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RFA-AG-03-005: COLLABORATIVE STUDIES ON ALZHEIMER'S DISEASE AND OTHER NEURODEGENERATIVE DISEASES ASSOCIATED WITH AGING COLLABORATIVE STUDIES ON ALZHEIMER'S DISEASE AND OTHER NEURODEGENERATIVE DISEASES ASSOCIATED WITH AGING RELEASE DATE: December 19, 2002 RFA: AG-03-005 National Institute on Aging (NIA) (http://www.nih.gov/nia/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) LETTER OF INTENT RECEIPT DATE: February 12, 2003 APPLICATION RECEIPT DATE: March 12, 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 Citations PURPOSE OF THIS RFA The purpose of this RFA is to facilitate collaborative cross- disciplinary and multi-institutional approaches that will contribute new and vital information about the clinical and pathological course of normal aging and the neurodegenerative diseases associated with aging. This RFA requires the utilization of data and/or samples from at least three currently funded NIA Alzheimer's Disease Centers with the possibility of using additional relevant data outside of the Centers. The project should use the National Alzheimer's Coordinating Center (NACC) http://www.alz.washington.edu/ for expert advice on planning, study design, statistical analysis and data management of the research projects. Applicants can be from the Alzheimer's Disease Centers, the Morris K. Udall Centers, or the research community at large. There must be a plan to share data originating from these studies by archiving them at NACC so that other investigators will be able to conduct additional analyses when appropriate. There must also be a plan for sample utilization beyond that of the initial application. This is a research opportunity for scientists within and outside the Alzheimer's Disease Centers to gain access to unique resources related to Alzheimer's Disease, other neurodegenerative diseases, and normal aging and to support collection of new data and samples. Applicants can also propose to utilize Center data and samples to investigate other age-related neurodegenerative diseases, such as Vascular dementia, Parkinson's dementia, Lewy Body disease, Fronto-Temporal dementia, as well as study psychiatric symptoms associated with dementia, socio— behavioral aspects of dementia, and management and care of dementia patients. The National Institute of Neurological Disorders and Stroke (NINDS) is interested in those specific applications which include the Morris K. Udall Centers of Excellence, or other Parkinson's research centers, in the pursuit of those research objectives focused on Parkinson's Disease (PD) or related parkinsonisms. The PD center need not be located with ADCs, but collaboration with those ADCs with existing samples and data sets focused on PD is required. Specific scientific projects of interest include the use of clinico-pathological correlations to study mechanisms of pathogenesis in PD or other parkinsonian conditions, characterization of the pathological features of these conditions, and the collection of patient data on their associated symptoms. RESEARCH OBJECTIVES Background As research on Alzheimer's disease (AD) has matured, new aspects of the disease are being addressed. More emphasis is being placed on the clinical and neuropathological changes that distinguish the initial stages of AD from normal aging. Also, as other neurodegenerative diseases, such as Vascular dementia, Parkinson's disease, Lewy Body disease, and Fronto-temporal dementia have features that overlap or coexist with AD, some research could focus on collecting diagnostic information that allows differentiation among the various diseases while documenting analogous features. Using the large subject pool enrolled at the Alzheimer's Disease Centers, larger scale multisite collaborative studies are feasible to study successful aging, normal aging, mild cognitive impairment (MCI) and mild AD. It is expected that access to larger data sets through data pooling will increase statistical power and permit characterization of the rarer and mixed phenotypes among the various diseases. Further, it may be possible to detect potential biomarkers or patterns that will help identify persons at risk for disease, characterize and diagnose the different disease entities, refine description of disease course, and monitor response to treatment in different subsets of AD and other patients e.g. genetic subsets, ethnic minorities, the oldest old, or those with less common neurodegenerative diseases. The NIA Alzheimer's Disease Centers (ADCs) program is authorized by the Public Health Service Act, Section 445, and includes seventeen Alzheimer's Disease Research Centers (ADRCs) and twelve Alzheimer's Disease Core Centers (ADCCs). The Alzheimer's Centers have provided a platform for the growth of research and training of scientists for AD research and have been the leaders in research on clinico-pathological correlations to compare normal aging and AD as well as in answering many basic research questions on AD and related dementias. The main function of the ADCs is to support cutting-edge research either directly or indirectly by providing well-characterized patients and family information and tissue and other biological specimens from persons with AD and from age-matched control subjects for various projects. The National Alzheimer's Coordinating Center (NACC) http://www.alz.washington.edu/ was established to collect a common data set from all NIA funded Alzheimer's Disease Centers in order to facilitate collaboration among the Alzheimer's Disease Centers on important unanswered questions pertaining to AD, related disorders, and normal aging. The database consists of several datasets. Objectives This RFA invites studies that utilize existing samples and data gathered by the Centers and/or studies that collect additional data and samples within the Center network to target specific research questions best addressed by collaborative studies. In such projects, collection and utilization of data need not be confined to the applicant Centers but also could involve other Centers and other data sources. Applicants will find on the NACC website the current directory of the Alzheimer's Disease Centers as well as a description of the data collected at the Centers. To initiate the process, potential applicants may contact the NIA Program Officer listed below or the Director of NACC to determine which Centers to contact to set up collaborations. Alternatively the applicant may contact Centers directly to discuss potential collaborations. Searches may be done on the entire database or on individual datasets after approval for access has been granted. NACC can use the MDS data to help applicants locate subjects with particular characteristics for whom tissues and biological specimens may be available at participating ADCs and will facilitate contact among applicants responding to this RFA with the ADCs to locate information and specimens for this project. Additionally NACC provides statistical and epidemiological consulting concerning research questions, study design and analytic methods best suited to the overall NACC database or the individual Centers. Applicants should budget funds for NACC for consulting and data management expenses. Possible examples of scientific problems that could be addressed by applications include but are not limited to collaborative projects that: o Study expression of Alzheimer's disease and other related dementias in specific minority groups, in terms of clinicopathological correlations, diagnostic issues, biomarkers, co-morbidities, particular risk factors, differential prevalence, clinical presentation or course of disease. o Determine the impact of co-morbid pathological conditions (such as diabetes; hypertension; heart disease; metabolic profiles) on normal and abnormal cognitive brain aging, especially in relation to vulnerable individuals, such as the oldest old. o Study biological samples (blood, CSF, and other body fluids) collected by standardized methods and currently stored at selected Alzheimer's Disease Centers to get sufficient numbers of samples to reach statistical significance; set up biochemical screens to identify molecules indicative of disease state (protein, carbohydrate, and lipid) and their relative concentration in serum, CSF, and other body fluids in various subject populations. For example, protein identity and concentration could be analyzed by proteomics methodologies, such as MALDI-TOF, using biological samples from persons with 1) successful aging, 2) normal aging, 3) mild cognitive impairment, 4) early stages of AD, 5) late stages of AD, 6) AD with Lewy bodies, 7) AD with cerebrovascular disease, 8) Parkinson's dementia, etc., at various ages and degrees of disease progression. It may then be possible to identify patterns or profiles of molecules that could be used to distinguish among the various conditions and serve as biomarkers for preclinical disease, diagnosis or disease progression. o Characterize the pathological features (such as plaques, tangles, Lewy bodies, cell death, synapse loss, atrophy, white matter lesions, and micro infarcts), in different brain regions of selected individuals to elucidate the temporal and spatial development of pathologies in successful aging, normal aging, MCI, and early stages of AD. o Identify the pathology or combination of pathologies that best explains the neuropsychological deficits, if any, in individual subjects. o Determine whether any of the possible precursors of overt pathology described below distinguish brains of persons with "normal" aging from brains of persons who show subtle age-related cognitive changes often preceding AD, from brains of persons with early AD. These changes could include but are not limited to regional alterations in levels or processing of tau or APP, changes in energy metabolism, oxidative stress, calcium-regulatory mechanisms, inflammatory processes, inappropriate neuronal entry into the cell cycle, altered metabolism or degradation of proteins, axonal transport, or synaptic changes. o Conduct microarray studies in specific brain regions and studies of gene expression in single identified cells to illuminate the local and widespread changes in gene expression that accompany successful aging, normal aging, MCI, and the different stages of AD. Appropriately characterized brains from persons who died with minimal agonal stress, with relatively short postmortem intervals, and from whom brain RNA can be analyzed quantitatively could be identified from Center resources for such studies. Proposed studies could include appropriately characterized brains of sufficient age ranges to allow for comparisons from young to middle to old age, to characterize persons with MCI, or pure AD pathology, etc. Microarray or cellular data generated from these brain sets by different investigators and compiled into a reference dataset would be one step towards identifying genomic expression changes that consistently parallel age or disease phenotypes. o Investigate relationships between exposure to certain agents (such as ACHE inhibitors, statins, antihypertensives, anti-inflammatories, antioxidants or vitamins) and onset or progression of the disease. o Study the incremental value of imaging on the clinical diagnosis of AD and non-AD dementias. o Investigate common mechanisms of disease pathogenesis in Alzheimer's disease, Parkinson's disease, and Lewy Body disease, through clinico- pathological correlations. o Characterize the role and impact of different socio-cultural environments in terms of risk of or protection from dementia. o Evaluate caregiver characteristics and the dynamics underlying care management across socio-economic groups, ethnicity, demographic variables, and along the continuum of disease development and progression. o Define the disease-related and/or socio-cultural factors impacting on consent to participate in clinical research, and testing of the validity of various approaches to determine consent to clinical research in different subgroups of patients in the Alzheimer's Disease Centers. o Utilize and/or collect data on behavioral components and psychiatric symptoms associated with the development and progression of Alzheimer's disease and other dementias such as vascular dementia, Parkinson's dementia, Lewy body disease, and mixed dementia. Applicants are encouraged to contact the Program Officers listed below to clarify requirements and to discuss potential projects. The National Institute of Mental Health The National Institute of Mental Health (NIMH) also supports studies of neurodegenerative diseases and special problems of the aging population that are related to and affected by mental illness. For more information on NIMH's late-life research program, please refer to program announcement PA-03-014 Research on Mental Illnesses in Older Adults (https://grants.nih.gov/grants/guide/pa-files/PA-03-014.html). MECHANISM OF SUPPORT This RFA will use the NIH R01 award mechanism. The total project period for an application submitted for the R01 mechanism in response to this RFA may not exceed five years. Applicants may request a budget for direct costs of up to $300,000 per year, excluding F&A costs on consortium arrangements, or up to $500,000 per year total costs. The anticipated award date is September 2003. FUNDS AVAILABLE NIA has set aside funds sufficient to make at least three awards of up to $500,000 per year (total cost). NINDS is setting aside funds to make one award if the focus is on Parkinson's Disease and related disorders and applicants utilize the resources of the Udall Centers. Awards are contingent upon availability of funds and receipt of a sufficient number of applications with outstanding scientific and technical merit. This is a one-time solicitation. 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 INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The Principal Investigator (PI) may be an Alzheimer's Disease Center or Udall Center based senior investigator or a scientist outside the Centers networks with demonstrated capability to organize, administer, and direct collaborative, interdisciplinary research activities. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS At least three Alzheimer's Disease Centers have to be involved in the collaborative projects funded by NIA. Other Centers as well as different data and specimen sources also may be utilized for data or tissue collection. There must be a comprehensive collaborative agreement among all participating entities that defines the relationships among the PI, the participating Centers and other data sources, and NACC. The PI must have a documented agreement and a plan to subcontract with NACC and use NACC to manage data related to the project. The participating Centers and other data sources must agree to provide the data and/or samples necessary to complete the project including the minimum data set for patients not enrolled in an ADC Clinical Core. There should be clear agreement from all parties regarding relationships, plans for interaction, details of data sharing and mechanisms for transferring data to NACC. The letters of agreement should be signed by an authorized individual at each participating site and should accompany the application. Applications that at the time of submission do not include within the application documentation of collaboration with at least three ADC sites, Udall Center sites, if appropriate, and NACC, will be returned without review. There must also be a plan for sample utilization beyond that of the initial application, including future access to data and samples. NIA will evaluate the adequacy of the sharing plan before making funding decisions. The PI should commit at least 10 percent effort to the project, whereas participating investigators at the Centers should commit at least 5 percent effort to this project. The application should provide detailed information regarding procedures for obtaining informed consent and adherence to local and state laws for surrogate consent. Applicants should provide insurance of compliance with relevant state and Federal regulations regarding confidentiality, consent and sharing of human data and biological samples. In order to assure active collaborations with the Alzheimer's Disease and Udall Centers and NACC, all senior members of the collaborative team in NIA-sponsored projects are expected to attend at least one of the semi-annual meetings of the Alzheimer's Center Directors or in the case of NINDS-sponsored projects, the annual Udall Centers meeting. The cost of data transfer to NACC, data management and statistical consulting by NACC, and travel for senior investigators to the Centers meetings should be included in the proposed budget. Sharing of Data and Biological Resources Restricted availability of unique research resources, upon which further studies are dependent, can impede the advancement of research. The NIH is interested in ensuring that particular research resources developed through grants become readily available to the broader research community in a timely manner for further research, development, and application, in the expectation that this will lead to products and knowledge of benefit to the public health. Resources to be shared will include appropriate data and biological samples collected and all analysis techniques. Data sharing will be accomplished through NACC. To address this interest in assuring that research resources are accessible, NIH requires applicants who respond to this RFA to submit a plan for exercising intellectual property rights, should any be generated through this grant, while making such research resources available to the broader scientific community. The sharing of research resources plan and intellectual property plan must make unique research resources readily available for research purposes to qualified individuals within the scientific community in accordance with the NIH Grants Policy Statement (https://grants.nih.gov/grants/policy/nihgps/) and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html) and (http://ott.od.nih.gov/NewPages/64FR72090.pdf). These documents also define terms, parties, responsibilities, prescribe the order of disposition of rights, prescribe a chronology of reporting requirements, and delineate the basis for and extent of government actions to retain rights. Patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page, http://www.iedison.gov. NIH program staff will consider the adequacy of the plan and its consistency with NIH and NIA/NINDS policies on data sharing and intellectual property when determining whether to recommend an application for award. The approved plan will become a condition of the grant award and Progress Reports must contain information on activities for the sharing of research resources and intellectual property. 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, Alzheimer's Centers and relationships with NACC to: Creighton H. Phelps, Ph.D. Program Director, Alzheimer's Disease Centers Neuroscience and Neuropsychology of Aging National Institute on Aging Gateway Building, Suite 350 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: 301 496-1494 Email: phelpsc@nia.nih.gov o Direct your questions regarding scientific/research issues, Parkinson's disease and related disorders, and Udall Centers to: Diane D. Murphy, Ph.D. Program Director Neurodegeneration Group National Institute of Neurological Disorders and Stroke NSC Rm 2223 6001 Executive Blvd. Rockville, MD 20852 Telephone: 301-496-5680 FAX: 301-480-1080 Email: dm152o@nih.gov o Direct your questions about peer review issues to: Mary Nekola, Ph.D., Chief Scientific Review Office National Institute on Aging Gateway Building, Room 2C212 Bethesda, MD 20892-9205 Telephone: (301) 496-9666 FAX: 301-402-0066 Email: NekolaM@nia.nih.gov o Direct your questions about financial or grants management matters to: Deborah Stauffer Lead Grants Management Specialist Office of Grants and Contract Management National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: 301-402-3672 Email: stauffed@nia.nih.gov or Kimberly Campbell Grants Management Specialist Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd. Rm. 3249 Rockville, MD 20892 Telephone: (301) 496-7809 FAX: (301) 402-0219 Email: kc274k@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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Mary Nekola, Ph.D., Chief Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9666 FAX: 301-402-0066 Email: NekolaM@nia.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at 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. 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 must be sent, along with all appendix materials, to: Mary Nekola, Ph.D., Chief Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o May 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 Advisory Council on Aging or the National Advisory Neurological Disorders and Stroke 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. (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), 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 BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o OTHER REVIEW CRITERIA: The adequacy of documented agreements and a plan to subcontract with NACC and use NACC to manage data related to the project. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 12, 2003 Application Receipt Date: March 12, 2003 Peer Review Date: Spring/Summer 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 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. 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. 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 are required to place data collected under this RFA in the NACC, which can provide protections for the data and manage the distribution for an indefinite period of time. 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. 93.866 and 93.853, 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 to 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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