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FBO DAILY - FEDBIZOPPS ISSUE OF DECEMBER 23, 2016 FBO #5509
SOURCES SOUGHT

65 -- Stockpile 2017 - Supplemental - Statement of Work (SoW) - CLIN Capability Summary

Notice Date
12/21/2016
 
Notice Type
Sources Sought
 
NAICS
325414 — Biological Product (except Diagnostic) Manufacturing
 
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
17-100-SOL-00007
 
Archive Date
2/7/2017
 
Point of Contact
Lynda M. Brown, Phone: 202-692-4760
 
E-Mail Address
Lynda.Brown@hhs.gov
(Lynda.Brown@hhs.gov)
 
Small Business Set-Aside
N/A
 
Description
Contract Line Item Number (CLIN) Capability Summary - Stockpile 2017 SoW for Stockpile 2017 The Government is seeking qualified small business concerns and seeks to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUB Zone small businesses, service-disabled, veteran-owned small business, 8(a) small businesses, woman-owned small businesses, or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code 325414. The small business size standard is 500 employees. Your response to the information requested will assist the Government in determining the appropriate acquisition strategy, including whether a set-aside is a possibility. This Sources Sought Notice (SSN) is not a Request for Proposal (RFP) and does not constitute a commitment by the United States Government (USG). The USG is currently conducting market research in accordance with Federal Acquisition Regulation, Part 10, to identify potential small business sources to fulfill the requirement and gather information on current capabilities within the market. All information submitted in response to this sources sought notice is voluntary and the USG will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the USG. Proprietary information submitted should be marked appropriately. All submitted information shall remain with the USG and will not be returned. Respondents to this sources sought notice may identify their interest by submitting a capability statement, including primary contact information at the organization (name, email, address and telephone number) handling this sources sought notice in the event HHS has additional questions or requires clarification of the submitted information. Chart 1, CLIN Capability Summary for Sources Sought is provided to assist respondents in summarizing their capability statements. Responses are limited to 15 pages including appendices and attachments. All respondents and comments to this sources sought notice shall reference solicitation number 17-100-SOL-00007, "Stockpile 2017," and be submitted to Lynda Brown, Contracting Officer at lynda.brown@hhs.gov. Assistant Secretary for Preparedness and Response (ASPR) encourages responses and/or participation by small business sources. Background: The priorities of the BARDA Influenza Division are closely aligned with the National Strategy for Pandemic Influenza Implementation Plan (2006), The Public Health Medical Countermeasures Enterprise Review (August 2010), The President's Council of Advisors on Science and Technology report on influenza vaccine manufacturing (August 2010), and the BARDA Strategic Plan 2011-2016 (October 2011). To achieve the goals described in these plans and to prepare the nation to be able to reduce significant morbidity and mortality caused by influenza, the Federal Government established stockpiles of influenza countermeasures, as well as domestic vaccine manufacturing capacity. Scope and Purpose: The Department of Health & Human Services (HHS) has a future requirement to continue the National Pre-Pandemic Influenza Vaccine Stockpile: Preparedness and Response Program. The future requirement is expected to include the procurement of cGMP Influenza Vaccine Master and Working Seeds; Influenza Vaccine Pilot Lots; cGMP Influenza Vaccine Clinical Lots; cGMP Influenza Vaccine Commercial Scale Bulk Lots; cGMP Adjuvant Commercial Scale Bulk Lots; Formulation and Filling in a variety of containers; Storage and stability; Shipping; Disposal; Laboratory Testing; Reagent and Standards Manufacture and Testing; Animal Studies; Clinical Studies and BARDA Tracking tool integration. 1) The anticipated minimum Mandatory Eligibility Criteria for this requirement include that the contractor shall produce vaccines against influenza and influenza strains with pandemic potential; shall demonstrate a successful experience in the manufacturing of influenza vaccine by: • Holding a US influenza vaccine license OR • Have developed an influenza vaccine as evidenced by: o A pivotal Phase 3 final clinical study report AND o Minutes from a FDA Pre-BLA meeting 2) Anticipated period of performance: A total of four (4) years or forty-eight months, which includes a two year base period and with a potential for two 12-month option periods. 3) Contract Type: Firm Fixed Price 4) Response Due Date: Qualified Offerors should submit the Capability Statement in response to this sources sought notice electronically by 10AM (EST) Monday, 23 January 2017 via email to the Contracting Officer, Lynda Brown at lynda.brown@hhs.gov 5) Questions: All questions pertaining to the notice are due by 10AM (EST) Friday, 6 January 2017 via email to Contracting Officer, Lynda Brown at lynda.brown@hhs.gov. Only one set of questions per contractor will be accepted.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/17-100-SOL-00007/listing.html)
 
Place of Performance
Address: Contractor's Facilities, United States, United States
 
Record
SN04357211-W 20161223/161221234356-a1dac2f83a41f352dfba460331fbc89d (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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