Presolicitation_Notice_of_RFP_CHEM IDIQ.pdf

Notice Type: Presolicitation

Solicitation Number: 75A50121R00012

Project Title: BARDA Chemical Animal Model Development

Classification Code: A – Research & Development

NAICS Code: 541715 – Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Synopsis:

SUMMARY

This is a notice of a proposed contract action issued in accordance with FAR 5.203(a). The Government intends to issue RFP No. 75A50121R00012, titled “BARDA CHEM Animal Development” via beta.SAM on or about February 14, 2021.

REQUIREMENT AND TYPE OF SERVICE

The Biomedical Advanced Research and Development Authority (BARDA) within the Oice of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), seeks laboratories capable of controlled exposures of various animal species to chemical agents, and capable of establishing models to evaluate the efficacy of potential MCMs. Task Orders derived from this IDIQ contract will be assigned to one of two groups:

Group A covers pulmonary agents, cyanide, opioids, toxic industrial chemicals (TICs), and other potential chemical agents of concern by inhalation, ingestion, and topical routes. Performers in this group must have performed at least one GLP study in the past three (3) years.

Group B covers nerve agents and vesicants (including sulfur mustard) by inhalation, ingestion, and topical routes. Performers in this group must be capable of working with chemical threat agents (i.e.

OPCW Schedule 1 compounds).

Please note that laboratories must be capable of performing tasks from at least one of the above groups (i.e., meeting the capabilities/requirements to belong to one group would suffice) Laboratories may belong to of either group so long as they meet the requirements for that group. In these models, the challenge dose should typically be similar to that which produces the human disease or condition and the pathophysiological mechanism of its toxicity should be reasonably well-understood and mimic the human disease/condition as closely as possible. When these models are used to test the efficacy of potential MCMs for chemical threat agents, the mechanism of action of the countermeasure in the animals will need to match the expected mechanism of action in human victims.

The Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 established the Biomedical Advanced Research and Development Authority (BARDA) to support development and acquisition of medical countermeasures (MCMs) to prevent or treat the medical consequences of chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza (PI), and emerging infectious diseases

(EID). These MCMs include vaccines, therapeutics, diagnostics, and medical devices. Additionally, BARDA is entrusted to foster innovation of technologies that enable better manufacturing, testing, and utilization of these medical countermeasures.

The development of animal models is a key element in the successful development of MCMs for chemical, threats, particularly since efficacy of products directed against most of these threats cannot be verified using clinical studies. In 2002, the FDA amended its regulations for drugs and biologics to permit approval or licensure of MCMs based on substantial evidence of effectiveness in animals when adequate and well-controlled efficacy studies in humans cannot be conducted because it would be unethical to expose healthy human volunteers to lethal or disabling toxic CBRN substances. This change in the regulations (21 CFR 314.600 for drugs and 21 CFR 601.90 for biologics), commonly referred to as the “Animal Rule,” made the design and conduct of adequate efficacy studies in appropriate animal models of paramount regulatory importance, since the inference of efficacy in humans necessary for drug approval or licensure is based solely on efficacy data derived in animals. Demonstration of the safety of the medical countermeasure (drug or biologic) is done in normal, healthy adult humans and in some cases safety in a related pathology particularly if the drug or biologic is already approved for the related pathology.

RELEASE OF SOLICITATION

The Government intends to issue a Request for Proposals on or about February 14, 2021. Proposals will be due 45 calendar days following release of the RFP.

The Government anticipates making multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract awards —with the eventual contracts being administered and funded via Task Orders (TOs).

The purpose of this acquisition is to maintain a network of nonclinical laboratories to support chemical MCM development. These nonclinical laboratories will be capable of conducting studies involving controlled exposures to chemical agents in various animal species. This effort will support nonclinical model development and evaluating the efficacy of potential chemical MCMs to (1) pulmonary agents, cyanide, toxic industrial chemicals (TICs), and other potential chemical agents of concern by inhalation ingestion and topical routes; and/or (2) nerve agents and vesicants, including sulfur mustard by inhalation, ingestion and topical routes.

This is a follow-on requirement. BARDA awarded multiple Nonclinical Model Development Chemical indefinite delivery, indefinite quantity (IDIQ) contracts in September 2015 to support chemical MCM development under RFP-15-100-SOL-00004, posted April 6, 2015. Those contracts included an ordering period of September 30, 2015 – September 29, 2020 and were awarded to:

Battelle Memorial Institute (HHSO100201500004I) Lovelace Biomedical and Environmental Research Institute (HHSO100201500001I) MRI Global (HHSO100201500003I) Netherlands Organisation for Applied Scientific Research - TNO (HHSO100201500005I)

The Government will select proposals that are most advantageous to the Government in accordance with the basis of award included in the solicitation.

The Government anticipates awards will be made in the third quarter of FY2021.

ABOUT BARDA

The Biomedical Advanced Research and Development Authority (BARDA) has a need to maintain a network of nonclinical laboratories to support chemical medical countermeasures (MCM) development.

The United States Department of Health and Human Services (HHS) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures for the adverse health effects resulting from intentional exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemics, and emerging infectious disease threats.

Strengthening America's national defense against weapons of mass destruction through provision of medical countermeasures (MCMs) are identified as a key line of effort to achieving strategic objectives in the December 2018 National Strategy for Countering Weapons of Mass Destruction Terrorism (https://www.whitehouse.gov/wp-content/uploads/2018/12/20181210_National-Strategy-for- Countering-WMD-Terrorism.pdf). The lead role of HHS with day-to-day coordination and execution in these endeavors is further emphasized in 2018 National Biodefense Strategy (https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Biodefense-Strategy.pdf). These documents represent the foundation for addressing the nation’s CBRN medical countermeasure needs.

Through the inter-agency Public Health Emergency and Medical Countermeasure Enterprise (PHEMCE), HHS is responsible for the integration of requirements for the advanced development and procurement of MCMs for CBRN, pandemic influenza, and emerging infectious disease threats, and the 2017-2018 HHS PHEMCE Strategy and Implementation Plan describes the strategic policy goals and objectives for identifying requirements and establishes the priorities for the development of the MCMs against such threats (https://www.phe.gov/Preparedness/mcm/phemce/Documents/2017-phemce-sip.pdf).

Development of nonclinical models plays a critical role in successful development of MCMs for chemical threats. The efficacy of MCMs against most chemical threats could never be verified using traditional clinical studies. In 2002, the United States Food and Drug Administration (FDA) amended its regulations for drugs and biologics to permit approval or licensure of MCMs based on evidence from nonclinical studies to provide substantial efficacy data of these MCMs when: (1) adequate and well-controlled efficacy studies in humans cannot be conducted because it would be unethical to expose healthy human volunteers to lethal or disabling toxic CBRN substances; and (2) relevant field efficacy trials in humans are not feasible. This change in the regulations (21 CFR 314.600 for drugs and 21 CFR 601.90 for biologics), commonly referred to as the “Animal Rule,” made the design and conduct of adequate efficacy studies in appropriate nonclinical models of paramount regulatory importance because the inference of efficacy in humans is based on efficacy data derived in animals. Demonstration of the safety of the MCMs (drug or biologic) is done in normal, healthy adult humans and in some cases safety in a related pathology particularly if the drug or biologic is already approved for the related pathology.

CONTRACTING OFFICE ADDRESS

Office of the Assistant Secretary for Preparedness & Response (ASPR) Department of Health and Human Services O’Neill Federal Building 200 C Street, SW Washington, DC 20201

United States

Primary Point of Contact:

de Ionne Jones Contract Specialist deionne.jones@hhs.gov Phone: 202-969-3872

Secondary Point of Contract:

Jeffrey Brown Contracting Officer jeffrey.brown@hhs.gov Phone: 202-730-8662 mailto:deionne.jones@hhs.gov mailto:jeffrey.brown@hhs.gov