SOLICITATION NOTICE
R -- CONSULTING SERVICES FOCUS ON PHARMACOLOGY RELATED STUDIES OF POTENTIAL CONTRACEPTIVES
- Notice Date
- 8/29/2022 12:41:02 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NICHD BETHESDA MD 20817 USA
- ZIP Code
- 20817
- Solicitation Number
- NICHD-22-272
- Response Due
- 9/7/2022 9:00:00 AM
- Archive Date
- 09/22/2022
- Point of Contact
- Patricia Haun, Phone: 13014437786
- E-Mail Address
-
haunp@mail.nih.gov
(haunp@mail.nih.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. �This announcement constitutes the only solicitation, and a separate written solicitation will not be issued. �This solicitation number is NIH-NICHD-22-272 and is issued as a Request for Quotation (RFQ). �The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2022-07. �The North American Industry Classification (NAICS) Code is 541690 and the business size standard is $16.5M. �This solicitation is set aside for small business.� It is the intent of The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to procure the services from Gardner Pharmacology, LLC, 1802 Brookstone CT, Vienna, VA 22182 to provide expertise that focus on pharmacology and pharmacokinetic consulting to the Contraception Research Branch (CRB). �This is pursuant to 41 U.S.C. 253(c)(1)�Only one responsible source and no other supplies or services will satisfy agency requirements. � The proposed contractor, Gardner Pharmacology, LLC has provided their service to CRB for many years. This contract will focus on pharmacology related studies of potential contraceptives. �There is a clear benefit to increasing the depth of CRB�s understanding for these identified investigations (e.g., in vivo studies including: �pharmacology studies, pharmacokinetic studies, mating studies, maximum tolerated dose studies). Gardner Pharmacology, LLC has the expertise with critical insight needed for these types of experimental design, execution and interpretation. � Scope of Work The scope of work is for the contractor to provide the following: �� 1.�� �Liaise between various research facilities and NICHD staff to ensure planned studies achieve necessary pharmacokinetic requirements to meet NICHD CRB objectives 2.�� �Evaluate existing non-clinical data and advise on optimal pharmacokinetic sampling strategies (including time points and matrices) 3.�� �Provide review of contractor bioanalytical methodology to ensure accuracy and precision in accordance with FDA guidance 4.�� �Perform preclinical non-compartmental pharmacokinetic data analysis (e.g., WinNonl in or equivalent software) generating basic pharmacokinetic parameters based on drug levels over time in plasma or other matrices 5.�� �Prepare standalone pharmacokinetic reports and/or pharmacokinetic supplements for inclusion in existing study reports 6.�� �In collaboration with a toxicologist(s), develop data models to jointly describe toxicology and pharmacokinetics 7.�� � Provide guidance on drug dose, route of administration and frequency �Review, monitor, and report on subject safety, protocol and regulatory compliance and pharmacological data accuracy to NICHD, as needed� 8.�� �Provide expert input regarding systemic pharmacology experiment design and procedures to NICHD who oversee grants, cooperative agreements, or contracts, as needed 9.�� �Review, evaluate, and provide expert consultation regarding safety issues for protocols funded on NICHD networks or other cooperative agreements or contracts 10.�� � At the direction of NICHD, provide expert input to the network investigator team on clinical development plans, protocol designs, and risk assessments 11.�� � Review planned studies and clinical trials to ensure necessary pharmacology components essential for drug development are adequately included prior to initiation 12.�� �Advise on milestones that utilize pharmacology experiments, and evaluate project progress 13.�� �Recommend potential solutions related to pharmacology for drug discovery and development, as needed 14.�� �Provide feedback to NICHD to improve successful pharmacology outcomes in line with scientific and program goals The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications � Commercial Items with its offer. �The provisions of FAR Clause 52.212-1 Instructions to Offerors � Commercial Items; FAR Clause 52.212-2, Evaluation � Commercial Items: Evaluation Factors (1) technical capability to provide all services, etc; (2) price; and (3) past performance. Technical capability and past performance, when combined, are significantly more important than cost/price; FAR Clause 52.212-4, Contract Terms and Conditions � Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders � Commercial Items � Deviation for Simplified Acquisitions applies to this acquisition. �FAR Clause 52.204-24, Representation Regarding Certain Telecommunication and Video Surveillance Services or Equipment; FAR Clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment; FAR Clause 52.213-4. �The offeror must include their Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. �The clauses are available in full text at http://www.arnet.gov/far. Quotations will be due eight (8) calendar days from the publication date of this synopsis or September 7, 2022 at 12:00 PM. �The quotation must reference �Solicitation number� NIH-NICHD-22-272. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. �Quotations must be submitted by email to Patricia Haun at Haunp@mail.nih.gov. � �Faxed copies will not be accepted �
- Web Link
-
SAM.gov Permalink
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- Record
- SN06444395-F 20220831/220829230127 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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