RFA-DK-04-016: CLINICAL NUTRITION RESEARCH UNIT CORE CENTERS

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CLINICAL NUTRITION RESEARCH UNIT CORE CENTERS RELEASE DATE: May 13, 2004 RFA Number: RFA-DK-04-016 EXPIRATION DATE: November 19, 2004 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: 93.848 LETTER OF INTENT RECEIPT DATE: October 18, 2004 APPLICATION RECEIPT DATE: November 18, 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 Special Requirements 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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite applications for Clinical Nutrition Research Unit (CNRU) grants. Three existing CNRUs are expected to submit competitive renewal applications. The Clinical Nutrition Research Unit grants are core centers (P30) that are part of an integrated program of nutrition and obesity-research support provided by NIDDK. The Centers currently funded in this program (http://www.niddk.nih.gov/fund/other/centers.htm#ClinicalNutrition) have provided a focus for increasing collaboration and improving cost effectiveness of supported research among groups of successful investigators at institutions with an established, federally supported, comprehensive nutritional sciences and obesity and related disorders research base. RESEARCH OBJECTIVES The objective of the Core Centers is to bring together basic science and clinical investigators from relevant disciplines to enhance and extend the effectiveness of research related to nutritional sciences, obesity, and related disorders, with clinical and/or translational applications in these areas. A Core Center must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the Core Center is to bring together clinical and basic science investigators in a manner that will enrich the effectiveness of nutritional sciences, obesity, and related disorders research. An existing program of excellence in biomedical basic and clinical research in the areas of nutritional sciences, obesity, and related disorders is required. The research must be in the form of research project grants (R01), program project grants (P01), or other peer-reviewed research that is already funded by NIH, other Federal Agencies, or non- federal groups at the time of submission of the Center grant application. It is required that at least fifty percent of the nutritional sciences and obesity or other related disorders research comprising the research base be supported by Federal Agencies. Close cooperation, communication, and collaboration among all involved personnel of various professional disciplines are ultimate objectives. A CNRU should be comprised of the following components: Required Components: (These are the fundamental components that a responsive application must include.) 1. Biomedical or behavioral clinical research with human subjects or populations; 2. Basic laboratory investigations; 3. Research training (funds to be derived from other sources*); 4. Shared facilities and research services; Encouraged Components: (The presence of these components demonstrates the institutional commitment and the recognition of clinical nutritional sciences and obesity within the Institution(s)). 5. Education programs emphasizing the nutritional sciences and obesity and related conditions or disorders for medical students, house staff, practicing physicians, and allied health personnel (funds to be derived from other sources*); 6. Research components of nutritional support services; and 7. Public information activities (funds to be derived from other sources*). *Funds to support these components may not be requested as part of an application in response to this announcement. The CNRUs are based on the core concept. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in the nutritional sciences, obesity and related areas to accomplish the stated goals of the Center. It is appropriate and may be beneficial to have one or more central themes around which core center research investigations are focused. CNRU applications must include an administrative core that will be responsible for oversight and allocation of Center resources. The Administrative core will also be responsible for planning an enrichment program and for implementing a process for solicitation, review, and selection of projects for the CNRU Pilot and Feasibility Program (P/F). A clinical component or core that deals with patients is often helpful. This clinical component can exist as a stand-alone core or as a part of another core such as the administrative core. Besides leading to a better understanding of disease etiology and natural history of disease, such cores might provide biostatistics support; enhance clinical study design; foster collaboration among researchers; aid in recruitment of subjects for clinical studies; support epidemiological studies in areas of nutritional sciences and obesity; or provide modest funding for tissue, DNA, or serum storage. In addition, a clinical or epidemiology core may help more effectively address NIH policies concerning the participation of women, children, and ethnic minority populations in clinical studies. The cores listed here do not represent a comprehensive list of possibilities. In responding to the RFA, applicants are encouraged to propose cores that address specific objectives based on the unique requirements of investigators and the research comprising the research base at the applicant institution. The P/F program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators and at investigators established in other research disciplines with expertise that may be applied to nutritional sciences or obesity research. Established clinical nutrition or obesity investigators pursuing high impact/ high risk projects or projects that are a significant departure from their usual work are also eligible for support under the CNRU P/F program. In addition, temporary salary support for one Named New Investigator in a specified area of research with a defined P/F study may be requested for up to 24 months. Subsequent individuals for this slot will be named by the Center Director and approved by the Center's External Advisory Board and the NIDDK. The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. Although funds are not provided directly for training purposes, applicants may wish to describe how the core laboratories and program enrichment activities will provide training opportunities for center members. MECHANISM OF SUPPORT This RFA will use the NIH Core Centers grant (P30) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed center grant. The NIDDK accepts P30 applications only when submitted in response to an RFA. The receipt of competing continuation applications from three P30 CNRUs is anticipated in response to this solicitation. These applications will compete for the three anticipated awards along with other applications received in response to this RFA. The anticipated award date is July 1, 2005. This RFA uses just-in-time concepts. It also uses the non-modular budgeting formats. FUNDS AVAILABLE The NIDDK intends to commit approximately $ 4,000,000 in FY 2005 to fund a total of 3 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $ 750,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award may also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to 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 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 institutions/organizations o Foreign institutions are not eligible to apply. For the purpose of the RFA, the NIDDK will not support more that one CNRU center grant (P30) in an applicant institution. More details on the CNRU program are available in the Clinical Nutrition Research Units Guidelines available on the internet at http://www.niddk.nih.gov/fund/other/centers/introcnru.htm or from the Program Director listed under INQUIRES, below 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, women, and individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS The CNRU Director, who is the Principal Investigator on the P30 application and Director of the Administrative Core, should be a scientist who can provide effective administrative and scientific leadership and can demonstrate proficiency in managing a large, multi-component project. The Director will be responsible for the organization and operation of the CNRU and for communication with the NIDDK on scientific and operational matters. Center Directors are required, and their administrators are strongly encouraged, to attend an annual meeting to be held at a location to be determined by the NIDDK. Funds for travel to this meeting should be included in the budget for the Administrative Core of the Center. Successful CNRU applications require an existing program of excellence in biomedical research in the areas of basic and clinical research related to the nutritional sciences, obesity, and related disorders. To justify Core Center support, the CNRU must serve a strong research base that has a consistent and outstanding record in NIH and other peer-reviewed funding. The research base grants must be summarized in accordance with the Administrative Guidelines for NIDDK Clinical Nutrition Research Units (CNRU). (See Application Procedures.) At lease 50 percent of the nutritional sciences and obesity-related research comprising the research base must be supported by Federal Agencies. Scientific personnel and institutional resources capable of supporting the research base must be available. In addition, the institution and pertinent departments must show a strong commitment to the Center’s support. Such commitment may be provided as dedicated space, staff recruitment, salary support for investigators, dedicated equipment, or other financial support for the proposed Center. Each core unit proposed for funding under the CNRU must be utilized by a minimum of two federally funded research projects. A detailed description of each core unit proposed as part of the Center must be provided, with a detailed budget and budget justification. A Core director must be named for each core proposed. The description of each core unit proposed should include a rationale, indicating how it will support the research effort in a cost- effective manner. Facilities must be available for the primary needs of the CNRU Program because funds for new construction are not available. Promoting interdisciplinary and multidisciplinary collaboration among scientists working within a Center is a major goal of the CNRU Program. Each Center application should describe how continuing and new interactions will be fostered and encouraged by the CNRU. Another goal of the CNRU is to attract scientists to the field of nutritional sciences and obesity research. Therefore, a Pilot and Feasibility (P/F) program as well as an Enrichment Program may be supported within the CNRU program. Because P30 funds do not directly support research projects, the issues of minority/gender representation, inclusion of children as participants in research involving human subjects, required education on the protection of human subject participants, and the use of human embryonic stem cells will have been addressed at the individual project level (i.e., R01 level). However, the application must specifically address these issues for any P/F projects or cores, as appropriate. All applications that list direct costs greater than $500,000 in any year of the proposed research must have a data sharing plan. 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: Carolyn W. Miles, Ph.D. Clinical Obesity and Nutrition Program Director National Institutes of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 665 Bethesda, MD 20892-8876 Telephone: (301) 451-3759 FAX: (301) 480-8300 Email: cm294e@nih.gov 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 Two Democracy Plaza, Room 752 Bethesda, MD 20892-5452 Telephone: (301) 594-8897 Email: fc15y@nih.gov o Direct your questions about financial or grants management matters to: Ms. Sharon Bourque Grants Management Specialist 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 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 (Associate Directors, Core Directors) 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: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 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 document 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. SUPPLEMENTARY INSTRUCTIONS: The Clinical Nutrition Research Unit Guidelines provide more detailed information on the Centers and on preparing the application. The guidelines are accessible at http://www.niddk.nih.gov/fund/other/centers/introcnru.htm or from the program director listed under INQUIRES. 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 and all copies of the appendix material must be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed in response to a previous Centers RFA, but such applications must include an introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness to the RFA by the NIDDK. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 NIDDK in accordance with the review criteria stated below. No site visits are planned in the review of these applications; all information required for evaluation must be contained in the application. As part of the initial merit review, all applications will: o Undergo a process in which all applications will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Diabetes, Digestive and Kidney Diseases Advisory Council. REVIEW CRITERIA All applications responding to this RFA will be evaluated according to the review criteria as outlined in the Clinical Nutrition Research Units Administrative Guidelines available on the Internet at http://www.niddk.nih.gov/fund/other/centers/introcnru.htm for from the Program Director listed under WHERE TO SEND INQUIRIES, above. As part of the initial scientific review, which will result in one overall priority score for the P30 application, reviewers will rate each individual research core and, if requested, the clinical component, as well as the P/F program. The evaluation of the Enrichment program will be reflected in the adjectival score of the Administrative Core. The merit descriptors for each of these components will appear in the summary statement. The review group will assign a descriptor, rather than a score, for the research base, the P/F program, and the Center Director. Review Criteria The most important component of a CNRU is an ongoing, strong base of nutritional sciences and obesity-related research. Specific review criteria for CNRU Core Centers are: o the scientific excellence of the Center's research base (its strengths and depth) as well as the relevance and interrelation of these separately funded research projects to the central theme(s) or focus of the Center and the likelihood for meaningful collaborations among Center investigators. The existence of a base of established, independently supported biomedical research of high quality is a prerequisite for the establishment of a CNRU Core Center and is the most important component of the review. (The results of previous peer reviews of its content will weigh heavily in the assessment of the application's overall strength as a potential recipient of an award.) o the strength of the clinical research components of the center o the qualifications, experience, and commitment of the Center investigators responsible for the individual research projects, and their willingness to interrelate with each other and contribute to the overall objectives of the CNRU Core Center. o the appropriateness and relevance of the proposed Cores and their modes of operation (such as how usage will be prioritized), facilities, and potential for contribution to ongoing research. Competing continuation applications must document the use, utility, quality control, and cost effectiveness of each Core requested to continue as part of the Center. Progress will be judged in part by the list of publications arising from the utilization of the cores. At least two users are required to establish a core. However, a greater number of users will be considered to be more cost effective. o for all applications, a description of current or proposed P/F studies should be submitted for evaluation as part of the review of the P/F program. In general for new applications, the proposed P/F projects will be examined to assess the eligibility of the P/F applicant and the adequacy of the selection process by which the individual studies were selected. For competitive renewal applications emphasis is accorded to the program as a whole, including past track record and management of the program. Applicants should refer to the Administrative Guidelines for CNRUs for specific details regarding the P/F program and its review. o a Named New Investigator, if requested, will be considered separately. o the scientific and administrative leadership abilities of the proposed Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the program. o the administrative organization proposed for the following: (a) Coordination of ongoing research between the separately funded projects and the Center, including mechanisms for internal monitoring; (b) Establishment and maintenance of internal communication and cooperation among the Center investigators; (c) Mechanism for selecting and replacing professional or technical personnel within the Core Center; (d) Mechanism for reviewing the use of and administering of funds for the P/F program; (e) Management capabilities that include fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities; o The institutional commitment to the program, including lines of accountability regarding management of the Center grant and the institution's contribution to the management capabilities of the Center; o The academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and institutions; o Efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities in enhancing the objectives of the Center; o Although the CNRUs do not specifically support research training, it should be a training environment, and demonstration of accomplishments and future plans related to the training of investigators necessary to conduct research in clinical nutrition and obesity will be considered in assessing the potential to meet Center objectives. The integration of these efforts into the overall Center, including core facilities, is of particular importance. Efficient and effective use and /or planned use of the limited enrichment funds, including the contribution of these activities in enhancing the objectives of the Center will also be considered. o The appropriateness of the budgets for the proposed and approved work to be done in Core facilities, for P/F studies (these are restricted funds), and for enrichment in relation to the total Center program. 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. 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 must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 18, 2004 Application Receipt Date: November 18, 2004 Peer Review Date: March 2005 Council Review: May 2005 Earliest Anticipated Start Date: July 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Relevance to research areas of high programmatic interest to the Division of Digestive Diseases and Nutrition, NIDDK and research areas targeted by Congress o Availability of funds o Geographic distribution 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: 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: 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. 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). 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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