82 FR 60408 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 243 (December 20, 2017)

Page Range		60408-60409
FR Document		2017-27417

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Federal Register, Volume 82 Issue 243 (Wednesday, December 20, 2017)

[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60408-60409]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27417]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Dr. Natalie Greco, 301-761-7898; 
[email protected]. Licensing information and copies of the patent 
applications listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Enhanced Tissue Clearing Solution, Clearing-Enhanced 3D (Ce3D), 
Compatible With Advanced Fluorescence Microscopy Imaging

    Description of Technology: NIH immunologists have created a 
solution, Clearing-enhanced 3D (Ce3D), that can be used to make entire 
organs extremely transparent. This allows the tissue to be imaged using 
advanced fluorescence microscopy techniques. Unlike current tissue 
clearing solutions, the Ce3D tissue clearing solution is robustly 
compatible with a variety of staining methods, and preserves tissue 
morphology and reporter fluorescence. Ce3D enabled microscopy provides 
unprecedented insight into the spatial organization of cells within 
intact organs. Further, when Ce3D enabled microscopy is coupled with 
multiplexed staining and a newly developed analysis pipeline, 
investigators are able to extensively characterize densely packed cells 
in situ, providing advantages to phenotyping cells with flow cytometric 
techniques.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.
    Potential Commercial Applications:
     Research reagent--can be applied to a variety of 
biological disciplines.
     Diagnostic medical imaging reagent--characterization of 
disease state/condition.
    Competitive Advantages:
     Simple, quick and inexpensive procedure that has been 
extensively validated.
     Generates excellent tissue transparency, resulting in high 
quality images.
     Compatible with highly multiplexed staining/labeling 
techniques, including antibody-based methods, fluorescently tagged 
reporter proteins, and RNA-FISH.
     Fluorescence is maintained in diverse fluorescent proteins 
and fluorophores.
     Enables quantitative analysis of tissue composition and 
cellular distribution in whole organs, and has advantages over flow 
cytometric techniques.
    Development Stage:

[[Page 60409]]

     Prototype.
    Inventors: Ronald N. Germain, Michael Y. Gerner, Weizhe Li (All 
from NIAID).
    Publications: Li W, et al. (2017)--Multiplex, quantitative cellular 
analysis in large tissue volumes with clearing-enhanced 3D microscopy 
(Ce3D) [PMID: 28808033--PMCID: PMC5584454].
    Intellectual Property: PCT Patent Application--PCT/US2017/049133, 
HHS Reference No. E-168-2016.
    Licensing Contact: Dr. Natalie Greco, 301-761-7898; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize tissue-clearing technologies. For 
collaboration opportunities, please contact Dr. Natalie Greco, 301-761-
7898; [email protected].

    Dated: December 13, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-27417 Filed 12-19-17; 8:45 am]
 BILLING CODE 4140-01-P

60408 Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Notices

collection techniques or other forms of doctoral, doctoral candidates, graduate potential as future scientists; to
information technology. and baccalaureate students, through full determine where mutual research
Proposed Collection Title: Fellowship time fellowships, summer fellowships, interests exist; and to make decisions
Program and Summer Student and internships in preparation for regarding which applicants will be
Applications 0925–0716, Exp., date 5/ research careers in cancer epidemiology proposed and approved for traineeship
31/2018, Extension, National Cancer and genetics. The proposed information awards. In each case, completing the
Institute (NCI), National Institutes of collection involves brief online application is voluntary, but in order to
Health (NIH). applications completed by applicants to receive due consideration, the
Need and Use of Information prospective trainee is encouraged to
Collection: This is a request for approval the full time and the summer fellowship
programs. Full-time fellowships complete all relevant fields. The
of an ‘‘Extension’’ for three years. The
include: Full-time Equivalents (FTE) information is for internal use to make
National Cancer Institute, Division of
and non-FTE fellowships for US decisions about prospective fellows and
Cancer Epidemiology and Genetics
(DCEG) Office of Education administers citizens, permanent residents and students that could benefit from the
a variety of programs and initiatives to international fellows. These DCEG program.
recruit pre-college through post-doctoral applications are essential to the OMB approval is requested for 3
educational level individuals into the administration of these training years. There are no costs to respondents
Intramural Research Program to programs as they enable OE to other than their time. The total
facilitate their development into future determine the eligibility and quality of estimated annualized burden hours are
biomedical scientists. DCEG trains post- potential awardees; to assess their 218 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average Total
Number of
Number of time per annual
Type of respondent responses per
respondents response burden
respondent (in hours) hour

Full-time Fellows .............................................................................................. 150 1 30/60 75
Summer Students ............................................................................................ 430 1 20/60 143

Total .......................................................................................................... 580 580 ........................ 218

Dated: December 4, 2017. indicated licensing contact at the cells in situ, providing advantages to
Karla Bailey, Technology Transfer and Intellectual phenotyping cells with flow cytometric
Project Clearance Liaison, National Cancer Property Office, National Institute of techniques.
Institute, National Institutes of Health. Allergy and Infectious Diseases, 5601 This technology is available for
[FR Doc. 2017–27415 Filed 12–19–17; 8:45 am] Fishers Lane, Rockville, MD 20852; tel. licensing for commercial development
BILLING CODE 4140–01–P 301–496–2644. A signed Confidential in accordance with 35 U.S.C. 209 and 37
Disclosure Agreement will be required CFR part 404, as well as for further
to receive copies of unpublished patent development and evaluation under a
DEPARTMENT OF HEALTH AND applications. research collaboration.
HUMAN SERVICES SUPPLEMENTARY INFORMATION: Potential Commercial Applications:
Technology description follows. • Research reagent—can be applied to
National Institutes of Health a variety of biological disciplines.
Enhanced Tissue Clearing Solution, • Diagnostic medical imaging
Government-Owned Inventions; Clearing-Enhanced 3D (Ce3D), reagent—characterization of disease
Availability for Licensing Compatible With Advanced state/condition.
Fluorescence Microscopy Imaging Competitive Advantages:
AGENCY: National Institutes of Health,
HHS. Description of Technology: NIH • Simple, quick and inexpensive
ACTION: Notice. immunologists have created a solution, procedure that has been extensively
Clearing-enhanced 3D (Ce3D), that can validated.
SUMMARY: The invention listed below is be used to make entire organs extremely • Generates excellent tissue
owned by an agency of the U.S. transparent. This allows the tissue to be transparency, resulting in high quality
Government and is available for imaged using advanced fluorescence images.
licensing to achieve expeditious microscopy techniques. Unlike current • Compatible with highly
commercialization of results of tissue clearing solutions, the Ce3D multiplexed staining/labeling
federally-funded research and tissue clearing solution is robustly techniques, including antibody-based
development. Foreign patent compatible with a variety of staining methods, fluorescently tagged reporter
applications are filed on selected methods, and preserves tissue proteins, and RNA–FISH.
inventions to extend market coverage morphology and reporter fluorescence. • Fluorescence is maintained in
for companies and may also be available Ce3D enabled microscopy provides
sradovich on DSK3GMQ082PROD with NOTICES

diverse fluorescent proteins and
for licensing. unprecedented insight into the spatial fluorophores.
FOR FURTHER INFORMATION CONTACT: Dr. organization of cells within intact • Enables quantitative analysis of
Natalie Greco, 301–761–7898; organs. Further, when Ce3D enabled tissue composition and cellular
Natalie.Greco@nih.gov. Licensing microscopy is coupled with multiplexed distribution in whole organs, and has
information and copies of the patent staining and a newly developed analysis advantages over flow cytometric
applications listed below may be pipeline, investigators are able to techniques.
obtained by communicating with the extensively characterize densely packed Development Stage:

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Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Notices 60409

• Prototype. DEPARTMENT OF HOMELAND upon Secretary’s determination that the
Inventors: Ronald N. Germain, SECURITY measures are maintained. The Secretary
Michael Y. Gerner, Weizhe Li (All from delegated the authority to carry out the
Coast Guard provisions of these sections to the Coast
NIAID).
[Docket No. USCG–2017–0466] Guard. Section 552(a)(1)(E) requires an
Publications: Li W, et al. (2017)— agency to provide a Federal Register
Multiplex, quantitative cellular analysis Removal of Conditions of Entry for notice to the public in regards to any
in large tissue volumes with clearing- Certain Vessels Arriving to the United amendment, revision or repeal of a rule
enhanced 3D microscopy (Ce3D) [PMID: States From Two Port Facilities in Côte adopted as authorized by law. The
28808033—PMCID: PMC5584454]. d’Ivoire Regulatory Docket for this Notice
Intellectual Property: PCT Patent (USCG–2017–0466) contains previous
AGENCY: Coast Guard, DHS. notices imposing or removing
Application—PCT/US2017/049133,
ACTION: Notice. conditions of entry on vessels arriving
HHS Reference No. E–168–2016.
SUMMARY: The Coast Guard announces from certain countries.
Licensing Contact: Dr. Natalie Greco,
that it is modifying the conditions of On May 27, 2011, the Coast Guard
301–761–7898; Natalie.Greco@nih.gov. determined that ports in the Republic of
entry for vessels arriving to the United
Collaborative Research Opportunity: States from Côte d’Ivoire by adding an Côte d’Ivoire did not maintain effective
The National Institute of Allergy and exception to the conditions of entry for anti-terrorism measures and that Côte
Infectious Diseases is seeking statements two facilities in the Republic of Côte d’Ivoire’s designated authority’s
of capability or interest from parties d’Ivoire. oversight, access control and cargo
interested in collaborative research to control remained deficient (76 FR
DATES: The policy takes effect January 3,
further develop, evaluate or 30954). However, since 2014 the Coast
2018.
commercialize tissue-clearing Guard has assessed and found that the
FOR FURTHER INFORMATION CONTACT: For port facilities listed in Table 1 do have
technologies. For collaboration information about this document call or
opportunities, please contact Dr. Natalie effective anti-terrorism measures. As
email Juliet Hudson, International Port such, port facilities listed in Table 1 are
Greco, 301–761–7898; Natalie.Greco@ Security Evaluation Division, United
nih.gov. exempted from the conditions of entry
States Coast Guard, telephone 202–372– previously imposed.
Dated: December 13, 2017. 1173.
Suzanne Frisbie, SUPPLEMENTARY INFORMATION: TABLE 1—EXEMPTED PORT FACILITIES
Deputy Director, Technology Transfer and Discussion
Intellectual Property Office, National Institute Port IMO port No.
of Allergy and Infectious Diseases.
The authority for this notice is 5
U.S.C. 552(a), 46 U.S.C. 70110, and Carena Shipyard .................. CIABJ–0004
[FR Doc. 2017–27417 Filed 12–19–17; 8:45 am]
Department of Homeland Security Terminal A Containers, CIABJ–0015
BILLING CODE 4140–01–P Delegation No. 0170.1(II)(97.f). Section Abidjan.
70110(a) provides that the Secretary of
Homeland Security may impose Accordingly, beginning January 3,
conditions of entry into the United 2018, the conditions of entry shown in
States from ports that are not Table 2 below will apply to any vessel
maintaining effective anti-terrorism that visited a non-exempted Côte
measures. Section 70110(d) provides d’Ivoire port facility in its last five port
that these conditions may be removed calls.

TABLE 2—CONDITIONS OF ENTRY FOR VESSELS VISITING CÔTE D’IVOIRE’S PORTS NOT LISTED IN TABLE 1
No. Each vessel must:

1 ........................................... Implement measures per the vessel’s security plan equivalent to Security Level 2 while in a port in the Republic
of Côte d’Ivoire. As defined in the ISPS Code and incorporated herein, ‘‘Security Level 2’’ refers to the ‘‘level
for which appropriate additional protective security measures shall be maintained for a period of time as a re-
sult of heightened risk of a security incident.’’
2 ........................................... Ensure that each access point to the vessel is guarded and that the guards have total visibility of the exterior
(both landside and waterside) of the vessel while the vessel is in ports in the Republic of Côte d’Ivoire.
3 ........................................... Guards may be provided by the vessel’s crew; however, additional crewmembers should be placed on the vessel
if necessary to ensure that limits on maximum hours of work are not exceeded and/or minimum hours of rest
are met, or provided by outside security forces approved by the vessel’s master and Company Security Officer.
As defined in the ISPS Code and incorporated herein, ‘‘Company Security Officer’’ refers to the ‘‘person des-
ignated by the Company for ensuring that a ship security assessment is carried out; that a ship security plan is
developed, submitted for approval, and thereafter implemented and maintained and for liaison with port facility
security officers and the ship security officer.’’
4 ........................................... Attempt to execute a Declaration of Security while in a port in the Republic of Côte d’Ivoire.
5 ........................................... Log all security actions in the vessel’s log; and
sradovich on DSK3GMQ082PROD with NOTICES

6 ........................................... Report actions taken to the cognizant Coast Guard Captain of the Port (COTP) prior to arrival into U.S. waters.
7 ........................................... In addition, based on the findings of the Coast Guard boarding or examination, the vessel may be required to en-
sure that each access point to the vessel is guarded by armed, private security guards and that they have total
visibility of the exterior (both landside and waterside) of the vessel while in U.S. ports. The number and position
of the guards has to be acceptable to the cognizant COTP prior to the vessel’s arrival.

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Document Created: 2018-10-25 10:57:08
Document Modified: 2018-10-25 10:57:08

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.
Contact		Dr. Natalie Greco, 301-761-7898; [email protected] Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.
FR Citation		82 FR 60408

82 FR 60408 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 243 (December 20, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health