DEVELOPMENT OF INNOVATIVE TREATMENT APPROACHES TO AUTISM Release Date: November 29, 2000 RFA: MH-01-010 National Institute of Child Health and Human Development (http://www.nichd.nih.gov/) National Institute on Deafness and Other Communication Disorders (http://www.nidcd.nih.gov/) National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute of Neurological Disorders and Stroke (http://www.ninds.nih.gov/) Letter of Intent Receipt Date: February 15, 2001 Application Receipt Date: March 22, 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 This Request for Applications (RFA) solicits applications to study the development or refinement of behavioral, pharmacological or other innovative treatment interventions for individuals with autism or other autism-spectrum disorders. In November 1999, the NIH Autism Coordinating Committee held a workshop to review the state of the field for treatment of autism and to develop recommendations for future National Institutes of Health (NIH) activities and initiatives. A report of this workshop and the resulting recommendations can be viewed at http://www.nimh.nih.gov/research/autismworkshop.cfm. The workshop participants recommended further investigations into areas of basic knowledge that could provide a foundation for treatment development research and called for support of innovative applications linking brain and/or behavioral processes that are at least partially understood with possible interventions. There was also a perceived need for pilot trials for treatments, and treatment efficacy or cost-effectiveness measures in several modalities. These recommendations provided the impetus for this RFA. One intention of the RFA is to encourage the formation of partnerships between investigators familiar with the phenomenology and treatment of autism on the one hand and basic behavioral or neuropharmacology investigators with innovative concepts on the other. This RFA seeks Exploratory/Development R21 applications in order to assist researchers in developing new treatments for autism and obtaining initial pilot data on the efficacy of new treatments. It is designed to support phases of intervention development that are prerequisite to (but do not include) conducting a full-scale intervention study or trial. The NIH supports many types of research on autism diagnosis, psychopathology, neural substrates, and interventions. PA-98-108 describes these interests and designates program contacts at the various institutes ( Research in Autism and Autism Spectrum Disorders, PA-98-108, located at http://grants.nih.gov/grants/guide/pa-files/PA-98-108.html). 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, DEVELOPMENT OF INNOVATIVE TREATMENT APPROACHES TO AUTISM, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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 grants for this specific program. 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) Exploratory/ Development Grant (R21) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This type of award is limited in time and amount, encourages innovative approaches, and is less dependent upon pilot/feasibility data than are typical for an R01 application. The total project period for an application submitted in response to this RFA may not exceed 3 years and funding is limited to a maximum of $100,000 per year in direct costs. This RFA is a one-time solicitation. The anticipated earliest award date is September 15, 2001. Specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being examined by the NIH. Complete and detailed information about Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. Further modification and clarification of modular grant procedures can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-046.html. FUNDS AVAILABLE The participating institutes intend to commit a total of approximately $1,000,000 in FY 2001 to fund about 6 new grants in response to this RFA. An applicant may request a project period of up to 3 years and a budget of up to $100,000 in direct costs per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Direct costs will be awarded in modules of $25,000, less any overlap and other administrative adjustments. Although the financial plans of the Institutes 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. RESEARCH OBJECTIVES Background Currently, treatments for autism are limited in their effectiveness, providing only partial alleviation for the symptoms that characterize this disorder. Available pharmacological treatments are especially limited in the scope, duration, and degree of their efficacy in alleviating the core features of this disorder. In addition, there is a lack of research data on the efficacy of existing pharmacological, psychotherapeutic, or other interventions. Thus, both further characterization of existing treatments and the development of novel approaches are needed, as well as better measures of treatment efficacy and effectiveness. This RFA is designed to support the early phases of treatment development and pilot testing, leading up to full-scale (e.g., randomized controlled, interrupted time series) studies or trials aimed at establishing efficacy and safety. Treatment development can be considered to have three stages: 1) conceptualizing an intervention approach based on theory and empirical research, 2) developing and standardizing the intervention and/or intervention outcome measures, and 3) pilot testing. This RFA solicits research applications for any of the above stages. Investigators are not expected to necessarily complete all phases of intervention development during the three- year duration of the award. They should propose feasible and systematic goals that can be accomplished within the time and funding periods of this award while considering the final aim of completing the prerequisites for conducting a controlled study or trial. Conceptualizing an intervention approach (Stage 1) could include research on developing new psychosocial, pharmacological or biological interventions for subjects with autism, adapting existing interventions to specific needs of a subgroup of patients, or attempts to translate basic neuroscience research findings into clinical treatment applications. These would be necessary preliminary steps to progressing to Stage 2, developing and standardizing an intervention. Intervention standardization (Stage 2) includes components such as the following: development of a treatment protocol, operationally defining intervention components for use in creating a manual (e.g., psychosocial intervention manual, initial medication dosing level), development or adaptation of relevant measures, including diagnostic, cost and outcome measurement, formulation of measures of provider competency, acceptance and adherence to the protocol, participant behavior change, and acceptance and adherence to treatment. Pilot and feasibility studies (Stage 3) may include: testing and further refining of initial intervention manual and measures developed during Stage 2, gathering data to estimate intervention parameters (e.g., effect size, attrition rates, response rates) and performing preliminary power analyses, evaluating feasibility of procedures for implementing and evaluating the intervention in a controlled outcome study (e.g., participant and provider recruitment, sample definition, intervention assignment, and outcome measures). Sample sizes for Stage 3 should be appropriately estimated to answer the relevant questions about the adequacy of the intervention development, or to establish reliable estimates of intervention effect parameters prior to trials, as applicable. The goals of the study should be clearly outlined and related to specific aims and procedures pertinent to whichever phase(s) (i.e., Stages 1, 2, or 3) of intervention development will be pursued. It is acknowledged that boundaries between the stages outlined above are non-discrete and therefore, investigators may propose ideas or methods including subsets of one or more categories. However, the application should include a clearly operationalized description of each component step, with decision points indicating when each has been successfully completed and when to move on to subsequent components. The development of both empirically indicated and theory-driven interventions is encouraged. Adaptation of existing treatments to new populations, settings, etc., is considered innovative within a public health model. Research Goals and Topics Types of Exploratory/Development Grants for Intervention Research The following are illustrative, but not restrictive, topics for consideration: o Identify clinical applications of basic neuroscience findings and develop applications relevant to the treatment of subjects with autism and autism- spectrum disorders. o Test treatments that are often used but have not been examined for their effectiveness. o Conduct pilot-testing, dose-finding, and exploratory studies of promising pharmacological, immunological, or dietary interventions for the treatment of subjects with autism and autism-spectrum disorders. o Validate and refine current approaches to the treatment of autism and autism spectrum disorders. o Analyze and define the critical features of effective interventions. o Develop interventions for subjects with autism and common comorbid symptoms or disorders. o Develop procedures that measure both proximal and distal effects of interventions, including developmental, ecological and multisystemic outcomes. o Develop family-based interventions to include maintenance and rehabilitative strategies. o Develop innovative behavioral, psychoeducational, psychopharmacological, or other biologically based treatments for children with autism and autism- spectrum disorders. o Examination of the biological basis of early behavioral interventions and how biologic factors might predict treatment response. o Pilot-test early interventions for toddlers and young children diagnosed with autism or autism-spectrum disorders. o Develop models to better understand variables (child-related, neurobiological, family-related, and/or cultural/environmental) that predict the range of responses to interventions. o Develop models to define the active components of interventions and possible relationship between dose and intensity of treatment on one side, and treatment outcomes on the other. o Develop procedures to identify developmentally sensitive outcomes, including behavioral and neurobiological outcome measures that are hypothesized to be associated with behavioral change. o Develop innovative approaches, including the use of newly emerging technologies for treating children who are not responding to current treatment methods. o Develop approaches to examine the effects of combined behavioral and psychopharmacological treatments, as compared to unimodal treatment. o Examine the effects of polypharmacy, including interactions of drugs with each other and with nutrients. o Development of metabolic treatment strategies targeted at specific subgroups of subjects with autism or autism-spectrum disorders. Examples of areas not supported by this RFA that are relevant to the more general autism Program Announcement: o Research that addresses the genetics and neurobiology of the disorder without directly focusing on treatment interventions. o Research that focuses on diagnostic assessments, subtyping, and clinical recognition, without a specific focus on treatment interventions. o Research on the epidemiology of the disorder. o Research on the identification of potential risk factors of the disorder. All these areas of research are not included in the present RFA, but are all relevant to the PA Research in Autism and Autism Spectrum Disorders (PA-98- 108), which is located at http://grants.nih.gov/grants/guide/pa-files/PA-98-108.html. 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 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. Vitiello, at the address listed under INQUIRIES, by the letter of intent receipt date listed in the heading of this RFA. 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, E-mail: GrantsInfo@nih.gov. The application is also available at http://grants.nih.gov/grants/funding/phs398/phs398.html. The usual 25-page limit applies to the narrative portion of R21 applications under 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 the total direct cost request of $100,000 per year allowed under this RFA. 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 the $100,000 maximum allowed under this RFA) 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 (rev 4/98). It is not required and will not be accepted at the time of application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget tables on page 5 of the PHS 398 (rev. 4/98) Form. It is not required and will not be accepted at the time of 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. o 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 3 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 3 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. o 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-01-010) 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, DEVELOPMENT OF INNOVATIVE TREATMENT APPROACHES TO AUTISM RFA [MH-01-010], must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample modified mailing label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and four 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, one additional copy of the application must be sent to: Benedetto Vitiello, M.D. Division of Services and Intervention Research National Institute of Mental Health, NIH 6001 Executive Boulevard, Room 7149, MSC 9633 Bethesda, MD 20892-9633 Rockville, MD 20852 (for express/courier service) Applications must be received by March 22, 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 NIH 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 NIH 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 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 15, 2001 Application Receipt Date: March 22, 2001 Peer Review Date: June/July 2001 Council Review: September 2001 Earliest Anticipated Start Date: September 15, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions are: 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, including eligibility and responsiveness, to one of the program staff members listed below: Benedetto Vitiello, M.D. Division of Services and Intervention Research National Institute of Mental Health, NIH 6001 Executive Boulevard, Room 7149, MSC 9633 Bethesda, MD 20892-9633 Telephone: (301) 443-4283 Fax: (301) 443-4045 Email: bvitiell@nih.gov Deborah Hirtz M.D. Neurodevelopment, Division of Extramural Research National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 2143, MSC 9523 Bethesda, MD 20892 Telephone: (301)496-5821 Fax: (301)480-1080 Email: dh83f@nih.gov Marie Bristol-Power, Ph.D. National Institute of Child Health and Human Development 6100 Executive Blvd, Room 4B09, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-1822 Fax: (301) 496-3791 Email: mb188y@nih.gov Judith A. Cooper, Ph.D. Scientific Programs Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C, MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 Fax: (301) 402-6251 Email: Judith_Cooper@nih.gov Direct inquiries regarding fiscal matters to one of the following: Diana S. Trunnell Grants Management Branch National Institute of Mental Health, NIH 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 Fax: (301) 443-6885 Email: Diana_Trunnell@nih.gov Gladys Melendez-Bohler, M.S. Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3290, MSC 9537 Bethesda, Maryland 20892-9537 Telephone: (301)496-3929 Fax: (301)402-0219 Email: gb13y@nih.gov Laura Reidy Grants Management Specialist National Institute of Child Health and Human Development 6100 Executive Blvd., Room 8A07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-7002 Fax: (301 402-0915 Email: lr155n@nih.gov Sherry Dabney Grants Management Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400B, MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 Fax: (301) 402-1758 Email: Sherry_Dabney@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242 and 93.858. 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 52 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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