PARTNERSHIPS FOR NOVEL THERAPEUTIC, DIAGNOSTIC AND VECTOR CONTROL STRATEGIES IN INFECTIOUS DISEASES Release Date: December 4, 2001 PA NUMBER: PAR-02-026 (also see addenda NOT-AI-02-022, NOT-AI-02-013, NOT-AI-02-007) National Institute of Allergy and Infectious Diseases (http://www.niaid.nih.gov/) Letter of Intent Receipt Date: February 20, 2002 Application Receipt Date: March 20, 2002 PURPOSE The objective of this program is to support the development of drugs and diagnostics for human infectious diseases of public health importance and products for controlling arthropod vectors that transmit infectious agents. This PAR emphasizes areas that could have a high impact on public health, but currently appear not to be a high priority or that may be considered too financially risky for industry. In addition, research on agents of bioterrorism concern are of high priority. Projects supported under this PAR should have the ultimate goal of producing a novel therapeutic, diagnostic tool, or vector control agent or strategy that adds substantively to the current armamentarium for control of an infectious disease that causes a significant public health burden but is not a current priority for industry Research and Development (see under Research Objectives and Scope for areas deemed responsive to this PAR). Research conducted through this program may fall anywhere along a broad spectrum of activities, from target identification and validation through preclinical development and initial clinical/field evaluation (phase I and II or limited field trials). A key component of this initiative is the development of appropriate partnerships among government, academia, and the biotechnology, chemical and pharmaceutical industries. This initiative is meant to stimulate industry participation in these research areas. For the purpose of this PAR, "industry" is defined as large and small pharmaceutical, biotechnology, and chemical companies, and Public Private Partnerships that include such entities as partners. All projects must demonstrate substantive involvement by a private sector (industry) component. "Substantive involvement" is defined, for the purpose of this PAR, as the commitment of any one or more of the following resources: funds, personnel, 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 preclinical development methods for toxicological and pharmacological testing, clinical testing and data management resources. The Principal Investigator may be affiliated with either a private- or public-sector institution. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has an interest in this research area. Support for applications within the mission of the NIBIB and of high scientific merit may be considered by NIBIB. 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 Request for Applications (PAR), PARTNERSHIPS FOR NOVEL THERAPEUTIC AND VECTOR CONTROL STRATEGIES IN INFECTIOUS DISEASES, 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign for-profit and non- profit organizations; public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments; and eligible agencies of the Federal government. All applications must include substantive involvement by industry (as defined above). Racial or ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U01), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific 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 otherwise stimulate the recipient's activity by involvement in and 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. Details of the responsibilities, relationships, and governance of a study funded under cooperative agreements are discussed later in this document under the section Terms and Conditions of Award. The total project period for applications submitted in response to this PAR may not exceed five years. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present PAR. The anticipated award date is September 3, 2002. 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 PAR will be $6 million. In Fiscal Year 2002, the NIAID plans to fund approximately 3-10 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 PAR 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. RESEARCH OBJECTIVES Background In late 2000, the NIAID led a Summit on Drug Development for Infectious Diseases. The purpose of this meeting was 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. A report of this meeting is available at http://www.niaid.nih.gov/dmid/drug/#7. Many recommendations from this workshop have been incorporated into this initiative. 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 important diseases for which effective vaccines or therapies are lacking or for which existing therapies are incompletely effective and/or toxic to humans. In addition, this initiative is focused on infectious diseases caused by agents of bioterrorism concern. The evolution of drug resistance has diminished the effectiveness of even some of the most safe and efficacious agents, creating a need for the discovery and development of therapeutic agents directed at novel targets. There is also an urgent need for sensitive, specific, rapid, cost-effective, point-of-care diagnostics to guide therapy and stimulate therapeutic development for many of these high public health impact infections, including agents of bioterrorism concern. The wealth of newly available genomic sequence information provides a superb source for the identification of novel targets to use as the basis of design of new specific and selective therapeutic agents and diagnostics. In addition, in some cases, already identified targets have not been used as the basis of drug or diagnostic development. The control of vector-borne diseases is imperiled by the emergence of vector control product resistance and growing concerns regarding safety and environmental impact of existing agents. The development of vector control products has the benefit of a long history of agricultural development and consequently, there exist a large number of validated targets and available chemical entities registered for related arthropods or partially developed for medically relevant vectors. This research will fill critical gaps and will not duplicate activities of industry or other public agencies. The need to support the research specified by this PAR has been emphasized by a number of advisory groups, Task Forces and Program reviews. In addition to the Summit on Drug Development for Infectious Diseases described above, these include NIAID-convened reviews of its TB (1996) and Clinical Antiviral Programs (1995), a review of NIAID's vector biology research agenda (2000), a Rockefeller Foundation-sponsored meeting on TB Drug Development (2000), the IOM report on TB Elimination: "Ending Neglect" (2000), and the NIAID Blue Ribbon Panel on Genomics (1999). In releasing its final report, the Interagency Task Force on Antimicrobial Resistance stated that the discovery and development of therapeutic agents that address new genetic targets is essential to combat antimicrobial resistance (2001). Research Objectives and Scope Responsive research proposals will address treatment or diagnostic strategies for human infections caused by bacteria, parasites, fungi or viruses other than HIV. In addition, projects may target the invertebrate vectors of human disease. Specifically, each proposal should be focused on development of a single ultimate product and address one of the following three high public health impact scientific areas: 1. Development of therapeutic agents for infections that cause significant public health burden for which there is currently felt to be insufficient return on investment to engage private sector investment. To be considered responsive within scientific area "1.", an application must address one of the following problems: a. Infectious diseases whose current treatments are too toxic for one or more medically important patient populations (e.g., cytomegalovirus, trypanosomiasis); b. Infections causing diseases for which there are no available effective drugs (e.g., hemolytic uremic syndrome, pathogenic fungi, Dengue virus, viral encephalitides); c. Infections for which drug resistance is making current therapies ineffective (e.g., bacterial nosocomial infections, tuberculosis, hepatitis B, viral infections, malaria). d. Infectious diseases that are relatively rare except for their emergence as a result of a bioterrorist incident (e.g. anthrax, plague, tularemia, botulism, smallpox, or viral hemorrhagic fevers). A number of scientific opportunities, including the newly available enabling technologies, exist for the development of new drugs to treat these high public health impact diseases. Responsive applications addressing scientific area "1." should propose research along the critical path for development of new therapeutic agents and may encompass one or more steps along this path, including but not limited to: the development and/or use of genomic/proteomic-based technologies to identify and validate novel targets for therapeutic intervention (targets may be either in the pathogen or the host); the utilization of structural and computer-assisted drug design strategies for the discovery of candidate compounds; the development of rapid and high throughput methods for producing and screening libraries of diverse chemical entities; the development of lead compounds through medicinal chemistry, iterative synthesis and evaluation, and preclinical toxicity and pharmacology testing; and early (phase I and II) clinical evaluation. 2. Development of vector control products. Vector-borne infectious diseases present an increasing threat to human health at the same time the tools used to control them are being lost.To be considered responsive within scientific area "2.", an application must address one of the following diseases: a. Malaria, vectored by anopheline mosquitoes; b. Dengue fever, vectored by Aedes mosquitoes; c. West Nile fever, vectored by Culex mosquitoes; d. Lyme disease, vectored by ticks; e. Leishmaniasis, vectored by phlebotomine sand flies; f. Chagas' disease, vectored by triatomine bugs; and g. African trypanosomiasis, vectored by tsetse flies Vector control products include, but are not limited to, adulticides, larvacides, synergists that alter the insects' susceptibility to an insecticide, and semiochemicals that alter insect behavior. Development of chemical entities as vector control products involves a series of steps, including: initial screening of candidates for activity against vector arthropods; dose finding studies; toxicology; formulation; environmental fate and effects studies; and field studies of efficacy in control of disease transmission. Since this vector control strategy development path presents significant hurdles for candidates, there may by candidate chemical entities developed for potential use against other targets that can be screened against medically important arthropods. Similarly, developing data about dipteran insect genomes may allow identification of novel targets for insecticidal or semiochemical activity. Research at any point along this development path is appropriate for this solicitation. Because this PAR is intended to support the development of environmentally sound vector control agents, particular attention should be paid to the development of data about the environmental fate and effects on non-target organisms. 3. Development of rapid, inexpensive, point-of-care diagnostic methods to guide therapy and stimulate therapeutic development. Responsive applications within scientific area "3." include but are not limited to those that propose to utilize genomics and related technologies to identify and validate targets for development of these diagnostic tools. Such tools should ideally be sensitive, specific, rapid, affordable, and easily implemented in routine clinical settings (i.e., at the point-of-care). Responsive applications in scientific area "3." must include projects focused on developing methods for detecting and diagnosing one of the following: a. drug resistance among (culturable or nonculturable) parasites, fungi, viruses and bacteria (including for example but not limited to: nosocomial infections and mycobacteria); b. viral respiratory infections and clinical syndromes such as otitis media, sinusitis, and pneumonia; c. enteric infections and clinical syndromes such as diarrhea and bloody diarrhea; d. neonatal and congenital infections; and e. infection with opportunistic fungi, especially Aspergillus and Candida, in immunocompromised hosts where diagnosis is rate-limiting to therapeutic development and testing. f. diseases caused by agents of bioterrorism concern. SPECIAL REQUIREMENTS Each application must propose a research and development project whose ultimate goal is to produce a novel therapeutic, diagnostic tool, or vector control agent or strategy that adds substantively to the current armamentarium for control of an infectious disease (other than HIV/AIDS) that causes a significant public health burden and is not a current priority for industry activity (as defined in the lists provided above, under Research Objectives and Scope), or is focused on an infectious disease caused by an agent of bioterrorism concern. Each applicant must define the proposed project goal, interim objectives (development milestones) and potential ultimate product, and provide a schedule or timeline for milestone and goal attainment. Any applicant proposing a clinical trial or field study as part of the project must submit a study protocol as part of the application. For guidance on protocol format and/or other clinical issues contact Dr. Ann Ginsberg (contact information is provided below). If appropriate to the proposed project (e.g., for Phase II clinical trials and some field studies), NIAID will require the establishment of an independent DSMB to oversee relevant studies. Applicants proposing clinical trials or field studies should discuss this possibility with NIAID Program Staff before submission of the application. If a DSMB is required, funds to support and convene the DSMB must be included within the proposed budget. Proposed budgets must include funds to travel at least the Principal Investigator to an annual two-day investigators' meeting in Bethesda, MD. In addition, 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. Proposed budgets must include funds to help support travel of two external advisors to an annual progress review meeting. 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 the cooperative agreement (U01), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and 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 the NIAID Scientific Coordinator. Cooperative agreements are subject to the administrative requirements outlined in OMB circulars A-102 and A-110. All pertinent HHS, PHS, and NIH grant regulations, policies and procedures, with particular emphasis on PHS regulations at 42 CFR Part 52 and HHS regulations at 45 CFR Part 74, are applicable. These special terms and conditions pertaining to the scope and nature of the interaction between the NIAID and the investigators will be incorporated in the Notice of Grant Award. However, these terms will be in addition to, not in lieu of, the customary programmatic and financial negotiations that occur in the administration of cooperative agreements. 1. 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 PAR and for performing the scientific activity. Specifically, awardees have primary responsibility as described below. The awardee performing clinical studies sponsored by the NIAID must comply with all Federal regulations for investigational agents. Federally Mandated Regulatory Requirements. The awardee shall be in compliance with all Federal regulations, and NIH policies applying to the conduct of research involving human subjects. These include but are not limited to: Title 21 CFR 50, 56, 312, and Title 45 CFR 46. 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 the awardee is responsible for abiding by all of the pertinent regulations and laws that exist in the jurisdiction where the work will take place. 2. NIAID Staff Responsibilities NIAID staff assistance will be provided by an NIAID Scientific Coordinator. The NIAID Scientific Coordinator will be the NIAID Program staff member with the most appropriate expertise for assisting the awardee. Therefore, the NIAID Program Officer and Scientific Coordinator may be the same individual. The Scientific Coordinator will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The NIAID Scientific Coordinator 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 Scientific Coordinator will facilitate coordination of project activities during the course of the project. The NIAID Scientific Coordinator will assist the awardee with access to other NIAID-supported resources and services, including resources for preclinical and clinical development, such as animal models, screening facilities, standardized research reagents, a genomics resource center and clinical trials networks, where available. The NIAID Scientific Coordinator will assist the awardee with advice about: (i) other NIAID/NIH clinical studies; (ii) subject safety; (iii) compliance with Federal regulations; (iv) study oversight and monitoring; (v) feasibility of timely completion; and (vi) when appropriate, plans for interim monitoring and analysis. 3. 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. 4. 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 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. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 (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 It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and which is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators may also obtain copies from Ann M. Ginsberg (contact information under INQUIRIES, below), who may also provide additional relevant information concerning the policy. 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 found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 PAR 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. LETTER OF INTENT Prospective applicants are asked to submit, by February 20, 2002, a letter of intent that includes a descriptive title of the overall proposed research; the name, address and telephone number of the Principal Investigator; the identities of other key personnel and participating institutions; and the number and title of this PAR. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Madelon Halula at the address listed under INQUIRIES by the letter of intent receipt date listed. APPLICATION PROCEDURES All potential applicants are strongly encouraged to call NIAID program staff before beginning to prepare an application to discuss the responsiveness of their proposed project to the goals of this PAR. The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES," the PAR number and the words "PARTNERSHIPS FOR NOVEL THERAPEUTIC AND VECTOR CONTROL STRATEGIES IN INFECTIOUS DISEASES" must be entered on the face page. Disposition of Intellectual Property. Since an application may include several institutions, including the private sector, complex intellectual property-related situations may arise. To avoid delays related to intellectual property issues, each multi-project group is required to provide, as part of the application, a plan detailing (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. Attention is drawn to the reporting requirements of 35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11 for intellectual property issues. Instructions were also published in the NIH GUIDE FOR GRANTS AND CONTRACTS, Vol. 19, No. 23, June 22, 1990. Note that all NIH grantees may elect title to any new invention made by their employee(s) under the grant or cooperative agreement. It is also noted that a Presidential memorandum of February 18, 1983 extended to all business concerns, regardless of size, the first option to the ownership of rights to inventions as provided in P.L. 96-517. As a result of this memorandum, the relationships among industrial organizations and other participants are simplified, since all group members can now be full partners in the research and in any inventions resulting there from. The specific patenting arrangements among the institutions may vary and could include joint patent ownership, exclusive licensing arrangements, etc. Applicants are encouraged to develop an arrangement that is most suitable for the group's particular circumstances. The disposition of intellectual property agreement among the institutions comprising the group, signed and dated by the organizational officials authorized to enter into intellectual property rights arrangements for each group member and member institution, should be submitted to Dr. Ginsberg (listed under INQUIRIES) prior to award. Details of financial arrangements may be redacted before submission. The agreement should not be submitted with the application. If the group wishes to place all inventions and discoveries resulting from these studies within the public domain, a letter to that effect must be submitted to Dr. Ginsberg in lieu of the intellectual property rights agreement. The letter must be co-signed by the Principal Investigators, the lead investigators for each institution, and each of the business officials representing the respective institutions. Applications must be received by March 20, 2002. Applications not received as a single package by this receipt date or not conforming to the instructions contained in PHS 398 (rev. 5/01) Application Kit, as modified in and superseded by the special instructions below for the purposes of this PAR, will be judged non-responsive and will be returned to the applicant. If the application submitted in response to this PAR is substantially similar to a grant application already submitted to the NIH for review, but that has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application that is essentially identical to one that has already been reviewed cannot be submitted in response to this PAR. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided 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 mail or 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) Applications must be received by the application receipt date listed in the heading of this PAR. If an application is received after that date, it will be returned to the applicant without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. When clinical studies or trials are a component of the research proposed, NIAID Clinical Terms and Conditions of Award will be included with awards. NIAID policy includes the requirement that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. NIAID policy was announced in the NIH Guide on February 24, 2000 and is available at http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html. The full policy including terms and conditions of award is available at http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. When experimental field applications of chemical pesticides are included in the scope of work the applicant 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review (CSR) and for responsiveness by NIAID staff; those judged to be incomplete or non-responsive will be returned to the applicant without review. Applications that are complete and responsive to the PAR will be evaluated for scientific and technical merit by an appropriate peer review committee convened by the Division of Extramural Activities, NIAID. As part of the initial merit review, all applications receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Allergy and Infectious Diseases Council. The NIAID will withdraw from competition those applications judged to be non- competitive for award and will notify the applicant and institutional business officials. 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 a novel therapeutic or vector control agent/strategy or diagnostic technique that will add substantively to our ability to diagnose or 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 diagnostic technologies 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, diagnostic and 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 diagnose, 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: O The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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 The adequacy of the proposed plan to share data, if appropriate. Schedule Letter of Intent Receipt Date: February 20, 2002 Application Receipt Date: March 20, 2002 Scientific Peer Review Date: July 8, 2002 Advisory Council Date: August, 2002 Earliest Anticipated Award Date: September 3, 2002 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 The earliest anticipated date of award is September 3, 2002. INQUIRIES Written and telephone inquiries concerning this PAR are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic, research scope, and eligibility issues to: Ann M. Ginsberg, M.D., Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 3133, MSC-7630 6700-B Rockledge Drive Bethesda, MD 20892-7630 Telephone: (301) 496-5305 FAX: (301) 496-8030 E-Mail: ag73i@nih.gov 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) 402-2636 FAX: (301) 402-2638 E-Mail: mhalula@niaid.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jeanette Gorden Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3222, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-5065 Fax: (301) 480-3780 E-mail: jgorden@niaid.nih.gov 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 Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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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