[Federal Register Volume 83, Number 157 (Tuesday, August 14, 2018)]
[Notices]
[Page 40303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17381]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


The Biomedical Advanced Research and Development Authority 
(BARDA)

AGENCY: Assistant Secretary for Preparedness and Response, HHS.

ACTION: Notice.

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SUMMARY: The Biomedical Advanced Research and Development Authority 
(BARDA), Office of the Assistant Secretary for Preparedness and 
Response (ASPR), in the Department of Health and Human Services intends 
to provide a Single Source Cooperative Agreement to Janssen Research & 
Development, LLC. The Cooperative Agreement will support QuickFire 
Challenges to spur innovation in respiratory protection. The total 
proposed cost of the Single Source Cooperative Agreement is not to 
exceed $100,000 for a total of 12 months.

DATES: 
    Project Period: The period of performance is from July 30, 2018 to 
June 30, 2019.
    Award amount: Estimate $100,000.

FOR FURTHER INFORMATION CONTACT: <a href="/cdn-cgi/l/email-protection#f0a39895828295848495deb6859e9eb0989883de979f86"><span class="__cf_email__" data-cfemail="1c4f74796e6e79686879325a6972725c74746f327b736a">[email protected]</span></a>, 202-795-7714, 
<a href="/cdn-cgi/l/email-protection#5218273e3b377c01313a33343720123a3a217c353d24"><span class="__cf_email__" data-cfemail="84cef1e8ede1aad7e7ece5e2e1f6c4ececf7aae3ebf2">[email protected]</span></a>, 202-205-1435.

SUPPLEMENTARY INFORMATION: The Biomedical Advanced Research and 
Development Authority (BARDA) is the program office for this 
Cooperative Agreement:
    Single Source Justification: Janssen Research & Development, LLC 
creates global challenges to spur innovation in health care in 
partnership with JLABS, a global network of open innovation ecosystems 
designed to support innovators and entrepreneurs in creating and 
accelerating innovative health care solutions.
    Janssen Research & Development, LLC and BARDA will collaborate on a 
global challenge for reimagined, transformative respiratory protection. 
Traditional respiratory protective devices used to protect against 
inhalation of harmful infectious agents were designed for use in 
occupational settings, to guard against inhalation of dangerous 
particulates. Disposable versions, such as N95 respirators, are only 
available for adults, must be fit-tested to ensure proper functioning, 
and can be uncomfortable to wear. In an outbreak of a novel or newly 
emerging respiratory disease, respiratory protection may be the only 
countermeasure available to protect health care workers and the general 
public.
    Janssen Research & Development, LLC will partner with JLABS, which 
exists to foster innovation in health care products and executes 
QuickFire Challenges for health care innovation. There is no direct 
equivalent of the QuickFire Challenge services for innovation specific 
to health care as is provided by JLABS. Its unique service will 
directly benefit BARDA's mission to make available medical 
countermeasures to address health security threats. Supporting 
innovation is an authority provided to BARDA under the Public Health 
Service Act and partnering with a company providing a diverse array of 
products and leveraging its expertise and infrastructure has the 
potential to provide solutions to the challenges in developing new 
respiratory devices.
    Reimagined, innovative respiratory protection would contribute 
directly to ASPR's mission to save lives and protect Americans against 
21st Century health security threats. Respiratory protection is often 
the first line of defense, and a radically improved approach to protect 
both health care workers and the general public, including children, 
would truly improve our ability to respond to public health 
emergencies. By generating interest and focusing innovation efforts on 
reimagining respiratory protection, BARDA's goal for the QuickFire 
Challenge is for the resulting innovative approaches to be eligible for 
continued testing and development and eventual regulatory approval, so 
that these revolutionary products can be widely available and used.
    Please submit an inquiry via the ASPR-BARDA Program Contact: Dr. 
Julie Schafer, <a href="/cdn-cgi/l/email-protection#450f30292c206b16262d24232037052d2d366b222a33"><span class="__cf_email__" data-cfemail="f3b9869f9a96dda0909b92959681b39b9b80dd949c85">[email protected]</span></a>, 202-205-1435.

Robert P. Kadlec,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2018-17381 Filed 8-13-18; 8:45 am]
 BILLING CODE 4150-28-P


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