Inactive Total Small Business Set-Aside (FAR 19.5)

Amendment 4 is to answer questions and to extend the due date of this RFP until 3:00 P.M. ET on Tuesday, October 13, 2020. Amendment 3 is to answer questions. All questions must be submited by Septemb... Amendment 4 is to answer questions and to extend the due date of this RFP until 3:00 P.M. ET on Tuesday, October 13, 2020. Amendment 3 is to answer questions. All questions must be submited by September 28, 2020. RFP 20R00011-2.pdf adds attachments. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Allergy, Immunology, and Transplantation (DAIT) has a requirement to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases. Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research that focuses on protective immune responses and immune-mediated diseases through grants and contracts awarded to domestic and foreign organizations. A critical component of the Division’s mission targets clinical research to develop new and/or improved therapies and prevention strategies through rigorous evaluation of the safety and efficacy of investigational products and approaches, clinical studies to elucidate underlying mechanisms, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of natural history, genetics/genomics and/or other “omic”, and lifetime exposures. Research encompasses a broad range of immune-mediated diseases, including: (i) allergic diseases and asthma; (ii) autoimmune disorders; (iii) immune-mediated rejection in solid organ, tissue and cell transplantation; (iv) primary immune deficiency disorders;(v) and other immune system disorders and treatments to enhance immune functions. The purpose of this request for proposals is to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases, examples of which are listed here: Immune Tolerance Network (ITN) Asthma and Allergic Diseases Clinical Research Programs Atopic Dermatitis Research Network (ADRN). Consortium for Food Allergy Research (CoFAR). Inner City Asthma Consortium (ICAC) which is to be replaced in 2021 by the Childhood Asthma in Urban Settings Clinical Research Network (CAUSE CRN) Autoimmune Diseases Clinical Research Programs Autoimmunity Centers of Excellence (ACE) Transplantation Clinical Research Programs Clinical Trials in Organ Transplantation (CTOT). Clinical Trials in Organ Transplantation in Children (CTOT-C). Clinical Trials in Organ Transplantation-Children and Adults (CTOT-CA). Statistical & Clinical Coordinating Centers (SCCCs) Allergy & Asthma SCCC Autoimmune Diseases SCCC Transplantation SCCC Clinical Site Monitoring Center (CSMC) Regulatory Management Center (RMC)