SOLICITATION NOTICE
A -- Operation of a Facility Testing Malaria Vaccines in Adult Human Subjects
- Notice Date
- 12/3/2014
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIAID-(AMOB)AO-P-2015-023
- Archive Date
- 1/2/2015
- Point of Contact
- Alice M. Sobsey, Phone: 240-669-5118, Dixie Harper, Phone: 240-669--5119
- E-Mail Address
-
alice.sobsey@nih.gov, dixie.harper@nih.gov
(alice.sobsey@nih.gov, dixie.harper@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Presolicitation Notice Information Introduction The National Institutes of Health (NIH)'s National Institute of Allergy and Infectious Diseases (NIAID) Division of Intramural Research (DIR) founded the Laboratory of Malaria Immunology and Vaccinology (LMIV) in 2009 to conduct basic and applied research relevant to malaria immunology and vaccine development, to pursue novel vaccine concepts, to produce prototype malaria vaccines, and to conduct early-phase clinical trials of promising vaccine candidates. The overarching goal is to develop malaria vaccines that will reduce severe disease and death among African children and pregnant women and will eliminate malaria from low-transmission areas of the world. Description NIAID intends to solicit proposals for contracts entitled Operation of a Facility Testing Malaria Vaccines in Adult Human Subjects to advance development of candidate malaria vaccines in order to reduce the number of malaria cases worldwide. The LMIV requires clinical trials to investigate initial safety, immunogenicity, and biologic impact of promising vaccine candidates. Clinical trials may also be conducted as part of pathogenesis research to facilitate vaccine development. These may include a Phase 1 Malaria Vaccine Trial, Phase 1-2 Challenge Trials, and Experimental Infection Trials. Draft clinical protocols will be provided by LMIV investigators. LMIV will develop protocol objectives and overall design. The Contractor will then assist in completing the final draft protocol. Upon LMIV review of the final draft, the Contractor will be responsible for submitting each protocol to the Contractor's Institutional Review Board (IRB) and obtaining approval. This effort shall be coordinated with LMIV staff for parallel approval by the NIAID IRB. The Contractor shall provide all final IRB documents to LMIV. Where investigational applications are required, approved protocols will be filed with the Center for Biologics Evaluation & Research of the Food and Drug Administration (FDA) by NIAID as part of an Investigational New Drug (IND) Application. The proposals will be evaluated on the ability to conduct Phase 1 Malaria Vaccine Trial, Phase 1-2 Challenge Trials, and Experimental Infection Trials. The ability of offerors to ensure delivery of fresh specimens according to protocol requirements (human PBMCs) to LMIV in Rockville, MD within two hours of initial processing and to deliver cryopreserved PBMCs to LMIV by 4:00pm EST on the next business day after the COR's request will also be evaluated. Evaluation of the proposals will be based on the following technical evaluation criteria: (1) Technical Plan/Approach, (2) Scientific and Technical Personnel, and (3) Facilities, Equipment, and Other Resources. NIAID expects to issue task orders for clinical trials of LMIV's promising vaccine candidates under approximately 5 Indefinite Delivery Indefinite Quantity (IDIQ) Contracts. These IDIQ contracts are expected to be awarded in June of 2015 for a period of 5 years. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about December 18, 2014 and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract or Task Order. 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: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/HHS-NIH-NIAID-(AMOB)AO-P-2015-023/listing.html)
- Place of Performance
- Address: Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Acquisition Management and Operations Branch (AMOB), Office of Acquisitions (AO), 5601 Fishers Lane, MSC 9822, Rockville, Maryland, 20852, United States
- Zip Code: 20852
- Zip Code: 20852
- Record
- SN03586418-W 20141205/141203234840-83285f17f381ab2da1a3c1ee7b0bb780 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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