Department of Health and Human Services August 31, 2009 – Federal Register Recent Federal Regulation Documents

Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E9-20967
Type: Notice
Date: 2009-08-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Board on Radiation and Worker Health: Notice of Charter Renewal
Document Number: E9-20958
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc), Centers for Disease Control and Prevention
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: E9-20932
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C 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), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E9-20900
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Decision To Evaluate a Petition To Designate a Class of Employees for the Metals and Controls Corporation in Attleboro, MA, To Be Included in the Special Exposure Cohort
Document Number: E9-20899
Type: Notice
Date: 2009-08-31
Agency: National Institute for Occupational Safety and Health, Department of Health and Human Services
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Metals and Controls Corporation in Attleboro, Massachusetts, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
Board of Scientific Counselors, Coordinating Center for Health Promotion (BSC, CCHP or the BSC)
Document Number: E9-20898
Type: Notice
Date: 2009-08-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
Document Number: E9-20895
Type: Notice
Date: 2009-08-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Office of Research Integrity; Privacy Act of 1974; Report of an Altered System of Records
Document Number: E9-20893
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services
HHS proposes to revise the Privacy Act exempt system of records 09-37-0021, entitled ``Public Health Service Records Related to Inquiries and Investigations of Scientific Misconduct, HHS/OASH/ORI.'' This system became effective on August 29, 1994 (59 FR 36717, July 19, 1994). Changes were made in response to comments received, and the revised systems notice was published on January 6, 1995 (60 FR 2140). The proposed revisions include changing the routine uses and changing the title of the system to ``HHS Records Related to Research Misconduct Proceedings, HHS/OS/ORI.'' The revisions are necessary to reflect the changes made by the Public Health Service Policies on Research Misconduct (``PHS Policies on Research Misconduct''), 42 CFR Part 93 (``Part 93''), and to update the system to reflect current practices and procedures under that regulation.
Request for Nominations to the SAMHSA National Advisory Council
Document Number: E9-20884
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Collection; Comment Request; Evaluation of the NIAID HIV Vaccine Research Education Initiative
Document Number: E9-20882
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Prospective Grant of Exclusive License: Development of Anti-Angiogenesis Cancer Therapeutics Targeting Adrenomedullin or Proadrenomedullin N-Terminal 20 Peptide (PAMP)
Document Number: E9-20881
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, National Institutes of Health
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 patent license to practice the inventions embodied in U.S. Patent Application No. 60/002,514, filed on August 18, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/0-US-01); U.S. Patent Application No. 60/002,936, filed on August 30, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/1-US-01); U.S. Patent Application No. 60/ 013,172, filed on March 12, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/2-US-01); PCT Application No. PCT/US96/13286, filed on August 16, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/3-PCT-01); Australian Patent No. 710662, issued on October 5, 2000, entitled ``Functional Role of Adrenomedullin (AM) and the Gene- Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-AU-02); Canadian Patent Application No. 2229741, filed on August 16, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-CA-03); U.S. Patent No. 6,320,022, issued on November 20, 2001, entitled ``Adrenomedullin Peptides'' (HHS Reference No. E-206-1995/3-US-04); European Patent No. 0845036, issued on June 2, 1999, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/3-EP-07), and validated in France, Germany, and the United Kingdom; Japanese Patent Application No. 509499/97, filed on August 16, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene- Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-JP-09); U.S. Patent No. 7,101,548, issued on September 5, 2006, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-US-10); U.S. Patent Application No. 11/ 517,599, filed on September 5, 2006, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-US-11); Japanese Patent No. 4077861, issued on February 8, 2008, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/3-JP-12); U.S. Patent Application No. 60/153,397, filed on September 10, 1999, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-US-01); PCT Application No. PCT/US00/24722, filed on September 8, 2000, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-PCT-02); Australian Patent No. 774725, issued on May 25, 2004, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E- 256-1999/0-AU-03); Canadian Patent Application No. 2383419, filed on September 8, 2000, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-CA-04); European Patent No. 1214600, issued on December 21, 2005, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E- 256-1999/0-EP-05), and validated in France, Germany, the United Kingdom, Italy, Spain, and Portugal; U.S. Patent Application No. 10/ 070,853, filed on March 8, 2002, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256 091999/0-US-06); U.S. Patent Application No. 11/ 530,411, filed on September 8, 2006, entitled ``Determination of AM- Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-US-13); U.S. Patent Application No. 12/ 236,418, filed on September 23, 2008, entitled ``Determination of AM- Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-US-14); U.S. Patent Application No. 60/ 425,018, filed on November 7, 2002, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294- 2002/0-US-01); PCT Application No. PCT/US03/35633, filed on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-PCT-02); U.S. Patent No. 7,462,593, issued on December 9, 2008, entitled ``Compositions and Methods for Promoting Angiogenesis'' (HHS Reference No. E-294-2002/0- US-03); European Patent Application No. 03786608.4, filed on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-EP-04); Australian Patent Application No. 2003295422, filed on April 18, 2005, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-AU-05); Canadian Patent Application No. 2504953, filed on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti- Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-CA-06); Japanese Patent Application No. 2004-551922, filed on May 9, 2005, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-JP-07); U.S. Patent Application No. 12/ 240,656, filed on September 29, 2008, entitled ``Target for Anti- Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-US-08); U.S. Patent Application No. 60/500,650, filed on September 8, 2003, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/0-US-01); PCT Application No. PCT/US04/29293, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-PCT-01); European Patent Application No. 04783513.7, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-EP-03); Canadian Patent Application No. 2539467, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-CA-04); Australian Patent Application No. 2004273057, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1- AU-05); and U.S. Patent Application No. 10/571,012, filed on March 8, 2006, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1- US-06) to Arana Therapeutics (VIC) Pty. Ltd., having a place of business at Level 5, Building 4, 399 Royal Parade, Parkville, Victoria 3052, Australia, a wholly-owned subsidiary of Arana Therapeutics Limited, having a place of business at Level 2, 37 Epping Road, Macquarie Park, NSW 2113, Australia, a wholly-owned subsidiary of Cephalon, Inc., having a place of business at 41 Moores Road, Frazer, PA 19355, USA. The patent rights in this invention have been assigned to the United States of America.
National Toxicology Program (NTP): Report on Carcinogens (RoC); Availability of the Draft Background Document for Formaldehyde; Request for Comments on the Draft Background Document; Announcement of the Formaldehyde Expert Panel Meeting
Document Number: E9-20878
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services
The NTP announces the availability of the draft background document for formaldehyde by September 3, 2009, on the RoC Web site (https://ntp.niehs.nih.gov/go/29679) or in printed text from the RoC
National Cancer Institute; Notice of Meeting
Document Number: E9-20877
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E9-20876
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E9-20875
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: E9-20874
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: E9-20873
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: E9-20872
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meetings
Document Number: E9-20871
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: E9-20859
Type: Notice
Date: 2009-08-31
Agency: Department of Health and Human Services, National Institutes of Health
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