Department of Health and Human Services April 5, 2011 – Federal Register Recent Federal Regulation Documents
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Prospective Grant of Exclusive License: Device and System for Two Dimensional Analysis of Biomolecules From Tissue and Other Samples
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 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 PCT Patent Application No. PCT/US03/37208 [HHS Ref. No. E-339-2002/0-PCT- 02], filed November 20, 2003, which published as WO 2004/048928 on June 10, 2004, now expired, entitled ``Method And Apparatus for Performing Multiple Simultaneous Manipulations of Biomolecules In a Two- Dimensional Array;'' U.S. Patent Application No. 10/535,521 [HHS Ref. No. E-339-2002/0-US-03], filed May 18, 2005, now abandoned, which published as US-2006-0147926 A1 on July 6, 2006 entitled ``Method And Apparatus for Performing Multiple Simultaneous Manipulations of Biomolecules In a Two-Dimensional Array;'' U.S. Patent Application No. 12/587,976 [HHS Ref. No. E-339-2002/0-US-04], filed October 14, 2009, which published as US-2010-010506 on April 29, 2010 entitled ``Device for External Movement Manipulation of Nucleic Acids and/or Proteins;'' U.S. Provisional Patent Application No. 61/206,458 [HHS Ref. No. E-130- 2006/0-US-01] filed January 30, 2009, entitled, ``Amplification Platform and Methods of Use Thereof, now expired, and PCT Patent Application No. PCT/US10/022586 [HHS Ref. No. E-130-2006/0-PCT-02] filed January 29, 2010 and which published as WO 2010/088517 on August 5, 2010, entitled, ``Methods and Systems for Purifying, Transferring and/or Manipulating Nucleic Acids;'' and all continuing applications and foreign counterparts to 2-D Bio, LLC, having a place of business in Gaithersburg, Maryland. The patent rights in these inventions have been assigned to the United States of America. However, the patent rights for HHS Ref. No. E-130-2006/0-US-01 and HHS Ref. No. E-130-2006/0-PCT- 02 are co-owned and co-assigned to the University of Maryland. The United States of America has obtained an exclusive license to the University of Maryland's rights in the invention. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to ``development of devices for sale and services for high throughput parallel analysis and two dimensional analyses of molecules for all uses.''
Oral Dosage Form New Animal Drugs; Robenacoxib
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of robenacoxib tablets in cats for the control of postoperative pain and inflammation.
Federal Monitoring of Child and Family Service Programs; Request for Public Comment and Consultation Meetings
The Children's Bureau is interested in improving the process by which we review title IV-B and IV-E plan requirements. CB currently reviews a State's compliance through Child and Family Service Reviews (CFSRs). Following two rounds of CFSRs in every State and the passage of several amendments to Federal child welfare laws since the CFSRs began, we believe it is time to reassess how CB reviews title IV-B and IV-E programs through the CFSR and identify enhancements and system improvements we could make.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2011. To fill these positions, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Preparation for International Cooperation on Cosmetics Regulations; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulations (ICCR)Preparation for ICCR-5 Meeting in Paris, France'' to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Paris, France. The topics to be discussed are the topics for discussion at the forthcoming ICCR Steering Committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working group meetings in Paris, France scheduled on June 28 through July 1, 2011.
Early Retiree Reinsurance Program
This notice announces that CMS is exercising its authority under section 1102(f) of the Affordable Care Act to stop accepting applications for the Early Retiree Reinsurance Program, due to the availability of funds, as of May 5, 2011.
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