Portfolio Impact Analysis for the Therapeutic Development Branch (TDB), NCATS
ID: 75N95024Q00564Type: Combined Synopsis/Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIDABethesda, MD, 20892, USA

NAICS

Administrative Management and General Management Consulting Services (541611)

PSC

SUPPORT- PROFESSIONAL: PROGRAM EVALUATION/REVIEW/DEVELOPMENT (R410)

Set Aside

SBA Certified Women-Owned Small Business (WOSB) Program Set-Aside (FAR 19.15) (WOSB)

Original Source

https://sam.gov/opp/c44524dd912c4963a119b8ceb37548ef/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking a contractor to conduct a Portfolio Impact Analysis for the Therapeutic Development Branch (TDB) within the National Center for Advancing Translational Sciences (NCATS). The objective of this procurement is to evaluate the program's research outcomes since its establishment in 2010, focusing on both economic and qualitative metrics that will inform future research policies and strategic planning. This analysis is crucial for understanding the impact of TDB's partnerships and projects, which have addressed a range of diseases, particularly rare and neglected conditions. Proposals are due by 2:00 PM ET on September 16, 2024, with the anticipated award date set for September 23, 2024. Interested vendors, particularly those certified as Women-Owned Small Businesses, should contact Kimberly Espinosa at kimberly.espinosa@nih.gov for further details.

    Point(s) of Contact
    Kimberly Espinosa
    kimberly.espinosa@nih.gov
    Files
    Title
    Posted
    D 75N95024Q00564_CSS_Amendment 1.pdf
    The document outlines a solicitation (75N95024Q00564) from the National Center for Advancing Translational Sciences (NCATS) for a portfolio impact analysis of its Therapeutic Development Branch (TDB), covering the period from 2010 to present. The analysis aims to assess the program’s research outcomes, including economic and qualitative impact measures relevant to further research and healthcare. The solicitation is specifically designated for Women-Owned Small Businesses (WOSB) and is structured under simplified acquisition regulations. Submissions are due by September 16, 2024, with the award anticipated for September 23, 2024. Proposals will be evaluated based on technical approach, personnel qualifications, past performance, and price. Respondents must include evidence of capability to fulfill requirements, along with necessary certifications and financial details. The document highlights the importance of the resulting analysis for future research policy and priorities at NCATS, emphasizing its strategic role in preclinical therapeutic development and collaboration within the NIH framework.
    D 75N95024Q00564_CSS.pdf
    The document is a combined synopsis and solicitation (RFQ) for a portfolio impact analysis for the Therapeutic Development Branch (TDB) within the National Center for Advancing Translational Sciences (NCATS) at the NIH. The purpose is to evaluate the branch's research outcomes since its inception in 2010, focusing on economic and qualitative metrics that will inform future research policies. This procurement is set aside for Women-Owned Small Businesses, with a performance period from September 24, 2024, to June 24, 2025, and a projected award date of September 23, 2024. Quotations will be assessed based on four criteria: technical approach, key personnel qualifications, past performance, and price. Responses are due by 2:00 PM ET on September 16, 2024, and must include pertinent certifications and proposed pricing details. The solicitation incorporates various provisions and clauses relevant to the procurement process, emphasizing contractor cooperation in investigations and confidentiality of information collected. This RFQ illustrates the NIH's commitment to advancing healthcare research through methodological assessments and partnerships.
    D 75N95024Q00564_QandA.pdf
    The file addresses vendor inquiries regarding the RFP titled "Portfolio Impact Analysis for the Therapeutic Development Branch (TDB), NCATS." A key question pertained to the requirement of using the IMPLAN model for data analysis, as mentioned in the statement of work. The government's response clarified that while IMPLAN is cited as an example, it is not mandatory; vendors may propose alternative models. The primary criterion is that any chosen model must effectively analyze both quantitative and qualitative data related to the impacts of research and development activities. Vendors are encouraged to provide justification for their model selection, which can be demonstrated through detailed descriptions, comparisons with other models, or other informative means. Overall, the document aims to clarify model expectations for prospective vendors in the context of this federal RFP.
    D1 75N95024Q00564_SOW.pdf
    The National Center for Advancing Translational Sciences (NCATS) is seeking a contractor to conduct a Portfolio Impact Analysis for the Therapeutic Development Branch (TDB). Established in 2010, the TDB aims to enhance preclinical development through partnerships, focusing on a range of diseases, particularly rare and neglected conditions. The analysis is intended to capture metrics on the program's outputs and evaluate the economic and qualitative impacts of its research partnerships, which number around 100 since inception. The contractor will design survey instruments, gather data from collaborators, and analyze results to inform NCATS leadership for strategic planning over the next 10-15 years. Deliverables include periodic reports, a final comprehensive analysis, and case studies that illustrate the impact of TDB’s projects. Key personnel must possess advanced degrees and relevant experience in economic analysis of research and development. Confidentiality of collected data will be maintained, conforming to specified federal guidelines. This effort reflects NCATS's ongoing commitment to effectively translate research into health solutions.
    D2 FAR 52.212-1 (Sep 2023) (TAILORED).pdf
    The document outlines the instructions for offerors proposing commercial products and services under federal acquisition guidelines, specifically referring to FAR Clause 52.212-1. It indicates the applicable North American Industry Classification System (NAICS) codes and small business size standards, emphasizing the importance of submission compliance. Key requirements for quotations include providing detailed technical descriptions, express warranty terms, pricing, and completed representations at FAR 52.212-3. Offerors are encouraged to submit their best terms initially, as the government intends to evaluate and issue a purchase order without further discussions. The document also addresses late submissions, multiple quotations, and the withdrawal process, alongside stipulations on unique entity identifiers for contractors. Lastly, it emphasizes the need for transparency, stating that vendors can request information on award decisions while safeguarding confidential business information. Overall, this provision supports the government's efforts in fair and responsible procurement practices for commercial items and services.
    D3 FAR 52.212-5 (May 2024).pdf
    This document outlines federal acquisition regulations (FAR) clauses applicable to contracts related to the procurement of commercial items. It emphasizes the contractor’s responsibility to comply with various federal laws and executive orders that govern areas such as subcontractor restrictions, ethics, and reporting obligations. Key requirements include compliance with clauses governing business ethics, whistleblower protections from the American Recovery and Reinvestment Act, reporting of executive compensation, and specific prohibitions on contracting with certain foreign entities. The document specifies various clauses that address small business considerations, labor standards, trade agreements, and environmental regulations. Noteworthy clauses include those addressing the limitations on subcontracting, minimum wage laws under executive orders, and provisions for electronic payment processes. The overarching purpose of the document is to ensure that contractors understand and adhere to the legal framework established to govern federal contracting, aiming for ethical conduct, fair labor practices, and compliance with national security guidelines. This structure serves as a guide for both contractors and contracting officers, outlining their responsibilities and legal obligations in federal procurement processes.
    D4 Invoice and Payment Provisions (Mar 2023).pdf
    The document outlines the invoice and payment provisions for contractors engaged with the federal government, specifically managed by the National Institutes of Health (NIH). It emphasizes the mandatory requirements for a valid invoice, detailing required components such as vendor identification, contract numbers, and service descriptions. The document mandates that invoices be submitted through the Department of Treasury’s Invoice Processing Platform (IPP), with specific timelines for payment processing—typically within 30 days of receipt or government acceptance of the deliverables. It also describes the conditions under which interest penalties for late payments will be applied, based on compliance with the Prompt Payment Act and absence of disputes over delivered goods or services. Furthermore, it includes directives regarding accelerated payments to small business subcontractors within 15 days after receiving government payments, aligning with federal regulations. Lastly, the document stipulates that while electronic submission is required, alternative procedures may be authorized by the contracting officer. This guidance ensures clarity and fairness in financial transactions related to government contracts, promoting prompt payment and compliance with federal standards.
    Lifecycle
    Title
    Type
    Portfolio Impact Analysis for the Therapeutic Development Branch (TDB), NCATS
    Currently viewing
    Combined Synopsis/Solicitation
    Similar Opportunities
    NIAID CLINICAL PRODUCTS CENTER (CPC)
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking proposals for a contract to provide pharmacy and pharmaceutical oversight for clinical trials, both nationally and internationally. The primary objective of this contract is to ensure the integrity of study products, participant safety, and compliance with pharmacy and pharmaceutical regulations throughout various NIH-funded clinical trials. This opportunity is critical for maintaining high standards in public health research, as it encompasses a wide range of services including product management, regulatory document maintenance, and clinical laboratory testing. Proposals are due by January 17, 2025, with the contract expected to commence on April 1, 2026, and run through March 31, 2027, potentially extending through 2033. Interested parties can contact Deborah Blyveis at blyveisd@niaid.nih.gov or Emily Bannister at emily.bannister@nih.gov for further information.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through the National Center for Advancing Translational Sciences (NCATS), is seeking qualified small businesses to provide Chemistry, Manufacturing, and Controls (CMC) and related services for the development of drug products. The objective of this procurement is to support the Therapeutic Development Branch in ensuring the delivery of drug products of sufficient quality and quantity for preclinical, IND-enabling, and clinical studies, which are critical for advancing therapeutic candidates through the drug development pipeline. This opportunity is part of a Small Business Sources Sought notice, aimed at gathering information on the capabilities of small businesses to fulfill these requirements, with a focus on compliance with applicable regulations and the potential for a multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) contract. Interested vendors must submit their capability statements by 10:00 AM Eastern Time on July 21, 2024, to Michelle Cecilia at michelle.cecilia@nih.gov.
    CRO Support for NCATS Bioanalytical Method Development for Biologics
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified contractors to provide support for bioanalytical method development for biologics under a Sources Sought notice. The primary objective is to identify capable organizations that can develop and validate bioanalytical methods for quantitative analyses of novel therapeutic biologics and anti-drug antibodies in various biological matrices, as well as manage project administration and quality assurance. This initiative is crucial for advancing drug development processes and ensuring compliance with regulatory standards, ultimately facilitating the transition of therapeutic candidates to clinical trials. Interested parties must submit their capability statements and relevant information by November 8, 2024, to Nick Niefeld at nick.niefeld@nih.gov.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is soliciting proposals for Chemistry, Manufacturing, and Control (CMC) services related to the development of drug substances under RFP number 75N95024R00094. The primary objective is to secure high-quality drug substances to support preclinical and Investigational New Drug (IND)-enabling studies, ensuring compliance with current Good Manufacturing Practices (cGMP) and federal regulations. This initiative is crucial for advancing therapeutic innovations and facilitating collaborations in drug development, with a total funding amount of up to $49.7 million over the contract period from September 1, 2025, to May 14, 2031. Interested parties must submit their proposals by December 3, 2024, and can direct inquiries to primary contact Samson Shifaraw at samson.shifaraw@nih.gov or secondary contact Valerie Whipple at valerie.whipple@nih.gov.
    Reagent Generation for Bioanalytical Method Development on Biologics
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified sources for a potential contract focused on reagent generation for bioanalytical method development related to biologics. The primary objective is to obtain information on the availability and capability of companies to generate and deliver reagents, including anti-drug antibodies, that support the quantification of novel biologic drugs in various biological matrices. This initiative is crucial for advancing drug development processes and improving success rates in preclinical stages, with the Therapeutic Development Branch (TDB) at NIH playing a pivotal role in moving therapeutic candidates through the drug development pipeline. Interested parties must submit their capability statements by November 8, 2024, to Nick Niefeld at nick.niefeld@nih.gov, referencing sources sought notice number 75N95025R00007.
    Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative – Subject Matter Expert in Medical Device Investment Development
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through the National Institute on Drug Abuse (NIDA), intends to award a sole-source contract for consulting services related to medical device development under the Blueprint MedTech Initiative. The objective is to procure a subject matter expert with extensive experience in neurotechnology and mental health product development, who will provide strategic guidance and oversight for projects aimed at accelerating the translation of innovative medical devices for neurological disorders. This initiative, established in 2019 with a funding allocation of $32 million, seeks to facilitate the development of groundbreaking technologies and ensure their progression to clinical studies by 2027. Interested parties may submit their qualifications by November 8, 2024, to the designated contacts, Tracy Cain and Llakim Dubroff, at the NIH.
    A--NIH NeuroBioBank Brain and Tissue Repository
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is soliciting proposals for the establishment of the NIH NeuroBioBank Brain and Tissue Repository under Request for Proposal (RFP) No. 75N95024R00124. The objective of this procurement is to create and manage contract collection sites for acquiring, storing, and distributing human brain and central nervous system tissues for research, aimed at advancing the understanding and treatment of nervous system disorders. This initiative is critical for enhancing biomedical research by improving access to well-characterized specimens, thereby supporting scientific investigations into neurological conditions. Proposals are due by November 14, 2024, with the anticipated contract performance period starting on May 1, 2025, and extending through optional years. Interested parties can direct inquiries to Robin D. Knightly at robin.knightly@nih.gov or call +1 301 827 5302 for further information.
    Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative – Subject Matter Expert in Medical Device Research and Development
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), intends to award a sole source contract to Luminescent Consulting LLC for consulting services related to medical device development under the Blueprint MedTech Initiative. The objective of this procurement is to secure a subject matter expert with at least 20 years of experience in medical device development, including a minimum of 10 years in a Program Director role, to provide strategic guidance and feedback on projects aimed at advancing translational neurological medical device technologies. This initiative, which has allocated $32 million from 2019 to 2027, seeks to facilitate the transition of innovative medical technologies from early development to clinical trials, with a goal of conducting at least ten first-in-human studies. Interested parties may submit capability statements by November 8, 2024, to Tracy Cain at tracy.cain@nih.gov or Llakim Dubroff at llakim.dubroff@nih.gov, although the government is not obligated to enter into a competitive procurement process.
    NIA Small Business R&D Programs Outreach and Communications
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through the National Institute on Aging (NIA), is seeking qualified small businesses to assist in creating a strategic marketing and communications campaign for its Small Business R&D Programs, including the SBIR and STTR funding initiatives. The objective is to enhance the accessibility and understanding of these programs among diverse potential applicants and stakeholders while providing resources for current awardees, which includes developing innovative communication strategies, conducting market research, and implementing targeted outreach efforts. This initiative is crucial for fostering entrepreneurial development in health research and addressing challenges related to aging and aging-related diseases. Interested companies must submit their capability statements by November 14, 2024, at 3:00 PM Eastern Time, to Eric McKay and Karen Mahon via email, ensuring they include relevant qualifications and experience.
    PREPARATION AND DISTRIBUTION OF RESEARCH DRUG PRODUCTS
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA), is seeking proposals for the "Preparation and Distribution of Research Drug Products" under solicitation number 75N95024R00003. The primary objective of this procurement is to acquire, analyze, create, and distribute a variety of drug compounds essential for drug abuse and addiction research, including controlled and uncontrolled substances, while ensuring compliance with DEA regulations. This contract, structured as an indefinite delivery, indefinite quantity (IDIQ) agreement for a five-year period, aims to enhance research capabilities in the field of drug abuse, with proposals due by November 15, 2024, at 1:00 PM (Eastern Time). Interested parties should contact Scott Duernberger at scott.duernberger@nih.gov or Josh Lazarus at josh.lazarus@nih.gov for further information.