SOLICITATION NOTICE
R -- In Vivo Toxicology studies of potential coontraceptives
- Notice Date
- 8/6/2021 2:02:36 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 813920
— Professional Organizations
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NICHD BETHESDA MD 20817 USA
- ZIP Code
- 20817
- Solicitation Number
- 21-254
- Response Due
- 8/13/2021 9:00:00 AM
- Archive Date
- 08/28/2021
- Point of Contact
- Patricia Haun, Phone: 3014437786
- 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-21-254 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 2021-06. �The North American Industry Classification (NAICS) Code is 813920 and the business size standard is $15.0M. �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 Leading Edge PharmTox, 9078 Barstow St., Lenexa, KS 66219 to provide expertise that focus on in vivo toxicology related studies of potential contraceptives. � 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, Leading Edge PharmTox, has provided their service to the Contraception Research Branch (CRB) for many years. �Leading Edge PharmTox has the expertise in reproductive toxicology that can provide the critical insight for experimental design, execution, and interpretation of results. �This will increase the knowledge needed by CRB to make informed scientific decisions and meet the needs of increasing fundamental understanding of contraceptive related in vivo studies. � � Scope of Work The scope of work is for the contractor to provide the following: �� 1.�� �Review, monitor, and report on subject safety, protocol and regulatory compliance and data accuracy, as needed. 2.�� �Liaise between various research facilities and NICHD to ensure planned studies in the target product profile and the drug development program that meet NICHD CRB objectives for regulatory submissions. 3.�� �Provide expert input regarding reproductive toxicology experiment design and procedures to NICHD staff who oversee grants, cooperative agreements or contracts, as needed. 4.�� �Review, evaluate, and provide expert consultation regarding safety issues for protocols funded on NICHD networks or other cooperative agreements or contracts. 5.�� �Provide expert input to the network investigator team on clinical development plans, protocol designs, and risk assessments. 6.�� �Advise on reproductive pharmacology, and/or related, milestones, and evaluate project progress relative to established milestones. 7.�� �Recommend potential solutions to NICHD staff relative to reproductive toxicology for drug discovery and development, as needed. 8.�� �Evaluate existing non-clinical development strategies and provide council on the optimal experimental design for pharmacokinetic studies and/or toxicokinetic study designs incorporated into pivotal toxicology studies. 9.�� �Provide an assessment of the analytical and bioanalytical methods used to support non-Good Laboratory Practices/Good Laboratory Practices (non-GLP/GLP) toxicology studies. 10.�� �In collaboration with pharmacokinetic scientist(s), at the Contract Research Organization (CRO) of choice, use Win-Nonlin equivalent software to generate basics PK parameters based on drug-plasma levels over time. 11.�� �Prepare stand-alone non-clinical gap assessments of ongoing non-clinical research and provide supplementary material to support those studies in study reports. 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 August 13,2021 at 12:00 PM. �The quotation must reference �Solicitation number� NIH-NICHD-21-254. 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
(https://beta.sam.gov/opp/000be869c12346d59b1597db4bd2caa4/view)
- Record
- SN06088093-F 20210808/210806230119 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |