Inactive

This is a SOURCES SOUGHT NOTICE to determine the availability of businesses, including small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, H... This is a SOURCES SOUGHT NOTICE to determine the availability of businesses, including small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses) having capability to support and provide resources to the participating grantees for completing biocompatibility studies, in vivo animal testing compliant with good laboratory (GLP) guidelines, and sterilization and shelf life testing. This contractor will provide support for research protocol development, research staff training, and conduct all testing necessary to support biocompatibility, sterilization, and animal safety studies. Blueprint (BP) MedTech is an accelerator initiative aimed at catalyzing the development of cutting-edge medical technologies to diagnose or treat nervous system disorders. By providing resources and funding, MedTech facilitates the translation of novel neurotechnologies through early-stage development and to first in human clinical studies. The program funds medical device development activities led by investigators and complemented by additional resources and expertise provided by MedTech. Funding will support services including but not limited to: Access to translational services and expertise (e.g. large animal testing, sterilization testing, biocompatibility assessment, manufacturing, medical monitoring). Assistance from consultants (e.g. regulatory, reimbursement, intellectual property, commercialization, strategic partnerships). Access to NIH staff for assistance with funding questions. The overall goal is to provide support in order to sufficiently de-risk technologies to the point where industry partners and/or investors will be enticed to bring these new diagnostic and therapeutic products to market. Specifically, NIDA is seeking capability statements from vendors with the capabilities to perform the following tasks: Task 1: Biocompatibility, chemical characterization, extractable/leachable, and biocompatibility risk assessment This includes the following subtasks: Conduct biocompatibility studies, chemical characterization studies, extractables/leachables studies and biocompatibility risk assessment in addition to generating detailed test reports in compliance with the following: International Standard series ISO 10993; AND FDA Guidance Document “Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Maintain all necessary licenses and certifications for compliance with PHS Policy on Humane Care and Use of Laboratory Animals (https://olaw.nih.gov/policies-laws/phs-policy.htm) Generate detailed test reports containing all relevant information from the above testing to meet regulatory requirements. Provide appropriate training and maintain records of training for all research personnel. Task 2: GLP-compliant animal studies This includes the following subtasks: Complete GLP-compliant animal studies in small and large animal models to demonstrate safety and/or efficacy of medical devices per the needs required for regulatory assessment Maintain all necessary licenses and certifications for compliance with PHS Policy on Humane Care and Use of Laboratory Animals (https://olaw.nih.gov/policies-laws/phs-policy.htm) Generate detailed test reports containing all relevant information from the above testing to meet regulatory requirements. Provide appropriate training and maintain records of training for all research personnel. Task 3: Sterilization and Shelf Life Testing Conduct the following assessments for novel medical devices: Sterilization validation testing LAL, pyrogen, and bioburden testing Cleaning validation and disinfection validation Shelf life validation testing Packaging and transport testing Generate detailed test reports containing all relevant information from the above testing to meet regulatory requirements. Provide appropriate training and maintain records of training for all research personnel. NIDA is requesting capability statements from businesses, including small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses), demonstrating their ability to perform the requirements described above. Capability statements should include any relevant experience as either prime or sub contractor performing work of a similar type and scale either for the government or in the private sector. Vendors are encouraged to provide a list of any relevant contracts they have performed that provided them with experience in performing the above tasks, including what their level of effort was for the performance. NIDA will evaluate the capability of vendors based on relevant experience in work of a similar type and scale, as well as any additional information provided by the vendor to demonstrate their capability. THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. All capability statements must provide the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as (i.e.: women-owned, HUBZONE, etc.), if applicable. Written capability statements must be SUBMITTED NO LATER THAN JUNE 16, 2021 to the above Contracting Office Address, Attn: Tracy Cain. Electronic capability statements will be accepted by the primary point of contact.