CLINICAL RESEARCH IN PERIPHERAL ARTERIAL DISEASE RELEASE DATE: October 10, 2002 RFA: HL-03-003 National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) LETTER OF INTENT RECEIPT DATE: January 24, 2003 APPLICATION RECEIPT DATE: February 26, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) 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 Citation PURPOSE OF THIS RFA This program aims to develop improved therapeutic and preventive approaches for atherosclerotic arterial diseases of the peripheral vasculature through integrated, multi-disciplinary clinical research projects. Key objectives include elucidating biological mechanisms related to the initiation, progression, and outcomes of disease; enhancing early detection by developing improved biomarkers, imaging approaches, and other relevant biomedical technologies; and developing novel therapeutic and preventive strategies. RESEARCH OBJECTIVES With the advent of new technologies and scientific concepts, opportunities now exist for translation of our knowledge of peripheral arterial disease (PAD)into better clinical management. Emphasis in this RFA will be placed on multi- disciplinary clinical research designed to improve understanding of underlying mechanisms and translate this understanding into improved strategies for diagnosis, therapy and prevention of PAD. Background: The Public Health Dimensions of PAD Pathologies of the peripheral vasculature are responsible for a wide variety of clinical conditions associated with considerable mortality and particularly high morbidity. For example, in 1999 there were 2 million physician office visits and 1.3 million hospitalizations in which peripheral vascular disease was cited as either a primary or secondary diagnosis. Of the peripheral vascular diseases, PAD is the most prevalent (8-12 million cases in the U.S.). The considerable economic damage attributable to PAD stems from lost productivity and high health care costs. Leg pain, impaired mobility, and even amputation are frequent consequences of PAD, with serious effects on functional capacity and quality of life. PAD may not be symptomatic at early stages, and even after symptoms occur they may not be perceived as needing medical attention. The risks and clinical course of PAD are affected by age, ethnicity, and the presence of other medical conditions. PAD is often considered to be a disease of the elderly, with more than 20% of people over 75 years affected; the number of cases is expected to increase as the population ages. However, attention has recently been drawn to higher-than-expected rates of PAD in younger individuals, and to the generally severe outcome in this age group. Similarly, PAD risk is elevated in individuals with diabetes, and as the rates of type 2 diabetes rise secondary to the increasing prevalence of obesity, PAD rates also will likely increase. Regarding gender, little is known of whether, or how, women differ from men regarding susceptibility to and progression of PAD. In the United States, minority populations suffer an undue burden of PAD. Notably, the rate of amputations performed in the U.S. is much higher in the African-American and Native American populations than in Caucasians, particularly among those with diabetes. Genetic and other factors influencing the development and progression of PAD and response to treatment among different racial/ethnic groups need to be better understood. Of deep concern is the degree to which PAD presages future serious events, particularly among middle-aged patients. In the Framingham study cohort, of the 35-64 year olds who were diagnosed with intermittent claudication, 35% of men and 23% of women were dead within 8 years. Research needs in PAD Research is needed that will focus specifically on knowledge gaps in PAD, as opposed to atherosclerotic disease in general (also see Exclusions, below). Important barriers to satisfactory prevention, diagnosis, and treatment of PAD include: insufficient understanding of the underlying pathophysiology and pathobiology; difficulty of predicting individual susceptibility; initial diagnosis at typically late stages of disease; and limited range of effective therapeutic options. Pathobiology, pathophysiology, and individual susceptibility Atherosclerosis accounts for most peripheral arterial occlusive disease. Although many of the risk factors for atherosclerotic coronary artery disease (such as smoking, hyperlipidemia, hypertension, hyperglycemia, obesity, and hyperhomocysteinemia) have been identified as risk factors for PAD, strong evidence is lacking that risk factor modification is effective in halting progression or improving outcomes. A better understanding is needed regarding the clinical and pathophysiologic responses to risk factor interventions. Genomic and proteomic approaches may be useful in identifying individuals at particular risk of PAD, independent of coronary artery disease risk, and in predicting the likelihood of benefit from interventions. Such approaches could provide key information for identifying those individuals who should be directed towards early detection programs. A better understanding is needed of the relationships among blood vessel function, hemodynamics, organ damage, and functional status of the patient. For example, many patients with ischemic limbs have experienced years of reduced blood flow to those limbs. Defects at the metabolic and structural levels may not be corrected by improving perfusion. Conversely, exercise often improves limb or organ function out of proportion to measurable changes in hemodynamics; this may be due to underlying metabolic changes that are poorly understood. It also is known that both exercise and arterial occlusion are potent stimuli to angiogenesis despite diverse metabolic effects. The specific metabolic pathways that are affected by PAD are not well understood at present, but ultimately metabolic changes may prove to be more useful than hemodynamic measurements as determinants of functional outcome. These observations suggest that a more thorough understanding is needed of biochemistry, muscle biology, and exercise physiology in PAD. The basis of the observed differences in risk factors and risk relationships for small vs. large vessel PAD needs to be clarified in terms of underlying pathophysiology. Also, the acute and chronic changes that occur in the microcirculation following large vessel obstruction are not well understood. For example, the effect of ischemia on vascular bed function has not been clearly defined. Once a vascular bed has been damaged, this injured vasculature and any newly-developed collateral vasculature may have properties that differ from those of the original bed. Earlier diagnosis and better therapies A majority of patients with significant atherosclerotic obstruction of the lower extremities (ankle/brachial artery indices (ABI) <0.9) do not seek clinical care until the disease reaches critical stages. There is a need to study the progression of PAD in individuals who have low ABI values either with or without coronary artery disease. Multifactorial interventions need to be evaluated (including lipid-lowering agents, anti-platelet therapy, anti-hypertensive therapy, exercise, and control of blood glucose) to determine how to attain the maximum benefit for these patients. It also may be important to investigate the effects of treatment on insulin requirements. Studies are needed that focus on the use of specific drugs or classes of drugs (e.g., statins, anti-platelet agents, and inhibitors of the renin-angiotensin system) in subsets of PAD patients. Another area to consider is the role of stenting, with or without other modalities, in non-coronary arteries. It is not known whether drug-eluting stents are helpful in reducing restenosis or native vessel disease progression in peripheral arterial occlusive disease. New techniques for functional imaging that provide quantitative and objective measures of impairment are critical to future vascular studies. Optimal imaging of the peripheral vessels may require approaches that differ from those developed for the coronary circulation. Imaging could also be used to assess the impact of systemic changes induced by drug treatment or other therapeutic modalities. Novel treatment options might include revascularization of damaged peripheral vessels through cell-based therapies. Gene therapy for PAD, another potentially fruitful approach, currently is directed towards inducing angiogenesis or arteriogenesis; however, other dimensions also merit exploration. Summary of Research Priorities The following describes areas of particularly high interest (also see Exclusions, below), which include but are not limited to: O Studies of interventions such as exercise, pharmacotherapy or percutaneous revascularization in PAD. o Studies of hemodynamic influences, regional microcirculation, and other factors in determining the distribution, severity, progression, and regression of PAD; o Evaluation of diagnostic techniques, including new markers and imaging approaches, having improved precision for detection and characterization of PAD; o Studies of the interactions among the coagulation system, inflammatory pathways, lipid pathways, and glucose homeostasis in the etiology, progression, and treatment of PAD; o Cell-based and gene transfer approaches for stimulating revascularization; o Tissue engineering approaches for treatment; and o Studies involving stem cell plasticity relevant to PAD. Multi-disciplinary research is encouraged. Relevant scientific disciplines and areas of expertise include but are not limited to: internal medicine and surgery; diagnostic imaging and biomedical engineering; biochemistry; vascular biology; physiology; pathology; genetics; immunology; genomics; proteomics; biostatistics and clinical trials management; pharmacology; nutrition; and exercise science. Although increasing, the small number of vascular surgeons engaged in active research has long been of concern, and is considered a hindrance to progress with PAD. There are similarly few clinicians in internal medicine with research interests in PAD per se. Individuals in these professions are strongly encouraged to apply or be involved in the planning and execution of these programs. MECHANISM OF SUPPORT This RFA will use the NIH R01 (Investigator-initiated research project grant) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2003. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://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. Otherwise follow the instructions for non-modular research grant applications. FUNDS AVAILABLE The NHLBI intends to commit approximately $5 million in total costs in FY 2003 to fund 5 to 7 new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for total costs of up to $1 million per year. 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 NHLBI 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 this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your 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 governments o Eligible agencies of the Federal government o Domestic or foreign 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 under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Clinical Research In order for a project to be considered clinical for the purposes of responsiveness to this RFA, the research must be patient-oriented. To be responsive, clinical investigations must include studies of patients with peripheral arterial disease. Normal healthy subjects may be included, but only in combination with studies involving patients. In studies involving the use of human specimens, the investigators must have direct interaction with the patient and relate the research results to the patient status or outcome for this to be considered a clinical project. Applicants are encouraged to pursue patient-oriented research on topics related to health disparities and the translation of this research to clinical practice for affected minority populations. Clinical research projects are required to include women, minorities and children in the study population unless such inclusion can be demonstrated to be inappropriate. Human biomedical studies of etiology, pathogenesis, prevention, diagnostic approaches, and treatment are responsive. However, clinical research projects focused on large epidemiologic studies will be considered unresponsive to this RFA. Clinical studies and trials undertaken in the context of this RFA should emphasize endpoints composed of symptom relief, functional improvement, and/or anatomic changes. Studies should be relatively modest in size so that they can be conducted or coordinated by a single program or small consortium. Clinical research projects will be subject to the standard NHLBI policies and procedures regarding human subjects monitoring. Exclusions Applications proposing programs that are not hypothesis-based and do not focus on clinical research will be considered non-responsive to the RFA. Certain types of investigations, although potentially of scientific interest, will not be appropriate for support by this program. Investigators wishing to develop proposals related to excluded categories are strongly encouraged to contact the NHLBI (see Inquiries, below) for information about other opportunities. Examples of excluded research are: o projects with a primary focus of prospective or descriptive epidemiology; o phase III clinical trials that cannot be completed, including analysis, within 5 years; o projects that do not include studies in humans; o projects with primary focus on the coronary circulation, cerebral vasculature, pulmonary vasculature, lymphatic system, or venous system; o projects with primary focus on thromboembolic and other coagulation disorders; o projects with primary focus on abdominal aortic aneurysm or stroke; and o projects having a primary focus on research resource development. Grantees' Meetings Upon initiation of the program, the NHLBI will sponsor annual meetings to encourage exchange of information among investigators who participate in this program. In their budgets, applicants should include funds for annual one-day grantees' meetings, most likely in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. The first such meeting likely will take place within 3 months of award. General Clinical Research Center (GCRC) Applicants from institutions that have a GCRC funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. Additional Considerations All grant applications submitted in response to this RFA should include sample size and statistical power calculations appropriate to the proposed study design. In addition, applicants proposing development of research resources are encouraged to describe a plan to share such resources with other researchers. This could include appropriate information technology (such as DNA/protein microarray databases) or shipment of tissues. Please note that applications having a primary focus on research resource development will be considered non- responsive. 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: Diane Reid, M.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive Suite 9044, MSC 7956 Bethesda, MD 20892-7940 Telephone: (301) 435-0515 Fax: (301) 480-1336 Email: ReidD@nhlbi.nih.gov o Direct your questions about peer review issues to: Anne Clark, Ph.D. Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive Room 7214, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0270 FAX: (301) 480-0730 Email: ClarkA@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Edward McGeehan Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive Suite 7044, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0148 FAX: (301) 480-3310 Email: McGeehaE@nhlbi.nih.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, and telephone number 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 NHLBI 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 Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRES. 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 https://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 https://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 https://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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and five collated sets of appendix material must be sent to Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRES. Please note that applications delivered by individuals are no longer accepted; all applications must either come via courier delivery or via the US Postal Service (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html) 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. Principal investigators should not send supplementary material without first contacting the Scientific Review Administrator (SRA). The SRA will be identified in the letter sent to you indicating that your application has been received. If you have not received such a letter within three weeks after submitting the application, contact Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 NHLBI 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 National Heart, Lung, and Blood Advisory Council REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Each project will be evaluated with respect to the following criteria: (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: 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 or resources. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o OTHER REVIEW CRITERIA: The safety and data monitoring plan will be evaluated for adequacy (also see Monitoring Plan and Data Safety and Monitoring Board, below). RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 24, 2003 Application Receipt Date: February 26, 2003 Peer Review Date: June/July, 2003 Council Review: September 4-5, 2003 Earliest Anticipated Start Date: September 30, 2003 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. 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: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at https://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://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 https://grants.nih.gov/grants/stem_cells.htm and at https://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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.837, 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 https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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