and Human Services (HHS)
EXPIRED
TECHNOLOGIES TO FIND FUNCTIONAL ELEMENTS IN GENOMIC DNA RELEASE DATE: January 6, 2004 RFA Number: RFA-HG-04-001 August 4, 2006 - This RFA has been reissued as RFA-HG-07-029 (R01) and RFA-HG-07-028 (R21). Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENT OF PARTICIPATING ORGANIZATION: National Human Genome Research Institute (NHGRI) (http://www.genome.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.172 LETTER OF INTENT RECEIPT DATE: February 20, 2004 APPLICATION RECEIPT DATE: March 23, 2004 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 Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions 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 solicit applications to develop new technologies for the efficient, comprehensive, high-throughput identification and verification of all types of sequence-based functional elements, particularly those other than coding sequences for which adequate methods do not currently exist. This effort is part of the Encyclopedia of DNA Elements (ENCODE) Project, the intent of which is to identify all functional elements in the human genome sequence (http://www.genome.gov/10005107). This RFA will augment the ongoing work of the ENCODE Consortium, which is (a) conducting a pilot project to test the ability of current methodologies to identify exhaustively the functional elements in a targeted region of the human genome and (b) supporting the development of new technology. Although all aspects of technology development will be considered, the emphasis for this RFA is on the development of completely novel techniques for identifying sequence-based functional elements in the genomes of eukaryotic organisms, especially heretofore uncharacterized elements, rather than on the incremental improvement of existing methods. RESEARCH OBJECTIVES Background In April 2003, the sequence of the human genome was essentially completed. For the scientific community to make the best use of that fundamental information resource, the identity and precise location of all sequence-based functional elements in the genome must be determined. While many of the protein-coding sequences are already known, many others remain to be identified. Beyond open reading frames, most other sequence-based functional elements, such as non-protein-coding genes, transcriptional regulatory elements and determinants of chromosome structure and function, remain largely unknown. A comprehensive encyclopedia of all of these features is needed to fully utilize the sequence of the human genome to better understand human biology, to predict potential disease risks, and to stimulate the development of new therapies and other interventions for preventing and treating disease. Among the primary reasons for the success of the Human Genome Project have been the development and use of high-throughput strategies for data generation, and the placement of the data immediately in the public domain. Most of the sequence data, the underlying maps and the sequence assemblies were generated through the use of large-scale automated processes. Now, methods such as sequence analysis of whole genomes, DNA microarray technology and mass spectrometry have been or are being developed as high-throughput approaches for additional types of genomic analyses, such as determining the parameters of gene expression and of the location of gene products by the thousands at a time instead of individually. High-throughput methods to determine the location of cis- regulatory elements and, to a lesser extent, other sequence elements, are also beginning to be developed. However, at present, there is no single approach or compilation of approaches that can accurately and efficiently identify every sequence feature in genomic DNA. To address this need, the NHGRI recently initiated the Encyclopedia of DNA Elements (ENCODE) Project, the goal of which is to comprehensively identify sequence-based functional elements in the human genome sequence. The ENCODE Project currently has two components. The first is a pilot in which existing methods for the exhaustive identification and verification of functional sequence elements are being tested and compared in a fraction (30 Mb) of human genomic DNA. This pilot is focused on established technologies that can primarily be applied to identify coding sequences, transcriptional units, and transcriptional control elements. The second component of the ENCODE Project addresses the need for new technologies that will be necessary to identify all sequence-encoded functional elements on a genome-wide scale. To this end, an initial set of grants was funded, under RFA HG-03-004, to develop novel technologies designed to effect systematic and high- throughput approaches to the comprehensive identification of functional sequence elements in the human genome. The current RFA (HG-04-001) is a reissuance of that RFA with an expansion in scope to include the support for high risk projects, for testing new ideas for which preliminary data have not yet been obtained, and for the development of new approaches to identify sequence-based functional elements in the genomes of model organisms even if such methods are not directly applicable to identifying features in the human genome. The goal of RFA HG-04-001 is to develop a new generation of methods to define functional elements in genomes of both human and model organisms. Research Scope When fully mature, the ENCODE Project will apply a set of high- throughput assays to scan the entire human genome for all types of sequence-encoded functional elements. However, many types of functional elements cannot currently be studied at such large scale, or even at smaller scale, because of the lack of effective, practical high- throughput methods. The purpose of this RFA is to stimulate the development of novel technologies and expand the tool box for identifying all sequence-based functional elements in eukaryotic genomes in a high-throughput manner. The RFA seeks applications for research projects to develop efficient technologies (both experimental and computational) for, but not limited to, the following areas: o Transcribed sequences; while the emphasis is on non-protein coding transcribed sequences, new approaches to identifying protein-coding transcribed sequences will be considered. A description of the entire structure of the transcriptional unit, with transcriptional start sites, polyadenylation sites, and all alternative transcripts, is an example. o Conserved non-coding sequences that represent functional elements. o Cis-acting elements that regulate gene expression at either the transcriptional or post-transcriptional levels, for example promoters, enhancers, insulators, and features that regulate RNA stability and translation. o Sequence features that affect or control various aspects of chromosome biology, including chromatin structure. Examples include origins of replication and hot spots for recombination. o Epigenetic changes, such as DNA methylation and chromatin modifications. These few examples are illustrative and should not be considered to be limiting in any way. Novel and innovative technologies to achieve high- throughput, large-scale analyses (i.e., applicable to an entire genome) of any type of sequence-encoded functional elements are sought. The "process" of technology development can be considered to span a spectrum of stages. Initially, it involves the development of an entirely new methodology (or the significant improvement of an existing methodology) to the point of proof of principle. The method must then be reduced to practice. For such a new method to have a significant impact for genomic studies, it also must be shown that it can be used efficiently on a large-scale, or genomic basis, which may require a further round of technology development effort. This RFA is intended to solicit applications that address any of these phases of technology development, with an emphasis on the development of completely novel techniques for identifying sequence-based functional elements, especially heretofore uncharacterized elements, rather than on the incremental improvement of existing methods. Although the long term goal of the ENCODE project is to develop a comprehensive understanding of the human genome sequence, this RFA is open to projects employing any other eukaryotic organism. Technology development in other organisms can aid in the identification of functional elements in the human genome in two ways: the technologies may be applicable to the human genome, or although uniquely applicable to specific genomes because of the characteristics of the organism, provide biological insights into functional elements that could not be determined from experiments in the human. The application of the proposed technology to organisms other than the one that is the focus of the application is not a requirement of this RFA. However, applicants should address the issue of broader application of the technology, if appropriate. An important feature of any newly developed technology will be the ease with which it can be exported into other laboratories, or in other ways made readily accessible to investigators. The issue of access, or technology transfer, should be specifically discussed in the grant application. The development of computational methods for the study of genomic function is encouraged under this solicitation. However, computational methods that incrementally improve on current technologies are not being sought. Any software developed under this RFA should be freely available to other biomedical researchers in the non-profit sector. As the technologies to be developed under this RFA are expected to be applied eventually to an entire genome, applications proposing to analyze a particular gene, gene product or non-coding functional element will not be considered to be responsive. To encourage the consideration of novel approaches, applicants responding to this RFA are not required to have preliminary data. However, the research project must be well designed, must be scientifically and technically sound, and should propose alternative solutions. In the absence of preliminary data, applicants are encouraged to present any other information that can be considered as evidence of feasibility. As the work funded under this RFA progresses, the principal investigators will be encouraged to interact with the ENCODE pilot project consortium and its members. If work supported under this RFA, such as a computational analysis, results in the generation of data pertaining to the complete set of target regions of the ENCODE project, the principal investigator may be invited to join the consortium (see http://www.genome.gov/10005107 for a description of the consortium). Among other requirements, this would involve sharing of the data with the members of the consortium, as participation involves concurrence with a specific data release policy (see RFA HG-03-003 for a detailed description of that policy). Applicants to HG-04-001 may wish to address their approach to data release in their proposal. MECHANISM OF SUPPORT This RFA will use the NIH investigator-initiated Research Project Grant (R01) and the Exploratory/Development Research Grant (R21) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The total requested project period for an application submitted in response to this RFA may not exceed 3 years for the R01 mechanism, and 2 years for the R21 mechanism. The anticipated award date is September 30, 2004. This RFA is a one-time solicitation. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html). The R21 mechanism (Exploratory/Developmental grant) is intended to encourage new exploratory/ developmental research projects by providing support for the early stages of their development. Awards are made to demonstrate feasibility of a subsequent project and to obtain preliminary data testing innovative ideas. Therefore, these grants are not renewable. Continuation of projects developed under this program will be through the regular research project grant mechanism (for example, R01). This RFA 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 budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NHGRI intends to commit approximately $2 million in FY2004 to fund 6 to 10 new and/or competitive continuation grant applications in response to this RFA. An applicant may request a project period of up to 3 years and a budget of up to $350,000 direct costs per year for an R01 application. For an R21 application, a project period of up to 2 years and a budget for direct costs of up to $100,000 for up to two years may be requested. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award may vary. Awards pursuant of this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. 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. 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 to: Elise Feingold, PhD or Peter Good, PhD Program Directors Division of Extramural Research NHGRI Building 31, Room B2B07 31 Center Drive, MSC 2033 Bethesda, MD 20892-2033 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: [email protected] or [email protected] o Direct your questions about peer review issues to: Rudy Pozzatti, PhD Scientific Review Administrator Review Branch Division of Extramural Research NHGRI Building 31, Room B2B37 31 Center Drive, MSC 2032 Bethesda, MD 20892-2032 Telephone: (301) 402-8739 FAX: (301) 435-1580 Email: [email protected] o Direct your questions about financial or grants management matters to: Jean Cahill Chief, Grants Administration Branch Division of Extramural Research NHGRI Building 31, Room B2B34 31 Center Drive, MSC 2031 Bethesda, MD 20892-2031 Telephone: (301) 301-435-7858 FAX: (301) 402-1951 Email: [email protected] 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: Peter Good, PhD Program Director Division of Extramural Research NHGRI Building 31, Room B2B07 31 Center Drive, MSC 2033 Bethesda, MD 20892-2033 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: [email protected] 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: [email protected]. 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. 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: http://grants.nih.gov/grants/funding/phs398/labels.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 to: Rudy Pozzatti, PhD Scientific Review Administrator Review Branch Division of Extramural Research NHGRI Building 31, Room B2B37 31 Center Drive, MSC 2033 Bethesda, MD 20892-2033 Telephone: (301) 402-8739 FAX: (301) 435-1580 Email: [email protected] APPLICATION PROCESSING: Applications must be received on or before 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. 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. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHGRI. Incomplete applications will not be reviewed. 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 NHGRI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o 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 written critique o Receive a second level review by the NHGRI National Advisory Council for Human Genome Research. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate 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 the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does the application address the problem outlined in this RFA? 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 as outlined in this RFA? Are potential problem areas acknowledged and alternative tactics considered? Does the technical approach have the potential to be applied efficiently and cost- effectively at large scale? INNOVATION: Does the project employ novel concepts, approaches, or methods for identifying and verifying sequence-based functional elements? Does the project challenge existing paradigms or develop new methodologies or technologies rather than providing an incremental improvement over existing technologies? Does the project develop new methods or technologies to reduce costs or increase quality or throughput? INVESTIGATOR: Is the principal 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: TECHNOLOGY DISSEMINATION: Does the applicant provide a plan for making the technology available to other labs? Will any software produced be freely available to biomedical researchers in the non-profit sector? 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. 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. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 27, 2004 Application Receipt Date: March 26, 2004 Peer Review Date: June-July 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 2004 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, including the likelihood that the proposed technology could be applied to the ENCODE project in a timely manner and the range of technologies that could be developed under this component of the ENCODE project. Preference will be given to applications that propose the development of completely novel technologies and/or the study of novel sequence elements. 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. 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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