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SAMDAILY.US - ISSUE OF APRIL 06, 2024 SAM #8166
SOLICITATION NOTICE

A -- Pharmacokinetic Analysis Resource Center

Notice Date
4/4/2024 12:50:16 PM
 
Notice Type
Presolicitation
 
NAICS
541715 — Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
 
Contracting Office
NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
 
ZIP Code
20892
 
Solicitation Number
75N95024R00078
 
Response Due
5/20/2024 10:00:00 AM
 
Archive Date
06/04/2024
 
Point of Contact
Robert Bailey, Phone: 3014517586, Andrew Varley, Phone: 3018275851
 
E-Mail Address
rob.bailey@nih.gov, andrew.varley@nih.gov
(rob.bailey@nih.gov, andrew.varley@nih.gov)
 
Small Business Set-Aside
SBA Total Small Business Set-Aside (FAR 19.5)
 
Description
The National Institute on Drug Abuse (NIDA), and the Division of Therapeutics and Medical Consequences (DTMC), intend to solicit proposals as a SMALL BUSINESS SET-ASIDE using competitive procedures from qualified organizations certified as SMALL BUSINESS under NAICS Code 541715. The purpose of this requirement is to provide clinical research support services and pharmacokinetic resources in support of pharmacokinetic (PK)/pharmacodynamic (PD) studies.� No actual clinical or laboratory studies will be carried out under the contract.� The successful awardee shall: Prepare study protocols; Monitor clinical studies to assure that pertinent FDA regulations are met; Perform data management for clinical and pharmacokinetic data; Perform statistical, PK and PK/PD analyses of experimental data obtained from clinical studies including clinical pharmacology and drug-drug interaction studies;� Perform population pharmacokinetic (PK) and pharmacodynamic (PD) analysis for data obtained from clinical trials to investigate the relationships among dose, plasma concentration, and effect and; Prepare study reports. The data/reports will be submitted to the FDA in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications); Provide support services which may include, but are not limited to, preparing progress reports, reviewing/revising protocols, consultation on design and data analysis, preparing PK/PD graphs and tables for presentations, performing literature search, as well as other support tasks; and Develop and maintain archival study records. NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity (IDIQ), task order contract. This award is a re-competition of 75N95019D00009, titled �Pharmacokinetic Analysis Resource Center.� NIDA may award either cost reimbursement and/or fixed price task orders under this contract.� Individual Task Orders may include options to extend the period of performance and/or Options for Increased Quantity. 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.� RFP No. 75N95024R00078 will be available electronically on or about April 18, 2024. You will be able to access the RFP through SAM.gov and 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 30 days after release of the RFP. NIDA will consider proposals submitted by any responsible SMALL BUSINESS under NAICS Code 541715. 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 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
SAM.gov Permalink
(https://sam.gov/opp/d61c4e25c3f84dc7b8c8643e0bda6a5e/view)
 
Place of Performance
Address: USA
Country: USA
 
Record
SN07019777-F 20240406/240404230051 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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