SPECIALIZED PROGRAM OF TRANSLATIONAL RESEARCH IN ACUTE STROKE Release Date: May 10, 2001 PA NUMBER: PAS-01-092 (This PA has been modified, see PAR-05-084) (see NOT-NS-03-020) National Institute of Neurological Disorders and Stroke PURPOSE The Clinical Trial Group and the Neural Environment Group of the National Institute of Neurological Disorders and Stroke (NINDS) invite grant applications for Specialized Programs of Translational Research in Acute Stroke (SPOTRIAS). The goal of the SPOTRIAS will be to reduce the disability of and mortality in stroke patients by promoting rapid diagnosis and effective interventions. The intent of the SPOTRIAS is to support a collaboration of clinical researchers from different specialties whose collective efforts will lead to new approaches to early diagnosis and treatment of acute stroke patients. Applicant institutions must be able to deliver rapid treatment for acute stroke and to conduct the highest quality translational research on the diagnosis and treatment of acute ischemic and hemorrhagic stroke. SPOTRIAS grants will require that a minimum number of stroke patients be treated two hours after the onset of their symptoms. Another important function of SPOTRIAS is to establish a program to recruit and train of the next generation of stroke researchers. BACKGROUND Despite enormous research efforts including many clinical trials, tissue plasminogen activator (tPA) remains the only FDA-approved treatment for acute ischemic stroke. Clinical trials that demonstrated the efficacy of tPA showed a improved outcome when tPA was given within three hours of stroke onset. The requirement for administration within three hours of stroke onset has proven a major obstacle to the widespread use of tPA. Delays in the response to stroke by medical personnel and the risks inherent in the use of tPA, which require careful patient evaluation before treatment, contribute to the inability to extend its benefits to many stroke victims. Dramatic improvements in stroke outcomes could be achieved by reducing the time necessary to respond to and diagnose stroke and by identifying new interventions that could be safely and expeditiously administered to a wider range of patients. RESEARCH OBJECTIVE The objective of the SPOTRIAS is to facilitate translation of basic research findings into clinical practice in settings where patients with acute ischemic and hemorrhagic stroke are evaluated and treated very rapidly after the onset of their symptoms. This program seeks to encourage clinical research directed toward improved treatments and treatment strategies for stroke. Basic research will be included if it will add to the overall progress made by the collaborative translational program. Because of the importance of early treatment in translational research, SPOTRIAS will be established at institutions with a strong commitment to the rapid treatment of acute stroke patients and which have demonstrated an active collaboration between emergency medical services, emergency physicians, neurologists, and radiologists. Using its shared resources, a SPOTRIAS will add to the scientific information base and maintain state-of-the-art research that contributes to improved rapid treatment of acute ischemic and hemorrhagic stroke. Components of each SPOTRIAS will include a special stroke response group that treats patients in the emergency department, a biostatistical and data management core, and a human tissue core (blood, genetic samples, and any autopsy material). SPOTRIAS are expected to conduct a wide spectrum of research activities, and to contribute significantly to the development of specialized research resources, to the development of improved research model systems and to the expansion of the research base through collaborative research with scientists and clinicians in other institutions locally and nationwide. The research supported through this program must have translational potential or significance, i.e., it must apply information developed in basic research laboratories to the design of clinical research that will test interventions or methods for improving the outcomes for patients with acute hemorrhagic or ischemic stroke. Translational research bridges the gap between the discoveries of basic scientists and definitive phase 3 trials of efficacy for specific treatments. Projects encouraged within the SPOTRIAS include: o phase I and phase II studies to evaluate novel stroke treatments; o development and testing of innovative systems for delivery of emergency medical services; o development and evaluation of clinical tools useful for rapid stroke treatment; o tests of potential biomarkers, surrogate outcomes, and clinical stroke scales useful in acute stroke research; o development and evaluation of new treatments and practices within critical care units for patients immediately after initial emergency department management; o tests of strategies for rehabilitation of acute stroke patients; o long term quality-of-life research for patients treated early for acute stroke. Beyond specific hypothesis testing projects, the network of SPOTRIAS will share several broad goals to: o provide career development opportunities for new investigators who wish to pursue active research careers in translational acute stroke research; a training component will recruit promising junior physicians for further career development activities supported through the network and NIH grants. The development of collaborative training within the SPOTRIAS network will be encouraged. The success of trainees in obtaining independent research funding will be carefully considered on a yearly basis and at the time that any competing renewal are reviewed. o share human tissue resources, including genetic material, that will benefit both basic and translational acute stroke research; o develop collaborations in critical areas of research need with basic and clinical scientists within and across institutions; o meet with other SPOTRIAS on a regular basis to share information, assess scientific progress in the field, identify new research opportunities, and promote inter-SPOTRIAS research collaborations to resolve areas of scientific controversy. Each SPOTRIAS and the network of SPOTRIAS is expected to conduct research that will have immediate impact on reducing disability and mortality in acute stroke by intervening as rapidly as possible after the onset of symptoms. It is expected that the national network of acute stroke research centers formed as a result of this PA will lead to significant changes in the care of stroke patients. Examples are: o physicians early in their careers would be trained to react promptly to stroke and be given experience in the complex process of running an acute stroke treatment center; o the acute stroke treatment centers would allow stroke fellows to develop clinical research careers by providing them access to stroke patients at the time when stroke can be treated; o new treatments could be developed in phase one and phase two studies; o therapies with little commercial interest could be developed; o collaboration between SPOTRIAS on clinical research projects could occur; o the emergency treatment of stroke could be further refined and developed; o basic research could be more directly tied to the critical acute periods of stroke. SPECIAL REQUIREMENTS SPOTRIAS will fulfill several special requirements. 1) There must be a core that provides access to patients very soon after the onset of stroke. Standard care of stroke now includes intravenous tPA given to eligible ischemic stroke patients three hours or less after the onset of stroke symptoms. Three hours is an upper limit and basic research data would indicate that earlier treatment would have additional benefit. Testing treatments early after stroke onset allows more opportunity for the treatments to show a measurable benefit when less of the brain is irreversibly injured. For this reason, each SPOTRIAS will be required to treat at least twelve eligible patients each year of the grant with tissue plasminogen activator within two hours of the onset of their symptoms. In order to fulfill this requirement patients that have hemorrhagic stroke or do not meet the strict requirements for tPA will have to be screened for eligibility. This will assure that ample early hemorrhagic and early ischemic stroke patients are available for clinical research studies. If a SPOTRIAS is not able to treat twelve patients with intravenous thrombolytic therapy within two hours of symptom onset each year, the SPOTRIAS will be terminated, the billing arrangement modified, and participation in the SPOTRIAS network limited. Terms for continuation of the SPOTRIAS that fails to treat the required number of patients may be modified to allow follow-up of patients already enrolled in SPOTRIAS studies and to complete any formal training obligations. Other cores and projects will be deleted. 2) Emergency medicine must be fully integrated into the leadership of the SPOTRIAS and the patient access core. It is likely that many individuals representing different medical specialties, organizations and hospital departments will be part of a successful SPOTRIAS patient access core. These include: the emergency medical system, the hospital emergency departments, radiology facilities, intensive care units, patient coordinators, neurologists, neurosurgeons, radiologists, patient advocates, and patient educators. Central to the treatment of acute stroke is the emergency department where initial contact with most patients is made and the early diagnostic and treatment activities occur. Hence, involvement of the leadership of participating emergency departments in the patient access core as well as in the SPOTRIAS projects and the SPOTRIAS itself is a requirement. Naturally, the organization best suited to rapidly evaluate and treat stroke patients varies according to the local availability of resources, and therefore, a specific emergency physician role is not specified. What is required is clear evidence of involvement of emergency physicians that will ensure the most rapid possible treatment of stroke patients and the development of new procedures and treatment that are broadly applicable. This requirement is consistent with recommendations for organizing the rapid treatment of acute stroke patients that were published in the Proceedings of a National Symposium on Rapid Identification and Treatment of Acute Stroke December 12-13, 1996 (http://www.ninds.nih.gov/news_and_events/proceedings/stroke_proceedings/sayre.htm). These recommendations emphasize the importance of coordinating pre-hospital emergency medical care systems, emergency departments, and acute hospital care. A coordinated rural network or local network of cooperating hospitals may be part of the stroke care system if organized and lead by the SPOTRIAS. 3) No treatment protocol performed as part of the SPOTRIAS will delay for any amount of time, the delivery of standard care for acute stroke patients. 4) Three or more translational research projects will be required at each SPOTRIAS, including at least one phase 1 or phase 2 clinical trial that will test an intervention intended to improve the outcome of patients who present very early after the onset of ischemic or hemorrhagic stroke. In some cases, collaboration with a manufacturer will be required to provide therapeutic agents. Each SPOTRIAS must monitor the safety of this phase 1 or phase 2 study, but overall data and safety monitoring will be done by an NINDS-appointed DSMB that will oversee the phase 1 and phase 2 studies in all SPOTRIAS in the network. 5) SPOTRIAS will provide resources required for their centers to participate in annual three-day meetings of the SPOTRIAS network. This participation will include travel for up to ten individuals to Rockville, Maryland, or to an institution hosting a meeting. Included will be the SPOTRIAS Principal Investigator, the Principal Investigator for each SPOTRIAS project, the clinical coordinators, and the lead statistician. The SPOTRIAS will be responsible for advance planning to ensure the fullest possible attendance at the network meetings. If the meeting is not hosted by NINDS in Rockville, MD, the host center will be chosen based on the number of patients treated within two hours of stroke onset. No center would host a SPOTRIAS network meeting more than once. 6) Between the annual meetings, conference calls with the NINDS Program Director and the Principal Investigators of all the SPOTRIAS will be scheduled quarterly. 7) NINDS is committed to the career development of clinically trained research scientists. The Institute supports several programs to advance the careers of clinician-scientists by: (1) encouraging the interest of outstanding physicians early in their career; (2) accelerating entry to independent research; (3) encouraging translational research; and (4) fostering research training by especially competent laboratories. SPOTRIAS will propose and carry out career development plans. SPOTRIAS will select candidates for career development who demonstrate potential for independent research careers or who are established investigators and are changing the direction of their research careers. In this selection process the SPOTRIAS will seek out and include qualified minorities, women, and persons with disabilities for inclusion in the career development program. After an individual is selected, a specific plan will be developed and facilitated by the leadership of the SPOTRIAS. A budget will be proposed for sustaining a significant activity in career development for a maximum of one year while applications for any further support are prepared. Further support would have to come from career development grants from NIH or other organizations. For example, the NINDS sponsors career development awards, minority career development supplements, and fellowships. For a description of these programs, please consult the NINDS training and career development website: http://www.ninds.nih.gov/funding/research_training.htm 8) There will be a central facility in each SPOTRIAS for collecting and sharing relevant tissue and blood samples collected in the projects. Particularly important will be samples for genetic studies. Some of the samples may be requested by other SPOTRIAS in the network. All such studies and the procedures for banking and sharing the specimens within the network will all be subject to approval by local Institutional Review Boards (IRBs) acting to protect human subjects from research risks. Some SPOTRIAS may wish to share autopsy material. 9) A biostatistical and data management core will be required to collect and analyze the data for each of the clinical research projects. For any phase 1 or phase 2 studies, reports summarizing patient safety, interim results, recruitment, and baseline description must be prepared for the NINDS-appointed DSMB as requested. The medical safety monitor on the site must be in close communication with this center and appropriate safeguards to prevent bias will be established by this core. TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the notice of grant award. The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH grant administration policies. 1) The awardees for a SPOTRIAS will treat within two hours of onset of stroke symptoms a minimum of twelve eligible ischemic stroke patients during each year of the project with standard thrombolytic treatment as approved by the FDA. It is the intention of this announcement to facilitate the creation of SPOTRIAS at which more than twelve patients will be treated per year. Therefore if a SPOTRIAS should not be able to achieve this minimum level of performance, then funding will be severely reduced. Noncompliance with the terms of award may result in a reduction of the recommended budget, withholding of support, suspension, or termination of the award. 2) A condition of any award will be the periodic review of the clinical research projects which compose a SPOTRIAS by a Data Safety And Monitoring Board (DSMB) established by and reporting to the NINDS. This DSMB will review research progress in the entire SPOTRIAS as well as the phase I or phase II studies in the SPOTRIAS. 3) Information concerning the number of patients enrolled in each SPOTRIAS protocol, the completeness of follow-up, and other data necessary to assess research progress and to plan expenditure of funds shall be made available to the NINDS on a quarterly basis. The report shall include the number of males and females, and the different ethnic groups, in the study population. Reports are to be sent to the NINDS program administrator, summarizing progress, including data on patient accrual, completeness of data, and patient safety. These will be due September 1, December 1, March 1 and June 1, each year of the grant (or as mutually agreed upon with the NINDS program administrator). 4) The NINDS reserves the right to terminate or curtail a SPOTRIAS (or an individual project or core) in the event of (a) a major breach in a clinical protocol or substantial changes in the agreed-upon protocol with which the Institute does not agree or (b) human subject ethical issues that may dictate a premature termination or (c) failure to pursue the objectives stated in this Program Announcement, or (d) shortfall in recruitment and/or retention of subjects or (e) a recommendation to the NINDS by the DSMB to a project. MECHANISM OF SUPPORT Support of the SPOTRIAS program will be through the specialized center grant (P50) mechanism. This mechanism supports any part of the full range of research and development from basic to clinical and intervention studies. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem. These grants differ from program project grants in that they are more complex and flexible in terms of the activities that can be supported. In addition to support for multidisciplinary research projects, the P50 provides for career development, pilot research projects, specialized resources and shared core facilities. Applicants will be responsible for the planning, direction, and execution of the proposed SPOTRIAS program. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. The total project period for applications submitted in response to this Program Announcement may not exceed five years. The number of awards to be made and level of support to be provided depend on receipt of a sufficient number of applications of high scientific merit. FUNDS AVAILABLE The maximum allowable direct cost per year for a SPOTRIAS will be $1,000,000. It is expected that approximately $1,400,000 total cost (direct plus the Facilities and Administrative (F&A) costs which vary depending on the applicant institution) will be available each year over a five year period for a SPOTRIAS. It is anticipated that awards for ten new SPOTRIAS grants will be made over three years. It is estimated that four awards will be made in the first two years and two in the third. A total of $ 5.6 million will be committed by the NINDS in FY 2002 and FY 2003 and $2.8 million in FY 2004 to fund applications of high scientific merit submitted in response to this Program Announcement. Although this program is provided for in the financial plans of the NINDS, the award of grants pursuant to this PA is also contingent upon the availability of funds for this purpose. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, clinics, laboratories, units of State and Local governments, and eligible agencies of the Federal Government. Foreign institutions are not eligible for P50 grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. INQUIRIES Written, including electronic mail, and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding scientific or programmatic issues to: Mary Ellen Michel, Ph.D. Neuroscience Center, Room 2222, MSC 9525 6001 Executive Boulevard Rockville, MD 20852 (courier) Bethesda, MD 20892-9525 Phone: 301-496-1447 FAX: 301-480-1080 email: mm108w@nih.gov Direct inquiries regarding fiscal matters to: Gladys Bohler Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd. Rm. #3290 Bethesda, MD 20892-9537 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: bohlerg@ninds.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent 30 days before the application receipt date (January 1 for the February 1 receipt date, May 1 for the June 1 receipt date, or September 1 for the October 1 receipt date). The letter of intent should include a descriptive title of the proposed research; name, address, and telephone number of the Principal Investigator; identities of other key personnel and participating institutions; and the number and title of the PA 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 subsequent applications, the information allows NINDS staff to estimate the potential review workload and to avoid conflict of interest in the review. The Letter of Intent is to be sent to: Scott Janis, PhD Program Analyst National Institute of Neurological Disorders and Stroke Neuroscience Center Room 2230 6001 Executive Blvd. Rockville, Maryland 20892 Telephone: (301) 496-9135 FAX: (301) 480-1080 email: janiss@ninds.nih.gov SCHEDULE SUMMARY SPOTRIAS applications may be submitted on February 1, June 1, and October 1. Applications will be reviewed by the NINDS according to the usual review schedule of the NINDS Review Branch. Secondary review by the National Advisory Council of the NINDS will follow. APPLICATION PROCEDURES The research grant application form PHS 398 is to be used in applying for these awards. These forms are available at most institutional offices of sponsored research; from the Grants Information Office, Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Suite 6095, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: GrantsInfo@nih.gov. The application should be prepared in the format required by NINDS for research program projects. This format is described at http://www.ninds.nih.gov/funding/ppg_guidelines.htm. Submit a signed, 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 (For express/courier use Bethesda, MD 20817) At the time of submission, two additional copies of the application must also be sent to: Lillian M. Pubols, Ph.D. Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke Neuroscience Center Suite #3208 6001 Executive Blvd. Bethesda, MD 20892-9529 (For express/courier use Rockville, MD 20852) Telephone: (301) 496-9223 Fax: (301) 402-0182 e-mail: LP28E@NIH.GOV REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NINDS. Incomplete or unresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NINDS in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Institute of Neurological Disorders and Stroke Advisory Council. Review Criteria Overall Review Criteria --The overall scientific objectives and hypothesis; --The thematic cohesion of the program; the interrelationship of individual projects and cores; --The administrative structure of the program, including any internal and external advisory committees; --The principal investigator/program director’s scientific and administrative qualifications and his/her commitment to the program; --The effective integration of specialists in emergency medicine into the leadership of the SPOTRIAS, its cores and individual projects. Review Criteria for Individual Projects (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? For proposed phase I and phase II trials: Is there adequate preliminary data from laboratory research or an adequate rationale for proposed interventions based on prior clinical experience? Do proposed phase one and phase two studies have a clearly defined place in the process of developing a new intervention? Will the proposed projects be likely to add significant information important to further steps in the development of a clinical intervention? (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? For phase I and phase II trials: Are the phase one and phase two studies appropriately designed? Are there appropriate data collection procedures (considering the budget limitations) and a reasonable design? (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)? Do the investigators demonstrate the capability to modify and refine projects to achieve the specific aims of the research proposed? Will the investigators appropriately modify their projects in response to intermediate results of ongoing projects and in response to results from other centers in the SPOTRIAS network? For phase I and phase II trials: Do the investigators demonstrate understanding that phase one and phase two trials provide limited preliminary data and are not definitive trials of efficacy? (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? General Review Criteria for Cores: - Quality of the facilities or services provided by this core (including procedures, techniques, and quality control) and criteria for prioritization of usage; - Qualifications, experience, and commitment of the personnel involved in the core Review Criteria for the Patient Access Core: - How well will the mission- critical patient access core exceed the minimum requirement to treat more than twelve patients with standard intravenous thrombolytic therapy within 2 hours of acute stroke onset in the manner approved by the FDA? (The scientific merit of the entire project will be significantly reduced if this core is not likely to function well.) - Does the applicant provide convincing evidence that within the SPOTRIAS there is 24- hour, seven day availability of a well- trained and organized stroke response system immediately available to all stroke patients with the full support and cooperation of departments of emergency medicine, radiology, neurology, and neurosurgery? - Is it clear that no project in the SPOTRIAS proposes a protocol, intervention or diagnostic test that delays the delivery of standard thrombolytic treatment for eligible ischemic stroke patients? Will all patients be treated as rapidly as possible after stroke onset? Review Criteria for the Biostatistical and Data Management Core - Is the biostatistical and data management core appropriate for the proposed studies? Is there evidence that biostatistical expertise will be available from the design to the reporting phase of all projects? Review Criteria for the Career Development Core - Is the proposed career development program likely to develop new leaders in the field of acute stroke research? Are the plans for this program inclusive and adequately funded? Are there appropriate links to NIH- funded career development programs? Review Criteria for the Blood and Tissue Specimen Core - Are the plans and facilities for storing and sharing any collected human blood or tissue specimens adequate? Additional Review Criteria In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: - 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. - The reasonableness of the proposed budget and duration in relation to the proposed research. - 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. AWARD CRITERIA Applications recommended by the National Institute of Neurological Disorders and Stroke Advisory Council will be considered for award based upon (a) scientific and technical merit as determined by peer review; (b) program balance, and (c) availability of funds. 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, available on the Internet at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html. 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 Although it is less frequent, childhood stroke is a significant problem. 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 these policies 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. 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 PAS, Specialized Program of Transnational Research in Acute Stroke (SPOTRIAS)", 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 No. 93.853. 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 and 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 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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