SOURCES SOUGHT
R -- PRIME SYSTEMS INTEGRATOR
- Notice Date
- 4/26/2016
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Army, Army Contracting Command, ACC - APG (W911QY) Natick (SPS), BLDG 1 KANSAS ST, Natick, Massachusetts, 01760-5011, United States
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-16-S-0005
- Archive Date
- 5/25/2016
- Point of Contact
- Jessica, Phone: 301-619-8457
- E-Mail Address
-
jessica.l.ely.civ@mail.mil
(jessica.l.ely.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a Request for Information (RFI) for market research purposes. The Medical Countermeasure Systems - Joint Vaccine Acquisition Program (MCS-JVAP) is seeking information from interested parties, with organic US based manufacturing and regulatory capabilities, in serving as a drug product sponsor for vaccine development from completion of phase 2 clinical trials through Food and Drug Administration (FDA) licensure. Synopsis: This is a Request for Information (RFI) for planning purposes only. This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Background: The Medical Countermeasure Systems - Joint Vaccine Acquisition Program (MCS-JVAP), is the life cycle manager for the Department of Defense (DoD) responsible for developing, producing and fielding FDA-licensed vaccines to protect the Warfighter from biological agents. The current MCS-JVAP portfolio includes vaccines in advanced stages of clinical development and Food and Drug Administration (FDA) licensed vaccines. Purpose and Objectives: The primary objective of issuing this Request for Information (RFI) is to survey vaccine manufacturers in the pharmaceutical industry on their interest in serving as an Integrator and manufacturer for DoD vaccine development efforts. In particular, MCS-JVAP will use the replies from this RFI to improve future Request for Proposal (RFP) solicitations and encourage more interest from industry. For the purposes of the RFI, MCS-JVAP is only interested in companies that poses drug substance manufacturing capabilities and would be able to take on responsibility as FDA product sponsor, program management and regulatory submission capabilities. The FDA product sponsor and manufacturer would be responsible for the management, quality oversight, and execution of all facets of FDA Animal Rule vaccine development: nonclinical IND enabling studies, clinical drug manufacturing, clinical drug supply, analytical methods development, and Phase 3 clinical trials. In addition, the product sponsor would be responsible for the development of regulatory strategies that would support FDA licensure. Finally, the delivery of FDA licensed vaccines. The Government would be interested in answers to the following questions: 1. Would your company be interested in serving as a Product Sponsor and manufacturer for vaccine development for future MCS-JVAP solicitations? Describe your company's experience, in short summary format, in the following areas: a. Manufacturing an FDA approved vaccine (in house capability) b. Progressing vaccines through phase 3 clinical trials c. Serving as a regulatory sponsor to the FDA d. Developing medical countermeasures with the "Animal Rule"; outlining experiences developing nonclinical strategies. 2. Would your company be interested in a transaction under Other Transaction (OT) Authority as defined by 10 U.S. Code § 2371? In your response, describe any issues/concerns your company may have in operating under OT Authority. OTs are used to attract nontraditional government contractors to stimulate innovation in the areas of research and development. They are flexible funding instruments, other than procurement contracts, grants, or cooperative agreements. OTs reduce normal contractual barriers by providing greater flexibility in cost accounting standards, intellectual property rights, certification requirements, and subcontractor management. Specific benefits of OTs include: * Provisions that allow for the use of Generally Approved Accounting Procedures, rather than Government Cost Accounting Standards * Cost and pricing data and certifications are negotiable, rather than mandatory * Intellectual property provisions are more commercially friendly * Increases the ability to establish innovative business arrangements, which include cost or resource sharing, establishment of Government-Contractor consortia The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. Submission Instructions: Submissions should: (1) be sent to jessica.l.ely.civ@mail.mil; (2) be sufficiently detailed and organized in a manner that relates to the information requested in this RFI; (3) include a company point of contact with name, title, telephone, and e-mail address(es); Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to the Point of Contact at the Contracting Office below. Contracting Office Address: ACC-APG NCD ATTN: Jessica Ely jessica.l.ely.civ@mail.mil (301) 619-8457 110 Thomas Johnson Drive Fort Detrick, MD 21702
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