Antiviral Medicine Oseltamivir (trade name Tamiflu)

The Department of Homeland Security (DHS), Office of Procurement Operations (OPO), intends to issue a sole source contract to Roche Labs, 340 Kingsland Street, Nutley, NJ 07110 for the antiviral medicine Oseltamivir (trade name Tamiflu), by other than full and open competition, in accordance with Federal Acquisition Regulation (FAR) 6.302-1. This is not a request for a proposal. A solicitation will not be issued and proposals will not be requested. DHS, Office of Health Affairs (OHA), requires this antiviral medicine for the DHS Antiviral Stockpile for pandemic and avian influenza preparedness. The stockpile is needed in order to have a readily available supply of medicine to protect DHS personnel in the event of a pandemic to ensure the continuity of its essential services and overall critical mission. The medicine must be approved by the Food and Drug Administration and demonstrated by the Centers for Disease Control to be effective in treating Influenza A, H1N1 Influenza and H5N1 Avian Influenza. The medicine must also be able to be administered orally in the form of a pill or capsule. Packaging and labeling specifications of this antiviral medicine are as follows: Each Tamiflu capsule shall contain 75 mg of oseltamivir phosphate. Each package shall contain capsules sufficient for one course (5 days treatment or 10 days prophylaxis). Product packaging shall be in accordance with Health and Human Services (HHS) Strategic National Stockpile (SNS) packaging. Product labeling shall be in accordance with HHS SNS labeling. The ordering period of the resulting contract will include a 12-month base and four (4) 12-month options. The statutory authority permitting other than full and open competition is 41 U.S.C. 253(c)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1 entitled "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements." CDC regards zanamivir (trade name Relenza), produced by GlaxoSmithKline (GSK), as a proven effective alternative to oseltamivir (Tamiflu) in the treatment and prevention of influenza. However, there is a proportion of the human population that can not take Relenza due to its delivery system (oral inhalation). Therefore, some people will require the antiviral medicine to be administered orally. Tamiflu is the only antiviral medicine shown to be effective that comes in the form of gel-caps. Market research has shown that no other known contractors presently exist who could get the necessary CDC/FDA approvals to produce the product in sufficient quantities and deliver it in time to meet the current requirement. A redacted copy of the justification prepared for this procurement is included with this notice pursuant to the requirements of FAR 5.102(a)(6). Based on the aforementioned facts and the statutory authority at FAR 6.302-1, the Government intends to award a single non-competitive contract to Roche Labs for this medicine after March 12, 2010.