Antiviral Medicine Zanamivir (trade name Relenza)

The Department of Homeland Security (DHS), Office of Procurement Operations (OPO), intends to issue a sole source contract to GlaxoSmithKline (GSK), 9917 Carrington Place, Richmond, Virginia 23238, for the antiviral medicine Zanamivir (trade name Relenza), 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 in the form of an inhalant or some other form that does not involve the oral ingestion of a pill or capsule. Packaging and labeling specifications of this antiviral medicine are as follows: The medicine shall be packaged in 4 evenly spaced double-foiled blisters with each blister containing a powder mixture of 5 mg of zanamivir and 20 mg of lactose. Each package shall contain medicine 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 oseltamivir (trade name Tamiflu), produced by Roche Labs, as a proven effective alternative to zanamivir (Relenza) in the treatment and prevention of influenza. However, there is a proportion of the human population that can not take Tamiflu due to its delivery system (orally via capsule or gel-cap). Therefore, some people will require the antiviral medicine to be administered through oral inhalation. Relenza is the only antiviral medicine shown to be effective and that comes in the form of an inhalant. 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 GlaxoSmithKline (GSK) for this medicine after March 12, 2010.