Presolicitation Notice_RFP 75A50121R00017_RADNUC.pdf

Notice Type: Presolicitation

Solicitation Number: 75A50121R00017

Project Title: BARDA Radiological and Nuclear (RADNUC) Animal Model and Medical

Countermeasures (MCM) Development

Classification Code: A – Research & Development

NAICS Code: 541714 - Research and Development in Biotechnology (except Nanotechnology)

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. 75A50121R00017, titled “BARDA RADNUC Animal Model and MCM Development” via beta.SAM.gov on or about February 18, 2021.

REQUIREMENT AND TYPE OF SERVICE

The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), seeks appropriate Good Laboratory Practices (GLP) facilities that are adequate and available to establish new or use existing animal models for the development of radiological and nuclear MCMs. In these models, the radiation exposure should be comparable 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. These models will be used to test the efficacy of potential RadNuc MCMs. The mechanism of action of the countermeasure will also need to establish the utility of the animal model as a surrogate for humans.

Laboratories must meet the following mandatory eligibility criteria to be considered:

Evidence of federal, state, and/or local licensure operation and control of a clinical level irradiation facility with qualified personnel for the operation, assigned safety restrictions, domestic and instrument calibration per licensed Health Physics authority;

Evidence of federal, state, and/or local licensure required for the storage, use, and disposal of select agents such as chemical agents and radionuclides and training of all associated staff responsible for the use of such material;

Evidence of accreditation or licensure of the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation or equivalent;

Evidence of U.S. Department of Agriculture (USDA) animal research facility, license, or equivalent;

Completion of at least one good laboratory practice (GLP) study; and

Evidence of capability to conduct studies in two animal models, with at least one being a large animal model. Subcontracting is an available option to expand capabilities.

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 RadNuc threats, particularly since efficacy of products directed against most of these threats cannot be verified using clinical studies. In 2002 and 2015, 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 18, 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 fixed-price and cost reimbursement type task orders. The purpose of this acquisition is to maintain a network of nonclinical laboratories to support radiological and nuclear MCM development. These nonclinical laboratories will be capable of conducting studies involving controlled exposures to radiological and nuclear agents in various animal species. This effort will support nonclinical model development and evaluating the efficacy of potential radiological and nuclear MCMs.

This is a follow-on requirement. BARDA awarded multiple Nonclinical Model Development Chemical indefinite delivery, indefinite quantity (IDIQ) contracts in September 2015 to support 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:

Lovelace Respiratory Research Institute (HHSO100201500002I) SNBL, USA. Ltd. (HHSO100201500006I) University of Illinois Chicago (HHSO100201500008I)

University of Maryland Baltimore (HHSO100201500009I) SRI International (HHSO100201500007I)

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 fourth 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 radiological and nuclear 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 exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemics, and emerging infectious disease threats.

Response and recovery were identified as key elements of national defense in the National Strategy for Countering Weapons of Mass Destruction Terrorism (https://www.acq.osd.mil/ncbdp/docs/20181210_National-Strategy-for-Countering-WMD- Terrorism.pdf). The lead role of HHS in these endeavors was emphasized most recently by the Presidential Memorandum on the Support for National Biodefense (National Security Presidential Memorandum 14 (NSPM 14) (https://fas.org/irp/threat/cbw/biodef-strat.pdf). These documents represent the foundation for addressing the nation’s CBRN MCM 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 threats specified by the Department of Homeland Security as material threats. The HHS PHEMCE Strategy for Chemical, Biological, Radiological, and Nuclear Threats (HHS PHEMCE Strategy), published in the Federal Register on March 20, 2007 describes the strategic policy goals and objectives for identifying requirements and establishes the priorities for the development of the MCMs.

The HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological, and Nuclear Threats (HHS PHEMCE Implementation Plan), published in the Federal Register on April 2007 with subsequent updates between December 2012 and 2018, delineates HHS MCM priorities for research, development and acquisition to address the highest priority CBRN threats.

The definition of animal models is a key element in the development of MCMs for CBRN threats, particularly since efficacy of products against most of these threats cannot be verified using human clinical studies. In 2002 and 2015, the FDA amended its regulations for drugs and biologics to permit approval or licensure of medical countermeasures 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, and 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 animal models of paramount regulatory importance, since the inference of efficacy in humans is based on efficacy data derived in animals. The primary demonstration of safety of the MCM (drug or biologic) is conducted in human clinical studies, although non-clinical data will also be used to evaluate safety.

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:

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

Secondary Point of Contract:

Danielle Hinton Contract Specialist danielle.hinton@hhs.gov Phone: 202-868-0904 mailto:jeffrey.brown@hhs.gov mailto:danielle.hinton@hhs.gov