Sample records for obtain prior approval

  1. 5 CFR 4701.102 - Prior approval for certain outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE FEDERAL ELECTION COMMISSION § 4701.102 Prior approval for... or consultation, which requires advanced knowledge in a field of science or learning customarily... obtain written approval from the Designated Agency Ethics Official before engaging in outside employment...

  2. 5 CFR 4701.102 - Prior approval for certain outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE FEDERAL ELECTION COMMISSION § 4701.102 Prior approval for... or consultation, which requires advanced knowledge in a field of science or learning customarily... obtain written approval from the Designated Agency Ethics Official before engaging in outside employment...

  3. 5 CFR 4701.102 - Prior approval for certain outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE FEDERAL ELECTION COMMISSION § 4701.102 Prior approval for... or consultation, which requires advanced knowledge in a field of science or learning customarily... obtain written approval from the Designated Agency Ethics Official before engaging in outside employment...

  4. 5 CFR 5001.104 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 5001.104 Section 5001.104 Administrative Personnel INTERSTATE COMMERCE COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INTERSTATE COMMERCE COMMISSION § 5001.104 Prior approval..., an employee of the Interstate Commerce Commission, other than a Commissioner, must obtain the written...

  5. 5 CFR 8701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 8701.102 Section 8701.102 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF MANAGEMENT AND BUDGET § 8701.102 Prior approval... employee of the Office of Management and Budget, other than a special Government employee, must obtain the...

  6. 12 CFR 303.62 - Transactions requiring prior approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... merger transaction that consists of the acquisition by an out of state bank of a branch without... FILING PROCEDURES Merger Transactions § 303.62 Transactions requiring prior approval. (a) Merger transactions. The following merger transactions require the prior written approval of the FDIC under this...

  7. 7 CFR 550.27 - Prior approvals.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AGRICULTURE GENERAL ADMINISTRATIVE POLICY FOR NON-ASSISTANCE COOPERATIVE AGREEMENTS Management of Agreements Program Management § 550.27 Prior approvals. (a) The budget is the financial expression of the project or... days prior to award date. All pre-award costs are incurred at the Cooperator's risk (i.e., the REE...

  8. 45 CFR 1630.5 - Costs requiring Corporation prior approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 4 2011-10-01 2011-10-01 false Costs requiring Corporation prior approval. 1630.5... CORPORATION COST STANDARDS AND PROCEDURES § 1630.5 Costs requiring Corporation prior approval. (a) Advance... nonallocability, recipients may seek a written understanding from the Corporation in advance of incurring special...

  9. 45 CFR 1630.5 - Costs requiring Corporation prior approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 4 2014-10-01 2014-10-01 false Costs requiring Corporation prior approval. 1630.5... CORPORATION COST STANDARDS AND PROCEDURES § 1630.5 Costs requiring Corporation prior approval. (a) Advance... nonallocability, recipients may seek a written understanding from the Corporation in advance of incurring special...

  10. 45 CFR 1630.5 - Costs requiring Corporation prior approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 4 2013-10-01 2013-10-01 false Costs requiring Corporation prior approval. 1630.5... CORPORATION COST STANDARDS AND PROCEDURES § 1630.5 Costs requiring Corporation prior approval. (a) Advance... nonallocability, recipients may seek a written understanding from the Corporation in advance of incurring special...

  11. 45 CFR 1630.5 - Costs requiring Corporation prior approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 4 2012-10-01 2012-10-01 false Costs requiring Corporation prior approval. 1630.5... CORPORATION COST STANDARDS AND PROCEDURES § 1630.5 Costs requiring Corporation prior approval. (a) Advance... nonallocability, recipients may seek a written understanding from the Corporation in advance of incurring special...

  12. 45 CFR 1630.5 - Costs requiring Corporation prior approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Costs requiring Corporation prior approval. 1630.5... CORPORATION COST STANDARDS AND PROCEDURES § 1630.5 Costs requiring Corporation prior approval. (a) Advance... nonallocability, recipients may seek a written understanding from the Corporation in advance of incurring special...

  13. 7 CFR 4290.480 - Prior approval of changes to RBIC's business plan.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Prior approval of changes to RBIC's business plan... § 4290.480 Prior approval of changes to RBIC's business plan. Without the Secretary's prior written approval, no change in your business plan, upon which you were selected and licensed as a RBIC, may take...

  14. 5 CFR 6201.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside employment. 6201.103 Section 6201.103 Administrative Personnel EXPORT-IMPORT BANK OF THE UNITED STATES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE EXPORT-IMPORT BANK OF THE UNITED STATES § 6201.103 Prior...

  15. 32 CFR 644.342 - Prior approval of Department of Defense.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Prior approval of Department of Defense. 644.342 Section 644.342 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) REAL... Department of Defense. (a) DOD Instruction 4165.12 requires advance approval by the Assistant Secretary of...

  16. 32 CFR 644.342 - Prior approval of Department of Defense.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 4 2014-07-01 2013-07-01 true Prior approval of Department of Defense. 644.342 Section 644.342 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) REAL... Department of Defense. (a) DOD Instruction 4165.12 requires advance approval by the Assistant Secretary of...

  17. 32 CFR 644.342 - Prior approval of Department of Defense.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 4 2012-07-01 2011-07-01 true Prior approval of Department of Defense. 644.342 Section 644.342 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) REAL... Department of Defense. (a) DOD Instruction 4165.12 requires advance approval by the Assistant Secretary of...

  18. 32 CFR 644.342 - Prior approval of Department of Defense.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 4 2013-07-01 2013-07-01 false Prior approval of Department of Defense. 644.342 Section 644.342 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) REAL... Department of Defense. (a) DOD Instruction 4165.12 requires advance approval by the Assistant Secretary of...

  19. 32 CFR 644.342 - Prior approval of Department of Defense.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 4 2011-07-01 2011-07-01 false Prior approval of Department of Defense. 644.342 Section 644.342 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) REAL... Department of Defense. (a) DOD Instruction 4165.12 requires advance approval by the Assistant Secretary of...

  20. 7 CFR 1726.252 - Prior approved contract modification related to liability for special and consequential damages.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... CONSTRUCTION POLICIES AND PROCEDURES Modifications to RUS Standard Contract Forms § 1726.252 Prior approved... difficulty in obtaining responsive bids on RUS standard contract forms due to a lack of limitation with... modifications in the RUS standard contract form on which the borrower solicits bids: (a) Insert new paragraphs...

  1. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior approval... an organization for which a different Deputy Ethics Official has responsibility, the employee must...

  2. 5 CFR 7901.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... ETHICAL CONDUCT FOR EMPLOYEES OF THE TENNESSEE VALLEY AUTHORITY § 7901.102 Prior approval for outside... or designee. The written request shall be submitted through the employee's supervisor or human... Designated Agency Ethics Official, exempt specified classes of employees from this section based upon a...

  3. 5 CFR 7901.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... ETHICAL CONDUCT FOR EMPLOYEES OF THE TENNESSEE VALLEY AUTHORITY § 7901.102 Prior approval for outside... or designee. The written request shall be submitted through the employee's supervisor or human... Designated Agency Ethics Official, exempt specified classes of employees from this section based upon a...

  4. 5 CFR 7901.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... ETHICAL CONDUCT FOR EMPLOYEES OF THE TENNESSEE VALLEY AUTHORITY § 7901.102 Prior approval for outside... or designee. The written request shall be submitted through the employee's supervisor or human... Designated Agency Ethics Official, exempt specified classes of employees from this section based upon a...

  5. 5 CFR 7901.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... ETHICAL CONDUCT FOR EMPLOYEES OF THE TENNESSEE VALLEY AUTHORITY § 7901.102 Prior approval for outside... or designee. The written request shall be submitted through the employee's supervisor or human... Designated Agency Ethics Official, exempt specified classes of employees from this section based upon a...

  6. 5 CFR 7901.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... ETHICAL CONDUCT FOR EMPLOYEES OF THE TENNESSEE VALLEY AUTHORITY § 7901.102 Prior approval for outside... or designee. The written request shall be submitted through the employee's supervisor or human... Designated Agency Ethics Official, exempt specified classes of employees from this section based upon a...

  7. 7 CFR 1726.251 - Prior approved contract modification related to price escalation on transmission equipment...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Prior approved contract modification related to price... SERVICE, DEPARTMENT OF AGRICULTURE ELECTRIC SYSTEM CONSTRUCTION POLICIES AND PROCEDURES Modifications to RUS Standard Contract Forms § 1726.251 Prior approved contract modification related to price...

  8. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES § 7701...

  9. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES § 7701...

  10. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES § 7701...

  11. 5 CFR 7301.102 - Prior approval for outside teaching, speaking and writing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside teaching... approval for outside teaching, speaking and writing. (a) Before engaging in outside teaching, speaking or... that the outside teaching, speaking or writing is not expected to involve conduct prohibited by statute...

  12. 5 CFR 4501.103 - Prior approval for certain outside activities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... activities. 4501.103 Section 4501.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF PERSONNEL MANAGEMENT § 4501.103 Prior approval... specialized skills or the same educational background as performance of the employee's official duties; (2...

  13. 12 CFR 550.80 - How do I obtain OTS approval?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 5 2011-01-01 2011-01-01 false How do I obtain OTS approval? 550.80 Section 550.80 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY FIDUCIARY POWERS OF SAVINGS ASSOCIATIONS Obtaining Fiduciary Powers § 550.80 How do I obtain OTS approval? You must file an...

  14. 12 CFR 550.80 - How do I obtain OTS approval?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false How do I obtain OTS approval? 550.80 Section 550.80 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY FIDUCIARY POWERS OF SAVINGS ASSOCIATIONS Obtaining Fiduciary Powers § 550.80 How do I obtain OTS approval? You must file an...

  15. 13 CFR 107.440 - Standards governing prior SBA approval for a proposed transfer of Control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... approval for a proposed transfer of Control. 107.440 Section 107.440 Business Credit and Assistance SMALL... Licensee; Transfer of License Changes in Control Or Ownership of Licensee § 107.440 Standards governing prior SBA approval for a proposed transfer of Control. SBA approval is contingent upon full disclosure...

  16. Why should ethics approval be required prior to publication of health promotion research?

    PubMed

    Newson, Ainsley J; Lipworth, Wendy

    2015-12-01

    Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee (HREC). Yet journals continue to receive submissions from authors who have failed to obtain such approval. In this paper, we provide an ethical justification of why journals should not, in general, publish articles describing research that has no ethics approval, with particular attention to the health promotion context. Using theoretical bioethical reasoning and drawing on a case study, we first rebut some potential criticisms of the need for research ethics approval. We then outline four positive claims to justify a presumption that research should, in most instances, be published only if it has been undertaken with HREC approval. We present four justifications for requiring ethics approval before publication: (1) HREC approval adds legitimacy to the research; (2) the process of obtaining HREC approval can improve the quality of an intervention being investigated; (3) obtaining HREC approval can help mitigate harm; and (4) obtaining HREC approval demonstrates respect for persons. This paper provides a systematic and comprehensive assessment of why research ethics approval should generally be obtained before publishing in the health promotion context. So what? Journals such as the Health Promotion Journal of Australia have recently begun to require research ethics approval for publishing research. Health promotion researchers will be interested in learning the ethical justification for this change.

  17. 7 CFR 4290.470 - Prior approval of merger, consolidation, or reorganization of RBIC.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... merge, consolidate, change form of organization (corporation, limited liability company, or limited partnership) or reorganize without the Secretary's prior written approval. Any such merger, consolidation, or...

  18. 5 CFR 3601.107 - Prior approval for outside employment and business activities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF DEFENSE § 3601.107 Prior approval for.... It does not include a routine commercial transaction or the purchase of an asset or interest, such as... component designated agency ethics official or designee may, by a written notice, exempt categories of...

  19. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

  20. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

  1. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

  2. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

  3. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

  4. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  5. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  6. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  7. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  8. 30 CFR 250.410 - How do I obtain approval to drill a well?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.410 How do I obtain approval to drill a well? You must obtain written... 30 Mineral Resources 2 2010-07-01 2010-07-01 false How do I obtain approval to drill a well? 250...

  9. 13 CFR 107.680 - Reporting changes in Licensee not subject to prior SBA approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Reporting changes in Licensee not subject to prior SBA approval. 107.680 Section 107.680 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES Recordkeeping, Reporting, and Examination Requirements for...

  10. 13 CFR 107.550 - Prior approval of secured third-party debt of leveraged Licensees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Prior approval of secured third-party debt of leveraged Licensees. 107.550 Section 107.550 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES Managing the Operations of a Licensee Borrowing by Licensees...

  11. 30 CFR 250.410 - How do I obtain approval to drill a well?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 2 2013-07-01 2013-07-01 false How do I obtain approval to drill a well? 250... THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.410 How do I obtain approval to drill a well? You...

  12. 30 CFR 250.410 - How do I obtain approval to drill a well?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 2 2014-07-01 2014-07-01 false How do I obtain approval to drill a well? 250... THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.410 How do I obtain approval to drill a well? You...

  13. 30 CFR 250.410 - How do I obtain approval to drill a well?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 2 2011-07-01 2011-07-01 false How do I obtain approval to drill a well? 250..., DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.410 How do I obtain approval to drill a...

  14. 30 CFR 250.410 - How do I obtain approval to drill a well?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 2 2012-07-01 2012-07-01 false How do I obtain approval to drill a well? 250... THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.410 How do I obtain approval to drill a well? You...

  15. 12 CFR Appendix to Part 1253 - Prior Approval for Enterprise Products-Instructions and Notice of New Activity Form

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Approval for Enterprise Products—Instructions and Notice of New Activity Form ER02JY09.000 ER02JY09.001... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Prior Approval for Enterprise Products-Instructions and Notice of New Activity Form Appendix to Part 1253 Banks and Banking FEDERAL HOUSING FINANCE...

  16. 13 CFR 108.680 - Reporting changes in NMVC Company not subject to prior SBA approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Reporting changes in NMVC Company not subject to prior SBA approval. 108.680 Section 108.680 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Recordkeeping, Reporting, and...

  17. 13 CFR 107.440 - Standards governing prior SBA approval for a proposed transfer of Control.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Standards governing prior SBA approval for a proposed transfer of Control. 107.440 Section 107.440 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES Changes in Ownership, Control, or Structure of...

  18. 13 CFR 107.440 - Standards governing prior SBA approval for a proposed transfer of Control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Standards governing prior SBA approval for a proposed transfer of Control. 107.440 Section 107.440 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES Changes in Ownership, Control, or Structure of...

  19. 13 CFR 107.440 - Standards governing prior SBA approval for a proposed transfer of Control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Standards governing prior SBA approval for a proposed transfer of Control. 107.440 Section 107.440 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES Changes in Ownership, Control, or Structure of...

  20. 13 CFR 107.440 - Standards governing prior SBA approval for a proposed transfer of Control.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false Standards governing prior SBA approval for a proposed transfer of Control. 107.440 Section 107.440 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES Changes in Ownership, Control, or Structure of...

  1. 5 CFR 412.301 - Obtaining approval to conduct a Senior Executive Service candidate development program (SESCDP).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Obtaining approval to conduct a Senior... DEVELOPMENT Senior Executive Service Candidate Development Programs § 412.301 Obtaining approval to conduct a Senior Executive Service candidate development program (SESCDP). (a) An SESCDP is an OPM-approved...

  2. 13 CFR 108.440 - Standards governing prior SBA approval for a proposed transfer of Control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Standards governing prior SBA approval for a proposed transfer of Control. 108.440 Section 108.440 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Changes in Ownership, Structure, or...

  3. 13 CFR 108.440 - Standards governing prior SBA approval for a proposed transfer of Control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Standards governing prior SBA approval for a proposed transfer of Control. 108.440 Section 108.440 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Changes in Ownership, Structure, or...

  4. 13 CFR 108.440 - Standards governing prior SBA approval for a proposed transfer of Control.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Standards governing prior SBA approval for a proposed transfer of Control. 108.440 Section 108.440 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Changes in Ownership, Structure, or...

  5. 13 CFR 108.440 - Standards governing prior SBA approval for a proposed transfer of Control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Standards governing prior SBA approval for a proposed transfer of Control. 108.440 Section 108.440 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Changes in Ownership, Structure, or...

  6. 12 CFR 24.5 - Public welfare investment after-the-fact notice and prior approval procedures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Public welfare investment after-the-fact notice and prior approval procedures. 24.5 Section 24.5 Banks and Banking COMPTROLLER OF THE CURRENCY... capital and surplus represented by the proposed investment and by the bank's aggregate outstanding public...

  7. 40 CFR 124.213 - What procedures must I follow to make routine changes with prior approval?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... routine changes with prior approval? 124.213 Section 124.213 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS PROCEDURES FOR DECISIONMAKING Procedures for RCRA Standardized Permit Maintaining A Standardized Permit § 124.213 What procedures must I follow to make routine changes...

  8. 40 CFR 124.213 - What procedures must I follow to make routine changes with prior approval?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... routine changes with prior approval? 124.213 Section 124.213 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS PROCEDURES FOR DECISIONMAKING Procedures for RCRA Standardized Permit Maintaining A Standardized Permit § 124.213 What procedures must I follow to make routine changes...

  9. 40 CFR 124.213 - What procedures must I follow to make routine changes with prior approval?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... routine changes with prior approval? 124.213 Section 124.213 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS PROCEDURES FOR DECISIONMAKING Procedures for RCRA Standardized Permit Maintaining A Standardized Permit § 124.213 What procedures must I follow to make routine changes...

  10. 45 CFR 95.611 - Prior approval conditions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...-GRANT PROGRAMS (PUBLIC ASSISTANCE, MEDICAL ASSISTANCE AND STATE CHILDREN'S HEALTH INSURANCE PROGRAMS... requests for approval which affect only one approving component of HHS (CMS, OCSE, or Children's Bureau... days for major milestones. For Aid to Families with Dependent Children (AFDC) Family Assistance...

  11. 45 CFR 95.611 - Prior approval conditions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...-GRANT PROGRAMS (PUBLIC ASSISTANCE, MEDICAL ASSISTANCE AND STATE CHILDREN'S HEALTH INSURANCE PROGRAMS... requests for approval which affect only one approving component of HHS (CMS, OCSE, or Children's Bureau... days for major milestones. For Aid to Families with Dependent Children (AFDC) Family Assistance...

  12. 45 CFR 95.611 - Prior approval conditions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...-GRANT PROGRAMS (PUBLIC ASSISTANCE, MEDICAL ASSISTANCE AND STATE CHILDREN'S HEALTH INSURANCE PROGRAMS... requests for approval which affect only one approving component of HHS (CMS, OCSE, or Children's Bureau... days for major milestones. For Aid to Families with Dependent Children (AFDC) Family Assistance...

  13. 45 CFR 95.611 - Prior approval conditions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...-GRANT PROGRAMS (PUBLIC ASSISTANCE, MEDICAL ASSISTANCE AND STATE CHILDREN'S HEALTH INSURANCE PROGRAMS... requests for approval which affect only one approving component of HHS (CMS, OCSE, or Children's Bureau... days for major milestones. For Aid to Families with Dependent Children (AFDC) Family Assistance...

  14. 25 CFR 162.213 - What supporting documents must be provided prior to BIA's grant or approval of an agricultural...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false What supporting documents must be provided prior to BIA's....213 What supporting documents must be provided prior to BIA's grant or approval of an agricultural... organizational and financial documents, as needed to show that the lease will be enforceable against the tenant...

  15. Sophisticated Approval Voting, Ignorance Priors, and Plurality Heuristics: A Behavioral Social Choice Analysis in a Thurstonian Framework

    ERIC Educational Resources Information Center

    Regenwetter, Michel; Ho, Moon-Ho R.; Tsetlin, Ilia

    2007-01-01

    This project reconciles historically distinct paradigms at the interface between individual and social choice theory, as well as between rational and behavioral decision theory. The authors combine a utility-maximizing prescriptive rule for sophisticated approval voting with the ignorance prior heuristic from behavioral decision research and two…

  16. An Analysis of Policies and Procedures for Obtaining New Course Approval at Oakton Community College.

    ERIC Educational Resources Information Center

    Woloshin, Phyllis Lerman

    Procedures and policies by which a new course is introduced into the Oakton Community College curriculum were analyzed in order to discover appropriate procedures for attaining course approval from the internal college governance structure, to implement those procedures in obtaining final approval, and to make recommendations for improvement of…

  17. 7 CFR 1751.104 - Obtaining RUS approval of a proposed Modernization Plan.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Obtaining RUS approval of a proposed Modernization Plan. 1751.104 Section 1751.104 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE TELECOMMUNICATIONS SYSTEM PLANNING AND DESIGN...

  18. 18 CFR 401.39 - Form of submission of projects not requiring prior approval by State or Federal agencies.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 2 2011-04-01 2011-04-01 false Form of submission of projects not requiring prior approval by State or Federal agencies. 401.39 Section 401.39 Conservation of Power and Water Resources DELAWARE RIVER BASIN COMMISSION ADMINISTRATIVE MANUAL RULES OF PRACTICE AND...

  19. Evaluating a Collaborative Approach to Improve Prior Authorization Efficiency in the Treatment of Hepatitis C Virus.

    PubMed

    Dunn, Emily E; Vranek, Kathryn; Hynicka, Lauren M; Gripshover, Janet; Potosky, Darryn; Mattingly, T Joseph

    A team-based approach to obtaining prior authorization approval was implemented utilizing a specialty pharmacy, a clinic-based pharmacy technician specialist, and a registered nurse to work with providers to obtain approval for medications for hepatitis C virus (HCV) infection. The objective of this study was to evaluate the time to approval for prescribed treatment of HCV infection. A retrospective observational study was conducted including patients treated for HCV infection by clinic providers who received at least 1 oral direct-acting antiviral HCV medication. Patients were divided into 2 groups, based on whether they were treated before or after the implementation of the team-based approach. Student t tests were used to compare average wait times before and after the intervention. The sample included 180 patients, 68 treated before the intervention and 112 patients who initiated therapy after. All patients sampled required prior authorization approval by a third-party payer to begin therapy. There was a statistically significant reduction (P = .02) in average wait time in the postintervention group (15.6 ± 12.1 days) once adjusted using dates of approval. Pharmacy collaboration may provide increases in efficiency in provider prior authorization practices and reduced wait time for patients to begin treatment.

  20. Evaluating a Collaborative Approach to Improve Prior Authorization Efficiency in the Treatment of Hepatitis C Virus

    PubMed Central

    Dunn, Emily E.; Vranek, Kathryn; Hynicka, Lauren M.; Gripshover, Janet; Potosky, Darryn

    2017-01-01

    Objective: A team-based approach to obtaining prior authorization approval was implemented utilizing a specialty pharmacy, a clinic-based pharmacy technician specialist, and a registered nurse to work with providers to obtain approval for medications for hepatitis C virus (HCV) infection. The objective of this study was to evaluate the time to approval for prescribed treatment of HCV infection. Methods: A retrospective observational study was conducted including patients treated for HCV infection by clinic providers who received at least 1 oral direct-acting antiviral HCV medication. Patients were divided into 2 groups, based on whether they were treated before or after the implementation of the team-based approach. Student t tests were used to compare average wait times before and after the intervention. Results: The sample included 180 patients, 68 treated before the intervention and 112 patients who initiated therapy after. All patients sampled required prior authorization approval by a third-party payer to begin therapy. There was a statistically significant reduction (P = .02) in average wait time in the postintervention group (15.6 ± 12.1 days) once adjusted using dates of approval. Conclusions: Pharmacy collaboration may provide increases in efficiency in provider prior authorization practices and reduced wait time for patients to begin treatment. PMID:28665904

  1. 12 CFR 550.70 - Must I obtain OTS approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... before I exercise fiduciary powers? 550.70 Section 550.70 Banks and Banking OFFICE OF THRIFT SUPERVISION... I obtain OTS approval or file a notice before I exercise fiduciary powers? You should refer to the following chart to determine if you must obtain OTS approval or file a notice with OTS before you exercise...

  2. 12 CFR 550.70 - Must I obtain OTS approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... before I exercise fiduciary powers? 550.70 Section 550.70 Banks and Banking OFFICE OF THRIFT SUPERVISION... I obtain OTS approval or file a notice before I exercise fiduciary powers? You should refer to the following chart to determine if you must obtain OTS approval or file a notice with OTS before you exercise...

  3. 12 CFR 550.70 - Must I obtain OTS approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... before I exercise fiduciary powers? 550.70 Section 550.70 Banks and Banking OFFICE OF THRIFT SUPERVISION... I obtain OTS approval or file a notice before I exercise fiduciary powers? You should refer to the following chart to determine if you must obtain OTS approval or file a notice with OTS before you exercise...

  4. 12 CFR 550.70 - Must I obtain OTS approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... before I exercise fiduciary powers? 550.70 Section 550.70 Banks and Banking OFFICE OF THRIFT SUPERVISION... I obtain OTS approval or file a notice before I exercise fiduciary powers? You should refer to the following chart to determine if you must obtain OTS approval or file a notice with OTS before you exercise...

  5. 12 CFR 550.70 - Must I obtain OTS approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... before I exercise fiduciary powers? 550.70 Section 550.70 Banks and Banking OFFICE OF THRIFT SUPERVISION... I obtain OTS approval or file a notice before I exercise fiduciary powers? You should refer to the following chart to determine if you must obtain OTS approval or file a notice with OTS before you exercise...

  6. Sophisticated approval voting, ignorance priors, and plurality heuristics: a behavioral social choice analysis in a Thurstonian framework.

    PubMed

    Regenwetter, Michel; Ho, Moon-Ho R; Tsetlin, Ilia

    2007-10-01

    This project reconciles historically distinct paradigms at the interface between individual and social choice theory, as well as between rational and behavioral decision theory. The authors combine a utility-maximizing prescriptive rule for sophisticated approval voting with the ignorance prior heuristic from behavioral decision research and two types of plurality heuristics to model approval voting behavior. When using a sincere plurality heuristic, voters simplify their decision process by voting for their single favorite candidate. When using a strategic plurality heuristic, voters strategically focus their attention on the 2 front-runners and vote for their preferred candidate among these 2. Using a hierarchy of Thurstonian random utility models, the authors implemented these different decision rules and tested them statistically on 7 real world approval voting elections. They cross-validated their key findings via a psychological Internet experiment. Although a substantial number of voters used the plurality heuristic in the real elections, they did so sincerely, not strategically. Moreover, even though Thurstonian models do not force such agreement, the results show, in contrast to common wisdom about social choice rules, that the sincere social orders by Condorcet, Borda, plurality, and approval voting are identical in all 7 elections and in the Internet experiment. PsycINFO Database Record (c) 2007 APA, all rights reserved.

  7. 25 CFR 115.904 - Where earnest money is paid prior to Secretarial approval of a conveyance or contract instrument...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Where earnest money is paid prior to Secretarial approval of a conveyance or contract instrument involving trust assets, may the BIA deposit that earnest money into a special deposit account? 115.904 Section 115.904 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR FINANCIAL ACTIVITIES TRUST...

  8. 47 CFR 63.11 - Notification by and prior approval for U.S. international carriers that are or propose to become...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ownership, indefeasible-right-of-user, or leasehold interest in bare capacity in international or domestic.... international carriers that are or propose to become affiliated with a foreign carrier. 63.11 Section 63.11... Notification by and prior approval for U.S. international carriers that are or propose to become affiliated...

  9. A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves.

    PubMed

    Yoganathan, Ajit P; Fogel, Mark; Gamble, Susan; Morton, Michael; Schmidt, Paul; Secunda, Jeff; Vidmar, Sara; Del Nido, Pedro

    2013-10-01

    Congenital heart valve disease is one of the most common abnormalities in children. There are limited technological solutions available for treating children with congenital heart valve diseases. The aim of this study is to provide the details of the consensus reached in terms of pediatric definitions, design approach, in vitro testing, and clinical trials, which may be used as guidance for developing prosthetic heart valves for the pediatric indication. In stark contrast to the various designs of adult-sized replacement valves available in the market, there are no Food and Drug Administration (FDA)-approved prosthetic heart valves available for use in the pediatric population. There is a pressing need for FDA-approved pediatric valve devices in the United States. The pediatric patient population has been typically excluded from replacement heart valve trials for several reasons. In January 2010, heart valve manufacturers and pediatric clinicians collaborated with academicians and FDA staff in a workshop to suggest ways to successfully evaluate pediatric prosthetic valves and conduct pediatric clinical trials to provide acceptable heart valve replacement options for this patient population. Recommendations, derived from ISO 5840:2005 and the 2010 FDA Draft Replacement Heart Valve Guidance, are provided for hydrodynamic, durability, and fatigue testing. The article specifically addresses in vitro and premarket and postmarket approval clinical studies that should be considered by a heart valve manufacturer for obtaining regulatory approval of pediatric sizes of prosthetic heart valve designs that are already approved for adult clinical use. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  10. 13 CFR 127.304 - How does a concern obtain certification from an approved certifier?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false How does a concern obtain certification from an approved certifier? 127.304 Section 127.304 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION WOMEN-OWNED SMALL BUSINESS FEDERAL CONTRACT ASSISTANCE PROCEDURES Certification of EDWOSB or WOSB...

  11. 12 CFR 550.580 - When may I conduct fiduciary activities without obtaining OTS approval?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 5 2011-01-01 2011-01-01 false When may I conduct fiduciary activities without obtaining OTS approval? 550.580 Section 550.580 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY FIDUCIARY POWERS OF SAVINGS ASSOCIATIONS Activities Exempt From This Part § 550.580...

  12. 40 CFR 80.1340 - How does a refiner obtain approval as a small refiner?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Provisions § 80.1340 How does a refiner obtain approval as a small refiner? (a) Applications for small refiner status must be submitted to EPA by December 31, 2007. (b) For U.S. Postal delivery, applications... small refiner status application must contain the following information for the company seeking small...

  13. 33 CFR 66.05-40 - Corps of Engineers' approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 1 2013-07-01 2013-07-01 false Corps of Engineers' approval. 66... AIDS TO NAVIGATION PRIVATE AIDS TO NAVIGATION State Aids to Navigation § 66.05-40 Corps of Engineers..., the State Administrator is responsible for obtaining prior permission from the District Engineer, U.S...

  14. 33 CFR 66.05-40 - Corps of Engineers' approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 1 2012-07-01 2012-07-01 false Corps of Engineers' approval. 66... AIDS TO NAVIGATION PRIVATE AIDS TO NAVIGATION State Aids to Navigation § 66.05-40 Corps of Engineers..., the State Administrator is responsible for obtaining prior permission from the District Engineer, U.S...

  15. 33 CFR 66.05-40 - Corps of Engineers' approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 1 2014-07-01 2014-07-01 false Corps of Engineers' approval. 66... AIDS TO NAVIGATION PRIVATE AIDS TO NAVIGATION State Aids to Navigation § 66.05-40 Corps of Engineers..., the State Administrator is responsible for obtaining prior permission from the District Engineer, U.S...

  16. 33 CFR 66.05-40 - Corps of Engineers' approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Corps of Engineers' approval. 66... AIDS TO NAVIGATION PRIVATE AIDS TO NAVIGATION State Aids to Navigation § 66.05-40 Corps of Engineers..., the State Administrator is responsible for obtaining prior permission from the District Engineer, U.S...

  17. 33 CFR 66.05-40 - Corps of Engineers' approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false Corps of Engineers' approval. 66... AIDS TO NAVIGATION PRIVATE AIDS TO NAVIGATION State Aids to Navigation § 66.05-40 Corps of Engineers..., the State Administrator is responsible for obtaining prior permission from the District Engineer, U.S...

  18. Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule.

    PubMed

    Park, Glen D; Mitchel, Jules T

    2016-06-01

    While the development of medical products and approval by the U.S. Food and Drug Administration (FDA) is well known, the development of countermeasures against exposure to toxic levels of radiation, chemicals, and infectious agents requires special consideration, and there has been, to date, little experience in working with the FDA to obtain approval of these products. The FDA has published a regulation entitled "Approval of Biological Products when Human Efficacy Studies are not Ethical or Feasible." This regulation, known simply as the "Animal Rule," was designed to permit approval or licensing of drugs and biologics when efficacy studies in humans are not ethical or feasible. To date, 12 products have been approved under the Animal Rule. It is highly recommended that sponsors of products that are to be developed under the Animal Rule meet with the FDA and other government entities early in the development process to ensure that the efficacy and safety studies that are planned will meet the FDA's requirements for approval of the product. © 2016 New York Academy of Sciences.

  19. 22 CFR 129.6 - Procedures for obtaining approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... brokering activities must be made to the Directorate of Defense Trade Controls, be signed by an empowered... activity in support of the U.S. Government. (c) The empowered official signing the request for approval...

  20. 5 CFR 7401.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... participation in the activities of a nonprofit charitable, religious, professional, social, fraternal... specialized instruction and study in an institution of higher education, hospital, or similar facility... alternate DAEO may issue instructions or manual issuances governing the submission of requests for approval...

  1. 5 CFR 7401.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... participation in the activities of a nonprofit charitable, religious, professional, social, fraternal... specialized instruction and study in an institution of higher education, hospital, or similar facility... alternate DAEO may issue instructions or manual issuances governing the submission of requests for approval...

  2. 5 CFR 7401.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... participation in the activities of a nonprofit charitable, religious, professional, social, fraternal... specialized instruction and study in an institution of higher education, hospital, or similar facility... alternate DAEO may issue instructions or manual issuances governing the submission of requests for approval...

  3. 5 CFR 7401.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... participation in the activities of a nonprofit charitable, religious, professional, social, fraternal... specialized instruction and study in an institution of higher education, hospital, or similar facility... alternate DAEO may issue instructions or manual issuances governing the submission of requests for approval...

  4. 5 CFR 7401.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... participation in the activities of a nonprofit charitable, religious, professional, social, fraternal... specialized instruction and study in an institution of higher education, hospital, or similar facility... alternate DAEO may issue instructions or manual issuances governing the submission of requests for approval...

  5. 46 CFR 162.018-8 - Procedure for approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

  6. 46 CFR 162.018-8 - Procedure for approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

  7. 46 CFR 162.018-8 - Procedure for approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

  8. 46 CFR 162.018-8 - Procedure for approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

  9. 46 CFR 162.018-8 - Procedure for approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

  10. 77 FR 55473 - Agency Information Collection Activities; Renewal of a Currently Approved Collection; Comment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-10

    ... that plan for any mergers, (3) obtain prior written approvals for the use of certain approaches for... of its continuing effort to reduce paperwork and respondent burden, invites the general public and... Rules: Standardized Approach for Risk-Weighted Assets; Market Discipline and Disclosure Requirements (77...

  11. 25 CFR 533.6 - Approval and disapproval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... management contract is a person whose prior activities, criminal record, if any, or reputation, habits, and... NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR MANAGEMENT CONTRACT PROVISIONS APPROVAL OF MANAGEMENT CONTRACTS § 533.6 Approval and disapproval. (a) The Chairman may approve a management contract if...

  12. 25 CFR 533.6 - Approval and disapproval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... management contract is a person whose prior activities, criminal record, if any, or reputation, habits, and... NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR MANAGEMENT CONTRACT PROVISIONS APPROVAL OF MANAGEMENT CONTRACTS § 533.6 Approval and disapproval. (a) The Chairman may approve a management contract if...

  13. 25 CFR 533.6 - Approval and disapproval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... management contract is a person whose prior activities, criminal record, if any, or reputation, habits, and... NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR MANAGEMENT CONTRACT PROVISIONS APPROVAL OF MANAGEMENT CONTRACTS § 533.6 Approval and disapproval. (a) The Chairman may approve a management contract if...

  14. 7 CFR 58.123 - Survey and approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 3 2013-01-01 2013-01-01 false Survey and approval. 58.123 Section 58.123 Agriculture... Survey and approval. Prior to the approval of a plant, a designated representative of the Administrator shall make a survey of the plant, premises, storage facilities, equipment and raw material, volume of...

  15. 7 CFR 58.123 - Survey and approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 3 2012-01-01 2012-01-01 false Survey and approval. 58.123 Section 58.123 Agriculture... Survey and approval. Prior to the approval of a plant, a designated representative of the Administrator shall make a survey of the plant, premises, storage facilities, equipment and raw material, volume of...

  16. 7 CFR 58.123 - Survey and approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Survey and approval. 58.123 Section 58.123 Agriculture... Survey and approval. Prior to the approval of a plant, a designated representative of the Administrator shall make a survey of the plant, premises, storage facilities, equipment and raw material, volume of...

  17. 7 CFR 58.123 - Survey and approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Survey and approval. 58.123 Section 58.123 Agriculture... Survey and approval. Prior to the approval of a plant, a designated representative of the Administrator shall make a survey of the plant, premises, storage facilities, equipment and raw material, volume of...

  18. 42 CFR 433.113 - Reduction of FFP for failure to operate a system and obtain initial approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Reduction of FFP for failure to operate a system... ADMINISTRATION Mechanized Claims Processing and Information Retrieval Systems § 433.113 Reduction of FFP for failure to operate a system and obtain initial approval. (a) Except as waived under § 433.130 or 433.131...

  19. 20 CFR 30.907 - Can an impairment evaluation obtained by OWCP be challenged prior to issuance of the recommended...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false Can an impairment evaluation obtained by OWCP... ILLNESS COMPENSATION PROGRAM ACT OF 2000, AS AMENDED Impairment Benefits Under Part E of EEOICPA Medical Evidence of Impairment § 30.907 Can an impairment evaluation obtained by OWCP be challenged prior to...

  20. 30 CFR 250.906 - What must I do to obtain approval for the proposed site of my platform?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... geological survey relevant to the design and siting of your platform. Your geological survey must assess: (1..., the possibility and effects of seafloor subsidence. (c) Subsurface surveys. Depending upon the design... obtain approval for the proposed site of my platform? (a) Shallow hazards surveys. You must perform a...

  1. 18 CFR 806.6 - Transfer of approvals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... initiated prior to January 23, 1971. (iv) The project has no associated groundwater withdrawal that was... associated groundwater withdrawal that was initiated prior to July 13, 1978 and that has not been approved by...

  2. 18 CFR 806.6 - Transfer of approvals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... initiated prior to January 23, 1971. (iv) The project has no associated groundwater withdrawal that was... associated groundwater withdrawal that was initiated prior to July 13, 1978 and that has not been approved by...

  3. 18 CFR 806.6 - Transfer of approvals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... initiated prior to January 23, 1971. (iv) The project has no associated groundwater withdrawal that was... associated groundwater withdrawal that was initiated prior to July 13, 1978 and that has not been approved by...

  4. 12 CFR 150.70 - Must I obtain OCC approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... before I exercise fiduciary powers? 150.70 Section 150.70 Banks and Banking COMPTROLLER OF THE CURRENCY....70 Must I obtain OCC approval or file a notice before I exercise fiduciary powers? You should refer... before you exercise fiduciary powers. This chart does not apply to activities that are exempt under...

  5. 12 CFR 150.70 - Must I obtain OCC approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... before I exercise fiduciary powers? 150.70 Section 150.70 Banks and Banking COMPTROLLER OF THE CURRENCY....70 Must I obtain OCC approval or file a notice before I exercise fiduciary powers? You should refer... before you exercise fiduciary powers. This chart does not apply to activities that are exempt under...

  6. 12 CFR 150.70 - Must I obtain OCC approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... before I exercise fiduciary powers? 150.70 Section 150.70 Banks and Banking COMPTROLLER OF THE CURRENCY....70 Must I obtain OCC approval or file a notice before I exercise fiduciary powers? You should refer... before you exercise fiduciary powers. This chart does not apply to activities that are exempt under...

  7. 33 CFR 115.70 - Advance approval of bridges.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false Advance approval of bridges. 115... BRIDGES BRIDGE LOCATIONS AND CLEARANCES; ADMINISTRATIVE PROCEDURES § 115.70 Advance approval of bridges. (a) The General Bridge Act of 1946 requires the approval of the location and plans of bridges prior...

  8. 33 CFR 115.70 - Advance approval of bridges.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Advance approval of bridges. 115... BRIDGES BRIDGE LOCATIONS AND CLEARANCES; ADMINISTRATIVE PROCEDURES § 115.70 Advance approval of bridges. (a) The General Bridge Act of 1946 requires the approval of the location and plans of bridges prior...

  9. 43 CFR 3271.13 - How do I obtain approval to build pipelines and facilities connecting the well field to...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false How do I obtain approval to build pipelines and facilities connecting the well field to utilization facilities not located on Federal lands leased for geothermal resources? 3271.13 Section 3271.13 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND...

  10. 43 CFR 3271.13 - How do I obtain approval to build pipelines and facilities connecting the well field to...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false How do I obtain approval to build pipelines and facilities connecting the well field to utilization facilities not located on Federal lands leased for geothermal resources? 3271.13 Section 3271.13 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND...

  11. 43 CFR 3271.13 - How do I obtain approval to build pipelines and facilities connecting the well field to...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false How do I obtain approval to build pipelines and facilities connecting the well field to utilization facilities not located on Federal lands leased for geothermal resources? 3271.13 Section 3271.13 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND...

  12. 43 CFR 3271.13 - How do I obtain approval to build pipelines and facilities connecting the well field to...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false How do I obtain approval to build pipelines and facilities connecting the well field to utilization facilities not located on Federal lands leased for geothermal resources? 3271.13 Section 3271.13 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND...

  13. 5 CFR 6601.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... of higher education, secondary school, elementary school, or an education or training program... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ENDOWMENT FOR THE HUMANITIES § 6601.102 Prior... within the meaning of 5 CFR 2635.203(d), whether or not for compensation, an employee other than a...

  14. 5 CFR 6601.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... of higher education, secondary school, elementary school, or an education or training program... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ENDOWMENT FOR THE HUMANITIES § 6601.102 Prior... within the meaning of 5 CFR 2635.203(d), whether or not for compensation, an employee other than a...

  15. 42 CFR 37.42 - Approval of roentgenographic facilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Approval of roentgenographic facilities. 37.42... roentgenographic facilities. (a) Approval of roentgenographic facilities given prior to January 1, 1976, shall terminate upon August 1, 1978 unless each of the following conditions have been met: (1) The facility must...

  16. Permit application and approval chronology for a small airgun survey offshore southern California, June 1999

    USGS Publications Warehouse

    Childs, Jonathan R.; Normark, William R.; Fisher, Michael A.

    1999-01-01

    Offshore geophysical surveys are subject to increased restrictions resulting from new or revised Federal legislation and increased authority of State agencies that deal with environmental issues. This report reviews the process followed by the U.S. Geological Survey to obtain necessary approvals for a marine geophysical survey conducted in June, 1999, offshore Southern California. Discussions and negotiations between the USGS, National Marine Fisheries Service, the California Coastal Commission, the California State Lands Commission, and various other interested parties during six months prior to the survey are documented. A suggested timeframe that should be followed for obtaining the approvals and permits for future work offshore California is based on the outcome of the permitting process for the 1999 cruise, as well as continuing dialog with representatives of the Federal and State entities involved.

  17. 7 CFR 764.458 - Vendor approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... (3) Any changes in curriculum, instructor, or cost require prior approval by the Agency. (4) The... agreement; (ii) Any changes in curricula, instructor, or cost; and (iii) Documentation that the vendor is...

  18. 7 CFR 764.458 - Vendor approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... (3) Any changes in curriculum, instructor, or cost require prior approval by the Agency. (4) The... agreement; (ii) Any changes in curricula, instructor, or cost; and (iii) Documentation that the vendor is...

  19. 76 FR 47531 - Approval of Classification Societies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-05

    ... proposed rulemaking (NPRM) proposing application procedures and performance standards that classification... exempt from Coast Guard approval prior to working in the United States. Because [[Page 47532

  20. 45 CFR 1386.31 - State Plan submittal and approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... State Plan to significant comments and suggestions. A summary of the Council's response to State Plan.... (c) Failure to submit an approvable State plan or amendment prior to the Federal fiscal years for... eligible for Federal financial participation. (d) The Commissioner must approve any State plan or plan...

  1. 45 CFR 1386.31 - State Plan submittal and approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... State Plan to significant comments and suggestions. A summary of the Council's response to State Plan.... (c) Failure to submit an approvable State plan or amendment prior to the Federal fiscal years for... eligible for Federal financial participation. (d) The Commissioner must approve any State plan or plan...

  2. 45 CFR 1386.31 - State Plan submittal and approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... State Plan to significant comments and suggestions. A summary of the Council's response to State Plan.... (c) Failure to submit an approvable State plan or amendment prior to the Federal fiscal years for... eligible for Federal financial participation. (d) The Commissioner must approve any State plan or plan...

  3. 45 CFR 1386.31 - State Plan submittal and approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... State Plan to significant comments and suggestions. A summary of the Council's response to State Plan.... (c) Failure to submit an approvable State plan or amendment prior to the Federal fiscal years for... eligible for Federal financial participation. (d) The Commissioner must approve any State plan or plan...

  4. 45 CFR 1386.31 - State Plan submittal and approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... State Plan to significant comments and suggestions. A summary of the Council's response to State Plan.... (c) Failure to submit an approvable State plan or amendment prior to the Federal fiscal years for... eligible for Federal financial participation. (d) The Commissioner must approve any State plan or plan...

  5. 30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

  6. 30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

  7. 30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

  8. 30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

  9. 30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

  10. 24 CFR 1000.108 - How is HUD approval obtained by a recipient for housing for non low-income Indian families and...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... recipient for housing for non low-income Indian families and model activities? 1000.108 Section 1000.108... AMERICAN HOUSING ACTIVITIES Affordable Housing Activities § 1000.108 How is HUD approval obtained by a.... Assistance to non low-income Indian families must be in accordance with § 1000.110. Proposals may be...

  11. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP... MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  12. 32 CFR 736.7 - Approval by the Attorney General.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Approval by the Attorney General. 736.7 Section..., PATENTS, AND CONTRACTS DISPOSITION OF PROPERTY § 736.7 Approval by the Attorney General. Prior to the... inventions, irrespective of cost, the Department of the Navy must notify the Attorney General of the proposed...

  13. Venetoclax: First Global Approval.

    PubMed

    Deeks, Emma D

    2016-06-01

    Venetoclax (Venclexta™) is an oral selective inhibitor of the prosurvival protein BCL-2 and therefore restores the apoptotic ability of malignant cells. The drug arose from research by Abbott Laboratories (now AbbVie) during a collaboration with Genentech and is being co-developed by AbbVie and Genentech/Roche primarily for the treatment of haematological malignancies. Venetoclax is approved in the USA for use as monotherapy in patients with chronic lymphocytic leukaemia (CLL) with the 17p deletion (as detected by an approved FDA test) who have received at least one prior therapy, and is awaiting approval for similar indications in the EU and Canada. Venetoclax is also in phase I-III development as combination therapy for CLL, phase I/II development as monotherapy and/or combination therapy for non-Hodgkin lymphomas (including diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma) and acute myeloid leukaemia, and phase I development for multiple myeloma, systemic lupus erythematosus and breast cancer. This article summarizes the milestones in the development of venetoclax leading to this first approval for CLL.

  14. 13 CFR 120.1716 - Required SBA approval of servicing actions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Required SBA approval of servicing actions. 120.1716 Section 120.1716 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS... § 120.1716 Required SBA approval of servicing actions. Seller shall not, without prior written consent...

  15. 24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

  16. 24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

  17. 24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

  18. 24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

  19. 24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

  20. [Role of Institutional Review Boards for multi-centre studies in national health services research - a cross-sectional study of the effort to obtain secondary ethical approvals for the DACAPO study].

    PubMed

    Blecha, Sebastian; Thomann-Hackner, Kathrin; Brandstetter, Susanne; Dodoo-Schittko, Frank; Seboek, Philipp; Apfelbacher, Christian; Graf, Bernhard M; Bein, Thomas

    2015-09-01

    Health services research (HSR) is of fundamental importance for the continuous improvement of preventive, diagnostic or therapeutic measures. The conduct of multi-centre HSR studies requires that ethical approval by Institutional review boards (IRB's) is obtained. We documented the effort, the complexity and the man power necessary to obtain secondary ethical approval for a national HSR in Germany ("Surviving the Acute Respiratory Distress Syndrome" [DACAPO-study]). Having obtained a primary ethical approval by the IRB of Regensburg University, the time, correspondence, necessity for amendments, corrections, or additional costs by 34 IRB's for 64 participating study centers was documented. The complete obtainment was found to be time consuming and associated with a high workload and man power. A time span of seven month was needed to receive votes from all IRB's. The median time span was 25,5 days (25 %/75 % percentile 13 and 42 days, respectively). Requirements in terms of corrections or amendments were inhomogeneous and frequent changes were necessary. There were additional fees for secondary votes of 4328,40 €. Total costs for the study center Regensburg were 21.193,40 € (2,6 % of the grant volume). Obtaining all ethical approvals for a multi-centre observational HSR study in Germany is complex and time consuming. Various and inhomogeneous formalities may delay the plan and realization of HSR. A Homogenization and simplification of the procedure of ethics votes should be discussed. © Georg Thieme Verlag KG Stuttgart · New York.

  1. Obtaining value prior to pulping with diethyl oxalate and oxalic acid

    Treesearch

    W.R. Kenealy; E. Horn; C.J. Houtman; J. Laplaza; T.W. Jeffries

    2007-01-01

    Pulp and paper are converted to paper products with yields of paper dependent on the wood and the process used. Even with high yield pulps there are conversion losses and with chemical pulps the yields approach 50%. The portions of the wood that do not provide product are either combusted to generate power and steam or incur a cost in waste water treatment. Value prior...

  2. [Prior harvesting and cryopreservation of peripheral blood stem cells from related donors: current situations in Japan].

    PubMed

    Kobayashi, Takeshi; Ohashi, Kazuteru; Haraguchi, Kyoko; Okuyama, Yoshiki; Hino, Masayuki; Tanaka, Junji; Ueda, Yasunori; Nishida, Tetsuya; Atsuta, Yoshiko; Takanashi, Minoko; Iida, Minako; Muroi, Kazuo; Yabe, Hiromasa; Miyamura, Koichi

    Although peripheral blood stem cell (PBSC) transplantations in an unrelated transplant setting have been performed since 2010, prior harvesting and cryopreservation of PBSCs from unrelated donors has not been approved in Japan. There are no restrictions with regard to related donors. Therefore, in April 2015, we conducted a nationwide survey and obtained written answers from 123 transplant hospitals throughout Japan. Our survey revealed that as much as 81.3% of transplant hospitals routinely perform prior harvesting and cryopreservation of PBSCs from related donors and that both cell processing and quality management of cryopreserved products have been appropriately conducted in line with domestic guidelines, although post-thaw quality control and storage period setting require further improvements. Moreover, informed consent obtained from both patients and donors with regard to cryopreservation of PBSCs was not always sufficient in some hospitals. We found that the average number of unused or discarded cryopreserved PBSCs is 1.09 per hospital, and the overall nonuse or discard rates of cryopreserved PBSCs were estimated to be as low as 2.67%.

  3. 7 CFR 966.124 - Approved receiver.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE TOMATOES GROWN IN FLORIDA Rules and..., as an approved receiver, tomatoes for purposes as set forth in § 966.120(a), shall annually, prior... specified purpose is to occur; (4) Whether or not the receiver packs, repacks or sells fresh tomatoes; (5) A...

  4. 46 CFR 175.800 - Approved equipment and material.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... required by this subchapter to be approved or of an approved type, must have been manufactured and approved... Accepted under Marine Inspection and Navigation Laws” lists approved equipment by type and manufacturer. COMDTINST M16714.3 (Series) may be obtained from New Orders, Superintendent of Documents, P.O. Box 371954...

  5. 46 CFR 175.800 - Approved equipment and material.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... required by this subchapter to be approved or of an approved type, must have been manufactured and approved... Accepted under Marine Inspection and Navigation Laws” lists approved equipment by type and manufacturer. COMDTINST M16714.3 (Series) may be obtained from New Orders, Superintendent of Documents, P.O. Box 371954...

  6. 14 CFR 415.5 - Policy and safety approvals.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 415.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH LICENSE General § 415.5 Policy and safety approvals. To obtain a launch license, an applicant must obtain policy and safety approvals from the FAA. Requirements...

  7. 14 CFR 415.5 - Policy and safety approvals.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 415.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH LICENSE General § 415.5 Policy and safety approvals. To obtain a launch license, an applicant must obtain policy and safety approvals from the FAA. Requirements...

  8. 14 CFR 431.5 - Policy and safety approvals.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Policy and safety approvals. 431.5 Section 431.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... Policy and safety approvals. To obtain either type of RLV mission license, an applicant must obtain...

  9. 14 CFR 431.5 - Policy and safety approvals.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Policy and safety approvals. 431.5 Section 431.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... Policy and safety approvals. To obtain either type of RLV mission license, an applicant must obtain...

  10. 14 CFR 431.5 - Policy and safety approvals.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Policy and safety approvals. 431.5 Section 431.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... Policy and safety approvals. To obtain either type of RLV mission license, an applicant must obtain...

  11. 14 CFR 431.5 - Policy and safety approvals.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Policy and safety approvals. 431.5 Section 431.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... Policy and safety approvals. To obtain either type of RLV mission license, an applicant must obtain...

  12. 14 CFR 431.5 - Policy and safety approvals.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Policy and safety approvals. 431.5 Section 431.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... Policy and safety approvals. To obtain either type of RLV mission license, an applicant must obtain...

  13. 24 CFR 200.160 - Redemption of debentures prior to maturity.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 2 2014-04-01 2014-04-01 false Redemption of debentures prior to... option of the Commissioner and with the approval of the Secretary of the Treasury, be redeemable at par... Commissioner may include with the notice of redemption an offer to purchase the debentures at par plus accrued...

  14. 24 CFR 200.160 - Redemption of debentures prior to maturity.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 2 2013-04-01 2013-04-01 false Redemption of debentures prior to... option of the Commissioner and with the approval of the Secretary of the Treasury, be redeemable at par... Commissioner may include with the notice of redemption an offer to purchase the debentures at par plus accrued...

  15. 24 CFR 200.160 - Redemption of debentures prior to maturity.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 2 2011-04-01 2011-04-01 false Redemption of debentures prior to... option of the Commissioner and with the approval of the Secretary of the Treasury, be redeemable at par... Commissioner may include with the notice of redemption an offer to purchase the debentures at par plus accrued...

  16. 24 CFR 200.160 - Redemption of debentures prior to maturity.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Redemption of debentures prior to... option of the Commissioner and with the approval of the Secretary of the Treasury, be redeemable at par... Commissioner may include with the notice of redemption an offer to purchase the debentures at par plus accrued...

  17. 24 CFR 200.160 - Redemption of debentures prior to maturity.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 2 2012-04-01 2012-04-01 false Redemption of debentures prior to... option of the Commissioner and with the approval of the Secretary of the Treasury, be redeemable at par... Commissioner may include with the notice of redemption an offer to purchase the debentures at par plus accrued...

  18. Obtaining NASA Approval for use of Non-Metallic Materials in Manned Space Flight

    NASA Technical Reports Server (NTRS)

    Davis, Samuel E.; Wise, Harry L.

    2003-01-01

    Material manufacturers and suppliers are often surprised when a material commonly provided to industry is not approved for use on manned spacecraft. Often the reason is a lack of test data in environments that simulate those encountered in space applications, especially oxygen-enriched conditions, which significantly increase both the likelihood of material combustion and the propagation of a fire. This paper introduces the requirements for flight approval of non-metallic materials, focusing on material testing for human-rated space flight programs; it reviews the history of flight materials requirements and provides the rationale for such and introduces specific requirements related to testing and to good material engineering and design practices. After describing the procedure for submitting materials to be tested, the paper outlines options available if a material fails testing. In addition, this treatise introduces the National Aeronautics and Space Administration's (NASA's) Materials and Processes Technical Information System (MAPTIS), a database housing all test data produced in accordance with NASA-STD-6001, Flammability, Odor, Offgassing, and Compatibility Requirements and Test Procedures for Materials in Environments that Support Combustion.

  19. Rational Clinical Experiment: Assessing Prior Probability and Its Impact on the Success of Phase II Clinical Trials

    PubMed Central

    Halperin, Daniel M.; Lee, J. Jack; Dagohoy, Cecile Gonzales; Yao, James C.

    2015-01-01

    Purpose Despite a robust clinical trial enterprise and encouraging phase II results, the vast minority of oncologic drugs in development receive regulatory approval. In addition, clinicians occasionally make therapeutic decisions based on phase II data. Therefore, clinicians, investigators, and regulatory agencies require improved understanding of the implications of positive phase II studies. We hypothesized that prior probability of eventual drug approval was significantly different across GI cancers, with substantial ramifications for the predictive value of phase II studies. Methods We conducted a systematic search of phase II studies conducted between 1999 and 2004 and compared studies against US Food and Drug Administration and National Cancer Institute databases of approved indications for drugs tested in those studies. Results In all, 317 phase II trials were identified and followed for a median of 12.5 years. Following completion of phase III studies, eventual new drug application approval rates varied from 0% (zero of 45) in pancreatic adenocarcinoma to 34.8% (24 of 69) for colon adenocarcinoma. The proportion of drugs eventually approved was correlated with the disease under study (P < .001). The median type I error for all published trials was 0.05, and the median type II error was 0.1, with minimal variation. By using the observed median type I error for each disease, phase II studies have positive predictive values ranging from less than 1% to 90%, depending on primary site of the cancer. Conclusion Phase II trials in different GI malignancies have distinct prior probabilities of drug approval, yielding quantitatively and qualitatively different predictive values with similar statistical designs. Incorporation of prior probability into trial design may allow for more effective design and interpretation of phase II studies. PMID:26261263

  20. Effects of Prior Aging at 191 C on Creep Response of IM7/BMI 5250-4

    DTIC Science & Technology

    2007-06-01

    EFFECTS OF PRIOR AGING AT 191°C ON CREEP RESPONSE OF IM7/BMI 5250-4 THESIS Robert A. Salvia...U.S. Government. AFIT/GAE/ENY/07-J23 EFFECTS OF PRIOR AGING AT 191°C ON CREEP RESPONSE OF IM7/BMI 5250-4 THESIS Presented to the...PRIOR AGING AT 191°C ON CREEP RESPONSE OF IM7/BMI 5250-4 Robert A. Salvia, BSAE LCDR, USN Approved

  1. 7 CFR 1717.603 - RUS approval of extensions and additions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... the acquisition or start of construction. (b) Power supply borrowers. Prior written approval by RUS is required for a power supply borrower to extend or add to its electric system if the extension or addition...

  2. Applying for ethical approval for research: the main issues.

    PubMed

    Gelling, Leslie

    2016-01-13

    The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

  3. 77 FR 24677 - Notice of Intent To Seek Approval to Revise and Extend a Currently Approved Information Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... (NASS) to request revision and extension of a currently approved information collection, the Egg...: Title: Egg, Chicken, and Turkey Surveys. OMB Number: 0535-0004. Expiration Date of Approval: October 31.... The Egg, Chicken, and Turkey Surveys obtain basic poultry statistics from voluntary cooperators...

  4. 77 FR 26474 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ...EPA proposes to approve State Implementation Plan (SIP) revisions submitted by the Maryland Department of the Environment (MDE). These revisions approve specific provisions of a 2011 Consent Decree between MDE and GenOn to reduce particulate matter (PM), sulfur oxides (SOX), and nitrogen oxides (NOX) from the GenOn Chalk Point generating station (Chalk Point). These revisions also remove the 1978 and 1979 Consent Orders for the Chalk Point generating station from the Maryland SIP as those Consent Orders have been superseded by the 2011 Consent Decree. In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

  5. New treatment options for metastatic renal cell carcinoma with prior anti-angiogenesis therapy.

    PubMed

    Zarrabi, Kevin; Fang, Chunhui; Wu, Shenhong

    2017-02-02

    Angiogenesis is a critical process in the progression of advanced renal cell carcinoma. Agents targeting angiogenesis have played a primary role in the treatment of metastatic renal cell carcinoma. However, resistance to anti-angiogenesis therapy almost always occurs, and major progress has been made in understanding its underlying molecular mechanism. Axitinib and everolimus have been used extensively in patients whom have had disease progression after prior anti-angiogenesis therapy. Recently, several new agents have been shown to improve overall survival in comparison with everolimus. This review provides an in-depth summary of drugs employable in the clinical setting, the rationale to their use, and the studies conducted leading to their approval for use and provides perspective on the paradigm shift in the treatment of renal cell carcinoma. Highlighted are the newly approved agents cabozantinib, nivolumab, and lenvatinib for advanced renal cell carcinoma patients treated with prior anti-angiogenesis therapy.

  6. 36 CFR 1228.12 - How do agencies obtain approval to loan permanent or unscheduled records?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Records Programs (NWM), 8601 Adelphi Road, College Park, MD 20740-6001, phone number (301) 837-1738... be submitted or approved by the individual authorized to sign records schedules as described in...

  7. 36 CFR 1228.12 - How do agencies obtain approval to loan permanent or unscheduled records?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Records Programs (NWM), 8601 Adelphi Road, College Park, MD 20740-6001, phone number (301) 837-1738... be submitted or approved by the individual authorized to sign records schedules as described in...

  8. Characteristics of rare disease marketing applications associated with FDA product approvals 2006-2010.

    PubMed

    Pariser, Anne R; Slack, Daniel J; Bauer, Larry J; Warner, Catherine A; Tracy, LaRee A

    2012-08-01

    New drug and biologic product marketing applications submitted to FDA's Center for Drug Evaluation and Research (CDER) between 2006 and 2010 were analyzed to identify rare disease application characteristics associated with higher approval rates. The results show that approval rates were similar for rare and common disease applications. Larger company size, prior regulatory experience and priority review designation were associated with higher approval rates. The study findings show that rare disease product development is feasible, and increased interactions between product developers and FDA in early investigational phases can facilitate product development. Published by Elsevier Ltd.

  9. 77 FR 47544 - Approval of Classification Societies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

    ...-AB35 Approval of Classification Societies AGENCY: Coast Guard, DHS. ACTION: Final rule. SUMMARY: Federal law requires that classification societies conducting certain work in the United States be... that classification societies must meet in order to obtain approval by the Coast Guard. Through this...

  10. 7 CFR 56.35 - Authority to use, and approval of official identification.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... review by the Food and Drug Administration prior to approval by the Department. (d) Refrigeration... indicate that refrigeration is required, e.g., “Keep Refrigerated,” or words of similar meaning. [40 FR...

  11. 7 CFR 56.35 - Authority to use, and approval of official identification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... review by the Food and Drug Administration prior to approval by the Department. (d) Refrigeration... indicate that refrigeration is required, e.g., “Keep Refrigerated,” or words of similar meaning. [40 FR...

  12. 48 CFR 237.170-2 - Approval requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...-2 Approval requirements. (a) Acquisition of services through a contract or task order that is not performance based. (1) For acquisitions at or below $85.5 million, obtain the approval of the official... the senior procurement executive. (b) Acquisition of services through use of a contract or task order...

  13. 7 CFR 1737.41 - Procedure for obtaining approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... RUS financing. (3) The proposed interim financing presents unacceptable loan security risks to RUS, or..., DEPARTMENT OF AGRICULTURE PRE-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND GUARANTEED TELECOMMUNICATIONS LOANS Interim Financing of Construction of Telephone Facilities § 1737.41 Procedure for obtaining...

  14. A drug's life: the pathway to drug approval.

    PubMed

    Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

    2013-10-01

    In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

  15. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... BE USED FOR SUCH CARRIAGE (ATP); INSPECTION, TESTING, AND CERTIFICATION OF SPECIAL EQUIPMENT Approval... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the ATP manager. The following information must be supplied in the application: (a) A statement that the...

  16. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... BE USED FOR SUCH CARRIAGE (ATP); INSPECTION, TESTING, AND CERTIFICATION OF SPECIAL EQUIPMENT Approval... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the ATP manager. The following information must be supplied in the application: (a) A statement that the...

  17. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... BE USED FOR SUCH CARRIAGE (ATP); INSPECTION, TESTING, AND CERTIFICATION OF SPECIAL EQUIPMENT Approval... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the ATP manager. The following information must be supplied in the application: (a) A statement that the...

  18. 75 FR 53371 - Liquefied Natural Gas Facilities: Obtaining Approval of Alternative Vapor-Gas Dispersion Models

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... factors as the approved models, are validated by experimental test data, and receive the Administrator's... stage of the MEP involves applying the model against a database of experimental test cases including..., particularly the requirement for validation by experimental test data. That guidance is based on the MEP's...

  19. 36 CFR § 1228.12 - How do agencies obtain approval to loan permanent or unscheduled records?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Records Programs (NWM), 8601 Adelphi Road, College Park, MD 20740-6001, phone number (301) 837-1738... be submitted or approved by the individual authorized to sign records schedules as described in...

  20. 40 CFR 35.925-18 - Limitation upon project costs incurred prior to award.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Limitation upon project costs incurred...-Clean Water Act § 35.925-18 Limitation upon project costs incurred prior to award. That project... project costs in the following cases: (1) Step 1 work begun after the date of approval by the Regional...

  1. 40 CFR 35.925-18 - Limitation upon project costs incurred prior to award.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Limitation upon project costs incurred...-Clean Water Act § 35.925-18 Limitation upon project costs incurred prior to award. That project... project costs in the following cases: (1) Step 1 work begun after the date of approval by the Regional...

  2. 40 CFR 35.925-18 - Limitation upon project costs incurred prior to award.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Limitation upon project costs incurred...-Clean Water Act § 35.925-18 Limitation upon project costs incurred prior to award. That project... project costs in the following cases: (1) Step 1 work begun after the date of approval by the Regional...

  3. 40 CFR 35.925-18 - Limitation upon project costs incurred prior to award.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Limitation upon project costs incurred...-Clean Water Act § 35.925-18 Limitation upon project costs incurred prior to award. That project... project costs in the following cases: (1) Step 1 work begun after the date of approval by the Regional...

  4. 40 CFR 35.925-18 - Limitation upon project costs incurred prior to award.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Limitation upon project costs incurred...-Clean Water Act § 35.925-18 Limitation upon project costs incurred prior to award. That project... project costs in the following cases: (1) Step 1 work begun after the date of approval by the Regional...

  5. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... and telephone number of the testing station, and name and title of person in charge of the station. (c... of Testing Stations § 3300.19 Application for approval. An application by an officer of the... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the...

  6. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... and telephone number of the testing station, and name and title of person in charge of the station. (c... of Testing Stations § 3300.19 Application for approval. An application by an officer of the... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the...

  7. 24 CFR 990.315 - Submission and approval of operating budgets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... operating budgets. 990.315 Section 990.315 Housing and Urban Development Regulations Relating to Housing and..., Monitoring, and Reporting § 990.315 Submission and approval of operating budgets. (a) Required documentation: (1) Prior to the beginning of its fiscal year, a PHA shall prepare an operating budget in a manner...

  8. FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.

    PubMed

    de Claro, R Angelo; McGinn, Karen M; Verdun, Nicole; Lee, Shwu-Luan; Chiu, Haw-Jyh; Saber, Haleh; Brower, Margaret E; Chang, C J George; Pfuma, Elimika; Habtemariam, Bahru; Bullock, Julie; Wang, Yun; Nie, Lei; Chen, Xiao-Hong; Lu, Donghao Robert; Al-Hakim, Ali; Kane, Robert C; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T; Pazdur, Richard

    2015-08-15

    On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (≥ 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea. ©2015 American Association for Cancer Research.

  9. [Local approval procedures act as a brake on RCTs].

    PubMed

    van der Stok, E P; Huiskens, J; Hemmes, B; Grünhagen, D J; van Gulik, T M; Verhoef, C; Punt, C J A

    2016-01-01

    Large multicentre randomised controlled trials (RCTs) in the Netherlands are increasingly being impeded by major differences between local approval procedures. However, no national agenda exists as yet to improve this situation. The existence of major local differences in processing time and documentation required has been reported previously but little is known about the costs incurred and whether or not specific certifications and research contracts are mandatory. The current study evaluated these aspects of local procedures for obtaining approval of two oncological multicentre RCTs. Retrospective, descriptive. All local procedures for obtaining approval of two randomised clinical trials were evaluated: the CAIRO5 and CHARISMA trials initiated by the Dutch Colorectal Cancer Group (DCCG). We objectified time between approval by the Medical Ethics Review Committee (METC) and final approval by the Board of Directors (RvB), the type and number of documents needed, and costs charged. The median time interval between the approval by the Medical Ethics Review Committee and the approval by the Board of Directors was 90 days (range 4-312). The number of documents required per centre ranged from 6-20. The costs charged ranged from € 0-€ 1750, and amounted to € 8575 for all procedures combined. No costs were charged by the majority of the centres. The approval procedures for multicentre clinical trials in the Netherlands demonstrate major differences. Processing times, documentation required and costs are unpredictable; greater uniformity is highly desirable in this context.

  10. Maximum entropy, fluctuations and priors

    NASA Astrophysics Data System (ADS)

    Caticha, A.

    2001-05-01

    The method of maximum entropy (ME) is extended to address the following problem: Once one accepts that the ME distribution is to be preferred over all others, the question is to what extent are distributions with lower entropy supposed to be ruled out. Two applications are given. The first is to the theory of thermodynamic fluctuations. The formulation is exact, covariant under changes of coordinates, and allows fluctuations of both the extensive and the conjugate intensive variables. The second application is to the construction of an objective prior for Bayesian inference. The prior obtained by following the ME method to its inevitable conclusion turns out to be a special case (α=1) of what are currently known under the name of entropic priors. .

  11. Self-prior strategy for organ reconstruction in fluorescence molecular tomography

    PubMed Central

    Zhou, Yuan; Chen, Maomao; Su, Han; Luo, Jianwen

    2017-01-01

    The purpose of this study is to propose a strategy for organ reconstruction in fluorescence molecular tomography (FMT) without prior information from other imaging modalities, and to overcome the high cost and ionizing radiation caused by the traditional structural prior strategy. The proposed strategy is designed as an iterative architecture to solve the inverse problem of FMT. In each iteration, a short time Fourier transform (STFT) based algorithm is used to extract the self-prior information in the space-frequency energy spectrum with the assumption that the regions with higher fluorescence concentration have larger energy intensity, then the cost function of the inverse problem is modified by the self-prior information, and lastly an iterative Laplacian regularization algorithm is conducted to solve the updated inverse problem and obtains the reconstruction results. Simulations and in vivo experiments on liver reconstruction are carried out to test the performance of the self-prior strategy on organ reconstruction. The organ reconstruction results obtained by the proposed self-prior strategy are closer to the ground truth than those obtained by the iterative Tikhonov regularization (ITKR) method (traditional non-prior strategy). Significant improvements are shown in the evaluation indexes of relative locational error (RLE), relative error (RE) and contrast-to-noise ratio (CNR). The self-prior strategy improves the organ reconstruction results compared with the non-prior strategy and also overcomes the shortcomings of the traditional structural prior strategy. Various applications such as metabolic imaging and pharmacokinetic study can be aided by this strategy. PMID:29082094

  12. Self-prior strategy for organ reconstruction in fluorescence molecular tomography.

    PubMed

    Zhou, Yuan; Chen, Maomao; Su, Han; Luo, Jianwen

    2017-10-01

    The purpose of this study is to propose a strategy for organ reconstruction in fluorescence molecular tomography (FMT) without prior information from other imaging modalities, and to overcome the high cost and ionizing radiation caused by the traditional structural prior strategy. The proposed strategy is designed as an iterative architecture to solve the inverse problem of FMT. In each iteration, a short time Fourier transform (STFT) based algorithm is used to extract the self-prior information in the space-frequency energy spectrum with the assumption that the regions with higher fluorescence concentration have larger energy intensity, then the cost function of the inverse problem is modified by the self-prior information, and lastly an iterative Laplacian regularization algorithm is conducted to solve the updated inverse problem and obtains the reconstruction results. Simulations and in vivo experiments on liver reconstruction are carried out to test the performance of the self-prior strategy on organ reconstruction. The organ reconstruction results obtained by the proposed self-prior strategy are closer to the ground truth than those obtained by the iterative Tikhonov regularization (ITKR) method (traditional non-prior strategy). Significant improvements are shown in the evaluation indexes of relative locational error (RLE), relative error (RE) and contrast-to-noise ratio (CNR). The self-prior strategy improves the organ reconstruction results compared with the non-prior strategy and also overcomes the shortcomings of the traditional structural prior strategy. Various applications such as metabolic imaging and pharmacokinetic study can be aided by this strategy.

  13. 75 FR 82535 - Limitation of Approval of Prevention of Significant Deterioration Provisions Concerning...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-30

    ...This action is another in a series of steps EPA is taking to implement the Prevention of Significant Deterioration (PSD) program for greenhouse gas (GHG)-emitting sources. EPA is finalizing its proposed rulemaking to narrow its previous approval of State Implementation Plan (SIP) PSD programs in 24 states that apply to GHG-emitting sources. Specifically, EPA is withdrawing its previous approval of those programs to the extent they apply PSD to GHG-emitting sources below the thresholds in the final Tailoring Rule, which EPA promulgated by Federal Register notice dated June 3, 2010. Having narrowed its prior approval, EPA asks that each affected state withdraw from EPA consideration the part of its SIP that is no longer approved. The states for whose SIPs EPA is narrowing approval are: Alabama, California, Colorado, Georgia, Indiana, Iowa, Louisiana, Maine, Maryland, Mississippi, Missouri, New Hampshire, New Mexico, North Carolina, Ohio, Oklahoma, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virginia, and Wisconsin.

  14. 44 CFR 350.10 - Public meeting in advance of FEMA approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... EMERGENCY PLANS AND PREPAREDNESS § 350.10 Public meeting in advance of FEMA approval. (a) During the FEMA Regional Office review of a State plan and prior to the submission by the Regional Administrator of the evaluation of the plan and exercise to the Deputy Administrator for the National Preparedness Directorate...

  15. Marketing approval for the lithotripter.

    PubMed

    Nightingale, S L; Young, F E

    1986-01-01

    In December 1984, the Food and Drug Administration (FDA) granted Dornier Systems (FRG) approval to market the external shock wave lithotripter (ESWL) in the USA. The Medical Device Amendments of the Food, Drug, and Cosmetic Act require that the FDA evaluate the safety and effectiveness of medical devices intended for commercial distribution in the U.S. Such evaluation includes basic scientific studies, animal testing, and investigational studies in human subjects, culminating in a judgment concerning acceptable risks in terms of anticipated benefits, and whether the device is effective for its intended use. Prior to human studies in West Germany, Dornier had evaluated the destruction of stones of varying composition, measured the rate and energy of stone destruction, and tested blood samples and lymphocyte cultures exposed to shock waves. In addition, studies in both rats and dogs had demonstrated the feasibility of the technique and evidence of safety. Such data are provided by manufacturers when applying for an investigational device exemption (IDE) from the FDA, which permits clinical studies in humans; such studies also require the approval of an Institutional Review Board. The FDA approved Dornier's IDE, allowing human investigational use of the ESWL in facilities in the U.S., conducted concurrently with similar studies in West Germany. Upon completion of clinical trials, data acquired in vitro, in laboratory animals, and in human investigations are submitted to the FDA for a premarked approval application (PMAA). The Agency was given 6 months to make a decision, taking into consideration the recommendation of an advisory panel of experts from outside the Agency who had reviewed the same data. In its evaluation of the ESWL for safety and effectiveness, the FDA considered the question of alternative practices and procedures to treat nephrolithiasis, including percutaneous nephrolithotomy and open surgical procedures, and the adverse effects of such procedures

  16. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

    PubMed

    DiMasi, Joseph A

    2013-06-01

    Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean

  17. 76 FR 32321 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Revision to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ...-day window allowed under the prior approved SIP. This SIP revision affects forty-two counties in... inspection stations in the forty-two non-I/M counties. The quality assurance program established a window...

  18. 77 FR 30885 - Clarification of Prior Interpretations of the Seat Belt and Seating Requirements for General...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... Aviation Flights AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Clarification of prior... seat usage conforms to the limitations contained in the approved portion of the Airplane Flight Manual... following. At the time of the impact, the Pilatus PC-12/45 airplane was operating as a personal flight under...

  19. 12 CFR 225.89 - How to request approval to engage in an activity that is complementary to a financial activity?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... activity that is complementary to a financial activity? 225.89 Section 225.89 Banks and Banking FEDERAL... CHANGE IN BANK CONTROL (REGULATION Y) Regulations Financial Holding Companies § 225.89 How to request approval to engage in an activity that is complementary to a financial activity? (a) Prior Board approval...

  20. 76 FR 48181 - Proposed Extension of the Approval of Information Collection Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ... employee during the prior week.'' This requirement is implemented by 29 CFR 3.3 and 3.4 and the standard... DEPARTMENT OF LABOR Wage and Hour Division Proposed Extension of the Approval of Information Collection Requirements AGENCY: Wage and Hour Division, Department of Labor. ACTION: Notice. SUMMARY: The...

  1. Effect of the Availability of Prior Full-Field Digital Mammography and Digital Breast Tomosynthesis Images on the Interpretation of Mammograms

    PubMed Central

    Catullo, Victor J.; Chough, Denise M.; Ganott, Marie A.; Kelly, Amy E.; Shinde, Dilip D.; Sumkin, Jules H.; Wallace, Luisa P.; Bandos, Andriy I.; Gur, David

    2015-01-01

    Purpose To assess the effect of and interaction between the availability of prior images and digital breast tomosynthesis (DBT) images in decisions to recall women during mammogram interpretation. Materials and Methods Verbal informed consent was obtained for this HIPAA-compliant institutional review board–approved protocol. Eight radiologists independently interpreted twice deidentified mammograms obtained in 153 women (age range, 37–83 years; mean age, 53.7 years ± 9.3 [standard deviation]) in a mode by reader by case-balanced fully crossed study. Each study consisted of current and prior full-field digital mammography (FFDM) images and DBT images that were acquired in our facility between June 2009 and January 2013. For one reading, sequential ratings were provided by using (a) current FFDM images only, (b) current FFDM and DBT images, and (c) current FFDM, DBT, and prior FFDM images. The other reading consisted of (a) current FFDM images only, (b) current and prior FFDM images, and (c) current FFDM, prior FFDM, and DBT images. Fifty verified cancer cases, 60 negative and benign cases (clinically not recalled), and 43 benign cases (clinically recalled) were included. Recall recommendations and interaction between the effect of prior FFDM and DBT images were assessed by using a generalized linear model accounting for case and reader variability. Results Average recall rates in noncancer cases were significantly reduced with the addition of prior FFDM images by 34% (145 of 421) and 32% (106 of 333) without and with DBT images, respectively (P < .001). However, this recall reduction was achieved at the cost of a corresponding 7% (23 of 345) and 4% (14 of 353) reduction in sensitivity (P = .006). In contrast, availability of DBT images resulted in a smaller reduction in recall rates (false-positive interpretations) of 19% (76 of 409) and 26% (71 of 276) without and with prior FFDM images, respectively (P = .001). Availability of DBT images resulted in 4% (15 of

  2. Form of prior for constrained thermodynamic processes with uncertainty

    NASA Astrophysics Data System (ADS)

    Aneja, Preety; Johal, Ramandeep S.

    2015-05-01

    We consider the quasi-static thermodynamic processes with constraints, but with additional uncertainty about the control parameters. Motivated by inductive reasoning, we assign prior distribution that provides a rational guess about likely values of the uncertain parameters. The priors are derived explicitly for both the entropy-conserving and the energy-conserving processes. The proposed form is useful when the constraint equation cannot be treated analytically. The inference is performed using spin-1/2 systems as models for heat reservoirs. Analytical results are derived in the high-temperatures limit. An agreement beyond linear response is found between the estimates of thermal quantities and their optimal values obtained from extremum principles. We also seek an intuitive interpretation for the prior and the estimated value of temperature obtained therefrom. We find that the prior over temperature becomes uniform over the quantity kept conserved in the process.

  3. 75 FR 20805 - Approval and Promulgation of Implementation Plans: Tennessee; Visibility Impairment Prevention...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2010-0150-201009(b); FRL-9138-8] Approval and Promulgation of Implementation Plans: Tennessee; Visibility Impairment Prevention for Federal... direct final rule without prior proposal because the Agency views this as a noncontroversial submittal...

  4. 33 CFR 66.01-30 - Corps of Engineers' approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 1 2014-07-01 2014-07-01 false Corps of Engineers' approval. 66... Corps of Engineers' approval. (a) Before any private aid to navigation consisting of a fixed structure... first be obtained from the District Engineer, U.S. Army Corps of Engineers in whose district the aid...

  5. 33 CFR 66.01-30 - Corps of Engineers' approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 1 2012-07-01 2012-07-01 false Corps of Engineers' approval. 66... Corps of Engineers' approval. (a) Before any private aid to navigation consisting of a fixed structure... first be obtained from the District Engineer, U.S. Army Corps of Engineers in whose district the aid...

  6. 33 CFR 66.01-30 - Corps of Engineers' approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 1 2013-07-01 2013-07-01 false Corps of Engineers' approval. 66... Corps of Engineers' approval. (a) Before any private aid to navigation consisting of a fixed structure... first be obtained from the District Engineer, U.S. Army Corps of Engineers in whose district the aid...

  7. 33 CFR 66.01-30 - Corps of Engineers' approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Corps of Engineers' approval. 66... Corps of Engineers' approval. (a) Before any private aid to navigation consisting of a fixed structure... first be obtained from the District Engineer, U.S. Army Corps of Engineers in whose district the aid...

  8. 33 CFR 66.01-30 - Corps of Engineers' approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false Corps of Engineers' approval. 66... Corps of Engineers' approval. (a) Before any private aid to navigation consisting of a fixed structure... first be obtained from the District Engineer, U.S. Army Corps of Engineers in whose district the aid...

  9. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... approval or disapproval of the machine. (a) If the qualified electrical representative recommends field..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or...

  10. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... approval or disapproval of the machine. (a) If the qualified electrical representative recommends field..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or...

  11. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  12. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  13. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  14. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  15. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  16. 76 FR 26616 - Wisconsin: Incorporation by Reference of Approved State Hazardous Waste Management Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-09

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 272 [FRL-9293-9 ] Wisconsin: Incorporation by... enforcement. This rule codifies in the regulations the prior approval of Wisconsin's hazardous waste... rule will not take effect. The incorporation by reference of authorized provisions in the Wisconsin...

  17. Responses to romidepsin in patients with cutaneous T-cell lymphoma and prior treatment with systemic chemotherapy.

    PubMed

    Duvic, Madeleine; Bates, Susan E; Piekarz, Richard; Eisch, Robin; Kim, Youn H; Lerner, Adam; Robak, Tadeusz; Samtsov, Alexey; Becker, Jürgen C; McCulloch, William; Waksman, Joel; Whittaker, Sean

    2018-04-01

    Cutaneous T-cell lymphomas (CTCL) are a group of non-Hodgkin lymphomas that typically present in the skin but can progress to systemic involvement. The optimal treatment for patients who relapse from or are refractory to systemic chemotherapy remains unclear. Romidepsin is a potent, class-I selective histone deacetylase inhibitor approved for the treatment of patients with CTCL who have had ≥1 prior systemic therapy. Here, we present a subanalysis of two phase-2 trials (NCT00106431, NCT00007345) of romidepsin in patients with CTCL who had prior treatment with systemic chemotherapy. Patients with prior chemotherapy were able to achieve durable responses to romidepsin, and response rates were similar to those in patients who were chemotherapy naïve. Overall, no new safety signals emerged in patients who had received prior chemotherapy. The data presented here suggest that romidepsin is safe and effective in patients with CTCL who received prior systemic chemotherapy.

  18. 21 CFR 316.23 - Timing of requests for orphan-drug designation; designation of already approved drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the time that sponsor submits a marketing application for the drug for the same rare disease or... use without regard to whether the prior marketing approval was for a rare disease or condition. [78 FR...

  19. Figure-ground segmentation based on class-independent shape priors

    NASA Astrophysics Data System (ADS)

    Li, Yang; Liu, Yang; Liu, Guojun; Guo, Maozu

    2018-01-01

    We propose a method to generate figure-ground segmentation by incorporating shape priors into the graph-cuts algorithm. Given an image, we first obtain a linear representation of an image and then apply directional chamfer matching to generate class-independent, nonparametric shape priors, which provide shape clues for the graph-cuts algorithm. We then enforce shape priors in a graph-cuts energy function to produce object segmentation. In contrast to previous segmentation methods, the proposed method shares shape knowledge for different semantic classes and does not require class-specific model training. Therefore, the approach obtains high-quality segmentation for objects. We experimentally validate that the proposed method outperforms previous approaches using the challenging PASCAL VOC 2010/2012 and Berkeley (BSD300) segmentation datasets.

  20. 14 CFR 21.339 - Special export airworthiness approval for aircraft.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... export airworthiness approval for an aircraft engine, propeller, or article is issued. (c) If the FAA... difference between the aircraft to be exported and its type design. § 21.331 Issuance of export airworthiness approvals for aircraft engines, propellers, and articles. (a) A person may obtain from the FAA an export...

  1. 77 FR 23598 - Technical Amendment to Cuba Airport List: Addition of Recently Approved Airports

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-20

    ...] Technical Amendment to Cuba Airport List: Addition of Recently Approved Airports AGENCY: Customs and Border... accept aircraft traveling to or from Cuba. DATES: Effective: April 20, 2012. FOR FURTHER INFORMATION... States to or from Cuba. Prior to January 2011, the regulations required direct flights between the United...

  2. 76 FR 78193 - Approval and Promulgation of Implementation Plans: Kentucky; Visibility Impairment Prevention for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-16

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2011-0867-201157(b); FRL-9507-2] Approval and Promulgation of Implementation Plans: Kentucky; Visibility Impairment Prevention for Federal... SIP revision as a direct final rule without prior proposal because the Agency views this as a...

  3. 29 CFR 5.16 - Training plans approved or recognized by the Department of Labor prior to August 20, 1975.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... payroll at a trainee rate who is not registered and participating in a program certified by ETA pursuant to this section, or approved and certified by ETA pursuant to § 5.5(a)(4)(ii), must be paid the wage...

  4. Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates.

    PubMed

    Berndt, Ernst R; Gottschalk, Adrian H B; Philipson, Tomas J; Strobeck, Matthew W

    2005-07-01

    The development of new therapies is a crucial component of efforts to improve healthcare. Because drug development and FDA regulatory review have historically been lengthy and costly processes, the US Congress passed a series of legislative acts, beginning in 1992, known collectively as the Prescription Drug User Fee Acts (PDUFA), which sought to expedite the FDA drug-review process. Here, we review data on drug approvals and drug-approval times, both as a whole and by therapeutic class, which demonstrate that implementation of the PDUFAs led to substantial incremental reductions in approval times beyond what would have been observed in the absence of these legislative acts. In addition, our preliminary examination of the trends in the number of new molecular entity withdrawals, frequently used as a proxy to assess the FDA's safety record, suggests that the proportion of approvals ultimately leading to safety withdrawals prior to PDUFA and during PDUFA I and II were not statistically different.

  5. Optimal Multiple Surface Segmentation With Shape and Context Priors

    PubMed Central

    Bai, Junjie; Garvin, Mona K.; Sonka, Milan; Buatti, John M.; Wu, Xiaodong

    2014-01-01

    Segmentation of multiple surfaces in medical images is a challenging problem, further complicated by the frequent presence of weak boundary evidence, large object deformations, and mutual influence between adjacent objects. This paper reports a novel approach to multi-object segmentation that incorporates both shape and context prior knowledge in a 3-D graph-theoretic framework to help overcome the stated challenges. We employ an arc-based graph representation to incorporate a wide spectrum of prior information through pair-wise energy terms. In particular, a shape-prior term is used to penalize local shape changes and a context-prior term is used to penalize local surface-distance changes from a model of the expected shape and surface distances, respectively. The globally optimal solution for multiple surfaces is obtained by computing a maximum flow in a low-order polynomial time. The proposed method was validated on intraretinal layer segmentation of optical coherence tomography images and demonstrated statistically significant improvement of segmentation accuracy compared to our earlier graph-search method that was not utilizing shape and context priors. The mean unsigned surface positioning errors obtained by the conventional graph-search approach (6.30 ± 1.58 μm) was improved to 5.14 ± 0.99 μm when employing our new method with shape and context priors. PMID:23193309

  6. Supplements and other changes to an approved application. Final rule.

    PubMed

    2004-04-08

    The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.

  7. Prior-based artifact correction (PBAC) in computed tomography

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Heußer, Thorsten, E-mail: thorsten.heusser@dkfz-heidelberg.de; Brehm, Marcus; Ritschl, Ludwig

    2014-02-15

    Purpose: Image quality in computed tomography (CT) often suffers from artifacts which may reduce the diagnostic value of the image. In many cases, these artifacts result from missing or corrupt regions in the projection data, e.g., in the case of metal, truncation, and limited angle artifacts. The authors propose a generalized correction method for different kinds of artifacts resulting from missing or corrupt data by making use of available prior knowledge to perform data completion. Methods: The proposed prior-based artifact correction (PBAC) method requires prior knowledge in form of a planning CT of the same patient or in form ofmore » a CT scan of a different patient showing the same body region. In both cases, the prior image is registered to the patient image using a deformable transformation. The registered prior is forward projected and data completion of the patient projections is performed using smooth sinogram inpainting. The obtained projection data are used to reconstruct the corrected image. Results: The authors investigate metal and truncation artifacts in patient data sets acquired with a clinical CT and limited angle artifacts in an anthropomorphic head phantom data set acquired with a gantry-based flat detector CT device. In all cases, the corrected images obtained by PBAC are nearly artifact-free. Compared to conventional correction methods, PBAC achieves better artifact suppression while preserving the patient-specific anatomy at the same time. Further, the authors show that prominent anatomical details in the prior image seem to have only minor impact on the correction result. Conclusions: The results show that PBAC has the potential to effectively correct for metal, truncation, and limited angle artifacts if adequate prior data are available. Since the proposed method makes use of a generalized algorithm, PBAC may also be applicable to other artifacts resulting from missing or corrupt data.« less

  8. Association of Prior Authorization and Out-of-pocket Costs With Patient Access to PCSK9 Inhibitor Therapy.

    PubMed

    Navar, Ann Marie; Taylor, Benjamin; Mulder, Hillary; Fievitz, Eugene; Monda, Keri L; Fievitz, Anna; Maya, Juan F; López, J Antonio G; Peterson, Eric D

    2017-11-01

    Although PCSK9 inhibitors (PCSK9i) were approved in 2015, their high cost has led to strict prior authorization practices and high copays, and use of PSCK9i in clinical practice has been low. To evaluate patient access to PCSK9i among those prescribed therapy. Using pharmacy transaction data, we evaluated 45 029 patients who were newly prescribed PCSK9i in the United States between August 1, 2015, and July 31, 2016. The proportion of PCSK9i prescriptions approved and abandoned (approved but unfilled); multivariable analyses examined factors associated with approval/abandonment including payor, prescriber specialty, pharmacy benefit manager, out-of-pocket cost (copay), clinical diagnoses, lipid-lowering medication use, and low-density lipoprotein cholesterol levels. Of patients given an incident PCSK9i prescription, 51.2% were women, 56.6% were 65 years or older, and 52.5% had governmental insurance. Of the patients given a prescription, 20.8% received approval on the first day, and 47.2% ever received approval. Of those approved, 65.3% filled the prescription, resulting in 30.9% of those prescribed PCSK9i ever receiving therapy. After adjustment, patients who were older, male, and had atherosclerotic cardiovascular disease were more likely to be approved, but approval rates did not vary by patient low-density lipoprotein cholesterol level nor statin use. Other factors associated with drug approval included having government vs commercial insurance (odds ratio [OR], 3.3; 95% CI, 2.8-3.8), and those filled at a specialty vs retail pharmacy (OR, 1.96; 95% CI, 1.66-2.33). Approval rates varied nearly 3-fold among the top 10 largest pharmacy benefit managers. Prescription abandonment by patients was most associated with copay costs (C statistic, 0.86); with abandonment rates ranging from 7.5% for those with $0 copay to more than 75% for copays greater than $350. In the first year of availability, only half of patients prescribed a PCSK9i received approval, and one

  9. Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

    PubMed Central

    Sumathipala, Athula; Siribaddana, Sisira; Hewege, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

    2008-01-01

    Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. PMID:18267015

  10. 42 CFR 84.30 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

  11. 42 CFR 84.30 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

  12. 42 CFR 84.30 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

  13. 42 CFR 84.30 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

  14. 42 CFR 84.30 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

  15. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  16. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  17. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  18. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  19. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  20. Problematic protocols: An overview of medical research protocols not approved by the LUMC medical ethics review committee.

    PubMed

    Tersmette, Derek Gideon; Engberts, Dirk Peter

    2017-01-01

    The Committee for Medical Ethics (CME) of Leiden University Medical Center (LUMC) was established as the first medical ethics reviewing committee (MREC) in the Netherlands. In the period 2000-2010 the CME received 2,162 protocols for review. Some of these protocols were never approved. Until now, there has existed neither an overview of these failed protocols nor an overview of the reasons for their failure. This report draws on data from the digital database, the physical archives, and the minutes of the meetings of the CME. Additional information has been obtained from the Central Committee on Research involving Human Subjects (CCRH) and survey-based research. Protocols were itemized based on characteristic features and their reviewing procedures were analyzed. In total, 1,952 out of 2,162 research protocols submitted during 2000-2010 (90.3%) were approved by the CME; 210 of 2,162 protocols (9.7%) were not approved. Of these 210 protocols, 177 failed due to reasons not related to CME reviewing. In 15 cases CME reviewing led to protocol failure, while another 10 protocols were rejected outright. Eight of the 210 submitted protocols without approval had been conducted prior to submission. In the aforementioned period, little protocol failure occurred. For the most part, protocol failure was caused by problems that are not CME related. This type of failure has several identifiable factors, none of which have anything to do with the ethical reviewing procedure by the CME. A mere 1.2% of protocols failed due to ethical review. Unacceptable burden and risks to the subject and an inadequate methodology are the most common reasons for this CME-related protocol failure.

  1. TSO C-129 approvals and anticipated approvals

    DOT National Transportation Integrated Search

    2001-01-01

    This document contains a table of the approvals and anticipated approvals of TSO-C129a equipment (the technical standard order (TSO) for Airborne Supplemental Navigation Equipment Using the Global Positioning System (GPS)). This TSO prescribes the mi...

  2. Impact of Alternative Medical Device Approval Processes on Costs and Health

    PubMed Central

    George, Benjamin P.; Venkataraman, Vinayak; Dorsey, E. Ray

    2014-01-01

    Background Medical devices are often introduced prior to randomized‐trial evidence of efficacy and this slows completion of trials. Alternative regulatory approaches include restricting device use outside of trials prior to trial evidence of efficacy (like the drug approval process) or restricting out‐of‐trial use but permitting coverage within trials such as Medicare's Coverage with Study Participation (CSP). Methods We compared the financial impact to manufacturers and insurers of three regulatory alternatives: (1) limited regulation (current approach), (2) CSP, and (3) restrictive regulation (like the current drug approval process). Using data for patent foramen ovale closure devices, we modeled key parameters including recruitment time, probability of device efficacy, market adoption, and device cost/price to calculate profits to manufacturers, costs to insurers, and overall societal impact on health. Results For manufacturers, profits were greatest under CSP—driven by faster market adoption of effective devices—followed by restrictive regulation. Societal health benefit in total quality‐adjusted life years was greatest under CSP. Insurers’ expenditures for ineffective devices were greatest with limited regulation. Findings were robust over a reasonable range of probabilities of trial success. Conclusions Regulation restricting out‐of‐trial device use and extending limited insurance coverage to clinical trial participants may balance manufacturer and societal interests. PMID:25185975

  3. [Reporting ethics board approval in German medical theses and journals].

    PubMed

    Zenz, Michael; Zenz, Julia; Grieger, Maximilian

    2018-06-05

    Since 1975, the Declaration of Helsinki of the World Medical Association (WMA) has clearly required ethics committee approval for research into humans. Nevertheless, this Declaration is violated quite often. As many English-language publications have addressed the theme of ethics board approval in theses and other published works, it is now to be investigated in Germany for the first time.From 2013 to 2014, a total of 1,482 medical theses at four selected universities in addition to three German-language scientific journals were reviewed. In 543 theses, reference to ethics approval would have been required according to the criteria of the Declaration of Helsinki.However, ethics approval was stated in only 58.7% of cases, and even less frequently if the prevailing doctoral regulations or instructions did not refer to the necessity of obtaining ethics approval. Theses on pediatrics mentioned ethics approval most frequently (78.6%), whereas the proportion of surgical papers was the lowest (34.9%). Among the journals, Der Nervenarzt mentioned ethics approval most frequently (59.4%) and Der Chirurg least frequently (30%).Our results point to significant deficits in mentioning ethics approval in medical theses and publications. These deficits could easily be compensated for by a thorough approach of the referees of doctoral regulations and by journal reviewers and editors.

  4. 22 CFR 123.9 - Country of ultimate destination and approval of reexports or retransfers.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the amount of $25,000,000 ($25 million) or more; the articles are not defense articles or defense services sold under a contract in the amount of $100,000,000 ($100 million) or more; and are not identified... Australia, Japan, New Zealand, or South Korea, are authorized without the prior written approval of the...

  5. 15 CFR 272.3 - Approved markings.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... approved by the Secretary of Commerce: (a) A blaze orange (Fed-Std-595B 12199) or orange color brighter... from the muzzle end of the barrel. (b) A blaze orange (Fed-Std-595B 12199) or orange color brighter..., December 1989, color number 12199 (Fed-Std-595B 12199), may be obtained from the General Services...

  6. 32 CFR 32.25 - Revision of budget and program plans.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... program plan revisions, in accordance with this section. (c) For nonconstruction awards, recipients shall..., recipients need not obtain prior approvals before: (i) Incurring pre-award costs 90 calendar days prior to... approval of the DoD Component). All pre-award costs are incurred at the recipient's risk (i.e., the DoD...

  7. 32 CFR 32.25 - Revision of budget and program plans.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... program plan revisions, in accordance with this section. (c) For nonconstruction awards, recipients shall..., recipients need not obtain prior approvals before: (i) Incurring pre-award costs 90 calendar days prior to... approval of the DoD Component). All pre-award costs are incurred at the recipient's risk (i.e., the DoD...

  8. 32 CFR 32.25 - Revision of budget and program plans.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... program plan revisions, in accordance with this section. (c) For nonconstruction awards, recipients shall..., recipients need not obtain prior approvals before: (i) Incurring pre-award costs 90 calendar days prior to... approval of the DoD Component). All pre-award costs are incurred at the recipient's risk (i.e., the DoD...

  9. 32 CFR 32.25 - Revision of budget and program plans.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... program plan revisions, in accordance with this section. (c) For nonconstruction awards, recipients shall..., recipients need not obtain prior approvals before: (i) Incurring pre-award costs 90 calendar days prior to... approval of the DoD Component). All pre-award costs are incurred at the recipient's risk (i.e., the DoD...

  10. 32 CFR 32.25 - Revision of budget and program plans.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... program plan revisions, in accordance with this section. (c) For nonconstruction awards, recipients shall..., recipients need not obtain prior approvals before: (i) Incurring pre-award costs 90 calendar days prior to... approval of the DoD Component). All pre-award costs are incurred at the recipient's risk (i.e., the DoD...

  11. 40 CFR 35.935-13 - Submission and approval of user charge systems.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... approval of the Regional Administrator of its system of user charges. (See also § 35.929 et seq.) (a) Step... paragraph (a)(2) of this section provides, the grantee must obtain the Regional Administrator's approval of its system of user charges based on actual use which complies with § 35.929-1(a). The Regional...

  12. Effects of social approval bias on self-reported fruit and vegetable consumption: a randomized controlled trial.

    PubMed

    Miller, Tracy M; Abdel-Maksoud, Madiha F; Crane, Lori A; Marcus, Al C; Byers, Tim E

    2008-06-27

    Self-reports of dietary intake in the context of nutrition intervention research can be biased by the tendency of respondents to answer consistent with expected norms (social approval bias). The objective of this study was to assess the potential influence of social approval bias on self-reports of fruit and vegetable intake obtained using both food frequency questionnaire (FFQ) and 24-hour recall methods. A randomized blinded trial compared reported fruit and vegetable intake among subjects exposed to a potentially biasing prompt to that from control subjects. Subjects included 163 women residing in Colorado between 35 and 65 years of age who were randomly selected and recruited by telephone to complete what they were told would be a future telephone survey about health. Randomly half of the subjects then received a letter prior to the interview describing this as a study of fruit and vegetable intake. The letter included a brief statement of the benefits of fruits and vegetables, a 5-A-Day sticker, and a 5-a-Day refrigerator magnet. The remainder received the same letter, but describing the study purpose only as a more general nutrition survey, with neither the fruit and vegetable message nor the 5-A-Day materials. Subjects were then interviewed on the telephone within 10 days following the letters using an eight-item FFQ and a limited 24-hour recall to estimate fruit and vegetable intake. All interviewers were blinded to the treatment condition. By the FFQ method, subjects who viewed the potentially biasing prompts reported consuming more fruits and vegetables than did control subjects (5.2 vs. 3.7 servings per day, p < 0.001). By the 24-hour recall method, 61% of the intervention group but only 32% of the control reported eating fruits and vegetables on 3 or more occasions the prior day (p = 0.002). These associations were independent of age, race/ethnicity, education level, self-perceived health status, and time since last medical check-up. Self-reports of

  13. Medicaid Prior Authorization Policies for Medication Treatment of Attention-Deficit/Hyperactivity Disorder in Young Children, United States, 2015.

    PubMed

    Hulkower, Rachel L; Kelley, Meghan; Cloud, Lindsay K; Visser, Susanna N

    In 2011, the American Academy of Pediatrics updated its guidelines for the diagnosis and treatment of children with attention-deficit/hyperactivity disorder (ADHD) to recommend that clinicians refer parents of preschoolers (aged 4-5) for training in behavior therapy and subsequently treat with medication if behavior therapy fails to sufficiently improve functioning. Data available from just before the release of the guidelines suggest that fewer than half of preschoolers with ADHD received behavior therapy and about half received medication. About half of those who received medication also received behavior therapy. Prior authorization policies for ADHD medication may guide physicians toward recommended behavior therapy. Characterizing existing prior authorization policies is an important step toward evaluating the impact of these policies on treatment patterns. We inventoried existing prior authorization policies and characterized policy components to inform future evaluation efforts. A 50-state legal assessment characterized ADHD prior authorization policies in state Medicaid programs. We designed a database to capture data on policy characteristics and authorization criteria, including data on age restrictions and fail-first behavior therapy requirements. In 2015, 27 states had Medicaid policies that prevented approval of pediatric ADHD medication payment without additional provider involvement. Seven states required that prescribers indicate whether nonmedication treatments were considered before Medicaid payment for ADHD medication could be approved. Medicaid policies on ADHD medication treatment are diverse; some policies are tied to the diagnosis and treatment guidelines of the American Academy of Pediatrics. Evaluations are needed to determine if certain policy interventions guide families toward the use of behavior therapy as the first-line ADHD treatment for young children.

  14. 30 CFR 28.20 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Certificates of approval; scope of approval. 28.20 Section 28.20 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT...

  15. Criteria for Operational Approval of Auto Guidance Systems

    DOT National Transportation Integrated Search

    1997-03-18

    This advisory circular (AC) states an acceptable means, but not the only means, : for obtaining operational approval of the initial engagement or use of an Auto : Flight Guidance System (AFGS) under Title 14 of the Code of Federal Regulations : (14 C...

  16. 30 CFR 746.14 - Approval, disapproval or conditional approval, of mining plan.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., of mining plan. 746.14 Section 746.14 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR FEDERAL LANDS PROGRAM REVIEW AND APPROVAL OF MINING PLANS § 746.14 Approval, disapproval or conditional approval, of mining plan. The Secretary shall approve, disapprove or...

  17. Uncertainty about effects is a key factor influencing institutional review boards' approval of clinical studies.

    PubMed

    Wao, Hesborn; Mhaskar, Rahul; Kumar, Ambuj; Miladinovic, Branko; Guterbock, Thomas; Hozo, Iztok; Djulbegovic, Benjamin

    2014-10-01

    To investigate factors, which influence institutional review boards' (IRBs') decision to approve or not approve clinical studies, a nationwide vignette-based online survey of IRB members was conducted. A factorial design was used, whereby seven aspects of each hypothetical study were randomly varied in 15 phrases in each vignette to produce unique vignettes. Participants indicated the degree of study approval and described factors influencing approval decision. Qualitative responses were thematically content analyzed. Sixteen themes were obtained from 208 participants from 42 institutions. Uncertainty, adherence, study design, and harms were frequently and intensely cited to influence study approval. Analysis of two extreme subgroups (approvers vs. nonapprovers) showed that uncertainty influenced approval decisions, odds ratios (OR) = 3.5 (95% confidence interval [CI], 1.3-9.8) and OR = 3.2 (95% CI, 1.1-8.9), respectively, based on theme frequency and theme intensity, ignoring multiple observations per person. Taking into consideration multiple observations per person, similar results were obtained for uncertainty: OR = 8.9 (95% CI, 0.93-85.4). Perceived uncertainty about benefits and harms of a proposed intervention is a key driver in IRB members' approval of clinical trials. This, in turn, calls for improved standardization in the communications of information on benefits and harms in the research protocols considered by the IRBs. Published by Elsevier Inc.

  18. Target-similarity search using Plasmodium falciparum proteome identifies approved drugs with anti-malarial activity and their possible targets

    PubMed Central

    Akala, Hoseah M.; Macharia, Rosaline W.; Juma, Dennis W.; Cheruiyot, Agnes C.; Andagalu, Ben; Brown, Mathew L.; El-Shemy, Hany A.; Nyanjom, Steven G.

    2017-01-01

    Malaria causes about half a million deaths annually, with Plasmodium falciparum being responsible for 90% of all the cases. Recent reports on artemisinin resistance in Southeast Asia warrant urgent discovery of novel drugs for the treatment of malaria. However, most bioactive compounds fail to progress to treatments due to safety concerns. Drug repositioning offers an alternative strategy where drugs that have already been approved as safe for other diseases could be used to treat malaria. This study screened approved drugs for antimalarial activity using an in silico chemogenomics approach prior to in vitro verification. All the P. falciparum proteins sequences available in NCBI RefSeq were mined and used to perform a similarity search against DrugBank, TTD and STITCH databases to identify similar putative drug targets. Druggability indices of the potential P. falciparum drug targets were obtained from TDR targets database. Functional amino acid residues of the drug targets were determined using ConSurf server which was used to fine tune the similarity search. This study predicted 133 approved drugs that could target 34 P. falciparum proteins. A literature search done at PubMed and Google Scholar showed 105 out of the 133 drugs to have been previously tested against malaria, with most showing activity. For further validation, drug susceptibility assays using SYBR Green I method were done on a representative group of 10 predicted drugs, eight of which did show activity against P. falciparum 3D7 clone. Seven had IC50 values ranging from 1 μM to 50 μM. This study also suggests drug-target association and hence possible mechanisms of action of drugs that did show antiplasmodial activity. The study results validate the use of proteome-wide target similarity approach in identifying approved drugs with activity against P. falciparum and could be adapted for other pathogens. PMID:29088219

  19. 7 CFR 1710.105 - State regulatory approvals.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... (3) Loans for the purpose of assisting borrowers to implement demand side management and energy conservation programs and on and off grid renewable energy systems. (b) At minimum, in the case of all loans in... to obtain approval of a project or its financing from a state regulatory authority, RUS may require...

  20. 7 CFR 1710.105 - State regulatory approvals.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... (3) Loans for the purpose of assisting borrowers to implement demand side management and energy conservation programs and on and off grid renewable energy systems. (b) At minimum, in the case of all loans in... to obtain approval of a project or its financing from a state regulatory authority, RUS may require...

  1. 7 CFR 1710.105 - State regulatory approvals.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... (3) Loans for the purpose of assisting borrowers to implement demand side management and energy conservation programs and on and off grid renewable energy systems. (b) At minimum, in the case of all loans in... to obtain approval of a project or its financing from a state regulatory authority, RUS may require...

  2. 7 CFR 1710.105 - State regulatory approvals.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... (3) Loans for the purpose of assisting borrowers to implement demand side management and energy conservation programs and on and off grid renewable energy systems. (b) At minimum, in the case of all loans in... to obtain approval of a project or its financing from a state regulatory authority, RUS may require...

  3. 13 CFR 107.420 - Prohibition on exercise of ownership or Control rights in Licensee before SBA approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Prohibition on exercise of... Prohibition on exercise of ownership or Control rights in Licensee before SBA approval. Without prior written... to the proposed new owner(s); (b) Permit the proposed new owner(s) to exercise voting rights with...

  4. 13 CFR 107.420 - Prohibition on exercise of ownership or Control rights in Licensee before SBA approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Prohibition on exercise of... Prohibition on exercise of ownership or Control rights in Licensee before SBA approval. Without prior written... to the proposed new owner(s); (b) Permit the proposed new owner(s) to exercise voting rights with...

  5. 13 CFR 107.420 - Prohibition on exercise of ownership or Control rights in Licensee before SBA approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Prohibition on exercise of... Prohibition on exercise of ownership or Control rights in Licensee before SBA approval. Without prior written... to the proposed new owner(s); (b) Permit the proposed new owner(s) to exercise voting rights with...

  6. 13 CFR 107.420 - Prohibition on exercise of ownership or Control rights in Licensee before SBA approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false Prohibition on exercise of... Prohibition on exercise of ownership or Control rights in Licensee before SBA approval. Without prior written... to the proposed new owner(s); (b) Permit the proposed new owner(s) to exercise voting rights with...

  7. 38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... approvals of community residential care facilities. 17.65 Section 17.65 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Community Residential Care § 17.65 Approvals and provisional approvals of community residential care facilities. (a) An approval of a facility meeting all of...

  8. 24 CFR 576.41 - Reallocation; lack of approved consolidated plan-formula cities and counties.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... consolidated plan-formula cities and counties. 576.41 Section 576.41 Housing and Urban Development Regulations... approved consolidated plan—formula cities and counties. (a) Applicability. This section applies where a formula city or county fails to submit or obtain HUD approval of its consolidated plan within 90 days of...

  9. 24 CFR 576.41 - Reallocation; lack of approved consolidated plan-formula cities and counties.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... consolidated plan-formula cities and counties. 576.41 Section 576.41 Housing and Urban Development Regulations... approved consolidated plan—formula cities and counties. (a) Applicability. This section applies where a formula city or county fails to submit or obtain HUD approval of its consolidated plan within 90 days of...

  10. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2012-10-01 2012-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

  11. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2011-10-01 2011-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

  12. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2013-10-01 2013-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

  13. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2010-10-01 2010-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

  14. Partner approval and intention to use contraception among Zanzibari women presenting for post-abortion care.

    PubMed

    Esber, Allahna; Foraker, Randi E; Hemed, Maryam; Norris, Alison

    2014-07-01

    We examined the effect of partner approval of contraception on intention to use contraception among women obtaining post-abortion care in Zanzibar. Our data source was a 2010 survey of 193 women obtaining post-abortion care at a large public hospital in Zanzibar. We used multivariable logistic regression analysis to assess associations between partner approval and intention to use contraception. Overall, 23% of participants had used a contraceptive method in the past, and 66% reported intending to use contraception in the future. We found that partner approval of contraception and ever having used contraception in the past were each associated with intending to use contraception in the future. In the multivariable model, adjusting for past contraception use, partner approval of contraception was associated with 20 times the odds of intending to use contraception (odds ratio, 20.25; 95% confidence interval, 8.45-48.56). We found a strong association between partner approval and intention to use contraception. Efforts to support contraceptive use must include both male and female partners. Public health and educational efforts to increase contraceptive use must include men and be targeted to both male and female partners. Given that male partners are often not present when women obtain health care, creative efforts will be required to meet men in community settings. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. External Prior Guided Internal Prior Learning for Real-World Noisy Image Denoising

    NASA Astrophysics Data System (ADS)

    Xu, Jun; Zhang, Lei; Zhang, David

    2018-06-01

    Most of existing image denoising methods learn image priors from either external data or the noisy image itself to remove noise. However, priors learned from external data may not be adaptive to the image to be denoised, while priors learned from the given noisy image may not be accurate due to the interference of corrupted noise. Meanwhile, the noise in real-world noisy images is very complex, which is hard to be described by simple distributions such as Gaussian distribution, making real noisy image denoising a very challenging problem. We propose to exploit the information in both external data and the given noisy image, and develop an external prior guided internal prior learning method for real noisy image denoising. We first learn external priors from an independent set of clean natural images. With the aid of learned external priors, we then learn internal priors from the given noisy image to refine the prior model. The external and internal priors are formulated as a set of orthogonal dictionaries to efficiently reconstruct the desired image. Extensive experiments are performed on several real noisy image datasets. The proposed method demonstrates highly competitive denoising performance, outperforming state-of-the-art denoising methods including those designed for real noisy images.

  16. 77 FR 44485 - Approval and Promulgation of Implementation Plans; Florida; Sections 128 and 110(a)(1) and (2...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-30

    ...): Interstate transport.\\3\\ \\3\\ Today's final rule does not address element 110(a)(2)(D)(i) (Interstate Transport) for the 1997 8-hour ozone NAAQS. Interstate transport requirements were formerly addressed by... 896 (D.C. Cir. 2008). Prior to this remand, EPA took final action to approve Florida's SIP revision...

  17. 19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115... 19 Customs Duties 1 2011-04-01 2011-04-01 false Certificate of approval for containers approved...

  18. 19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115... 19 Customs Duties 1 2010-04-01 2010-04-01 false Certificate of approval for containers approved...

  19. 19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115... 19 Customs Duties 1 2012-04-01 2012-04-01 false Certificate of approval for containers approved...

  20. 19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115... 19 Customs Duties 1 2014-04-01 2014-04-01 false Certificate of approval for containers approved...

  1. 19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115... 19 Customs Duties 1 2013-04-01 2013-04-01 false Certificate of approval for containers approved...

  2. 78 FR 17282 - Agency Information Collection Activities; Approval of a Currently Approved Information Collection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

    ... Research and Information Technology and Chief Information Officer. [FR Doc. 2013-06361 Filed 3-19-13; 8:45...-0379] Agency Information Collection Activities; Approval of a Currently Approved Information Collection... March 1, 2013, concerning request for comments on the approval of a currently approved information...

  3. Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000-2015.

    PubMed

    Vivot, A; Jacot, J; Zeitoun, J-D; Ravaud, P; Crequit, P; Porcher, R

    2017-05-01

    Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical benefit of new drugs for treating advanced solid tumors at the time of their approval by the US Food and Drug Administration (FDA) and to search for a relation between price and clinical benefit of drugs. We included all new molecular entities and new biologics for treating advanced solid cancer that were approved by the FDA between 2000 and 2015. The clinical benefit of drugs was graded based on FDA medical review of pivotal clinical trials using the 2016-updated of the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Characteristics of drugs and approvals were obtained from publicly available FDA documents and price was evaluated according to US Medicare, US Veterans Health Administration and United Kingdom market systems. The FDA approved 51 new drugs for advanced solid cancer from 2000 to 2015; we could evaluate the value of 37 drugs (73%). By the ESMO-MCBS, five drugs (14%) were grade one (the lowest), nine (24%) grade two, 10 (27%) grade three, 11 (30%) grade four and two (5%) grade five (the highest). Thus, 13 drugs (35%) showed a meaningful clinical benefit (scale levels 4 and 5). By the ASCO-VF which had a range of 3.4-67, the median drug value was 37 (interquartile range 20-52). We found no relationship between clinical benefit and drug price (P = 0.9). No characteristic of drugs and of approval was significantly associated with clinical benefit. Many recently FDA-approved new cancer drugs did not have high clinical benefit as measured by current scales. We found no relation between the price of drugs and benefit to society and patients. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. 42 CFR 433.114 - Procedures for obtaining initial approval; notice of decision.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Mechanized Claims Processing and Information Retrieval Systems § 433.114 Procedures for obtaining initial... the system, the notice will include all of the following information: (1) The findings of fact upon...

  5. 42 CFR 433.114 - Procedures for obtaining initial approval; notice of decision.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Mechanized Claims Processing and Information Retrieval Systems § 433.114 Procedures for obtaining initial... the system, the notice will include all of the following information: (1) The findings of fact upon...

  6. 42 CFR 433.114 - Procedures for obtaining initial approval; notice of decision.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Mechanized Claims Processing and Information Retrieval Systems § 433.114 Procedures for obtaining initial... the system, the notice will include all of the following information: (1) The findings of fact upon...

  7. 42 CFR 433.114 - Procedures for obtaining initial approval; notice of decision.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Mechanized Claims Processing and Information Retrieval Systems § 433.114 Procedures for obtaining initial... the system, the notice will include all of the following information: (1) The findings of fact upon...

  8. Selected aspects of prior and likelihood information for a Bayesian classifier in a road safety analysis.

    PubMed

    Nowakowska, Marzena

    2017-04-01

    The development of the Bayesian logistic regression model classifying the road accident severity is discussed. The already exploited informative priors (method of moments, maximum likelihood estimation, and two-stage Bayesian updating), along with the original idea of a Boot prior proposal, are investigated when no expert opinion has been available. In addition, two possible approaches to updating the priors, in the form of unbalanced and balanced training data sets, are presented. The obtained logistic Bayesian models are assessed on the basis of a deviance information criterion (DIC), highest probability density (HPD) intervals, and coefficients of variation estimated for the model parameters. The verification of the model accuracy has been based on sensitivity, specificity and the harmonic mean of sensitivity and specificity, all calculated from a test data set. The models obtained from the balanced training data set have a better classification quality than the ones obtained from the unbalanced training data set. The two-stage Bayesian updating prior model and the Boot prior model, both identified with the use of the balanced training data set, outperform the non-informative, method of moments, and maximum likelihood estimation prior models. It is important to note that one should be careful when interpreting the parameters since different priors can lead to different models. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. Newly approved antibiotics and antibiotics reserved for resistant infections: Implications for emergency medicine.

    PubMed

    Mazer-Amirshahi, Maryann; Pourmand, Ali; May, Larissa

    2017-01-01

    Millions of patients are evaluated every year in the emergency department (ED) for bacterial infections. Emergency physicians often diagnose and prescribe initial antibiotic therapy for a variety of bacterial infections, ranging from simple urinary tract infections to severe sepsis. In life-threatening infections, inappropriate choice of initial antibiotic has been shown to increase morbidity and mortality. As such, initiation of appropriate antibiotic therapy on the part of the emergency physician is critical. Increasing rates of antibiotic resistance, drug allergies, and antibiotic shortages further complicates the choice of antibiotics. Patients may have a history of prior resistant infections or culture data indicating that common first-line antibiotics used in the ED may be ineffective. In recent years, there have been several new antibiotic approvals as well as renewed interest in second and third line antibiotics because of the aforementioned concerns. In addition, several newly approved antibiotics have the advantage of being administered once weekly or even as a single infusion, which has the potential to decrease hospitalizations and healthcare costs. This article reviews newly approved antibiotics and antibiotics used to treat resistant infections with a focus on implications for emergency medicine. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Bayesian bivariate meta-analysis of diagnostic test studies with interpretable priors.

    PubMed

    Guo, Jingyi; Riebler, Andrea; Rue, Håvard

    2017-08-30

    In a bivariate meta-analysis, the number of diagnostic studies involved is often very low so that frequentist methods may result in problems. Using Bayesian inference is particularly attractive as informative priors that add a small amount of information can stabilise the analysis without overwhelming the data. However, Bayesian analysis is often computationally demanding and the selection of the prior for the covariance matrix of the bivariate structure is crucial with little data. The integrated nested Laplace approximations method provides an efficient solution to the computational issues by avoiding any sampling, but the important question of priors remain. We explore the penalised complexity (PC) prior framework for specifying informative priors for the variance parameters and the correlation parameter. PC priors facilitate model interpretation and hyperparameter specification as expert knowledge can be incorporated intuitively. We conduct a simulation study to compare the properties and behaviour of differently defined PC priors to currently used priors in the field. The simulation study shows that the PC prior seems beneficial for the variance parameters. The use of PC priors for the correlation parameter results in more precise estimates when specified in a sensible neighbourhood around the truth. To investigate the usage of PC priors in practice, we reanalyse a meta-analysis using the telomerase marker for the diagnosis of bladder cancer and compare the results with those obtained by other commonly used modelling approaches. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  11. 7 CFR 2500.049 - Prior approvals.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... detailed budget for the subcontract must be submitted to the ADO. (b) No-cost extensions of time—(1... being requested; and signature of the AOR and the PD. (3) Requests for no-cost extensions of time after...

  12. 7 CFR 2500.049 - Prior approvals.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... detailed budget for the subcontract must be submitted to the ADO. (b) No-cost extensions of time—(1... being requested; and signature of the AOR and the PD. (3) Requests for no-cost extensions of time after...

  13. 7 CFR 2500.049 - Prior approvals.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... detailed budget for the subcontract must be submitted to the ADO. (b) No-cost extensions of time—(1... being requested; and signature of the AOR and the PD. (3) Requests for no-cost extensions of time after...

  14. 7 CFR 3430.58 - Prior approvals.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... (b) No-cost extensions of time—(1) General. Awardees may initiate a one-time no-cost extension of the... for which the extension is being requested; and signature of the AR and the PD. (3) Requests for no...

  15. 7 CFR 3430.58 - Prior approvals.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... must be submitted to the ADO. (b) No-cost extensions of time—(1) General. Awardees may initiate a one...; and signature of the AR and the PD. (3) Requests for no-cost extensions of time after expiration date...

  16. 7 CFR 3430.58 - Prior approvals.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... (b) No-cost extensions of time—(1) General. Awardees may initiate a one-time no-cost extension of the... portion(s) of the project for which the extension is being requested; and signature of the AR and the PD...

  17. 7 CFR 3430.58 - Prior approvals.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... (b) No-cost extensions of time—(1) General. Awardees may initiate a one-time no-cost extension of the... for which the extension is being requested; and signature of the AR and the PD. (3) Requests for no...

  18. 7 CFR 3430.58 - Prior approvals.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... (b) No-cost extensions of time—(1) General. Awardees may initiate a one-time no-cost extension of the... for which the extension is being requested; and signature of the AR and the PD. (3) Requests for no...

  19. 7 CFR 1944.415 - Grant approval and other approving authorities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., DEPARTMENT OF AGRICULTURE (CONTINUED) PROGRAM REGULATIONS (CONTINUED) HOUSING Self-Help Technical Assistance... 7 Agriculture 13 2010-01-01 2009-01-01 true Grant approval and other approving authorities. 1944.415 Section 1944.415 Agriculture Regulations of the Department of Agriculture (Continued) RURAL...

  20. 78 FR 66826 - Prior Label Approval System: Generic Label Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... container of a misleading form or size.\\1\\ FSIS has interpreted these provisions as requiring that the...-evaluating-labeling . Labels submitted as an extraordinary circumstance are given the highest priority for... submissions to FSIS headquarters, thus increasing the availability of FSIS labeling staff. Upon publication of...

  1. 76 FR 75809 - Prior Label Approval System: Generic Label Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

    ... tracking and reporting systems; and (4) design and implement a survey of the effects of the limited generic... and poultry product inspection programs designed to assure consumers that meat and poultry products... mandatory features are designed to ensure that meat and poultry products are accurately and truthfully...

  2. 10 CFR 1016.8 - Approval for processing access permittees for security facility approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Approval for processing access permittees for security facility approval. 1016.8 Section 1016.8 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) SAFEGUARDING OF RESTRICTED DATA Physical Security § 1016.8 Approval for processing access permittees for security facility...

  3. 10 CFR 1016.8 - Approval for processing access permittees for security facility approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Approval for processing access permittees for security facility approval. 1016.8 Section 1016.8 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) SAFEGUARDING OF RESTRICTED DATA Physical Security § 1016.8 Approval for processing access permittees for security facility...

  4. Punishments: What Predicts Adult Approval.

    ERIC Educational Resources Information Center

    Buntain-Ricklefs, Joanne J.; And Others

    1994-01-01

    A survey of 449 parents found that 24% experienced uncommon punishments (such as burning) during their childhoods and 6% approved; 45% experienced and 17% approved of common punishments (shaking); and 94% experienced and 88% approved of very common punishments (spanking). Approval of each punishment was related to experience. Race, income, and…

  5. Redfield Energy Approval

    EPA Pesticide Factsheets

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-This October 27, 2016 letter from EPA approves the petition from Redfield Energy, LLC, regarding non-grandfathered ethanol produced

  6. Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

    PubMed

    Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

    2017-01-01

    The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P < .001). Radiologic devices are largely approved by multireader, multicenter studies, the recommended standard for assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  7. 12 CFR 1253.8 - Availability of new product to an Enterprise after it has been approved for the other Enterprise.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Availability of new product to an Enterprise... HOUSING FINANCE AGENCY ENTERPRISES PRIOR APPROVAL FOR ENTERPRISE PRODUCTS § 1253.8 Availability of new... a new product for one Enterprise or the new product is otherwise available to that Enterprise under...

  8. Comparing hard and soft prior bounds in geophysical inverse problems

    NASA Technical Reports Server (NTRS)

    Backus, George E.

    1988-01-01

    In linear inversion of a finite-dimensional data vector y to estimate a finite-dimensional prediction vector z, prior information about X sub E is essential if y is to supply useful limits for z. The one exception occurs when all the prediction functionals are linear combinations of the data functionals. Two forms of prior information are compared: a soft bound on X sub E is a probability distribution p sub x on X which describes the observer's opinion about where X sub E is likely to be in X; a hard bound on X sub E is an inequality Q sub x(X sub E, X sub E) is equal to or less than 1, where Q sub x is a positive definite quadratic form on X. A hard bound Q sub x can be softened to many different probability distributions p sub x, but all these p sub x's carry much new information about X sub E which is absent from Q sub x, and some information which contradicts Q sub x. Both stochastic inversion (SI) and Bayesian inference (BI) estimate z from y and a soft prior bound p sub x. If that probability distribution was obtained by softening a hard prior bound Q sub x, rather than by objective statistical inference independent of y, then p sub x contains so much unsupported new information absent from Q sub x that conclusions about z obtained with SI or BI would seen to be suspect.

  9. Comparing hard and soft prior bounds in geophysical inverse problems

    NASA Technical Reports Server (NTRS)

    Backus, George E.

    1987-01-01

    In linear inversion of a finite-dimensional data vector y to estimate a finite-dimensional prediction vector z, prior information about X sub E is essential if y is to supply useful limits for z. The one exception occurs when all the prediction functionals are linear combinations of the data functionals. Two forms of prior information are compared: a soft bound on X sub E is a probability distribution p sub x on X which describeds the observer's opinion about where X sub E is likely to be in X; a hard bound on X sub E is an inequality Q sub x(X sub E, X sub E) is equal to or less than 1, where Q sub x is a positive definite quadratic form on X. A hard bound Q sub x can be softened to many different probability distributions p sub x, but all these p sub x's carry much new information about X sub E which is absent from Q sub x, and some information which contradicts Q sub x. Both stochastic inversion (SI) and Bayesian inference (BI) estimate z from y and a soft prior bound p sub x. If that probability distribution was obtained by softening a hard prior bound Q sub x, rather than by objective statistical inference independent of y, then p sub x contains so much unsupported new information absent from Q sub x that conclusions about z obtained with SI or BI would seen to be suspect.

  10. Addressing potential prior-data conflict when using informative priors in proof-of-concept studies.

    PubMed

    Mutsvari, Timothy; Tytgat, Dominique; Walley, Rosalind

    2016-01-01

    Bayesian methods are increasingly used in proof-of-concept studies. An important benefit of these methods is the potential to use informative priors, thereby reducing sample size. This is particularly relevant for treatment arms where there is a substantial amount of historical information such as placebo and active comparators. One issue with using an informative prior is the possibility of a mismatch between the informative prior and the observed data, referred to as prior-data conflict. We focus on two methods for dealing with this: a testing approach and a mixture prior approach. The testing approach assesses prior-data conflict by comparing the observed data to the prior predictive distribution and resorting to a non-informative prior if prior-data conflict is declared. The mixture prior approach uses a prior with a precise and diffuse component. We assess these approaches for the normal case via simulation and show they have some attractive features as compared with the standard one-component informative prior. For example, when the discrepancy between the prior and the data is sufficiently marked, and intuitively, one feels less certain about the results, both the testing and mixture approaches typically yield wider posterior-credible intervals than when there is no discrepancy. In contrast, when there is no discrepancy, the results of these approaches are typically similar to the standard approach. Whilst for any specific study, the operating characteristics of any selected approach should be assessed and agreed at the design stage; we believe these two approaches are each worthy of consideration. Copyright © 2015 John Wiley & Sons, Ltd.

  11. Institutional Review Board approval and innovation in urology: current practice and safety issues.

    PubMed

    Sundaram, Varun; Vemana, Goutham; Bhayani, Sam B

    2014-02-01

    To retrospectively review recent publications describing novel procedures/techniques, and describe the Institutional Review Board (IRB)/ethics approval process and potential ethical dilemmas in their reporting. We searched PubMed for papers about innovative or novel procedures/techniques between 2011 and August 2012. A query of titles/abstracts in the Journal of Urology, Journal of Endourology, European Urology, BJU International, and Urology identified relevant papers. These results were reviewed for human studies that described an innovative technique, procedure, approach, initial series, and/or used new technology. In all, 91 papers met criteria for inclusion; 25 from the Journal of Endourology, 14 from the Journal of Urology, nine from European Urology, 15 from the BJU International and 28 from Urology. IRB/ethics approval was given for an experimental procedure or database in 24% and 22%, respectively. IRB/ethics approval was not mentioned in 52.7% of studies. Published IRB/ethics approvals for innovative techniques are heterogeneous including database, retrospective, and prospective approvals. Given the concept that innovations are likely not in the legal or ethical standard of care, strong consideration should be given to obtaining IRB/ethics approval before the actual procedure, instead of approval to merely report database outcomes. © 2013 The Authors. BJU International © 2013 BJU International.

  12. National Term and Condition for Light Refreshments and Meals

    EPA Pesticide Factsheets

    Unless the event(s) are specified in the approved workplan, the recipient agrees to obtain prior approval from EPA for the use of grant funds for light refreshments and/or meals served at meetings, conferences, training workshops, and outreach activities.

  13. 38 CFR 21.292 - Course approvals.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Course approvals. 21.292... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only those courses approved by the Department of Veterans Affairs shall be utilized to provide training and...

  14. 38 CFR 21.292 - Course approvals.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Course approvals. 21.292... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only those courses approved by the Department of Veterans Affairs shall be utilized to provide training and...

  15. 38 CFR 21.292 - Course approvals.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Course approvals. 21.292... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only those courses approved by the Department of Veterans Affairs shall be utilized to provide training and...

  16. 38 CFR 21.292 - Course approvals.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Course approvals. 21.292... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only those courses approved by the Department of Veterans Affairs shall be utilized to provide training and...

  17. 38 CFR 21.292 - Course approvals.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Course approvals. 21.292... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only those courses approved by the Department of Veterans Affairs shall be utilized to provide training and...

  18. 78 FR 65030 - Agency Requests for Renewal of a Previously Approved Information Collection(s): Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ... Previously Approved Information Collection(s): Approval of Underwriters of Marine Hull Insurance AGENCY...: Approval of Underwriters of Marine Hull Insurance. Form Numbers: None. Type of Review: Renewal of an... approval of marine hull underwriters to insure Maritime Administration program vessels. Foreign and...

  19. Incorporation of prior information on parameters into nonlinear regression groundwater flow models: 1. Theory

    USGS Publications Warehouse

    Cooley, Richard L.

    1982-01-01

    Prior information on the parameters of a groundwater flow model can be used to improve parameter estimates obtained from nonlinear regression solution of a modeling problem. Two scales of prior information can be available: (1) prior information having known reliability (that is, bias and random error structure) and (2) prior information consisting of best available estimates of unknown reliability. A regression method that incorporates the second scale of prior information assumes the prior information to be fixed for any particular analysis to produce improved, although biased, parameter estimates. Approximate optimization of two auxiliary parameters of the formulation is used to help minimize the bias, which is almost always much smaller than that resulting from standard ridge regression. It is shown that if both scales of prior information are available, then a combined regression analysis may be made.

  20. Drugs Approved for Brain Tumors

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Brain Tumors This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Brain Tumors Afinitor (Everolimus) Afinitor Disperz (Everolimus) Avastin (Bevacizumab) ...

  1. 38 CFR 21.7720 - Course approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Course approval. 21.7720... of Courses § 21.7720 Course approval. (a) Courses must be approved. (1) A course of education offered...)(iii), and (c)(2)(iv) apply. (3) A course approved under 38 U.S.C. chapter 36 is approved for purposes...

  2. 38 CFR 21.7720 - Course approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Course approval. 21.7720... of Courses § 21.7720 Course approval. (a) Courses must be approved. (1) A course of education offered...)(iii), and (c)(2)(iv) apply. (3) A course approved under 38 U.S.C. chapter 36 is approved for purposes...

  3. 38 CFR 21.7720 - Course approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Course approval. 21.7720... of Courses § 21.7720 Course approval. (a) Courses must be approved. (1) A course of education offered...)(iii), and (c)(2)(iv) apply. (3) A course approved under 38 U.S.C. chapter 36 is approved for purposes...

  4. 38 CFR 21.7720 - Course approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Course approval. 21.7720... of Courses § 21.7720 Course approval. (a) Courses must be approved. (1) A course of education offered...)(iii), and (c)(2)(iv) apply. (3) A course approved under 38 U.S.C. chapter 36 is approved for purposes...

  5. 18 CFR 806.31 - Term of approvals.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... approval issued under this part shall be no longer than 15 years or the anticipated life of the project... AND APPROVAL OF PROJECTS Terms and Conditions of Approval § 806.31 Term of approvals. (a) Approvals... approval of a project shall expire three years from the date of such approval if the withdrawal, diversion...

  6. 75 FR 8425 - Agency Information Collection Activity Seeking OMB Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ... Transportation (AST) conducts this survey in order to obtain industry input on customer service standards which have been developed and distributed to industry customers. DATES: Please submit comments by March 26... Customer Service Survey. Type of Request: Extension without change of a currently approved collection. OMB...

  7. A Method for Constructing Informative Priors for Bayesian Modeling of Occupational Hygiene Data.

    PubMed

    Quick, Harrison; Huynh, Tran; Ramachandran, Gurumurthy

    2017-01-01

    In many occupational hygiene settings, the demand for more accurate, more precise results is at odds with limited resources. To combat this, practitioners have begun using Bayesian methods to incorporate prior information into their statistical models in order to obtain more refined inference from their data. This is not without risk, however, as incorporating prior information that disagrees with the information contained in data can lead to spurious conclusions, particularly if the prior is too informative. In this article, we propose a method for constructing informative prior distributions for normal and lognormal data that are intuitive to specify and robust to bias. To demonstrate the use of these priors, we walk practitioners through a step-by-step implementation of our priors using an illustrative example. We then conclude with recommendations for general use. © The Author 2017. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

  8. 23 CFR 710.503 - Protective buying and hardship acquisition.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... hardship acquisition. (a) General conditions. Prior to the STD obtaining final environmental approval, the STD may request FHWA agreement to provide reimbursement for advance acquisition of a particular parcel... the currently approved STIP; (2) The STD has complied with applicable public involvement requirements...

  9. 23 CFR 710.503 - Protective buying and hardship acquisition.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... hardship acquisition. (a) General conditions. Prior to the STD obtaining final environmental approval, the STD may request FHWA agreement to provide reimbursement for advance acquisition of a particular parcel... the currently approved STIP; (2) The STD has complied with applicable public involvement requirements...

  10. 23 CFR 710.503 - Protective buying and hardship acquisition.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... hardship acquisition. (a) General conditions. Prior to the STD obtaining final environmental approval, the STD may request FHWA agreement to provide reimbursement for advance acquisition of a particular parcel... the currently approved STIP; (2) The STD has complied with applicable public involvement requirements...

  11. 7 CFR 4284.19 - Programmatic changes.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) RURAL BUSINESS-COOPERATIVE SERVICE AND RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE GRANTS General Requirements for Cooperative Services... the scope or objectives of the approved project. Failure to obtain prior approval of changes to the...

  12. 7 CFR 1425.7 - Suspension and termination of approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... ASSOCIATIONS § 1425.7 Suspension and termination of approval. (a) CCC may suspend a CMA from obtaining loans and LDP's when CCC determines the CMA has not: (1) Operated according to the CMA's application for... deficiencies of the CMA's operation as noted by CCC; or (4) Violated any of its agreements with CCC. (b) A...

  13. 7 CFR 1425.7 - Suspension and termination of approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... ASSOCIATIONS § 1425.7 Suspension and termination of approval. (a) CCC may suspend a CMA from obtaining loans and LDP's when CCC determines the CMA has not: (1) Operated according to the CMA's application for... deficiencies of the CMA's operation as noted by CCC; or (4) Violated any of its agreements with CCC. (b) A...

  14. 7 CFR 1425.7 - Suspension and termination of approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... ASSOCIATIONS § 1425.7 Suspension and termination of approval. (a) CCC may suspend a CMA from obtaining loans and LDP's when CCC determines the CMA has not: (1) Operated according to the CMA's application for... deficiencies of the CMA's operation as noted by CCC; or (4) Violated any of its agreements with CCC. (b) A...

  15. 7 CFR 1425.7 - Suspension and termination of approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... ASSOCIATIONS § 1425.7 Suspension and termination of approval. (a) CCC may suspend a CMA from obtaining loans and LDP's when CCC determines the CMA has not: (1) Operated according to the CMA's application for... deficiencies of the CMA's operation as noted by CCC; or (4) Violated any of its agreements with CCC. (b) A...

  16. 7 CFR 1425.7 - Suspension and termination of approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... ASSOCIATIONS § 1425.7 Suspension and termination of approval. (a) CCC may suspend a CMA from obtaining loans and LDP's when CCC determines the CMA has not: (1) Operated according to the CMA's application for... deficiencies of the CMA's operation as noted by CCC; or (4) Violated any of its agreements with CCC. (b) A...

  17. 12 CFR 723.11 - How do you obtain a waiver?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... BUSINESS LOANS § 723.11 How do you obtain a waiver? To obtain a waiver, a federal credit union must submit... business lending policy; (b) The higher limit sought (if applicable); (c) An explanation of the need to... (e) An analysis of the credit union's prior experience making member business loans, including as a...

  18. Testing Small Variance Priors Using Prior-Posterior Predictive p Values.

    PubMed

    Hoijtink, Herbert; van de Schoot, Rens

    2017-04-03

    Muthén and Asparouhov (2012) propose to evaluate model fit in structural equation models based on approximate (using small variance priors) instead of exact equality of (combinations of) parameters to zero. This is an important development that adequately addresses Cohen's (1994) The Earth is Round (p < .05), which stresses that point null-hypotheses are so precise that small and irrelevant differences from the null-hypothesis may lead to their rejection. It is tempting to evaluate small variance priors using readily available approaches like the posterior predictive p value and the DIC. However, as will be shown, both are not suited for the evaluation of models based on small variance priors. In this article, a well behaving alternative, the prior-posterior predictive p value, will be introduced. It will be shown that it is consistent, the distributions under the null and alternative hypotheses will be elaborated, and it will be applied to testing whether the difference between 2 means and the size of a correlation are relevantly different from zero. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  19. Identification of subsurface structures using electromagnetic data and shape priors

    NASA Astrophysics Data System (ADS)

    Tveit, Svenn; Bakr, Shaaban A.; Lien, Martha; Mannseth, Trond

    2015-03-01

    We consider the inverse problem of identifying large-scale subsurface structures using the controlled source electromagnetic method. To identify structures in the subsurface where the contrast in electric conductivity can be small, regularization is needed to bias the solution towards preserving structural information. We propose to combine two approaches for regularization of the inverse problem. In the first approach we utilize a model-based, reduced, composite representation of the electric conductivity that is highly flexible, even for a moderate number of degrees of freedom. With a low number of parameters, the inverse problem is efficiently solved using a standard, second-order gradient-based optimization algorithm. Further regularization is obtained using structural prior information, available, e.g., from interpreted seismic data. The reduced conductivity representation is suitable for incorporation of structural prior information. Such prior information cannot, however, be accurately modeled with a gaussian distribution. To alleviate this, we incorporate the structural information using shape priors. The shape prior technique requires the choice of kernel function, which is application dependent. We argue for using the conditionally positive definite kernel which is shown to have computational advantages over the commonly applied gaussian kernel for our problem. Numerical experiments on various test cases show that the methodology is able to identify fairly complex subsurface electric conductivity distributions while preserving structural prior information during the inversion.

  20. 49 CFR 451.1 - Application for approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

  1. 49 CFR 451.1 - Application for approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

  2. 49 CFR 451.1 - Application for approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

  3. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box. ...

  4. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box. ...

  5. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box. ...

  6. 14 CFR 141.53 - Approval procedures for a training course: General.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... TRANSPORTATION (CONTINUED) SCHOOLS AND OTHER CERTIFICATED AGENCIES PILOT SCHOOLS Training Course Outline and... school certificate or provisional pilot school certificate must obtain the Administrator's approval of... duplicate to the FAA Flight Standards District Office having jurisdiction over the area where the school is...

  7. 14 CFR 141.53 - Approval procedures for a training course: General.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... TRANSPORTATION (CONTINUED) SCHOOLS AND OTHER CERTIFICATED AGENCIES PILOT SCHOOLS Training Course Outline and... school certificate or provisional pilot school certificate must obtain the Administrator's approval of... duplicate to the FAA Flight Standards District Office having jurisdiction over the area where the school is...

  8. 14 CFR 141.53 - Approval procedures for a training course: General.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... TRANSPORTATION (CONTINUED) SCHOOLS AND OTHER CERTIFICATED AGENCIES PILOT SCHOOLS Training Course Outline and... school certificate or provisional pilot school certificate must obtain the Administrator's approval of... duplicate to the FAA Flight Standards District Office having jurisdiction over the area where the school is...

  9. 75 FR 8406 - Aerial Lifts; Extension of the Office of Management and Budget's (OMB) Approval of an Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ...] Aerial Lifts; Extension of the Office of Management and Budget's (OMB) Approval of an Information... extend OMB approval of the information collection requirement contained in the Aerial Lift Standard. Employers who modify an aerial lift for uses other than those provided by the manufacturer must obtain a...

  10. Digital mammography. Why hasn't it been approved for U.S. hospitals?

    PubMed

    2000-01-01

    Mammography is the only major imaging technique still unavailable in the United States in digital form. This is because the Food and Drug Administration (FDA) has been unable to devise an effective method for manufacturers to demonstrate the safety and efficacy of digital mammography systems. As a result, the agency has been unable to approve any of those systems for marketing in the United States. In this Regulatory Update, we describe FDA's recent efforts to help manufacturers obtain approval and the reasons those efforts have so far proved ineffective.

  11. 46 CFR 356.39 - Charters.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... REGISTERED LENGTH TO OBTAIN A FISHERY ENDORSEMENT TO THE VESSEL'S DOCUMENTATION Charters, Management... bareboat charterer of Fishing Industry Vessel must submit an Affidavit of U.S. Citizenship to the Citizenship Approval Officer for review and approval prior to entering into such charter. (2) Time charters...

  12. 46 CFR 356.39 - Charters.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... REGISTERED LENGTH TO OBTAIN A FISHERY ENDORSEMENT TO THE VESSEL'S DOCUMENTATION Charters, Management... bareboat charterer of Fishing Industry Vessel must submit an Affidavit of U.S. Citizenship to the Citizenship Approval Officer for review and approval prior to entering into such charter. (2) Time charters...

  13. Improving Bayesian credibility intervals for classifier error rates using maximum entropy empirical priors.

    PubMed

    Gustafsson, Mats G; Wallman, Mikael; Wickenberg Bolin, Ulrika; Göransson, Hanna; Fryknäs, M; Andersson, Claes R; Isaksson, Anders

    2010-06-01

    Successful use of classifiers that learn to make decisions from a set of patient examples require robust methods for performance estimation. Recently many promising approaches for determination of an upper bound for the error rate of a single classifier have been reported but the Bayesian credibility interval (CI) obtained from a conventional holdout test still delivers one of the tightest bounds. The conventional Bayesian CI becomes unacceptably large in real world applications where the test set sizes are less than a few hundred. The source of this problem is that fact that the CI is determined exclusively by the result on the test examples. In other words, there is no information at all provided by the uniform prior density distribution employed which reflects complete lack of prior knowledge about the unknown error rate. Therefore, the aim of the study reported here was to study a maximum entropy (ME) based approach to improved prior knowledge and Bayesian CIs, demonstrating its relevance for biomedical research and clinical practice. It is demonstrated how a refined non-uniform prior density distribution can be obtained by means of the ME principle using empirical results from a few designs and tests using non-overlapping sets of examples. Experimental results show that ME based priors improve the CIs when employed to four quite different simulated and two real world data sets. An empirically derived ME prior seems promising for improving the Bayesian CI for the unknown error rate of a designed classifier. Copyright 2010 Elsevier B.V. All rights reserved.

  14. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

  15. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

  16. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

  17. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

  18. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

  19. 28 CFR 2.41 - Travel approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval. 2.41 Section 2.41..., YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.41 Travel approval. (a) The probation officer may approve travel outside the district without approval of the...

  20. 40 CFR 52.1522 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Hampshire § 52.1522 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves New Hampshire's plan as... Federal approval of State issued new source review permits pursuant to section 173 of the Clean Air Act...

  1. 40 CFR 52.1522 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Hampshire § 52.1522 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves New Hampshire's plan as... Federal approval of State issued new source review permits pursuant to section 173 of the Clean Air Act...

  2. 40 CFR 52.1522 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Hampshire § 52.1522 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves New Hampshire's plan as... Federal approval of State issued new source review permits pursuant to section 173 of the Clean Air Act...

  3. 40 CFR 52.1522 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Hampshire § 52.1522 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves New Hampshire's plan as... Federal approval of State issued new source review permits pursuant to section 173 of the Clean Air Act...

  4. Effect of Prior Exposure at Elevated Temperatures on Tensile Properties and Stress-Strain Behavior of Three Oxide/Oxide Ceramic Matrix Composites

    DTIC Science & Technology

    2015-03-26

    OF THREE OXIDE/OXIDE CERAMIC MATRIX COMPOSITES THESIS Christopher J. Hull, Captain, USAF AFIT- ENY -MS-15-M-228 DEPARTMENT OF THE AIR FORCE...Government and is not subject to copyright protection in the United States. AFIT- ENY -MS-15-M-228 EFFECT OF PRIOR EXPOSURE AT ELEVATED TEMPERATURES ON...BS Captain, USAF March 2015 DISTRIBUTION STATEMENT A: APPROVED FOR PUBLIC RELEASE; DISTRIBUTION UNLIMITED AFIT- ENY - MS-15-M-228 EFFECT OF

  5. 46 CFR 11.302 - Course approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 1 2013-10-01 2013-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

  6. 46 CFR 11.302 - Course approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 1 2011-10-01 2011-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

  7. 46 CFR 11.302 - Course approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

  8. 46 CFR 11.302 - Course approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 1 2012-10-01 2012-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

  9. The influence of prior knowledge on the retrieval-directed function of note taking in prior knowledge activation.

    PubMed

    Wetzels, Sandra A J; Kester, Liesbeth; van Merriënboer, Jeroen J G; Broers, Nick J

    2011-06-01

    Prior knowledge activation facilitates learning. Note taking during prior knowledge activation (i.e., note taking directed at retrieving information from memory) might facilitate the activation process by enabling learners to build an external representation of their prior knowledge. However, taking notes might be less effective in supporting prior knowledge activation if available prior knowledge is limited. This study investigates the effects of the retrieval-directed function of note taking depending on learners' level of prior knowledge. It is hypothesized that the effectiveness of note taking is influenced by the amount of prior knowledge learners already possess. Sixty-one high school students participated in this study. A prior knowledge test was used to ascertain differences in level of prior knowledge and assign participants to a low or a high prior knowledge group. A 2×2 factorial design was used to investigate the effects of note taking during prior knowledge activation (yes, no) depending on learners' level of prior knowledge (low, high) on mental effort, performance, and mental efficiency. Note taking during prior knowledge activation lowered mental effort and increased mental efficiency for high prior knowledge learners. For low prior knowledge learners, note taking had the opposite effect on mental effort and mental efficiency. The effects of the retrieval-directed function of note taking are influenced by learners' level of prior knowledge. Learners with high prior knowledge benefit from taking notes while activating prior knowledge, whereas note taking has no beneficial effects for learners with limited prior knowledge. ©2010 The British Psychological Society.

  10. 38 CFR 21.7220 - Course approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Course approval. 21.7220... Bill-Active Duty) Approval of Courses § 21.7220 Course approval. (a) Courses must be approved. (1) A course of education, including the class schedules of a resident course not leading to a standard college...

  11. 38 CFR 21.7220 - Course approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Course approval. 21.7220... Bill-Active Duty) Approval of Courses § 21.7220 Course approval. (a) Courses must be approved. (1) A course of education, including the class schedules of a resident course not leading to a standard college...

  12. 38 CFR 21.7220 - Course approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Course approval. 21.7220... Bill-Active Duty) Approval of Courses § 21.7220 Course approval. (a) Courses must be approved. (1) A course of education, including the class schedules of a resident course not leading to a standard college...

  13. 38 CFR 21.7220 - Course approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Course approval. 21.7220... Bill-Active Duty) Approval of Courses § 21.7220 Course approval. (a) Courses must be approved. (1) A course of education, including the class schedules of a resident course not leading to a standard college...

  14. 9 CFR 147.52 - Approved tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In addition...

  15. 9 CFR 147.52 - Approved tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In addition...

  16. Atezolizumab: First Global Approval.

    PubMed

    Markham, Anthony

    2016-08-01

    Atezolizumab (Tecentriq™)-a monoclonal antibody targeting programmed death ligand 1 (PD-L1 or CD274 antigen)-is being developed by Genentech as treatment for a variety of haematological malignancies and solid tumours. It been approved in the US as a second-line therapy for urothelial carcinoma and is awaiting approval as a second-line therapy for non-small cell lung cancer. This article summarizes the milestones in the development of atezolizumab leading to this first approval for urothelial carcinoma.

  17. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

    PubMed

    Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

    The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data

  18. 34 CFR 674.16 - Making and disbursing loans.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... financial assistance amounts during an academic year and needs additional funds in a particular payment... withdrawn. (g) An institutional official may not, without prior approval from the Secretary, obtain a... deadline date established by the Secretary. (Approved by the Office of Management and Budget under control...

  19. 7 CFR 4284.668 - Programmatic changes.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) RURAL BUSINESS-COOPERATIVE SERVICE AND RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE GRANTS Rural Business Opportunity Grants § 4284.668... approved project. Failure to obtain prior approval of changes to the scope of work or budget may result in...

  20. 7 CFR 3570.85 - Programmatic changes.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Programmatic changes. 3570.85 Section 3570.85... AGRICULTURE COMMUNITY PROGRAMS Community Facilities Grant Program § 3570.85 Programmatic changes. The grantee shall obtain prior Agency approval for any change to the objectives of the approved project. (For...

  1. Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study.

    PubMed

    Jadhav, Pravin R; Zhang, Jialu; Gobburu, Jogarao V S

    2009-01-01

    The manuscript presents the FDA's focus on leveraging prior knowledge in designing informative pediatric trial through this case study. In developing written request for Drug X, an anti-hypertensive for immediate blood pressure (BP) control, the sponsor and FDA conducted clinical trial simulations (CTS) to design trial with proper sample size and support the choice of dose range. The objective was to effectively use prior knowledge from adult patients for drug X, pediatric data from Corlopam (approved for a similar indication) trial and general experience in developing anti-hypertensive agents. Different scenarios governing the exposure response relationship in the pediatric population were simulated to perturb model assumptions. The choice of scenarios was based on the past observation that pediatric population is less responsive and sensitive compared with adults. The conceptual framework presented here should serve as an example on how the industry and FDA scientists can collaborate in designing the pediatric exclusivity trial. Using CTS, inter-disciplinary scientists with the sponsor and FDA can objectively discuss the choice of dose range, sample size, endpoints and other design elements. These efforts are believed to yield plausible trial design, qrational dosing recommendations and useful labeling information in pediatrics. Published in 2009 by John Wiley & Sons, Ltd.

  2. Reference analysis of the signal + background model in counting experiments II. Approximate reference prior

    NASA Astrophysics Data System (ADS)

    Casadei, D.

    2014-10-01

    The objective Bayesian treatment of a model representing two independent Poisson processes, labelled as ``signal'' and ``background'' and both contributing additively to the total number of counted events, is considered. It is shown that the reference prior for the parameter of interest (the signal intensity) can be well approximated by the widely (ab)used flat prior only when the expected background is very high. On the other hand, a very simple approximation (the limiting form of the reference prior for perfect prior background knowledge) can be safely used over a large portion of the background parameters space. The resulting approximate reference posterior is a Gamma density whose parameters are related to the observed counts. This limiting form is simpler than the result obtained with a flat prior, with the additional advantage of representing a much closer approximation to the reference posterior in all cases. Hence such limiting prior should be considered a better default or conventional prior than the uniform prior. On the computing side, it is shown that a 2-parameter fitting function is able to reproduce extremely well the reference prior for any background prior. Thus, it can be useful in applications requiring the evaluation of the reference prior for a very large number of times.

  3. 14 CFR 21.325 - Export airworthiness approvals.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Export airworthiness approvals. 21.325... AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Export Airworthiness Approvals § 21.325 Export airworthiness approvals. (a) Kinds of approvals. (1) Export airworthiness approval of Class I products is issued...

  4. Priming in implicit memory tasks: prior study causes enhanced discriminability, not only bias.

    PubMed

    Zeelenberg, René; Wagenmakers, Eric-Jan M; Raaijmakers, Jeroen G W

    2002-03-01

    R. Ratcliff and G. McKoon (1995, 1996, 1997; R. Ratcliff, D. Allbritton, & G. McKoon, 1997) have argued that repetition priming effects are solely due to bias. They showed that prior study of the target resulted in a benefit in a later implicit memory task. However, prior study of a stimulus similar to the target resulted in a cost. The present study, using a 2-alternative forced-choice procedure, investigated the effect of prior study in an unbiased condition: Both alternatives were studied prior to their presentation in an implicit memory task. Contrary to a pure bias interpretation of priming, consistent evidence was obtained in 3 implicit memory tasks (word fragment completion, auditory word identification, and picture identification) that performance was better when both alternatives were studied than when neither alternative was studied. These results show that prior study results in enhanced discriminability, not only bias.

  5. Minimally Informative Prior Distributions for PSA

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Dana L. Kelly; Robert W. Youngblood; Kurt G. Vedros

    2010-06-01

    A salient feature of Bayesian inference is its ability to incorporate information from a variety of sources into the inference model, via the prior distribution (hereafter simply “the prior”). However, over-reliance on old information can lead to priors that dominate new data. Some analysts seek to avoid this by trying to work with a minimally informative prior distribution. Another reason for choosing a minimally informative prior is to avoid the often-voiced criticism of subjectivity in the choice of prior. Minimally informative priors fall into two broad classes: 1) so-called noninformative priors, which attempt to be completely objective, in that themore » posterior distribution is determined as completely as possible by the observed data, the most well known example in this class being the Jeffreys prior, and 2) priors that are diffuse over the region where the likelihood function is nonnegligible, but that incorporate some information about the parameters being estimated, such as a mean value. In this paper, we compare four approaches in the second class, with respect to their practical implications for Bayesian inference in Probabilistic Safety Assessment (PSA). The most commonly used such prior, the so-called constrained noninformative prior, is a special case of the maximum entropy prior. This is formulated as a conjugate distribution for the most commonly encountered aleatory models in PSA, and is correspondingly mathematically convenient; however, it has a relatively light tail and this can cause the posterior mean to be overly influenced by the prior in updates with sparse data. A more informative prior that is capable, in principle, of dealing more effectively with sparse data is a mixture of conjugate priors. A particular diffuse nonconjugate prior, the logistic-normal, is shown to behave similarly for some purposes. Finally, we review the so-called robust prior. Rather than relying on the mathematical abstraction of entropy, as does the

  6. 49 CFR 451.1 - Application for approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to.... (b) Each application must include the following for each container: (1) Date and place of manufacture...

  7. 49 CFR 451.1 - Application for approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to.... (b) Each application must include the following for each container: (1) Date and place of manufacture...

  8. 78 FR 38256 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Redesignation of the Ohio...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ...EPA is issuing a supplement to its proposed approval of Ohio's request to redesignate the Ohio portion of the Parkersburg-Marietta, West Virginia-Ohio, area to attainment for the 1997 annual National Ambient Air Quality Standards (NAAQS or standard) for fine particulate matter (PM2.5). This supplemental proposal revises and expands the basis for proposing approval of the state's request, in light of developments since EPA issued its initial proposal on November 30, 2012. This supplemental proposal addresses the effects of a January 4, 2013, decision of the United States Court of Appeals for the District of Columbia (D.C. Circuit or Court) to remand to EPA two final rules implementing the 1997 PM2.5 standard. In this supplemental proposal, EPA is also proposing to approve a supplement to the emission inventories previously submitted by Ohio. EPA is proposing that the inventories for ammonia and volatile organic compounds (VOC), in conjunction with the inventories for nitrogen oxides (NOX), direct PM2.5, and sulfur dioxide (SO2) that EPA previously proposed to approve, meet the comprehensive emissions inventory requirements of the Clean Air Act (CAA or Act). EPA is seeking comment only on the issues raised in its supplemental proposal, and is not re-opening for comment other issues raised in its prior proposal.

  9. 40 CFR 52.1972 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment and...

  10. 40 CFR 52.1972 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment and...

  11. 40 CFR 52.1972 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment and...

  12. 40 CFR 52.1972 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment and...

  13. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment and...

  14. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment and...

  15. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment and...

  16. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment and...

  17. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment and...

  18. 40 CFR 52.2722 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Puerto Rico § 52.2722 Approval status. With the exceptions set forth in this subpart, the Administrator approves Puerto Rico's plans for the...

  19. 40 CFR 52.2722 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Puerto Rico § 52.2722 Approval status. With the exceptions set forth in this subpart, the Administrator approves Puerto Rico's plans for the...

  20. 40 CFR 52.2722 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Puerto Rico § 52.2722 Approval status. With the exceptions set forth in this subpart, the Administrator approves Puerto Rico's plans for the...

  1. 40 CFR 52.1673 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New York § 52.1673 Approval status. (a) With the exceptions set forth in this section, the Administrator approves the New York State Implementation...

  2. 46 CFR 160.017-21 - Approval tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval tests. 160.017-21 Section 160.017-21 Shipping...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Chain Ladder § 160.017-21 Approval tests. (a) General. Each approval test must be conducted on a ladder of the longest length for which approval has been requested. If...

  3. 46 CFR 160.017-21 - Approval tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Approval tests. 160.017-21 Section 160.017-21 Shipping...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Chain Ladder § 160.017-21 Approval tests. (a) General. Each approval test must be conducted on a ladder of the longest length for which approval has been requested. If...

  4. [Informed Consent and the Approval by Ethics Committees of Studies Involving the Use of Atypical Antipsychotics in the Management of Delirium].

    PubMed

    Millán-González, Ricardo

    2012-03-01

    Delirium is an acute alteration of consciousness and cognition. Atypical antipsychotics (AA) have recently become a main part of its treatment. Studies in this population generate a series of ethical dilemmas concerning the voluntary participation of patients and their state of vulnerability since their mental faculties are, by definition, compromised. To assess whether studies with AA for the treatment of delirium obtained an approval by an ethics committee on human research (ECHR), if an informed consent (IC) was obtained, whether the IC was verbal or written, and who gave the approval to participate. Systematic review of Medline for studies of delirium where quetiapine and olanzapine were the main treatment, assessing the existence of an ECHR approval and implementation of an IC. 11 studies were identified (6 of quetiapine and 5 of olanzapine). 5 had an ECHR approval. Most studies examining the treatment of delirium with quetiapine or olanzapine were not subject to approval by an ECHR and most of them did not obtain an IC from the patient's legal guardian. It is essential that future studies of antipsychotics and other drugs for the treatment of delirium have the protocol approved by an ECHR and a written IC signed by the patient's legal representative, since by definition delirium is a condition that compromises superior mental processes. Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

  5. 46 CFR 160.076-35 - Information pamphlet.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... pamphlet prior to purchase. The pamphlet text and layout must be submitted to the Commandant for approval... information, instructions, or illustrations must not be included within the approved text and layout. Sample pamphlet text and layout may be obtained by contacting the Commandant. This pamphlet may be combined with...

  6. 46 CFR 160.076-35 - Information pamphlet.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... pamphlet prior to purchase. The pamphlet text and layout must be submitted to the Commandant for approval... information, instructions, or illustrations must not be included within the approved text and layout. Sample pamphlet text and layout may be obtained by contacting the Commandant. This pamphlet may be combined with...

  7. The nightmare of FDA clearance/approval to market: perception or reality?

    PubMed

    Tylenda, C A

    1996-09-01

    Over the last few years the Center for Device Evaluation and Research (CDRH) at the Food and Drug Administration (FDA) has received annually over 16 thousand submissions related to medical devices. Over 10,000 of these are major submissions which include applications to conduct clinical trials and applications to market medical devices for a specified indication for use. Each application is carefully considered. FDA personnel work closely with applicants to ensure that clinical trial design minimizes risk to the patients and maximizes benefit with respect to addressing the safety and effectiveness of the device being tested. Applicants are given every opportunity to provide additional information when necessary to assure that applications to market medical devices are complete. Applicants have the opportunity to meet with FDA staff prior to submitting applications in cases where the application is other than a straight forward, uncomplicated submission. In addition, FDA assists applicants through the development of guidance documents, which discuss the type of information that would be beneficial to include in a submission. The Division of Small Manufacturers Assistance at FDA is dedicated to helping interested persons understand the clearance/approval process. This paper will discuss the role of FDA in the regulation of medical devices, with an emphasis on the pathway to obtaining permission to market medical devices in the United States.

  8. 33 CFR 67.10-35 - Notice of approval and withdrawal of approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false Notice of approval and withdrawal of approval. 67.10-35 Section 67.10-35 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY AIDS TO NAVIGATION AIDS TO NAVIGATION ON ARTIFICIAL ISLANDS AND FIXED STRUCTURES General...

  9. 33 CFR 67.10-35 - Notice of approval and withdrawal of approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Notice of approval and withdrawal of approval. 67.10-35 Section 67.10-35 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY AIDS TO NAVIGATION AIDS TO NAVIGATION ON ARTIFICIAL ISLANDS AND FIXED STRUCTURES General...

  10. Subjective and objective peer approval evaluations and self-esteem development: A test of reciprocal, prospective, and long-term effects.

    PubMed

    Gruenenfelder-Steiger, Andrea E; Harris, Michelle A; Fend, Helmut A

    2016-10-01

    A large body of literature suggests a clear, concurrent association between peer approval and self-esteem in adolescence. However, little empirical work exists on either the prospective or reciprocal relation between peer approval and self-esteem during this age period. Moreover, it is unclear from past research whether both subjectively perceived peer approval and objectively measured peer approval are related to subsequent self-esteem over time (and vice versa) and whether these paths have long-term associations into adulthood. Using data from a large longitudinal study that covers a time span of 2 decades, we examined reciprocal, prospective relations between self-esteem and peer approval during ages 12-16 in addition to long-term relations between these variables and later social constructs at age 35. Cross-lagged regression analyses revealed small but persistent effect sizes from both types of peer approval to subsequent self-esteem in adolescence, controlling for prior self-esteem. However, effects in the reverse direction were not confirmed. These findings support the notion that peer relationships serve an important function for later self-esteem, consistent with many theoretical tenets of the importance of peers for building a strong identity. Finally, we found long-term relations between adult social constructs and adolescent objective and subjective peer approval as well as self-esteem. Therefore, not only do peer relationships play a role in self-esteem development across adolescence, but they remain impactful throughout adulthood. In sum, the current findings highlight the lasting, yet small link between peer relationships and self-esteem development and call for investigations of further influential factors for self-esteem over time. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  11. Integration of new technology into clinical practice after FDA approval.

    PubMed

    Govil, Ashul; Hao, Steven C

    2016-10-01

    Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

  12. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  13. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  14. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  15. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  16. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  17. Effects of prior aversive experience upon retrograde amnesia induced by hypothermia.

    PubMed

    Jensen, R A; Riccio, D C; Gehres, L

    1975-08-01

    Two experiments examined the extent to which retrograde amnesia (RA) is attenuated by prior learning experiences. In Experiment 1, rats initially received either passive avoidance training in a step-through apparatus, exposure to the apparatus, or noncontingent footshock. When training on a second but different passive avoidance task was followed by hypothermia treatment, RA was obtained only in the latter two groups. In Experiment 2, one-way active avoidance training, yoked noncontingent shocks, or apparatus exposure constituted the initial experience. Subsequent step-down passive avoidance training and amnestic treatment resulted in memory loss for the prior apparatus exposure group, but not for either of the preshocked conditions. These experiments demonstrate that certain types of prior aversive experience can substantially modify the magnitude of RA, and, in conjunction with other familiarization studies, emphasize a paradox for interpretations of RA based solely upon CNS disruption. The possibility that hypothermia treatment serves as an important contextual or encoding cue necessary for memory retrieval was considered. It was suggested that prior experience may block RA by enabling rats to differentiate training and treatment conditions.

  18. Ethics approval: responsibilities of journal editors, authors and research ethics committees.

    PubMed

    Bain, Luchuo Engelbert

    2017-01-01

    Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

  19. The possibility of obtaining marketing authorization of orphan pharmaceutical compounding preparations: 3,4-DAP for Lambert-Eaton Myasthenic Syndrome.

    PubMed

    de Wilde, Sofieke; de Jong, Maria G H; Lipka, Alexander F; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

    2018-03-01

    Pharmaceutical compounding preparations, produced by (hospital) pharmacies, usually do not have marketing authorization. As a consequence, some of these pharmaceutical compounding preparations can be picked-up by a pharmaceutical company to obtain marketing authorization, often leading to price increases. An example is the 3,4-diaminopyridine slow release (3,4-DAP SR) tablets for Lambert-Eaton Myasthenic Syndrome (LEMS). In 2009 marketing authorization was given for the commercial immediate release phosphate salt of the drug, including a fifty-fold price increase compared to the pharmaceutical compounding preparation. Obtaining marketing authorization for 3,4-DAP SR by academia might have been a solution to prevent this price increase. To determine whether the available data of a pharmaceutical compounding preparation with long-term experience in regular care are adequate to obtain marketing authorization, 3,4-DAP SR is used as a case study. A retrospective qualitative case-study was performed. Initially, document analysis was executed by collecting the required data for marketing authorization in general and whether data of Firdapse® and 3,4-DAP SR met these requirements. Secondly, the (non-) available data of the two formulations were compared with each other to determine the differences in availability. At the time of approval, almost all data were available for both Firdapse® and 3,4-DAP SR. Conversely, much of the data used for the approval of Firdapse® originated from the 3,4-DAP immediate release (3,4-DAP IR) formulation. Only two bioequivalence studies and one pharmacology safety study was performed with Firdapse® before marketing authorization application. In conclusion, at time Firdapse® obtained approval, the data available did not differ substantially from 3,4-DAP SR, indicating that approval with 3,4-DAP SR would have been possible. We make a plea for approval of orphan medicinal products developed and manufactured by academic institutions as to

  20. 49 CFR 451.15 - Application for individual approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

  1. 49 CFR 451.15 - Application for individual approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

  2. 49 CFR 451.15 - Application for individual approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

  3. 49 CFR 451.15 - Application for individual approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

  4. 49 CFR 451.15 - Application for individual approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

  5. 45 CFR 74.25 - Revision of budget and program plans.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... items. (c) For nonconstruction awards, recipients shall obtain prior approvals from the HHS awarding... approval of the HHS awarding agency. However, all pre-award costs are incurred at the recipient's risk: the... does not receive an award or if the award to the recipient is less than anticipated and inadequate to...

  6. 45 CFR 74.25 - Revision of budget and program plans.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... items. (c) For nonconstruction awards, recipients shall obtain prior approvals from the HHS awarding... approval of the HHS awarding agency. However, all pre-award costs are incurred at the recipient's risk: the... does not receive an award or if the award to the recipient is less than anticipated and inadequate to...

  7. 45 CFR 74.25 - Revision of budget and program plans.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... items. (c) For nonconstruction awards, recipients shall obtain prior approvals from the HHS awarding... approval of the HHS awarding agency. However, all pre-award costs are incurred at the recipient's risk: the... does not receive an award or if the award to the recipient is less than anticipated and inadequate to...

  8. 45 CFR 74.25 - Revision of budget and program plans.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... items. (c) For nonconstruction awards, recipients shall obtain prior approvals from the HHS awarding... approval of the HHS awarding agency. However, all pre-award costs are incurred at the recipient's risk: the... does not receive an award or if the award to the recipient is less than anticipated and inadequate to...

  9. 30 CFR 7.311 - Approval checklist.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Electric Motor Assemblies § 7.311 Approval checklist. Each motor assembly bearing an MSHA approval marking shall be accompanied by a list of items necessary for maintenance of the motor assembly as approved. ...

  10. The power prior: theory and applications.

    PubMed

    Ibrahim, Joseph G; Chen, Ming-Hui; Gwon, Yeongjin; Chen, Fang

    2015-12-10

    The power prior has been widely used in many applications covering a large number of disciplines. The power prior is intended to be an informative prior constructed from historical data. It has been used in clinical trials, genetics, health care, psychology, environmental health, engineering, economics, and business. It has also been applied for a wide variety of models and settings, both in the experimental design and analysis contexts. In this review article, we give an A-to-Z exposition of the power prior and its applications to date. We review its theoretical properties, variations in its formulation, statistical contexts for which it has been used, applications, and its advantages over other informative priors. We review models for which it has been used, including generalized linear models, survival models, and random effects models. Statistical areas where the power prior has been used include model selection, experimental design, hierarchical modeling, and conjugate priors. Frequentist properties of power priors in posterior inference are established, and a simulation study is conducted to further examine the empirical performance of the posterior estimates with power priors. Real data analyses are given illustrating the power prior as well as the use of the power prior in the Bayesian design of clinical trials. Copyright © 2015 John Wiley & Sons, Ltd.

  11. The Power Prior: Theory and Applications

    PubMed Central

    Ibrahim, Joseph G.; Chen, Ming-Hui; Gwon, Yeongjin; Chen, Fang

    2015-01-01

    The power prior has been widely used in many applications covering a large number of disciplines. The power prior is intended to be an informative prior constructed from historical data. It has been used in clinical trials, genetics, health care, psychology, environmental health, engineering, economics, and business. It has also been applied for a wide variety of models and settings, both in the experimental design and analysis contexts. In this review article, we give an A to Z exposition of the power prior and its applications to date. We review its theoretical properties, variations in its formulation, statistical contexts for which it has been used, applications, and its advantages over other informative priors. We review models for which it has been used, including generalized linear models, survival models, and random effects models. Statistical areas where the power prior has been used include model selection, experimental design, hierarchical modeling, and conjugate priors. Prequentist properties of power priors in posterior inference are established and a simulation study is conducted to further examine the empirical performance of the posterior estimates with power priors. Real data analyses are given illustrating the power prior as well as the use of the power prior in the Bayesian design of clinical trials. PMID:26346180

  12. 49 CFR 1522.113 - Withdrawal of approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening Program... TSA-approved validation firm if the validation firm ceases to meet the standards for approval, fails...

  13. Hemicelluloses prior to aspen chemithermomechanical pulping: pre-extraction, separation, and characterization.

    PubMed

    Liu, Wei; Hou, Qingxi; Mao, Changbin; Yuan, Zhirun; Li, Kecheng

    2012-05-16

    A portion of hemicelluloses and acetic acid can be pre-extracted with dilute sulfuric acid prior to the aspen chemithermomechanical pulp process. The streams collected from the second press-impregnation stage after acid pre-extraction contain a significant amount of acid pre-extracted hemicelluloses. Most of the total sugars obtained from the pressate were xylan, in which xylan was further hydrolyzed to sugar monomers under the acid pre-extraction condition. To fully understand the characteristics of hemicelluloses yielded prior to pulping, the pre-extracted hemicelluloses were separated and characterized by FT-IR, (1)H NMR, and thermogravimetric analysis in this study. Most of the FT-IR bonds from the hemicelluloses agreed well with the other two spectra of birch xylan and CA0050 xylan, except a new absorption at 1734 cm(-1) contributed to acetyl groups. The hemicelluloses obtained from acid pre-extraction began to decompose significantly at about 225 °C, slightly lower in comparison with organosolv and alkaline hemicelluloses reported in the literature.

  14. 30 CFR 22.10 - Approval plate.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.10 Approval plate. (a) Attachment to be made by manufacturers. (1) Manufacturers shall attach, stamp, or mold an approval plate on each permissible methane... follows: Permissible Methane Detector (or Permissible Methane Indicating Detector) Approval No. ___ issued...

  15. EVALUATION OF DATA OBTAINED ON "MANUFACTURING PROCESS" DEVELOPMENT BUNDLES PD 1 THROUGH 5 PRIOR TO MACHINING OPERATIONS

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Frankhouser, W.L.; Eyler, J.H.

    1956-07-24

    Five reference fuel rod bundles were welded and evaluated dimensionally. Dimensional data are presented for the as-welded condition and for the annealed bundle with spacer strips removed (prior to the final machining operations). The welding sequence developed for Core Manufacturing should provide A'' boundles in respect to rod spacing measurements. It will probably not be possible to meet the same requirements for water channel averages, because the design tolerances are not consistent with some factors inherent to the production process. A method to improve this situation is presented. The data presented were evaluated in a fashion similar to that whichmore » would be used in the proposed scheme. Rods tended to bow resulting in a slightly barrel-shaped'' boundle. It is believed this condition can be overcome by providing special bundle peripheral clamps during annealing. Rod distortion should also be reduced by a redesign and relocation of strip spacers. The new design is proposed. (auth)« less

  16. Marketing Approval of Ethical Kampo Medicines.

    PubMed

    Hakamatsuka, Takashi

    2017-01-01

    Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

  17. 75 FR 54654 - Agency Information Collection Activities; Proposals, Submissions, and Approvals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

    ... request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the... frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site at http... Department of Labor--Wage and Hour Division, Office of Management and Budget, Room 10235, Washington, DC...

  18. 45 CFR 95.611 - Prior approval conditions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...-GRANT PROGRAMS (PUBLIC ASSISTANCE, MEDICAL ASSISTANCE AND STATE CHILDREN'S HEALTH INSURANCE PROGRAMS... Children and Families, Office of State Systems. The State shall send to ACF one copy of the request for... than 60 days for major milestones. For Aid to Families with Dependent Children (AFDC) Family Assistance...

  19. 22 CFR 129.7 - Prior approval (license).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...; (ii) Nuclear weapons strategic delivery systems and all components, parts, accessories, attachments specifically designed for such systems and associated equipment; (iii) Nuclear weapons design and test equipment of a nature described by Category XVI of Part 121; (iv) Naval nuclear propulsion equipment of a...

  20. 22 CFR 129.7 - Prior approval (license).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...; (ii) Nuclear weapons strategic delivery systems and all components, parts, accessories, attachments specifically designed for such systems and associated equipment; (iii) Nuclear weapons design and test equipment of a nature described by Category XVI of part 121; (iv) Naval nuclear propulsion equipment of a...

  1. 42 CFR 495.324 - Prior approval conditions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...: (1) The HIT advance planning document and the implementation advance planning document. (2) A request... $100,000 or contract time extensions of more than 60 days. (4) The State Medicaid HIT plan. (c) Failure...-competitively from a nongovernmental source HIT equipment or services, with proposed FFP under this subpart if...

  2. 22 CFR 129.7 - Prior approval (license).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... defense services (other than those that are arranged wholly within and destined exclusively for the North... Zealand, or the Republic of Korea (see §§ 129.6(b)(2) and 129.7(a)). (2) Brokering activities involving... under this subchapter, for or from any country not a member of the North Atlantic Treaty Organization...

  3. 22 CFR 129.7 - Prior approval (license).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... as significant military equipment under this subchapter, for or from any country not a member of the... following factors are present: (i) The value of the significant military equipment is $1,000,000 or more; (ii) The identical significant military equipment has not been previously licensed for export to the...

  4. 40 CFR 52.2122 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... sources covered by CTGs issued by the previous January. (b) EPA disapproved South Carolina's generic...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Carolina § 52.2122 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves South Carolina's plans for...

  5. 40 CFR 52.2062 - Plan approvals.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Plan approvals. 52.2062 Section 52.2062... PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Pennsylvania § 52.2062 Plan approvals. (a) Emission limitations and related provisions which are established in Pennsylvania plan approvals as federally...

  6. Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval.

    PubMed

    Prasad, Vinay; Mailankody, Sham

    2017-11-01

    A common justification for high cancer drug prices is the sizable research and development (R&D) outlay necessary to bring a drug to the US market. A recent estimate of R&D spending is $2.7 billion (2017 US dollars). However, this analysis lacks transparency and independent replication. To provide a contemporary estimate of R&D spending to develop cancer drugs. Analysis of US Securities and Exchange Commission filings for drug companies with no drugs on the US market that received approval by the US Food and Drug Administration for a cancer drug from January 1, 2006, through December 31, 2015. Cumulative R&D spending was estimated from initiation of drug development activity to date of approval. Earnings were also identified from the time of approval to the present. The study was conducted from December 10, 2016, to March 2, 2017. Median R&D spending on cancer drug development. Ten companies and drugs were included in this analysis. The 10 companies had a median time to develop a drug of 7.3 years (range, 5.8-15.2 years). Five drugs (50%) received accelerated approval from the US Food and Drug Administration, and 5 (50%) received regular approval. The median cost of drug development was $648.0 million (range, $157.3 million to $1950.8 million). The median cost was $757.4 million (range, $203.6 million to $2601.7 million) for a 7% per annum cost of capital (or opportunity costs) and $793.6 million (range, $219.1 million to $2827.1 million) for a 9% opportunity costs. With a median of 4.0 years (range, 0.8-8.8 years) since approval, the total revenue from sales of these 10 drugs since approval was $67.0 billion compared with total R&D spending of $7.2 billion ($9.1 billion, including 7% opportunity costs). The cost to develop a cancer drug is $648.0 million, a figure significantly lower than prior estimates. The revenue since approval is substantial (median, $1658.4 million; range, $204.1 million to $22 275.0 million). This analysis provides a transparent estimate

  7. 40 CFR 52.1973 - Approval of plans.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1973 Approval of plans. (a) Carbon monoxide. (1) EPA approves as a revision to the Oregon State Implementation Plan, the Second... December 27, 2004. (2) EPA approves as a revision to the Oregon State Implementation Plan, the Salem carbon...

  8. 40 CFR 52.1973 - Approval of plans.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1973 Approval of plans. (a) Carbon monoxide. (1) EPA approves as a revision to the Oregon State Implementation Plan, the Second... December 27, 2004. (2) EPA approves as a revision to the Oregon State Implementation Plan, the Salem carbon...

  9. 40 CFR 52.1973 - Approval of plans.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1973 Approval of plans. (a) Carbon monoxide. (1) EPA approves as a revision to the Oregon State Implementation Plan, the Second... December 27, 2004. (2) EPA approves as a revision to the Oregon State Implementation Plan, the Salem carbon...

  10. 40 CFR 52.1973 - Approval of plans.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1973 Approval of plans. (a) Carbon monoxide. (1) EPA approves as a revision to the Oregon State Implementation Plan, the Second... December 27, 2004. (2) EPA approves as a revision to the Oregon State Implementation Plan, the Salem carbon...

  11. 46 CFR 160.176-13 - Approval Tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval Tests. 160.176-13 Section 160.176-13 Shipping...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Inflatable Lifejackets § 160.176-13 Approval Tests. (a) General. (1) This section contains requirements for approval tests and examinations of inflatable lifejackets...

  12. 40 CFR 52.672 - Approval of plans.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Idaho § 52.672 Approval of plans. (a) Carbon Monoxide. (1) EPA approves as a revision to the Idaho State Implementation Plan, the Limited Maintenance Plan for.... [Reserved] (e) Particulate Matter. (1) EPA approves as a revision to the Idaho State Implementation Plan...

  13. 7 CFR 996.22 - USDA-approved laboratory.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 8 2013-01-01 2013-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

  14. 7 CFR 996.22 - USDA-approved laboratory.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 8 2012-01-01 2012-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

  15. 7 CFR 996.22 - USDA-approved laboratory.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 8 2014-01-01 2014-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

  16. 7 CFR 996.22 - USDA-approved laboratory.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

  17. 75 FR 48302 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-10

    ....gov ). FOR FURTHER INFORMATION CONTACT: For information on credit account approval for reimbursable..., at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable... Inspection Service [Docket No. APHIS-2010-0071] Notice of Request for Extension of Approval of an Information...

  18. 78 FR 54617 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ...] Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval for... (202) 799-7039 before coming. FOR FURTHER INFORMATION CONTACT: For information on credit account... Coordinator, at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable...

  19. Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

    PubMed

    Lawrence, Dana J

    2011-11-01

    To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby

  20. Development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US food and drug administration: the class of 2008.

    PubMed

    Moore, Thomas J; Furberg, Curt D

    2014-01-01

    The US Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points. To inform the debate about appropriate standards, we studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the FDA in 2008, when most provisions of current law, regulation, and policies were in effect. Descriptive study of the drugs classified as new molecular entities using preapproval FDA evaluation documents, agency drug information databases, prescribing information, and other primary data sources. Comparison of drugs that received standard review and those deemed sufficiently innovative to receive expedited review with regard to clinical development and FDA review time, the size and duration of efficacy trials, safety issues, and postmarket follow-up. In 2008, the FDA approved 20 therapeutic drugs, 8 with expedited review and 12 with standard review. The expedited drugs took a median of 5.1 years (range, 1.6-10.6 years) of clinical development to obtain marketing approval compared with 7.5 years (range, 4.7-19.4 years) for the standard review drugs (P = .05). The expedited drugs were tested for efficacy in a median of 104 patients receiving the active drug (range, 23-599), compared with a median of 580 patients (range, 75-1207) for standard review drugs (P = .003). Nonclinical testing showed that 6 therapeutic drugs were animal carcinogens, 5 were in vitro mutagens, and 14 were animal teratogens. Other safety concerns resulted in 5 Boxed Warnings; 8 drugs required risk management plans. The FDA required 85 postmarket commitments. By 2013, 5 drugs acquired a new or expanded Boxed Warning; 26 of 85 (31%) of the postmarketing study commitments had been fulfilled, and 8 (9%) had been submitted for agency review. For new drugs approved by the FDA in 2008, those

  1. 40 CFR 52.1772 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Carolina § 52.1772 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves North Carolina's plans for... CTGs issued by the previous January. (b) New Source review permits issued pursuant to section 173 of...

  2. 40 CFR 52.2572 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Wisconsin § 52.2572 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Wisconsin's plans for the... Wisconsin. (b) [Reserved] [75 FR 82563, Dec. 30, 2010, as amended at 78 FR 30209, May 22, 2013] ...

  3. 40 CFR 52.2572 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Wisconsin § 52.2572 Approval status. With the exceptions set forth in this subpart, the Administrator approves Wisconsin's plans for the attainment and... schedule contained in the 1982 Ozone SIP revision for Southeastern Wisconsin. [49 FR 8923, Mar. 9, 1984] ...

  4. 40 CFR 52.2572 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Wisconsin § 52.2572 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Wisconsin's plans for the... Wisconsin. (b) [Reserved] [75 FR 82563, Dec. 30, 2010, as amended at 78 FR 30209, May 22, 2013] ...

  5. 19 CFR 115.42 - Approval plates.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.42 Approval plates. (a) The owner or operator... plate in the manner specified for containers approved by design type (see § 115.32). (b) Although an...

  6. 19 CFR 115.42 - Approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.42 Approval plates. (a) The owner or operator... plate in the manner specified for containers approved by design type (see § 115.32). (b) Although an...

  7. 19 CFR 115.42 - Approval plates.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.42 Approval plates. (a) The owner or operator... plate in the manner specified for containers approved by design type (see § 115.32). (b) Although an...

  8. 19 CFR 115.42 - Approval plates.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.42 Approval plates. (a) The owner or operator... plate in the manner specified for containers approved by design type (see § 115.32). (b) Although an...

  9. 19 CFR 115.42 - Approval plates.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.42 Approval plates. (a) The owner or operator... plate in the manner specified for containers approved by design type (see § 115.32). (b) Although an...

  10. 14 CFR 25.1535 - ETOPS approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false ETOPS approval. 25.1535 Section 25.1535 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRWORTHINESS....1535 ETOPS approval. Except as provided in § 25.3, each applicant seeking ETOPS type design approval...

  11. 14 CFR 25.1535 - ETOPS approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false ETOPS approval. 25.1535 Section 25.1535 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRWORTHINESS....1535 ETOPS approval. Except as provided in § 25.3, each applicant seeking ETOPS type design approval...

  12. 14 CFR 25.1535 - ETOPS approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false ETOPS approval. 25.1535 Section 25.1535 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRWORTHINESS....1535 ETOPS approval. Except as provided in § 25.3, each applicant seeking ETOPS type design approval...

  13. 14 CFR 25.1535 - ETOPS approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false ETOPS approval. 25.1535 Section 25.1535 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRWORTHINESS....1535 ETOPS approval. Except as provided in § 25.3, each applicant seeking ETOPS type design approval...

  14. 14 CFR 25.1535 - ETOPS approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false ETOPS approval. 25.1535 Section 25.1535 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRWORTHINESS....1535 ETOPS approval. Except as provided in § 25.3, each applicant seeking ETOPS type design approval...

  15. No. 127-The Evaluation of Stress Incontinence Prior to Primary Surgery.

    PubMed

    Farrell, Scott A

    2018-02-01

    To provide clinical guidelines for the evaluation of women with stress urinary incontinence prior to primary anti-incontinence surgery. The modalities of evaluation range from basic pelvic examination through to the use of adjuncts including ultrasound and urodynamic testing. These guidelines provide a comprehensive approach to the preoperative evaluation of urinary incontinence to ensure that excessive evaluation is avoided without sacrificing diagnostic accuracy. Published opinions of experts, supplemented by evidence from clinical trials, where appropriate. The quality of the evidence is rated using the criteria described by the Canadian Task Force on the Periodic Health Examination. Comprehensive evaluation of women considering surgery to treat urinary incontinence is essential to rule out causes of incontinence that may not be amenable to surgical treatment. Simplifying the evaluation minimizes the discomfort and embarrassment potentially experienced by women. VALIDATION: These guidelines have been approved by the Urogynaecology Committee and the Executive and Council of The Society of Obstetricians and Gynaecologists of Canada. Copyright © 2018. Published by Elsevier Inc.

  16. 46 CFR 161.012-11 - Approval tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Approval tests. 161.012-11 Section 161.012-11 Shipping...: SPECIFICATIONS AND APPROVAL ELECTRICAL EQUIPMENT Personal Flotation Device Lights § 161.012-11 Approval tests. (a) The approval tests described in this section must be conducted for each light submitted for Coast...

  17. 46 CFR 161.012-11 - Approval tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval tests. 161.012-11 Section 161.012-11 Shipping...: SPECIFICATIONS AND APPROVAL ELECTRICAL EQUIPMENT Personal Flotation Device Lights § 161.012-11 Approval tests. (a) The approval tests described in this section must be conducted for each light submitted for Coast...

  18. 30 CFR 20.13 - Approval plate.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval plate. 20.13 Section 20.13 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.13 Approval plate. The...

  19. 28 CFR 2.93 - Travel approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval. 2.93 Section 2.93... Travel approval. (a) A parolee's Supervision Officer may approve travel outside the district of... possibilities. (3) Recurring travel across a district boundary, not to exceed fifty miles outside the district...

  20. 30 CFR 7.309 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Electric Motor Assemblies § 7.309 Approval marking. Each approved motor assembly shall be identified by a legible and permanent approval plate inscribed.... The plate shall be securely attached to the motor assembly in a manner that does not impair any...