and Human Services (HHS)
EXPIRED
TRANSLATIONAL APPROACHES IN BIPOLAR DISORDER RESEARCH RELEASE DATE: August 1, 2003 RFA Number: RFA-MH-04-004 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242 LETTER OF INTENT RECEIPT DATE: October 17, 2003 APPLICATION RECEIPT DATE: November 17, 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 The purpose of this RFA is to alert the research community to the National Institute of Mental Health's (NIMH) strong interest in bipolar disorder, particularly its key feature of cycling, and to encourage applications that seek to develop relevant animal models, endophenotypic markers, and translational research approaches that address this and related issues. Recognizing that scientific knowledge is rapidly enhanced when research questions can be addressed in both clinical populations and animal models, the NIMH seeks to encourage research that fosters a translational approach to the critically understudied area of bipolar illness. Although potential applicants will not be required to have both human and animal components in their applications, they are encouraged to identify one or more relevant aspects of bipolar disorder that can be modeled in both humans and animals or to focus on developing appropriate assessment tool(s) that can be utilized in both humans and animals (parallel measures). Such measures might include electrophysiological, pharmacological, genetic, neuroimaging or behavioral techniques that can reliably quantify the targeted characteristic(s). Research involving aspects of bipolar disorder that could possibly serve as the basis for an endophenotype, such as fluctuations in mood states or irritability, relevant sleep or circadian cycling, psychomotor activity levels, or other relevant neurobiological characteristics are of particular interest. RESEARCH OBJECTIVES Bipolar disorder (BD) is a severe psychiatric illness characterized by alternating manic and depressed mood states, with associated disturbances in energy levels, sleep, appetite, and cognition. BD affects about 1% of the population and carries high morbidity, mortality and disability rates. Multiple studies indicate that about 1/3 of patients with BD suffer from additional comorbid personality disorders, and about 40-60% abuse one or more substances. One-third of BP patients have attempted suicide at least once, and completed suicide rates are 20 times higher among patients with BD than in the general population. Large epidemiological studies indicate that although about 2/3 of patients with BD are unemployed, BD still represents the largest burden to employers in health and productivity costs relative to other mental health disorders, with lifetime costs estimated at $24 billion in 1998. Although prevalence rates for BD are similar to those seen for schizophrenia, the NIMH receives a dramatically smaller number of research applications dedicated to elucidating potential mechanisms and pathophysiology of BD than it does for schizophrenia. Several NIMH-sponsored workgroups have targeted bipolar illness as a critically understudied area and have strongly emphasized the need for increased research efforts. These working groups have also recognized that a number of factors have made rigorous, controlled research on BD particularly challenging to conduct. One major difficulty is that, by definition, BD symptoms shift or cycle intermittently along a spectrum of states. Research becomes complicated by uncertainty as to which symptom or state is most profitably targeted and when, and whether the investigator's action or intervention has produced a given change in the patient or whether the change is due to the endogenous cycling. It is clear that cycling is a key factor in BD pathophysiology and an important area for investigation in and of itself. With this RFA, the NIMH seeks to build on a number of recent research findings that may provide important clues to fundamental questions regarding the mechanisms underlying BD and its key feature of cycling. Many of these findings stem from research on animals, suggesting that translational approaches would contribute significantly towards elucidating BD pathophysiology. Some of the scientific areas and approaches that may have important implications for understanding BD neurobiology include the following: 1. A number of cycling or circadian phenomena that may be relevant to BD have been mapped out to varying degrees in animals and humans. For example, research indicates that mood cycling in patients with BD may be linked to shifts in circadian light (both diurnal and seasonal), sleep/activity, and menstrual/ hormonal cycles. Although substantial literature exists on the physiology of these specific cycles, as well as on circadian regulators like clock genes, little information is available on how these mechanisms might interrelate with or contribute specifically to BD pathophysiology. 2. Although the nature of cycling in BD is important in itself, the essential symptom that cycles is mood. Newer studies using measurements designed to assess or manipulate emotion and mood in humans, in conjunction with neurophysiological methods, have provided considerable information on the neurobiology relevant to these states. This approach could productively be utilized more frequently in BD research, particularly if applied over time and across mood cycles. In addition, the use of animals in research on mood or emotion is critically underdeveloped. Assessment tools that can measure mood or emotion in animals, especially assessments that can be used in parallel in human research, would be of immense value. The availability of such assessments would be expected to further enhance the development of more convincing animal models of mood disorders (particularly of BD), another area that is important but under-researched. 3. Various second-messenger signaling pathways have been linked to the actions of the mood stabilizing drugs commonly used to successfully treat BD. However, few studies have attempted further investigations of these effects in animal models or in human postmortem tissue. 4. The current focus on identifying endophenotypes (i.e. traits associated with disease expression that are heritable, are present before the disease is manifest, and occur in unaffected relatives) has proven to be especially profitable for research on complex genetic diseases. Knowledge about schizophrenia has advanced substantially due to recent efforts to identify endophenotypes for this illness. Identifying endophenotypes for BD, which also has a significant genetic component with complex inheritance, would be of great value. Neuroimaging, electrophysiological, neuroendocrine, and neuroimmunology literature suggest that BD may have unique brain structural and functional characteristics that could serve as endophenotypes. This topic in BD research would benefit from further elaboration, as well as increased inclusion of first-episode patients and unaffected relatives. Given the above, examples of potential research topics include, but are not limited to: o Mechanisms of cycling or circadian phenomena, especially as related to periodic changes in mood states or psychomotor activity levels. o Neurobiology underlying changes in vegetative functions in BD (e.g., sleep patterns, appetite, and stress reactivity). o Affect regulation (e.g., positive and negative affect, affect valence stability, irritability, and impulsiveness). o Cognitive processes, such as inhibitory control, processing of temporal cues, and risk assessment, that may be unique in BD. o Neuroimaging or postmortem studies that target identification of neural mechanisms underlying BD, particularly those that can also be studied in more detail in animal models. o Genetic and pharmacogenetic research linking neural mechanisms with key behaviors that are symptomatic of bipolar disorder. o Development of credible animal models of mood disorder or reliable assessments for emotion/mood that can be used in both animals and humans. o Identification of potential endophenotypes for BD, especially in studies that include first-episode or unaffected relative samples. o Investigations of BP symptoms or mechanisms that utilize data from both animals and humans. In order to be judged responsive, applications submitted under this RFA must have clear and compelling relevance to the goal of understanding the neurobiological mechanisms of bipolar disorder. Applications that propose to address cycling, that employ translational approaches, or that seek to identify potential endophenotypes will be considered of high program priority. Collaborations between basic and clinical scientists are encouraged. Applicants are strongly encouraged to contact one of the NIH program staff listed under INQUIRIES with any questions regarding the responsiveness of their proposed project to the goals of this RFA. MECHANISM(S) OF SUPPORT This RFA will use the National Institutes of Health (NIH) Research Project Grant (R01) and the Exploratory/Developmental Grant (R21) award mechanisms (see http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). Under this RFA, an applicant may request a project period of up to five years for R01 applications and up to three years for the R21 applications. Applications for the R21 award may request direct costs of up to $125,000 per year to support exploratory research where sufficient pilot data (that are ordinarily required to substantiate R01 research grant applications) are lacking. 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 1, 2004. This RFA uses just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. 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. RESUBMISSION OF UNFUNDED APPLICATIONS Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications only, as described at NOT-OD-03-019. These NEW applications must be submitted on the standard receipt dates (http://grants.nih.gov/grants/funding/submissionschedule.htm). All R21 applicants who wish to resubmit their applications as R21s will also submit them as NEW, and will be expected to conform to the requirements of the standard NIH Exploratory/Developmental Grant award mechanism, which limits the award to 2 years with a combined direct cost budget of up to $275,000 for the 2-year period, as well as a 15-page research plan (see http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). FUNDS AVAILABLE The NIMH intends to commit approximately $2.5 million in FY 2004 to fund 5-10 new grants in response to this RFA. 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 NIMH 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 o Faith-based or community based organizations Foreign institutions are not eligible to apply. 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. 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: Debra J. Babcock, Ph.D., M.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7178, MSC 9639 Bethesda, MD 20892-9639 Telephone: (301) 443-1692 FAX: (301) 402-4740 Email: dbabcock@mail.nih.gov o Direct your questions about peer review issues to: Michael Kozak, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892-9608 Rockville, MD 20852-9608 (for express/courier service) Telephone: (301) 443-1340 FAX: (301) 443-4720 Email: kozakm@mail.nih.gov o Direct your questions about financial or grants management matters to: Carol J. Robinson Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6118 Bethesda, MD 20892 Telephone: (301) 443-3858 FAX: (301) 443-6885 Email: crobinso@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 NIMH 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: Debra J. Babcock, Ph.D., M.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7178, MSC 9639 Bethesda, MD 20892-9639 Telephone: (301) 443-1692 FAX: (301) 402-4740 Email: dbabcock@mail.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. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C 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 modular budget grant applications is available at http://grants.nih.gov/grants/funding/modular/modular.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: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9663 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3367 FAX: (303) 443-4720 Email: jnoronha@mail.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 the NIMH. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR 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 NIMH 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 Mental Health 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. SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? ENVIRONMENT: Does the scientific environment in which your 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? 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. SPECIFIC R21 REVIEW CRITERIA Innovation of the project and potential significance of the proposed research will be the major considerations in the evaluation of the R21 exploratory grant mechanism. Because the R21 is designed to support innovative ideas, preliminary data as evidence of feasibility of the project are not required. However, the applicant is responsible for presenting the background literature that provides some basis for the approach and for developing a rigorous research plan. Relevant pilot data should be cited when available. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 17, 2003 Application Receipt Date: November 17, 2003 Peer Review Date: February 2004 Council Review: May 2004 Earliest Anticipated Start Date: July 1, 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 HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as approipriate, 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 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. 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: 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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