CRO Support for NCATS Regulatory Affairs Support and Related Services   5

Amendment 3 is attached. Amendment 3 adds FAR Clause 52.223-99, Ensuring Adequate 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. 13 in 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 is attached and corrects a date on the Combined Synopsis / Solicitation. The Phase I Questions and Government Responses are attached.

The National Center for Advancing Translational Sciences (NCATS) at the National Institute of Health (NIH) has a need for both preclinical and clinical regulatory support so that projects can meet theregulatory requirements of the FDA and other non-US regulatory bodies. Therapies underdevelopment can cover a wide range of modalities, such as small molecules and biologics (e.g.antibody, proteins, and cell and gene therapy), and can be at different stages of pre-clinical orclinical development that requires varying levels of support.

The objective of this contract is to support the DPI drug development programs by providing regulatory affairs services that can fully support drug development projects from pre-clinicalthrough clinical phases. This may include drugs, medical devices used in drug delivery, or drug-device combinations.

It is anticipated that multiple IDIQ contracts will be awarded under this solicitation.

See attached Combined Synopsis / Solicitation and attachments for full requirement details.

IMPORTANT DEADLINES

• Proposal Intent Response Forms are due before 12:00:00PM Eastern Time on August 16, 2021.
• Phase I submissions are due before 12:00:00PM Eastern Time on August 30, 2021.
• Phase II proposals are due before 12:00:00PM Eastern Time on October 25, 2021.