This Solicitation opportunity from Department Of Health And Human Services was posted on June 26, 2023. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Safety Evaluation and Toxicology Studies and Related Services for Drug Development

Closed

75N95023R00029Federal

Submission Closed07/24/2023, 07:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 541715

New

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Defense Advanced Research Projects Agcy

POSTED

1 day ago

DEADLINE

in 2 months

General Info

Agency

Department Of Health And Human Services → National Institutes Of Health Nida

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

Set-Aside

NONE

Documents

75N95023R00029 Amendment 01

amendment

High

75N95023R00029 Amendment 02

amendment

High

RFP 75N95023R00029 and Attachments Amended 2023-06-26

amendment

High

AI Contract Breakdown

Uniform Contract Format

Contract not broken down yet

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Timeline

2 updates

PhaseClosed

PostedMay 11

Presolicitation

Type ChangedMay 26

Presolicitation → Solicitation

Notice updatedJun 20

The notice description changed.

Notice updatedJun 26

Response deadline changed from Jul 10, 2023 to Jul 24, 2023. The notice description changed.

Response DeadlineJul 24

Deadline has passed

Submission Closed

07/24/2023, 07:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health Nida

Contacts2 people available

OfficeBethesda, MD, 20892, USA

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Nida

Office AddressBethesda, MD, 20892, USA

Contacts

Mark McNally Contract Specialist

contact@example.gov

+1 (555) 000-0000

Khurram Shaikh Contracting Officer

contact@example.gov

+1 (555) 000-0000

Full Description

The purpose of RFP Amendment Number 02 is to extend the proposal deadine to 03:00 PM local time on July 24, 2023; and to share the following SBCX link through which offerors are required to submit their subcontracting plans: https://osdbu.hhs.gov/subcontracting/b08bd2d7-6f7c-4317-af71-8e2302ba62b3 The purpose of RFP Amendment Number 01 is to distribute RFP questions and answers. The Therapeutic Development Branch (TDB) within the Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), conducts translational research on human therapeutics development by moving small molecule and biologic drug candidates forward in the drug development pipeline. Upon reaching predetermined milestones, TDB hands off clinical candidates to external partners to bring these novel therapies to patients. In addition to developing new candidate drugs, TDB seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial preclinical stage of drug development. The scope of this requirement is providing safety assessment of therapeutics and diagnostics. These assessments play a pivotal role in determining and evaluating therapeutic targets; selecting and optimizing therapeutic lead candidates; and establishing first in human starting doses, dose limiting toxicities, safety/pharmacodynamic biomarkers and therapeutic indexes. The objective is to conduct toxicology studies to support the preclinical development of therapeutics and diagnostics including the submission of regulatory filings. Contractors will be required to perform in vitro and in vivo safety studies for small and large molecules to support the submission of regulatory filings to the US Food and Drug Administration (FDA) or other regulatory bodies, such as Investigational New Drug (IND) applications, New Drug Applications (NDA) and Biologics License Applications (BLA). In addition, in vitro tests and in vivo exploratory studies will be carried out to aid therapeutic target evaluation, lead optimization, and compound selection processes on a case-by-case basis. Therapeutic modalities may include new and repurposed chemical entities and biological products (e.g., monoclonal antibodies, enzymes, gene vectors, etc.). Offerors' questions regarding this RFP must be emailed by 03:00 PM EDT, June 9, 2023, to the Contract Specialist at contact@example.gov. Qestions and answers shall be published on SAM.gov to this Notice ID as an RFP amendment.