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Department: DEPARTMENT OF HEALTH AND HUMAN SERVICES

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51. Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Post-Approval Studies Imposed

NOTICES: Post-approval studies imposed by premarket approval application order; handling procedures,

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Procedures for Handling Post Approval Studies Imposed by PMA Order.'' The guidance provides a standard format and content for submitting postapproval studies. The guidance is issued to help ensure that sponsors provide adequate information about the
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

52. Agency Information Collection Activities: Proposed Collection; Comment Request

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

53. Office of the National Coordinator for Health Information Technology; American Health Information Community

NOTICES: American Health Information Community,

This notice announces the first meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.)
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

54. Office of the National Coordinator for Health Information Technology; American Health Information Community

NOTICES: American Health Information Community,

This notice announces the 13th meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.).
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

55. Office of the National Coordinator for Health Information Technology, American Health Information Community

NOTICES: American Health Information Community,

This notice announces the sixth meeting of the American Health Information Community Confidentiality, Privacy and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92 463, 5 U.S.C., App.).
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

56. Office of the National Coordinator for Health Information Technology, American Health Information Community Chronic

NOTICES: American Health Information Community,

This notice announces the 12th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92463, 5 U.S.C., App.).
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

57. Office of the National Coordinator; American Health Information Community Electronic Health Records Workgroup Meeting

NOTICES: American Health Information Community,

This notice announces the 12th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92463, 5 U.S.C., App.).
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

58. Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer

NOTICES: American Health Information Community,

This notice announces the 13th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92463, 5 U.S.C., App.).
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

59. Office of the National Coordinator for Health Information Technology; American Health Information Community Quality

NOTICES: American Health Information Community,

This notice announces the fifth meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92463, 5 U.S.C., App.).
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

60. Contracts Under the Indian Self-Determination and Education Assistance Act; Change of Address for the Civilian Board

RULES: Civilian Board of Contract Appeals; address change,

The Indian Health Service is revising its regulations governing contracts under the Indian SelfDetermination and Education Assistance Act to reflect a change of address due to a move for the Civilian Board of Contract Appeals (CBCA).

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Indian Health Service

61. OFFICE OF INSPECTOR GENERAL

NOTICES: Evaluation and Inspections Office et al.,


Statement of Organization, Functions, and Delegations of

Authority

This notice amends Part A (Office of the Secretary), chapter AF of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS) to reflect title changes and responsibilities within the Office of Inspector

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Inspector General Office, Health and Human Services Department

62. Agency Forms Undergoing Paperwork Reduction Act Review

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6395960 or send an email

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

63. Uniform Compliance Date for Food Labeling Regulations

RULES: Food labeling—; Uniform compliance date,

The Food and Drug Administration (FDA) is establishing January 1, 2010, as the uniform compliance date for food labeling regulations that are issued between January 1, 2007, and December 31, 2008. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On March 14,
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

64. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

65. Proposed Data Collections Submitted for Public Comment and Recommendations

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

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 Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

66. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

67. Proposed Data Collections Submitted for Public Comment and Recommendations

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

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 Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

68. Marketed Unapproved Drugs; Public Workshop; Change of Meeting Location and Time

NOTICES: Marketed unapproved drugs application process; workshop,

The Food and Drug Administration (FDA) is announcing a change of location and time for the upcoming public workshop on marketed unapproved drugs. Registration for the public workshop is closed. A new address and time are given for those persons who have previously registered with FDA.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

69. Government-Owned Inventions; Availability for Licensing

NOTICES: Inventions, Government-owned; 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 federallyfunded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies
DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

70. Government-Owned Inventions; Availability for Licensing

NOTICES: Inventions, Government-owned; 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 federallyfunded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies
DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

71. National Center for Complementary & Alternative Medicine; Notice of Meeting

NOTICES: National Center for Complementary and Alternative Medicine,

Pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the National Advisory Council for Complementary and Alternative Medicine (NACCAM) meeting.

The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

72. 315, 316, 319, 323, 324, 325, 330, 332, 333, 334, 335, 339, 342, 352, and 370

Part III: Health and Human Services Department,

The Department of Health and Human Services is amending its acquisition regulations (HHSAR) to make administrative and editorial changes to reflect organizational title changes resulting from Office of the Secretary (OS) and Operating Division (OPDIV) reorganizations and to update or remove outdated text and references. The intent of the final
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Treasury Department

73. National Institute of Allergy and Infectious Diseases; Notice of Meetings

NOTICES: National Institute of Allergy and Infectious Diseases,

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of meetings of the National Advisory Allergy and Infectious Diseases Council.

The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

74. National Institute of Allergy and Infectious Diseases; Notice of Meetings

NOTICES: National Institute of Allergy and Infectious Diseases,

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the meetings of the AIDS Research Advisory Committee, NIAID.

The meetings will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

75. Prospective Grant of Exclusive License: Immunoconjugates Having High Binding Affinity

NOTICES: Cambridge Antibody Technology, Ltd.,

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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent No. 7,081,518, issued July 25, 2006, entitled ``AntiMesothelin Antibodies
DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

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