PA-04-093: NOVEL APPROACHES TO STUDY POLYMICROBIAL DISEASES

Department of Health
and Human Services (HHS)

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NOVEL APPROACHES TO STUDY POLYMICROBIAL DISEASES RELEASE DATE: April 15, 2004 PA NUMBER: PA-04-093 December 14, 2006 - The R01 portion of this funding opportunity has been replaced by PA-07-171, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond. 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. Accordingly, this funding opportunity expires on the date indicated below. A replacement R21 (PA-06-210) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE: for R21 Applications: March 2, 2006 Expiration Date for R01 Non-AIDS Applications: November 2, 2006 Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.121 (NIDCR); 93.837 (NHLBI); 93.173 (NIDCD); 93.286 and 93.287 (NIBIB) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators 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 NIH Institutes listed above invite research grant applications to conduct studies designed to develop innovative approaches that would contribute to our understanding of the mechanisms that impact on the virulence of infections involving two or more microorganisms or strains of microorganisms (with the exception of HIV). This announcement encourages investigators to think beyond the one organism-one disease concept and instead to consider the fact that many diseases are caused by the synergistic and inhibitory interactions of bacteria, viruses, parasites, and fungi. Projects should include studies aimed at understanding the cellular and molecular interactions of pathogens with the normal flora as well as the interactions among pathogens themselves, and how commensal organisms can be used to prevent or treat infections; however, this PA is limited to those projects that involve or are based on intermicrobial interactions that have been well documented to occur in clinical settings. In addition, extensive research is needed on the host responses to polymicrobial infections in order to develop new approaches to treat and prevent these infections. The development of co-infection models and the use of genomic and proteomic technologies to identify common virulence mechanisms and host response patterns as well as the development of diagnostic and prognostic microbial/host signature patterns are encouraged. Because of the complexity of such projects, the establishment of collaborative scientific teams, both domestic and international, with diverse scientific disciplines studying polymicrobial diseases, including microbiology, immunology, biochemistry, clinical medicine, pathology, bioengineering, material science, imaging technology, and mathematical modeling are encouraged. RESEARCH OBJECTIVES Background There is increasing evidence in the literature for the importance of polymicrobial infections in which microorganisms interact in a synergistic or inhibitory fashion, impacting on pathogenesis or the maintenance of health. Among these, bacteria-bacteria, virus-virus, parasite-parasite or virus-bacteria interactions have been described. For example, co-infection of Borrelia and Ehrlichia have been reported to enhance the severity and complicate the diagnosis of Lyme borreliosis. Also, it is known that the occurrence of multiple hepatotropic viruses influence the progression of the disease and that individuals infected with parasitic helminthes have increased susceptibility to malaria. Further, mixed viral-bacterial infections have been associated with excess mortality and meningitis during influenza pandemics, increased incidence of otitis media during influenza and respiratory syncytial virus epidemics in children, as well as antibiotic treatment failures and severe post-transplant complications. In addition, epidemiologic shifts in the spectrum of bacterial infection have been noted in cancer patients resulting in changes in the use of antimicrobial therapy during the management of these individuals. It is conceivable that a viral infection, for instance, may facilitate bacterial colonization and enhanced adherence to host cells, paving the way for invasive disease. For example, a virus infection may induce host cell membrane changes such as the expression of viral glycoproteins that may serve as receptors for bacteria, or up-regulate platelet activating factor receptor thereby promoting increased bacterial adherence. Likewise, it is equally conceivable that a bacterial infection may pave the way for increased viral disease. Also, the ability of various bacteria in the microbial complex of the oral cavity to express surface molecules (e.g., bacteriocins) that specifically interact with other bacterial species and host cells has been suggested to be a critical determinant in plaque formation and structure. Indeed, a number of recent studies have focused on these research areas including those using experimental animal models. However, in future studies it will be important to develop appropriate experimental models to examine the mechanisms associated with the actual pathogen-to-pathogen interaction within the same host environment that may lead to increased susceptibility or resistance to infection. It is anticipated that a better understanding of the mechanisms involved in the observed clinical phenomena may provide opportunities to more critically evaluate the role of suspected virulence determinants involved in these mixed infections and the innate or specific host immune response patterns involved; these projects should also provide useful information for investigators in the development of more effective diagnostic, prevention and treatment strategies. For example, there is good clinical evidence that eradication of predisposing viral infections reduce the onset of otitis media. Thus, therapeutic approaches can be strengthened by taking into account the polymicrobial nature of the disease. Research Objectives and Scope A major focus of this PA is to encourage investigators to develop novel approaches for examining polymicrobial interactions and to think beyond the one organism-one disease concept. Projects will be considered responsive to this PA if the studies involve intermicrobial interactions that have been well-documented to occur in clinical settings or are based on clinically significant studies and are designed on the basis of sound scientific arguments with clearly defined endpoints such as profiles of immunological responses, synergizing metabolic activities or the inhibition/promotion of adherence to host cells. The NIBIB has specific interest on the development of new imaging and bioengineering technologies. Proposals submitted to the NIBIB should have a primary emphasis on the development of new technologies useful for studying polymicrobial interactions. Research studies to be investigated under this PA are expected to develop novel, mechanistic ideas for polymicrobial interactions. Projects to be examined include, but are not limited to the following: o Elucidation of the mechanisms by which viral or parasitic infections increase the risk for bacterial infection or vice versa; o Determination of how surface adhesions are altered during microbial interactions; o Identify the mechanisms by which polymicrobial infections lead to enhanced resistance of microbes to acquired or innate immunity; o Development of co-infection animal models or cell culture systems for multiple pathogens; o Development of vaccines against polymicrobial infections; o Use of genomics and proteomics to identify microbial virulence genes and/or proteins that may be uniquely expressed during co-infection; o Evaluation of host response patterns, in response to single vs. multiple infections (simultaneous or sequential activation), required to elicit synergy or inhibition; o Ability of bacteria to colonize or invade host tissues following recent viral infection; o Development of biotherapeutics such as phage therapy and the ability of bacteria to block the pathogenicity of other bacteria (i.e. probiotic organisms); o Characterization of lung host responses to polymicrobial infections and lung host response patterns; o Polymicrobial interactions as determinants of lung disease; o Development of new imaging techniques for probing polymicrobial interactions; and, o Development of mathematical models and analysis tools for the study of polymicrobial interactions. MECHANISMS OF SUPPORT This PA will use the NIH R01 and R21 award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The R21 proposals should have the potential for truly groundbreaking impact. Use of this mechanism to explore new biomedical approaches to address basic and applied research questions is encouraged. Applicants are encouraged to contact program staff for advice about choosing the appropriate grant mechanism. R21 applications may request up to a total of two years of support, and total direct costs for the two years cannot exceed $275,000. The objective of the R21 mechanism is to support innovative, high risk/high impact research requiring preliminary testing or development; exploration of the use of approaches and concepts new to polymicrobial research; research and development of new technologies, techniques or methods; or initial research and development of data upon which significant future research may be built. Applications will be considered as high impact if they demonstrate the potential for ground- breaking, precedent-setting significance, and high risk because they either lack sufficient preliminary data to ensure their feasibility, or involve using a new model system or technique. While this PA is intended to encourage innovation and high impact research, and while minimal preliminary data are expected to be described in the application, applications should clearly indicate that the proposed research and/or development is scientifically sound, that the qualifications of the investigators are appropriate, and that resources available to the investigators are adequate. This PA uses just-in-time concepts. It also uses the modular 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 format. Otherwise follow the instructions for non-modular 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_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: o Direct your questions about scientific/research issues to: Dennis F. Mangan, Ph.D. Division Basic and Translational Sciences, NIDCR Building 45, Room 4AN-12J Bethesda, MD 20892-6402 Telephone: (301) 594-2421 FAX: (301) 402-8319 Email: Dennis.Mangan@nih.gov Susan Banks-Schlegel, Ph.D. Division of Lung Diseases, NHLBI Two Rockledge Center, Suite 10018 6701 Rockledge Drive Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: Schleges@nih.gov Bracie Watson, Jr., Ph.D. Hearing Program Division of Scientific Programs, NIDCD 6120 Executive Blvd., 400-C, MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 E-mail: watsonb@nidcd.nih.gov Peter Moy, Ph.D. Division of Discovery Science and Technology, NIBIB 6707 Democracy Boulevard, Suite 200 Bethesda, MD 20892 Telephone: (301) 496-9270 FAX: (301) 480-4973 Email: moype@mail.nih.gov o Direct your questions about financial or grants management matters to: Mary Daley Chief Grants Management Officer, NIDCR 45 Center Drive MSC 6402 Building 45, Room 4AN-44B Bethesda, MD 20892-6402 Telephone: (301) 594-4808 FAX: (301) 480-8303 Email: md74u@nih.gov Robert A. Pike Lung Team Section Chief Grants Operations Branch, NHLBI Two Rockledge Center, Room 7154 6701 Rockledge Drive Bethesda, MD 20892-7926 Telephone: (301) 435-0182 FAX: (301) 480-3310 Email: Piker@mail.nhlbi.nih.gov Sara Stone Chief, Grants Management Branch, NIDCD Executive Plaza South, Room 400B 6120 Executive Boulevard, MSC-7180 Bethesda, MD 20892 Rockville, MD 20852 (express mail) Telephone: (301) 402-0909 Email: stones@nidcd.nih.gov Karen Shields Grants Management Specialist, NIBIB 6707 Democracy Boulevard, Suite 900 Bethesda, MD 20892 Telephone: (301) 451-4971 FAX: (301) 480-4974 Email: shieldsk@mail.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 in 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. SUPPLEMENTARY INSTRUCTIONS: R21 Applications: All application instructions outlined in the PHS 398 application kit are to be followed with the following modifications for R21 applications: 1. FACE PAGE, Item 6: Up to a total of two years of support may be requested. Total direct costs for the two years cannot exceed $275,000. 2. Items a-d of the Research Plan for the R21 application may not exceed fifteen (15) pages, including tables and figures. The following information should be taken into account for items a, b and c: o Item a, SPECIFIC AIMS--The instructions for this section suggest that the applicant state "the hypotheses to be tested". Since some applications submitted in response to this PA may also be design- or problem-driven (e.g., development of novel technologies), or need- driven (initial research to develop a body of data upon which future research will build), hypothesis testing per se may not be the driving force in developing such a proposal and, therefore, may not be applicable. The application should state the hypotheses, design, problem and/or need which will drive the proposed research. o Item b, BACKGROUND AND SIGNIFICANCE--In this section, it is important to identify clearly how the application addresses the specific objectives of this PA and the purpose of the R21 mechanism. o Item c, PRELIMINARY STUDIES/PROGRESS REPORT No preliminary data are required for an R21 application. 3. APPENDIX - Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included. 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 (IC) 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 original copy 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 by or 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 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 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? 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. (See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html) 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. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing . Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm . The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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