PA-04-033: DIET COMPOSITION AND ENERGY BALANCE

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

DIET COMPOSITION AND ENERGY BALANCE RELEASE DATE: December 10, 2003 PA NUMBER: PA-04-033 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, this funding opportunity expires on the date indicated below. Replacement R01 (PA-06-173) and R21 (PA-06-174) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. See NOT-OD-06-048 for information on May 1, 2006 Submission Date for AIDS and AIDS-related R03 and R21 Applications. EXPIRATION DATE: March 2, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/index.htm) National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/ National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.847, 93.848, 93.853, 93.399, 93.866, 93.273, 93.213, 93.837, and 93.865 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Supplementary Instructions o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The goal of this program announcement is to invite research applications investigating the role of diet composition in energy balance, including studies in both animals and humans. Both short and longer-term studies would be encouraged, ranging from basic studies investigating the impact of micro-or macronutrient composition on appetite, metabolism, and energy expenditure through clinical studies evaluating the efficacy of diets differing in micro- or macronutrient composition, absorption, dietary variety, or energy density for weight loss or weight maintenance. RESEARCH OBJECTIVES Overweight and obesity have increased dramatically in prevalence in the US. More than 60 percent of the US population is overweight (BMI ?25) and 31 percent meet criteria for obesity (BMI ?30. Obesity is particularly prevalent among some minority populations, such as African American, Hispanic, and Native American women. Overweight prevalence is also increasing in children, with more than 15 percent of children and adolescents considered overweight and an additional 15 percent at risk for overweight. Obesity is associated with numerous serious and chronic diseases, including type 2 diabetes, cardiovascular disease, sleep apnea, and certain forms of cancer. The causes of obesity are complex, and involve both genetic and environmental components. Environmental changes over the past two decades have increased sedentary behaviors, decreased physical activity, and increased consumption of more energy dense foods and larger portion sizes. Although an imbalance in energy consumption and expenditure are required to promote inappropriate weight gain, the relative contributions of each to the burgeoning obesity epidemic remain in dispute. An important gap in knowledge concerns the role of diet composition in energy balance. Diets low in carbohydrates have been purported to enhance weight loss, while those high in carbohydrates (particularly simple sugars and refined grain products) have been cited by some as contributing to weight gain. Some shorter-term studies (up to six months in duration) have reported greater weight loss in those who consumed a low-carbohydrate diet compared with a diet higher in carbohydrate; however, the contribution of reduced caloric consumption to weight loss with such diets has not been adequately studied. Even when carbohydrate level is similar, factors such as glycemic index, nutrient density, fiber content, and dietary variety, have also been proposed to affect energy intake, with potential relevance for enhancing attempts to promote weight loss and prevent inappropriate weight gain. In addition to carbohydrates, further research is needed to elucidate the role of other macronutrients in energy balance (including fats, proteins and ethanol). Some fatty acids (such as conjugated linoleic acid) have been alleged to promote weight loss and/or improve body composition, although studies in humans have been inconsistent. Micronutrients such as calcium have been proposed to play a role in energy balance, either through decreased fat absorption or via other mechanisms, although research in this area is still formative. In addition, the relative impact of calcium from dairy products versus other food or supplement sources also remains in question. The mechanisms by which diet composition affects energy balance are not well understood, but may include alternations in appetite, nutrient absorption, neuroendocrine and gastrointestinal factors, energy partitioning, physical activity and other components of energy expenditure. Furthermore, the short- and long-term impact of diet composition on factors such as body composition, risk factors for cardiovascular disease, cancer, renal function, psychosocial function, and other health parameters is also not well characterized. Although there have been numerous animal studies assessing the impact of diet composition on appetite and body weight, these studies have been limited by availability and use of well-defined and standardized diets. Lack of methods in laboratory practice that would permit the assessment of dietary composition and the lack of data comparing commercial preparations from various suppliers may contribute significant variability to studies designed to assess the impact of diet on energy balance. In addition to long-term studies of weight gain in response to standardized diets, short-terms studies with well-characterized diets varying in macro- and micronutrient composition would help to define the effect of diet composition on endocrine and neuronal axes involved in regulation of both food intake and energy partitioning. This program announcement invites research applications investigating the role of diet composition in energy balance, including studies in both animals and humans. Collaborations between basic and clinical researchers, which explore mechanisms underlying differences in response to diet composition, are particularly encouraged. Examples of the type of research topics and approaches that would be solicited under this program announcement include (but are not limited to): 1) Studies addressing the impact of diets varying in levels of protein, carbohydrate, fat, phytochemicals, or ethanol on appetite, food selection and intake, and energy expenditure. 2) Studies examining the role of diets differing in glycemic index, dietary variety, food volume, or nutrient density on appetite, caloric intake, nutrient absorption, weight, metabolomic profiles, and body composition both short- and long-term. 3) Investigation of the impact of diet composition on neuroendocrine, gastrointestinal, and other factors that may impact energy balance. 4) Research assessing the impact of diets differing in macronutrient composition on psychological/behavioral function (including mood and eating- related cognitions and behaviors), bone, renal function, cardiovascular disease, and cancer risk. 5) The impact of food components such as conjugated linoleic acid (either from food or supplement sources) or calcium (either from dairy or non-dairy sources, including dietary supplements) on energy balance, body composition, and disease risk. 6) Studies assessing genomic and epigenomic factors underlying individual or population differences in response to diet composition that relate to chronic disease prevention. 7) Brain imaging studies in humans and non-human primates to assess positron emission tomography, functional magnetic resonance, or cerebral blood flow imaging responses to specific dietary constituents. 8) Studies to develop methods to assess dietary composition. 9) Studies measuring the effects of sleep deprivation, either by experimental manipulation or due to a disease process on macronutrient consumption (e.g., does sleep deprivation lead to changes in cravings for carbohydrate and fat? Does sleep deprivation lead to change in body weight?) 10) Studies assessing dietary composition effects on the magnitude and time course of neurobehavioral and physiological responses to sleep loss, and the interaction of these effects with BMI, gender, age, and ethnicity 11) Studies assessing life-stage, racial/ethnic, and gender-related factors underlying response to diet composition, including studies in children, adolescents, and adults of various ages. 12) Validation of medium or long-term effects of different dietary macronutrient composition on energy intake in community-dwelling individuals using doubly labeled water MECHANISM(S) OF SUPPORT This PA will use the NIH R01 and R21 award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (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 budget format. Otherwise, follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 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 institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Susan Z. Yanovski, M.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 665 Bethesda, MD 20892-5450 Phone: (301) 594-8882 Fax: (301) 480-8300 Email: sy29f@nih.gov John A. Milner, Ph.D. Nutritional Science Research Group Division of Cancer Prevention National Cancer Institute 6130 Executive Blvd., Suite 3164 Rockville, MD 20892 Phone: (301) 496-0118 Fax (301) 480-3925 Email: jm524n@nih.gov Marguerite Klein National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 Phone: (301) 402-5860 Fax: (301) 480-3621 Email: kleinm@mail.nih.gov Catherine (Cay) Loria, Ph.D., M.S., M.A. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 8150 Bethesda, MD 20892-7934 Phone: (301) 435-0702 Fax: (301) 480-1667 Email: loriac@nih.gov Chhanda Dutta, Ph.D. Geriatrics and Clinical Gerontology Program National Institute on Aging Gateway Building, Suite 3C-307 7201 Wisconsin Avenue Bethesda, MD 20892-9205 Phone: (301) 435-3048 Fax: (301) 402-1784 Email: duttac@nia.nih.gov R. Thomas Gentry, Ph.D. Division of Metabolism and Health Effects National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd., Suite 302 Bethesda, MD, 20892-7003 Phone: (301) 443-6009 Fax: (301) 480-2358 Email: tgentry@niaaa.nih.gov Gilman D. Grave, M.D. Endocrinology, Nutrition and Growth Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Blvd., Suite 4B-11 Bethesda, MD 20892-7510 Phone: (301) 496-5593 Fax: (301) 480-9791 Email: gg37v@nih.gov Merrill M. Mitler, Ph.D. Systems and Cognitive Neuroscience National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 2116 Bethesda, MD 20892 Phone: (301) 496-9964 Fax: (301) 402-2060 Email: mitlerm@ninds.nih.gov Paul Coates, Ph.D. Office of Dietary Supplements 6100 Executive Blvd., 3 B01, Bethesda, MD 20892-7517 Phone: (301) 435-2920 Fax: (301) 480-1845 Email: CoatesP@od.nih.gov o Direct your questions about financial or grants management matters to: Sharon Bourque Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 719 Bethesda, MD 20892-5456 Phone: (301) 594-8846 FAX: (301) 480-3504 Email: sb114m@nih.gov Debra Dunne Grants Management Specialist National Cancer Institute 6120 Executive Blvd., Room 243 Bethesda MD 20892 Phone: (301) 496-3154 FAX: (301) 496-8601 Email: dunne@mail.nih.gov Marc Milton Pitts, M.B.A. Senior Grants Management Specialist National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 Phone: (301)594-9095 Fax: (301) 480-1552 Email: pittsm@mail.nih.gov Kieran Kelley Senior Grants Management Specialist National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7170 Bethesda, Maryland 20892-7926 Phone: (301)-435-0154 FAX: (301)-480-3310 Email: kelleyk@nhlbi.nih.gov John Bladen Grants Management Specialist National Institute on Aging 7201 Wisconsin Avenue, Room 2N212 Bethesda, MD 20892-9205 Phone: (301)402-1472 Fax: (301)402-3672 Email: jbladen@mail.nih.gov Judy S. Fox Chief, Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd, Willco Bldg, 504 Bethesda, MD 20892-7003 Phone: (301) 443-4704 FAX: (301) 443-3891 Email: jsimons@niaaa.nih.gov Lisa Moeller Grants Management Specialist National Institute of Child Health and Human Development 6100 Executive Blvd., Room 8A17F Bethesda, MD 20892-7510 Phone: (301) 496-1305 FAX: (301) 480-4783 Email: lm236j@nih.gov Kimberly D. Campbell Grants Management Specialist National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Suite 3249 Bethesda, Maryland 20892-9537 Phone: (301) 496-7809 Fax: (301) 402-0219 Email: KC274K@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html n an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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. INSTRUCTIONS FOR R21 APPLICATIONS: This program announcement allows the submission of R21 (Exploratory/Developmental Research Grant) applications. R21 applications must adhere to the page and budgetary limitations described in the trans-NIH R21 program announcement (PA-03-107) available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the appropriate national advisory council or 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 evaluate application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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. 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? 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? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants.(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing . Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://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 http://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 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://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans, which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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