SPECIAL NOTICE
A -- Replication-Deficient, Human Adenovirus-Vectored Foot-and-Mouth Disease Vaccine Countermeasures Research and Development Sources Sought - Draft RFI FMDVX
- Notice Date
- 2/5/2016
- Notice Type
- Special Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Office of the Chief Procurement Officer, Washington, District of Columbia, 20528, United States
- ZIP Code
- 20528
- Solicitation Number
- HSHQDC-16-I-FMDVX
- Archive Date
- 3/23/2016
- Point of Contact
- John Whipple, Phone: 202-254-2389, Marcus Datcher, Phone: 2022548286
- E-Mail Address
-
john.whipple@hq.dhs.gov, marcus.datcher@hq.dhs.gov
(john.whipple@hq.dhs.gov, marcus.datcher@hq.dhs.gov)
- Small Business Set-Aside
- N/A
- Description
- RFI FMD Seed Vx - 5 Feb 2016 I. General A. The U.S. Department of Homeland Security (DHS), Office of Procurement Operations (OPO) issues this Research and Development (R&D) Sources Sought on behalf of the DHS Science and Technology Directorate (S&T), Chemical and Biological Division (CBD), Agricultural Defense Branch (AgDef, collectively "the Government" hereafter). This notice is issued pursuant to Federal Acquisition Regulation subpart 5.205(a). The reference number for this announcement is HSHQDC-16-I-FMDVX. B. THIS IS A SOURCES SOUGHT NOTICE ONLY. This notice is issued solely for market research and planning purposes; it does not constitute a Request for Proposal (RFP), or a promise to issue an RFP at a later time. Respondents to this notice should not anticipate feedback with regard to their submissions other than acknowledgment of receipt if a request for an acknowledgement is requested. C. This notice does not commit the Government to enter into an agreement, contractual or otherwise, for any supply or service. DHS is not at this time seeking proposals. Respondents are advised that the Government will not pay any cost incurred in preparing and submitting a response to this notice. All costs associated with responding to this notice will be solely at the interested party's expense. Not responding to this notice does not preclude participation in any future RFP if one is issued. D. The information received in response to this notice may be used to develop criteria, requirements, and/or make decisions and recommendations with regard to the development of an appropriate planning and procurement strategy that may be included in future RFPs. Only unclassified submissions will be accepted. E. The information provided in this notice is subject to change and is not binding on the Government. All submissions become the property of the Government, and will not be returned. Respondents providing submissions containing sensitive or proprietary information must ensure this information is clearly marked. Provided respondents have appropriately marked the information they consider to be protected as sensitive/proprietary, that information will not be disclosed outside the Government consistent with Federal Acquisition Regulation Subpart 3.104, and other applicable laws and regulations. Submissions that are strictly generic marketing materials or inquiries from market research firms will be discarded if received. F. The information contained in this notice constitutes a new Government requirement. There is no incumbent and no estimated dollar value at this time. Market research efforts, of which this notice is a part, are ongoing. II. Responses A. Content Section Title: Introductory Letter Content • Brief background on your entity including corporate make-up, major operating units, and strategic business units (include DUNS number, CAGE code, and address(es) for all sections/levels). • Identify individual(s) (include name, title, and contact information) within your entity capable of responding to Government inquiries about your entity's submission and stated technical capabilities. Page Limit: 2 Section Title:Capabilities Content • Clear and concise articulation of your entity's capabilities in the areas out lined in Section IV. • NOTE: There is no page limit on capabilities response content, but see total maximum pages per submission below. Page Limit: N/A Section Title:Experience Content • List current or past awards/agreements, within past three (3) years, with U.S. Government entities providing services similar to the areas out lined in section IV. of this notice including identification numbers and brief project descriptions (200 words or less per entry). Page Limit: 2 Section Title: Additional Information Content (Optional) • Other relevant information including work with private entities similar to the areas out lined in section IV. of this notice or information on any pre-existing Government Contract vehicles held by your entity, e.g., ID/IQ Contracts, GSA Federal Supply Schedule contracts. Page Limit: 1 Total maximum pages per submission 17 B. Format a. Fonts used in drafting responses must be clearly legible when printed on standard 8½ x 11 inch paper with one (1) inch margins. b. The content outlined in the table at paragraph II.A. must be submitted to the Government contacts as one (1) Portable Document Format (PDF) file five (5) megabytes, or less, in size. c. Only typed, e-mailed submissions will be accepted. C. Submission Instructions and Deadline a. Responses must be submitted via e-mail to the Government contacts on page 1 of this notice before 4:00PM Eastern Standard Time on March 21, 2016. I II. Background A. The Government's objective in this area is to establish a relationship, potentially through a formal written agreement, with an entity able to produce master seeds and master seed-derived production lots of veterinary foot-and-mouth disease (FMD) medical countermeasures. Those countermeasures must comply with the regulatory frameworks of the U.S. Department of Agriculture's (USDA) Center for Veterinary Biologics (CVB) and the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicine Products (VICH). The Government is specifically seeking interested parties capable of providing: a. Pre-master and master viral seeds for replication deficient, human adenovirus vectored FMD (AdFMD) vaccine candidates for new and emerging FMD virus topotypes and genotypes. b. R&D manufacturing, analytical and clinical testing of currently available AdFMD master viral seeds for use in the regulatory development of FMD vaccine candidates toward USDA product licensure. IV. Technical Capabilities of Interest A. The Government requests that interested parties provide detailed information for all of the following questions, whether or not they possess the capability discussed, along with the other information identified in the table in Section II. of this notice: 1. Does your firm/university/organization currently have the appropriate legal agreements in place to use an E1/E3 replication-deficient human adenovirus vectored platform and 293 cell line derived system to construct, produce and test FMD vaccine candidates? If the answer to this question is "No," please outline estimated timelines to establish those legal agreements. 2. What is your firm/university/organization's record of accomplishment in the technical capability to produce and characterize replication-deficient human adenovirus vectored FMD vaccine candidates? 3. What is your firm/university/organization's regulatory project management experience and historical interactions with USDA CVB on FMD vaccine candidates? 4. What is your firm/university/organization's track record in R&D process development and process optimization of AdFMD vaccine candidates? Please include performance metrics in your response if they used by your firm/university/organization to gauge success or progress. 5. What is your firm/university/organization's experience in the R&D production and release of small scale (e.g., 5-10 liters) and moderate scale (e.g., 50 liters) AdFMD vaccine candidates? 6. Describe your firm/university/organization's track record and capabilities to develop and verify analytical assays for AdFMD vaccine candidates. 7. What is your firm/university/organization's experience in the testing and evaluation of AdFMD vaccine candidates in livestock species (e.g., cattle and/or swine)? Provide specific examples and please cross reference projects cited in the "Experience" section of your submission (See Table in Section II.).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DHS/OCPO/DHS-OCPO/HSHQDC-16-I-FMDVX/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN04011863-W 20160207/160205234310-cf3fac602d3aebfb648136bdfe57baf0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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