Regulatory Support for Cancer Prevention Agent Dev
Closed Solicitation Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- 75N98023R00011
- Agency
- National Cancer Institute National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- R499 Support- Professional: Other
Notice details come from SAM.gov. Updated .
About this opportunity
The National Cancer Institute seeks a contractor to provide regulatory services and technical support. The selected offeror will gather and summarize preclinical and clinical data on potential cancer prevention agents from scientific and laboratory sources to prepare regulatory reports and applications for the FDA. The contractor must collect, prepare, submit, and continually update this regulatory data in accordance with applicable regulations and guidelines. Proposals are due May 4, 2023 and will be evaluated based on technical approach, management approach, and past performance. An amendment extended the page limit for technical proposals and provided responses to vendor questions.
This requirement is set aside for small businesses and utilizes NAICS 541712 with a place of performance at the National Cancer Institute. The single-award IDIQ contract has a one base year and four option years with budgets estimated between $5-10 million total. The incumbent contractor is Anthropic which provides similar regulatory support and informatics services to help prevent cancer and improve health outcomes.
Notice text
The purpose of this contract is to provide regulatory services and technical support to the Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI). NCI and DCP has a recurring requirement for regulatory services and technical support to gather and summarize a vast amount of preclinical and clinical data associated with potential cancer preventive agents. This data is generated by the scientific community and NCI contract labs. The majority of the data is used to prepare required regulatory reports and application submissions for the U.S. Food and Drug Administration (FDA), which will be made in accordance with FDA regulations, ICH (International Committee on Harmonization) guidelines, NIH, NCI, and DCP requirements in addition to other relevant regulations, laws, and guidelines. This procurement encompasses the. collection, preparation, submission, and continual update of regulatory data. Successful performance of this requirement is critical to DCP?s ability to further support NCI's mission by leading, supporting, and promoting rigorous, innovative research and training to prevent cancer and its consequences to improve the health of all people.
Attachments
| File | Type | Posted |
|---|---|---|
| Amendment_1_RFP_Ques_and_Resp_04_18_23_0001.pdf | ||
| Sol_75N98023R00011_Amd_0001.pdf | ||
| Regulatory_Support_for_Cancer_Prevention_Agent_RFP_75N98023R00011.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Regulatory Support for Cancer Prevention Agent Dev | Award Notice | |
| Regulatory Support for Cancer Prevention Agent Dev | Solicitation | |
| Regulatory Support for Cancer Prevention Agent Dev | Pre-Solicitation |
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