Leukine-ASPR-2019-00406_J_&_A_Clarification.docx

This posting is to clarify “Item 6” of the J & A recently posted on September 26, 2019 for solicitation no. Leukine-ASPR-2019-00406 to be consistent with “Item 9.”

“Item 6”, is hereby updated to reflect the following:

1. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A sources sought notice (HHS-OS-ASPRBARDA-2018- RFI_Cytokines_to_Treat_Neutropenia) was issued in September 24, 2018 with a closing date of November 23, 2018. Partner Therapeutics was the only source that provided a response specific to G-CSF (Leukine) and Amgen was the only source that provided a response specific to PEGylated G-CSF (Neulasta) and G-CSF (Neupogen).

41 U.S.C.3304 (a) (3), FAR 6.302-3(a) (2) (i) allows the US Government to maintain a facility, producer, manufacturer, and supplier of FDA approved Cytokines in case of a national emergency, to achieve industrial mobilization. This statutory authority permits the government to provide for an adequate industrial mobilization base.