and the innovative nature of the application will be part of the review criteria. For some high risk applications, it may be appropriate to use the R21 mechanism to generate preliminary data. Most applications will use the combined R21/R33 mechanism. APPLICATION PROCEDURES SPECIFIC INSTRUCTIONS FOR PREPARING THE COMBINED R21/R33 PHASED INNOVATION AWARD APPLICATION Applications for R21/R33 grants are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the application deadlines given on the first page of this solicitation. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: [email protected]. Application kits are also available online at http://grants.nih.gov/grants/funding/phs398/phs398.html. The combined R21/R33 application must include the specific aims for each phase and the feasibility milestones that would justify transition to the R33 phase. Applications must include a specific section labeled Milestones following the Research Plan of the R21 phase. Milestones should be well described, quantifiable and scientifically justified. A discussion of the milestones relative to the progress of the R21 phase, as well as, the implications of successful completion of the milestones for the R33 phase should be included. The milestone section should be indicated in the Table of Contents. Applications lacking this information, as determined by the NIH program staff, will be returned to the applicant without review. Prior to funding an application, the Program Director will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Director and the applicant will negotiate and agree on a final set of milestones. These will be the basis for judging the success of the R21 work. For funded applications, the PI will submit a progress report to the program upon completion of the R21 milestones. Receipt of this progress report will trigger a review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of negotiated scientific milestones, program priorities, and on the availability of funds. The expedited review may result in additional negotiations of award. The R21/R33 Phased Innovation Award application must be submitted as a single application, with one face page. Although it is submitted as a single application, it should be clearly organized into two phases. To accomplish a clear distinction between the two phases, applicants are directed to complete Sections a-d (Specific Aims, Background and Significance, Preliminary Studies, Research Design) for the R21 phase and then sections a and d (Specific Aims, Research Design) for the R33 phase. The Form 398 Table of Contents should be modified to show the sections for each phase as well as the milestones. There is a page limit of 25 pages for the composite research plan. Section a-d of the R21 research plan must not be longer than 15 pages. The milestones, and the a-d sections for the R33 application can take, at most, an additional 10 pages. The clarity and completeness of the R21/R33 application with regard to specific goals and feasibility milestones is critical. The presentation of milestones that are not sufficiently scientifically rigorous to be valid for assessing progress in the R21 phase will reflect upon the scientific judgment of the applicant in this application. 1. Face Page of the application: Item 2. Check the box marked "YES" and type the number and title of this program announcement. Also indicate that the application is R21/R33 in the title. Items 7 and 8: Costs Requested For the R21 phase of the application, direct costs are limited to a maximum of $100,000 per year for a maximum of three years. R21 budgets can exceed this cap to accommodate F&A costs of subcontracts to the project. For the R33 phase of the application, approval must be obtained for direct costs in excess of $500,000 per year. Contact program staff for approval (see INQUIRIES section). The R33 phase is limited to three years. The combined R21/R33 application is limited to five years. The Modular Budget approach is not to be used. 2. Page 2 - Description: As part of the description, identify concisely the fundamental research and/or technology or tool to be developed, its innovative nature, its relationship to presently available capabilities, and its expected impact on biomedical research. 3. Budget: The application should provide a detailed budget for Initial Budget Period (form page 4), for each of the initial years of the R21 and R33 phases as well as a budget for the entire proposed period of support (form page 5). Form pages should indicate which years are R21 and which are R33. All budgets should include a written justification. 4. Research Plan: Item a: Specific Aims. The applicants must present specific aims that the applicant considers to be scientifically appropriate for the relevant phases of the project. The instructions in the PHS 398 booklet for this section of research grant applications suggest that the applicant state the hypotheses to be tested. Since the goal of this PA is to develop innovative technologies and tools, hypothesis testing per se may not be the driving force in developing such an application and, therefore, may not be applicable. Furthermore for R21 grant applications, preliminary data are not required, although they should be included when available. For both the R21 and R33 phase, research that develops new technologies or tools is likely to require the application of principles of fields such as analytical chemistry, mathematics, physics, and engineering. Clear statements of these underlying principles within this section are essential. Item b: Background and Significance Elaborate on the innovative nature of the proposed research. Clarify how the fundamental tools or technologies to be developed as proposed in this project will result in a significant improvement over existing approaches. Explain the potential of the proposed technology for having an impact on a compelling area of biomedical research. Clearly identify how the project, if successful, would result in new capabilities for biomedical research, the immediacy of the opportunity, and how any proposed technologies or tools would differ from existing technologies or tools. This item will not be present in the R33 portion of the application. Item c: Preliminary Studies/Progress Report While preliminary data are not required for submission of the R21 phase, this section should provide current thinking or evidence in the field to substantiate feasibility of the R21 phase. This item will not be present in the R33 portion of the application. Item d: Research Design and Methods Follow the instructions in the PHS 398 booklet. For this particular program, applicants should also address plans to make the products, tools, or technologies forthcoming from this research available to the relevant biomedical research user community. 5. Milestones: For combined R21/R33 applications, a specific section labeled Milestones must be included following the Research Design and Methods of the R21 phase. Milestones should be well described, quantifiable, and scientifically justified. Milestones should not be simply a restatement of the specific aims. The milestones section should be indicated in the Table of Contents. Applications lacking this information, as determined by the program staff, will be returned to the applicant without review. When the R21 milestones have been achieved, the PI will submit a progress report to the program. Receipt of this progress report will elicit a review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of milestones, program priorities and on the availability of funds. The expedited review may result in additional negotiations of award. SPECIFIC INSTRUCTIONS FOR PREPARATION OF THE R21 APPLICATION WHEN SUBMITTED WITHOUT THE R33 PHASE. Applications for R21 grants are to be submitted on the grant application form PHS 398 (rev. 4/98) and prepared according to the instructions provided unless specified otherwise within items 1-5 below. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: [email protected]. Application kits are also available online at http://grants.nih.gov/grants/funding/phs398/phs398.html. 1. Face Page of the application: Item 2. Check the box marked "YES" and type the number and title of this program announcement and indicate R21 in the title. Item 7a: DIRECT COSTS REQUESTED FOR INITIAL PERIOD OF SUPPORT For the R21 application, direct costs are limited to a maximum of $100,000 per year for a maximum of three years. R21 budgets can exceed this cap to accommodate F&A costs of subcontracts to the project. The Modular Budget approach is not to be used. 2. Page 2 - Description: As part of the description, identify concisely the fundamental research and/or technology or tool to be developed, its innovative nature, its relationship to presently available capabilities, and its expected impact on biomedical research. 3. Budget: The application should provide a detailed budget for Initial Budget Period (form page 4), for the R21 phase as well as a budget for the entire proposed period of support (form page 5). All budgets should include a written justification. 4. Research Plan: The research plan for an R21 application is limited to 15 pages. Item a: Specific Aims. The instructions in the PHS 398 booklet for this section of research grant applications suggest that the applicant state the hypotheses to be tested. Since the goal of this PA is to develop innovative technologies and tools, hypothesis testing per se may not be the driving force in developing such an application and, therefore, may not be applicable. Furthermore for R21 grant applications, preliminary data are not required, although they should be included when available. For the R21 phase, research that develops new technologies or tools is likely to require the application of principles of fields such as analytical chemistry, mathematics, physics, and engineering. Clear statements of these underlying principles within this section are essential. Item b: Background and Significance Elaborate on the innovative nature of the proposed research. Clarify how the fundamental research or tools or technologies to be developed in this project will result in a significant improvement over existing approaches. Explain the potential of the proposed technology for having an impact on a compelling area of biomedical research. Clearly identify how the project, if successful, would result in new capabilities for biomedical research, the immediacy of the opportunity, and how any proposed technologies or tools would differ from existing technologies or tools. Item c: Preliminary Studies/Progress Report For R21 grant applications, preliminary data are not required, although they should be included when available. Item d: Research Design and Methods Follow the instructions in the PHS 398 booklet. FOR ALL APPLICATIONS Appendix: The only items that may be included in the appendix are original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy of the same size is included within the research plan. 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 copies of the application, and five copies of the Appendix, are to be sent to: Office of Review National Center For Research Resources 6705 Rockledge Drive, Suite 6018, MSC 7965 Bethesda, MD 20892-7965 Bethesda, MD 20817 (for express/courier service) Applications must be received by the application deadline dates given on the first page of this solicitation. 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 program 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. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines and will be reviewed for completeness by the Center for Scientific Review. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NCRR in accordance with the standard NIH peer review procedures. 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 applications under review) will be discussed, assigned a priority score, and receive a second-level review by the National Advisory Research Resources 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. 1. Significance. o Does this study address an important problem? o Are the results of the study likely to allow an important area of biomedical research to move forward? o If the aims of the application are achieved, how will scientific knowledge be advanced? o To what degree does the research or development of technologies or tools support the needs of the targeted biomedical research community? o For tools and technologies intended for clinical research or use, two additional criteria will be considered: 1) To what degree is the approach, technology or tool appropriate for clinical research and likely to have utility in a clinical setting? 2) Do applicants adequately address such issues as the protection of patient information and confidentiality? 2. Approach. o Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? o Does the applicant acknowledge potential problem areas and consider alternative tactics? o What is the time frame for developing the proposed approaches, tools, or technologies? Is this time frame suitable for meeting the relevant biomedical research community"s needs? o How easy will it be to use the proposed approach, tool, or technology? o Are the plans for dissemination of the proposed endpoints, tools or technologies of the project adequate? 3. Milestones. o How appropriate are the proposed milestones for judging the success of the proposed R21 work? o How appropriate are the proposed milestones in determining whether the R33 phase should be awarded? o Has an appropriate scientific meeting been identified to present the results of the R21 phase? 4. Innovation. o Does the project employ novel concepts, approaches or method? o Are the aims original and innovative? o Does the project challenge existing paradigms or develop new methodologies or technologies? o Will there be additional application opportunities for the approach, technology or tool proposed? 5. Investigator. o Is the investigator appropriately trained and well suited to carry out this work? o Does the project team have adequate expertise in both the areas of technique development and biomedical research? o Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 6. Environment. o Does the scientific environment in which the work will be done contribute to the probability of success? o Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Additional Considerations For the R21/R33 Phased Innovation Award Application, the scientific review group will evaluate the specific goals for each phase and the feasibility milestones that would justify expansion to the R33 phase. The scientific review group will also examine the appropriateness of the proposed project budget and duration, the adequacy of plans to include both genders and minorities and their subgroups 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 as well as plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. (See section on NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS). AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding general programmatic issues should be directed to: Gregory K. Farber, Ph.D. Biomedical Technology National Center for Research Resources 6705 Rockledge Drive, Room 6152 Bethesda, MD 20892 TEL: (301) 435-0755 FAX: (301) 480-3659 Email: [email protected] Inquiries regarding review issues should be directed to: Charles G. Hollingsworth, Dr. P.H. Director, Office of Review National Center for Research Resources 6705 Rockledge Drive, Room 6114 Bethesda, MD 20892 TEL: (301) 435-0807 FAX: (301) 480-3660 Email: [email protected] Inquiries regarding fiscal matters should be directed to: Mary Niemiec Team Leader Office of Grants Management National Center for Research Resources 6705 Rockledge Drive, Room 6086 Bethesda, MD 20892 TEL: (301) 435-0842 FAX: (301) 480-3777 Email: [email protected] 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 Program Announcement 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/. 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report 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 or 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 may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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 for 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. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.371. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended by Public Law 99-158, 42 USC 241 and 287 and 287a) and administered under NIH grants policies and Federal regulations 42 CFR 52 and 45 CFR 74. 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 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, 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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