Department of Health and Human Services June 5, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Prospective Grant of Co-Exclusive License: Human Monoclonal Antibody, Their Fragments and Derivatives as Biotherapeutics for the Treatment of HIV Infections
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 (NIH), Department of Health and Human Services, is contemplating the grant of a co-exclusive license to practice the inventions embodied in: 1. U.S. Provisional Patent Application Serial No. S/N 60/378,406, PCT/US03/14905, NIH (DHHS) Ref. No. E-144-2002/1-PCT-02 converted into 03733940.5 (E-144-2002/1-EP-04) filed in Europe on November 25, 2004, and 2003239356 (E-144-2002/1-AU-05) filed in Australia October 29, 2004, 10/512,966 (E-144-2002/1-US-03) filed in USA October 28, 2004, as well as 2485120 (E-144-2002/1-CA-06) filed in Canada May 6, 2003, entitled: ``Identification of Novel Broadly Cross-Reactive Neutralizing Human Monoclonal Antibodies''. Inventor(s): Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC). 2. U.S. Patent Application, S/N 60/506,946 (E-316-2003/0-US-01), PCT/US2004/31878 (E-316-2003/0-PCT-02) entered the national stage filing on March 29, 2006 in USA (E-316-2003/0-US-03), in Canada (E-316- 2003/0-CA-04), in Europe (E-316-2003/0-EP-05), and in Australia (E-316- 2003/0-AU-06), entitled: ``Immunoglobulins With Potent and Broad Antiviral Activity''. Inventor(s): Dimiter S. Dimitrov (NCI) and Mei- Yun Zhang (SAIC) to Virosys Pharmaceuticals Inc. (hereafter Virosys) having a place of business in Los Altos Hills, California, and Profectus Biosciences, Inc. (hereafter Profectus) having a place of business in Baltimore, Maryland. The patent rights in these inventions have been assigned to the United States of America.
Proposed Collection; Comment Request; NCCAM Customer Service Data Collection
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Complementary and Alternative Medicine (NCCAM), the National Institutes of Health (NIH), will submit to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. A notice of this proposed information collection was previously published in the Federal Register on February 22, 2006, pages 9135- 9136. To date, no public comments have been received. The purpose of this notice is to announce a final 30 days for public comment. NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: NCCAM Customer Service Data Collection. Type of Information Collection Request: Renewal. Need and Use of Information Collection: NCCAM provides the public, patients, families, health care providers, complementary and alternative medicine (CAM) practitioners, and others with the latest scientifically based information on CAM and information about NCCAM's programs through a variety of channels, including its toll-free telephone information service and its quarterly newsletter. NCCAM wishes to continue to measure customer satisfaction with NCCAM telephone interactions and the NCCAM newsletter and to assess which audiences are being reached through these channels. This effort involves a telephone survey consisting of 10 questions, which 25 percent of all callers are asked to answer, for an annual total of approximately 1,210 respondents, and a newsletter survey consisting of 10 questions, which is sent to all U.S.-based print newsletter subscribers and which Web users have the option of completing when they exit the page where the latest issue of the newsletter is posted, for an annual total of approximately 839 respondents. NCCAM uses the data collected from the surveys to help program staff measure the impact of their communication efforts, tailor services to the public and health care providers, measure service use among special populations, and assess the most effective media and messages to reach these audiences. Frequency of Response: Once for the telephone survey and periodically for the newsletter survey (to measure any changes in customer satisfaction). Affected Public: Individuals and households. Type of Respondents: For the telephone survey, patients, spouses/family/friends of patients, health care providers, physicians, CAM practitioners, or other individuals contacting the NCCAM Clearinghouse; for the newsletter survey, subscribers to the print NCCAM newsletter and visitors to the newsletter page on NCCAM's Web site. The annual reporting burden is as follows:
Prospective Grant of Exclusive License: GLP-1 Exendin-4 Peptide Analogs and Uses Thereof
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 (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in U.S. Patent Application Number 10/485,140 filed January 27, 2004, entitled ``GLP-1 Exendrin-4 Peptide Analogs and Uses Thereof,'' to Amylin Pharmaceuticals, Inc., having a place of business in San Diego, CA 92121. The contemplated exclusive license may be limited to use to human therapeutics for diabetes, obesity and cardiovascular disease, as well as neurological and neurodegenerative diseases, disorders and injuries. The United States of America is the assignee of the patent rights in this invention.
National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Draft NTP Brief on Di-(2-ethylhexyl) phthalate; Request for Public Comments
CERHR invites the submission of public comments on the draft NTP Brief for di-(2-ethylhexyl)phthalate (DEHP). The draft NTP Brief is available from the CERHR Web site (https://cerhr.niehs.nih.gov see ``CERHR Reports & Monographs'') or in hardcopy from CERHR (see ADDRESSES below). Public comments will be considered during the peer review and finalization of the NTP Brief.
Notice of Public Input Opportunity
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following: Availability of opportunity for the Public to Provide Input on a proposed Web based document:
Notice of Public Input Opportunity
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following: Availability of opportunity for the Public to provide input on a proposed document:
Guidance for Industry on Antiviral Product Development-Conducting and Submitting Virology Studies to the Agency; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Antiviral Product DevelopmentConducting and Submitting Virology Studies to the Agency.'' The purpose of this guidance is to assist sponsors in developing and submitting nonclinical and clinical virology data, which are important to support clinical trials of antiviral products. Nonclinical and clinical virology reports are essential components in the review of investigational antiviral products. The information in this guidance will facilitate the development of antiviral products.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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