Stability Testing Of rBV A/B And rF1V Critical Material Lots
Closed Solicitation Posted
- Solicitation number
- W911QY-21-R-0021
- Agency
-
ACC Aberdeen Proving Ground
Army Contracting Command, Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
Notice details come from SAM.gov. Updated .
About this opportunity
The U.S. Army Contracting Command - Aberdeen Proving Ground, on behalf of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, seeks proposals to conduct three, six, and twelve month stability testing of recombinant Botulinum A/B and recombinant Plague F1V vaccine materials, including several lots of drug product, drug substance, reference materials, and other critical reagents. Offerors must be capable of successfully executing or managing the required stability testing in compliance with FDA cGMP regulations and ICH guidelines over a five year base period and four option years. Proposals are due by May 14, 2021.
The contract has no set-aside designations. The NAICS code is 541715 and the PSC code is R425. The single award is for a firm fixed price contract not to exceed $5 million over five years. The place of performance will be at the contractor's facility. Testing will include continued analysis of several critical material lots to ensure ongoing and future vaccine development activities can proceed as planned.
Notice text
3 versions
Update #3 · Latest ·
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
Update #2 ·
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***
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
Update #1 ·
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.
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
Files
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Solicitation | |
| Stability Testing Of rBV A/B And rF1V Critical Material Lots | Pre-Solicitation | |
| Sources Sought Notice (SSN) Stability Testing Of rBV A/B And rF1V Critical Material Lots | Pre-Solicitation |
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