The National Heart, Lung, and Blood Institute (NHLBI) intends to award to a sole source Indefinite Delivery Indefinite Quantity (IDIQ) contract with multiple fixed priced task orders with options and cost reimbursement task orders with options and no fee to the University of North Carolina, Chapel Hill under the authority of HHSAR 306.302-1 “Only one responsible source and no other supplies or services will satisfy agency requirements. See FAR 6.302-1.� The purpose of this announcement is to provide a Presolicitation Notice for the release of Solicitation 75N92019R0040. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. Purpose and Objectives The purpose of the procurement is to produce and sustain a colony of research animal with bleeding disorders to be used in research to benefit public health. One of the primary manifestations of this benefit is to publish articles in the scientific and medical literature so that the clinical teams who take care of those affected by bleeding disorders are aware of new treatments that have been tested in animals. The objectives are: 1) To sustain a breeding colony of well-characterized dogs with inherited bleeding disorders; 2) To produce purpose-bred, affordable research animals with these bleeding disorders in a cost effective manner; 3) To provide specialized support services for research projects using these dogs including canine blood banking and coagulation analyses; and 4) To produce and characterize new canine models of inherited bleeding disorders. Project Requirements The NHLBI shall require the contractor to work independently, and not as an agent of the Government, the contractor shall furnish all necessary personnel, laboratory facilities, equipment and support services not otherwise furnished by the Government, as needed to perform the work set forth below. The contractor shall operate in accordance with current acceptable standards as indicated by federal, state, and local government regulations, policies, and/or guidelines in conducting the task areas delineated below. 1. The contractor shall maintain general Quality Control and Quality Assurance operating procedures, critical to the successful operation of the program. 2. The contractor shall provide detailed plans describing data security, back-up and disaster recover measures and incorporate the details into the Information System Security Plan. The plan shall include a daily backup of all changes to the electronic resources to protect against accidental loss. A back-up copy of the electronic resources shall be stored in a remote, secure location and shall be updated at least weekly. 3. The contractor shall not use the data and documentation acquired or developed through this contract for any purpose other than that specified in the contract, without prior written approval of the Contracting Officer (CO). 4. The contractor shall comply with NHLBI IT security policies and procedures for contracts. The contractor shall ensure that the computer programs, databases and other resources developed through this contract are compliant with terminology and data standards established by NHLBI. The web-based platform shall comply with all applicable Federal and State regulations, including Section 508 of the Rehabilitation Act of 1973 (29 USC 794d). See http://www.nih.gov/icd/ The services to be provided are divided into the following three (3) task areas: Task Area A - Core Colony Production and Sustenance Tasks The main purpose of this task area is to produce and sustain an inventory of up to 200 purpose based dogs, consisting of both dog colonies with well-characterized inherited bleeding disorders and non-affected dogs to serve as blood donors and research controls for use by the NHLBI research community. The services to be provided may include, but are not limited to, the following: 1. The contractor shall accomplish a smooth, efficient, and orderly transition for the contract work at the start of the contract. 2. The contractor shall provide administrative support through dedicated staff who manage scientific, fiscal, and regulatory aspects for sustaining the colony. 3. The contractor shall adhere to the treatment of animals in accordance with IACUC (Institutional Animal Care and Use Committee) guidelines, as well as all local, state, and Federal guidelines. 4. The contractor shall provide colony sustenance services including dedicated personnel to perform daily health checks and weekly examination of research and donor/normal animals: a. Sustenance services shall include provision of general preventative health and well-being services to all animals. 5. The contractor shall administer a comprehensive breeding program to produce and sustain an inventory of up to 225 dogs with bleeding disorders including artificial insemination as well as natural mating: a. The breeding program shall include prenatal care as well as whelping procedures and peripartum care. 6. The contractor shall manufacture and maintain an inventory of canine plasma-derived products for use in the treatment of animals experiencing bleeding events. 7. The contractor shall maintain the capability to conduct the imaging and laboratory procedures for use in the treatment of animals experiencing bleeding events. 8. The contractor shall provide treatment for animals experiencing bleeding events. 9. The contractor shall form and convene necessary advisory panels to monitor the progress of the colony and the utility of the colony inventory in meeting the needs of the investigator community. 10. The contractor shall assist the COR in identifying and establishing collaborations with non-NHLBI scientific groups throughout the contract period to increase the visibility of the dog colony resources and disseminate information to raise awareness of the canine colony inventory to the bleeding disorder research community: a. The dissemination plan shall include participation of the contractor at national and international scientific meetings on bleeding disorders. 11. The contractor shall develop, and regularly maintain for the life of the contract, a Manual of Procedures (MOP) describing processes and methodologies to be employed for animal care, investigator and NHLBI staff communications, protocol development, execution and management. 12. The contractor shall develop and maintain a public-facing website to communicate information about the canine colony including but not limited to the mission and features of the program and the process for applying for services. The code for the website shall be open source, Section 508 compliant, compliant with all NIH/HHS/Federal security policies, and made available at the discretion of the COR. 13. The contractor shall develop a private electronic application receipt and review process that is accessed through the public-facing website, as well as a system for monitoring the workflow and status of the application process and migrate content from the current website (www.med.unc.edu/fobrl) as appropriate. 14. The contractor shall produce purpose-bred dogs for NHLBI approved projects. 15. The contractor shall provide the necessary data management system(s), informatics and statistical support and staff to coordinate, process and track in an efficient manner all requests received through the website following the procedures established in conjunction with the NHLBI COR and documented in the MOP. 16. The contractor shall produce and maintain, in a secure and confidential manner, an electronic database of all research requests received, including the name of the requesting investigator, the related NHLBI grant number or other means of support, the name of the project and the therapeutic agent under study, what human disease or condition the translational study relates to, information on quality control and quality assurance methods employed any other pertinent data for the animal study in a request that was fulfilled. These records shall be complete, accurate, legible, well-organized, and comprehensive. 17. The contractor shall facilitate the completion of site visits or audits to be conducted by either NHLBI or Federal oversight representatives or designated outside experts. a. Make available all reports and supporting documents and data as requested by the COR. b. Prepare materials for, and participate in, any planned site visits to the contractor’s facilities. c. Maintain up-to-date versions of all required certifications, inspections, and assurances and have them available for review during site visits. 18. The contractor shall participate, as necessary, in teleconference and meetings with the requesting investigator, NHLBI staff, and other federal agency staff members (e.g., staff from other NIH ICs or the FDA) as applicable. 19. The contractor shall develop and maintain a listing of publications and presentations that were supported by work performed by the canine colony. Task Area B-Core Scientific Projects The services described in this task area shall only be performed upon the award of a task order. The services include the acquisition and characterization of new canine models of inherited bleeding disorders (including variations of existing bleeding disorders, e.g. hemophilia inhibitors) and/ or the establishment of new diagnostic, laboratory and imaging services. The specific activities to be performed will vary depending on the nature of the project and the services needed. The exact number of projects to be conducted will depend upon various factors including identification of new genetic variants, diagnostic tools and veterinary procedures that can be benefit the care and evaluation of dogs with bleeding disorders. The services to be provided may include, but are not limited to, the following: 1. The contractor shall acquire, produce a breeding colony inventory and characterize new canine models of inherited bleeding disorders. 2. The contractor shall develop and establish procedures and protocols for animal-care related or laboratory techniques, veterinary procedures or imaging studies needed to support the care, maintenance and evaluation of current and/or new canine models. 3. The contractor shall adhere to the treatment of animals in accordance with IACUC (Institutional Animal Care and Use Committee) guidelines, as well as all local, state, and Federal guidelines. Task Area C- Program Closeout At completion of the contract, the contractor shall ensure an orderly and safe transition of the Government owned resources in the event there is a re-competition of the contract and an organization other than the incumbent is selected for contract award. The contractor shall prepare and execute a transition plan upon approval by the COR. 1. The Contractor shall submit a transition-out plan that identifies a delivery schedule for transferring all materials identified to the successor contractor. 2. The Contractor shall cooperate fully with the successor Contractor. 3. The Contractor shall participate in meetings and telephone conversations with the COR and the successor Contractor in which current procedures and activities are discussed in detail. 4. The Contractor shall provide a detailed list of all task orders currently in progress. 5. The Contractor shall deliver in clearly labeled packaging to the successor Contractor the following in accordance with the delivery schedule provided in the approved transition plan, including: all stored materials; all Government-furnished property; electronic versions of documents developed under this contract; Web-related files; mailing lists; and all related materials developed under this contract. 6. The Contractor shall deliver to the successor Contractor all software programs, all source code documentation and data developed or altered in the performance of this contract and for which contract funds were expended, including the laboratory information system and sample tracking system. Deliverables shall be provided in an appropriate form, such as duplicate copies of electronically stored records and web content, and images of stored media. The Contractor shall also provide full documentation pertaining to the programs. 7. The Contractor shall pack all items and equipment in a safe and appropriate manner to ensure that equipment is not damaged and adherence to warranty conditions and service agreements is maintained. 8. The Contractor shall be responsible for transportation of equipment and materials and other costs required for the transition This is notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.2 requiring dissemination of information of proposed contract actions. This is a notice of intent to award a sole-source contract and is not a request for competitive proposals. The statutory authority for this sole-source procurement is HHSAR 306.302-1 ,�Only one responsible source and no other supplies or services will satisfy agency requirements. See FAR 6.302-1.� The Government is not committed to award a contract pursuant to this announcement. This notice of intent is not a request for competitive proposals. Any Interested party that believes it can meet the requirement, may submit a capability statement through FedConnect before 3:00PM ET on August 5, 2019. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. If no responsive statements are received before the closing date and time, an RFP will be issued and an award will subsequently be made to the University of North Carolina, Chapel Hill. Point of Contact: Jeffrey Williams, Contracting Officer, Office of Acquisitions, NHLBI, Email:
[email protected]. Information Submission Instructions Interested parties shall submit capability statements via the FedConnect web portal (www.fedconnect.net) and reference Pre-solicitation Number 75N92019R0060. The due date for receipt of statements is Monday, August 5, 2019 by 3:00 PM Eastern Time. Vendors can register with FedConnect at https://www.fedconnect.net/FedConnect/default.htm Please note that FedConnect is used by multiple federal agencies and therefore FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI OA. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf . For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at
[email protected]. Please use the Contracting Officer contact information provided, should you require a waiver to not use FedConnect for submitting your capability statement. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).