82 FR 43026 - Government-Owned Inventions; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 176 (September 13, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 176 (September 13, 2017)
| Page Range | 43026-43027 | |
| FR Document | 2017-19315 |
[Federal Register Volume 82, Number 176 (Wednesday, September 13, 2017)] [Notices] [Pages 43026-43027] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19315] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Department of Health and Human Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: Government owned intellectual property covering HIV-1 reverse transcriptase inhibitors available for licensing and commercialization. FOR FURTHER INFORMATION CONTACT: Licensing information and copies of the patent applications listed below may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of [[Page 43027]] 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 copies of the patent applications. SUPPLEMENTARY INFORMATION: 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. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. A description of the technology available for licensing follows. Pyrophosphate Analog HIV-1 Reverse Transcriptase Inhibitors Description of Technology: The invention relates to compounds that inhibit HIV-1 DNA synthesis mediated by reverse transcriptase (RT). HIV-1 DNA synthesis by RT utilizes deoxynucleoside 5'-triphosphate (dNTP) as substrate and like many other enzymes, the reaction is reversible. Pyrophosphate analogs like imidodiphosphate strongly promote reverse reaction dNTP products containing the imidodiphosphate group instead of the naturally occurring pyrophosphate group. This imidodiphosphate-containing dNTP was found to be a potent inhibitor of the forward RT reaction. Whereas pyrophosphorolysis is limited by a nonchemical step, replacing the bridging oxygen of pyrophosphate with an imido group resulted in a change in the rate-limiting step, so that the imidodiphosphate-dependent reverse reaction was limited by chemistry. There exists, then, the potential to use pyrophosphate analogs therapeutically. Potential Commercial Applications:Anti-microbial. HIV therapeutic. Development Stage: In vitro data available. Inventors: Samuel Wilson, William Beard, David Dion Shock (all of NIEHS). Intellectual Property: HHS Reference No. E-210-2017/0-US-01. U.S. Provisional Patent Application 62/542,600 filed August 8, 2017. Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; [email protected]. Collaborative Research Opportunity: The National Institute of Environmental Health Sciences seeks statements of capability or interest from parties interested in collaborative research to further develop and evaluate, please contact Sally E. Tilotta, Ph.D., Director, Office of Technology Transfer, National Institute of Environmental Health Sciences, Phone: (919) 316-4526; [email protected]. Dated: September 7, 2017. Michael Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development. [FR Doc. 2017-19315 Filed 9-12-17; 8:45 am] BILLING CODE 4140-01-P
![43026 Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Notices
identifies you in the body of your and other applicable disclosure law. For diagnostic drugs. It does not establish
comments, that information will be more information about FDA’s posting any rights for any person and is not
posted on https://www.regulations.gov. of comments to public dockets, see 80 binding on FDA or the public. You can
• If you want to submit a comment FR 56469, September 18, 2015, or access use an alternative approach if it satisfies
with confidential information that you the information at: https://www.gpo.gov/ the requirements of the applicable
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- statutes and regulations. This guidance
public, submit the comment as a 23389.pdf. is not subject to Executive Order 12866.
written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper II. The Paperwork Reduction Act of
read background documents or the
Submissions’’ and ‘‘Instructions’’). 1995
electronic and written/paper comments
received, go to https:// This guidance refers to previously
Written/Paper Submissions
www.regulations.gov and insert the approved collections of information that
Submit written/paper submissions as docket number, found in brackets in the are subject to review by the Office of
follows: heading of this document, into the Management and Budget (OMB) under
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts the Paperwork Reduction Act of 1995
written/paper submissions): Dockets and/or go to the Dockets Management (44 U.S.C. 3501–3520). The collections
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, of information in 21 CFR parts 312 and
Drug Administration, 5630 Fishers 314 have been approved under OMB
Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any control numbers 0910–0014 and 0910–
• For written/paper comments 0001, respectively. The collection of
guidance at any time (see 21 CFR
submitted to the Dockets Management information for radioactive drug
10.115(g)(5)). Submit written requests
Staff, FDA will post your comment, as research committees in 21 CFR 361.1
well as any attachments, except for for single copies of the draft guidance to
the Division of Drug Information, Center has been approved under OMB control
information submitted, marked and number 0910–0053. The collection of
identified, as confidential, if submitted for Drug Evaluation and Research, Food
and Drug Administration, 10001 New information for the regulations on in
as detailed in ‘‘Instructions.’’ vivo radiopharmaceuticals used for
Instructions: All submissions received Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993– diagnosis and monitoring in 21 CFR
must include the Docket No. FDA–
0002. Send one self-addressed adhesive 315.4, 315.5, and 315.6 has been
2017–D–5297 for ‘‘Microdose
label to assist that office in processing approved under OMB control number
Radiopharmaceutical Diagnostic Drugs:
your requests. See the SUPPLEMENTARY 0910–0409.
Nonclinical Study Recommendations;
Draft Guidance for Industry; INFORMATION section for electronic II. Electronic Access
Availability.’’ Received comments will access to the draft guidance document.
Persons with access to the internet
be placed in the docket and, except for FOR FURTHER INFORMATION CONTACT:
may obtain the draft guidance at either
those submitted as ‘‘Confidential Adebayo Laniyonu, Center for Drug
https://www.fda.gov/Drugs/Guidance
Submissions,’’ publicly viewable at Evaluation and Research, Food and
ComplianceRegulatoryInformation/
https://www.regulations.gov or at the Drug Administration, 10903 New
Guidances/default.htm or https://
Dockets Management Staff between 9 Hampshire Ave., Bldg. 22, Rm. 5400,
www.regulations.gov.
a.m. and 4 p.m., Monday through Silver Spring, MD 20993–0002, 301–
Friday. 796–1392. Dated: September 7, 2017.
• Confidential Submissions—To SUPPLEMENTARY INFORMATION: Leslie Kux,
submit a comment with confidential Associate Commissioner for Policy.
information that you do not wish to be I. Background [FR Doc. 2017–19435 Filed 9–12–17; 8:45 am]
made publicly available, submit your FDA is announcing the availability of BILLING CODE 4164–01–P
comments only as a written/paper a draft guidance for industry entitled
submission. You should submit two ‘‘Microdose Radiopharmaceutical
copies total. One copy will include the Diagnostic Drugs: Nonclinical Study DEPARTMENT OF HEALTH AND
information you claim to be confidential Recommendations.’’ This draft guidance HUMAN SERVICES
with a heading or cover note that states is intended to assist developers of
‘‘THIS DOCUMENT CONTAINS microdose radiopharmaceutical National Institutes of Health
CONFIDENTIAL INFORMATION.’’ The diagnostic drugs on the nonclinical
Agency will review this copy, including studies recommended to support human Government-Owned Inventions;
the claimed confidential information, in clinical trials and marketing Availability for Licensing
its consideration of comments. The authorization. The draft guidance AGENCY: National Institutes of Health,
second copy, which will have the discusses how to refine nonclinical Department of Health and Human
claimed confidential information study recommendations for this class of Services.
redacted/blacked out, will be available drug given its unique characteristics. ACTION: Notice.
for public viewing and posted on This draft guidance is intended to
https://www.regulations.gov. Submit provide recommendations for a pathway SUMMARY: Government owned
both copies to the Dockets Management to full drug development (marketing intellectual property covering HIV-1
Staff. If you do not wish your name and authorization) for microdose reverse transcriptase inhibitors available
contact information to be made publicly radiopharmaceutical diagnostic drugs. for licensing and commercialization.
sradovich on DSK3GMQ082PROD with NOTICES
available, you can provide this This draft guidance is being issued FOR FURTHER INFORMATION CONTACT:
information on the cover sheet and not consistent with FDA’s good guidance Licensing information and copies of the
in the body of your comments and you practices regulation (21 CFR 10.115). patent applications listed below may be
must identify this information as The draft guidance, when finalized, will obtained by emailing the indicated
‘‘confidential.’’ Any information marked represent the current thinking of FDA licensing contact at the National Heart,
as ‘‘confidential’’ will not be disclosed on nonclinical studies recommended for Lung, and Blood, Office of Technology
except in accordance with 21 CFR 10.20 microdose radiopharmaceutical Transfer and Development Office of
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![Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Notices 43027
Technology Transfer, 31 Center Drive further develop and evaluate, please Health, 6701 Rockledge Drive, Room 4154,
Room 4A29, MSC2479, Bethesda, MD contact Sally E. Tilotta, Ph.D., Director, MSC 7806, Bethesda, MD 20892, (301) 435–
20892–2479; telephone: 301–402–5579. Office of Technology Transfer, National 2037, mackj2@csr.nih.gov.
A signed Confidential Disclosure Institute of Environmental Health Name of Committee: Healthcare Delivery
Agreement may be required to receive Sciences, Phone: (919) 316–4526; and Methodologies Integrated Review Group
Community Influences on Health Behavior
copies of the patent applications. sally.tilotta@nih.gov. Study Section.
SUPPLEMENTARY INFORMATION: The Dated: September 7, 2017. Date: October 4–5, 2017.
inventions listed below are owned by an Michael Shmilovich, Time: 8:00 a.m. to 6:00 p.m.
agency of the U.S. Government and are Senior Licensing and Patenting Manager, Agenda: To review and evaluate grant
available for licensing in the U.S. in National Heart, Lung, and Blood Institute, applications.
accordance with 35 U.S.C. 209 and 37 Office of Technology Transfer and Place: Washington Plaza Hotel, 10 Thomas
CFR part 404 to achieve expeditious Development. Circle, NW., Washington, DC 20005.
Contact Person: Tasmeen Weik, DRPH,
commercialization of results of [FR Doc. 2017–19315 Filed 9–12–17; 8:45 am] MPH, Scientific Review Officer, Center for
federally-funded research and BILLING CODE 4140–01–P Scientific Review, National Institutes of
development. Foreign patent Health, 6701 Rockledge Drive, Room 3141,
applications are filed on selected Bethesda, MD 20892, 301–827–6480, weikts@
inventions to extend market coverage DEPARTMENT OF HEALTH AND mail.nih.gov.
for companies and may also be available HUMAN SERVICES Name of Committee: Center for Scientific
for licensing. A description of the Review Special Emphasis Panel Lymphatics
technology available for licensing National Institutes of Health in Health and Disease in the Digestive
follows. System, Kidney and Urinary Tract.
Center for Scientific Review; Notice of Date: October 4, 2017.
Pyrophosphate Analog HIV-1 Reverse Closed Meetings Time: 2:00 p.m. to 3:30 p.m.
Transcriptase Inhibitors Agenda: To review and evaluate grant
Pursuant to section 10(d) of the applications.
Description of Technology: The Federal Advisory Committee Act, as Place: National Institutes of Health, 6701
invention relates to compounds that amended, notice is hereby given of the Rockledge Drive, Bethesda, MD 20892
inhibit HIV-1 DNA synthesis mediated following meetings. (Telephone Conference Call).
by reverse transcriptase (RT). HIV-1 The meetings will be closed to the Contact Person: Jianxin Hu, Ph.D.,
DNA synthesis by RT utilizes public in accordance with the Scientific Review Officer, Center for
deoxynucleoside 5′-triphosphate (dNTP) provisions set forth in sections Scientific Review, National Institutes of
as substrate and like many other Health, 6701 Rockledge Drive, Room 2156,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
enzymes, the reaction is reversible. Bethesda, MD 20892, 301–827–4417,
as amended. The grant applications and jianxinh@csr.nih.gov.
Pyrophosphate analogs like the discussions could disclose
imidodiphosphate strongly promote Name of Committee: Molecular, Cellular
confidential trade secrets or commercial and Developmental Neuroscience Integrated
reverse reaction dNTP products property such as patentable material, Review Group Neurogenesis and Cell Fate
containing the imidodiphosphate group and personal information concerning Study Section.
instead of the naturally occurring individuals associated with the grant Date: October 5, 2017.
pyrophosphate group. This applications, the disclosure of which Time: 8:00 a.m. to 6:30 p.m.
imidodiphosphate-containing dNTP was would constitute a clearly unwarranted Agenda: To review and evaluate grant
found to be a potent inhibitor of the invasion of personal privacy. applications.
forward RT reaction. Whereas Place: Hyatt Regency Crystal City, 2799
Name of Committee: Center for Scientific Jefferson Davis Highway, Arlington, VA
pyrophosphorolysis is limited by a Review Special Emphasis Panel Shared
nonchemical step, replacing the 22202.
Instruments: NMR spectrometers and X-ray Contact Person: Joanne T Fujii, Ph.D.,
bridging oxygen of pyrophosphate with crystallography/scattering. Scientific Review Officer, Center for
an imido group resulted in a change in Date: October 3, 2017. Scientific Review, National Institutes of
the rate-limiting step, so that the Time: 11:00 a.m. to 6:00 p.m. Health, 6701 Rockledge Drive, Room 4184,
imidodiphosphate-dependent reverse Agenda: To review and evaluate grant MSC 7850, Bethesda, MD 20892, (301) 435–
reaction was limited by chemistry. applications.
1178, fujiij@csr.nih.gov.
Place: National Institutes of Health, 6701
There exists, then, the potential to use Rockledge Drive, Bethesda, MD 20892 Name of Committee: Oncology 2—
pyrophosphate analogs therapeutically. (Virtual Meeting). Translational Clinical Integrated Review
Potential Commercial Applications: Contact Person: David R Jollie, Ph.D., Group Developmental Therapeutics Study
• Anti-microbial. Scientific Review Officer, Center for Section.
• HIV therapeutic. Scientific Review, National Institutes of Date: October 5–6, 2017.
Development Stage: Health, 6701 Rockledge Drive, Room 4150, Time: 8:00 a.m. to 5:00 p.m.
• In vitro data available. MSC 7806, Bethesda, MD 20892, (301) 435– Agenda: To review and evaluate grant
Inventors: Samuel Wilson, William 1722, jollieda@csr.nih.gov. applications.
Beard, David Dion Shock (all of NIEHS). Name of Committee: Center for Scientific Place: Embassy Suites Alexandria Old
Intellectual Property: HHS Reference Review Special Emphasis Panel Shared Town, 1900 Diagonal Road, Alexandria, VA
No. E–210–2017/0–US–01. Instruments: NMR spectrometers and X-ray 22314.
• U.S. Provisional Patent Application crystallography/scattering. Contact Person: Sharon K Gubanich, Ph.D.,
Date: October 3, 2017. Scientific Review Officer, Center for
62/542,600 filed August 8, 2017. Scientific Review, National Institutes of
Time: 3:00 p.m. to 5:00 p.m.
sradovich on DSK3GMQ082PROD with NOTICES
Licensing Contact: Michael Health, 6701 Rockledge Drive, Room 6214,
Shmilovich, Esq, CLP; 301–435–5019; Agenda: To review and evaluate grant
applications. MSC 7804, Bethesda, MD 20892, (301) 408–
shmilovm@nih.gov. 9512, gubanics@csr.nih.gov.
Place: National Institutes of Health, 6701
Collaborative Research Opportunity: Rockledge Drive, Bethesda, MD 20892 Name of Committee: Interdisciplinary
The National Institute of Environmental (Virtual Meeting). Molecular Sciences and Training Integrated
Health Sciences seeks statements of Contact Person: James W Mack, Ph.D., Review Group Enabling Bioanalytical and
capability or interest from parties Scientific Review Officer, Center for Imaging Technologies Study Section.
interested in collaborative research to Scientific Review, National Institutes of Date: October 5–6, 2017.
VerDate Sep<11>2014 17:34 Sep 12, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1](https://thefederalregister.org/doc/82_FR_43202/page/2.svg)
Document Created: 2017-09-13 00:09:17
Document Modified: 2017-09-13 00:09:17
| 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 patent applications listed below 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 copies of the patent applications. | |
| FR Citation | 82 FR 43026 |
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