GENE DISCOVERY FOR COMPLEX NEUROLOGICAL AND NEUROBEHAVIORAL DISORDERS RELEASE DATE: March 31, 2003 (see correction NOT-NS-03-013) PA NUMBER: PAS-03-092 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, the R21 portion of this funding opportunity expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. A replacement R21 (PAS-06-204) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE: for R21 Applications: March 2, 2006 EXPIRATION DATE: for R01 Applications: July 2, 2006 National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) National Institute on Aging (NIA) (http://www.nia.nih.gov) National Institute of Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.853 (NINDS), 93.866 (NIA), 93.279 (NIDA), 93.113 and 93.115 (NIEHS) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Special Requirements o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators 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 (PA) is to promote the identification of susceptibility genes for complex neurological and neurobehavioral disorders. For this PA, complex disorders are defined as those caused by the interaction of multiple genes, or by a combination of genetic and environmental risk factors. Many of these disorders are relatively common and clinically heterogeneous. Projects focusing on any phase of the gene discovery process, from initial patient ascertainment to positional cloning, are appropriate. Novel approaches, including the use of intermediate phenotypes that potentially underlie complex disorders, are also encouraged. RESEARCH OBJECTIVES Background Genetic factors contribute to a broad spectrum of neurological and neurobehavioral diseases. During the last decade, genes that cause many single-gene neurological disorders have been identified (e.g. Huntington's disease, neurofibromatosis, and Rett Syndrome). For these disorders, familial inheritance patterns follow the rules of Mendelian segregation. For many common disorders (e.g. stroke, Parkinson's disease, epilepsy, Alzheimer's disease, and attention deficit hyperactivity disorder), inheritance patterns are more complex, and progress in identifying genes that affect susceptibility and disease outcome has been slow. Such disorders appear to be caused by multiple genes or by a combination of genetic and environmental factors. The wealth of genomic information becoming available through the Human Genome Project is providing a powerful tool for gene discovery. Once disease susceptibility genes are identified, it will be possible to study gene function, investigate disease pathophysiology, and explore strategies for therapeutic intervention. Gene identification will also provide a basis for improved diagnostic classification, genetic counseling and understanding of pharmacogenetic interactions. Scope Applications submitted in response to this announcement should focus on the identification of susceptibility genes that contribute to genetically complex disorders affecting the nervous system, or to the phenotypes that underlie these disorders. Proposed studies can involve the initial collection of biomaterials and clinical information from a patient population or the subsequent application of genetic or molecular strategies for gene localization. Possible methodologies include, but are not limited to, traditional linkage analysis, sib-pair and affected-pedigree-member methods, case-control or family-based association studies, linkage disequilibrium mapping in genetically isolated populations, candidate gene analysis, cytogenetic studies to identify chromosomal abnormalities associated with a disorder, and positional cloning. This PA focuses on human studies - projects using invertebrate or vertebrate animal models are not appropriate. Since gene discovery requires collaborations among epidemiologists, geneticists, clinicians, molecular biologists, and other researchers, multidisciplinary projects are encouraged. Since complex disorders are clinically and genetically heterogenous, the identification of susceptibility genes by standard genetic methodologies has been difficult. Therefore, the development of novel approaches and the use of state-of-the-art technologies are essential. An example of such an emerging strategy is the use of intermediate phenotypes (endophenotypes) to facilitate gene discovery. Endophenotypes are characteristics that may represent more proximal readouts of gene function. Examples include enzyme activities, plasma levels of particular neurotransmitters, changes in gene expression, structural or functional phenotypes detected by brain imaging, and behavioral or cognitive deficits. Classifying patients based on such parameters has, in certain cases, accelerated the process of gene discovery. The use of this strategy is appropriate if the applicant: (1) demonstrates that the phenotype in question can be reliably and accurately measured (2) provides evidence suggesting that the phenotype underlies a particular neurological/neurobehavioral disorder or group of disorders and (3) makes a strong case that use of this phenotype will facilitate the discovery of susceptibility genes. Applications should focus on complex neurological or neurobehavioral disorders relevant to the research missions of NINDS, NIA, NIDA, or NIEHS. A partial list of diseases of interest to NINDS is given in Appendix A of the planning document Neuroscience at the New Millennium; http://www.ninds.nih.gov/about_ninds/plans/strategic_plan.htm). These include neurological disorders (e.g. stroke, Parkinson's disease, epilepsy, multiple sclerosis, and Alzheimer's disease) and neurobehavioral disorders (e.g. autism, attention deficit hyperactivity disorder, and Tourette Syndrome). Disorders of interest to NIA for this PA include Alzheimer's disease and other age-associated neurodegenerative, cognitive, and motor system disorders (see http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/ NeuroscienceOfAging/Research+Areas.htm and http://www.nia.nih.gov/strat-plan/2001-2005). Disorders of interest to NIDA for this PA include drug abuse and/or drug dependence on stimulants (e.g., cocaine and amphetamine), narcotics (e.g., opiates), nicotine, benzodiazepines, barbiturates, cannabis, hallucinogens, and/or multiple drugs of abuse in human beings. Intermediate phenotypes of interest to NIDA include but are not limited to sensation seeking, impulse control, responses to rewarding stimuli as measured by neuroimaging, and initial reactivity to drug exposure. Disorders of interest to NIEHS for this PA are Parkinson's disease, amyotrophic lateral sclerosis (ALS), ADHD, autism and autism spectrum disorders and other neurodegenerative disorders when the focus of the gene discovery is on those genes that can be influenced by environmental exposures contributing to the onset of the disorders. An important resource available to applicants is the Center for Inherited Disease Research (CIDR), a centralized facility established to provide high- throughput genotyping and statistical genetics services. CIDR was established in 1996 as a joint effort of eight NIH Institutes, and is supported through a contract to Johns Hopkins University. CIDR is available to all investigators through competitive peer review by a chartered CIDR Access Committee (CAC). Projects are evaluated based on the need for high throughput genotyping and the likelihood that genotyping will lead to successful mapping of genes contributing to that disease. Since NINDS, NIA, and NIDA support CIDR, research projects funded by these Institutes under this PA are eligible for no-cost genotyping. Further information about CIDR may be found at http://www.cidr.jhmi.edu. Submission deadlines for applications requesting CIDR access are November 1, March 1 and July 1. An approval letter from the CAC may then be included in the application. SPECIAL REQUIREMENTS Plan for Dissemination of Data and Biomaterials Sharing of biomaterials, data, and software in a timely manner has been an essential element in the rapid progress that has been made in the genetic analysis of human diseases. PHS policy requires that investigators make unique research resources available for research purposes to qualified individuals within the scientific community when they have been published (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/guide/notice-files/not96-184.html). In addition, NIH recently released a statement on the sharing of research data that applies to all investigator-initiated applications with direct costs greater than $500,000 in any single year (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). All applicants who respond to this PA must propose plans for sharing data and biomaterials generated through the grant. Applicants should explain how funds for the storage and distribution of data and biomaterials will be obtained, and may request such funds in the budget of the application. It is expected that the information to be shared will include clinical, diagnostic, and pedigree structure information. Biomaterials to be shared should include patient DNAs and cell lines. When possible, data and biomaterials should be placed in databases or repositories that will permit their efficient distribution to investigators throughout the scientific community. An example of such a facility is the NINDS Human Genetics Resource Center (http://locus.umdnj.edu/ninds). Rapid sharing of data and biomaterials is strongly encouraged. The Initial Review Group will evaluate the proposed sharing plan and comment on its adequacy in an administrative note in the summary statement. Reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score. The adequacy of the plan will be considered by NIH staff in determining whether the grant shall be awarded. The sharing plan as approved, after negotiation with the applicant when necessary, will be a condition of the award. Phenotyping Issues Phenotyping subjects for the analysis of complex diseases presents numerous challenges. It is expected that applicants will use the most sophisticated methodologies currently available for a particular disorder. When possible, applicants are encouraged to include the following methodological features in their proposals: o Use of a structured or semi-structured diagnostic interview with patients or other informants. It is expected that such procedures will greatly facilitate the establishment of a reliable diagnosis, and thus will increase the statistical power and utility of the data set for genetic analysis. o Comprehensive synthesis of information systematically collected from laboratory procedures, structured or semi-structured clinical interviews of high reliability, medical records, and multiple informants. o Entry of comprehensive phenotypic data described above into a computerized database that may be easily shared with other researchers. MECHANISMS OF SUPPORT This PA will use the NIH research project grant (R01) and exploratory/developmental grant (R21) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applicants are encouraged to contact program staff for advice about choosing the appropriate grant mechanism. The R21 mechanism is intended to encourage new exploratory/developmental research projects by providing support for the early stages of their development. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models or applications that could have major impact on a field of biomedical, behavioral, or clinical research. Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. R21 applications may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two year period. For example, you may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of your project. Normally, no more than $200,000 may be requested in any single year. 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. Competing continuation applications submitted in response to this PA will compete with all investigator-initiated applications and be referred and reviewed according to the customary peer review procedures. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The earliest anticipated award date is April 1, 2004. FUNDS AVAILABLE Applications submitted in response to this PA will compete with all investigator-initiated applications for funding. The participating Institutes intend to commit a total of approximately $3,000,000 (total costs) per year in additional funding to this PA. The total project period for an application submitted in response to this PA may not exceed 5 years. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the Institute provide support for this program, awards pursuant to this PA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this PA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign 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: Direct inquiries regarding scientific/research issues to: Dr. Robert Finkelstein NINDS Neuroscience Center, Rm 2143 6001 Executive Blvd. Bethesda, MD 20892-9527 Telephone: (301) 496-5745 FAX: (301) 401-1501 Email: finkelsr@ninds.nih.gov Dr. Marilyn Miller Neuroscience and Neuropsychology of Aging NIA 7201 Wisconsin Avenue Suite 350 Bethesda, MD 20892 Telephone (301) 496-9350 Fax: (301) 496-1494 Email: MillerM@nia.nih.gov Jonathan D. Pollock, Ph.D. Genetics and Molecular Neurobiology Research Branch NIDA 6001 Executive Blvd, Rm 4274 Bethesda, MD 20892 Telephone: (301) 435-1309 FAX: (301) 594-6043 Email: jp183r@nih.gov Kimberly A. Gray, Ph.D. Chemical Exposures and Molecular Biology Branch NIEHS PO Box 12233 (MD EC-21) Research Triangle Park, NC 27709 Telephone: (919) 541-0293 FAX: (919) 316-4606 Email: kg89o@nih.gov Direct inquiries regarding financial or grants management matters to: Ms. Kathleen Howe Grants Management Branch NINDS 6001 Executive Boulevard, Rm 3266 Bethesda, MD 20892 Telephone: (301) 496-7392 Email: howek@ninds.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 http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. 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. SUPPLEMENTAL INSTRUCTIONS: All instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions: o Research Plan For R21 applications only, items a d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required for R21 proposals, but may be included if it is available. Please note that a Progress Report is not needed for R21 awards; competing continuation applications for an exploratory/developmental grant will not be accepted. Appendix. Use the instructions for the appendix detailed in the PHS 398 except that for R21 applications, no more than 5 manuscripts, previously accepted for publication, may be included. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in the 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. In addition, beginning with the October 1, 2003 receipt deadline, all applications requesting direct costs greater than $500,000 in any single year must include a plan for data sharing in accordance with the recent NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.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 received by or 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. An appropriate scientific review group 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 Receive a written critique 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 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 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: SHARING PLAN: The adequacy of the proposed plan to make all data and biological materials collected and produced as a result of the proposed research accessible to the biomedical research community in a timely manner. Reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score, but will be asked to comment on the plan in an administrative note in the summary statement. 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. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) 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 o Adequacy of proposed sharing plan 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. 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: http://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 (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://grants.nih.gov/grants/stem_cells.htm 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 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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