NEUROCOGNITIVE, NEUROIMAGING, AND NEUROPSYCHIATRIC CORRELATES OF HIV INFECTION Release Date: December 14, 2000 RFA: MH-01-007 National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute on Drug Abuse (http://www.nida.nih.gov/) National Institute of Child Health and Human Development (http://www.nichd.nih.gov/) Letter of Intent Receipt Date: February 13, 2001 Application Receipt Date: March 20, 2001 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA) and the National Institute of Child Health and Human Development (NICHD) invite research grant applications through this Request for Applications (RFA) to support research focused on the neuropsychological, neurobehavioral, neuroimaging and neuropsychiatric correlates of human immunodeficiency virus/central nervous system (HIV/CNS) disease. As new and improved therapeutic interventions are becoming available for controlling HIV disease progression, the importance of non-invasive monitoring of HIV/CNS disease using neuropsychological/neurobehavioral approaches is necessary for treatment monitoring and disease progression. These approaches offer promise for early diagnosis and can be informative regarding the neural bases underlying functional alterations. Advanced structural and functional neuroimaging methods (sometimes in combination with behavioral methods) offer the opportunity to examine relevant brain circuitry in HIV disease and identify clinically significant abnormalities. The psychiatric sequelae frequently found in an immuno-compromised state interact with other chronic medical conditions and their involvement in HIV disease can also be understood through the use of neurobehavioral and neuroimaging modalities. The main objective of this RFA is to foster investigations that will identify and clarify the critical questions in the assessment and etiology of neurobehavioral complications of HIV. Multidisciplinary research teams and collaborative alliances are encouraged but not required. 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, Neurocognitive, Neuroimaging, and Neuropsychiatric Correlates of HIV, is related to the priority area of neurological complications of HIV infection. Potential applicants may obtain a copy of Healthy People 2010 at: http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for small grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) and small research grant (R03) award mechanisms. Collaborative R01s will also be accepted. The total project period for an application submitted in response to this RFA may not exceed 5 years. R03 grants are limited to two years and are not renewable. The R03 is limited to $50,000 direct costs for each of these 2 years. This RFA is a one-time solicitation. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2001. For the purposes of this RFA, the guidelines provided in PAR-98-017 (http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html)are to be followed for applications using the Collaborative R01 mechanism. Information and application instructions for the NIMH Small Grant are available in the NIH Guide for Grants and Contracts at: http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html. Information and application instructions for the NICHD Small Grant are available in the NIH Guide for Grants and Contracts at: http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html. For applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being examined by NIH. Complete and detailed instructions and information about Modular Grant applications can be found at: http://grants.nih.gov/grants/funding/modular/modular.htm. Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. FUNDS AVAILABLE The NIMH intends to commit approximately $1,500,000 to fund 6 to 8 new and/or competitive continuation grants in response to this RFA. The NIDA intends to commit approximately $1,000,000 to fund 4 to 6 new and/or competitive continuation grants in response to this RFA. The NICHD intends to commit approximately $250,000 to fund 1 new and/or competitive continuation grant responding to this RFA. An applicant may request a project period of up to 5 years for an R01 application. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. It is expected that direct costs will be awarded in modules of $25,000, however, program and grants management adjustments may be necessary prior to award. Although the financial plans of the Institute 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 applications of outstanding scientific and technical merit. At this time, it is not known whether competing renewal applications will be accepted and/or if this RFA will be reissued. RESEARCH OBJECTIVES Background HIV not only leads to immunodeficiency but also invades the CNS shortly after infection. HIV-associated dementia complex (ADC) and less severe MCMD develop in 20 percent of patients with AIDS and are associated with HIV-1 infection of macrophages and microglia in the CNS. Milder forms of neurocognitive impairment without significant loss of daily function may precede such syndromes. In general, the clinical manifestations of these disorders occur in the more advanced stages of disease when ribonucleic acid (RNA) viral load increases and CD4 counts decrease, these changes are linked to release of neurotoxic metabolites and cytokines by infected macrophages and microglia. Ultimately, ADC patients show dramatic loss of brain volume along with progressive deficits in psychomotor function and cognition. Although productive infection of the CNS is clearly a prerequisite for the development of ADC, the role of viral replication within the CNS for the pathogenesis of this disorder has not yet been demonstrated conclusively. Previous studies have shown that HIV infection produces structural damage to the brain, particularly to the cerebral white matter, striatum and limbic system. Neuropathologic data are generally consistent with the subcortical nature of the neurologic deficits. A growing body of evidence suggests that neuronal death and dysfunction result from secondary events, which follow infection and/or activation of mononuclear phagocytes in the CNS. Additionally, drugs of abuse have been shown to suppress immunity and therefore interact with HIV to alter the course of the disease. It is not known how this interaction of HIV and drug abuse affects brain degenerative processes and how these changes are reflected in behavioral/neurocognitive impairment. The development of precise criteria for the diagnosis of ADC and related disorders has been difficult, in part because of the lack of objective measures of functional impairment, since neurocognitive dysfunction in AIDS manifests as degrees of dysfunction from minor (no significant loss of daily function) to profound (ADC). Unfortunately, by the time functional impairment develops in patients, significant brain atrophy may occur, suggesting that clinical manifestations of cognitive impairment often herald significant structural brain damage and cellular loss. In addition, the onset of HIV-related CNS pathology is difficult to predict, and the course is variable within the HIV positive (HIV+) population. Furthermore, there is evidence for some dissociation between viral replication in the brain and systemic viral load levels. This dissociation further complicates the accurate assessment of CNS damage and hinders the development of more specific treatments to prevent or ameliorate CNS dysfunction. For these reasons, there is a need for direct non-invasive, assessments of brain function that are sensitive to the earliest effects of HIV, appropriate for monitoring the status of the brain over time and informative with respect to the neural bases (anatomy) of the underlying functional alterations. The use of sensitive neuropsychological and neurobehavioral tests are presently the best available means of detecting the CNS effects of HIV and research employing these techniques is urgently needed. In addition, functional magnetic resonance imaging (fMRI) techniques, particularly in combination with structural imaging approaches (e.g., magnetic resonance imaging (MRI) and fMRI) show promise as early diagnosis methods since they could combine the advantage of sensitive behavioral assessments with the anatomical specificity of fMRI and other imaging modalities. Advanced structural and functional neuroimaging techniques provide opportunities to identify clinically significant abnormalities that are associated with psychiatric complications. Most of the initial HIV imaging studies addressed the CNS complications of AIDS in patients with more advanced disease and clarification is needed on imaging abnormalities during the asymptomatic period. With the exception of a large literature addressing cognitive impairment and dementia, limited published information is available on other HIV-related neuropsychiatric complications, such as psychotic disorders and mood disorders. Because many of the medical illnesses that patients develop when they become immunocompromised involve the brain and may mimic psychiatric conditions, research is needed to differentiate the features of true psychiatric conditions and those secondary to immunocompromise. The psychiatric sequelae of HIV infection and AIDS are not final end points. At each step the psychiatric consequences (as well as the sequelae of alcohol and drug abuse) become part of the system of influences determining subsequent behavior, and thus, their consequences may become etiologic factors themselves. Psychiatric disorders, including affective disorders (both major depression and mania), dementia, addiction, personality disorders, are common and severely impairing in patients with HIV infection. These disorders have tremendous impact on subjective well-being, self-care, level of overall function, adherence with medical treatment and continuation of risk behaviors with implications for further HIV transmission. Research is essential to understand these psychiatric sequelae and how they interact with the neural-damaging and neurotoxic effects of HIV and the resulting neurocognitive dysfunction. Areas of Interest Examples of research that would be an appropriate response to this RFA include, but are not limited to, the following: (Investigators are particularly encouraged to use existing databases and repositories of biologic materials in the three research areas below to address critical hypotheses in applications responding to this RFA.) Neurocognitive/Neurobehavioral o Methodological and longitudinal studies of changes in neuropsychological patterns and neuropsychological deficits in HIV-infected individuals (e.g., reliability studies, detection of subtle/early neuropsychological changes in at-risk populations, identify neurocognitive status over time, normative neuropsychological data for underserved minority populations) o Antemortem-postmortem studies of the association between neurocognitive dysfunction, HIV encephalitis neurodegeneration, neuroprotective effects and anatomic/functional brain changes o Studies that assess the direct correlation between brain changes and neuropsychological/neurocognitive status in drug abusing HIV-positive individuals o Correlative studies of neuropsychologic impairment and improvement with surrogate laboratory markers of the spectrum of injury to the brain in HIV- infected individuals (e.g., HIV RNA in CSF or plasma compartments, markers of systemic immune function and HIV replication) o Studies that assess gender-related differences in drug abusing HIV- positive individuals in terms of neurocognitive function o Research specifically focused on neurocognitive and neurobehavioral HIV- related changes over time in children and youth with particular emphasis on impact of therapy o Studies of the ecological validity of neuropsychological impairment/minor cognitive motor disorder (e.g., translating neuropsychological impairment to real life activities such as adherence and management of complex drug regimens, returning to work, quality of life), the adoption of compensatory strategies to overcome disabilities, and the effects of neurocognitive impairment on family and social adaptation o Research on method development for the delay, prevention and treatment of neurocognitive impairment, for example, through targeted cognitive rehabilitation techniques Neuroimaging o Improved statistical approaches and innovative neuroimaging methods (e.g., repeated measures of in vivo morphometry, more sophisticated assessments in cerebral white matter) o Novel neuroimaging techniques (PET, MR spectroscopy, fMRI) related to HIV disease progression, HIV-induced CNS degeneration and dysfunction, neuropsychiatric symptom status, neuropsychologic performance, cognitive and memory processes, treatment monitoring and drug treatment interactions with drugs of abuse o Structural and/or functional neuroimaging techniques to characterize brain changes over the course of infection in drug abusing HIV-positive individuals, as well as over the course of treatment o Studies in HIV infected individuals to identify non-invasive surrogate markers for viral load within the CNS, assess drug and alcohol comorbidity and monitor CNS disease progression and remission o Research to identify regional metabolic changes reflective of brain injury or to study metabolic changes with other parameters that are reflective of HIV-induced brain injury, such as astrocytosis or changes in synaptophysin levels o Studies that assess brain activation using neuroimaging techniques and neurocognitive tasks to determine effects of HIV infection as a function of disease progression and drug status o Research to identify early morphologic or metabolic alterations associated with onset of cognitive impairment and to confirm neuroimaging findings with postmortem neuropathological findings Neuropsychiatry o Studies of Axis I and Axis II psychopathology in HIV disease (e.g., differentiating preexisting psychopathology from new onset psychiatric disorders) o Studies of the influence of comorbid mental and substance abuse disorders in HIV- infected individuals (e.g., immunomodulatory properties of drugs of abuse and reduced adherence related to mental disorders) o Studies of psychiatric sequelae of HIV infection and AIDS (e.g., grief response and reactions to disability, exacerbation of psychopathology or development of new primary psychiatric symptoms) o Studies on individual difference factors related to HIV disease (e.g., personality or temperamental variables such as impulsivity, their interaction with Axis I and II pathology and HIV neurocognitive deficits) o Studies of the interaction of psychiatric complications with chronic medical disorders, opportunistic infections and systemic abnormalities that impact on neuronal function o Studies that tailor adherence and prevention strategies to neuropsychiatric symptoms (e.g., address the influence of personality variables and psychiatric disorders on adherence to psychosocial interventions and complex drug regimens, coping skills and quality of life) o Treatment studies in HIV infection and AIDS examining neuropsychiatric syndromes, neurocognitive/motor dysfunction and neuroimaging correlates, behavioral effectiveness and functional outcomes and interactions of psychotropics, drugs of abuse and antiretrovirals INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at: http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 Institute staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. David M. Stoff at the address listed under INQUIRIES, by the receipt date listed. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The application is also available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding the responsiveness of their proposed project to the goals of this RFA. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS 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 Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,00) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget tables on page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH: The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o CHECKLIST: This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number (MH-01-007) 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, Neurocognitive, Neuroimaging, and Neuropsychiatric Correlates of HIV Infection, MH-01-007, must be typed on line 2 of the face page of the application form and the YES box must be marked. A sample modified mailing label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in PDF format. 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, 2 additional copies of the application must be sent to: David M. Stoff, Ph.D. Center for Mental Health Research on AIDS Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6210, MSC 9619 Bethesda, MD 20892-9619 Applications must be received by March 20, 2001. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIMH staff. 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 NIMH in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications receive a written critique and 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, assigned a priority score, and receive a second level review by the NIMH, NIDA, or NICHD National Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) 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? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) 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? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o 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. Schedule Letter of Intent Receipt Date: February 13, 2001 Application Receipt Date: March 20, 2001 Peer Review Date: April 2001 Council Review: May/June 2001 Earliest Anticipated Start Date: September 30, 2001 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. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: David M. Stoff, Ph.D. Center for Mental Health Research on AIDS Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6210, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-4625 FAX: (301)443-9719 Email: dstoff@nih.gov Ro Nemeth-Coslett, Ph.D. Clinical Neurobiology Branch Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Blvd, Room 4238, MSC 9669 Bethesda, MD 20892-9669 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: rn29e@nih.gov Anne Willoughby, M.D., M.P.H. Chief, Pediatric, Adolescent and Maternal AIDS Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Blvd Room 4B113, MSC7510 Bethesda, MD 20892-7510 Telephone: (301) 402-0699 FAX: (301) 496-8678 Email: aw55g@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Daisey Parker Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Blvd, Room 3126, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: dp64@nih.gov Christopher Myers Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17F, MSC 7510 Bethesda Maryland 20892-7510 Telephone: (301) 435- 6996 FAX: (301) 402-0915 Email: cm143g@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR and 45 CFR Part 74. 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 promote the non-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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