INTERNATIONAL RESEARCH SCIENTIST DEVELOPMENT AWARD RELEASE DATE: February 5, 2004 PA NUMBER: PAR-04-058 (Reissued as PAR-07-014) EXPIRATION DATE: February 17, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATION: Fogarty International Center (FIC) ( National Institute of Nursing Research (NINR) ( Office of Dietary Supplements (ODS) ( National Institute of Environmental Health Sciences (NIEHS) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.989, 93.361, 93.113, 93.114, 93.115 APPLICATION RECEIPT DATES: February 18, 2004; February 18, 2005; February 16, 2006 This Program Announcement (PA) replaces PAR-02-041, which was published in the NIH Guide on December 21, 2001. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The Fogarty International Center (FIC), the National Institute of Nursing Research (NINR), the NIH Office of Dietary Supplements (ODS), and the National Institute of Environmental Health Sciences (NIEHS) solicit proposals for the International Research Scientist Development Award (IRSDA). This program supports U.S. postdoctoral biomedical, social, and behavioral scientists in the formative stages of their careers to conduct research in, or extend their research into, developing countries. It provides the successful candidate with a period of mentored research as part of an established collaboration between a U.S. sponsor and a leading developing country scientist at an internationally recognized research institution in a developing country. It is expected that this experience will prepare scientists to pursue an international research career involving on-going collaboration with developing country scientists on global health challenges. The IRSDA is part of the FIC strategy to encourage research collaborations in developing countries in order to build research capacity to address global health research priorities. The role of the IRSDA is to: o Attract new research talent to global health research and enhance multi- disciplinary synergy among the research collaborators at the U.S. and foreign site; o Advance the career paths of exceptional junior U.S. scientists with mentored training in health issues of developing country populations; o Extend the impact and reach of existing research and training support for developing country scientists and U.S. scientists committed to international research; o Provide opportunities for developing country institutions with significant potential to advance to higher levels of research excellence; and o Stimulate a more effective translation of the results of research on global health problems into practical public health actions. With IRSDA support, the investigator will have the opportunity to work closely with both an established foreign scientist in the developing world and a U.S. investigator who are involved in collaborative research. The applicant will conduct research and receive training at both the developed and developing country institutions. It is expected that these awards will serve to forge collaborative relationships between established, developing country researchers and outstanding U.S. junior scientists, who are potential future heads of basic, clinical and behavioral/social health research programs in the U.S. Collaborations are expected to lead to advances that will reduce the impact of global health problems and narrow the gap in health disparities between developed and developing countries. RESEARCH OBJECTIVES The IRSDA provides international research opportunities and cutting-edge technical training (in eligible developing countries) for U.S. postdoctoral biomedical, epidemiological, clinical and behavioral scientists who are committed to careers in international health research. The award supports the recipient to directly collaborate with a U.S. mentor and an established developing country mentor on a research project of mutual interest in the context of an ongoing or recent research relationship between the U.S. and foreign mentors. The award is specifically designed to facilitate the candidate's productive interaction with both the U.S. and foreign institutions, and to enhance subsequent pursuit of an independent international research career. The specific research training may be new to the candidate or an extension of the candidate's prior research, but should focus on international research areas pertinent to global health concerns. Applicants are encouraged to consult the global health research priorities defined by the World Health Organization ( which include, but are not limited to, infectious diseases, nutrition, chronic/degenerative conditions, trauma/injury and mental health disorders, all of which can pose an increasing global burden in the coming decades. Basic, behavioral/social and clinical biomedical research will be supported in clinical, field or laboratory settings. The FIC recognizes that there will be significant differences in the U.S. and foreign institutional environments, applicants, U.S. and foreign mentor backgrounds and approaches to international research collaboration among applications. Therefore, applicants should clearly define specific research and training goals, methods to achieve these goals, and specific measurable objectives to enable assessment of the proposed project, with reference to the overall goals described above. MECHANISM OF SUPPORT This PA will use the NIH career development (K01) award mechanism (general K01 guidelines may be found at: Please note that this K01 award has some important differences from the K01 award described in PA-00-0019. These include: o The original award period is for three to four years o A competitive renewal is possible for up to three years o Both a U.S. and a foreign mentor are required and must have a current or past research collaboration with each other o Requirement of significant time spent in the foreign country NINR is only interested in applications from nursing scientists who are pursuing careers related to HIV/AIDS. NINR will support initial applications for K01 awards. Renewal applications will be supported by Fogarty International Center. This PA uses just-in-time concepts. The IRSDA will provide direct costs for salary for the Principal Investigator up to $75,000 (based on the actual salary scale at his/her institution) plus applicable fringe benefits, plus an additional $20,000 for travel and research development support each year for up to four years. The award supports an intensive, mentored research experience in a clinical, field or lab setting associated with strong research collaboration at a well-recognized research institution in a developing country. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Current IRSDA grantees who have obtained a tenure-track position at a domestic institution (or a developing country institution with prior approval from the IRSDA FIC program official) may submit a competitive renewal application at the same direct cost level described above in the case of an appointment at the assistant professor level, or up to $100,000 per year if the appointment is at the associate professor level. At institutions or in departments where tenure-track positions are not available, the institution must demonstrate a comparable commitment to the candidate at the assistant professor level or above. In such cases, consultation with the FIC IRSDA program officer is required. The renewal may be for up to a three-year period and should be a continuation or extension of the research collaboration begun under the original K01. Although additional training may be justified, the focus in the renewal should be on research. As stipulated in the original K01 application, most of the proposed research should take place at the foreign site and the grantee is expected to spend as much time there as possible. A minimum of one year of total time is required at the foreign site during the period of the grant with at least three months per year at the foreign site. Responsibility for the planning, direction, and execution of the proposed project will be that of the candidate, her/his mentor at the foreign site and her/his U.S. mentor on behalf of the applicant institution. Facilities and administrative (F & A) costs of eight percent should be used for IRSDA applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o Non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Domestic institutions/organizations o Faith-based or community-based organizations 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. SPECIAL REQUIREMENTS To be eligible for the award the applicant must: 1. Be a U.S. citizen, a non-citizen national or a permanent resident and in possession of an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals are usually born in areas that are not states but are under U.S. sovereignty, jurisdiction or administration. Individuals on temporary or student visas are not eligible. 2. Have earned a doctoral, dental or medical degree or the equivalent in a health, social or behavioral science field within seven years of the receipt date, except as noted below. Exceptions must be approved by the FIC program officer. o Time spent in clinical or other related training that is not research (such as policy training), or time spent obtaining another degree (e.g. M.P.H.), does not count toward the seven-year limit. o Candidates who are more than seven years beyond the eligible degree, but who have interrupted their careers because of illness or family commitments, may also apply. They must clearly demonstrate the potential for productive independent research and the need for an additional period of mentored research experience in order to accomplish an effective scientific re-entry. 3. Have demonstrated a commitment and competence in health and health-related research, as well as the potential to engage in independent and productive biomedical, social, behavioral or epidemiological/clinical research in the period following the award. 4. Have mentors in the United States and in the eligible developing country where the proposed research will be performed, who are committed to both the research and training requirements of the candidate. o The U.S. mentor must be at a U.S. institution of higher learning or non- profit research institution. o The developing country mentor must be in an internationally-recognized developing country research institution addressing one or more of that country's major health problems. Eligible countries include those in the following regions: Africa, Asia (except Japan, Singapore, South Korea and Taiwan), Russia and countries of the Former Soviet Union, Central and Eastern Europe, Latin America and the Caribbean, the Middle East (except Israel) and the Pacific Ocean Islands (except Australia and New Zealand). Applications for work in institutions in sub-Saharan Africa are especially encouraged. Awards may be delayed or denied by any State Department restrictions in effect at the time of award. o The two mentors for the IRSDA applicant must have a recent or on-going collaboration on a relevant research program or project. An enhancing factor for consideration is a funded collaboration between the mentors. Funding may include, but is not limited to, sources such as a National Institutes of Health (NIH) R01 grants with a foreign component, Fogarty International Research Collaboration Awards, World Health Organization grants, Burroughs- Wellcome Foundation grants or other U.S. or international agency funding. 5. Submit a research proposal related to, but not overlapping with, the collaborative research project of the U.S. and foreign site mentors; Applicationsmust be submitted on behalf of the candidate by the U.S. mentor's institution, which must be a U.S. research institution. While in most cases the applicant will be at the same U.S. institution as his/her mentor, s/he need not hold a position at the U.S. mentor's institution. Applicants awarded an initial competitive IRSDA grant agree to spend a minimum of 50 percent of the period of the grant at the foreign research site, with at least three months per year at the site. Applicants who already have a faculty position need a letter of support from their institution that shows they will be released from clinical and teaching duties to conduct research at the foreign site for the required minimum time. Applicants awarded a competitive renewal grant agree to spend a minimum of one year of total time at the foreign site and a minimum of three months per year at the foreign site. 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: Rachel A. Nugent, Ph.D. Division of International Training and Research Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892-2220 Telephone: (301) 496-8733 Fax: 301-402-0779 Email: Martha L. Hare, Ph.D., R.N NIH/National Institute of Nursing Research 6701 Democracy Boulevard One Democracy Plaza, Room 710 Bethesda, MD 20892-4870 (Courier: 20817) Phone: 301-451-3874 Fax: 301-480-8260 Email: Mary Frances Picciano, Ph. D. Senior Nutrition Research Scientist Office of Dietary Supplements National Institutes Of Health 31 Center Drive, 1B29 Bethesda, MD 20892-2086 Telephone: 301-435-3608 Fax: 301-480-1845 Email: Dr. Carol Shreffler National Institute of Environmental Health Sciences P.O. Box 12233 (MD EC-23) Research Triangle Park, NC 27709-2233 Telephone: 919-541-1445 Fax: 919-541-5064 Email: o Direct your questions about peer review issues to: Sherry L. Dupere, Ph.D. Chief, Biology of Development and Aging IRG Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, MSC 7840, Room 5136 Bethesda, MD 20892-7840 (Courier: 20817) Telephone: (301) 435-1021 Fax: (301) 480-3567 Email: o Direct your questions about financial or grants management matters to: Bruce Butrum Office of the Director Fogarty International Center Building 31, Room B2C29 Bethesda, MD 20892-2220 Telephone: (301) 496-1670 Fax: 301-594-1211 Email: Teresa Marquette Office of Grants and Contracts Management National Institute of Nursing Research 6701 Democracy Boulevard, Room 710 Bethesda, MD 20892-4870 Telephone: 301-594-2154 Fax: 301-402-4502 Email: 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 The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS The application must: o Establish the candidate's commitment to a career in international biomedical, clinical, social or behavioral research addressing a major global health problem. o Establish the candidate's potential to develop into a successful independent investigator. o Summarize the candidate's immediate and long-term career objectives, explaining how the award will contribute to their attainment. o Provide a career development plan. The plan should incorporate a detailed description of Ph.D. and other previous research experiences, as well as an explanation of long-term career goals of the applicant and role of this award in achieving them, including intentions to establish future foreign collaborations. It should delineate a systematic approach to achieving the necessary basic biomedical, social or behavioral science background and research experience to launch an independent international research career addressing a major global health problem. o Provide a research plan using form PHS 398 and the use of a sound research approach to a biomedical, social or behavioral problem including the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods sections. It should include an annual schedule of planned research activities at the U.S. and foreign sites during that period. The research plan should serve as a justification for conducting research abroad and provide a clear description of the relationship between the proposed research and current research efforts at U.S. and foreign labs. o For renewal applications, the research plan must describe progress made under the original K01 and how the research proposed in the renewal continues or extends the original research. U.S. and foreign mentor statements must: o Be included in the application and provide information from the U.S. and foreign mentors about their research collaboration, their research qualifications and previous experience, and their record in supervising research training (number of Ph.D. and post-docs mentored and their current career status). Both the U.S. and foreign mentors should submit Biographical Sketches, Other Support and Resources Forms. The application must also include a detailed plan for the supervision of the Fellow, by both mentors, at each institution, during the proposed award period. Support Letters o For the original K01 application, three sealed letters of recommendation from senior research scientists, addressing the candidate's potential for an international research career, must be included as part of the application. One of the three letters should be from the applicant's thesis advisor, research supervisor, chief of staff or department head. Letters of recommendation should not be submitted from either the U.S. or foreign mentor. o For renewal applications, a letter from the applicant's U.S. institution must be submitted indicating commitment to provide the candidate with the necessary support and time, free from clinical and teaching duties, to continue the international work proposed in the application. Training in Responsible Conduct of Research o Candidates must describe evidence of previous training or plans to receive instruction in the responsible conduct of research in an international context. The topics, format, frequency and duration of instruction, as well as the amount and nature of faculty participation, should be detailed. No award will be made if an application lacks this component. U.S. and Foreign Institutional Commitments o The extent and quality of the research environment, relevant to the candidate's research focus, should be described for the U.S. and foreign institutions. The research environment includes faculty and staff capable of productive collaboration with the candidate, seminars and opportunities for interactions with other research groups and scientists and available research facilities and equipment. o A detailed description of overall research funding at the foreign institution (government, non-government and international sources), specific for the proposed research area, should be included to support its status as an existing or potential center of research excellence. Budget o Budget requests must be provided according to instructions in form PHS 398 (rev. 5/2001) Allowable Costs: 1. The IRSDA will provide direct costs for salary for the Principal Investigator up to $75,000 (based on the actual salary scale at his/her U.S. institution) plus applicable fringe benefits, plus an additional $20,000 for travel and research development support each year for up to four years. The IRSDA will provide up to $100,000 per year for a renewal candidate who has been appointed to a tenure-track position at the associate professor level. The institution may supplement the NIH contribution to the candidate's salary up to a level that is consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the award. 2. Research Development Support: These funds may be used for expenses such as: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) language training; (d) statistical and computational services (including personnel and computer time; (e) in-country travel required for research, research meetings or training; round trip economy class airfare (on a U.S. carrier) and necessary ground transportation for the candidate to and from the foreign site over the duration of the project; roundtrip economy airfare for each dependent accompanying the awardee for four months or more abroad. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. All expenses must be directly related to the proposed research career development program. Facilities and Administrative (F & A) costs of eight percent are applied to allowable direct costs. Concurrent Applications A candidate for the K01 award may not have pending nor concurrently apply for any other career development award. Subsequent Applications for NIH Research Support Subsequent to receiving the K01 Award, incumbents are encouraged to apply for independent research support (e.g., R01, etc.). K01 recipients who are successful in obtaining NIH research grant support may receive salary support from the research grant under the policy described in 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 mailed on or before the receipt dates. The application must be received by the date listed on the front of this program announcement. 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures ( will evaluate applications for scientific and technical merit. 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 an appropriate national advisory council or board. REVIEW CRITERIA Candidate: o Commitment to an independent international research career including potential to contribute to knowledge that will address a major global health problem; o Potential to develop (or evidence of the capacity to develop) as an independent investigator pursuing international research; o Quality and relevance of prior scientific training and experience including detailed description of previous research, record of previous research support and publications. Career Development Plan: o Likelihood that the research and training in the plan will contribute substantially to the scientific development of the candidate, the achievement of scientific independence and ongoing involvement in collaborative international research; o Appropriateness of the plan to the career goals of the candidate; o Appropriateness of the plan to increase conceptual and theoretical knowledge in the research area proposed; o Consistency of the plan with the candidate's prior training, research and academic experience and the stated career goals; o Clarity of the goals and scope of the plan and the need for the proposed research and training experience at the foreign site; o Adequacy of the proposed training for responsible conduct of research in an international context; o Clear description of the roles of the U.S. and foreign mentors in the training and research planned. Research Plan: o Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan; o Scientific and technical merit of the research question, design and methodology judged in the context of the candidate's previous training and experience; o Relevance of the proposed research to a major global health problem; o Relevance of the proposed research to the candidate's career objectives. U.S. and Foreign Mentors: o Appropriateness of U.S. and foreign mentors' collaborative research and their other research and training qualifications for the proposed project; o The extent of the commitment of each mentor to supervising and guiding the candidate throughout the award period; o Adequacy of each mentor's previous experience in fostering the development of independent researchers highlighting persons involved in international research; o Adequacy of each mentor's research productivity and grant support related to the proposed project. U.S. and Foreign Institutional Environment: o Adequacy of the research facilities at the U.S. and foreign institutions; o Adequacy of the training opportunities and quality of the environment for scientific and professional development at the U.S. and foreign institutions. If applying for a renewal K01 award: Soundness of the rationale for an extended career development award rather than a research grant (R01, etc.) award. 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, will be assessed. 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 VERTERBRATE 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 ADDTIIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget in relation to career development goals and research aims and plans. 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 Scientific, technical and educational merit as determined by peer review o Availability of funds o Likelihood that the proposal will contribute to the achievement of FIC's objectives. 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. 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 (; a complete copy of the updated Guidelines are available at 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 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 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 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. 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). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( 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 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at 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 287b) 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 The Office of Dietary Supplements (ODS) was mandated by Congress in 1994 and established within the Office of the Director, National Institutes of Health (NIH). The Dietary Supplement Health and Education Act (DSHEA) [Public Law 103-417, Section 3.a] amended the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements. This law authorized the establishment of ODS. 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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