Assess the Safety of a Microneedle Patch for Vaccination Against Rotavirus When Given Intradermally for Four (4) Administrations in Rats
No further questions were received by the March 28, 2022, deadline. The question period is now closed. Quotes are due by April 7, 2022, at 4:30pm Eastern time, by e-mail to Joshua Houston, Contract Sp... No further questions were received by the March 28, 2022, deadline. The question period is now closed. Quotes are due by April 7, 2022, at 4:30pm Eastern time, by e-mail to Joshua Houston, Contract Specialist, at pkf5@cdc.gov. Please see attached Questions and Answers posted March 25, 2022. Assess the Safety of a Microneedle Patch for Vaccination Against Rotavirus When Given Intradermally for Four (4) Administrations in Rats (GLP compliant) (a) This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. (b) The solicitation number is 75D301-22-Q-74545. This solicitation is being issued as a request for quotations (RFQ) under the authority of FAR subpart 13.5, Simplified Procedures for Certain Commercial Products and Commercial Services. (c) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-04. (d) This acquisition is not set aside. The NAICS code is 541715 and the small business size standard is 1,000 employees. (e) The objective of this project is to assess the safety of an inactivated rotavirus vaccine microneedle patch for vaccination against rotavirus when given intradermally for four (4) administrations in rats (Good Laboratory Practice (GLP) compliant). This requirement involves the development of a toxicology protocol, conduct of preclinical toxicology services, laboratory analyses, and reporting. See Attachment 1. (f) The Government contemplates award of a firm-fixed-price purchase order resulting from this solicitation. (g) The period of performance is no more than one year from the date of award. The award is anticipated to be made on or about May 2, 2022. (h) This solicitation incorporates one or more solicitation provisions and contract clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The vendor is cautioned that the listed provisions may include blocks that must be completed by the vendor and submitted with its quotation. In lieu of submitting the full text of those provisions, the vendor may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision or contract clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.acquisition.gov/hhsar (i) The provision at FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services, applies to this acquisition. The following addenda apply to this provision: (1) All responsible sources are invited to submit a quotation in response to this solicitation. (2) The vendor’s Dun & Bradstreet Number (DUNS) and Unique Entity Identifier (UEI) must be included in the response. All vendors must have an active registration in the System for Award Management (SAM) at www.sam.gov. (3) Quotations must be submitted in two parts, a slide deck and business volume, as described below: (i) Slide deck for the oral presentation. The oral presentation shall address: (A) The vendor’s experience. See paragraph (j)(1) below. (B) Good Laboratory Practice (GLP) compliant facilities. See paragraph (j)(2) below. (C) Technical approach to the project. See paragraph (j)(3) below. (ii) Business volume. The business volume shall include: (A) The vendor’s proposed price for this work. (B) Completed representations and certifications, as required. (C) Evidence of the vendor’s approved Animal Welfare Assurance on file with the Office of Laboratory Animal Welfare (OLAW). (D) Draft or approved Institutional Animal Care and Use Committee (IACUC) protocol. Vendors are advised that a draft IACUC protocol may be submitted with its quote. If a vendor’s quote is selected for award (i.e., the Government determines that the vendor is best suited for the requirement) and the vendor does not already have an IACUC-approved protocol in place, the vendor will be provided up to 30 additional days from the date it is notified that it has been selected for award to obtain IACUC approval. An IACUC-approved protocol must be in place prior to the award of a purchase order. If the selected vendor does not obtain IACUC approval within the 30 additional days provided, CDC reserves the right to select another vendor for award and finalize a purchase order with another vendor. (4) Oral presentation. The oral presentation will be scheduled either on Monday, April 11, 2022, or Tuesday, April 12, 2022. The Government will schedule the oral presentation upon receipt of the vendor’s quote. The Government intends to hold the oral presentation virtually via a Microsoft Teams meeting. Once the oral presentation is scheduled, the Government will provide the vendor with a meeting invite link. The oral presentation session will be scheduled for 60 minutes. The vendor will have no more than 40 minutes to deliver its presentation. The Government may ask clarification questions or engage in interactive dialogue both during and after the vendor’s presentation. Exchanges between the Government and the vendor are viewed as a component of the oral presentation itself and do not constitute discussions or negotiations. At minimum, the vendor’s project manager, principal investigator, or an equivalent position shall attend the oral presentation. The vendor is not restricted in the number of briefers that are used to deliver the oral presentation or respond to Government questions. The vendor’s briefer(s) must be an employee of the vendor or a proposed subcontractor. A vendor may only attend one oral presentation, whether for itself as the proposed prime contractor or as a proposed subcontractor for another vendor. A slide deck must accompany the oral presentation. The slide deck shall be provided in either .ppt, .pptx, or .pdf format, and shall be submitted with the quote by the April 7, 2022, deadline. The Government will display the slide deck during the meeting and will advance the slides at the direction of the vendor. The Government may record the oral presentation. (5) The Government may perform a comparative evaluation (comparing quotes to each other) to select the contractor that is best suited and provides the best value, considering the evaluation factors in this solicitation. Once the Government determines the vendor that is best suited for the requirement (i.e., the apparent successful vendor), the Government reserves the right to communicate with only that vendor to address any remaining issues for negotiation. These issues may involve technical matters and price. If the parties successfully negotiate all remaining issues, the Government will finalize a purchase order with that vendor. If the parties cannot successfully negotiate all remaining issues, as determined at the sole discretion of the Government, the Government reserves the right to communicate with the next best-suited vendor based on the original evaluation results to address any remaining issues for negotiation with that vendor. (j) The provision at FAR 52.212-2, Evaluation-Commercial Products and Commercial Services applies. The specific evaluation criteria to be included in paragraph (a) of that provision is as follows. The non-price factors, when combined, are approximately equal in importance to price. (1) Experience. The experience factor will be evaluated based on a vendor’s experience with the testing of vaccines for use in humans in animals, vaccine research and development, preclinical toxicology services, the preparation of documentation related to animal toxicology, and evidence of accreditation by the American Association for Accreditation of Laboratory Animal Care (AAALC), if applicable. (2) GLP compliant facilities. This factor will be evaluated based on evidence that the vendor proposes the use of GLP compliant facilities for this work. (3) Technical approach. This factor will be evaluated based on the feasibility, efficiency, and effectiveness of the vendor’s technical approach to successfully perform the required tasks. (4) Price. (k) Vendors are advised to include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, with their quote. If the vendor has completed FAR 52.212-3 at www.sam.gov, then the vendor does not need to provide a completed copy with its quote. (l) The following provisions also apply to this solicitation: (1) FAR 52.204-7 System for Award Management (Oct 2018). (2) FAR 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020). (3) FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021). See full text of this provision in Attachment 2. Vendors must complete and return a copy of this representation with the business volume. (4) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020). See full text of this provision in Attachment 2. Vendors must complete and return a copy of this representation with the business volume. (5) FAR 52.209-5 Certification Regarding Responsibility Matters (Aug 2020). (6) HHSAR 352.239-73 Electronic and Information Technology Accessibility Notice (December 18, 2015). (7) HHSAR 352.270-5(a) Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (December 18, 2015). (8) CDC42.0001 Contractor Performance Assessment Reporting System (CPARS) Requirements (Aug 2021). See full text of this provision in Attachment 2. Vendors must complete and return a copy of this representation with the business volume. (9) CDC100_0004 Data Management Plan (Instructions) (Nov 2018). See full text of this provision in Attachment 2. (m) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services, applies to this acquisition. (n) The clause at FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Products and Commercial Services, applies to this acquisition. See full text of this clause in Attachment 2. (o) The following clauses also apply to this solicitation: (1) FAR 52.204-13 System for Award Management Maintenance (Oct 2018). (2) FAR 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020). (3) FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Nov 2021). (4) FAR 52.227-14 Rights in Data-General (May 2014). (5) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Nov 2021). (6) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 18, 2015). (7) HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022). See full text of this clause in Attachment 2. (8) HHSAR 352.239-74 Electronic and Information Technology Accessibility (December 18, 2015). See Attachment 2. (9) HHSAR 352.270-5(b) Care of Live Vertebrate Animals (December 18, 2015). (10) CDC0_G018 Payment by Electronic Funds Transfer (Feb 2018). See full text of this clause in Attachment 2. (11) CDC37.0001 Non-Personal Services (Apr 2015). See full text of this clause in Attachment 2. (12) CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (Aug 2021). See full text of this clause in Attachment 2. (13) CDC100_0003 Public Access To CDC Funded Digital Public Health Data (Nov 2018). See full text of this clause in Attachment 2. (p) The Defense Priorities and Allocations System (DPAS) does not apply to this acquisition. (q) Quotes (including the slide deck for the oral presentation and business volume) are to be submitted by e-mail to Joshua Houston, Contract Specialist, at pkf5@cdc.gov, no later than April 7, 2022, at 4:30pm Eastern time. (r) Any inquiries regarding this solicitation must be sent to Joshua Houston, Contract Specialist, at pkf5@cdc.gov. The last date and time questions will be accepted is Monday, March 28, 2022, at 4:30pm Eastern time. Attachments 1- Statement of Work 2- Provisions and Clauses in full text
Data sourced from SAM.gov.
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