PARTNERSHIPS: HEPATITIS B AND VECTOR BORNE DISEASES CONTROL RELEASE DATE: November 13, 2002 RFA NUMBER: AI-03-003 Letter of Intent Receipt Date: February 24, 2003 Application Receipt Date: March 24, 2003 National Institute of Allergy and Infectious Diseases (NIAID) ( THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of the RFA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Terms and Conditions of Award 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 THE RFA Research of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic biomedical research, such as studies of microbial physiology and antigenic structure; applied research, including the development of diagnostic tests; and clinical trials to evaluate experimental drugs and vaccines. This Partnership program will use the cooperative agreement (U01) funding mechanism to support the development and testing of products for selected human infectious diseases of public health importance. A key component of the Partnership initiatives is the development of appropriate partnerships among government, academia, and the biotechnology, chemical or pharmaceutical industries. This RFA is specifically focused on: A) Development of novel therapies against hepatitis B virus (HBV); B) Development of products/strategies for controlling the transmission of infectious agents by Ixodes ticks; and C) Assessing and/or extending the effectiveness of other arthropod vector control tools or strategies. For the purpose of this RFA, "industry" is defined as large and small pharmaceutical, biotechnology, and chemical companies. All projects must demonstrate substantive involvement by a commercial sector (industry) component. For the purpose of this RFA, "substantive involvement" is defined as the commitment of any one or more of the following resources: funds; personnel; or in-kind contributions of materials and reagents, including but not limited to chemical libraries, innovative biotechnology platforms for screening drugs and inhibitors, scale up GMP chemical synthesis, access to tick colonies, provision of animal or other laboratory models, and data management resources. The Principal Investigator may be affiliated with either a commercial or academic organization. PARTNERSHIPS The Partnership Program is intended to support all phases of development of a candidate product or platform technology including, but not limited to, early validation, pre-clinical stages, scale-up, production, regulatory requirements, and, where appropriate, clinical or field evaluation. The NIAID recognizes that the inherent nature and demands of the product development process may require funding large, complex grants with interdependent specific aims. Furthermore, some aspects of the product development process (e.g., large-scale production of cGMP product) are inherently not innovative. Recognizing that product development is often an iterative and sequential process, and that steps early in the process may not be successful and may need to be modified or reworked, NIAID staff, through the cooperative agreement grant mechanism, will be actively involved in evaluating the milestones of awardees and determining whether additional investment in the development is warranted. RESEARCH OBJECTIVES Background In late 2000, the NIAID convened a panel of experts to discuss the role and nature of NIAID/industry collaborations in antimicrobial drug development for public health needs and to learn how NIAID could better assist industry and academia in these endeavors ("Summit on Drug Development for Infectious Diseases.") One of the recommendations from this meeting was the need to continue to pursue innovative opportunities to form partnerships with the private sector for the control of a number of infectious diseases with public health importance. A report of this meeting is available at The need to support the research specified by this RFA has been emphasized by the NIAID-convened review of its Clinical Antiviral Programs in 1995 and a review of the NIAID vector biology research agenda in 2000. Investment by industry in the commercialization of products for the control of a number of infectious diseases of public health importance remains limited. This initiative is meant to help stimulate industry participation in decreasing the impact of these targeted important diseases for which effective new therapeutics or control measures are lacking. This program is seeking applications that propose to: A. Exploit known or to-be-discovered targets for the design and testing of new classes of drugs/therapies against chronic HBV infection; B. Develop novel, environmentally safe strategies for limiting the ability of Ixodes ticks to transmit pathogens. Projects responsive to this area could include, but are not necessarily limited to, the development and/or proof of principle testing of novel immunological, genetic or molecular approaches that interfere with tick physiology and/or reproduction or the ability of ticks to transmit specific infectious agents; or C. Evaluate the epidemiological impact of vector control products; and/or identify entomological correlates of prevention that can be monitored, and that have significance for public health vector control (e.g., insecticide resistance). Research Objectives and Scope Responsive research applications should focus on the development of a single ultimate product or strategy for one of the following three areas of high public health importance: A. Development of novel therapies against hepatitis B virus Therapies for chronic hepatitis B viral infection are few, require protracted treatment, and are generally not curative. Currently there are only two licensed therapies: interferon alpha and the nucleoside analogue, lamivudine. Most drugs in development are similar to lamivudine, essentially targeting the same function in viral replication. Although some drugs may reduce viremia more than others, most have limited efficacy against evasive mutant viruses. Concerted efforts are needed to define key steps in the infection, replication and assembly of New analytical methods could identify these steps and open pathways to the design and testing of new classes of curative antivirals or immunostimulators. Applications are sought that include, the following areas of research: o The use of emerging analytical technologies and methodologies to identify and verify viral/host targets for new designs for HBV therapies; o The design, synthesis, purification, validation and testing of drugs/immunostimulators for efficacy and toxicity in model assays and in relevant animal models. Part of this work may involve a reiterative process of redesign and revalidation; o The performance of pharmacokinetic and pharmacodynamic studies of lead candidates and the assessment of their bioavailability and mechanism(s) of action; o The identification of optimal host conditions and delivery systems for the administration of therapeutics; and, o The determination of drug interactions in the molecular processes of the host and efficacy against evolving viral mutants. NOTE: Chemically defined active component(s) of natural products can be explored as potential drug sources for development. The screening of natural products for biological activities will not be supported under Part A of this initiative. B. Development of products/strategies to prevent the transmission of Ixodes tick-borne diseases. Tick-borne infectious diseases are an increasing threat to human health, and new, more efficient approaches are required to prevent transmission to humans. To be considered responsive, an application must identify a novel molecular, genetic, and/or immunological approach that is, or can be demonstrated to be, effective in preventing the transmission of tick-borne infectious diseases. The application should include a well-defined and controlled experimental laboratory animal model to prevent the transmission of infection by Ixodes ticks. The goal is to acquire preliminary data on transmission-interruption approaches that will ultimately support future field trials. The conduct of field trials will not be supported under this part of this initiative. C. Evaluation of the ongoing epidemiological effects of vector control approaches or products currently in use and/or identification of entomological correlates or surrogate markers of prevention that can be monitored, and that have significance for public health vector control, (e.g. insecticide resistance). Applications are sought that include, but are not limited to: o Assessments of the effectiveness of arthropod vector control tools and strategies used in public health programs. Specifically, this research would include studies that establish links between entomological (e.g. insect killing, repellency, blood feeding,) and epidemiological parameters (e.g., disease incidence or prevalence, infection status of humans or sentinel animals) as the basis for ongoing monitoring of vector- and disease-control impact. o Collection of standardized, Geographic Information Systems (GIS)-based data on the incidence of insecticide resistance and other forms of control failures, the distribution of vector species and sub-species, environmental factors, patterns of agricultural insecticide use, vector migration patterns, and other key factors determining the development of insecticide resistance or the impact of vector control. o Studies to evaluate and limit the effects of pesticide resistance on practical control measures. o Studies to develop or refine pesticide resistance management strategies (e.g., rotational use of insecticides, inclusion of refugia, altered duration or pattern of application). o Creation of predictive regional models of the spread of insecticide resistance related to disease transmission. NOTE: Field studies may be supported for applicants responding to Part C. MECHANISM OF SUPPORT The U01 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." The total project period for applications submitted in response to this RFA may not exceed five years. FUNDS AVAILABLE The estimated total funds [direct and facilities and administrative (F&A) costs] available for the first year of support for all awards made under this RFA will be $4 million. In Fiscal Year 2003, the NIAID plans to fund approximately 6-10 awards with a mixture of both large and small grants. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of high scientific merit. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. ELIGIBILE 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 Both domestic and foreign organizations are eligible. Institutions must be in compliance with U.S. laws and regulations and DHHS and NIH policies in effect at the time of grant award and during the period of performance of the research. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS All applications must include substantive involvement by industry (as defined above). 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 Depending upon the scientific area, each application must propose a research and development project whose ultimate goal is to produce a novel therapeutic against HBV, an approach to limit the ability of Ixodes ticks to transmit infectious agents to humans, or a strategy to evaluate the epidemiological effects of other vector control products. Applications must propose clear project goal(s), including one (or more) final product or stage of development to be completed during the award period. The applicant must clearly state the interim objectives (developmental milestones) to be achieved during the project, identify impediments or critical decision points that could require a revision in the work plan or milestones, and provide a detailed schedule or timeline for the attainment of each milestone and/or goal. For applications that contain a clinical or field study (Part C only), a mandatory milestone that must be included is the approval of the final clinical protocol by NIAID. Applicants must build this milestone into their application. Clinical or field studies will only be supported for applicants responding to scientific area C (Arthropod vector control) Any applicant proposing a clinical or field study for Part C must submit a study protocol as part of the application. For guidance on protocol format and/or other issues related to clinical or field studies for Part C contact Dr. Kate Aultman (contact information provided below). Intellectual Property The successful development of these high priority products for biodefense will require substantial involvement and support of private sector industries and may also involve collaborations with multiple organizations, including academic and/or non-profit research institutions. It is the intent of this initiative to support the formation of the appropriate public-private partnerships that are essential to meet these urgent public health needs. Intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, the NIAID requires that at the time of application all applicants must provide a letter ("Proprietary Rights Assurance Letter") containing the following assurances, which is signed by a representative who is duly authorized to provide such assurances on behalf of the applicant organization: o Applicant is solely responsible for the timely acquisition of all proprietary rights, including intellectual property rights, and all materials needed for applicant to perform the project o Applicant acknowledges that prior to, during, and subsequent to the award, the U.S. Government is not required to obtain for applicant any proprietary rights, including intellectual property rights, or any materials needed by applicant to perform the project o Applicant acknowledges the requirement to report to the U.S. Government all inventions made in the performance of the project, as specified at 35 U.S.C. Sect. 202. Apart from the Proprietary Rights Assurance Letter, applicants are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goals of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit. In addition, applicants are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, reports to the NIAID or other mechanisms. Mandatory Meetings Proposed budgets must include funds for travel by the Principal Investigator, other key personnel as needed, and two external advisors to an annual two-day progress review meeting in Bethesda, MD. Progress will be reviewed annually by NIAID with the help of external advisors, to be named after award by NIAID in consultation with the Principal Investigator. Names of suggested advisors should not be included in the application, nor should these individuals be contacted prior to the review. TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is cooperative agreement (U01), [an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and their NIAID Program Officers. 1. Clinical Terms of Award When human subjects or human samples are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to human subjects. Terms and Conditions of Award will be included with awards. The NIAID policy including terms and conditions of award is available at: 2. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the RFA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below. Awardees may be from academia or industry. However, the industrial portion of the partnership is critical for compliance and substantive involvement by industry, directed to the specific project being proposed, must be clearly defined. Awardees will comply with the approved intellectual property disposition plan that details (1) the approach agreed to by all parties for disposition of intellectual property, including but not limited to obtaining patent coverage and licensing, where appropriate, and (2) procedures to be followed for the resolution of legal problems that potentially may develop. For research conducted in foreign countries, the awardee must assure compliance with the host country regulations for human subjects, and must assure that the trials are conducted according to one of the following: the US Federal Policy (Common Rule) for the Protection of Human Subjects and/or the US Department of Health and Human Services (HHS) regulations at 45 CFR 46; the May 1, 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice (ICH-GCP-E6) Sections 1 through 4; The 1993 Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects; the 1998 Medical Research Council of Canada Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans; the 2000 Indian Council of Medical Research Ethical Guidelines for Biomedical Research on Human Subjects; or other internationally recognized standards for the protection of human subjects. When experimental field applications of chemical pesticides are included in the scope of work (Part C ONLY) the awardee must abide by all of the pertinent regulations and laws that exist in the jurisdiction where the work will take place. In the United States, that usually involves application for and receipt of an Experimental Use Permit from the Environmental Protection Agency (EPA). When such work would take place outside the Untied States, NIAID may also solicit the advice of appropriate experts, and awardees will be expected to provide the same level of protection for the environment as would be afforded if the work were being done in the United States. 3. NIAID Staff Responsibilities The NIAID Program Officer will provide normal stewardship and will also have substantial scientific/programmatic involvement during the conduct of this activitiy through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The NIAID Program Officer will serve as a liaison/facilitator between the awardee, pharmaceutical and biotech industries, and other government agencies (e.g., FDA, USDA, CDC), and will serve as a resource of scientific and policy information related to the goals of the awardee's research. The NIAID Program Officer will facilitate coordination of project activities during the course of the project. The NIAID Program Officer will assist the awardee with access to other NIAID- supported resources and services, including resources for preclinical development such as animal models, screening facilities, standardized research reagents, and a genomics resource center where available. 4. Collaborative Responsibilities The specific timelines, interim objectives and funding levels agreed to by the awardee and the NIAID shall be included in the terms and conditions of award. Given the nature of product development, it is recognized that timelines and interim objectives may require revision and renegotiation during the course of the project period. All such revisions must be agreed to by the awardee and NIAID. Release of each funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon interim objective. 5. Arbitration Any disagreement that may arise on scientific or programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Steering Committee or by the individual awardee in the event of an individual disagreement, a second member selected by the NIAID, and the third member with expertise in the relevant area and selected by the two prior members will be formed to review any scientific or programmatic issue that is significantly restricting progress. While the decisions of the Arbitration Panel are binding, these special arbitration procedures will in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, subpart D, and HHS regulations at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this RFA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into three areas: scientific/research-three parts, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Part A: Hepatitis B Therapies Diana S. Berard Division of Microbiology & Infectious Diseases National Institute of Allergy and Infectious Diseases Room Number 6002, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone: (301) 402-8617 FAX: (301) 402-1456 Email: Part B: Tick-borne diseases transmission prevention Dr. Phillip Baker Division of Microbiology & Infectious Diseases National Institute of Allergy and Infectious Diseases Room Number 3114, MSC-7630 6700B Rockledge Drive Bethesda, MD 20892-7630 Telephone: (301) 435-2855 FAX: (301) 402-2508 Email: Part C: Arthropod vector control epidemiology Dr. Kate Aultman Division of Microbiology & Infectious Diseases National Institute of Allergy and Infectious Diseases Room Number 6014, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone: (301) 435-2854 FAX: (301) 402-0659 Email: o Direct inquiries regarding protocol format and/or other issues related to clinical or field studies to: Dr. Kate Aultman Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room Number 6014, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone: (301) 435-2854 FAX: (301) 402-0659 Email: Direct inquiries regarding review issues, address the letter of intent, and mail two copies of the application and all five sets of appendices to: Madelon Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2150, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 496 2550 FAX: (301) 402-2638 E-Mail: Direct inquiries regarding fiscal matters to: Ms Sharie Bernard Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3219, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-5540 Fax: (301) 480-3780 E-mail: 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 PAR 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 Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2150, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 BETHESDA, MD 20817 (for express mail or courier service) SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at in an interactive format. Please refer to SPECIAL REQUIREMENTS list above. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: APPLICATION RECEIPT DATES: Applications submitted in response to this RFA must be received by the date listed on the first page. 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 will be judged non-responsive and will be returned to the applicant. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES," the RFA number and the words " PARTNERSHIPS: HEPATITIS B AND VECTOR BORNE DISEASES CONTROL" must be entered on the face page. 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 Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2150, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 BETHESDA, MD 20817 (for express mail or courier service) 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: APPLICATION PROCESSING: Applications must be received by the date listed on the first page. The CSR will not accept any application in response to this RFA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIAID. Incomplete or late 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 appropriate peer review groups convened by the NIAID in accordance with the review criteria stated below. There will be three different review groups to handle the three subject areas described in Parts A, B, and C above. 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 Institute of Allergy and Infectious Diseases Council REVIEW CRITERIA The criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of the PAR goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a 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. 1. Significance. Is this project likely to result in or significantly advance development of (Part A) a novel HBV therapeutic, (Part B) a tick borne infectious agent preventative, or (Part C) an arthropod vector control agent/strategy that will add substantively to our ability to treat or control an infectious disease of public health importance? Is the industry commitment adequate to have an impact on the success of the proposed research objectives? If the aims of the application are achieved, are important biomedical agents or products likely to result? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the likelihood of successful project completion high given the current state of research and development and the technical approach? Are the proposed timeline and interim milestones appropriate, feasible and technically sound? 3. Innovation. Many aspects of drug and arthropod vector control method development are not inherently innovative. However, each project will be judged on whether, if successful in completing its aims, the project will add substantially to our ability to treat or control an infectious disease that currently causes a public health burden and is not currently considered an attractive investment by the private sector (i.e., biotechnology, chemical or pharmaceutical industry). 4. Investigator. Is the research and development team appropriately trained and experienced 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)? Is there strong evidence of substantive industrial commitment? 5. Environment. Does the 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 environments including partnerships with industry or employ useful collaborative arrangements? Is there adequate evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE: Letter of Intent Receipt Date: February 24, 2003 Application Receipt Date: March 24, 2003 Scientific Peer Review Date: May, 2003 Advisory Council Date: June, 2003 Earliest Anticipated Award Date: September 2003 AWARD CRITERIA The following will be considered in making funding decisions: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 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 (; a complete copy of the updated Guidelines are available at 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 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at 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. 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 PAR is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance 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 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. 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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