RFA-AI-00-008: SMALL BUSINESS INNOVATION RESEARCH: ANIMAL MODELS OF HCV INFECTION

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

SMALL BUSINESS INNOVATION RESEARCH: ANIMAL MODELS OF HCV INFECTION Release Date: November 30, 1999 RFA: AI-00-008 National Institute of Allergy and Infectious Diseases National Cancer Institute National Institute of Alcohol Abuse and Alcoholism National Center for Research Resources Letter of Intent Receipt Date: January 24, 2000 Application Receipt Date: February 24, 2000 PURPOSE This is a multi-Institute solicitation targeting the development/identification of one or more small animal models of hepatitis C infection and disease progression including acute and chronic states, fibrosis/cirrhosis, and liver tumor development-not necessarily all in the same model. Identification of a small, inexpensive, reproducible, well-defined, and non-endangered mammalian animal model for hepatitis C research is critical to the progress of exploration of this pathogen. It is needed to study the pathogenesis, immunology, natural history, and viral replication of hepatitis C as well as to act as a model for the testing of new therapies and, hopefully, vaccine candidates. To date, the chimpanzee, expensive and of limited access, is the only non-human model. This Request for Applications invites grant applications for Small Business Innovation Research (SBIR) projects with award duration and amounts greater than those routinely allowed under the SBIR program. This RFA must be read in conjunction with the Omnibus Solicitation of the Public Health Service (Omnibus Solicitation) for Phase I SBIR Grant Applications (PHS 98-2) and the instructions for Phase II Grant Applications revised March 1998. All instructions and information in these documents also apply to applications. Recently the NIH has announced that applicants may request a larger budget and period of support if necessary for completion of the project (See NIH Guide for Grants and Contracts, February 13, 1998 at: http://grants.nih.gov/grants/guide/notice-files/not98-014.html This RFA provides a flexible system within the SBIR program to cover the extensive needs and complex development processes needed to identify/define and develop a novel animal model of a hazardous infection-hepatitis C. 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 RFA, SBIR: Animal Models of HCV Infection, is related to the priority areas of immunization and infectious diseases, HIV infection, sexually transmitted diseases, clinical preventive services, maternal and infant health, diabetes and chronic disabling conditions, and surveillance and data systems. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY Eligibility requirements are described in the Omnibus Solicitation. Any small business, independently owned and operated by United States citizens or permanent resident aliens may apply. It must be organized for-profit, cannot be dominant in its field of expertise, and must have its principal place of business in the United States. Including any affiliates, the company can be the employer of no more than 500 people. MECHANISM OF SUPPORT - PHASE I Phase I applications in response to this RFA will be funded as Phase I SBIR Grants (R43) with modifications as described below. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Applications for Phase I grants should be prepared following the directions for Phase I SBIR applications as described in the Omnibus Solicitation. Phase II applications in response to this RFA will only be accepted as competing continuations of previously funded NIH Phase I SBIR awards. The Phase II application must be a logical extension of the Phase I research. The Omnibus Solicitation and information on the FAST-TRACK process are available on the Internet at: http://grants.nih.gov/grants/funding/sbir1/SBIR.HTM A limited number of hard copies of the Omnibus Solicitation are available from: PHS SBIR/STTR Solicitation Office 13685 Baltimore Avenue Laurel, MD 20707-5096 Telephone: (301) 206-9385 FAX: (301) 206-9722 Email: [email protected] PROJECT PERIOD AND AMOUNT OF AWARD PHASE I: Because the length of time and cost of research involving development and evaluation of animal models for infectious diseases often exceeds that routinely awarded for SBIR grants, the participating Institutes will entertain well-justified Phase I applications for an SBIR award with a project period up to two years and a budget not to exceed a total cost of $300,000 per year. Consultant and contractual costs associated with Phase I: The total amount of all consultant costs and contractual costs normally may not exceed 33% of the total costs requested for Phase I SBIR applications. However, we will entertain well-justified Phase I applications for an SBIR award with greater than 33% contractual costs when those costs are necessary to support development and evaluation of animal models. Page Limitations: The 25-page limitation for Phase I applications applies (see Omnibus Solicitation). PHASE II: Phase II applications in response to the second release of this RFA will be awarded as Phase II SBIR grants (R44). Phase II applications in response to this RFA will only be accepted as competing continuations of previously funded NIH Phase I SBIR awards. Applications for Phase II awards should be prepared following the instructions for NIH Phase II SBIR applications. The Phase II SBIR instructions and application may be found on the Internet at: http://grants.nih.gov/grants/funding/sbir2/index.htm Project Period and Amount of Award: Because the length of time and cost of research involving animal model development projects often exceeds that routinely awarded for SBIR grants, participating Institutes will entertain well-justified Phase II applications for an SBIR award with a project period up to three years and a budget not to exceed $1 million per year total cost. Consultant and contractual costs: The total amount of all consultant costs and contractual costs normally may not exceed 50% of the total costs requested for Phase II SBIR applications. However, participating Institutes will entertain well-justified Phase II applications for an SBIR award with greater than 50% contractual costs when those costs are necessary to support animal model development and evaluation, including clinical studies in academic institutions. FUNDS AVAILABLE It is expected that approximately 10 awards will be made in FY2000. $3.2 million from the SBIR set-asides of the participating Institutes will be designated for this purpose. The number of awards will be dependent upon receipt of a sufficient number and diversity of applications with high scientific merit. RESEARCH OBJECTIVES The participating Institutes invite applications for SBIR awards in the following areas: A. Identification/creation of suitable animal models for studying one or more key aspects of HCV infection, replication, and pathogenesis. Suitability includes animals that are easily housed and subject to experimental manipulation, not protected species, and to the maximum extent possible small, inexpensive, and easily procurable. B. Development and testing of animal models for HCV infection identified in part A, from initial infection through chronic infection, liver disease, cirrhosis, and liver cancer. Such models should ideally mimic the full range of the disease spectrum or, more realistically, one or more critical aspects of the following phases of human disease by HCV: initial/acute infection, chronicity, disease stages and progression including inflammation, fibrosis, cirrhosis and other aspects of morbidity, and mortality causes such as liver failure or hepatocellular cancer. C. Validation of such model systems, including the applicable properties indicated in part B, by qualified independent investigators. LETTER OF INTENT Prospective applicants are asked to submit, by the receipt date listed at the beginning of this RFA, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIAID staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent (fax, e:mail, or post) to Dr. Leslye D. Johnson, NIAID, at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants should follow the instructions for SBIR Phase I or Phase II submission with the modifications as noted in this RFA. An example of an outstanding SBIR application can be found on the Web at http://www.nhlbi.nih.gov/nhlbi/sbir/modelsbi.htm This RFA must be read in conjunction with the OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH GRANT (SBIR) APPLICATIONS (PHS 98-2). All of the instructions within the omnibus solicitation apply with the following exceptions: -Special receipt date -Additional award considerations -Increased award amount and duration Applications received in response to this RFA are to be prepared as described in the OMNIBUS SOLICITATIONS for the SBIR program. OMNIBUS SOLICITATIONS are available electronically through the NIH, Office of Extramural Research "Small Business Funding Opportunities" Website: http://grants.nih.gov/grants/funding/sbir.htm. Hard copies, subject to availability, may be obtained from the PHS SBIR/STTR Solicitation Office, phone (301) 206-9385, FAX (301) 206-9722, email [email protected]. Helpful information in preparation of the application can be obtained: http://grants.nih.gov/grants/funding/sbirsttradvice.htm Applications in response to this RFA are to be submitted on the applicable grant application forms as follows: SBIR Phase I - PHS 6246-1 (1/98) http://grants.nih.gov/grants/funding/sbir1/SBIR.HTM SBIR Phase II - PHS 6246-2 (1/98) http://grants.nih.gov/grants/funding/sbir2/index.htm The application forms are also located in the back pages of the OMNIBUS SOLICITATIONS. Applications will be accepted on or before February 24, 2000. The RFA title and number must be typed in line 2 on the face page of the application form. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. If an application is received after the application receipt 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 review, unless the applicant withdraws the pending application. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. SBIR projects submitted in response to this RFA must contain a Phase I feasibility segment that must be successful prior to a Phase II award. Applications can be submitted for Phase I or Phase II support, or as a combined Phase I and II (FAST TRACK). Phase II applications will only be accepted as continuations of previously funded Phase I grants. The Phase II proposal must be a logical extension of the Phase I research but not necessarily a Phase I supported in response to this RFA. Projects may be presented for SBIR support at all stages of the HCV animal model discovery and development process. Projects will be evaluated on overall innovation and success potential of the research path proposed to animal model identification/development. Larger budgets could be considered for phase I if required for conduct of the research and appropriately justified in the application. The second year of support will be contingent upon NIAID (or appropriate Institute) programmatic evaluation to ensure that investigators are accomplishing milestones and time lines presented in the original application. PHASE II: Continuing support for development of HCV animal infection models and for establishment of model validity by in-house and by independent investigators knowledgeable of animal model characteristics. Potential animal model candidates may extend to assessment for use in studies in immunology including autoimmune diseases, alcohol and drug abuse, pathogenesis, natural history studies, antiviral screenings, etc. This may include the identification of surrogate endpoints to define success of therapeutic treatments or efficacy of vaccine candidates. Outside of presently licensed therapies, NIAID has the potential to provide novel antiviral compounds for testing in proven models. Phase II awards may be for up to three years at $1 million, total costs, per year. As with Phase I, requests for larger budgets may be considered, and support for years four and five is dependent upon Institute Programmatic review of progress and achievement of proposed milestones and evaluation of additional information not required in the original application. FAST TRACK: Due to the complex nature of the HCV animal identification/development process, it is recommended that only well defined and more advanced projects be proposed for support through this mechanism. FAST TRACK applications must specify clear, measurable goals for Phase I that should be achieved prior to Phase II funding. Failure to provide measurable goals in the Phase I application and/or sufficient detail in the Phase II application may be sufficient reason for the peer review committee to exclude the Phase II from consideration. If so, the applicant may apply later for Phase II support. Special provisions described in this RFA pertaining to Phase I and Phase II also apply to FAST TRACK applications. The completed original application and two single sided copies must be sent or delivered 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) For purposes of identification and processing, the title and number of this RFA must be shown in item 2 on the face page of the SBIR Phase I applications and in item 1A of the face page of Phase II grant applications (i.e., "SBIR: HCV Animal Models of Infection," AI-00-008). Follow the mailing instructions in the Omnibus Solicitation for Phase I applications. Follow the mailing instructions in the Phase II application package for Phase II applications. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review. Incomplete applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by an initial review group convened by the Center for Scientific Review, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. REVIEW CRITERIA Review criteria are described in the Omnibus Solicitation. The Phase I application should specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II. AWARD CRITERIA The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, the availability of funds, and the commercialization status where the small business concern has received more than 15 Phase II wards in the prior five (5) fiscal years, if applicable (see this application requirement under "Prior SBIR Phase II Awards" found in the "Introduction and Application Instructions" portion of the Omnibus Solicitation). ADVICE ON SUBMITTING APPLICATIONS: Potential applicants are strongly encouraged to contact program staff for pre-application guidance and/or for more specific information on the research topics described in this RFA. They are also encouraged to read the advice and information on SBIR programs located on the Internet at: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Dr. Leslye D. Johnson Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6700B Rockledge Drive, Rm. 3209 MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7051 FAX: (301) 402-1456 Email: [email protected] Dr. John Cole III Division of Cancer Biology National Cancer Institute Executive Plaza North, Room 540 Bethesda, MD 20892-7209 Telephone: (301) 496-1718 FAX: (301) 496-2025 Email: [email protected] Dr. Thomas Kresina Biomedical Research Branch National Institute of Alcohol Abuse and Alcoholism 6000 Executive Blvd, 402 MSC 7003 Bethesda, MD 20892 Telephone: (301) 443-6537 FAX: (301) 496-0537 Email: [email protected] Dr. Raymond O Neil Director, Chimpanzee Management Plan (ChiMP) Comparative Medicine, NCRR, NIH Suite 6030 6705 Rockledge Drive Bethesda, MD 20892-7965 Telephone: (301) 435-0744 FAX :(301) 480-3819 Email: [email protected] Direct inquiries regarding fiscal matters to: Ms. Mary Kirker Grants Management Branch National Institute of Allergy and Infectious Diseases 6700B Rockledge Drive, Room 2116 MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: [email protected] AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Numbers are 93.855 and 93.856. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract 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