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[FR Doc E9-791] 1426.Secure Supply Chain Pilot Program; Notice of Pilot Program
The Food and Drug Administration (FDA) is announcing an opportunity for sponsors and foreign manufacturers of finished drug products and active pharmaceutical ingredients (APIs) intended for human use imported by a secure supply chain to apply to participate in a voluntary Secure Supply Chain (SSC) pilot program to be conducted by FDA's Center for Drug
Published: 2009-01-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-537] 1427.Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Improving Patient Flow and Reducing Emergency Department Crowding.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C.
Published: 2009-01-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Agency for Healthcare Research and Quality
[FR Doc E9-682] 1428.Institutional Review Boards; Registration Requirements
The Food and Drug Administration (FDA, we) is issuing a final rule to require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). The registration information includes contact information (such as addresses and telephone numbers), the number of active protocols involving
Published: 2009-01-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-782] 1429.Agency Information Collection Activities; Submission for Office of Management
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.
Published: 2009-01-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-683] 1430.Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Adverse Event ReportingImproving Human Subject Protection.'' This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to
Published: 2009-01-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-687] 1431. Agency Information Collection Activities: Submission for OMB Review; Comment
Published: 2009-01-14 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services
[FR Doc E9-573] 1432. Agency Information Collection Activities; Submission for Office of Management
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.
Published: 2009-01-14 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-574] 1433. Agency Information Collection Activities; Proposed Collection; Comment
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 agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each
Published: 2009-01-14 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-495] 1434. Solicitation of Written Comments on Draft Strategic National Vaccine Plan
On behalf of the National Vaccine Advisory Committee (NVAC), the National Vaccine Program Office (NVPO) is soliciting public comment on the draft strategic National Vaccine Plan.
Published: 2009-01-14 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department
[FR Doc E9-451] 1435. Advisory Committees; Tentative Schedule of Meetings for 2009
The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2009. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-417] 1436. National Center for Research Resources; 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
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
[FR Doc E9-453] 1437. Draft Guidance for Industry on Good Importer Practices; Availability
The Food and Drug Administration (FDA) is announcing on behalf of several members of the Interagency Working Group on Import Safety (agencies) the availability of a draft guidance for industry entitled ``Good Importer Practices.'' This draft guidance document provides general recommendations to importers on possible practices and procedures they
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-426] 1438. National Center for Research Resources; Notice of 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 National Advisory Research Resources Council.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
[FR Doc E9-452] 1439. Guidance for Industry on Good Reprint Practices for the Distribution of
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.'' The guidance provides drug,
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-424] 1440. National Institute of Allergy and Infectious Diseases; Notice of Closed
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
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
[FR Doc E9-450] 1441. Participation of Certain Population Subsets in Clinical Drug Trials; Request
The Food and Drug Administration (FDA) is seeking information and comments on issues related to the enrollment of certain populations in clinical drug trials. Particularly, we are requesting information and comments from medical product manufacturers, institutional review boards (IRBs), patient groups, universities, researchers, community groups,
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-420] 1442. National Institute of Dental & Craniofacial Research; Notice of Closed
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
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
[FR Doc E9-400] 1443. National Institute of Diabetes and Digestive and Kidney Diseases; Notice of
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 Diabetes and Digestive and Kidney Diseases Advisory Council.
The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
[FR Doc E9-401] 1444. 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
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
[FR Doc E9-280] 1445. National Institute on Drug Abuse; 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
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
[FR Doc E9-405] 1446. 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 projects or to obtain a
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention
[FR Doc E9-447] 1447. Submission for OMB Review; Comment Request
Title: Child Care Quarterly Case Record ReportACF801.
OMB No.: 09700167.
Description: Section 658K of the Child Care and Development Block Grant Act of 1990 (Pub. L. 101508, 42 U.S.C. 9858) requires that States and Territories submit monthly caselevel data on the children and families receiving direct services under the Child Care and
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration
[FR Doc E9-484] 1448. Submission for OMB Review; Comment Request; Follow-up of Kidney Cancer
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
[FR Doc E9-482] 1449. Eunice Kennedy Shriver National Institute of Child Health & Human
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
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
[FR Doc E9-483] 1450. Eunice Kennedy Shriver National Institute of Child Health & Human
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
Published: 2009-01-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
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