Blueprint MedTech (BPMT) Biocompatibility, Sterilization, and Animal Studies

The National Institute on Drug Abuse (NIDA) intends to solicit proposals from qualified organizations (NAICS Code 541715) having in-house 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.

The Contractor shall provide NIDA with a broad and flexible range of administrative and research support and related services in support of the BP MedTech program. The work required under this contract includes:

1.  Biocompatibility, chemical characterization, extractable/leachable, and biocompatibility risk assessment

This includes the following subtasks:

1. 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:
   1. International Standard series ISO 10993; AND
   2. 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."
2. 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)
3. Generate detailed test reports containing all relevant information from the above testing to meet regulatory requirements.
4. Provide appropriate training and maintain records of training for all research personnel.

1. GLP-compliant animal studies

This includes the following subtasks:

1. 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
2. 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)
3. Generate detailed test reports containing all relevant information from the above testing to meet regulatory requirements.
4. Provide appropriate training and maintain records of training for all research personnel.

1. Sterilization and Shelf Life Testing

1. Conduct the following assessments for novel medical devices:
   1. Sterilization validation testing
   2. LAL, pyrogen, and bioburden testing
   3. Cleaning validation and disinfection validation
   4. Shelf life validation testing
   5. Packaging and transport testing
2. Generate detailed test reports containing all relevant information from the above testing to meet regulatory requirements.
3. Provide appropriate training and maintain records of training for all research personnel.

Mandatory Criteria:

The offeror must demonstrate its understanding and compliance with the NIH Guide for Care and Use of Laboratory Animals (https://olaw.nih.gov/home.htm).  The Offeror shall submit evidence that its protocols will be reviewed and approved by the Institution’s Animal Care and Use Committee (IACUC). The Assurance number shall be provided with the proposal.

Notice:

NIDA anticipates that one (1) indefinite delivery, indefinite quantity (IDIQ), task order contract will be awarded for a period of performance of five (5) years.  NIDA may award either cost reimbursement and/or fixed price task orders under this contract. These individual task orders may include options and/or option quantities. If options or option quantities are utilized for an individual task order the will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award.  NIDA anticipates that at least one or more task orders will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds.  Various task orders will be issued to support distinct tasks and studies which will support the BP MedTech Initiative.

PLEASE NOTE THIS SOLICITATION HAS BEEN AMENDED.

The purpose of this amendment to the Request for Proposal (RFP) is to incorporate questions from offerors and responses in reference to the solicitation. Please see the Attachment RFP_75N95022R00022_Amendment for details.