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 intends to issue a full and open competition 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.

The solicitation may result in a firm fixed price contract(s) 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 intends to use FAR Part 12 for this acquisition as commercial services may satisfy the agency's requirement. It is anticipated a firm fixed price contract will be awarded to a single contractor. A combination of evaluation techniques may be utilized for this acquisition, a tradeoff evaluation technique is contemplated.

Any subsequent solicitation related to this pre-solicitation notice is expected to be issued within 15 days of the published date of this notice.

The North American Industry Classification System (NAICS) code for this procurement is

541715. In accordance with DFARS

252.204-7004, Alternate A, all interested offerors shall be registered in the

System for Award Management (SAM) database.

Proposal costs or any responses to this notice shall not be reimbursed. If a full solicitation is released, all interested parties will be able to view, download, and print a copy of the solicitation and any resulting amendments at beta.sam.gov, reference:W911QY-21-R-0021

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.

Contracting Office Information:

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, Contract Specialist

Scott.i Hoffman2.civ@mail.mil