Sample records for drug administration advisory

  1. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-22

    ...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...

  2. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

  3. The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

    PubMed

    Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D

    2014-10-01

    Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

  4. 77 FR 27072 - Gastrointestinal Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastrointestinal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Gastrointestinal Drugs Advisory Committee scheduled for May 31, 2012, is...

  5. 75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee scheduled for February 9, 2011, is...

  6. 77 FR 63839 - Oncologic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee Meeting scheduled for November 8, 2012, is...

  7. 76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ..., Advisory committees, Color additives, Drugs, Radiation protection. Therefore, under the Federal Food, Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 [Docket No... AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration...

  8. 75 FR 59732 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Gastrointestinal 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...

  9. 78 FR 12762 - Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...; 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...

  10. 75 FR 5333 - Endocrinologic and Metabolic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Endocrinologic and Metabolic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Endocrinologic and Metabolic Drugs Advisory Committee...

  11. 75 FR 36101 - Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee...

  12. 77 FR 50702 - Cardiovascular and Renal Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Cardiovascular and Renal Drugs Advisory Committee scheduled for...

  13. 76 FR 59404 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Gastrointestinal 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...

  14. 78 FR 48690 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] 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...

  15. 77 FR 31025 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] 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...

  16. 77 FR 58399 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] 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...

  17. 77 FR 5813 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] 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...

  18. 75 FR 47309 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Psychopharmacologic 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...

  19. 78 FR 13349 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Psychopharmacologic 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...

  20. 77 FR 50701 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastrointestinal 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...

  1. 78 FR 37820 - Nonprescription Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Nonprescription 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...

  2. 76 FR 32220 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Gastrointestinal 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...

  3. 76 FR 11489 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 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...

  4. 77 FR 37414 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastrointestinal 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...

  5. 78 FR 57166 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Antiviral 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...

  6. 75 FR 16151 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Antiviral 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...

  7. 76 FR 82309 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 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...

  8. 77 FR 17078 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastrointestinal 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...

  9. 76 FR 82310 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 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...

  10. 76 FR 44595 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 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...

  11. 77 FR 7587 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastrointestinal 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...

  12. 77 FR 32125 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] 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...

  13. 75 FR 75680 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] 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...

  14. 76 FR 65736 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Psychopharmacologic 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...

  15. 78 FR 13348 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] 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...

  16. 75 FR 9419 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] 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...

  17. 75 FR 32189 - Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-07

    ... Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General Function of...] Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  18. 78 FR 22270 - Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-15

    ... Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General Function of...] Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  19. 75 FR 876 - Anesthetic and Life Support Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Anesthetic and Life Support Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Anesthetic and Life Support Drugs Advisory Committee...

  20. 77 FR 4566 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  1. 77 FR 74486 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  2. 77 FR 69636 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  3. 75 FR 9420 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  4. 75 FR 5334 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  5. 77 FR 69635 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  6. 75 FR 5333 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  7. 76 FR 29766 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  8. 78 FR 46976 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  9. 75 FR 82031 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  10. 75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory...

  11. 76 FR 70462 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory...

  12. 76 FR 19374 - Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-07

    ...: Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee...] Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  13. 78 FR 17413 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-21

    ...] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... rescheduled due to the postponement of the March 7, 2013, Pulmonary-Allergy Drugs Advisory Committee meeting due to unanticipated weather conditions. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee...

  14. 76 FR 37131 - Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management...: Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General...

  15. 75 FR 8377 - Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ...] Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS... of a meeting of the Pulmonary-Allergy Drugs Advisory Committee. This meeting was announced in the... February 2, 2010, FDA announced that a meeting of the Pulmonary-Allergy Drugs Advisory Committee would be...

  16. 77 FR 12062 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee...

  17. 75 FR 12767 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General Function of...] Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  18. 75 FR 67093 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-01

    ...: Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory...] Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  19. 75 FR 32188 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-07

    ... Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General Function of...] Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  20. 75 FR 59730 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General Function of...] Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  1. 75 FR 1395 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  2. 78 FR 36787 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  3. 75 FR 35496 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  4. 77 FR 43093 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  5. 76 FR 39404 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  6. 75 FR 30839 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  7. 75 FR 52762 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  8. 75 FR 56548 - Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug Safety... and Central Nervous System Drugs Advisory Committee and the Drug Safety and Risk Management Advisory...

  9. 78 FR 2677 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  10. 76 FR 59143 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  11. 76 FR 59142 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  12. 78 FR 16271 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-14

    ... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  13. 75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...

  14. 77 FR 64346 - Nonprescription Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-19

    ... for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Building 31... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Nonprescription Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION...

  15. 75 FR 81618 - Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration...: Anesthetic and Life Support Drugs Advisory Committee. General Function of the Committee: To provide advice...

  16. 75 FR 39032 - Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES> Food and Drug Administration [Docket No. FDA-2010-N-0001] Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration...: Anesthetic and Life Support Drugs Advisory Committee. General Function of the Committee: To provide advice...

  17. 75 FR 71450 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a...

  18. 77 FR 37911 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs 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...

  19. 75 FR 70932 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-19

    ... and Risk Management Advisory Committee scheduled for December 2, 2010, is cancelled. This meeting was...] Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  20. 78 FR 42088 - Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation AGENCY: Food and Drug Administration..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31...

  1. 78 FR 64957 - Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management... Committee and the Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To...

  2. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees for...

  3. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees for...

  4. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees for...

  5. 75 FR 70933 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-19

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committees... appropriate clinical study design for thromboxane receptor antagonists for prevention of cardiovascular events...

  6. 78 FR 76307 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. FDA intends...

  7. 75 FR 57474 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... analyses of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study of ARANESP...

  8. 78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and..., Inc., for the proposed indication to reduce the risk of thrombotic cardiovascular events in patients...

  9. 77 FR 21982 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-12

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...., to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS...

  10. 78 FR 29142 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Anesthetic and Analgesic Drug Products Advisory Committee. General Function of the Committee: To provide...

  11. 77 FR 67380 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Anesthetic and Analgesic Drug Products Advisory Committee. General Function of the Committee: To provide...

  12. 76 FR 78283 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Anesthetic and Analgesic Drug Products Advisory Committee. General Function of the Committee: To provide...

  13. 76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

  14. 78 FR 64956 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

  15. 77 FR 59624 - Gastrointestinal Drugs Advisory Committee; Notice of Postponement of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-28

    ... FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation and Research, Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastrointestinal Drugs Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration...

  16. 76 FR 44595 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee...

  17. 75 FR 16148 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ..., artesunate rectal suppositories, submitted by the World Health Organization, for the proposed use as a single... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Anti-Infective Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...

  18. 75 FR 17417 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  19. 78 FR 63478 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  20. 75 FR 36428 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  1. 77 FR 20037 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  2. 78 FR 63481 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  3. 76 FR 3912 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  4. 75 FR 12768 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  5. 76 FR 58520 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General...

  6. 76 FR 71349 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-17

    .... Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration... following topics related to the use of ophthalmic drug products (products intended for use in the eye): (1... infection. FDA's Center for Drug Evaluation and Research would like the advisory committee to provide advice...

  7. Oncologic Drugs Advisory Committee Recommendations and Approval of Cancer Drugs by the US Food and Drug Administration.

    PubMed

    Tibau, Ariadna; Ocana, Alberto; Anguera, Geòrgia; Seruga, Bostjan; Templeton, Arnoud J; Barnadas, Agustí; Amir, Eitan

    2016-06-01

    The US Food and Drug Administration (FDA) advisory committees influence decisions relating to the regulatory approval of drugs in the United States. Outside of the field of oncology, prosponsor voting bias has been observed among members with financial conflicts of interest (FCOIs). To explore factors associated with Oncologic Drugs Advisory Committee (ODAC) recommendations and the influence ODAC members' FCOIs on the drug approval process. Retrospective analysis of 82 ODAC meeting transcripts between January 2000 and December 2014. Analysis was restricted to meetings at which votes were cast relating to oncologic drugs. The influence of methodology of trials supporting approval and frequency and type of self-reported FCOIs of voting members was explored using logistic regression. ODAC recommendation for drug approval and subsequent FDA approval. Eighty-two transcripts of ODAC meetings between January 2000 and December 2014 were available for analysis. During the time period analyzed, ODAC members voted on 68 applications in 79 meetings (the remaining 3 meetings included voting questions regarding postmarketing safety or trial design). There was agreement between ODAC recommendations and final FDA approval; FDA approval was received for all 41 drugs that ODAC recommended approval. Additionally, the FDA approved 7 out of 41 agents that were not recommended for approval by ODAC (κ = 0.83). In 51 of 79 meetings, more than 1 trial was available to support the indication of a particular drug, and favorable ODAC recommendations were more likely when this was the case (odds ratio [OR], 1.82; 95% CI, 1.19-2.78; P = .01). Availability of randomized data did not appear to be important with selected single-arm phase 2 trials leading to recommendations for approval, especially in rare diseases. There has been a significant reduction in FCOIs over time (31 of 77 voting members [40%] in 2000 vs 0 of 20 voting members in 2014 [0%]; P < .001). Recommendations for

  8. 21 CFR 861.38 - Standards advisory committees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Standards advisory committees. 861.38 Section 861.38 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Development and Publication § 861.38 Standards advisory committees. (a) The Food and Drug Administration will...

  9. 78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 [Docket No. FDA-2013-N-1380] Advisory Committee; Veterinary Medicine Advisory Committee; Termination AGENCY: Food... announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the...

  10. 78 FR 20327 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice... focus on postmarketing reports of oil microembolism in the lungs and potential anaphylactic reactions... in regard to oil microembolism and potential anaphylactic reactions reported for those products. This...

  11. 21 CFR 20.118 - Advisory committee records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Advisory committee records. 20.118 Section 20.118 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.118 Advisory committee records. All advisory...

  12. 75 FR 74735 - Food Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food 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...

  13. 76 FR 29767 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis 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...

  14. 77 FR 45638 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Blood Products 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...

  15. 78 FR 2677 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Blood Products Advisory...

  16. 75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory...

  17. 78 FR 17414 - Risk Communications Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-21

    ...] Risk Communications Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communications Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Communication Staff, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm...

  18. 76 FR 44017 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to...

  19. 77 FR 31025 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to...

  20. Brief report on the United States Food and Drug Administration Blood Products Advisory Committee recommendations for management of donors and units testing positive for hepatitis B virus DNA.

    PubMed

    Lucey, C

    2006-11-01

    This article briefly recounts the 21st July 2005, Blood Products Advisory Committee (BPAC) meeting concerning recommendations for management of donors and units testing positive for hepatitis B virus (HBV) DNA. The author attended the meeting. The United States Food and Drug Administration (FDA) web site was used for meeting materials, and handouts were collected at the meeting to provide narrative information. Two European experts assisted with HBV subject matter. The proceedings of the advisory committee, the issue briefing materials, and testing algorithms are presented. BPAC voted concurrence with the FDA algorithm for Management of Donors and Units Testing Positive for Hepatitis B Virus DNA.

  1. 76 FR 36930 - National Advisory Council on Alcohol Abuse and Alcoholism and National Advisory Council on Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... National Institute on Drug Abuse. The meeting will be open to the public as indicated below, with... Alcohol Abuse and Alcoholism and National Advisory Council on Drug Abuse; Notice of Joint Meeting Pursuant... Alcoholism and National Advisory Council on Drug Abuse. Date: September 12, 2011. Open: September 12, 2011...

  2. 77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-24

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...

  3. 78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...

  4. 75 FR 65641 - Risk Communication Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Risk Communication Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS... meeting of the Risk Communication Advisory Committee. This meeting was announced in the Federal Register...

  5. 75 FR 15342 - Advisory Committees; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 [Docket No. FDA-2010-N-0001] Advisory Committees; Technical Amendment Agency: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending its...

  6. 77 FR 69869 - National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National Cancer Advisory Board; Notice of Joint Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given o...

  7. 21 CFR 14.140 - Establishment of a color additive advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Establishment of a color additive advisory committee. 14.140 Section 14.140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  8. 21 CFR 14.142 - Functions of a color additive advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Functions of a color additive advisory committee. 14.142 Section 14.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  9. 21 CFR 14.140 - Establishment of a color additive advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Establishment of a color additive advisory committee. 14.140 Section 14.140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  10. 21 CFR 14.145 - Procedures of a color additive advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Procedures of a color additive advisory committee. 14.145 Section 14.145 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  11. 21 CFR 14.142 - Functions of a color additive advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Functions of a color additive advisory committee. 14.142 Section 14.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  12. 21 CFR 14.145 - Procedures of a color additive advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Procedures of a color additive advisory committee. 14.145 Section 14.145 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  13. 21 CFR 14.147 - Membership of a color additive advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Membership of a color additive advisory committee. 14.147 Section 14.147 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  14. 21 CFR 14.140 - Establishment of a color additive advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Establishment of a color additive advisory committee. 14.140 Section 14.140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  15. 21 CFR 14.140 - Establishment of a color additive advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Establishment of a color additive advisory committee. 14.140 Section 14.140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  16. 21 CFR 14.142 - Functions of a color additive advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Functions of a color additive advisory committee. 14.142 Section 14.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  17. 21 CFR 14.145 - Procedures of a color additive advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Procedures of a color additive advisory committee. 14.145 Section 14.145 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  18. 21 CFR 14.147 - Membership of a color additive advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Membership of a color additive advisory committee. 14.147 Section 14.147 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  19. 21 CFR 14.147 - Membership of a color additive advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Membership of a color additive advisory committee. 14.147 Section 14.147 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  20. 21 CFR 14.142 - Functions of a color additive advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Functions of a color additive advisory committee. 14.142 Section 14.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  1. 21 CFR 14.147 - Membership of a color additive advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Membership of a color additive advisory committee. 14.147 Section 14.147 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  2. 21 CFR 14.145 - Procedures of a color additive advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Procedures of a color additive advisory committee. 14.145 Section 14.145 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14...

  3. 77 FR 7588 - Blood Products Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Blood Products Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION... Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, Contact 1- 301...

  4. The Drug Safety and Risk Management Advisory Committee: a case study of meeting frequency, content, and outcomes before and after FDAAA.

    PubMed

    Morrato, Elaine H; Ling, Sarah B

    2012-11-01

    The Food and Drug Administration Amendments Act (FDAAA) of 2007 granted FDA-expanded drug safety authority. We hypothesized that meetings involving the FDA Drug Safety and Risk Management (DSaRM) Advisory Committee might serve as a barometer for the impact of FDAAA on drug safety regulatory decision making. We conducted a case study analysis of 42 DSaRM advisory committee meetings held between 2002 and 2011. Publicly available sources (FDA meeting minutes and materials, safety alerts, and drug manufacturer Web sites) were reviewed to describe and compare DSaRM meeting frequency, content and outcomes between the pre-FDAAA (2002-2007) and post-FDAAA (2008-2011) periods. DSaRM meeting frequency increased after FDAAA (from 2.7 to 6.5 meetings per year). DSaRM meetings were more likely to be held jointly with other drug advisory committees after FDAAA (from 68% to 92% of meetings). DSaRM members were invited participants in 35 additional meetings of other drug advisory committees (2007-2011). DSaRM meetings were more likely to review issues of approvability (eg, new drugs, new indications, and new product formulations) after FDAAA. FDA questions to the committee were more likely to request an explicit drug safety assessment after FDAAA (from 31% to 76% of meetings). Content analysis of meeting outcomes and subsequent FDA regulatory decisions did not suggest a more or less risk aversive climate after FDAAA. Increased DSaRM advisory committee activity indicates its advice was being sought more broadly for drug regulatory decision making and at earlier stages of drug development after FDAAA was enacted.

  5. 75 FR 47523 - Assembly of the Administrative Conference; Filing of Advisory Committee Charter

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Assembly of the Administrative Conference; Filing of Advisory Committee Charter AGENCY: Administrative... Conference of the United States will file an advisory committee charter for the Assembly of the... United States, 202- 326-2305. SUPPLEMENTARY INFORMATION: The purpose of the Assembly is to adopt...

  6. 78 FR 32403 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-30

    ...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee..., the committee will discuss the Assessment of SpondyloArthritis international Society classification...

  7. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14.155 Fees and compensation pertaining to a color additive advisory committee. (a...

  8. 77 FR 14529 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ... the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...

  9. 75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... potential of the drug dextromethorphan and the public health benefits and risks of dextromethorphan use as a...

  10. 77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

  11. 21 CFR 14.7 - Administrative remedies.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Administrative remedies. 14.7 Section 14.7 Food... BEFORE A PUBLIC ADVISORY COMMITTEE General Provisions § 14.7 Administrative remedies. A person who... Federal Advisory Committee Act may pursue the following administrative remedies: (a) If the person objects...

  12. 21 CFR 14.7 - Administrative remedies.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Administrative remedies. 14.7 Section 14.7 Food... BEFORE A PUBLIC ADVISORY COMMITTEE General Provisions § 14.7 Administrative remedies. A person who... Federal Advisory Committee Act may pursue the following administrative remedies: (a) If the person objects...

  13. 75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ...] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory... Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was... Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the...

  14. 76 FR 52334 - Arthritis Advisory Committee; Notice of Postponement of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-22

    ...: Philip A. Bautista, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS...

  15. 77 FR 34051 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-08

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... comments to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA...

  16. 21 CFR 14.84 - Nominations and selection of nonvoting members of standing technical advisory committees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Nominations and selection of nonvoting members of standing technical advisory committees. 14.84 Section 14.84 Food and Drugs FOOD AND DRUG ADMINISTRATION... Advisory Committees § 14.84 Nominations and selection of nonvoting members of standing technical advisory...

  17. 75 FR 35494 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... transfusions and the status of laboratory tests. On July 27, 2010, the committee will discuss blood donor...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Blood Products Advisory...

  18. 76 FR 39405 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-06

    ... blood donors and its implications for selective testing of blood donors. On August 3, 2011, the...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Blood Products Advisory...

  19. 75 FR 52605 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-26

    ...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory..., Rockville, MD 20852, 301-468-1100. Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3...

  20. 76 FR 72422 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ...] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration.... Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of the Committee... the Tobacco Products Scientific Advisory Committee's required report to the Secretary of Health and...

  1. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...

  2. 75 FR 65641 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ...] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Products Scientific Advisory Committee. General Function of the Committee: To provide advice and... by the committee at the March 30 and 31, 2010, meeting of the Tobacco Products Scientific Advisory...

  3. 75 FR 76993 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ...] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Products Scientific Advisory Committee. General Function of the Committee: To provide advice and... March 30 and 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee. FDA intends to...

  4. 76 FR 2398 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ...] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration.... Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of the Committee... Committee at the March 30 through 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee...

  5. Management Advisory on Deployment Readiness Review - Federal Aviation Administration

    DOT National Transportation Integrated Search

    1997-12-08

    This management advisory discusses the best practices identified during our review of the Federal Aviation Administration's (FAA) Deployment Readiness Review (DRR) process which should be adopted and strengthened as part of FAA's new Acquisition Mana...

  6. 77 FR 10755 - Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication Advisory... Administration (FDA) is requesting nominations for members to serve on the Risk Communication Advisory Committee...

  7. Using long-acting beta2-agonists safely: What will be the impact of the US Food and Drug Administration's panel recommendations?

    PubMed

    Smart, Brian A

    2009-01-01

    The US Food and Drug Administration (FDA) has launched an investigation into the safety of long-acting beta(2)-agonists (LABAs). While the impact of this investigation is yet to be seen, clinicians should be circumspect in the use of these agents and prescribe them according to the recommendations of current asthma guidelines, informing patients and their caretakers about potential risks. As clinical trials attempt to address the question of whether LABAs are safe for use in pediatric and adult populations, current data provide no clear answers. A special hearing of the FDA's Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and Pediatric Advisory Committee attempted to seek consensus on the matter as it reviewed the results of controlled clinical trials and conducted a benefit:risk assessment of LABAs to make recommendations on their safety.

  8. 75 FR 24773 - Research and Innovative Technology Administration Advisory Council on Transportation Statistics...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... DEPARTMENT OF TRANSPORTATION Bureau of Transportation Statistics Research and Innovative Technology Administration Advisory Council on Transportation Statistics; Notice of Meeting AGENCY: Research...-363; 5 U.S.C. app. 2), a meeting of the Advisory Council on Transportation Statistics (ACTS). The...

  9. 21 CFR 70.51 - Advisory committee on the applicability of the anticancer clause.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Advisory committee on the applicability of the anticancer clause. 70.51 Section 70.51 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.51 Advisory committee on the applicability...

  10. 21 CFR 70.51 - Advisory committee on the applicability of the anticancer clause.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Advisory committee on the applicability of the anticancer clause. 70.51 Section 70.51 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.51 Advisory committee on the applicability...

  11. 21 CFR 70.51 - Advisory committee on the applicability of the anticancer clause.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Advisory committee on the applicability of the anticancer clause. 70.51 Section 70.51 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.51 Advisory committee on the applicability...

  12. 21 CFR 70.51 - Advisory committee on the applicability of the anticancer clause.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Advisory committee on the applicability of the anticancer clause. 70.51 Section 70.51 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.51 Advisory committee on the applicability...

  13. 78 FR 17086 - Public Hearing Before a Public Advisory Committee; Technical Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

    ... Administrative practice and procedure, Advisory committees, Color additives, Drugs, Foods, Medical Devices... device good manufacturing practice advisory committees established under section 520(f)(3) of the FD&C...) Color additive advisory committees are required to be established under the circumstances specified in...

  14. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any...

  15. 75 FR 5335 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... previously issued communications, emphasizing communications challenges. Examples, selected for illustrative...

  16. 77 FR 73472 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug... closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General...

  17. 76 FR 64951 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...

  18. 76 FR 10609 - Tobacco Products Scientific Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-25

    ...] Tobacco Products Scientific Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration... of a meeting of the Tobacco Products Scientific Advisory Committee. This meeting was announced in the... Scientific Advisory Committee would be held on March 1 and 2, 2011. On page 4075, in the third column, the...

  19. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive...

  20. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive...

  1. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive...

  2. 76 FR 58519 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-21

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss implications, for strategic communication, of recent theoretical developments on information use...

  3. 76 FR 42714 - Science Board Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Science Board Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... scientific evolutions in the fields of regulatory science, on formulating an appropriate research agenda, and...

  4. 76 FR 25359 - Science Board Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Science Board Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... scientific evolutions in the fields of regulatory science, on formulating an appropriate research agenda, and...

  5. 77 FR 70450 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... barriers such as prevention or warning fatigue or inaccurate risk perception. FDA intends to make...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Risk...

  6. 75 FR 57279 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-20

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Committee will hear and discuss developments in FDA's ongoing communications programs, such as FDA's...

  7. 76 FR 5380 - Advisory Committees; Filing of Closed Meeting Reports

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

    ... for Biologics Evaluation and Research: Blood Products Advisory Committee, Vaccines and Related Biological Products Advisory Committee. National Center for Toxicological Research: Science Board to the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2011-N-0002...

  8. 78 FR 70954 - Risk Communications Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... awareness and understanding of the key risk messages, as well as whether the communications are having the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Risk Communications Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...

  9. 75 FR 20608 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... relevant to improving risk communication at FDA, and discuss applications or gaps for strategic planning of...

  10. 76 FR 16427 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss developments in FDA's ongoing communications programs. The discussion will focus on the use of...

  11. 78 FR 63224 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... oncology indications. The subcommittee will consider and discuss issues relating to the development of each...

  12. 76 FR 61713 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... adult oncology indication, or in late stage development in pediatric patients with cancer. The...

  13. 75 FR 66773 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-29

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... or, are in late stage development for an adult oncology indication. The subcommittee will consider...

  14. 77 FR 57095 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-17

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... that are in development for an adult oncology indication. The subcommittee will consider and discuss...

  15. 77 FR 67013 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ..., 2012, the Committee will meet in open session to discuss labeling of Red Blood Cells with historical...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Blood...

  16. 78 FR 63222 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... the public. Name of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory... measures in the pediatric development plans of oncology products. The half-day session will provide an...

  17. 75 FR 8368 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name... comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane...

  18. 78 FR 42966 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name..., Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993...

  19. 76 FR 72954 - Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug...

  20. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  1. 76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  2. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  3. 78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave...

  4. 76 FR 4705 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-26

    ...] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration.... Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of the Committee... nature of the evidence or arguments they wish to present, the names and addresses of proposed...

  5. 75 FR 56547 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-16

    ...] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Products Scientific Advisory Committee. General Function of the Committee: To provide advice and... evidence or arguments they wish to present, the names and addresses of proposed participants, and an...

  6. 75 FR 47308 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-05

    ...] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Products Scientific Advisory Committee General Function of the Committee: To provide advice and... submit a brief statement of the general nature of the evidence or arguments they wish to present, the...

  7. 76 FR 58019 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ...] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration.... Name of Committee: Tobacco Products Scientific Advisory Committee (TPSAC). General Function of the... notify the contact person and submit a brief statement of the general nature of the evidence or arguments...

  8. 77 FR 7589 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ...] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration.... Name of Committee: Tobacco Products Scientific Advisory Committee (TPSAC). General Function of the... notify the contact person and submit a brief statement of the general nature of the evidence or arguments...

  9. 78 FR 52531 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-23

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-07; Docket No. 2013-0002; Sequence 24] The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting Notice. SUMMARY: The...

  10. 78 FR 45200 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-26

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-06; Docket No. 2013-0002; Sequence 22] The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting Notice. SUMMARY: The...

  11. 78 FR 64942 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-10; Docket No. 2013-0002; Sequence 32] The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting AGENCY: Office of Government-Wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting notice. SUMMARY: The...

  12. 78 FR 34384 - The President's Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-07

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-04; Docket No. 2013-0002; Sequence 19] The President's Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting Notice. SUMMARY: The...

  13. 78 FR 55079 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-08; Docket No. 2013-0002; Sequence 27] The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meetings AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting notice. SUMMARY: The...

  14. 78 FR 38042 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... GENERAL SERVICES ADMINISTRATION [Notice--MK-2013-05; Docket No. 2013-0002; Sequence 20] The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting; Correction AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting notice...

  15. 78 FR 35272 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-05; Docket No. 2013-0002; Sequence 20] The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: M eeting notice. SUMMARY: The...

  16. 78 FR 69416 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-19

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-11; Docket No. 2013-0002; Sequence No. 36] The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting AGENCY: Office of Government-Wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting Notice. SUMMARY: The...

  17. 76 FR 3912 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name... is 214- 651-1234. Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and...

  18. 75 FR 64736 - Request for Nominations for Voting Members on a Public Advisory Committee; Science Board to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Request for Nominations for Voting Members on a Public Advisory Committee; Science Board to the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  19. 78 FR 45545 - National Advisory Council; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration... meeting of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory... and Prescription Drug Abuse Issues. The meeting is open to the public and will be held at the SAMHSA...

  20. 78 FR 15961 - National Advisory Council; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration... meeting of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory... Dialogue, and prescription drug abuse. The meeting is open to the public and will be held at the SAMHSA...

  1. 76 FR 82311 - Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency; Availability AGENCY: Food and Drug...

  2. 75 FR 76992 - Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0072] (formerly Docket No. 2005D-0042) Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings; Availability AGENCY: Food and Drug...

  3. 77 FR 42746 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  4. 75 FR 10488 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  5. 77 FR 1696 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  6. 21 CFR 14.40 - Establishment and renewal of advisory committees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Establishment and renewal of advisory committees. 14.40 Section 14.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., color, national origin, religion, age, or sex. (3) It is constituted and utilizes procedures designed to...

  7. 78 FR 13350 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

  8. 77 FR 13131 - Advisory Committees; Filing of Closed Meeting Reports

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-05

    ..., 2010 through September 30, 2011: Center for Biologics Evaluation and Research Allergenic Products... Vaccines and Related Biological Products Advisory Committee Center for Drug Evaluation and Research... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001...

  9. Non-steroidal anti-inflammatory drug administration after coronary artery bypass surgery: utilization persists despite the boxed warning.

    PubMed

    Kulik, Alexander; Bykov, Katsiaryna; Choudhry, Niteesh K; Bateman, Brian T

    2015-06-01

    In 2005, the US Food and Drug Administration (FDA) issued a boxed warning against the administration of non-steroidal anti-inflammatory drugs (NSAIDs) after coronary artery bypass graft (CABG) surgery because of cardiovascular safety concerns. We assessed utilization rates before and after the advisory and evaluated predictors of NSAID administration following CABG. We assembled a cohort of 277,576 patients who underwent CABG from 2004 to 2010. Temporal trends in NSAID exposure were evaluated, and predictors of postoperative NSAID use were identified using generalized estimating equations. Over the study period, 92,938 CABG patients (33.5%) received NSAIDs following surgery. The frequency of NSAID administration declined steadily over time, from a peak of 38.9% in 2004 to a low of 29.0% in 2010 (p < 0.0007). Ketorolac was the most frequent NSAID prescribed, commonly on the first postoperative day. Surgery performed after the boxed warning was independently associated with a 20% lower odds of NSAID administration [odds ratio (OR): 0.80; p = 0.0003]. Other factors that predicted a lower odds of NSAID use following surgery included a history of renal disease (OR: 0.33; p < 0.0001) and liver disease (OR: 0.66; p < 0.0001), and the need for concurrent valve surgery (OR: 0.78; p < 0.0001). A mammary graft at the time of surgery increased the odds of NSAID administration (OR: 1.23; p < 0.0001). The frequency of NSAID administration after CABG has declined since the FDA advisory, yet many patients continue to receive them in recent years. Our data highlight the need for future research initiatives to further define the risks associated with NSAID use in this population. Copyright © 2015 John Wiley & Sons, Ltd.

  10. 21 CFR 14.35 - Written submissions to an advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Written submissions to an advisory committee. 14.35 Section 14.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... of the written summary along with a proposed agenda outlining the topics to be covered and...

  11. 21 CFR 14.35 - Written submissions to an advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Written submissions to an advisory committee. 14.35 Section 14.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... of the written summary along with a proposed agenda outlining the topics to be covered and...

  12. 21 CFR 14.35 - Written submissions to an advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Written submissions to an advisory committee. 14.35 Section 14.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... of the written summary along with a proposed agenda outlining the topics to be covered and...

  13. 21 CFR 14.35 - Written submissions to an advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Written submissions to an advisory committee. 14.35 Section 14.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... of the written summary along with a proposed agenda outlining the topics to be covered and...

  14. 21 CFR 14.35 - Written submissions to an advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Written submissions to an advisory committee. 14.35 Section 14.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... of the written summary along with a proposed agenda outlining the topics to be covered and...

  15. 78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction...

  16. An observational study of drug administration errors in a Malaysian hospital (study of drug administration errors).

    PubMed

    Chua, S S; Tea, M H; Rahman, M H A

    2009-04-01

    Drug administration errors were the second most frequent type of medication errors, after prescribing errors but the latter were often intercepted hence, administration errors were more probably to reach the patients. Therefore, this study was conducted to determine the frequency and types of drug administration errors in a Malaysian hospital ward. This is a prospective study that involved direct, undisguised observations of drug administrations in a hospital ward. A researcher was stationed in the ward under study for 15 days to observe all drug administrations which were recorded in a data collection form and then compared with the drugs prescribed for the patient. A total of 1118 opportunities for errors were observed and 127 administrations had errors. This gave an error rate of 11.4 % [95% confidence interval (CI) 9.5-13.3]. If incorrect time errors were excluded, the error rate reduced to 8.7% (95% CI 7.1-10.4). The most common types of drug administration errors were incorrect time (25.2%), followed by incorrect technique of administration (16.3%) and unauthorized drug errors (14.1%). In terms of clinical significance, 10.4% of the administration errors were considered as potentially life-threatening. Intravenous routes were more likely to be associated with an administration error than oral routes (21.3% vs. 7.9%, P < 0.001). The study indicates that the frequency of drug administration errors in developing countries such as Malaysia is similar to that in the developed countries. Incorrect time errors were also the most common type of drug administration errors. A non-punitive system of reporting medication errors should be established to encourage more information to be documented so that risk management protocol could be developed and implemented.

  17. 77 FR 29667 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-18

    ...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Blood... Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics...

  18. 78 FR 38351 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Blood... Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics...

  19. 76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...

  20. The debate on FDA reform: a view from the U.S. Senate. Food and Drug Administration.

    PubMed

    Baker, R

    1995-09-01

    The recently released concept paper on Food and Drug Administration (FDA) reform from Republican Senator, Nancy Kassebaum, is reviewed. Senator Kassebaum chairs the Senate Committee on Labor and Human Resources that will influence the Senate's action on FDA reform. The paper outlines the Senator's priorities for Congressional legislation on FDA reform in the following areas: the FDA mission and its accountability; creation of a Performance Review Panel and Industry Advisory Council; approval and access of products for seriously ill patients; the FDA's responsibility for good manufacturing practices; establishment of an Ombudsman Office for resolving disputes; dissemination of information on unapproved uses of approved products; and approval standards for new drugs.

  1. 75 FR 12768 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Blood... Biochemistry and Vascular Biology, Division of Hematology, Office of Blood Research and Review, CBER, FDA. FDA...

  2. [Anatomophysiological bases of drug administration. Dosage forms and routes of administration].

    PubMed

    Carillo Norte, Juan Antonio; Gañán Presmanes, Yolanda

    2010-12-01

    The administration of the right dose to the right patient is of paramount importance to obtain an optimal drug response within the scope of clinical pharmacology and tailored medicine. The marketing of safer and more efficient drug entities, along with the development of new drug administration devices provide a major boost for the diagnosis and treatment of diseases, beyond our imagination. However dose adjustment is not enough to produced the desired effect, and drug therapy should include an appropriate route of drug administration. Currently, there are many different and sophisticated methods to incorporate drugs into the patients that nurses should be familiar with. When there is no contraindication, oral route of drug administration is of choice and most frequently used as a physiological pathway of drug intake.

  3. 78 FR 734 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-04

    ... committee link, or call the advisory committee information line to learn about possible modifications before... new drug application (NDA) 022506, gabapentin 600 milligram (mg) tablets, submitted by Depomed, Inc...

  4. 21 CFR 14.20 - Notice of hearing before an advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Notice of hearing before an advisory committee. 14.20 Section 14.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... function of the committee; (4) A list of all agenda items, showing whether each will be discussed in an...

  5. 21 CFR 14.20 - Notice of hearing before an advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Notice of hearing before an advisory committee. 14.20 Section 14.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... function of the committee; (4) A list of all agenda items, showing whether each will be discussed in an...

  6. 21 CFR 14.20 - Notice of hearing before an advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Notice of hearing before an advisory committee. 14.20 Section 14.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... function of the committee; (4) A list of all agenda items, showing whether each will be discussed in an...

  7. 21 CFR 14.20 - Notice of hearing before an advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Notice of hearing before an advisory committee. 14.20 Section 14.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... function of the committee; (4) A list of all agenda items, showing whether each will be discussed in an...

  8. 21 CFR 14.20 - Notice of hearing before an advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Notice of hearing before an advisory committee. 14.20 Section 14.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... function of the committee; (4) A list of all agenda items, showing whether each will be discussed in an...

  9. 78 FR 63224 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ...: Endocrinologic and Metabolic Drugs Advisory Committee. General Function of the Committee: To provide advice and... disorder caused by the absence or malfunctioning of an enzyme involved in an important metabolic pathway...

  10. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...

  11. 78 FR 32306 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-29

    ... DEPARTMENT OF THE TREASURY Internal Revenue Service Open Meeting for the Electronic Tax... notice. SUMMARY: An open meeting of the Electronic Tax Administration Advisory Committee (ETAAC) will be conducted via telephone conference call. The ETAAC will discuss recommendations for electronic tax...

  12. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

  13. 76 FR 6623 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory...

  14. Management advisory memorandum on National Airspace System infrastructure management system prototype, Federal Aviation Administration

    DOT National Transportation Integrated Search

    1997-03-01

    This is our Management Advisory Memorandum on the National Airspace : System (NAS) Infrastructure Management System (NIMS) prototype : project in the Federal Aviation Administration (FAA). Our review was : initiated in response to a hotline complaint...

  15. 21 CFR 14.86 - Rights and responsibilities of nonvoting members of advisory committees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Rights and responsibilities of nonvoting members of advisory committees. 14.86 Section 14.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... meeting dates; (2) A nonvoting member who is a representative of industry interest may have access to data...

  16. 78 FR 69133 - Drug Enforcement Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances..., California 94085, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule...

  17. 78 FR 13348 - Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001... for Devices and Radiological Health Research Review subcommittee and the Global Health subcommittee. Progress updates will be presented regarding the Global Health subcommittee and the recently established...

  18. 76 FR 6186 - Applications for Membership on the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... DEPARTMENT OF THE TREASURY Internal Revenue Service Applications for Membership on the Electronic Tax Administration Advisory Committee (ETAAC) AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Request for Applications. SUMMARY: The Internal Revenue Service (IRS) requests applications of individuals...

  19. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...

  20. 75 FR 66381 - Pediatric Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0553... meeting. Agenda: The Pediatric Advisory Committee (PAC) will meet to discuss donor and banked human milk... with a better understanding of current practices, and potential benefits and risks associated with the...

  1. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... deposits and fees required by this section are to be paid by money order, bank draft, or certified check...

  2. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any... monitoring of the matter and consultation with FDA on behalf of the committee. The member or consultant may...

  3. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any... monitoring of the matter and consultation with FDA on behalf of the committee. The member or consultant may...

  4. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any... monitoring of the matter and consultation with FDA on behalf of the committee. The member or consultant may...

  5. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any... monitoring of the matter and consultation with FDA on behalf of the committee. The member or consultant may...

  6. 75 FR 72834 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... Pearline Muckelvene, Center for Biologics Evaluation and Research, Food and Drug Administration (HFM- 71... following topics: (1) November 4 and 5, 2010, meeting of the Health and Human Services Advisory Committee on... (3) Research programs in the Laboratories of Hemostasis and Plasma Derivatives, Division of...

  7. Drug Abuse Control--Administrative Guidelines.

    ERIC Educational Resources Information Center

    Los Angeles City Schools, CA.

    These guidelines were developed to assist administrators, teachers, and other staff members of the Los Angeles Public Schools in the formulation of an effective program designed to alleviate drug abuse. Staff responsibilities are spelled out. Specific attention is directed to the problems of drug abuse, drug possession and drug selling. The…

  8. 78 FR 55728 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ...: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration...

  9. 78 FR 1265 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-001] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel..., Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...

  10. 76 FR 62455 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-088)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Burch, Aerospace Safety Advisory Panel Administrative Officer, National Aeronautics and Space...

  11. 5 CFR 724.403 - Advisory guidelines.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Advisory guidelines. 724.403 Section 724.403 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

  12. 75 FR 61219 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-04

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-116)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...

  13. 77 FR 20489 - Open Season for Membership to the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-04

    ... returns, (3) tax software developers, (4) large and small business, (5) employers and payroll service... DEPARTMENT OF THE TREASURY Internal Revenue Service Open Season for Membership to the Electronic Tax Administration Advisory Committee (ETAAC) AGENCY: Internal Revenue Service (IRS), Treasury. ACTION...

  14. 75 FR 4631 - Open Season for Membership to the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-28

    ... DEPARTMENT OF THE TREASURY Internal Revenue Service Open Season for Membership to the Electronic Tax Administration Advisory Committee (ETAAC) AGENCY: Internal Revenue Service (IRS), Treasury. ACTION... continued input into the development and implementation of the Internal Revenue Service (IRS) strategy for...

  15. 78 FR 10693 - Open Season for Membership to the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    ... returns, (3) tax software developers, (4) large and small business, (5) employers and payroll service... DEPARTMENT OF THE TREASURY Internal Revenue Service Open Season for Membership to the Electronic Tax Administration Advisory Committee (ETAAC) AGENCY: Internal Revenue Service (IRS), Treasury. ACTION...

  16. 75 FR 9416 - Advisory Committee Information Hotline

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... Drugs Advisory Committee 3014512542 Peripheral and Central Nervous System Drugs Advisory Committee... Devices Panel 3014512624 Circulatory System Devices Panel 3014512625 Clinical Chemistry and Clinical... about any particular advisory committee meeting, this system will provide interested parties with timely...

  17. 78 FR 40144 - Governmentwide Travel Advisory Committee (GTAC); Upcoming Public Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-03

    ...] Governmentwide Travel Advisory Committee (GTAC); Upcoming Public Advisory Committee Meeting AGENCY: Office of Governmentwide Policy, General Services Administration (GSA). ACTION: Notice. SUMMARY: The Governmentwide Travel... Officer (DFO), Governmentwide Travel Advisory Committee (GTAC), Office of Governmentwide Policy, General...

  18. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

  19. Administration costs of intravenous biologic drugs for rheumatoid arthritis.

    PubMed

    Soini, Erkki J; Leussu, Miina; Hallinen, Taru

    2013-01-01

    Cost-effectiveness studies explicitly reporting infusion times, drug-specific administration costs for infusions or real-payer intravenous drug cost are few in number. Yet, administration costs for infusions are needed in the health economic evaluations assessing intravenously-administered drugs. To estimate the drug-specific administration and total cost of biologic intravenous rheumatoid arthritis (RA) drugs in the adult population and to compare the obtained costs with published cost estimates. Cost price data for the infusions and drugs were systematically collected from the 2011 Finnish price lists. All Finnish hospitals with available price lists were included. Drug administration and total costs (administration cost + drug price) per infusion were analysed separately from the public health care payer's perspective. Further adjustments for drug brand, dose, and hospital type were done using regression methods in order to improve the comparability between drugs. Annual expected drug administration and total costs were estimated. A literature search not limited to RA was performed to obtain the per infusion administration cost estimates used in publications. The published costs were converted to Finnish values using base-year purchasing power parities and indexing to the year 2011. Information from 19 (95%) health districts was obtained (107 analysable prices out of 176 observations). The average drug administration cost for infliximab, rituximab, abatacept, and tocilizumab infusion in RA were €355.91; €561.21; €334.00; and €293.96, respectively. The regression-adjusted (dose, hospital type; using semi-log ordinary least squares) mean administration costs for infliximab and rituximab infusions in RA were €289.12 (95% CI €222.61-375.48) and €542.28 (95% CI €307.23-957.09). The respective expected annual drug administration costs were €2312.96 for infliximab during the first year, €1879.28 for infliximab during the forthcoming years, and

  20. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

  1. 77 FR 55863 - NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-072)] NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory Group Meeting AGENCY: National Aeronautics... the Applied Science Advisory Group. This Subcommittee reports to the Earth Science Subcommittee...

  2. 76 FR 64122 - NASA Advisory Committee; Renewal of NASA's International Space Station Advisory Committee Charter

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-095)] NASA Advisory Committee; Renewal of NASA's International Space Station Advisory Committee Charter AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the Charter of the International...

  3. 76 FR 52016 - NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-074)] NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space... meeting of the NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel...

  4. Preclinical Determinants of Drug Choice under Concurrent Schedules of Drug Self-Administration

    PubMed Central

    Banks, Matthew L.; Negus, S. Stevens

    2012-01-01

    Drug self-administration procedures have played a critical role in the experimental analysis of psychoactive compounds, such as cocaine, for over 50 years. While there are numerous permutations of this procedure, this paper will specifically focus on choice procedures using concurrent schedules of intravenous drug self-administration. The aims of this paper are to first highlight the evolution of drug choice procedures and then review the subsequent preclinical body of literature utilizing these choice procedures to understand the environmental, pharmacological, and biological determinants of the reinforcing stimulus effects of drugs. A main rationale for this paper is our proposition that choice schedules are underutilized in investigating the reinforcing effects of drugs in assays of drug self-administration. Moreover, we will conclude with potential future directions and unexplored scientific space for the use of drug choice procedures. PMID:23243420

  5. 77 FR 72365 - National Institute on Drug Abuse; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-05

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of... of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

  6. 75 FR 60484 - NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-30

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-115)] NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory Group Meeting AGENCY: National Aeronautics...) announces a meeting of the Applied Science Advisory Group. This Subcommittee reports to the Earth Science...

  7. 76 FR 19147 - Aerospace Safety Advisory Panel; Meeting.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-06

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-030)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel.... Kathy Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  8. 78 FR 56941 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-16

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-114] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  9. 77 FR 58413 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-074] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  10. 77 FR 38090 - Aerospace Safety Advisory Panel; Meeting.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-26

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-044] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  11. 76 FR 25358 - 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food...

  12. 75 FR 14176 - National Institute on Drug Abuse; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... announcements and reports of administrative, legislative and program developments in the drug abuse field. Place... Person: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse...

  13. 76 FR 51381 - National Institute on Drug Abuse; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of.... (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

  14. 75 FR 59747 - NASA Advisory Council; Meeting.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-113)] NASA Advisory Council; Meeting. AGENCY: National Aeronautics and Space Administration. ACTION: Notice of meeting. SUMMARY: In accordance... Space Administration announces a meeting of the NASA Advisory Council. DATES: Wednesday, October 6, 2010...

  15. 75 FR 16438 - U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... Tourism Advisory Board (Board) will hold a meeting to discuss topics related to the travel and tourism...

  16. 75 FR 14135 - U.S. Travel And Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel And Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S. Department of Commerce. ACTION: Notice of an open meeting. SUMMARY: The U.S. Travel and Tourism Advisory...

  17. 75 FR 39496 - U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-09

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S. Department of Commerce. ACTION: Notice of an open meeting. SUMMARY: The U.S. Travel and Tourism Advisory...

  18. 75 FR 29561 - Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004] [FDA 225-09-0012] Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com... Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Drugs.Com. The...

  19. 76 FR 21072 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-14

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-039)] NASA Advisory Council; Meeting AGENCY: National Aeronautics and Space Administration. ACTION: Notice of meeting. SUMMARY: In accordance... Space Administration announces a meeting of the NASA Advisory Council. DATES: Thursday, May 5, 2011, 8 a...

  20. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner of... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration-requested recall. 7.45 Section 7.45 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  1. 75 FR 80039 - U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...

  2. 76 FR 53666 - U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-29

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...

  3. 76 FR 21703 - U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-18

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...

  4. Evaluation of drug administration errors in a teaching hospital

    PubMed Central

    2012-01-01

    Background Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Methods Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Results Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors) with one or more errors were detected (27.6%). There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501). The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%). The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission). In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC) and the number of patient under the nurse's care. Conclusion Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions. PMID:22409837

  5. Evaluation of drug administration errors in a teaching hospital.

    PubMed

    Berdot, Sarah; Sabatier, Brigitte; Gillaizeau, Florence; Caruba, Thibaut; Prognon, Patrice; Durieux, Pierre

    2012-03-12

    Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors) with one or more errors were detected (27.6%). There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501). The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%). The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission). In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC) and the number of patient under the nurse's care. Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions.

  6. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

  7. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

  8. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

  9. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

  10. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

  11. 78 FR 70623 - Pipeline Safety: Meeting of the Gas Pipeline Advisory Committee and the Liquid Pipeline Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-26

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2009-0203] Pipeline Safety: Meeting of the Gas Pipeline Advisory Committee and the Liquid Pipeline Advisory Committee AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. [[Page...

  12. 76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

  13. [New drug development by innovative drug administration--"change" in pharmaceutical field].

    PubMed

    Nagai, T

    1997-11-01

    New drug development can be made by providing products of higher "selectivity for the drug" for medical treatment. There are two ways for the approach to get higher "selectivity of drug": 1) discovery of new compounds with high selectivity of drug; 2) innovation of new drug administration, that is new formulation and/or method with high selectivity of drug by integration and harmonization of various hard/soft technologies. An extensive increase of biological information and advancement of surrounding science and technology may modify the situation as the latter overcomes the former in the 21 century. As the science and technology in the 21 century is said to be formed on "3H", that is, 1. hybrid; 2. hi-quality; 3. husbandry, the new drug development by innovative drug administration is exactly based on the science and technology of 3H. Its characteristic points are interdisciplinary/interfusion, international, of philosophy/ethics, and systems of hard/hard/heart. From these points of view, not only the advance of unit technology but also a revolution in thinking way should be "must" subjects. To organize this type of research well, a total research activity such as ROR (research on research) might take an important and efficient role. Here the key words are the "Optimization technology" and "Change in Pharmaceutical Fields." As some examples of new drug innovation, our trials on several topical mucosal adhesive dosage forms and parenteral administration of peptide drugs such as insulin and erythropoietin will be described.

  14. 28 CFR 1.11 - Advisory nature of regulations.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Advisory nature of regulations. 1.11 Section 1.11 Judicial Administration DEPARTMENT OF JUSTICE EXECUTIVE CLEMENCY § 1.11 Advisory nature of regulations. The regulations contained in this part are advisory only and for the internal guidance of...

  15. 28 CFR 1.11 - Advisory nature of regulations.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Advisory nature of regulations. 1.11 Section 1.11 Judicial Administration DEPARTMENT OF JUSTICE EXECUTIVE CLEMENCY § 1.11 Advisory nature of regulations. The regulations contained in this part are advisory only and for the internal guidance of...

  16. 28 CFR 1.11 - Advisory nature of regulations.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Advisory nature of regulations. 1.11 Section 1.11 Judicial Administration DEPARTMENT OF JUSTICE EXECUTIVE CLEMENCY § 1.11 Advisory nature of regulations. The regulations contained in this part are advisory only and for the internal guidance of...

  17. 28 CFR 1.11 - Advisory nature of regulations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Advisory nature of regulations. 1.11 Section 1.11 Judicial Administration DEPARTMENT OF JUSTICE EXECUTIVE CLEMENCY § 1.11 Advisory nature of regulations. The regulations contained in this part are advisory only and for the internal guidance of...

  18. 28 CFR 1.11 - Advisory nature of regulations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Advisory nature of regulations. 1.11 Section 1.11 Judicial Administration DEPARTMENT OF JUSTICE EXECUTIVE CLEMENCY § 1.11 Advisory nature of regulations. The regulations contained in this part are advisory only and for the internal guidance of...

  19. 78 FR 31977 - NASA Applied Sciences Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-061] NASA Applied Sciences Advisory... Aeronautics and Space Administration (NASA) announces a meeting of the Applied Sciences Advisory Committee (ASAC). This Committee functions in an advisory capacity to the Director, Earth Science Division. The...

  20. 78 FR 15976 - Aerospace Safety Advisory Panel; Meeting.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-023] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel... Space Administration, Washington, DC 20546, (202) 358-1857. SUPPLEMENTARY INFORMATION: The Aerospace...

  1. Revisiting financial conflicts of interest in FDA advisory committees.

    PubMed

    Pham-Kanter, Genevieve

    2014-09-01

    The Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members' financial relationships on the FDA's drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests. The study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997-2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members' financial interests and their voting behavior. Individuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005). There appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial relationships of FDA advisory committee members.

  2. 76 FR 36937 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-055)] Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of meeting. SUMMARY... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel...

  3. 77 FR 1955 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-12

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-001] Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of meeting. SUMMARY... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel...

  4. 78 FR 36793 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-068] Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of meeting. SUMMARY... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel...

  5. 75 FR 36697 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-071)] Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of meeting. SUMMARY... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel...

  6. 77 FR 25502 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-30

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-030)] Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of meeting. SUMMARY... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel...

  7. 75 FR 6407 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-09

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10- 020)] Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of Meeting. SUMMARY... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel...

  8. 76 FR 2923 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-18

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-004)] Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of Meeting. SUMMARY... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel...

  9. 75 FR 19662 - Aerospace Safety Advisory Panel; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-15

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-043)] Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of meeting. SUMMARY... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel...

  10. 76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) is announcing a...

  11. 76 FR 57023 - Science Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-15

    ... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration (NOAA) Science Advisory... forth the schedule and proposed agenda of a forthcoming meeting of the NOAA Science Advisory Board. The... date. SUPPLEMENTARY INFORMATION: The Science Advisory Board (SAB) was established by a Decision...

  12. 75 FR 54854 - Science Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

    ... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Science Advisory Board... the schedule and proposed agenda of a forthcoming meeting of the NOAA Science Advisory Board. The... FURTHER INFORMATION CONTACT: Dr. Cynthia Decker, Executive Director, Science Advisory Board, NOAA, Rm...

  13. Retention of drug administration skills after intensive teaching.

    PubMed

    Wheeler, D W; Degnan, B A; Murray, L J; Dunling, C P; Whittlestone, K D; Wood, D F; Smith, H L; Gupta, A K

    2008-04-01

    We have identified deficiencies in medical students' drug administration skills, and we attempted to address them with interactive online teaching modules and simulated critical incident scenarios. Short-term improvements have been evident with this intensive effort, but medium-term retention of skills has not been measured. A drug administration lecture, an online module and a simulated emergency scenario were offered to final year clinical students. None of the teaching was compulsory but participation was recorded, along with students' simulator performances and marks in an objective structured practical examination 9 months later. A poor simulator score predicted a poor performance in the later examination. Participation in the simulated scenario only significantly improved examination scores when supplemented by online teaching (p = 0.002). Intensive drug administration teaching using an online module and high fidelity simulation improves drug administration skills in the medium term. Students found simulation much more engaging than online teaching.

  14. 77 FR 476 - Science Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-05

    ... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration (NOAA) Science Advisory... forth the schedule and proposed agenda of a forthcoming meeting of the NOAA Science Advisory Board. The... INFORMATION: The Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25...

  15. 75 FR 7628 - Founding Fathers Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-22

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Founding Fathers Advisory Committee AGENCY: National Archives and Records Administration. ACTION: Notice of Establishment of a NARA Advisory Committee, Pursuant... is in the public interest in connection with the Presidential Historical Records Preservation Act of...

  16. 77 FR 5578 - Founding Fathers Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-03

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Founding Fathers Advisory Committee AGENCY: National Archives and Records Administration. ACTION: Notice of meeting. SUMMARY: In accordance with the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), and the Presidential Historical Records...

  17. 78 FR 72719 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-03

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (13-140)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council (NAC). DATES: Wednesday, December...., Local Time. ADDRESSES: NASA Kennedy Space Center, Headquarters Building, Room 2201, Kennedy Space Center...

  18. 76 FR 40768 - Occupational Information Development Advisory Panel Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-11

    ... SOCIAL SECURITY ADMINISTRATION [Docket No. SSA-2011-0044] Occupational Information Development Advisory Panel Meeting AGENCY: Social Security Administration (SSA). ACTION: Notice of upcoming panel... addressed to the Occupational Information Development Advisory Panel, Social Security Administration, 6401...

  19. United States Food and Drug Administration Product Label Changes.

    PubMed

    Kircik, Leon; Sung, Julie C; Stein-Gold, Linda; Goldenberg, Gary

    2017-02-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug.

  20. 77 FR 1547 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-10

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings... quarter meetings of the National Small Business Development Center (SBDC) Advisory Board. DATES: The...

  1. 76 FR 1657 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-11

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings... quarter meetings of the National Small Business Development Center (SBDC) Advisory Board. DATES: The...

  2. 77 FR 22057 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-12

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings... quarter meetings of the National Small Business Development Center (SBDC) Advisory Board. DATES: The...

  3. 75 FR 4122 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-26

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings... quarter meetings of the National Small Business Development Center (SBDC) Advisory Board. DATES: The...

  4. 78 FR 23622 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings... quarter meetings of the National Small Business Development Center (SBDC) Advisory Board. DATES: The...

  5. 78 FR 39823 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings... quarter meetings of the National Small Business Development Center (SBDC) Advisory Board. DATES: The...

  6. 78 FR 76886 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-19

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings... quarter meetings of the National Small Business Development Center (SBDC) Advisory Board. DATES: The...

  7. 77 FR 64836 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-23

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings... quarter meetings of the National Small Business Development Center (SBDC) Advisory Board. DATES: The...

  8. 76 FR 41320 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-13

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings... quarter meetings of the National Small Business Development Center (SBDC) Advisory Board. DATES: The...

  9. 75 FR 17793 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-07

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings... quarter meetings of the National Small Business Development Center (SBDC) Advisory Board. DATES: The...

  10. 21 CFR 20.1 - Testimony by Food and Drug Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... laws administered by the Food and Drug Administration, shall give any testimony before any tribunal...

  11. The runway model of drug self-administration

    PubMed Central

    Ettenberg, Aaron

    2009-01-01

    Behavioral scientists have employed operant runways as a means of investigating the motivational impact of incentive stimuli for the better part of the past 100 years. In this task, the speed with which a trained animal traverses a long straight alley for positive incentive stimuli, like food or water, provides a reliable index of the subject’s motivation to seek those stimuli. The runway is therefore a particularly appropriate tool for investigating the drug-seeking behavior of animals working for drugs of abuse. The current review describes our laboratory’s work over the past twenty years developing and implementing an operant runway model of drug self-administration. Procedures are described that methodologically dissociate the antecedent motivational processes that induce an animal to seek a drug, from the positive reinforcing consequences of actually earning the drug. Additional work is reviewed on the use of the runway method as a means of modeling the factors that often result in a “relapse” of drug self-administration after a period of abstinence (i.e., a response reinstatement test), as are runway studies that revealed the presence of opposing positive and negative consequences of self-administered cocaine. This body of work suggests that the runway method has served as a powerful behavioral tool for the study of the behavioral and neurobiological basis of drug self-administration. PMID:19032964

  12. 76 FR 52377 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-22

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings... Meeting of the National Small Business Development Center (SBDC) Advisory Board at the ASBDC Conference...

  13. Early lessons from schistosomiasis mass drug administration programs

    PubMed Central

    Secor, W. Evan

    2015-01-01

    Mass drug administration using praziquantel is the backbone of the current strategy for the control of schistosomiasis. As the theoretical plans have moved into practical application, certain challenges with this approach have surfaced, and it is likely that annual mass drug administration alone may not be sufficient to achieve program goals. However, mass drug administration is still the only available intervention that can be readily used in the wide variety of settings where schistosomiasis is endemic. The task then becomes how to improve this approach and identify what adjuncts to mass drug administration are effective, as programs move from morbidity control to elimination goals. Other aspects worthy of consideration include how best to employ new diagnostic tools to more easily identify where treatment is needed, and new formulations of praziquantel to extend the availability of treatment to all age groups. The aim of this review is to highlight both areas of challenge and of opportunity to improve the public health impact of schistosomiasis control programs. PMID:26937275

  14. 77 FR 58356 - Science Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Science Advisory Board... the schedule and proposed agenda of a forthcoming meeting of the NOAA Science Advisory Board. The... Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the...

  15. 76 FR 41825 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-15

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-066)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council (NAC). The agenda topics for the....-12 p.m., Local Time. ADDRESSES: NASA Ames Conference Center (Building 3), Ballroom, 500 Severyns...

  16. United States Food and Drug Administration Product Label Changes

    PubMed Central

    Sung, Julie C.; Stein-Gold, Linda; Goldenberg, Gary

    2017-01-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:28367259

  17. United States Food and Drug Administration Product Label Changes

    PubMed Central

    Sung, Julie C.; Stein-Gold, Linda; Goldenberg, Gary

    2016-01-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:26962391

  18. 78 FR 6824 - Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... Amyotrophic Lateral Sclerosis; Public Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA or the Agency) is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0035...

  19. 5 CFR 724.403 - Advisory guidelines.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 2 2011-01-01 2011-01-01 false Advisory guidelines. 724.403 Section 724... (CONTINUED) IMPLEMENTATION OF TITLE II OF THE NOTIFICATION AND FEDERAL EMPLOYEE ANTIDISCRIMINATION AND RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

  20. 5 CFR 724.403 - Advisory guidelines.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 2 2013-01-01 2013-01-01 false Advisory guidelines. 724.403 Section 724... (CONTINUED) IMPLEMENTATION OF TITLE II OF THE NOTIFICATION AND FEDERAL EMPLOYEE ANTIDISCRIMINATION AND RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

  1. 5 CFR 724.403 - Advisory guidelines.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 2 2014-01-01 2014-01-01 false Advisory guidelines. 724.403 Section 724... (CONTINUED) IMPLEMENTATION OF TITLE II OF THE NOTIFICATION AND FEDERAL EMPLOYEE ANTIDISCRIMINATION AND RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

  2. 5 CFR 724.403 - Advisory guidelines.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 2 2012-01-01 2012-01-01 false Advisory guidelines. 724.403 Section 724... (CONTINUED) IMPLEMENTATION OF TITLE II OF THE NOTIFICATION AND FEDERAL EMPLOYEE ANTIDISCRIMINATION AND RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

  3. 21 CFR 14.84 - Nominations and selection of nonvoting members of standing technical advisory committees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... one person selected by consumer groups and organizations and one person selected by industry groups... subcommittees may be made at any time. All nominations are to be submitted in writing to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 1503...

  4. 77 FR 61432 - NASA Advisory Council; Aeronautics Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-09

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-080] NASA Advisory Council; Aeronautics Committee; Meeting AGENCY: National Aeronautics and Space Administration. ACTION: Notice of Meeting. SUMMARY... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory...

  5. 75 FR 4589 - NASA Advisory Council Exploration Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-012)] NASA Advisory Council Exploration... Aeronautics and Space Administration announces a meeting of the NASA Advisory Council Exploration Committee... Parham, Exploration Committee Administrative Officer, Mail Stop 7C27, National Aeronautics and Space...

  6. 78 FR 9928 - Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0124] Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: To assist the Food...

  7. 78 FR 20357 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-035] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council (NAC). DATES: Wednesday, April 24...: NASA Headquarters, 300 E Street SW., Room 9H40, Program Review Center (PRC), Washington, DC, 20456 FOR...

  8. 78 FR 41804 - NASA Advisory Council; Meeting.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-11

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (13-077)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council (NAC). DATES: Wednesday, July 31... ADDRESSES: NASA Headquarters, Room 9H40, Program Review Center, 300 E Street SW., Washington, DC 20456 FOR...

  9. 77 FR 38336 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-050] NASA Advisory Council; Meeting... Space Administration (NASA) announces a meeting of the NASA Advisory Council (NAC). DATES: Wednesday..., 9 a.m.-12 p.m.; Local Time. ADDRESSES: NASA Goddard Space Flight Center (GSFC), Building 1, Rooms...

  10. 76 FR 65540 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-21

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-100)] NASA Advisory Council; Meeting... Aeronautics and Space Administration announces that the meeting of the NASA Advisory Council scheduled to be held at NASA Goddard Space Flight Center in Greenbelt, Maryland, on November 3-4, 2011, has been...

  11. Zohydro approval by food and drug administration: controversial or frightening?

    PubMed

    Manchikanti, Laxmaiah; Atluri, Sairam; Candido, Kenneth D; Boswell, Mark V; Simopoulos, Thomas T; Grider, Jay S; Falco, Frank J E; Hirsch, Joshua A

    2014-01-01

    The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the U.S., specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA's own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the U.S. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health

  12. 28 CFR 0.129 - Professional Responsibility Advisory Office.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Professional Responsibility Advisory... OF JUSTICE 2-Professional Responsibility Advisory Office § 0.129 Professional Responsibility Advisory Office. (a) The Professional Responsibility Advisory Office is headed by a Director appointed by the...

  13. [Innovative therapeutic strategies for intravesical drug administration].

    PubMed

    Moch, C; Salmon, D; Rome, P; Marginean, R; Pivot, C; Colombel, M; Pirot, F

    2013-05-01

    Perspectives for innovative pharmaceutical molecules and intravesical administration of pharmacological agents are presented in the present review carried out from a recent literature. This review of the literature was built by using the PubMed and ScienceDirect databases running 20keywords revealing 34publications between 1983 and 2012. The number of referenced articles on ScienceDirect has increased in recent years, highlighting the interest of scientists for intravesical drug administration and the relevance of innovating drug delivery systems. Different modalities of intravesical administration using physical (e.g., iontophoresis, electroporation) or chemical techniques (e.g., enzyme, solvent, nanoparticles, liposomes, hydrogels) based on novel formulation methods are reported. Finally, the development of biopharmaceuticals (e.g., bacillus Calmette-Guérin, interferon α) and gene therapies is also presented and analyzed in this review. The present review exhibits new development in the pipeline for emerging intravesical drug administration strategies. Knowledge of all these therapies allows practitioners to propose a specific and tailored treatment to each patient with limiting systemic side effects. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  14. 77 FR 5494 - Commerce Spectrum Management Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-03

    ... DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Commerce Spectrum Management Advisory Committee Meeting AGENCY: National Telecommunications and Information... Management Advisory Committee, National Telecommunications and Information Administration, 1401 Constitution...

  15. 75 FR 75968 - Commerce Spectrum Management Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-07

    ... DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Commerce Spectrum Management Advisory Committee Meeting AGENCY: National Telecommunications and Information... Advisory Committee, National Telecommunications and Information Administration, 1401 Constitution Avenue...

  16. 78 FR 57370 - Commerce Spectrum Management Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Commerce Spectrum Management Advisory Committee Meeting AGENCY: National Telecommunications and Information... Management Advisory Committee, National Telecommunications and Information Administration, 1401 Constitution...

  17. 75 FR 60493 - Aviation Rulemaking Advisory Committee; Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-30

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Aviation Rulemaking Advisory Committee; Renewal AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Renewal. SUMMARY... Aviation Rulemaking Advisory Committee (ARAC) for a 2-year period beginning September 17, 2010. The...

  18. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  19. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  20. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  1. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  2. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  3. 76 FR 52991 - Renewal of Advisory Committee on Electronic Records Archives

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-24

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Renewal of Advisory Committee on Electronic Records... Records Administration's (NARA) Advisory Committee on Electronic Records Archives. In accordance with... Committee on Electronic Records Archives in NARA's ceiling of discretionary advisory committees. FOR FURTHER...

  4. Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.

    PubMed

    Altomare, Christopher; Kinzler, Eric R; Buchhalter, August R; Cone, Edward J; Costantino, Anthony

    The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.

  5. 75 FR 5629 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-03

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-019)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council. DATES: Thursday, February 18, 2010, 9 a.m.-5 p.m. EST; Friday, February 19, 2010, 9 a.m.-1 p.m., EST. ADDRESSES: NASA Headquarters...

  6. 76 FR 64111 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-087)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council. DATES: Thursday, November 3, 2011, 8 a.m.-5 p.m., Local Time Friday, November 4, 2011, 8 a.m.--12 p.m., Local Time. ADDRESSES: NASA...

  7. 76 FR 4133 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-24

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-007)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council. DATES: Thursday, February 10, 2011, 8 a.m.-5 p.m., Local Time. Friday, February 11, 2011, 8 a.m.-12 p.m., Local Time. ADDRESSES: NASA...

  8. 77 FR 56698 - Air Traffic Procedures Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-13

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Air Traffic Procedures Advisory... advise the public that a meeting of the Federal Aviation Administration Air Traffic Procedures Advisory Committee (ATPAC) will be held to review present air traffic control procedures and practices for...

  9. 76 FR 27168 - Air Traffic Procedures Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-10

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Air Traffic Procedures Advisory... advise the public that a meeting of the Federal Aviation Administration Air Traffic Procedures Advisory Committee (ATPAC) will be held to review present air traffic control procedures and practices for...

  10. 75 FR 22892 - Air Traffic Procedures Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Air Traffic Procedures Advisory... advise the public that a meeting of the Federal Aviation Administration Air Traffic Procedures Advisory Committee (ATPAC) will be held to review present air traffic control procedures and practices for...

  11. 78 FR 2711 - Air Traffic Procedures Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Air Traffic Procedures Advisory... advise the public that a meeting of the Federal Aviation Administration Air Traffic Procedures Advisory Committee (ATPAC) will be held to review present air traffic control procedures and practices for...

  12. 76 FR 59481 - Air Traffic Procedures Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Air Traffic Procedures Advisory... advise the public that a meeting of the Federal Aviation Administration Air Traffic Procedures Advisory Committee (ATPAC) will be held to review present air traffic control procedures and practices for...

  13. 77 FR 27835 - Air Traffic Procedures Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Air Traffic Procedures Advisory... advise the public that a meeting of the Federal Aviation Administration Air Traffic Procedures Advisory Committee (ATPAC) will be held to review present air traffic control procedures and practices for...

  14. 77 FR 2603 - Air Traffic Procedures Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-18

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Air Traffic Procedures Advisory... advise the public that a meeting of the Federal Aviation Administration Air Traffic Procedures Advisory Committee (ATPAC) will be held to review present air traffic control procedures and practices for...

  15. 76 FR 2672 - Science Advisory Board Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

    ... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Science Advisory Board... forth the schedule and proposed agenda of a forthcoming meeting of the NOAA Science Advisory Board. The... CONTACT: Dr. Cynthia Decker, Executive Director, Science Advisory Board, NOAA, Rm. 11230, 1315 East-West...

  16. 75 FR 51853 - NASA Advisory Council; Space Operations Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-092)] NASA Advisory Council; Space Operations Committee; Meeting AGENCY: National Aeronautics and Space Administration. ACTION: Notice of..., the National Aeronautics and Space Administration announces a meeting of the NASA Advisory Council...

  17. 77 FR 67029 - NASA Advisory Council Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-094)] NASA Advisory Council Meeting... Administration announces a meeting of the NASA Advisory Council. DATES: Wednesday, November 28, 2012, from 1:00... 9:00 a.m. to 11:30 a.m. Note: All times listed are local time. ADDRESSES: NASA Marshall Space Flight...

  18. 75 FR 39973 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-13

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-077)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council. DATES: Thursday, August 5, 2010, 8 a.m.-5 p.m. (local time) Friday, August 6, 2010, 8 a.m.-12 a.m. (local time). ADDRESSES: NASA Jet...

  19. 75 FR 4588 - NASA Advisory Council; meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 10-013] NASA Advisory Council; meeting... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory..., 12 p.m. to 5 p.m.; Wednesday, February 17, 2010, 9 a.m. to 3 p.m. ADDRESSES: NASA Headquarters, 300 E...

  20. 77 FR 9997 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-016)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council (NAC). DATES: Thursday, March 8, 2012, 8 a.m.-5 p.m., local time and Friday, March 9, 2012, 8 a.m.-12 p.m., local time. ADDRESSES: NASA...

  1. 75 FR 18240 - NASA Advisory Council; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-042)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council. DATES: Wednesday, April 28, 2010, 8 a.m.-5 p.m. CDT; Thursday, April 29, 2010, 8 a.m.-3 p.m. CDT ADDRESSES: NASA Johnson Space Center...

  2. 78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  3. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  4. 78 FR 66098 - Air Traffic Procedures Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Air Traffic Procedures Advisory... issuing this notice to advise the public that a meeting of the Federal Aviation Administration Air Traffic Procedures Advisory Committee (ATPAC) will be held to review present air traffic control procedures and...

  5. [Preparation and administration of cytotoxic drugs: prickly innovation].

    PubMed

    Mullot, H; Simon, L; Payen, C; Gentes, P

    2005-06-01

    The requirement for safe and optimal administration of cytotoxic drugs led us to test a new product manufactured by Codan. The transfer set (CONNECT SET) and the administration set (CYTO-AD-SET) were assessed successively by pharmacist assistance within a centralized unit for cytotoxic drug preparation and by the nursing staff in an ambulatory unit. Transfer sets can be handled in the centralized units without using needles, but with an increased sterilization load and production cost. Assessment of the administration sets demonstrated time saving for the nursing staff. These materials require significant expenditures, careful training, and a change in treatment routine, but provide important time savings for the nursing staff and considerable improvement in the safety of handling cytotoxic drugs.

  6. 78 FR 54680 - NASA Federal Advisory Committees

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-109] NASA Federal Advisory Committees... by U.S. Citizens for Service on NASA Federal Advisory Committees. SUMMARY: NASA announces its annual invitation for public nominations for service on NASA Federal advisory committees. U.S. citizens may nominate...

  7. 78 FR 20685 - Aviation Security Advisory Committee (ASAC) Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration Aviation Security Advisory...; Notice of Closed Federal Advisory Committee Meeting. SUMMARY: The Aviation Security Advisory Committee... Committee Act, 5 U.S.C. App. (Pub. L. 92-463). The Aviation Security Advisory Committee (ASAC) provides...

  8. 75 FR 70031 - Advisory Committee on the Records of Congress

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Advisory Committee on the Records of Congress AGENCY: National Archives and Records Administration. ACTION: Notice of meeting. SUMMARY: In accordance with the Federal Advisory Committee Act, the National Archives and Records Administration (NARA) announces a...

  9. 76 FR 31367 - Advisory Committee on the Records of Congress

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Advisory Committee on the Records of Congress AGENCY: National Archives and Records Administration. ACTION: Notice of meeting. SUMMARY: In accordance with the Federal Advisory Committee Act, the National Archives and Records Administration (NARA) announces a...

  10. 78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0196] Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice, request for comments. SUMMARY: The Food and...

  11. 78 FR 66964 - NASA Advisory Council; Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (13-130)] NASA Advisory Council; Charter Renewal AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the charter of the NASA Advisory Council. SUMMARY: Pursuant to sections 14(b)(1) and 9(c) of...

  12. 75 FR 52375 - NASA Advisory Council; Exploration Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-25

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-094)] NASA Advisory Council... National Aeronautics and Space Administration announces a meeting of the Exploration Committee of the NASA Advisory Council. DATES: Tuesday, September 21, 2010, 1 p.m.-6:30 p.m., Local Time. ADDRESSES: NASA...

  13. 76 FR 67482 - NASA Advisory Council; Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-01

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-108)] NASA Advisory Council; Charter Renewal AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the charter of the NASA Advisory Council. SUMMARY: Pursuant to sections 14(b)(1) and 9(c) of...

  14. 77 FR 49446 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... Person: Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... development programs necessary to support approval of parenteral lipid emulsion products as nutritional...

  15. 77 FR 56909 - Aviation Rulemaking Advisory Committee (ARAC); Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Aviation Rulemaking Advisory Committee (ARAC); Renewal AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Renewal. SUMMARY: The FAA announces the charter renewal of the Aviation Rulemaking Advisory Committee (ARAC), a...

  16. 75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

  17. 76 FR 12211 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-04

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference (COMSTAC). SUMMARY: Pursuant...

  18. 5 CFR 2638.304 - Form of requests for formal advisory opinions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Form of requests for formal advisory opinions. 2638.304 Section 2638.304 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT ETHICS... Service § 2638.304 Form of requests for formal advisory opinions. (a) A request for a formal advisory...

  19. 77 FR 28421 - Railroad Safety Advisory Committee; Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-14

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket No. FRA-2000-7257: Notice No. 70] Railroad Safety Advisory Committee; Charter Renewal AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Announcement of Charter Renewal of the Railroad Safety Advisory...

  20. 75 FR 27053 - Railroad Safety Advisory Committee; Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-13

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket No. FRA-2000-7257; Notice No. 61] Railroad Safety Advisory Committee; Charter Renewal AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Announcement of Charter Renewal of the Railroad Safety Advisory...

  1. 76 FR 67018 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-28

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  2. 77 FR 35102 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee; Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  3. 78 FR 53496 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-29

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee; Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  4. 75 FR 38866 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-06

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  5. 76 FR 4743 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-26

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  6. 76 FR 15041 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-18

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  7. 77 FR 48585 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  8. 75 FR 51332 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-19

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  9. 78 FR 14401 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee; Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  10. 75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  11. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  12. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  13. A Guide for Planning, Organizing, and Utilizing Advisory Councils.

    ERIC Educational Resources Information Center

    Illinois State Office of Education, Springfield. Div. of Vocational and Technical Education.

    Designed for administrators and teachers at the community college/secondary/elementary levels, the guide is a reference source for establishing and developing citizen advisory councils. A section on Advisory Councils--Planning discusses the need for citizen advisory councils, definition and purpose, advisory council types, and operational…

  14. 76 FR 65750 - Aerospace Safety Advisory Panel; Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-105)] Aerospace Safety Advisory Panel; Charter Renewal AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the charter of the NASA Aerospace Safety Advisory Panel. SUMMARY: Pursuant to...

  15. 78 FR 69885 - NASA Advisory Council; Aeronautics Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-21

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-133] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory... INFORMATION CONTACT: Ms. Susan L. Minor, Executive Secretary for the Aeronautics Committee, NASA Headquarters...

  16. 75 FR 80082 - State, Local, Tribal, and Private Sector Policy Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION State, Local, Tribal, and Private Sector Policy Advisory Committee AGENCY: National Archives and Records Administration. ACTION: Notice of Establishment of a NARA Advisory Committee, Pursuant to the Federal Advisory Committee Act, 5 U.S.C. Appendix 2 and...

  17. 75 FR 52058 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-24

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee-Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section 10...

  18. 75 FR 63208 - Advisory Committee on the Electronic Records Archives (ACERA)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Advisory Committee on the Electronic Records Archives (ACERA) AGENCY: National Archives and Records Administration. ACTION: Notice of meeting. SUMMARY: In... and Records Administration (NARA) announces a meeting of the Advisory Committee on the Electronic...

  19. 76 FR 65218 - Advisory Committee on the Electronic Records Archives (ACERA)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-20

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Advisory Committee on the Electronic Records Archives (ACERA) AGENCY: National Archives and Records Administration. ACTION: Notice of meeting. SUMMARY: In... and Records Administration (NARA) announces a meeting of the Advisory Committee on the Electronic...

  20. [Pharmaceutical revision of hospital drug administration].

    PubMed

    Smith-Meyer, Ellen; Bjørneklett, Arvid; Swärd, Elisabeth; Refsum, Nina

    2002-01-20

    Quality audits of the implementation of drug administration procedures are carried out in order to determine objectively to what extent implementation conforms to procedures. Since September 1997, the pharmacy at Rikshospitalet University Hospital in Norway has performed quality audits of drug administration at the hospital, using interviews and surveys. Staff members in the audited unit and the auditing pharmacist agree on prospects for quality improvements and review possible action. A survey was carried out in the autumn of 2000 in order to determine staff opinion of the quality audits. On the basis of the observations made, improvements have been carried out at all levels of the organisation. The survey indicates that hospital staff members are satisfied with the quality audits performed by the pharmacy.

  1. 78 FR 36711 - Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ...: Food and Drug Administration, HHS. ACTION: Notification of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a public meeting regarding FDA's... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket Nos...

  2. 76 FR 51001 - Environmental Technologies Trade Advisory Committee Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... DEPARTMENT OF COMMERCE International Trade Administration Environmental Technologies Trade Advisory Committee Public Meeting AGENCY: International Trade Administration, DOC. ACTION: Notice of... meeting of the Environmental Technologies Trade Advisory Committee (ETTAC). DATES: The meeting is...

  3. 76 FR 67715 - Science Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-02

    ... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Science Advisory Board... (NOAA), Department of Commerce (DOC). ACTION: Notice of open meeting. SUMMARY: The Science Advisory... on strategies for research, education, and application of science to operations and information...

  4. 75 FR 34464 - Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com; Correction of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004] FDA 225-09-0012 Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com... date of the memorandum of understanding (MOU) between FDA and Drugs.Com that published in the Federal...

  5. 75 FR 19662 - Advisory Committee on Presidential Libraries Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-15

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Advisory Committee on Presidential Libraries Meeting... Records Administration (NARA) announces a meeting of the Advisory Committee on Presidential Libraries. The meeting will be held to discuss the Presidential Library program and topics related to the public-private...

  6. 75 FR 63255 - Air Traffic Procedures Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Air Traffic Procedures Advisory... notice to advise the public that a meeting of the Federal Aviation Administration Air Traffic Procedures Advisory Committee (ATPAC) will be held to review present air traffic control procedures and practices for...

  7. 78 FR 77502 - NASA Applied Sciences Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-23

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (13-152)] NASA Applied Sciences Advisory... Aeronautics and Space Administration (NASA) announces a meeting of the Applied Sciences Advisory Committee.... ADDRESSES: NASA Headquarters, Room 3P40, 300 E Street SW., Washington, DC 20546. FOR FURTHER INFORMATION...

  8. 76 FR 16643 - NASA Advisory Council; Aeronautics Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-24

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-024)] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory.... ADDRESSES: Thursday, April 14, 2011--NASA Dryden Flight Research Center (DFRC), Lilly Drive Building 4825...

  9. 76 FR 58843 - NASA Advisory Council; Aeronautics Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-22

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 11-082] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory... Headquarters, Washington, DC 20546, (202) 358-0566, or [email protected]nasa.gov . SUPPLEMENTARY INFORMATION: The...

  10. 78 FR 57178 - NASA Applied Sciences Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-17

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-115] NASA Applied Sciences Advisory... Aeronautics and Space Administration (NASA) announces a meeting of the Applied Sciences Advisory Committee.... ADDRESSES: NASA Headquarters, Room 1Q39, 300 E Street SW., Washington, DC 20546. FOR FURTHER INFORMATION...

  11. 75 FR 41240 - NASA Advisory Council; Aeronautics Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-15

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-079)] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory....m. to 4 p.m. (local time). ADDRESSES: NASA Glenn Research Center, Building 15, Small Dining...

  12. 75 FR 15743 - NASA Advisory Council; Exploration Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-30

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-034)] NASA Advisory Council; Exploration... Aeronautics and Space Administration announces a meeting of the Exploration Committee of the NASA Advisory...-358-1715; [email protected]nasa.gov . SUPPLEMENTARY INFORMATION: The agenda topics for the meeting will...

  13. 78 FR 59005 - Civil Nuclear Trade Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... DEPARTMENT OF COMMERCE International Trade Administration Civil Nuclear Trade Advisory Committee... of the Civil Nuclear Trade Advisory Committee (CINTAC). DATES: The meeting is scheduled for Wednesday... administration of programs to expand United States exports of civil nuclear goods and services in accordance with...

  14. 75 FR 64368 - SBA North Florida District Advisory Council

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-19

    ... SMALL BUSINESS ADMINISTRATION SBA North Florida District Advisory Council AGENCY: U.S. Small Business Administration. ACTION: Notice of open Federal advisory committee meeting. SUMMARY: The SBA is... need for SBA programs, particularly within North Florida and for listening to what is currently...

  15. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ...] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration... an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The...: 510-287-2739; or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109...

  16. 5 CFR 591.244 - How does OPM select COLA Advisory Committee members?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 1 2011-01-01 2011-01-01 false How does OPM select COLA Advisory... Areas Program Administration § 591.244 How does OPM select COLA Advisory Committee members? (a) In establishing a COLA Advisory Committee, OPM invites local agencies and employee organizations to nominate...

  17. 5 CFR 591.244 - How does OPM select COLA Advisory Committee members?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false How does OPM select COLA Advisory... Areas Program Administration § 591.244 How does OPM select COLA Advisory Committee members? (a) In establishing a COLA Advisory Committee, OPM invites local agencies and employee organizations to nominate...

  18. 5 CFR 591.244 - How does OPM select COLA Advisory Committee members?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false How does OPM select COLA Advisory... Areas Program Administration § 591.244 How does OPM select COLA Advisory Committee members? (a) In establishing a COLA Advisory Committee, OPM invites local agencies and employee organizations to nominate...

  19. 5 CFR 591.244 - How does OPM select COLA Advisory Committee members?

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 1 2013-01-01 2013-01-01 false How does OPM select COLA Advisory... Areas Program Administration § 591.244 How does OPM select COLA Advisory Committee members? (a) In establishing a COLA Advisory Committee, OPM invites local agencies and employee organizations to nominate...

  20. 5 CFR 591.244 - How does OPM select COLA Advisory Committee members?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 1 2012-01-01 2012-01-01 false How does OPM select COLA Advisory... Areas Program Administration § 591.244 How does OPM select COLA Advisory Committee members? (a) In establishing a COLA Advisory Committee, OPM invites local agencies and employee organizations to nominate...

  1. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

  2. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

  3. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

  4. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

  5. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

  6. Discrete-choice modelling of patient preferences for modes of drug administration.

    PubMed

    Tetteh, Ebenezer Kwabena; Morris, Steve; Titcheneker-Hooker, Nigel

    2017-12-01

    The administration of (biologically-derived) drugs for various disease conditions involves consumption of resources that constitutes a direct monetary cost to healthcare payers and providers. An often ignored cost relates to a mismatch between patients' preferences and the mode of drug administration. The "intangible" benefits of giving patients what they want in terms of the mode of drug delivery is seldom considered. This study aims to evaluate, in monetary terms, end-user preferences for the non-monetary attributes of different modes of drug administration using a discrete-choice experiment. It provides empirical support to the notion that there are significant benefits from developing patient-friendly approaches to drug delivery. The gross benefits per patient per unit administration is in the same order of magnitude as the savings in resource costs of administering drugs. The study argues that, as long as the underlying manufacturing science is capable, a patient-centred approach to producing drug delivery systems should be encouraged and pursued.

  7. 75 FR 56654 - RTCA NextGen Advisory Committee (NAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-16

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration RTCA NextGen Advisory Committee (NAC) AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of RTCA NextGen Advisory Committee (NAC) SUMMARY: The FAA published a Notice in the Federal Register on September 3, 2010 (75-FR-54221...

  8. 77 FR 52379 - Advisory Committee on Veterans Business Affairs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-29

    ... SMALL BUSINESS ADMINISTRATION Advisory Committee on Veterans Business Affairs AGENCY: U.S. Small Business Administration. ACTION: Notice of open Federal Advisory Committee meeting. SUMMARY: The SBA is... Committee on Veterans Business Affairs. The meeting will be open to the public. DATES: September 10, 2012...

  9. 78 FR 70088 - Advisory Committee on Veterans Business Affairs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... SMALL BUSINESS ADMINISTRATION Advisory Committee on Veterans Business Affairs AGENCY: U.S. Small Business Administration. ACTION: Notice of open Federal Advisory Committee meeting. SUMMARY: The SBA is... Committee on Veterans Business Affairs. The meeting will be open to the public. DATES: December 5, 2013 from...

  10. 75 FR 22434 - Advisory Committee on Veterans Business Affairs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-28

    ... SMALL BUSINESS ADMINISTRATION Advisory Committee on Veterans Business Affairs AGENCY: U.S. Small Business Administration. ACTION: Notice of open Federal Advisory Committee Meeting. SUMMARY: The SBA is... Committee on Veterans Business Affairs. The meeting will be open to the public. DATES: Tuesday, May 25, 2010...

  11. 75 FR 17166 - NASA Advisory Council; Aeronautics Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-038)] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory... a.m. to 1 p.m.; Eastern Daylight Time. ADDRESSES: NASA Langley Research Center, Building 1219, Room...

  12. 75 FR 54389 - NASA Advisory Council; Science Committee; Meeting.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-103)] NASA Advisory Council; Science... National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The Meeting will be held for the...

  13. 78 FR 10640 - NASA Advisory Council; Aeronautics Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (13-010)] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory..., or [email protected]nasa.gov . SUPPLEMENTARY INFORMATION: The meeting will be open to the public up to...

  14. 75 FR 14472 - NASA Advisory Council; Science Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-25

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-033)] NASA Advisory Council; Science...: The National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The Meeting will be held for...

  15. 78 FR 41115 - NASA Advisory Council; Science Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-074] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory... Time. ADDRESSES: NASA Headquarters, Room 7H45, 300 E Street SW., Washington, DC 20546. FOR FURTHER...

  16. 76 FR 18800 - NASA Advisory Council; Exploration Committee; Meeting.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-05

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-028)] NASA Advisory Council; Exploration... National Aeronautics and Space Administration announces a meeting of the Exploration Committee of the NASA Advisory Council. DATES: Tuesday, April 26, 2011, 1 p.m.-6 p.m., Local Time ADDRESSES: NASA Headquarters...

  17. 75 FR 2892 - NASA Advisory Council; Science Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-19

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-003)] NASA Advisory Council; Science...: The National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The Meeting will be held for...

  18. 75 FR 3959 - Railroad Safety Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-25

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket No. FRA-2000-7257; Notice No. 58] Railroad Safety Advisory Committee; Notice of Meeting AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Announcement of Railroad Safety Advisory Committee...

  19. 78 FR 66964 - International Space Station Advisory Committee; Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (13-128)] International Space Station Advisory Committee; Charter Renewal AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the charter of the International Space Station Advisory Committee...

  20. 78 FR 41114 - NASA Advisory Council; Aeronautics Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-075] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory... planning. DATES: Tuesday, July 30, 2013, 9:00 a.m. to 5:00 p.m.; Local Time. ADDRESSES: NASA Headquarters...

  1. 75 FR 50782 - NASA Advisory Council; Aeronautics Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-087)] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory..., 2010, 8 a.m. to 12:30 p.m.; Local Time. ADDRESSES: NASA Ames Conference Center, Building 3, 500...

  2. 78 FR 35937 - Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug...

  3. 76 FR 6170 - Federal Register Meeting Notice: Advisory Committee on Veterans Business Affairs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... SMALL BUSINESS ADMINISTRATION Federal Register Meeting Notice: Advisory Committee on Veterans Business Affairs AGENCY: U.S. Small Business Administration. ACTION: Notice of open Federal Advisory... for the next meeting of the Advisory Committee on Veterans Business Affairs. The meeting will be open...

  4. 75 FR 29384 - Motor Carrier Safety Advisory Committee Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2010-0143] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee meeting. SUMMARY: FMCSA...

  5. 21 CFR 20.2 - Production of records by Food and Drug Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... upon an officer or employee of the Food and Drug Administration commanding the production of any record... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Production of records by Food and Drug Administration employees. 20.2 Section 20.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

  6. 21 CFR 14.145 - Procedures of a color additive advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Procedures of a color additive advisory committee... SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14.145 Procedures of a color additive advisory committee. (a) A color additive advisory committee is...

  7. 21 CFR 14.142 - Functions of a color additive advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Functions of a color additive advisory committee... SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14.142 Functions of a color additive advisory committee. (a) A color additive advisory committee reviews...

  8. Adverse drug event monitoring at the Food and Drug Administration.

    PubMed

    Ahmad, Syed Rizwanuddin

    2003-01-01

    The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients. Despite its limitations, the spontaneous reporting system is an extremely valuable mechanism by which hazards with drugs that were not observed or recognized at the time of approval are identified. Physicians are strongly encouraged to submit reports of adverse outcomes with suspect drugs to the FDA, and their reports make a difference. The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk.

  9. Adverse Drug Event Monitoring at the Food and Drug Administration

    PubMed Central

    Ahmad, Syed Rizwanuddin

    2003-01-01

    The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients. Despite its limitations, the spontaneous reporting system is an extremely valuable mechanism by which hazards with drugs that were not observed or recognized at the time of approval are identified. Physicians are strongly encouraged to submit reports of adverse outcomes with suspect drugs to the FDA, and their reports make a difference. The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk. PMID:12534765

  10. 78 FR 66983 - National Small Business Development Center Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... SMALL BUSINESS ADMINISTRATION National Small Business Development Center Advisory Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open Federal Advisory Committee meetings..., 2013 and the cancellation for the December 17, 2013 meeting of the National Small Business Development...

  11. 76 FR 41824 - NASA Advisory Council; Science Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-15

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-068)] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory..., 2011, 7:30 a.m. to 11:30 a.m., Local Time. ADDRESSES: NASA Ames Research Center, NASA Ames Conference...

  12. 78 FR 20357 - NASA Advisory Council; Science Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-037] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory...:30 a.m. to 3:00 p.m., Local Time. ADDRESSES: NASA Headquarters, 300 E Street SW., Room 6H45...

  13. 77 FR 38093 - NASA Advisory Council; Science Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-26

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-046] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory.... to 2:30 p.m., local time. ADDRESSES: NASA Goddard Space Flight Center (GSFC), Building 1, Room E100E...

  14. 78 FR 67202 - NASA Advisory Council; Science Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-08

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-131] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory..., 2013, 8:30 a.m. to 3:00 p.m., Local Time. ADDRESSES: This meeting will take place at NASA Headquarters...

  15. 76 FR 17158 - NASA Advisory Council; Science Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-026)] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory....m. to 2 p.m., Local Time. ADDRESSES: NASA Headquarters, 300 E Street, SW., Room 5H45, Washington, DC...

  16. 76 FR 15349 - Advisory Committee on the Electronic Records Archives (ACERA); Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-21

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Advisory Committee on the Electronic Records Archives (ACERA); Meeting AGENCY: National Archives and Records Administration. ACTION: Notice of Meeting. SUMMARY... Archives and Records Administration (NARA) announces a meeting of the Advisory Committee on the Electronic...

  17. Pharmacokinetics of rectal drug administration, Part I. General considerations and clinical applications of centrally acting drugs.

    PubMed

    van Hoogdalem, E; de Boer, A G; Breimer, D D

    1991-07-01

    Generally, oral administration is the route of choice in the daily practice of pharmacotherapy. However, in some circumstances this is impractical or even impossible (during nausea and vomiting or convulsions, in uncooperative patients and before surgery). In these cases, the rectal route may represent a practical alternative and rectal administration is now well accepted for delivering, for example, anticonvulsants, non-narcotic and narcotic analgesics, theophylline, antiemetics and antibacterial agents, and for inducing anaesthesia in children. It may also represent an interesting alternative to intravenous or other injection routes of drug administration. The rate and extent of rectal drug absorption are often lower than with oral absorption, possibly an inherent factor owing to the relatively small surface area available for drug uptake. In addition, the composition of the rectal formulation (solid vs liquid, nature of the suppository base) appears to be an important factor in the absorption process by determining the pattern of drug release. This relation between formulation and drug uptake has been clearly demonstrated for drugs like diazepam, paracetamol (acetaminophen), indomethacin, methadone and diflunisal. Coadministration of absorption-promoting agents (surfactants, sodium salicylate, enamines) represents another approach towards manipulating rectal drug absorption, although this concept requires further research concerning both efficacy and safety. For a number of drugs the extent of rectal absorption has been reported to exceed oral values, which may reflect partial avoidance of hepatic first-pass metabolism after rectal delivery. This phenomenon has been reported for morphine, metoclopramide, ergotamine, lidocaine (lignocaine) and propranolol. Rectal drug delivery in a site- and rate-controlled manner using osmotic pumps or hydrogel formulations may provide opportunities for manipulating systemic drug concentrations and drug effects. The extent of

  18. 21 CFR 14.147 - Membership of a color additive advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Membership of a color additive advisory committee... SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14.147 Membership of a color additive advisory committee. (a) The members of a color additive advisory...

  19. 77 FR 67028 - NASA Advisory Council; Commercial Space Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-093] NASA Advisory Council; Commercial..., the National Aeronautics and Space Administration (NASA) announces a meeting of the Commercial Space Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The [[Page 67029

  20. 76 FR 20717 - NASA Advisory Council; Space Operations Committee; Meeting.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-035)] NASA Advisory Council; Space..., the National Aeronautics and Space Administration announces a meeting of the NASA Advisory Council... Headquarters, Washington, DC 20546, 202/358-1507, [email protected]nasa.gov . SUPPLEMENTARY INFORMATION: The agenda...

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