PRESOLICITATION NOTICE: INTENT TO AWARD A SOLE-SOURCE CONTRACT
MODIFICATION
INTENDED SOURCE: LELAND STANFORD JUNIOR UNIVERSITY
ANTICIPATED PERIOD of PERFORMANCE: Date of Modification Award to 05/31/2021
DESCRIPTION OF REQUIREMENT:
This synopsis is hereby issued in accordance with FAR Part 5.203 and FAR 6.302 in response to
the mandatory requirement for a 15-day notification. The purpose of this synopsis is to announce
the Food and Drug Administration's intent to negotiate a sole source contract modification to
LELAND STANFORD JUNIOR UNIVERSITY. This modification is to modify existing FDA
Ebola research contract number HHSF223201610018C with Stanford University) to include a
near-term analysis of 2019 Novel Coronavirus (2019-n CoV).
On January 31, 2020, the Secretary of Health and Human Services (HHS) issued a Public Health
Emergency Declaration pursuant to section 319 of the Public Health Service (PHS) Act “as a
result of confirmed cases of 2019 Novel Coronavirus (2019-nCoV)”. Following a section 319
declaration, the Secretary is authorized to take appropriate actions in response to the emergency
including providing grants, entering into contracts; and conducting and supporting investigations
into the cause, treatment, or prevention of the disease or disorder. An urgent requirement now
exists for additional research in order to aid in the development of effective medical
countermeasures (MCMs) to combat this emerging threat.
Pursuant to the requirements of FAR 6.302-2 The Government intends to solicit and negotiate
directly with LELAND STANFORD JUNIOR UNIVERSITY to modify the above referenced
contract. The current contract is a study focused on Sequelae and Immunopathology of Ebola
Virus Infections. This modification is necessary to respond to the ongoing 2019-nCoV virus
(nCoV) outbreak and leverages the technology and methodology for examining Ebola sequelae
and Zika immunopathology to extend analysis and gather critical information about the nature of
nCoV virus infection. This work aims to characterize the effects of nCoV virus infection using
samples from non-human primate (NHP) animal models and human tissues (pending
availability) to empower future regulatory decision making. Stanford shall apply a set of
technologies for high parameter antibody-based profiling of blood and tissues (CyTOF, CODEX)
along with viral nucleic acid detection in situ (viralMIBI).
Stanford University has a demonstrated and unique expertise in performing research with similar
viruses; under their existing contract they have developed multiple cutting-edge technologies and
analytical methods (including CODEX, viralMIBI, and CyTOFF) that were not only effective in
the study of Ebola but were leveraged in 2017 for urgent Zika research. Furthermore, Stanford is
the only known source that can undertake OCET’s required research in a timely, safe and
effective manner, given that these tools are only available via the Nolan laboratory therein. This
Contractor is the only performer with sufficient facilities, tools, and protocols to safely
experiment on samples from COVID-19-positive individuals and non-human primates, and
characterize immune correlates with these tools. Based on prior publication history, including

 previous actions under this contract, Stanford has the capability to document and deliver all
research objectives within a compressed timeline. Due to this unusual and compelling urgency, it
is not possible to evaluate alternate sources or award through full and open competition as this
would create an unacceptable delay and seriously jeopardize the agency’s ability to identify
timely and effective MCMs under the current public health emergency.
This notice of intent is not a request for competitive proposals or quotations; however, if any
interested party believes they can meet the above requirement, it may submit a statement of
capabilities. The statement of capabilities shall be submitted in writing and shall contain material
in sufficient detail to allow the government to determine if the party can perform the
requirement. A determination by the Government not to compete this proposed requirement
based on responses to this notice is solely within the discretion of the Government. All interested
parties shall express their interest and capabilities in writing via email to
Robert.Maydwell@fda.hhs.gov within fifteen (15) days after the date of publication of this
notice. No faxed documents will be accepted. If no responsive statements are received within
fifteen (15) days, an award will subsequently be made to LELAND STANFORD JUNIOR
UNIVERSITY.
This is a Federal contract opportunity; FDA-NOI-1225983 for services at Food and Drug
Administration Office of Acquisitions and Grants Services - Beltsville, MD.
Response Due NLT 10:00 AM March 19, 2020
Due
03/19/2020
Solicitation Number
FDA-NOI-1225983
Set-Aside
No Set-Aside Used
Contact(s)
Robert Maydwell
Agency
Department of Health and Human Services
Office
Food and Drug Administration
Location
Office of Acquisitions and Grants Services - Beltsville