36C10G18R0003 Biologics
Closed Pre-Solicitation Posted
This opportunity was awarded. See the award notice from , or the latest solicitation from .
- Solicitation number
- 36C10G18R0003
- Agency
-
VA Strategic Acquisition Center Frederick
Headquarters, Department of Veterans Affairs
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 36C10G18D0127 Federal IDV award
- Awardee
- Affirmative Solutions LLC
- NAICS code
- 339113 Surgical Appliance and Supplies Manufacturing
- PSC
- Not on record
- More information
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs Strategic Acquisition Center intends to issue a request for proposal to establish multiple-award indefinite delivery indefinite quantity contracts for the procurement of various types of biologics and biological implants, including allografts from human cadavers and xenografts from animals, to be used in surgeries and medical procedures. The biological implants must be FDA approved, tracked from source to implantation, and labeled in accordance with ISBT 128. Evaluation criteria will include technical compliance, pricing, and subcontracting plans from large businesses. A draft RFP was posted on December 15, 2017, with final RFP expected on December 31, 2017 and proposals due periodically through November 2018.
There is no set-aside designation. The main NAICS code is 339113 for Surgical Appliance and Supplies Manufacturing. The government anticipates awarding up to 30 contracts worth a total of $2.1 billion over five years under this opportunity. Key details include a one-year base period for the contracts plus four one-year options, and quantity of goods consisting of various types of biologics and biological implants for use in VA medical procedures and surgeries.
Notice text
6 versions
Update #6 · Latest ·
The purpose of this amendment is to:
add a column in Attachment 6 Technical Acceptability Worksheet for the offeror to identify the reference where the specific item is addressed within their proposal, e.g. Volume number, page, and section, etc.
Extend the 2nd submission date and time of closing from August 15, 2018, Noon EST to August 30, 2018, Noon EST.
Changes to the conformed copy are typed in blue text.
All other terms and conditions remain unchanged.
Update #5 ·
Summary of Changes
36C10G18R0003 Amendment 1
Section D Contract Documents, Exhibits, or Attachments.
Exhibit D.6 Attachment 6 Technical Acceptability Worksheet is deleted in its entirety and replaced by Attachment 6 Amendment 1 Technical Acceptability Worksheet that removes language for item M and N and marks them
Reserved .
In Section 1.7.4 deletes reference to B.11 and replaces with B.5.11 .
In Section 3.2.1 deletes reference to B.6 and replaces with B.5.6 .
In Section E.16. Proposal Submission Instructions paragraph 6 shall be deleted in its entirety:
The solicitation will remain open and continuous until the maximum number of awards is made. If all the awards are made prior to 2nd submission date as outlined below, the solicitation will be amended and closed. The proposal shall be emailed to the CS at Lawrence.Toperoff@va.gov and CO at LeShanna.Calahan@va.gov.
and replaced with:
The solicitation will remain open and continuous. If there is a reasonable expectation that the number of awards will be made by offerors received in the first submission. The solicitation will be amended and closed. The proposal shall be emailed to the CS at Lawrence.Toperoff@va.gov , copy to Michelle.Bailey@va.gov ,and CO LeShanna.Calahan@va.gov.
Virtual Pre-proposal Conference: A virtual pre-proposal conference will be held Tuesday, May 8, 2018 at 1:00 p.m. EDT to 3:00 p.m. EDT. Contractor representatives must register for the virtual conference by sending an e-mail to lawrence.toperoff@va.gov , copy to michelle.bailey@va.gov and leshanna.calahan@va.gov no later than 4 p.m. EDT, Sunday, May 6, 2018. Access instructions to the virtual pre-proposal conference will be provided by email to registrants the day before the conference.
All others terms and conditions remain unchanged.
Update #4 ·
This modification to the pre solicitation notice is to notify prospective offerors that when the solicitation was published it was incorrectly posted as a combined synopsis/solicitation and it should have been posted solely as a solicitation to the pre solicitation notice.
Update #3 ·
PRE-SOLICITATION NOTICE: The Department of Veterans Affairs (VA), Strategic Acquisition Center in Fredericksburg, Virginia intends to issue a solicitation for the procurement of various types of biologics and biological implants, which include any human cell, tissue, or cellular or tissue-based product or animal product inserted or grafted into the body for prosthetic, therapeutic purposes.
These biologics and biological implants are to be used in various surgeries and medical procedures to treat, prevent, or diagnose diseases. Biologic implants will consist of Allograft and Xenograft tissue. Allografts are bone and soft tissue grafts taken from human cadavers of genetically non-identical member of the same species. Most human tissue and organ transplants are Allografts. Xenografts are bone and soft-tissue grafts taken from animals, typically pigs and cows.
All products shall be Food and Drug Administration (FDA) approved and labeled in accordance with the International Standard for Blood and Transplant (ISBT) 128 only for Medical Products of Human Origin, such as Allografts, which is the global standard for the identification, labeling, and information transfer of medical products used in the VA. Biological implants must be tracked from human donor or animal source at each step of distribution to implantation so that all patients who receive a biological implant by the VA can be notified of a recall subject to the evaluation by appropriate medical personnel.
The Government intends to issue a Request for Proposal (RFP) to establish multiple-award Indefinite Delivery Indefinite Quantity contracts. The anticipated period of performance is 1-year base with four 1-year option. The Government anticipates awarding up to 30 awards from the resulting solicitation.
The Government intends to post the RFP to Federal Business Opportunities website at http://www.fbo.gov/ not later than 28 February 2018 that is changed from the previous notice of on or about 31 December 2018. The solicitation will remain open and continuous for 1-year with submission cut offs dates in May, August and November 2018 and February 2019 for proposals to be submitted for evaluation. Specific details will be included in the final solicitation.
All responsible sources must be registered in the System for Award Management (SAM) under NAICS Code: 339113 Surgical Appliance and Supplies Manufacturing, 750 Employees database at the following website: https://www.sam.gov/portal/public/SAM/.
No telephone or email requests for information will be taken at this time.
Update #2 ·
The Department of Veterans Affairs (VA) is providing the attached DRAFT solicitation for Industry review and for providing feedback. This feedback is for informational and planning purposes only. The VA does not intend on providing answers to any questions asked at this time.
Industry participation while encouraged is strictly voluntary. Not providing a response/feedback will not prevent a vendor from submitting a formal response to the VA s release of the future solicitation. The VA will not pay for any information received or costs incurred in preparing the response to the draft solicitation.
All feedback regarding this announcement must be sent to Lawrence.toperoff@va.gov and copy to Leshanna.calahan@va.gov no later than Tuesday, December 26, 2017 at 12:00 PM EST using the attached Excel spreadsheet entitled DRAFT Solicitation Feedback. Note only one Feedback sheet per company may be submitted per company.
Please use the following subject line for email submissions: Draft Biologic and Biologics Implants Industry Feedback: Vendor Name. File size of email is restricted to be no larger than 6MB.
Update #1 ·
PRE-SOLICITATION NOTICE: The Department of Veterans Affairs (VA), Strategic Acquisition Center in Fredericksburg, Virginia intends to issue a solicitation for the procurement of various types of biologics and biological implants, which include any human cell, tissue, or cellular or tissue-based product or animal product inserted or grafted into the body for prosthetic, therapeutic purposes.
These biologics and biological implants are to be used in various surgeries and medical procedures to treat, prevent, or diagnose diseases. Biologic implants will consist of Allograft and Xenograft tissue. Allografts are bone and soft tissue grafts taken from human cadavers of genetically non-identical member of the same species. Most human tissue and organ transplants are Allografts. Xenografts are bone and soft-tissue grafts taken from animals, typically pigs and cows.
All products shall be Food and Drug Administration (FDA) approved and labeled in accordance with the International Standard for Blood and Transplant (ISBT) 128, which is the global standard for the identification, labeling, and information transfer of medical products used in the VA. Biological implants must be tracked from human donor or animal source at each step of distribution to implantation so that all patients who receive a biological implant by the VA can be notified of a recall subject to the evaluation by appropriate medical personnel.
The Government intends to issue a Request for Proposal (RFP) to establish multiple-award Indefinite Delivery Indefinite Quantity contracts. The anticipated period of performance is 1-year base with four 1-year option. The Government anticipates awarding up to 30 awards from the resulting solicitation.
The Government intends to post a draft RFP to Federal Business Opportunities website at http://www.fbo.gov/ on or about 15 December 2017 for industry feedback and comment. A final solicitation will be posted on or about 31 December 2017. The solicitation will remain open and continuous for 1-year with submission cut offs dates in February, May, August and November 2018 for proposals to be submitted for evaluation. Specific details will be included in the draft and final solicitation.
All responsible sources must be registered in the System for Award Management (SAM) under NAICS Code: 339113 Surgical Appliance and Supplies Manufacturing, 750 Employees database at the following website: https://www.sam.gov/portal/public/SAM/.
No telephone or email requests for information will be taken at this time.
Files
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Notice history
| Notice | Type | Posted |
|---|---|---|
| 36C10G19D0024 Kandu Supplies and Services Biologics | Award Notice | |
| 36C10G18R0003 Biologics | Solicitation | |
| This notice | Pre-Solicitation |
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