Manufacturing of a Dissolving Microneedle Patch to Administer Inactivated Rotavirus Vaccine for Preclinical Toxicology in Animals and Phase I Clinical Trial in Humans
The Centers for Disease Control and Prevention, NCIRD/DVD/VGB, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to Micro Biomedical, 57514th Street NE #100, Atlanta, Ga 30318 to manufacture cGMP microneedle (MN) patch to deliver IRV for use in animal toxicology and a Phase 1 clinical trial in humans. A cGMP manufacturing process will be implemented to produce MN patches that are suitable for a future Phase 1 clinical trial. As such, appropriate controls will be implemented to meet and/or exceed the requirements described in FDA’s Guidance for Industry: cGMP for Phase 1 Investigational Drugs (2008). Controls will be developed and implemented for the process, personnel, equipment, facilities, environment, materials/components, packaging/labeling, records, and testing. Also, because IRV antigens are sensitive to heat and other sterilization methods, terminal sterilization is not an option. Therefore, the MN patches will be manufactured under controlled bioburden conditions. Tough contamination control methodologies along with aseptic techniques Micron will conduct production runs of a high quality, cGMP batch of IRV MN patches. The IRV formulation will be optimized for stability and potency, and a scalable manufacturing process will be developed that is compatible with aseptic processing within a cGMP environment. The specific deliverables will be to: qualify all test methods to support the release and stability studies of IRV MN patch, optimize a cGMP IRV MN patch manufacturing process, and manufacture cGMP IRV MN patch suitable for pre-clinical toxicology study. Micron Biomedical is the only vendor in the US that has this highly specialized microneedle manufacturing facility for human vaccines. CDC will be using Micron Biomedical's proprietary research data to complete our GMP manufacturing, which cannot be provided by any other source. Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement which shall be considered by the agency. Please forward the capability statement information to Maria Shamburger, Contracting Officer, Reference 2020-44118, Centers for Disease Control, Office of Acquisition Services, ATTN: Maria Shamburger, heg9@cdc.gov. All vendors must be registered in the System for Award Management (SAM) prior to an award of a federal contract. The website is: www.sam.gov. Awarded contract TBD to unknown vendor for unknown amount on 2020-07-01. 2020-44118 Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services
4/30/20, 3:40 PM AN73--HUMAN RNA SEQUENCING SERVICES
COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24120Q0540 Posted Date: September 2, 2020 Response Date: September 8, 2020; 12:00 NOON EST Product or Service Code: AN73 Set Aside: NO SET ASIDE. FULL AND OPEN COMPETITION NAICS Code: 541715 Contracting Office Address Network Contracting Office 01 623 Atwells Avenue, Uncas Bldg Providence, RI 02909 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular 2020-08. The associated North American Industrial Classification System (NAICS) code for this procurement is 541715 with a small business size standard of 1,000 employees. The Department of Veteran Affairs Network Contracting Office 01 is seeking to purchase the services described in the following Statement of Work. --------------------------------------------- BEGIN STATEMENT OF WORK ----------------------------------------- PERFORMANCE WORK STATEMENT GENERAL INFORMATION Title of Projects: PTSD-associated gene expression in the BNST Scope of Work: The Vendor will use next-generation sequencing and RNAseq techniques to create a gene expression profile of the bed nucleus of the stria terminalis (BNST) in 100 samples from the VA National Center for PTSD (NCPTSD) Brain Bank. They will receive RNA samples from the lab which extracted the BNST, measure sample quality, perform next generation sequencing, and provide output files to which will be returned to Dr. Logue who will use these to look for gene expression signatures of PTSD and depression in the BNST region of the brain. B. GENERAL REQUIREMENTS Description of Requirements and Associated Deliverables:. The Vendor shall perform services utilizing equipment and methodology best suited for desired results. The need for reproducibility and follow-on to previous work which is why the Government desires the following methods, procedures, and equipment be used. Deliverables: The first step is to quantify the quality of the RNAseq samples: Assessing RNA integrity by Agilent Tapestation and concentration by Qubit assay. Assessing library size on the Agilent Tapestation, concentration by Qubit assay, and final quantitation by qPCR The next step is to remove ribosomal RNA tough the use of Ribo-Zero depletion. Then, RNA will be sequenced using the Illumina HiSeq, 2x150bp configuration, single index, ~350M raw paired-end reads per lane for a target coverage of 50 million reads per sample. It is guaranteed that 80% of bases Q30 The RIN values, raw FASTQ files summarizing all of the read information will be returned to Dr. Logue using a secure method. Period of Performance: The resulting contract will be for a base year and one (1) option year. C. SCHEDULE FOR DELIVERABLES Results of each test (deliverable) will be provided within 60 days of completion of the step. If for any reason any deliverable cannot be delivered within the scheduled time frame, the Vendor is required to notify the Contracting Officer. D.A CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only tough written correspondence from the CO.A A copy of each change will be kept in a project folder along with all other products of the project.A Costs incurred by the Vendor tough the actions of parties other than the CO shall be borne by the Vendor. E.A REPORTING REQUIREMENTS As requested by Government but no less than once per annual performance period, provide a written report that includes: Test results with interpretation and comment. Information pertaining to quality control. Provide telephone support discussing/clarifying test results with Government as may be required/requested. Results of this work shall be made available via encrypted hard drive, thumb drive, or via email. The report may be in either Word format or PowerPoint format. Delivery of the report may be via upload to a Government issued encrypted thumb drive entrusted to the VA Principal Investigator to be picked up at the Vendor s location or via email direct to the VA Principal Investigator.A This work does not involve VA human subjects data or biospecimens. It is a molecular follow-up to better understand the significance of prior results identified in the principal investigator s lab. F.A TRAVELA No travel reimbursements will be made under this contract. G.A GOVERNMENT RESPONSIBILITIES Government will collaborate with the Vendor regarding additional SNPs of interest that are identified in the principal investigator s research.A A A H. VENDOR EXPERIENCE REQUIREMENTSA Laboratory and associated personnel shall be qualified to run the required assays and certified in accordance with all applicable laws and regulations. I. PUBLICATIONS AND PRESENTATION: Without the express written consent of the Government, results of this Scope of Work may not be used by the Vendor in grant applications, scientific publications or presentations until such a time as the results are published by the Government in a peer review journal. --------------------------------------------- END STATEMENT OF WORK -------------------------------------------- Solicitation Information The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items (OCT 2018) FAR 52.212-3, Offerors Representations and Certifications Commercial Items (OCT 2018) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://beta.sam.gov/ in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. This is an open-market combined synopsis/solicitation under full and open competition for Specialized RNA Sequencing Services.A A The government intends to award a firm fixed-price purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items (OCT 2018) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (AUG 2020) FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) FAR 52.227-14 RIGHTS IN DATA GENERAL (MAY 2014) FAR 52.232-19 AVILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018) VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009) VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984) Submission of Quotes All Vendors shall submit the following information or their quotes or may be deemed non-responsive: Technical Vendor Capabilities Statement which shall describe equipment and practices utilized by vendor to produce the deliverables as specified in Section B, above. Pricing - The below price list with each of the line items filled out with pricing for each line. Pricing should be all inclusive and take into account all contractor incurred costs. Do not add additional line items. Past Performance - List of any prior specialized RNA Sequencing Services contracts with the Department of Veterans Affairs To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" and the Vendor shall list exception(s) and rationale for the exception(s). Quote Due Date and Time Submission shall be received not later than Tuesday, September 8, 2020 at 12 noon EST via email to the Point of Contact listed below. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the contracting officer at the information below no later than Friday, September 4, 2020 at 11:00 pm EST. Phone calls will not be returned. Award shall be made to the vendor whose quote includes the required documentation and technical capabilities listed above at the lowest price. Point of Contact Anna Norcross, Contracting Officer anna.norcross@va.gov Price/Cost Schedule ITEM # DESCRIPTION OF SUPPLIES/SERVICES ESTIMATED QTY UNIT UNIT PRICE AMOUNT 0001 Standard RNA-Sequencing. RNA Library preparation with rRNA depletion, Sequencing on lllumina NovaSeq 2x150 bp sequencing for -50 million reads per sample and in accordance with the Statement of Work. Contract Period: Base POP Begin: 09-15-2020 POP End: 09-14-2021 100 EA 0002 Mapping and hit counts in accordance with the Statement of Work Contract Period: Base POP Begin: 09-15-2020 POP End: 09-14-2021 60 EA 1001 Standard RNA-Sequencing. RNA Library preparation with rRNA depletion, Sequencing on lllumina NovaSeq 2x150 bp sequencing for -50 million reads per sample and in accordance with the Statement of Work. Contract Period: Option 1 POP Begin: 09-15-2021 POP End: 09-14-2022 100 EA 1002 Mapping and hit counts in accordance with the Statement of Work Contract Period: Option 1 POP Begin: 09-15-2021 POP End: 09-14-2022 60 EA TOTAL 36C24120Q0540 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 1
9/2/20, 8:47 AM AN73--HUMAN RNA SEQUENCING SERVICES
SOURCES SOUGHT NOTICE # 36C24120Q0540 This is a Sources Sought Notice with regards to the following Statement of Work: This information will be used for solicitation planning purposes only. No quotes are being requested or accepted at this time. This is not a solicitation and no contract shall be awarded from this Sources Sought Notice. In accordance with Public Law 109-461, the Department of Veterans Affairs is particularly interested in Service Disabled Veteran Owned Small Business (SDVOSB) and/or Veteran Owned Small Businesses (VOSB) that are interested. Interested parties responding to this Notice should submit the following information: company name and address, point of contact with phone number, and DUNS number; company socio-economic status to identify business as being an SDVOSB, VOSB, Small Business, Hubzone, 8a, Woman Owned, etc. Primary NAICS for this procurement will be 541715 (Research and Development in the Physical, Engineering, and Life Sciences) with a small business size standard of 1,000 employees; Statement of capability; if an SDVOSB or VOSB, provide proof of registration in the VA Vet Biz website and verification by VA Center for Veterans Enterprise (CVE) or intention of registration prior to submission of offers to a solicitation; all interested firms must be registered in SAM (www.sam.gov); all interested SDVOSB or VOSB firms must be registered in VETBIZ.GOV and Verified by VA CVE and registered in SAM to be eligible for award of Government contracts; and any other pertinent company documentation. The response date to this Notice is August 20, 2020, at 11:00 AM EST. ELECTRONIC SUBMISSIONS ONLY to be sent to: anna.norcross@va.gov. PERFORMANCE WORK STATEMENT GENERAL INFORMATION Title of Projects: PTSD-associated gene expression in the bed nucleus of the stria terminalis (BNST). Scope of Work: The Vendor will use next-generation sequencing and RNAseq techniques to create a gene expression profile of the BNST in 100 samples from the PTSD Brain bank. They will receive RNA samples from the lab which extracted the BNST, measure sample quality, perform next generation sequencing, and provide output files to which will be returned to Dr. Mark Logue who will use these to look for gene expression signatures of PTSD and depression in the BNST region of the brain. Background: Dr. Mark Logue currently has a VA Merit award to study the genetics and epigenetics of PTSD. As part of this project he has studied pre-frontal cortex tissue from the PTSD brain bank and found evidence of the involvement of immune system genes and oligodendrocytes in PTSD pathogenesis. This project would extend this work to the BNST which plays a role in HPA axis activation, and is activated both in conic states of teat response and heightened awareness (anxiety) and to more acute and immediate teats (fear). Performance Period and Type of Contract: The resulting Non-personal Services contract will have a Base Year with 1 anticipated annual option year. B. GENERAL REQUIREMENTS Description of Requirements and Associated Deliverables:. The Vendor shall perform services utilizing equipment and methodology best suited for desired results. The need for reproducibility and follow-on to previous work which is why the Government desires the following methods, procedures, and equipment be used. Deliverables: The first step is to quantify the quality of the RNAseq samples: Assessing RNA integrity by Agilent Tapestation and concentration by Qubit assay. Assessing library size on the Agilent Tapestation, concentration by Qubit assay, and final quantitation by qPCR The next step is to remove ribosomal RNA tough the use of Ribo-Zero depletion. Then, RNA will be sequenced using the Illumina HiSeq, 2x150bp configuration, single index, ~350M raw paired-end reads per lane for a target coverage of 50 million reads per sample. It is guaranteed that 80% of bases Q30 The RIN values, raw FASTQ files summarizing all of the read information will be returned to Dr. Logue using a secure method. C. SCHEDULE FOR DELIVERABLES Results of each test (deliverable) will be provided within 60 days of completion of the step. If for any reason any deliverable cannot be delivered within the scheduled time frame, the Vendor is required to explain why in writing to the Contracting Officer, including a firm commitment of when the work shall be completed.A This notice to the CO shall cite the reasons for the delay, and the impact on the overall project.A The CO will then review the facts and issue a response, in accordance with applicable regulations. D.A CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only tough written correspondence from the CO.A A copy of each change will be kept in a project folder along with all other products of the project.A Costs incurred by the Vendor tough the actions of parties other than the CO shall be borne by the Vendor. E.A REPORTING REQUIREMENTS As requested by Government but no less than once per annual performance period, provide a written report that includes: Test results with interpretation and comment. Information pertaining to quality control. Provide telephone support discussing/clarifying test results with Government as may be required/requested. Results of this work shall be available via encrypted hard drive or thumb drive or via email. The report may be in either Word format or PowerPoint format. Delivery of the report may be via upload to a Government issued encrypted thumb drive entrusted to the VA Principal Investigator to be picked up at the Vendor s location or via email direct to the VA Principal Investigator.A This work does not involve VA human subjects data or biospecimens. It is a molecular follow-up to better understand the significance of prior results identified in the principal investigator s lab. F.A TRAVELA No travel reimbursements will be made under this contract. G.A GOVERNMENT RESPONSIBILITIES Government will collaborate with the Vendor regarding additional SNPs of interest that are identified in the principal investigator s research.A A A H. Vendor EXPERIENCE REQUIREMENTSA Laboratory and associated personnel shall be qualified to run the required assays and certified in accordance with all applicable laws and regulations. I. PUBLICATIONS AND PRESENTATION: Without the express written consent of the Government, results of this Scope of Work may not be used by the Vendor in grant applications, scientific publications or presentations until such a time as the results are published by the Government in a peer review journal. 36C24120Q0540 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 1
8/16/20, 12:59 PM