81_FR_62689 81 FR 62514 - Government-Owned Inventions; Availability for Licensing

81 FR 62514 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 175 (September 9, 2016)

Page Range62514-62515
FR Document2016-21699

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 results of federally-funded research and development.

Federal Register, Volume 81 Issue 175 (Friday, September 9, 2016)
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62514-62515]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21699]


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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.

-----------------------------------------------------------------------

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 results of federally-funded research and 
development.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by emailing the indicated licensing contact at the National Heart, 
Lung, and Blood, Office of Technology Transfer and Development Office 
of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, 
MD 20892-2479; telephone: 301-402-5579. A signed Confidential 
Disclosure Agreement may be required to receive any unpublished 
information.

SUPPLEMENTARY INFORMATION: Technology description follows.
Reagent for Mapping Genome-Wide Enhancer-Promoter Interactions
    This invention is a research reagent named the ``bivalent Tn5 
complex'' used in transposition-mediated analysis of chromatin looping 
(TrAC-looping) to determine genome-wide enhancer-promoter interactions 
during studies of 4D nucleomes in normal development and disease 
conditions. Enhancer-promoter interactions are key in temporospatial 
control of gene expression during normal development and pathological 
conditions. Currently available methods of analyzing genome-wide 
enhancer-promoter interactions are insufficient in achieving necessary 
resolution, give rise to false positive artifacts due to in vitro 
ligation steps, or too expensive due to the necessity of sequencing 
over a billion reads. The instant reagent and associated TrAC-looping 
technique effectively reduce false positive detection and achieve a 10 
to 100-times higher resolution at lower cost for mapping genome-wide 
interactions between enhancers and promotes essential for the control 
of gene expression in normal development and pathological conditions.

References

--Lieberman-Aiden E et al., Science 2009 Oct 9;326(5950):289-93.

[[Page 62515]]

--Rao S et al., Cell. 2014 Dec 18;159(7):1665-80.
--Goryshin et al., JBC 1998 March 273(13) 7367-7374.

Potential Commercial Applications

--Genome wide Enhancer-Promoter mapping
--Functional annotation of genomic structure
--Three-dimensional chromatin organization
--Analysis of 4D Nucleomes during development of diseases
--Identification of key genomic sequences involved in diseases
--Diagnostic for diseases associated with aberrant gene expression

Competitive Advantages

--Transposition mediated analysis of chromatin looping

    Development Stage: Research reagent.
    Inventors: Keji Zhao and Qingsong Tang (both of NHLBI).
    Intellectual Property: HHS Reference No. E-266-2016/0;--Research 
reagent.
    Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; 
[email protected].

    Dated: September 2, 2016.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2016-21699 Filed 9-8-16; 8:45 am]
 BILLING CODE 4140-01-P



                                                    62514                       Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices

                                                    Institute of Environmental Health                       organization. Guidelines for public                   DEPARTMENT OF HEALTH AND
                                                    Sciences, 111 T.W. Alexander Drive,                     comments are at http://                               HUMAN SERVICES
                                                    P.O. Box 12233, Research Triangle Park,                 ntp.niehs.nih.gov/ntp/about_ntp/
                                                    NC 27709.                                               guidelines_public_comments_508.pdf.                   National Institutes of Health
                                                    SUPPLEMENTARY INFORMATION:                                 Responses to this request for                      Government-Owned Inventions;
                                                       Request for Information: NTP requests                information are voluntary. This request               Availability for Licensing
                                                    information on four substances that                     for information is for planning purposes
                                                    have been nominated for possible                        only and is not a solicitation for                    AGENCY:    National Institutes of Health,
                                                    review for future editions of the RoC                   applications or an obligation on the part             HHS.
                                                    (see http://ntp.niehs.nih.gov/go/                       of the U.S. Government to provide                     ACTION:   Notice.
                                                    rocnom); three of these four substances
                                                                                                            support for any ideas identified in                   SUMMARY:   The inventions listed below
                                                    are also under consideration for
                                                                                                            response to it. Please note that the U.S.             are owned by an agency of the U.S.
                                                    evaluation of non-cancer health
                                                    outcomes (see http://ntp.niehs.nih.gov/                 Government will not pay for the                       Government and are available for
                                                    go/763346). The four nominations are:                   preparation of any information                        licensing in the U.S. in accordance with
                                                       • Consumption of red meat: cancer                    submitted or for its use. No proprietary,             35 U.S.C. 209 and 37 CFR part 404 to
                                                    and non-cancer health hazard                            classified, confidential, or sensitive                achieve expeditious commercialization
                                                    evaluations.                                            information should be included in your                of results of federally-funded research
                                                       • Consumption of processed meat:                     response.                                             and development.
                                                    cancer and non-cancer health hazard                        Background Information on ORoC: On                 FOR FURTHER INFORMATION CONTACT:
                                                    evaluations.                                            behalf of NTP, ORoC prepares the RoC                  Licensing information may be obtained
                                                       • Consumption of meat cooked at                      following an established, four-part                   by emailing the indicated licensing
                                                    high temperatures: cancer and non-                      process (http://ntp.niehs.nih.gov/go/                 contact at the National Heart, Lung, and
                                                    cancer health hazard evaluations.                       rocprocess). The RoC is a                             Blood, Office of Technology Transfer
                                                       • Antimony trioxide: cancer hazard                   congressionally mandated, science-                    and Development Office of Technology
                                                    evaluation.                                             based, public health report that                      Transfer, 31 Center Drive, Room 4A29,
                                                       Cancer hazard evaluation of a                        identifies agents, substances, mixtures,              MSC2479, Bethesda, MD 20892–2479;
                                                    substance for the RoC may seek to list                  or exposures (collectively called                     telephone: 301–402–5579. A signed
                                                    a new substance in the report, reclassify               ‘‘substances’’) in our environment that               Confidential Disclosure Agreement may
                                                    the listing status of a substance already                                                                     be required to receive any unpublished
                                                                                                            pose a cancer hazard for people in the
                                                    listed, or remove a listed substance.                                                                         information.
                                                                                                            United States. Published biennially,
                                                       Specifically, NTP requests                                                                                 SUPPLEMENTARY INFORMATION:
                                                    information on: (1) Current production,                 each edition of the RoC is cumulative
                                                                                                            and consists of substances newly                      Technology description follows.
                                                    use patterns, and human exposure
                                                    estimates for antimony trioxide; (2) data               reviewed in addition to those listed in               Reagent for Mapping Genome-Wide
                                                    on dietary intake estimates of red meat,                previous editions. Newly reviewed                     Enhancer-Promoter Interactions
                                                    processed meat, or meat cooked at high                  substances with their recommended                        This invention is a research reagent
                                                    temperatures; and for all four                          listing are reviewed and approved by                  named the ‘‘bivalent Tn5 complex’’
                                                    nominations (3) recently published,                     the Secretary of Health and Human                     used in transposition-mediated analysis
                                                    ongoing, or planned studies related to                  Services. The 13th RoC, the latest                    of chromatin looping (TrAC-looping) to
                                                    evaluating adverse health outcomes                      edition, was published on October 2,                  determine genome-wide enhancer-
                                                    (e.g., cancer, development,                             2014 (available at http://                            promoter interactions during studies of
                                                    reproductive, or immunological                          ntp.niehs.nih.gov/go/roc13). The 14th                 4D nucleomes in normal development
                                                    disorders); (4) scientific issues                       RoC is under development.                             and disease conditions. Enhancer-
                                                    important for prioritizing and assessing                   Background Information on OHAT:                    promoter interactions are key in
                                                    adverse health outcomes; and (5) names                  On behalf of NTP, OHAT conducts                       temporospatial control of gene
                                                    of scientists with expertise or                         literature-based evaluations to assess the            expression during normal development
                                                    knowledge on any of these substances—                   evidence whether environmental                        and pathological conditions. Currently
                                                    please indicate the substance and                                                                             available methods of analyzing genome-
                                                                                                            chemicals, physical substances, or
                                                    include any bibliographic citations                                                                           wide enhancer-promoter interactions
                                                                                                            mixtures (collectively called
                                                    when available. NTP will use this                                                                             are insufficient in achieving necessary
                                                    information in determining which                        ‘‘substances’’) cause adverse non-cancer
                                                                                                                                                                  resolution, give rise to false positive
                                                    substances to propose for formal health                 health outcomes. As part of these
                                                                                                                                                                  artifacts due to in vitro ligation steps, or
                                                    hazard evaluations.                                     evaluations, NTP may also provide
                                                                                                                                                                  too expensive due to the necessity of
                                                       Information on substances for                        opinions on whether these substances                  sequencing over a billion reads. The
                                                    possible review should be submitted                     might be of concern for causing adverse               instant reagent and associated TrAC-
                                                    electronically at http://                               effects on human health given what is                 looping technique effectively reduce
                                                    ntp.niehs.nih.gov/go/778417 or emailed                  known about toxicity and current                      false positive detection and achieve a 10
                                                    to Dr. Lunn or Dr. Boyd (see FOR                        human exposure levels. Information                    to 100-times higher resolution at lower
                                                    FURTHER INFORMATION CONTACT). Contact                   about OHAT can be found at http://
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                                                                  cost for mapping genome-wide
                                                    information for comments should                         ntp.niehs.nih.gov/go/ohat.                            interactions between enhancers and
                                                    include the submitter’s name,                             Dated: September 6, 2016.                           promotes essential for the control of
                                                    affiliation, sponsoring organization (if                                                                      gene expression in normal development
                                                                                                            John R. Bucher,
                                                    any), telephone, and email. Written                                                                           and pathological conditions.
                                                    information received in response to this                Associate Director, National Toxicology
                                                    notice will be posted on the NTP Web                    Program.                                              References
                                                    site, and the submitter identified by                   [FR Doc. 2016–21698 Filed 9–8–16; 8:45 am]            —Lieberman-Aiden E et al., Science
                                                    name, affiliation, and/or sponsoring                    BILLING CODE 4140–01–P                                 2009 Oct 9;326(5950):289–93.


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                                                                                Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices                                          62515

                                                    —Rao S et al., Cell. 2014 Dec                           test has been a success, as ACE has                   announcing its plan to begin a phased
                                                     18;159(7):1665–80.                                     proven capable of receiving and                       decommissioning of ACS for entry and
                                                    —Goryshin et al., JBC 1998 March                        processing the data required by FSIS,                 entry summary filings, making ACE the
                                                     273(13) 7367–7374.                                     and sharing that data with FSIS.                      sole CBP-authorized electronic data
                                                                                                            Accordingly, this NCAP test will be                   interchange (EDI) system for processing
                                                    Potential Commercial Applications
                                                                                                            concluded on October 11, 2016. CBP has                those electronic filings. See 81 FR 10264
                                                    —Genome wide Enhancer-Promoter                          made ACE the sole CBP-authorized                      (February 29, 2016). As part of this
                                                     mapping                                                electronic data interchange (EDI) system              phased decommissioning, CBP
                                                    —Functional annotation of genomic                       for most entry and entry summary                      announced that ACE would become the
                                                     structure                                              filings, including entry and entry                    sole CBP-authorized EDI for processing
                                                    —Three-dimensional chromatin                            summary filings for meat, poultry and                 certain electronic entries and entry
                                                     organization                                           egg products regulated by FSIS. As a                  summaries for merchandise subject to
                                                    —Analysis of 4D Nucleomes during                        result, filers transmitting electronic                the import requirements of the Food and
                                                     development of diseases                                import data required by FSIS with their               Drug Administration on June 15, 2016.
                                                    —Identification of key genomic                          electronic entry or entry summary must                See 81 FR 30320 (May 16, 2016). On
                                                     sequences involved in diseases                         use ACE.                                              July 23, 2016, CBP completed this
                                                    —Diagnostic for diseases associated                     DATES: The NCAP test will conclude on                 phased decommissioning, and ACE
                                                     with aberrant gene expression                          October 11, 2016.                                     became the sole CBP-authorized EDI
                                                    Competitive Advantages                                  ADDRESSES: Comments concerning this                   system for most entry and entry
                                                                                                            notice and any aspect of this test may                summary filings for all filers. See 81 FR
                                                    —Transposition mediated analysis of                                                                           32339 (May 23, 2016). Entries and entry
                                                      chromatin looping                                     be submitted via email to Josephine
                                                                                                            Baiamonte, ACE Business Office (ABO),                 summaries for the entry types specified
                                                      Development Stage: Research reagent.                                                                        in the May 23, 2016 notice, including
                                                                                                            Office of Trade, at
                                                      Inventors: Keji Zhao and Qingsong                                                                           entries and entry summaries
                                                                                                            josephine.baiamonte@cbp.dhs.gov.
                                                    Tang (both of NHLBI).                                                                                         accompanied by data required by the
                                                      Intellectual Property: HHS Reference                  FOR FURTHER INFORMATION CONTACT: For
                                                                                                            CBP-related questions, contact Jeffrey                Food Safety and Inspection Service
                                                    No. E–266–2016/0;—Research reagent.                                                                           (FSIS), must be filed in ACE. ACS is no
                                                      Licensing Contact: Michael                            Nii, Director, Inter-Agency
                                                                                                            Collaboration Division, Office of Trade,              longer available for these filings.
                                                    Shmilovich, Esq, CLP; 301–435–5019;
                                                    shmilovm@mail.nih.gov.                                  at jeffrey.c.nii@cbp.dhs.gov.                         II. The Partner Government Agency
                                                      Dated: September 2, 2016.
                                                                                                            SUPPLEMENTARY INFORMATION:                            Message Set Test for FSIS Data
                                                    Michael Shmilovich,                                     I. Background                                            The Partner Government Agency
                                                    Senior Licensing and Patenting Manager,                    The National Customs Automation                    (PGA) Message Set is the data required
                                                    National Heart, Lung, and Blood Institute,              Program (NCAP) was established by                     to satisfy a PGA’s reporting
                                                    Office of Technology Transfer and                       Subtitle B of Title VI—Customs                        requirements through ACE. It enables
                                                    Development.                                                                                                  the trade community to submit trade-
                                                                                                            Modernization, in the North American
                                                    [FR Doc. 2016–21699 Filed 9–8–16; 8:45 am]              Free Trade Agreement Implementation                   related data required by the PGA only
                                                    BILLING CODE 4140–01–P                                  Act (Pub. L. 103–182, 107 Stat. 2057,                 once to CBP, thus improving
                                                                                                            December 8, 1993) (Customs                            communications between the agency
                                                                                                            Modernization Act). See 19 U.S.C. 1411.               and filers, and shortening entry
                                                    DEPARTMENT OF HOMELAND                                  Through NCAP, the thrust of customs                   processing time. Also, by virtue of being
                                                    SECURITY                                                modernization was on trade compliance                 electronic, the PGA Message Set
                                                                                                            and the development of the Automated                  eliminates the necessity for the
                                                    U.S. Customs and Border Protection                      Commercial Environment (ACE), the                     submission and subsequent manual
                                                                                                            planned successor to the legacy                       processing of paper documents.
                                                    Conclusion of the National Customs                                                                               Through the Customs Modernization
                                                                                                            Automated Commercial System (ACS).
                                                    Automation Program (NCAP) Test                                                                                Act and section 101.9 of title 19 of the
                                                                                                            ACE is an automated and electronic
                                                    Concerning the Submission of Data                                                                             Code of Federal Regulations (19 CFR
                                                                                                            system for commercial trade processing.
                                                    Required by the Food Safety and                                                                               101.9(b)), the Commissioner of CBP has
                                                                                                            ACE will streamline business processes,
                                                    Inspection Service (FSIS) in the                                                                              authority to conduct limited test
                                                                                                            facilitate growth in trade, ensure cargo
                                                    Automated Commercial Environment                                                                              programs or procedures designed to
                                                                                                            security, and foster participation in
                                                    (ACE)                                                                                                         evaluate planned components of the
                                                                                                            global commerce, while ensuring
                                                    AGENCY:  U.S. Customs and Border                        compliance with U.S. laws and                         NCAP. See Treasury Decision (T.D.) 95–
                                                    Protection, Department of Homeland                      regulations and reducing costs for U.S.               21.
                                                    Security.                                               Customs and Border Protection (CBP)                      On December 13, 2013, CBP
                                                    ACTION: General notice.                                 and its communities of interest. The                  published a notice in the Federal
                                                                                                            ability to meet these objectives depends              Register announcing CBP’s plan to
                                                    SUMMARY:   This document announces the                  upon successfully modernizing CBP’s                   conduct an NCAP test concerning the
                                                    conclusion of the National Customs                      business functions and the information                electronic transmission of the PGA
                                                    Automation Program (NCAP) test                          technology that supports those                        Message Set data elements required by
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    concerning the electronic transmission                  functions. CBP’s modernization efforts                FSIS for the importation of certain meat,
                                                    of certain import data required by the                  are accomplished through phased                       poultry, and egg products to CBP
                                                    Food Safety and Inspection Service                      releases of ACE component                             through ACE. See 78 FR 75931
                                                    (FSIS) to the Automated Commercial                      functionality, designed to introduce a                (December 13, 2013). Under this test,
                                                    Environment (ACE) using the Partner                     new capability or to replace a specific               the PGA Message Set satisfied the FSIS
                                                    Government Agency (PGA) Message Set.                    legacy ACS function.                                  data requirements for electronic entries
                                                    U.S. Customs and Border Protection                         On February 29, 2016, CBP published                filed in ACE and enabled the trade
                                                    (CBP) has determined that the NCAP                      a notice in the Federal Register                      community to use the CBP-managed


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Document Created: 2018-02-09 13:15:01
Document Modified: 2018-02-09 13:15:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactLicensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.
FR Citation81 FR 62514 

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