82 FR 53512 - Prospective Grant of Exclusive Patent Commercialization License: Direct Reading Detection Kits for Surface Contamination by Antineoplastic Drugs
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 220 (November 16, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 220 (November 16, 2017)
| Page Range | 53512-53513 | |
| FR Document | 2017-24774 |
[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)] [Notices] [Pages 53512-53513] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24774] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 [email protected]. 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
![53512 Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices
433: Support of NIGMS Program Project Contact Person: Alessandra C Rovescalli, Dated: November 9, 2017.
Grants. Ph.D., Scientific Review Officer, National Natasha M. Copeland,
Date: November 29, 2017. Institutes of Health, Center for Scientific Program Analyst, Office of Federal Advisory
Time: 1:00 p.m. to 5:00 p.m. Review, 6701 Rockledge Drive, Rm. 5205, Committee Policy.
Agenda: To review and evaluate grant MSC 7846, Bethesda, MD 20892, (301) 435–
applications. 1021, rovescaa@mail.nih.gov. [FR Doc. 2017–24761 Filed 11–15–17; 8:45 am]
Place: National Institutes of Health, 6701 (Catalogue of Federal Domestic Assistance BILLING CODE 4140–01–P
Rockledge Drive, Bethesda, MD 20892 Program Nos. 93.306, Comparative Medicine;
(Virtual Meeting). 93.333, Clinical Research, 93.306, 93.333,
Contact Person: Eduardo A. Montalvo, 93.337, 93.393–93.396, 93.837–93.844, DEPARTMENT OF HEALTH AND
Ph.D., Scientific Review Officer, Center for 93.846–93.878, 93.892, 93.893, National HUMAN SERVICES
Scientific Review, National Institutes of Institutes of Health, HHS)
Health, 6701 Rockledge Drive, Room 5108, National Institutes of Health
MSC 7852, Bethesda, MD 20892, (301) 435– Dated: November 9, 2017.
1168, montalve@csr.nih.gov. Melanie J. Pantoja, Prospective Grant of Exclusive Patent
Name of Committee: Center for Scientific Program Analyst, Office of Federal Advisory Commercialization License: Direct
Review Special Emphasis Panel; Member Committee Policy. Reading Detection Kits for Surface
Conflict: AIDS and Related Research. [FR Doc. 2017–24759 Filed 11–15–17; 8:45 am] Contamination by Antineoplastic
Date: December 1, 2017. Drugs
BILLING CODE 4140–01–P
Time: 3:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant AGENCY: Centers for Disease Control and
applications. Prevention, National Institutes of
Place: National Institutes of Health, 6701 DEPARTMENT OF HEALTH AND
HUMAN SERVICES Health.
Rockledge Drive, Bethesda, MD 20892
ACTION: Notice.
(Telephone Conference Call).
Contact Person: Robert Freund, Ph.D., National Institutes of Health
SUMMARY: The National Institute of
Scientific Review Officer, Center for
National Institute of Allergy and Allergy and Infectious Diseases, an
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216, Infectious Diseases; Notice of Closed institute of the National Institutes of
MSC 7852, Bethesda, MD 20892, 301–435– Meeting Health, Department of Health and
1050, freundr@csr.nih.gov. Human Services, on behalf of the
Name of Committee: Center for Scientific Pursuant to section 10(d) of the Centers for Disease Control and
Review Special Emphasis Panel; PAR Panel: Federal Advisory Committee Act, as Prevention, Department of Health and
AIDS and AIDS-Related Research. amended, notice is hereby given of a Human Services, is contemplating the
Date: December 7, 2017. meeting of the Division of Intramural grant of an exclusive patent
Time: 1:00 p.m. to 6:00 p.m. Research Board of Scientific Counselors, commercialization license to Becton,
Agenda: To review and evaluate grant NIAID. The meeting will be closed to Dickinson and Company, located in
applications. the public as indicated below in Franklin Lakes, New Jersey, to practice
Place: National Institutes of Health, 6701
accordance with the provisions set forth the inventions embodied in the patent
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting). in section 552b(c)(6), Title 5 U.S.C., as applications listed in the
Contact Person: Robert Freund, Ph.D., amended for the review, discussion, and Supplementary Information section of
Scientific Review Officer, Center for evaluation of individual intramural this notice.
Scientific Review, National Institutes of programs and projects conducted by the DATES: Only written comments and/or
Health, 6701 Rockledge Drive, Room 5216, National Institute of Allergy and applications for a license which are
MSC 7852, Bethesda, MD 20892, 301–435– Infectious Diseases, including received by the Technology Transfer
1050, freundr@csr.nih.gov. consideration of personnel and Intellectual Property Office,
Name of Committee: Center for Scientific qualifications and performance, and the National Institute of Allergy and
Review Special Emphasis Panel; Member competence of individual investigators, Infectious Diseases on or before
Conflict: Developmental Abnormalities of the the disclosure of which would
Nervous System.
December 1, 2017 will be considered.
constitute a clearly unwarranted ADDRESSES: Requests for copies of the
Date: December 8, 2017.
Time: 2:00 p.m. to 6:00 p.m. invasion of personal privacy. patent applications, inquiries, and
Agenda: To review and evaluate grant Name of Committee: Division of Intramural comments relating to the contemplated
applications. Research Board of Scientific Counselors, exclusive patent commercialization
Place: National Institutes of Health, 6701 NIAID. license should be directed to: Karen
Rockledge Drive, Bethesda, MD 20892 Date: December 11–13, 2017. Surabian, Licensing and Patenting
(Telephone Conference Call). Time: 8:00 a.m. to 5:00 p.m. Manager, Technology Transfer and
Contact Person: Suzan Nadi, Ph.D., Agenda: To review and evaluate personal
Scientific Review Officer, Center for qualifications and performance, and
Intellectual Property Office, National
Scientific Review, National Institutes of competence of individual investigators. Institute of Allergy and Infectious
Health, 6701 Rockledge Drive, Room 5217B, Place: National Institutes of Health, Diseases, 5601 Fishers Lane, Suite 2G,
MSC 7846, Bethesda, MD 20892, 301–435– Building 50, 1227/1233, 50 Center Drive, MSC9804, Rockville, MD 20852–9804,
1259, nadis@csr.nih.gov. Bethesda, MD 20892. phone number 301–594–9719, or
Name of Committee: Center for Scientific Contact Person: Steven M. Holland, MD, karen.surabian@nih.gov.
Review Special Emphasis Panel; PAR17–031: Ph.D., Chief, Laboratory of Clinical Infectious
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUPPLEMENTARY INFORMATION: The
Role of Age-Associated Metabolic Changes in Diseases, National Institutes of Health/ following represents the intellectual
Alzheimer’s Disease. NIAID, Hatfield Clinical Research Center,
Bethesda, MD 20892–1684, 301–402–7684,
property to be licensed under the
Date: December 13, 2017.
sholland@mail.nih.gov. prospective agreement: HHS Reference
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance
No. E–162–2013/0–US–01, United
applications. Program Nos. 93.855, Allergy, Immunology, States Provisional Patent Application
Place: National Institutes of Health, 6701 and Transplantation Research; 93.856, Serial Number 61/672,059, filed 07/16/
Rockledge Drive, Bethesda, MD 20892 Microbiology and Infectious Diseases 2012; HHS Reference No. E–162–2013/
(Telephone Conference Call). Research, National Institutes of Health, HHS) 0–PCT–02, PCT Patent Application
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![Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 53513
Serial Number PCT/US2013/050688, evidence and argument that establishes (Catalogue of Federal Domestic Assistance
filed 07/16/2013; HHS Reference No. E– that the grant of the license would not Program Nos. 93.867, Vision Research,
162–2013/0–US–03, United States be consistent with the requirements of National Institutes of Health, HHS)
Patent Application Serial Number 13/ 35 U.S.C. 209 and 37 CFR part 404. Dated: November 9, 2017.
943,430, filed 07/16/2013; HHS Complete applications for a license in Natasha M. Copeland,
Reference No. E–162–2013/0–EP–04, the prospective field of use that are Program Analyst, Office of Federal Advisory
European Patent Application Serial timely filed in response to this notice Committee Policy.
Number 13819718.1, filed 02/05/2015; will be treated as objections to the grant [FR Doc. 2017–24760 Filed 11–15–17; 8:45 am]
and HHS Reference No. E–162–2013/0– of the contemplated exclusive patent BILLING CODE 4140–01–P
JP–05, Japanese Patent Application commercialization license. Comments
Serial Number 2015–523183, filed 01/ and objections submitted in response to
08/2015. All rights in these inventions this notice will not be made available
have been assigned to the Government for public inspection and, to the extent DEPARTMENT OF HOMELAND
of the United States of America. permitted by law, will not be released SECURITY
The prospective exclusive patent under the Freedom of Information Act,
commercialization license territory may 5 U.S.C. 552. Federal Emergency Management
be worldwide and the field of use may Agency
Dated: November 9, 2017.
be limited to: ‘‘Use of the licensed
patent rights for the development, Suzanne Frisbie,
Deputy Director, Technology Transfer and [Internal Agency Docket No. FEMA–4344–
manufacture, and sale of a lateral flow DR; Docket ID FEMA–2017–0001]
device for detection of antineoplastic Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
drugs from surfaces’’. California; Amendment No. 5 to Notice
Many types of cancers are treated [FR Doc. 2017–24774 Filed 11–15–17; 8:45 am]
of a Major Disaster Declaration
with antineoplastic drugs, also known BILLING CODE 4140–01–P
as anti-cancer drugs or chemotherapy. AGENCY: Federal Emergency
Exposure of healthcare workers to these Management Agency, DHS.
hazardous drugs from contaminated DEPARTMENT OF HEALTH AND
HUMAN SERVICES ACTION: Notice.
surfaces may cause acute and long-term
effects. Approximately eight (8) million SUMMARY: This notice amends the notice
National Institutes of Health
United States healthcare workers are of a major disaster declaration for the
potentially exposed to these hazardous National Eye Institute; Notice of Closed State of California (FEMA–4344–DR),
drugs. Although there are potential Meeting dated October 10, 2017, and related
therapeutic benefits of hazardous drugs determinations.
that outweigh the risks of side effects for Pursuant to section 10(d) of the
ill patients, healthcare workers are Federal Advisory Committee Act, as DATES: This amendment was issued
exposed to the risk with the same side amended, notice is hereby given of a November 7, 2017.
effects with no therapeutic benefit. meeting of the Board of Scientific FOR FURTHER INFORMATION CONTACT:
Occupational exposures to hazardous Counselors, National Eye Institute. Dean Webster, Office of Response and
drugs can lead to skin rashes and major The meeting will be closed to the Recovery, Federal Emergency
reproductive effects, which include public as indicated below in accordance Management Agency, 500 C Street SW.,
increased fetal loss, congenital with the provisions set forth in section Washington, DC 20472, (202) 646–2833.
malformations, low birth weight, 552b(c)(6), Title 5 U.S.C., as amended
SUPPLEMENTARY INFORMATION: Notice is
congenital abnormalities, and infertility. for the review, discussion, and
The risk of cancer is also increased after evaluation of individual grant hereby given that the incident period for
exposure to these drugs. applications conducted by the this disaster is closed effective October
This invention, developed within the NATIONAL EYE INSTITUTE, including 31, 2017.
National Institute for Occupational consideration of personnel The following Catalog of Federal Domestic
Safety and Health at the Centers for qualifications and performance, and the Assistance Numbers (CFDA) are to be used
Disease Control and Prevention, competence of individual investigators, for reporting and drawing funds: 97.030,
describes a lateral flow assay-based the disclosure of which would Community Disaster Loans; 97.031, Cora
antineoplastic drug detection method Brown Fund; 97.032, Crisis Counseling;
constitute a clearly unwarranted 97.033, Disaster Legal Services; 97.034,
that utilizes antibodies specific for invasion of personal privacy. Disaster Unemployment Assistance (DUA);
individual drugs. It uses detectors for Name of Committee: Board of Scientific 97.046, Fire Management Assistance Grant;
the assessment of drug residues on Counselors, National Eye Institute. 97.048, Disaster Housing Assistance to
surfaces, which can be incorporated into Date: December 3–5, 2017. Individuals and Households In Presidentially
small, portable drug detection devices Time: 6:00 p.m. to 5:00 p.m. Declared Disaster Areas; 97.049,
that allow healthcare workers to sample Agenda: To review and evaluate grant Presidentially Declared Disaster Assistance—
surfaces in near real time, avoiding the applications. Disaster Housing Operations for Individuals
need to take samples back to the Place: National Institutes of Health, and Households; 97.050 Presidentially
laboratory to be tested. Building 31, Conference Room 6C6, 31 Declared Disaster Assistance to Individuals
Center Drive, Bethesda, MD 20892. and Households—Other Needs; 97.036,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
This notice is made in accordance
Contact Person: Sheldon S. Miller, Ph.D., Disaster Grants—Public Assistance
with 35 U.S.C. 209 and 37 CFR part 404. (Presidentially Declared Disasters); 97.039,
Scientific Director, National Institutes of
The prospective exclusive patent Health, National Eye Institute, Bethesda, MD Hazard Mitigation Grant.
commercialization license will be 20892, (301) 451–6763.
royalty bearing and may be granted Brock Long,
Information is also available on the
unless within fifteen (15) days from the Institute’s/Center’s home page: Administrator, Federal Emergency
date of this published notice, the www.nei.nih.gov, where an agenda and any Management Agency.
National Institute of Allergy and additional information for the meeting will [FR Doc. 2017–24910 Filed 11–15–17; 8:45 am]
Infectious Diseases receives written be posted when available. BILLING CODE 9111–23–P
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Document Created: 2017-11-16 03:53:04
Document Modified: 2017-11-16 03:53:04
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | 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. | |
| FR Citation | 82 FR 53512 |
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