81 FR 78792 - Notice of Availability for Licensing-NIST's Patented Microfluidic Apparatus and Method To Control Liposome Formation
DEPARTMENT OF COMMERCE
National Institute of Standards and Technology Federal Register Volume 81, Issue 217 (November 9, 2016)
National Institute of Standards and Technology
Federal Register Volume 81, Issue 217 (November 9, 2016)
| Page Range | 78792-78793 | |
| FR Document | 2016-26995 |
[Federal Register Volume 81, Number 217 (Wednesday, November 9, 2016)] [Notices] [Pages 78792-78793] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26995] ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE National Institute of Standards and Technology Notice of Availability for Licensing--NIST's Patented Microfluidic Apparatus and Method To Control Liposome Formation AGENCY: National Institute of Standards and Technology. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, owns two patents related to controlled liposome formation using microfluidic channels: U.S. Patent [[Page 78793]] 9,198,645, titled ``Controlled Vesicle Self-Assembly in Continuous Two Phase Flow Microfluidic Channels'' (NIST Docket 04-003); and U.S. Patent 8,715,591, title ``Microfluidic Apparatus to Control Liposome Formation'' (NIST Docket 09-017). Further details about these patents are provided in the SUPPLEMENTARY INFORMATION section, below. ADDRESSES: For further information about these patented inventions or other licensing and partnership opportunities, please contact Honeyeh Zube, CRADA and License Officer, National Institute of Standards and Technology's Technology Partnerships Office, by mail to 100 Bureau Drive, Mail Stop 2200, Gaithersburg, Maryland 20899, by electronic mail to [email protected], or by telephone at (301) 975-2209. SUPPLEMENTARY INFORMATION: NIST's Patent 9,198,645, titled ``Controlled Vesicle Self-Assembly in Continuous Two Phase Flow Microfluidic Channels'' (NIST Docket 04-003) claims novel methods for the formation of liposomes that encapsulate reagents in a continuous two-phase flow microfluidic network with precision control of size, for example, from 100 nm to 300 nm, by manipulation of liquid flow rates are described. By creating a solvent-aqueous interfacial region in a microfluidic format that is homogenous and controllable on the length scale of a liposome, fine control of liposome size and polydispersity can be achieved. NIST's Patent 8,715,591, title ``Microfluidic Apparatus to Control Liposome Formation,'' (NIST Docket 09-017) is available for license and claims the apparatus and method of using a microfluidic device that controls the amount of delivery compound incorporated in a liposome on a nanometer size scale using laminar flow and miscible fluids, thereby increasing loading efficiency. The patent was filed on Apr. 19, 2010 and was issued on May 6, 2014. The invention was first published in Jahn, et al., Microfluidic Directed Formation of Liposomes of Controlled Size, American Chemical Society Langmuir, 23 (11) pp 6289- 6293. 2007. The liposomes formed by the self-assembly process are characterized using asymmetric flow field-flow fractionation combined with quasi- elastic light scattering and multiangle laser-light scattering. The vesicle size and size distribution are tunable over a mean diameter from 50 to 150 nm by adjusting the ratio of the alcohol-to-aqueous volumetric flow rate. Liposome formation depends more strongly on the focused alcohol stream width and its diffusive mixing with the aqueous stream than on the sheer forces at the solvent-buffer interface. The inventions have application in drug delivery, gene therapy, and potential application for on-demand liposome-mediated delivery of point-of-care therapeutics. The inventions can obviate the need for post-processing in drug manufacturing. NIST is authorized to license its rights in these inventions to organizations on a non-exclusive or exclusive basis for specified fields of use. The rights to these patents are available for exclusive or non-exclusive licensing by the authority granted to the NIST under 35 U.S.C. 209 and 37 CFR 404. NIST researchers are interested in potential collaborations with licensees to bring this invention to practical application and to promote innovation, enhance economic security and improve quality of life. Kevin Kimball, Chief of Staff. [FR Doc. 2016-26995 Filed 11-8-16; 8:45 am] BILLING CODE 3510-13-P
![78792 Federal Register / Vol. 81, No. 217 / Wednesday, November 9, 2016 / Notices
requirements will be effective upon e. The Vietnam-Wide Entity Co., Ltd.
publication of the final results for f. Separate Rate for Eligible, Non-Examined 30. Mp Consol Co., Ltd.
shipments of the subject merchandise Respondents 31. New Wind Seafood Co., Ltd.
V. Recommendation 32. Ngoc Chau Co., Ltd. and/or Ngoc Chau
from Vietnam entered, or withdrawn Seafood Processing Company
from warehouse, for consumption on or Appendix II 33. Ngoc Sinh, aka
after the publication date, as provided Ngoc Sinh Fisheries, aka
Companies Subject To Review Determined
by sections 751(a)(2)(C) of the Act: (1) To Be Part of the Vietnam-Wide Entity Ngoc Sinh Private Enterprises, aka
For the companies listed above, which Ngoc Sinh Seafoods, aka
1. Amanda Foods (Vietnam) Ltd. Ngoc Tri Ngoc Sinh Seafood Processing Company,
have a separate rate, the cash deposit Seafood Company (Amanda’s affiliate)
rate will be that established in the final aka
2. Amanda Seafood Co., Ltd. Ngoc Sinh Seafood Trading & Processing
results of this review (except, if the rate 3. An Giang Coffee JSC Enterprise
is zero or de minimis, then zero cash 4. Anvifish Joint Stock Co. 34. Nhat Duc Co., Ltd. (‘‘Nhat Duc’’), aka
deposit will be required); (2) for 5. Asia Food Stuffs Import Export Co., Ltd. Nhat Duc Co., Ltd., aka
previously investigated or reviewed 6. Binh Thuan Import—Export Joint Stock Nhat Duc Co. Ltd.
Vietnam and non-Vietnam exporters not Company (THAIMEX) 35. Phu Cuong Jostoco Seafood Corporation,
listed above that received a separate rate 7. Binh An Seafood Joint Stock Company aka
8. B.O.P. Limited Co. Phu Cuong Jostoco Corp.
in a prior segment of this proceeding, 9. C.P. Vietnam Corporation, aka
the cash deposit rate will continue to be 36. Quoc Ai Seafood Processing Import
C.P. Vietnam Corporation (‘‘C.P. Export Co., Ltd.
the existing exporter-specific rate; (3) for Vietnam’’), aka 37. S.R.V. Freight Services Co., Ltd.
all Vietnam exporters of subject C.P. Vietnam Livestock Company Limited, 38. Saigon Food Joint Stock Company
merchandise that have not been found aka 39. Sustainable Seafood
to be entitled to a separate rate, the cash C.P. Vietnam Livestock Corporation 40. Tan Thanh Loi Frozen Food Co., Ltd.
deposit rate will be the existing rate for 10. Can Tho Agricultural and Animal 41. Tan Phong Phu Seafood Co., Ltd., aka
the Vietnam-Wide entity of 25.76 Product Import Export Company Tan Phong Phu Seafood Company Ltd.
(‘‘CATACO’’), aka (‘‘TPP Co., Ltd.’’), aka
percent; and (4) for all non-Vietnam Can Tho Agricultural and Animal Products
exporters of subject merchandise which Tan Phong Phu Seafood Co. Ltd. (‘‘TPP Co.,
Import Export Company (‘‘CATACO’’), Ltd.’’)
have not received their own rate, the aka 42. Thanh Doan Seaproducts Import & Export
cash deposit rate will be the rate Can Tho Agricultural and Animal Products Processing Joint-Stock Company
applicable to the Vietnam exporter that Imex Company, aka (THADIMEXCO)
supplied that non-Vietnam exporter. Can Tho Agricultural Products 43. Thanh Hung Frozen Seafood Processing
These deposit requirements, when 11. Can Tho Import Export Seafood Joint Import Export Co., Ltd.
imposed, shall remain in effect until Stock Company (CASEAMEX) 44. Thanh Tri Seafood Processing Co. Ltd.
12. Cautre Export Goods Processing Joint 45. Thinh Hung Co., Ltd.
further notice.
Stock Company 46. Trang Khan Seafood Co., Ltd.
Notification to Importers 13. Coastal Fisheries Development 47. Tien Tien Garment Joint Stock Company
Corporation (‘‘COFIDEC’’) 48. Tithi Co., Ltd.
This notice also serves as a 14. Danang Seaproducts Import-Export 49. Viet Cuong Seafood Processing Import
preliminary reminder to importers of Corporation (‘‘Seaprodex Danang’’) (and Export Joint-Stock Company
their responsibility under 19 CFR its affiliates), aka 50. Vietnam Northern Viking Technologies
351.402(f)(2) to file a certificate Danang Seaproducts Import Export Co. Ltd.
regarding the reimbursement of Corporation (and its affiliate, Tho Quang 51. Vinatex Danang
antidumping duties prior to liquidation Seafood Processing and Export 52. Vinh Loi Import Export Company
of the relevant entries during this Company) (collectively, ‘‘Seaprodex (‘‘VIMEX’’), aka
Danang’’)), aka Vinh Loi Import Export Company
review period. Failure to comply with Danang Seaproducts Import Export
this requirement could result in the (‘‘Vimexco’’)
Corporation (‘‘Seaprodex Danang’’), aka 53. Xi Nghiep Che Bien Thuy Sue San Xuat
Department’s presumption that Seaprodex Danang, aka Kau Cantho
reimbursement of antidumping duties Tho Quang Co, aka
[FR Doc. 2016–27071 Filed 11–8–16; 8:45 am]
occurred and the subsequent assessment Tho Quang Seafood Processing and Export
of double antidumping duties. Company, aka BILLING CODE 3510–DS–P
This determination is issued and Frozen Seafoods Factory No. 32 (Tho
published in accordance with sections Quang Seafood Processing and Export
751(a)(1) and 777(i)(1) of the Act and 19 Company) DEPARTMENT OF COMMERCE
15. Duy Dai Corporation
CFR 351.221(b)(4). 16. D & N Foods Processing (Danang National Institute of Standards and
Dated: October 31, 2016. Company Ltd.) Technology
Paul Piquado, 17. Gallant Ocean (Quang Ngai) Co., Ltd.
18. Gn Foods Notice of Availability for Licensing—
Assistant Secretary for Enforcement and
19. Hai Thanh Food Company Ltd. NIST’s Patented Microfluidic
Compliance.
20. Hai Vuong Co., Ltd. Apparatus and Method To Control
Appendix I 21. Han An Trading Service Co., Ltd.
22. Hoang Hai Company Ltd.
Liposome Formation
List of Topics Discussed in the Preliminary 23. Hua Heong Food Industries Vietnam Co.
Decision Memorandum
AGENCY: National Institute of Standards
Ltd. and Technology.
I. Summary 24. Huynh Huong Seafood Processing
sradovich on DSK3GMQ082PROD with NOTICES
(Huynh Houng Trading and Import ACTION: Notice.
II. Background
III. Scope of the Order Export Joint Stock Company) SUMMARY: The National Institute of
IV. Discussion of the Methodology 25. Kien Long Seafoods Co. Ltd.
a. Respondent Selection 26. Khanh Loi Seafood Factory Standards and Technology (NIST), an
b. Preliminary Determination of No 27. Long Toan Frozen Aquatic Products Joint agency of the United States Department
Shipments Stock Company of Commerce, owns two patents related
c. Non-Market Economy Country 28. Luan Vo Fishery Co., Ltd. to controlled liposome formation using
d. Separate Rates 29. Minh Chau Imp. Exp. Seafood Processing microfluidic channels: U.S. Patent
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![Federal Register / Vol. 81, No. 217 / Wednesday, November 9, 2016 / Notices 78793
9,198,645, titled ‘‘Controlled Vesicle focused alcohol stream width and its contained a collection-of-information
Self-Assembly in Continuous Two diffusive mixing with the aqueous requirement subject to the Paperwork
Phase Flow Microfluidic Channels’’ stream than on the sheer forces at the Reduction act (PRA). Specifically, 50
(NIST Docket 04–003); and U.S. Patent solvent-buffer interface. The inventions CFR 224.105(c) requires a logbook entry
8,715,591, title ‘‘Microfluidic Apparatus have application in drug delivery, gene to document that a deviation from the
to Control Liposome Formation’’ (NIST therapy, and potential application for 10-knot speed limit was necessary for
Docket 09–017). Further details about on-demand liposome-mediated delivery safe maneuverability under certain
these patents are provided in the of point-of-care therapeutics. The conditions.
SUPPLEMENTARY INFORMATION section, inventions can obviate the need for In certain sea and weather conditions,
below. post-processing in drug manufacturing. a large ship may lose maneuverability at
ADDRESSES: For further information NIST is authorized to license its rights slow speeds. Therefore, under such
about these patented inventions or other in these inventions to organizations on conditions a ship, at the captain’s
licensing and partnership opportunities, a non-exclusive or exclusive basis for discretion, may opt not to abide by the
please contact Honeyeh Zube, CRADA specified fields of use. The rights to speed restrictions. If she/he chooses this
and License Officer, National Institute these patents are available for exclusive option, she/he is required to make an
of Standards and Technology’s or non-exclusive licensing by the entry into the ship’s log, providing such
Technology Partnerships Office, by mail authority granted to the NIST under 35 information as: the reasons for the
to 100 Bureau Drive, Mail Stop 2200, U.S.C. 209 and 37 CFR 404. NIST deviation, the speed at which the vessel
Gaithersburg, Maryland 20899, by researchers are interested in potential is operated, the area, and the time and
electronic mail to honeyeh.zube@ collaborations with licensees to bring duration of such deviation.
nist.gov, or by telephone at (301) 975– this invention to practical application Affected Public: Business or other for-
2209. and to promote innovation, enhance profit organizations.
economic security and improve quality Frequency: On occasion.
SUPPLEMENTARY INFORMATION: NIST’s Respondent’s Obligation: Mandatory.
Patent 9,198,645, titled ‘‘Controlled of life.
This information collection request
Vesicle Self-Assembly in Continuous Kevin Kimball, may be viewed at reginfo.gov. Follow
Two Phase Flow Microfluidic Chief of Staff. the instructions to view Department of
Channels’’ (NIST Docket 04–003) claims [FR Doc. 2016–26995 Filed 11–8–16; 8:45 am] Commerce collections currently under
novel methods for the formation of BILLING CODE 3510–13–P review by OMB.
liposomes that encapsulate reagents in a Written comments and
continuous two-phase flow microfluidic recommendations for the proposed
network with precision control of size, DEPARTMENT OF COMMERCE information collection should be sent
for example, from 100 nm to 300 nm, by within 30 days of publication of this
manipulation of liquid flow rates are National Oceanic and Atmospheric notice to OIRA_Submission@
described. By creating a solvent-aqueous Administration omb.eop.gov or fax to (202) 395–5806.
interfacial region in a microfluidic
Submission for OMB Review; Dated: November 3, 2016.
format that is homogenous and
Comment Request Sarah Brabson,
controllable on the length scale of a
liposome, fine control of liposome size NOAA PRA Clearance Officer.
The Department of Commerce will [FR Doc. 2016–27012 Filed 11–8–16; 8:45 am]
and polydispersity can be achieved.
NIST’s Patent 8,715,591, title submit to the Office of Management and BILLING CODE 3510–22–P
‘‘Microfluidic Apparatus to Control Budget (OMB) for clearance the
Liposome Formation,’’ (NIST Docket following proposal for collection of
09–017) is available for license and information under the provisions of the DEPARTMENT OF DEFENSE
claims the apparatus and method of Paperwork Reduction Act (44 U.S.C.
using a microfluidic device that controls Chapter 35). Office of the Secretary
Agency: National Oceanic and
the amount of delivery compound [Docket ID: DOD–2016–OS–0062]
Atmospheric Administration (NOAA).
incorporated in a liposome on a Title: Implementation of Vessel Speed
nanometer size scale using laminar flow Restrictions to Reduce the Threat of Submission for OMB Review;
and miscible fluids, thereby increasing Ship Collisions with North Atlantic Comment Request
loading efficiency. The patent was filed Right Whales.
on Apr. 19, 2010 and was issued on May ACTION: Notice.
OMB Control Number: 0648–0580.
6, 2014. The invention was first Form Number(s): None. SUMMARY: The Department of Defense
published in Jahn, et al., Microfluidic Type of Request: Regular (extension of has submitted to OMB for clearance, the
Directed Formation of Liposomes of a currently approved information following proposal for collection of
Controlled Size, American Chemical collection). information under the provisions of the
Society Langmuir, 23 (11) pp 6289– Number of Respondents: 3,047. Paperwork Reduction Act.
6293. 2007. Average Hours per Response: 5
The liposomes formed by the self- DATES: Consideration will be given to all
minutes.
assembly process are characterized Burden Hours: 254. comments received by December 9,
using asymmetric flow field-flow Needs and Uses: This request is for an 2016.
fractionation combined with quasi- extension of a current information FOR FURTHER INFORMATION CONTACT: Fred
sradovich on DSK3GMQ082PROD with NOTICES
elastic light scattering and multiangle collection. On October 10, 2008, NMFS Licari, 571–372–0493.
laser-light scattering. The vesicle size published a final rule promulgated SUPPLEMENTARY INFORMATION:
and size distribution are tunable over a under the Endangered Species Act Title, Associated Form and OMB
mean diameter from 50 to 150 nm by implementing speed restrictions to Number: Synchronized Predeployment
adjusting the ratio of the alcohol-to- reduce the incidence and severity of and Operational Tracker Enterprise
aqueous volumetric flow rate. Liposome ship collisions with North Atlantic right Suite (SPOT–ES); OMB Control Number
formation depends more strongly on the whales (73 FR 60173). That final rule 0704–0460.
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Document Created: 2016-11-09 01:39:26
Document Modified: 2016-11-09 01:39:26
| 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. | |
| FR Citation | 81 FR 78792 |
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