Prospective Grant of an Exclusive Patent License: Field-Deployable Mass Spectrometer Diagnostic for SARS, SARS-CoV-2 and Other Viruses, Bacteria and Bacterial Serovar, and Drug Impurities, 72672 [2020-25142]

Download as PDF 72672 Federal Register / Vol. 85, No. 220 / Friday, November 13, 2020 / Notices documenting electronic data files and statistical analyses submitted to CVM to support new animal drug applications. These recommendations are intended to reduce the number of revisions that may be required for CVM to effectively review data submissions. They are also intended to simplify submission preparation for sponsors by providing a suggested documentation framework, including a sample structure on how to describe and organize the information regarding the electronic data files and statistical analysis programs. This Level I guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Documenting Electronic Data Files and Statistical Analysis Programs.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required. However, this guidance refers to previously approved collections of information. These collections of information are subject to review by OMB under the PRA (44 U.S.C. 3501– 3521). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/animal-veterinary/ guidance-regulations/guidance-industry or https://www.regulations.gov. Dated: November 9, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–25131 Filed 11–12–20; 8:45 am] jbell on DSKJLSW7X2PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 17:19 Nov 12, 2020 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1992] Prospective Grant of an Exclusive Patent License: Field-Deployable Mass Spectrometer Diagnostic for SARS, SARS–CoV–2 and Other Viruses, Bacteria and Bacterial Serovar, and Drug Impurities AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is contemplating the grant of an Exclusive Patent License to practice the invention embodied in the U.S. Patent listed in the Supplementary Information section of this notice to Advion, Inc. located in Ithaca, New York. DATES: Only written comments and/or applications for a license which are received by the Food and Drug Administration’s Technology Transfer Program on or before November 30, 2020 will be considered. ADDRESSES: Inquiries and comments relating to the contemplated Exclusive Patent License should be directed to: Ken Millburne, Food and Drug Administration Technology Transfer Program, Bldg. 1, Rm. 4213, Silver Spring, MD 20993, 240–478–1662; email: Kenneth.millburne@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Intellectual Property FDA Reference No.: E–2011–021: ‘‘Direct Impact Ionization (DII) Mass Spectrometry.’’ I. U.S. Non-Provisional Application 13/271,182, filed October 11, 2011 (FDA Reference No.: E–2011–021/US–02). II. U.S. Patent granted April 22, 2014: U.S. Patent 8,704,169 B2 (FDA Reference No. E–2011–021/U.S.–02) The patent rights in this invention have been assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide and in fields of use that may be limited to manufacture and commercialization of a field-deployable mass spectrometer diagnostic for the rapid detection of SARS, SARS–CoV–2 and other viruses, bacteria and bacterial serovar, and drug impurities. Above listed patent covers inventions directed to a mass spectrometer for analyzing samples suspected of having microorganisms. It is also directed to methods for generating a mass spectrum profile of a sample. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing. The prospective exclusive license may be granted unless within 15 days from the date of this published notice, FDA receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. In response to this notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: November 9, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–25142 Filed 11–12–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Special Volunteer and Guest Researcher Assignment (Office of Intramural Research, Office of the Director) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the Office of Intramural Research (OIR), Office of the Director (OD), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection SUMMARY: E:\FR\FM\13NON1.SGM 13NON1

Agencies

[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Notices]
[Page 72672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1992]


Prospective Grant of an Exclusive Patent License: Field-
Deployable Mass Spectrometer Diagnostic for SARS, SARS-CoV-2 and Other 
Viruses, Bacteria and Bacterial Serovar, and Drug Impurities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is contemplating the 
grant of an Exclusive Patent License to practice the invention embodied 
in the U.S. Patent listed in the Supplementary Information section of 
this notice to Advion, Inc. located in Ithaca, New York.

DATES: Only written comments and/or applications for a license which 
are received by the Food and Drug Administration's Technology Transfer 
Program on or before November 30, 2020 will be considered.

ADDRESSES: Inquiries and comments relating to the contemplated 
Exclusive Patent License should be directed to: Ken Millburne, Food and 
Drug Administration Technology Transfer Program, Bldg. 1, Rm. 4213, 
Silver Spring, MD 20993, 240-478-1662; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    FDA Reference No.: E-2011-021: ``Direct Impact Ionization (DII) 
Mass Spectrometry.''
    I. U.S. Non-Provisional Application 13/271,182, filed October 11, 
2011 (FDA Reference No.: E-2011-021/US-02).
    II. U.S. Patent granted April 22, 2014: U.S. Patent 8,704,169 B2 
(FDA Reference No. E-2011-021/U.S.-02)
    The patent rights in this invention have been assigned to the 
Government of the United States of America.
    The prospective exclusive license territory may be worldwide and in 
fields of use that may be limited to manufacture and commercialization 
of a field-deployable mass spectrometer diagnostic for the rapid 
detection of SARS, SARS-CoV-2 and other viruses, bacteria and bacterial 
serovar, and drug impurities.
    Above listed patent covers inventions directed to a mass 
spectrometer for analyzing samples suspected of having microorganisms. 
It is also directed to methods for generating a mass spectrum profile 
of a sample.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing. 
The prospective exclusive license may be granted unless within 15 days 
from the date of this published notice, FDA receives written evidence 
and argument that establishes that the grant of the license would not 
be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 
404.
    In response to this notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: November 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25142 Filed 11-12-20; 8:45 am]
BILLING CODE 4164-01-P

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