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NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)

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The NIAID's Division of AIDS, Division of Allergy, Immunology, and Transplantation, and Division of Microbiology and Infectious Diseases fund SBIR/STTR grants on topics related to their mission and activities as described below. Questions on specific research areas may be addressed to the NIAID Program Officials listed below. General questions on the NIAID SBIR and STTR programs and on administrative and business management may be addressed to contacts listed for the NIAID section. When possible, applicants are encouraged to use email for communication. For information about NIAID's Small Business Programs, please visit http://funding.niaid.nih.gov/researchfunding/sb/pages/default.aspx. Limited Amount of Award (Total not Annual) For budgetary or programmatic reasons, NIAID may decrease the requested length of an award or the requested amount of an award. Applicants considering requesting a Phase I grant greater than $300,000 total cost or a Phase II grant greater than $2 million total cost are strongly encouraged to contact Gregory Milman (below) before submitting an application. Phase IIB SBIR Competing Renewal Awards The NIAID will accept Phase IIB SBIR Competing Renewal grant applications to continue the process of developing products that require approval of a regulatory agency (e.g., FDA). Projects that are particularly encouraged include those in the NIAID Small Business High Priority Areas of Interest (http://funding.niaid.nih.gov/researchfunding/sb/pages/sbirareas.aspx). NIAID will not accept Phase IIB STTR Competing Renewal applications. NIAID will accept Phase IIB SBIR Competing Renewal applications for a project period of up to three years and a budget not to exceed a total cost of $1 million per year (including direct cost, F&A, and fee/profit) provided the time period and amount are well justified. The total amount of all consultant costs and contractual costs normally may not exceed 50% of the total costs requested for initial SBIR Phase II applications. NIAID SBIR Phase IIB Competing Renewal grant applications may exceed this guideline, however, when well justified and when those costs are necessary to support preclinical studies and related expenses. Examples of well founded reasons for exceeding this guideline include, but are not limited to, subcontracts for safety, toxicity, or efficacy testing in animals, and subcontracts to assure compliance with Good Manufacturing Practices expectations of the FDA. Human clinical trials may not be a component of proposed SBIR or STTR research. See Notice of NIAID Policy on investigator initiated clinical trials at http://grants.nih.gov/grants/guide/notice-files/NOT-AI-10-024.html. Small business applicants are encouraged to contact Gregory Milman (below) to discuss NIAID funding for human clinical trials. NIAID does NOT request a letter of intent for Phase IIB Competing Renewal Applications. However, prior to submission, applicants are strongly encouraged to contact: Gregory Milman, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2130, MSC-7610 6700-B Rockledge Drive Bethesda, MD 20892-7610 (US Mail) Rockville, MD 20817-7610 (Delivery Services) Telephone 301-496-8666 Fax: 301-402-0369 Email: gm16s@nih.gov Division of AIDS The Division of AIDS (DAIDS) supports research on the pathogenesis, natural history, and transmission of HIV and HIV disease, and promotes progress in its detection, treatment, and prevention. Director: Dr. Carl Dieffenbach 301-496-0545 Email: cd17u@nih.gov BASIC SCIENCES PROGRAM Supports basic and applied research on the causes, diagnosis, treatment and prevention of HIV and AIDS. Director: Dr. Susan Plaeger 301-402-9444 Email: splaeger@niaid.nih.gov A. Epidemiology Branch. Population-based research and modeling studies of HIV transmission and associated biological and behavioral factors. Also, the treated and natural history of HIV, including research on immunology, virology, therapy and other issues surrounding care, and other co-morbidities, their interactions and impact on clinical outcome. Contact: Joana Roe 301-435-3759 Email: jr108r@nih.gov B. Pathogenesis Branch. Molecular and cellular biology, virology, and immunology of virus-host interactions and mechanisms of immunopathogenesis and HIV transmission. Identification and characterization of host and viral factors that impact viral transmission, host restriction, pathogenesis and latency. Characterization of potential targets for discovery or design of novel therapeutic strategies. Innovative approaches for monitoring or studying viral infection, pathogenesis and latency. Contact: Dr. Karl Salzwedel 301-496-5332 Email: salzwedelkd@niaid.nih.gov C. Targeted Interventions Branch. Research areas: (1) targeted therapeutics emphasizing under-explored viral and cellular targets; (2) innovative therapeutic strategies including immune-based and gene-based therapies and therapeutic vaccines; (3) translational research for effective therapeutics spanning preclinical discovery through IND-enabling studies; (4) animal models for evaluating new therapeutic entities, regimens, and strategies; and (5) therapeutic approaches using nanotechnology. Contact: Dr. Roger Miller 301-496-6430 Email: rm42i@nih.gov VACCINE RESEARCH PROGRAM Supports the development of vaccines to prevent AIDS. Director: Dr. Margaret (Peggy) Johnston 301-402-0846 Email: pj7p@nih.gov A. Vaccine Clinical Research and Development Branch. Research areas: (1) coordination of phase I, II, and III domestic and international clinical trials of candidate AIDS vaccines; (2) coordination of the characterization of immune responses in HIV-infected and uninfected immunized volunteers, using micro and macro assays; and (3) coordination of studies to identify, validate, and standardize immunologic and virologic markers for monitoring response of participants in vaccine clinical trials. Contact: Dr. Jim Lane 301-451-2758 Email: laneji@mail.nih.gov B. Preclinical Research and Development Branch. Support of applied preclinical development of candidate AIDS vaccines, delivery methods and novel vaccine vectors, and adjuvants for the prevention of AIDS; promotion and evaluation of safety and efficacy of the prevention modalities, especially novel vaccine concepts identified in preclinical models including trials in non-human primates; genetic and immunologic variation; and mucosal immunity in SIV, HIV, and SHIV models. Contact: Dr. Yen Li 301-496-3816 Email: yli@niaid.nih.gov C. Vaccine Discovery Branch. Research on: 1) identification of optimal antigens for HIV vaccine design (e.g., epitope mapping, epitope dominance, etc.); 2) identification of cellular components or novel antigens created by env-host interactions as vaccine targets; 3) development of innovative small animal models and in vitro systems to assess immune responses to vaccines; and 4) novel innate and mucosal immune pathways, adjuvants and immunomodulators to improve vaccine responses. Contact: Dr. Geetha Bansal 301-496-5042 Email: gbansal@niaid.nih.gov THERAPEUTICS RESEARCH PROGRAM Develops and oversees research and development of therapies for HIV disease, including complications, co-infections, co-morbidities and cancers, in adults, infants, children, and adolescents. Acting Director: Dr. Carla Pettinelli 301-402-5582 Email: pettinelli@niaid.nih.gov A. Drug Development and Clinical Sciences Branch. Discovery and preclinical development of experimental therapies for HIV, TB and other infectious diseases; maintenance of a database of potential anti-HIV and anti-opportunistic infection compounds; immunologic, virologic, and pharmacologic research related to the design and conduct of clinical trials. Chief: Dr. Mike Ussery 301-402-0134 Email: mussery@niaid.nih.gov B. HIV Research Branch. Clinical research of strategies to treat adult primary HIV infection and complications; strategies to augment HIV immune responses and general host immunity. Contact: Daniella Livnat 301-435-3775 Email: dlivnat@niaid.nih.gov C. Complications & Co-Infections Research Branch. Preclinical and clinical research to develop new or improved therapies for the treatment and prophylaxis of Pneumocystis carinii pneumonia, Mycobacterium avium disease, and cryptococcosis. Evaluation of diagnostics of or agents for treatment or prevention of hepatitis B or hepatitis C secondary to HIV infection in adults. Contact : Dr. Chris Lambros 301-435-3769 Email: clambros@niaid.nih.gov D. International Maternal, Adolescent and Pediatric Medicine Branch. HIV therapies in children and adolescents. Strategies to reduce transmission from mother to infant or fetus. Chief: Dr. Ed Handelsman 301-402-3221 Email: handelsmane@niaid.nih.gov E. Prevention Sciences Program. Conduct basic research on mechanisms of HIV transmission supportive of new biomedical strategies for interrupting transmission. Conduct of domestic and international phase I, II, and III clinical trials to evaluate HIV/AIDS prevention strategies, including microbicides, chemoprophylactic agents, and other biomedical and behavioral risk reduction interventions. Acting Director: Sheryl Zwerski, MSN, CRNP 301-402-4032 Email: szwerski@niaid.nih.gov F. Microbicide Research Branch. Basic research on mechanisms of HIV transmission leading to new biomedical strategies for interrupting transmission. Translational research on microbicides, spanning discovery and preclinical through pilot human clinical research. Pilot clinical studies of the performance of microbicide vehicles with regard to coverage of and persistence on mucosal surfaces, potential biomarkers of safety, behavioral acceptability, and new technology to evaluate safety. Dr. Roberta Black Chief Topical Microbicide Research Branch 301-496-8199 Email: rblack@niaid.nih.gov Division of Allergy, Immunology, and Transplantation The Division of Allergy, Immunology, and Transplantation (DAIT) supports studies of the immune system in health and the cause, pathogenesis, diagnosis, prevention, and treatment of disease caused by immune dysfunction. Director: Daniel Rotrosen, M.D. 301-496-1886 Email: drotrosen@niaid.nih.gov A. Asthma, Allergy, and Inflammation Branch. Asthma, atopic dermatitis, hypersensitivity reactions, rhinitis, sepsis, sinusitis, urticaria, basic studies of asthma and allergy mechanisms, new therapies to prevent or treat asthma and allergic diseases, food allergies, epidemiology and prevention, phagocyte biology, eosinophilic gastroenteritis, and mechanisms of host defense. Methodologies to design, manage, and analyze clinical and epidemiologic research of the etiology, prevention, and treatment of asthma, allergy, and inflammatory diseases. Chief: Dr. Matthew Fenton 301-451-0144 Email: fentonm@niaid.nih.gov B. Basic Immunology Branch. Origin, maturation, and interactions of immune cells, immune cell receptors, ligands, cytokine biology, molecular basis of activation, antigen recognition, immune tolerance, immune response regulation, hematopoiesis and stem cell biology, enhancement of vaccine effectiveness in neonates and adults, and basic immunology of vaccines and immunotherapeutics as medical countermeasures for biodefense. Chief: Dr. Helen Quill 301-496-7551, Fax: 301-480-2381 Email: hquill@niaid.nih.gov C. Clinical Immunology Branch. Preclinical and clinical research to develop and improve therapies for the treatment of autoimmune diseases, primary immune deficiencies (not HIV), basic research of disease mechanisms, and biomarkers, immunotherapy of disease processes, disorders mediated by lymphocyte products, and mucosal immunity. Chief: Dr. James McNamara 301-451-3121, Fax: 301-480-1450 Email: jmcnamara@niaid.nih.gov D. Transplantation Immunobiology Branch. Acute and chronic graft rejection, allogeneic and xenogeneic transplantation, development of immunomodulatory agents to prevent and treat graft rejection, genomics of the alloimmune response, hematopoietic stem cell transplantation, major histocompatibility complex, minor histocompatibility antigens, infectious and malignant complications of immunosuppression in transplantation, and technologies for MHC typing. Chief: Dr. Nancy Bridges 301-496-5598 Email: nbridges@niaid.nih.gov E. Radiation Countermeasures Program. Radioprotectants, mitigators and therapeutics for acute radiation syndrome or the delayed effects of acute radiation exposure; radionuclide-specific therapies, including chelating agents, blocking agents, and other novel decorporation agents; improved methods of radiation biodosimetry and bioassay for radionuclide contamination; biomarkers of organ-specific radiation injury; therapeutics for radiation combined injury; therapeutics for radiation-induced immunosenescence. Chief: Dr. Richard Hatchett 301-451-3109 Email: hatchettr@niaid.nih.gov Division of Microbiology and Infectious Diseases The Division of Microbiology and Infectious Diseases (DMID) supports research to better understand, treat, and ultimately prevent infectious diseases caused by virtually all infectious agents, except HIV. DMID supports a broad spectrum of research from basic molecular structure, microbial physiology and pathogenesis, to the development of new and improved vaccines and therapeutics. DMID also supports medical diagnostics research, which is defined as research to improve the quality of patient assessment and care that would result in the implementation of appropriate therapeutic or preventive measures. DMID does not support research directed at decontamination or the development of environmentally oriented detectors, whose primary purpose is the identification of specific agents in the environment. Note that some of the organisms and toxins listed below are considered NIAID priority pathogens or toxins for biodefense and emerging infectious disease research. Director: Dr. Carole Heilman 301-496-1884 Email: ch25v@nih.gov A. Bacteriology and Mycology Branch. The branch oversees research on medical mycology, hospital infections (including Acinetobacter, Klebsiella, Serratia, Legionella, Pseudomonas, Aeromonas, Enterobacter, Proteus, non-enteric E. coli, actinomycetes and others), staphylococci, enterococci, bacterial zoonoses (plague, anthrax, tularemia, glanders, melioidosis, Lyme disease, rickettsial diseases, anaplasmosis, ehrlichiosis and Q fever), and leptospirosis. Research is encouraged in the following general areas: (1) product vaccines, adjuvants, therapeutics and diagnostics (including target identification and characterization, device or apparatus development, novel delivery, and preclinical evaluation); (2) products to combat antibacterial and antifungal drug resistance; (3) applied proteomics and genomics; (4) host-pathogen interactions, including pathogenesis and host response; (5) genetics, molecular, and cell biology; (6) microbial structure and function; and (7) vector-pathogen interactions or disease transmission to humans via arthropod vectors. Research in the following areas is of particular interest to the branch, but research on all of the above is welcome: • Vaccines, therapeutics, and medical diagnostics for hospital infections • Adjunctive therapies to combat antimicrobial resistance • Diagnostics for aspergillosis • Novel approaches for the diagnosis of Lyme disease Contact: Dr. Alec Ritchie 301-402-8643, Fax: 301-402-2508 Email: aritchie@niaid.nih.gov B. Enteric and Hepatic Diseases Branch. Special emphasis areas include vaccines against hepatitis C virus; antimicrobials and antivirals that focus on novel targets such as host-pathogen interactions to combat the development of resistance; vaccines and therapies for botulinum neurotoxins, especially therapies that that target toxins once they enter cells; therapies and diagnostics for Clostridium difficile that include recurrent disease issues; development of a simple, rapid point-of-care diagnostic tool for the simultaneous identification of multiple diarrheal pathogens that includes their antibiotic resistance profiles; pediatric vaccines to prevent the major worldwide causes of diarrhea; more stable vaccines and improved formulation methods; and novel therapeutics for chronic hepatitis B and C. Research areas of the Branch include the following organisms and diseases: astrovirus, Bacteroides spp., Campylobacter spp., enteric Clostridia spp. including botulinum neurotoxins, commensals and normal flora, pathogenic Escherichia coli, gastroduodenal disease, gastroenteritis, Helicobacter spp., Listeria spp., Noroviruses including Norwalk, ricin toxin, rotaviruses, Salmonella serovars, Shigella spp., Staphylococcus enterotoxin B, Vibrio spp. enteric Yersinia spp., hepatitis viruses A, B, C, D, and E, as well as cholera, diarrhea, enterotoxins, gastroenteritis, gastroduodenal disease and ulcers, and Guillain-Barre syndrome. Program Contact: Dr. Marian Wachtel 301-451-3754, Fax: 301-402-1456 Email: wachtelm@niaid.nih.gov C. Parasitology and International Programs Branch. Research areas: (1) protozoan infections, including amebiasis, cryptosporidiosis, cyclosporiasis, giardiasis, leishmaniasis, malaria, trypanosomiasis, toxoplasmosis; helminth infections, including cysticercosis, echinococcosis, lymphatic filariasis, schistosomiasis, onchocerciasis, others (e.g., roundworms, tapeworms, and flukes); invertebrate vectors/ectoparasites, black flies, sandflies, tsetse flies, mosquitoes, ticks, snails, mites; (2) parasite biology (genetics, genomics, physiology, molecular biology, and biochemistry); (3) protective immunity, immunopathogenesis, evasion of host responses; (4) clinical, epidemiologic, and natural history studies of parasitic diseases; (5) research and development of vaccines, drugs, immunotherapeutics, and medical diagnostics, and (6) vector biology and management; mechanisms of pathogen transmission. Chief: Dr. Lee Hall 301-496-2544, Fax: 301-402-0659 Email: lhall@niaid.nih.gov D. Respiratory Diseases Branch. Research areas: (1) viral respiratory diseases, including those caused by: human coronaviruses (including SARS), influenza viruses, and paramyxoviruses (including parainfluenza viruses and respiratory syncytial virus); (2) bacterial respiratory infections, including those caused by Moraxella catarrhalis (chronic obstructive pulmonary disease), Pseudomonas aeruginosa and Burkholderia cepacia (associated with cystic fibrosis), Corynebacterium diphtheriae (diphtheria), groups A and B streptococci, Haemophilus influenzae, Neisseria meningitidis, Bordetella pertussis (pertussis), Streptococcus pneumoniae, Mycoplasma pneumoniae, Chlamydia pneumoniae, Klebsiella pneumoniae and community acquired pneumonia; (3) acute otitis media; (4) mycobacterial diseases, including those caused by: M. tuberculosis (tuberculosis), extensively- and multi-drug resistant M. tuberculosis, M. leprae (leprosy), and M. ulcerans (Buruli ulcer) and other non-tuberculous mycobacterial diseases. Areas of emphasis include: development of new antibiotics with novel mechanisms of action, improved therapeutics for viral and bacterial respiratory diseases including immunotherapeutics, new or improved vaccines (with and without adjuvants), improved and more rapid multiplex point-of-care diagnostic tests or other screening tools that can detect infection prior to active disease and identify drug resistance. Contact: Dr. Gail Jacobs 301-496-5305, Fax: 301-496-8030 Email: ggjacobs@niaid.nih.gov E. Sexually Transmitted Infections Branch. Areas of emphasis include the development of medical diagnostics including better and more rapid multiplex point of care tests and other screening or novel delivery systems for diagnostic tools, topical microbicides, vaccines and drugs for sexually transmitted infections (STIs) and other reproductive tract syndromes, such as bacterial vaginosis; molecular immunology; vaginal ecology and immunology; epidemiologic and behavioral research including strategies to reduce transmission of STIs; genomics and proteomics of sexually transmitted pathogens; adolescents and STIs; STIs and medically underserved populations and minority groups; STIs and infertility and adverse outcomes of pregnancy; role of STIs in HIV transmission; role of HIV in altering the natural history of STIs; and other sequellae of STIs. Contact: Elizabeth Rogers 301-451-3742, Fax: 301-480-3617 Email: erogers@niaid.nih.gov F. Virology Branch. Areas of emphasis for SBIR/STTR applications include:1) vaccine development; 2) viral vectors; 3) structure and function of viruses and viral proteins as targets for therapeutic interventions or diagnostics; 4) the development and validations of assays for disease diagnosis and to measure response to therapy; 5) the development and preclinical testing of immunotherapeutic and antiviral drugs for acute and chronic viral illnesses; 6) approaches to identify antiviral targets and agents; 7) chemical design and synthesis of novel antiviral agents; 8) preclinical antiviral evaluations including in vitro screening and prophylactic or therapeutic antiviral evaluations of human viral infections in animal models; 9) the development of rapid medical diagnostic systems. The Virology Branch focuses on the following: acute viral infections (including Nipah and Hendra viruses), arthropod-borne and rodent-borne viral diseases (including Dengue, West Nile, Japanese encephalitis, Chikungunya, yellow fever, hantavirus, etc.), viral hemorrhagic fevers (Ebola, Lassa fever, etc.), measles, polio, coxsackie virus, enterovirus 71 and other enteroviruses, poxviruses, rabies, and rubella. The Virology Branch also focuses on the following persistent viral diseases and viruses: adenoviruses, BK virus, bornaviruses, coronaviruses, herpesviruses, human T-lymphotrophic virus, JC virus, human papillomaviruses, parvoviruses, and prion diseases. Applications targeting the development of therapies, immunotherapies, vaccines and diagnostics for any of these infections are sought. The Virology Branch does not support applications covering environmental detection and decontamination. Contact: Dr. Ramya Natarajan 301-594-1586, Fax: 301-402-0659 Email: ramya.natarajan@nih.gov Other Research Topic(s) Within the Mission of the Institute For additional information on research topics, contact: Dr. Gregory Milman National Institute of Allergy and Infectious Diseases 301-496-8666, Fax: 301-402-0369 Email: gmilman@niaid.nih.gov For administrative and business management questions, contact: Mr. Michael Wright Grants Management Specialist National Institute of Allergy and Infectious Diseases 301-451-2688, Fax: 301-493-0597 Email: mawright@mail.nih.gov