Synthetic Peptides & Other Drugs of Abuse: Purity Determination, Stability Testing & Quantitative Analysis

INTRODUCTION The National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. The NIDA Division of Therapeutics and Medical Consequences (DTMC) has a requirement for logistical support for their mission of developing new treatments agents for drug dependence. DESCRIPTION The National Institute on Drug Abuse (NIDA) plans to solicit proposals under full and open competition procedures from qualified organizations having the capability to (1) analyze and establish the purity of peptides that are synthesized through a separate NIDA contract, and also of those peptides that are obtained by NIDA for medication development, (2) regularly monitor the stability and purity of these peptides, and (3) to develop and perform assays to analyze and authenticate the purity of various of drugs of abuse in the NIDA drug supply inventory as needed. The prospective offeror must possess the necessary equipment and facilities for this project. Additionally, it must have extensive experience in general purity determination of peptides and in opioid peptides specifically. Specifically, the project requires the following tasks: 1. The Contractor must establish the chemical and optical purity of peptides: The Contractor must determine the chemical purity of all assigned peptides by using Thin-Layer Chromatography (TLC) four systems, High-Performance Liquid Chromatography (HPLC) two systems, Capillary Electrophoresis (CE), Amino Acid Analyzer (AAA), sequencing, Liquid Chromatography/Mass Spectrometry (LC/MS), and/or any other suitable method. The contractor must also analyze peptides for their optical purity by at least one method. 2. The Contractor must develop highly sensitive analytical methods for peptide analysis, such as LC/MS, CE or other suitable method for assigned number of compounds and determine their peptide contents. 3. The Contractor must analyze chemical purity and physical & chemical characteristics of required drugs of abuse or related compounds by latest available methods; if methods are not available, develop appropriate analytical methods and then analyze. 4. The Contractor must monitor the stability of an assigned number of compounds. 5. The Contractor must monitor the batch to batch variation of assigned number of compounds. 6. The NIDA Contracting Officer's Representative (COR) will select compounds and determine the priority of each task. The peptides assigned may be obtained not only from the SPSC A and SPSC B, but also from any other sources; such as, pharmaceutical industries, research and/or academic institutions. Drugs of abuse and related compounds for purity determination and methods development may be assigned from the NIDA drug supply inventory or any other source as appropriate. 7. Prior to starting any analysis or method development, the Contractor must provide an estimate of cost in terms of materials and labor hours involved for each compound, and must provide the basis for setting priorities to the COR. 8. The Contractor must maintain close contact with the NIDA COR and inform him/her of progress and any problems associated with the execution of tasks as required under the contract. 9. NIDA will be responsible for supplying peptides and other compounds. The Contractor must provide adequate facilities for their proper storage and be responsible for maintaining inventory records. 10. The Contractor must store all compounds under optimum shelf life conditions and must maintain the purity of all compounds. 11. The Contractor must follow all Drug Enforcement Administration (DEA) requirements for controlled substances. 12. All required facilities and equipment (e.g., HPLC, LC/MS, CE, AAA, sequencing equipment, and TLC and others) must be available for analytical, purity and stability studies and method development. 13. The Contractor must maintain all records generated as a result of contract work for the duration of the contract, and turn over all records to NIDA upon contract expiration. 14. The Contractor must transmit the information generated as a result of the contract to the NIDA COR in the Monthly Letter Reports, Semi-Annual Progress Reports, Annual Progress Reports, Final Report and the Summary of Salient Results, described in Article C.2. of this contract. NIDA anticipates the award of a single, one year, cost reimbursement contract with four one year option periods plus option quantities for additional levels of effort. This award is a competitive renewal of HHSN271201300013C, titled " Synthetic Peptides & Other Drugs of Abuse - Purity Determination, Stability Testing & Quantitative Analysis." MANDATORY CRITERIA In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Registration for Chemical Analysis or Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances prior to the award of the contract. The offeror must demonstrate prior to the award of the contract the availability of a DEA approved and secure storage facility to store controlled substances at suitable temperatures for analytical work. NOTICE RFP No. NIHDA-2018-00204 will be available electronically on or about 15 days from the date of this posting. You can access the RFP through the FedBizOpps (URL: http://fedbizopps.gov) or through the NIDA website (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contractproposals-rfps). All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 30 days from the release date. NIDA anticipates a September 2018 award date. NIDA will consider proposals submitted by any responsible offeror. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons or organizations may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice. This advertisement does not commit the Government to award a contract.