and Human Services (HHS)
EXPIRED
HYPERACCELERATED AWARD/MECHANISMS IN IMMUNOMODULATION TRIALS RELEASE DATE: March 11, 2002 RFA: AI-02-003 (see also RFA-AI-04-001) National Institute of Allergy and Infectious Diseases (NIAID) http://www.niaid.nih.gov/ National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) http://www.niams.nih.gov/ National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) http://www.niddk.nih.gov/ National Institute of Neurological Disorders and Stroke (NINDS) http://www.ninds.nih.gov/ National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov/ LETTER OF INTENT RECEIPT DATE: One month prior to application receipt date. APPLICATION RECEIPT DATE: Applications will be accepted MONTHLY on the 9th of each month. 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 Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH) invite investigator-initiated research applications for mechanistic studies in clinical trials of immunomodulatory interventions for immune system mediated diseases, including, but not limited to, asthma and allergy, graft failure in solid organ, tissue, cell and stem cell transplantation, and chronic inflammatory, immunodeficiency and autoimmune diseases. This Request for Applications (RFA) is a continuation and modification of RFA AI-01-001. Specifically, this RFA calls for the inclusion of patients and utilization of patient samples for the evaluation of immunologic and other relevant parameters to facilitate the study and definition of immunological mechanisms underlying the intervention, the mechanisms of disease pathogenesis, surrogate/biomarkers markers of disease activity and therapeutic effect, and mechanisms of human immunologic function. The parent or core clinical trial must have independent financial support and will NOT receive support under this RFA. Proposed mechanistic studies associated with clinical trials supported by industry are particularly encouraged but clinical trials supported by any source, public or private, are eligible. In order to review and confer awards to applications received in response to this RFA in a timely fashion, without delay of the parent or core clinical trial, NIAID has developed a pilot project in collaboration with the Center for Scientific Review (CSR): NIAID/CSR PILOT OF HYPERACCELERATED REVIEW/AWARD. All applications responding to this RFA will be subject to this hyperaccelerated review/award process. Highly meritorious applications selected for funding under this RFA will receive their awards thirteen weeks after the application receipt date. Holidays and other circumstances may alter this schedule slightly. RESEARCH OBJECTIVES Background In December 1996, NIAID convened a workshop at which leading basic and clinical immunologists discussed the role the NIH should play in current and projected clinical trials for various immune mediated diseases. It was considered likely that clinical trials of many new immunologic interventions would be supported by the pharmaceutical/biotechnology industry. However, gaps in both knowledge and in research effort were identified which represent opportunities for the NIH to contribute to progress in this area. There was agreement that the mechanisms underlying immunologic interventions are poorly understood even in cases where efficacy has been shown (e.g., allergen immunotherapy, in treatment of multiple sclerosis with interferons, Copolymer-I, and in other immunomodulatory regimens under development). In addition, clinical trials supported by industry and other sources including NIH often do not include studies of underlying mechanisms. There was consensus that high priority should be given to the utilization of patient samples from clinical trials in immunologic diseases for studies of the basic underlying mechanisms of therapeutic effect, immunologic function, and disease pathogenesis. There was also agreement that the usual time required for grant review and funding is often incompatible with the time line of a clinical trial. Specifically, when a clinical protocol is finalized (which is required for applications submitted under this RFA), investigators are often ready to begin as soon as Institutional Review Board approval is obtained. NIAID was encouraged to develop a means of responding rapidly to opportunities to study underlying mechanisms in order to facilitate collaborations with industry- supported clinical trials. These recommendations were strongly supported by a large number of investigators who participated in NIAID focus groups in the winter/spring of 1997. The RFA AI-98-006 and the NIAID/CSR PILOT OF HYPERACCELERATED REVIEW/AWARD were developed in order to implement these recommendations and exploit the research opportunities identified. Based on the successful implementation of RFA AI-98-006, the follow-up RFAs AI-00-005 and AI-01-001 and the Pilot, the current RFA is being issued to continue this effort. Research Objectives and Scope The objective of this RFA is to support mechanistic research studies in clinical trials of immunomodulatory interventions for immune system mediated diseases, including asthma and allergy, graft failure in solid organ and stem cell transplantation, and autoimmune diseases, and of vaccines for the prevention and treatment of infectious diseases. Specifically, the goal is to utilize patients and patient materials from such trials for the evaluation of immunologic and other relevant parameters in order to study the underlying mechanisms of the intervention, the mechanisms of disease pathogenesis, surrogate markers of disease activity and therapeutic effect, and mechanisms of human immunologic function. Such studies are not part of the parent or core clinical trial, and are commonly referred to as substudies or ancillary studies. The parent or core clinical trial must have independent financial support and will NOT receive support under this RFA. Clinical trials supported by any source, public or private, are eligible. Clinical trials of any phase (i.e. I-IV) are eligible. Examples of relevant research include, but are not limited to, the following: o Quantitation of disease-related, autoreactive or alloreactive lymphocytes using methods such as MHC/peptide tetramers, chimeric antibodies, or very early activation antigens. o Analysis of autoreactive or alloreactive cells by PCR for expression of genes implicated in immunity or inflammation, or by FACS for cell surface markers that identify functions (e.g., cytokine receptors that distinguish TH1 from TH2 or chemokine receptors or integrins that indicate preferential patterns of homing). o Assessment of reagents that can identify newly recognized populations of regulatory T cells (e.g., Valpha24JalphaQ bearing invariant T cells) which appear to be altered in autoimmune disease. o Identification and evaluation of cytokine and cytokine receptor polymorphisms and analysis for genetic linkage to disease. o Use of high throughput technologies (e.g. chip technology using expressed sequence tags) to identify and evaluate genes activated in disease sites. o Identification of useful surrogate markers by correlation of the above parameters with disease activity and/or response to intervention. o Comparison of samples from peripheral blood with those from sites of disease, i.e., do peripheral blood samples provide useful information? o Assessment for the presence of molecular evidence (e.g. using PCR probes) of potential causative environmental agents. o The molecular and cellular mechanisms by which lymphocytes, macrophages, neutrophils, antibodies, cytokines and complement contribute to successful immunotherapy for chronic inflammatory diseases. o Immune mechanisms of vaccines. Studies to define the underlying mechanisms of protection induced by vaccines against infectious diseases, including investigation of the specificity and kinetics of cellular and antibody responses, Th1/Th2 and cytotoxic T cell characterization, and immune memory. The areas outlined above are not intended to be all-inclusive. NOTE: Clinical trials of drug (ex. antibiotics or antiviral drugs) treatments of infectious diseases (e.g. AIDS and Lyme Disease) are NOT eligible for this RFA. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) award mechanism. As an applicant you will be solely responsible for the planning, direction, and execution of the proposed project. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The total requested project period for an application submitted in response to this RFA may not exceed four years. Some sponsoring Institutes may administratively limit the duration of award. Applicants for the R01 mechanism must not exceed a first-year limit of $250,000 direct costs. Modular grant procedures should be used. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. FUNDS AVAILABLE The participating ICs intend to commit approximately $1,900,000 in FY 2003 to fund 8 to 10 new grants in response to this RFA. An applicant may request a project period of up to 4 years and a budget for direct costs of up to $250,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs 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. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS To assist in the overall evaluation of this RFA, the Principal Investigators of grants funded under this RFA will be asked to provide brief (1-2 pages) summary report one year following the end of the funding period. The reports will summarize the major scientific knowledge gained and identify other substantive outcomes such as publications, patents, and new grants, contracts, or research studies based on this mechanistic research. The research plan in the application should be limited to 15 pages. The research plan includes specific aims, background and significance, preliminary studies, and research design and methods (Sections A to D). In the research plan, include a justification for why the proposed studies require the use of patients in this clinical trial as opposed to using patients with the same disease state but not in a trial. Methods of data analysis and power calculations must be included. Include a justification for the required sample size. A restatement of the sample size calculations from the parent clinical trial is insufficient. If appropriate to your application, discuss whether it is necessary to perform the mechanistic studies on all patients enrolled in the parent trial or whether a sub-sample would be sufficient. There must be a discussion of the statistical procedures that will be used to analyze the data. The manner in which immunological parameters will be related to the clinical outcomes in the main study should also be discussed. The protocol and the investigators" brochure for the parent or core clinical trial should be included with the application as part of the human subjects" section. Inclusion of the complete clinical protocol within the PHS 398 grant application is intended to simplify the application process by eliminating the need to duplicate protocol details in the Research Plan section. Informed Consent form(s) must also be included as part of this section. While drafts of the consent forms at participating sites are not required, it would be useful to include them if they are available. NIH will treat as confidential any scientific, preclinical, clinical, or formulation data and information that the sponsor deems to be proprietary and confidential. Amended applications will be accepted for Hyperaccelerated Review/Award ONLY if invited by NIH. Applicants with minor or easily corrected problems will be invited to submit an abbreviated amendment (5 page limit and one time only), which directly addresses the questions and concerns raised in the initial review. In order to ensure coordination between the mechanistic studies and the parent or core clinical trial, the principal investigator and the sponsor of the parent or core clinical trial must provide written agreement for the conduct of the mechanistic studies as presented in the application. Prior to award, the applicant must provide to the funding institute a memorandum of understanding signed by the applicant, an appropriate representative of the applicant institution, the principal investigator of the parent or core clinical trial, and an appropriate representative of the sponsor of the parent or core clinical trial. This memorandum will indicate agreement and will outline the specifics of the agreement for the following areas: 1) data from the mechanistic studies (including ownership, analysis, access, and release), 2) access to the data from the parent or core clinical trial (how/when) which is needed to analyze the mechanistic studies, including procedures for prevention of unblinding of the parent trial, 3) documentation of quality assurance procedures for both the parent trial and the mechanistic studies, and documentation of Data Safety Monitoring procedures for the parent trial, especially for efficacy trials, 4) ownership of intellectual property developed during the mechanistic studies, and 5) publication of the results of the mechanistic studies. 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: Kristy Kraemer, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Room 5124, MSC-7640 6700-B Rockledge Drive Bethesda, MD 20892-7640 (Express Mail: 20817) Phone: 301-496-5598 Fax: 301-402-0175 e-mail: [email protected] Susana A. Serrate-Sztein, M.D. Rheumatic Diseases Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Room 5AS-25E, MSC-6500 45 Center Drive Bethesda, MD 20892-6500 Phone: 301-594-5032 FAX: 301-480-4543 e-mail: [email protected] Beena Akolkar, Ph.D. Program Director, Immunopathogenesis and Genetics of Type 1 Diabetes Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Room 681 6707 Democracy Boulevard Bethesda, MD 20892 Phone: 301-594-8812 FAX: 301-480-3503 e-mail: [email protected] A. P. Kerza-Kwiatecki, Ph.D. Program Director, NE National Institute of Neurological Disorders and Stroke NSC, Room 2115 6001 Executive Boulevard Bethesda, MD 20892 Phone: 301-496-1431 FAX: 301-402-2060 e-mail: [email protected] Dennis F. Mangan, Ph.D. Immunology and Immunotherapy Program National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-Suite 18 Bethesda, MD 20892-6402 Phone: (301) 594-2421 FAX: (301) 480-8318 e-mail: [email protected] o Direct your questions about peer review issues to: Alexander D. Politis, Ph.D. Center for Scientific Review National Institutes of Health Room 4204, MSC-7812 6701 Rockledge Drive Bethesda, MD 20892-7812 (Express Mail: 20817) Phone: 301-435-1225 FAX: 301-480-4042 e-mail: [email protected] o Direct your questions about financial or grants management matters to: Ann White-Devine Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2118, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Phone: 301-402-5601 FAX: 301-480-3780 e-mail: [email protected] LETTER OF INTENT Prospective applicants are asked to submit, one month prior to the application receipt date, a letter of intent that includes the following information: o Descriptive title of the overall proposed research o Name, address and telephone number of the Principal Investigator o Identities of other key personnel o Participating institutions o Number and title of this RFA Although the 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 NIH staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent one month prior to the application receipt date to Dr. Politis at the address listed under INQUIRIES. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number "AI-02-003" 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: "HYPERACCELERATED AWARD/MECHANISMS IN IMMUNOMODULATORY TRIALS" and RFA number "AI-02-003" 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/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and five signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) Applications must be received by the 9th of each month. If the ninth of the month falls on a weekend day or Federal Holiday, then the receipt date is advanced to the next business day. The application must not arrive more than two days prior to the receipt date. Applications, which are received after the 9th, will automatically be processed the following month. Applications not received as a single package on the receipt date or not conforming to the instructions contained in PHS 398 (rev. 5/2001) Application Kit (as modified in, and superseded by, the special instructions below, for the purposes of this RFA), will be judged non- responsive and will be returned to the applicant. APPLICATION PROCESSING: 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, 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 by the ICs. 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 NIH in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the National Advisory Council or Board of the assigned Institutes. 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 judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 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 method? 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)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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 included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o 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: One month before application receipt date. Application Receipt Date: 9th of each month. Peer Review Date: 4-6 weeks after receipt date Council Review Date: Special Electronic Council Earliest Anticipated Start Date: 13 weeks after receipt of application. 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 MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "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.ht m. 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://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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. 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.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalogue of Federal Domestic Assistance in the following citations: NIAID No. 93.855, and No. 93.856, NIDDK No. 93.847, No. 93.848 and No. 93.849, NIAMS No. 93.866, Oral Diseases and Disorders Research Awards No. 93.121, NINDS No.93.853, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The Public Health Service 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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