CRO Support for NCATS Regulatory Affairs Support and Related Services
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 14, 2021.
75N95021R00008 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
8/4/21, 4:17 PM CRO Support for NCATS Regulatory Affairs Support and Related Services
This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.
This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.
Please note that to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting).
Background
This Notice is an update from a prior Small Business Sources Sought Notice (75N95019R00050) that was posted on April 4, 2019. This subsequent Small Business Sources Sought is being posted due to the length of time elapsed since the original notice was posted and due to updates made to the requirement.
Purpose and Objectives
The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research in human therapeutics development and aims to move small molecule and biologic drug candidates forward in the drug development pipeline. At predetermined milestones, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients. In addition to developing new candidate drugs, DPI 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 pre-clinical stage of drug development. DPI’s model is to operate as a full range small molecule and biologics drug development organization, moving drug candidates through each phase of the pre-clinical drug development process until an Investigational New Drug (IND) is filed with the US Food and Drug Administration (FDA), and, on a case by case basis, to continue into clinical development studies.
DPI conducts drug development as collaborations through programs such as the Therapeutics for Rare and Neglected Diseases (TRND), Helping to End Addiction Long-term (HEAL) Initiative and the Bridging Interventional Development Gaps (BrIDGs) programs. DPI drug development programs originate from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes. The R&D operational strategy is to combine the capabilities of DPI in-house staff and DPI partners, who may be the drug originators. Each drug program operates in a multi-disciplinary, multi-partnership matrix team environment, and a DPI program officer is responsible for the overall planning, execution, and reporting of the program.
Contract research organizations (CROs) and contract manufacturing organizations (CMOs) provide DPI with manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to assist with drug development. Planning and execution of each individual drug development program includes identification of scientific and regulatory areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program.
DPI has a need for both preclinical and clinical regulatory support so that projects can meet the regulatory requirements of the FDA and other non-US regulatory bodies. Therapies under development 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 or clinical 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-clinical through clinical phases. This may include drugs, medical devices used in drug delivery, or drug-device combinations. While this contract will be primarily in support of the NCATS DPI drug development programs, the Government reserves the right to allow other drug development programs at NIH to solicit task order proposals. As such, this contract is not limited to requirements under the TRND, HEAL or BrIDGs programs, or under NCATS as a whole.
Project requirements
See the attached Draft Statement of Work for project requirements.
Contract Type and Anticipated Period of Performance
The Government anticipates making multiple awards of Indefinite Delivery/Indefinite Quantity (IDIQ) contracts under a future solicitation, which are anticipated to have a five-year ordering period.
Required Information
Responses must include information about the respondent’s current in-house capability and capacity to perform the work. If subcontracting is anticipated, responses should note the extend of subcontracting anticipated and which area(s) the respondent anticipates subcontracting. Responses must include information about the respondent’s prior completed projects of similar nature.
Responses must also include (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code.
Submission Instructions and Due Date
Responses must be submitted electronically to Kimberly Espinosa, Contract Specialist, at kimberly.espinosa@nih.gov. Responses must be received on or before Monday, January 4, 2021, at 3:00pm Eastern Time.
Disclaimer and Important Notes
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.
Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Beta.SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality
No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
75N95021R00008 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
12/14/20, 7:37 AM