PREDOCTORAL RESEARCH TRAINING IN BIOSTATISTICS RELEASE DATE: July 27, 2004 PA NUMBER: PAR-04-132 EXPIRATION DATE: September 12, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov) APPLICATION RECEIPT DATE: October 14, 2004; September 10, 2005 and September 10, 2006 CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.859 (NIGMS) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose o Training Program Objectives o Special Program Considerations o Mechanism of Support o Eligible Institutions o Eligible Training Program Directors o Eligible Trainees o Allowable Costs o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Additional Review Considerations o Award Criteria o Required Federal Citations PURPOSE The National Institute of General Medical Sciences (NIGMS) announces a new predoctoral institutional training grant program in biostatistics. The purpose of the program is to provide support for predoctoral training in biostatistical theory and evolving methodologies related to basic biomedical research, including, but not limited to, bioinformatics, genetics, molecular biology, cellular processes, and physiology, as well as epidemiological, clinical and behavioral studies. The goal is to ensure that a workforce of biostatisticians with a deep understanding of statistical theory and new methodologies is available to assume leadership roles related to the Nation’s biomedical, clinical, and behavioral research needs. Implementation will depend on the integration of biostatistics and basic biological sciences to create effective interdisciplinary training grant programs. The Biostatistics Training Grant Program is administrated by NIGMS with funds contributed by the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, the National Heart, Lung and Blood Institute, the National Human Genome Research Institute, the National Institute of Dental and Craniofacial Research, the National Institute of Deafness and Other Communication Disorders, and the National Institute of Neurological Disorders and Stroke. TRAINING PROGRAM OBJECTIVES Biostatistics is an essential discipline in advancing and integrating biomedical, behavioral, and clinical research. In 2001, the National Institutes of Health (NIH) sponsored a workshop to evaluate future needs and opportunities in biostatistics research and training. The Workshop documented that the demand for biostatisticians exceeded the supply and recommended the establishment of a new training program in biostatistics that would provide in-depth training in statistical theory and methodologies and offer a broad scope of research opportunities for future biostatisticians. In response to NIH-wide discussions, NIGMS, with support from other NIH institutes and centers, hosted a workshop in December of 2003 to assess the need for training in biostatistics and to identify the important elements that would characterize a multidisciplinary training program in biostatistics. The outcome of the 2003 Workshop, which included leading researchers in biostatistics, biomedical research, clinical research, and bioinformatics, was a reiteration of the biomedical workforce need for biostatisticians trained in more than one discipline. Specifically, the Workshop participants recommended establishing a predoctoral training program that is grounded in rigorous training in biostatistics and includes training in other disciplines. Successful training programs would be interdisciplinary, connecting biostatistics to basic biomedical, epidemiological, clinical, and behavioral research. The participants noted that to be effective members of the biomedical research community the next generation of biostatisticians, in addition to mastering traditional statistical theory and methods, will need to be trained in basic biological sciences (e.g., genetics, molecular biology, biochemistry, cell biology, evolution, bioinformatics, and computational biology). One recommendation to achieve this integration is for biostatistics graduate students to train in experimental laboratories in order to gain first-hand experience and insight into the nature of problems faced by biomedical researchers. The goal is to produce broadly trained biostatisticians with expertise in research areas that enable them to be integrated members of multidisciplinary teams at all levels of research and to play key roles in hypothesis development, experimental design, data gathering and analysis, and formulation of models and conclusions. The NIGMS predoctoral biostatistics training program differs from existing NIH biostatistics training programs, which are focused primarily on specific diseases, by emphasizing the integration of statistical theory and methodologies with basic biomedical research, as well as clinical and behavioral studies. This new program complements the more focused training programs, providing balance between the need for biostatistics tailored to a specific disease and developing biostatistical formalisms for emerging areas of research. The aim is to provide opportunities for students with strong quantitative talents to pursue a wide range of opportunities in biostatistics research. This is the 10th institutional predoctoral training grant program created by NIGMS over the past 25 years. The goal of the NIGMS training programs is to provide graduate students with access to research opportunities across disciplinary and departmental lines by supporting the development of comprehensive interdisciplinary and multidisciplinary graduate training. Further information about NIGMS training grant programs, including descriptions of the individual institutional training grant programs and special requirements, can be found at the NIGMS website: (http://www.nih.gov/nigms/funding/trngmech.html). SPECIAL PROGRAM CONSIDERATIONS Applicants for a predoctoral institutional training grant in biostatistics need to describe an interdisciplinary program that is built on a strong foundation in statistical theory and methodology and that provides a clear understanding of basic biological research, including bioinformatics, computational biology, and the relationship of these scientific domains to epidemiological, clinical, and behavioral research. One of the main challenges in this training program is to bridge cultural differences between disciplines. To promote these aims, NIGMS asks all applicants to address the following items and challenges: o Description of the mission and objectives of the program. o Creation of a collaborative infrastructure for training faculty: To develop a vital collaborative infrastructure that provides interdisciplinary training, faculty must be recruited from more than one department. Evidence for this infrastructure could include collaborative research projects, co- authored publications, joint service on dissertation committees, collaborative teaching, and regular interactions in journal clubs and seminar series. o Training of graduate students from diverse scientific backgrounds: The application should address at least two scenarios for student success, one involving students coming from a biological background and the other involving students coming from a quantitative or computational science background. o Degree requirements: While it is recognized that biostatistics depends on a theoretical formalism that requires an essential core of didactic courses, this requirement must be balanced with training in other disciplines. Applicants must identify the key ideas and skills that are essential to multidisciplinary training in biostatistics and monitor the impact of core requirements on time to degree. o Institutional commitment: Successful training programs depend on strong institutional support. The application must provide statements from the appropriate administrators and/or deans outlining how the proposed training program contributes to the broader vision of the institution with respect to faculty recruitment, curriculum development, and the integration of undergraduate, graduate and postdoctoral training. o Applicant pool: It is important to identify and recruit students with strong quantitative skills from biological backgrounds, and students from statistical, mathematical, physical, and computational backgrounds with an interest in biological problem solving. o Rotations: A major goal of this new program is to train biostatisticians who are conversant in experimental biology, computational implementation, and application of new methodologies. Students should be exposed to the realities of daily life in these very different research environments. One way to accomplish this objective is through research rotations in which students with predominantly quantitative training rotate in biology laboratories, and conversely, students with predominantly biological backgrounds rotate in quantitative/computer science laboratories. Rotations are widely recognized as effective means to introduce students to the broadest choice of potential thesis laboratories and cultures. o Emphasis on team research: The solution for many biomedical research problems depends on the effective collaboration of researchers from different disciplines. To advance the field of statistical research and its application to biomedical, epidemiological, clinical, and behavioral research, it is important that biostatisticians acquire the skills and knowledge necessary to become intellectual collaborators from initial experimental design through data analysis and interpretation. To achieve this, students should participate in a variety of interdisciplinary training activities that will enable them to bring together knowledge from different domains to solve important problems. One way to promote interdisciplinary training is to arrange for co-mentorship. o Statistics, biology, and computer science courses: Students must be able to understand the theoretical and methodological literature in statistics to be able to develop new methods appropriate for biomedical problems. It is incumbent on the applicant to define a set of core concepts that all students in the program will master. Core courses in statistics might include mathematical statistics, including theory of estimation and inference; probability theory; linear models, including regression analysis of variance and generalized linear models; non parametric methods; and data analysis. Core courses in biology should be designed to provide fundamental knowledge in basic biomedical research, whereas core computational courses should focus on understanding the foundations of bioinformatics and computational biology. Courses in these areas might include, but are not limited to, basic concepts in molecular biology, genetics, computer algorithms, and databases, including algorithms developed in computational biology and bioinformatics. o Student interactions: It is important to provide forums that enable predoctoral and other students in biostatistics to interact with one another and with visiting scholars in their field. The aim is to help students develop a sense of identity within their field and expose them to successes and challenges in biostatistics research. Mechanisms for fostering student interactions may include seminar series with presentations from students, faculty and outside speakers; retreats; and journal clubs. o Teaching skills: To produce a workforce that can assume faculty positions at academic institutions, trainees should be given the opportunity to learn teaching methods and be provided with opportunities to teach. o Involving industry in creative ways: Industry provides significant research opportunities for biostatisticians. Affiliate programs should be considered that provide exposure to industrial research and development through internships and other activities. o Academic and career advising: Early mentoring of students concerning their academic and career options is an important factor in the success of all training programs. The special considerations involved in deciding between careers in industry and academia should be discussed, as should methods for developing skills for obtaining research funding. o Monitoring students: Students should be monitored throughout their graduate careers with close attention paid to time to degree and retention in the program. MECHANISM OF SUPPORT This program announcement will use the National Research Service Award (NRSA) Institutional Training Grant mechanism (T32). Predoctoral institutional training grant funds are intended to support trainee stipends; partially cover tuition, fees, and health insurance; and provide modest sums for equipment, supplies, and travel to scientific meetings. Predoctoral trainees may receive up to five years of support under the NRSA provisions. However, the normal period of support for trainees on NIGMS institutional predoctoral training grants is between one and three years, and is typically offered in the early years of training to provide students with flexibility to select courses, laboratory rotations, and mentors. Institutional training grants are awarded for project periods of up to five years and are renewable. Awards within an approved competitive segment are normally made in 12-month increments with support for additional years based on satisfactory progress and the continued availability of funds. Information on the policies governing the institutional predoctoral training grant awards, including notification, tenure, trainee eligibility, and other provisions, may be found on the NIH home page at http://grants.nih.gov/training/extramural.htm. ELIGIBLE INSTITUTIONS Applications may be submitted by domestic, non-profit, private and public institutions with established programs leading to the Ph.D. degree. The applicant institution must have a strong research program in the areas proposed for research training. ELIGIBLE TRAINING PROGRAM DIRECTORS Any individual with the skills, knowledge, and resources necessary to organize and implement a high-quality research training program is invited to work with his/her 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. The research training program director at the institution will be responsible for selection and appointment of trainees to the NRSA research training grant and for the overall direction, management, and administration of the program. ELIGIBLE TRAINEES Predoctoral students appointed to the training program must have the opportunity to carry out supervised biomedical research with the primary objective of developing or extending their research skills and knowledge in preparation for a research career. Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, and must be training at the post-baccalaureate level and enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program. A trainee must be a citizen or non-citizen national of the United States or must have been lawfully admitted for permanent residence. Individuals on temporary or student visas are not eligible. ALLOWABLE COSTS Details about allowable costs and current stipend levels are available at http://grants.nih.gov/training/nrsa.htm. Stipends: National Research Service Awards provide funds to graduate student trainees in the form of stipends. A stipend is provided as a subsistence allowance to help trainees defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. The training institution may not alter established stipend levels. Further, stipend amounts are not to be changed in the middle of an appointment period. Stipends may be adjusted only at the time of appointment or reappointment. Finally, stipends must be based on the levels established for the current fiscal year of the grant. Tuition, Fees, and Health Insurance: The NIH will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate), currently at the following rate: 100 percent of all costs up to $3,000 and 60 percent of costs above $3,000. Costs associated with tuition, fees, and health insurance are allowable only if they are applied consistently to all persons in a similar research training status at the institution regardless of the source of support. A full description of the tuition policy is contained within the Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm. Other Trainee Costs: Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's research training, is an allowable trainee expense. Training Related Expenses: Currently, institutional costs of $2,200 a year per predoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and travel expenses for the training faculty. Training related expenses may be adjusted in future fiscal years. Facilities and Administrative Costs: A facilities and administrative allowance (indirect cost allowance) based on 8 percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. Applications from state and local government agencies may request full indirect cost reimbursement. Information on Facilities and Administrative Costs is available in the Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: John Whitmarsh, Ph.D. Center for Bioinformatics and Computational Biology National Institute of General Medical Sciences Building 45, Room 2AS.55F Bethesda, MD 20892 Telephone: (301) 451-6446 FAX: (301) 480-2802 Email: Whitmarj@nigms.nih.gov o Direct your questions about peer review issues to: Helen R. Sunshine, Ph.D. Office of Scientific Review National Institute of General Medical Sciences Building 45, Room 3AN.12F Bethesda, MD 20892 Telephone: (301) 594-2881 Fax: (301) 480-8506 Email: sunshinh@nimgs.nih.gov o Direct your questions about financial or grants management matters to: Grace Olascoaga Grants Management Analyst National Institute of General Medical Sciences Building 45, Room 2AN.32E Bethesda, MD 20892 Telephone: (301) 594-5520 FAX: (301) 480-2554 Email: olascoag@nigms.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using institutional NRSA section of the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705- 5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at: http://grants.nih.gov/grants/funding/phs398/phs398.html. Helpful information for preparing applications and organizing required materials for NIGMS institutional training grant applications can be found at: http://www.nigms.nih.gov/training/nrsatablesintro.html. The Center for Scientific Review (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 unfunded version of an application already reviewed, but such an application must include an Introduction addressing the previous critique. Applications must be mailed on or before the receipt date listed on the first page of this PA. Submit a signed, original application, including the checklist, and five signed copies of the application in a single package to: Mailing Address: 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) Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and responsiveness by NIGMS. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIGMS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the National Advisory General Medical Sciences Council REVIEW CRITERIA Applications will be reviewed according to the review criteria outlined in the NIH NRSA Institutional Research Training Grants ( http://grants1.nih.gov/grants/guide/pa-files/PA-02-109.html) and on the NIGMS website (http://www.nigms.nih.gov/training/nrsatablesintro.html). Review criteria related to this PA include: Program Direction/Administrative Structure o Research, training, and leadership ability of the program director o Adequacy of the program administration and advisory structure Training Faculty o Composition of the faculty (by rank and distribution in different fields/departments) o Mechanisms and criteria for inclusion/exclusion of faculty o Current independent research grant support (obtained through peer-reviewed competition) o Publication records o Nature and breadth of research conducted o Evidence of collaboration and cooperation among faculty members o Experience in the supervision of research training (related to the proposed program) Training Program o Aims of the program in relation to this program announcement o Program components (nature and extent of courses, research/rotation opportunities, seminars, examinations, teaching opportunities, other), including any innovative features o Opportunities for interdisciplinary training and collaborative research o Provisions/activities to promote cohesiveness of the program o Integration of biostatistics and basic biomedical research o Mechanisms to monitor and guide trainees (e.g., by the Ph.D. degree departments/programs, training program, mentors, thesis committees) Applicant Pool o Size and distribution (regional or national, proportion eligible for training grant support) o Quality (based on academic credentials and other factors, e.g., research experience) Trainees and Candidates for Training o Mechanisms and criteria for the recruitment and selection of trainees o Number; distribution in departments, programs, and among training faculty o Caliber of current and/or potential trainees and others identified with the program o Racial and ethnic diversity of the trainee pool (including participation of underrepresented minority students) o Quality of research; postdoctoral and career plans Research and Training Environment o Institutional support for the training program o Other sources of training support available o Facilities and resources available to the program (including clinics, where relevant) o Numbers of predoctoral and postdoctoral students affiliated with participating laboratories Outcomes (where relevant for existing programs) o Record of completion of training o Average time to completion of Ph.D. degree o Publication records of past and current trainees o Success of graduates: nature, quality, and research relevance of subsequent positions--e.g., postdoctoral, academic, industrial, clinical ADDITIONAL REVIEW CONSIDERATIONS MINORITY RECRUITMENT PLANS: Plans to recruit and retain minority trainees is a factor in the assessment of the quality of the trainee pool and thus will be included within the priority score. In addition, peer reviewers will separately evaluate the minority recruitment plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of minorities, and whether any prior experience in recruitment of minorities has been incorporated into the formulation of the plan for the next award period. The evaluation will be included in an administrative note in the summary statement. If the plan for minority recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is a received. Staff within the NIGMS, with guidance from the National General Medical Sciences Advisory Council, will determine whether amended plans and reports submitted after the initial review are acceptable. Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993 (see http://grants.nih.gov/grants/guide/notice-files/not93-188.html). TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH: Every predoctoral NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, data management, and data sharing. (For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992 at: (http://grants.nih.gov/grants/guide/notice-files/not92-236.html). The plans for responsible conduct of research will be discussed after the overall determination of merit, so that the review panel's evaluation of the plans will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. AWARD CRITERIA Applications submitted in response to this PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Quality of the proposed training program as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety 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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html ); a complete copy of the updated Guidelines are available at: http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm . The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subject research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. 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. 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.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/policy.htm. 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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