j&a.pdf

Justification for Other than Full and Open Competition In Accordance with 10 USC 2304(c)(l)

Zauamivir for Inhalation (Relenza)

1. Defense Logistics Agency (DLA) Troop Suppmi, Medical Supply Chain, is the contracting activity.

2. The action being approved is the ability to solicit for DLA requirements on an Other Than Full and Open Competition basis.

3. The proposed acquisition will result in a contract for Zanamivir for Inhalation. The sole source for this drug is GlaxoSmithKline (GSK).

National Stock Number (NSN): 6505-01-657-8192

Estimated Quantity: 335,000 Each

Contract Type: Firm Fixed Price Requirements

The estimated quantity is based on the direction given to DLA Troop Suppo1i by the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA))

4. The applicable statutory authority permitting Other Than Full and Open Competition is 10 U.S.C. 2304(c)(l), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5.

Zanamivir (Relenza) is one of the three anti-viral drugs approved by the Food and Drug Administration (FDA) for use against circulating influenza viruses.

Oseltamivir Phosphate (brand name Tamiflu) and Peramivir (brand name Rapivab) are the other two FDA approved anti-viral drugs. The differences between Zanamivir (Relenza), Oseltamivir Phosphate (Tamiflu), and Peramivir (Rapivab) are how they are administered and FDA recommended patient age for use. Zanamivir (Relenza) is a powder that is inhaled, Oseltamivir Phosphate (Tamiflu) is available as a pill or liquid, and Peramivir (Rapivab) is administered intravenously by a health care provider. Zanamivir (Relenza) is FDA approved for the treatment of influenza in persons aged seven (7) years and older, and for the prevention of influenza in persons aged five (5) years and older. Oseltamivir Phosphate (Tamiflu) is FDA approved for the treatment of influenza in persons aged two (2) weeks and older, and for the prevention of influenza in persons aged one (1) year and older. Peramivir (Rapivab) is FDA approved for use only in adults aged eighteen (18) and older.

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