PA-03-145: UBIQUITIN AND UBIQUITIN-LIKE MODIFICATIONS REGULATING DISEASE PROCESSES

Department of Health
and Human Services (HHS)

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UBIQUITIN AND UBIQUITIN-LIKE MODIFICATIONS REGULATING DISEASE PROCESSES RELEASE DATE: July 1, 2003 PA NUMBER: PA-03-145 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, this funding opportunity expires on the date indicated below. Replacement R01 (PA-06-167) and R21 (PA-06-168) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. See NOT-OD-06-048 for information on May 1, 2006 Submission Date for AIDS and AIDS-related R03 and R21 Applications. EXPIRATION DATE: March 2, 2006 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) National Institutes of Aging (NIA) (http://www.nia.nih.gov) National Cancer Institute (NCI) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.847, 93.848, 93.849, 93.866, and 93.396 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 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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Aging (NIA), and the National Cancer Institute (NCI) invite investigator-initiated research projects (R01 and R21) focused on elucidating the various roles of ubiquitin and ubiquitin-like modifications in the development, normal physiology and/or disease progression in cells, organs, and tissues of interest to NIDDK, NCI, and NIA. The NIDDK supports research pertaining to diabetes, endocrine and metabolic diseases; nutritional disorders, obesity and digestive diseases; and kidney, urologic and hematologic diseases. The NIA supports research pertaining to the basic biology of aging and age-associated diseases in various models including, but not limited to, tissue culture models and other cell-based paradigms, and tissues such as heart, muscle, brain and prostate. The Division of Cancer Biology of the NCI supports basic research projects covering a broad spectrum of topics directed at understanding the biological basis of cancer. RESEARCH OBJECTIVES Background Ubiquitin, a highly conserved 76 amino acid polypeptide, was the first protein shown to be covalently attached to other proteins. Through a multi- enzyme cascade, polyubiquitin chains are added to a variety of different proteins that are then ultimately degraded by the 26S proteasome. Recent mining of the human and mouse genomes, use of yeast genetics, and detailed analyses of several biochemical pathways, have resulted in the identification of many new roles for ubiquitin conjugation. Searches of the available genomes suggest that many ubiquitin ligases and deconjugating enzymes are also present in eukaryotes. Mono-ubiquitination has now been shown to be involved in the regulation of wide variety of important cellular processes including receptor internalization and down-regulation, gene transcription, and virus budding. Furthermore, several ubiquitin-like modifications (e.g. Sumoylation, Neddylation, and ISGylation) have been recently identified. The known functions of ubiquitin and ubiquitin-like modifications are already quite diverse, and their biological role is expanding beyond the original notion that these modifications simply mark proteins for destruction. Ubiquitin and ubiquitin-like modifications are increasingly recognized as key regulatory events in many basic cell biology processes that impact the development of cancer, such as regulation of the cell cycle, protein trafficking, and cell survival versus cell death decisions. Ubiquitin and ubiquitin-like modifications and the processes activated by these modifications are also increasingly being investigated as potential cancer therapeutics. On March 24th and 25th, 2003 the NIDDK sponsored a meeting entitled "Ubiquitin and Ubiquitin-like modifications in Health and Disease". The meeting highlighted some of the most recent advances in our understanding of how ubiquitination and similar modifications affect the regulation of metabolism and gene transcription, protein sorting and intracellular trafficking, as well as proteasomal degradation. The goal of current research is to try and understand the many rules governing signaling by ubiquitin and ubiquitin-like modifications, so that we can better understand the clinical implications of defects in this abundant, complex, and highly regulated protein modification machinery. Objectives and Scope This program announcement (PA) is intended to stimulate novel and productive research focused on the involvement of ubiquitin and ubiquitin-like modifications in normal physiology and in disease processes of interest to the NIDDK, NIA, and NCI. Areas of interest for NIDDK include research on cell types of the kidney, pancreas, liver, gastrointestinal tract, and blood; diseases such as diabetes, obesity, and other metabolic and nutritional disorders; as well as hematologic, urologic and kidney diseases. Areas of interest for NIA include research on a variety of cellular, tissue and animal models of aging. Areas of interest for NCI include the identification of genes, proteins, and signaling networks responsible for the cancer phenotype; investigation of aberrantly modified processes that promote cell proliferation or inhibit cell death; and the exploration of molecular events that determine tumor cell survival and progression. Examples that illustrate possible areas of research are presented below. They are intended only to provide a broad direction for research and should be considered illustrative and not restrictive. Some potential topics include, but are not limited to: o Investigation of the role of ubiquitin ligases in attenuation of receptor signals initiated by growth factors, cytokines and hormones binding in cells of the liver, pancreas, kidney, intestine, bladder, prostate, or blood o Exploring how Cbl and other ubiquitin ligases are involved in immune responses and how alterations in the system can lead to defects in immuno- regulation and development of type I diabetes, intestinal inflammation or cholestatic liver disease o Study of ubiquitin mediated proteosome degradation in insulin resistance and sensitivity of beta cells to autoimmune destruction o Characterizing the role of ubiquitin and ubiquitin-like modifications in the regulation of cellular metabolism and gene transcription by the adipocyte, hepatocyte, or pancreatic beta cell o Research on ubiquitin modifications and protein degradation associated with cachexia o Elucidating the physiological relevance of ubiquitin-like modifications such as sumoylation or neddylation of ion channels and transporters o Investigation of the role of ubiquitin modifications in diseases caused by misfolded or misprocessed proteins, such as cystic fibrosis, nephrogenic diabetes insipidus, and alpha-1-antitrypsin deficiency o Investigation of the role of ubiquitin and ubquitin-like modifications in the oncogenesis of preneoplastic lesions leading to gastrointestinal and hepatic cancers o Elucidation of the involvement of ubiquitin-like modifications in the regulation of hepatitis C replication o Research on ubiquitin modifications and protein degradation associated with the process of aging o Investigation of the role of ubiquitin in age-related protein diseases MECHANISM(S) OF SUPPORT This PA 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 PA may not exceed 5 years for the R01 mechanism, and 2 years for the R21 mechanism. R21 grants will not be renewable; continuation of projects developed under this program will be through the R01 grant program. The R21 awards are to demonstrate feasibility and to obtain preliminary data testing innovative ideas that represent a clear departure from ongoing research interests. These grants are intended to: 1) allow exploration of possible innovative new directions for established investigators; and 2) stimulate investigators from other areas to lend their expertise to research within the scope of this solicitation. Applicants for the R21 may request a project period of up to two years with a combined budget for direct costs of up to $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 can be requested in a single year. This PA uses just-in-time concepts. It also uses the modular budgeting format (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. 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 INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research, and financial or grants management issues: o Direct your questions about scientific/research issues to: Carol Renfrew Haft, Ph.D. Program Director Division of Diabetes, Endocrinology and Metabolism National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Room 605 Bethesda, MD 20892-5460 Telephone: (301) 594-7689 FAX: (301) 480-3503 E-mail: cr84g@nih.gov Christopher Mullins, Ph.D. Program Director Division of Kidney, Urology and Hematology National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Room 637 Bethesda, MD 20892-5460 Telephone: (301) 451-4902 FAX: (301) 480-3510 E-mail: cm@419z@nih.gov Jose Serrano, M.D., Ph.D. Program Director Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Room 657 Bethesda, MD 20892-5460 Telephone: (301) 594-8871 FAX: (301) 480-8300 E-mail: js362q@nih.gov Felipe Sierra, Ph. D. Program Director Biology of Aging Program National Institute on Aging Gateway Building, Room 2C231 Bethesda, MD 20892 Tel: (301) 496-6402 FAX: (301) 402-0010 E-mail: fs78n@nih.gov Mary Perry, Ph. D. Program Director Division of Cancer Biology National Cancer Institute EPN 5018 Bethesda, MD 20892-7396 Tel: (301) 496-7028 FAX: (301) 402-1037 E-mail: mp372j@nih.gov o Direct your questions about financial or grants management matters to: Denise Payne Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 733 Bethesda, MD 20892-5456 Telephone: (301) 594-8845 FAX: (301) 480-3504 E-mail: dp43@nih.gov Linda Whipp Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 E-mail: lw17m@nih.gov Aida Vasquez Grants Management Specialist Division of Cancer Biology National Cancer Institute 6120 Executive Blvd., Suite 243 Bethesda, MD 20892 Telephone: (301) 496-2736 FAX: (301) 496-8601 E-mail: av47p@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) 710-0267, Email: GrantsInfo@nih.gov. The program announcement title and number must be typed on line 2 of the face page of the application form and the YES box marked. Also indicate if the application in an R01 or R21. 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 R21 APPLICATIONS All application instructions outlined in the PHS 398 application kit are to be followed, with the following requirements for R21 applications: 1. R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" concepts, with direct costs requested in $25,000 modules, up to a combined budget for direct costs of up to $275,000 for the two year period. 2. Preliminary data for the actual studies proposed in the R21 application are not required. However, the PI should demonstrate that he/she has the appropriate expertise and resources on hand to perform the proposed experiments. If not evidenced by publications, this may require inclusion of preliminary data to demonstrate facility in the methodologies proposed. 3. Sections a-d of the Research Plan of the R21 application may not exceed 15 pages, including tables and figures. 4. R21 appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism, and should not be used to circumvent the page limit for the research plan. Copies of appendix material will only be provided to the assigned reviewers of the application and will not be reproduced for wider distribution. The following materials may be included in the appendix: o Up to 5 publications, including manuscripts (submitted or accepted for publication), abstracts, patents, or other printed materials directly relevant to the project. These may be stapled as sets. o Surveys, questionnaires, data collection instruments, and clinical protocols. These may also be stapled as sets. o Original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 15 page limit of items a-d of the research plan. 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 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 the 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 the application's overall score, weighting them as appropriate for each application. 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? SPECIAL R21 REVIEW CRITERIA: The R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, as well as for supporting the development of tools and technologies that have the potential to significantly advance our knowledge or the status of health- related research. Because the research plan is limited to 15 pages, an R21 grant application need not have background material or preliminary information as one might normally expect in an R01 application. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator- generated data. Preliminary data are not required for these R21 applications. 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 CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. Do investigators state their willingness to submit data to a public database in a timely fashion or make the information available to the community at large in another way? Do the investigators agree to share reagents such as knock- out mice, cell populations, plasmids and antibodies? The plans proposed for sharing and data release will be reviewed for adequacy by reviewers as well as NIDDK, NIA or NCI staff prior to award and will be considered as a criterion for award. 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 . MONITORING PLAN AND DATA AND SAFETY 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 and Safety 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 "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: tc "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 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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