Department of Health and Human Services August 8, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Prospective Grant of Exclusive License: Use of PKM2 Activators for the Treatment of Cancer
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 ``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.
Andrew K. Choi: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Andrew K. Choi, M.D. for 4 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Choi was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Choi was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Choi failed to respond. Dr. Choi's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Fiscal Year (FY) 2011 Funding Opportunity
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.
Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments device: Cardiovascular permanent pacemaker electrode. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the cardiovascular permanent pacemaker electrode based on new information. This action implements certain statutory requirements.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cooperative Manufacturing Arrangements for Licensed Biologics
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the Cranial Electrotherapy Stimulator. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the cranial electrotherapy stimulator based on new information. This action implements certain statutory requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the blood establishment registration and product listing requirements in the Agency's regulations and Form FDA 2830.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2011 and Proposal for Future Notices
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2011, relating to the Medicare and Medicaid programs and other programs administered by CMS. It also solicits comments on a process that CMS is considering to provide current up-to-date information in a Web friendly format. We are soliciting feedback on options that would improve accessibility and be less burdensome to beneficiaries, providers, and suppliers.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2012
This final rule updates the payment rates used under the prospective payment system for skilled nursing facilities (SNFs) for fiscal year 2012. In addition, it recalibrates the case-mix indexes so that they more accurately reflect parity in expenditures between RUG-IV and the previous case-mix classification system. It also includes a discussion of a Non-Therapy Ancillary component currently under development within CMS. In addition, this final rule discusses the impact of certain provisions of the Affordable Care Act, and reduces the SNF market basket percentage by the multi-factor productivity adjustment. This rule also implements certain changes relating to the payment of group therapy services and implements new resident assessment policies. Finally, this rule announces that the proposed provisions regarding the ownership disclosure requirements set forth in section 6101 of the Affordable Care Act will be finalized at a later date.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
