SMALL BUSINESS INITIATIVE FOR ALCOHOL PROTEOMICS RELEASE DATE: October 1, 2002 RFA: AA-03-003 National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) LETTER OF INTENT RECEIPT DATE: December 16, 2002 APPLICATION RECEIPT DATE: January 16, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support 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 PURPOSE OF THIS RFA This Request for Applications (RFA) seeks grant applications for Small Business Innovation Research (SBIR) projects and for Small Business Technology Transfer Research (STTR) projects that use currently available technologies or emerging new methodologies in protein analysis and proteomics research to conduct studies relevant to alcohol research. For example, the identification of diagnostic biomarkers that may provide an early diagnosis of alcohol-induced diseases as well as biomarkers associated with excessive alcohol consumption and alcohol consumption during pregnancy are particularly encouraged. NIAAA is also interested in the use of proteomics to identify molecular targets for medication development related to the medical sequelae associated with chronic alcohol abuse. Consequences include neurodegeneration, cirrhosis, pancreatitis, cardiomyopathy, immune disorders, fetal alcohol syndrome, etc. Realizing that proteomics companies may not be acquainted with research on alcohol abuse/dependence and that most alcohol researchers may not have access to proteomics and bioinformatics technologies, this RFA encourages an interactive approach. Collaborative submissions that include preclinical or clinical alcohol researchers and a proteomics company are highly encouraged. Synopses of funded alcohol grant applications are in the CRISP database (http://crisp.cit.nih.gov/). To assist in the teaming process, a web site has been established at URL: http://www.sainc.com/niaaa. In case of conflict, information in the RFA takes precedence over information at this web site. The web site also allows individual researchers and organizations with specific, applicable expertise or capabilities to provide non- proprietary descriptions of their capabilities and interests. The web site will remain active from the date of issuance of this RFA until the deadline for proposals. Specific information content, communications, networking, and team formation are the sole responsibilities of the participants. NIAAA will not participate in these activities other than to provide the web site forum to enable others to initiate communications. RESEARCH OBJECTIVES Background Approximately 14 million Americans (7.4% of the population) meet the diagnostic criteria for alcohol abuse and alcoholism. In addition, an estimated three million teenagers between 14 and 17 are regular drinkers who may develop alcohol use problems. These data demonstrate that large numbers of individuals have problems with alcohol and its sequelae, and the numbers affected will grow due to the increase in excessive alcohol consumption by youth. Alcohol abuse results in disease, death, and enormous costs to society in terms of lost productivity and health-care costs. Early identification of alcohol-related diseases as well as new innovative treatments are desired. Alcohol is known to modulate gene transcription, mRNA stability, protein synthesis, and post-translational modifications of proteins in many tissues. Alcohol-induced modulations of various proteins may correlate with the severity of tissue injury and associated medical disorders. The lack of objective measures to detect the early stages of alcohol-induced tissue injury has hindered diagnosis, prevention, and treatment of alcohol-related medical disorders. Proteomics can provide powerful tools for the identification of alcohol-induced changes in protein that occur before clinically detectable signs of damage. In addition to pursuing traditional hypothesis-driven approaches to identify targets to treat the consequences of chronic excessive alcohol consumption, it is prudent to initiate broad-based searches for molecules involved in the disease process. Proteomics is the measurement of a complete complement of protein expression patterns within cells, tissues, or organisms at a specific point in time under specific conditions. One potential application of proteomics to alcohol research is the identification of biomarkers for disease progression as well as biomarkers for alcohol tolerance, dependence, relapse, and withdrawal. Biomarkers could detect and monitor progression of neurodegeneration, fetal alcohol syndrome, cirrhosis, pancreatitis, cardiomyopathy, immune disorders, certain types of cancers, and other alcohol-related diseases. Another potential application of proteomics to alcohol research is the identification of cellular or molecular targets for drug development, and determining responsiveness to novel compounds in high throughput screens. For example, the use of proteomics can be used to screen clinical subjects that respond or fail to respond to existing drugs such as acamprosate and naltrexone. Proteomics has been enabled by the accumulation of both DNA and protein sequence databases as well as the development of tools that enable the identification and quantification of proteins. These include matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometry and isotope-coded affinity tag (ICAT) as well as the development of computer algorithms for database searching such as Sequest and SALSA (Scoring Algorithm for Spectral Analysis). These techniques are currently being used to test large-scale variations in protein expression levels (expression proteomics) and Cell Map proteomics, referred to as functional proteomics. Therefore, NIAAA seeks small business projects that will utilize state-of- the-art mass spectrometry techniques, protein separation techniques, as well as bioinformatics to study alcohol-related pathologies. Genomic data and transcriptional profiling have offered tremendous opportunities to identify changes in gene expression. However, these techniques show only a moderate correlation between changes in protein abundance and mRNA and do not specify protein interactions, how interactions occur, or protein localization. The proteomics approach, on the other hand, could reveal the levels, activities, regulation, and interactions of proteins in the cell and how these are modified to a particular stimulus such as alcohol. Objectives and Scope Among the many challenges to alcohol research is the identification of biomarkers for improved diagnosis and the definition of effective therapeutic measures. The range of topics to be addressed under this RFA includes but is not limited to: - Identification of biomarkers associated with excessive alcohol consumption as well as biomarkers that will provide early detection of alcohol-related conditions. These include neurodegeneration, fetal alcohol syndrome, cirrhosis and other liver diseases, pancreatitis, cardiomyopathy, immune disorders, and certain types of cancers. - Detection of definitive stages of alcohol mediated disease progression that could be targeted for therapeutic intervention through proteomic screening panels. For example, various stages of alcoholic liver disease including early fibrogenesis and other organ pathology. - Development of protein profiles that predict pathology before overt cell and tissue damage such as pro-inflammatory, adhesion molecule, immune mediator profiles and oxidant stress. - Identification of molecular targets for medications development for alcohol-associated medical conditions, alcohol susceptibility, alcohol dependence, alcohol consumption, withdrawal, and relapse. - Adaptation of methods to detect protein:protein interactions that are relevant to alcohol associated diseases and alcohol-related phenotypes by the generation of appropriate protein chips. Phenotypes include tolerance, preference, dependence, withdrawal, and relapse. - The use of bioinformatics for the development of improved computational analysis tools for the analysis of proteomics data related to alcohol research. MECHANISM OF SUPPORT PHASE I Phase I applications in response to this RFA will use the Phase I SBIR (R43) and STTR (R41) award mechanisms with modifications as described below. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. In preparing your proposal, you should refer to the "Omnibus Solicitation of the National Institutes of Health for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR)Grant Applications", http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf, which describes the SBIR/STTR grant program. Applications for Phase I applications 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/STTR application. PHS 398 forms specific to SBIR/STTR applications are available. See http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc. Project Period and Amount of Award SBIR Phase I awards normally may not exceed $100,000 total costs [including direct costs, indirect costs and profit/fee] for a period of 6 months. STTR Phase I awards normally may not exceed $100,000 total costs for a period of 1 year. The duration and cost of research to develop proteomics technologies and tools to be used for identifying biomarkers of, and therapeutic targets for treating alcohol abuse are likely to exceed that routinely awarded for SBIR/STTR grants. Therefore, well-justified Phase I applications of longer duration than typical SBIR/STTR projects will be considered. These applications can request a project period of up to two years and a budget not to exceed total costs of $400,000 (i.e., an average of $200,000 total costs per year). Consultant and Contractual Costs The total amount of all consultant costs and contractual costs normally may not exceed 33% of the total costs requested for Phase I SBIR/STTR applications. Phase I grant applications submitted under this RFA may exceed this limit if the resources required for developing proteomics technologies and tools to be used for identifying biomarkers of, and therapeutic targets for treating, alcohol abuse are relatively scarce, highly specialized, and multidisciplinary. Deviations must be appropriate and fully justified. Page Limitations The page limitations for Phase I applications applies (see Omnibus Solicitation). MECHANISM OF SUPPORT - PHASE II Phase II applications in response to this RFA will use the Phase II SBIR (R44) and STTR (R42) award mechanisms with modifications as described below. All Phase II applications 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 application 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 SBIR Phase II awards normally may not exceed $750,000 total costs [including direct costs, indirect costs and profit/fee] for a period of 2 years. STTR Phase II awards normally may not exceed $500,000 total costs for a period of 2 years. The duration and cost of research to develop proteomics technologies and tools to be used for identifying biomarkers of, and therapeutic targets for treating alcohol abuse is likely to exceed that routinely awarded for SBIR/STTR grants. Therefore, well-justified Phase II applications of longer duration than typical SBIR/STTR projects will be considered. These applications can request a project period of up to three years and a budget not to exceed total costs of $1,200,000 (i.e., an average of $400,000 for each of three years). Consultant and Contractual Costs The total amount of all consultant costs and contractual costs normally may not exceed 50% of the total costs requested for Phase II SBIR/STTR applications. Phase II grant applications submitted under this PA may exceed this limit if the resources required for developing an alcohol sensor and/or data analysis system are relatively scarce, highly specialized, and multidisciplinary. Deviations must be appropriate and fully justified. The Fast-Track initiative can be used under this RFA. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/phs398/instructions2/p1_SBIRSTTR _general_instructions.htm. Specifically, if you are submitting an application budget of $100,000 total costs or less, use the modular format. PROGRAM OBJECTIVES The SBIR/STTR programs consist 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/STTR funding. FUNDS AVAILABLE The NIAAA intends to commit approximately $2,500,000 in FY 2003 to award 12 to 15 new Phase I or Phase II SBIR/STTR grants in response to this RFA. An applicant may request a project period of up to 2 years and a budget for total costs of up to $200,000 per year for Phase I applications, and a project period of up to 3 years and a budget for total costs of up to $400,000 per year for Phase II applications. Because the nature and scope of the proposed research will vary between applications, it is anticipated that the size and duration of each award will also vary. 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. ELIGIBLE INSTITUTIONS Eligible small business concerns must meet all of the following criteria to receive an SBIR or STTR award. 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/. 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 applicant 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 applicant'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. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: - Direct questions about scientific/research issues to: Lisa A. Neuhold, Ph.D. Program Director for Genetics Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 594-6228 Fax: (301) 594-0673 Email: Lneuhold@willco.niaaa.nih.gov Roger G. Sorensen, Ph.D, MPA Program Director for Neurochemistry, Neurotoxicology and Molecular Pharmacology Research Branch Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2678 Fax: (301) 594-0673 Email: rsorense@mail.nih.gov Marvin Salin, Ph.D. Program Director for Metabolic Diseases Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4225 Fax: (301) 594-0673 Email: msalin@mail.nih.gov - Direct 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 LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o 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 NIAAA 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-03-003 Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409, MSC 7003 Bethesda, MD 20892-7003 (use Rockville, MD 20852 for express/courier service) Telephone: (301) 443-4375 FAX: (301) 443-6077 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. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: SBIR applications requesting up to $100,000 per year in total costs (direct costs, indirect costs and fee) must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Section VI of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by- step guidance for preparing modular grants. Additional information on SBIR modular grants is available at http://grants.nih.gov/grants/funding/phs398/instructions2/p1_SBIRSTTR _general_instructions.htm. 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: Extramural Project Review Branch Attn: AA-03-003 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409, MSC 7003 Bethesda, MD 20892-7003 (use Rockville, MD 20852 for express/courier service) 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. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAAA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 o Receive a second level review by the NIAAA 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 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: o Significance o Approach o Innovation o Investigator o 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. In considering the scientific and technical merit of each application, the following criteria will be used: ALL SBIR/STTR APPLICATIONS o 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? Will the proposed research 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? o 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? o INNOVATION: Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims original and innovative? o 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? o 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o 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. o 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) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. Phase II Application Review Criteria In addition to the above criteria: 1. 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? 2. Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in the Research Plan item J? 3. Does the project carry a high degree of commercial potential, as described in the Product Development Plan? Phase I/Phase II Fast-Track Application Review Criteria For Phase I/Phase II Fast Track applications, the following criteria also will be applied: 1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? 2. Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in the Research Plan, item J? 3. 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? 4. 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 16, 2002 Application Receipt Date: January 16,2003 Peer Review Date: March-April 2003 Council Review: June 4, 2003 Earliest Anticipated Start Date: July 1, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. Note that applicants may achieve all Phase I goals and milestones and still not receive Phase II funding. 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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