EXPLORATORY/DEVELOPMENTAL TRANSLATIONAL GRANTS FOR BORDERLINE PERSONALITY RELEASE DATE: August 28, 2002 (see reissuance RFA-MH-04-006) RFA: MH-03-001 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) LETTER OF INTENT RECEIPT DATE: January 13, 2003 APPLICATION RECEIPT DATE: February 12,2003 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 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 Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA) are undertaking efforts to increase research concerning borderline personality disorder, a disorder that has not received research attention commensurate with its prevalence in clinical settings and its seriousness. In this Request for Applications (RFA), NIMH and NIDA extend their translational research initiatives to borderline personality disorder research, inviting exploratory/ developmental R21 applications for new, innovative translations of basic science theories, methods and findings to clinical research concerning borderline personality disorder, its features, and its relationship to co-occurring disorders, e.g., depression, post-traumatic stress disorder, and drug dependence. Applicants for these R21 grants should be committed to pursuing the proposed line of research subsequently through R01 and other appropriate grant mechanisms with benefit of the data developed through the exploratory/developmental work. The areas of basic science for possible translation include modern psychometrics and measurement theory, basic behavioral science, social science and neuroscience. The specific clinical focus chosen by an applicant should reflect the potential for innovative, important, scientifically sound translations of basic science to clinical research concerning borderline personality disorder. RESEARCH OBJECTIVES Borderline personality disorder (BPD) is a complex, serious, disabling disorder with significant mortality that is frequently encountered in clinical settings; however, it has not received commensurate research attention. Only a small number of investigators have undertaken research concerning this disorder, with the result that the institute portfolios do not reflect its importance as a public health problem. With few researchers working in an area of study, there are in turn few opportunities for training and mentoring new researchers, which perpetuates the limited amount of research and NIMH and NIDA grants for the field of study. Recently, several developments have occurred that offer the potential for increasing NIMH and NIDA support for research concerned with BPD. First, in 1999 the Borderline Personality Disorder Research Foundation (BPDRF) generated a significant increase in BPD research when this new foundation initiated support for research centers concerned with BPD in the United States and in Europe. Subsequently, the BPDRF has sought to encourage government research funders in the United States and in Europe to increase their support for BPD research and to encourage early career researchers to undertake programs of research concerning BPD. Second, several years ago NIMH and NIDA launched translational research initiatives to encourage the involvement of basic researchers and clinical scientists in the translation of basic science theories, methods and findings to the clinical arena. The magnitude, scientific merit, innovativeness, and potential contributions of the subsequent translational research applications have demonstrated the readiness and ability of the field to enhance and strengthen the clinical research enterprise in this way. This RFA seeks to build on the two developments mentioned above: the increased research activity and interest concerning BPD that the BPDRF has generated, and the new energy and cutting edge methods that the institute's translational research initiatives have brought to clinical research. Specifically, the RFA seeks to extend the institute's translational research initiatives to BPD research, and thereby bring cutting edge theories, methods and findings from modern psychometrics and measurement theory, behavioral science, social science and neuroscience to clinical research concerning BPD. Such extensions offer considerable promise for enabling advances in better measuring and understanding the complexities of this disorder and its core features the pervasive instabilities in affect, interpersonal relationships, behavior, concept of self, and cognitions, and the co-occurrence of BPD with other disorders, e.g., depression, post-traumatic stress disorder, and drug dependence. Such extensions also offer the promise of new, science based treatment models and procedures for development and preliminary testing. The potential for extending NIMH's translational research initiative to BPD research and for involving more researchers, particularly early career investigators, was explored in the summer of 2001 at a conference, New Directions in Borderline Personality, at Rockefeller University that was co-sponsored by NIMH and the BPDRF. This possibility was further explored in the early summer of 2002 at a follow through conference, New Directions in Borderline Personality II, that the University of Minnesota Department of Psychiatry hosted. This RFA reflects the growing interest in translational research for BPD and among researchers in pursuing research concerning BPD. The potential translations of basic science for BPD clinical research are broad, and include advances in understanding, measurement, and the development and preliminary testing of new, science based treatments, pharmacological and psychosocial. For this RFA, NIMH will consider translational research applications for BPD across this entire spectrum. For this RFA, NIDA's focus is on the translation of basic science findings for the development and preliminary testing of new behavioral treatments for persons with co-occurring BPD and drug dependence, a group that is frequently encountered in drug dependence programs, and for which treatments of demonstrated efficacy do not yet exist. The areas of basic science for possible translation include modern psychometrics, measurement theory, basic behavioral science, social science, and neuroscience. The exploratory/development grants are to enable the researchers to develop procedures and data that will enable R01 applications. The potential focuses for NIMH support under this announcement encompass all aspects of BPD, including but not limited to better specification of the disorder and the criteria for this diagnosis; determination of possible subtypes of BPD and their associated features and correlates; illumination of the role of gender, SES and culture in the ways in which the disorder is manifest; elucidation of the mechanisms of expression and moderation of the extreme temperament and behavioral traits that are presumed to substantially account for this disorder; clarification of the relationship of BPD to other disorders and their mechanisms; identification of factors that are involved in the onset, escalation and cessation of BPD features; development of more complete, accurate and on-going measurement of the pervasive instabilities of affect, interpersonal relationships, concept of self, behavior, and cognitions and determination of factors involved in variations in time between extremes, in the duration of extreme states, and in the moderation of expressions of extreme states of these features; the role of learning, biological factors and the brain in the instabilities that characterize BPD; and elucidation of factors that account for periods of self-injury and the mechanisms that support this type of behavior; and the development and preliminary testing of new treatment models and procedures that are based on translations of basic science. The specific BPD focuses should reflect the opportunity for the innovative and scientifically meritorious translation of basic science to advance BPD clinical research. Applications submitted under this RFA must meet the following criteria to be considered responsive: 1. The proposed research must have as a major feature the translation (application) of basic science (theory, methods, or findings) to clinical research concerning BPD. 2. The research principal(s) for the proposed research must have substantial expertise in both the area of basic science from which the translation is to be made and in relevant clinical research. Collaborations of basic and clinical scientists are encouraged. Collaborating scientists need not be at the same institution, but in such cases, the procedures for achieving collaboration during the project must be specified. Substantial expertise in the areas of science involved in the research is required so that the research team can look beyond the immediate research to other possibilities for translation and consider other clinical issues that might benefit from new basic research, and so that there can be broad training in translational research (see below). 3. Consistent with the need to develop a cadre of translational researchers, the project must include provision for an advanced graduate student, a post doc, or an early career researcher to receive additional training in the basic science area from which the translation for the research project is drawn (e.g., in modern measurement theory for the translation of item response theory to developing a measure of a BPD latent construct) and similarly to receive training in the clinical science involved in the research. The goal for this training is to prepare this person to initiate translational research upon the completion of the project. The project budget must include provision for this training and a potential training plan must be briefly described. The training may utilize various modalities, including courses, directed readings, tutorials, and visits to labs of other scientists, as well as active involvement in the proposed research as a collaborating junior colleague. 4. The proposed research must have clear, immediate and compelling relevance to the clinical phenomena of borderline personality disorder. (It is anticipated that this requirement will most often be met by having persons who meet diagnostic criteria for BPD as the primary subjects.) 5. The proposed research will be a new line of investigation for BPD, and so, consistent with the R21 exploratory/development mechanism, preliminary data, while always desirable, is neither expected nor required. The proposed research should be scientifically sound and the qualifications of the research team appropriate. It is expected that funded projects will need to make adjustments based on their initial work, and the work plan and budget should provide for this. 6. The principal researcher(s) of the team should be committed to pursuing this line of research beyond the exploratory/development grant period if the data developed with the R21 grant support this course. The further research that would be enabled by the requested R21 grant support must be indicated. 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. Possible Research Topics The following research areas are presented only as illustrations of possible topics. The list is not intended to be comprehensive or restrictive. The topics are expected to reflect the opportunities for new and innovative applications of basic science to BPD and its features: o The application of taxonomic science to BPD to explore the possibility of subtypes of BPD and shared and distinct biological, development, clinical, and social factors. The DSM criteria for the diagnosis of BPD are that any 5 (or more) of 9 symptom criteria be met. Thus, scores of diverse combinations of symptom criteria enable the diagnosis of this disorder, suggesting the possibility that the disorder is not homogenous but consists of two or more subtypes. Identification of valid subtypes and their shared and distinct factors would advance diagnosis, treatment and research. o The use of measurement theory and behavioral science to develop accurate, ongoing measures of one or more of the core features of BPD, e.g., instability in concept of self. The availability of such measures could enhance the accuracy of diagnosis and evaluation of intervention and advance the study of factors associated with potentially important facets of instability such as variation in the time between extremes. The availability of validated measures for two or more such features would enable research on the relationship of variations in one to the other and the shared and unique factors associated with the expression of these features. o The use of systematic observations of behavior and emotions to determine patterns of dyadic interactions and to test learning theory, pharmacological and other intervention methods to determine the role of different approaches and factors in preventing the escalation of anger and aggression and in obtaining therapeutic change in interpersonal relationships. o The use of item response theory (irt) to develop items measuring the latent constructs of BPD that are not influenced by gender, socioeconomic status (SES) and culture/ethnicity, and thus reflect pure expressions. And, conversely, to identity sets of items that reflect gender, SES and culture/ethnicity specific expressions of BPD so that the mechanisms by which these factors affect the differential expression of BPD symptoms can be investigated. o Application of methods and principles from affective neuroscience to explicate dimensions of mood and emotional response in BPD, employing standard paradigms for which normative data exist and recording multiple response systems in order to contribute to an integrative understanding of the biobehavioral organization of affect and/or social cognition in BPD. o Studies that attempt to define more precisely the relevant temperament and other biobehavioral dimensions relevant to BPD, and to specify which combinations of dimensional characteristics may contribute to subtypes, severity, or risks for disorder. Such studies might employ designs that are intended to explore the full range of these dimensions by combining patient groups, non-clinical subjects at high risk or with elevated scores on screening questionnaires, and non-clinical subjects scoring low of screening measures. o The translation of new basic science findings in to a new treatment model or procedure, and the development and preliminary testing of this approach. NIDA's focus in the spectrum of areas for such new, science based treatment models and procedures is on co-morbid BDP and drug abuse. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Exploratory/ Developmental Grant (R21) 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 December 1, 2003. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). FUNDS AVAILABLE The NIMH intends to commit approximately $1.2 million in FY 2003 to fund up to eight new grants in response to this RFA. NIDA intends to commit approximately $250,000 to fund up to two new grants for the development and preliminary testing of new behavioral treatment models or procedures based on the translation of basic science findings for persons with co-occurring BPD and drug dependence. An applicant may request a project period of up to 3 years and a budget for direct costs of up to $125,000 (5 modules) per year. Direct costs of up to $150,000 (six modules) per year may be requested to allow for facilities and administrative (F&A) costs on consortium arrangements. 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 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 mental health scientific/research issues to: James Breiling, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS (DMDBA) National Institute of Mental Health 6001 Executive Boulevard, Room 6-179 Bethesda, MD 20892 Telephone: (301) 443-3527 FAX: (301) 443-4611 Email: jbreilin@mail.nih.gov o Direct your scientific/research questions about the development and preliminary testing of new, science-based behavioral treatments for persons with co-occurring BPD and drug dependence to: Cecelia L. McNamara, Ph.D. Division of Treatment Research and Development Behavioral Treatment Development Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 4219 Bethesda, MD 20892-9551 Telephone: (301) 402-1488 FAX: (301) 443-6814 Email: cmcnamar@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 Telephone: (301) 443-1340 FAX: (301) 443-4720 Email: mkozak@nih.gov o Direct your questions about financial or grants management matters to: Brian Albertini Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6135, MSC 9605 Bethesda, MD 20892-9625 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: albertib2@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: Dr. James Breiling Division of Mental Disorders, Behavioral Research and AIDS (DMDBA) National Institute of Mental Health 6001 Executive Boulevard, Room 6179 Bethesda, MD 20892 Telephone: (301) 443 3527 FAX: (301) 443 4611 Email: jbreilin@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. PLEASE NOTE THAT THE RESEARCH PLAN IS LIMITED TO 15 PAGES. APPENDIX MATERIAL IS LIMITED TO 3 ITEMS. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions beginning on page 13 of the application instructions. 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 by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications will be considered as new, rather than revised. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by 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 and 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 Councils of the NIMH or NIDA, as appropriate. 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. (1) 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? (2) 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? (3) 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? (4) 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)? (5) 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, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o 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: January 13, 2003 Application Receipt Date: February 12, 2003 Peer Review Date: June 2003 Council Review: September 2003 Earliest Anticipated Start Date: December 1, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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. 93.242 and 93.279 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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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