SOLICITATION NOTICE
68 -- Merck Storage and Rotation of Vaccines
- Notice Date
- 4/14/2009
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Archive Date
- 5/1/2009
- Point of Contact
- Gary L. Morgan,, Phone: (770) 488-2639, Jeff A Miller,, Phone: 770-488-2651
- E-Mail Address
-
glm5@cdc.gov, afx2@cdc.gov
- Small Business Set-Aside
- N/A
- Award Number
- 200-2009-29183
- Award Date
- 4/1/2009
- Description
- JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION (JOFOC) PART I - Program Office 1. IDENTIFICATION OF AGENCY, CONTRACTING ACTIVITY AND IDENTIFICATION OF PROJECT: a. Program Office and Address: Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases 1600 Clifton Road, Corporate Square, E52 Atlanta, Georgia 30333 b. Project Officer's Name and Telephone Number: Evern G. Thompson 404-XXX-XXXX c. Contracting Authority: Centers for Disease Control and Prevention Procurement and Grants Office Acquisition and Assistance 2920 Brandywine Road Atlanta, GA 30341 d. Identification of Project: Merck Storage and Rotation Contract 2. NATURE OF ACTION BEING APPROVED: Negotiations with a single source for the storage and rotation of stockpiled vaccine. 3. DESCRIPTION OF SERVICES AND ESTIMATED CONTRACT VALUE: a. Description of Services: The CDC has a requirement to establish a stockpile of certain vaccines for a national stockpile to be used in the event of an emergency outbreak or unexpected shortage. Current manufacturers of vaccines with FDA licenses are the only ones who have the national market - both public and private - to store and rotate the vaccines that they manufacture. b. Estimated Contract Value: $750,390.00 for the first 12 months and an additional $218,863.75 for a 3 ½ month option period. Total contract value = $969,253.75. c. Period of Performance: One (1) base year and one 3½ month option period. Total performance period = 15 ½ months. 4. STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN COMPETITION 41 U.S.C. 253 (c) (3) (A) a. Reason authority cited: It is necessary to award the contract to a particular source or sources in order to maintain a national market, facility, producer, manufacturer, or other supplier available for furnishing property or services in case of a national emergency or to achieve industrial mobilization. 5. REASONS TO JUSTIFY OTHER THAN FULL AND OPEN COMPETITION: a. Background: When stockpiled vaccines are called into use for emergency outbreaks or vaccine supply disruptions, they must be viable for administration. The CDC pediatric stockpiled vaccines are held at the manufacturers' facilities in a storage and rotation system that makes it possible to rotate stock efficiently and thus minimize CDC's cost and risk resulting from vaccine that would otherwise expire. These shelf-life concerns are exclusively addressed by the manufacturer because the manufacturer has the market to rotate older stockpiled vaccines into operating inventory before expiration, and to continually replenish stockpiled vaccines with fresh vaccine produced more recently by them. b. Alternatives: No known alternatives. c. Justification: All of the stockpiled vaccine is manufactured by Merck. To our knowledge there is no other manufacturer of these particular vaccines meeting the requirements for storage and rotation set forth by the FDA. d. Impact: Allowing the vaccine manufacturer to store and rotate the stockpiled vaccines keeps CDC's purchased vaccines viable for use year after year. CDC would need to re-purchase vaccines upon expiration if they could not be continuously rotated out into the market. 6. ACTIONS TAKEN TO REMOVE BARRIERS TO COMPETITION FOR SUBSEQUENT ACQUISITIONS OF THIS TYPE: Without the capability for an organization to rotate the vaccines into the market and then replace those rotated vaccines with fresh vaccines it could not most efficiently and effectively manage CDC's pediatric vaccine stockpile program. Another key aspect is that even if an organization could rotate the product into the market place, unless it was the vaccine manufacturer performing the rotations, that organization would not be able to replenish the rotated vaccines with a more fresh vaccine without CDC re-purchasing the vaccines. 7. MARKET RESEARCH A vaccine manufacturer, under our contract terms and conditions, will maintain the potency and freshness of the vaccines by storing the vaccines and rotating them when they get close to expiration and then replacing those rotated vaccines at no additional charge to the Federal Government and thereby maintaining our CDC pediatric vaccine stockpile in the most effective and efficient manner possible. Merck is the only organization that has the full, optimal, market to store and rotate the product, in the quantities that we want stored and rotated. If CDC selected another vendor to store and rotate the vaccines being held in CDC's pediatric vaccine stockpiles, those entities would not have the market size in which to fully rotate the quantities of product and therefore CDC would not be able to store the selected vaccine quantities. The ability to rotate the product is a key aspect for the selection of the organization storing CDC's vaccines. 8. INTERESTED SOURCES: The only interested source for procurement is identified as: Merck Attn: XXXXXXXXX 770 Sumney Town Pike West Point, PA 119486 9. SIGNATURES ARE REQUIRED BELOW: I have reviewed this JOFOC and certify the justification is adequate to support other than full and open competition. _____'S'______________________________ _____________________________ PROJECT OFFICER (PO) DATE ______'S'______________________________ _____________________________ (Print) PO SUPERVISOR DATE _______'S'_____________________________ SIGNATURE of PO SUPERVISOR
- Web Link
-
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- Place of Performance
- Address: Merck, 770 Sumney Town Pike, West Point, PA 19486-0004, West Point, Pennsylvania, 19486-0004, United States
- Zip Code: 19486-0004
- Zip Code: 19486-0004
- Record
- SN01792536-W 20090416/090414221732-480786a917ae62a08b28ee82479a8707 (fbodaily.com)
- Source
-
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