RFA-AI-00-010: CHALLENGE GRANTS: JOINT VENTURES IN BIOMEDICINE AND BIOTECHNOLOGY

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.

CHALLENGE GRANTS: JOINT VENTURES IN BIOMEDICINE AND BIOTECHNOLOGY Release Date: February 10, 2000 RFA: AI-00-010 National Institute of Allergy and Infectious Diseases (http://www.niaid.nih.gov) Phase I Application Receipt Date: March 9, 2000 Phase I Award Date: April 10, 2000 Phase II Application Receipt Date: June 9, 2000 Phase II Award Date: September 2000 PURPOSE The purpose of this initiative is to support research and development efforts whose outcomes could significantly reduce the impact of infectious diseases nationally and worldwide. Included in FY 2000 Public Health and Social Services Emergency Fund appropriation is $20,000,000 designated for "NIH Challenge Grants and Partnerships." This new initiative is intended "to promote joint ventures between the National Institutes of Health and the biotechnology, pharmaceutical, and medical device industries" and involves a "one-on-one matching of federal dollars by qualified organizations that are conducting R&D activities in biomedical research or biotechnology with commercializable potential or conducting research in promising therapies." The National Institute of Allergy and Infectious Diseases (NIAID) has identified areas of high importance where it believes successful product research and development combined with existing infrastructures and federal challenge grant funding could significantly impact a major health or medical problem. Applications in response to this RFA for challenge grants are limited to these areas (see RESEARCH SCOPE below). In summary, this initiative seeks to stimulate progress in each of the following areas: o Medicines for Malaria o Medicines for Tuberculosis o Vaccines for Influenza o Vaccines for Emerging and Resistant Infections o Therapeutics for Emerging and Resistant Infections. Potential applicants are encouraged to send an e-mail to NIAIDCHALLENGE@NIAID.NIH.GOV identifying their organization, topic of their possible R&D effort, and proposed principal investigator. Based on the research and development topic, appropriate NIAID Program Officers will contact the potential applicant and assist in determining whether the proposed research would be responsive to this RFA. Awards will be made in each of the research priority areas pending successful peer review. Awards will be made in two Phases: Phase I awards will be short-term (two month), small dollar ($25,000) research grants for development of detailed plans for implementation of research and development efforts (i.e., a Phase II grant application), Phase II awards will be cooperative agreement awards to those Phase I awardees whose research plans present the best opportunities, based on peer review and potential public health significance, for products that will benefit the public health. It is expected that not all Phase I awardees will be selected for Phase II awards. Phase I grants do not require matching funds. Phase II Challenge grants require that the awardee provide support from non-federal funds equal to or greater than the grant award amount. Matching includes in-kind resources such as staff salary, facilities and equipment, other direct costs (e.g., travel, subcontracts) to be expended during the period of performance of the grant. Past expenditures cannot be used as matching. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications, CHALLENGE GRANTS: JOINT VENTURES IN BIOMEDICINE AND BIOTECHNOLOGY, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at <http://odphp.osophs.dhhs.gov/pubs/hp2000>. ELIGIBILITY REQUIREMENTS Phase I applications must directly address one or more of the research topics in RESEARCH SCOPE below. Only Phase I awardees will be eligible for Phase II awards (See APPLICATION PROCEDURES below). Applications may be submitted by domestic for-profit and non-profit organizations such as biotechnology, bioengineering and pharmaceutical companies with collaborators as necessary from universities, colleges, hospitals, and laboratories. Participation of international partners is encouraged where appropriate. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Each Phase II awardee organization must match on at least a 1:1 basis each dollar awarded by the NIH in this challenge grant program. Phase II awards will be performance-based, that is, funding will be tied to the achievement of agreed to interim research objectives. Awardee matching must be done over the period of the award. MECHANISMS OF SUPPORT Two administrative funding mechanisms will be used to fund the Challenge Grant program: the RC1 grant will support Phase I R&D planning efforts, the UC1 cooperative agreement will support Phase II R&D implementation. Phase I Applications. The NIH Challenge Grant and Partnership Program Phase I (RC1) grant mechanism will be used. A Phase I award will be made for two months for a total cost of $25,000 to provide support for costs associated with planning a large scale research and development effort. There is no matching funds requirement for this small award. Abbreviated applications are to be prepared for Phase I awards (see APPLICATION INSTRUCTIONS BELOW). Phase II Applications. Only Phase I awardees will be eligible for a Phase II cooperative agreement award. The NIH Challenge Grant and Partnership Program Phase II Cooperative Agreement (UC1) grant mechanism will be used. A Phase II award will be made for a period of up to three years. Phase II awards will be performance-based awards. That is, funds will be awarded in increments based on the attainment of interim research objectives defined by the applicant and approved by the NIAID (see APPLICATION INSTRUCTIONS and TERMS AND CONDITIONS OF AWARD below). Because funding will be tied to the attainment of interim research objectives, funding will not be provided annually as is traditional for NIH grants, but will be linked to project timelines and interim objectives (see APPLICATION INSTRUCTIONS below). The UC1 cooperative award is an "assistance" mechanism, rather than an "acquisition" mechanism. 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. Essential elements of the challenge grant cooperative agreement mechanism include: (1) interim research and development targets upon whose achievement the next increment of funds will be released to the awardee, (2) a single Principal Investigator who will be scientifically and administratively responsible for the research and development effort, and (3) a single applicant organization that will be legally and financially responsible for the use and disposition of funds awarded. Details of the responsibilities and relationships for research and development funded under a cooperative agreement are discussed later in this document under the section "Terms and Conditions of Award." FUNDS AVAILABLE NIAID intends to commit approximately $20,000,000 in total costs in FY 2000 to fund Phase I and Phase II awards. NIAID intends to fund 10 to 15 Phase I awards at $25,000 each from the five research areas identified below. The balance of the $20,000,000 will be used to fund Phase II awards. NIAID plans to fund only some of the Phase I awardees for Phase II. A Phase II applicant may request a project period of up to three years. The actual number, budget, and distribution of awards will be determined based on the scientific merit of the applications received, their contribution toward meeting the goals of this RFA, and their potential contribution to the public health. It is anticipated that Phase II awards will vary widely in award amounts from hundreds of thousands to millions of dollars per award. RESEARCH OBJECTIVES Background The FY 2000 Public Health and Social Services Emergency Fund appropriation provides $20 million to the NIH for the NIH Challenge Grants and Partnership Program. The last half of the 20th Century has been witness to two contradictory phenomena. There have been dramatic improvements in our ability to treat and prevent many common infectious diseases. At the same time it is also apparent that many other infections, such as dengue, tuberculosis and malaria, have eluded control efforts and other infectious diseases have been newly recognized. This new initiative is intended "to promote joint ventures between the National Institutes of Health and the biotechnology, pharmaceutical, and medical device industries" and involves a "one-on-one matching of federal dollars by qualified organizations that are conducting R&D activities in biomedical research or biotechnology with commercializable potential or conducting research in promising therapies." The NIAID will be piloting a new performance-based grants mechanism for this initiative. For this pilot program, NIAID has identified five areas of high importance where it believes successful product research and development combined with existing infrastructures and federal challenge grant funding could significantly impact a major health or medical problem. NIAID will use this new challenge grants mechanism to advance global and national health, by addressing emerging diseases including antimicrobial resistance by utilizing genomics and other cutting edge technologies and by coordinating with existing infrastructures to advance product development. This solicitation seeks to stimulate progress in the following areas: development of medicines for malaria, medicines for tuberculosis (TB), influenza vaccines for pandemic preparedness, vaccines for emerging and resistant infections, and therapeutics for emerging and resistant infections. Research Scope To be responsive to this announcement, applications must address one or more of the following topics. 1. Medicines for Malaria Almost 500 million people suffer from acute malaria each year resulting in an annual death toll of at least one million individuals, most of malaria’s victims are children. With the absence of a vaccine and problems with vector control, efforts to control malaria rely on drugs. Unfortunately, safe, effective and affordable drugs, such as chloroquine, are failing as a result of the selection and spread of drug resistant strains of malaria parasites. New drugs are desperately needed. The NIAID has supported basic, field and clinical research on malaria. Drug research and development, however, requires the kinds of expertise, coordination and management that are the hallmarks of industry. Therefore, there is a critical need to engage the private sector in the malaria drug development process. Advances in malaria research, including genomics, and genetic manipulation of parasites, are providing new opportunities for identifying and validating drug targets. Similarly, advances in structural biology and synthetic chemistry are providing chemical entities that will provide new leads for drugs. The private sector is well poised to pursue the development of validated targets and/or lead inhibitors that are further along the critical pathway, including through their preclinical and clinical stages. This challenge grants program seeks to support such private sector R&D efforts, with matching funds, for projects that will lead to the commercialization of a new antimalarial compound. 2. Medicines for Tuberculosis Tuberculosis (TB) is a leading cause of death worldwide, killing 2-3 million people every year, it is the number one killer of women between the ages of 15 and 44 years. Although effective and relatively inexpensive therapy exists, standard regimens require patients to take three to four drugs for a minimum of six months. Such complicated regimens are logistically difficult to implement and extraordinarily hard for patients to comply with. As a result, the WHO estimates that only 15% of TB patients worldwide are receiving adequate regimens. Partial treatment in large numbers of patients has led to a global crisis caused by the development and spread of multi-drug resistant (MDR) strains. MDR-TB has been identified on five continents and in 42 States and the District of Columbia in the U.S. As a result, there is a crucial need for new drugs: both to treat these drug resistant organisms, and most importantly for the long run, to shorten and simplify the standard treatment regimens, thereby helping to prevent the continuing development of new drug resistant strains. It is the intention of these challenge grants to encourage the private sector to develop new TB drugs, including: identification of potential new drug targets and novel classes of drugs (making use, where appropriate, of knowledge of the M. tuberculosis genome sequence and high throughput approaches), preclinical development of novel classes of drugs and optimization of lead compounds, and clinical testing of potential new therapies. 3. Influenza Vaccine Development for Pandemic Preparedness The influenza pandemic of 1918-1919 was one of the worst epidemics of an infectious disease ever recorded, with an estimated world death toll of 20-25 million. Five major influenza pandemics have occurred since 1889, the most recent in 1968 (Hong Kong flu). Experts predict we are due for a new pandemic at any time. The overall goal of the NIAID Influenza Program is to stimulate research that leads to more effective approaches to controlling influenza virus infections. As part of the NIAID/NIH contribution to Influenza Pandemic Preparedness, NIAID is seeking challenge grant applications for 1) the production of pilot lots of inactivated, live attenuated, or recombinant influenza virus vaccines to support clinical studies and 2) the development of a suitable cell culture system as an alternative to egg-derived influenza vaccines. The vaccines required for the clinical studies are to be prepared from avian influenza subtypes with high pandemic potential. For each vaccine lot, the manufacturer would be expected to provide no less than 2000 single dose containers (in doses to be established by the Government) produced according to current good manufacturing practices to permit use of the vaccines in clinical trials. The manufacturer is expected to take responsibility for all release testing, including required and appropriate tests for safety, sterility, and potency, and to provide full documentation to the Government. 4. Vaccines for Emerging and Resistant Infections (Dengue and/or West Nile Virus, TB, and multidrug resistant Staphylococcal infections) Dengue Many of the mosquito-borne viral diseases in the flavivirus group are emerging and causing severe epidemics in areas where outbreaks were not previously common. Within this group of viruses are over 20 human pathogens including dengue, West Nile, Japanese encephalitis and yellow fever viruses. Dengue viruses are the most widespread arthropod-borne viruses. It is estimated that 35 to 60 million people are infected with dengue each year. The disease threatens ever-larger areas as urbanization promotes infestation of expanding regions by potential vectors. Control of dengue would benefit greatly from an efficient vaccine. A number of dengue vaccine candidates are in pre-clinical development. West Nile Virus In 1999, there was a deadly outbreak of West Nile virus in New York. West Nile virus belongs to the family of flaviviridae, which also includes St. Louis encephalitis, yellow fever, dengue, and hepatitis C virus. Alarmingly, as scientists briefed the Congress recently, it appeared that the virus that emerged in New York is a new strain never before seen in the Western hemisphere. It is highly probable that the virus will return in the Spring with migrating birds. This challenge grants program seeks to support such private sector R&D efforts, with matching funds, for projects that will lead to the commercialization of a vaccine for the prevention of dengue virus and/or West Nile virus infections. Tuberculosis Tuberculosis (TB) continues to be the leading infectious cause of death worldwide, including the over 30% of AIDS patients who die of TB, and the global crisis is worsening as multi-drug resistant strains develop and spread throughout much of the world. One in three people is believed latently infected with M. tuberculosis, the bacterium that causes TB, and 10 % of these are likely to progress to active disease at some time in their lives. The only currently available vaccine for tuberculosis, BCG, is delivered in more doses annually than any other vaccine worldwide, yet it is having little discernible impact on the global TB epidemic. BCG appears to have reasonable efficacy in protecting against extrapulmonary TB in young children, but clinical trials have demonstrated variable efficacy (0-80%) for this vaccine against adult pulmonary TB, which causes the major morbidity and mortality burden of this disease. As a result, development of improved TB vaccines, both to prevent primary disease and to block reactivation in those already infected, must be a major global public health priority. NIH seeks to encourage the private sector to increase its commitment to TB vaccine development through these challenge grants. In particular, it encourages the use of whole genome approaches for the identification of promising protective antigens, and the development of both pre- exposure and post-infection candidate vaccines from pre-clinical through clinical testing. Infections Due to Multi-Drug Resistant Staphylococcus aureus and Coagulase Negative Staphylococcal Species Staphylococcus aureus and coagulase negative staphylococci (CNS) are a major health concern as evidenced by the widespread occurrence of hospital- and community-acquired infections, including skin, soft tissue, and surgical wound infection, abscesses, bacteremia, pneumonia, endocarditis, osteomyelitis, and septic arthritis. Together S. aureus and CNS account for over half of all nosocomial infections and a significant proportion of community-acquired infections. Attributable increased morbidity and mortality, increased length of hospital stay, and direct medical care costs are exceedingly high and pose objectives for reduction. Strains of staphylococci resistant to first-line drugs such as synthetic penicillins are becoming more common, especially in hospitalized patients. Of greatest concern however, is the emergence of strains with reduced susceptibility to vancomycin, the antibiotic of last resort occurring in hospitalized patients suffering from chronic and complicated illnesses. Through the challenge grants mechanism NIAID seeks to interest the private sector in pursuing preclinical and clinical studies of passive or active immunization candidates to protect against resistant staphylococcal infection, first in the most vulnerable populations such as severely-ill hospitalized patients and patients facing major surgery and at risk for infection, and then also for potentially broader application to community situations. 5. Therapeutics for Emerging and Resistant Infections (vancomycin resistant enterococcal, multi-drug resistant staphylococcal, West Nile and Nipah Viruses). Vancomycin-Resistant Enterococci Enterococci are among the most important and difficult to treat nosocomial bacterial pathogens in the U.S. today, and are becoming a substantial problem in Canada and Western Europe. Currently, enterococci are the second most common cause of hospital-acquired infections in the U.S., and cause many urinary tract, surgical wound, soft tissue, and bloodstream infections. While Enterococcus faecalis has been the predominant pathogen in the past, the rapid spread of vancomycin resistance has been associated with a massive shift in species selection. E. faecium now predominates over E. faecalis by a 10:1 ratio in vancomycin-resistant enterococcal (VRE) infections. VRE is on the rise with VRE hospital-acquired infections increasing from less than 1% of all infections in 1989 to over 23% in 1998 in representative U.S. hospitals. In addition to having acquired resistance to vancomycin, enterococci are intrinsically resistant to a number of antimicrobials, and the few agents that remain active against enterococci are bacteriostatic making treatment difficult or impossible. New and innovative interventions are needed for managing these infections. The discovery of viruses that can infect and destroy bacteria (bacteriophages) is a promising therapeutic approach for VRE, particularly in high-risk populations such as the immunosuppressed and/or seriously ill patients in cancer centers and organ transplant units. This challenge grants program seeks to support clinical research and trials to determine whether bacteriophage therapy is both efficacious and safe and whether development of resistance to the phage is a significant deterrent to its widespread adoption in hospital settings. Multi-Drug Resistant Staphylococcus aureus and Coagulase Negative Staphylococci Staphylococcus aureus and coagulase-negative staphylococci (CNS) cause 40 to 60% of the 2-3 million hospital-acquired infections each year in the U.S. Methicillin was one of the first synthetic penicillins developed to treat penicillin-resistant staphylococcal infections, however, shortly after introduction, methicillin-resistant Staphylococcus aureus (MRSA) isolates began to appear and their prevalence has increased rapidly. MRSA increased from almost 24% to nearly 45%, and methicillin resistant-CNS increased from 69% to over 82%, between 1989 and 1998 in representative hospitals throughout the United States. The emergence of methicillin-resistant strains of S. aureus and CNS prompted the extensive use of vancomycin, which has resulted in changes in susceptibility of S. aureus to glycopeptide antibiotics. There have been reports of S. aureus with reduced susceptibility to vancomycin from France, Japan, the U.S, and China advancing us toward the possible emergence of untreatable staphylococcal infections. It is the intention of this challenge grants program to encourage the private sector to develop narrowly targeted alternative therapies that could be reserved for treatment of resistant staphylococcal infections. West Nile and Nipah Viruses In 1999, there were two outbreaks of exotic viral infections that caused deadly diseases: (1) West Nile virus in New York and (2) Nipah virus in Malaysia and Singapore. West Nile virus belongs to the family of flaviviridae, which also includes St. Louis encephalitis, yellow fever, dengue, and hepatitis C virus. Alarmingly, as scientists briefed the Congress recently, it appeared that the virus that emerged in New York is a new strain never before seen in the Western hemisphere. It is highly probable that the virus will return in the Spring with migrating birds. Nipah virus is a member of the paramyxovirus family-a family noted for spontaneous mutations leading to changes in host range. A few US pharmaceutical companies have recently engaged in the development of antiviral drugs that may have the potential to treat these viral infections. Support from NIH challenge grants may facilitate their ability to develop drugs to treat these deadly diseases. General Goal for All Supported Priority Areas The goal of each supported research and development endeavor must be to produce usable and useful research tools or biomedical products by the end of the grant period. Each applicant must define the proposed products and interim objectives with a proposed schedule for their attainment. TERMS AND CONDITIONS OF AWARD FOR PHASE II (UC1) AWARDS 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 NIH Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps. Applicants should pay particular attention to the section Availability of Research Results: Publications and Intellectual Property Rights, Including Unique Research Resources . The administrative and funding instrument used for this program is the challenge grant cooperative agreement (UC1), 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. 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 RFA 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. 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 the International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for International Organizations of Medical Sciences (CIOMS). 2. NIAID Staff Responsibilities NIAID staff assistance will be provided by a NIAID Scientific Coordinator. The NIAID Scientific Coordinator will be the NIAID staff member with the most appropriate expertise for assisting the awardee. The Scientific Coordinator will have substantial scientific/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). NIAID will serve as a resource of scientific and policy information related to the goals of the awardee’s research. The NIAID Scientific Coordinator will assist the awardee with access to resources and services available from other NIAID awardees. When required (i.e., for phase II and phase III clinical trials) NIAID will independently support a Data and Safety Monitoring Board (DSMB) that will oversee clinical trials. 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. Joint Responsibilities The specific timelines, interim objectives and funding for their achievement agreed to by the awardee and the NIAID shall be included in the terms and conditions of award. It is suggested that an applicant proposed no more than two interim objectives and a final objective (or product). Initial release of funds will be to support achievement of the first interim objective. Release of the next funding increment will be based on the achievement of the previous 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, a second member selected by the NIAID, and the third member with expertise in the relevant area selected by the first two members 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. 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. 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 subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: <http://grants.nih.gov/grants/guide/notice-files/not94-100.html>. 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 is available at the following URL address: <http://grants.nih.gov/grants/guide/notice-files/not98-024.html>. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES It is in the interest of both the NIAID and the R&D community to ensure that time and effort are not expended in preparation of non-responsive or non-competitive grant applications for either Phase I and Phase II grant applications. To that end, potential applicants for Phase I (RC1) planning grant for development of a detailed research plan (i.e., Phase II grant application) should identify their research topics and are encouraged to send them via e-mail to NIAIDCHALLENGE@NIAID.NIH.GOV prior to preparation of a grant application. For potential applicants whose projects may not be suitable as responses to this RFA (e.g., no or very small probability of successful completion of a commercializable or otherwise specified product within three years), there are other opportunities for support of R&D efforts such as investigator-initiated research grants (R01s) and SBIR and STTR grants including the SBIR-AT-NIAID program which supports large dollar research and development effort on topics included in this RFA. The application procedure for this RFA has two parts: Phase I (RC1) Grant Application Procedures Phase II (UC1) Grant Application Procedures PHASE I (RC1) APPLICATION PROCEDURES Phase I awards are intended to support detailed planning of the large scale R&D project for submission as a Phase II application. In general, the Phase I application will be used to gauge the significance and feasibility of the full R&D effort. Specific review criteria are discussed below. Applicants must submit, by March 9, 2000, a Phase I application that contains an overview of the proposed R&D project. Phase I applications will be evaluated by an appropriately constituted peer review group convened by NIAID. Phase I applicants will be advised by April 5, 2000 whether their applications will be funded, awards will be made for $25,000 for the period April 10, 2000 to June 9, 2000. Phase II applications will be due on June 9, 2000. Only Phase I awardees may submit Phase II applications for scientific merit review. Contents of Phase I Applications Phase I applications are to be submitted on the standard research grant application form PHS 398 (rev. 4/98). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: grantinfo@nih.gov and on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html. A Phase I response to this RFA should follow the PHS 398 instructions with the following modifications to allow briefer submissions: Application face page (form AA). Complete all data items on the Face Page (see PHS 398 instructions). The RFA label found in the PHS-398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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. On line 2, the RFA number, AI-00- 011, and RFA title, CHALLENGE GRANTS: JOINT VENTURES IN BIOMEDICINE AND BIOTECHNOLOGY, must be entered and the YES box must be marked. Do not complete items 4 and 5. This information will be needed for a Phase II application. For items 6, 7, and 8, enter the following information: 6. Dates of proposed period of support: From 4/9/2000 through 6/8/2000. 7. Cost requested for initial budget period: 7a ($17,000), 7b. Total Costs $25,000. 8. Cost requested for proposed period of support: 8a ($17,000), 8b Total Costs $25,000. Form BB - Complete as instructed in PHS 398 kit. Form CC (Table of Contents) - Complete as instructed. Form DD, EE, FF, GG do not complete, do not submit. Form HH Resources complete as instructed. The Research Plan may not exceed 10 pages. The research plan must have the following five sections: a. Specific Aims What do you intend to do? What product or products will be developed? (recommend one page or less) b. Background and Significance Why is the R&D important? What is the potential public health benefit? What is the probability of a beneficial product? (recommend one to two pages) c. Preliminary Studies What has already been done? How does this support the proposed R&D effort? (recommend two to three pages) d. Research Methods In general, how are you going to perform the R&D effort? (recommend four to six pages) e. Preliminary Phase II Grant Duration and Budget. Recognizing that a Phase II grant application will provide more detailed project plans and estimates of the duration and costs of the full R&D effort, please provide the following three items: 1. Estimated duration of Phase II R&D effort: can range from one year to three years. 2. Estimated total cost for full R&D effort (excluding previously incurred costs): 3. Estimated grant funds needed to support the R&D effort. Remember: (1) grant funds cannot exceed one-half of the total amount, and (2) matching funds from non-Federal sources must be provided for the other half or more of the costs. Form II Checklist. Check the box for the Type of Application (new). Do not complete Items 1, 2 and 3 for the phase I application. Complete Item 4, Smoke Free Workplace. Form KK Personal Data complete as instructed. The sample RFA label is available at the following URL: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist and three 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 copies of the application must be sent to: Madelon Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Room 2150, MSC 7616 Bethesda, MD 20892-7616 Applications for Phase I awards must be received by March 9, 2000, If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. PHASE II (UC1) APPLICATION PROCEDURES Phase II projects can be for up to three years. Phase II awardees must match grant funds 1:1 with funds from non-Federal sources. Phase II applications must be received by June 9, 2000. Phase II applications will be evaluated by an appropriately constituted peer review group. Phase II applicants will be advised by September 15, 2000 whether their applications will be funded, awards will be made by September 29, 2000. Contents of Phase II Applications Phase II applications are to be submitted on the standard research grant application form PHS 398 (rev. 4/98). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: grantinfo@nih.gov and on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html. The Phase II Challenge (UC1) grants will be performance based, that is: (1) applicants must identify the final product(s) including the stage of development to be completed during the period of the grant. Some examples could be: an influenza vaccine ready for clinical studies, or, a malaria drug ready for clinical testing (INDA process completed), or, a new drug for multiple drug resistant TB ready for Phase II clinical trials. (2) interim objectives to be achieved during the project period of performance. Grant funds will be released initially for funds needed to meet the first interim objective, with the achievement of that interim objective, funds will be released to meet the next objective (interim or final product). Some examples of interim objectives could be: completion of a prototype of a diagnostic tool, submission of an INDA to FDA, or initiation of a Phase III clinical trial. The budget submission (both in the research plan and on the three PHS 398 form pages which contain proposed budgets) must be linked to the interim objectives and final R&D products rather than the traditional annual budget periods requested in NIH grants. The detailed budget data for the first budget period (see instructions for form page DD below) are to be the budget to attain the first interim research objective whether that is in six month period or an 18 month period. The Budget for the Entire Proposed Period of Support (see instructions for form page EE below) should be structured so that the budget for the 2nd budget period shows the funds needed for reaching the second interim objective (or the final products if there is no second interim objective) and the 3rd budget period shows the funds needed to complete the R&D effort (if there were two interim objectives). Again, these budget periods are tied to performance and not to the calendar, so the budgets can be for periods of more than or less than one year. A Phase II response to this RFA should follow the PHS 398 instructions with the following modifications: Application face page (form AA). Complete all data items on the Face Page (see PHS 398 instructions). The RFA label found in the PHS-398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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. On line 2, the RFA number, AI-00- 011, and RFA title, CHALLENGE GRANTS: JOINT VENTURES IN BIOMEDICINE AND BIOTECHNOLOGY, must be entered and the YES box must be marked. Form BB - Complete as instructed in PHS 398 kit. Form CC (Table of Contents) Complete as instructed in PHS 398 kit. Form DD, Detailed Budget for Initial Budget Period. For Phase II applications in response to this RFA, the initial budget period is defined as the time period needed to complete the first interim objective. In the upper right-hand corner of this page, enter the proposed From (use 9/30/2000) and Through dates for research to complete the first interim objectives. Complete the balance of the form based the efforts to be performed during this interval. Form EE, Budget for Entire Proposed Period of Support. The budgets for a second or a second and a third budget period must be based on the funds needed to attain the next objective, interim or final, not on an annual period. Form FF, Biographical Sketch Follow standard instructions. Form GG, Other Support - Complete as instructed. Form HH Resources complete as instructed. The Research Plan may not exceed 25 pages. The Research Plan must have the following six sections: a. Specific Aims What do you intend to do? What product or products will be developed? b. Background and Significance Why is the R&D important? What is the potential public health benefit? What is the probability of a beneficial product? c. Preliminary Studies What has already been done? How does this support the proposed R&D effort? d. Research Methods How are you going to perform the R&D effort? e. Management Plan What are the major segments of the research effort and the timeline for completion of each and for completion of the research project? What interim objectives are proposed to measure progress? f. Phase II budget narrative (See forms DD and EE above). For each interim objective and for the entire R&D project, what is the total R&D budget, how much is requested from this grant, and how much is being provided by the applicant? What will constitute the matching funds (e.g., funds from investors, applicants own resources (staff time and effort), etc. Remember that matching funds from non-Federal sources must at least equal the funds requested for this grant. Form Page II Checklist. Check the box for the Type of Application (Competing Continuation) and enter Grant number of the Phase I Grant. Complete other information as instructed Form Page KK Personal Data complete as instructed. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 sample RFA label is available at the following URL: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in pdf format. 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 copies of the application must be sent to: Madelon Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Room 2150, MSC 7616 Bethesda, MD 20892-7616 Applications for Phase II awards must be received by June 9, 2000, If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR. Incomplete applications will be returned to the applicant without further consideration. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which 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. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered 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 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: Does this research and development project address an important problem within the scope of this RFA (see RESEARCH SCOPE)? If the aims of the application are achieved, are important biomedical products or biotechnologies likely to result? (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? (3) Investigator(s): Is the research and development team appropriately trained and experienced and well suited to carry out this work? (4) Environment: Does the environment in which the work will be done contribute to the probability of success? Does the proposed research and development take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there adequate evidence of organizational support (i.e., does the applicant meet or exceed the requirement of a 1 to 1 match of non-federal funds for the project)? 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. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities including potential public health significance of scientifically meritorious applications INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic (eligibility and responsiveness) issues and fiscal matters to: NIAIDCHALLENGE@NIAID.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Diseases. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) 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 PHS 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices