NIDA NEUROPROTEOMICS RESEARCH CENTERS (NIDA NPRCs) RELEASE DATE: April 28, 2003 (see addendum NOT-DA-03-006) RFA NUMBER: DA-04-004 National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.279 LETTER OF INTENT RECEIPT DATE: September 24, 2003 APPLICATION RECEIPT DATE: October 24, 2003 THIS REQUEST FOR APPLICATIONS (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 on Drug Abuse is requesting applications for the support of Neuroproteomics Research Centers (NPRCs). These Centers should be built around scientific themes that address questions relevant to the mission of the National Institute on Drug Abuse. The Centers will support already existing neuroscience research, provide training in proteomics technologies and develop new proteomics technologies. The objective of this program is to provide technical and administrative support for proteomics Centers in order to increase the accessibility of the Centers to neuroscience researchers at institutions with a demonstrated need for such a resource, to develop new or improve existing proteomics technologies that would be applied to the analysis of tissues of the nervous system and promote sharing of information with the scientific community. While Centers should be at institutions that have extensive ongoing neurobiology research, they will not be restricted to working solely with investigators from their own institution. The objectives in establishing these Centers are to: (1) provide neurobiologists with the ability to benefit from proteomics experiments, (2) build a cadre of proteomics experts who will develop expertise in analyzing neural tissues, and (3) develop new or improve existing proteomics technologies as they relate to neurobiology or tissues of the nervous system. This announcement does not support the purchase of large pieces of equipment ($100,000 +). Investigators may seek funding from the National Center for Research Resources at the NIH for the purchase of equipment. http://www.ncrr.nih.gov/rsrch_funding.asp RESEARCH OBJECTIVES Background: Proteomics is generally defined as the study of the complement of proteins produced by a given tissue, cell or subcellular organelle under specific conditions. The proteome is not simply a catalog of proteins, but also subsumes the post-translational modifications and relative quantities of proteins. Ideally the entire proteome of a cell or tissue would be examined, but in reality one is only able to look at a subset of the proteome. That subset is defined by either the investigator who selects a population of proteins based on some intrinsic or extrinsic characteristic, or by limitations of the technology or a combination of the two. In spite of these limitations, proteomics is an extraordinarily powerful way to approach a scientific question in that proteomics experiments presuppose very little about the outcome of the experiment. As the hypotheses of proteomics experiments are much broader than those of traditional experiments, results from proteomics experiments can generate new hypotheses or help guide current ideas. Furthermore, as a more global analysis of a system, proteomics lends itself to the identification of multi- component systems such as mechanistic pathways and signal transduction cascades. By monitoring changes in the proteome that occur with a given disease or treatment, one may gain insight into the mechanisms of health and disease. Current technology requires a significant financial and educational investment to obtain, manage and interpret high quality data. Thus, it is not feasible or practical for individual investigators to establish such a resource for use by their laboratory alone. Furthermore, information gathered from a single proteomics experiment provides a wealth of information for subsequent hypothesis-driven experiments. By providing a shared facility, a greater number of neuroscience researchers will have the opportunity to benefit from these information-rich experiments. Whenever possible, applicants are encouraged to build the Center around a specific neuroscience theme that will facilitate integration and synergy among the Center's collaborators. In addition to the collaborative efforts of the Centers with the neuroscience community, the scientific cores are expected to develop new technology that will improve the analysis of samples relevant to neuroscience research. This announcement focuses on supporting Centers that will assist neuroscientists in identifying additional targets and markers toward which future research can be directed. Areas of Scientific Interest - A Center should be thematically integrated. Each project should benefit from the other components of the Center. The Center components may include, but are not limited to: o Long-term changes in CNS associated with substance abuse to identify proteins that may be involved in molecular mechanisms of relapse o The use of proteomics to identify common cellular mechanisms triggered by different substances of abuse o Studies directed toward understanding signal transduction in cells of the CNS and how the cascades differ with exposure to drugs of abuse o Studies designed to identify possible therapeutic target proteins for the treatment of drug abuse o Changes in CNS associated with HIV/AIDS and/or HCV infection and the effects of drugs of abuse on disease progression, pathology and treatment o Studies directed toward understanding neural plasticity such as proteomics on the post-synaptic density, dendrites and presynaptic terminals of neurons from various states of drug exposure o Proteomics of cytoskeletal proteins in neurons and glia involved in mediating the addictive process o Proteomics of the effect of drugs of abuse on regulating extracellular matrix proteins and adhesion molecules o Studies on the proteomics of drug-induced neurotoxicity or neuroprotection o Studies defining how drugs of abuse affect the processes of exocytosis and endocytosis o Studies directed toward understanding the effects of drugs of abuse on development o Proteomic approaches to identifying peptides and proteins secreted by glia in response to drugs of abuse o Studies to evaluate effects of therapeutics for substance abuse o Proteomic analysis of the proteins involved in mRNA trafficking in neurons and glia o Proteomics of neuronal and glial transcription factors and chromatin regulation o Studies that identify molecular changes in the proteome that correlate with changes in behavior o Studies of genetic effects on the proteome of CNS cells or tissue o Proteomics as a diagnostic or prognostic tool for CNS diseases o Proteomics of membrane proteins o Analysis of lipid raft and caveolae using proteomic approaches Additionally, given the scientific evidence on sex differences in genetic factors of drug abuse, NIDA encourages the evaluation of data to determine if there are sex differences in the proteomes analyzed. Areas of Interest in Technology Development - It is recommended that a Center focus its technology development efforts on select aspects of technology that capitalize on the strengths of the research team. Areas of interest in proteomics technology development include, but are not limited to: o Methods to improve analysis of low copy number proteins o Methods that improve the quality of absolute or relative quantitative data o Methods that increase dynamic range of analysis o Methods that allow functional analysis of a proteome o Methods that improve in situ proteomic analysis o Development of new separations technology including isolation of cellular or subcellular components from neural samples o Development of new, high throughput technology for analyzing protein-protein interactions o Improved methods or software for the analysis of complex mixtures o Development of technology for real time proteomics in culture systems o Development of "turn-key" technology such as protein chips for neuroproteomics o Improvements in the analysis of traditionally difficult proteins such as very acidic, very alkaline or hydrophobic proteins o Development of software or hardware that will increase efficiency Evaluation Of Progress Following Grant Award - Among the criteria used for evaluation of progress are the following: o Number and quality of publications on which this grant is cited each year, whether or not the Center PI is listed as a co-author o New technology developed by the Center o New technology implemented by the Center o Overall benefit to the neuroscience community o Sharing of data and resources with the neuroscience community MECHANISM OF SUPPORT This RFA will use NIH Center Core grant (P30) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. 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 July 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA will support the establishment of Neuroproteomics Research Centers (P30) at institutions with a demonstrated need for such a Center. Each application at a minimum must contain the following: a protein separations core, a protein identification core, a bioinformatics core and an administrative core. Each core, except the administrative core, will be required to devote no less than 20 percent effort and no more than 40 percent effort to technology development for the improvement of the analysis of samples relevant to neuroscience. Technology development will be one of the criteria on which the competitive and noncompetitive renewal will be assessed. The Center must be able to demonstrate that it will collaborate with at least two other funded projects (e.g. R01 grants) and these projects must be described in summary form in the application. The projects need not be limited to researchers at the applicants' institutions. This RFA uses just-in-time concepts. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NIDA intends to commit approximately $2.5 million in FY 2004 to fund 1 to 3 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIDA 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 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 To be eligible, the application must list qualified personnel to implement proteomics experiments. The institutions must have a neuroscience constituency with substantial ongoing research in the various subdisciplines of neuroscience. The Center must be able to demonstrate that it will collaborate with at least two other funded projects (e.g. R01 grants) and these projects must be described in summary form in the application. The projects need not be limited to researchers at the applicants' institutions, however large numbers of collaborators from distant institutions are discouraged. The applicant must clearly demonstrate how a proteomics research core Center would enhance the individually funded projects and improve programmatic coherence, synergy, and integration. Applicants must demonstrate the potential for the continuation of funding of the individual projects included in the Center application, and each project must have at least two years of funding remaining at the time of submission. Pilot projects will not be supported under the P30 mechanism. 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. To be eligible, a PI must have the technical background and the administrative skills needed to operate a proteomics Center. The applicant must have substantial experience in the experimental design, implementation and interpretation of proteomic data. The applicant must be able to devote no less than a total of 25 percent effort to the Center. SPECIAL REQUIREMENTS Key to a successful Center is the implementation of a well-designed management plan. Internal and external advisory boards are recommended for providing guidance regarding administrative issues that arise when managing a Center with multiple users. It is also important that at least one member of the Center work closely with the Center project PIs after data is generated. While this requires more time on the part of Center personnel, it ultimately lends itself to a more productive environment. The complexity of proteomics data and the statistical analysis needed for some experiments requires much more interaction between the proteomics research team and the neuroscience research team. In addition to the science addressed in the application, the PI should consider the following questions: Communication: How will Center project PIs interact with the individual cores, if at all? At what stage of the experimental design will the Center director or core directors work with the Center users? Who will be responsible for various aspects of data analysis (e.g. interpretation of technical data or statistical interpretation of large data sets)? What will the format be for joint review of the data by the Center members and the Center users? How will the efforts of the various core components be coordinated? How will the cores and the core leaders interact and communicate with one another? How will the PIs participating in the Center be informed about guidelines and expectations? How will summarizing progress and potential problems be communicated to P30 participants? Will the Center do anything to foster communication and/or collaboration among Center users? Administration: How will the Center recruit users and prioritize projects? Who will advise the Center regarding the merit of the biological questions being asked by the various Center users? How will new administrative functions be developed? How will progress be assessed? What are the plans for regularly scheduled seminars/meetings/progress reports? How will these meeting be used to train junior investigators? How will ongoing strategic planning for the Center be conducted? How will the director ensure proper budget management and necessary oversight? How will the Center ensure proper regulatory guidelines are followed: Human Subject/IRB approval if human subjects are used? Data Sharing: How will data be annotated, managed, archived and queried? How will Center users access their own data (e.g. via intra- or internet connection or through local computers)? Will the users be able to manipulate the data and if so are there software licensing issues? Will the format of the data be raw or summarized? How and when will the data be shared with the scientific community? How will the Center enforce data sharing obligations? NIDA strongly encourages full and open access to well annotated data from control/normal samples. Also see data sharing requirements under ADDITIONAL CONSIDERATIONS. Advisory boards: Are the administrative functions of the internal advisory and external advisory boards well developed? What is the expertise of the external advisory board? What are the functions of the external advisory board? How will progress and problems be communicated by the director to members of external advisory board before each meeting with the external advisory board? What will be the frequency and regularity of the meetings among core heads and internal advisory board? What will be discussed? How will conflicts be resolved within the Center? How will the core directors work with the internal/external advisory boards to draft guidelines of Center operations and oversight? Technology: Are the aims for technical development appropriate for nervous system tissue samples? How will quality control be maintained? How many proteomics experiments are anticipated per year? How will new issues in neuroproteomics be identified? How frequently will the directors of the Center interact with the office of technology transfer and their institutions about issues surrounding intellectual property? Scientific Cores: How will technology developed in one core affect the other cores in the Center? What are the qualifications of the core directors? Do any of the core directors have a history of collaboration with one another? Do any of the core directors have a history of collaboration with prospective Center users and if so how will that affect prioritization of projects? 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: Christine Colvis, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Rockville, MD 20852 (for express or courier service) Telephone: (301) 435-1323 Fax: (301) 594-6043 Email: ccolvis@nida.nih.gov o Direct your questions about peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express or courier service) Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov o Direct your questions regarding financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@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 NIDA 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: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express or courier service) Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@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) 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: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov 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 NIDA. 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 NIDA 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 Council on Drug Abuse. 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. 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, 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? Is there evidence that the proposed neuroproteomics Center is needed? If the aims in the technology development are achieved, how will the neuroscience community benefit? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? Are weaknesses acknowledged and alternative approaches considered? 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? If other proteomics labs or facilities already exist at the principal investigator's institution, how will this Center differ and how will the facilities interact if at all? If other proteomics labs or facilities already exist at the principal investigator's institution, why is there a need for an additional proteomics resource? 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 core leaders? ENVIRONMENT: Will the PI's institution cover the cost of equipment maintenance? Does the scientific environment in which the work will be conducted contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Do the members of the external advisory committee seem appropriate? Is the described role and extent of involvement of an external advisory committee sufficient? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: 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 adequacy of the proposed plan to share data. The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers. Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why data sharing is not possible. Applicants are encouraged to discuss their data sharing plan with their program contact at the time they negotiate an agreement with the Institute/Center (IC) staff to accept assignment of their application as described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. Applicants are reminded that agreement to accept assignment of applications over $500,000 must be obtained at least six weeks in advance of the anticipated submission date. Reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score. Program staff will be responsible for overseeing the data sharing policy and for assessing the appropriateness and adequacy of the proposed data-sharing plan. Full content of the final NIH statement on sharing of research data may be found at http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-03-032.html. Also see Data Sharing under SPECIAL REQUIREMENTS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: September 24, 2003 Application Receipt Date: October 24, 2003 Peer Review Date: January/February 2004 Council Review: May 2004 Earliest Anticipated Start Date: July 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. o Geographic balance REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phases 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 "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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-03-025.html 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 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 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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