NIAID/DAIT Regulatory Management Center (RMC)   3

Presolicitation Notice Information

Introduction
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 regulatory management activities in support of NIAID-funded clinical trials and clinical studies of immune mediated diseases.

Description
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), 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, nonclinical 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 in 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. Another component of DAIT- NIAID's mission focuses on the planning and implementation of research, development, and evaluation of medical countermeasures for radiation injury.

All NIAID funded clinical research studies and trials (whether or not conducted under US IND or outside-US IND-Equivalent), must be conducted in accordance with US-federal regulations and guidelines, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines, as well as countryspecific regulations and requirements.

As the sponsor of US Investigational New Drug Applications (IND) and Investigational Device Exemption (IDE) applications as well as country-specific Regulatory Health Authority (RHA) Applications for DAIT-NIAID-supported clinical trials, DAIT-NIAID is required to provide study-specific regulatory management activities to ensure: (i) compliance with the applicable regulations; and (ii) study/trial data integrity.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about September 04, 2020 and may be accessed through beta.SAM.gov. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
For this solicitation, the NIAID requires proposals to be submitted electronically via the NIAID electronic Contract Proposal Submission (eCPS) website. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."