80 FR 15220 - Prospective Grant of an Exclusive Commercial License Agreement: Development of 5T4 Antibody-Drug Conjugates for the Treatment of Human Cancers
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 55 (March 23, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 55 (March 23, 2015)
| Page Range | 15220-15221 | |
| FR Document | 2015-06488 |
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)] [Notices] [Pages 15220-15221] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06488] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Commercial License Agreement: Development of 5T4 Antibody-Drug Conjugates for the Treatment of Human Cancers AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an start-up exclusive commercial license to practice the inventions embodied in U.S. Patent Application No. 62/034,995 entitled ``Human Monoclonal Antibodies Specific for 5T4 and Methods of Their Use'' filed August 8, 20014 [HHS Ref. E-158-2014/0-US-01] and all related continuing and foreign patents/patent applications for the technology family to Concortis, Inc. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective start-up exclusive commercial license territory may be worldwide and the field of use may be limited to the development of 5T4 antibody drug conjugate therapeutics for the treatment of human cancers using Concortis' proprietary conjugation technologies. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 7, 2015 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, comments, and other materials relating to the contemplated exclusive evaluation option license should be directed to: Whitney Hastings, Ph.D., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 451-7337; Facsimile: (301) 402-0220; Email: hastingw@mail.nih.gov. SUPPLEMENTARY INFORMATION: 5T4 is an antigen expressed in a number of [[Page 15221]] carcinomas. Its expression is limited in normal tissue, but is prevalent in malignant tumors throughout their development. This confined expression makes it an attractive target for cancer immunotherapy. 5T4 is often found in colorectal, ovarian, and gastric tumors and thus has been used as a prognostic aid for these cancers. In addition, its role in antibody-directed immunotherapy for delivering response modifiers to tumors has been studied using murine monoclonal antibodies (mAbs) and the cancer vaccine TroVax (currently in clinical trials for multiple solid tumors) targets 5T4. The present invention describes the identification and characterization of two fully human mAbs (m1001 and m1002) that bind to 5T4. Since the mAbs are fully human, they could have less immunogenicity and better safety profiles than the existing mouse and humanized antibodies. The prospective start-up exclusive commercial license is being considered under the small business initiative launched on October 1, 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective start-up exclusive commercial license may be granted unless within fifteen (15) days from the date of this published notice, the NIH 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. Any additional, properly filed, and complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive commercial license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: March 17, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015-06488 Filed 3-20-15; 8:45 am] BILLING CODE 4140-01-P
![15220 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
Average Total
Number of
Type of Number of burden per annual
Form name responses per
respondent respondents response burden
respondent (in hours) hour
Risk Factor Assessment .......................................................... Adult Donors 100 1 19/60 40
Dated: March 11, 2015. Improvement and Patient Safety, AHRQ, DEPARTMENT OF HEALTH AND
Lynn Susulske, 540 Gaither Road, Rockville, MD 20850; HUMAN SERVICES
NHLBI Project Clearance Liaison, National Telephone (toll free): (866) 403–3697;
Institutes of Health. Telephone (local): (301) 427–1111; TTY National Institutes of Health
[FR Doc. 2015–06565 Filed 3–20–15; 8:45 am] (toll free): (866) 438–7231; TTY (local):
Prospective Grant of an Exclusive
BILLING CODE 4141–01–P (301) 427–1130; Email: PSO@
Commercial License Agreement:
AHRQ.hhs.gov.
Development of 5T4 Antibody-Drug
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: Conjugates for the Treatment of
HUMAN SERVICES Human Cancers
Background
AGENCY: National Institutes of Health,
Agency for Healthcare Research and The Patient Safety Act authorizes the HHS.
Quality
listing of PSOs, which are entities or ACTION: Notice.
Patient Safety Organizations: Expired component organizations whose
mission and primary activity are to SUMMARY: This is notice, in accordance
Listing From Premerus PSO, LLC with 35 U.S.C. 209 and 37 CFR part 404,
conduct activities to improve patient
AGENCY: Agency for Healthcare Research that the National Institutes of Health,
safety and the quality of health care
and Quality (AHRQ), Department of Department of Health and Human
delivery.
Health and Human Services (HHS). Services, is contemplating the grant of
HHS issued the Patient Safety Rule to an start-up exclusive commercial
ACTION: Notice of delisting.
implement the Patient Safety Act. license to practice the inventions
SUMMARY: The Patient Safety and AHRQ administers the provisions of the embodied in U.S. Patent Application
Quality Improvement Act of 2005, 42 Patient Safety Act and Patient Safety No. 62/034,995 entitled ‘‘Human
U.S.C. 299b–21 to b–26, (Patient Safety Rule relating to the listing and operation Monoclonal Antibodies Specific for 5T4
Act) and the related Patient Safety and of PSOs. The Patient Safety Rule and Methods of Their Use’’ filed August
Quality Improvement Final Rule, 42 authorizes AHRQ to list as a PSO an 8, 20014 [HHS Ref. E–158–2014/0–US–
CFR part 3 (Patient Safety Rule), entity that attests that it meets the 01] and all related continuing and
published in the Federal Register on statutory and regulatory requirements foreign patents/patent applications for
November 21, 2008, (73 FR 70732– for listing. A PSO can be ‘‘delisted’’ if the technology family to Concortis, Inc.
70814), provide for the formation of it is found to no longer meet the The patent rights in these inventions
Patient Safety Organizations (PSOs), requirements of the Patient Safety Act have been assigned to the Government
which collect, aggregate, and analyze and Patient Safety Rule, when a PSO of the United States of America. The
confidential information regarding the chooses to voluntarily relinquish its prospective start-up exclusive
quality and safety of healthcare status as a PSO for any reason, or when commercial license territory may be
delivery. The Patient Safety Rule the PSO’s listing expires. Section worldwide and the field of use may be
authorizes AHRQ, on behalf of the limited to the development of 5T4
3.108(d) of the Patient Safety Rule
Secretary of HHS, to list as a PSO an antibody drug conjugate therapeutics for
requires AHRQ to provide public notice
entity that attests that it meets the the treatment of human cancers using
when it removes an organization from Concortis’ proprietary conjugation
statutory and regulatory requirements
the list of federally approved PSOs. technologies.
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found to no longer Premerus PSO, LLC, PSO number
P0120, a component entity of Premerus, DATES: Only written comments and/or
meet the requirements of the Patient applications for a license which are
Safety Act and Patient Safety Rule, Inc., chose to let its listing expire by not
seeking continued listing. Accordingly, received by the NIH Office of
when a PSO chooses to voluntarily Technology Transfer on or before April
relinquish its status as a PSO for any Premerus PSO, LLC was delisted
7, 2015 will be considered.
reason, or when a PSO’s listing expires. effective at 12:00 Midnight ET (2400) on
ADDRESSES: Requests for copies of the
The listing from the Premerus PSO, LLC January 10, 2015.
patent applications, inquiries,
has expired and AHRQ has delisted the More information on PSOs can be comments, and other materials relating
PSO accordingly. obtained through AHRQ’s PSO Web site to the contemplated exclusive
DATES: The directories for both listed at http://www.pso.AHRQ.gov/ evaluation option license should be
and delisted PSOs are ongoing and index.html. directed to: Whitney Hastings, Ph.D.,
reviewed weekly by AHRQ. The Dated: March 17, 2015. Senior Licensing and Patenting
delisting was effective at 12:00 Midnight Manager, Office of Technology Transfer,
mstockstill on DSK4VPTVN1PROD with NOTICES
ET (2400) on January 10, 2015. Sharon B. Arnold,
National Institutes of Health, 6011
ADDRESSES: Both directories can be Deputy Director, AHRQ.
Executive Boulevard, Suite 325,
accessed electronically at the following [FR Doc. 2015–06454 Filed 3–20–15; 8:45 am] Rockville, MD 20852–3804; Telephone:
HHS Web site: http:// BILLING CODE 4160–90–P (301) 451–7337; Facsimile: (301) 402–
www.pso.AHRQ.gov/index.html. 0220; Email: hastingw@mail.nih.gov.
FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: 5T4 is an
Eileen Hogan, Center for Quality antigen expressed in a number of
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![Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices 15221
carcinomas. Its expression is limited in not be made available for public that fall under the GDTA contract. This
normal tissue, but is prevalent in inspection and, to the extent permitted currently only includes discretionary
malignant tumors throughout their by law, will not be released under the grants but is expected to include block
development. This confined expression Freedom of Information Act, 5 U.S.C. grants in future years. Training and
makes it an attractive target for cancer 552. technical assistance from the GDTA
immunotherapy. 5T4 is often found in Dated: March 17, 2015. contract will focus on helping grantees
colorectal, ovarian, and gastric tumors Richard U. Rodriguez, use their Government and Performance
and thus has been used as a prognostic Acting Director, Office of Technology
Results Act of 1993 (GPRA) data for
aid for these cancers. In addition, its Transfer, National Institutes of Health. performance management and
role in antibody-directed [FR Doc. 2015–06488 Filed 3–20–15; 8:45 am]
monitoring, and services improvement.
immunotherapy for delivering response The information being collected in this
BILLING CODE 4140–01–P
modifiers to tumors has been studied needs assessment will inform CBHSQ
using murine monoclonal antibodies regarding the types of activities
(mAbs) and the cancer vaccine TroVax DEPARTMENT OF HEALTH AND SAMHSA’s grants use their funding for
(currently in clinical trials for multiple HUMAN SERVICES and what types of training activities
solid tumors) targets 5T4. The present they would like to receive in the future.
invention describes the identification Substance Abuse and Mental Health Description of Forms: Forms will
and characterization of two fully human Services Administration include two questions. The first
mAbs (m1001 and m1002) that bind to question asks about the services
5T4. Since the mAbs are fully human, Agency Information Collection provided under the grant. Answer
they could have less immunogenicity Activities: Submission for OMB options include activities such as
and better safety profiles than the Review; Comment Request behavioral health care services,
existing mouse and humanized Periodically, the Substance Abuse and screening, prevention activities, and
antibodies. Mental Health Services Administration services to specific populations. The
The prospective start-up exclusive (SAMHSA) will publish a summary of second question asks respondents to
commercial license is being considered information collection requests under identify topics for training and technical
under the small business initiative OMB review, in compliance with the assistance they would like to receive
launched on October 1, 2011 and will Paperwork Reduction Act (44 U.S.C. from a pre-populated list. Answer
comply with the terms and conditions Chapter 35). To request a copy of these options include items such as data
of 35 U.S.C. 209 and 37 CFR part 404. documents, call the SAMHSA Reports collection, data entry, and using data in
The prospective start-up exclusive Clearance Officer on (240) 276–1243. creative ways. Both questions have an
commercial license may be granted option for respondents to write-in an
unless within fifteen (15) days from the Project: Grantee Data Technical answer that is not included in the list.
date of this published notice, the NIH Assistance (GDTA) Training Needs Description of Respondents: The
receives written evidence and argument Assessment Survey for SAMHSA respondent universe for this data
that establishes that the grant of the Grantees-NEW collection effort is one Project Director
license would not be consistent with the In 2014, the Center for Behavioral from each SAMHSA-funded grants
requirements of 35 U.S.C. 209 and 37 Health Statistics and Quality (CBHSQ) being served by the GDTA contract. This
CFR part 404. funded the GDTA contract to provide currently only includes discretionary
Any additional, properly filed, and training and technical assistance to all grants but is expected to include block
complete applications for a license in grantees receiving funding from the grants in future years. There are
the field of use filed in response to this Center for Substance Abuse Treatment currently 2,670 SAMHSA-funded
notice will be treated as objections to (CSAT), the Center for Mental Health discretionary grants served by the GDTA
the grant of the contemplated exclusive Services (CMHS), and some grantees contract, therefore this is the number of
commercial license. Comments and receiving funding from the Center for respondents expected for this data
objections submitted to this notice will Substance Abuse Prevention (CSAP) collection effort.
TABLE 1—ANNUAL BURDEN ESTIMATE
Annual
Number of Total annual Hours per Total annual
Form name responses per
respondents responses response hour burden
respondent
Grantee Needs Assessment ................................................ 2,670 1 2,670 0.1 267
Written comments and their comments to OMB via email to: Affairs, New Executive Office Building,
recommendations concerning the OIRA_Submission@omb.eop.gov. Room 10102, Washington, DC 20503.
proposed information collection should Although commenters are encouraged to
Summer King,
be sent by April 22, 2015 to the send their comments via email,
SAMHSA Desk Officer at the Office of commenters may also fax their Statistician.
mstockstill on DSK4VPTVN1PROD with NOTICES
Information and Regulatory Affairs, comments to: 202–395–7285. [FR Doc. 2015–06532 Filed 3–20–15; 8:45 am]
Office of Management and Budget Commenters may also mail them to: BILLING CODE 4162–20–P
(OMB). To ensure timely receipt of Office of Management and Budget,
comments, and to avoid potential delays Office of Information and Regulatory
in OMB’s receipt and processing of mail
sent through the U.S. Postal Service,
commenters are encouraged to submit
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Document Created: 2018-02-21 09:47:47
Document Modified: 2018-02-21 09:47:47
| 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. | |
| Dates | Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 7, 2015 will be considered. | |
| FR Citation | 80 FR 15220 |
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