SMALL GRANT PROGRAM FOR NIDDK K08/K23 RECIPIENTS Release Date: March 7, 2001 PA NUMBER: PAR-01-066 (see replacement PAR-04-070) National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov/) THIS PAR USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PAR. This Program Announcement replaces Program Announcement, PAR-98-087 (Small Grant Program for K08 Recipients), which was published in the NIH Guide July 9, 1998. PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) re-announces a program that provides NIDDK-supported K08 and K23 recipients the opportunity to apply for Small Grant (R03) support to run concurrently with the latter years of their K08/K23 award. Through the use of this mechanism, which allows up to $50,000 per year for two years in additional research development costs, the NIDDK is seeking to enhance the capability of its K08 and K23 award recipients to conduct research as they complete their transition to fully independent investigator status. 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. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS This mechanism is available only to investigators currently holding either a K08 or a K23 award from the NIDDK. Details of the K08 Award are given in NIH Program Announcement PA-00-003 (http://grants.nih.gov/grants/guide/pa-files/PA-00-003.html) Details of the K23 Award are given in NIH Program Announcement PA-00- 004 (http://grants.nih.gov/grants/guide/pa-files/PA-00-004.html) NIDDK K08/K23 award recipients will be invited, near the beginning of their third year of K support, to submit an R03 application. Awardees must have at least two years remaining on their K08/K23 at the intended start date of the R03. Under certain circumstances, and on a case-by- case basis, permission may be given for an applicant with less than two years remaining on their K08/K23 award to apply for the R03. Applications may be submitted by domestic for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PAR will use the National Institutes of Health (NIH) small grant (R03) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PAR may not exceed two years. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. DURATION OF PROGRAM ANNOUNCEMENT This PAR replaces PA-DK-98-087, which was published in the NIH Guide, July 9, 1998. This PAR will remain active for three years, until February 2004, at which time applications may no longer be submitted in response to this announcement. RESEARCH OBJECTIVES The NIDDK invites recipients of its K08/K23 awards to apply for grant support during the latter years of their awards through the NIDDK's Small Grant Program (R03). This additional support will enable K awardees to either expand their current research objectives or to branch out to a closely related pilot study, thus demonstrating their growth as investigators and their independence. This should facilitate the transition to fully independent investigator status. The added grant support in the latter years of a K08/K23 award is expected to have the following benefits: o increased fiscal independence for the K08/K23 award recipient as a precursor to complete independence; o an opportunity for the recipient to generate additional publications and data to form the basis for an R01 application; o an opportunity for a Scientific Review Group (SRG) to evaluate accomplishments made during the first two years of the K08/K23 award; o an opportunity for the applicant to provide more detailed research plans for the last two years of the K award; and o an opportunity for the applicant to demonstrate additional success in the peer review process during the course of their K08/K23 award. In implementing this program, the NIDDK will pay special attention to several factors: (1) the institutional commitment to the career of the applicant; (2) the career development program itself as supported by the K award; and (3) the potential for the funds provided by the R03 program to enhance the career of the applicant. In no case will the NIDDK discourage K08/K23 recipients from applying for and receiving R01 support during the course of their career awards. However, any K08/K23 recipient who receives an R01 will not be eligible to receive an R03 under this program. 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 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. Updates to policies can be seen at the following site: http://grants.nih.gov/grants/guide/notice-files/not99-082.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 APPLICATONS 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 Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research, or may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, email: GrantsInfo@nih.gov. 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 Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. Specific allowable costs for this R03 include: o Salary: none for the Principal Investigator since this is covered under the K08/K23. Salary for technical support is permitted, but not for mentor(s) salaries, or for secretarial or administrative assistance. o Research development costs: tuition, fees, and books related to career development; supplies and equipment; travel to research meetings or training; statistical services, including personnel and computer time. Applications, must include the following information: o Research accomplishments. Describe the research accomplishments to date under the auspices of the K08/K23 award. This should include progress that has been made toward the goals of the K award as they were presented in the original application as evidenced by publications, presentations, manuscripts submitted or in preparation, and any collaboration(s) made possible by the K award. o Research plan. Describe the research goals for the final two years of the K award. While the original K08/K23 application provided a research plan, this R03 application allows the candidate the opportunity to provide specific, detailed information about the research plan for the final two years of the K award, particularly relating to how the additional financial resources of the R03 would affect these plans and enhance progress. If the original goals of the K08/K23 award have been modified, detail the changes and the reasons for them. o Environment and career development plan. The institution's continued commitment to the career development goals of the applicant should be documented. For example: What facilities are to be placed at the disposal of the applicant? What educational opportunities, if necessary, will be available to the applicant? o A letter from the applicant's mentor must be included. It should address the applicant's progress, the applicant's potential for a future research career, and the mentor's continuing relationship with the applicant. It is expected that, during the final two years of the K award, and with the added resources provided by the R03, the applicant will become increasingly independent of his/her mentor. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $50,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $50,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. Since the K08/K23 award supports the Principal Investigator’s salary, he/she should be listed at 10 - 25% effort as appropriate, with no salary support from the R03 grant. o CONSORTIUM/CONTRACTUAL COSTS - Provide an estimate of Total Costs (direct plus F&A costs) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. o BIOGRAPHICAL SKETCH: The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations; o CHECKLIST: This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. o 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) The Center for Scientific Review (CSR) will not accept any application in response to this PA 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 Public Health Service referral guidelines. Applications will be reviewed by the Center for Scientific Review (CSR) for completeness. An appropriate scientific review group convened by the NIDDK in accordance with standard NIH peer review procedures will evaluate applications for scientific and technical merit. 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 NIDDK National Advisory 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. In the written comments, reviewers will be asked to discuss the following as 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. o 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? o 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? o Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o 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)? o 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 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 to the proposed research. o The adequacy of the proposed protection of humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. The following special review criteria will be applied to these R03 applications: o Research accomplishments: What has the applicant accomplished to date toward the goals of the awarded K08/K23? Have the research goals of the current application diverged from the original K08/K23 aims? o Scientific merit of research plan: How feasible is the research plan for two years of work? How likely is it that the proposed work will lead to an independent line of investigation for the applicant, distinct from that of his/her mentor? o Potential: What is the potential of this mechanism to successfully prepare the applicant to be competitive for funding opportunities at the end of the award? Has the institution's commitment to the scientific development of the applicant changed? o Relationship to mentor: Does the mentor's letter adequately discuss the applicant's progress? What is the continuing relationship between the applicant and the mentor? AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the National Institute of Diabetes and Digestive and Kidney Diseases. 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. Direct inquiries regarding programmatic issues to the program director responsible for the K08 or K23 award: James Hyde, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Room 603 Bethesda, MD 20892-5460 Telephone: (301) 594-7692 FAX: (301) 480-3768 Email: jh486z@nih.gov Judith Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Room 667 Bethesda, MD 20892-5450 Telephone: (301) 594-8876 FAX: (301) 480-8300 Email: jp53s@nih.gov Terry Rogers Bishop, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 619 Bethesda, MD 20892-5458 Telephone: (301) 594-7721 FAX: (301) 480-3510 Email: tb232j@nih.gov Direct inquiries regarding fiscal matters to: Donna Huggins Division of Extramural Activities NIDDK 6707 Democracy Boulevard, Rm. 637 MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8848 FAX: (301) 480-3504 E-mail: dh48v@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847, 93.848, and 93.849. Awards are 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 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 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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