PA-01-127: PILOT AND FEASIBILITY PROGRAM RELATED TO THE KIDNEY

Department of Health
and Human Services (HHS)

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This Program Announcement expired on May 6, 2005 PILOT AND FEASIBILITY PROGRAM RELATED TO THE KIDNEY Release Date: August 14, 2001 PA NUMBER: PA-01-127 (This PA has been reissued, see PA-05-103) (Expiration date extended, see NOT-DK-04-017) National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) National Institute on Aging (http://www.nih.gov/nia) National Cancer Institute (http://www.nci.nih.gov) THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. USE THE MODULAR BUDGET INSTRUCTIONS THAT BEGIN ON PAGE 13 IN THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. THE INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS MUST BE USED WHEN RESPONDING TO THIS PA. PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Biology of Aging Program of the National Institute on Aging (NIA) and the Cancer Cell Biology Branch of the National Cancer Institute (NCI) invites applications through the exploratory/developmental (R21) grant mechanism from investigators with research interests related to the kidney and fall within the purview the NIH mission. The primary intent of this initiative is to foster the development of high-risk pilot and feasibility research by newly independent or established investigators, to develop new ideas sufficiently to allow for subsequent submission of R01 applications focusing on research problems relevant to the study of both acute and chronic kidney diseases, and their complications, in both the adult and pediatric populations. These grants are not intended to support or supplement ongoing funded research of an established investigator, or to serve as an alternative mechanism of support for projects not receiving funding as competitive continuation applications. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to increasing the quality and years of healthy life and to eliminating health disparities as described in the objectives of Healthy People 2010 . This document is a PHS-led national activity for setting priority areas and is available at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, and 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. Further, this mechanism is for the support of either new investigators [defined as independent investigators who have not held R01, R29, and subprojects of program project (P01) or center grants (P50) or equivalent], or established investigators entering a new research field or developing a new line of research. MECHANISM OF SUPPORT 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. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm This program will be supported through the exploratory/developmental grant (R21) mechanism. These awards are to demonstrate feasibility and obtain preliminary data testing innovative ideas that represent a clear departure from ongoing research interests. These grants will not be renewable, continuation of projects developed under this program will be through the regular research grant (R01) program. Projects will be limited to $100,000 direct costs per year and are limited to two years duration. RESEARCH OBJECTIVES The NIDDK, the NIA and the NCI invite investigator-initiated applications. Appropriate topics for investigation would include, but are not limited to: o Development of methods to identify and define novel signaling molecules and pathways involved in renal cellular and tissue development, and the genetic programming of renal morphogenesis and angiogenesis. o Development of animal models reflecting the complexity of human kidney diseases, that permits exploration of candidate mechanisms leading to development, injury, and/or tolerance to injury. o Development of less complex models to take advantage of evolutionary- conserved mechanisms involving responses to injury and repair. o Development of new approaches for utilizing mutant organisms for the study of membrane transport. o Crystallization of new regulatory and membrane proteins for study of their structural biology. o Development of technological tools, to improve molecular studies of renal disease, such as methods to permit parallel assessment of gene expression on renal biopsies. o Development of animal models of inflammation/endothelial dysfunction/sepsis leading to kidney disease. o Development of novel vectors and delivery systems for use in gene therapy of systemic and inherited kidney diseases, including disorders such as polycystic kidney disease, diabetic nephropathy, diabetes insipidus, cystinuria, renal hypertension, tubulointerstitial nephropathy, Alport s, Bartter s, Gittelman s, Liddle s, and Fanconi syndromes. o Development of new methods to determine the role of complement and complement regulatory proteins, oxidants and proteases, cytokines, chemokines, growth factors, and adhesion molecules and matrix components in immunologic kidney disease. o Combinatorial chemistry for development of new renal reagents. o Identification and characterization of early markers of renal disease severity. o Identification of novel approaches to improve the immediate and long- term outcome in pediatric chronic renal failure. o Development of new methods for temporal and spatial control of transgene expression in the kidney. o Development of micro-methods and miniaturized assays for physiologic and metabolic studies/measurements in small/young animals and children. o Development and use of array technology and bioinformatics to characterize renal tissues in health and disease states. o Use of molecular and proteomic techniques, such as differential display, arrays, second-generation library screens, 2-D gels, etc. to screen for novel kidney tissue-specific genes, novel disease or regulatory genes, and/or etiologic agents. o Use of phage display or other novel approaches to identify kidney- specific proteins. o Development of novel strategies for treating progressive renal disease using animal models and/or short term feasibility studies in humans. o Identify new factors contributing to symptoms and morbidity in patients with treated end stage renal disease. o Use of molecular and proteomic techniques on urine, blood or tissue to discover more sensitive markers of chronic renal disease, its progression and response to treatment. o Identification of new pathophysiologic mechanisms and modes of treatment for diabetic nephropathy. o Use of epidemiological and biochemical approaches to identifying new, non-traditional risk factors for cardiovascular disease in patients with chronic real disease. o Studies focused on age-related changes in the biology of the kidney and kidney function, and propensity for diseases of the kidney relevant to older subjects. o Studies focused on mechanisms of biological, chemical and physical carcinogenesis and subsequent tumor growth and progression to kidney metastasis. 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 subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 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 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: 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 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. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. 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 beginning on page 13 of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. All application instructions outlined in the PHS 398 application kit are to be followed, with the following modifications for R21 applications: 1. R21 applications will use the MODULAR GRANT and JUST-IN-TIME concepts, with direct costs requested in $25,000 modules, up to the total direct costs limit of $100,000 per year. 2. Although preliminary data are not required for an R21 application, they may be included. 3. Sections a-d of the Research Plan of the R21 application may not exceed 15 pages, including tables and figures. 4. R21 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 15 page limit of items a-d of the research plan The program announcement title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Mail the signed, original, single-sided application, along with five exact, single-sided copies and five collated sets of appendix materials 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with 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 appropriate national advisory council or board. Review Criteria The goals of the supported research are to advance our understanding of biological systems, improve the control of disease, improve health care services, 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. (1) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (2) 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)? Is the investigator a new investigator, an established investigator entering a new field, or an established establishing a new of investigation? (3) 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? (4) 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? (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. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program priority INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Relevant Scientific Program Officers may be identified through the DKUHD webpage at http://www.niddk.nih.gov/welcome/org/tables/kuh_table.htm or by making direct inquiries to: M. James Scherbenske, Ph.D. Renal Physiology/Cell Biology and Kidney Centers and SBIR Programs Director DKUHD National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Room 613 Bethesda, MD 20892-5458 Telephone: (301) 594-7719 FAX: (301) 480-3510 E-mail: js255f@nih.gov Direct inquiries regarding NIA programmatic issues to: Frank Bellino, Ph.D. Biology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 2C231 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: bellinof@nia.nih.gov Direct inquiries regarding NCI programmatic issues to: Judy Mietz, Ph.D. Cancer Cell Biology Branch National Cancer Institute 6130 Executive Boulevard Executive Plaza North, Room 5032 Rockville, MD 20852 Telephone: (301) 496-7028 FAX: (301) 402-1037 Email: mietzj@nih.gov Inquiries regarding NIDDK fiscal and administrative matters may be directed to: Mrs. Helen Y.S. Ling Division of Extramural Activities NIDDK 6707 Democracy Blvd, Room 629 Bethesda, MD 20892 Telephone: (301) 594-8857 FAX: (301) 480-3504 E-Mail: hl12d@nih.gov Inquiries regarding NIA fiscal and administrative matters may be directed to: Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: lw17m@nih.gov Inquiries regarding NCI fiscal and administrative matters may be directed to: Crystal Wolfrey National Cancer Institute GAB Executive Plaza South, Room 243, MSC 7150 6120 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8634 FAX: 301-496-8601 Email: cw104j@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 and 93.866. 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 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 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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