Stability Testing Of rBV A/B And rF1V Critical Material Lots   3

The U.S. Army Contracting Command Aberdeen Proving Ground, Natick Division, on behalf of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), Joint Project Manager for Chemical Biological Radiological and Nuclear Medical (JPM-CBRN-Medical), Joint Project Lead BIO1 is issuing a full and open competitive solicitation for Stability Testing of Drug Product, Drug Substance, Reference Materials, recombinant Botulinum A/B (rBV A/B) vaccine materials, and recombinant Plague F1V (rF1V) vaccine materials. The anticipated period of performance is 60 months after date of contract award, comprised of one 12-month base period with four 12 month option periods.

This solicitation may result in a single firm fixed price contract for the conduct of 3, 6, and 12 month stability testing to continue stability testing of rBV A/B and rF1V critical material lots and reagents in anticipation of ongoing and future activities. Testing of critical material includes the continued testing of several lots of cGMP drug product (DP), cGMP drug substance (DS), associated reference materials, and other critical reagents. Stability testing shall require compliance/conformance with regulations established by the U.S. Food and Drug Administration's (FDA) such as Good Manufacturing Practice regulations (cGMP) and International Conference on Harmonization (ICH) guidelines. Interested parties must be capable of successfully executing or managing the required Stability Testing.

Data generated under the contract will be considered Department of Defense Controlled Unclassified Information (CUI) and fall under ITAR 120.10 whose export is restricted by the Arms Export Control Act (Title 22, U.S.C. Sec 2778, et seq.) Violations of United States export laws are subject to severe criminal penalties.

The Government is using FAR Part 12 for this acquisition as commercial services may satisfy the agency's requirement. It is anticipated that a single firm fixed price contract will be awarded to a single responsible offeror.

Interested sources are advised to carefully read the following attachments: "W911QY-21-R-0021 Solicitation", "Attachments 0001-0003 -W911QY-21-R-0021", "Attachment 0004 - W911QY-21-R-0021 Price", "Exhibits A001-A004".

Proposal costs or any responses to this notice shall not be reimbursed.

No telephone calls will be accepted. No paper copies of the RFP will be provided and no mailing list will be maintained.

All inquiries related to this notification should reference in the Subject Line RFP number W911QY-21-R-0021.

****Amendment 0001 to this notice is hereby issued to incorporate the below:

Government responses to Industry questions are added as an attachment, dated 10 May 2021.

****End of Amendment***

****Amendment 0002 to this notice is hereby issued to incorporate the below:

Updated Government clarification/responses to Industry questions is added as an attachment titled: "Questions Answers W911QY-21-R-0021 11 May 2021."

Updated attachment titled: "W911QY-21-R-0021 Solicitation Amendment 0002 11 May 2021" is added.

****End of Amendment***

Contracting Office Address:

ACC-APG - Natick, Natick Division

Building 1, Kansas Street, Natick, MA 01760-5011

Place of Performance: To be Determined (TBD)

ACC-APG - Natick (SPS) ATTN: AMSRD-ACC-N, Natick Contracting Division, Building 1, Kansas Street Natick MA

01760-5011

US

Point of Contact(s):

Scott Hoffman, 301-619-8148

Scott.i Hoffman2.civ@mail.mil