[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Notices]
[Pages 53512-53513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24774]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent Commercialization License: 
Direct Reading Detection Kits for Surface Contamination by 
Antineoplastic Drugs

AGENCY: Centers for Disease Control and Prevention, National Institutes 
of Health.

ACTION: Notice.

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SUMMARY: The National Institute of Allergy and Infectious Diseases, an 
institute of the National Institutes of Health, Department of Health 
and Human Services, on behalf of the Centers for Disease Control and 
Prevention, Department of Health and Human Services, is contemplating 
the grant of an exclusive patent commercialization license to Becton, 
Dickinson and Company, located in Franklin Lakes, New Jersey, to 
practice the inventions embodied in the patent applications listed in 
the Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases on or 
before December 1, 2017 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent 
commercialization license should be directed to: Karen Surabian, 
Licensing and Patenting Manager, Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Suite 2G, MSC9804, Rockville, MD 20852-9804, phone 
number 301-594-9719, or <a href="/cdn-cgi/l/email-protection#177c766572793964626576757e767957797e7f39707861"><span class="__cf_email__" data-cfemail="1b707a697e7535686e697a79727a755b757273357c746d">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: HHS Reference 
No. E-162-2013/0-US-01, United States Provisional Patent Application 
Serial Number 61/672,059, filed 07/16/2012; HHS Reference No. E-162-
2013/0-PCT-02, PCT Patent Application

[[Page 53513]]

Serial Number PCT/US2013/050688, filed 07/16/2013; HHS Reference No. E-
162-2013/0-US-03, United States Patent Application Serial Number 13/
943,430, filed 07/16/2013; HHS Reference No. E-162-2013/0-EP-04, 
European Patent Application Serial Number 13819718.1, filed 02/05/2015; 
and HHS Reference No. E-162-2013/0-JP-05, Japanese Patent Application 
Serial Number 2015-523183, filed 01/08/2015. All rights in these 
inventions have been assigned to the Government of the United States of 
America.
    The prospective exclusive patent commercialization license 
territory may be worldwide and the field of use may be limited to: 
``Use of the licensed patent rights for the development, manufacture, 
and sale of a lateral flow device for detection of antineoplastic drugs 
from surfaces''.
    Many types of cancers are treated with antineoplastic drugs, also 
known as anti-cancer drugs or chemotherapy. Exposure of healthcare 
workers to these hazardous drugs from contaminated surfaces may cause 
acute and long-term effects. Approximately eight (8) million United 
States healthcare workers are potentially exposed to these hazardous 
drugs. Although there are potential therapeutic benefits of hazardous 
drugs that outweigh the risks of side effects for ill patients, 
healthcare workers are exposed to the risk with the same side effects 
with no therapeutic benefit. Occupational exposures to hazardous drugs 
can lead to skin rashes and major reproductive effects, which include 
increased fetal loss, congenital malformations, low birth weight, 
congenital abnormalities, and infertility. The risk of cancer is also 
increased after exposure to these drugs.
    This invention, developed within the National Institute for 
Occupational Safety and Health at the Centers for Disease Control and 
Prevention, describes a lateral flow assay-based antineoplastic drug 
detection method that utilizes antibodies specific for individual 
drugs. It uses detectors for the assessment of drug residues on 
surfaces, which can be incorporated into small, portable drug detection 
devices that allow healthcare workers to sample surfaces in near real 
time, avoiding the need to take samples back to the laboratory to be 
tested.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent commercialization license 
will be royalty bearing and may be granted unless within fifteen (15) 
days from the date of this published notice, the National Institute of 
Allergy and Infectious Diseases receives written evidence and argument 
that establishes that the grant of the license would not be consistent 
with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 
commercialization license. Comments and objections submitted in 
response to this notice will not be made available for public 
inspection and, to the extent permitted by law, will not be released 
under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: November 9, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-24774 Filed 11-15-17; 8:45 am]
 BILLING CODE 4140-01-P


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