PRESOL | 99 | Soliciting for service to provide Phase 1 of a Course of Action Alternative (COAA) analysis for the Pilot Bioproductivity Facility with modernized capabilities for WRAIR.

FBO DAILY ISSUE OF MAY 10, 2006 FBO #1626
SOLICITATION NOTICE

99 -- Soliciting for service to provide Phase 1 of a Course of Action Alternative (COAA) analysis for the Pilot Bioproductivity Facility with modernized capabilities for WRAIR.

Notice Date: 5/8/2006
Notice Type: Solicitation Notice
NAICS: 541690 — Other Scientific and Technical Consulting Services
Contracting Office: US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
ZIP Code: 21702-5014
Solicitation Number: W81XWH-06-T-0213
Response Due: 5/13/2006
Archive Date: 7/12/2006
Small Business Set-Aside: N/A
Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. STATEMENT OF WORK Walter Reed Army Institute of Research (WRAIR) Bio-Production Facility (BPF) Courses of Action Alternatives (COAAs) BACKGROUND: Immunization is the most cost-effective and efficient means of disease prevention. Vaccine discovery, development, and licensure rely on a dwindling number of vaccine production facilities. The Institute of Medicine report, The Childrens Va ccine Initiative (1993), identified vaccine pilot and small-scale production facilities as a major barrier to effective reliance on immunizations for disease control. Since the increase in U.S. Food and Drug Administration (FDA) regulation of biologics in the 1970s, the number of U.S. vaccine manufacturers has dwindled to a handful. Industrial mergers have further reduced the number of small biotech firms engaged in the business of contract scale-up and manufacture of biological products. Simultaneously, FDA regulations were modified to allow virtual pharmaceutical companies and distributed, licensed, biologics production. Lead time for access to regulated facilities for pilot manufacturing, scale-up, and small-to-medium scale production of bacterial and viral productswhich must be segregatedhas evolved as a significant barrier to evaluation of biologic technologies and schedules of research, development, and fielding. The WRAIR BPF is an essential, unique Department of Defense (DoD) asset that provide s DoD the capability to demonstrate proof of principle in human trials of concepts for militarily relevant diseases. No other current or planned DoD facility will meet FDA requirements for Good Manufacturing Practices (GMP) production. WRAIR BPF capabili ties must be modernized to remain responsive to DoD and Army biologic research, development, and acquisition (RDA) needs. OBJECTIVE: The contractor shall develop a COAA for ensuring DoD and Army capabilities for pilot, scale-up, and small-scale production of biologicalbacterial and viralproducts that are fully FDA compliant. The contract shall develop the COAA in phases t o include the identification of alternatives, analysis of factors, and recommended courses of action. PHASE I: The contractor shall develop and describe alternatives that consider government versus contract facility ownership, management, and operation. Alternatives shall include but are not limited to the status quo, external procurement of production r equirements, Enhanced Use Lease (EUL) of facilities/production by private industry, consolidation of services within existing facilities, and consolidation of services with construction of additional facilities. The recent feasibility study conducted by K ling, Whiting Turner (2005) for a replacement biomanufacturing facility and a previous study by SAIC on the Vaccine Production Facility operations alternatives (1997) should be used as the basis for new facility capabilities and operational evaluations. T he contractor shall address overall operating scenarios taking into account, for example, the move of the Division of Retrovirology onto the Post, the current operating capacity, and the need to compartmentalize operations for decontamination requirements. Within each of these possible alternatives, the contractor shall address possible operating alternatives appropriate to the operating scenario. These may include but are not limited to Government Owned/Government Operated (GOGO), Government Owned/Contract or Operated (GOCO), and Contractor Owned/Contractor Operated (COCO). Alternatives shall include descriptions of operational scenarios as they apply to the WRAIR BPF mission. The contractor shall review these alternativ es with the government Task Order Contracting Officers Representative (TOCOR) prior to starting Phase II. PHASE II: The contactor shall develop findings for key factors for each alternative selected by the government that include but not limited to the following: Facility and operational requirements, including biosafety requirements and select agent security Operational descriptions, including expected life, atypical maintenance, or upgrade (renovation) planning factors Quality assurance Order of magnitude costs Sources of funding (e.g., federal [sources], private, and combination) and the value and price of in-kind procured services performed at the BPF RDA program requirementstypes of candidate vaccines RDA program scheduleconcurrent and sequential tasks FDA regulatory compliance Operational indemnification Product indemnification Ability to accommodate changing priorities The contractor shall review these alternatives with the government TOCOR prior to starting Phase III. PHASE III: The contractor shall develop assessments for each of the alternatives within respective groupings using the preceding factors based on best business practices, government procurement (e.g., Federal Acquisition Regulation) and construction polic ies, DoD accepted cost estimating, and net present value procedures. The assessments shall include but are not limited to the following: Mission success Facility construction issues Operational issues Net Present Value of costs Regulatory issues Technical performance issues Technology advancement Based on the assessments, the contractor shall develop recommended COAA. The contractor shall document these recommendations and present them to the government for their use as appropriate. Government-Furnished Information Kling Whiting Turner Biomanufacturing Facility Study, 2005 USAMRMC, WRAIR) Pilot Bioproduction Facility Economic Analysis, September 3, 1997 DELIVERABLES The following is the list of deliverables and respective due dates: Deliverable Presentation of Phase I list of alternatives. DUE: 2 weeks after start of work Presentation of Phase II findings. DUE: 8 weeks after government approval of alternatives Presentation of draft COAA. DUE: 6 weeks after Phase II presentation Final COAA Documentation. DUE: 15 days after receipt of government comments on draft
Place of Performance: Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD; Zip Code: 21702-5014; Country: US
Record: SN01043986-W 20060510/060508220852 (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

| FSG Index | This Issue's Index | Today's FBO Daily Index Page |

Loren Data's SAM Daily™

99 -- Soliciting for service to provide Phase 1 of a Course of Action Alternative (COAA) analysis for the Pilot Bioproductivity Facility with modernized capabilities for WRAIR.