81 FR 76372 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 212 (November 2, 2016)

Page Range		76372-76373
FR Document		2016-26390

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization 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 81 Issue 212 (Wednesday, November 2, 2016)

[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76372-76373]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26390]


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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 inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious 
commercialization 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: Licensing information and copies of 
the U.S. patent applications listed below may be obtained by writing to 
the indicated licensing contact at the National Heart, Lung and Blood 
Institute, Office of Technology Transfer and Development, National 
Institutes of Health, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 
20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

Methods for Artificial Oocyte Activation

Description of Technology

    Available for licensing and commercial development for both human 
and veterinary uses is a method of activating mammalian oocytes. These 
methods include contacting a mammalian oocyte of interest arrested at 
metaphase II with an effective amount of a Regulator of G-Protein 
Signaling (RGS)2 inhibitor; and contacting the mammalian oocyte of 
interest with an effective amount of a G protein coupled receptor 
activator. In general, RGS proteins stimulate the hydrolysis of GTP 
bound to activated G[alpha] subunits, leading to signal termination. 
RGS2, which inhibits both G-[alpha]q and G-[alpha]s signaling 
suppresses Ca2+ release in mature mammalian eggs. Regulators of G-
Protein Signaling (RGS)2 inhibitor and a G protein coupled receptor 
activator can be used to artificially activate a mammalian oocyte such 
that it re-enters the cell cycle. Examples of RGS2 inhibitors can be 
nucleic acids like siRNAs or dsRNAs. G-protein coupled receptor 
activators can be acetylcholine, a neurotransmitter such as serotonin, 
hormones, natural or synthetic G

[[Page 76373]]

protein coupled receptor ligands or modulator, and acidic pH. The 
oocyte can be fertilized in vitro to form an embryo, which can be 
implanted in a subject and developed to term or can be used for the 
preparation of stem cells.

Potential Commercial Applications

 in vitro fertilization

Development Stage

 Early Stage

    Inventors: Miranda L. Bernhardt, Carmen J. Williams, Andres Gambini 
(all of NIEHS), and Lisa M. Mehlmann (University of Connecticut).
    Intellectual Property: HHS Reference No. E-253-2016/0.
     U.S. Provisional Patent Application No. 62/405,803 filed 7 
October 2016.
    Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; 
[email protected].

    Dated: October 24, 2016.
Michael Shmilovich,
National Heart, Lung and Blood Institute, Office of Technology Transfer 
and Development, National Institutes of Health.
[FR Doc. 2016-26390 Filed 11-1-16; 8:45 am]
 BILLING CODE 4140-01-P

76372 Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices

requirements are simultaneously needed. The collection of more registering or reporting their trials with
consolidated under 0925–0001 and the structured information in the PHS ClinicalTrials.gov.
changes to the collection here are applications and pre-award reporting Frequency of response: Applicants
related. Clinical trials are complex and requirements as well as continued may submit applications for published
challenging research activities. monitoring and update during the post- receipt dates. For NRSA awards,
Oversight systems and tools are critical award reporting requirements will fellowships are activated and trainees
for the NIH to ensure participant safety, facilitate the NIH’s oversight of clinical appointed.
data integrity, and accountability of the trials. In addition, some of the data OMB approval is requested for 3
use of public funds. The NIH has been reported in the RPPR will ultimately be years. There are no costs to respondents
engaged in a multi-year effort to accessible to investigators to update other than their time. The total
examine how clinical trials are certain sections of forms when estimated annualized burden hours are
supported and the level of oversight 307,116.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total annual
Number of burden per
Information collection forms responses per burden
respondents response
respondent hours
(in hours)

Reporting:
PHS 416–7 ............................................................................................... 12,580 1 30/60 6,290
PHS 6031–1 ............................................................................................. 1,778 1 20/60 593
PHS 568 ................................................................................................... 11,180 1 5/60 932
iEdison ...................................................................................................... 5,697 1 15/60 1,424
PHS 2271 ................................................................................................. 22,035 1 15/60 5,509
PHS 2590 ................................................................................................. 243 1 15 3,645
RPPR—Core Data .................................................................................... 32,098 1 8 256,784
Biosketch (Part of RPPR) ......................................................................... 2,544 1 2 5,088
Data Tables (Part of RPPR) ..................................................................... 758 1 4 3,032
PHS Inclusion Enrollment Report (Part of RPPR) ................................... 2,544 1 1 2,544
PHS Clinical Trial Report/Form (Part of RPPR) ....................................... 8,264 1 1 8,264
Trainee Diversity Report (Part of RPPR) ................................................. 480 1 15/60 120
Publication Reporting ............................................................................... 32,341 3 5/60 8,085
PHS 3734 ................................................................................................. 479 1 30/60 240
Final Progress Report .............................................................................. 11,125 1 1 11,125
SBIR/STTR Phase II Final Progress Report ............................................ 1,330 1 1 1,330

Reporting Burden Total ..................................................................... ........................ ........................ ........................ 306,741
Recordkeeping:
SBIR/STTR Life Cycle Certification .......................................................... 1,500 1 15/60 375

Grand Total ................................................................................ ........................ 203,394 ........................ 307,116

Dated: October 22, 2016. applications are filed on selected human and veterinary uses is a method
Lawrence A. Tabak, inventions to extend market coverage of activating mammalian oocytes. These
Deputy Director, National Institutes of Health. for companies and may also be available methods include contacting a
[FR Doc. 2016–26447 Filed 11–1–16; 8:45 am] for licensing. mammalian oocyte of interest arrested at
BILLING CODE 4140–01–P FOR FURTHER INFORMATION CONTACT: metaphase II with an effective amount
Licensing information and copies of the of a Regulator of G-Protein Signaling
U.S. patent applications listed below (RGS)2 inhibitor; and contacting the
DEPARTMENT OF HEALTH AND may be obtained by writing to the mammalian oocyte of interest with an
HUMAN SERVICES indicated licensing contact at the effective amount of a G protein coupled
National Heart, Lung and Blood receptor activator. In general, RGS
National Institutes of Health Institute, Office of Technology Transfer proteins stimulate the hydrolysis of GTP
and Development, National Institutes of bound to activated Ga subunits, leading
Government-Owned Inventions; Health, 31 Center Drive Room 4A29, to signal termination. RGS2, which
Availability for Licensing MSC2479, Bethesda, MD 20892–2479; inhibits both G-aq and G-as signaling
AGENCY: National Institutes of Health, telephone: 301–402–5579. A signed suppresses Ca2+ release in mature
HHS. Confidential Disclosure Agreement may mammalian eggs. Regulators of G-
be required to receive copies of the Protein Signaling (RGS)2 inhibitor and a
ACTION: Notice. patent applications. G protein coupled receptor activator can
SUMMARY: The inventions listed below SUPPLEMENTARY INFORMATION: be used to artificially activate a
sradovich on DSK3GMQ082PROD with NOTICES

are owned by an agency of the U.S. Technology descriptions follow. mammalian oocyte such that it re-enters
Government and are available for Methods for Artificial Oocyte the cell cycle. Examples of RGS2
licensing in the U.S. in accordance with Activation inhibitors can be nucleic acids like
35 U.S.C. 209 and 37 CFR part 404 to siRNAs or dsRNAs. G-protein coupled
achieve expeditious commercialization Description of Technology receptor activators can be acetylcholine,
of federally-funded research and Available for licensing and a neurotransmitter such as serotonin,
development. Foreign patent commercial development for both hormones, natural or synthetic G

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Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices 76373

protein coupled receptor ligands or the statement to the Contact Person listed on Date: November 29, 2016.
modulator, and acidic pH. The oocyte this notice. The statement should include the Time: 12:30 p.m. to 5:30 p.m.
can be fertilized in vitro to form an name, address, telephone number and when Agenda: To review and evaluate grant
applicable, the business or professional applications.
embryo, which can be implanted in a affiliation of the interested person. Place: National Institutes of Health, 6701
subject and developed to term or can be Information is also available on the Rockledge Drive, Bethesda, MD 20892
used for the preparation of stem cells. Institute’s/Center’s home page: https:// (Virtual Meeting).
prescancerpanel.cancer.gov/, where an Contact Person: Liying Guo, Ph.D.,
Potential Commercial Applications
agenda and any additional information for Scientific Review Officer, Center for
• in vitro fertilization the meeting will be posted when available. Scientific Review, National Institutes of
(Catalogue of Federal Domestic Assistance Health, 6701 Rockledge Drive, Room 4016F,
Development Stage Bethesda, MD 20892, 301–435–0908, lguo@
Program Nos. 93.392, Cancer Construction;
• Early Stage 93.393, Cancer Cause and Prevention mail.nih.gov.
Inventors: Miranda L. Bernhardt, Research; 93.394, Cancer Detection and (Catalogue of Federal Domestic Assistance
Carmen J. Williams, Andres Gambini Diagnosis Research; 93.395, Cancer Program Nos. 93.306, Comparative Medicine;
Treatment Research; 93.396, Cancer Biology 93.333, Clinical Research, 93.306, 93.333,
(all of NIEHS), and Lisa M. Mehlmann
Research; 93.397, Cancer Centers Support; 93.337, 93.393–93.396, 93.837–93.844,
(University of Connecticut). 93.398, Cancer Research Manpower; 93.399, 93.846–93.878, 93.892, 93.893, National
Intellectual Property: HHS Reference Cancer Control, National Institutes of Health, Institutes of Health, HHS)
No. E–253–2016/0. HHS)
• U.S. Provisional Patent Application Dated: October 28, 2016.
Dated: October 26, 2016. Anna Snouffer,
No. 62/405,803 filed 7 October 2016.
Licensing Contact: Michael Natasha M. Copeland, Deputy Director, Office of Federal Advisory
Shmilovich, Esq, CLP; 301–435–5019; Program Analyst, Office of Federal Advisory Committee Policy.
shmilovm@mail.nih.gov. Committee Policy.
[FR Doc. 2016–26450 Filed 11–1–16; 8:45 am]
[FR Doc. 2016–26389 Filed 11–1–16; 8:45 am]
Dated: October 24, 2016. BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
Michael Shmilovich,
National Heart, Lung and Blood Institute,
Office of Technology Transfer and DEPARTMENT OF HEALTH AND
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Development, National Institutes of Health.
HUMAN SERVICES
[FR Doc. 2016–26390 Filed 11–1–16; 8:45 am]
National Institutes of Health
BILLING CODE 4140–01–P National Institutes of Health
Center for Scientific Review; Notice of
Center for Scientific Review; Notice of
Closed Meetings
DEPARTMENT OF HEALTH AND Closed Meetings
HUMAN SERVICES Pursuant to section 10(d) of the
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
National Institutes of Health Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
National Cancer Institute; Notice of hereby given of the following meetings. The meetings will be closed to the
Meeting The meetings will be closed to the
public in accordance with the
public in accordance with the
Pursuant to section 10(a) of the provisions set forth in sections
provisions set forth in sections
Federal Advisory Committee Act, as 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
amended (5 U.S.C. App.), notice is as amended. The grant applications and
as amended. The grant applications and
hereby given of the meeting of the the discussions could disclose the discussions could disclose
President’s Cancer Panel. confidential trade secrets or commercial confidential trade secrets or commercial
The meeting will be open to the property such as patentable material, property such as patentable material,
public, with attendance limited to space and personal information concerning and personal information concerning
available. Individuals who plan to individuals associated with the grant individuals associated with the grant
attend and need special assistance, such applications, the disclosure of which applications, the disclosure of which
as sign language interpretation or other would constitute a clearly unwarranted would constitute a clearly unwarranted
reasonable accommodations, should invasion of personal privacy. invasion of personal privacy.
notify the Contact Person listed below Name of Committee: Center for Scientific
Name of Committee: Center for Scientific
in advance of the meeting. Review Special Emphasis Panel, Member
Review Special Emphasis Panel, Member
Name of Committee: President’s Cancer Conflict: Topics in Cell Biology. Conflicts—Molecular and Cellular
Panel. Date: November 29, 2016. Neuroscience.
Date: December 9, 2016. Time: 12:15 p.m. to 2:15 p.m. Date: November 17, 2016.
Time: 9:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant Time: 1:00 p.m. to 4:00 p.m.
Agenda: Emerging Opportunities to applications. Agenda: To review and evaluate grant
Streamline Cancer Drug Development. Place: National Institutes of Health, 6701 applications.
Place: The Ritz Carlton Pentagon City, Rockledge Drive, Bethesda, MD 20892 Place: National Institutes of Health, 6701
1250 S. Hayes Street, Arlington, VA 22202. (Telephone Conference Call). Rockledge Drive, Bethesda, MD 20892
Contact Person: Abby B. Sandler, Ph.D., Contact Person: Janet M Larkin, Ph.D., (Telephone Conference Call).
Executive Secretary, President’s Cancer Scientific Review Officer, Center for Contact Person: Brian H Scott, Ph.D.,
sradovich on DSK3GMQ082PROD with NOTICES

Panel, Special Assistant to the Director, Scientific Review, National Institutes of Scientific Review Officer, National Institutes
Center for Cancer Research, National Cancer Health, 6701 Rockledge Drive, Room 1102, of Health, Center for Scientific Review, 6701
Institute, NIH, 9000 Rockville Pike, Building MSC 7840, Bethesda, MD 20892, 301–806– Rockledge Drive, Bethesda, MD 20892, 301–
31, Room B2B37, MSC 2590, Bethesda, MD 2765, larkinja@csr.nih.gov. 435–1730, brianscott@mail.nih.gov.
20892–8349, 301–451–9399, sandlera@ Name of Committee: Center for Scientific Name of Committee: Center for Scientific
mail.nih.gov. Review Special Emphasis Panel; Member Review Special Emphasis Panel; Program
Any interested person may file written Conflict: Allergy, Autoimmunity, Projects: Mechanisms of Cell Division.
comments with the committee by forwarding Transplantation, and Tumor Immunology. Date: November 28, 2016.

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Document Created: 2016-11-02 01:41:10
Document Modified: 2016-11-02 01:41:10

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		Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the National Heart, Lung and Blood Institute, Office of Technology Transfer and Development, National Institutes of Health, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
FR Citation		81 FR 76372

81 FR 76372 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 212 (November 2, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health