SPECIAL NOTICE
H -- Add CLIN to Maintain FDA Licensure for hBat
- Notice Date
- 6/23/2014
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), Office of the Assistant Secretary for Preparedness & Response (ASPR), Department of Health and Human Services, 330 Independence Ave. SW, G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- HHS-OS-ASPRBARDA-SN-14-001
- Archive Date
- 7/18/2014
- Point of Contact
- Francine L. Hemphill, Phone: 2025731113, Matthew Rose, Phone: 2022052901
- E-Mail Address
-
Francine.Hemphill@hhs.gov, matthew.rose@hhs.gov
(Francine.Hemphill@hhs.gov, matthew.rose@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The Department of Health and Human Services, Assistant Secretary for Preparedness & Response, intends to negotiate a sole source Firm-Fixed Price CLIN under Contract# HHSO100200600017C to maintain license activities for the FDA license of hBAT. The hBAT contract provides product development and procurement services. This includes clinical, nonclinical, and manufacturing needed to support the filing of a BLA as well as post-licensure activities. Maintaining FDA licensure is relevant to the current activities for the hBAT contract because it allows the government to maintain license for the use of hBAT in the treatment of confirmed or suspected cases of botulism. The period for these activities will be from Sept 1, 2014 to 30 August 2019. The proposed contract action will maintain FDA license of hBAT and program management support activities associated with this requirement. The government intends to solicit and negotiate with Cangene, (Winnipeg, MB, Canada) under the authority of FAR 6.302-1. The current contract is scheduled to expire on May 29, 2026. The period of performance will not extend the overall period of performance of the contract. Adding an additional CLIN to the current contract will maintain the license of hBAT which was granted by the FDA in March, 2013, through August, 2019. Fulfilling the purpose of this contract to maintain useful hBAT product until 2024. This is not a request for competitive proposals, and no solicitation is available. Not awarding this extension would cause serious harm to the Government; however, the Government will consider responses from all responsible sources received by the date and time identified. All interested sources must respond in writing with clear and convincing evidence to support their ability to provide timely and effective services within two (2) weeks of this publication. Any responses received will only be considered for the purpose of determining whether to conduct a competitive procurement in lieu of the sole source extension described in this notice, and such determination shall be made at the sole discretion of Francine Hemphill, the Procuring Contracting Officer. Written comments or questions regarding this notice must be emailed to Matthew Rose at Matthew.Rose@hhs.govl or Francine Hemphill at Francine.Hemphill@hhs.gov, no later than 1400 CDT on July 3, 2014.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/HHS-OS-ASPRBARDA-SN-14-001 /listing.html)
- Place of Performance
- Address: Winnipeg, MB, Canada, United States
- Record
- SN03402744-W 20140625/140623234321-aa39919ca535c12e0669ff2d7ff3db74 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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