SBIR/STTR INITIATIVE FOR SOFTWARE DEVELOPMENT FOR LONGITUDINAL ANALYSIS OF COMPLEX SURVEY DATA RELEASE DATE: October 21, 2002 RFA NUMBER: AA-03-006 National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) Letter of Intent Receipt Date: December 24, 2002 Application Receipt Date: January 24, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Mechanism Objectives o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations o PURPOSE This Request for Applications (RFA) invites grant applications for Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) projects on software development for longitudinal analysis of complex survey data. o RESEARCH OBJECTIVES Background Research studies in the alcohol field are concerned with the causes and consequences of alcohol abuse and dependence and their associated physical and mental disabilities with a view towards diagnosis, treatment and prevention. Because of the recent attention to the importance of gene- environment interactions, more and more research will begin to focus on the iterative process of longitudinal development to explain the initiation, continuation, stability, and remission of alcohol use disorders and their associated disabilities. Comprehensive software packages are currently limited relative to the complexity of developmental theories that must be tested. Research Topics Despite recent advances made in developing software programs for longitudinal latent and observed variable structural modeling, very little has been accomplished in this research arena regarding modeling with complex sample data. Currently there is no comprehensive statistical software package that allows such modeling that takes into account sampling weights, stratification and clustering while at the same time allowing for these observed variables to be either categorical, continuous, or a combinations of both. Moreover, there is no currently available comprehensive statistical package that allows for the longitudinal analysis of complex survey data for the variety of models necessary for the analysis of alcohol-related longitudinal data (e.g., linear, probit and logistic regression, survival analysis [continuous and discrete-time allowing for time-varying covariates], path analysis, exploratory and confirmatory factor analysis, growth modeling, growth mixture modeling, multilevel modeling, linear and nonlinear growth modeling, and combinations and variants of these models). o MECHANISM OF SUPPORT – PHASE I Phase I applications in response to this RFA will be funded as Phase I SBIR grants (R43) or STTR grants (R41) with modifications as described below. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Applications for Phase I grants should be prepared using the PHS 398 instructions and forms: http://grants.nih.gov/grants/funding/phs398/phs398.html. Please refer to Chapter VI of the PHS 398 instructions prior to preparing an SBIR or STTR application. PHS 398 forms specific to SBIR and STTR applications are available. See http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc. Project Period and Amount of Award The duration and cost of research for Phase I applications under this RFA will be six months and a total cost of $100,000. Consultant and Contractual Costs Because the resources required for developing data analysis systems are relatively scarce, highly specialized, and multidisciplinary, the total amount of consultant costs and contractual costs requested by applicants may exceed the statutory guidelines. Requests in excess of the guidelines must be fully justified. o MECHANISM OF SUPPORT - PHASE II Phase II applications in response to this RFA will be awarded as Phase II SBIR grants (R44) or STTR grants (R42) with modifications as described below. Phase II applications in response to this RFA will only be accepted as competing continuations of previously funded NIH Phase I SBIR awards. The previously funded Phase I award need not have been awarded under this RFA but the Phase II proposal must be a logical extension of the Phase I research. Applications for Phase II awards should be prepared using the PHS 398 instructions and forms: http://grants.nih.gov/grants/funding/phs398/phs398.html. Please refer to Chapter VI of the PHS 398 instructions prior to preparing an SBIR application. PHS 398 forms specific to SBIR applications are available. See http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc. Project Period and Amount of Award The guideline duration and cost of research for Phase II is two years and a total cost of $750,000. Consultant and Contractual Costs Because the resources required for data analysis systems are relatively scarce, highly specialized, and multidisciplinary, the total amount of consultant costs and contractual costs requested by applicants may exceed the statutory guidelines. Requests in excess of the guidelines must be fully justified. The Fast-Track initiative can be utilized under this RFA. Applications for Fast Track SBIR grants should be prepared following the instructions for Phase I and Phase II applications at http://grants.nih.gov/grants/funding/phs398/phs398.html, and the additional instructions at http://grants.nih.gov/grants/funding/sbirsttr1/sbirsttrft-rs.pdf. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the small business variation of modular format. o MECHANISM OBJECTIVES The SBIR program consists of the following three phases: Phase I The objective of Phase I is to establish the technical merit and feasibility of the proposed research, or research and development efforts, and to determine the quality of performance of the small business grantee organization prior to providing further federal support in Phase II. Phase II The objective of this phase is to continue the research or research and development efforts initiated in Phase I. Phase III The objective of this phase, where appropriate, is for the small business concern to pursue the commercialization of the results of the research or research and development funded in Phases I and II. Phase III occurs without SBIR funding. o FUNDS AVAILABLE NIAAA intends to commit approximately $500,000 in FY 2003 to fund 3 to 5 new SBIR or STTR grants in response to this RFA. Although the financial plans of NIAAA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. o ELIGIBLE INSTITUTIONS Small business concerns are eligible to submit (an) application(s). A small business concern is one that, on the date of award for both Phase I and Phase II agreements, meets ALL of the following criteria: 1. is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; 2. is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture (as defined in this section) there can be no more than 49 percent participation by foreign business entities in the joint venture; 3. is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; has, including its affiliates, not more than 500 employees, and meets the other regulatory requirements found in 13 CFR Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 CFR 121.3-2(a). The term "number of employees" is defined in 13 CFR 121.3-2(t). Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Size District Office at http://www.sba.gov/size/. o INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The primary employment of the PI must be with the small business concern at the time of award and during the conduct of the proposed project. Primary employment means that more than one half of the PI's time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization. o WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: Direct your questions about scientific/research issues to: Bridget Grant, Ph.D. Biometry Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd., Suite 514 Bethesda, MD 20892-7003 Telephone: (301) 443-7370 Fax: (301) 443-8614 Email: bgrant@willco.niaaa.nih.gov Direct your questions about peer review issues to: Eugene G. Hayunga, Ph.D. Chief, Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-4375 FAX: (301) 443-6077 Direct your questions about financial or grants management matters to: Judy Fox Simons Chief, Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 (301) 443-4704 (telephone) (301) 443-3891 (fax) email: jsimons@willco.niaaa.nih.gov o LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by that includes the following information: - Descriptive title of the proposed research - Name, address, and telephone number of the Principal Investigator - Names of other key personnel - Participating institutions - Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: RFA-AA-03-006 Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-4375 FAX: (301) 443-6077 o SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Please refer to Chapter VI of the PHS 398 instructions prior to preparing a SBIR application. PHS 398 forms specific to SBIR applications are available: http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. Using the RFA Label The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Sending an Application to the NIH 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 must be sent to: AA-03-006 Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd., Suite 409 Bethesda, 20892-7003 Telephone: (301) 443-4375 Fax: (301) 443-6077 Application Processing Applications must be received by the application receipt date listed in the heading of this RFA. 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 RFA 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. An appropriate peer review group convened by NIAAA in accordance with the review criteria stated below will evaluate applications that are complete and responsive to the RFA for scientific and technical merit. As part of the initial merit review, all applications will: - Receive a written critique - Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score - Receive a second level review by the NIAAA National Advisory Council. o 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: Significance Approach Innovation Investigator Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Review criteria for all SBIR/STTR applications: 1. Significance - Does the proposed project have commercial potential to lead to a marketable product or process? Does this study address an important problem? - What may be the anticipated commercial and societal benefits of the proposed activity? - If the aims of the application are achieved, how will scientific knowledge be advanced? - Does the proposal lead to enabling technologies (e.g., instrumentation, software) for further discoveries? -Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs? 2. Approach - Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? - Is the proposed plan a sound approach for establishing technical and commercial feasibility? - Does the applicant acknowledge potential problem areas and consider alternative strategies? - Are the milestones and evaluation procedures appropriate? 3. Innovation - Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? - Are the aims original and innovative? 4. Investigators - Is the Principal Investigator capable of coordinating and managing the proposed SBIR/STTR? - Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)? - Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed? 5. Environment - Is there sufficient access to resources (e.g., equipment, facilities)? - Does the scientific and technological 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? Review criteria for Phase II applications: - How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity? - Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in the Research Plan item J? - Does the project carry a high degree of commercial potential, as described in the Product Development Plan? Review criteria for Phase I/Phase II Fast Track applications: - Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? - Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in the Research Plan, item J? - To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/ STTR funding sources that would enhance the likelihood for commercialization? - Does the project carry a high degree of commercial potential, as described in the Product Development Plan? Phase I and Phase II Fast-Track applications that satisfy all of the review criteria will receive a single rating. Failure to provide clear, measurable goals may be sufficient reason for the scientific review group to exclude the Phase II application from Fast-Track review. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 24, 2002 Application Receipt Date: January 24, 2003 Peer Review Date: March-April 2003 Council Review: June 4, 2003 Earliest Anticipated Start Date: July 1, 2003 o AWARD CRITERIA Award criteria that will be used to make award decisions include: Scientific merit (as determined by peer review) Availability of funds Programmatic priorities Commercialization potential Applications will compete for available funds with all other favorably recommended SBIR applications. Note that applicants may achieve all Phase I goals and milestones and still not receive Phase II funding. o REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. 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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 RFA 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.273, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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