PA-04-006: NEUROTECHNOLOGY RESEARCH, DEVELOPMENT, AND ENHANCEMENT

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

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NEUROTECHNOLOGY RESEARCH, DEVELOPMENT, AND ENHANCEMENT RELEASE DATE: October 08, 2003 PA NUMBER: PA-04-006 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. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. The R01 portion of this announcement has been replaced by (PA-06-279) and will continue to be accepted using paper PHS 398 applications. A replacement R21 (PA-06-278) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: March 24, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.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) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute on Aging (NIA) (http://www.nia.nih.gov) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242 (NIMH), 93.173 (NIDCD), 93.865 and 93.929 (NICHD), 93.853 (NINDS), 93.279 (NIDA), 93.866 (NIA), 93.286 (NIBIB) 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 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 This Program Announcement replaces PA-02-003. The purpose of this Program Announcement (PA) is to encourage submission of new research project grant (R01) and exploratory/developmental grant (R21) applications to research and develop innovative technologies, methodologies, or instrumentation for basic or clinical studies of the brain or behavior in human or non-human animals. Also solicited are applications for support to research, develop, and significantly enhance existing technologies that are important to understanding the brain or behavior. RESEARCH OBJECTIVES In biomedicine, new tools and approaches often make possible quantum advances in research on health and disease, and sometimes shift the manner in which such research is undertaken, and results interpreted. Conversely, the complexity of living systems represent interesting challenges to researchers, providing ample opportunity for testing and expanding the limits of their science and technology. The brain, and its product, behavior, represent one of the most complex systems in biomedicine. Despite this, brain and behavioral sciences are rapidly advancing, with important discoveries coming to light almost daily. These discoveries will improve understanding of healthy brain function and offer promise to the millions suffering from brain disorders of all types. This PA seeks to enable neuroscience and behavioral research by soliciting research and development of novel tools and approaches for the study of the development, structure, and function of the brain. Such tools could include those used for clinical assessment, diagnosis, and treatment of brain disorders. Significant enhancements of existing technologies are also solicited. Research solicited under this program announcement is not limited to any particular type of technology, level of analysis, or approach. Multidisciplinary teams of researchers are encouraged to apply. Technologies appropriate for study, development and enhancement under this PA include hardware, software, and wetware (and combinations of thereof) that would be used to study the brain or behavior in basic or clinical research. The research topics identified here represent examples of technologies that are appropriate for this solicitation. These examples are not a complete list of the technologies sought; they are intended only as a guide for determining the appropriateness of a research topic. Summary This PA is expected to advance understanding of the nervous system and its product, behavior, through support of research, development, and enhancement of a wide range of technologies. Examples of hardware, software, and wetware that would be considered appropriate under this PA for research, development and enhancement include, but are not limited to: o Microfluidic systems for in-vivo spatial and temporal controlled delivery of neurotransmitters and other biomolecules o Proteome analysis arrays, proteome data storage and analysis of proteome data from the nervous system o Genetic approaches to study structure or function of neural circuits in animal models o Biosensors that would be selectively activated by neurochemicals, such as particular neurotransmitters or pharmacological compounds o Delivery systems for exogenous agents such as drugs, gene transfer vectors, and cells o Non-invasive methods for in-vivo tracking of implanted cells o Tools for real-time analysis of neurophysiological events o Tools for data mining for genetic discovery and functional insights into genomics and proteomics of the nervous system o Nanocrystals or quantum dots covalently bonded to neural receptor ligands o Probes of brain gene expression that can be imaged non-invasively (e.g., with magnetic resonance or near infrared optical imaging) o Genetic approaches to manipulate or monitor synaptic activity o Microelectromechanical system (MEMS) devices used for monitoring neuron function in slice and culture preparations o Amplifiers that are small and light enough to be worn by mice for recording neural activity from many neurons o Tools, technologies and algorithms for neuroprosthesis development o Tools to enhance visualization of specific brain markers o New methods to study neural connectivity in living or post mortem brain, especially human brain o Improved electrodes, microcomputer interfaces, and microcircuitry for chronic implantation, monitoring of neural activity, and promoting efferent function o Dynamic monitors of intracranial pressure and cerebral spinal fluid composition (particularly important in following disease progression or recovery from brain injury) o Devices for non-invasive diagnosis and precise identification of pathogens involved in central and peripheral neural infectious diseases o Tools for relatively non-invasive ways to assess damage and monitor function in regions of injured or diseased brain tissue o Non-invasive optical imaging instruments o Technologies for detection, intervention, and prevention of acute, adverse neurological events o Tools for early-warning detection of imminent seizure activity; application of targeted treatment to abort seizures o Technologies to facilitate high-throughput analysis of behavior o Tools for therapeutic electrical stimulation for rehabilitation following stroke, trauma or other events or disorders that disrupt normal function of the nervous system o Telemetry devices small and light enough to be worn by mice for transmitting data (e.g., electrophysiological data) during behavior o Software to translate neuroimaging data from one data format into another o Algorithms that use shape analysis approaches to understand human neuroimaging data o Computational approaches to analyzing video data (like those used in behavioral research) o Computational approaches and improved paradigms for analysis of kinematic data It is stressed that the examples given above are not meant to be exhaustive, they are merely given to suggest the kinds of projects that would be appropriate. MECHANISM(S) OF SUPPORT This PA will use the NIH Research Project Grant (R01) and Exploratory/Developmental Grant (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Information on the Exploratory/Developmental Grant (R21) is available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. This PA uses just-in-time concepts. It also uses the modular 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 format. Otherwise follow the instructions for non-modular 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 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. SPECIAL REQUIREMENTS Applications submitted in response to this program announcement may be design-, problem-, need-, or hypothesis-driven. Thus, the application should state the hypotheses, designs, problems and/or needs that will drive the proposed research. As plans for technology research, development, and enhancement are augmented by specific feasibility tests of the technology and/or milestones, these should be presented in the Research Design and Methods section. Finally, applications should include a plan for making available to the research community the technologies developed or enhanced by grants funded under this PA; this should be described in the Research Design and Methods section of the application. NIH policy requires that investigators make unique research resources produced with DHHS funding available for research purposes to qualified individuals within the scientific community (NIH Grants Policy Statement - March 2001, Part II Subpart A, Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources, page 120-122, "Sharing Biomedical Research Resources," available at http://grants.nih.gov/grants/policy/nihgps_2001/nihgps_2001.pdf; see also PHS policy relating to the distribution of unique research resources produced with PHS funding at http://grants.nih.gov/grants/guide/notice-files/not96-184.html. The intent of this policy, however, is not to discourage, impede, or prohibit the organization that develops unique research resources or intellectual property from commercializing the products. 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: Michael Huerta, Ph.D. Division of Basic and Clinical Neuroscience Research National Institute of Mental Health 6001 Executive Blvd. Room 7202, MSC 9645 Bethesda, MD 20892-9645 Rockville, MD 20852 (for express or courier service) Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: mhuert1@mail.nih.gov Roger Miller, Ph.D. Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: millerr@nidcd.nih.gov Ralph Nitkin, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-4206 FAX: (301) 402-0832 Email: rn21e@nih.gov Daofen Chen, Ph.D. Program Director, Channels/Synapses/Circuits National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 2131, MSC 9523 Bethesda, MD 20892-9523 Telephone: (301) 496-1917 FAX: (301) 402-1501 Email: dc342b@nih.gov Thomas G. Aigner, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 443-6975 FAX: (301) 594-6043 Email: ta17r@nih.gov Bradley C. Wise, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 350, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: wiseb@nia.nih.gov Grace C.Y. Peng, Ph.D. Division of Discovery Science and Technology National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Boulevard, Suite 200, MSC 5469 Bethesda, MD 20892 Telephone: (301) 496-9178 FAX: (301) 480-4973 Email: penggr@mail.nih.gov Philip F. Smith, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 689, MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 594-8816 FAX: (301)480-3503 Email: ps56z@nih.gov o Direct your questions about financial or grants management matters to: Carol J. Robinson Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6118, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-3858 FAX: (301) 443-6885 Email: crobinso@mail.nih.gov Ms. Sara Stone Grants Management Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400B, MSC-7180 Bethesda, MD 20892 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: stones@nidcd.nih.gov Annette Hanopole Grants Management Branch National Institute for Child Health and Human Development 6100 Executive Boulevard, Room 8A01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5002 Email: ah23k@NIH.GOV Ms. Karen Dunlap Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3290, MSC 9537 Bethesda, MD 20892-9537 Telephone: (301) 496-7359 FAX: (301) 402-0219 Email: kd177c@nih.gov Gary Fleming, J.D. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov Ms. Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: whippl@nia.nih.gov Mr. Nick Mitrano Grants Management Branch National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Boulevard, Suite 920, MSC 5469 Bethesda, MD 20892 Telephone: (301) 451-4782 FAX: (301) 480-4974 Email: mitranni@mail.nih.gov Kathleen Shino Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room, 708 MSC 5452 Bethesda, MD 20892-5452 Telephone: (301) 594-8869 FAX: (301) 480-3504 Email: ks48e@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 in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this PA must be typed on line 2 of the face page of the application. 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 GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. 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 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 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. The scientific review group will address and consider each of these 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). 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 $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 PA 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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