Name | Type | Posted | Actions |
|---|---|---|---|
75N95021R00008_Synopsis and Solicitation_Amendment 3.pdf | Oct 15, 2021 | ||
RFP Attachment 13_FAR Clause 52.223-99.pdf | Oct 15, 2021 | ||
75N95021R00008_Excel Template.xlsx | XLSX | Oct 8, 2021 | |
Phase II Questions and Government Responses.pdf | Oct 8, 2021 | ||
75N95021R00008_Synopsis and Solicitation_Amendment 2.pdf | Oct 8, 2021 | ||
75N95021R00008_Synopsis and Solicitation_Amendment 1.pdf | Aug 20, 2021 | ||
Phase I Questions and Government Responses.pdf | Aug 20, 2021 | ||
RFP Attachment 3_IDIQ Statement of Work.pdf | Aug 4, 2021 | ||
RFP Attachment 2_Packaging and Delivery of Proposals_eCPS.pdf | Aug 4, 2021 | ||
RFP Attachment 1_Proposal Intent Response Form.pdf | Aug 4, 2021 | ||
75N95021R00008_Synopsis and Solicitation.pdf | Aug 4, 2021 | ||
RFP Attachment 11_Electronic Invoice Instructions.pdf | Aug 4, 2021 | ||
RFP Attachment 10_Nondisclosure Agreement.pdf | Aug 4, 2021 | ||
RFP Attachment 6_Summary of Related Activities.pdf | Aug 4, 2021 | ||
RFP Attachment 12_Labor Hour Invoice Instructions.pdf | Aug 4, 2021 | ||
RFP Attachment 8_Disclosure of Lobbying Activities.pdf | Aug 4, 2021 | ||
RFP Attachment 9_NIH Invoice Instructions (RC)-2.pdf | Aug 4, 2021 | ||
75N95021R00008_Cover Letter.pdf | Aug 4, 2021 | ||
RFP Attachment 7_Proposal Summary and Data Record.pdf | Aug 4, 2021 | ||
RFP Attachment 5_Section K RepsandCerts.pdf | Aug 4, 2021 | ||
RFP Attachment 4_TORFP and TOSOW.pdf | Aug 4, 2021 |
CRO Support for NCATS Regulatory Affairs Support and Related Services
Contact and place of performance
Rieka Plugge
Not specified
Amendment 3 is attached. Amendment 3 adds FAR Clause 52.223-99, EnsuringAdequate COVID-19 Safety Protocols for Federal Contractors (Oct 2021) (DEVIATION) to Article I.3, and adds the full text of this clause as Attachment No. 13in Section J. Amendment 2 is attached and postpones the due date for Phase II proposals until October 25, 2021. The Phase II Questions and Government Responses are also attached. Amendment 1 i...
View moreThe National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) requires preclinical and clinical regulatory affairs support to ensure drug development projects meet the requirements of the FDA and international regulatory bodies. This requirement supports the Division of Preclinical Innovation (DPI) drug development programs by providing services that span the entire development lifecycle, from preclinical research through clinical phases. The scope of work includes therapies across a wide range of modalities, such as small molecules and biologics, as well as medical devices used in drug delivery and drug-device combinations.
This solicitation, identified by number 75N95021R00008, is a combined synopsis/solicitation for the procurement of professional services. The NIH anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) contracts for this requirement. The opportunity is classified under NAICS code 541690 Other Scientific and Technical Consulting Services and PSC code R499 SUPPORT- PROFESSIONAL: OTHER. This procurement is designated as an SBA (SBA) set-aside. Rieka Plugge is the primary point of contact for this requirement through the NIH NIDA office.
Phase I submissions were due by August 30, 2021, and the deadline for Phase II proposals was October 25, 2021. The solicitation includes 21 total attachments, including several amendments that addressed questions from potential offerors and incorporated FAR Clause 52.223-99 regarding safety protocols for federal contractors. Documentation also includes an Excel template and formal government responses to questions from both Phase I and Phase II of the solicitation process.
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Scoped analysis and attachments—go beyond the summary when you need detail from the solicitation package.