NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR TUBERCULOSIS (NCDDG-TB) RELEASE DATE: November 18, 2002 (see amendment NOT-AI-03-009) PA NUMBER: PAR-03-028 RECEIPT DATE: May 13, 2003, 2004, and 2005 (per amendment NOT-AI-03-009) EXPIRATION DATE: May 14, 2005 (per amendment NOT-AI-03-009) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) APPLICATIONS IN RESPONSE TO THIS PROGRAM ANNOUNCEMENT (PA) MUST BE PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" WHICH IS AVAILABLE AT THE FOLLOWING LINK: http://www.niaid.nih.gov/ncn/grants/multibron.htm THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), invites multidisciplinary program project grant applications to support projects with adequate preliminary data for serious development of new therapies to treat tuberculosis, a prominent AIDS- associated co-infection. Studies may include research on identified targets for rational design of inhibitors or projects with candidate compounds of known chemical identity with suitable efficacy and selectivity for exploration as candidate drugs. It is anticipated that multidisciplinary approaches by scientists from a combination of academic, non-profit research, and commercial organizations, with the assistance of NIAID, will be necessary to effectively accelerate development of new therapeutics. The focus of this PA is on targeted drug discovery research; random or large scale screening as well as clinical trials will not be supported under this PA. Applications that include collaborations with the private sector (e.g., pharmaceutical, chemical or biotechnological companies) are strongly encouraged. RESEARCH OBJECTIVES Although HIV is the primary cause of the progressive immunological deterioration seen in AIDS, associated infectious diseases remain the most life-threatening complications of HIV infection, resulting in profound morbidity and mortality. Populations without access to potent antiretroviral drugs are especially vulnerable to infectious diseases. The most deadly reported co-infection in Africa, Asia, and Eastern Europe is tuberculosis. The clinical management of co-infections in immunocompromised patients remains difficult. Available drugs to treat opportunistic infections (including tuberculosis) do not exhibit adequate potency to completely eradicate infecting organisms, and prolonged HIV-mediated immunosuppression requires prolonged treatment schedules and prophylaxis regimens against recurrence of infections. Existing anti-tuberculosis drugs administered under directly observed therapy are effective in HIV infected patients, but the duration and expense of management are considerable obstacles for some societies. Toxicity and adverse side effects of therapeutic agents, long-term drug use leading to patient intolerance or drug resistance, frequent relapses, and drug-drug interactions, complicate the medical management of AIDS patients. The alarming emergence of multiple drug resistant Mycobacterium tuberculosis strains is causing many of the current anti-TB drugs to become ineffective. New ideas and novel approaches are urgently needed to overcome the lack of therapeutic options available, particularly to people with AIDS. Research Objectives and Scope The objective of this PA is to encourage biological, chemical/biochemical, or pharmacological studies directed toward development of candidate drugs that are lethal to the pathogen with minimal toxicity for the host. The research scope emphasizes studies on drugs to treat pulmonary Mycobacterium tuberculosis infection. Example areas of research may include, but are not limited to the following suggestions: o expression of confirmed drug targets; modeling and synthesis of inhibitors; efficacy evaluations in vitro and in vivo; mechanisms of action studies. o evaluation of known gene products expressed during infection for targeted drug intervention; comparison of synthesized or known therapeutics on organisms growing intracellularly or at the site of infection; selection and production of candidate therapeutic agents for animal efficacy and toxicity testing. o development, validation, and implementation of drug evaluation systems capable of predicting bactericidal and sterilizing activity of new agents, or combinations of agents against M. tuberculosis. o molecular modeling using available crystalline proteins; selection and synthesis of ligands; evaluation of molecular interactions and microbiological effects. o further preclinical development to examine the clinical candidacy of a selected compound including synthesis research, biological efficacy testing in animal systems, bioavailability estimations, pharmacokinetics and preliminary toxicity testing; metabolic effects or modification; interactions with anti-retroviral agents. MECHANISM OF SUPPORT This PA will use the NIH cooperative agreement grant (U19) award mechanism. U19 awards support broadly based, multidisciplinary research programs that have a well-defined, central research focus or objective. An important feature is that the interrelationships of the individual scientifically meritorious projects will results in a greater contribution to the overall program goals than if each project were pursued individually. The cooperative agreement grant consists of a minimum of two interrelated individual research projects that contribute to the program objective. This type of award also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the award. The total project period for U19 grants may not exceed five years. In addition, U19 grant applications submitted in response to this PA may not request in excess of $900,000 first-year total (direct and indirect) costs. Applicants for U19 grants must follow special application guidelines in the NIAID Brochure entitled "Instructions for Applications For Multi-Project Awards"; this brochure is available via the World Wide Web at: http://www.niaid.nih.gov/ncn/grants/multibron.htm This PA uses just-in-time concepts. The NIH U19 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". ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions 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 Patent Coverage and Reporting Because inventions leading to new drugs are the anticipated products of this program announcement, it is essential that applicants provide plans to ensure such coverage. Since several institutions may be involved in these collaborative projects, complex patent situations may arise. Where applicable, each applicant must provide a detailed description of (1) the approach to be used for obtaining patent coverage and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution; and (2)the procedures to be followed for the resolution of legal issues 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. Instructions were also published in the NIH Guide to Grants and Contracts, Volume 19, Number 23, June 22, 1990. Note that non- profit organizations (including universities) and small business firms retain the rights to any patents resulting from Government contracts, grants or Cooperative Agreements. 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 members can be full partners in the research and in any inventions resulting therefrom. 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 their own particular circumstances. The patent agreement among the collaborating institutions, signed and dated by the organizational official authorized to enter into patent arrangements for each investigator and institution, must be delivered to Dr. Barbara Laughon prior to an award at the address listed under INQUIRIES. A copy of the proposed patent agreement should be submitted with the application. If the collaborators wish to place all inventions and discoveries resulting from these studies within the public domain, a letter to that effect must be submitted to Dr. Laughon in lieu of the patent agreement prior to award. The letter must be co-signed by the Principal Investigator, each investigator, and each of the business officials representing the respective institutions. Federal regulation clause 37 CFR 401 and HHS Inventions regulations at 45 CFR Parts 6 and 8 require that NIH be informed of inventions and licensing occurring under NIH funded research. Invention and licensing reports must be submitted to the Division of Extramural Invention and Technology Resources, Office of Extramural Research, NIH, 6701 Rockledge Drive, Room 3188, Bethesda, MD 20892. Cooperative Agreement Terms 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] multiproject cooperative agreement (U19), [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 the NIAID Scientific Coordinator. When clinical studies or trials 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: http://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. Integration into the on-going program of the National Cooperative Drug Discovery Groups for the Treatment of Opportunistic Infections (NCDDG) is anticipated. Principal Investigators and project leaders will be expected to attend an annual NCDDG meeting to review progress and share information among awardees. Awardee Rights and Responsibilities and Nature of NIAID Participation It is the primary responsibility of the Principal Investigator to clearly define the objectives and approaches of the Group, to plan and conduct the research stipulated in the proposal, and to ensure that the results obtained are analyzed and published in a timely manner. The data obtained will be the property of the awardee. 1. Meetings a. One mandatory intra-Group meeting is required per year. The Principal Investigator and Project and Core Leaders will meet to review progress, plan and design research activities, and establish priorities within the Group. The Principal Investigator will be responsible for scheduling the time and place (generally at one of the performance sites), for notifying the Scientific Coordinator at least thirty days prior to the meeting date, and for preparing concise (2-3 pages) minutes or summaries of the Group meetings which will be delivered to the members of the Group including the Scientific Coordinator within thirty days following the meeting. NIAID Scientific Coordinator will participate but not chair Group meetings. b. One mandatory meeting of the entire NCDDG program will be held each year at a site designated by NIAID (Bethesda, Maryland is anticipated) during which all Principal Investigators and Project Leaders will present significant findings in symposium format. Data presented at this meeting are selected by the individual presenters in consultation with their Principal Investigator thus affording appropriate protection of proprietary or commercially sensitive information. c. Group communications. A critical determinant of Group success will be the degree of communication among members. Therefore, in addition to the three meetings listed above, additional meetings for coordination of Group activities may be necessary. Regular telephone and written communication will be important and are encouraged. 2. Publications The Principal Investigator will be responsible for the timely submission to the Scientific Coordinator of all abstracts, manuscripts, and reviews (co)authored by members of the Group and supported in part or in total under this Agreement. The Principal Investigator and Project Leader are requested to submit manuscripts to the Scientific Coordinator within three weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications or oral presentations of work done under this Agreement are the responsibility of the Principal Investigator and appropriate Project Leader. All publications (abstracts, peer reviewed manuscripts, reviews) and oral presentations of work supported in part or in total by the NCDDG cooperative agreement must be acknowledged as part of the presentation and will include the mechanism, cooperative agreement number and Institute; for example, "This work was supported in whole (or in part) by the NCDDG program, cooperative agreement number U01-AI-12345, NIAID." 3. Progress Reports An annual Progress Report will be submitted with the Non-Competing Grant Progress Report" which must include significant experimental data obtained and a complete and cumulative list of all publications (abstracts, manuscripts, reviews) (co)authored by Group members and supported in part or in total under this Agreement. Each Progress Report should also include a brief section outlining intra-Group interactions that have augmented activities, citing specific occurrences (e.g., compound X was synthesized under Project 1 and transferred to Project 2 for bioassays). Inter-Group collaboration with other NCDDGs should be specified, where applicable. Interaction with the Scientific Coordinator and the NIAID during the reporting period should be described. The Progress Report must also include basic information as instructed with PHS 2590 "Non-Competing Grant Progress Report" 4. Rights to Data Although the NIAID Scientific Coordinator has a right of access to the data (see NIAID staff responsibilities below), the awardee will retain custody of and rights to the data. Information obtained from the data may be used by the Scientific Coordinator for the preparation of internal reports on the Group's activities. Timely publication of major findings is strongly encouraged. The NIAID Scientific Coordinator may assist the Groups by providing them with compounds for voluntary initial and confirmatory testing. In testing compounds supplied by the NIAID, the Groups agree to abide by any confidentiality agreement between the NIAID and a third party who may have supplied the compounds for testing through NIAID. The awardee institution and the Principal Investigator will be responsible for the Group's application. The award will be made to the applicant institution on behalf of the Group as a whole and not to individual research projects within the Group. The awardee institution will provide a Central Operations Office for the Group, will be responsible for the performance of the entire Group, and will be accountable for the funds awarded. NIAID Staff Responsibilities: Nature of NIAID Participation Assistance via a Cooperative Agreement differs from the traditional research grant in that, in addition to the normal programmatic and administrative stewardship responsibilities, the awarding component (NIAID) anticipates substantial programmatic involvement during performance of the research program. NIAID shall participate as a member of the Group and shall be represented by a Scientific Coordinator. The Coordinator shall be selected from the Division of Acquired Immunodeficiency Syndrome, or from the Division of Microbiology and Infectious Diseases, which are extramural programs of the NIAID. During performance of the award, the NIAID Scientific Coordinator, may provide appropriate assistance, advice, and guidance by: participating in the design of Group activities; advising in the selection of sources or resources; coordinating or participating in collection and/or analysis of data; advising in management and technical performance; or participating in the preparation of publications. However, the role of NIAID will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the Group and that NIAID staff will be given the opportunity to offer input to this process. The manner of reaching this consensus and the final decision-making authority will rest with the Principal Investigator. NIAID Participation in Design of Group Activities, Development of Research Protocols and Evaluation of Results a. The NIAID Scientific Coordinator, like other Group members, may suggest studies within the scope of the Group's objectives and research activities; may present to the Group experimental findings from published sources or from contract projects in support of these suggestions; may participate in the design, but not in the execution, of experiments agreed to by the Group; and may participate in the analysis of results. b. The NIAID Scientific Coordinator may assist the Group or other individual members in research planning, particularly by: o providing needed resources and information that may not be otherwise be available to the Group; o providing data from testing conducted in resource contract laboratories; o providing information concerning work being conducted in other NIAID- supported extramural projects, in order to reduce or prevent duplication of efforts. c. The Scientific Coordinator may serve as a resource for information, laboratory testing, and biological supplies, when such resources are not a normal requirement of the Group's day-to-day research activities but may be required on an occasional basis. The NIAID has a contract program for the preclinical development of compounds for the treatment of AIDS-associated opportunistic infections, including animal models. These resources are intended for initial studies and may not be available on a continual basis. Examples of potential assistance include: reference compounds for standardization of test systems, facilitation of confirmatory testing at research sites including other NCDDG Groups, limited testing in appropriate animal model(s), focused searches of NIAID's computer files of chemical structures and biological activity, chemical re-synthesis, analysis, formulation, and toxicology testing through existing pre-clinical development contracts (contingent upon NIAID's recommendation and prioritization), and networking with other NIH staff, NCDDGs, other collaborators and other Government and non-Government researchers who may provide guidance, expertise or resources to facilitate development of therapies identified by the Group. In addition, the NIAID supports Phase I, Phase II and Phase III clinical trials through a variety of mechanisms. These clinical development resources are available to study promising therapies brought forward from sources such as the NCDDG program. It is understood that the Government provides its consulting and testing services in the interest of promoting experimental anti-infective agents through preclinical and clinical testing and development in the most expeditious fashion, and that newly marketed agents that have utilized this service will be offered to the public at a reasonable cost. NIAID Participation in Collection and Analysis of Data, Procedures for Submission of Results to NIAID, and Preparation of Group Findings for Presentation and Publication. In addition to the special reports and stipulations described below, reporting requirements will be identical to those currently in existence for awardees of traditional NIH research project grants. a. The principal end product of NCDDG activities will be the development of new entities and strategies for treatment of AIDS-associated tuberculosis. Subsequent developmental work through private resources is encouraged. Alternatively, the Group may recommend that development be sponsored by NIAID (see below). In the latter case, it will be necessary for the Principal Investigator, appropriate Project Leaders and NIAID Scientific Coordinator to collaborate in the analysis, summarization, preparation, and presentation of data to the appropriate NIAID staff and its advisory committees. b. NIAID will retain the option to cross-file or independently file an application for investigational clinical trial; e.g., an Investigational New Drug (IND) application to the United States Food and Drug Administration of any invention resulting from these NIAID supported Cooperative Agreements. Reports of data generated by the Group or any of its members required for inclusion in INDs and Clinical Brochures and for cross-filing purposes will be submitted by the Principal Investigator to the Scientific Coordinator upon request. Such reports will be in final draft form and include background information, methods, results, and conclusions. They will be subject to approval and revision by NIAID and may be augmented with test results from other Government sponsored projects prior to submission to the appropriate regulatory agency. Arbitration Process 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 formed to review any scientific or programmatic issue that is significantly restricting progress. This 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 a third member with expertise in the relevant area and selected by the two prior members. 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 PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Barbara E. Laughon, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Room 5108, MSC-7624 6700-B Rockledge Drive Bethesda, MD 20892-7624 Telephone: (301) 402-2304 FAX: (301) 402-3171 Email: Blaughon@niaid.nih.gov Direct inquiries regarding review issues to: Edward W. Schroder, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2151, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Zip code for express couriers: 20817 Phone: 301-435-8537 FAX: 301-402-2638 Email: es170m@nih.gov Direct inquiries regarding fiscal matters to: Jeannette Gordon Division of Extramural Activities National Institute of Allergy and Infectious Disease, NIH Room 2125, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Zip code for express couriers: 20817 Tel: (301) 402-5065 Fax: (301) 480-3780 Email: jg82s@nih.gov SUBMITTING AN APPLICATION Applicants for U19 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 http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. 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: Edward W. Schroder, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2151, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Zip code for express couriers: 20817 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. SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA: Applicants for U19 cooperative agreements must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available from NIAID listed under INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. This brochure presents specific instructions for sections of the PHS 398 (rev. 5/01) application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398. APPLICATION PROCESSING: Applications must be received by the receipt date shown on the first page. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAID. Incomplete or non-responsive applications will be returned to the applicant without further consideration. An appropriate peer review group convened by the Division of Extramural Affairs (DEA) at NIAID, in accordance with the review criteria stated below, will evaluate applications that are complete and responsive to this PA for scientific and technical merit. 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 general review criteria for U19 multi-project cooperative agreement 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 o Overall evaluation and scoring The overall application score will be based on review and merit of the individual components as well as the merit of the application taken as a whole. A single numerical priority score will be assigned to the whole application after consideration of all of the review elements listed below. The overall research plan and the individual Research Projects will be assigned numerical priority scores, while the Administrative and Facilities Cores will be rated acceptable or unacceptable without numeric scores. The overall score will be based on the scientific merit of the individual components as well as the overall synergy, the effectiveness and adequacy of plans for sharing resources, the overall program organization and capability of the associated personnel and the likelihood that new, effective antimicrobial agents will be identified during the course of the proposed research. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: 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. 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) DATA SHARING: The NIH encourages the timely dissemination of research tools and results, in support of further research and development. The NIH has issued a document that addresses these concerns: http://www.ott.nih.gov/policy/rt_guide_final.html COMPLIANCE WITH THE NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES: Applications proposing to use recombinant DNA molecules and techniques must adhere to the NIH Guidelines for Research Involving Recombinant DNA Molecules, http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html, which outline practices to ensure the safety and containment of this research. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities and programmatic balance 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: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (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 http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 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 http://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. 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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NIH Funding Opportunities and Notices
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