CDC PUBLIC HEALTH RESEARCH: HEALTH PROTECTION RESEARCH INITIATIVE MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (KO1) RELEASE DATE: April 22, 2004 RFA Number: RFA-CD-04-001 EXPIRATION DATE: June 23, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: Office of the Director (OD), Office of Science Policy and Technology Transfer, Office of Public Health Research (OPHR), http://www.cdc.gov/od/ads Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.063 LETTER OF INTENT RECEIPT DATE: May 24, 2004 APPLICATION RECEIPT DATE: June 22, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of This RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Centers for Disease Control and Prevention (CDC) Office of Public Health Research (OPHR) announces the availability of FY 2004 public health research funds to support the development of a qualified and experienced cadre of independent public health researchers to addresses priority health protection issues. Health protection should be interpreted to include activities that 1) promote health/or prevent disease, injury, or disability or 2) protect people from health threats including infectious, environmental, and terrorist threats. RESEARCH OBJECTIVES Background The large discrepancies between what Americans spend on health and the outcomes they experience may stem from how the nation’s health knowledge and resources are deployed within the health system and other sectors of society. Most resources are deployed when people seek care for specific diseases and health conditions. Health protection, health promotion, and prevention activities account for less than 3% of the nation’s investment for health services. A major obstacle to prioritizing health promotion is the fact that there is insufficient evidence to support specific programs, practices, and policies that affect health decisions made by people and those responsible for health policies and programs in the public health, health care delivery, and educational systems, as well as their counterparts in businesses and other private sector enterprises, governments, and governmental agencies. Development of this evidence is hampered by the lack of appropriately trained, qualified, and supported public health research investigators in relevant disciplines across all academic environments. CDC has initiated this focus on career development of qualified investigators as one key component of its public health research agenda to address this gap in health promotion. CDC has aligned its priorities and investments with those of the Department of Health and Human Services to achieve 2 overarching health protection goals: 1) Health promotion/Disease, injury and disability prevention: All people will achieve their optimal lifespan with the best possible quality of health in every life stage. The strategy to accomplish this goal includes developing the knowledge and tools that integrate perspectives from multiple scientific disciplines to focus on health evolving in life stages over a lifetime (infants, children, adolescents, young adults, middle-age adults, and older adults), and in all situations (at work, in communities, in school, at home, and at play). Integral to the successful accomplishment of this goal is the elimination of health disparities that afflict many people in our society. 2) Preparedness: People in all communities will be protected from infectious, environmental, and terrorist threats. The strategies to accomplish this goal include developing the knowledge and tools that integrate perspectives from multiple scientific disciplines to focus on exposure prevention, rapid detection and diagnosis, investigation, containment, and recovery from health threats. CDC’s health protection research initiative is designed to support achievement of these goals, and will help develop and disseminate the knowledge and tools that can be used by individuals, public health professionals, health care providers, educators, policy makers, businesses, private sector organizations, and others to measurably improve the health of Americans and reduce health disparities at all life stages and in all settings at home, in school, at work and at play. CDC’s intent is to ensure that a diverse pool of highly trained and creative scientists will be available in adequate numbers to carry out the nation’s public health research agenda. The objective of this RFA is to develop a qualified, experienced, and sustainable cadre of independent public health researchers to address CDC’s health promotion research priorities. This award will support career development experiences that lead to independence and substantially expand the knowledge and capabilities of current research scientists. Hence, the award is specifically designed to support postdoctoral professionals with research experience at the time of application. The characteristics of ideal candidates vary. Some individuals may propose to refocus their current research career trajectory to address health protection priorities. Others may transition from a completely different field of investigation or may be returning to their research career after a hiatus. Other applicants may be research faculty from underrepresented groups or faculty at minority serving institutions who want to enhance their research skills and knowledge through a period of supervised training at a research center. The proposed career development experience should add substantially to the existing research capabilities of the applicant or result in new research capabilities. The candidate must provide a plan for achieving independent research support in the specified field by the end of the award period. Objectives and Focus Areas Applicants should focus their projects to achieve substantive contributions to CDC’s overarching goals (above) and a measurable impact on people’s health status. Specifically, the research outcomes should translate into extended lifespan or improved quality of health at any or all of the life stages as defined in the background portion of this section, and/or should substantively contribute to people’s protection from non-occupational infectious, environmental, or terrorist threats. Public health research should help close the gap between fundamental scientific knowledge and the information and motivators needed by individuals, families, communities, or the sectors that serve them to effectively use new knowledge and tools for making or supporting health decisions. In addition, the knowledge gained should be useful to public health practitioners, policy-makers, or even to the self-help or self-management of diseases, risk factors, or risk conditions by individuals, communities, and populations. Although CDC’s public health research priorities involve a broad range of activities, applicants are encouraged to seek career development strategies that include close collaboration with members of the study population and colleagues from non-academic sectors including public health agencies, healthcare organizations, schools, or businesses. Such research systematically engages the collaborators in formulating, conducting, interpreting, communicating, and disseminating the research aimed at improving health quality, increasing lifespan, encouraging healthy lifestyles, and protecting communities from a variety of health threats. Translating research findings into effective solutions people or organizations can utilize will require investigators to address one or more of the following focus areas: 1. Identification of new social, environmental, genomic, and developmental determinants of health amenable to intervention. 2. Identification of cost-effective interventions that improve the health of individuals, families, or communities. 3. Identification of the determinants of successful implementation and dissemination of evidence-based interventions among individuals, families, communities, or the sectors serving them. 4. Identification of the determinants of successful translation of evidence-based interventions to special populations to reduce health disparities. 5. Applications of genetic information to improve health. 6. Evaluation of the impact of policy alternatives on the health of individuals, families, or communities. 7. Determinants of the economic drivers of health and health decisions for individuals, families, communities, or the sectors serving them. 8. Identification and evaluation of public health informatics and communication strategies and tools to improve health decisions, health alerting, health literacy, or health assessment. 10. Identification of strategies to improve the prevention and early detection of public health threats. MECHANISM OF SUPPORT This RFA will use the K01 award mechanism. The applicant and her/his mentor on behalf of the applicant's institution, are responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Awards are not renewable. This RFA uses the non-modular budget format. Follow the instructions for non-modular budget research grant applications. This program does not require cost sharing, as defined in the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. FUNDS AVAILABLE The CDC intends to commit up to $10,000,000 in FY 2004 funds for approximately 20 new grants in response to this RFA. The award provides up to three consecutive 12-month budget periods within a project period of up to 3 years. An applicant may request a budget for direct costs of up to $300,000 per year. Direct costs include salary support (plus fringe benefits), technical assistance, equipment, supplies, consulting fees, domestic travel, publications, and other costs. Because the nature and scope of the proposed research training will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of CDC provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At least 75 percent of the recipient's full-time professional effort must be devoted to the goals of this award. The remainder may be devoted to teaching, practice, or other research pursuits consistent with the objectives of the award. Both the didactic and the research phases of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution is a(n): o Public or private academic institution o Eligible agency of the federal government o Unit of state, county, local, or tribal government o Healthcare organization o Research institution The institution must be located in the United States and its territories and have, or be affiliated with, a well-established research and public health career development program, with qualified faculty in public health, and/or clinical, or basic research to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent researcher. 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. Because of the focus on progression to independence as a researcher, a candidate for the K01 should propose a period of career development consistent with his or her previous research experience. It is open to candidates having faculty appointments, or similar appointments at eligible institutions and holding a Ph.D., M.D., D.V.M., D.O., or equivalent professional degree, who wish to develop research capabilities in research areas relevant to the nation’s public health research agenda. All programs must be tailored to meet the individual needs of the candidate ensuring that he/she will gain the skills and knowledge necessary to carry out high-quality, public health research. The candidate and the mentor are jointly responsible for the preparation of the plan for this program. The sponsoring institution may form an advisory committee to assist with the development of a program of study or to monitor the candidate’s progress through the career development program. Applications may be submitted, on behalf of candidates, by domestic, non-Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Minorities, women, and individuals with disabilities are encouraged to apply. Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence by the time of award. Individuals admitted for permanent residence must be able to produce documentation of their immigration status such as an Alien Registration Receipt Card (I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible for this award. SPECIAL REQUIREMENTS Mentor at Same or Collaborating Research Center Each candidate must also identify and complete arrangements with a mentor (at the same institution or at a collaborating research center) who is recognized as an accomplished investigator in the proposed research area and who will provide guidance for the candidate's development and research plan. Arrangements with mentors at institutions at a distance from the applicant institution will be considered, but approaches for ensuring close and active involvement of a distant mentor must be clearly outlined in the application. Plans for intensive training of the candidate should be developed with the mentor. The establishment of a viable mentoring plan is essential to the success of the candidate. The commitment of the mentor and the mentor's department chair to training must be documented in the application. A mentoring plan that describes the candidate’s interaction with the mentor and his/her staff, how it will enhance the candidate’s research capabilities and teaching skills, and steps to assist the candidate advance his or her career goals must be delineated in the application. The mentor must provide an annual evaluation of the candidate’s career development. This evaluation is to be included as part of the annual progress report if an award is made. Allowable Costs: 1. Salary: The CDC will provide salary and fringe benefits for the career award recipient. The total salary requested is based on a full- time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Additional information on the cost principles for educations institutions is available on the website: http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html The institution may supplement the CDC salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Because the salary amount provided by this award is based on the full- time institutional salary, no other PHS funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K01. 2. Research Development Support: All expenses must be directly related to the proposed research career development program. The facilities and administrative cost rate applied is limited to 8 percent of the direct cost, excluding tuition and related fees and equipment expenses, or to the facilities and administrative cost rate, whichever results in the lesser amount. Ancillary Personnel Support: Salary for secretarial and administrative assistance, etc., is not allowed. 3. Evaluation: In carrying out its stewardship of human resource related programs, the CDC may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. 4. Other Income: The career award recipient may not retain fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award. CDC assigns fees to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the CDC policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. o The funds may be used for health-related research purposes. o The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, CDC, and forwarded to the Director, Office of Financial Management, CDC, Atlanta, Georgia, 30333. Checks must identify the relevant award account and reason for the payment. o Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. o Funds budgeted in a CDC supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be re-budgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the CDC. 5. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the CDC is required. To obtain prior approval, the award recipient must submit a letter to the CDC describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the CDC and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Under unusual and pressing circumstances, an award recipient may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case, will it be permissible to work at a rate of less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the award recipient. Further, the award recipient must submit assurance of his or her intention to return to full-time professional effort (at least 75 percent) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. 6. Termination or Change of Institution: When a grantee institution plans to terminate an award, the CDC must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Associate Director for Science (ADS) of the CDC may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the CDC shall notify the grantee institution and career award recipient in writing of this determination, the reasons, the effective date, and the right to appeal the decision. Awardees planning a change of institution, must submit a written request for transfer to CDC in advance of the change, countersigned by the appropriate institutional business official, describing the reasons for the change and including the new sponsor's name and bios ketch. The award recipient must establish in this request that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer reviewed research program. Additionally, the new sponsor must have the appropriate research expertise to supervise the program and sufficient research support to ensure continuation of the research program to the end of the award. CDC staff will review this request and may require a review by an initial review group and/or the appropriate National Advisory Council or Board. Upon approval of this request, a new career award application must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested in the new application must be no more than the time remaining within the existing award period. 7. Change of Mentor: When a mentor at the grantee institution is to be replaced, the institution must submit a letter from the proposed mentor documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for the candidate's career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. CDC staff will evaluate the request, and will notify the grantee institution of the evaluation results. 8. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: Tanja Popovic, M.D., Ph.D., F.A.A.M. Acting Associate Director for Science Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road, N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (404) 639-7240 Email: TPopovic@cdc.gov o Direct your questions about peer review issues to: Catherine Spruill Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (404) 639-7240 Email: CSpruill@cdc.gov o Direct your questions about financial or grants management matters to: Sylvia Dawson Procurements and Grants Office Centers for Disease Control and Prevention Koger Office Park, Colgate Building, Mail-Stop E-14 2920 Brandywine Road, Atlanta, Georgia, 30341-5539 Telephone: (770) 488-2771 Email: SDawson@cdc.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, telephone number, and e-mail address of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows OPHR staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Heidi Steele Office of Public Health Research Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (770) 488-8612 Email: HSteele@cdc.gov SUBMITTING AN APPLICATION Applications must be prepared using 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 document 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. The application must address the following issues: Candidate o Describe the candidate's commitment to a career in public health research and his/her potential to make future contributions to public health. o Establish the candidate's potential to develop into an independent investigator, describe the long-term career objectives, and explain how this award will contribute to these goals. o Affirm a commitment of at least 75 percent effort to research career development activities. o Include as part of the application three sealed letters of recommendation addressing the candidate's potential for a research career. Career Development Plan o The career development and training experience must focus on health protection research. Describe the career development plan incorporating consideration of the candidate's goals and prior experience. A systematic plan should be presented for obtaining the necessary basic science/clinical background and research experience to launch an independent research career. The career development plan must be specifically tailored to the needs of the candidate and the ultimate goal of achieving independence as a researcher. Research Plan o The research project for his award must specifically be in the area of health protection research. The research plan must be described as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods. The K01 candidate should consult with the proposed mentor(s) regarding the development of this section. Training in the Responsible Conduct of Research o Candidates for K01 awards must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction. No award will be made if an application lacks this component. Mentor's Statement o The application must include a statement from the mentor including information on the mentor's experience in public health research and previous experience as a research supervisor. The application must also include information to describe the mentor's research support related to the candidate's research plan and the nature of the supervision that will occur during the proposed award period. Because this program is intended to provide a means to promote more extensive interaction among researchers, in some cases more than one mentor will be appropriate. The co-mentor(s) must provide similar information. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described. Environment and Institutional Commitment o The sponsoring institution must document a strong, well- established public health research program including a high- quality research environment with faculty that have had productive collaborations. The sponsoring institution also must provide a statement to document the level of commitment to the candidate's development into a productive, independent investigator during the period of the award. This must include an indication of support for the candidate's proposed level of effort (at least 75 percent), commitment to the necessary release time, as well as the availability of support and supervision during the award period. Budget requests must be provided according to the instructions in form PHS 398, and the limitations referenced above. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 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. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html 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. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier services) At the time of submission, two additional copies of the application and the appendix material must be sent to: Heidi Steele Office of Public Health Research Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (770) 488-8612 Email: HSteele@cdc.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. Upon receipt, applications will be reviewed for completeness by Center for Scientific Review, NIH, and for responsiveness by the Office of Public Health Research, CDC. Incomplete applications and applications that are not responsive to the eligibility criteria will not be reviewed. Applicants will be notified that their applications did not meet submission requirements. PEER REVIEW PROCESS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group in accordance with the review criteria stated below. CDC uses a peer review process modeled after that of the NIH, including a streamline review process, essentially as spelled out in the website located at: http://www.csr.nih.gov/REVIEW/streamln.htm As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique Applications in the upper half will receive a secondary review by the secondary review committee. REVIEW CRITERIA The mentored research scientist award aims to increase the number of independent researchers that have the capacity to conduct innovative public health research that addresses priority health protection issues. The following criteria will be considered in the evaluation of the proposed mentored research scientist development award program: o Candidate -- The candidate's overall qualification as demonstrated by academic record and research performance, potential for a career as an independent researcher, commitment toward pursuit of a research career. o Candidate's Career Development Plan -- The quality of the research career development plan, based on the candidate's past research experience, training, and career goals, as demonstrated by such things as relevance of the proposed didactic training, and structure of interaction with the mentor. The likelihood that the plan will contribute substantially to the achievement of scientific independence and the quality of the proposed training in responsible conduct of research will be considered. o Research Project -- Scientific and technical merit or the research question, design, and methodology. Reviewers recognize that applicants will have variable amounts of previous research experience. Those with limited research experience are less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Nevertheless, all applications must include a fundamentally sound research plan but reviewers will consider the applicant’s prior experience in judging the level of detail provided. Appropriateness of the research project as a vehicle for developing the candidate's research skills. o Mentor(s)/ Co-Mentor (s) -- The mentor's accomplishments in the scientific research area(s) proposed, plans for mentoring the candidate, experience and record in training investigators, and commitment for the duration of the project. A curriculum vitae with relevant publications and a list of current and pending research support must be included for all mentors. Mentors should also include a list of current and past research trainees (not more than the last 10 years) with information on their current positions. o Environment -- The applicant institution's ability to provide adequate facilities, resources, and opportunities necessary for the candidate's training, and the institutional commitment to the candidate. If the mentor(s)' institution is different from the applicant, the quality and extent of interaction of the faculty and assurance that the candidate is an integral part of the institution’s research program. The quality of the research and research training programs at the mentor's institution will be considered. o Institutional commitment -- The institution's commitment to the development of the candidate. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. RECEIPT SCHEDULE Letter of Intent Receipt Date: May 24, 2004 Application Receipt Date: June 22, 2004 Earliest Anticipated Award Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities (as determined by secondary review committee. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45 CFR Part 46) 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 INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of CDC to ensure that individuals of both sexes and the various racial and ethnic groups will be included in all CDC-supported studies involving human subjects, whenever feasible and appropriate. Furthermore, it is CDC policy to identify significant gaps in knowledge about health problems that affect women and racial and ethnic minority populations and to encourage studies which address these problems. Policy available in the Federal Register volume 60 number 179, September 15, 1995, page 47948-51. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. 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. Guidance is available at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN CDC GRANT APPLICATIONS OR APPENDICES: All applications and proposals for CDC funding must be self-contained within specified page limitations. Unless otherwise specified in a CDC 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 CDC is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA 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 Section 301 of the Public Health Service Act as amended (42 USC section 241). 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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