RFA-DE-04-007: THE SALIVARY PROTEOME: CATALOGUE OF SALIVARY SECRETORY COMPONENTS

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THE SALIVARY PROTEOME: CATALOGUE OF SALIVARY SECRETORY COMPONENTS RELEASE DATE: August 1, 2003 RFA Number: RFA-DE-04-007 National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.121 LETTER OF INTENT RECEIPT DATE: December 20, 2003 APPLICATION RECEIPT DATE: January 20, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements 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 The National Institute of Dental and Craniofacial Research (NIDCR) invites Cooperative Agreement Applications (U01) for outstanding multidisciplinary research, aimed at generation of a complete catalogue of all salivary secretory components using state of the art, sensitive and high-throughput proteomics technologies. These methodologies should include two-dimensional gel electrophoresis for profiling complex mixtures; protein arrays; yeast two-hybrid systems; phage display; antibodies, DNA, RNA, or other molecules as bait for analysis of salivary secretory protein complexes for analysis by TOF MS/MS, MALDI- TOF, ESI-MS/MS. In addition, computational and novel biocomputing methods should be utilized for maintenance and provision of a stable, comprehensive, fully classified, and accurately annotated protein sequence knowledgebase. The identification and cataloging of the salivary secretory components and their complexes is likely to be design-directed rather than hypothesis-driven research. Therefore, rather than presenting a hypothesis and an experimental plan to test it, applicants should address: i) the technologies that will allow the identification and cataloguing of the parotid, submandibular and sublingual secretory components; ii) the program plan that includes the overall plan, with a timetable, for accomplishing and coordinating robust operation and high quality data; and iii) the anticipated barriers and approaches for overcoming them. RESEARCH OBJECTIVES Secretions from the major salivary glands (parotid, submandibular and sublingual) contain a number of glycoproteins, peptides and non- glycosylated proteins that contribute to the important roles that saliva plays in maintaining the health of the oral cavity and of the whole body. To date, through traditional biochemical approaches studying individual genes and proteins, salivary researchers have made impressive progress on the elucidation of the structure and functions of some of the major salivary secretory components. For example, the structure and function of the genes and proteins of high molecular weight glycoproteins such as mucins, low molecular weight proline rich proteins, histatins, amylase and antimicrobial secretory proteins, have been determined. Mucins act as lubricates and as protectors of the oral mucosa. Proline rich proteins are stabilizers of the calcium phosphate equilibrium in saliva and have been shown to help in the re- mineralization of tooth enamel. Histatins are responsible for preventing the sporulation of Candida albicans while lysozyme, lactoferrin, saliva peroxidase and secretory immunoglobulins confer the immune and non-immune functions of saliva. However, there is a need for the systematic study of all salivary secretory components and their complexes, with the aims of identifying and cataloguing them, and providing detailed descriptions of their structure and function. Proteomics is essential for a comprehensive approach for cataloging all salivary secretory components and, if possible, creating the "periodic table" of the salivary proteome that will help elucidate disease pathogenesis and evaluate the influence of medications on the structure, composition and secretion of all salivary secretory constituents. The field of proteomics has garnered renewed interest, with advances in mass spectrometry allowing the analysis of ever-diminishing quantities of proteins, and the refinement of identification software is providing the means to match these data with translations predicted from nucleotide sequence data (originating from the genome projects). To date much of the effort in contemporary proteomics is directed toward the development of suitable platforms (chips) in order to interrogate each component in a complex mixture prior to its being resolved by mass spectrometry. The complex chemical nature of high molecular weight glycoproteins, hydrophobic peptides and proteins, the diversity of binding interactions, and the variety of conditions for optimum binding, make the development of protein-based arrays more challenging than that of gene chips. Each element of a chip for protein profiling should be functionalized with a capture agent to interrogate its interacting partner(s) in a complex protein mixture. Capture agents can be specific, such as natural or phage display antibodies, protein protein interaction partners or protein binding ligands. The arrays must be robust, and linkage to the chip surface should neither mask the recognition site(s) nor significantly alter binding parameters, such as the dissociation constant (on-rate and off-rate), and specificity of the interaction. The generation and analysis of proteome data are becoming increasingly widespread, as the field of proteomics is moving incrementally toward high-throughput approaches. Techniques are also increasing in complexity as the relevant technologies evolve. Thus there is a need for a systematic approach to modeling, capturing, and disseminating proteomics experimental data. The creation, maintenance and provision of a stable, comprehensive, fully classified, richly and accurately annotated protein sequence knowledgebase, with extensive cross- references and querying interfaces of structural and functional proteomics projects are important in order to understand the genetic and biological mechanisms causing human disease. Scope: This RFA will support the range of activities required to assemble the salivary proteome, that is, the first comprehensive list of all salivary secretory components and their complexes. It is envisioned that these studies will help create the "periodic table" of the parotid, submandibular and sublingual secretory components. The information will be invaluable in: i) developing an artificial salivary gland that secretes the necessary glycoproteins, peptides and proteins; ii) launching functional studies of the salivary secretory components; and iii) complementing the NIDCR's Program on Salivary-Based Diagnostic Technologies; particularly the validation of the developed diagnostic technologies. Applicants should address most if not all of the following topics, though additional methods complementing these topics are highly encouraged: o use of state-of-the-art methods coupled to mass spectrometry to analyze salivary secretory protein complexes and to identify and catalogue all proteins, peptides and glycoproteins and their complexes present in parotid, submandibular and sublingual secretions; o utilization of specific protein-binding ligands, nucleic acid aptamers, polypeptides, oligonucleotides, polysaccharides and phospholipids, or even less specific chemistries such as reverse-phase media or functional chemical groups to enrich for low abundance proteins or to reduce the complexity of the salivary mixture prior to mass spectrometry; and o development of computer programs and algorithms for data entry, storage, acquisition and input of data sets as well as development of informatics tools and resources to share and analyze the collected data. Accomplishing these activities will require the participation of multidisciplinary teams that will include biologists, chemists, technology developers, engineers and computer scientists. MECHANISM OF SUPPORT This RFA is a one-time solicitation. Future unsolicited, competing- continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 2004. This RFA will use the NIH cooperative agreement (U01) award mechanism. The NIH U01 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award". This RFA uses just-in-time concepts and the non-modular budgeting formats. Follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NIDCR intends to commit approximately $3 million in FY 04 to fund two new grants in response to this RFA. An applicant may request a project period of up to 4 years and a budget for direct costs of up to $1 million per year. Although the financial plans of the NIDCR 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. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations 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 institution 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. SPECIAL REQUIREMENTS In order to ensure maximum progress in the identification and cataloguing of all parotid, submandibular and sublingual components, several special activities will be required of the funded investigators. The Principal Investigators (PIs) are expected to present a cost-effective plan to recruit and apply the appropriate expertise needed to meet the project goals. The research plan must describe how effective communication between the various components will be established and maintained, the information flow by which input from various perspectives will be gathered and used to implement the research plan, and how decisions will be made on resource deployment. Principal Investigators will be expected to attend Steering Committee meetings (see below) and participate in conference calls on a regular basis. Budget requests should include funds to support travel of the PI and one other investigator to attend the scheduled Steering Committee meetings. Restricted availability of unique research resources, upon which further studies are dependent, can impede the advancement of research and delivery of health care. Thus, the NIH is interested in ensuring that the information about new methods, technologies, and computer software that is developed through this program becomes readily available to the research community for further research and development, with the expectation that this will eventually lead to information and products that improve the health of the public. For this reason, applicants should develop and propose specific plans for sharing the data, materials, and software generated through the grant. These plans should be consistent with the policies of their institutional offices of technology transfer. NIH has developed guidance on developing such policies; information is available at: (http://www.ott.nih.gov/policy/rt_guide_final.html). The scientific review group will evaluate the adequacy of the proposed plans for sharing data. Comments on the plan and any concerns will be presented in an administrative note in the Summary Statement. The adequacy of the plan will be considered by NIDCR program staff and will be important in determining whether a grant shall be awarded. The sharing plan as approved, after negotiation with the applicant when necessary, will be a condition of the award. Evaluation of non- competing continuation applications will include assessment of the effectiveness and timeliness of research resource release. Applicants are reminded that the grantee institution is required to disclose each invention to NIH within two months after the inventor discloses it in writing to grantee institutional personnel responsible for patent matters. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, PHS regulations at 42 CFR Part 52 and DHHS grant administration regulations at 45 CFR Parts 74 and 92, as applicable, and other DHHS, PHS, and NIH Grant Administration policy statements. As stated above, the administrative and funding instrument used for this program is a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activities. Under the cooperative agreement, NIDCR's purpose is to work with the PI as a partner to assist and stimulate planning and implementation. NIDCR will not assume primary direction, responsibility, or a dominant operating role in the research. The primary role and total responsibility for this program resides with each Principal Investigator. The NIDCR, as noted below, will share specific tasks and activities in completing the agreement. 1. Awardee Rights and Responsibilities o The PI will have primary authority and responsibility to define objectives and approaches and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award. In addition, the PI agrees to follow the common protocols developed by the Steering Committee. o The PI will assume responsibility and accountability to the awardee organization officials and to the NIDCR for the performance and proper conduct of the research supported by the project in accordance with the terms and conditions of the award. o The PI will serve as a voting member of the Steering Committee, will attend the Planning Meeting and two Steering Committee meetings in the first year, and one Steering Committee meeting a year in subsequent years. o The PI will be responsible for sharing standardized information on new developments and/or methods for solving obstacles with the investigators funded through this initiative and with the NIDCR staff. o The PI will be responsible for implementing the plan for sharing data, materials and software resulting from this grant. o The PI will establish an Internal Advisory Committee to provide scientific and administrative oversight. The Internal Advisory Committee will be composed of the lead institute personnel and other technical or research personnel. The committee is expected to meet at least twice a year. Minutes of these meetings will be made available to NIDCR staff upon request. o Awardees will retain custody of, and have primary rights to, the data developed under these awards, subject to Government rights of access consistent with current DHHS and NIH policies. o Upon completion of the project, the PI is expected to put all study design materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NIDCR, for the conduct of research at no charge other than the costs of reproduction and distribution. 2. NIDCR Staff Responsibilities The dominant role and prime responsibility for the project as a whole resides with the awardees although specific tasks and activities in carrying out the studies will be shared by awardees and the NIDCR. The Institute will designate a Program Scientist who will have substantial scientific-programmatic involvement above and beyond normal program stewardship during contact of this activity. o The NIDCR Program Scientist will be a voting member of the Steering Committee and its subcommittees. o The NIDCR will designate a Program Director and a Grants Management Specialist to provide administrative oversight of the cooperative agreement. o The NIDCR Program Scientist will be responsible for using the information of the Steering committee to coordinate and facilitate the research activities for the creation of the salivary proteome, and attend and participate in all meetings of the Steering Committee. o The NIDCR Program Scientist will help the Steering Committee develop and draft operating policies and policies addressing recurring situations that require coordinated action. o The NIDCR Program Director will review the scientific progress of the individual grants for compliance with operating policies developed by the Steering Committee, and may recommend to the NIDCR to withhold support, suspend, or terminate an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee. o The NIDCR reserves the right to require the transfer of appropriate reagents, tools and pertinent data that are generated as the result of participation in research supported under these awards to an eligible third party, in order to advance the research. Collaborators supported under these awards must be informed of this right. o Support or other involvement of industry or any other collaborators in any study performed by the awardees may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification to, and concurrence by the NIDCR. 3. Collaborative Responsibilities (Steering Committee) o The NIDCR Program Scientist and PIs of the projects funded under this RFA will be responsible for forming a Steering Committee as defined below. The Steering Committee will act as the main governing board that will review the progress of the research activities, develop collaborative protocols, identify technological impediments to the progress, select strategies to surmount them, and identify opportunities for sharing techniques and tools developed within each individual project. The Steering Committee will advise NIDCR Program Staff of scientific developments and opportunities that may enhance the achievement of the program. o The Steering Committee will be composed of the PI from each project funded through RFA DE-04-007, and the NIDCR Program Scientist. The PI from each project will have one vote and the NIDCR Program Scientist will have one vote. o The Steering Committee may, as it deems necessary, invite additional, non-voting scientific advisors to meetings at which research priorities and opportunities are discussed. o There will be two meetings of the Steering Committee in the first year and one meeting per year in the following years. The first meeting of the PIs funded under this RFA will be a Planning Meeting in the Bethesda, MD area soon after grants are awarded. At the planning Meeting the Steering Committee will be formed and select a chairperson. At the first Steering Committee meeting the members may: (a) draft a charter to detail policies and procedures and develop a process for monitoring compliance with the policies and procedures and for recommending that the NIDCR Program Director act on evidence of non- compliance with Steering Committee policies; (b) agree upon the terms of the charter; and (c) discuss the approaches that were proposed in the project applications and any relevant new information, and set initial priorities for the projects to be pursued. 4. Arbitration Any disagreement that may arise on scientific and programmatic matters within the scope of the cooperative agreement and between award recipients and NIDCR may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Principal Investigator; a second member selected by NIDCR; and, the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is subject to appeal in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and DHHS regulations at 45 CFR Part 16. 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: o Direct your questions about scientific/research issues to: Eleni Kousvelari, DDS, D.Sc. Chief, Cellular & Molecular Biology, Physiology & Biotechnology Branch Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN 12K Bethesda, MD 20892-6402 Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: kousvelari@de45.nidr.nih.gov o Direct your questions about peer review issues to: H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Natcher Bldg. 45, Room 4AN-44F Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: George.Hausch@nih.gov o Direct your questions about financial or grants management matters to: Mary Daley, Chief Grants Management Branch, Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Natcher Bldg. 45, Room 4AN-44B Bethesda, MD 20892 Telephone: (301) 594-4808 FAX: (301) 480-3562 Email: daleym@mail.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 NIDCR 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 (December 20, 2003). The letter of intent should be sent to: Eleni Kousvelari, DDS, D.Sc. Chief, Cellular & Molecular Biology, Physiology & Biotechnology Branch Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN 12K Bethesda, MD 20892-6402 Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: kousvelari@de45.nidr.nih.gov 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. SUPPLEMENTAL INSTRUCTIONS The form PHS 398 should be modified as follows: Biographical Sketches should be included for all personnel. Page limitations for the Research Plan have been increased to a maximum of 40 pages from the usual 25 page limit for the "Research Plan" of an application. This 40 page limit is an absolute maximum. However, applicants are encouraged to be concise and use fewer pages. Applicants should divide the "Research Plan" into the following sections: o Description of the proteomics and biocomputational technologies; o Description of the design aspects/plans that will be completed during the period of the award; o Description of how the technologies will contribute to automated, low cost, more efficient, and rapid identification and cataloguing of all salivary secretory components; In the sections listed above, the roles and expertise of all key personnel, collaborators, and consultants who are associated with this part of the application should be well documented. Applicants must provide methods to maintain records, establish, standardize, and distribute protocols and provide for quality control and budgetary oversight. Applicants also should include the description of the internal advisory board consisting of the Principal Investigator and other key personnel that will oversee the daily operation of the activities. Applicants should state their willingness to collaborate and share data freely with the other investigators supported by this RFA and the wider research community. Applicants should discuss their willingness to serve on the Steering Committee and should state their willingness to follow the common protocols that will be developed by the Committee. Applicants should also describe how they would comply with the involvement of NIDCR Program Scientists to work together cooperatively. Applicants who have additional funds to support ('leverage') the proposed project should indicate the source of funds (institutional, NIH grant number, etc.) that permit them to accomplish the project goals. Applicants must budget for travel and per diem expenses for participation in the Steering Committee meetings, workshops, and symposia. Applicants should budget for at least one meeting in the Bethesda, MD area each year. 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: H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Natcher Bldg. 45, Room 4AN-44F, MSC 6402 Bethesda, MD 20892-6402 APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCR. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 NIDCR 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 National Advisory Dental & Craniofacial Research 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 the 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 the application's overall score, weighting them as appropriate for each application. 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. 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? 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? 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? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 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? PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The scientific review group will evaluate the adequacy of the proposed plans for sharing data. Comments on the plan and any concerns will be presented in an administrative note in the Summary Statement. BUDGET: The reasonableness of the proposed budget and the requested period of support will be evaluated in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 20, 2003 Application Receipt Date: January 20, 2004 Peer Review Date: April 2004 Council Review: August 2004 Earliest Anticipated Start Date: September 2004 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. REQUIRED FEDERAL CITATIONS 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 "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 RFA 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 Nos. 93.121 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm 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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