Health Care - Government
- Notice - Meetings: National Institute of Dental and Craniofacial Research Special Emphasis Panel
National Institutes of Health
Notice
Meetings:
National Institute of Dental and Craniofacial Research Special Emphasis Panel,
28490 [E8-10835]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental and Craniofacial Research; Notice of Closed Meeting 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 following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions... [read document]
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(May 15, 2008) - Notice - Meetings: Center for Scientific Review
National Institutes of Health
Notice
Meetings:
Center for Scientific Review,
28488-28489 [E8-10840]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Pathobiology of Kidney Disease Study Section, June 12, 2008, 8 a.m. to June 13, 2008, 5 p.m., Hotel Deca, 4507 Brooklyn Avenue, NE., Seattle, WA 98105 which was published in the Federal Register on May 2, 2008, 73 FR 24296-24298. The meeting will be held one day only June 12, 2008. The meeting time and location... [read document]
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(May 15, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
28486-28488 [E8-11057]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0073] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of... [read document]
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(May 15, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Centers for Medicare and Medicaid Services
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
28484 [E8-10664]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [Document Identifier: CMS-R-267] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare and Medicaid Services, Department of Health and Human Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services, is... [read document]
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(May 15, 2008) - Notice - Meetings: Board of Scientific Counselors, National Institute of Dental and ...
National Institutes of Health
Notice
Meetings:
Board of Scientific Counselors, National Institute of Dental and Craniofacial Research,
28488 [E8-10836]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental and Craniofacial Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Dental and Craniofacial Research. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section... [read document]
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(May 15, 2008) - Notice - Meetings: National Institute of Mental Health Special Emphasis Panel
National Institutes of Health
Notice
Meetings:
National Institute of Mental Health Special Emphasis Panel,
28491 [E8-10841]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meetings 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 following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose... [read document]
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(May 15, 2008) - Notice - Meetings: Center for Scientific Review Special Emphasis Panel
National Institutes of Health
Notice
Meetings:
Center for Scientific Review Special Emphasis Panel,
28488 [E8-10837]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting 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 following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential... [read document]
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(May 15, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Centers for Disease Control and Prevention
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
28478-28479 [E8-10935]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-08-08BD] Proposed Data Collections Submitted for Public Comment and Recommendations 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... [read document]
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(May 15, 2008) - Notice - Meetings:
National Institutes of Health
Notice
Meetings:
28491 [E8-10839]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Notice of Closed Meetings 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 following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions... [read document]
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(May 15, 2008) - Notice - Meetings:
National Institutes of Health
Notice
Meetings:
28489-28490 [E8-10948]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings 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 following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential... [read document]
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(May 15, 2008) - Notice - Program Reporting and Accountability Changes to the Hospital Preparedness Program
Department of Health and Human Services
Notice
Program Reporting and Accountability Changes to the Hospital Preparedness Program,
28472-28478 [E8-11015]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Program Reporting and Accountability Changes to the Hospital Preparedness Program (HPP) AGENCY: Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, ASPR (HHS). ACTION: Notification of intent to fund and information on: (1) Maintenance of Funding (MOF); (2) Evidenced-Based Benchmarks and Objective Standards; (3) Reporting; (4) Funding Formula; (5) Withholding; and (6) Maximum Carryover Amount. The final... [read document]
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(May 15, 2008) - Notice - Meetings: National Institute of Child Health and Human Development
National Institutes of Health
Notice
Meetings:
National Institute of Child Health and Human Development,
28490 [E8-10838]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Notice of Closed Meeting 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 following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions... [read document]
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(May 15, 2008) - Notice - Statement of Organization, Functions, and Delegations of Authority
Centers for Disease Control and Prevention
Notice
Statement of Organization, Functions, and Delegations of Authority,
28480-28483 [E8-10982]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 73 FR 20297-304, dated April 15, 2008) is amended to... [read document]
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(May 15, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Department of Health and Human Services
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
28469 [E8-11031]
DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS-0990-New; 30-day notice] Agency Information Collection Request. 30-Day Public Comment Request AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send... [read document]
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(May 15, 2008) - Notice - Meetings: Advisory Council for the Elimination of Tuberculosis
Centers for Disease Control and Prevention
Notice
Meetings:
Advisory Council for the Elimination of Tuberculosis,
28479-28480 [E8-10993]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Council for the Elimination of Tuberculosis In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following council meeting. Name: Advisory Council for the Elimination of Tuberculosis Times and Dates: 8:30 a.m.-5 p.m., June 17, 2008. 8:30 a.m.-2 p.m., June 18, 2008. Place: Corporate Square, Building... [read document]
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(May 15, 2008) - Notice - Statement of Organization, Functions, and Delegations of Authority
Centers for Disease Control and Prevention
Notice
Statement of Organization, Functions, and Delegations of Authority,
28483-28484 [E8-10986]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 73 FR 20297-3 04, dated April 15, 2008) is amended to... [read document]
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(May 15, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
28484-28486 [E8-10985]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0094] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations AGENCY: Food and Drug Administration, HHS. ACTION: Notice.... [read document]
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(May 15, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Department of Health and Human Services
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
28471 [E8-11045]
DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS-0990-New; 30-day notice] Agency Information Collection Request. 30-Day Public Comment Request AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send... [read document]
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(May 15, 2008) - Notice - Meetings: Healthcare Infection Control Practices Advisory Committee
Centers for Disease Control and Prevention
Notice
Meetings:
Healthcare Infection Control Practices Advisory Committee,
28480 [E8-10991]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee In accordance with section 10(a) (2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following meeting for the aforementioned committee: Name: Healthcare Infection Control Practices Advisory Committee (HICPAC). Times and Dates: 9 a.m.-5 p.m., June 12, 2008. 9 a.m.-1 p.m., June 13,... [read document]
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(May 15, 2008) - Notice - Hospital Preparedness Program (HPP)
Department of Health and Human Services
Notice
Hospital Preparedness Program (HPP),
28471-28472 [E8-10970]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Hospital Preparedness Program (HPP) AGENCY: Office of the Assistant Secretary for Preparedness and Response, ASPR (HHS). ACTION: Notice. SUMMARY: This notice sets forth the Secretary's proposal to require Hospital Preparedness Program (HPP) cooperative agreement recipients to contribute non-federal matching funds starting with the FY 2009 funding cycle and each year thereafter. The amount of the cost sharing requirement in FY 2009 will be five percent of... [read document]
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(May 15, 2008) - Notice - Meetings: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel
Centers for Disease Control and Prevention
Notice
Meetings:
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel,
28480 [E8-10974]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Preparedness and Emergency Response Research Centers: A Public Health System Approach, Program Announcement Number (PA) TP 08-001 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting. Times and Dates: 7... [read document]
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(May 15, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Department of Health and Human Services
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
28469-28471 [E8-11032]
DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS-0990-0281] Agency Information Collection Request; 60-Day Public Comment Request AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed information collection request for public comment. Interested persons are invited to send... [read document]
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(May 15, 2008) - Notice - Meetings: National Institute on Aging Initial Review Group Biological Aging Review ...
National Institutes of Health
Notice
Meetings:
National Institute on Aging Initial Review Group Biological Aging Review Committee,
28123-28124 [E8-10673]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meetings 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 following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential... [read document]
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(May 14, 2008) - Notice - Meetings: Health Care Policy and Research Special Emphasis Panel
Agency for Healthcare Research and Quality
Notice
Meetings:
Health Care Policy and Research Special Emphasis Panel,
28119 [E8-10565]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Notice of Meeting In accordance with section 10(d) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), announcement is made of a Health Care Policy and Research Special Emphasis Panel (SEP) meeting. A Special Emphasis Panel is a group of experts in fields related to health care research who are invited by the Agency for Healthcare Research and Quality (AHRQ), and agree to be available, to conduct on an... [read document]
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(May 14, 2008) - Notice - Meetings: Center for Scientific Review Special Emphasis Panel; Cancellation
National Institutes of Health
Notice
Meetings:
Center for Scientific Review Special Emphasis Panel; Cancellation,
28120 [E8-10672]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Cancellation of Meeting Notice is hereby given of the cancellation of the Center for Scientific Review Special Emphasis Panel, June 10, 2008, 6 a.m. to June 11, 2008, 6 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on April 29, 2008, 73 FR 23257-23259. The meeting is cancelled due to the applications being withdrawn.... [read document]
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(May 14, 2008) - Notice - Meetings: Biophysics of Neural Systems Study Section; change
National Institutes of Health
Notice
Meetings:
Biophysics of Neural Systems Study Section; change,
28120 [E8-10671]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Biophysics of Neural Systems Study Section, June 12, 2008, 8 a.m. to June 12, 2008, 8 p.m., Hotel Lombardy, 2019 Pennsylvania Avenue, NW., Washington, DC 20006 which was published in the Federal Register on April 29, 2008, 73 FR 23257-23259. The meeting will be held June 12, 2008, 8 a.m. to June 13, 2008, 4 p.m.... [read document]
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(May 14, 2008) - Notice - Meetings: National Institute on Aging Special Emphasis Panel
National Institutes of Health
Notice
Meetings:
National Institute on Aging Special Emphasis Panel,
28124 [E8-10675]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meetings 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 following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential... [read document]
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(May 14, 2008) - Notice - Statement of Organization, Functions, and Delegations of Authority
National Institutes of Health
Notice
Statement of Organization, Functions, and Delegations of Authority,
28124-28126 [E8-10637]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Statement of Organization, Functions, and Delegations of Authority The Statement of Organization, Functions, and Delegations of Authority Part N, National Institutes of Health (NIH), of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (DHHS) (40 FR 22859, May 27, 1975, as amended most recently at 71 FR 46495, August 14, 2006, and redesignated from Part HN... [read document]
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(May 14, 2008) - Notice - Meetings: Immunology Integrated Review Group
National Institutes of Health
Notice
Meetings:
Immunology Integrated Review Group,
28121-28122 [E8-10674]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings 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 following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential... [read document]
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(May 14, 2008) - Notice - Determination of Regulatory Review Period for Purposes of Patent Extension; TYZEKA
Food and Drug Administration
Notice
Determination of Regulatory Review Period for Purposes of Patent Extension; TYZEKA,
28119-28120 [E8-10857]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0035 (formerly Docket No. 2007E-0133) and [Docket No. FDA-2007-E-0227 (formerly Docket No. 2007E-0148)] Determination of Regulatory Review Period for Purposes of Patent Extension; TYZEKA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for TYZEKA and is publishing this notice of that determination as... [read document]
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(May 14, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Substance Abuse and Mental Health Services Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
28126-28127 [E8-10855]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on... [read document]
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(May 14, 2008) - Notice - Meetings: Musculoskeletal, Oral and Skin Sciences Integrated Review Group and Others
National Institutes of Health
Notice
Meetings:
Musculoskeletal, Oral and Skin Sciences Integrated Review Group and Others,
28122-28123 [E8-10670]
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings 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 following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential... [read document]
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(May 14, 2008) - Notice - Delegation of Authority
Children and Families Administration
Notice
Delegation of Authority,
27836 [E8-10766]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Delegation of Authority Notice is hereby given that I have redelegated to Charles N.W. Keckler, Esq., Senior Advisor, Immediate Office of the Assistant Secretary, Administration for Children and Families (ACF), the following authority vested in the Assistant Secretary for Children and Families. (a) Authority Delegated. Authority to review and make decisions to approve or disapprove requests for testimony by ACF... [read document]
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(May 13, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Department of Health and Human Services
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
27831-27832 [E8-10798]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Request; 30-Day Public Comment Request, Grants.gov AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or... [read document]
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(May 13, 2008) - Notice - Meetings: American Health Information Community
Department of Health and Human Services
Notice
Meetings:
American Health Information Community,
27832 [E8-10660]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting ACTION: Meeting announcement. SUMMARY: This notice announces the meeting date for the 22nd meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to... [read document]
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(May 13, 2008) - Notice - Meetings:
Centers for Disease Control and Prevention
Notice
Meetings:
27835 [E8-10751]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Injury Prevention and Control/ Initial Review Group, (NCIPC/IRG) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned review group: Time and Date: 1 p.m.-3 p.m., May 19, 2008 (Closed). Place: Teleconference. Status: The meetings will be closed to the... [read document]
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(May 13, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Department of Health and Human Services
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
27829-27830 [E8-10795]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Request; 30-Day Public Comment Request, Grants.gov AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or... [read document]
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(May 13, 2008) - Notice - Preference for Healthy Start Grantees
Health Resources and Services Administration
Notice
Preference for Healthy Start Grantees,
27839 [E8-10684]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Preference for Healthy Start Grantees AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: General notice. BACKGROUND: This notice supplements the 2007 HRSA announcement (HRSA 08-023/08-031) of the availability of fiscal year (FY) 2008 funding for new and competing continuation applications for Healthy Start. Healthy Start strengthens communities to effectively address the causes of infant... [read document]
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(May 13, 2008) - Notice - Determination of Regulatory Review Period for Purposes of Patent Extension: INVEGA
Food and Drug Administration
Notice
Determination of Regulatory Review Period for Purposes of Patent Extension:
INVEGA,
27837-27838 [E8-10685]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0399] (formerly Docket No. 2007E-0145) Determination of Regulatory Review Period for Purposes of Patent Extension; INVEGA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for INVEGA and is publishing this notice of that determination as required by law. FDA has made the determination because of the... [read document]
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(May 13, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Department of Health and Human Services
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
27829 [E8-10794]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Request; 30-Day Public Comment Request, Grants.gov AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or... [read document]
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(May 13, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Department of Health and Human Services
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
27828-27829 [E8-10793]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Request; 30-Day Public Comment Request, Grants.gov AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or... [read document]
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(May 13, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Centers for Disease Control and Prevention
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
27833-27834 [E8-10791]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-8AZ] Proposed Data Collections Submitted for Public Comment and Recommendations 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... [read document]
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(May 13, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Department of Health and Human Services
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
27830-27831 [E8-10796]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Request; 30-Day Public Comment Request, Grants.gov AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or... [read document]
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(May 13, 2008) - Notice - Determination of Regulatory Review Period for Purposes of Patent Extension: AVASTIN
Food and Drug Administration
Notice
Determination of Regulatory Review Period for Purposes of Patent Extension:
AVASTIN,
27836-27837 [E8-10726]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0102] (formerly Docket No. 2007E-0184) Determination of Regulatory Review Period for Purposes of Patent Extension; AVASTIN AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for AVASTIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the... [read document]
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(May 13, 2008) - Notice - Meetings: National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Notice
Meetings:
National Institute for Occupational Safety and Health,
27835-27836 [E8-10753]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Notice of Meeting AGENCY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of Public Meeting. SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships... [read document]
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(May 13, 2008) - Notice - Meetings: Scientific Peer Review Groups
Agency for Healthcare Research and Quality
Notice
Meetings:
Scientific Peer Review Groups,
27832-27833 [E8-10564]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Notice of Meetings In accordance with section 10(d) of the Federal Advisory Committee Act as amended (5 U.S.C., Appendix 2), the Agency for Healthcare Research and Quality (AHRQ) announces meetings of scientific peer review groups. The subcommittees listed below are part of the Agency's Health Services Research Initial Review Group Committee. The subcommittee meetings will be closed to the public in accordance... [read document]
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(May 13, 2008) - Notice - Meetings: National Center for Injury Prevention and Control Initial Review Group
Centers for Disease Control and Prevention
Notice
Meetings:
National Center for Injury Prevention and Control Initial Review Group,
27834-27835 [E8-10747]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Injury Prevention and Control In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned review group: Name: National Center for Injury Prevention and Control Initial Review Group (NCIPC/IRG). Time and Date: 1 p.m.--3 p.m., May 16, 2008 (closed). Place:... [read document]
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(May 13, 2008) - Notice - Determination of Regulatory Review Period for Purposes of Patent Extension: ZOLINZA
Food and Drug Administration
Notice
Determination of Regulatory Review Period for Purposes of Patent Extension:
ZOLINZA,
27838-27839 [E8-10689]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0278] (formerly Docket No. 2007E-0143) Determination of Regulatory Review Period for Purposes of Patent Extension; ZOLINZA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ZOLINZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the... [read document]
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(May 13, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Centers for Disease Control and Prevention
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
27834 [E8-10792]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-08-07BL] Agency Forms Undergoing Paperwork Reduction Act Review 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) 639-5960 or send an e-mail... [read document]
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(May 13, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Department of Health and Human Services
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
27831 [E8-10797]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Request; 30-Day Public Comment Request, Grants.gov AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or... [read document]
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(May 13, 2008) - Notice - OMNARIS
Food and Drug Administration
Notice
OMNARIS,
26999-27000 [E8-10466]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0398] (formerly Docket No. 2007E-0131) Determination of Regulatory Review Period for Purposes of Patent Extension; OMNARIS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for OMNARIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the... [read document]
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(May 11, 2008) - Notice - Determination of Regulatory Review Period for Purposes of Patent Extension; VECTIBIX
Food and Drug Administration
Notice
Determination of Regulatory Review Period for Purposes of Patent Extension; VECTIBIX,
27000-27001 [E8-10512]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0047] (formerly Docket No. 2007E-0139) Determination of Regulatory Review Period for Purposes of Patent Extension; VECTIBIX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for VECTIBIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the... [read document]
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(May 11, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
26998-26999 [E8-10467]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0271] Agency Information Collection Activities; Proposed Collection; Comment Request; Consumer Survey on the Impact of Perceptions of the 2006 Spinach Recall on Current Spinach Consumption AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the... [read document]
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(May 11, 2008) - Notice - Pilot Program to Evaluate Proposed Name Submissions; Concept Paper
Food and Drug Administration
Notice
Pilot Program to Evaluate Proposed Name Submissions; Concept Paper,
27001-27002 [E8-10513]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0281] Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) are announcing a public technical meeting in preparation... [read document]
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(May 11, 2008) - Notice - Meetings: Oncologic Drugs Advisory Committee
Food and Drug Administration
Notice
Meetings:
Oncologic Drugs Advisory Committee,
26120-26121 [E8-10258]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA's... [read document]
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(May 7, 2008) - Notice - Meetings: Anti-Infective Drugs Advisory Committee
Food and Drug Administration
Notice
Meetings:
Anti-Infective Drugs Advisory Committee,
26119-26120 [E8-10307]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anti-Infective Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Anti-Infective Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on... [read document]
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(May 7, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
26119 [E8-10204]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0063] (formerly Docket No. 2008N-0016) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of... [read document]
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(May 7, 2008) - Notice - Meetings: Science Board
Food and Drug Administration
Notice
Meetings:
Science Board,
26121 [E8-10257]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board... [read document]
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(May 7, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
25749-25750 [E8-10180]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0272] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of... [read document]
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(May 6, 2008) - Notice - Guidance for Industry and Food and Drug Administration Staff: Administrative ...
Food and Drug Administration
Notice
Guidance for Industry and Food and Drug Administration Staff:
Administrative Procedures for CLIA Categorization; Availability,
25752-25753 [E8-10178]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0228] (formerly Docket No. 00D-1401) Guidance for Industry and Food and Drug Administration Staff; Administrative Procedures for CLIA Categorization; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Administrative Procedures for CLIA Categorization.'' The guidance describes... [read document]
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(May 6, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
25750-25752 [E8-10194]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0269] Agency Emergency Processing Under Office of Management and Budget Review; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget... [read document]
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(May 6, 2008) - Notice - Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for ...
Food and Drug Administration
Notice
Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment,
24599 [E8-9726]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0257] Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft drug safety 5-year plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five- Year Plan.'' This plan is intended to... [read document]
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(May 4, 2008) - Notice - Meetings: The 11th Annual Food and Drug Administration-Orange County Regulatory ...
Food and Drug Administration
Notice
Meetings:
The 11th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference,
24599-24600 [E8-9728]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The 11th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration (FDA) is announcing the following conference: 11th Annual Educational Conference co-sponsored with the Orange County Regulatory Affairs Discussion Group (OCRA). The conference is intended to provide the Drug, Device, and... [read document]
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(May 4, 2008) - Notice - Determination of Regulatory Review Period for Purposes of Patent Extension; TEKTURNA
Food and Drug Administration
Notice
Determination of Regulatory Review Period for Purposes of Patent Extension; TEKTURNA,
24295 [E8-9699]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0282] (formerly Docket No. 2007E-0256) Determination of Regulatory Review Period for Purposes of Patent Extension; TEKTURNA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for TEKTURNA and is publishing this notice of that determination as required by law. FDA has made the determination because of the... [read document]
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(May 1, 2008) - Notice - Determination of Regulatory Review Period for Purposes of Patent Extension: ...
Food and Drug Administration
Notice
Determination of Regulatory Review Period for Purposes of Patent Extension:
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee,
24074-24075 [E8-9537]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices... [read document]
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(April 30, 2008) - Notice - Determination of Regulatory Review Period for Purposes of Patent Extension: ...
Food and Drug Administration
Notice
Determination of Regulatory Review Period for Purposes of Patent Extension:
Dermatologic and Ophthalmic Drugs Advisory Committee,
24075-24076 [E8-9549]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee. General Function of the Committee: To provide advice and... [read document]
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(April 30, 2008) - Notice - Determination of Regulatory Review Period for Purposes of Patent Extension: AZILECT
Food and Drug Administration
Notice
Determination of Regulatory Review Period for Purposes of Patent Extension:
AZILECT,
24073-24074 [E8-9591]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-E-0196] (formerly Docket No. 2006E-0500) Determination of Regulatory Review Period for Purposes of Patent Extension; AZILECT AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for AZILECT and is publishing this notice of that determination as required by law. FDA has made the determination because of the... [read document]
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(April 30, 2008) - Notice - Determination of Regulatory Review Period for Purposes of Patent Extension: ARTEFILL
Food and Drug Administration
Notice
Determination of Regulatory Review Period for Purposes of Patent Extension:
ARTEFILL,
24072-24073 [E8-9592]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0457] (formerly Docket No. 2007E-0138) Determination of Regulatory Review Period for Purposes of Patent Extension; ARTEFILL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ARTEFILL and is publishing this notice of that determination as required by law. FDA has made the determination because of the... [read document]
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(April 30, 2008) - Notice - Draft Guidance for Industry: Risk Communication Advisory Committee
Food and Drug Administration
Notice
Draft Guidance for Industry:
Risk Communication Advisory Committee,
22959-22960 [E8-9177]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0226] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Risk Communication Advisory Committee. General Function of the Committee: To provide advice and... [read document]
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(April 27, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
22951-22955 [E8-9157]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0240] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork... [read document]
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(April 27, 2008) - Notice - Cooperative Agreement to Support the World Health Organization International Programme ...
Food and Drug Administration
Notice
Cooperative Agreement to Support the World Health Organization International Programme on Chemical Safety,
22956-22958 [E8-9251]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cooperative Agreement to Support the World Health Organization International Programme on Chemical Safety AGENCY: Food and Drug Administration, HHS. ACTION: Notice. I. Funding Opportunity Description The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement (U01), a new Sole Source, Competitive Continuation in fiscal year 2008... [read document]
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(April 27, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
22955-22956 [E8-9159]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0239] Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork... [read document]
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(April 27, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
22951 [E8-9155]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-N-0154] (formerly Docket No. 2007N-0444) Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recordkeeping and Records Access Requirements for Food Facilities AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recordkeeping and Records Access... [read document]
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(April 27, 2008) - Notice - Draft Guidance for Industry: TAPAZOLE Tablets and 18 Other Drug Products
Food and Drug Administration
Notice
Draft Guidance for Industry:
TAPAZOLE Tablets and 18 Other Drug Products,
22960-22961 [E8-9161]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0238] Determination That TAPAZOLE Tablets and 18 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined that the 19 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that... [read document]
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(April 27, 2008) - Notice - Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of ...
Food and Drug Administration
Notice
Draft Guidance for Industry:
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors, etc.,
22958-22959 [E8-9253]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0233] Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... [read document]
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(April 27, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
22423-22424 [E8-8973]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0030] (formerly Docket No. 2004D-0466) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a... [read document]
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(April 24, 2008) - Notice - Guidance for Industry; Availability: Recommendations for Sampling and Testing Yellow ...
Food and Drug Administration
Notice
Guidance for Industry; Availability:
Recommendations for Sampling and Testing Yellow Corn and Dry-Millled Yellow Corn Shipments for Cry9C Protein Residues,
22716-22717 [E8-8805]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0229 (formerly Docket No. 2001D-0025)] Guidance for Industry on the Food and Drug Administration Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. SUMMARY: The Food and Drug Administration (FDA) is announcing the... [read document]
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(April 24, 2008) - Notice - Guidance for Industry; Availability: EPA White Paper Regarding StarLink Corn Dietary ...
Food and Drug Administration
Notice
Guidance for Industry; Availability:
EPA White Paper Regarding StarLink Corn Dietary Exposure and Risk,
22716 [E8-9003]
Part V Environmental Protection Agency Department of Health and Human Services Food and Drug Administration EPA White Paper Regarding StarLink[reg] Corn Dietary Exposure and Risk; Availability; Notice Guidance for Industry on FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Use for Cry9C Protein Residues; Withdrawal of Guidance; Notice ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2007-0832; FRL-8358-7] EPA White Paper Regarding... [read document]
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(April 24, 2008) - Notice - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing ...
Food and Drug Administration
Notice
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability,
22157-22159 [E8-9007]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA) is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments... [read document]
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(April 23, 2008) - Notice - Draft Guidance for Industry on Developing Coronary Drug Eluting Stents; Public Workshop
Food and Drug Administration
Notice
Draft Guidance for Industry on Developing Coronary Drug Eluting Stents; Public Workshop,
22156-22157 [E8-8853]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0180] Draft Guidance for Industry on Developing Coronary Drug Eluting Stents; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of a public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Coronary Drug-Eluting Stent (DES) Guidance Document Workshop.'' FDA is cosponsoring the workshop with the Advanced Medical Technology... [read document]
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(April 23, 2008) - Notice - Meetings: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee
Food and Drug Administration
Notice
Meetings:
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee,
22157 [E8-8845]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is postponing the meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee scheduled for May 16, 2008. The meeting was announced in the Federal Register of March 27, 2008 (73... [read document]
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(April 23, 2008) - Notice - Public Workshop:
Developing Guidance on Pharmacoepidemiologic Safety Studies- ...
Food and Drug Administration
Notice
Public Workshop:
Developing Guidance on Pharmacoepidemiologic Safety Studies-
Conducting Scientifically Sound Safety Studies Using Large Electronic Healthcare Data Sets,
21963-21964 [E8-8772]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0234] Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. SUMMARY: The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the... [read document]
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(April 22, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
21959-21962 [E8-8710]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0227] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal... [read document]
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(April 22, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
21631 [E8-8680]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0302] (formerly Docket No. 2006D-0419) Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary National Retail Food Regulatory Program Standards AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary National Retail Food Regulatory... [read document]
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(April 21, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
21631-21632 [E8-8682]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0050] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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... [read document]
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(April 21, 2008) - Notice - Meetings: Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and ...
Food and Drug Administration
Notice
Meetings:
Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee,
21632-21633 [E8-8683]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This... [read document]
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(April 21, 2008) - Notice - Meeting to Present Changes to the Animal Feed Safety System Project: Notice of Meeting
Food and Drug Administration
Notice
Meeting to Present Changes to the Animal Feed Safety System Project:
Notice of Meeting,
21357-21359 [08-1155]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2007-N-0442 (formerly Docket No. 2007N-0487) Opportunity for Public Input on Standards for Pet Food and Other Animal Feeds; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting to obtain input from stakeholder groups, including, but not limited to, the Association of American Feed Control... [read document]
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(April 20, 2008) - Notice - Meeting to Present Changes to the Animal Feed Safety System Project: Ranking of Feed ...
Food and Drug Administration
Notice
Meeting to Present Changes to the Animal Feed Safety System Project:
Ranking of Feed Hazards According to the Risks They Pose to Animal and Public Health,
21355-21357 [08-1154]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0189] (formerly Docket No. 2003N-0312) Meeting to Present Changes to the Animal Feed Safety System Project and the Ranking of Feed Hazards According to the Risks They Pose to Animal and Public Health; Part 3: Swine Feed Example; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing... [read document]
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(April 20, 2008) - Notice - Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug ...
Food and Drug Administration
Notice
Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff:
Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions,
21142-21144 [E8-8349]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0224] Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/ Submissions: Compliance With Section 402(j) of the Public Health Service Act, Added by Title VIII of the Food and Drug Administration Amendments Act of 2007 AGENCY: Food and Drug Administration, HHS. ACTION: Notice.... [read document]
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(April 17, 2008) - Notice - Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug ...
Food and Drug Administration
Notice
Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff:
Pediatric Ethics Subcommittee of the Pediatric Advisory Committee,
21145 [E8-8352]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. General Function of the Committee: To... [read document]
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(April 17, 2008) - Notice - Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug ...
Food and Drug Administration
Notice
Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff:
Dermatologic and Ophthalmic Drugs Advisory Committee,
21144 [E8-8351]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee. General Function of the Committee: To provide advice and... [read document]
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(April 17, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
21139-21142 [E8-8459]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-N-0321] (formerly Docket No. 2007N-0485) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been... [read document]
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(April 17, 2008) - Notice - Antimicrobial resistance; Public Hearing; Request for Comments
Food and Drug Administration
Notice
Antimicrobial resistance; Public Hearing; Request for Comments,
20309-20311 [08-1129]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0225] Antimicrobial Resistance; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing a public hearing on antimicrobial resistance. FDA is seeking general information about the problem of antimicrobial resistance, recommendations as to possible approaches to... [read document]
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(April 14, 2008) - Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals
Food and Drug Administration
Notice
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
19508-19509 [E8-7637]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0027] (formerly Docket No. 2007N-0495) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, Form FDA 3602A AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed... [read document]
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(April 9, 2008)