PROTEIN STRUCTURE INITIATIVE (STRUCTURAL GENOMICS) -- SBIR/STTR Release Date: June 22, 1999 PA NUMBER: PA-99-117 National Institute of General Medical Sciences National Institute of Diabetes and Digestive and Kidney Diseases National Heart, Lung, and Blood Institute National Center for Research Resources National Library of Medicine STTR Application Receipt Dates: August 1, December 1, April 1 SBIR Application Receipt Dates: August 1, December 1, April 1 PURPOSE The purpose of this SBIR/STTR program announcement (PA) is to encourage research on the development of methodology and technology underpinning the emerging field of structural genomics, whose goal is the understanding of protein structural families, structural folds, and the relation of structure and function. Projects related to high throughput structure determination by x-ray crystallography and NMR, as well as those addressing other constituent tasks of structural genomics, are relevant to this PA. 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 PA, Protein Structure SBIR/STTR Initiative (Structural Genomics), is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html ELIGIBILITY REQUIREMENTS Eligibility requirements are described in the Omnibus Solicitation. Any small business concern, independently owned and operated by United States citizens or lawfully admitted permanent resident aliens, which is located in the United States and is organized for profit, may apply. MECHANISM OF SUPPORT Support for the PA is through the SBIR and STTR mechanisms. Applications can be submitted for support as Phase I STTR (R41) or Phase I SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; or under the SBIR/STTR FAST-TRACK option as described in the Omnibus Solicitations. Phase II applications in response to this PA will only be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase II proposal must be a logical extension of the Phase I research. Information on the FAST-TRACK process and the Omnibus Solicitations is available at http://www.nih.gov/grants/funding/sbir.htm. RESEARCH OBJECTIVES Following the completion of the sequence of the human genome, a crucial step in understanding living systems is the determination of the structure and function of the entire set of gene products. Data from the genome project have led to comparative protein sequence analyses and numerous efforts to develop methodologies for the identification of protein families. Utilization of these computational analyses with structural determinations by X-ray crystallography and NMR techniques to study protein structural families constitutes the new field of structural genomics and is the goal of the NIGMS Protein Structure Initiative (PSI). These studies should lead to an understanding of structure/function relationships and the ability to obtain structural models of all proteins identified by genomics. This project will require the determination of a large number (perhaps 10,000) of protein structures in a high throughput mode. Recent and anticipated technological developments in protein structural determinations make this formidable task feasible. The availability of comparative sequence analyses and methodological improvements now make such a large-scale structural project appropriate. Three recent workshops sponsored by NIGMS have focussed on the practicality, constituent tasks, goals, and planning of this project. There was general agreement on technical feasibility due to advances in the development of high throughput expression systems, protein purification, and sample preparation (crystallization for X-ray and isotopic labeling for NMR). All of these can likely be organized on the large scale required. Methods for the structure determination of proteins have also improved significantly in recent years. The identification of protein families and target selection proved to be the most controversial topic and was the focus of the third workshop. A summary of these meetings can be found on the NIGMS web site at http://www.nih.gov/nigms/funding/psi.html. Following the workshops and discussions by the National Advisory General Medical Sciences Council, it was concluded that the necessary tasks for the PSI project are feasible and that the goal of this initiative is an important scientific endeavor. The resulting basis set of protein structures and structure folds will be crucial in understanding protein structure and evolution, will contribute to the solution of the protein folding problem, and will provide insights into the relationship of structure and function. These discussions have led to the development of this support program for research on the development of methodology and technology for the constituent tasks of structural genomics and the PSI. The scope of this PA includes all the computational and experimental facets described above. These applications must directly address one or more of the constituent tasks of structural genomics and lead to likely improvements in the efficiency of the subsequent large scale program for structural determination in a high throughput mode. Grantees in the PSI program will be expected to attend an annual meeting at the NIH to discuss their progress and results. Summary The purpose of this SBIR/STTR program announcement is to stimulate research projects on the development of methodology and technology related to structural determinations in a high throughput mode and the other constituent tasks of structural genomics. This research is crucial for the subsequent development of a structural genomics research program and a structural inventory of proteins in living systems. There are two other initiatives related to this one: 1. A similar program for structural genomics methodology and technology development for individual research project applications (R01) and program project applications (P01). This PA is available at: http://www.nih.gov/grants/guide/pa-files/PA-99-116.html 2. Projects to serve as pilots to examine the best approach to integrated PSI (Structural Genomics) programs. These applications should include all the constituent parts of the overall PSI project. These pilots will be supported as research centers and the Request for Applications (RFA) for this program was published on June 3, 1999. The RFA is available at the following URL: http://www.nih.gov/grants/guide/rfa-files/RFA-GM-99-009.html APPLICATION PROCEDURES This PA must be read in conjunction with the Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant Applications (PHS 99-2) and the Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications (PHS 99-3). All of the instructions within the Omnibus Solicitation apply. Omnibus Solicitations for both the SBIR and STTR programs are available electronically through the NIH, Office of Extramural Research "Small Business Funding Opportunities" web site: http://www.nih.gov/grants/funding/sbir.htm. Hard copies, subject to availability, may be obtained from the PHS SBIR/STTR Solicitation Office, phone (301) 206-9385; FAX (301) 206-9722; email a2y@cu.nih.gov. Helpful information in preparation of the application can be obtained at: https://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf and https://grants.nih.gov/grants/funding/sbirsttr1/index.htm Applications in response to this PA are to be submitted on the grant application form PHS 6246-1 (1/98) for SBIR Phase I [http://www.nih.gov/grants/funding/sbir1/sbir.htm], PHS 6246-3 (1/98) for STTR Phase I [http://www.nih.gov/grants/funding/sttr1/toc.htm], PHS 6246-2 (1/98) for SBIR Phase II [http://www.nih.gov/grants/funding/sbir2/index.htm], and PHS 6246-4 (1/98) for STTR Phase II [http://www.nih.gov/grants/funding/sttr2/index.html]. The Phase I applications are also located in the back pages of the Omnibus Solicitation. The title and number of this PA must be typed in line 2 on the face page of the application. Potential applicants are encouraged to contact program staff for guidance and to read the advice and information on the web sites. However, responsibility for planning, direction, and execution of the proposed research will be solely that of the applicant. As stated in the MECHANISMS OF SUPPORT section, applications may be submitted for Phase I alone (R41/43), or Phase II (R42/44) alone if there has been previous and successful Phase I support, or through the FAST-TRACK mechanism. Application instructions specified in the Omnibus Solicitation for each mechanism must be followed. The normal level of support and period of time for a Phase I SBIR award is $100,000 and six months; for a Phase II SBIR award, $750,000 and two years. The normal level of support and period of time for a Phase I STTR award is $100,000 and one year; for a Phase II STTR award is $500,000 and two years. However, applicants may propose longer periods of time and greater amounts of funds if necessary for completion of the project. (See NIH Guide, February 12, 1998; http://www.nih.gov/grants/guide/notice-files/not98-014.html.) Phase I, FAST-TRACK applications must specify clear, measurable goals that should be achieved prior to Phase II funding. Failure to provide measurable goals in sufficient detail in the Phase II application may be a reason for the peer review committee to exclude the Phase II application from consideration. Phase II applications submitted in response to this PA will only be accepted as continuations of previously funded Phase I grants. The Phase II proposal must be a logical extension of the Phase I research but not necessarily a Phase I supported in response to this PA. The National Institutes of Health (NIH) is employing features of the Modular Grant Application and Award procedures under its SBIR program. SBIR Phase I grant applications requesting up to $100,000 total costs (direct costs, indirect costs, and fixed fee) will request direct costs in a budget narrative format rather than being compiled from detailed and separate categories. A summary of the unique features of the SBIR modular grant application and award process can be found at http://www.nih.gov/grants/funding/sbir1/modular.htm. These features are described in more detail within the SBIR Omnibus Solicitation (PHS 99-2, page 1). Similarly, a summary of the unique features of the STTR modular grant application and award process can be found at http://www.nih.gov/grants/funding/sttr1/modular.htm and are described in more detail within the STTR Omnibus Solicitation (PHS 99-3, page 1). For applications requesting in excess of $100,000 total costs (direct costs, indirect costs, and fixed fee) the Modular Grant features do not apply. The completed original application and one legible copy must be sent or delivered 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) Applications must be received by the receipt dates listed at the top of the first page of this PA. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Center for Scientific Review (CSR) for completeness and by the NIH institutes for responsiveness. Applications not adhering to application instructions described above and those applications that are incomplete or non-responsive will be returned to the applicant without review. Applications will be assigned on the basis of established NIH referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific 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, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. 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. Review criteria are as described in the Omnibus Solicitation: 1. The soundness and technical merit of the proposed approach. 2. The qualifications of the proposed Principal Investigator, supporting staff, and consultants. 3. The scientific, technical, or technological innovation of the proposed research. 4. The potential of the proposed research for commercial application. 5. The appropriateness of the budget requested. 6. The adequacy and suitability of the facilities and research environment. 7. Where appropriate, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects and/or (b) protecting against or minimizing any adverse effect on the environment. The phase I application should specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II. Failure to provide clear, measurable goals may be sufficient reason for the study section to judge the application non-competitive. AWARD CRITERIA Applications will compete for available funds with all other recommended SBIR and STTR applications. Funding decisions for Phase I or Phase II applications will be based on quality of the proposed project as determined by peer review, availability of funds, and program priority. Particular attention will also be given to whether or not the development of methods and technologies described in the application are likely to increase high throughput structure determination and provide the underpinning for structural genomics projects. In addition, the application must include plans for rapid dissemination of the results, and, if applicable, rapid deposition and release of all protein coordinates into the Protein Data Bank, i.e., holds on release are not permitted. FAST-TRACK Phase II applications may be funded following submission of the Phase I progress report and other documents necessary for continuation. Phase II applications will be selected for funding based on the initial priority score, NIGMS' assessment of the Phase I progress and determination that Phase I goals were achieved, the project's potential for commercial success, and the availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: John C. Norvell, Ph.D. Division of Cell Biology and Biophysics National Institute of General Medical Sciences 45 Center Drive, Room 2AS.13B Bethesda, MD 20892-6200 Telephone: (301) 594-0533 FAX: (301) 480-2004 Email: norvellj@nigms.nih.gov Maren R. Laughlin, Ph.D. Director of Metabolism Program, DDEM, NIDDK Natcher room 5AN-24J 45 Center Dr. MSC 6600 Bethesda, MD 20892-6600 Telephone: (310) 594-8802 FAX: (301) 480-3503 Email: LaughlinM@extra.niddk.nih.gov Carol H. Letendre, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10142 Bethesda, MD 20892-7950 Telephone: (301) 435-0080 FAX: (301) 480-0867 Email: letendrc@gwgate.nhlbi.nih.gov Abraham Levy, Ph.D. Biomedical Technology National Center for Research Resources 6705 Rockledge Drive, Room 6150 Bethesda, MD 20892-7965 Telephone: (301) 435-0755 FAX: (301) 480-3659 Email: al26y@nih.gov Peter Clepper, Ph.D. Program Officer Extramural Programs National Library of Medicine Bethesda, MD 20894 Telephone: (301) 594-4882 FAX: (301) 402-2952 Email: peter_clepper@nlm.nih.gov Direct inquiries regarding fiscal matters to: Ms. Linda Roberts Grants Management Office National Institute of General Medical Sciences 45 Center Drive, Room 2AS.55E Bethesda, MD 20892-6200 Telephone: (301) 594-5141 FAX: (301) 480-2554 Email: robertsl@nigms.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.821 for NIGMS; No. 93.847 for NIDDK; Nos. 93.837, 93.838, and 93.839 for NHLBI; No. 93.371 for NCRR; and 93.879 for NLM. 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 the NIH Grant Policy Statement (10/1/98) and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and Part 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, and 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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