and Human Services (HHS)
EXPIRED
CYSTIC FIBROSIS RESEARCH AND TRANSLATION CORE CENTERS RELEASE DATE: March 11, 2004 RFA Number: RFA-DK-04-008 (This RFA has been reissued, see RFA-DK-06-009) 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) (http://www.niddk.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.847. 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) invites applications for Cystic Fibrosis Research and Translation Core Centers to support both basic and clinical research on Cystic Fibrosis (CF). Core Centers provide shared resources to support research to develop and test new therapies for CF and foster collaborations among institutions with a strong existing research base in CF. The Center will also support pilot and feasibility studies to develop and test new approaches to therapy. RESEARCH OBJECTIVES Cystic Fibrosis is one of the most common, life-limiting genetic diseases affecting 30,000 Americans. Patients with CF have two mutated copies of the gene, CFTR, in every tissue of the body. Although lung disease is the primary cause of death in CF, multiple organs systems have altered functions including the lung, liver, pancreas, sweat glands, GI, and reproductive systems. Treatment of the pancreatic symptoms and lung infections has extended the mean life expectancy of patients to 30 years. Some states have instituted newborn screening for CF to provide presymptomatic support for nutrition and infection that may further improve the quality of life for these patients. Children identified at birth avoid the malnutrition that is a common presenting symptom for CF. In addition, these patients could benefit from many new forms of therapy that are being developed to aggressively eradicate bacterial colonization of the lung, control inflammation, treat diabetes and provide nutritional support to prevent muscle wasting. In addition to treating the symptoms of CF, researchers are investigating molecular and pharmacologic methods to treat the underlying cause of CF. Methods to increase expression, processing and or trafficking of CFTR or other complementary channels are being tested. Several recent studies have shown some promising results. A recent clinical trial tested the ability of the drug, gentamicin, to suppress stop mutations in CFTR. This study showed evidence of functional correction when administered to the nasal epithelium of CF patients with stop mutations in CFTR. Another study has reported the identification of small molecules that can correct plasma-membrane channel activity in the most common mutation in CFTR, ?F508. Two gene therapy trials using AAV to deliver CFTR to the lung have reported some evidence of improved lung function. These encouraging early findings suggest that collaborative efforts between basic and clinical research could stimulate the translation of basic findings to clinical applications. The goal of these Cystic Fibrosis Research and Translation Core Centers is to support research to develop and test therapies for CF. These Centers will provide resources for communication and collaboration between basic and clinical researchers. Core Centers will provide shared resources to enhance the efficiency of research and foster collaborations within and among institutions with strong existing bases of research on cystic fibrosis. Centers may be located in a single institution or in multiple institutions with complementary research bases. Project Organization A biomedical research core is defined as a shared resource that provides essential services, techniques, or instrumentation to Center participants enabling them to conduct their funded individual research projects more efficiently and/or more effectively. Cores provide specialized technologies and expertise needed to accomplish the stated goals of the Center toward the development of therapies for CF. Each core should provide services to multiple funded research projects. Centers may propose either Institutional Cores or Regional/National/International Cores. Whereas Institutional Cores support research at a single institution or a set of cooperating institutions, Regional/National/International Shared Resources serve specific scientific communities on a regional, national, or international level. A new category of research base for cores that are used as a regional, national, or international resource should be considered the "extended research base". The extended research base for a regional, national or international core could include all investigators who might expect to use the core in some way. This might include investigators who would be expected to fully compensate the core service through a charge-back, and thus would not be obtaining direct financial assistance from the Center. The list could include investigators who use the core services but otherwise have no collaborative interactions with other Center investigators. The extended research base should be defined as an entity separate from the institutional research base. For review purposes, it should be evaluated as part of the proposed International/National/Regional core, in order to distinguish it from the local institutional research base. Examples of types of biomedical core resources that would be considered responsive to this Request for Applications include: o Collection, analysis, storage and distribution of data and samples; o Provision of specialized tools and technologies or access to specialized expertise; o Development, standardization and distribution of reagents and/or protocols; o Provision of technical assistance, training, and enrichment programs; o Recruitment of patients and coordination of patient studies; o Development, beta-testing and dissemination of specialty assays, methods, and services on an institutional level; o Increase interdisciplinary interactions at the institution through cross- project/laboratory exchange; o Sharing of specialized tools, technologies and expertise between collaborating investigators. In addition to biomedical cores, an administrative core must be described which will be responsible for allocation of resources within the Center and distribution of resources to Center participants. The Administrative core will also be responsible for planning the Educational Enrichment Program consisting of a seminar series, guest lectures, and workshops, and convening a Committee to oversee the solicitation, review and selection of the pilot projects. Although funds are not provided directly for training purposes, the core laboratories and program enrichment activities should provide training opportunities for Center members. Each Core Center must develop a cohesive Pilot and Feasibility Program to develop new research directions or provide an opportunity for new investigators or established investigators to enter the field of CF research. A pilot and feasibility project is intended to provide modest support that will allow an investigator the opportunity to develop sufficient preliminary data as a basis for an application for independent research support. Pilot and feasibility projects are not intended to support or supplement ongoing research of an established investigator. This Program should be integrated into the overall research goals of the Center and make use of the resources provided by the cores. Each Core Center application must include a minimum of two up to a maximum of five pilot projects. Each pilot project may request a maximum of $50,000 direct costs per year for up to two years. A comprehensive description of the Pilot and Feasibility Program can be found in the Administrative Guidelines. Pilot and Feasibility projects could include clinical projects to investigate basic research findings in a clinical setting. The National Center for Research Resources (NCRR) supports approximately 80 General Clinical Research Centers (GCRC) nationwide, which provide services and resources to enhance clinical research (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp). Research Centers supported by the NIDDK are encouraged to collaborate with GCRCs to avoid duplication of effort and enhance utilization of services and resources. MECHANISM OF SUPPORT This RFA will use NIH core center research grant (P30) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is July 1, 2005. This RFA uses just-in-time concepts and non-modular budgets. Follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NIDDK intends to commit up to $1,400,000 in FY 2005 to fund 1 to 2 new 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. Equipment costs requested in the first year and indirect costs on subcontracts are not included in the $750,000 direct cost cap. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NIDDK 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 Foreign institutions are not eligible to apply as the applicant organization however; consortia agreements to foreign institutions are permitted 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. Because the Center has a complex administrative structure, the principal investigator should have a demonstrated ability to manage a large, multicomponent project. SPECIAL REQUIREMENTS An existing program of biomedical research in cystic fibrosis is required. This research base must consist of NIH and other peer-reviewed funded research projects and be substantial to justify the requested Core support. A clinical research base is not required but would be considered a strength. Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines. 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: Catherine McKeon, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 6103 Bethesda, MD 20892-5460 Telephone: (301) 594-8810 FAX: (301) 480-3503 Email: [email protected] 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 Boulevard, Room 752 Bethesda, MD 20892-5452 Telephone: (301) 594-8897 FAX: (301) 480-3505 Email: [email protected] o Direct your questions about financial or grants management matters to: Randi Freundlich Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 724 Bethesda, MD 20892-5452 Telephone: (301) 594-8825 FAX: (301) 480-3504 Email: [email protected] LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDDK 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: [email protected]. SUPPLEMENTARY INSTRUCTIONS: Applicants should consult the Administrative Guidelines for Cystic Fibrosis Research and Translation Core Centers located at: http://www.niddk.nih.gov/fund/other/centers.htm#CFR These guidelines contain important additional information on the format, content, and review of the applications and review criteria. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. The goals of the CF Research and Translation Core center are to facilitate development and testing of therapies for CF. Because the Core Center mechanism supports infrastructure, the most important component of Center is the quality (strengths, breadth and depth) of its established, independently supported, ongoing base of research on CF at the institution(s) to be served by the center. The initial review group will review each application using the criteria stated below: o Scientific excellence of the Center's research base that must have a broad and central focus in basic and/or clinical research in CF. The relevance of the separately funded research to the Center objectives and the likelihood for meaningful collaboration among Center investigators must be demonstrated. o Potential of the cores for contribution to ongoing research, including their appropriateness, impact, relevance, uniqueness, modes of operation, and suitability of facilities. Renewal applications must document the use, impact, quality control, and cost effectiveness of each core, and demonstrate progress of any developmental research in the cores. Progress will be judged in part by the publications supported by the cores. While a minimum of two users (exclusive of Pilot and Feasibility projects) are required to establish a core, a greater number of users will be considered to be more cost effective. o Regional/National/International Cores should be judged by their ability to provide a unique resource or service; their use by the extended research base; and their potential impact on the field. o Scientific and administrative abilities of the Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the CF Research and Translation Core Center. o The qualifications, experience, accomplishments, and commitment of the Center investigators and their inter-relatedness and collaborations. o The Administrative organization proposed, including: coordination of ongoing research; establishment and maintenance of internal communication and cooperation among investigators; mechanisms for prioritizing usage of shares resources; mechanisms of selecting and replacing essential personnel within the Center; mechanisms for reviewing the use of and administering funds for the pilot and feasibility program, and management capabilities. o The appropriateness of the budgets for the proposed and approved work to be done in core facilities, for pilot and feasibility studies, and for enrichment in relation to the total Center program. o Institutional commitment to the program, including lines of accountability regarding management of the Core Center grant and a commitment to establish new positions as necessary. o For new applications, the pilot and feasibility program is judged on the basis of: (1) scientific merit of the studies as submitted and (2) the merit of the administrative process for selecting subsequent studies. The scientific merit of the submitted pilot and feasibility studies will be evaluated for: (1) 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? (2) 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? (3) 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? (4) 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)? Does the PI meet one of the eligibility criteria set out in the Administrative Guidelines for pilot and feasibility studies? (5) 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? In competing renewal applications, emphasis is placed on the pilot and feasibility program as a whole, including past track record and management of the program. o Although the Core Center does not specifically support research training, demonstration of accomplishments and future plans related to the training of investigators necessary to conduct research in cystic fibrosis 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. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o Adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget to the proposed research. O The adequacy of the proposed protection of humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. 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 core, 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. (See information below) 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: February March 2005 Council Review: May 2005 Earliest Anticipated Start Date: July 1, 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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