The Department of Homeland Security (DHS), Office of Procurement Operations (OPO), Protection and Health Affairs Acquisition Division (PHAAD) intends to negotiate on a sole source basis with Roche Labs (Roche) 340 Kingsland Street, Nutley, NJ 07110 for the antiviral medicine Oseltamivir. This is not a request for a proposal. A solicitation will not be issued and proposals will not be requested. DHS requires an 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 medicines to protect DHS personnel in the event of a pandemic to ensure continuity of its essential services and overall critical mission. The medicine must be approved by the Food and Drug Administration (FDA) and demonstrated by the Centers for Disease Control (CDC) to be effective in treating Influenza A 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 medicine are as follows: Each 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. It is anticipated that the ordering period of the resulting contract will include a 12-month base and two (2) 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.” Roche is the only source that will satisfy the agency requirements. The oseltamivir medication manufactured by Roche is produced as a gel-cap, is approved by the FDA, and has been demonstrated by the CDC to be effective in the protective treatment and prevention of Influenza Virus A and H5N1. 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 for this medicine after August 4, 2008.

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