Notice Number: NOT-AI-16-036
Key Dates
Release Date: March 3, 2016
This RFP will be available electronically on/about March 11, 2016
Issued by
National Institute of Allergy and Infectious Diseases (NIAID)
Purpose
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. NIAID, has a requirement for seeking a contractor to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies.
The primary intent of this RFP solicitation is to provide preclinical development support for promising products when such candidates emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. The Contractor shall provide support needed for small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing.
Specifically, the Contractor shall manage a preclinical research program that identifies and develops potential HIV products by providing scientific, technical, and management expertise. The Contractor shall assist in identification, testing, and development of products; participate in and manage preclinical testing including in vitro laboratory testing, immunogenicity testing, efficacy studies, and toxicology testing using laboratory animals; and utilize GMP production protocols to produce promising products. Furthermore, the Contractor shall also maintain inventories of products, provide quality assurance and quality control, provide the appropriate regulatory documentation, and develop and manage a database that tracks the preclinical development of the products. The Contractor shall carry out, either directly or through subcontractors and/or consultants, tasks in the following areas:
This is a recompetition of an existing contract entitled “Preclinical Development Support” with Advanced BioScience Laboratories, Inc., under contract number HHSN272201100021I.
It is anticipated that one Indefinite Delivery Indefinite Quantity (IDIQ) type contract will be awarded for a 7-year period of performance beginning on or about March, 2017.
All responsible sources may submit a proposal which shall be considered by the Agency. This RFP will be available electronically on or about 3/11/2016 and may be accessed through FedBizOpps http://www.fedbizopps.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 via two methods:
For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."
To submit online using eCPS, offerors must have a valid NIH electronic Research Administration (eRA) Commons account, which provides authentication and serves as a vehicle for secure transmission of documents and communication with the NIAID. The eRA Commons registration process may take up to 4 weeks. For more information, please see http://era.nih.gov/applicants/how-to_steps.cfm#register.”
Inquiries
Please direct all inquiries to:
Kishan Patel
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5157
Email: patelki@niaid.nih.gov
Michelle L. Scala
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5156
Email: mscala@niaid.nih.gov