RFA-AI-03-018: TROPICAL DISEASE RESEARCH UNITS

TROPICAL DISEASE RESEARCH UNITS RELEASE DATE: April 2, 2003 RFA: AI-03-018 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research LETTER OF INTENT RECEIPT DATE: July 19, 2003 APPLICATION RECEIPT DATE: August 19, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), invites applications for program project (P01) grants to conduct multidisciplinary research leading to the development and evaluation of new strategies to prevent and control diseases caused by protozoan and helminth parasites. Programs will focus on one of the following areas: (1) therapeutics -- discovery and validation of drug targets and development of new chemotherapeutic agents for treating and preventing parasitic infections; or (2) vector control -- development of new approaches for interruption of the parasite life cycle at the level of the invertebrate (vector) host. RESEARCH OBJECTIVES Background Parasitic diseases continue to represent tremendous public health problems, especially for people living in the tropics where parasitic infections are responsible for deaths and impaired growth and development among children as well as for debilitating, chronic diseases among adults. Parasitic infections have been recognized with increasing frequency as responsible for diseases in the United States and other industrialized countries. Of special interest to clinicians and public health workers in developed nations is the occurrence of severe parasitic disease in individuals who acquired their infection congenitally or as a result of immunosuppression. Prevention and treatment of parasitic diseases remain problematic. Many of the currently available drugs exhibit either excessive toxicity and/or inadequate efficacy. Several previously useful compounds are no longer effective due to the spread of drug resistant parasite variants. Licensed vaccines do not exist for any human parasitic infection. Erosion of public health vector control programs, appearance of insecticide resistance among vector populations and environmental changes, notably those associated with land and water management practices, has contributed to the emergence or re- emergence of parasitic diseases. In response to growing concerns about the use of biological agents in acts of terrorism, NIAID has developed a strategic plan for research on biodefense and emerging infectious diseases (http://www.niaid.nih.gov/biodefense/research/strategic.pdf). As a focus of this strategic plan, the NIAID has identified a number of priority organisms, including several food and water borne protozoan pathogens (http://www.niaid.nih.gov/biodefense/bandc_priority.htm). Translational research leading to the development of new therapeutics to treat diseases caused by these pathogens is encouraged. Current parasitology research supported by the DMID, NIAID, is largely conducted under investigator initiated research project grants focusing on the molecular and cellular biology, immunology, and biochemistry of the medically important protozoa and helminths as well as on the biology of invertebrate vectors. The Institute also supports several special programs for studies on parasitic and other tropical diseases. Research reagents in support of schistosomiasis, filariasis and malaria research are available through repository contracts funded by NIAID (http://www.niaid.nih.gov/reposit/default.htm). The International Centers for Tropical Disease Research (ICTDR) network serves to coordinate many of the Institute's activities in the area of tropical infectious diseases. Within the ICTDR network, studies in areas endemic for tropical parasitic diseases are funded through its International Collaboration in Infectious Disease Research (ICIDR) and Tropical Medicine Research Center (TMRC) programs. Available resources in endemic areas supported by the ICIDR and TMRC programs may provide opportunities for field testing of new intervention strategies as they arise. In addition, NIAID is developing clinical trial sites in endemic areas for evaluation of malaria vaccines or therapies. This RFA represents a continuation of another major component of NIAID's ICTDR network, the Tropical Disease Research Units (TDRUs). This program was initiated in 1980 and originally designed to stimulate advanced biomedical research on the five parasitic diseases that form the basis of the World Health Organization's Special Programme for Research and Training in Tropical Diseases (WHO/TDR) -- filariasis, leishmaniasis, malaria, schistosomiasis and trypanosomiasis. Since the inception of the TDRU program, much has been learned about the biology of these and other parasites as a result of the dramatic advances in molecular and cellular biology and in immunology. Recent advances in our understanding of the basic biology of parasites and of invertebrate vectors and of host-parasite interactions have created unique opportunities for discovering and evaluating new means of controlling the mortality and morbidity associated with parasitic infections. In 1995, recognizing that substantial advances have been made in the understanding of many parasitic diseases of significant global public health impact, the NIAID expanded the scope of the TDRU program to encompass all medically important human parasitic diseases. Under the current renewal, TDRUs will be expected to provide focused concerted efforts in the development and preclinical and pre-field testing of new intervention strategies for parasitic diseases. Components of the TDRU program may have the opportunity to work with other members of the ICTDR network to move promising therapeutic or vector control strategies toward clinical or field trials. Opportunities for moving candidate therapeutics or vector control methods into clinical and field-testing are also available through other mechanisms. Research Objectives and Scope NIAID wishes to support multidisciplinary, state-of-the-art biomedical research units focused on preclinical and pre-field) testing of new intervention strategies to control protozoal and helminthic infections. For the purpose of this RFA, intervention strategies to be considered are: i) therapeutic agents to prevent and/or treat infection; and ii) methods to control invertebrate vectors. The entire program project grant (see definition under 'MECHANISM OF SUPPORT'), must address the development of one of these intervention strategies. The program project must also focus on a single parasitic infection or a single related target common to several parasitic organisms or vectors. Studies on human pathogens are preferred but studies on animal pathogens that are recognized to provide relevant models of human disease will also be acceptable. The entire program project should be designed to address the common goal in a cohesive manner. Responsive programs would be those in which each project provides information necessary for further development of the single intervention strategy chosen as the overall program objective and/or evaluation of its utility in an appropriate in vitro or in vivo system. Each program project application must clearly define the coordinating structure to be used to ensure integration and information exchange among the different projects of the program in pursuit of this single goal. Therapeutics: NIAID wishes to support research units that consist of focused, coordinated projects with a common preclinical development objective. Of significant interest are units with methods and /or test systems for accelerated evaluation/selection of preclinical candidate therapeutic compounds. Proposed units with crosscutting, complementary disciplines that are designed to more rapidly facilitate selection of preclinical chemotherapy candidates are of special interest. Efforts to facilitate high throughput screening (HTS) of chemical candidates and lead selection and optimization may include combined areas of chemical synthesis, medicinal chemistry and proteomic target expression. Another combined effort may be use of appropriate test systems for integration of preclinical phamacokinetics, efficacy pharmacodynamics and metabolism of candidate compounds. Areas of research relevant to this program include, but are not restricted to, studies designed to: o Identify and characterize novel potential targets of chemotherapeutic agents for medically relevant protozoa or helminth pathogens; of special interest are targets that can be validated and applied to high throughput screening methodologies for lead compound discovery; o Elucidate mechanisms of resistance to antiparasitic agents; develop methods or strategies to overcome such resistance; o Identify lead compounds utilizing molecular modeling and/or library screening methods; o Develop methods or systems of reiterative design, chemical synthesis and in vitro or animal testing for the selection of lead compounds; and o Develop methods and/or systems for preclinical evaluation of candidate therapeutics with a goal of expeditiously moving drug candidates into phase I clinical trials (http://www.fda.gov/cder/regulatory/default.htm). Vector control: NIAID wishes to support research units focused on development and testing of novel, environmentally sound intervention strategies for vector-borne infectious diseases. This research should be translational in nature, and should focus on one or more specific public health vector control interventions. Ideally, the vector control research supported under the TDRU program should be just short of wide scale field trials, and the results of the research funded under the TDRU program will be quickly testable in large- scale field trials in endemic areas. Applicants responding to this area of the announcement should include a description of the intervention(s), its/their stage of development, and justification for its/their being ready to move to this pre-field or limited field-testing stage. Areas of research relevant to this program include, but are not restricted to studies designed to: o Assess attractant-baited traps as point source removal strategies, especially for vectors like Culex (oviposition traps) or Anopheles (bednet traps); o Adapt IPM strategies for community-specific vector-control; and o Develop biological control agents targeted to individual vector species, e.g. densoviruses. Validation: Each application, whether targeted to therapeutics or vector control, must provide an experimental plan that details the methods that will be used to validate the utility of the chosen approach. The experimental plans must indicate relevant validation strategies and major decision milestones. Examples of validation strategies include: o Use of site-directed mutagenesis, gene knockouts, testing of specific inhibitors, antisense technology or RNAi to establish the essential nature of a drug target; o Examination of the inhibition of infection, parasite function or of documented correlates of pathology in in vitro or animal model systems in programs seeking to develop therapeutic agents; and o Assessment of the effectiveness of the vector control product or strategy in reducing transmission of the parasite to humans, through its impact on vector abundance, density, longevity etc. MECHANISM OF SUPPORT This RFA will use the NIH program project (P01) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This type of award supports broadly based multidisciplinary research programs that have a well-defined central research focus or objective. An important feature is that the interrelationships among the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project was pursued individually. The program project grant consists of a minimum of three interrelated individual research projects that contribute to the program objective. The award also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the award. This RFA is a one-time solicitation. Future unsolicited, competing- continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. FUNDS AVAILABLE NIAID intends to commit approximately $2.4M in FY 2004 to fund 3 to 5 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for total costs of up to $800K per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIAID provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(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 o Faith-based or community-based organizations Foreign organizations are not eligible to apply; however, collaboration(s) with investigators at foreign sites are encouraged. 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 When clinical studies are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: https://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. Development of vector control products that are intended for use in the environment will eventually require review and approval of appropriate regulatory agencies (in the U.S. the Environmental Protection Agency). While any field application proposed must have the necessary regulatory approvals, even earlier development phases should be undertaken with this requirement in mind. Applicants are encouraged to discuss their plans with NIAID staff prior to submission and to be explicit within the application itself about the regulatory approval process. Institutions receiving TDRU awards are considered as Centers in the NIAID ICTDR network, and TDRU program directors are designated as Center Directors in this network. A further description of the network available on the NIAID Website at http://www.niaid.nih.gov/ictdr. The application should budget appropriate funds to allow the TDRU program director to attend the annual meeting of the network that is generally held in Bethesda in the Spring. Attendance of other key personnel is encouraged. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries fall into three areas: scientific/research; peer review; and financial or grants management issues: o Direct your questions about scientific/research issues related to THERAPEUTICS to: Michael Gottlieb, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 5099, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 [for express mail use Bethesda, MD 20817] Telephone: (301) 496-2544 FAX: (301) 402-0659 Email: mgottlieb@niaid.nih.gov o Direct your questions about scientific/research issues related to VECTOR CONTROL to: Kathryn Aultman Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 5097, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 [for express mail use Bethesda, MD 20817] Telephone: (301) 435-2854 FAX: (301) 402-0659 Email: ka6z@nih.gov o Direct your questions about peer review issues to: Madelon C. Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2150, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301)402-2636 FAX: (301) 402-2638 Email: mh30x@nih.gov o Direct your questions about financial or grants management issues o: Mollie Shea Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2234, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 [for express mail use Bethesda, MD 20817] Telephone: (301) 402-6576 FAX: (301) 480 3780 Email: ms256g@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Madelon C. Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2150, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301)402-2636 FAX: (301) 402-2638 Email: mh30x@nih.gov SUBMITTING AN APPLICATION Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to: Madelon C. Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2150, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Bethesda, MD 20817 (for express mail or courier service) Applications must be received by August 19, 2003. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/01) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned to the applicant. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. Concurrent submission of an R01 and a Component Project of a Multi-project Application: Current NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. 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 Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIAID. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a 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 second level review by the National Advisory Allergy and Infectious Diseases Council REVIEW CRITERIA The general review criteria for P01 grant applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" at http://www.niaid.nih.gov/ncn/grants/multibron.htm. ADDITIONAL REVIEW CRITERIA: In addition, the following review criteria 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. 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 CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: July 18, 2003 Application Receipt Date: August 19, 2003 Scientific Peer Review Date: December, 2003 Advisory Council Review: February, 2004 Earliest Anticipated Start Date: April, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_ 10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at https://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. This policy announcement is in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 https://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 https://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 Catalogue of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH Grants Policy Statement is available at https://grants.nih.gov/grants/policy/policy.htm. This document includes general information about the grant application and review process; information on the terms and conditions that apply to NIH Grants and cooperative agreements; and a listing of pertinent offices and officials at the NIH. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. 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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