NIAAA SMALL GRANT PROGRAM Release Date: May 7, 1999 PA NUMBER: PAR-99-098 P.T. National Institute on Alcohol Abuse and Alcoholism THIS PROGRAM ANNOUNCEMENT (PA) USES MODULAR GRANT PROCEDURES. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. (SEE APPLICATION PROCEDURES. ALSO SEE MODULAR GRANT APPLICATION AND AWARD NOTICE This PA replaces and supersedes the NIAAA portion of PA-91-08. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites Small Grant (R03) applications relating to research on alcohol-related problems. These are short-term awards (up to two years) with limited funding (up to $50,000 per year for direct costs) that are intended to provide support for pilot/feasibility projects, testing of new techniques, secondary analysis of existing data, or development of innovative or high-risk projects that could provide a basis for submission of a regular research project grant application. An NIAAA Small Grant may also be used as a pilot or planning grant for the design and coordination of full-scale clinical trials. The program is also intended to stimulate and facilitate the entry of less experienced investigators and established investigators in other fields into alcohol-related research and shorten the time for the application award process. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement is related to several priority areas applicable to alcohol abuse and alcoholism. Potential applicants may obtain a copy of "Healthy People 2000" at ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit 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. Foreign organizations and institutions are not eligible. Participation in the program by investigators at minority institutions is strongly encouraged. Small grant support may not be used to supplement research projects already being supported or to provide interim support of projects under review by the National Institutes of Health (NIH). Simultaneous submission of both a small and regular research project grant (R01) on the same topic is not permitted. Small grant support may not be requested for thesis or dissertation research. MECHANISM OF SUPPORT Applicants may request either $25,000 or $50,000 in direct costs per year for up to two years through the Small Grant (R03) mechanism. Facilities and Administrative (F&A) costs will be awarded based on the negotiated rate at the time of the award. These awards are not renewable, however, a no-cost extension of up to one year may be granted to the grantee institution prior to expiration of the project period. Before completion of the R03, investigators are encouraged to seek continuing support for research through a research project grant (R01). Replacement of the Principal Investigator on this award is not permitted. RESEARCH OBJECTIVES The NIAAA Small Grant Program provides limited financial support for research within the program interests of the NIAAA. This includes basic and applied research on biochemical, physiological, genetic, and behavioral mechanisms leading to pathological drinking behavior, mechanisms of alcohol-induced organ damage, including fetal injury, and clinical, behavioral, and epidemiological approaches to more effective diagnosis, prevention, and treatment of alcohol abuse and alcoholism and the associated problems. While applications may involve a wide variety of biomedical, behavioral, or clinical disciplines, relevance to the mission of the NIAAA must be clear. The Institute"s mission statement, research program description, and special emphasis areas may be found at the NIAAA"s Internet website: Examples of studies suitable for the small grant mechanism include, but are not limited to: - Studies on the etiology of alcoholism, - Validation of alcohol-related behavioral phenotypes suitable for genetic analysis, - Development of new models to study alcohol preferences, reinforcement, tolerance and craving at different life stages, - Development of improved methods, either biological or behavioral, for identifying individuals at risk for alcohol abuse/alcoholism or its medical consequences, - Development of prototypic therapeutic agents to reduce alcohol consumption, reverse craving, reduce acute intoxication, and prevent withdrawal-related brain damage, - Development of prototypic therapeutic agents to prevent or treat the medical consequences of alcohol abuse, including effects on the developing fetus, - Pilot clinical trials to evaluate the potential efficacy of new pharmacological or behavioral approaches to treatment or prevention of alcohol-related problems, - Studies to test putative markers of alcohol consumption or markers of fetal alcohol exposure, - Evaluation of new approaches to study mechanisms of organ and tissue injury, such as liver, pancreas, heart, brain, and fetus, - Development, modification, or enhancement of instruments, techniques, or analytic strategies to assist in alcoholism treatment or prevention studies, - Planning grants or pilot testing for planned large, complex clinical trials, prevention programs, genetic studies, or epidemiological studies, and - Secondary analyses of large data sets to test new hypotheses. 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 are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. These may be accessed at: 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. 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: Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and prepared according to the directions in the application packet, with the exceptions noted 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, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)435-0714, FAX (301) 480- 0525, Email: On the face page of the application, Item 2, type "NIAAA SMALL GRANT PROGRAM - PAR-99-098." Check the "YES" box. RESEARCH PLAN: Do not exceed a total of 10 pages for the following parts (a-d): Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Experimental Design and Methods. Tables and figures are included in the 10- page limitation. Applications that exceed the page limitation or PHS requirements for type size and margins(refer to PHS 398 application instructions for details) will be returned to the investigator. The 10-page limitation does not include parts e through i. (Human Subjects, Vertebrate Animals, Literature Cited, Consortium Arrangements, Consultants). The NIAAA Small Grant Program will follow modular procedures for application instructions and award. The following changes to the instructions in the PHS 398 form pertain to the use of the modular application and award process. Use these instructions to complete the application. FACE PAGE: Item 7a should be completed, indicating Total Direct Costs for the first year requested either as $25,000 or $50,000 annual direct costs. Item 7b should reflect Total Costs (Modular Total Direct plus Facilities and Administrative (F&A) costs) for the first year. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. 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. 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. NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page. (See sample at At the top of the page enter the total direct costs requested. Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. For Consortium/Contractual costs, provide an estimate of total costs (direct and F&A) for each year rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key 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. 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: o Complete the educational block at the top of the form page, o List current position(s) and then previous positions, o List selected peer-reviewed publications, with full citations, and o Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. 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. It is important to identify all exclusions that were used in the calculation of the F&A costs for the initial budget period and future budget year. Submit a signed original of the application and five exact photocopies, including the checklist, 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) The submission, review, and award schedule for the NIAAA Small Grant Program is: Application Receipt Dates: Feb 1 Jun 1 Oct 1 Institute Committee Review: Jun Oct Feb Earliest Funding: Aug Dec Apr REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened 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 and assigned a priority score. 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 review, comments on the following aspects of the application will be made 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? 3. 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? 4. Investigator. Is the investigator appropriately trained and well-suited to carry out the 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, 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. Additional considerations pertinent to the review of Small Grant (R03) applications: - Because the research plan is limited to 10 pages, a Small Grant application may not have the same level of detail or extensive discussion normally found in an R01 application. Review emphasis should be placed on conceptual framework and general approach to the problem, with less emphasis on methodological details. - Pilot/feasibility studies contain little or no preliminary data. Review should focus on whether the rationale for the study is well developed and whether the proposed research is likely to generate data that will lead to a regular research project grant or full-scale clinical trial. Adequate justification for the proposed work may be provided through literature citations, data from other sources, or investigator-generated data. 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 program balance and priorities, and o availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquires regarding programmatic issues to: Dr. Ernestine Vanderveen Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2530 Fax: (301) 594-0673 Email: Dr. Richard Fuller Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1206 Fax: (301) 443-8774 Email: Dr. Mary Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-3851 Fax: (301) 443-8614 Email: Direct inquiries regarding fiscal matters to: Ms. Judy Simons Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2434 Fax: (301) 443-3891 Email: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.273. 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, 285 and 290) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 or Part 92, as appropriate. 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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