82_FR_44611 82 FR 44428 - Government-Owned Inventions; Availability for Licensing

82 FR 44428 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 183 (September 22, 2017)

Page Range44428-44429
FR Document2017-20232

The inventions listed below are owned by an agency of the U.S. Government and are 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 183 (Friday, September 22, 2017) 
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44428-44429]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20232]


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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 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: Chris Kornak, 240-627-3705, 
[email protected]. Licensing

[[Page 44429]]

information and copies of the U.S. patent applications listed below may 
be obtained by communicating with the indicated licensing contact at 
the Technology Transfer and Intellectual Property Office (TTIPO), 5601 
Fishers Lane, Suite 6D, MSC 9804, Rockville, MD 20892, tel: 301-496-
2644, fax: 240-627-3117. A signed Confidential Disclosure Agreement 
will be required to receive copies of unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

Research Material: A Potent, Broadly-Neutralizing, Anti-HIV Antibody 
(35O22) That Binds a Novel Epitope

    Description of Technology: Millions of people are infected with 
HIV-1 worldwide. In the U.S., there are about 30,000 new cases of HIV 
infection reported annually. Researchers at NIAID are actively 
investigating broadly neutralizing anti-HIV-1 antibodies which can be 
used as therapeutics or prophylactics for HIV infection.
    NIAID and Scripps researchers have discovered a potent anti-HIV 
antibody (35O22) that binds a novel HIV epitope. This antibody 
neutralizes at least 80% of HIV isolates tested so far. The unique 
binding of 35O22 makes it an attractive candidate to combine with other 
HIV antibodies or antivirals in treating or preventing HIV infection.
    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:

 HIV-1 therapeutics
 HIV-1 prophylactics

    Competitive Advantages:

 Unique epitope
 Broad neutralization of HIV isolates

    Development Stage: Pre-Clinical.
    Inventors: Mark Connors, John Mascola, Peter Kwong, Tongqing Zhou, 
Jinghe Huang, Byong Ha Kang, all of NIAID, NIH; Andrew Ward, Scripps 
Research Institute.
    Publications: Huang, J et al., Broad and potent HIV-1 
neutralization by a human antibody that binds the gp41-gp120 interface. 
Nature 515, 138-142.
    Intellectual Property: Not applicable.
    Licensing Contact: Chris Kornak, 240-627-3705, 
[email protected].
    Collaborative Research Opportunity: The Technology Transfer and 
Intellectual Property Office (TTIPO) is seeking parties interested in 
collaborative research to further develop 35O22 in combination with 
other NIAID antibodies. For collaboration opportunities, please contact 
Chris Kornak, 240-627-3705, [email protected].

    Dated: September 12, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-20232 Filed 9-21-17; 8:45 am]
 BILLING CODE 4140-01-P

44428 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices be used if they contain all of the On February 23, 2012, we issued an particular party. Such a case file would required information and are retained interim final rule in the Federal be opened as part of the request to for the required time period. Register (77 FR 10658) (the 2012 IFR) access records under § 1.361. Section 101 of the FDA Food Safety amending § 1.361 to be consistent with Accordingly, we have not included an Modernization Act (FSMA) (Pub. L. the current statutory language in section estimate of burden hours associated 414(a) of the FD&C Act, as amended by with § 1.361 in table 1. 111–353) amended section 414(a) of the section 101 of FSMA. In the 2012 IFR, Description of Respondents: Persons FD&C Act and expanded our access to we concluded that the information that manufacture, process, pack, hold, records. Specifically, FSMA expanded collection provisions of § 1.361 were receive, distribute, transport, or import our access to records beyond records exempt from OMB review under 44 relating to the specific suspect article of food in the United States are required to U.S.C. 3518(c)(1)(B)(ii) and 5 CFR establish and maintain records, food to records relating to any other 1320.4(a)(2) as collections of article of food that we reasonably including persons that engage in both information obtained during the interstate and intrastate commerce. believe is likely to be affected in a conduct of a civil action to which the similar manner. In addition, we can United States or any official or agency In the Federal Register of June 14, access records if we believe that there is thereof is a party, or during the conduct 2017 (82 FR 27263), FDA published a a reasonable probability that the use of of an administrative action, 60-day notice requesting public or exposure to an article of food, and investigation, or audit involving an comment on the proposed collection of any other article of food that we agency against specific individuals or information. FDA received one reasonably believe is likely to be entities (77 FR 10658 at 10661). The comment. The comment was supportive affected in a similar manner, will cause interim final rule was made final, of the information collection but serious adverse health consequences or without change, on April 4, 2014 (79 FR requested that FDA coordinate with the death to humans or animals. To gain 18799). The regulations at 5 CFR U.S. Department of Agriculture. FDA access to these records, our officer or 1320.3(c) provide that the exception in addresses issues regarding duplication employee must present appropriate 5 CFR 1320.4(a)(2) applies during the of information collection in question 4 credentials and a written notice, at entire course of the investigation, audit, of the Agency’s supporting statement. reasonable times and within reasonable or action, but only after a case file or FDA estimates the burden of this limits and in a reasonable manner. equivalent is opened with respect to a collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Average Number of Total annual 21 CFR section records per burden per Total hours recordkeepers records recordkeeper recordkeeping 1.337, 1.345, and 1.352 (Records main- tenance) ............................................. 379,493 1 379,493 13.228 5,020,000 1.337, 1.345, and 1.352 (Learning for new firms) ........................................... 18,975 1 18,975 4.790 90,890 Total ................................................ .............................. .............................. .............................. .............................. 5,110,890 1 There are no capital costs or operating and maintenance costs associated with this collection of information. This estimate is based on our estimate facilities will spend 4.790 hours DEPARTMENT OF HEALTH AND of the number of facilities affected by learning about the recordkeeping and HUMAN SERVICES the final rule entitled ‘‘Establishment records access requirements, for a total and Maintenance of Records Under the of 90,890 hours annually. We estimate National Institutes of Health Public Health Security and Bioterrorism that approximately the same number of Preparedness and Response Act of Government-Owned Inventions; firms (18,975) will exit the affected 2002,’’ published in the Federal Availability for Licensing businesses in any given year, resulting Register of December 9, 2004 (69 FR in no growth in the number of total AGENCY: National Institutes of Health, 71562 at 71650). With regard to records firms reported on line 1 of table 1. HHS. maintenance, we estimate that Therefore, the total annual ACTION: Notice. approximately 379,493 facilities will recordkeeping burden is estimated to be spend 13.228 hours collecting, recording, and checking for accuracy the 5,110,890 hours. SUMMARY: The inventions listed below limited amount of additional Dated: September 15, 2017. are owned by an agency of the U.S. information required by the regulations, Government and are available for Anna K. Abram, for a total of 5,020,000 hours annually. licensing to achieve expeditious Deputy Commissioner for Policy, Planning, commercialization of results of In addition, we estimate that new firms Legislation, and Analysis. entering the affected businesses will federally-funded research and [FR Doc. 2017–20239 Filed 9–21–17; 8:45 am] development. Foreign patent incur a burden from learning the regulatory requirements and BILLING CODE 4164–01–P applications are filed on selected understanding the records required for inventions to extend market coverage compliance. In this regard, we estimate for companies and may also be available the number of new firms entering the for licensing. affected businesses to be 5 percent of FOR FURTHER INFORMATION CONTACT: 379,493, or 18,975 firms. Thus, we Chris Kornak, 240–627–3705, estimate that approximately 18,975 chris.kornak@nih.gov. Licensing VerDate Sep<11>2014 18:11 Sep 21, 2017 Jkt 241001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\22SEN1.SGM 22SEN1

Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44429 information and copies of the U.S. opportunities, please contact Chris DEPARTMENT OF HEALTH AND patent applications listed below may be Kornak, 240–627–3705, chris.kornak@ HUMAN SERVICES obtained by communicating with the nih.gov. indicated licensing contact at the National Institutes of Health Dated: September 12, 2017. Technology Transfer and Intellectual Property Office (TTIPO), 5601 Fishers Suzanne Frisbie, National Eye Institute; Notice of Closed Lane, Suite 6D, MSC 9804, Rockville, Deputy Director, Technology Transfer and Meeting MD 20892, tel: 301–496–2644, fax: 240– Intellectual Property Office, National Institute Pursuant to section 10(d) of the 627–3117. A signed Confidential of Allergy and Infectious Diseases. Federal Advisory Committee Act, as Disclosure Agreement will be required [FR Doc. 2017–20232 Filed 9–21–17; 8:45 am] amended, notice is hereby given of the to receive copies of unpublished patent BILLING CODE 4140–01–P following meeting. applications. The meeting will be closed to the SUPPLEMENTARY INFORMATION: public in accordance with the Technology descriptions follow. DEPARTMENT OF HEALTH AND provisions set forth in sections HUMAN SERVICES 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Research Material: A Potent, Broadly- as amended. The grant applications and Neutralizing, Anti-HIV Antibody National Institutes of Health the discussions could disclose (35O22) That Binds a Novel Epitope confidential trade secrets or commercial Description of Technology: Millions of National Institute on Aging; Notice of property such as patentable material, people are infected with HIV–1 Closed Meeting and personal information concerning worldwide. In the U.S., there are about individuals associated with the grant 30,000 new cases of HIV infection Pursuant to section 10(d) of the applications, the disclosure of which reported annually. Researchers at NIAID Federal Advisory Committee Act, as would constitute a clearly unwarranted are actively investigating broadly amended, notice is hereby given of the invasion of personal privacy. neutralizing anti-HIV–1 antibodies following meeting. Name of Committee: National Eye Institute which can be used as therapeutics or The meeting will be closed to the Special Emphasis Panel NEI; Institutional prophylactics for HIV infection. public in accordance with the Training Grant Applications. NIAID and Scripps researchers have provisions set forth in sections Date: October 16, 2017. discovered a potent anti-HIV antibody 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 8:00 a.m. to 5:00 p.m. (35O22) that binds a novel HIV epitope. Agenda: To review and evaluate grant as amended. The grant applications and applications. This antibody neutralizes at least 80% the discussions could disclose Place: Hilton Garden Inn Bethesda, 7301 of HIV isolates tested so far. The unique confidential trade secrets or commercial Waverly Street, Bethesda, MD 20814. binding of 35O22 makes it an attractive property such as patentable material, Contact Person: Jeanette M. Hosseini, candidate to combine with other HIV Ph.D., Scientific Review Officer, NEI/DEA/ and personal information concerning antibodies or antivirals in treating or SRB, National Institutes of Health, 5635 individuals associated with the grant preventing HIV infection. Fishers Lane, Suite 1300, Bethesda, MD This technology is available for applications, the disclosure of which 20892, 301–451–2020, jeanetteh@ licensing for commercial development would constitute a clearly unwarranted mail.nih.gov. in accordance with 35 U.S.C. 209 and 37 invasion of personal privacy. (Catalogue of Federal Domestic Assistance CFR part 404, as well as for further Name of Committee: National Institute on Program Nos. 93.867, Vision Research, development and evaluation under a Aging Special Emphasis Panel; Drug National Institutes of Health, HHS) research collaboration. Repurposing for Alzheimer’s Disease. Dated: September 18, 2017. Potential Commercial Applications: Date: October 17, 2017. Natasha M. Copeland, • HIV–1 therapeutics Time: 10:30 a.m. to 12:00 p.m. Program Analyst, Office of Federal Advisory • HIV–1 prophylactics Agenda: To review and evaluate grant Committee Policy. Competitive Advantages: applications. [FR Doc. 2017–20178 Filed 9–21–17; 8:45 am] Place: National Institute on Aging, • Unique epitope BILLING CODE 4140–01–P Gateway Building, Suite 2W200, 7201 • Broad neutralization of HIV isolates Wisconsin Avenue, Bethesda, MD 20814 Development Stage: Pre-Clinical. (Telephone Conference Call). Inventors: Mark Connors, John DEPARTMENT OF HEALTH AND Contact Person: Anita H. Undale, Ph.D., Mascola, Peter Kwong, Tongqing Zhou, HUMAN SERVICES MD, Scientific Review Branch, National Jinghe Huang, Byong Ha Kang, all of Institute on Aging, Gateway Building, Suite NIAID, NIH; Andrew Ward, Scripps National Institutes of Health 2W200, 7201 Wisconsin Avenue, Bethesda, Research Institute. MD 20892, 240–747–7825, anita.undale@ National Cancer Institute; Notice of Publications: Huang, J et al., Broad nih.gov. Closed Meetings and potent HIV–1 neutralization by a (Catalogue of Federal Domestic Assistance human antibody that binds the gp41– Pursuant to section 10(d) of the Program Nos. 93.866, Aging Research, gp120 interface. Nature 515, 138–142. Federal Advisory Committee Act, as National Institutes of Health, HHS) Intellectual Property: Not applicable. amended, notice is hereby given of the Licensing Contact: Chris Kornak, 240– Dated: September 18, 2017. following meetings. 627–3705, chris.kornak@nih.gov. Melanie J. Pantoja, The meetings will be closed to the Collaborative Research Opportunity: Program Analyst, Office of Federal Advisory public in accordance with the The Technology Transfer and Committee Policy. provisions set forth in sections Intellectual Property Office (TTIPO) is [FR Doc. 2017–20230 Filed 9–21–17; 8:45 am] 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., seeking parties interested in as amended. The grant applications and BILLING CODE 4140–01–P collaborative research to further develop the discussions could disclose 35O22 in combination with other NIAID confidential trade secrets or commercial antibodies. For collaboration property such as patentable material, VerDate Sep<11>2014 18:11 Sep 21, 2017 Jkt 241001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\22SEN1.SGM 22SEN1


Document Created: 2017-09-22 01:52:44
Document Modified: 2017-09-22 01:52:44
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.
ContactChris Kornak, 240-627-3705, [email protected] Licensing information and copies of the U.S. patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office (TTIPO), 5601 Fishers Lane, Suite 6D, MSC 9804, Rockville, MD 20892, tel: 301-496- 2644, fax: 240-627-3117. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.
FR Citation82 FR 44428 
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