21 CFR 1271.160 - Establishment and maintenance of a quality program.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Establishment and maintenance of a quality program. 1271.160 Section 1271.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION...

14 CFR 120.111 - Administrative and other matters.

Code of Federal Regulations, 2014 CFR

2014-01-01

... ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.111 Administrative and other matters. (a... for the employer must be produced at the employer's place of business. (c) Release of drug testing information. An employer shall release information regarding an employee's drug testing results, evaluation...

14 CFR 120.111 - Administrative and other matters.

Code of Federal Regulations, 2012 CFR

2012-01-01

... ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.111 Administrative and other matters. (a... for the employer must be produced at the employer's place of business. (c) Release of drug testing information. An employer shall release information regarding an employee's drug testing results, evaluation...

14 CFR 120.111 - Administrative and other matters.

Code of Federal Regulations, 2010 CFR

2010-01-01

... ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.111 Administrative and other matters. (a... for the employer must be produced at the employer's place of business. (c) Release of drug testing information. An employer shall release information regarding an employee's drug testing results, evaluation...

14 CFR 120.111 - Administrative and other matters.

Code of Federal Regulations, 2013 CFR

2013-01-01

... ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.111 Administrative and other matters. (a... for the employer must be produced at the employer's place of business. (c) Release of drug testing information. An employer shall release information regarding an employee's drug testing results, evaluation...

14 CFR 120.111 - Administrative and other matters.

Code of Federal Regulations, 2011 CFR

2011-01-01

... ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.111 Administrative and other matters. (a... for the employer must be produced at the employer's place of business. (c) Release of drug testing information. An employer shall release information regarding an employee's drug testing results, evaluation...

77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0530... Program and Meetings With FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.601 - Railroad random drug testing programs.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

49 CFR 219.601 - Railroad random drug testing programs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

49 CFR 219.601 - Railroad random drug testing programs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 4 2014-10-01 2014-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

49 CFR 219.601 - Railroad random drug testing programs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 4 2013-10-01 2013-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

49 CFR 219.601 - Railroad random drug testing programs.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

78 FR 38053 - Regulatory Systems Strengthening

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-25

... Science Policy Analysis/Office of International Programs, HFG-1, Food and Drug Administration, 10903 New... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0010] Regulatory Systems Strengthening AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

The New Drug Conditional Approval Process in China: Challenges and Opportunities.

PubMed

Yao, Xuefang; Ding, Jinxi; Liu, Yingfang; Li, Penghui

2017-05-01

Our aim was to characterize the newly established new drug conditional approval process in China and discuss the challenges and opportunities with respect to new drug research and development and registration. We examined the new approval program through literature review, law analysis, and data analysis. Data were derived from published materials, such as journal articles, government publications, press releases, and news articles, along with statistical data from INSIGHT-China Pharma Databases, the China Food and Drug Administration website, the Center for Drug Evaluation website, the US Food and Drug Administration website, and search results published by Google. Currently, there is a large backlog of New Drug Applications in China, mainly because of the prolonged review time at the China Food and Drug Administration, resulting in a lag in drug approvals. In 2015, the Chinese government implemented the drug review and registration system reform and tackled this issue through various approaches, such as setting up a drug review fee system, adjusting the drug registration classification, and establishing innovative review pathways, including the conditional approval process. In Europe and the United States, programs comparable to the conditional approval program in China have been well developed. The conditional approval program recently established in China is an expedited new drug approval process that is expected to affect new drug development at home and abroad and profoundly influence the public health and the pharmaceutical industry in China. Like any program in its initial stage, the conditional approval program is facing several challenges, including setting up a robust system, formatting new drug clinical research requirements, and improving the regulatory agency's function for drug review and approval. The program is expected to evolve and improve as part of the government mandate of the drug registration system reform. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

A Guide for the Management of Special Education Programs. 1.0 Program Organization. Newday Operations Guide for Drug Dependent Minor Programs.

ERIC Educational Resources Information Center

Santa Cruz County Superintendent of Schools, CA.

Presented is the first component, Program Organization, of a special day class educational program emphasizing rehabilitation, remedial instruction, and return to regular school programs for drug dependent minors. Included are statistics on drug use in California and the administrative code under which drug dependent minors are eligible for…

Drug Abuse Control--Administrative Guidelines.

ERIC Educational Resources Information Center

Los Angeles City Schools, CA.

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

49 CFR 219.605 - Positive drug test results; procedures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.605 Positive drug test results; procedures. (a) [Reserved] (b) Procedures for administrative... 49 Transportation 4 2012-10-01 2012-10-01 false Positive drug test results; procedures. 219.605...

49 CFR 219.605 - Positive drug test results; procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.605 Positive drug test results; procedures. (a) [Reserved] (b) Procedures for administrative... 49 Transportation 4 2010-10-01 2010-10-01 false Positive drug test results; procedures. 219.605...

49 CFR 219.605 - Positive drug test results; procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.605 Positive drug test results; procedures. (a) [Reserved] (b) Procedures for administrative... 49 Transportation 4 2011-10-01 2011-10-01 false Positive drug test results; procedures. 219.605...

49 CFR 219.605 - Positive drug test results; procedures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.605 Positive drug test results; procedures. (a) [Reserved] (b) Procedures for administrative... 49 Transportation 4 2013-10-01 2013-10-01 false Positive drug test results; procedures. 219.605...

49 CFR 219.605 - Positive drug test results; procedures.

Code of Federal Regulations, 2014 CFR

2014-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.605 Positive drug test results; procedures. (a) [Reserved] (b) Procedures for administrative... 49 Transportation 4 2014-10-01 2014-10-01 false Positive drug test results; procedures. 219.605...

28 CFR 550.54 - Incentives for RDAP participation.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Incentives for RDAP participation. 550.54 Section 550.54 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.54 Incentives for RDAP participation. (a) An inmate...

28 CFR 550.54 - Incentives for RDAP participation.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Incentives for RDAP participation. 550.54 Section 550.54 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.54 Incentives for RDAP participation. (a) An inmate...

28 CFR 550.54 - Incentives for RDAP participation.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Incentives for RDAP participation. 550.54 Section 550.54 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.54 Incentives for RDAP participation. (a) An inmate...

28 CFR 550.54 - Incentives for RDAP participation.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Incentives for RDAP participation. 550.54 Section 550.54 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.54 Incentives for RDAP participation. (a) An inmate...

28 CFR 550.54 - Incentives for RDAP participation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Incentives for RDAP participation. 550.54 Section 550.54 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.54 Incentives for RDAP participation. (a) An inmate...

28 CFR 550.51 - Drug abuse education course.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Drug abuse education course. 550.51... DRUG PROGRAMS Drug Abuse Treatment Program § 550.51 Drug abuse education course. (a) Purpose of the drug abuse education course. All institutions provide a drug abuse education course to: (1) Inform...

28 CFR 550.51 - Drug abuse education course.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Drug abuse education course. 550.51... DRUG PROGRAMS Drug Abuse Treatment Program § 550.51 Drug abuse education course. (a) Purpose of the drug abuse education course. All institutions provide a drug abuse education course to: (1) Inform...

28 CFR 550.51 - Drug abuse education course.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Drug abuse education course. 550.51... DRUG PROGRAMS Drug Abuse Treatment Program § 550.51 Drug abuse education course. (a) Purpose of the drug abuse education course. All institutions provide a drug abuse education course to: (1) Inform...

28 CFR 550.51 - Drug abuse education course.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Drug abuse education course. 550.51... DRUG PROGRAMS Drug Abuse Treatment Program § 550.51 Drug abuse education course. (a) Purpose of the drug abuse education course. All institutions provide a drug abuse education course to: (1) Inform...

28 CFR 550.51 - Drug abuse education course.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Drug abuse education course. 550.51... DRUG PROGRAMS Drug Abuse Treatment Program § 550.51 Drug abuse education course. (a) Purpose of the drug abuse education course. All institutions provide a drug abuse education course to: (1) Inform...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-05

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-18

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

28 CFR 550.52 - Non-residential drug abuse treatment services.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Non-residential drug abuse treatment... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.52 Non-residential drug abuse treatment services. All institutions must have non-residential drug abuse treatment services, provided...

28 CFR 550.52 - Non-residential drug abuse treatment services.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Non-residential drug abuse treatment... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.52 Non-residential drug abuse treatment services. All institutions must have non-residential drug abuse treatment services, provided...

28 CFR 550.52 - Non-residential drug abuse treatment services.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Non-residential drug abuse treatment... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.52 Non-residential drug abuse treatment services. All institutions must have non-residential drug abuse treatment services, provided...

28 CFR 550.52 - Non-residential drug abuse treatment services.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Non-residential drug abuse treatment... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.52 Non-residential drug abuse treatment services. All institutions must have non-residential drug abuse treatment services, provided...

28 CFR 550.52 - Non-residential drug abuse treatment services.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Non-residential drug abuse treatment... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.52 Non-residential drug abuse treatment services. All institutions must have non-residential drug abuse treatment services, provided...

75 FR 54343 - Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Blood...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0436... That Collect Whole Blood and Blood Components AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) is...

78 FR 65332 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0530... Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

76 FR 79195 - Animal Drug User Fee Act; Reopening of the Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0656] Animal Drug User Fee Act; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS... notice, FDA requested comments on the Animal Drug User Fee Act (ADUFA) program to date and solicited...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 83.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2012 CFR

2012-07-01

...-free awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b..., and employee assistance programs; and (d) The penalties that you may impose upon them for drug abuse... 28 Judicial Administration 2 2012-07-01 2012-07-01 false What must I include in my drug-free...

28 CFR 83.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2011 CFR

2011-07-01

...-free awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b..., and employee assistance programs; and (d) The penalties that you may impose upon them for drug abuse... 28 Judicial Administration 2 2011-07-01 2011-07-01 false What must I include in my drug-free...

28 CFR 83.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2014 CFR

2014-07-01

...-free awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b..., and employee assistance programs; and (d) The penalties that you may impose upon them for drug abuse... 28 Judicial Administration 2 2014-07-01 2014-07-01 false What must I include in my drug-free...

28 CFR 83.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2013 CFR

2013-07-01

...-free awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b..., and employee assistance programs; and (d) The penalties that you may impose upon them for drug abuse... 28 Judicial Administration 2 2013-07-01 2013-07-01 false What must I include in my drug-free...

28 CFR 83.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2010 CFR

2010-07-01

...-free awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b..., and employee assistance programs; and (d) The penalties that you may impose upon them for drug abuse... 28 Judicial Administration 2 2010-07-01 2010-07-01 false What must I include in my drug-free...

21 CFR 1301.74 - Other security controls for non-practitioners; narcotic treatment programs and compounders for...

Code of Federal Regulations, 2012 CFR

2012-04-01

... the substances(s) by contacting the Drug Enforcement Administration. (h) The acceptance of delivery of... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Other security controls for non-practitioners... and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE REGISTRATION OF MANUFACTURERS...

21 CFR 1301.74 - Other security controls for non-practitioners; narcotic treatment programs and compounders for...

Code of Federal Regulations, 2013 CFR

2013-04-01

... the substances(s) by contacting the Drug Enforcement Administration. (h) The acceptance of delivery of... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Other security controls for non-practitioners... and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE REGISTRATION OF MANUFACTURERS...

21 CFR 1301.74 - Other security controls for non-practitioners; narcotic treatment programs and compounders for...

Code of Federal Regulations, 2014 CFR

2014-04-01

... the substances(s) by contacting the Drug Enforcement Administration. (h) The acceptance of delivery of... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Other security controls for non-practitioners... and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE REGISTRATION OF MANUFACTURERS...

Drug Free Communities Support Program. Prevention Update

ERIC Educational Resources Information Center

Higher Education Center for Alcohol, Drug Abuse, and Violence Prevention, 2012

2012-01-01

Administered by the Office of National Drug Control Policy (ONDCP), in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA), the Drug Free Communities Support Program (DFC) is a federal grant program that provides funding to community-based coalitions that organize to prevent youth substance use. Since the…

Program Administrator's Handbook. Strategies for Preventing Alcohol and Other Drug Problems. The College Series.

ERIC Educational Resources Information Center

CSR, Inc., Washington, DC.

This handbook is for administrators of programs in higher education settings which deal with alcohol and other drug (AOD) related problems. Chapter 1, "Defining the Problem, Issues, and Trends" examines the problem from various perspectives and presents the latest statistics on the extent of AOD use on campuses, specific problems affecting…

Syringe Exchange, Injecting and Intranasal Drug Use

PubMed Central

Arasteh, Kamyar; McKnight, Courtney; Ringer, Martin; Friedman, Samuel R.

2016-01-01

Objective To assess trends in injecting and non-injecting drug use after implementation of large-scale syringe exchange in New York City. The belief that implementation of syringe exchange will lead to increased drug injecting has been a persistent argument against syringe exchange. Methods Administrative data on route of administration for primary drug of abuse among patients entering the Beth Israel methadone maintenance program from 1995 – 2007. Approximately 2000 patients enter the program each year. Results During and after the period of large scale implementation of syringe exchange, the numbers of methadone program entrants reporting injecting drug use decreased while the numbers of entrants reporting intranasal drug use increased (p < .001). Conclusion While assessing possible effects of syringe exchange on trends in injecting drug use is inherently difficult, this may be the strongest data collected to date showing a lack of increase in drug injecting following implementation of syringe exchange. PMID:19891668

Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs.

PubMed

Le, Tran T

2017-01-01

Over 30 years ago, the United States (US) Congress passed the Orphan Drug Act (ODA) to encourage the development of products for rare diseases or conditions ("orphan products"). The Act provided incentives to sponsors for developing products with orphan designation and established a grant program to fund studies of orphan products. Since its enactment in 1983, the ODA has been credited for bringing more than 590 orphan drugs to the market, inspiring the implementation of orphan legislation globally, and enabling the creation of other programs that extend existing knowledge of the natural history of rare diseases and stimulate the development of medical devices for children and patients with rare diseases. This chapter provides a brief overview of the main features and successes of 5 of the orphan incentive programs administered by the US Food and Drug Administration (FDA): the Orphan Drug Designation Program, the Humanitarian Use Device (HUD) Designation Program, the Orphan Products Clinical Trials Grants Program, the Pediatric Device Consortia (PDC) Grant Program, and the Orphan Products Natural History Grants Program.

76 FR 24035 - Generic Drug User Fee; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-29

...] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS... development of a generic drug user fee program. A user fee program could provide necessary supplemental... announcing its intention to hold a public meeting related to generic drug user fees. The Agency continues to...

76 FR 44014 - Generic Drug User Fee; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

...] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS... development of a generic drug user fee program. A user fee program could provide necessary supplemental... generic drug user fees. New legislation would be required for FDA to establish and collect user fees for...

13 CFR 147.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2013 CFR

2013-01-01

... establish an ongoing drug-free awareness program to inform employees about— (a) The dangers of drug abuse in... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false What must I include in my drug... ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (NONPROCUREMENT) Requirements for Recipients...

13 CFR 147.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2012 CFR

2012-01-01

... establish an ongoing drug-free awareness program to inform employees about— (a) The dangers of drug abuse in... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false What must I include in my drug... ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (NONPROCUREMENT) Requirements for Recipients...

13 CFR 147.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2014 CFR

2014-01-01

... establish an ongoing drug-free awareness program to inform employees about— (a) The dangers of drug abuse in... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false What must I include in my drug... ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (NONPROCUREMENT) Requirements for Recipients...

13 CFR 147.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2010 CFR

2010-01-01

... establish an ongoing drug-free awareness program to inform employees about— (a) The dangers of drug abuse in... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false What must I include in my drug... ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (NONPROCUREMENT) Requirements for Recipients...

14 CFR 1267.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2010 CFR

2010-01-01

... establish an ongoing drug-free awareness program to inform employees about— (a) The dangers of drug abuse in... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false What must I include in my drug-free... ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Requirements for...

13 CFR 147.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2011 CFR

2011-01-01

... establish an ongoing drug-free awareness program to inform employees about— (a) The dangers of drug abuse in... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false What must I include in my drug... ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (NONPROCUREMENT) Requirements for Recipients...

14 CFR 1267.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2013 CFR

2013-01-01

... establish an ongoing drug-free awareness program to inform employees about— (a) The dangers of drug abuse in... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false What must I include in my drug-free... ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Requirements for...

14 CFR 1267.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2012 CFR

2012-01-01

... establish an ongoing drug-free awareness program to inform employees about— (a) The dangers of drug abuse in... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false What must I include in my drug-free... ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Requirements for...

14 CFR 1267.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2011 CFR

2011-01-01

... establish an ongoing drug-free awareness program to inform employees about— (a) The dangers of drug abuse in... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true What must I include in my drug-free... ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Requirements for...

49 CFR 219.608 - FRA Administrator's determination of random alcohol testing rate.

Code of Federal Regulations, 2012 CFR

2012-10-01

... alcohol testing rate. 219.608 Section 219.608 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.608 FRA Administrator's determination of random alcohol...

49 CFR 219.608 - FRA Administrator's determination of random alcohol testing rate.

Code of Federal Regulations, 2011 CFR

2011-10-01

... alcohol testing rate. 219.608 Section 219.608 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.608 FRA Administrator's determination of random alcohol...

49 CFR 219.608 - FRA Administrator's determination of random alcohol testing rate.

Code of Federal Regulations, 2014 CFR

2014-10-01

... alcohol testing rate. 219.608 Section 219.608 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.608 FRA Administrator's determination of random alcohol...

49 CFR 219.608 - FRA Administrator's determination of random alcohol testing rate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... alcohol testing rate. 219.608 Section 219.608 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.608 FRA Administrator's determination of random alcohol...

49 CFR 219.608 - FRA Administrator's determination of random alcohol testing rate.

Code of Federal Regulations, 2013 CFR

2013-10-01

... alcohol testing rate. 219.608 Section 219.608 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.608 FRA Administrator's determination of random alcohol...

The Evolution of a Community Drug Abuse Program: Families Have a Critical Role.

ERIC Educational Resources Information Center

Hyland, Timothy F.; Schrenker, Robert J.

This description of the Merrillville Substance Abuse Program initially reviews the problems that student drug abuse poses for school administrators. A community needs assessment is described and the evolution of a developmental drug education program is presented. Educational strategies targeted to parents, teachers, and students are discussed,…

Administrator's Handbook for Crime Prevention and Drug Education.

ERIC Educational Resources Information Center

Texas Education Agency, Austin. Div. of Crime Prevention and Drug Education.

Acts of three Texas Legislatures have mandated that the schools of Texas provide a program for all public school students, grades K-12, in crime prevention and drug education. To assist schools in formulating a philosophy about and in developing appropriate programs and techniques for drug education and crime prevention programs, the Texas…

14 CFR § 1267.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2014 CFR

2014-01-01

... establish an ongoing drug-free awareness program to inform employees about— (a) The dangers of drug abuse in... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false What must I include in my drug-free... ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Requirements for...

Working together: Expanding the availability of naloxone for peer administration to prevent opioid overdose deaths in the Australian Capital Territory and beyond.

PubMed

Lenton, Simon; Dietze, Paul; Olsen, Anna; Wiggins, Nicole; McDonald, David; Fowlie, Carrie

2015-07-01

Since the mid-1990s, there have been calls to make naloxone, a prescription-only medicine in many countries, available to heroin and other opioid users and their peers and family members to prevent overdose deaths. In Australia there were calls for a trial of peer naloxone in 2000, yet at the end of that year, heroin availability and harm rapidly declined, and a trial did not proceed. In other countries, a number of peer naloxone programs have been successfully implemented. Although a controlled trial had not been conducted, evidence of program implementation demonstrated that trained injecting drug-using peers and others could successfully administer naloxone to reverse heroin overdose, with few, if any, adverse effects. In 2009 Australian drug researchers advocated the broader availability of naloxone for peer administration in cases of opioid overdose. Industrious local advocacy and program development work by a number of stakeholders, notably by the Canberra Alliance for Harm Minimisation and Advocacy, a drug user organisation, contributed to the rollout of Australia's first prescription naloxone program in the Australian Capital Territory (ACT). Over the subsequent 18 months, prescription naloxone programs were commenced in four other Australian states. The development of Australia's first take-home naloxone program in the ACT has been an 'ice-breaker' for development of other Australian programs. Issues to be addressed to facilitate future scale-up of naloxone programs concern scheduling and cost, legal protections for lay administration, prescribing as a barrier to scale-up; intranasal administration, administration by service providers and collaboration between stakeholders. © 2014 Australasian Professional Society on Alcohol and other Drugs.

Oral Fluid Testing for Drugs of Abuse

PubMed Central

Bosker, Wendy M.; Huestis, Marilyn A.

2011-01-01

BACKGROUND Oral fluid (OF) is an exciting alternative matrix for monitoring drugs of abuse in workplace, clinical toxicology, criminal justice, and driving under the influence of drugs (DUID) programs. During the last 5 years, scientific and technological advances in OF collection, point-of-collection testing devices, and screening and confirmation methods were achieved. Guidelines were proposed for workplace OF testing by the Substance Abuse and Mental Health Services Administration, DUID testing by the European Union’s Driving under the Influence of Drugs, Alcohol and Medicines (DRUID) program, and standardization of DUID research. Although OF testing is now commonplace in many monitoring programs, the greatest current limitation is the scarcity of controlled drug administration studies available to guide interpretation. CONTENT This review outlines OF testing advantages and limitations, and the progress in OF that has occurred during the last 5 years in collection, screening, confirmation, and interpretation of cannabinoids, opioids, amphetamines, cocaine, and benzodiazepines. We examine controlled drug administration studies, immunoassay and chromatographic methods, collection devices, point-of-collection testing device performance, and recent applications of OF testing. SUMMARY Substance Abuse and Mental Health Services Administration approval of OF testing was delayed because questions about drug OF disposition were not yet resolved, and collection device performance and testing assays required improvement. Here, we document the many advances achieved in the use of OF. Additional research is needed to identify new bio-markers, determine drug detection windows, characterize OF adulteration techniques, and evaluate analyte stability. Nevertheless, there is no doubt that OF offers multiple advantages as an alternative matrix for drug monitoring and has an important role in DUID, treatment, workplace, and criminal justice programs. PMID:19745062

75 FR 3153 - Drug and Alcohol Testing Program; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-20

.... FAA-2008-0937; Amendment No. 120-0A, 135-117A] RIN 2120-AJ37 Drug and Alcohol Testing Program... Aviation Administration (FAA) is correcting its drug and alcohol testing regulations published on May 14... and alcohol testing requirements. The final rule was necessary to gather all of the existing drug and...

28 CFR 550.40 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.40... community treatment center (CTC) participate in a program of urine testing for drug use. An inmate who is...

21 CFR 1305.07 - Special procedure for filling certain orders.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Special procedure for filling certain orders. 1305.07 Section 1305.07 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ORDERS FOR... management programs, or research, and is authorized by the Administrator to handle these substances, may fill...

49 CFR 219.607 - Railroad random alcohol testing programs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.607 Railroad random alcohol testing programs. (a) Each railroad must submit for FRA approval... 49 Transportation 4 2012-10-01 2012-10-01 false Railroad random alcohol testing programs. 219.607...

49 CFR 219.607 - Railroad random alcohol testing programs.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.607 Railroad random alcohol testing programs. (a) Each railroad must submit for FRA approval... 49 Transportation 4 2010-10-01 2010-10-01 false Railroad random alcohol testing programs. 219.607...

49 CFR 219.607 - Railroad random alcohol testing programs.

Code of Federal Regulations, 2011 CFR

2011-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.607 Railroad random alcohol testing programs. (a) Each railroad must submit for FRA approval... 49 Transportation 4 2011-10-01 2011-10-01 false Railroad random alcohol testing programs. 219.607...

49 CFR 219.607 - Railroad random alcohol testing programs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.607 Railroad random alcohol testing programs. (a) Each railroad must submit for FRA approval... 49 Transportation 4 2013-10-01 2013-10-01 false Railroad random alcohol testing programs. 219.607...

49 CFR 219.607 - Railroad random alcohol testing programs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.607 Railroad random alcohol testing programs. (a) Each railroad must submit for FRA approval... 49 Transportation 4 2014-10-01 2014-10-01 false Railroad random alcohol testing programs. 219.607...

The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.

PubMed

Wallach, Joshua D; Ross, Joseph S; Naci, Huseyin

2018-06-01

The US Food and Drug Administration has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs is the regulatory flexibility, which allows for a customized approval approach that enables market authorization on the basis of less rigorous evidence, in exchange for requiring postmarket evidence generation. An increasing share of therapeutic agents approved by the Food and Drug Administration in recent years are associated with expedited programs. In this article, we provide an overview of the evidentiary standards required by the Food and Drug Administration's expedited development and review programs, summarize the findings of the recent academic literature demonstrating some of the limitations of these programs, and outline potential opportunities to address these limitations. Recent evidence suggests that therapeutic agents in the Food and Drug Administration's expedited programs are approved on the basis of fewer and smaller studies that may lack comparator groups and random allocation, and rather than focusing on clinical outcomes for study endpoints, rely instead on surrogate markers of disease. Once on the market, agents receiving expedited approvals are often quickly incorporated into clinical practice, and evidence generated in the postmarket period may not necessarily address the evidentiary limitations at the time of market entry. Furthermore, not all pathways require additional postmarket studies. Evidence suggests that drugs in expedited approval programs are associated with a greater likelihood that the Food and Drug Administration will take a safety action following market entry. There are several opportunities to improve the timeliness, information value, and validity of the pre- and postmarket studies of therapeutic agents receiving expedited approvals. When use of nonrandomized and uncontrolled studies cannot be avoided prior to market entry, randomized trials should be mandatory in the postmarket period, unless there are strong justifications for not carrying out such studies. In the premarket period, validity of the surrogate markers can be improved by more rigorously evaluating their correlation with patient-relevant clinical outcomes. Opportunities to reduce the duration, complexity, and cost of postmarket randomized trials should not compromise their validity and instead incorporate pragmatic "real-world" design elements. Despite recent enthusiasm for widely using real-world evidence, adaptive designs, and pragmatic trials in the regulatory setting, caution is warranted until large-scale empirical evaluations demonstrate their validity compared to more traditional trial designs.

Comparing errors in ED computer-assisted vs conventional pediatric drug dosing and administration.

PubMed

Yamamoto, Loren; Kanemori, Joan

2010-06-01

Compared to fixed-dose single-vial drug administration in adults, pediatric drug dosing and administration requires a series of calculations, all of which are potentially error prone. The purpose of this study is to compare error rates and task completion times for common pediatric medication scenarios using computer program assistance vs conventional methods. Two versions of a 4-part paper-based test were developed. Each part consisted of a set of medication administration and/or dosing tasks. Emergency department and pediatric intensive care unit nurse volunteers completed these tasks using both methods (sequence assigned to start with a conventional or a computer-assisted approach). Completion times, errors, and the reason for the error were recorded. Thirty-eight nurses completed the study. Summing the completion of all 4 parts, the mean conventional total time was 1243 seconds vs the mean computer program total time of 879 seconds (P < .001). The conventional manual method had a mean of 1.8 errors vs the computer program with a mean of 0.7 errors (P < .001). Of the 97 total errors, 36 were due to misreading the drug concentration on the label, 34 were due to calculation errors, and 8 were due to misplaced decimals. Of the 36 label interpretation errors, 18 (50%) occurred with digoxin or insulin. Computerized assistance reduced errors and the time required for drug administration calculations. A pattern of errors emerged, noting that reading/interpreting certain drug labels were more error prone. Optimizing the layout of drug labels could reduce the error rate for error-prone labels. Copyright (c) 2010 Elsevier Inc. All rights reserved.

49 CFR 199.113 - Employee assistance program.

Code of Federal Regulations, 2013 CFR

2013-10-01

... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.113 Employee assistance program. (a) Each operator shall provide an employee... must be drug tested based on reasonable cause. The operator may establish the EAP as a part of its...

49 CFR 199.113 - Employee assistance program.

Code of Federal Regulations, 2010 CFR

2010-10-01

... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.113 Employee assistance program. (a) Each operator shall provide an employee... must be drug tested based on reasonable cause. The operator may establish the EAP as a part of its...

49 CFR 199.113 - Employee assistance program.

Code of Federal Regulations, 2012 CFR

2012-10-01

... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.113 Employee assistance program. (a) Each operator shall provide an employee... must be drug tested based on reasonable cause. The operator may establish the EAP as a part of its...

49 CFR 199.113 - Employee assistance program.

Code of Federal Regulations, 2011 CFR

2011-10-01

... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.113 Employee assistance program. (a) Each operator shall provide an employee... must be drug tested based on reasonable cause. The operator may establish the EAP as a part of its...

49 CFR 199.113 - Employee assistance program.

Code of Federal Regulations, 2014 CFR

2014-10-01

... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.113 Employee assistance program. (a) Each operator shall provide an employee... must be drug tested based on reasonable cause. The operator may establish the EAP as a part of its...

42 CFR 423.800 - Administration of subsidy program.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Administration of subsidy program. 423.800 Section 423.800 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Premiums and Cost...

21 CFR 1403.40 - Monitoring and reporting program performance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Monitoring and reporting program performance. 1403.40 Section 1403.40 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY UNIFORM ADMINISTRATIVE... developments. Events may occur between the scheduled performance reporting dates which have significant impact...

United States Food and Drug Administration Product Label Changes

PubMed Central

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

2017-01-01

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

United States Food and Drug Administration Product Label Changes

PubMed Central

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

2016-01-01

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

United States Food and Drug Administration Product Label Changes.

PubMed

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

2017-02-01

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

One day access to a running wheel reduces self-administration of d-methamphetamine, MDMA and Methylone

PubMed Central

Aarde, Shawn M.; Miller, Michelle L.; Creehan, Kevin M.; Vandewater, Sophia A.; Taffe, Michael A.

2015-01-01

Background Exercise influences drug craving and consumption in humans and drug self-administration in laboratory animals, but the effects can be variable. Improved understanding of how exercise affects drug intake or craving would enhance applications of exercise programs to human drug users attempting cessation. Methods Rats were trained in the intravenous self-administration (IVSA) of d-methamphetamine (METH; 0.05 mg/kg/inf), 3,4-methylenedioxymethamphetamine (MDMA; 0.5 mg/kg/inf) or methylone (0.5 mg/kg/inf). Once IVSA was established, the effect of ~22 hrs of wheel access in the home cage on subsequent drug taking was assessed in a two cohort crossover design. Results Provision of home cage wheel access during the day prior to IVSA sessions significantly decreased the self-administration of METH, MDMA and methylone. At the individual level, there was no correlation between the amount a rat used the wheel and the size of the individual’s decrease in drug intake. Conclusions Wheel access can reduce self-administration of a variety of psychomotor stimulants. It does so immediately, i.e., without a need for weeks of exercise prior to drug access. This study therefore indicates that future mechanistic investigations should focus on acute effects of exercise. In sum, the results predict that exercise programs can be used to decrease stimulant drug use in individuals even with no exercise history and an established drug taking pattern. PMID:25863714

Adverse drug events and medication problems in "Hospital at Home" patients.

PubMed

Mann, Elizabeth; Zepeda, Orlando; Soones, Tacara; Federman, Alex; Leff, Bruce; Siu, Albert; Boockvar, Kenneth

2018-03-26

"Hospital at Home(HaH)" programs provide an alternative to traditional hospitalization. However, the incidence of adverse drug events in these programs is unknown. This study describes adverse drug events and potential adverse drug events in a new HaH program. We examined the charts of the first 50 patients admitted. We found 45 potential adverse drug events and 14 adverse drug events from admission to 30 days after HaH discharge. None of the adverse drug events were severe. Some events, like problems with medication administration, may be unique to the hospital at home setting. Monitoring for adverse drug events is feasible and important for hospital at home programs.

Drug Enforcement Administration

MedlinePlus

... Cannabis Plant Counterfeit Prescription Pills Containing Fentanyls: A Global Threat Public Drug Disposal: Search for an Authorized Drug Disposal Location RESOURCE CENTER Controlled Substances Act DEA Museum and Visitors Center Doing Business with DEA Drug Disposal Employee Assistance Program For ...

28 CFR 550.41 - Urine surveillance.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Urine surveillance. 550.41 Section 550.41 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine...

28 CFR 550.42 - Procedures for urine surveillance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Procedures for urine surveillance. 550.42 Section 550.42 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs...

28 CFR 550.41 - Urine surveillance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Urine surveillance. 550.41 Section 550.41 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine...

28 CFR 550.42 - Procedures for urine surveillance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Procedures for urine surveillance. 550.42 Section 550.42 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs...

28 CFR 550.41 - Urine surveillance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Urine surveillance. 550.41 Section 550.41 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine...

28 CFR 550.42 - Procedures for urine surveillance.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Procedures for urine surveillance. 550.42 Section 550.42 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs...

28 CFR 550.41 - Urine surveillance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Urine surveillance. 550.41 Section 550.41 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine...

28 CFR 550.41 - Urine surveillance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Urine surveillance. 550.41 Section 550.41 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine...

28 CFR 550.42 - Procedures for urine surveillance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Procedures for urine surveillance. 550.42 Section 550.42 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs...

28 CFR 550.42 - Procedures for urine surveillance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Procedures for urine surveillance. 550.42 Section 550.42 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs...

The Best Prevention: Model Alcohol and Drug Education Program. NHTSA Prevention Guide.

ERIC Educational Resources Information Center

National Highway Traffic Safety Administration (DOT), Washington, DC.

This guide was created for school administrators, parents, teachers, and community groups interested in developing effective alcohol and drug abuse prevention programs for elementary and secondary schools. A comprehensive approach to school-based alcohol and drug prevention is described and various prevention activities which have been selected by…

New Jersey's Emergency Retrovir Reimbursement Program (ERRP).

ERIC Educational Resources Information Center

Conviser, Richard; And Others

In 1987 Congress made available a one-time, 1-year emergency appropriation to pay for Food and Drug Administration (FDA)-approved life-sustaining drugs for people with Acquired Immune Deficiency Syndrome (AIDS). New Jersey received $1.5 million from this program for antiviral drugs for low-income people with AIDS and AIDS Related Complex lacking…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-16

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

5 CFR 792.103 - Coverage.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 2 2013-01-01 2013-01-01 false Coverage. 792.103 Section 792.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) FEDERAL EMPLOYEES' HEALTH, COUNSELING, AND WORK/LIFE PROGRAMS Alcoholism and Drug Abuse Programs and Services for...

5 CFR 792.103 - Coverage.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 2 2012-01-01 2012-01-01 false Coverage. 792.103 Section 792.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) FEDERAL EMPLOYEES' HEALTH AND COUNSELING PROGRAMS Regulatory Requirements for Alcoholism and Drug Abuse Programs and...

5 CFR 792.103 - Coverage.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 2 2011-01-01 2011-01-01 false Coverage. 792.103 Section 792.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) FEDERAL EMPLOYEES' HEALTH AND COUNSELING PROGRAMS Regulatory Requirements for Alcoholism and Drug Abuse Programs and...

5 CFR 792.103 - Coverage.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Coverage. 792.103 Section 792.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) FEDERAL EMPLOYEES' HEALTH AND COUNSELING PROGRAMS Regulatory Requirements for Alcoholism and Drug Abuse Programs and...

5 CFR 792.103 - Coverage.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 2 2014-01-01 2014-01-01 false Coverage. 792.103 Section 792.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) FEDERAL EMPLOYEES' HEALTH, COUNSELING, AND WORK/LIFE PROGRAMS Alcoholism and Drug Abuse Programs and Services for...

78 FR 37723 - Laser Products; Proposed Amendment to Performance Standard

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1002, 1010, and... promote the public health. DATES: Submit either electronic or written comments on the proposed rule by... Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New...

Evidence-based treatment practices for drug-involved adults in the criminal justice system.

PubMed

Friedmann, Peter D; Taxman, Faye S; Henderson, Craig E

2007-04-01

The aim of this study was to estimate the extent and organizational correlates of evidence-based practices (EBPs) in correctional facilities and community-based substance abuse treatment programs that manage drug-involved adult offenders. Correctional administrators and treatment program directors affiliated with a national sample of 384 criminal justice and community-based programs providing substance abuse treatment to adult offenders in the United States were surveyed in 2004. Correctional administrators reported the availability of up to 13 specified EBPs, and treatment directors up to 15. The sum total of EBPs indicates their extent. Linear models regress the extent of EBPs on variables measuring structure and leadership, culture and climate, administrator attitudes, and network connectedness of the organization. Most programs offer fewer than 60% of the specified EBPs to drug-involved offenders. In multiple regression models, offender treatment programs that provided more EBPs were community based, accredited, and network connected, with a performance-oriented, nonpunitive culture, more training resources, and leadership with a background in human services, a high regard for the value of substance abuse treatment, and an understanding of EBPs. The use of EBPs among facility- and community-based programs that serve drug-involved adult offenders has room for improvement. Initiatives to disseminate EBPs might target these institutional and environmental domains, but further research is needed to determine whether such organization interventions can promote the uptake of EBPs.

EVIDENCE-BASED TREATMENT PRACTICES FOR DRUG-INVOLVED ADULTS IN THE CRIMINAL JUSTICE SYSTEM

PubMed Central

Friedmann, Peter D.; Taxman, Faye S.; Henderson, Craig E.

2007-01-01

OBJECTIVE To estimate the extent and organizational correlates of evidence-based practices (EBPs) in correctional facilities and community-based substance abuse treatment programs that manage drug-involved adult offenders. METHODS Correctional administrators and treatment program directors affiliated with a national sample of 384 criminal justice and community-based programs providing substance abuse treatment to adult offenders in the United States were surveyed in 2004. Correctional administrators reported the availability of up to 13 specified EBPs and treatment directors up to 15. The sum total of EBPs indicates their extent. Linear models regress the extent of EBPs on variables measuring structure and leadership, culture and climate, administrator attitudes and network connectedness of the organization. RESULTS Most programs offer fewer than 60% of the specified EBPs to drug-involved offenders. In multiple regression models, offender treatment programs that provided more EBPs were community-based, accredited, and network-connected; with a performance-oriented, non-punitive culture, more training resources; and leadership with a background in human services, a high regard for the value of substance abuse treatment and an understanding of EBPs. CONCLUSIONS The use of EBPs among facility- and community-based programs that serve drug-involved adult offenders has room for improvement. Initiatives to disseminate EBPs might target these institutional and environmental domains, but further research is needed to determine whether such organization interventions can promote the uptake of EBPs. PMID:17383551

48 CFR 1823.570 - Drug- and alcohol-free workforce.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Drug- and alcohol-free... ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 1823.570 Drug- and alcohol-free workforce...

48 CFR 1823.570 - Drug- and alcohol-free workforce.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Drug- and alcohol-free... ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 1823.570 Drug- and alcohol-free workforce...

Consequences of the 340B Drug Pricing Program.

PubMed

Desai, Sunita; McWilliams, J Michael

2018-02-08

The 340B Drug Pricing Program entitles qualifying hospitals to discounts on outpatient drugs, increasing the profitability of drug administration. By tying the program eligibility of hospitals to their Disproportionate Share Hospital (DSH) adjustment percentage, which reflects the proportion of hospitalized patients who are low-income, the program is intended to expand resources for underserved populations but provides no direct incentives for hospitals to use financial gains to enhance care for low-income patients. We used Medicare claims and a regression-discontinuity design, taking advantage of the threshold for program eligibility among general acute care hospitals (DSH percentage, >11.75%), to isolate the effects of the program on hospital-physician consolidation (i.e., acquisition of physician practices or employment of physicians by hospitals) and on the outpatient administration of parenteral drugs by hospital-owned facilities in three specialties in which parenteral drugs are frequently used. For low-income patients, we also assessed the effects of the program on the provision of care by hospitals and on mortality. Hospital eligibility for the 340B Program was associated with 2.3 more hematologist-oncologists practicing in facilities owned by the hospital, or 230% more hematologist-oncologists than expected in the absence of the program (P=0.02), and with 0.9 (or 900%) more ophthalmologists per hospital (P=0.08) and 0.1 (or 33%) more rheumatologists per hospital (P=0.84). Program eligibility was associated with significantly higher numbers of parenteral drug claims billed by hospitals for Medicare patients in hematology-oncology (90% higher, P=0.001) and ophthalmology (177% higher, P=0.03) but not rheumatology (77% higher, P=0.12). Program eligibility was associated with lower proportions of low-income patients in hematology-oncology and ophthalmology and with no significant differences in hospital provision of safety-net or inpatient care for low-income groups or in mortality among low-income residents of the hospitals' local service areas. The 340B Program has been associated with hospital-physician consolidation in hematology-oncology and with more hospital-based administration of parenteral drugs in hematology-oncology and ophthalmology. Financial gains for hospitals have not been associated with clear evidence of expanded care or lower mortality among low-income patients. (Funded by the Agency for Healthcare Research and Quality and others.).

Controlling prescription drug costs: regulation and the role of interest groups in Medicare and the Veterans Health Administration.

PubMed

Frakt, Austin B; Pizer, Steven D; Hendricks, Ann M

2008-12-01

Medicare and the Veterans Health Administration (VA) both finance large outpatient prescription drug programs, though in very different ways. In the ongoing debate on how to control Medicare spending, some suggest that Medicare should negotiate directly with drug manufacturers, as the VA does. In this article we relate the role of interest groups to policy differences between Medicare and the VA and, in doing so, explain why such a large change to the Medicare drug program is unlikely. We argue that key policy differences are attributable to stable differences in interest group involvement. While this stability makes major changes in Medicare unlikely, it suggests the possibility of leveraging VA drug purchasing to achieve savings in Medicare. This could be done through a VA-administered drug-only benefit for Medicare-enrolled veterans. Such a partnership could incorporate key elements of both programs: capacity to accept large numbers of enrollees (like Medicare) and leverage to negotiate prescription drug prices (like the VA). Moreover, it could be implemented at no cost to the VA while achieving savings for Medicare and beneficiaries.

Characteristics of substance abuse treatment programs providing services for HIV/AIDS, hepatitis C virus infection, and sexually transmitted infections: the National Drug Abuse Treatment Clinical Trials Network.

PubMed

Brown, Lawrence S; Kritz, Steven Allan; Goldsmith, R Jeffrey; Bini, Edmund J; Rotrosen, John; Baker, Sherryl; Robinson, Jim; McAuliffe, Patrick

2006-06-01

Illicit drug users sustain the epidemics of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis C (HCV), and sexually transmitted infections (STIs). Substance abuse treatment programs present a major intervention point in stemming these epidemics. As a part of the "Infections and Substance Abuse" study, established by the National Drug Abuse Treatment Clinical Trials Network, sponsored by National Institute on Drug Abuse, three surveys were developed; for treatment program administrators, for clinicians, and for state and District of Columbia health and substance abuse department administrators, capturing service availability, government mandates, funding, and other key elements related to the three infection groups. Treatment programs varied in corporate structure, source of revenue, patient census, and medical and non-medical staffing; medical services, counseling services, and staff education targeted HIV/AIDS more often than HCV or STIs. The results from this study have the potential to generate hypotheses for further health services research to inform public policy.

75 FR 70679 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-18

... ``Manufactured Food Regulatory Program Standards'' has been approved by the Office of Management and Budget (OMB... Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0554...

78 FR 950 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0530... Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Withdrawal... a Food and Drug Administration (FDA) notice that published in the Federal Register of December 11...

What You Need to Know about Starting a Student Drug-Testing Program

ERIC Educational Resources Information Center

Office of National Drug Control Policy, 2004

2004-01-01

"What You Need to Know About Starting a Student Drug-Testing Program" is meant to Complement, and build on information provided in an earlier publication, "What You Need to Know about Drug Testing in Schools." This booklet assumes that you as a school, administrator, staff member, or parent involved in the decision have considered all the…

49 CFR 219.603 - Participation in drug testing.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 4 2014-10-01 2014-10-01 false Participation in drug testing. 219.603 Section 219... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.603 Participation in drug testing. A railroad shall, under the conditions specified in this...

49 CFR 219.603 - Participation in drug testing.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 4 2013-10-01 2013-10-01 false Participation in drug testing. 219.603 Section 219... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.603 Participation in drug testing. A railroad shall, under the conditions specified in this...

49 CFR 219.603 - Participation in drug testing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Participation in drug testing. 219.603 Section 219... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.603 Participation in drug testing. A railroad shall, under the conditions specified in this...

49 CFR 219.603 - Participation in drug testing.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Participation in drug testing. 219.603 Section 219... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.603 Participation in drug testing. A railroad shall, under the conditions specified in this...

49 CFR 219.603 - Participation in drug testing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Participation in drug testing. 219.603 Section 219... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.603 Participation in drug testing. A railroad shall, under the conditions specified in this...

76 FR 24537 - Paperwork Reduction Act; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

...: ONDCP directs the Drug Free Communities (DFC) Program in partnership with the Substance Abuse and Mental Health Services Administration's Center for Substance Abuse Prevention. The DFC Program has two primary goals: To reduce youth substance abuse, and to support community anti-drug coalitions by establishing...

28 CFR 550.10 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Purpose and scope. 550.10 Section 550.10 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Alcohol Testing § 550.10 Purpose and scope. The Bureau of Prisons maintains a surveillance program in...

20 CFR 418.3610 - Is there administrative or judicial review for administrative actions that are not initial...

Code of Federal Regulations, 2010 CFR

2010-04-01

...' Benefits SOCIAL SECURITY ADMINISTRATION MEDICARE SUBSIDIES Medicare Part D Subsidies Determinations and the... these sections. For example, changes in your prescription drug program or voluntary disenrollment in the...

75 FR 79308 - Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... from Management Information System annual reports, FRA has determined that the 2009 rail industry... program data taken from FRA's Management Information System. Based on this data, the Administrator... effective December 20, 2010. FOR FURTHER INFORMATION CONTACT: Lamar Allen, Alcohol and Drug Program Manager...

49 CFR 655.12 - Required elements of an anti-drug use and alcohol misuse program.

Code of Federal Regulations, 2012 CFR

2012-10-01

... verified positive drug test result or an alcohol concentration of 0.04 or greater to a Substance Abuse... misuse program. 655.12 Section 655.12 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND...

49 CFR 655.12 - Required elements of an anti-drug use and alcohol misuse program.

Code of Federal Regulations, 2011 CFR

2011-10-01

... verified positive drug test result or an alcohol concentration of 0.04 or greater to a Substance Abuse... misuse program. 655.12 Section 655.12 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND...

49 CFR 655.12 - Required elements of an anti-drug use and alcohol misuse program.

Code of Federal Regulations, 2010 CFR

2010-10-01

... verified positive drug test result or an alcohol concentration of 0.04 or greater to a Substance Abuse... misuse program. 655.12 Section 655.12 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND...

49 CFR 655.12 - Required elements of an anti-drug use and alcohol misuse program.

Code of Federal Regulations, 2014 CFR

2014-10-01

... verified positive drug test result or an alcohol concentration of 0.04 or greater to a Substance Abuse... misuse program. 655.12 Section 655.12 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND...

49 CFR 655.12 - Required elements of an anti-drug use and alcohol misuse program.

Code of Federal Regulations, 2013 CFR

2013-10-01

... verified positive drug test result or an alcohol concentration of 0.04 or greater to a Substance Abuse... misuse program. 655.12 Section 655.12 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND...

78 FR 48691 - Food and Drug Administration Patient Network Annual Meeting; Demystifying Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-09

... 240-316-3200 ext. 207. If you need special accommodations due to a disability, please specify those... impact the drug development and review paradigm. Though several programs exist that facilitate patient...

Drug and alcohol testing results 2004 annual report

DOT National Transportation Integrated Search

2006-11-01

This is the 10th annual report of the results of the Federal Transit Administrations (FTA) Drug and Alcohol Testing Program. This report summarizes the reporting requirements for calendar year 2006, the requirements of the overall drug and alcohol...

Drug and alcohol testing results 2005 annual report

DOT National Transportation Integrated Search

2008-01-01

This is the 11th annual report of the results of the Federal Transit Administrations (FTA's) Drug and Alcohol Testing Program. This report summarizes the reporting requirements for calendar year 2005, the requirements of the overall drug and alcoh...

Drug and Alcohol Testing Results 2008 Annual Report

DOT National Transportation Integrated Search

2010-09-01

This is the 14th annual report of the results of the Federal Transit Administration's (FTA) Drug and Alcohol Testing : Program. This report summarizes the reporting requirements for calendar year 2008, the requirements of the overall : drug and alcoh...

Drug and alcohol testing results 2009 annual report

DOT National Transportation Integrated Search

2013-12-01

This is the 15th annual report of the results of the Federal Transit Administrations (FTA) Drug and Alcohol Testing : Program. This report summarizes the reporting requirements for calendar year 2009, the requirements of the overall : drug and alc...

Drug and alcohol testing results 2009 annual report

DOT National Transportation Integrated Search

2013-11-01

This is the 15th annual report of the results of the Federal Transit Administrations (FTA) Drug and Alcohol Testing Program. This report summarizes the reporting requirements for calendar year 2009, the requirements of the overall drug and alcohol...

Drug and alcohol testing results 2007 annual report

DOT National Transportation Integrated Search

2009-05-01

This is the 13th annual report of the results of the Federal Transit Administrations (FTA) Drug and Alcohol Testing Program. This report summarizes the reporting requirements for calendar year 2007, the requirements of the overall drug and alcohol...

77 FR 74582 - Small Entity Compliance Guide: What You Need To Know About Registration of Food Facilities...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-17

..., Division of Field Programs and Guidance (HFS-615), Center for Food Safety and Applied Nutrition, Food and..., Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No FDA...

28 CFR 550.30 - Purpose and scope.

Code of Federal Regulations, 2013 CFR

2013-07-01

... drug use, to monitor specific groups or individual inmates who are considered as high risk for drug use, such as those involved in community activities, those with a history of drug use, and those inmates... Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS...

28 CFR 550.30 - Purpose and scope.

Code of Federal Regulations, 2011 CFR

2011-07-01

... drug use, to monitor specific groups or individual inmates who are considered as high risk for drug use, such as those involved in community activities, those with a history of drug use, and those inmates... Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS...

28 CFR 550.30 - Purpose and scope.

Code of Federal Regulations, 2014 CFR

2014-07-01

... drug use, to monitor specific groups or individual inmates who are considered as high risk for drug use, such as those involved in community activities, those with a history of drug use, and those inmates... Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS...

28 CFR 550.30 - Purpose and scope.

Code of Federal Regulations, 2012 CFR

2012-07-01

... drug use, to monitor specific groups or individual inmates who are considered as high risk for drug use, such as those involved in community activities, those with a history of drug use, and those inmates... Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS...

28 CFR 550.30 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-07-01

... drug use, to monitor specific groups or individual inmates who are considered as high risk for drug use, such as those involved in community activities, those with a history of drug use, and those inmates... Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS...

Drug Testing of Public Employees: An Introduction.

ERIC Educational Resources Information Center

Jascourt, Hugh D.

1988-01-01

The Federal Government has pushed employers to establish programs to test applicants and employees for drug use. The accompanying articles discuss legal barriers to drug testing and test administration and practical problems that limit the feasibility of drug testing and carry with them potential legal problems. (MLF)

Drug and alcohol testing results 2006 annual report.

DOT National Transportation Integrated Search

2008-08-01

This is the 12th annual report of the results of the Federal Transit Administration's (FTA) Drug and Alcohol Testing Program. This report summarizes the reporting requirements for calendar year 2006, the requirements of the overall drug and alcohol t...

42 CFR 52.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... for Health, the Substance Abuse and Mental Health Administration, and the Agency for Toxic Substances... organization to have the appropriate level of authority and responsibility to direct the project or program... and Prevention, the Food and Drug Administration, the Health Resources and Services Administration...

42 CFR 52.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... for Health, the Substance Abuse and Mental Health Administration, and the Agency for Toxic Substances... organization to have the appropriate level of authority and responsibility to direct the project or program... and Prevention, the Food and Drug Administration, the Health Resources and Services Administration...

42 CFR 52.2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... for Health, the Substance Abuse and Mental Health Administration, and the Agency for Toxic Substances... organization to have the appropriate level of authority and responsibility to direct the project or program... and Prevention, the Food and Drug Administration, the Health Resources and Services Administration...

42 CFR 52.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... for Health, the Substance Abuse and Mental Health Administration, and the Agency for Toxic Substances... organization to have the appropriate level of authority and responsibility to direct the project or program... and Prevention, the Food and Drug Administration, the Health Resources and Services Administration...

42 CFR 52.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... for Health, the Substance Abuse and Mental Health Administration, and the Agency for Toxic Substances... organization to have the appropriate level of authority and responsibility to direct the project or program... and Prevention, the Food and Drug Administration, the Health Resources and Services Administration...

Nepafenac Ophthalmic

MedlinePlus

... inflammatory drugs (NSAIDs). It works by stopping the production of certain natural substances that cause pain and ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

76 FR 59415 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-26

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, Multisites... Administrator, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4234, MSC 9550... funding cycle. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction...

76 FR 65909 - Medicare and Medicaid Program; Regulatory Provisions To Promote Program Efficiency, Transparency...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... commonly found in other medical facilities, for example, cooking, anesthesia, paint shops, or piped-in... Part A and Part B claims appeals. In 2003, the Medicare Prescription Drug, Improvement, and... BIPA. The Food and Drug Administration's (FDA) categorization of a product as a category A device is...

Program Administration | Division of Cancer Prevention

Cancer.gov

Governance Structure Recognizing the importance of an integrated approach to preventative drug development, there is a unified Governance Structure for the PREVENT Program responsible for coordinating and integrating available resources. With the goal of reaching go/no-go decisions as efficiently as possible, the purpose is to ensure a pragmatic approach to drug development

49 CFR 219.611 - Test result indicating prohibited alcohol concentration; procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.611 Test result indicating prohibited alcohol...

49 CFR 219.611 - Test result indicating prohibited alcohol concentration; procedures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.611 Test result indicating prohibited alcohol...

49 CFR 219.611 - Test result indicating prohibited alcohol concentration; procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.611 Test result indicating prohibited alcohol...

49 CFR 219.611 - Test result indicating prohibited alcohol concentration; procedures.

Code of Federal Regulations, 2014 CFR

2014-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.611 Test result indicating prohibited alcohol...

49 CFR 219.611 - Test result indicating prohibited alcohol concentration; procedures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.611 Test result indicating prohibited alcohol...

34 CFR 636.6 - What regulations apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (8) 34 CFR part 86 (Drug-Free Schools and Campuses...

34 CFR 636.6 - What regulations apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (8) 34 CFR part 86 (Drug-Free Schools and Campuses...

34 CFR 654.4 - What regulations apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (8) 34 CFR part 86 (Drug-Free Schools and Campuses...

34 CFR 636.6 - What regulations apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (8) 34 CFR part 86 (Drug-Free Schools and Campuses...

34 CFR 636.6 - What regulations apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (8) 34 CFR part 86 (Drug-Free Schools and Campuses...

34 CFR 654.4 - What regulations apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (8) 34 CFR part 86 (Drug-Free Schools and Campuses...

34 CFR 654.4 - What regulations apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (8) 34 CFR part 86 (Drug-Free Schools and Campuses...

34 CFR 654.4 - What regulations apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (8) 34 CFR part 86 (Drug-Free Schools and Campuses...

34 CFR 636.6 - What regulations apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (8) 34 CFR part 86 (Drug-Free Schools and Campuses...

34 CFR 654.4 - What regulations apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (8) 34 CFR part 86 (Drug-Free Schools and Campuses...

48 CFR 1823.570-2 - Contract clause.

Code of Federal Regulations, 2013 CFR

2013-10-01

... ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 1823.570-2 Contract clause. The contracting officer shall insert the clause at 1852.223-74, “Drug- and Alcohol-Free Workforce,” in all solicitations...

48 CFR 1823.570-2 - Contract clause.

Code of Federal Regulations, 2011 CFR

2011-10-01

... ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 1823.570-2 Contract clause. The contracting officer shall insert the clause at 1852.223-74, “Drug- and Alcohol-Free Workforce,” in all solicitations...

National Drug Control Strategy. FY 2009 Budget Summary

ERIC Educational Resources Information Center

The White House, 2008

2008-01-01

The National Drug Control Budget Summary identifies resources and performance indicators for programs within the Executive Branch that are integral to the President's National Drug Control Strategy. The Strategy, which is the Administration's plan for reducing drug use and availability, is based on three pillars: (1) Stopping Use Before It Starts,…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-24

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

49 CFR 219.4 - Recognition of a foreign railroad's workplace testing program.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE... contains equivalents to subparts B, E, F, and G of this part: (i) Pre-employment drug testing; (ii) A policy dealing with co-worker and self-reporting of alcohol and drug abuse problems; (iii) Random drug...

49 CFR 219.4 - Recognition of a foreign railroad's workplace testing program.

Code of Federal Regulations, 2014 CFR

2014-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE... contains equivalents to subparts B, E, F, and G of this part: (i) Pre-employment drug testing; (ii) A policy dealing with co-worker and self-reporting of alcohol and drug abuse problems; (iii) Random drug...

49 CFR 219.4 - Recognition of a foreign railroad's workplace testing program.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE... contains equivalents to subparts B, E, F, and G of this part: (i) Pre-employment drug testing; (ii) A policy dealing with co-worker and self-reporting of alcohol and drug abuse problems; (iii) Random drug...

49 CFR 219.4 - Recognition of a foreign railroad's workplace testing program.

Code of Federal Regulations, 2012 CFR

2012-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE... contains equivalents to subparts B, E, F, and G of this part: (i) Pre-employment drug testing; (ii) A policy dealing with co-worker and self-reporting of alcohol and drug abuse problems; (iii) Random drug...

7 CFR Appendix C to Part 225 - Child Nutrition (CN) Labeling Program

Code of Federal Regulations, 2010 CFR

2010-01-01

... calculated using the Food Buying Guide for Child Nutrition Programs (Program Aid Number 1331). 5. In the... Marine Fisheries Service of the USDC, Food and Drug Administration, or the Department of Justice for...

7 CFR Appendix C to Part 226 - Child Nutrition (CN) Labeling Program

Code of Federal Regulations, 2010 CFR

2010-01-01

... calculated using the Food Buying Guide for Child Nutrition Programs (Program Aid Number 1331). 5. In the... Marine Fisheries Services of the USDC, Food and Drug Administration, or the Department of Justice for...

7 CFR Appendix C to Part 210 - Child Nutrition Labeling Program

Code of Federal Regulations, 2010 CFR

2010-01-01

... calculated using the Food Buying Guide for Child Nutrition Programs (Program AID Number 1331). 5. In the... Drug Administration, or the Department of Justice for action against the company. Any or all of the...

77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-17

... Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver... request, or fax your request to CDRH at 301-847-8149. The draft guidance may also be obtained by mail by... using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda...

Identifying injection drug use and estimating population size of people who inject drugs using healthcare administrative datasets.

PubMed

Janjua, Naveed Zafar; Islam, Nazrul; Kuo, Margot; Yu, Amanda; Wong, Stanley; Butt, Zahid A; Gilbert, Mark; Buxton, Jane; Chapinal, Nuria; Samji, Hasina; Chong, Mei; Alvarez, Maria; Wong, Jason; Tyndall, Mark W; Krajden, Mel

2018-05-01

Large linked healthcare administrative datasets could be used to monitor programs providing prevention and treatment services to people who inject drugs (PWID). However, diagnostic codes in administrative datasets do not differentiate non-injection from injection drug use (IDU). We validated algorithms based on diagnostic codes and prescription records representing IDU in administrative datasets against interview-based IDU data. The British Columbia Hepatitis Testers Cohort (BC-HTC) includes ∼1.7 million individuals tested for HCV/HIV or reported HBV/HCV/HIV/tuberculosis cases in BC from 1990 to 2015, linked to administrative datasets including physician visit, hospitalization and prescription drug records. IDU, assessed through interviews as part of enhanced surveillance at the time of HIV or HCV/HBV diagnosis from a subset of cases included in the BC-HTC (n = 6559), was used as the gold standard. ICD-9/ICD-10 codes for IDU and injecting-related infections (IRI) were grouped with records of opioid substitution therapy (OST) into multiple IDU algorithms in administrative datasets. We assessed the performance of IDU algorithms through calculation of sensitivity, specificity, positive predictive, and negative predictive values. Sensitivity was highest (90-94%), and specificity was lowest (42-73%) for algorithms based either on IDU or IRI and drug misuse codes. Algorithms requiring both drug misuse and IRI had lower sensitivity (57-60%) and higher specificity (90-92%). An optimal sensitivity and specificity combination was found with two medical visits or a single hospitalization for injectable drugs with (83%/82%) and without OST (78%/83%), respectively. Based on algorithms that included two medical visits, a single hospitalization or OST records, there were 41,358 (1.2% of 11-65 years individuals in BC) recent PWID in BC based on health encounters during 3- year period (2013-2015). Algorithms for identifying PWID using diagnostic codes in linked administrative data could be used for tracking the progress of programing aimed at PWID. With population-based datasets, this tool can be used to inform much needed estimates of PWID population size. Copyright © 2018 Elsevier B.V. All rights reserved.

49 CFR 219.905 - Access to facilities and records.

Code of Federal Regulations, 2013 CFR

2013-10-01

... with this section. (For purposes of this section only, urine drug testing records are considered... drug testing programs conducted under this part and any other information pertaining to the railroad's... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Recordkeeping Requirements § 219.905...

49 CFR 219.905 - Access to facilities and records.

Code of Federal Regulations, 2012 CFR

2012-10-01

... with this section. (For purposes of this section only, urine drug testing records are considered... drug testing programs conducted under this part and any other information pertaining to the railroad's... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Recordkeeping Requirements § 219.905...

49 CFR 219.905 - Access to facilities and records.

Code of Federal Regulations, 2010 CFR

2010-10-01

... with this section. (For purposes of this section only, urine drug testing records are considered... drug testing programs conducted under this part and any other information pertaining to the railroad's... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Recordkeeping Requirements § 219.905...

49 CFR 219.905 - Access to facilities and records.

Code of Federal Regulations, 2011 CFR

2011-10-01

... with this section. (For purposes of this section only, urine drug testing records are considered... drug testing programs conducted under this part and any other information pertaining to the railroad's... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Recordkeeping Requirements § 219.905...

49 CFR 219.905 - Access to facilities and records.

Code of Federal Regulations, 2014 CFR

2014-10-01

... with this section. (For purposes of this section only, urine drug testing records are considered... drug testing programs conducted under this part and any other information pertaining to the railroad's... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Recordkeeping Requirements § 219.905...

75 FR 57233 - 340B Drug Pricing Program Administrative Dispute Resolution Process

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

... Dispute Resolution Process AGENCY: Health Resources and Services Administration, HHS. ACTION: Advance...) to promulgate regulations to establish and implement an administrative dispute resolution process for... does not currently refer to HRSA's plan on how it will resolve any decision made through the new...

78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

...] International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot... Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device Single Audit Program (MDSAP) was designed and...

What You Need To Know about Starting a Student Drug-Testing Program.

ERIC Educational Resources Information Center

Colston, Stephenie; Stephenson, Bob; LoDico, Charles; Vogl, Walt; Price, Deborah; Disselkoen, Robyn; Modzeleski, Bill; Deramond, Helene; Mazza, Jacqueline

2004-01-01

Drugs are a significant barrier to learning, and the use of drugs by even a small number of students can affect the entire atmosphere of a school. Recognizing this, many administrators, parents, and students appreciate having a tool as powerful as student drug testing available as an additional component in their school?s comprehensive drug and…

7 CFR Appendix C to Part 220 - Child Nutrition (CN) Labeling Program

Code of Federal Regulations, 2010 CFR

2010-01-01

... using the Food Buying Guide for Child Nutrition Programs (Program Aid Number 1331). 5. In the event a... and AMS of the USDA, National Marine Fisheries Services of the USDC, Food and Drug Administration, or...

Food and Drug Labeling and the Adult Reader.

ERIC Educational Resources Information Center

McKenna, Michael C.; Aker, Richard

1978-01-01

Full disclosure of ingredients on food, drugs, and cosmetic labels is really non-disclosure where the chemical formulation has no common name or where one generic name covers a variety of formations. The Food and Drug Administration offers suggestions for adult education programs in consumer awareness, understanding compound nomenclature, and…

21 CFR 1301.73 - Physical security controls for non-practitioners; compounders for narcotic treatment programs...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Physical security controls for non-practitioners... and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE REGISTRATION OF MANUFACTURERS... such as walls or partitions, by traffic control lines or restricted space designation. The employee...

21 CFR 892.5300 - Medical neutron radiation therapy system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical neutron radiation therapy system. 892.5300 Section 892.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... analysis and display equipment, patient and equipment support, treatment planning computer programs...

21 CFR 892.5300 - Medical neutron radiation therapy system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical neutron radiation therapy system. 892.5300 Section 892.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... analysis and display equipment, patient and equipment support, treatment planning computer programs...

21 CFR 892.5300 - Medical neutron radiation therapy system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical neutron radiation therapy system. 892.5300 Section 892.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... analysis and display equipment, patient and equipment support, treatment planning computer programs...

21 CFR 892.5300 - Medical neutron radiation therapy system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical neutron radiation therapy system. 892.5300 Section 892.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... analysis and display equipment, patient and equipment support, treatment planning computer programs...

21 CFR 892.5300 - Medical neutron radiation therapy system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical neutron radiation therapy system. 892.5300 Section 892.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... analysis and display equipment, patient and equipment support, treatment planning computer programs...

77 FR 55482 - Center for Substance Abuse Prevention; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-10

... Abuse Prevention (CSAP) Drug Testing Advisory Board (DTAB) will meet on September 24, 2012 from 9 a.m... revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs. Therefore, this meeting... Administration's Center for Substance Abuse Prevention, Drug Testing Advisory Board. Dates/Time/Type: September...

Drug and alcohol testing results 2003 annual report

DOT National Transportation Integrated Search

2005-09-01

This is the eighth annual report of the results of the Federal Transit Administration's (FTA's) Drug and Alcohol Testing Program. The report summarizes the new reporting requirements introduced for calendar year 2003, the requirements of the overall ...

Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.

PubMed

Green, Dionna J; Liu, Xiaomei I; Hua, Tianyi; Burnham, Janelle M; Schuck, Robert; Pacanowski, Michael; Yao, Lynne; McCune, Susan K; Burckart, Gilbert J; Zineh, Issam

2017-12-08

Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. We analyzed the use of enrichment strategies in pediatric trials submitted to the US Food and Drug Administration from 2012-2016. In all, 112 efficacy studies associated with 76 drug development programs were assessed and their overall success rates were 78% and 75%, respectively. Eighty-eight trials (76.8%) employed at least one enrichment strategy; of these, 66.3% employed multiple enrichment strategies. The highest trial success rates were achieved when all three enrichment strategies (practical, predictive, and prognostic) were used together within a single trial (87.5%), while the lowest success rate was observed when no enrichment strategy was used (65.4%). The use of enrichment strategies in pediatric trials was found to be associated with trial and program success in our analysis. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Implementation guidelines for drug and alcohol regulations in mass transit

DOT National Transportation Integrated Search

2002-08-01

These guidelines will assist transit agencies in developing drug and alcohol testing programs that comply with regulations of the Federal Transit Administration (FTA). The guidelines provide a comprehensive, up-to-date summary of the regulatory requi...

Drug and alcohol testing results 2001 annual report

DOT National Transportation Integrated Search

2003-12-01

This is the sixth annual report of the results of the Federal Transit Administration's (FTA) Drug and Alcohol Testing Program. The report summarizes the new reporting requirements introduced for calendar year 2001, the requirements of the overall dru...

Executive Policy--Administration: E11.201, Illegal Drug and Substance Abuse. Executive Policy E11.203, Illegal Drugs and Alcohol Abuse.

ERIC Educational Resources Information Center

Hawaii Univ., Honolulu.

This document includes two statements of policy for the University of Hawaii's drug and alcohol abuse prevention program. The first, "Illegal Drugs and Substance Abuse," opens with an introduction stating the University's general mission and that mission's incompatibility with substance abuse. A second section details the University's…

78 FR 14217 - Control of Alcohol and Drug Use: Addition of Post-Accident Toxicological Testing for Non...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-05

... (post-accident testing) program to test railroad employees who had been involved in serious train... clear that FRA intends to keep the post-accident test results for these non-controlled substances... post-accident tests for alcohol and for certain drugs classified by the Drug Enforcement Administration...

A Winning Combination: An Alcohol, Other Drug, and Traffic Safety Handbook for College Campuses.

ERIC Educational Resources Information Center

Anderson, David, Ed.

This manual addresses the social and legal issues facing college administrators today in dealing with alcohol and other drug problems. It is a guide for colleges and universities to develop individualized alcohol, drug, and traffic safety programs. The first part, entitled "Insights," presents background articles by professionals in higher…

75 FR 47820 - Generic Drug User Fee; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381... fee program. The number of human generic drug applications awaiting FDA action and the median review... needed for presentations, FDA reserves the right to terminate the meeting early. If you need special...

78 FR 42084 - Electronic Study Data Submission; Data Standard Support; Availability of the Center for Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-15

...] Electronic Study Data Submission; Data Standard Support; Availability of the Center for Drug Evaluation and Research Data Standards Program Documents AGENCY: Food and Drug Administration, HHS. ACTION: Notice... announcing the availability of the CDER Data Standards Strategy (version 1.0) and the CDER Data Standards...

77 FR 38019 - Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: TRICARE Retail...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... prescriptions approved through the non-formulary special approval process that validates the medical necessity... the process for formulary placement of newly approved drugs; streamline the process for updating... clarify the process for formulary placement of newly approved drugs by the Food and Drug Administration...

34 CFR 369.3 - What regulations apply to these programs?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Service Program for American Indians with Disabilities. (5) 34 CFR part 80 (Uniform Administrative... (Grants)). (9) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 369. (c...

34 CFR 385.3 - What regulations apply to these programs?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 385. (c) The...

34 CFR 385.3 - What regulations apply to these programs?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 385. (c) The...

34 CFR 369.3 - What regulations apply to these programs?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Service Program for American Indians with Disabilities. (5) 34 CFR part 80 (Uniform Administrative... (Grants)). (9) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 369. (c...

34 CFR 369.3 - What regulations apply to these programs?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Service Program for American Indians with Disabilities. (5) 34 CFR part 80 (Uniform Administrative... (Grants)). (9) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 369. (c...

34 CFR 369.3 - What regulations apply to these programs?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Service Program for American Indians with Disabilities. (5) 34 CFR part 80 (Uniform Administrative... (Grants)). (9) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 369. (c...

34 CFR 385.3 - What regulations apply to these programs?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 385. (c) The...

34 CFR 385.3 - What regulations apply to these programs?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 385. (c) The...

76 FR 40734 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-11

...; Voluntary Cosmetic Registration Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... ``Voluntary Cosmetic Registration Program'' has been approved by the Office of Management and Budget [[Page...

34 CFR 400.3 - What other regulations apply to the Vocational and Applied Technology Education Programs?

Code of Federal Regulations, 2011 CFR

2011-07-01

... applicable to parts 401, 410, 411, 413, 418, and 419). (6) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (10) 34 CFR part 86 (Drug-Free Schools and...

34 CFR 400.3 - What other regulations apply to the Vocational and Applied Technology Education Programs?

Code of Federal Regulations, 2013 CFR

2013-07-01

... applicable to parts 401, 410, 411, 413, 418, and 419). (6) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (10) 34 CFR part 86 (Drug-Free Schools and...

34 CFR 400.3 - What other regulations apply to the Vocational and Applied Technology Education Programs?

Code of Federal Regulations, 2012 CFR

2012-07-01

... applicable to parts 401, 410, 411, 413, 418, and 419). (6) 34 CFR part 80 (Uniform Administrative... Governmentwide Requirements for Drug-Free Workplace (Grants)). (10) 34 CFR part 86 (Drug-Free Schools and...

Types of HIV/AIDS Antiretroviral Drugs

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

34 CFR 460.3 - What regulations apply to the adult education programs?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Education Programs and Activities). (6) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 460. (c) The...

34 CFR 614.3 - What regulations apply to this program?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... (Grants)). (9) 34 CFR part 86 (Drug-Free Schools and Campuses). (10) 34 CFR part 97 (Protection of Human...

34 CFR 460.3 - What regulations apply to the adult education programs?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Education Programs and Activities). (6) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 460. (c) The...

34 CFR 460.3 - What regulations apply to the adult education programs?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Education Programs and Activities). (6) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 460. (c) The...

34 CFR 614.3 - What regulations apply to this program?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... (Grants)). (9) 34 CFR part 86 (Drug-Free Schools and Campuses). (10) 34 CFR part 97 (Protection of Human...

34 CFR 460.3 - What regulations apply to the adult education programs?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Education Programs and Activities). (6) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 460. (c) The...

34 CFR 614.3 - What regulations apply to this program?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Review of Department of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative... (Grants)). (9) 34 CFR part 86 (Drug-Free Schools and Campuses). (10) 34 CFR part 97 (Protection of Human...

34 CFR 460.3 - What regulations apply to the adult education programs?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Education Programs and Activities). (6) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 460. (c) The...

28 CFR 83.220 - By when must I publish my drug-free workplace statement and establish my drug-free awareness...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false By when must I publish my drug-free...) Requirements for Recipients Other Than Individuals § 83.220 By when must I publish my drug-free workplace....215, you must publish the statement and establish the program by the time given in the following table...

48 CFR 1823.570 - Drug- and alcohol-free workforce.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Drug- and alcohol-free workforce. 1823.570 Section 1823.570 Federal Acquisition Regulations System NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES...

48 CFR 1823.570 - Drug- and alcohol-free workforce.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Drug- and alcohol-free workforce. 1823.570 Section 1823.570 Federal Acquisition Regulations System NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES...

48 CFR 1823.570 - Drug- and alcohol-free workforce.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Drug- and alcohol-free workforce. 1823.570 Section 1823.570 Federal Acquisition Regulations System NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES...

48 CFR 301.270 - Executive Committee for Acquisition.

Code of Federal Regulations, 2011 CFR

2011-10-01

...). (10) Program Support Center (PSC). (11) Substance Abuse and Mental Health Services Administration... Acquisition. 301.270 Section 301.270 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES GENERAL... Medicare and Medicaid Services (CMS). (6) Food and Drug Administration (FDA). (7) Health Resources and...

48 CFR 301.270 - Executive Committee for Acquisition.

Code of Federal Regulations, 2010 CFR

2010-10-01

...). (10) Program Support Center (PSC). (11) Substance Abuse and Mental Health Services Administration... Acquisition. 301.270 Section 301.270 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES GENERAL... Medicare and Medicaid Services (CMS). (6) Food and Drug Administration (FDA). (7) Health Resources and...

The pharmacist and adverse drug reaction reporting.

PubMed

Pearson, K

1982-08-01

During premarketing trials, the number of patients exposed to a drug and the length of exposure to a drug are both limited. After marketing, many thousands, frequently millions, of patients are exposed to the drug over considerably longer periods of time, and adverse drug reactions not previously recognized appear. Because of these factors, postmarketing surveillance is extremely important. Pharmacists can contribute to drug safety and improved patient care by understanding and actively participating in the Food and Drug Administration's Spontaneous Reporting Program.

21 CFR 1301.72 - Physical security controls for non-practitioners; narcotic treatment programs and compounders for...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Physical security controls for non-practitioners... 1301.72 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE REGISTRATION OF... a central protection company or a local or State police agency which has a legal duty to respond, or...

45 CFR 30.2. - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Services, the Food and Drug Administration, the National Institutes of Health, Substance Abuse and Mental... program beneficiaries, contractors, providers, suppliers, and grantees; audit disallowance determinations... amounts include amounts owed to the Medicare program under section 1862(b) of the Social Security Act...

45 CFR 30.2. - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Services, the Food and Drug Administration, the National Institutes of Health, Substance Abuse and Mental... program beneficiaries, contractors, providers, suppliers, and grantees; audit disallowance determinations... amounts include amounts owed to the Medicare program under section 1862(b) of the Social Security Act...

45 CFR 30.2. - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Services, the Food and Drug Administration, the National Institutes of Health, Substance Abuse and Mental... program beneficiaries, contractors, providers, suppliers, and grantees; audit disallowance determinations... amounts include amounts owed to the Medicare program under section 1862(b) of the Social Security Act...

Adolescent Drug Abuses-A Problem of Interpersonal Relations and School Organization

ERIC Educational Resources Information Center

Dearden, Marlin H.

1971-01-01

This paper stresses the importance of listening to students and to each other, and the willingness to explore together those areas of personal concern as they exist in individuals and organizational and administrative operation for an effective drug education program. (Author)

21 CFR 25.10 - Policies and NEPA planning.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... integrated with other program planning at the earliest possible time to ensure that planning and decisions... environmental effects. (d) Environmental documents shall concentrate on timely and significant issues, not amass...

Improving Coverage and Compliance in Mass Drug Administration for the Elimination of LF in Two ‘Endgame’ Districts in Indonesia Using Micronarrative Surveys

PubMed Central

Krentel, Alison; Damayanti, Rita; Titaley, Christiana Rialine; Suharno, Nugroho; Bradley, Mark; Lynam, Timothy

2016-01-01

Background As the Global Programme to Eliminate Lymphatic Filariasis (LF) approaches its 2020 goal, an increasing number of districts will enter the endgame phase where drug coverage rates from mass drug administration (MDA) are used to assess whether MDA can be stopped. As reported, the gap between reported and actual drug coverage in some contexts has overestimated the true rates, thus causing premature administration of transmission assessment surveys (TAS) that detect ongoing LF transmission. In these cases, districts must continue with additional rounds of MDA. Two districts in Indonesia (Agam District, Depok City) fit this criteria—one had not met the pre-TAS criteria and the other, had not passed the TAS criteria. In both cases, the district health teams needed insight into their drug delivery programs in order to improve drug coverage in the subsequent MDA rounds. Methodology/Principal Findings To inform the subsequent MDA round, a micronarrative survey tool was developed to capture community members’ experience with MDA and the social realm where drug delivery and compliance occur. A baseline survey was implemented after the 2013 MDA in endemic communities in both districts using the EPI sampling criteria (n = 806). Compliance in the last MDA was associated with perceived importance of the LF drugs for health (p<0.001); perceived safety of the LF drugs (p<0.001) and knowing someone in the household has complied (p<0.001). Results indicated that specialized messages were needed to reach women and younger men. Both districts used these recommendations to implement changes to their MDA without additional financial support. An endline survey was performed after the 2014 MDA using the same sampling criteria (n = 811). Reported compliance in the last MDA improved in both districts from 57% to 77% (p<0.05). Those who reported having ever taken the LF drug rose from 79% to 90% (p<0.001) in both sites. Conclusions/Significance Micronarrative surveys were shown to be a valid and effective tool to detect operational issues within MDA programs. District health staff felt ownership of the results, implementing feasible changes to their programs that resulted in significant improvements to coverage and compliance in the subsequent MDA. This kind of implementation research using a micronarrative survey tool could benefit underperforming MDA programs as well as other disease control programs where a deeper understanding is needed to improve healthcare delivery. PMID:27812107

Drug Abuse: The Crack Cocaine Epidemic Health Consequences and Treatment.

DTIC Science & Technology

1991-01-01

addicts . Buackground Once considered to be nonaddictive, recent studies show that cocaine is one of the most potent drugs of abuse. Cocaine is a...responsibility for addiction prevention and treatment programs. The agencies we contacted include NIDA, the Alcohol, Drug Abuse, and Mental Health Administration...heroin addicts for Treating Crack are being used to treat many crack addicts . Meanwhile, drug treatment Addicts researchers are experimenting with new

45 CFR 84.53 - Drug and alcohol addicts.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Drug and alcohol addicts. 84.53 Section 84.53 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Health, Welfare, and...

45 CFR 84.53 - Drug and alcohol addicts.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Drug and alcohol addicts. 84.53 Section 84.53 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Health, Welfare, and...

23 CFR 1205.3 - Identification of National Priority Program Areas.

Code of Federal Regulations, 2010 CFR

2010-04-01

... to guidelines issued by the National Highway Traffic Safety Administration and the review procedure set forth in § 1205.4: (1) Alcohol and Other Drug Countermeasures (2) Police Traffic Services (3....3 Section 1205.3 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY...

[Filariasis control: entry point for other helminthiasis control programs?].

PubMed

Boussinesq, M

2006-08-01

Filariasis control programs are based on a decentralized drug distribution strategy known as "community-directed". This strategy could also be applied to the control of schistosomiasis and intestinal nematode infections. Integration of these control programs could be highly cost-effective. However, as a prerequisite for integration, it would be necessary to identify zones where these helminthic infections co-exist, specify the population categories that should receive each medication (ivermectin, albendazole, mebendazole, and praziquantel), check that combined administration of these drugs is safe and ensure that an integrated program would have no detrimental effect on the health care system and on the efficacy of ongoing programs.

75 FR 1547 - Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-12

...: Notice of Determination. SUMMARY: Using data from Management Information System annual reports, FRA has... taken from FRA's Management Information System. Based on this data, the Administrator publishes a... effective upon publication. FOR FURTHER INFORMATION CONTACT: Lamar Allen, Alcohol and Drug Program Manager...

Crossing the Quality Chasm: Challenges for Counselor Training Programs

ERIC Educational Resources Information Center

McCarty, Dennis; Gardin, John; Edmundson, Eldon

2007-01-01

Treatment for alcohol and drug disorders is changing. The evidence is emerging in federally sponsored reports, initiatives, and strategic plans from the Substance Abuse and Mental Health Services Administration (SAMHSA), the National Institute on Drug Abuse (NIDA), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The reports and…

49 CFR 219.609 - Participation in alcohol testing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.609 Participation in alcohol testing. A railroad must, under the conditions specified in... 49 Transportation 4 2011-10-01 2011-10-01 false Participation in alcohol testing. 219.609 Section...

49 CFR 219.609 - Participation in alcohol testing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.609 Participation in alcohol testing. A railroad must, under the conditions specified in... 49 Transportation 4 2010-10-01 2010-10-01 false Participation in alcohol testing. 219.609 Section...

49 CFR 219.609 - Participation in alcohol testing.

Code of Federal Regulations, 2012 CFR

2012-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.609 Participation in alcohol testing. A railroad must, under the conditions specified in... 49 Transportation 4 2012-10-01 2012-10-01 false Participation in alcohol testing. 219.609 Section...

49 CFR 219.609 - Participation in alcohol testing.

Code of Federal Regulations, 2014 CFR

2014-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.609 Participation in alcohol testing. A railroad must, under the conditions specified in... 49 Transportation 4 2014-10-01 2014-10-01 false Participation in alcohol testing. 219.609 Section...

49 CFR 219.609 - Participation in alcohol testing.

Code of Federal Regulations, 2013 CFR

2013-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.609 Participation in alcohol testing. A railroad must, under the conditions specified in... 49 Transportation 4 2013-10-01 2013-10-01 false Participation in alcohol testing. 219.609 Section...

42 CFR 403.812 - HIPAA privacy, security, administrative data standards, and national identifiers.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 2 2012-10-01 2012-10-01 false HIPAA privacy, security, administrative data standards, and national identifiers. 403.812 Section 403.812 Public Health CENTERS FOR MEDICARE & MEDICAID... Prescription Drug Discount Card and Transitional Assistance Program § 403.812 HIPAA privacy, security...

42 CFR 403.812 - HIPAA privacy, security, administrative data standards, and national identifiers.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false HIPAA privacy, security, administrative data standards, and national identifiers. 403.812 Section 403.812 Public Health CENTERS FOR MEDICARE & MEDICAID... Prescription Drug Discount Card and Transitional Assistance Program § 403.812 HIPAA privacy, security...

42 CFR 403.812 - HIPAA privacy, security, administrative data standards, and national identifiers.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false HIPAA privacy, security, administrative data standards, and national identifiers. 403.812 Section 403.812 Public Health CENTERS FOR MEDICARE & MEDICAID... Prescription Drug Discount Card and Transitional Assistance Program § 403.812 HIPAA privacy, security...

42 CFR 403.812 - HIPAA privacy, security, administrative data standards, and national identifiers.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 2 2013-10-01 2013-10-01 false HIPAA privacy, security, administrative data standards, and national identifiers. 403.812 Section 403.812 Public Health CENTERS FOR MEDICARE & MEDICAID... Prescription Drug Discount Card and Transitional Assistance Program § 403.812 HIPAA privacy, security...

42 CFR 403.812 - HIPAA privacy, security, administrative data standards, and national identifiers.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 2 2011-10-01 2011-10-01 false HIPAA privacy, security, administrative data standards, and national identifiers. 403.812 Section 403.812 Public Health CENTERS FOR MEDICARE & MEDICAID... Prescription Drug Discount Card and Transitional Assistance Program § 403.812 HIPAA privacy, security...

78 FR 23702 - Copayment for Extended Care Services

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-22

... Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Government contracts, Grant programs--health, Grant programs--veterans, Health care, Health facilities... DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900-AO59 Copayment for Extended Care Services...

Army Drug Development Program. Phase 1. Clinical Testing

DTIC Science & Technology

1981-02-01

drug administration, the subjects fasted from 2400 to 0600, at which time they were given 360 ml Sustacal (Mead Johnson product ...Such factors as time of day, meals, alcohol, other drugs, and lack of proper sleep may affect the level of drug in your blood on...Sustacal (Mead Johnson product ) containing a total of 360 calories. Subjects ingested a single oral 750 mg dose of WR 180,409•H3PO4 in

Acute bouts of wheel running decrease cocaine self-administration: Influence of exercise output.

PubMed

Smith, Mark A; Fronk, Gaylen E; Zhang, Huailin; Magee, Charlotte P; Robinson, Andrea M

Exercise is associated with lower rates of drug use in human populations and decreases drug self-administration in laboratory animals. Most of the existing literature examining the link between exercise and drug use has focused on chronic, long-term exercise, and very few studies have examined the link between exercise output (i.e., amount of exercise) and drug self-administration. The purpose of this study was to examine the effects of acute bouts of exercise on cocaine self-administration, and to determine whether these effects were dependent on exercise output and the time interval between exercise and drug self-administration. Female rats were trained to run in automated running wheels, implanted with intravenous catheters, and allowed to self-administer cocaine on a fixed ratio (FR1) schedule of reinforcement. Immediately prior to each test session, subjects engaged in acute bouts of exercise in which they ran for 0, 30, or 60min at 12m/min. Acute bouts of exercise before test sessions decreased cocaine self-administration in an output-dependent manner, with the greatest reduction in cocaine intake observed in the 60-min exercise condition. Exercise did not reduce cocaine self-administration when wheel running and test sessions were separated by 12h, and exercise did not reduce responding maintained by food or responding during a saline substitution test. These data indicate that acute bouts of exercise decrease cocaine self-administration in a time- and output-dependent manner. These results also add to a growing body of literature suggesting that physical activity may be an effective component of drug abuse treatment programs. Copyright © 2016 Elsevier Inc. All rights reserved.

76 FR 66309 - Pilot Program for Parallel Review of Medical Products; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-3180-N2] Food and Drug Administration [Docket No. FDA-2010-N-0308] Pilot Program for Parallel Review of Medical... technologies to participate in a program of parallel FDA-CMS review. The document was published with an...

77 FR 40072 - Assessment of the Program for Enhanced Review Transparency and Communication for New Molecular...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0603] Assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New... statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for...

76 FR 75509 - Autopsies at VA Expense

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-02

... Administrative practice and procedure; Alcohol abuse; Alcoholism; Claims; Day care; Dental health; Drug abuse...; Health professions; Health records; Homeless; Mental health programs; Nursing homes; Philippines...

Multisite cost analysis of a school-based voluntary alcohol and drug prevention program.

PubMed

Kilmer, Beau; Burgdorf, James R; D'Amico, Elizabeth J; Miles, Jeremy; Tucker, Joan

2011-09-01

This article estimates the societal costs of Project CHOICE, a voluntary after-school alcohol and other drug prevention program for adolescents. To our knowledge, this is the first cost analysis of an after-school program specifically focused on reducing alcohol and other drug use. The article uses microcosting methods based on the societal perspective and includes a number of sensitivity analyses to assess how the results change with alternative assumptions. Cost data were obtained from surveys of participants, facilitators, and school administrators; insights from program staff members; program expenditures; school budgets; the Bureau of Labor Statistics; and the National Center for Education Statistics. From the societal perspective, the cost of implementing Project CHOICE in eight California schools ranged from $121 to $305 per participant (Mdn = $238). The major cost drivers included labor costs associated with facilitating Project CHOICE, opportunity costs of displaced class time (because of in-class promotions for Project CHOICE and consent obtainment), and other efforts to increase participation. Substituting nationally representative cost information for wages and space reduced the range to $100-$206 (Mdn = $182), which is lower than the Substance Abuse and Mental Health Services Administration's estimate of $262 per pupil for the "average effective school-based program in 2002." Denominating national Project CHOICE costs by enrolled students instead of participants generates a median per-pupil cost of $21 (range: $14-$28). Estimating the societal costs of school-based prevention programs is crucial for efficiently allocating resources to reduce alcohol and other drug use. The large variation in Project CHOICE costs across schools highlights the importance of collecting program cost information from multiple sites.

Multisite Cost Analysis of a School-Based Voluntary Alcohol and Drug Prevention Program*

PubMed Central

Kilmer, Beau; Burgdorf, James R.; D'amico, Elizabeth J.; Miles, Jeremy; Tucker, Joan

2011-01-01

Objective: This article estimates the societal costs of Project CHOICE, a voluntary after-school alcohol and other drug prevention program for adolescents. To our knowledge, this is the first cost analysis of an after-school program specifically focused on reducing alcohol and other drug use. Method: The article uses microcosting methods based on the societal perspective and includes a number of sensitivity analyses to assess how the results change with alternative assumptions. Cost data were obtained from surveys of participants, facilitators, and school administrators; insights from program staff members; program expenditures; school budgets; the Bureau of Labor Statistics; and the National Center for Education Statistics. Results: From the societal perspective, the cost of implementing Project CHOICE in eight California schools ranged from $121 to $305 per participant (Mdn = $238). The major cost drivers included labor costs associated with facilitating Project CHOICE, opportunity costs of displaced class time (because of in-class promotions for Project CHOICE and consent obtainment), and other efforts to increase participation. Substituting nationally representative cost information for wages and space reduced the range to $100–$206 (Mdn = $182), which is lower than the Substance Abuse and Mental Health Services Administration's estimate of $262 per pupil for the "average effective school-based program in 2002." Denominating national Project CHOICE costs by enrolled students instead of participants generates a median per-pupil cost of $21 (range: $14—$28). Conclusions: Estimating the societal costs of school-based prevention programs is crucial for efficiently allocating resources to reduce alcohol and other drug use. The large variation in Project CHOICE costs across schools highlights the importance of collecting program cost information from multiple sites. PMID:21906509

The pneumatic syringe: a simple apparatus for self-administration of drugs by rats.

PubMed

Weeks, J R

1977-12-01

Drug solution is delivered by a syringe operated by a pneumatic cylinder. Recommended delivery volumes are from 10 to 200 microliter. A solid-state control unit is described which can operate two syringes (drug injection and flush), has outputs for recording responses and injections, and can be programmed to provide several schedules of reinforcement. All components are readily commercially available.

28 CFR 545.21 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Definitions. 545.21 Section 545.21... COMPENSATION Inmate Work and Performance Pay Program § 545.21 Definitions. (a) Physically and mentally able... work assignments are ordinarily made in conjunction with drug treatment programming, education, and/or...

Factors associated with failure of oncology drugs in late-stage clinical development: A systematic review.

PubMed

Jardim, Denis L; Groves, Eric S; Breitfeld, Philip P; Kurzrock, Razelle

2017-01-01

We aimed to describe the reasons for failure of experimental anticancer drugs in late-stage clinical development. We searched the PharmaProjects database (https://citeline.com/products/pharmaprojects/) for anticancer drugs discontinued between 01/01/2009 and 06/30/2014. Drug programs that reached phase III trials, but never gained Food and Drug Administration (FDA) approval were compared to 37 anti-cancer drugs achieving FDA approval in this time period. Forty-two drugs fit our criteria for development failures. These failed drugs (49% targeted, 23% cytotoxics, and 28% other) were tested in 43 cancer indications (drug programs). Only 16% (7/43) of failed drug programs adopted a biomarker-driven rationale for patient selection versus 57% (21/37) of successful drug programs (P<0.001). Phase II trial information was available in 32 of 43 failed drug programs and in 32 of 37 successful programs. Nine of the 32 trials (28%) of failed drugs versus 28 of 32 trials (87%) of successful drugs (P<0.001) achieved proof of concept (single agent response rate (RR) ⩾20% or combination therapy showing a ⩾20% RR increase above the median historical RR without the experimental agent (with a minimal absolute increase of 5%) or a randomized phase II trial showing significance (P⩽0.05) for its primary outcome). No pattern of study sites, trial design or funding characteristics emerged from the failed drug analysis. For drugs that reached Phase III, lack of a biomarker-driven strategy and failure to attain proof of concept in phase II are potential risk factors for later discontinuation, especially for targeted agents. Copyright © 2016 Elsevier Ltd. All rights reserved.

Health plan approach to operationalizing a specialty drug management program.

PubMed

Tegenu, Mesfin

2008-05-01

Expenditures related to specialty drugs consume a significant percentage of available health care resources. Explain the process of transitioning the management of specialty drugs from medical services to pharmacy services in 2 managed care plans and provide insight into the issues encountered and solutions implemented based on 6 years of experience using traditional and innovative pharmacy utilization management tools to insure appropriate specialty drug use and reimbursement. The level of involvement in a specialty management program varies from managing only products dispensed by the retail, mail, and specialty pharmacy vendor to encompassing a broad list of specialty drugs distributed through a variety of channels. Efficient administrative, operational, and clinical processes are critical to the success of the program. Additionally, an accurate and timely claims processing procedure is also essential for success as is the ability to mine data and effectively report on the use of specialty products. A clinically sound, cost-effective, and patient-friendly program requires input from health plan members, pharmacy service leaders, and physician providers, and must overcome challenges associated with disrupting current relationships and removing competing incentives. A well-constructed and properly funded specialty drug management program results in clinical and financial benefits for the plan.

77 FR 2446 - Amendments to Regulations Regarding Eligibility for a Medicare Prescription Drug Subsidy

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-18

... Administration. ACTION: Final rule. SUMMARY: This final rule adopts, without change, the interim final rule with... incorporated changes to the Medicare prescription drug coverage low-income subsidy (Extra Help) program made by..., 2011. We also revised our regulations to incorporate changes made by the Medicare Improvements for...

3 CFR 8850 - Proclamation 8850 of August 31, 2012. National Alcohol and Drug Addiction Recovery Month, 2012

Code of Federal Regulations, 2013 CFR

2013-01-01

... substance use. My Administration is committed to advancing evidence-based recovery solutions. Over the past 3 years, we have worked to strengthen substance abuse prevention and treatment programs, and to... substance use disorders commit to managing their health by maintaining their recovery from drug or alcohol...

76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-28

... Memorandum titled ``Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3,'' a... achieves its intended goals. In September 2009, FDA's Center for Devices and Radiological Health (CDRH... regarding the strengths and challenges associated with the 510(k) program. In August 2010, CDRH published...

10 CFR 712.11 - General requirements for HRP certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., “Drug-Free Federal Workplace Testing Implementation Program,” for DOE employees; (9) An initial alcohol... the HRP and complete initial instruction on the importance of security, safety, reliability, and... the Manager, the NNSA Administrator, his or her designee, or the appropriate Lead Program Secretarial...

A program for identification of linear systems

NASA Technical Reports Server (NTRS)

Buell, J.; Kalaba, R.; Ruspini, E.; Yakush, A.

1971-01-01

A program has been written for the identification of parameters in certain linear systems. These systems appear in biomedical problems, particularly in compartmental models of pharmacokinetics. The method presented here assumes that some of the state variables are regularly modified by jump conditions. This simulates administration of drugs following some prescribed drug regime. Parameters are identified by a least-square fit of the linear differential system to a set of experimental observations. The method is especially suited when the interval of observation of the system is very long.

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

PubMed

Kesselheim, Aaron S; Wang, Bo; Franklin, Jessica M; Darrow, Jonathan J

2015-09-23

To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. Cohort study. FDA approved novel therapeutics between 1987 and 2014. Publicly available sources provided each drug's year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA's four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review. Logistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not. The FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction). In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs. Though expedited programs should be strictly limited to drugs providing noticeable clinical advances, this trend is being driven by drugs that are not first in class and thus potentially less innovative. © Kesselheim et al 2015.

Risk evaluation mitigation strategies: the evolution of risk management policy.

PubMed

Hollingsworth, Kristen; Toscani, Michael

2013-04-01

The United States Food and Drug Administration (FDA) has the primary regulatory responsibility to ensure that medications are safe and effective both prior to drug approval and while the medication is being actively marketed by manufacturers. The responsibility for safe medications prior to marketing was signed into law in 1938 under the Federal Food, Drug, and Cosmetic Act; however, a significant risk management evolution has taken place since 1938. Additional federal rules, entitled the Food and Drug Administration Amendments Act, were established in 2007 and extended the government's oversight through the addition of a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs. REMS is a mandated strategy to manage a known or potentially serious risk associated with a medication or biological product. Reasons for this extension of oversight were driven primarily by the FDA's movement to ensure that patients and providers are better informed of drug therapies and their specific benefits and risks prior to initiation. This article provides an historical perspective of the evolution of medication risk management policy and includes a review of REMS programs, an assessment of the positive and negative aspects of REMS, and provides suggestions for planning and measuring outcomes. In particular, this publication presents an overview of the evolution of the REMS program and its implications.

76 FR 21431 - Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

...This final rule makes revisions to the Medicare Advantage (MA) program (Part C) and Prescription Drug Benefit Program (Part D) to implement provisions specified in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) (ACA) and make other changes to the regulations based on our experience in the administration of the Part C and Part D programs. These latter revisions clarify various program participation requirements; make changes to strengthen beneficiary protections; strengthen our ability to identify strong applicants for Part C and Part D program participation and remove consistently poor performers; and make other clarifications and technical changes.

78 FR 76628 - Pilot Program for Parallel Review of Medical Products; Extension of the Duration of the Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-18

...The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) (the Agencies) are announcing the extension of the ``Pilot Program for Parallel Review of Medical Products.'' The Agencies have decided to continue the program as currently designed for an additional period of 2 years from the date of publication of this notice.

Can increases in CHIP copayments reduce program expenditures on prescription drugs?

PubMed

Sen, Bisakha; Blackburn, Justin; Morrisey, Michael; Becker, David; Kilgore, Meredith; Caldwell, Cathy; Menachemi, Nir

2014-01-01

The primary aim is to explore whether prescription drug expenditures by enrollees changed in Alabama's CHIP program, ALL Kids, after copayment increases in fiscal year 2004. The subsidiary aim is to explore whether non-pharmaceutical expenditures also changed. Data on ALL Kids enrollees between 1999-2007, obtained from claims files and the state's administrative database. We used data on children who were enrolled between one and three years both before and after the changes to the copayment schedule, and estimate regression models with individual-level fixed effects to control for time-invariant heterogeneity at the child level. This allows an accurate estimate of how program expenditures change for the same individual following copayment changes. Primary outcomes of interest are expenditures for prescription drugs by class and brand-name and generic versions. We estimate models for the likelihood of any use of prescription drugs and expenditure level conditional on use. Following the copayment increase, the probability of any expenditure decline by 5.8%, brand name drugs by 6.9%, generic drugs by 7.4%. Conditional on any use, program expenditures decline by 7.9% for all drugs, by 9.6% for brand name drugs, and 6.2% for generic drugs. The largest declines are for antihistamine drugs; the least declines are for Central Nervous System agents. Declines are smaller and statistically weaker for children with chronic health conditions. Concurrent declines are also seen for non-pharmaceutical medical expenditures. Copayment increases appear to reduce program expenditures on prescription drugs per enrollee and may be a useful tool for controlling program costs.

Dofetilide

MedlinePlus

... than normal) If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/ ...

Dutasteride

MedlinePlus

... alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate. ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Salsalate

MedlinePlus

... called salicylates. It works by stopping the body's production of a substance that causes pain, fever, and ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Glycopyrrolate

MedlinePlus

... of medications called anticholinergics. It decreases stomach acid production by blocking the activity of a certain natural ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Diflunisal

MedlinePlus

... called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Sulindac

MedlinePlus

... called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Qualitative assessment of take-home naloxone program participant and law enforcement interactions in British Columbia.

PubMed

Deonarine, Andrew; Amlani, Ashraf; Ambrose, Graham; Buxton, Jane A

2016-05-21

The British Columbia take-home naloxone (BCTHN) program has been in operation since 2012 and has resulted in the successful reversal of over 581 opioid overdoses. The study aims to explore BCTHN program participant perspectives about the program, barriers to participants contacting emergency services (calling "911") during an overdose, and perspectives of law enforcement officials on naloxone administration by police officers. Two focus groups and four individual interviews were conducted with BCTHN program participants; interviews with two law enforcement officials were also conducted. Qualitative analysis of all transcripts was performed. Positive themes about the BCTHN program from participants included easy to understand training, correcting misperceptions in the community, and positive interactions with emergency services. Potential barriers to contacting emergency services during an overdose include concerns about being arrested for outstanding warrants or for other illegal activities (such as drug possession) and confiscation of kits. Law enforcement officials noted that warrants were complex situational issues, kits would normally not be confiscated, and admitted arrests for drug possession or other activities may not serve the public good in an overdose situation. Law enforcement officials were concerned about legal liability and jurisdictional/authorization issues if naloxone administration privileges were expanded to police. Program participants and law enforcement officials expressed differing perspectives about warrants, kit confiscation, and arrests. Facilitating communication between BCTHN program participants and other stakeholders may address some of the confusion and remove potential barriers to further improving program outcomes. Naloxone administration by law enforcement would require policies to address jurisdiction/authorization and liability issues.

Competing values among criminal justice administrators: The importance of substance abuse treatment.

PubMed

Henderson, Craig E; Taxman, Faye S

2009-08-01

This study applied latent class analysis (LCA) to examine heterogeneity in criminal justice administrators' attitudes toward the importance of substance abuse treatment relative to other programs and services commonly offered in criminal justice settings. The study used data collected from wardens, probation and/or parole administrators, and other justice administrators as part of the National Criminal Justice Treatment Practices survey (NCJTP), and includes both adult criminal and juvenile justice samples. Results of the LCA suggested that administrators fell into four different latent classes: (1) those who place a high importance on substance abuse treatment relative to other programs and services, (2) those who place equal importance on substance abuse treatment and other programs and services, (3) those who value other programs and services moderately more than substance abuse treatment, and (4) those who value other programs and services much more than substance abuse treatment. Latent class membership was in turn associated with the extent to which evidence-based substance abuse treatment practices were being used in the facilities, the region of the country in which the administrator worked, and attitudes toward rehabilitating drug-using offenders. The findings have implications for future research focused on the impact that administrators' attitudes have on service provision as well as the effectiveness of knowledge dissemination and diffusion models.

Long-term Outcomes among Drug Dependent Mothers Treated in Women-only versus Mixed-gender Programs

PubMed Central

Hser, Yih-Ing; Evans, Elizabeth; Huang, David; Messina, Nena

2011-01-01

This study examined the long-term outcomes of women who were pregnant or parenting at admission to women-only (WO; n=500) versus mixed-gender (MG; a matched sample of 500) substance abuse treatment programs. Administrative records on arrests, incarcerations, mental health services utilization, and drug treatment participation were collected, covering 3 years pre-admission and 8 years post-admission. Women treated in WO programs had lower levels of arrest, mental health services utilization rates, and drug treatment participation during the first year after drug treatment. No differences were found between the two groups in the long-term trajectories except that WO program participants had lower incarceration rates during the third year after treatment. The study findings suggest a positive short-term impact of WO versus MG programs with regard to arrest and mental health service utilization. Limited long-term gain is shown in the reductions in post-treatment incarceration. The study findings suggest the added value of specialized WO programs and begin to address the gap in knowledge regarding long-term outcomes for substance-abusing women. PMID:21466942

75 FR 63845 - Medical Device User Fees; Public Meeting; Extension of Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

...] Medical Device User Fees; Public Meeting; Extension of Comment Period AGENCY: Food and Drug Administration... stakeholders on the Agency's medical user fee program and requested suggestions regarding the commitments FDA... interested stakeholders to discuss the Agency's medical user fee program and requested suggestions regarding...

28 CFR 0.138 - Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco...

Code of Federal Regulations, 2010 CFR

2010-07-01

... Justice Programs, Executive Office for Immigration Review, Executive Office for United States Attorneys... the Office of Justice Programs, the Director of the Executive Office for Immigration Review, the... JUSTICE ORGANIZATION OF THE DEPARTMENT OF JUSTICE Authorizations With Respect to Personnel and Certain...

10 CFR 26.153 - Using certified laboratories for testing urine specimens.

Code of Federal Regulations, 2011 CFR

2011-01-01

... for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration, Room 815.... 26.153 Section 26.153 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Laboratories... Workplace Drug Testing Programs [published in the Federal Register on April 11, 1988 (53 FR 11970), and as...

10 CFR 26.153 - Using certified laboratories for testing urine specimens.

Code of Federal Regulations, 2012 CFR

2012-01-01

... for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration, Room 815.... 26.153 Section 26.153 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Laboratories... Workplace Drug Testing Programs [published in the Federal Register on April 11, 1988 (53 FR 11970), and as...

10 CFR 26.153 - Using certified laboratories for testing urine specimens.

Code of Federal Regulations, 2014 CFR

2014-01-01

... for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration, Room 815.... 26.153 Section 26.153 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Laboratories... Workplace Drug Testing Programs [published in the Federal Register on April 11, 1988 (53 FR 11970), and as...

10 CFR 26.153 - Using certified laboratories for testing urine specimens.

Code of Federal Regulations, 2013 CFR

2013-01-01

... for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration, Room 815.... 26.153 Section 26.153 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Laboratories... Workplace Drug Testing Programs [published in the Federal Register on April 11, 1988 (53 FR 11970), and as...

10 CFR 26.153 - Using certified laboratories for testing urine specimens.

Code of Federal Regulations, 2010 CFR

2010-01-01

... for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration, Room 815.... 26.153 Section 26.153 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Laboratories... Workplace Drug Testing Programs [published in the Federal Register on April 11, 1988 (53 FR 11970), and as...

Responsible Conduct of Scientific Research: A One-Semester Course for Graduate Students.

ERIC Educational Resources Information Center

Hoshiko, T.

1993-01-01

Describes a course developed in part to satisfy the requirement that a program in the principles of scientific integrity be part of any training program funded by the National Institutes of Health (NIH) or the Alcohol, Drug Abuse, and Mental Health Administration. Contains 17 references. (DDR)

76 FR 68197 - Clinical Development Programs for Sedation Products; Public Workshop; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0547] Clinical Development Programs for Sedation Products; Public Workshop; Request for Comments AGENCY: Food and... clinically meaningful (e.g., subjective and objective assessments of memory, recall, anxiety, agitation, or...

Medicare Part D: successes and continuing challenges. Impact of Medicare Part D on Massachusetts health programs and beneficiaries.

PubMed

Thomas, Cindy Parks; Sussman, Jeffrey

2007-05-30

On January 1, 2006, the Centers for Medicare and Medicaid Services (CMS) implemented the Medicare Drug Benefit, or "Medicare Part D." The program offers prescription drug coverage for the one million Medicare beneficiaries in Massachusetts. Part D affects Massachusetts state health programs and beneficiaries in a number of ways. The program: (1) provides prescription drug insurance, including catastrophic coverage, through a choice of private prescription drug plans (PDPs) or integrated Medicare Advantage (MA-PD) health plans; (2) shifts prescription drug coverage for dual-eligible Medicare / Medicaid beneficiaries from Medicaid to Medicare Part D drug plans; (3) requires a maintenance-of-effort, or "clawback" payments from states to CMS designed to capture a portion of states' Medicaid savings to help finance the benefit; (4) offers additional help for premiums and cost sharing to low income beneficiaries through the Low Income Subsidy (LIS); and (5) provides a subsidy to employer groups that maintain their own prescription drug coverage for retired beneficiaries. This paper summarizes the activities involved in implementing Medicare Part D, the impact it has had on Massachusetts health programs, and the experiences of beneficiaries and others conducting outreach and enrollment. The data are drawn from interviews with officials and documents provided by state health programs, CMS and the Social Security Administration, and representatives of provider and advocacy groups involved in the enrollment and ongoing support of Medicare beneficiaries.

"Creating hope" and other incentives for drug development for children.

PubMed

Connor, Edward; Cure, Pablo

2011-01-19

Enhancing drug development for pediatric disease is a priority and a public responsibility. The Creating Hope Act of 2010 is important new proposed legislation that adds drugs and biologics for treating rare diseases in children to those for neglected tropical diseases as eligible for a priority review voucher from the U.S. Food and Drug Administration. The Act enhances existing incentive programs through specific financial benefits to companies who seek a pediatric indication for a new drug to treat an orphan disease that occurs specifically in children.

Cromolyn Ophthalmic

MedlinePlus

... keratitis (a condition that causes swelling of the cornea [tissue in the front of the eye] that ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Ofloxacin Ophthalmic

MedlinePlus

... including conjunctivitis (pink eye) and ulcers of the cornea. Ofloxacin is in a class of medications called ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Famotidine Injection

MedlinePlus

... the pancreas and small intestine that caused increased production of stomach acid). Famotidine injection is in a ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Ranitidine Injection

MedlinePlus

... the pancreas and small intestine that caused increased production of stomach acid). Ranitidine injection is in a ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

78 FR 45231 - Medicare and Medicaid Programs; Initial Approval of Center for Improvement in Healthcare Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

....23(c)(1), CIHQ modified its standards to address biologicals. To meet the requirements at Sec. 482.23... sets, and protocols for orders related to the preparation and administration of drugs and biologicals... to limit the removal of drugs and biologicals from the pharmacy or storage area only by personnel...

Alcohol and Drug Abuse. Policy Guidelines for Boards. Campus Life Policy Series.

ERIC Educational Resources Information Center

Goodale, Thomas G.

1992-01-01

The guide presents facts and issues concerning drug and alcohol abuse so that college and university administration and governing boards can make informed decisions about programs, policy, and procedures to minimize their occurrence on campus. Chapter 1 examines issues related to substance abuse on campus: risk factors in the campus community; the…

Azelaic Acid Topical

MedlinePlus

... the bacteria that infect pores and by decreasing production of keratin, a natural substance that can lead ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Population-based coverage survey results following the mass drug administration of azithromycin for the treatment of trachoma in Amhara, Ethiopia.

PubMed

Astale, Tigist; Sata, Eshetu; Zerihun, Mulat; Nute, Andrew W; Stewart, Aisha E P; Gessese, Demelash; Ayenew, Gedefaw; Melak, Berhanu; Chanyalew, Melsew; Tadesse, Zerihun; Callahan, E Kelly; Nash, Scott D

2018-02-01

Trachoma is the leading infectious cause of blindness worldwide. In communities where the district level prevalence of trachomatous inflammation-follicular among children ages 1-9 years is ≥5%, WHO recommends annual mass drug administration (MDA) of antibiotics with the aim of at least 80% coverage. Population-based post-MDA coverage surveys are essential to understand the effectiveness of MDA programs, yet published reports from trachoma programs are rare. In the Amhara region of Ethiopia, a population-based MDA coverage survey was conducted 3 weeks following the 2016 MDA to estimate the zonal prevalence of self-reported drug coverage in all 10 administrative zones. Survey households were selected using a multi-stage cluster random sampling design and all individuals in selected households were presented with a drug sample and asked about taking the drug during the campaign. Zonal estimates were weighted and confidence intervals were calculated using survey procedures. Self-reported drug coverage was then compared with regional reported administrative coverage. Region-wide, 24,248 individuals were enumerated, of which, 20,942 (86.4%) individuals were present. The regional self-reported antibiotic coverage was 76.8% (95%Confidence Interval (CI):69.3-82.9%) in the population overall and 77.4% (95%CI = 65.7-85.9%) among children ages 1-9 years old. Zonal coverage ranged from 67.8% to 90.2%. Five out of 10 zones achieved a coverage >80%. In all zones, the reported administrative coverage was greater than 90% and was considerably higher than self-reported MDA coverage. Main reasons reported for MDA campaign non-attendance included being physically unable to get to MDA site (22.5%), traveling (20.6%), and not knowing about the campaign (21.0%). MDA refusal was low (2.8%) in this population. Although self-reported MDA coverage in Amhara was greater than 80% in some zones, programmatic improvements are warranted throughout Amhara to achieve higher coverage. These results will be used to enhance community mobilization and improve training for MDA distributors and supervisors to improve coverage in future MDAs.

Perceptions of practicing pharmacists in Idaho about a potential behind-the-counter drug program.

PubMed

Hunt, Timothy L; Culbertson, Vaughn L; Erramouspe, John; Casperson, Kerry

2010-09-01

In late 2007, the Food and Drug Administration (FDA) held public hearings exploring the establishment of a new behind-the-counter (BTC) drug program. However, little is known about the views of pharmacists regarding such a program. To assess the overall perceptions of Idaho's practicing pharmacists about the creation of a formal BTC drug program, the appropriateness of including certain drug categories, specific barriers to its adoption, and the impact of the new program on access to medicines. A survey of practicing pharmacists in Idaho was conducted by mail, utilizing anonymous responses. Key questions exploring the views of pharmacists about the new BTC drug program utilized 5-point Likert scales. Data were also collected on respondent characteristics. A total of 357 practicing pharmacists in Idaho (31% response rate) returned the mail survey; 84% of pharmacists agreed that the FDA should be exploring an expanded BTC program, and 88% of pharmacists agreed that this program would improve access to some prescription-only products and convenience for patients. Almost 71% of pharmacists reported a personal willingness to both initiate and monitor certain BTC drug therapies. When focusing on specific drug categories for BTC status, the highest support was for selected agents within smoking cessation therapies (85%), nasal corticosteroids for allergies (81%), and vaccines (75%). Pharmacists who reported low barriers to the adoption of a new BTC program were significantly more likely to support this program than were those reporting high barriers. Only 39% of pharmacists agreed that adequate facilities were currently available for private evaluation and counseling of BTC patients. Pharmacists in a statewide survey of perceptions regarding a new BTC drug program overwhelmingly believe that patients would benefit. Pharmacists strongly support the development of the new program, and more than two thirds indicate that they would likely participate, given the necessary supporting institutional framework. Perceived barriers are related to willingness to participate and likely can be minimized through education and provision of private consulting areas.

Strategic planning for clinical services: St. Joseph Hospital and Health Care Center.

PubMed

Linggi, A; Pelham, L D

1986-09-01

A pharmacy department at a 340-bed community hospital based its strategic plan for developing patient-oriented services on a sound drug distribution system, a credible work-measurement program, and fiscal responsibility. In 1982 the department of pharmacy and i.v. therapy implemented a strategic plan for improving pharmaceutical services. The plan involved developing goals and objectives for the department; marketing the department's services and fiscal management to hospital administrators, medical staff, and nursing staff; building teamwork among the pharmacy staff; and improving the drug distribution system before instituting clinical services. Hiring of additional pharmacy staff was justified on the basis of work-measurement data. By adjusting staffing levels every two weeks based on work-measurement data, the department increased the efficiency of drug distribution activities; the pharmacy also implemented cost-saving programs like selection of therapeutic alternates and formulary restrictions. The savings were then reinvested in labor-intensive patient-oriented pharmaceutical services. A staff development program using staff pharmacists as preceptors expanded the breadth and depth of pharmacists' clinical skills. The planning efforts were successful because the needs of hospital administrators, the pharmacy department, and staff members were addressed.

Awareness of the Food and Drug Administration's Bad Ad Program and Education Regarding Pharmaceutical Advertising: A National Survey of Prescribers in Ambulatory Care Settings.

PubMed

O'Donoghue, Amie C; Boudewyns, Vanessa; Aikin, Kathryn J; Geisen, Emily; Betts, Kevin R; Southwell, Brian G

2015-01-01

The U.S. Food and Drug Administration's Bad Ad program educates health care professionals about false or misleading advertising and marketing and provides a pathway to report suspect materials. To assess familiarity with this program and the extent of training about pharmaceutical marketing, a sample of 2,008 health care professionals, weighted to be nationally representative, responded to an online survey. Approximately equal numbers of primary care physicians, specialists, physician assistants, and nurse practitioners answered questions concerning Bad Ad program awareness and its usefulness, as well as their likelihood of reporting false or misleading advertising, confidence in identifying such advertising, and training about pharmaceutical marketing. Results showed that fewer than a quarter reported any awareness of the Bad Ad program. Nonetheless, a substantial percentage (43%) thought it seemed useful and 50% reported being at least somewhat likely to report false or misleading advertising in the future. Nurse practitioners and physician assistants expressed more openness to the program and reported receiving more training about pharmaceutical marketing. Bad Ad program awareness is low, but opportunity exists to solicit assistance from health care professionals and to help health care professionals recognize false and misleading advertising. Nurse practitioners and physician assistants are perhaps the most likely contributors to the program.

National Mass Drug Administration Costs for Lymphatic Filariasis Elimination

PubMed Central

Goldman, Ann S.; Guisinger, Victoria H.; Aikins, Moses; Amarillo, Maria Lourdes E.; Belizario, Vicente Y.; Garshong, Bertha; Gyapong, John; Kabali, Conrad; Kamal, Hussein A.; Kanjilal, Sanjat; Kyelem, Dominique; Lizardo, Jefrey; Malecela, Mwele; Mubyazi, Godfrey; Nitièma, P. Abdoulaye; Ramzy, Reda M. R.; Streit, Thomas G.; Wallace, Aaron; Brady, Molly A.; Rheingans, Richard; Ottesen, Eric A.; Haddix, Anne C.

2007-01-01

Background Because lymphatic filariasis (LF) elimination efforts are hampered by a dearth of economic information about the cost of mass drug administration (MDA) programs (using either albendazole with diethylcarbamazine [DEC] or albendazole with ivermectin), a multicenter study was undertaken to determine the costs of MDA programs to interrupt transmission of infection with LF. Such results are particularly important because LF programs have the necessary diagnostic and treatment tools to eliminate the disease as a public health problem globally, and already by 2006, the Global Programme to Eliminate LF had initiated treatment programs covering over 400 million of the 1.3 billion people at risk. Methodology/Principal Findings To obtain annual costs to carry out the MDA strategy, researchers from seven countries developed and followed a common cost analysis protocol designed to estimate 1) the total annual cost of the LF program, 2) the average cost per person treated, and 3) the relative contributions of the endemic countries and the external partners. Costs per person treated ranged from $0.06 to $2.23. Principal reasons for the variation were 1) the age (newness) of the MDA program, 2) the use of volunteers, and 3) the size of the population treated. Substantial contributions by governments were documented – generally 60%–90% of program operation costs, excluding costs of donated medications. Conclusions/Significance MDA for LF elimination is comparatively inexpensive in relation to most other public health programs. Governments and communities make the predominant financial contributions to actual MDA implementation, not counting the cost of the drugs themselves. The results highlight the impact of the use of volunteers on program costs and provide specific cost data for 7 different countries that can be used as a basis both for modifying current programs and for developing new ones. PMID:17989784

Modeling the Impact and Costs of Semiannual Mass Drug Administration for Accelerated Elimination of Lymphatic Filariasis

PubMed Central

de Vlas, Sake J.; Fischer, Peter U.; Weil, Gary J.; Goldman, Ann S.

2013-01-01

The Global Program to Eliminate Lymphatic Filariasis (LF) has a target date of 2020. This program is progressing well in many countries. However, progress has been slow in some countries, and others have not yet started their mass drug administration (MDA) programs. Acceleration is needed. We studied how increasing MDA frequency from once to twice per year would affect program duration and costs by using computer simulation modeling and cost projections. We used the LYMFASIM simulation model to estimate how many annual or semiannual MDA rounds would be required to eliminate LF for Indian and West African scenarios with varied pre-control endemicity and coverage levels. Results were used to estimate total program costs assuming a target population of 100,000 eligibles, a 3% discount rate, and not counting the costs of donated drugs. A sensitivity analysis was done to investigate the robustness of these results with varied assumptions for key parameters. Model predictions suggested that semiannual MDA will require the same number of MDA rounds to achieve LF elimination as annual MDA in most scenarios. Thus semiannual MDA programs should achieve this goal in half of the time required for annual programs. Due to efficiency gains, total program costs for semiannual MDA programs are projected to be lower than those for annual MDA programs in most scenarios. A sensitivity analysis showed that this conclusion is robust. Semiannual MDA is likely to shorten the time and lower the cost required for LF elimination in countries where it can be implemented. This strategy may improve prospects for global elimination of LF by the target year 2020. PMID:23301115

49 CFR 655.62 - Referral, evaluation, and treatment.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., including the names, addresses, and telephone numbers of substance abuse professionals (SAPs) and counseling and treatment programs. ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND PROHIBITED DRUG USE IN TRANSIT...

49 CFR 655.62 - Referral, evaluation, and treatment.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., including the names, addresses, and telephone numbers of substance abuse professionals (SAPs) and counseling and treatment programs. ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND PROHIBITED DRUG USE IN TRANSIT...

49 CFR 655.62 - Referral, evaluation, and treatment.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., including the names, addresses, and telephone numbers of substance abuse professionals (SAPs) and counseling and treatment programs. ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND PROHIBITED DRUG USE IN TRANSIT...

49 CFR 655.62 - Referral, evaluation, and treatment.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., including the names, addresses, and telephone numbers of substance abuse professionals (SAPs) and counseling and treatment programs. ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND PROHIBITED DRUG USE IN TRANSIT...

49 CFR 655.62 - Referral, evaluation, and treatment.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., including the names, addresses, and telephone numbers of substance abuse professionals (SAPs) and counseling and treatment programs. ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND PROHIBITED DRUG USE IN TRANSIT...

Phenelzine as a stimulant drug antagonist: a preliminary report.

PubMed

Maletzky, B M

1977-08-01

Phenelzine administration, monitored via a pharmacy-controlled program, was employed in 38 subjects over a 6-month period to prevent amphetamine-type drug abuse, in much the same manner as disulfiram programs are employed against alcohol abuse. Advantages of the program were apparent, with a majority of subjects abstaining during the enforced phenelzine trial. Subjects generally made use of this abstinent period to benefit from a variety of psychotherapeutic modes, and demonstrated enhanced job and school performance and improved marital relationships. Results based on subject and observer reports, reports from dispensing pharmacies, and random urinalyses for drugs were encouraging. However, the study was uncontrolled and observational, and thus results are merely suggestive at present. Potential dangers as well as benefits of administering phenelzine to such a population are discussed.

Measuring Social Innovation.

ERIC Educational Resources Information Center

Sviridoff, Mitchell

In this report a program of supported work developed by the Employment and Training Administration of the Department of Labor and the Ford Foundation is discussed. Supported work is designed for the disadvantaged, people who face barriers in seeking and holding regular jobs. A pilot program for former drug addicts was begun in 1972 by the Vera…

75 FR 76472 - Biologics Price Competition and Innovation Act of 2009; Meetings on User Fee Program for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0602] Biologics Price Competition and Innovation Act of 2009; Meetings on User Fee Program for Biosimilar and Interchangeable Biological Product Applications; Request for Notification of Stakeholder Intention To Participate...

77 FR 37055 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... Request; Secure Supply Chain Pilot Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice... identified with the title Secure Supply Chain Pilot Program. Also include the FDA docket number found in... following proposed collection of information to OMB for review and clearance: ``Secure Supply Chain Pilot...

78 FR 11204 - Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-15

...] Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I; Draft Guidance... announcing the availability of the draft guidance entitled ``Accreditation and Reaccreditation Process for... Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), requires FDA...

A STUDY TO EVALUATE THE LEVELS OF DIOXIN-LIKE COMPOUNDS IN DAIRY FEEDS IN THE U.S.

EPA Science Inventory

The Environmental Protection Agency (EPA), in cooperation with USDA and the US Food and Drug Administration (FDA), has undertaken a program to study the presence of dioxin-like compounds in animal feeds. Two phases of this program have been completed, and this paper reports on t...

34 CFR 380.8 - What regulations apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

... of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for... (Grants)). (9) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 380. (c...

34 CFR 377.4 - What regulations apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The following regulations in 34 CFR part 369...

34 CFR 377.4 - What regulations apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The following regulations in 34 CFR part 369...

34 CFR 380.8 - What regulations apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

... of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for... (Grants)). (9) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 380. (c...

34 CFR 377.4 - What regulations apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The following regulations in 34 CFR part 369...

34 CFR 380.8 - What regulations apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

... of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for... (Grants)). (9) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 380. (c...

34 CFR 377.4 - What regulations apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The following regulations in 34 CFR part 369...

34 CFR 377.4 - What regulations apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for Grants and...) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The following regulations in 34 CFR part 369...

34 CFR 380.8 - What regulations apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

... of Education Programs and Activities). (5) 34 CFR part 80 (Uniform Administrative Requirements for... (Grants)). (9) 34 CFR part 86 (Drug-Free Schools and Campuses). (b) The regulations in this part 380. (c...

Rufinamide

MedlinePlus

... unusual problems while taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/ ...

The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program.

PubMed

Forrow, Susan; Campion, Daniel M; Herrinton, Lisa J; Nair, Vinit P; Robb, Melissa A; Wilson, Marcus; Platt, Richard

2012-01-01

The US Food and Drug Administration's Mini-Sentinel pilot program is developing an organizational structure as well as principles and policies to govern its operations. These will inform the structure and function of the eventual Sentinel System. Mini-Sentinel is a collaboration that includes 25 participating institutions. We describe the program's current organizational structure and its major principles and policies. The organization includes a coordinating center with program leadership provided by a principal investigator; a planning board and subcommittees; an operations center; and data, methods, and protocol cores. Ad hoc workgroups are created as needed. A privacy panel advises about protection of individual health information. Principles and policies are intended to ensure that Mini-Sentinel conforms to the principles of fair information practices, protects the privacy of individual health information, maintains the security and integrity of data, assures the confidentiality of proprietary information, provides accurate and timely communications, prevents or manages conflicts of interest, and preserves respect for intellectual property rights. Copyright © 2012 John Wiley & Sons, Ltd.

Raising suspicions with the Food and Drug Administration: detecting misconduct.

PubMed

Hamrell, Michael R

2010-12-01

The clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. A comprehensive program of on-site inspections and data verification, the BIMO program routinely performs random inspections to verify studies submitted to the FDA to support a marketing application. On occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have previously been identified. The inspection of a clinical study sometimes uncovers evidence of research fraud or misconduct and it must be decided how to deal with the investigator and the suspect data. The prevention of [or] decreasing the incidence of fraud and misconduct through monitoring by the sponsor is one way to manage compliance issues and can help prevent misconduct. A training program is another way to manage compliance issues in clinical research. While training does not guarantee quality, it does help to ensure that all individuals involved understand the rules and the consequences of research misconduct.

Faculty buy-in to teach alcohol and drug use screening.

PubMed

Puskar, Kathy; Mitchell, Ann M; Kane, Irene; Hagle, Holly; Talcott, Kimberly S

2014-09-01

Educating nursing faculty about the use of an evidence-based practice to screen and intervene earlier along the continuum of alcohol and other drug use, misuse, and dependence is essential in today's health care arena. Misuse of alcohol and other drugs is a significant problem for both individual health and societal economic welfare. The purpose of this article is to describe nursing faculty buy-in for the implementation of an evidence-based addiction training program at a university-based school of nursing. Derived from an academic-community partnership, the training program results suggest implications for continuing education and curriculum innovation in schools of nursing and clinical practice. The training content presented can be used in continuing education for nursing faculty across all types of nursing school programs and professional nursing staff employed in multiple settings. The training program was funded by the Health Resources and Services Administration.

Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain.

PubMed

Chambers, James D; May, Katherine E; Neumann, Peter J

2013-06-01

The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.

Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

PubMed Central

Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.

2015-01-01

Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691

Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

PubMed

Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E

2015-10-01

The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.

Complying with the Drug-Free Schools and Campuses Regulations (34 CFR Part 86). A Guide for University and College Administrators.

ERIC Educational Resources Information Center

Pittayathikhun, Tanutda; Ku, Richard; Rigby, Donna; Mattsson, Marilyn; DeJong, William

This document describes ways in which higher education institutions have responded to the requirements of the 1989 amendments to the Drug-Free Schools and Campuses Act, Part 86, Regulations, and is intended to help institutions improve current programs and avoid overlooking requirements that might result in noncompliance. Chapter 1 presents the…

The need of adequate information to achieve total compliance of mass drug administration in Pekalongan

NASA Astrophysics Data System (ADS)

Ginandjar, Praba; Saraswati, Lintang Dian; Taufik, Opik; Nurjazuli; Widjanarko, Bagoes

2017-02-01

World Health Organization (WHO) initiated The Global Program to Eliminate Lymphatic Filariasis (LF) through mass drug administration (MDA). Pekalongan started MDA in 2011. Yet the LF prevalence in 2015 remained exceed the threshold (1%). This study aimed to describe the inhibiting factors related to the compliance of MDA in community level. This was a rapid survey with cross sectional approach. A two-stages random sampling was used in this study. In the first stage, 25 clusters were randomly selected from 27 villages with proportionate to population size (PPS) methods (C-Survey). In the second stage, 10 subjects were randomly selected from each cluster. Subject consisted of 250 respondents from 25 selected clusters. Variables consisted of MDA coverage, practice of taking medication during MDA, enabling and inhibiting factors to MDA in community level. The results showed most respondents had poor knowledge on filariasis, which influence awareness of the disease. Health-illness perception, did not receive the drugs, lactation, side effect, and size of the drugs were dominant factors of non-compliance to MDA. MDA information and community empowerment were needed to improve MDA coverage. Further study to explore the appropriate model of socialization will support the success of MDA program

Federalizing Medical Campaigns against Alcoholism and Drug Abuse

PubMed Central

Metlay, Grischa

2013-01-01

Context The formation of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Special Action Office for Drug Abuse Prevention (SAODAP) in the early 1970s dramatically expanded scientific and medical efforts to control alcoholism and drug abuse in the United States. Methods Drawing on a variety of primary, secondary, and archival sources, this article describes the creation and early years of these agencies. Findings I show that while the agencies appeared at roughly the same time, their creation involved separate sets of issues and actors. In addition, I show that SAODAP received more money and resources, even though advocates for alcoholics mobilized a stronger lobbying campaign. Conclusions Two factors explain this discrepancy in money and resources: (1) alcoholism was framed as a public health problem, whereas drug abuse was drawn into broader debates about crime and social decline; and (2) alcohol programs relied on congressional support, whereas drug programs found champions at high levels of the Nixon administration. These political and cultural factors help explain why current programs for illegal drugs receive more federal support, despite alcohol's greater public health burden. PMID:23488713

Federalizing medical campaigns against alcoholism and drug abuse.

PubMed

Metlay, Grischa

2013-03-01

The formation of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Special Action Office for Drug Abuse Prevention (SAODAP) in the early 1970s dramatically expanded scientific and medical efforts to control alcoholism and drug abuse in the United States. Drawing on a variety of primary, secondary, and archival sources, this article describes the creation and early years of these agencies. I show that while the agencies appeared at roughly the same time, their creation involved separate sets of issues and actors. In addition, I show that SAODAP received more money and resources, even though advocates for alcoholics mobilized a stronger lobbying campaign. Two factors explain this discrepancy in money and resources: (1) alcoholism was framed as a public health problem, whereas drug abuse was drawn into broader debates about crime and social decline; and (2) alcohol programs relied on congressional support, whereas drug programs found champions at high levels of the Nixon administration. These political and cultural factors help explain why current programs for illegal drugs receive more federal support, despite alcohol's greater public health burden. © 2013 Milbank Memorial Fund.

Community Attitudes toward Mass Drug Administration for Control and Elimination of Neglected Tropical Diseases after the 2014 Outbreak of Ebola Virus Disease in Lofa County, Liberia

PubMed Central

Bogus, Joshua; Gankpala, Lincoln; Fischer, Kerstin; Krentel, Alison; Weil, Gary J.; Fischer, Peter U.; Kollie, Karsor; Bolay, Fatorma K.

2016-01-01

The recent outbreak of Ebola virus disease (EVD) interrupted mass drug administration (MDA) programs to control and eliminate neglected tropical diseases in Liberia. MDA programs treat entire communities with medication regardless of infection status to interrupt transmission and eliminate lymphatic filariasis and onchocerciasis. Following reports of hostilities toward health workers and fear that they might be spreading EVD, it was important to determine whether attitudes toward MDA might have changed after the outbreak. We surveyed 140 community leaders from 32 villages in Lofa County, Liberia, that had previously participated in MDA and are located in an area that was an early epicenter of the EVD outbreak. Survey respondents reported a high degree of community trust in the MDA program, and 97% thought their communities were ready to resume MDA. However, respondents predicted that fewer people would comply with MDA after the EVD epidemic than before. The survey also uncovered fears in the community that EVD and MDA might be linked. Respondents suggested that MDA programs emphasize to people that the medications are identical to those previously distributed and that MDA programs have nothing to do with EVD. PMID:26666700

76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-24

...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of neglected diseases of the developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment or prevention of neglected tropical diseases (NTDs), including clinical trial designs and internal review standards to support approval of drugs.

Pharmacokinetics and selected pharmacodynamics of trazodone following intravenous and oral administration to horses undergoing fitness training.

PubMed

Knych, Heather K; Mama, Khursheed R; Steffey, Eugene P; Stanley, Scott D; Kass, Philip H

2017-10-01

OBJECTIVE To measure concentrations of trazodone and its major metabolite in plasma and urine after administration to healthy horses and concurrently assess selected physiologic and behavioral effects of the drug. ANIMALS 11 Thoroughbred horses enrolled in a fitness training program. PROCEDURES In a pilot investigation, 4 horses received trazodone IV (n = 2) or orally (2) to select a dose for the full study; 1 horse received a vehicle control treatment IV. For the full study, trazodone was initially administered IV (1.5 mg/kg) to 6 horses and subsequently given orally (4 mg/kg), with a 5-week washout period between treatments. Blood and urine samples were collected prior to drug administration and at multiple time points up to 48 hours afterward. Samples were analyzed for trazodone and metabolite concentrations, and pharmacokinetic parameters were determined; plasma drug concentrations following IV administration best fit a 3-compartment model. Behavioral and physiologic effects were assessed. RESULTS After IV administration, total clearance of trazodone was 6.85 ± 2.80 mL/min/kg, volume of distribution at steady state was 1.06 ± 0.07 L/kg, and elimination half-life was 8.58 ± 1.88 hours. Terminal phase half-life was 7.11 ± 1.70 hours after oral administration. Horses had signs of aggression and excitation, tremors, and ataxia at the highest IV dose (2 mg/kg) in the pilot investigation. After IV drug administration in the full study (1.5 mg/kg), horses were ataxic and had tremors; sedation was evident after oral administration. CONCLUSIONS AND CLINICAL RELEVANCE Administration of trazodone to horses elicited a wide range of effects. Additional study is warranted before clinical use of trazodone in horses can be recommended.

Analysis of Physicochemical Properties for Drugs of Natural Origin.

PubMed

Camp, David; Garavelas, Agatha; Campitelli, Marc

2015-06-26

The impact of time, therapy area, and route of administration on 13 physicochemical properties calculated for 664 drugs developed from a natural prototype was investigated. The mean values for the majority of properties sampled over five periods from pre-1900 to 2013 were found to change in a statistically significant manner. In contrast, lipophilicity and aromatic ring count remained relatively constant, suggesting that these parameters are the most important for successful prosecution of a natural product drug discovery program if the route of administration is not focused exclusively on oral availability. An examination by therapy area revealed that anti-infective agents had the most differences in physicochemical property profiles compared with other areas, particularly with respect to lipophilicity. However, when this group was removed, the variation between the mean values for lipophilicity and aromatic ring count across the remaining therapy areas was again found not to change in a meaningful manner, further highlighting the importance of these two parameters. The vast majority of drugs with a natural progenitor were formulated for either oral and/or injectable administration. Injectables were, on average, larger and more polar than drugs developed for oral, topical, and inhalation routes.

Drug and Alcohol Testing Survey - 1998 Results

DOT National Transportation Integrated Search

1997-01-01

This application was identified as a promising rural Intelligent Transportation Systems (ITS) solution under a project sponsored by the Federal Highway Administration (FHWA) and the ENTERPRISE program. This summary describes the solution as well as o...

78 FR 69602 - Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Extension of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

... ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2011-N-0143] RIN 0910-AG64 Foreign Supplier Verification Programs for Importers of Food for Humans and...

Employee Assistance Program Cost Containment through the Utilization of Community-Based, Social Model Treatment Providers.

ERIC Educational Resources Information Center

de Miranda, John; Lampe, Marc

Statewide efforts by the California Department of Alcohol and Drug Programs to secure third-party payments for nonhospital alcoholism services gradually dissolved due to changes in political administration and overall priorities. San Mateo County, however, served as a demonstration county for the effort and has continued to explore third-party…

Asynchronous Training in Pharmaceutical Manufacturing: A Model for University and Industrial Collaboration

ERIC Educational Resources Information Center

Elliot, Norbert; Haggerty, Blake; Foster, Mary; Spak, Gale

2008-01-01

The present study documents the results of a 17-month program to train Cardinal Health Pharmaceutical Technology Services (PTS) employees in an innovative model that combines investigative and writing techniques. Designed to address the Code of Federal Regulations (CFR) for the United States Food and Drug Administration (FDA), the program is a…

Design Considerations for the Development of Interactive Video (IV) in Nurse Education.

ERIC Educational Resources Information Center

Chandra, Peter; And Others

A computer assisted learning (CAL) program in the area of intravenous drug administration developed by the Nightingale Project is currently being used in a number of nursing schools and hospitals throughout the United Kingdom. The success of this program and the emergence of interactive video as a significant training medium persuaded the…

Validation of the IntelliCap® system as a tool to evaluate extended release profiles in human GI tract using metoprolol as model drug.

PubMed

Söderlind, Erik; Abrahamsson, Bertil; Erlandsson, Fredrik; Wanke, Christoph; Iordanov, Ventzeslav; von Corswant, Christian

2015-11-10

A clinical study was conducted to validate the in vivo drug release performance of IntelliCap® CR capsules. 12 healthy, male volunteers were administered IntelliCap® CR capsules, filled with metoprolol as a BCS 1 model drug, and programmed to release the drug with 3 different release profiles (2 linear profiles extending over 6h and 14h, respectively, and a pulsed profile with two equal pulses separated by 5h) using a cross-over design. An oral metoprolol solution was included as a reference. Standard bioavailability variables were determined. In vivo drug release-time profiles for the IntelliCap® CR capsules were calculated from the plasma drug concentrations by deconvolution, and they were subsequently compared with the in vitro drug release profiles including assessment of level A in vitro/in vivo correlation (IVIVC). The relative bioavailability for the linear, extended release profiles was about 85% which is similar to other extended release administrations of metoprolol. There was an excellent agreement between the predetermined release profiles and the in vivo release for these two administrations. For IntelliCap® CR capsules programmed to deliver 2 distinct and equal drug pulses, the first pulse was delivered as expected whereas only about half of the second dose was released. Thus, it is concluded that the IntelliCap® system is well suited for the fast and reliable generation of in vivo pharmacokinetic data for extended release drug profiles, e.g. in context of regional drug absorption investigations. For immediate release pulses delivered in the distal GI tract this version of the device appears however less suitable. Copyright © 2015 Elsevier B.V. All rights reserved.

Animal NARMS Surveillance Data

USDA-ARS?s Scientific Manuscript database

The National Antimicrobial Resistance Monitoring System (NARMS) is a collaborative program between the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the United States Department of Agriculture to prospectively monitor changes in antimicrobial susceptibilities of zoon...

76 FR 19998 - Supplemental Funding Under the Food and Drug Administration Pediatric Device Consortia Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-11

... adults. Children differ from adults in terms of their size, growth, development, and body chemistry... devices designed specifically with children in mind. Such needs include the original development of...

48 CFR 523.370 - Solicitation provision.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Solicitation provision. 523.370 Section 523.370 Federal Acquisition Regulations System GENERAL SERVICES ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, CONSERVATION, OCCUPATIONAL SAFETY AND DRUG-FREE WORKPLACE Hazardous...

48 CFR 523.370 - Solicitation provision.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Solicitation provision. 523.370 Section 523.370 Federal Acquisition Regulations System GENERAL SERVICES ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, CONSERVATION, OCCUPATIONAL SAFETY AND DRUG-FREE WORKPLACE Hazardous...

48 CFR 523.370 - Solicitation provision.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Solicitation provision. 523.370 Section 523.370 Federal Acquisition Regulations System GENERAL SERVICES ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, CONSERVATION, OCCUPATIONAL SAFETY AND DRUG-FREE WORKPLACE Hazardous...

48 CFR 523.370 - Solicitation provision.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Solicitation provision. 523.370 Section 523.370 Federal Acquisition Regulations System GENERAL SERVICES ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, CONSERVATION, OCCUPATIONAL SAFETY AND DRUG-FREE WORKPLACE Hazardous...

48 CFR 523.370 - Solicitation provision.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Solicitation provision. 523.370 Section 523.370 Federal Acquisition Regulations System GENERAL SERVICES ADMINISTRATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, CONSERVATION, OCCUPATIONAL SAFETY AND DRUG-FREE WORKPLACE Hazardous...

State of Utopia v. Jamie Davidson. 2002-2003 Oklahoma High School Mock Trial Program.

ERIC Educational Resources Information Center

Benischek, Sandra; Davis, Courtney; Horton, Johnathan; Longwell, Nicole; Williams, Keri

In the spring of 2001, illegal drug use had risen by 40% among teens in the town of Springdale, Utopia. School administrators and the Springdale Police Department decided to implement a crackdown on teen drug use in all high schools in Springdale. A high school principal received a tip on a hotline that Jamie Davidson, a senior, had been seen…

United States Air Force Summer Research Program -- 1993. Volume 7. Armstrong Laboratory

DTIC Science & Technology

1993-12-01

formulation, absorption, plasma binding affinity, biomembrane barriers, and relative extraction by the specific organ of the body concerned with...simultaneously administered or a drug may "interact" with itself. The concomitant administration of phenobarbital and warfarin results in lower plasma ... plasma protein which binds to basic lipophilic drugs including propranolol, meperidine, quinidine, and chlorpromazine. If a variation in the plasma

Nurse turnover in substance abuse treatment programs affiliated with the National Drug Abuse Treatment Clinical Trials Network.

PubMed

Knudsen, Hannah K; Abraham, Amanda J; Roman, Paul M; Studts, Jamie L

2011-04-01

Voluntary nurse turnover, which is costly and disrupts patient care, has not been studied as an organizational phenomenon within substance abuse treatment organizations. In this exploratory study, we examined the frequency and correlates of nurse turnover within treatment programs affiliated with the National Drug Abuse Treatment Clinical Trials Network. During face-to-face interviews conducted in 2005-2006, 215 program administrators reported the number of nurses currently employed. Leaders of programs with nursing staff then described the number of nurses who had voluntarily quit in the past year, the degree to which filling vacant nursing positions was difficult, and the average number of days to fill a vacant position. About two thirds of these programs had at least one nurse on staff. In programs with nurses, the average rate of voluntary turnover was 15.0%. Turnover was significantly lower in hospital-based programs and programs offering adolescent treatment but higher in facilities offering residential treatment. Most of the administrators indicated that filling vacant nurse positions was difficult and took more than 2 months to complete. These findings suggest that nurse turnover is a significant issue facing many substance abuse treatment facilities. Efforts to improve retention of the addiction treatment workforce should be expanded to include nursing professionals. Copyright © 2011 Elsevier Inc. All rights reserved.

Long-Lasting Insecticidal Nets Are Synergistic with Mass Drug Administration for Interruption of Lymphatic Filariasis Transmission in Nigeria

PubMed Central

Eigege, Abel; Miri, Emmanuel; Sallau, Adamu; Umaru, John; Mafuyai, Hayward; Chuwang, Yohanna S.; Danjuma, Goshit; Danboyi, Jacob; Adelamo, Solomon E.; Mancha, Bulus S.; Okoeguale, Bridget; Patterson, Amy E.; Rakers, Lindsay; Richards, Frank O.

2013-01-01

In central Nigeria Anopheles mosquitoes transmit malaria and lymphatic filariasis (LF). The strategy used for interrupting LF transmission in this area is annual mass drug administration (MDA) with albendazole and ivermectin, but after 8 years of MDA, entomological evaluations in sentinel villages showed continued low-grade mosquito infection rates of 0.32%. After long-lasting insecticidal net (LLIN) distribution by the national malaria program in late 2010, however, we were no longer able to detect infected vectors over a 24-month period. This is evidence that LLINs are synergistic with MDA in interrupting LF transmission. PMID:24205421

Self-administration of cocaine, cannabis and heroin in the human laboratory: benefits and pitfalls.

PubMed

Haney, Margaret

2009-01-01

The objective of this review is to describe self-administration procedures for modeling addiction to cocaine, cannabis and heroin in the human laboratory, the benefits and pitfalls of the approach, and the methodological issues unique to each drug. In addition, the predictive validity of the model for testing treatment medications will be addressed. The results show that all three drugs of abuse are reliably and robustly self-administered by non-treatment-seeking research volunteers. In terms of pharmacotherapies, cocaine use is extraordinarily difficult to disrupt either in the laboratory or in the clinic. A range of medications has been shown to significantly decrease cocaine's subjective effects and craving without decreasing either cocaine self-administration or cocaine abuse by patients. These negative data combined with recent positive findings with modafinil suggest that self-administration procedures are an important intermediary step between pre-clinical and clinical studies. In terms of cannabis, a recent study suggests that medications that improve sleep and mood during cannabis withdrawal decrease the resumption of marijuana self-administration in abstinent volunteers. Clinical data on patients seeking treatment for their marijuana use are needed to validate these laboratory findings. Finally, in contrast to cannabis or cocaine dependence, there are three efficacious Food and Drug Administration-approved medications to treat opioid dependence, all of which decrease both heroin self-administration and subjective effects in the human laboratory. In summary, self-administration procedures provide meaningful behavioral data in a small number of individuals. These studies contribute to our understanding of the variables maintaining cocaine, marijuana and heroin intake, and are important in guiding the development of more effective drug treatment programs.

School climate and adolescent drug use: mediating effects of violence victimization in the urban high school context.

PubMed

Reid, Robert J; Andrew Peterson, N; Hughey, Joseph; Garcia-Reid, Pauline

2006-05-01

This study tested the mediating effects of violence victimization in the relationship between school climate and adolescent drug use. The hypothesized path model fit data collected from a probability sample of urban high school students (N=586) participating in an evaluation of a violence prevention program funded by the Substance Abuse and Mental Health Services Administration. Findings indicated that the lack of enforcement of school rules and the presence of unsafe places in and around the school influenced adolescent drug use directly and indirectly through their effects on violence victimization.Editors' Strategic Implications: This research confirms the importance of the environment as a contributor to violence victimization. Violence victimization is obviously of concern in its own right, but in addition, these data indicate that it also contributes to adolescent drug use. School administrators should be aware that unsafe places in schools and the failure to enforce school rules may affect such victimization and drug use.

Competing Values Among Criminal Justice Administrators: The Importance of Substance Abuse Treatment*

PubMed Central

Henderson, Craig E.; Taxman, Faye S.

2009-01-01

This study applied latent class analysis (LCA) to examine heterogeneity in criminal justice administrators’ attitudes toward the importance of substance abuse treatment relative to other programs and services commonly offered in criminal justice settings. The study used data collected from wardens, probation and/or parole administrators, and other justice administrators as part of the National Criminal Justice Treatment Practices survey (NCJTP), and includes both adult criminal and juvenile justice samples. Results of the LCA suggested that administrators fell into four different latent classes: (1) those who place a high importance on substance abuse treatment relative to other programs and services, (2) those who place equal importance on substance abuse treatment and other programs and services, (3) those who value other programs and services moderately more than substance abuse treatment, and (4) those who value other programs and services much more than substance abuse treatment. Latent class membership was in turn associated with the extent to which evidence-based substance abuse treatment practices were being used in the facilities, the region of the country in which the administrator worked, and attitudes toward rehabilitating drug-using offenders. The findings have implications for future research focused on the impact that administrators’ attitudes have on service provision as well as the effectiveness of knowledge dissemination and diffusion models. PMID:19054632

Slow launch for HGH.

PubMed

Gilden, D

1995-05-01

The human growth hormone (HGH) expanded access program for people with AIDS wasting syndrome is now in its fourth month. Enrollment has been slow, largely due to cost. Since HGH falls under the Food and Drug Administration's (FDA) Treatment Investigational New Drug (TIND) regulations, patients are required to pay for the drug--at a cost of about $150 per day, or more than $1,000 per week. Few insurance companies will compensate for the cost of HGH, and no state Medicaid or AIDS Drug Assistance Programs have agreed to cover the compound. Serono Laboratories, the manufacturer, is operating an indigent program that provides free or discount HGH for individuals who cannot purchase the drug any other way. There are only 25 slots available in this program. Lack of available data on how and when to use the drug creates obstacles for physicians. Most of the public data available comes from a single, twelve-week, placebo-controlled study involving 178 participants. However, there are alternative treatments for wasting syndrome. A regimen of testosterone and synthetic anabolic steroids, given to men, has provided positive results on an anecdotal basis. Wasting syndrome comes from a metabolic change which occurs with chronic HIV infection. Rather than first using stores of fat, the body breaks down protein to meet its energy requirements.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-11

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

Evolution of the Food and Drug Administration approach to liver safety assessment for new drugs: current status and challenges.

PubMed

Senior, John R

2014-11-01

Prompted by approval in 1997 of troglitazone and bromfenac, two drugs that promptly began to show serious and sometimes fatal liver toxicity, we began at the Food and Drug Administration (FDA) a series of annual conferences in 1999 to consider issues of drug-induced liver injury (DILI). First inviting reviewers of new drug applications we opened the audiences in 2001 to pharmaceutical industry and academic consultants to industry and FDA, and slides shown at the meetings were posted on the internet to be available at the website of the American Association for the Study of Liver Diseases (AASLD)-go to ( http://www.aasld.org/dili/Pages/default.aspx ). Observations by Dr. Hyman J. Zimmerman that "drug-induced hepatocellular jaundice is a serious lesion" with possible mortality formed a basis for developing a computer program to plot peak serum values for alanine aminotransferase (ALT) and total bilirubin (TBL) in an x-y log-log graph for all subjects enrolled in clinical trials. This program had the capability to show the time course of all liver tests for individuals who had both hepatocellular injury and reduced whole liver function, plus clinical narratives to diagnose the severity and most likely cause of the abnormalities. We called the program eDISH (for evaluation of Drug-Induced Serious Hepatotoxicity), and began in 2004 to use it to assess DILI in clinical trial subjects. From 2008, comments made by the presenters at the conferences about their slides and ensuing discussions have been added to the website. All this has raised awareness of the problem, and since 1997, the FDA has not had to withdraw a single drug because of post-marketing hepatotoxicity. Many issues still remain to be resolved; among the most controversial is the best method to estimate likelihood that a given liver injury was actually caused by the drug in question. On November 9, 2012, a workshop was convened to discuss the best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

49 CFR 40.7 - How can you get an exemption from a requirement in this regulation?

Code of Federal Regulations, 2010 CFR

2010-10-01

... FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Administrative Provisions § 40.7 How... provision from which an exemption is granted. (d) We will issue written responses to all exemption requests. ...

75 FR 54496 - Medical; Nonsubstantive Miscellaneous Changes; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-08

... and organizational titles were changed, and material previously deleted was restored. The document...), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC..., Claims, Day care, Dental health, Drug abuse, Foreign relations, Government contracts, Grant programs...

76 FR 10038 - Determination That a Demonstration Needle Exchange Program Would be Effective in Reducing Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-23

... Administration (SAMHSA), 1 Choke Cherry Road, Rockville, Maryland, attention John Campbell, 240-276-2891... tracks individuals in treatment over extended periods of time, most people who get into and remain in...

Amphotericin B Injection

MedlinePlus

... antifungals. It works by slowing the growth of fungi that cause infection. ... may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Caspofungin Injection

MedlinePlus

... echinocandins. It works by slowing the growth of fungi that cause infection. ... may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

77 FR 41416 - Food and Drug Administration/Xavier University Global Outsourcing Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... International Initiatives, FDA Inspection Trends, Supply Chain Development, Quality Agreements, Supplier... the World Establishing a Meaningful Supplier Qualification Program Supply Chain Development Finished... Agreements Business Process Management Global Standards Association Near Term Solutions The conference...

Assessment of Risk Evaluation and Mitigation Strategies in Oncology: Summary of the Oncology Risk Evaluation and Mitigation Strategies Workshop

PubMed Central

Frame, James N.; Jacobson, Joseph O.; Vogel, Wendy H.; Griffith, Niesha; Wariabharaj, Darshan; Garg, Rekha; Zon, Robin; Stephens, Cyntha L.; Bialecki, Alison M.; Bruinooge, Suanna S.; Allen, Steven L.

2013-01-01

To address oncology community stakeholder concerns regarding implementation of the Risk Evaluation and Mitigation Strategies (REMS) program, ASCO sponsored a workshop to gather REMS experiences from representatives of professional societies, patient organizations, pharmaceutical companies, and the US Food and Drug Administration (FDA). Stakeholder presentations and topical panel discussions addressed REMS program development, implementation processes, and practice experiences, as well as oncology drug safety processes. A draft REMS decision tool prepared by the ASCO REMS Steering Committee was presented for group discussion with facilitated, goal-oriented feedback. The workshop identified several unintended consequences resulting from current oncology REMS: (1) the release of personal health information to drug sponsors as a condition for gaining access to a needed drug; (2) risk information that is not tailored—and therefore not accessible—to all literacy levels; (3) exclusive focus on drug risk, thereby affecting patient-provider treatment discussion; (4) REMS elements that do not consider existing, widely practiced oncology safety standards, professional training, and experience; and (5) administrative burdens that divert the health care team from direct patient care activities and, in some cases, could limit patient access to important therapies. Increased provider and professional society participation should form the basis of ongoing and future REMS standardization discussions with the FDA to work toward overall improvement of risk communication. PMID:23814522

Pharmacological mechanism-based drug safety assessment and prediction.

PubMed

Abernethy, D R; Woodcock, J; Lesko, L J

2011-06-01

Advances in cheminformatics, bioinformatics, and pharmacology in the context of biological systems are now at a point that these tools can be applied to mechanism-based drug safety assessment and prediction. The development of such predictive tools at the US Food and Drug Administration (FDA) will complement ongoing efforts in drug safety that are focused on spontaneous adverse event reporting and active surveillance to monitor drug safety. This effort will require the active collaboration of scientists in the pharmaceutical industry, academe, and the National Institutes of Health, as well as those at the FDA, to reach its full potential. Here, we describe the approaches and goals for the mechanism-based drug safety assessment and prediction program.

Concurrent Group Treatment for Hepatitis C: Implementation and Outcomes in a Methadone Maintenance Treatment Program

PubMed Central

Stein, Melissa R.; Soloway, Irene J.; Jefferson, Karen S.; Roose, Robert J.; Arnsten, Julia H.; Litwin, Alain H.

2012-01-01

Chronic hepatitis C virus (HCV) infection is highly prevalent among current and former drug users. However, the minority of patients enrolled in drug treatment programs have initiated HCV treatment. New models are needed to overcome barriers to care. In this retrospective study, we describe the implementation and outcomes of 42 patients treated in a Concurrent Group Treatment (CGT) program. Patients participated in weekly provider-led group treatment sessions which included review of side effects; discussion of adherence and side effect management; administration of interferon injections; brief physical exam; and ended with brief meditation. Of the first 27 patients who initiated CGT, 42% achieved a sustained viral response. Additionally, 87% (13/15) of genotype-1 infected patients treated with direct acting antiviral agent achieved an undetectable viral load at 24 weeks. The CGT model may be effective in overcoming barriers to treatment and improving adherence and outcomes among patients enrolled in drug treatment programs. PMID:23036920

Community Attitudes Toward Mass Drug Administration for Control and Elimination of Neglected Tropical Diseases After the 2014 Outbreak of Ebola Virus Disease in Lofa County, Liberia.

PubMed

Bogus, Joshua; Gankpala, Lincoln; Fischer, Kerstin; Krentel, Alison; Weil, Gary J; Fischer, Peter U; Kollie, Karsor; Bolay, Fatorma K

2016-03-01

The recent outbreak of Ebola virus disease (EVD) interrupted mass drug administration (MDA) programs to control and eliminate neglected tropical diseases in Liberia. MDA programs treat entire communities with medication regardless of infection status to interrupt transmission and eliminate lymphatic filariasis and onchocerciasis. Following reports of hostilities toward health workers and fear that they might be spreading EVD, it was important to determine whether attitudes toward MDA might have changed after the outbreak. We surveyed 140 community leaders from 32 villages in Lofa County, Liberia, that had previously participated in MDA and are located in an area that was an early epicenter of the EVD outbreak. Survey respondents reported a high degree of community trust in the MDA program, and 97% thought their communities were ready to resume MDA. However, respondents predicted that fewer people would comply with MDA after the EVD epidemic than before. The survey also uncovered fears in the community that EVD and MDA might be linked. Respondents suggested that MDA programs emphasize to people that the medications are identical to those previously distributed and that MDA programs have nothing to do with EVD. © The American Society of Tropical Medicine and Hygiene.

A critical analysis of studies of state drug reimbursement policies: research in need of discipline.

PubMed

Soumerai, S B; Ross-Degnan, D; Fortess, E E; Abelson, J

1993-01-01

Concerns over pharmaceutical costs and appropriateness of medication use have led state Medicaid programs to restrict drug reimbursement. This article critically reviews 20 years of research on cost sharing, drug reimbursement limits, and administrative limitations on access to particular drugs via formularies, category exclusions, or prior authorization requirements; evaluates their methodological rigor; summarizes the state of current knowledge; and proposes future research directions. Drug reimbursement caps and modest cost sharing can reduce the use of both essential and less important drugs in Medicaid populations; severe reimbursement caps may precipitate serious unintended effects. Limitations on access to particular drugs can cause both rational and irrational drug substitution effects; it is unclear whether such limits reduce expenditures either for drugs or for overall health care.

14 CFR 120.103 - General.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false General. 120.103 Section 120.103 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM...

United States Food and Drug Administration and Department of Defense shelf-life extension program of pharmaceutical products: progress and promise.

PubMed

Khan, Saeed R; Kona, Ravikanth; Faustino, Patrick J; Gupta, Abhay; Taylor, Jeb S; Porter, Donna A; Khan, Mansoor

2014-05-01

The Department of Defense (DoD)-United States Food and Drug Administration (FDA) shelf-life extension program (SLEP) was established in 1986 through an intra-agency agreement between the DoD and the FDA to extend the shelf life of product nearing expiry. During the early stages of development, special attention was paid to program operation, labeling requirements, and the cost benefits associated with this program. In addition to the substantial cost benefits, the program also provides the FDA's Center for Drug Evaluation and Research with significant scientific understanding and pharmaceutical resource. As a result of this unique resource, numerous regulatory research opportunities to improve public health present themselves from this distinctive scientific database, which includes examples of products shelf life, their long-term stability issues, and various physical and chemical tests to identify such failures. The database also serves as a scientific resource for mechanistic understanding and identification of test failures leading to the development of new formulations or more robust packaging. It has been recognized that SLEP is very important in maintaining both national security and public welfare by confirming that the stockpiled pharmaceutical products meet quality standards after the "expiration date" assigned by the sponsor. SLEP research is an example of regulatory science that is needed to best ensure product performance past the original shelf life. The objective of this article is to provide a brief history and background and most importantly the public health benefits of the SLEP. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Medicare part D data: major changes on the horizon.

PubMed

Greenwald, Leslie M

2007-10-01

The 3 primary administrative data sets developed by the Centers for Medicare and Medicaid services (CMS) to support the Medicare Part D program implementation represent a valuable source of data for health services researchers. This paper describes the structure of the Medicare Part D program and the related databases, and discusses their utilization for research purposes. The Medicare Part D administrative data include information on plan benefits (integrated into the Health Plan Management System), beneficiary enrollment files, and prescription drug event (PDE) claims-type data. The enrollment data may be of use in investigating the benefits and plan types that appeal to beneficiaries, but their application is limited by the fact that, although individual beneficiaries' enrollment choices are recorded, only summary enrollment data are currently publicly available. PDE data are likely to be of most interest to researchers as they are detailed (including beneficiary identifiers, contract identifiers pharmacy provider information on drugs provided, drug cost, and insurance status), beneficiary-specific (allowing them to be linked to beneficiary characteristics), and an unusual output for a program reimbursed under a capitation-based system. Because PDE data are highly sensitive, only summary data on the number of Part D prescriptions filled are publicly available. Although the data collected in relation to the Medicare Part D program could be applied to many questions of interest to health services researchers, their utility is limited by the sensitive natures of many of these data, making it difficult currently to obtain access for research purposes.

The experience of rural independent pharmacies with medicare part D: reports from the field.

PubMed

Radford, Andrea; Slifkin, Rebecca; Fraser, Roslyn; Mason, Michelle; Mueller, Keith

2007-01-01

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) created prescription drug coverage for Medicare beneficiaries through a new Part D program, the single largest addition to Medicare since its creation in 1965. Prior to program implementation in January 2006, concerns had been voiced as to how independent pharmacies, which represent a higher proportion of all retail pharmacies in rural areas, would fare under the new program. This article describes first-hand reports from rural pharmacist-owners about their experiences with Medicare Part D plans in the first 7 months of 2006 in order to gain a more thorough understanding of the challenges faced by rural independent pharmacies as a result of program implementation. A semi-structured interview protocol was utilized in telephone interviews with 22 pharmacist-owners of rural independent pharmacies in 10 states. The rural independent pharmacists interviewed are experiencing major changes in payment, administrative burden, and interaction with patients as a result of the shift of patients into Medicare Part D plans. While administrative burden has greatly increased, payment and clinical interaction have decreased. Actions should be considered that would help rural independent pharmacists adjust to the new circumstances of having Medicare patients mirror, for administrative and payment purposes, commercially insured patients. Long-term modification of existing policies and regulations may be necessary to assure reasonable access to pharmaceuticals for rural populations. Further study is needed to determine how best to target these modifications to essential pharmacies.

APhA 2011 REMS white paper: Summary of the REMS stakeholder meeting on improving program design and implementation.

PubMed

American Pharmacists Association; Bough, Marcie

2011-01-01

To develop an improved risk evaluation and mitigation strategies (REMS) system for maximizing effective and safe patient medication use while minimizing burden on the health care delivery system. 34 stakeholders gathered October 6-7, 2010, in Arlington, VA, for the REMS Stakeholder Meeting, convened by the American Pharmacists Association (APhA). Participants included national health care provider associations, including representatives for physicians, physician assistants, nurses, nurse practitioners, and pharmacists, as well as representatives for patient advocates, drug distributors, community pharmacists (chain and independent), drug manufacturer associations (brand, generic, and biologic organizations), and health information technology, standards, and safety organizations. Staff from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research participated as observers. The meeting built on themes from the APhA's 2009 REMS white paper. The current REMS environment presents many challenges for health care providers due to the growing number of REMS programs and the lack of standardization or similarities among various REMS programs. A standardized REMS process that focuses on maximizing patient safety and minimizing impacts on patient access and provider implementation could offset these challenges. A new process that includes effective provider interventions and standardized tools and systems for implementing REMS programs may improve patient care and overcome some of the communication issues providers and patients currently face. Metrics could be put in place to evaluate the effectiveness of REMS elements. By incorporating REMS program components into existing technologies and data infrastructures, achieving REMS implementation that is workflow neutral and minimizes administrative burden may be possible. An appropriate compensation model could ensure providers have adequate resources for patient care and REMS implementation. Overall, stakeholders should continue to work collaboratively with FDA and manufacturers to improve REMS program design and implementation issues. A workable REMS system will require effective patient interventions, standardized elements that limit barriers to implementation for both patients and providers, standardized yet flexible implementation strategies, use of existing technologies in practice settings, increased opportunities for provider input early in REMS design processes, improved communication strategies and awareness of program requirements, and viable provider compensation models needed to offset costs to implement and comply with REMS program requirements.

Mass drug administration and the global control of schistosomiasis: successes, limitations and clinical outcomes.

PubMed

Olveda, David U; McManus, Donald P; Ross, Allen G P

2016-12-01

Preventive chemotherapy is advocated for the global control and elimination of schistosomiasis. Despite the well known short-term benefits of treating patients for schistosomiasis, the impact of mass drug administration (MDA) campaigns to control the disease in the long term remains unresolved. Many studies have advocated the success of MDA programs in order to attract donor funds for elimination efforts but such successes are often short-lived given the drug does not alter the life cycle of the organism or prevent reinfection. Within a matter of months to years after halting treatment, the prevalence, intensity of infection and morbidity of disease return to baseline levels. Other mitigating factors contribute to the failings of MDA campaigns namely: poverty, poor drug coverage, poor drug compliance, and, in the case of Asiatic schistosomiasis, zoonotic transmission. Genetic and innate and acquired immunologic mechanisms complicate the epidemiologic picture of schistosomiasis globally, and may contribute indirectly to MDA shortcomings. The possibility of drug resistance is an ever present concern because of the sole reliance on one drug, praziquantel. Preventive chemotherapy is advocated for the global control and elimination of schistosomiasis. The short-term benefits of MDA campaigns are well documented but the long-term benefits are questionable.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-30

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

A critical review of accounting and economic methods for estimating the costs of addiction treatment.

PubMed

Cartwright, William S

2008-04-01

Researchers have been at the forefront of applying new costing methods to drug abuse treatment programs and innovations. The motivation for such work has been to improve costing accuracy. Recent work has seen applications initiated in establishing charts of account and cost accounting for service delivery. As a result, researchers now have available five methods to apply to the costing of drug abuse treatment programs. In all areas of costing, there is room for more research on costing concepts and measurement applications. Additional work would be useful in establishing studies with activity-based costing for both research and managerial purposes. Studies of economies of scope are particularly relevant because of the integration of social services and criminal justice in drug abuse treatment. In the long run, managerial initiatives to improve the administration and quality of drug abuse treatment will benefit directly from research with new information on costing techniques.

78 FR 5813 - 2013 Assuring Radiation Protection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

...] 2013 Assuring Radiation Protection AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... of the Center for Devices and Radiological Health (CDRH) radiation protection program. The goal of the 2013 Assuring Radiation Protection will be to coordinate Federal, State, and Tribal activities to...

78 FR 29427 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

... provide annual Management Information System testing information, and to communicate with entities subject... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Anti-Drug Program...

78 FR 31626 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-24

... provide annual Management Information System testing information, and to communicate with entities subject... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Anti-Drug Program...

Pentamidine Injection

MedlinePlus

... is used to treat pneumonia caused by a fungus called Pneumocystis carinii. It is in a class ... may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

49 CFR 199.215 - Alcohol concentration.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Alcohol concentration. 199.215 Section 199.215... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Alcohol Misuse Prevention Program § 199.215 Alcohol concentration. Each operator shall prohibit a covered employee from...

49 CFR 199.215 - Alcohol concentration.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false Alcohol concentration. 199.215 Section 199.215... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Alcohol Misuse Prevention Program § 199.215 Alcohol concentration. Each operator shall prohibit a covered employee from...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

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

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... information may include but are not limited to: (A) Medical and pharmaceutical textbooks and reference books... Book) published by the Food and Drug Administration, or any successor to such reference. Generics are...) Cross-sectional or retrospective economic evaluations; (F) Pharmacoeconomic models; (G) Patent...

[Regulatory science: modern trends in science and education for pharmaceutical products].

PubMed

Beregovykh, V V; Piatigorskaia, N V; Aladysheva, Zh I

2012-01-01

This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

Community health workers' experiences and perspectives on mass drug administration for schistosomiasis control in western Kenya: the SCORE Project.

PubMed

Omedo, Martin O; Matey, Elizabeth J; Awiti, Alphonce; Ogutu, Michael; Alaii, Jane; Karanja, Diana M S; Montgomery, Susan P; Secor, W Evan; Mwinzi, Pauline N M

2012-12-01

Abstract. The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) includes communitywide treatment in areas with ≥ 25% prevalence of schistosomiasis along the shores of Lake Victoria using community health workers (CHWs). The CHWs are key drivers in community-owned mass drug administration (MDA) intervention programs. We explored their experiences and perceptions after initial MDA participation. Unstructured open-ended group discussions were conducted after completion of MDA activities. Narratives were obtained from CHWs using a digital audio recorder during the group discussion, transcribed verbatim and translated into English where applicable. Thematic decomposition of data was done using ATLAS.t.i. software. From the perspective of the CHWs, factors influencing MDA compliance included drug side effects, food supply stability, and conspiracy theories about the "real" purpose of treatment. The interest of CHWs to serve as community drug distributors stemmed from both intrinsic and extrinsic factors. Feedback from CHWs can promote more effective MDA in rural Kenyan communities.

Mectizan(®) procurement and delivery for onchocerciasis mass drug administration programmes.

PubMed

Ogoussan, Kisito T; Hopkins, Adrian

2011-09-01

The discovery of Mectizan has engendered a safe onchocerciasis chemoprevention tool. To make the drug available promptly to people at risk of onchocerciasis, a procurement and delivery mechanism has been put in place around the Mectizan Donation Program, which oversees the Merck donation of Mectizan. The number of yearly approved treatment doses has increased rapidly since 1988 from 255,000 to more than 80 million in 2007 and 2008. Cumulatively, from 1987 to 2008 more than 697 million treatment doses have been approved corresponding to 1.5 billion Mectizan tablets shipped. Although the current demand for treatment is met, the ultimate goal is to cover all people at risk. A comprehensive drug policy from recipient countries is still needed to back up the current efficient procurement and delivery mechanism in order to attain the ultimate to goal, and is equally important for scaling up mass drug administration as part of national neglected tropical disease control/elimination strategies. Copyright © 2010 Elsevier B.V. All rights reserved.

How Often Are Drugs Made Available Under the Food and Drug Administration's Expanded Access Process Approved?

PubMed

McKee, Amy E; Markon, André O; Chan-Tack, Kirk M; Lurie, Peter

2017-10-01

In this review of individual patient expanded-access requests to the Center for Drug Evaluation and Research for the period Fiscal Year 2010 to Fiscal Year 2014, we evaluated the number of applications received and the number allowed to proceed. We also evaluated whether drugs and certain biologics obtained under expanded access went on to be approved by the Food and Drug Administration. Finally, we considered concerns that adverse events occurring during expanded access might place sponsors at risk for legal liability. Overall, 98% of individual patient expanded-access requests were allowed to proceed. During the study period, among drugs without a previous approval for any indication or dosage form, 24% of unique drugs (ie, multiple applications for access to the same drug were considered to relate to 1 unique drug), and 20% of expanded-access applications received marketing approval by 1 year after initial submission; 43% and 33%, respectively, were approved by 5 years after initial submission. A search of 3 legal databases and a database of news articles did not appear to identify any product liability cases arising from the use of a product in expanded access. Our analyses seek to give physicians and patients a realistic perspective on the likelihood of a drug's approval as well as certain information regarding the product liability risks for commercial sponsors when providing expanded access to investigational drugs. The US Food and Drug Administration (FDA)'s expanded-access program maintains a careful balance between authorizing patient access to potentially beneficial drugs and protecting them from drugs that may have unknown risks. At the same time, the agency wishes to maintain the integrity of the clinical trials process, ultimately the best way to get safe and effective drugs to patients. © 2017, The American College of Clinical Pharmacology.

Partnerships and pathways of dissemination: the National Institute on Drug Abuse-Substance Abuse and Mental Health Services Administration Blending Initiative in the Clinical Trials Network.

PubMed

Martino, Steve; Brigham, Gregory S; Higgins, Christine; Gallon, Steve; Freese, Thomas E; Albright, Lonnetta M; Hulsey, Eric G; Krom, Laurie; Storti, Susan A; Perl, Harold; Nugent, Cathrine D; Pintello, Denise; Condon, Timothy P

2010-06-01

Since 2001, the National Drug Abuse Treatment Clinical Trials Network (CTN) has worked to put the results of its trials into the hands of community treatment programs, in large part through its participation in the National Institute on Drug Abuse-Substance Abuse and Mental Health Services Administration Blending Initiative and its close involvement with the Center for Substance Abuse Treatment's Addiction Technology Transfer Centers. This article describes (a) the CTN's integral role in the Blending Initiative, (b) key partnerships and dissemination pathways through which the results of CTN trials are developed into blending products and then transferred to community treatment programs, and (c) three blending initiatives involving buprenorphine, motivational incentives, and motivational interviewing. The Blending Initiative has resulted in high utilization of its products, preparation of more than 200 regional trainers, widespread training of service providers in most U.S. States, Puerto Rico, and the U.S. Virgin Islands and movement toward the development of Web-based implementation supports and technical assistance. Implications for future directions of the Blending Initiative and opportunities for research are discussed.

340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. Final rule; further delay of effective date.

PubMed

2017-05-19

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the "340B Drug Pricing Program" or the "340B Program." HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. In accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, entitled "Regulatory Freeze Pending Review," HRSA issued an interim final rule that delayed the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. HHS invited commenters to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate. After consideration of the comments received on the interim final rule, HHS is delaying the effective date of the January 5, 2017 final rule, to October 1, 2017.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-23

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

75 FR 19353 - Notice of Funding Availability: Rural Development Voucher Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-14

... DEPARTMENT OF AGRICULTURE Rural Housing Service Notice of Funding Availability: Rural Development... Availability SUMMARY: This notice informs the public that the U.S. Department of Agriculture (USDA) in Fiscal... the requirements in the Agriculture, Rural Development, Food and Drug Administration, and Related...

32 CFR 634.17 - Extensions of suspensions and revocations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ENFORCEMENT AND CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Driving Privileges § 634.17... years. In addition, administrative action may be initiated based on the commission of any traffic... or alcohol or drug counseling programs after proof is provided. (d) Commanders may extend a...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

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

Plan selection in Medicare Part D: Evidence from administrative data

PubMed Central

Heiss, Florian; Leive, Adam; McFadden, Daniel; Winter, Joachim

2014-01-01

We study the Medicare Part D prescription drug insurance program as a bellwether for designs of private, non-mandatory health insurance markets, focusing on the ability of consumers to evaluate and optimize their choices of plans. Our analysis of administrative data on medical claims in Medicare Part D suggests that fewer than 25 percent of individuals enroll in plans that are ex ante as good as the least cost plan specified by the Plan Finder tool made available to seniors by the Medicare administration, and that consumers on average have expected excess spending of about $300 per year, or about 15 percent of expected total out-of-pocket cost for drugs and Part D insurance. These numbers are hard to reconcile with decision costs alone; it appears that unless a sizeable fraction of consumers place large values on plan features other than cost, they are not optimizing effectively. PMID:24308882

The pediatric studies initiative: after 15 years have we reached the limits of the law?

PubMed

Milne, Christopher-Paul; Davis, Jonathan

2014-02-01

Despite considerable disincentives for conducting drug studies in children, 15 years ago the Food and Drug Administration, pediatric health advocates and congressional sponsors created a carrot-and-stick policy approach of voluntary and mandatory programs to encourage the pharmaceutical industry to include children in the drug development process. After several rounds of reauthorization of the laws on a temporary basis, the enabling statutes have been made permanent. The purpose of this analysis is to review the advances that resulted from the law and the areas where further progress is needed. A brief review of the history and results of the pediatric studies initiative was conducted by the authors and a determination made about the accomplishments of the law and remaining challenges. Indicators of the changes that resulted from this pediatric studies initiative are both indirect, such as the increase in the number of indication supplements for new populations, and direct, such as the decrease in the percentage of medicines used off-label in children. Although the pediatric studies initiative has significantly improved therapeutic options for children, concern still exists that drug companies are reluctant to include children in drug development unless continuously incentivized, whether positively or negatively. Two challenges are particularly problematic: neonatal studies and child-friendly formulations. Although the latest round of legislation should provide opportunities to address these problems, significantly more effort will be needed to achieve real culture change. Ultimately, the solution will require full program implementation by the Food and Drug Administration and close collaboration by many key stakeholders to ensure that pediatric studies become a routine part of the drug development process. © 2013 Elsevier HS Journals, Inc. All rights reserved.

75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-04

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

Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

PubMed

Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

2015-06-01

Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.

Cue dependency of nicotine self-administration and smoking.

PubMed

Caggiula, A R; Donny, E C; White, A R; Chaudhri, N; Booth, S; Gharib, M A; Hoffman, A; Perkins, K A; Sved, A F

2001-12-01

A paradox exists regarding the reinforcing properties of nicotine. The abuse liability associated with smoking equals or exceeds that of other addictive drugs, yet the euphoric, reinforcing and other psychological effects of nicotine, compared to these other drugs, are more subtle, are manifest under more restricted conditions, and do not readily predict the difficulty most smokers experience in achieving abstinence. One possible resolution to this apparent inconsistency is that environmental cues associated with drug delivery become conditioned reinforcers and take on powerful incentive properties that are critically important for sustaining smoking in humans and nicotine self-administration in animals. We tested this hypothesis by using a widely employed self-administration paradigm in which rats press a lever at high rates for 1 h/day to obtain intravenous infusions of nicotine that are paired with two types of visual stimuli: a chamber light that when turned on signals drug availability and a 1-s cue light that signals drug delivery. We show that these visual cues are at least as important as nicotine in sustaining a high rate of responding once self-administration has been established, in the degree to which withdrawing nicotine extinguishes the behavior, and in the reinstatement of lever pressing after extinction. Additional studies demonstrated that the importance of these cues was manifest under both fixed ratio and progressive ratio (PR) schedules of reinforcement. The possibility that nicotine-paired cues are as important as nicotine in smoking behavior should refocus our attention on the psychology and neurobiology of conditioned reinforcers in order to stimulate the development of more effective treatment programs for smoking cessation.

The US Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) Program - Current Status and Future Direction.

PubMed

Wu, Jasmanda; Juhaeri, Juhaeri

2016-12-01

The US Food and Drug Administration (FDA) Amendments Act of 2007 granted the FDA new authorities to enhance drug safety by requiring application holders to submit a proposed Risk Evaluation and Mitigation Strategy (REMS). A REMS is a required risk management plan that uses tools beyond the package insert. REMS elements may include a medication guide and patient package insert for patients and a communication plan focused on health care professionals. Elements to assure safe use (ETASUs) are put in place to mitigate a specific known serious risk when other less restrictive elements of a REMS are not sufficient to mitigate such risk. An implementation system is required for an REMS that includes the ETASUs. With approximately eight years of experience with REMS programs, many health care settings have created systems to manage REMS and also to integrate REMS into their practice settings. At the same time, there are issues associated with the development and implementation of REMS. In 2011, FDA created the REMS Integration Initiative to develop guidance on how to apply statutory criteria to determine when a REMS is required, to improve standardization and assessment of REMS, and to improve integration of REMS into the existing healthcare system. A key component of the REMS Integration Initiative is stakeholder outreach to better understand how existing REMS programs are working and to identify opportunities for improvement. This review attempts to share our company's experience with the REMS program, and to provide updates on FDA's efforts to improve REMS communication, to standardize REMS process, to reduce REMS program burdens and to build a common REMS platform. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0590] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

77 FR 21784 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No FDA-2012-N-0001] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science...

78 FR 30317 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-22

...] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The...

78 FR 6332 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-30

...] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The...

77 FR 51031 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-23

...] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-04

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

Desmopressin Nasal

MedlinePlus

... you experience any unusual problems while using this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

49 CFR 655.15 - Policy statement contents.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 7 2014-10-01 2014-10-01 false Policy statement contents. 655.15 Section 655.15 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PREVENTION OF ALCOHOL MISUSE AND PROHIBITED DRUG USE IN TRANSIT OPERATIONS Program Requirements § 655.15 Policy...

49 CFR 199.202 - Alcohol misuse plan.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Alcohol misuse plan. 199.202 Section 199.202... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Alcohol Misuse Prevention Program § 199.202 Alcohol misuse plan. Each operator must maintain and follow a written alcohol...

49 CFR 199.202 - Alcohol misuse plan.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false Alcohol misuse plan. 199.202 Section 199.202... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Alcohol Misuse Prevention Program § 199.202 Alcohol misuse plan. Each operator must maintain and follow a written alcohol...

49 CFR 199.237 - Other alcohol-related conduct.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false Other alcohol-related conduct. 199.237 Section 199... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Alcohol Misuse Prevention Program § 199.237 Other alcohol-related conduct. (a) No operator shall...

49 CFR 199.237 - Other alcohol-related conduct.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Other alcohol-related conduct. 199.237 Section 199... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Alcohol Misuse Prevention Program § 199.237 Other alcohol-related conduct. (a) No operator shall...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

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

78 FR 59706 - Secure Supply Chain Pilot Program; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0656...,'' in the third full paragraph, the sentence that reads ``For communications other than the submission....hhs.gov '' is corrected to read ``For communications other than the submission of the SSCPP...

76 FR 76168 - Regulatory Site Visit Training Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0824... routine manufacturing practices and to give CBER staff a better understanding of the biologics industry... quality of its regulatory efforts and interactions, by providing CBER staff with a better understanding of...

Clinical trials for vaccine development in registry of Korea Food and Drug Administration.

PubMed

Kang, Seog-Youn

2013-01-01

Based on the action plan "Ensuring a stable supply of National Immunization Program vaccines and sovereignty of biopharmaceutical products," Korea Food and Drug Administration (KFDA) has made efforts to develop vaccines in the context of self reliance and to protect public health. Along with the recognized infrastructures for clinical trials, clinical trials for vaccines have also gradually been conducted at multinational sites as well as at local sites. KFDA will support to expand six to eleven kinds of vaccines by 2017. In accordance with integrated regulatory system, KFDA has promoted clinical trials, established national lot release procedure, and strengthened good manufacturing practices inspection and post marketing surveillance. Against this backdrop, KFDA will support the vaccine development and promote excellent public health protection.

A scoring system for selection of essential drugs.

PubMed

Mathur, V S; Chaudhury, R R; Fraser, H S

1988-03-01

A scoring system is presented for selection of essential drugs, using criteria of efficacy, safety, cost of a course of therapy, compliance, multiple usage and storage, ease of administration and local availability. Such a system allows for different weighting of factors whose relative importance varies from country to country and would help in choosing the most appropriate and cost-effective drugs for use in developing countries. The importance of such factors as cost and compliance has been illustrated with suitable examples. This approach could also be used for individual patient decisions with the aid of a computer program.

Blueprint for prescriber continuing education program.

PubMed

2012-06-01

On October 25, 2011, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) posted online this Blueprint for Prescriber Continuing Education, labeled "final," relating to extended-release and long-acting opioids. The pending FDA Risk Evaluation Management Strategy (REMS) requires prescriber education. This document provides guidance to sponsors of these dosage forms in developing the prescvriber education component of their REMS. This report was posted online by the federal agency on October 25, 2011 at: http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf. It is in the public domain.

Tramadol post-marketing surveillance in health care professionals.

PubMed

Knisely, Janet S; Campbell, Eleanor D; Dawson, Kathryn S; Schnoll, Sidney H

2002-09-01

Tramadol has been marketed in the US since 1995. The US Food and Drug Administration agreed to release tramadol as a non-scheduled drug if proactive post-marketing surveillance studies would be conducted. This study was one of two phase IV protocols that were part of the overall surveillance program. It focused on impaired health professionals who are a high risk/high access population for drug abuse. All active participants in four state monitoring programs between November 1, 1995 and August 15, 1998 (n = 1,601) were recruited for the study. With the exceptions of implementing a standardized intake interview and urine testing for tramadol metabolites, all states operated their programs in the usual fashion. The programs were alerted to persistent non-prescribed tramadol use so that appropriate interventions could be employed. Despite availability of tramadol and the conditions that might lead to its abuse, the incidence rate for tramadol use in the study population was only 69 per thousand persons per year and the incidence rate for tramadol abuse or dependence was 6.9 per thousand persons per year.

Quality-improvement analytics for intravenous infusion pumps.

PubMed

Skledar, Susan J; Niccolai, Cynthia S; Schilling, Dennis; Costello, Susan; Mininni, Nicolette; Ervin, Kelly; Urban, Alana

2013-04-15

The implementation of a smart-pump continuous quality-improvement (CQI) program across a large health system is described, with an emphasis on key metrics for outcomes analyses and program refinement. Three years ago, the University of Pittsburgh Medical Center health system launched a CQI initiative to help ensure the safe use of 6000 smart pumps in its 14 inpatient facilities. A centralized team led by pharmacists is responsible for the retrieval and interpretation of smart-pump data, which is continuously transmitted to a main server. CQI findings are regularly posted on the health system's interdisciplinary intranet. Monitored metrics include rates of compliance with preprogrammed infusion limits, the top 20 drugs involved in alerts, drugs associated with alert-override rates of ≥90%, numbers of alerts by infusion type, nurse responses to alerts, and alert rate per drug library update. Based on the collected CQI data and site-specific requests, four systemwide updates of the smart-pump drug library were performed during the first 18 months of the program, reducing "nuisance alerts" by about 10% per update cycle and enabling targeted interventions to reduce rapid-infusion errors, other adverse drug events (ADEs), and pump-programming workarounds. Over one 12-month period, bedside alerts prompted nurses to reprogram or cancel continuous infusions an average of 400 times per month, potentially averting i.v. medication ADEs. A smart-pump CQI program is an effective tool for enhancing the safety of i.v. medication administration. The ongoing refinement of the drug library through the development and implementation of key interventions promotes the growth and sustainability of the smart-pump initiative systemwide.

77 FR 52744 - Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration's (FDA) Office of Orphan Products Development...

76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY Food and Drug Administration Privacy Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record...

Smart syringe pumps for drug infusion during dental intravenous sedation

PubMed Central

Lee, Kiyoung

2016-01-01

Dentists often sedate patients in order to reduce their dental phobia and stress during dental treatment. Sedatives are administered through various routes such as oral, inhalation, and intravenous routes. Intravenous administration has the advantage of rapid onset of action, predictable duration of action, and easy titration. Typically, midazolam, propofol or dexmedetomidine are used as intravenous sedatives. Administration of these sedatives via infusion by using a syringe pump is more effective and successful than infusing them as a bolus. However, during intravenous infusion of sedatives or opioids using a syringe pump, fatal accidents may occur due to the clinician's carelessness. To prevent such risks, smart syringe pumps have been introduced clinically. They allow clinicians to perform effective sedation by using a computer to control the dose of the drug being infused. To ensure patient safety, various alarm features along with a drug library, which provides drug information and prevents excessive infusion by limiting the dose, have been added to smart pumps. In addition, programmed infusion systems and target-controlled infusion systems have also been developed to enable effective administration of sedatives. Patient-controlled infusion, which allows a patient to control his/her level of sedation through self-infusion, has also been developed. Safer and more successful sedation may be achieved by fully utilizing these new features of the smart pump. PMID:28884149