Department of Health and Human Services March 2009 – Federal Register Recent Federal Regulation Documents

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E9-7227
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: E9-7226
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: E9-7223
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Announcement of an Independent Scientific Peer Review Panel on Alternative Ocular Safety Testing Methods; Availability of Draft Background Review Documents (BRD); Request for Comments
Document Number: E9-7220
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services
NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), announces a public meeting of an independent scientific peer review panel (Panel) on alternative ocular safety testing methods. The Panel will evaluate (1) the validation status of a testing strategy that proposes the use of three in vitro test methods to assess the eye irritation potential of antimicrobial cleaning products (AMCPs), (2) the validation status of four in vitro test methods for identifying moderate (EPA Category II, UN Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Category 2A) and mild (EPA Category III, GHS Category 2B) ocular irritants and substances not classified as ocular irritants (EPA Category IV, GHS Not Classified), (3) the validation status of the in vivo Low Volume Eye Test, and (4) a proposal for the routine use of topical anesthetics, systemic analgesics, and humane endpoints to avoid and minimize pain and distress during in vivo ocular irritation testing.
Government-Owned Inventions; Availability for Licensing
Document Number: E9-7213
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
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.
Prospective Grant of Exclusive License: Orally Active Synthetic Estrogens for Fertility Control, Hormone Replacement Therapy, and Endometriosis
Document Number: E9-7210
Type: Notice
Date: 2009-03-31
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)(1), 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 invention embodied in United States Patent No. 5,554,603, issued September 10, 1996, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-US-01); PCT Application No. PCT/US94/10393, filed September 15, 1994, now expired, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-PCT-02); Australian Patent No. 700576, issued April 22, 1999, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137- 1993/0-AU-03); Canadian Patent No. 2171740, issued July 26, 2005, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-CA-04); European Patent No. 719276, issued November 26, 1997, entitled ``Orally Active Derivatives of 1, 3, 5(10)- Estratriene'' (HHS Ref. No. E-137-1993/0-EP-05) and validated in Austria, Switzerland, Germany, Denmark, Spain, France, Greece, Ireland, Italy, Luxembourg, Monaco, the Netherlands, Portugal, Sweden, Belgium, and Great Britain; and Japanese Patent No. 3993228, issued August 3, 2007, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-JP-06) to Evestra, Inc., having a place of business in San Antonio, Texas. The patent rights in this invention have been assigned to the United States of America.
Government-Owned Inventions; Availability for Licensing
Document Number: E9-7207
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Cancer Institute; Notice of Closed Meetings
Document Number: E9-7206
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: E9-7200
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: E9-7197
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E9-7171
Type: Notice
Date: 2009-03-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Public Health Informatics (BSC, NCPHI)
Document Number: E9-7166
Type: Notice
Date: 2009-03-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medical Devices; Technical Amendment
Document Number: E9-7073
Type: Rule
Date: 2009-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending a medical device regulation to correct a statutory reference to reflect the current citation and to ensure accuracy and clarity in the agency's regulations.
Statement of Organization, Functions and Delegations of Authority
Document Number: E9-6959
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Delegation of Authority
Document Number: E9-6958
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E9-6956
Type: Notice
Date: 2009-03-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``CAHPS Field Test of Proposed Health Information Technology Questions and Methodology.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E9-6955
Type: Notice
Date: 2009-03-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow information collection related to implementation of the Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to 299b-26, in: ``Patient Safety Organization Certification for Initial Listing and Related Forms and a Patient Safety Confidentiality Complaint Form.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: E9-6929
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: E9-6787
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E9-6785
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Amended Notice of Meeting
Document Number: E9-6783
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: E9-6781
Type: Notice
Date: 2009-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: E9-7023
Type: Notice
Date: 2009-03-30
Agency: Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: E9-7021
Type: Notice
Date: 2009-03-30
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Center for Injury Prevention and Control, Initial Review Group, (NCIPC, IRG)
Document Number: E9-7016
Type: Notice
Date: 2009-03-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Injury Prevention and Control Initial Review Group (NCIPC IRG)
Document Number: E9-7014
Type: Notice
Date: 2009-03-30
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc), Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control
Document Number: E9-7010
Type: Notice
Date: 2009-03-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT
Document Number: E9-7002
Type: Notice
Date: 2009-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: E9-6960
Type: Notice
Date: 2009-03-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: E9-6941
Type: Notice
Date: 2009-03-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E9-6939
Type: Notice
Date: 2009-03-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: E9-6938
Type: Notice
Date: 2009-03-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: E9-6936
Type: Notice
Date: 2009-03-30
Agency: Department of Health and Human Services, National Institutes of Health
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.
Government-Owned Inventions; Availability for Licensing
Document Number: E9-6935
Type: Notice
Date: 2009-03-30
Agency: Department of Health and Human Services, National Institutes of Health
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.
Proposed Collection; Comment Request; Generic Clearance to Conduct Voluntary Customer/Partner Surveys
Document Number: E9-6934
Type: Notice
Date: 2009-03-30
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 to provide opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), 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.
Government-Owned Inventions; Availability for Licensing
Document Number: E9-6933
Type: Notice
Date: 2009-03-30
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: E9-6930
Type: Notice
Date: 2009-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E9-6910
Type: Notice
Date: 2009-03-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
Medicaid Program; Premiums and Cost Sharing
Document Number: E9-6907
Type: Rule
Date: 2009-03-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This action temporarily delays the effective date of the November 25, 2008 final rule entitled, ``Medicaid Program; Premiums and Cost Sharing'' (73 FR 71828) until December 31, 2009. In addition, this action reopens the comment period on the policies set out in the November 25, 2008 final rule, and specifically solicits comments on the effect of certain provisions of the American Recovery and Reinvestment Act of 2009.
Deeming Notice for the College of American Pathologists (CAP) as an Accrediting Organization Under the Clinical laboratory Improvement Amendments of 1988
Document Number: E9-6903
Type: Notice
Date: 2009-03-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the application of the College of American Pathologists (CAP) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialties and subspecialties. In this notice, we announce the approval and grant the CAP deeming authority for all CLIA specialties and subspecialties for a period of 6 years. We have determined that the CAP meets or exceeds the applicable CLIA requirements.
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