and Human Services (HHS)
EXPIRED
This Program Announcement expires on October 1, 2004 unless reissued. CHROMIUM AS ADJUVANT THERAPY FOR TYPE 2 DIABETES AND IMPAIRED GLUCOSE TOLERANCE Release Date: July 2, 2001 PA NUMBER: PA-01-114 Office of Dietary Supplements (http://dietary-supplements.info.nih.gov/) National Center for Complementary and Alternative Medicine (http://nccam.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov/) THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The Office of Dietary Supplements (ODS), the National Center for Complementary and Alternative Medicine (NCCAM), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite basic and clinical applications to study the role of chromium as adjuvant therapy in type 2 diabetes and/or impaired glucose tolerance. The use of chromium supplements among individuals with diabetes is not an uncommon practice and the accumulating evidence from small, non-controlled clinical trials suggests that chromium supplementation may alleviate symptoms associated with diabetes and reduce the need for extraneous insulin in patients with type 2 diabetes. The results of a systematic review together with the findings from a scientific workshop conducted by the ODS have provided convincing reasons to support the conduct of small-scale, focused clinical studies. The potential mechanism of action of chromium in enhancing insulin secretion or action is not known. The purpose of this Program Announcement (PA) is to encourage 1) basic studies of chromium action on insulin secretory and signaling pathways and 2) clinical studies to assess the safety and efficacy of chromium as an adjuvant treatment of type 2 diabetes and/or impaired glucose tolerance. 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 Program Announcement, Chromium as Adjuvant Therapy for Type 2 Diabetes and Impaired Glucose Tolerance, 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Research Project Grant (R01) and Exploratory/Developmental Research Grant (R21) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an R01 application submitted in response to this PA may not exceed five years. The R21 awards are to demonstrate feasibility and to obtain preliminary data testing innovative ideas that represent clear departure from ongoing research interests. These grants are intended to 1) provide initial support for new investigators, 2) allow exploration of possible innovative new directions for established investigators, and 3) stimulate investigators from other areas to lend their expertise to research within the scope of this announcement. Applicants for the R21 must limit their requests to $125,000 direct costs per year for a two-year period. These R21 grants are not renewable and may not be used to supplement an ongoing project. Applicants who anticipate submitting an R21 application should review the NCCAM web site at http://nccam.nih.gov/research/instructions/r21/index.htm Continuation of projects developed under this program may be through the regular research grant (R01) program. Additional information on this mechanism may be obtained from the NIH web site (Research Grants, Application Guidelines) at http://grants.nih.gov/grants/forms.htm. RESEARCH OBJECTIVES Background Diabetes is common, affecting 16 million people or 6.9% of the US adult population, 800,000 new cases are diagnosed each year. The Diabetes Control and Complications Trial (DCCT), for type 1 diabetes, and the United Kingdom Prospective Diabetes Study (UKDPS), for type 2 diabetes, established the importance of intensive diabetes control in dramatically reducing the devastating complications that result from poorly controlled diabetes. Both the DCCT and the UKPDS demonstrated the efficacy of intensive glucose control in reducing the risk for the microvascular complications of diabetes, such as retinopathy, neuropathy, and nephropathy. In addition, results from the UKPDS suggested that strokes may be reduced in patients with type 2 diabetes through a combined regimen of intensive blood pressure and glycemic control. Unfortunately, the advances of these studies have not been successfully incorporated into general health care practice. Prevention and treatment of long-term micro- and macrovascular complications remain critical problems in the management of type 1 and type 2 diabetes mellitus. In the United States, diabetes is the leading cause of new blindness in working-age adults, of new cases of end-stage renal disease and of non-traumatic lower leg amputations. In addition, cardiovascular complications are now the leading cause of diabetes-related morbidity and mortality, particularly among women and the elderly. In adult patients with diabetes, the risk of cardiovascular disease (CVD) is three-to-five fold greater than in the general population. Diabetes is the seventh leading cause of death in the United States and costs the American economy approximately $98 billion annually. Type 2 diabetes is treated with diet, exercise and medication. However, for many patients, achievement of tight glucose control is difficult with current regimens. Given the enormous public health cost of diabetes, the prospect of being able to use a relatively low-cost dietary supplement, such as chromium, as an adjuvant therapy to help in achieving euglycemia merits further study. Despite the large gaps in our knowledge regarding chromium, the US public uses chromium supplements for the treatment of diabetes and its complications. This widespread use warrants extensive testing of its efficacy and monitoring of its safety for long-term use. Chromium Chromium remains the only essential transition metal whose mechanism of action is not known. Chromium is thought to play a role in normal carbohydrate metabolism by potentiating the action of insulin. Chromium may increase insulin binding to cells and insulin receptor number, as well as activate insulin receptor kinase, leading to increased insulin sensitivity. Chromium exists in several valence states, the most prevalent oxidation states being hexavalent chromium (which is associated with industrial exposure and toxicity) and trivalent chromium (which is stable and the biologically active form). Chromium supplements are available as trivalent chromium in the chloride or picolinate salt form. Trivalent chromium also occurs in organic complexes with nicotinic acid. For purposes of this document, chromium will refer to trivalent chromium unless otherwise noted. The concentration of chromium in foods varies widely, there is also considerable variation between batches or lots of the same foods. Therefore, chromium intakes cannot be accurately predicted from dietary information. Survey data exist for a small number of isolated groups, however, no comprehensive studies exist determining intakes of individual subgroups. No national survey data are available. Estimates of chromium intake from diet in the United States are roughly 25 ug for women and 33 ug for men, which are thought to be reflective of an adequate intake for the population. The frequency of actual chromium deficiency in the general population is unknown, however, an intake level of 5 ug /1,000 kcal has been shown to deplete subjects in well-controlled studies. Clinically, chromium deficiency has been well characterized in three patients who did not receive chromium in total parenteral nutrition solutions. Reliable measures for assessing chromium status in humans are limited. Chromium is present in biological tissues and fluids at extremely low levels, so many of the problems associated with finding a measure of status have been analytical in nature. Only three analytical techniques have the required sensitivity to make these measurements, however, neutron activation analysis and mass spectrometry are not widely available, and graphite furnace atomic absorption spectrometry is the one most susceptible to interference from the sample matrix. Collecting samples without contaminating them and generating sufficiently low analytical and reagent blanks is extremely difficult. Therefore, plasma chromium is unlikely to be a viable clinical indicator because it is easily contaminated. Additional investigation of urinary chromium in response to very low levels of intake is needed. A putative chromium deficiency, as induced by feeding a chromium-deficient diet, has been reported in mammals and centers on disturbances involving insulin insensitivity. The signs and symptoms of chromium deficiency in mammals include impaired glucose tolerance, elevated circulating insulin concentration, glycosuria, fasting hyperglycemia, impaired growth, hypoglycemia, elevated circulating cholesterol and triglyceride concentrations, neuropathy, decreased insulin binding, decreased insulin receptor number and impaired humoral immune response. Chromium Supplementation in Diabetes Several studies have suggested that chromium supplementation might be beneficial in individuals with glucose intolerance, type 2 diabetes, gestational diabetes or steroid-induced diabetes, as evidenced by decreased blood glucose values or decreased insulin requirements. However, randomized trials of chromium supplementation in diabetes have not been definitive. Many studies have not been blinded, have used inappropriate glucose metabolism assessment parameters, or have included heterogeneous and not well- characterized patient populations. In addition, studies are difficult to compare because they have used different doses (ranging from 200 ug to 1000 ug) and formulations of chromium (such as chromium rich yeast, chromium chloride, chromium picolinate and chromium nicotinate), and have been short in duration. More rigorous, blinded and well-controlled studies are needed to fully assess the efficacy and mechanism of action of chromium supplementation as an adjuvant therapy for type 2 diabetes and impaired glucose tolerance. Trivalent chromium, the form found in foods and dietary supplements, is believed to be safe. The Environmental Protection Agency established a reference dose (an estimate of daily exposure that is likely to be without appreciable risk of deleterious effect over a lifetime) for chromium that is 350 times the estimated safe and adequate daily dietary intake. Because of the widespread use of supplementation, more research is needed to assess the safety of high-dose chromium. Most reports of adverse events to the Food and Drug Administration involved chromium taken in conjunction with various herbal preparations or other pharmacological agents, which may have been responsible for the adverse events. In a recent review of 19 randomized controlled trials in which individuals received between 175 and 1,000 ug /day chromium for duration of between 6 and 64 weeks, there was no evidence of any toxic effects. However, there are data to suggest that individuals with preexisting renal and liver disease may be particularly susceptible to adverse effects from excess chromium intake. There have been only a few confirmed case reports of toxicity attributed to chromium chloride and picolinate, including induced rhabdomyolysis and acute renal failure due to interstitial nephritis. In vivo genotoxicity assays for chromium and most studies of genotoxicity in cellular systems have been negative. Chromium picolinate is extremely stable, but concern has been expressed that reduction of chromium picolinate within cells could lead to the generation of hydroxyl radicals and potential DNA lipid damage. In fact, a few studies suggest that chromium picolinate and tri-picolinate may cause DNA damage. Therefore, there is a need to consider the genotoxicities of a variety of chromium complexes particularly when high doses are administered. There are no human studies that report reproductive toxicity or fetotoxic effects with chromium supplementation, but animal studies suggest reduced fertility in male mice, a reduction in the number of implantation sites and the number of viable fetuses, and delayed sexual maturity. In November 1999, the Office of Dietary Supplements (ODS) sponsored a workshop on Chromium and Diabetes (http://ods.od.nih.gov/news/conferences/chromium_diabetes.html), to review studies of chromium supplementation in diabetes and identify priority research areas. Workshop members reached consensus that small-scale, focused clinical studies might be warranted in certain population groups. In addition, in a recent report, the Institute of Medicine (IOM) of the National Academy of Sciences also recommended the need for research related to chromium and diabetes. Research initiatives should be directed at investigating the possible relationships between chromium status and insulin resistance, impaired glucose tolerance, and type 2 diabetes, monitoring any adverse effects of self-supplementation, and design of controlled studies to assess potential beneficial, as well as, adverse effects of high-dose chromium supplementation (IOM, 2001). As a follow-up to the workshop and prior to initiating clinical studies, the ODS sponsored a systematic review and meta-analysis of published clinical trial reports evaluating the role of chromium in individuals with glucose intolerance or type 2 diabetes. The report concluded there was strong evidence that chromium has no effect on glucose control in healthy subjects. However, the data for patients with diabetes were found to be equivocal and pointed to the need for small, focused, clinical trials in glucose-intolerant and diabetic subjects. These studies would further explore the efficacy of chromium as an adjunct treatment in type 2 diabetes and impaired glucose tolerance and determine the effective dose and formulation of chromium supplementation. In addition, they would provide additional information on the long-term safety of chromium supplementation. Scope and Objectives The purpose of this PA is to encourage 1) basic studies of chromium action on insulin secretory and signaling pathways and 2) clinical studies to assess the safety and efficacy of chromium as an adjuvant treatment of type 2 diabetes and/or impaired glucose tolerance. It is not the intent of this PA to support phase III clinical trials, as developmental studies are needed. The main objective of a full-scale, definitive phase III trial is to determine whether the intervention is more effective than that used in a control (or comparison) group. Also, this PA does not have as its primary focus case-control studies, health services studies, surveys or epidemiological studies. Appropriate topics for investigation under this PA include, but are not limited to: o Studies to determine what form of chromium is present in the tissues, blood, and urine, o Studies to determine factors that impact on chromium bioavailability, o Studies to develop tests or biomarkers of chromium toxicity, both systemically and at the tissue level, o Dose-response studies to delineate physiological versus pharmacological doses and responses to chromium supplementation, o Studies to develop improved techniques for the analysis of chromium in biological fluids, o Studies to develop tests or biomarkers that can be used to measure and monitor chromium status, o Small, focused phase I and phase II clinical trials to determine the safe and effective dose and formulation of chromium supplementation in individuals with type 2 diabetes or impaired glucose tolerance, o Studies to establish clinically relevant biomarkers for assessing the efficacy of chromium supplementation in individuals with type 2 diabetes or impaired glucose tolerance, o Studies to elucidate the mechanisms by which chromium enhances insulin secretion or action, o Studies to determine factors that predict response to chromium supplementation in individuals with type 2 diabetes or impaired glucose tolerance (e.g., diet, degree of insulin resistance or secretion, duration of diabetes), o Studies to evaluate the effects of long-term use of chromium on iron status. SPECIAL REQUIREMENTS Phase I or II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. Patient eligibility is limited to US residents since chromium status may vary by culture and geographic location. 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). The NIH has also released Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials, NIH Guide, June 5, 2000: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. In addition, NCCAM requires that all masked clinical trials, regardless of size, establish an independent data and safety monitoring board. The NCCAM Data Safety and Monitoring Guidelines for clinical trials are available at: http://nccam.nih.gov/research/policies/datasafety/index.htm Funds should be budgeted for these activities. They should not duplicate internal review and monitoring systems that are already in place at the institution. 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants an Contracts, June 5, 2000 (Revised August 25, 2000), available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an internet site. 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 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. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) at: http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: [email protected]. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the appropriate Institute’s program staff (see below, Inquiries ) before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. R21 APPLICATION GUIDELINES o The R21 mechanism is specifically intended to support innovative ideas where preliminary data as evidence of feasibility are sparse or do not exist. These grants are not intended for large-scale undertakings or to support or supplement ongoing research. Rather, R21-supported projects are intended to serve as a basis for planning and strengthening future investigator-initiated research project grant applications (R01). It is important to note that, while originality of approach and potential significance of the proposed research are major considerations in evaluation for funding R21 grants, the applicant is also responsible for presenting the background literature that provides some basis for the approach and developing a rigorous research plan. o For R21 applications, direct costs are limited to a maximum of $125,000 per year for a maximum of two years. Direct costs requested for the proposed period may not exceed $250,000. Direct costs should be requested in increments of $25,000. Total costs should equal the modular direct costs plus Facilities and Administrative (F&A) costs. The award is nonrenewable and may not be used to supplement an ongoing project. o Do not exceed a total of 15 pages for Items a-d in the Research Plan. Tables and figures are included in the page limitation. Applications that exceed the page limitation or NIH requirements for type size and margins (refer to PHS 398 application for details) will be returned to the applicant without further consideration. The 15-page limitation does not include Items e-l (Human Subjects, Vertebrate Animals, Literature Cited, Consortia, and Consultants). SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. 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) Applications will be accepted on the standard application receipt dates for investigator-initiated research as indicated in the PHS 398 directions. The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR staff. Incomplete applications will be returned to applicants without further consideration. Applications that are complete will be evaluated for scientific and technical merit in accordance with the standard NIH peer review procedures. 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Review Criteria (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? 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? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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 The adequacy of the proposed plan to share data, if appropriate. 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 Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Rebecca B. Costello, PhD Office of Dietary Supplements Office of Disease Prevention, Office of the Director BuiLding 31, 1B29 Bethesda, MD 20892 Telephone: (301) 435-2920 FAX: 301-480-1845 Email: [email protected] Marguerite Evans, MS, RD National Center for Complementary and Alternative Medicine 6707 Democracy Blvd. Democracy 2, Suite 106 Bethesda, MD 20892-5475 Telephone: 301-402-5860 FAX: 301-480-3621 Email: [email protected] Barbara Linder, MD, PhD Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 699 Bethesda, MD 20892-5460 Telephone: 301-594-0021 FAX: 301-480-3503 Email: [email protected] Direct inquiries regarding fiscal matters to: Victoria C. Carper, MPA Chief, Grants Management Officer, National Center for Complementary and Alternative Medicine 6707 Democracy Boulevard Democracy Two, Room 106 Bethesda, Maryland 20892 Direct: (301) 594-9102 Office: (301) 496-4792 Fax: (301) 480-3621 Email: [email protected] Charlette Kenley Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 640 MSC 54444456 Bethesda, MD 20892-5456 Telephone: (301) 594-8847 FAX: (301) 480-3504 E-mail: [email protected] AUTHORITY AND REGULATIONS 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 the ODS. This program is described in the Catalog of Federal Domestic Assistance No. 93.213 and 93.847. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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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