PAR-04-078: ANCILLARY STUDIES TO MAJOR ONGOING NIDDK CLINICAL RESEARCH STUDIES

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ANCILLARY STUDIES TO MAJOR ONGOING NIDDK CLINICAL RESEARCH STUDIES RELEASE DATE: March 19, 2004 PA NUMBER: PAR-04-078 (This PA has been modified, see PAR-06-216) EXPIRATION DATE: After March 2, 2007, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH) (http://www.niddk.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.847, 93.848, 93.849 THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of the PAR o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PAR The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites investigator-initiated research project applications for ancillary studies to ongoing large-scale clinical trials, epidemiological studies and disease databases supported by the Institute. These studies are focused on a wide range of diseases and conditions including diabetes, obesity, acute and chronic liver disease, chronic kidney disease, benign prostatic hyperplasia, among others. The goal of these ancillary study proposals must complement but not overlap or interfere with the primary and secondary objectives of the parent study. Each applicant must abide by the procedures for conducting ancillary studies established by the parent study group. RESEARCH OBJECTIVES The NIDDK supports a large number of clinical trials in patients with diabetes, obesity, acute and chronic liver disease, chronic kidney disease, non-malignant urological conditions such as benign prostatic hyperplasia and other diseases/conditions within the purview of the Institute. The Institute also conducts several large-scale epidemiological studies and disease databases to better characterize the treated natural history of type 1 and type 2 diabetes, chronic kidney disease, acute and chronic liver disease, a wide range of non-malignant urological conditions in men and women as well as other diseases. Each of these studies represents a substantial financial commitment from the NIDDK to establish an infrastructure for participant recruitment and follow-up. These studies offer unique opportunities to conduct additional investigations to fully exploit the research potential of each of these established cohorts. Each of the studies for which ancillary study proposals may be submitted has limitations on the type of investigations permissible and each has specific requirements for partnership with parent study investigators. You may not request support for activities that are part of the core protocol for the parent study. Likewise, you may not seek funds for analysis of existing data or for studies that substantially duplicate ongoing ancillary studies to the parent studies. In most cases, expansion of intervention protocols for clinical trials will not be permitted; however, in certain limited circumstances, this might be considered by the parent study. The goal of this Program Announcement (PAR) is to support projects that are designed to provide additional information concerning the primary and secondary objectives of the parent study. It is required that proposed ancillary studies be integrated with and complement the studies carried out by the parent study, and there be close collaboration between ancillary study and parent study investigators. Applications proposing additional data collection and/or analyses of patient samples that do not clearly extend and enhance the stated major research objectives of the parent study will be considered non-responsive to this PAR. Descriptions of the NIDDK supported clinical trials, epidemiological studies and disease databases eligible for ancillary studies in response to this PAR can be found at the following website: http://www.niddk.nih.gov/fund/ancillary-studies/. For many of the studies eligible for this PAR, ancillary study policies are described at their websites, which are noted in these descriptions. For those studies without such a website, ancillary study policies may be found at the same website listing descriptions of eligible studies. Note that some studies are undergoing protocol development. As soon as ancillary study policies become available for these studies, they will be posted on the website noted above. In addition, the list of eligible consortia and networks will change over time. MECHANISM OF SUPPORT This PAR will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. 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 PAR may not exceed five years. This PAR uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm) as well as the non-modular budgeting formats. 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_2003/NIHGPS_Part2.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS To be responsive to the requirements of this Program Announcement, you must propose studies using only the ongoing NIDDK supported clinical trials, epidemiological studies and disease databases found at the website established for this solicitation. Ancillary studies associated with major clinical trials and epidemiological studies/disease databases provide a valuable opportunity to further extend the knowledge gained from these studies. However, the potential value of such studies must be balanced against the need to ensure that the main clinical trial outcomes or objectives of the epidemiological studies/disease databases are not compromised by the burden of additional studies. Hence, you must provide documentation at the time of grant submission that you have received approval from the appropriate governing body of the parent study to conduct your proposed ancillary study. Each clinical trial, network or epidemiological study/disease database covered by this announcement has provided guidelines for which types of ancillary studies are currently acceptable and for the process of obtaining approval. These study-specific guidelines are either currently posted on each study’s website or links will be provided as they become available via the website for this Program Announcement located at: http://www.niddk.nih.gov/fund/ancillary-studies/. In addition, ancillary study policies for selected studies are posted at the website established for this PAR. Please note that study-specific restrictions may limit the types of ancillary proposals that are acceptable. Applications not containing documentation of preliminary approval from the appropriate governing body (such as the Steering Committee) will be considered non-responsive to this announcement and will be returned to the Investigator, without having undergone peer review, by the NIDDK. You must include a statement of your willingness to work collaboratively with the parent study and to abide by all parent study policies, publication restrictions, data access provisions, etc. You may be required by specific trials, networks, or epidemiological studies/disease databases to include funds in your application to travel to national Steering Committee meetings and/or to cover the cost of access to samples and data held by the parent study Data Coordinating Center or by central repositories. Data Sharing Plan Due to the collaborative nature of the parent studies, all applicants will be required to submit a data sharing plan, regardless of the dollar amount of their application. Reviewers will assess the adequacy of the proposed plan. Ancillary studies will also be required to abide by the data sharing policies of the parent study. NIH policy requires that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice (http://www.ott.nih.gov/policy/rt_guide_final.html). Therefore, it is expected that the specimens and data collected in projects funded by the PAR will be made available to the broader scientific community, after a proprietary period, at no charge other than the costs of reproduction and distribution. This PAR has a special requirement that applicants include a Sharing Plan in the application that describes how they will share the specimens and data collected with the wider scientific community. The Plan must include the eventual transfer of these materials to the NIDDK Central Biosample and Data Repositories or another archival storage facility designated by NIDDK. Approval of the data sharing plan will be a condition of the award. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-competing Grant Progress Report (PHS 2590). Data and Safety Monitoring Plan All applicants must include a data and safety monitoring plan for the ancillary study activities even when the parent trial already has a central Data and Safety Monitoring Board and even if the study is of minimal risk. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PAR 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: Barbara Harrison, M.S. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 661 Bethesda, MD 20892-5450 Telephone: 301-594-8858 Fax: 301-480-8300 E-mail: bh72k@nih.gov John W. Kusek, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 617 Bethesda, MD 20892-5458 Telephone: 301-594-7735 FAX: 301-480-3510 Email: jk61x@nih.gov Sanford A. Garfield, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 685 Bethesda, MD 20892-5460 Telephone: 301-594-8803 Fax: 301-480-6271 E-mail: sg50o@nih.gov Scientific/research questions on a specific study should be directed to the contact listed on the website for that study. o Direct your questions about peer review issues to: Francisco O. Calvo, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 752 Bethesda, MD 20892-5452 Telephone: (301) 594-8897 FAX: (310) 480-3505 Email: fc15y@nih.gov o Direct your questions about financial or grants management matters to: Sharon Bourque Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 719 Bethesda, MD 20892-5456 Telephone: 301-594-8846 Fax: 301-480-3504 Email: sb114m@nih.gov Helen Ling Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 732 Bethesda, MD 20892-5456 Telephone: 301-594-8857 FAX: 301-480-3504 Email: hl12d@nih.gov Florence Danshes Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 734 Bethesda, MD 20892-5456 Telephone: 301-594-8861 Fax: 301-480-3504 Email: fd39j@nih.gov Financial/grants management questions on a specific study should be directed to the contact listed on the website for that study. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS You must submit a letter documenting the preliminary approval of your proposed ancillary study by the parent trial, network or epidemiological study/disease database. The required documentation varies somewhat between the parent studies, so be sure to follow the procedures provided by the parent trial, network, or epidemiological study of interest to you. In addition, you must explicitly state your willingness to abide by the policies of the parent trial, network, or epidemiological study. It is strongly advised that the letter documenting the preliminary approval be sent to the NIDDK Programmatic contact (see "Where to Send Inquires") at an early stage of application development. NIDDK's receipt of the letter of preliminary approval, signed by the representatives of the consortium/network Steering Committee, will allow NIDDK Staff to plan for the Referral and Review of the application. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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 three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all appendices must be sent to: Francisco O. Calvo, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 752 Bethesda, MD 20892-5452 (Courier use ZIP 20817) 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 PAR 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 unfunded version 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 Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to this PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate 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 this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: Justification of the need for access to the clinical trial, network of epidemiological study/disease database. 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score (http://grants.nih.gov/grants/policy/data_sharing) Data and Safety Monitoring Plan The adequacy of a data and safety monitoring plan for the ancillary study will be assessed by the reviewers. 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 PAR 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 Programmatic priorities: Only very meritorious applications within the scientific interests and scope of the NIDDK mission will be supported o Cumulative burden to the parent study: The cumulative burden to the parent study of all ancillary studies ongoing and proposed for funding under this PAR may be a limiting factor. For example, if small quantities of biological samples are available, not all studies rated as highly meritorious may be able to access them. Likewise, the cumulative burden of studies already approved for funding may be such that those of lower priority cannot be funded, regardless of priority score. REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. 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 PAR 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 PAR 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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