RFA-TW-02-002: GLOBAL HEALTH RESEARCH INITIATIVE PROGRAM FOR NEW FOREIGN INVESTIGATORS (R01)

Department of Health
and Human Services (HHS)

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GLOBAL HEALTH RESEARCH INITIATIVE PROGRAM FOR NEW FOREIGN INVESTIGATORS (R01) RELEASE DATE: January 29, 2002 RFA: RFA-TW-02-002 PARTICIPATING INSTITUTES AND CENTERS (ICs): Fogarty International Center (FIC) (http://www.nih.gov/fic/) Office of Dietary Supplements (ODS) (http://ods.od.nih.gov/) National Eye Institute (NEI) (http://www.nei.nih.gov/) Office of Research on Women"s Health (ORWH) (http://www4.od.nih.gov/orwh/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov) Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) LETTER OF INTENT RECEIPT DATE: March 22, 2002 APPLICATION RECEIPT DATE: April 19, 2002 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 and Review Schedule o Award Criteria o Required Federal Citations: PURPOSE OF THIS RFA This RFA is intended to promote productive re-entry of NIH-trained foreign investigators into their home countries as part of a broader program to enhance the scientific research infrastructure in developing countries, to stimulate research on a wide variety of high priority health-related issues in these countries, and to advance NIH efforts to address health issues of global import. The specific goal of this initiative is to provide funding opportunities upon return home for the increasing pool of foreign biomedical and behavioral scientists, clinical investigators, nurses, and other health professionals with state-of-the-art knowledge of research methods to advance critical issues in global health when they return home. Upon completion of their research experiences using this grant mechanism, developing country participants supported by this RFA are expected to continue to pursue independent and productive careers, including expert training and consultation and/or research of biomedical issues within their home institutions. RESEARCH OBJECTIVES As a part of its global health initiative of the Department of Health and Human Services, the National Institutes of Health (NIH), led by the Fogarty International Center (FIC), in partnership with Office of Dietary Supplements (ODS), the National Eye Institute (NEI), the Office of Research on Women"s Health (ORWH), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Aging (NIA), the Office of Behavioral and Social Science Research (OBSSR), the National Institute of Environmental Health Sciences (NIEHS), and the National Institute of Mental Health (NIMH), invites applications from current foreign investigator trainees, and former trainees that have returned to their home country in the last three years, to support research projects in their home countries. Eligible trainees include trainees from FIC-supported international training programs (in those using the D43 and other training mechanisms) and through the NIH Visiting Program, with an emphasis on Visiting Fellows. Current Visiting Fellows are particularly encouraged to apply as they prepare to return home. Eligibility of intramural trainees is restricted to those from Institutes that are partners on this RFA, or (with FIC pre-approval) candidates of interest to ODS, ORWH or OBSSR. The NIH has made a significant investment in training biomedical and behavioral researchers through various programs. For example, the NIH Visiting Program hosts more than 1,600 junior scientists from almost 100 countries for periods of one to five years. Training received at NIH is critical as they develop independent research careers. In addition, through the NIH D43 and other (with pre-approval) training and capacity-building grant mechanisms, hundreds of researchers receive training in academic institutions all across the United States in a range of medical research areas critical to advancing global health. As junior scientists complete their training programs in the U.S., many encounter obstacles in identifying continuing support to further their research studies in their home countries. This program provides opportunities for junior foreign scientists to compete for funds through a peer-reviewed process and as a critical adjunct to further promising independent research of benefit to their home countries and the world. As women scientists may meet these obstacles even more than men, women scientists are especially encouraged to apply for these re-entry grants. The proposed research topics to be supported through this program are targeted to the research interests of the collaborating NIH Institutes and Centers, and, additionally, should primarily focus on health and healthcare problems of high priority in the investigator"s home country and that have global import. It is, however, expected that the research topics will be diverse. Research on issues related to women"s health, including studies on gender differences in disease onset and progression, identification of behavioral strategies that are effective in encouraging healthy lifestyles in young girls, and studies that address diseases that are of higher incidence or have a particular significance to women than men, including infectious diseases, lupus, multiple sclerosis and depression, are particularly encouraged. Also encouraged is research focused on the behavioral and social determinants and consequences of health. All research must be carried out in accordance with the relevant NIH and U.S. Government regulations and aspects of the ethical, legal and social principles guiding the responsible conduct of research in developing countries, particularly related to scientific integrity and the protection of the interests of research participants. Applicants are encouraged to review the relevant informative areas of the OHRP web site (http://www.hhs.gov/ohrp/). This RFA contributes to the FIC mission and to the broad NIH initiative to reduce health disparities among nations by strengthening research in developing countries, makes possible the continuation of research activities of recently trained international health and health care researchers, and maximizes the investment that the NIH has already made in these trainees. The FIC recognizes that highly trained individuals from a number of disciplines are needed to provide guidance to the research community on medical and ethical questions that arise during the conduct of research in settings where cultural differences may be relevant. It is expected that such advanced training will enhance the career development of individuals in developing countries, will further strengthen collaboration between the awardees and their former U.S. scientific mentors, and will help to strengthen biomedical and behavioral research expertise at their home institutions. MECHANISM OF SUPPORT This RFA will use the NIH Research Project Grant (R01) mechanism using the modular grant format. If an application has a significant collaboration with a NIH intramural laboratory, the application will be converted to the cooperative agreement (U01) mechanism and awarded as a cooperative agreement. This RFA is issued for fiscal year 2002. FIC and our NIH partners expect that a similar RFA will be issued for the next several years, depending on the availability of funds. Applications submitted in response to this RFA may have a project period from three to five years. A project period of three years is the minimum amount of time that is acceptable. An applicant can request up to two modules of $25,000 each, or total direct costs of $50,000 per year, plus Facilities and Administrative (F&A) costs up to a maximum of eight percent for a foreign institution. The PI is expected to devote at least 50 percent of his/her total effort to this project. This RFA uses just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Any future unsolicited competing continuation applications based on this project will compete with all investigator-initiated applications. FUNDS AVAILABLE The participating ICs intend to commit approximately $1 million in FY 2002 to fund up to 18 new grants in response to this RFA. An applicant may request a project period from three to five years and a budget of direct costs of up to $50,000 per year. The PI is expected to devote at least 50 percent of his/her total effort to this project. Because the nature and scope of the proposed research 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 the ICs 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. Grants, once awarded, are not transferable to another Principal Investigator and may not be transferred to another foreign institution. The earliest anticipated award date is September 30, 2002. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your foreign institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of state and local government of developing countries o Faith-based organizations Only foreign institutions from developing countries are eligible to apply. For the purpose of this RFA, the following geographic regions or countries could be represented in the final award pool: North Africa, West Africa, East Africa, Central Africa, Southern Africa, Russia, the Newly Independent States (NIS), Eastern Europe, the Middle East (except Israel), India, Asia (except Japan, Singapore, South Korea, and Taiwan), the Pacific Islands region (except Australia and New Zealand), Latin America, and the Caribbean. INDIVIDUALS ELIGIBILE 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. Only applicants from developing countries are eligible to apply. For the purpose of this RFA, the following geographic regions or countries could be represented in the final award pool: North Africa, West Africa, East Africa, Central Africa, Southern Africa, Russia, the Newly Independent States (NIS), Eastern Europe, the Middle East (except Israel), India, Asia (except Japan, Singapore, South Korea, and Taiwan), the Pacific Islands region (except Australia and New Zealand), Latin America, and the Caribbean. Applications may be submitted by investigators who have recently completed (within three years of the receipt date in this RFA), or who are in the process of completing, a training program under the NIH D43 or other international training and capacity-building grant mechanism (with pre- approval from FIC staff), or who have completed or are presently completing an appointment in the NIH intramural research program as a Visiting Fellow in an NIH intramural laboratory of a partner Institute or Center for this RFA. Under extraordinary circumstances, on a case-by-case basis with FIC staff pre-approval, consideration may be made for previous trainees who have completed such training within three to five years of the receipt date of this RFA. Applicants should expect to return to their home country as a condition of this award since the research to be supported must be carried out in their home country and the award will be made to their home institution on their behalf. Therefore, the application must be submitted by the institution to which the applicant has returned or will be returning. Eligibility of intramural trainees is restricted to those from Institutes that are partners on this RFA, or (with FIC pre-approval) candidates of interest to ODS, ORWH or OBSSR. It is expected that the Principal Investigator will have an appointment at an academic or other institution in his/her home country and that the institution has the capacity to support the research proposed. One indicator of an institution"s support is the institution"s commitment to pay part of the potential awardee"s salary. Applicants are encouraged to develop collaboration with the U.S. institution from which they have received or are receiving research training through the D43 or other mechanisms, or a comparable U.S. institution/laboratory, in order to build on experience, partnership, mentorship and prior investments. Intramural laboratories at the NIH are considered appropriate U.S. mentors and collaborators in this RFA. U.S. collaborators should demonstrate how this program will support ongoing research collaborations. The NIH intramural researcher must have pre-approval of the Associate Director for Intramural Research and the Scientific Director from their NIH Institute prior to the submission of the grant application. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into four areas: scientific/research, eligibility, peer review, and financial or grants management issues. o Direct your questions about scientific/research and eligibility issues to: Aron Primack, MD, MA Fogarty International Center National Institutes of Health Bldg. 31, Room B2C39 31 Center Drive Bethesda, MD 20892-2220 Tel: (301) 496-4596 Fax: (301) 402-0779 email: primacka@mail.nih.gov Direct your questions about review issues to: Sandy Warren, Ph.D. Center for Scientific Review 6701 Rockledge Drive, Room 5134 Bethesda, MD 20852 Tel: (301) 435-1019 Email: warrens@csr.nih.gov Direct your questions about financial or grants management matters to: Mr. Bruce Butrum Grants Management Officer Fogarty International Center Building 31, Room B2C29 31 Center Drive, MSC 2220 Bethesda, Maryland 20892-2220 Telephone: (301) 496-1670 Fax: (301) 594-1211 Email: butrumb@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by March 22, 2002, which includes the following information: o Descriptive title of the proposed research o Name, address, and telephone and fax numbers of the Principal Investigator o Name of the foreign institution to which the trainee has returned or intends to return o Names of other key personnel o Name and address of the leader of the training program in which the trainee has participated or is participating 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 IC 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: Aron Primack, MD, MA Fogarty International Center National Institutes of Health Bldg. 31, Room B2C39 31 Center Drive Bethesda, MD 20892-2220 Tel: (301) 496-4596 Fax: (301) 402-0779 email: primacka@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. 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. SUPPLEMENTAL INSTRUCTIONS: Applicants may request up to two modules, or $50,000, of direct costs per year and the application must be in modular format. The PI is expected to devote at least 50 percent of his/her total effort to this project. The modular grant concept establishes specific modules in which direct costs may be requested, as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. It is understood that writing an application for such a R01 grant may be difficult and time-consuming. Therefore, it is encouraged that potential applicants seek assistance in such grant writing. Those being trained via the D43 grant mechanism should seek such assistance at or from their training institutions. Those within the NIH intramural program should seek such training within the NIH framework. Applicants are strongly encouraged to call the program contacts listed in INQUIRIES with any questions regarding the adherence to the guidelines of their proposed project to the goals of this RFA. Budget Instructions Applicants will request direct costs in $25,000 modules, up to a total direct cost request of $50,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. The PI is expected to devote at least 50 percent of his/her total effort to this project. The Principal Investigator may only request support of up to 50 percent of his/her effort on this project. The Principal Investigator"s salary and any other salaries should be commensurate with the salary structure at the applicant institution. Other Requirements o The applicant should list the date that he/she has or expects to return to their home country. o For investigators associated with D43 grants and other NIH capacity- building programs: include a letter from the U.S. host institution, outlining the nature of the future collaborative relationship, and how the NIH laboratory or other program supported, and/or will support, a continued collaboration with the investigator, using all appropriate resources. o For NIH Visiting Fellows: include a letter from the NIH laboratory chief outlining the nature of the collaborative relationship and how the NIH laboratory will support a continued collaboration with the investigator, using all appropriate resources. Participation by NIH intramural programs requires concurrence by both the scientific directors of the participating Institutes and the Deputy Director for Intramural Research of the NIH. Eligibility of Visiting Fellows to apply is limited to those from Institutes that have agreed to participate in this program. o The investigator must describe current or previous training under the D43 (or other) mechanism or the NIH intramural program. The applicant must provide a brief paragraph providing the grant number, the name and address of the NIH mentor or Principal Investigator of the D43 or other eligible grant, and a description of the training received. o Include two letters of reference relating to the abilities of the applicant investigator, specifically indicating the ability to become a leader in scientific pursuits. o Checklist: This page should be completed and submitted with the application. Applications submitted by foreign or international institutions or applications can request F&A costs up to a maximum of eight percent. Please see the web site http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for more information on the allowability of F&A costs for foreign and international organizations. Applications not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further review. 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 two 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/label-bk.pdf. SENDING AN APPLICATION TO THE NIH (Do not hand-carry applications): 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 208892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by 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. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the FIC. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the FIC Advisory Board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals including the career development of the Principal Investigator. o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem and is it specifically a priority issue in your home country? If the aims of your application are achieved, how will scientific knowledge be advanced and your research career be enhanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to your experience level as the Principal Investigator and other researchers (if any)? How will this award enhance your career development and help you achieve a position of scientific leadership in your home country? Do the letters of support document a strong commitment to help develop your career? (5) ENVIRONMENT: Does the scientific environment, in which your work will be done, contribute to the probability of success? Has your home institution made a convincing commitment to you (e.g. to provide a research/academic appointment and partial salary support)? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? What is the continuing commitment of the U.S. collaborating institution (e.g., the institution associated with the NIH D43 award or the NIH intramural program laboratory) to further develop your career and research interests? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 22, 2002 Application Receipt Date: April 19, 2002 Peer Review Date: July 2002 Council Review: September 10, 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA Applications will compete with all other recommended applications for available funds. Award criteria that will be used to make award decisions include: o Quality of the proposed project, as determined by peer review o Availability of funds o Geographic balance o Programmatic priority Awards will not be made until applicants have actually returned to their home countries (or other developing countries). Awards, once made, are not transferable to another PI. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of the NIH that women and members of minority groups, and their sub-populations, must be included in all NIH-supported clinical research projects, unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of a NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups, if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at: http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH 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 in the NIH Guide for Grants and Contracts, June 5, 2000 at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for Federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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 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. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place date 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. 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 a 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. Because the applications are expected to cover many and varied areas, this RFA will probably be related to many priority areas of this activity including general public health, cardiovascular disease, diabetes, and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.989, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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