[Federal Register Volume 85, Number 176 (Thursday, September 10, 2020)]
[Notices]
[Page 55853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19998]



[[Page 55853]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Information (RFI): Testing for Coronavirus Disease 
2019 (COVID-19)--Surge Capacity

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services (HHS).

ACTION: Request for information.

-----------------------------------------------------------------------

SUMMARY: The Office of the Assistant Secretary for Health (OASH) in the 
Department of Health and Human Services (HHS) seeks to obtain 
information regarding the ability of Clinical Laboratory Improvement 
Amendments (CLIA)-certified/accredited commercial, academic, medical 
center, and public health laboratories to feasibly provide additional 
COVID-19 testing capability if supplementary testing instruments were 
made available. A set of questions is available in the Supplementary 
Information section below.

DATES: To be considered, comments must be received electronically at 
the email address provided below, no later than 5:00 p.m. Eastern Time 
(ET) on September 21, 2020.

ADDRESSES: Individuals are encouraged to submit responses 
electronically to LCDR Natalie Gibson, 200 Independence Avenue SW, 
Washington, DC 20201, (240) 743-1757, [email protected].
    Please indicate ``RFI RESPONSE'' in the subject line of your email. 
Submissions received after the deadline will not be reviewed. Responses 
to this notice are not offers and cannot be accepted by the federal 
government to form a binding contract or issue a grant. Respond 
concisely and in plain language. You may use any structure or layout 
that presents your information well. You may respond to some or all of 
our questions, and you can suggest other factors or relevant questions. 
You may also include links to online material or interactive 
presentations. Clearly mark any proprietary information, and place it 
in its own section or file. Your response will become government 
property, and we may publish some of its non-proprietary content.

SUPPLEMENTARY INFORMATION: HHS is working together with state, local, 
tribal and territorial governments, public health officials, health 
care providers, researchers, private sector organizations, and the 
public to execute a whole-of-America response to the COVID-19 pandemic 
to protect the health and safety of the American people. Timely and 
accurate diagnostic testing is paramount to the response. Diagnostic 
testing must be maximized across all platforms and venues to enable 
early detection, containment of potential outbreaks, and protect all 
Americans--especially the vulnerable and otherwise high-risk 
populations.
    In order to expand diagnostic testing capacity and fully leverage 
the national testing ecosystem, the purpose of this request for 
information (RFI) is to obtain information regarding the ability of 
CLIA-certified or accredited commercial, academic, medical center and 
public health laboratories to feasibly provide additional testing 
capability if supplementary testing instruments and reagents from 
Thermo Fisher Scientific were made available. Because HHS is seeking to 
significantly expand testing capability, responses that propose 
substantial increases in capability, and provide adequate justification 
(e.g., can demonstrate the necessary personnel, infrastructure and 
other ancillary support needs to accommodate such expansions) are 
preferred.
    We encourage eligible performers to answer the follow questions:
     Do you represent a CLIA-certified or accredited 
laboratory?
     What is your current laboratory testing capacity (e.g., 
installed base of platforms, throughput, level of personnel, etc.)?
     What is your current ability to accession specimens and 
report out laboratory results in no less than 24-48 hours?
     What level of additional capacity could your laboratory 
provide if additional testing instruments were made available?
    [cir] Please provide a proposed request for instruments and any 
other requirements.
    Please provide a timeline for implementation of increased capacity, 
assuming the laboratory receives the requested instruments.
    This information will inform the ongoing response to the COVID-19 
pandemic.

    Dated: September 3, 2020.
Tammy R. Beckham,
Director, COVID-19 Laboratory Testing and Diagnostics Working Group.

[FR Doc. 2020-19998 Filed 9-9-20; 8:45 am]
BILLING CODE 4150-28-P