Department of Health and Human Services August 2009 – Federal Register Recent Federal Regulation Documents
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Current List of Laboratories 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 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).
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
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:
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
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
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.
Proposed Collection; Comment Request; Evaluation of the NIAID HIV Vaccine Research Education Initiative
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)
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
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
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-October 21, 2009
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, October 21, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of catheter ablation for the treatment of atrial fibrillation. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Notice of Availability of Draft Policy Document for Comment
HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the PIN referenced above. Comments will be reviewed and analyzed, and a summary and general response will be published as soon as possible after the deadline for receipt of comments.
Medicare and Medicaid Programs; Application of the American Osteopathic Association for Continued Deeming Authority for Hospitals
This notice announces our decision to approve the American Osteopathic Association (AOA) for continued recognition as a national accreditation program for hospitals seeking to participate in the Medicare or Medicaid programs.
Medicare Program; Request for Nominations for the Advisory Panel on Medicare Education
This notice requests nominations for individuals to serve on the Advisory Panel on Medicare Education (the Panel) to fill current vacancies and vacancies that will become available in 2009. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the effectiveness of consumer education strategies concerning the Medicare program.
Interagency Risk Assessment of the Public Health Impact From Foodborne Listeria monocytogenes in Some Ready-to-Eat Foods Sliced, Prepared, and/or Packaged in Retail Facilities; Request for Comments and for Scientific Data and Information; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until September 29, 2009, the comment period for the notice published in the Federal Register of January 21, 2009 (74 FR 3617). In that document, FDA requested comments and scientific data and information that would assist in the conduct of a risk assessment of the public health impact of foodborne Listeria monocytogenes in some ready-to-eat foods sliced, prepared, and/or packaged in retail facilities. The risk assessment is being conducted by FDA in collaboration with the Food Safety and Inspection Service (FSIS). The agency is reopening the comment period because FDA and FSIS held a public meeting on June 23, 2009, to present the background, approach, scope, and data needs for the recently initiated interagency risk assessment (74 FR 27276; June 9, 2009) and this additional time will allow for public comment after this meeting.
Memorandum of Understanding Between the Food and Drug Administration, National Center for Toxicological Research, and the Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate, Biosciences and Protection Division, for Toxicity of Nanomaterials
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Air Force Research Laboratory. This Memorandum of Understanding (MOU) between the Food and Drug Administration, National Center for Toxicological Research (NCTR), and the Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate, Biosciences and Protection Division, Applied Biotechnology Branch (711 HPW/RHPB) (hereinafter referred to as ``the Parties''), sets forth the agreement of the Parties to facilitate information sharing in the area of toxicogenomic and computational toxicology research. Through the exchange of information, the Parties intend to coordinate research efforts so as to identify and expedite research and development of new tools and technologies that can be implemented that promote new understanding of the mechanisms of biological responses to environmental stressors, including toxic injury, and to identify biomarkers of exposure and disease that can be used to improve and protect human health.
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Fiscal Year 2010 Rates; and Changes to the Long-Term Care Hospital Prospective Payment System and Rate Years 2010 and 2009 Rates
We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems, and to implement certain provisions made by the TMA, Abstinence Education, and QI Program Extension Act of 2007, the Medicare Improvements for Patients and Providers Act of 2008, and the American Recovery and Reinvestment Act of 2009. In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capital-related costs. These changes are applicable to discharges occurring on or after October 1, 2009. We also are setting forth the update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The updated rate-of- increase limits are effective for cost reporting periods beginning on or after October 1, 2009.
Electronic Public Comment Transmission Error for Two Medicare Program Rules
This document requests that the public resubmit their comments on the CY 2010 Physician Fee Schedule or CY 2010 Hospital Outpatient Prospective Payment System/Ambulatory Surgical Center Payment System proposed rule before the close of the comment period for these rules (that is, August 31, 2009) if their comments were originally submitted via www.regulations.gov during the period from July 26, 2009 through July 30, 2009.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should e-mail nvpo@hhs.gov, call 202-690-5566, or complete the on-line form on the NVAC Web site (https:// www.hhs.gov/nvpo/nvac/.) to register.
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