PA-04-080: PATHOGENESIS OF SARS LUNG DISEASE: IN VITRO STUDIES AND ANIMAL MODELS

Department of Health
and Human Services (HHS)

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PATHOGENESIS OF SARS LUNG DISEASE: IN VITRO STUDIES AND ANIMAL MODELS RELEASE DATE: April 1, 2004 PA NUMBER: PA-04-080 Expiration Date for R01 Non-AIDS Applications: November 2, 2006 Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007 January 3, 2007 - Effective with the February 5, 2007 submission date, all R01 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, this funding opportunity expires on January 3, 2007. Unsolicited or investigator-initiated R01 electronic SF424 (R&R) applications may be submitted through the Research Project Grant (Parent R01) announcement. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/index.htm) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.838 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Supplementary Instructions o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The goal of this program announcement is to invite research applications to rapidly advance understanding of the pathogenesis of severe acute respiratory syndrome (SARS) in the lung using the following: o in vitro techniques (especially, using human viral isolates, human tissues and cells, and other biological samples) o existing animal models of related coronavirus infections (e.g., porcine respiratory CoV) o non-human primate models of SARS o new ferret models of SARS o new rodent models of SARS o other appropriate animal models of SARS The PA invites R01 applications for both high risk hypothesis generating research and hypothesis driven projects (if sufficient preliminary data are available), relevant to the pathogenesis of human lung disease caused by the human SARS coronavirus (SARS-CoV). RESEARCH OBJECTIVES SARS, manifested by fever, pulmonary infiltrates, and often respiratory failure and death, infected more than 8000 people worldwide during the winter and spring of 2003. Overall, the death rate for SARS is estimated at 9.6%, but this rate is 50% or more for patients over 60 years of age. The World Health Organization (WHO) and the Centers for Disease Control (CDC) quickly identified a new human coronavirus, SARS- CoV, which appears to have jumped species from an animal reservoir, to infect humans and cause SARS. At present, the outbreak has subsided, due to rigorous public health measures and probably to the seasonal nature of the coronavirus life cycle. Questions about viral persistence in asymptomatic animal or human hosts or how SARS might emerge next remain unanswered for now. The mechanism is not known. It has been postulated that this might occur as a result of persistence and shedding of virus by asymptomatic human hosts or as a consequence of human contact with animals that are harboring the virus (possibly civet cats in China). A few new cases have been reported from China in December 2003 and January 2004, but fortunately the disease does not appear to have spread. At least some cases appear to have had contact with civet cats. Clinical and histopathological descriptions from Hong Kong, Toronto, Taiwan and elsewhere indicate that SARS causes severe pneumonia in a large proportion of infected individuals. Many patients (19% of 196 studied in Toronto) develop an acute respiratory distress syndrome (ARDS), usually during the second week of illness. The pulmonary histopathology of severe cases of SARS appears typical of ARDS. Timing of the lung damage suggests that much of the injury may be mediated by the host immune system. However, the extent to which lung injury results from SARS-CoV itself, by infection and replication in lung epithelial cells (and perhaps other cells), and the extent to which it is caused by the host immune responses to the virus are unclear. Co-existing infections (e.g., human paramyxovirus) are present in some specimens and may possibly play a role in triggering events leading to severe lung damage. Treatment with the wide spectrum antiviral drug ribavirin does not seem to be of any benefit. Since it appears that the pathogenesis of lung disease in SARS may be largely due to an immune component, corticosteroids have been administered in an attempt to control this. The use of corticosteroids to reduce lung injury is currently controversial. Other immune modulating agents (interferons) are being screened and considered for possible treatment studies, if there is a new outbreak of disease. An issue for patients who survive SARS is the extent of residual lung damage and other sequellae. Evidence of fibrosis, reported on lung biopsies and findings compatible with fibrosis on follow-up high resolution CT scans support the need to study this. At this time, very little is known about the pathogenesis of SARS in the lung. Macaques have been infected in preliminary experiments and are reported to have lung lesions similar to those seen in humans. Attempts to establish rodent models of lung disease have not succeeded yet, but infection can be established in rodents and models of other animal coronavirus diseases make it likely that a model may be established soon, either by direct infection or by modifying the SARS-CoV genome. Recently, ferrets and domestic cats have been infected with SARS-CoV. These animals can spread infection. The ferrets become ill and die, not apparently from pneumonia, but the model is reproducible. Meanwhile, much essential information about the pathogenesis of SARS in the lung could be gained from using established animal models of other coronaviruses and in vitro studies of SARS-CoV interactions with lung and immune cells. In addition to learning about how the virus infects lung cells, this PA specifically encourages in vitro research on the role of lung collectins and other extracellular lung host factors. It encourages studies of endothelial and epithelial permeability, effects of SARS on fluid movements, and growth and differentiation of human lung cells (alveolar epithelial cells, fibroblasts, etc.). Research on SARS-CoV interactions with human lung and immune cells and tissues is the primary focus, but research using engineered and related coronaviruses and animal cells pertinent to pathogenesis of SARS may also be responsive. This PA encourages pulmonary investigators to form collaborations to take full advantage of already established animal models of coronavirus infection and newly developed animal resources. Of equal importance, pulmonary investigators are encouraged to use existing genetically altered mouse resources (e.g., the NHLBI Programs of Genomic Applications (PGA)) and if necessary to develop novel mice, engineered to incorporate or ablate components of immune function, to study the pathogenesis of SARS lung injury. Collaborations with virologists to develop and study chimeric viruses are encouraged. Chimeras might make it possible to use many existing mouse models and reagents that could quickly provide data on mechanisms of lung damage in SARS. Great care will be needed to protect personnel and prevent spread of viruses to other animals. Investigators will need to document that they have access to appropriate BSL3 level facilities and that the investigators and other personnel are appropriately trained. Research utilizing patient viral isolates, cells, tissue and other biological samples is encouraged if these are available. It may also be possible to gain useful information by working with adapted strains of virus, e.g., a murine adapted strain or with existing animal models of related coronavirus diseases (pig, mouse, cat, etc.,) that may not require such stringent isolation. Examples of the type of research topics and approaches that would be solicited under this program announcement include (but are not limited to) the following: Determine which lung structural cells (e.g., epithelial, endothelial, etc.,)and immune and inflammatory cells support human SARS-CoV infection. Study viral binding, receptors, co-receptors, replication, persistence, effects on host cell gene expression, and apoptosis. Investigate immunological aspects of SARS-CoV infection, e.g., elaboration of cytokines, antigen presentation and effects of co-stimulation with other pathogens. Address the role of immune responses, age related issues, surfactant proteins, and the effects of co-morbidities (e.g., underlying emphysema, diabetes) using animal models of SARS. Elucidate pathogenesis by using animal models to study the effects of vaccines, antiviral drugs, and immune modulating agents that might moderate the manifestations of SARS in the lung. MECHANISM(S) OF SUPPORT This PA will use the NIH R01 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (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 budget format. Otherwise, follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Investigators working with SARS-CoV and other potentially dangerous infectious agents will need to document that they have access to carefully controlled BSL3 laboratories, properly isolated animal housing, and the availability of appropriately trained personnel. This program announcement requires that investigators who plan to work with SARS-CoV and other agents needing BSL3 facilities must demonstrate close coordination with groups that have BSL3 facilities and expertise. This is not intended as a vaccine or drug development program. Studies in which vaccines or drugs are used to elucidate the pathogenesis of SARS in the lung may be considered responsive to this PA. However, studies that focus on vaccine and drug development will not be considered responsive. Work on normal lung tissue and cells may be used for comparison purposes, but to be responsive to the PA the proposed research projects must focus on the pathogenesis of SARS in the lung. All applications submitted in response to this PA must include plans for sharing data and other resources. Grantee's Meetings Upon initiation of the program, the NHLBI will sponsor meetings to encourage exchange of information among investigators who participate in this program announcement. In their budgets, applicants should include funds for annual one-day grantees' meetings, most likely in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. The first such meeting probably will take place about 12 months after the awards are issued. 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: o Direct your questions about scientific/research issues to: Hannah H. Peavy, M.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10018 Bethesda, MD 20892-7952 Phone: (301) 435-0222 Fax: (301) 480-3557 Email: peavyh@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Robert Pike Grants Management Officer Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7144, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: piker@nhlbi.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html n an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and 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 mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this 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. Appropriate scientific review groups 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 appropriate national advisory council or 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 application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (http://grants.nih.gov/grants/policy/data_sharing ) 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 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 (Type1) 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 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). 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.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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