Prospective Grant of Exclusive License: Use of PKM2 Activators for the Treatment of Cancer, 48172-48173 [2011-20003]

Download as PDF 48172 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices E-mail comments to paperwork@hrsa.gov or mail to the HRSA Reports Clearance Officer, Room 10–33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 30 days of this notice. Dated: August 2, 2011. Reva Harris, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2011–20077 Filed 8–5–11; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Reports Clearance Officer at (301) 443– 1129. Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the Agency; (b) the accuracy of the Agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: National Sample Survey of Nurse Practitioners (OMB No. 0915–xxxx)–[NEW] Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, e-mail paperwork@hrsa.gov or call the HRSA The number of Nurse Practitioners (NP) in the United States has been growing rapidly over the past decade and continued growth is expected as the annual number of graduates of NP programs is at an all time high. Furthermore, over the past 20 years, many regulatory and financial barriers to using NPs have been removed. The expansion of health insurance under the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111–148) will also increase the demand for services. With increasing numbers, NPs are poised to play a critical role in the nation’s efforts to expand access to health care services. Despite the increasing number and role of NPs, unfortunately, there is currently only limited, inconsistent data available to policy makers and the health care community. Accordingly, it is difficult for these leaders to quantify Number of respondents Instrument Responses per respondent or fully understand the role of NPs in the current or future health care system. In fact, it is difficult to project with confidence the number of NPs practicing in the United States today. The primary purpose of the Bureau of Health Professions’ National Sample Survey of Nurse Practitioners data collection is to: (1) Improve estimates of NPs providing services; (2) describe the settings where NPs are working; (3) identify the positions/roles in which NPs are working; (4) describe the activities and services NPs are providing in the healthcare workforce; (5) determine the specialties in which NPs are working; (6) explore NPs’ satisfaction with and perception of the extent to which they are working to their full scope of practice; and (7) assess variations in practice settings, positions, and practice patterns by demographic and educational characteristics. The statutory provision that authorizes this data collection is section 761 of the Public Health Service Act, ‘‘Health Professions Workforce Information and Analysis,’’ which is codified at 42 U.S.C. 294n. The information obtained from this survey will ultimately lead to more accurate and complete national estimates of the current NP supply, as well as assist in the development of more accurate supply and demand projections for NPs. This, in turn, is likely to influence decisions regarding both the educational capacity and the number of NP programs at the national level. The annual estimate of burden is as follows: Total responses Hours per response Total burden hours National Sample Survey of Nurse Practitioners .................. 10,000 1 10,000 .33 3,300 Total .............................................................................. 10,000 ........................ 10,000 ........................ 3,300 mstockstill on DSK4VPTVN1PROD with NOTICES E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports Clearance Officer, Room 10–33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: August 2, 2011. Reva Harris, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2011–20000 Filed 8–5–11; 8:45 am] BILLING CODE 4165–15–P VerDate Mar<15>2010 18:57 Aug 05, 2011 Jkt 223001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Use of PKM2 Activators for the Treatment of Cancer National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 61/104,091, entitled ‘‘Activators of Human Pyruvate Kinase,’’ filed October 9, 2008, now abandoned [HHS Ref. No. E–326–2008/0–US–01]; PCT/US2009/60237 Application entitled ‘‘Small Molecule Activators of Pyruvate Kinase,’’ filed October 9, 2009, now abandoned [HHS Ref. No. E–326– 2008/0–PCT–02]; EP Application No. 09740795.1, entitled ‘‘Small Molecule Activators of Pyruvate Kinase,’’ filed October 9, 2009 [HHS Ref. No. E–326– 2008/0–EP–05]; U.S. Non-Provisional Application No. 13/123,297, entitled E:\FR\FM\08AUN1.SGM 08AUN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices ‘‘Small Molecule Activators of Pyruvate Kinase,’’ filed April 8, 2011 [HHS Ref. No. E–326–2008/0–US–07]; Australian National Application No. 2009303335, entitled ‘‘Small Molecule Activators of Pyruvate Kinase,’’ filed October 9, 2010 [HHS Ref. No. E–326–2008/0–AU–03]; Canadian National Application, entitled ‘‘Small Molecule Activators of Pyruvate Kinase,’’ filing date pending [HHS Ref. No. E–326–2008/0–CA–04]; Japanese National Application, entitled ‘‘Small Molecule Activators of Pyruvate Kinase,’’ filing date pending [HHS Ref. No. E–326–2008/0–JP–06]; U.S. Provisional Patent Application No. 61/ 329,158, entitled ‘‘Pyruvate Kinase M2 Activators for the Treatment of Cancer,’’ filed April 29, 2010, now abandoned [HHS Ref. No. E–120–2010/0–US–01]; and PCT Application PCT/US2011/ 033852 entitled ‘‘Pyruvate Kinase M2 Activators for the Treatment of Cancer,’’ filed April 26, 2011 [HHS Ref. No. E– 120–2010/0–PCT–02] to Forma Therapeutics, Inc., having an office at 790 Memorial Drive, Cambridge, MA 02139. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of PKM2 activators as human therapeutics for the treatment of cancer. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before September 7, 2011 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Steven Standley, PhD, Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 4074; Facsimile: (301) 402–0220; E-mail: sstand@od.nih.gov. SUPPLEMENTARY INFORMATION: The fetal form of Pyruvate Kinase, called PKM2, is expressed in all cancer cells and imparts an important metabolic change on cancer cells which allows them to grow and divide rapidly. That is, PKM2 is normally inactive, which allows cancer cells to create an abundance of molecules for cellular growth and division. The products and methods sought in the prospective license activate PKM2 and result in inhibition of tumor development. This invention relates to products and methods of administering PKM2 activators of various types and methods VerDate Mar<15>2010 18:57 Aug 05, 2011 Jkt 223001 of treating cancer and diseases susceptible to PKM2 activators. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless within thirty (30) 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 404.7. 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 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: August 2, 2011. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2011–20003 Filed 8–5–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Fiscal Year (FY) 2011 Funding Opportunity Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice of intent to award a Single Source Grant to the Health Service Center, Inc., Anniston, AL. AGENCY: This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $300,000 (total costs) per year for up to four years to the Health Service Center, Inc., Anniston, AL. This is not a formal request for applications. Assistance will be provided only to the Health Service Center, Inc., Anniston, AL, based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SP–11– 005. SUMMARY: Catalog of Federal Domestic Assistance (CFDA) Number: 93.243 apply. The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Prevention (CSAP) is seeking to award a single source grant to the Health Service Center, Inc., Anniston, AL, for the Capacity Building Initiative (CBI). CBI is one of CSAP’s Minority AIDS Initiative (MAI) programs. The purpose of the MAI is to provide substance abuse and HIV prevention services to at-risk minority populations in communities disproportionately affected by HIV/ AIDS. The purpose of the CBI program is to support an array of activities to assist grantees in building a solid foundation for delivering and sustaining quality and accessible state of the science substance abuse and HIV prevention services. Specifically, the program aims to engage colleges, universities and community-level domestic public and private non-profit entities to prevent and reduce the onset of SA and transmission of HIV/AIDS among at-risk racial/ethnic minority young adults, ages 18–24. The Health Service Center, Inc., Anniston, AL, was funded under the SP–10–004 CBI Initiative in FY 2010. At that time, the Health Services Center, Inc. proposed a 5-year program in their grant application, but inadvertently requested one year of funding rather than the full program funding period of 5 years. It was clear from language in the original application (which specifically referred to individual years of the program, and numbers served throughout the project) that the grantee intended to apply for funding for the full five years. The purpose of this sole source award is to fund the 4 out years of the 5 year cooperative agreement awarded under the initial announcement. SAMHSA will not accept an application from any other entity. FOR FURTHER INFORMATION CONTACT: Shelly Hara, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 8–1095, Rockville, MD 20857; telephone: (240) 276–2321; E-mail: shelly.hara@samhsa.hhs.gov. Cathy Friedman, Public Health Analyst, SAMHSA . [FR Doc. 2011–19965 Filed 8–5–11; 8:45 am] BILLING CODE 4162–20–P Authority: Section 516 of the Public Health Service Act, as amended. Justification: Only the Health Service Center, Inc., Anniston, AL, is eligible to PO 00000 Frm 00057 Fmt 4703 Sfmt 9990 48173 E:\FR\FM\08AUN1.SGM 08AUN1

Agencies

[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48172-48173]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20003]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of PKM2 Activators 
for the Treatment of Cancer

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive patent license to practice the inventions embodied in U.S. 
Provisional Patent Application No. 61/104,091, entitled ``Activators of 
Human Pyruvate Kinase,'' filed October 9, 2008, now abandoned [HHS Ref. 
No. E-326-2008/0-US-01]; PCT/US2009/60237 Application entitled ``Small 
Molecule Activators of Pyruvate Kinase,'' filed October 9, 2009, now 
abandoned [HHS Ref. No. E-326-2008/0-PCT-02]; EP Application No. 
09740795.1, entitled ``Small Molecule Activators of Pyruvate Kinase,'' 
filed October 9, 2009 [HHS Ref. No. E-326-2008/0-EP-05]; U.S. Non-
Provisional Application No. 13/123,297, entitled

[[Page 48173]]

``Small Molecule Activators of Pyruvate Kinase,'' filed April 8, 2011 
[HHS Ref. No. E-326-2008/0-US-07]; Australian National Application No. 
2009303335, entitled ``Small Molecule Activators of Pyruvate Kinase,'' 
filed October 9, 2010 [HHS Ref. No. E-326-2008/0-AU-03]; Canadian 
National Application, entitled ``Small Molecule Activators of Pyruvate 
Kinase,'' filing date pending [HHS Ref. No. E-326-2008/0-CA-04]; 
Japanese National Application, entitled ``Small Molecule Activators of 
Pyruvate Kinase,'' filing date pending [HHS Ref. No. E-326-2008/0-JP-
06]; U.S. Provisional Patent Application No. 61/329,158, entitled 
``Pyruvate Kinase M2 Activators for the Treatment of Cancer,'' filed 
April 29, 2010, now abandoned [HHS Ref. No. E-120-2010/0-US-01]; and 
PCT Application PCT/US2011/033852 entitled ``Pyruvate Kinase M2 
Activators for the Treatment of Cancer,'' filed April 26, 2011 [HHS 
Ref. No. E-120-2010/0-PCT-02] to Forma Therapeutics, Inc., having an 
office at 790 Memorial Drive, Cambridge, MA 02139. The patent rights in 
these inventions have been assigned to the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the use of PKM2 activators as human 
therapeutics for the treatment of cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
September 7, 2011 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Steven Standley, PhD, Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-4074; Facsimile: (301) 402-0220; E-mail: 
sstand@od.nih.gov.

SUPPLEMENTARY INFORMATION: The fetal form of Pyruvate Kinase, called 
PKM2, is expressed in all cancer cells and imparts an important 
metabolic change on cancer cells which allows them to grow and divide 
rapidly. That is, PKM2 is normally inactive, which allows cancer cells 
to create an abundance of molecules for cellular growth and division. 
The products and methods sought in the prospective license activate 
PKM2 and result in inhibition of tumor development.
    This invention relates to products and methods of administering 
PKM2 activators of various types and methods of treating cancer and 
diseases susceptible to PKM2 activators.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless within thirty 
(30) 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 404.7.
    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 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: August 2, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-20003 Filed 8-5-11; 8:45 am]
BILLING CODE 4140-01-P

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