and Human Services (HHS)
EXPIRED
QUICK-TRIALS FOR NOVEL CANCER THERAPIES: EXPLORATORY GRANTS RELEASE DATE: August 31, 2004 PA NUMBER: PAR-04-155 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date. The non-AIDS portion of this funding opportunity expires on the date indicated below. A replacement R21 (PAR-06-451) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.393, 93.394, 93.395 APPLICATION RECEIPT DATES: December 9, 2004; April 9, 2005; August 9, 2005; December 9, 2005; April 9, 2006; August 9, 2006; December 9, 2006 April 9, 2007; August 9, 2007; December 9, 2007 This Program Announcement (PA) replaces PAR-03-005, which was published in the NIH Guide on October 7, 2002. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA Continuing progress in basic cancer research and drug development has led to discoveries of new agents or approaches for molecular targeting in novel cancer therapies. These new agents or approaches suppress tumor growth through multiple mechanisms such as cell cycle control, activation of tumor suppressor genes, essential signal pathway blockage, tumor vaccines, tumor microenvironment modification, etc. Rapid translation of these exciting discoveries into clinical practice requires timely support to accommodate the special needs of novel cancer therapy development. This Program Announcement (PA) is intended to provide investigators with rapid access to support for pilot, Phase I, and Phase II cancer clinical trials as well as support for patient monitoring and laboratory studies linked to a cancer clinical trial. Phase III trials are not excluded but such trials generally require greater resources and duration than available from an R21 award. Applications that do not propose a cancer clinical trial or patient monitoring or laboratory studies linked to a cancer clinical trial may be returned to applicants without being reviewed. The focus of this QUICK-TRIAL PA is on translational research in new agent development to ensure the timely exploitation of new cancer therapeutic approaches including the development of new cancer prevention agents. This PA is aimed at providing a new approach in the grant application process by offering a rapid turnaround from application submission to funding. Features of this initiative include a modular grant application and award process, inclusion of the clinical protocol within the grant application, and an accelerated peer review with the goal of issuing new awards within six months of application receipt. 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 and to insure proper peer review of the application. In addition, QUICK-TRIAL applications do not require extensive preliminary data in the grant application and support exploratory translational and clinical research studies involving cancer prevention, chemotherapy and rapid development and application of novel clinical cancer therapies including image guided therapeutic procedures. Investigators may apply for a maximum of two years of funding support using the exploratory or developmental (R21) grant mechanism for up to $250,000 direct costs per year. RESEARCH OBJECTIVES Advances in the understanding of molecular cancer genetics, basic cancer biology, and the development of powerful technologies such as microarray, proteomics and bioinformatics have led to the identification of many new molecular targets and pathways in cancer cells. These discoveries have created new frontiers for novel molecular cancer prevention and treatment leading to the development of molecular medicine in cancer therapy. In addition, these novel targets and pathways have presented excellent translational research opportunities for revolutionizing cancer drug development and bringing more effective molecular cancer therapies and cancer prevention strategies into clinical practice. Novel approaches or agents for inhibiting tumor growth either directly or by impacting the tumor microenvironment are ready to be tested in the clinic with new tools and laboratory analyses that allow investigators to ascertain how specific targets are affected by therapy. These agents include new classes of cytotoxic agents, agents or approaches that act via immune- stimulatory effects, agents that stimulate apoptosis, inhibit angiogenesis and metastasis or alter tumor cell signaling pathways, and agents targeted specifically to novel cancer cell targets. New clinical therapeutic trials may employ drugs/agents, biologics, radiation, heat, or surgery used as single agents/modalities or in combination for the treatment of early and advanced disease. In addition, clinical trials of therapies for cancer treatment, including but not limited to herbal therapies, dietary supplements, bioactive food components, or unconventional pharmacological and biological interventions (e.g. antineoplastons, Coley's toxin, enzyme therapies, etc.) will be considered. Another relevant area of investigation is the use of anatomical and molecular image guidance for targeted treatment with ablative techniques or delivery of chemotherapeutic agents. At present, there are few funding mechanisms targeted to stimulate the translation of promising and potentially relevant advances in new prevention or therapeutic agent development from the laboratory into the clinical setting. Quite frequently the initial stages of clinical investigation are the most difficult to accomplish. They are resource intensive, and, to be done well, they require laboratory, pharmacology, and other resource support, as well as substantial personnel effort, none of which is supported by traditional health benefit programs. Nonetheless, these early studies tend to fare poorly in competition for conventional grant support precisely because they are preliminary and cannot serve as the definitive tests of new approaches. Even when funding is received, the review and award cycle may introduce a year or more of delay. Except where there is an industrial sponsor with a particular commitment to development of an agent, it may take a long time for a promising approach to get through the initial phase of demonstrating feasibility and interest, or it may never be tested in more than one or two diseases. This PA will continue to support scientific, technological, clinical and logistical needs in novel cancer therapy development. In addition, this PA will complement the Rapid Access to Intervention Development (RAID) program http://dtp.nci.nih.gov/docs/raid/raid_index.html by providing an initiative with accelerated peer review and funding to support the clinical and laboratory costs of early clinical testing to ensure the timely development of new therapeutic approaches. MECHANISM OF SUPPORT This PA will use the NIH exploratory/development (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The applicant may request a project period of up to 2 years with direct costs limited to $250,000 per year. This PA uses just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: Direct your questions about scientific/research issues to: Dr. Roy Wu, Clinical Grants & Contracts Branch Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute 6130 Executive Boulevard. EPN Room 7009 Bethesda, MD 20892-7432 Rockville, MD 20852 (for express/courier service) Telephone: 301-496-8866 Fax: 301-480-4663 E-mail: [email protected] Direct your questions about financial or grants management matters to: Ms. Amy Connolly Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8786 FAX: (301) 496-8601 Email: [email protected] 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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B 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]. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. Because Quick-Trial applications will propose cancer clinical trials or patient monitoring or laboratory studies linked to a cancer clinical trial, applicants are reminded to properly complete item e- Humans Subjects Research of the Research Plan. This is described in PHS 398. As applicable, the Human Subjects Research portion of the Research Plan includes, but is not limited, to a Data and Safety Monitoring Plan, Women, Minority, and Children Inclusion sections, and a Targeted/Planned Enrollment Table. In addition please note special requirements for item e- Humans Subjects Research of the Research Plan below. SUPPLEMENTARY INSTRUCTIONS 1. Although preliminary data are not required for an R21 application, they may be included. Because of the clinical nature of Quick-Trial applications, applicants should consider the importance of providing preliminary data to justify human experimentation. 2. RESOURCES: A description of both the clinical and laboratory facilities and resources should be included in the grant application. This includes detailed information on plans for data management, quality control of patient and laboratory data, and computer resources and plans for handling both laboratory and clinical data. If Cancer Center cores will be used for these tasks, letters of support from the appropriate individual with authority to commit the needed resources should be included in the application. Provide information on resources provided by the drug sponsor if not in your institution. 3. RESEARCH PLAN: Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required but may be included if it is available. Please note that a Progress Report is not needed; competing-continuation applications for an exploratory/developmental grant will not be accepted. Item a - Specific Aims - In one page or less, list in priority order, the broad, long-range objectives. Describe concisely and realistically the hypothesis to be tested and what the specific research described in this application is intended to accomplish. Item b - Background and Significance - In two pages or less, use this section to describe (a) how the proposed research will contribute to meeting the goals and objectives of the PA; and, (b) explain the rationale for the selection of the general methods and approaches proposed to accomplish your specific aims. Describe the significance of the planned studies and consider how the pilot study, if encouraging, could transition into an eventual definitive test of the therapeutic approach. Describe the innovative aspects of the studies including novel concepts, approaches, or methodologies. Do not include background material provided in the clinical protocol document but you may refer to the appropriate sections/pages of the protocol. Items c-d - Progress Report/Preliminary Studies, Research Design and Methods - In twelve pages or less, complete as instructed in the PHS 398 booklet. TO THE EXTENT THAT MATERIAL INCLUDED IN THE CLINICAL PROTOCOL IS ADEQUATE FOR REVIEW, IT NEED NOT BE REPEATED IN THESE SECTIONS c-d. (The clinical protocol and informed consent form(s) must be included in the Human Subjects section even if support is only requested for related laboratory or patient monitoring studies.) The investigator may use these sections (c-d) to address the following: o Preliminary studies pertinent to the application; o Rationale and hypothesis for the clinical trial and laboratory studies; o General methods that will be utilized (clinical, laboratory, or both, as appropriate); reason(s) for selecting these approaches; provide specific details for those techniques which are unique or where a significant departure from a generally accepted technique is important for reviewers to know; o Outcome measures that will be used to assess the success or failure of each set of experiments (include statistical analyses for laboratory and clinical studies); clinical endpoints should be discussed with particular emphasis on those aspects that may be especially complicated in clinical trials (e.g., lack of conventionally measurable disease; patients whose only evidence of disease is biochemical); o A statistical section should be included discussing the choice of the clinical trial design and laboratory analyses with power calculations. The statistician involved with the study should be identified and a letter of support included if no effort is requested on the grant application. Plans for data management and verification of research data should also be included; o Potential pitfalls in the experimental design and alternative studies that will be done if the proposed experiments fail. 4. HUMAN SUBJECTS: IN ADDITION TO THE INFORMATION REQUESTED IN THE PHS 398 FORM, INCLUDE THE COMPLETE CLINICAL PROTOCOL AND INFORMED CONSENT FORM(S) IN THIS SECTION. Include the complete clinical protocol and informed consent forms(s) even if support is only requested for related laboratory or patient monitoring studies. NIH will treat as confidential any scientific, preclinical, clinical, or formulation data and information that the sponsor deems to be proprietary and confidential. 5. IN ADDITION, applicants must insure that the first page of the human subjects section includes the following drug availability/IND information: 1a) If NCI-provided agent(s) will be used, indicate the CTEP-assigned LOI/Protocol number and date of the CTEP LOI/Protocol response letter confirming potential availability. 1b) If agent(s) will be provided by a company, indicate that a letter is provided confirming plans to provide agents and the date of availability. 1c) If this protocol is an initial IND-filing study, indicate the date the IND was submitted to the FDA and the status of the application. An IND is not required to submit a Quick-Trials application, but for trials in which an IND is necessary, it is required before a Quick-Trials award can be made. 1d) If none of the above (1a, 1b, or 1c) applies indicate this on the first page of the human subjects section. NCI/CTEP or drug company correspondence addressing agent availability should be included in the human subjects section, as applicable. 6. APPENDIX: Include a maximum of 5 publications, manuscripts (accepted for publication), abstracts, patents, or other printed material relevant to this project. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: All investigator initiated R21 applications 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. SENDING AN APPLICATION TO THE NIH: Submit a signed, type written original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before the receipt dates listed on the first page of this PA. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to 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 these criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. See 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. (See NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-084.html.) Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. For additional information, see NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available at http://www.cancer.gov/clinical_trials/. 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. A continuing education program in the protection of human participants in research is available online at http://cme.nci.nih.gov/. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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