RFP Notice:  Analytical Services Center for Medications Development Program


Notice Number: NOT-DA-13-033

Key Dates

Release Date:  January 7, 2013

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

The National Institute on Drug Abuse (NIDA) intends to solicit proposals from offerors having the capability to act as a centralized laboratory to carry out validated quantitative and/or qualitative assays for a variety of compounds in biological specimens collected from preclinical and clinical studies. The data obtained will be used by NIDA to support the development of new medications for the treatment of drug addiction. The laboratory must be able to perform the tasks listed below:

1. Quantitative assay for samples collected from metabolic, pharmacokinetic/toxicokinetic studies:

The laboratory must be able to perform quantitative assays for samples collected from preclinical metabolic and pharmacokinetic/toxicokinetic studies, as well as samples collected from all phases of clinical studies. The analytes include, but are not limited to, potential therapeutic compounds and/their metabolites, abused drugs and/their metabolites, concomitant medications/compounds, and endogenous substances (e.g. proteins, enzymes etc). Sample matrices include biological fluids (plasma, urine, saliva, etc) and tissues (liver, brain, hair etc). The analytical laboratory must be able to develop and validate new assay methods for drugs/metabolites for which established assays do not exist. The analytes may appear in biological matrices at concentrations of low ng/mL or subnanogram/mL and therefore require the use of state of the art analytical methods including gas chromatography-mass spectrometry (GC-MS), high performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), liquid chromatography-mass spectrometry-mass spectrometry (LC-MS-MS) and immunoassays.

2. Assay for surrogate outcome measures and/molecular biomarkers (protein, enzymes, etc.):

The laboratory must be able to perform assays for surrogate outcome measures and/molecular biomarkers for the assessment of efficacy and safety of study medications in clinical trials. Monitoring of abused drugs in biological fluids serves as a surrogate outcome measure for assessing drug use in clinical trials. The abused drugs include, but are not limited to, cocaine/benzoylecgonine (a cocaine metabolite), methamphetamine, amphetamine, morphine (or morphine-glucuronide), cannabinoids, and benzodiazepines. Automated qualitative/semi-quantitative immunoassays are generally used for screening of abused drugs in biological fluids, primarily in urine. Validated quantitative methods using GC-MS or LC-MS are generally required for confirmatory/quantitative assay for samples which showed positive for screening. Immunoassays are generally required for quantitative assay of molecular biomarkers.

3. Sample collection and shipping containers, as well as on-site test devices:

The laboratory is required to supply clinical sites with sample collection and shipping containers, as well as on-site test devices for screening of abused drugs.

The methods for quantitative assays must be validated for reproducibility, accuracy, sensitivity, and specificity at the concentration ranges required for the preclinical and clinical studies. The laboratory must follow appropriate Food and Drug Administration guidance regarding assay validation and the assay must be carried out in compliance with pertinent current Good Laboratory Practices regulations. The laboratory must have automated equipment for handling sample preparation and injection as well as computer software for data acquisition and report generation. The laboratory must also have sufficient resources to ensure high throughput of samples and must provide secured facilities appropriate for storing biological samples and analytical data as well as computerized systems for tracking samples.

In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that the successful offeror possess a Drug Enforcement Agency (DEA) Registration for Chemical Analysis or DEA Research Registration for Schedules II to V controlled substances and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances.

NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity (IDIQ) task order contract. NIDA may award either cost reimbursement and/or fixed price task orders under this contract. NIDA anticipates that at least one task order will be awarded with the initial contract.

RFP No. N01DA-13-8910 will be available electronically on or about January 18, 2013. You will be able to access the RFP through FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of an offer will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 45 days after release of the RFP. NIDA will consider proposals submitted by any responsible offeror.

Based upon market research, the Government is not using the policies contained in FAR Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons 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.

Inquiries

Please direct all inquiries to:

Andrew Hotaling
Contract Specialist
Phone: (301) 443-6677
Fax: (301) 443-7595
Email: hotalingar@mail.nih.gov


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