SOLICITATION NOTICE
A -- Analytical Services Center for Medications Development Program
- Notice Date
- 6/5/2018
- Notice Type
- Presolicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- NIHDA201800009
- Archive Date
- 8/3/2018
- Point of Contact
- Kenneth V Janosko, Phone: 3014436677, Lisa V. Bielen, Phone: 301.443.6677
- E-Mail Address
-
kenneth.janosko@nih.gov, lisa.bielen@nih.gov
(kenneth.janosko@nih.gov, lisa.bielen@nih.gov)
- Small Business Set-Aside
- N/A
- 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 act as a centralized bioanalytical facility to support the preclinical pharmacokinetic (PK)/toxicokinetic studies, clinical PK studies and clinical trials for assessing efficacy and safety of the study medications. Specifically, the project requires the following tasks: 1. Develop and validate assays for the quantitative determination of target analytes in biological specimens. · Utilize of state of the art analytical methods (e.g. gas chromatography-mass spectrometry (GCMS), high performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), liquid chromatographytandem mass spectroscopy (LC-MS/MS) and immunoassays) for analytes that appear in biological matrices at concentrations of low ng/mL or subnanogram/mL · Assay radiolabeled compounds collected from mass balance studies · Utilize HPLC methods with radiochemical detectors · Utilize immunoassays or quantitative assays of peptides and proteins in biological matrix · Utilize commercially available reagents or assay kits · Develop and validate new analytical methods when there are no established methods available · Reproduce (and if necessary, modify) and validate existing assays to quantify analytes in biological specimens · Determine the stability of the target analytes in the biological matrices to establish the proper procedures for sample handling and storage · Carry out research and development to improve the sensitivity and efficiency of assays used in the ongoing quantitative studies · Follow pertinent Food and Drug Administration (FDA) guidelines regarding analytical methods validation 2. Perform quantitative assays of a variety of compounds using analytical methods validated at the concentration range required for preclinical and clinical studies. Perform qualitative screening and quantitative assays of abused drugs in biological samples collected from clinical trials. · It is preferable that the lab is accredited by College of American Pathologists (CAP), or certified by Substance Abuse and Mental Health Administration (SAMHSA), state government, or any other appropriate government agencies for conducting illicit drug testing · Perform initial testing of biological specimens for abused drugs including, but not limited to, benzoylecgonine, methamphetamine, amphetamine, morphine (or morphine-glucuronide), methadone, cannabinoids, phencyclidine and benzodiazepines as well as creatinine. · Perform quantitative/confirmatory assay of abused drugs in biological samples showing positive results for the target abused drug in the initial screening using assay methods developed and validated for the specific target at the concentration range required. · Utilize mass spectrometric methods including, but not limited to, GC-MS, LC-MS and LC-MS-MS. · Utilize immunoassays for the confirmation and quantitation of the target abused drug if the method has been validated and is acceptable to the COR. 4. Acquire and distribute on-site multi-panel drug testing devices including Delta-9-tetrahydrocannabinol (THC) 50, Cocaine 150, Opioid/Morphine 300, Barb 200, Benzodiazepines 200, Methamphetamine 500 (or lower), Amphetamine 1000 (or lower), Methadone 300, and Oxycodone 100 ng/mL. Acquire and distribute containers for collection, storage, and shipment of biological specimens to clinical trial sites. · Provide supplies including, but are not limited to urine collection cups (with temperature strips), urine storage bottles, and plasma storage vials. · Provide labels, shipping containers and shipment cartons along with instructions for use and shipment conditions · Provide collection and shipping containers for other sample matrices · Utilize bar code reading system and proper chain-of-custody procedures 6. Prepare and maintain all assay results in electronic files for submission to NIDA with corresponding reports and for submission to the data management centers designated by NIDA. Archive all data, including laboratory notebooks, hard copies of raw data, and databases of assay results, in secure storage in case a good laboratory practice (GLP) audit is required by FDA in connection with an investigational new drug (IND) or new drug application (NDA) submission. NIDA anticipates the award of a single five-year indefinite delivery/indefinite quantity (IDIQ) contract with cost-reimbursement and fixed-price task orders. This award is a recompetition of HHSN271201300043C, titled "Analytical Services Center for Medications Development." 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. NOTICE RFP No. NIHDA201800009 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 45 days from the release date. NIDA anticipates a January 2019 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/NIHDA201800009/listing.html)
- Record
- SN04944205-W 20180607/180605231148-ead39449edb3e02f26d5be53bd713616 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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