INNOVATIVE TECHNOLOGIES FOR ENHANCING FUNCTION FOR INDIVIDUALS WITH DISABILITIES RELEASE DATE: March 4, 2002 PA NUMBER: PA 02-071 EXPIRATION DATE: January 25, 2005 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) National Institute on Aging (NIA) (http://www.nia.nih.gov) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov) National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) National Eye Institute (NEI) (http://www.nei.nih.gov) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) U.S. Department of Education, National Institute on Disability and Rehabilitation Research (NIDRR) (http://www.ed.gov/offices/OSERS/NIDRR/) National Science Foundation (NSF) (http://www.nsf.gov/pubs/2001/nsf0128rev/nsf0128rev.htm) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This Program Announcement (PA) is to encourage small businesses to participate in assistive technology research that facilitates the rehabilitation of individuals with disabilities resulting from injury and disease. The National Institutes of Health (NIH), the National Institute on Disability and Rehabilitation Research (NIDRR) of the U.S. Department of Education, Office of Special Education and Rehabilitative Services, and the National Science Foundation (NSF) encourage SBIR/STTR applications in innovative technologies for enhancing function for individuals with disabilities within their major solicitation topics. Ultimately, the goal of this program is to improve the physical and/or mental function of individuals with disabilities through new technologies, delivery systems, and/or training techniques. For this purpose, this announcement is designed to expedite the transition of innovative technology and development into practical applications. RESEARCH OBJECTIVES BACKGROUND: Assistive technology use is increasing as the population of individuals with disabilities grows. To a large extent, consumer use is associated with the desire to remain independent and improve and maintain function. Within the past decade, the increase in scientific discoveries in the biologic and engineering sciences provides the basis for the development of a wide array of new assistive technologies. There is a need to expand on these emerging technologies and translate the science into devices needed by individuals with disabilities. This PA seeks to encourage potential applicants to take full advantage of the SBIR/STTR program mechanism for multidisciplinary rehabilitation research projects that develop technology to reduce impairment and increase function of individuals with disabilities resulting from injury and disease. This PA is open to all relevant, meritorious research ideas involving the development of innovative assistive technology where progress is likely to make a significant contribution to improving the cognitive, emotional, and physical health of individuals with disabilities. Assistive technology research should be science based, developed in collaboration with consumers, industry, and academia, and result in high- quality products, services or training media that have been evaluated for utilization, efficacy, and functional impact on target audiences. Researchers should pursue the research with the safety, good health, and welfare of the potential user of their technology in mind. Research Scope: The following examples of projects are not all-inclusive, but indicate the type of knowledge to be achieved through this PA. (1) Technology o Develop tissue science solutions to enhance the biocompatibility of assistive technology in terms of the person/machine interface. o Develop innovative power supplies for mobility devices. o Develop biosensors for reducing health risks for individuals with disabilities. o Develop new cognitive prostheses for individuals with cognitive impairments. o Develop multifunction wearable computers to facilitate health status monitoring, enhance communication, etc. for individuals with disabilities. o Develop assistive devices, environmental modifications, and rehabilitation strategies to minimize the impact of visual impairment in everyday life. o Develop assistive devices, environmental modifications, and rehabilitation strategies to minimize the impact of disordered processes of hearing, balance, smell, taste, voice, speech, and language. (2) Systems o Develop consumer report types of evaluations of assistive technology. o Develop long-term assistive technology tracking systems that monitor outcome measures. o Develop integrated systems of rehabilitation practice and best practices information on appropriate use of assistive technology. o Develop information systems on assistive technology for the public or health care profession that give individuals with disabilities the information they want. (3) Training o Develop training modules for health professionals on the appropriate use of assistive technology and to help individuals with disabilities make better choices. o Develop training modules on assistive technology for caregivers to clarify risks and reduce disparities in demand for, access to, and use of assistive technology. o Develop training modules on the appropriate use of assistive technology to increase function, facilitate adaptation, and clarify expectations regarding function and costs for persons with disabilities. MECHANISMS OF SUPPORT This PA will use the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. NIH and NSF participate in the SBIR and STTR Programs; NIDRR participates only in the SBIR Program. ELIGIBLE INSTITUTIONS You may submit an application if your institution meets the relevant agency's SBIR/STTR Program and application requirements. Agency-specific SBIR/STTR information, including eligibility requirements, mechanism of support, award levels, and application preparation requirements, is located at the following websites: NIH: http://grants.nih.gov/grants/funding/sbir.htm U.S. Department of Education: http://www.ed.gov/offices/OERI/SBIR/ NSF: http://www.eng.nsf.gov/sbir/. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS The following information is specific only to NIH applicants: This PA must be read in conjunction with the current NIH Omnibus Solicitation for SBIR/STTR Grant Applications, which may be accessed at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. Because the length of time and cost of research involving technology projects may exceed that normally awarded for NIH SBIR/STTR grants, the NICHD, NIA, NIBIB, NIDCD, NEI and NIMH will allow well-justified Phase I applications with a project period of up to two years and a budget, including fixed fees, not to exceed $100,000 per year total costs (maximum of $200,000 total costs for two years). Phase II applications in response to this PA will only be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. The previously funded Phase I award need not have been awarded under this PA, but the Phase II application must be a logical extension of the Phase I research. The NICHD and NIA will consider Phase II projects with a project period up to three years and a budget not to exceed $400,000 per year total costs, including fixed fees. All of the instructions within the NIH Omnibus Solicitation for SBIR/STTR Grant Applications apply, including Fast-Track applications, with the following exceptions: o Opportunity for two years of Phase I support with a budget not to exceed $100,000 in total costs including fixed fees, per year; o Opportunity for three years of Phase II support with a budget not to exceed $400,000 in total costs, including fixed fees, per year. INDIVIDUAL PHASE I APPLICATIONS: Phase I applications in response to this PA will be funded as Phase I SBIR Grants (R43) or Phase I STTR Grants (R41) with modifications as described below. For Phase I applications, applicants are strongly encouraged to highlight the innovation of their proposed research and to clearly state the milestones that will be used to demonstrate feasibility. Applications for Phase I grants should be prepared using the PHS 398 (rev. 5/2001) forms in accordance with Section VI of the PHS 398 instructions. See http://grants.nih.gov/grants/funding/phs398/phs398.html. Well-justified Phase I applications with a project period up to two years and a budget not to exceed $100,000 per year total cost, including fixed fees, (maximum of $200,000 total costs for two years) will be allowed. INDIVIDUAL PHASE II APPLICATIONS: Phase II applications in response to this PA will be awarded as Phase II SBIR Grants (R44) or Phase II STTR Grants (R42) with modifications as described below. For Phase II applications, the demonstration of feasibility accomplished in Phase I should be clearly indicated. Phase II applications will only be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase II application must be a logical extension of the Phase I research and must be responsive to this PA. Applications for Phase II SBIR or STTR awards should be prepared using the PHS 398 forms in accordance with Section VI of the PHS 398 instructions. See http://grants.nih.gov/grants/funding/phs398/phs398.html. Well-justified Phase II applications with a project period up to three years and a budget not to exceed $400,000 in total costs, including fixed fees, per year will be allowed. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/phs398/instructions2/p1_SBIRSTTR_general_instructions.htm). Specifically, if you are submitting an application with total costs in each year of $100,000 or less, use the modular format. Otherwise follow the instructions for non-modular SBIR/STTR grant applications. WHERE TO SEND INQUIRES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific /research and financial or grants management issues: o Direct your questions about scientific/research issues to: Louis Quatrano, Ph.D. Behavioral Sciences and Rehabilitation Engineering National Institute of Child Health and Human Development National Institutes of Health 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-4221 FAX: (301) 496-0832 E-mail: quatranl@exchange.nih.gov Sidney M. Stahl, Ph.D. National Institute on Aging National Institutes of Health Gateway Building, Room 533 7201 Wisconsin Avenue Bethesda, MD 20892-9205 Telephone: (301) 402-4156 Fax: (301) 402-0051 E-mail: StahlS@nia.nih.gov Joan T. Harmon, Ph.D. Senior Advisor for Program National Institute of Biomedical Imaging and Bioengineering National Institutes of Health 6707 Democracy Boulevard, Room 697 Bethesda, MD 20892 Telephone: (301) 594-8813 FAX: (301) 480-3503 E-mail: joan_harmon@nih.gov Lana Shekim, Ph.D. Director, Voice & Speech Program Scientific Programs Branch, DER National Institute on Deafness and Other Communication Disorders National Institutes of Health 6120 Executive Boulevard, EPS-400-C, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 FAX: (301) 402-6251 E-mail: shekiml@nidcd.nih.gov Dr. Michael D. Oberdorfer Director, Low Vision and Its Rehabilitation Program National Eye Institute National Institutes of Health 6120 Executive Boulevard, Suite 350, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 496-5301 FAX: (301) 402-0528 E-mail: oberdorfer@nei.nih.gov Enid Light, Ph.D. Division of Services and Interventions Research National Institute of Mental Health National Institutes of Health 6001 Executive Boulevard, Room 7155, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-3599 FAX: (301) 594-6784 E-mail: elight@nih.gov Kristi Wilson, Ph.D., Program Officer Constance Pledger, Ed.D., Associate Director, Division of Research Sciences National Institute on Disability and Rehabilitation Research Office of Special Education and Rehabilitative Services U.S. Department of Education Telephone: (202) 260-0988 FAX: (202) 205-8515 E-mail: Connie.pledger@ed.gov Dr. Joseph E. Hennessey Acting Director, SBIR/STTR National Science Foundation 4201 Wilson Boulevard, Room 570.10 Arlington, VA 22210 Telephone: (703) 292-7069 FAX: (703) 292-9057 E-mail: jhenness@nsf.gov o Direct your questions about financial or grants management matters to: Christopher Myers Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6996 FAX: (301) 402-0915 E-mail: cm143g@nih.gov Deborah Stauffer Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 E-mail: Staufferd@exchange.nih.gov Annette Hanopole, CRA Grants Management Branch National Institute of Biomedical Imaging and Bioengineering 31 Center Drive, Room 1B37, MSC 2077 Bethesda, Maryland 20892-2077 Telephone: (301) 451-6768 FAX: (301) 480-4515 E-mail: Hanopola@mail.nih.gov Sara Stone Chief, 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 E-mail: stones@nidcd.nih.gov William W. Darby Grants Management Officer National Eye Institute 6120 Executive Boulevard, Suite 350, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 496-5884 FAX: (301) 496-9997 E-mail: wwd@nei.nih.gov Diana S. Trunnell 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 E-mail: Diana_Trunnell@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard SBIR/STTR application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. Applicants planning to submit an SBIR or STTR Phase I or Phase II application AFTER April receipt dates should check the NIH Small Business Funding Opportunities website http://grants.nih.gov/grants/funding/sbir.htm for more specific details and instructions. The title and number of this program announcement must be entered on line 2 of the face page of the application (PHS 398) form and the YES box must be marked. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $100,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Section C of the SBIR/STTR grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing_SBIR_STTR_app.htm includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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) APPLICATION PROCESSING: Applications must be received by or mailed before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? 2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below). DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: In addition to the above criteria, Phase II applications will be evaluated with respect to the following: (1) How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity? (2) Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in the Research Plan, item J? (3) Does the project carry a high degree of commercial potential, as described in the Product Development Plan? In addition to the above criteria, the following criterion will be applied to revised applications: (1) Are the responses to comments from the previous SRG review adequate? Are the improvements in the revised application appropriate? PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA: For Phase I/Phase II Fast Track applications, the following criteria also will be applied: (1) Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? (2) Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in the Research Plan, item J? (3) To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization? (4) Does the project carry a high degree of commercial potential, as described in the Product Development Plan? Phase I and Phase II Fast-Track applications that satisfy all of the review criteria will receive a single rating. Failure to provide clear, measurable goals may be sufficient reason for the scientific review group to exclude the Phase II application from Fast-Track review. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended SBIR/STTR applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm . The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Nos. 93.837, 93.838, 93.839, 93.866, 93.867, 93.173, 93.286, 93.287, and 93.242 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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