Sample records for fda staff computer-assisted
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The nightmare of FDA clearance/approval to market: perception or reality?
Tylenda, C A
1996-09-01
Over the last few years the Center for Device Evaluation and Research (CDRH) at the Food and Drug Administration (FDA) has received annually over 16 thousand submissions related to medical devices. Over 10,000 of these are major submissions which include applications to conduct clinical trials and applications to market medical devices for a specified indication for use. Each application is carefully considered. FDA personnel work closely with applicants to ensure that clinical trial design minimizes risk to the patients and maximizes benefit with respect to addressing the safety and effectiveness of the device being tested. Applicants are given every opportunity to provide additional information when necessary to assure that applications to market medical devices are complete. Applicants have the opportunity to meet with FDA staff prior to submitting applications in cases where the application is other than a straight forward, uncomplicated submission. In addition, FDA assists applicants through the development of guidance documents, which discuss the type of information that would be beneficial to include in a submission. The Division of Small Manufacturers Assistance at FDA is dedicated to helping interested persons understand the clearance/approval process. This paper will discuss the role of FDA in the regulation of medical devices, with an emphasis on the pathway to obtaining permission to market medical devices in the United States.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-03
...] Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection Devices Applied... Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to... guidance, entitled ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-P-0176... of FDA's Denial of Premarket Approval AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that it intends to refer for review before...
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Losco, Alessandra; Viganò, Chiara; Conte, Dario; Cesana, Bruno Mario; Basilisco, Guido
2009-05-01
Assessing perianal disease activity is important for the treatment and prognosis of Crohn's disease (CD) patients, but the diagnostic accuracy of the activity indices has not yet been established. The aim of this study was to determine the accuracy and agreement of the Fistula Drainage Assessment (FDA), Perianal Disease Activity Index (PDAI), and computer-assisted anal ultrasound imaging (AUS). Sixty-two consecutive patients with CD and perianal fistulae underwent clinical, FDA, PDAI, and AUS evaluation. Perianal disease was considered active in the presence of visible fistula drainage and/or signs of local inflammation (induration and pain at digital compression) upon clinical examination. The AUS images were analyzed by calculating the mean gray-scale tone of the lesion. The PDAI and gray-scale tone values discriminating active and inactive perianal disease were defined using receiver operating characteristics statistics. Perianal disease was active in 46 patients. The accuracy of the FDA was 87% (confidence interval [CI]: 76%-94%). A PDAI of >4 and a mean gray-scale tone value of 117 maximized sensitivity and specificity; their diagnostic accuracy was, respectively, 87% (CI: 76%-94%) and 81% (CI: 69%-90%). The agreement of the 3 evaluations was fair to moderate. The addition of AUS to the PDAI or FDA increased their diagnostic accuracy to respectively 95% and 98%. The diagnostic accuracy of the FDA, PDAI, and computer-assisted AUS imaging was good in assessing perianal disease activity in patients with CD. The agreement between the techniques was fair to moderate. Overall accuracy can be increased by combining the FDA or PDAI with AUS.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0072] (formerly Docket No. 2005D-0042) Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings; Availability AGENCY: Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-28
... Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New... CONTACT: For devices regulated by CDRH: Ruth Fischer, Center for Devices and Radiological Health, Food and... search capability is available for all CDRH guidance documents at http://www.fda.gov/MedicalDevices...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0792] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...
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Computer-Assisted Assessment in Higher Education. Staff and Educational Development Series.
ERIC Educational Resources Information Center
Brown, Sally, Ed.; Race, Phil, Ed.; Bull, Joanna, Ed.
This book profiles how computer-assisted assessment can help both staff and students by drawing on the experience and expertise of practitioners, in the United Kingdom and internationally, who are already using computer-assisted assessment. The publication is organized into three main sections--"Pragmatics and Practicalities of CAA,""Using CAA for…
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0490] Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0305] Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0742 (formerly Docket No. 1999D-4396)] Draft Guidance for Clinical Investigators, Industry, and FDA Staff...: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff... Administration (FDA) is announcing the availability of the guidance entitled ``Center for Devices and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-24
... Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for... Guidance for Industry and FDA Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for... and FDA Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products (OMB...
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21 CFR 60.10 - FDA assistance on eligibility.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in...
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21 CFR 60.10 - FDA assistance on eligibility.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in...
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21 CFR 60.10 - FDA assistance on eligibility.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in...
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21 CFR 60.10 - FDA assistance on eligibility.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in...
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How to set up a robotic-assisted laparoscopic surgery center and training of staff.
Lenihan, John P
2017-11-01
The use of computers to assist surgeons in the operating room has been an inevitable evolution in the modern practice of surgery. Robotic-assisted surgery has been evolving now for over two decades and has finally matured into a technology that has caused a monumental shift in the way gynecologic surgeries are performed. Prior to robotics, the only minimally invasive options for most Gynecologic (GYN) procedures including hysterectomies were either vaginal or laparoscopic approaches. However, even with over 100 years of vaginal surgery experience and more than 20 years of laparoscopic advancements, most gynecologic surgeries in the United States were still performed through an open incision. However, this changed in 2005 when the FDA approved the da Vinci Surgical Robotic System tm for use in gynecologic surgery. Over the last decade, the trend for gynecologic surgeries has now dramatically shifted to less open and more minimally invasive procedures. Robotic-assisted surgeries now include not only hysterectomy but also most all other commonly performed gynecologic procedures including myomectomies, pelvic support procedures, and reproductive surgeries. This success, however, has not been without controversies, particularly around costs and complications. The evolution of computers to assist surgeons and make minimally invasive procedures more common is clearly a trend that is not going away. It is now incumbent on surgeons, hospitals, and medical societies to determine the most cost-efficient and productive use for this technology. This process is best accomplished by developing a Robotics Program in each hospital that utilizes robotic surgery. Copyright © 2017. Published by Elsevier Ltd.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-02
...] Draft Guidance for Industry and FDA Staff: Processing/ Reprocessing Medical Devices in Health Care... Devices in Health Care Settings: Validation Methods and Labeling.'' The recommendations in this guidance... Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-18
... Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k... for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k... Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k)] Submissions--0910-NEW...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-03
...] Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug... and FDA staff entitled ``Glass Syringes for Delivering Drug and Biological Products: Technical... supplemental data are necessary for FDA to ensure the safe and effective use of glass syringes that comply with...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...
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Evaluating Imaging and Computer-aided Detection and Diagnosis Devices at the FDA
Gallas, Brandon D.; Chan, Heang-Ping; D’Orsi, Carl J.; Dodd, Lori E.; Giger, Maryellen L.; Gur, David; Krupinski, Elizabeth A.; Metz, Charles E.; Myers, Kyle J.; Obuchowski, Nancy A.; Sahiner, Berkman; Toledano, Alicia Y.; Zuley, Margarita L.
2017-01-01
This report summarizes the Joint FDA-MIPS Workshop on Methods for the Evaluation of Imaging and Computer-Assist Devices. The purpose of the workshop was to gather information on the current state of the science and facilitate consensus development on statistical methods and study designs for the evaluation of imaging devices to support US Food and Drug Administration submissions. Additionally, participants expected to identify gaps in knowledge and unmet needs that should be addressed in future research. This summary is intended to document the topics that were discussed at the meeting and disseminate the lessons that have been learned through past studies of imaging and computer-aided detection and diagnosis device performance. PMID:22306064
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75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-20
...-847-8149 to receive a hard copy. Please use the document number (1607). CDRH maintains an entry on the... personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device... capability for all CDRH guidance documents is available at http://www.fda.gov/medicaldevices...
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FDA toxicity databases and real-time data entry.
Arvidson, Kirk B
2008-11-15
Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.
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2003-04-22
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).
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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...
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Navigating through the domains of biology and chemistry
Developing computational toxicology methods to assist the risk assessment process has recently gained much attention both in regulatory agencies and industries. The FDA Center for Food Safety and Applied Nutrition’s Office of Food Additive Safety (CFSAN OFAS) uses (Q)SAR approach...
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FDA toxicity databases and real-time data entry
DOE Office of Scientific and Technical Information (OSTI.GOV)
Arvidson, Kirk B.
Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributedmore » in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.« less
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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...
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2017-10-01
hypothesis that a computer machine learning algorithm can analyze and classify burn injures using multispectral imaging within 5% of an expert clinician...morbidity. In response to these challenges, the USAISR developed and obtained FDA 510(k) clearance of the Burn Navigator™, a computer decision support... computer decision support software (CDSS), can significantly change the CDSS algorithm’s recommendations and thus the total fluid administered to a
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Some Measurement and Instruction Related Considerations Regarding Computer Assisted Testing.
ERIC Educational Resources Information Center
Oosterhof, Albert C.; Salisbury, David F.
The Assessment Resource Center (ARC) at Florida State University provides computer assisted testing (CAT) for approximately 4,000 students each term. Computer capabilities permit a small proctoring staff to administer tests simultaneously to large numbers of students. Programs provide immediate feedback for students and generate a variety of…
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-23
...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' FDA is issuing this guidance to inform industry and Agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for artificial pancreas systems.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0324..., FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business... Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of...
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Agenda: EDRN FDA Education Workshop — EDRN Public Portal
The purpose of this workshop was to open dialogue between FDA staff that provide oversight for review of in vitro diagnostic applications and EDRN scientists currently performing clinical validation studies on cancer biomarkers. Issues related to FDA review of diagnostic tests were presented by FDA personnel. Representatives from EDRN provided details on supporting data of their validation studies and the resources developed within EDRN to facilitate such research for FDA compliance. The agenda provided here provides links to the presentations by each speaker.
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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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0324... Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User...: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of...
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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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0324...; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small...: The Food and Drug Administration (FDA) is announcing that a collection of information entitled...
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76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-06
...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. This draft guidance is not final nor is it in effect at this time.
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EPA uses high-end scientific computing, geospatial services and remote sensing/imagery analysis to support EPA's mission. The Center for Environmental Computing (CEC) assists the Agency's program offices and regions to meet staff needs in these areas.
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FDA Response to the Fukushima Dai-ichi Nuclear Power Facility Incident
... products from Japan. This means that whole shipping containers are screened by CBP. FDA field staff also ... by consumers or doctors claiming amazing results; limited availability and advance payment requirements; promises of no-risk, ...
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Preparing for Computer Use. Revised.
ERIC Educational Resources Information Center
South Carolina State Dept. of Education, Columbia.
Intended to assist school districts in designing high school credit courses, preparing staff development activities related to computer utilization, and selecting and evaluating instructional software, this document offers outlines for the following student courses: (1) Introduction to Computers, a computer literacy course covering computer…
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Exploiting the Potential of CD-ROM Databases: Staff Induction at the University of East Anglia.
ERIC Educational Resources Information Center
Guillot, Marie-Noelle; Kenning, Marie-Madeleine
1995-01-01
Overviews a project exploring the possibility of using CD-ROM applications and the design of exploratory didactic materials to introduce academic staff to the field of computer-assisted instruction. The project heightened the staff's awareness of electronic resources and their potential as research, teaching, and learning aids, with particular…
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ERIC Educational Resources Information Center
HANKIN, EDWARD K.; AND OTHERS
THIS TECHNICAL PROGRESS REPORT COVERS THE FIRST THREE MONTHS OF A PROJECT TO DEVELOP COMPUTER ASSISTED PREVOCATIONAL READING AND ARITHMETIC COURSES FOR DISADVANTAGED YOUTHS AND ADULTS. DURING THE FIRST MONTH OF OPERATION, PROJECT PERSONNEL CONCENTRATED ON SUCH ADMINISTRATIVE MATTERS AS TRAINING STAFF AND PREPARING FACILITIES. AN ARITHMETIC PROGRAM…
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0776] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... based upon estimates by FDA administrative and technical staff who: (1) Are familiar with the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-22
... Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0114...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-12
...] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters... a draft guidance for industry and FDA staff entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' Dear Health Care Provider (DHCP) Letters are correspondence...
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Biomedical applications of tissue engineering technology: regulatory issues.
Hellman, K B
1995-01-01
Novel emerging technologies such as tissue engineering, which utilize the approaches of molecular and cell biology, biotechnology, as well as materials science and engineering, are being used in the development of a wide range of biomedical products developed by industries regulated by the U.S. Food and Drug Administration (FDA). The FDA's mission is to promote and protect the public health by ensuring the safety and effectiveness of pharmaceuticals and medical devices, including those manufactured by novel technology, as assessed by scientific principles and methods. Regulatory review is conducted on a product-by-product basis. To accomplish its mission over the wide range of products in its regulatory purview, the FDA has six centers, each staffed with the scientific and regulatory expertise to evaluate the products in the center's jurisdiction. Recent legislative and regulatory changes are designed to simplify and facilitate the administrative process for evaluating novel combination products emanating from such interdisciplinary technology as tissue engineering and to resolve questions of product regulatory jurisdiction. Under the new procedures, the FDA may designate a lead FDA center for product review based on the primary mode of action of the combination product, with additional center(s) designated to assist in the evaluation in a collaborative or consultative capacity. In addition, FDA centers have increased their cooperation and information sharing with regard to evolving interdisciplinary technology. The FDA InterCenter Tissue Engineering Initiative was established to develop information on intercenter efforts in the evaluation of tissue engineering applications and to identify areas for further consideration. The FDA InterCenter Tissue Engineering Working Group, comprised of staff from the Center for Biologies Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Veterinary Medicine (CVM) has developed a Draft Report considering recent developments in tissue engineering and scientific and regulatory issues in the product application areas. The Working Group has identified generic safety and effectiveness issues for consideration by the research and development community in its development of products. The FDA centers are using multiple approaches at their disposal in the evaluation of tissue engineered products including research, data and information monitoring, regulatory guidance, training and education, and cooperation with public and private groups.
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Corazzini, Kirsten; Rapp, Carla Gene; McConnell, Eleanor S.; Anderson, Ruth A.
2013-01-01
Staff development nurses in long-term care are challenged to implement training programs that foster quality unlicensed assistive personnel (UAP) care and improve the transfer of their observations to licensed nursing staff for care planning. This study describes the outcomes of a program where UAP recorded behavioral problems of residents to inform care. Findings suggest staff development nurses who aim to improve UAP reporting without simultaneously targeting licensed nursing staff behaviors may worsen nursing staff relationships. PMID:19182546
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1981-06-30
manpower needs as to quantity, quality and timing; all the internal functions of the personnel service are tapped to help meet these ends. Manpower...Program ACOS - Automated Computation of Service ACQ - Acquisition ACSAC - Assistant Chief of Staff for Automation and Comunications ACT - Automated...ARSTAF - Army Staff ARSTAFF - Army Staff ARTEP - Army Training and Evaluation Program ASI - Additional Skill Identifier ASVAB - Armed Services
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-09
... of Special Health Issues, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD... between health professional organizations and FDA staff. The Office of Special Health Issues serves as a... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-18
... requirements in high and maximum biocontainment, scientists working in this environment and FDA staff who will...] Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments... Containment Environments (U24).'' In this FOA, FDA announces its intention to accept and consider a single...
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78 FR 63988 - Clinical Investigator Training Course
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-25
... communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1214... support regulatory decisions. This course is intended to assist clinical investigators in understanding...
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13 CFR 306.4 - Purpose and scope.
Code of Federal Regulations, 2013 CFR
2013-01-01
... faculty, staff, libraries, laboratories and computer systems that can address local economic problems and opportunities. With Investment Assistance, institutions of higher education establish and operate research...
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13 CFR 306.4 - Purpose and scope.
Code of Federal Regulations, 2014 CFR
2014-01-01
... faculty, staff, libraries, laboratories and computer systems that can address local economic problems and opportunities. With Investment Assistance, institutions of higher education establish and operate research...
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13 CFR 306.4 - Purpose and scope.
Code of Federal Regulations, 2011 CFR
2011-01-01
... faculty, staff, libraries, laboratories and computer systems that can address local economic problems and opportunities. With Investment Assistance, institutions of higher education establish and operate research...
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13 CFR 306.4 - Purpose and scope.
Code of Federal Regulations, 2012 CFR
2012-01-01
... faculty, staff, libraries, laboratories and computer systems that can address local economic problems and opportunities. With Investment Assistance, institutions of higher education establish and operate research...
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Academic Computing at Florida A&M University. A Case Study.
ERIC Educational Resources Information Center
Hunter, Beverly; Kearsley, Greg
This case study is one of a series on academic computing at minority institutions which is designed to assist educators at other such institutions in identifying academic computing needs, establishing realistic goals, organizing a staff, and selecting materials. Following a brief description of the purpose and background of the overall study, the…
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Smith, W; Bedayse, S; Lalwah, S L; Paryag, A
2009-08-01
The University of the West Indies (UWI) Dental School is planning to implement computer-based information systems to manage student and patient data. In order to measure the acceptance of the proposed implementation and to determine the degree of training that would be required, a survey was undertaken of the computer literacy and attitude of all staff and students. Data were collected via 230 questionnaires from all staff and students. A 78% response rate was obtained. The computer literacy of the majority of respondents was ranked as 'more than adequate' compared to other European Dental Schools. Respondents < 50 years had significantly higher computer literacy scores than older age groups (P < 0.05). Similarly, respondents who owned an email address, a computer, or were members of online social networking sites had significantly higher computer literacy scores than those who did not (P < 0.05). Sex, nationality and whether the respondent was student/staff were not significant factors. Most respondents felt that computer literacy should be a part of every modern undergraduate curriculum; that computer assisted learning applications and web-based learning activity could effectively supplement the traditional undergraduate curriculum and that a suitable information system would improve the efficiency in the school's management of students, teaching and clinics. The implementation of a computer-based information system is likely to have widespread acceptance among students and staff at the UWI Dental School. The computer literacy of the students and staff are on par with those of schools in the US and Europe.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-03
... all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationand...),'' from CDRH you may either send an e-mail request to [email protected] to receive an electronic copy of... guidance describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-06
...] Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information...
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Machine-Assisted Indexing of Scientific Research Summaries
ERIC Educational Resources Information Center
And Others; Hunt, Bernard L.
1975-01-01
At the Smithsonian Science Information Exchange, a computer system indexes word combinations in research summaries, according to a Classifying Dictionary, prior to review by the professional staff. (Author/PF)
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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...
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FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster
By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National
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Computer Assisted Instruction in the Health Professions.
ERIC Educational Resources Information Center
Stolurow, Lawrence M.; And Others
Introductory remarks by staff members at Ohio State University College of Medicine, Harvard Medical School, U.S. Naval Medical School, Harvard School of Public Health, and Michigan State University explore the educational requirements of the health professions and the ways in which the computer can aid in fulfilling these requirements. Programs…
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-26
... http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsand...] (formerly 1999D-4396) Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-15
... of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza... of Influenza Viruses.'' FDA is issuing this guidance to inform industry and Agency staff of its... diagnostic devices intended for the detection or detection and differentiation of influenza viruses. DATES...
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76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0635] Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...
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76 FR 69272 - Gayle Rothenberg: Debarment Order
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-08
... this conviction is as follows: Dr. Rothenberg was a physician licensed by the State of Texas as a... injections. From February to September 2004, Dr. Rothenberg and her office manager caused staff members to... was not approved by FDA. Dr. Rothenberg informed staff members that a new BOTOX product would be used...
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Implementation of Audio Computer-Assisted Interviewing Software in HIV/AIDS Research
Pluhar, Erika; Yeager, Katherine A.; Corkran, Carol; McCarty, Frances; Holstad, Marcia McDonnell; Denzmore-Nwagbara, Pamela; Fielder, Bridget; DiIorio, Colleen
2007-01-01
Computer assisted interviewing (CAI) has begun to play a more prominent role in HIV/AIDS prevention research. Despite the increased popularity of CAI, particularly audio computer assisted self-interviewing (ACASI), some research teams are still reluctant to implement ACASI technology due to lack of familiarity with the practical issues related to using these software packages. The purpose of this paper is to describe the implementation of one particular ACASI software package, the Questionnaire Development System™ (QDS™), in several nursing and HIV/AIDS prevention research settings. We present acceptability and satisfaction data from two large-scale public health studies in which we have used QDS with diverse populations. We also address issues related to developing and programming a questionnaire, discuss practical strategies related to planning for and implementing ACASI in the field, including selecting equipment, training staff, and collecting and transferring data, and summarize advantages and disadvantages of computer assisted research methods. PMID:17662924
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76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-07
...://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm , is intended to assist... , http://www.hhs.gov/ohrp/newsroom/rfc/index.html , or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm . III. Request for Comments OHRP and FDA are making their joint draft...
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Nurses using futuristic technology in today's healthcare setting.
Wolf, Debra M; Kapadia, Amar; Kintzel, Jessie; Anton, Bonnie B
2009-01-01
Human computer interaction (HCI) equates nurses using voice assisted technology within a clinical setting to document patient care real time, retrieve patient information from care plans, and complete routine tasks. This is a reality currently utilized by clinicians today in acute and long term care settings. Voice assisted documentation provides hands & eyes free accurate documentation while enabling effective communication and task management. The speech technology increases the accuracy of documentation, while interfacing directly into the electronic health record (EHR). Using technology consisting of a light weight headset and small fist size wireless computer, verbal responses to easy to follow cues are converted into a database systems allowing staff to obtain individualized care status reports on demand. To further assist staff in their daily process, this innovative technology allows staff to send and receive pages as needed. This paper will discuss how leading edge and award winning technology is being integrated within the United States. Collaborative efforts between clinicians and analyst will be discussed reflecting the interactive design and build functionality. Features such as the system's voice responses and directed cues will be shared and how easily data can be documented, viewed and retrieved. Outcome data will be presented on how the technology impacted organization's quality outcomes, financial reimbursement, and employee's level of satisfaction.
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Faculty and staff health promotion: results from the School Health Policies and Programs Study 2006.
Eaton, Danice K; Marx, Eva; Bowie, Sara E
2007-10-01
US schools employ an estimated 6.7 million workers and are thus an ideal setting for employee wellness programs. This article describes the characteristics of school employee wellness programs in the United States, including state-, district-, and school-level policies and programs. The Centers for Disease Control and Prevention conducts the School Health Policies and Programs Study every 6 years. In 2006, computer-assisted telephone interviews or self-administered mail questionnaires were completed by state education agency personnel in 49 states plus the District of Columbia and among a nationally representative sample of school districts (n=445). Computer-assisted personal interviews were conducted with personnel in a nationally representative sample of elementary, middle, and high schools (n=873). During the 2 years preceding the study, 67.3% of states provided assistance to districts or schools on how to develop or implement faculty and staff health promotion activities or services. Although nearly all schools offered at least 1 health promotion service or activity, few schools offered coordinated activities and services within a comprehensive employee wellness program. During the 12 months preceding the study, none of the health screenings were offered by more than one third of schools; only a few of the health promotion activities and services were offered by more than one third of schools; about one third of schools offered physical activity programs, employee assistance programs, and subsidies or discounts for off-site health promotion activities; and only 1 in 10 schools provided health-risk appraisals for faculty and staff. More schools should implement comprehensive employee wellness programs to improve faculty and staff health behaviors and health status.
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Legal considerations for social media marketing by pharmaceutical industry.
Yang, Y Tony; Chen, Brian
2014-01-01
Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.
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ODU-CAUSE: Computer Based Learning Lab.
ERIC Educational Resources Information Center
Sachon, Michael W.; Copeland, Gary E.
This paper describes the Computer Based Learning Lab (CBLL) at Old Dominion University (ODU) as a component of the ODU-Comprehensive Assistance to Undergraduate Science Education (CAUSE) Project. Emphasis is directed to the structure and management of the facility and to the software under development by the staff. Serving the ODU-CAUSE User Group…
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Computer-Aided Design in Further Education.
ERIC Educational Resources Information Center
Ingham, Peter, Ed.
This publication updates the 1982 occasional paper that was intended to foster staff awareness and assist colleges in Great Britain considering the use of computer-aided design (CAD) material in engineering courses. The paper begins by defining CAD and its place in the Integrated Business System with a brief discussion of the effect of CAD on the…
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Code of Federal Regulations, 2010 CFR
2010-01-01
... staff; (4) Committee computer, software or Internet service provider failures; (5) A committee's failure... software despite the respondent seeking technical assistance from Commission personnel and resources; (2) A... Commission's or respondent's computer systems or Internet service provider; and (3) Severe weather or other...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0431] Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No... entitled ``Civil Money Penalties and No- Tobacco-Sale Orders for Tobacco Retailers.'' This guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1083] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1083] Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers... the guidance entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0147] Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Availability AGENCY: Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-22
... intends to provide the underlying principles to determine the type of marketing submission that may be... industry and FDA staff on the underlying principles to determine the type of marketing submission that may... Modifications to a Combination Product Approved Under Certain Marketing Applications; Availability AGENCY: Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data; Availability AGENCY: Food and Drug Administration...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-15
... medical device for its intended use. Evidence from one or more pivotal clinical studies generally serves... some cases, a PMA may include multiple studies designed to answer different scientific questions. The... studies intended to support premarket submissions for medical devices and for FDA staff who review those...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0469] Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0147] Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-26
...] Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion... the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump--Premarket Notification... this issue of the Federal Register, FDA is announcing a public meeting regarding external infusion...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-10
...] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray... guidance entitled ``Pediatric Information for X-ray Imaging Device Premarket Notifications.'' This draft... premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-28
... method comparison section and the sample selection inclusion and exclusion criteria section. The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-09
... selection inclusion and exclusion criteria section. The revisions define and differentiate the required... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...
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NASA Technical Reports Server (NTRS)
1994-01-01
In laparoscopic surgery, tiny incisions are made in the patient's body and a laparoscope (an optical tube with a camera at the end) is inserted. The camera's image is projected onto two video screens, whose views guide the surgeon through the procedure. AESOP, a medical robot developed by Computer Motion, Inc. with NASA assistance, eliminates the need for a human assistant to operate the camera. The surgeon uses a foot pedal control to move the device, allowing him to use both hands during the surgery. Miscommunication is avoided; AESOP's movement is smooth and steady, and the memory vision is invaluable. Operations can be completed more quickly, and the patient spends less time under anesthesia. AESOP has been approved by the FDA.
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10 CFR 605.5 - The Office of Energy Research Financial Assistance Program.
Code of Federal Regulations, 2012 CFR
2012-01-01
...) Scientific Computing Staff (7) Superconducting Super Collider (8) University and Science Education Programs... appendix A of this part. (b) The Program areas are: (1) Basic Energy Sciences (2) Field Operations...
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10 CFR 605.5 - The Office of Energy Research Financial Assistance Program.
Code of Federal Regulations, 2013 CFR
2013-01-01
...) Scientific Computing Staff (7) Superconducting Super Collider (8) University and Science Education Programs... appendix A of this part. (b) The Program areas are: (1) Basic Energy Sciences (2) Field Operations...
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10 CFR 605.5 - The Office of Energy Research Financial Assistance Program.
Code of Federal Regulations, 2011 CFR
2011-01-01
...) Scientific Computing Staff (7) Superconducting Super Collider (8) University and Science Education Programs... appendix A of this part. (b) The Program areas are: (1) Basic Energy Sciences (2) Field Operations...
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10 CFR 605.5 - The Office of Energy Research Financial Assistance Program.
Code of Federal Regulations, 2014 CFR
2014-01-01
...) Scientific Computing Staff (7) Superconducting Super Collider (8) University and Science Education Programs... appendix A of this part. (b) The Program areas are: (1) Basic Energy Sciences (2) Field Operations...
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21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.
Code of Federal Regulations, 2014 CFR
2014-04-01
... and 2301? How can I get them? Can I use computer-generated equivalents? 514.80(d) Reporting forms. How... provided on the forms. Computer-generated equivalents of Form FDA 1932 or Form FDA 2301, approved by FDA... Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764. (e) Records to...
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21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.
Code of Federal Regulations, 2012 CFR
2012-04-01
... and 2301? How can I get them? Can I use computer-generated equivalents? 514.80(d) Reporting forms. How... provided on the forms. Computer-generated equivalents of Form FDA 1932 or Form FDA 2301, approved by FDA... Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764. (e) Records to...
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21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.
Code of Federal Regulations, 2013 CFR
2013-04-01
... and 2301? How can I get them? Can I use computer-generated equivalents? 514.80(d) Reporting forms. How... provided on the forms. Computer-generated equivalents of Form FDA 1932 or Form FDA 2301, approved by FDA... Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764. (e) Records to...
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21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.
Code of Federal Regulations, 2011 CFR
2011-04-01
... and 2301? How can I get them? Can I use computer-generated equivalents? 514.80(d) Reporting forms. How... provided on the forms. Computer-generated equivalents of Form FDA 1932 or Form FDA 2301, approved by FDA... Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764. (e) Records to...
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21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.
Code of Federal Regulations, 2010 CFR
2010-04-01
... and 2301? How can I get them? Can I use computer-generated equivalents? 514.80(d) Reporting forms. How... provided on the forms. Computer-generated equivalents of Form FDA 1932 or Form FDA 2301, approved by FDA... Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764. (e) Records to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0431] Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and... guidance entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-06
...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0429] Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs... Action'' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act...
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Nosik, Melissa R; Williams, W Larry; Garrido, Natalia; Lee, Sarah
2013-01-01
In the current study, behavior skills training (BST) is compared to a computer based training package for teaching discrete trial instruction to staff, teaching an adult with autism. The computer based training package consisted of instructions, video modeling and feedback. BST consisted of instructions, modeling, rehearsal and feedback. Following training, participants were evaluated in terms of their accuracy on completing critical skills for running a discrete trial program. Six participants completed training; three received behavior skills training and three received the computer based training. Participants in the BST group performed better overall after training and during six week probes than those in the computer based training group. There were differences across both groups between research assistant and natural environment competency levels. Copyright © 2012 Elsevier Ltd. All rights reserved.
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ERIC Educational Resources Information Center
Butler, A. K.; And Others
The performance/design requirements and a detailed technical description for a Computer-Directed Training Subsystem to be integrated into the Air Force Phase II Base Level System are described. The subsystem may be used for computer-assisted lesson construction and has presentation capability for on-the-job training for data automation, staff, and…
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Implementation of audio computer-assisted interviewing software in HIV/AIDS research.
Pluhar, Erika; McDonnell Holstad, Marcia; Yeager, Katherine A; Denzmore-Nwagbara, Pamela; Corkran, Carol; Fielder, Bridget; McCarty, Frances; Diiorio, Colleen
2007-01-01
Computer-assisted interviewing (CAI) has begun to play a more prominent role in HIV/AIDS prevention research. Despite the increased popularity of CAI, particularly audio computer-assisted self-interviewing (ACASI), some research teams are still reluctant to implement ACASI technology because of lack of familiarity with the practical issues related to using these software packages. The purpose of this report is to describe the implementation of one particular ACASI software package, the Questionnaire Development System (QDS; Nova Research Company, Bethesda, MD), in several nursing and HIV/AIDS prevention research settings. The authors present acceptability and satisfaction data from two large-scale public health studies in which they have used QDS with diverse populations. They also address issues related to developing and programming a questionnaire; discuss practical strategies related to planning for and implementing ACASI in the field, including selecting equipment, training staff, and collecting and transferring data; and summarize advantages and disadvantages of computer-assisted research methods.
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Bayomy, Hanaa; El Awadi, Mona; El Araby, Eman; Abed, Hala A
2016-12-01
Computer-assisted medical education has been developed to enhance learning and enable high-quality medical care. This study aimed to assess computer knowledge and attitude toward the inclusion of computers in medical education among second-year medical students in Benha Faculty of Medicine, Egypt, to identify limitations, and obtain suggestions for successful computer-based learning. This was a one-group pre-post-test study, which was carried out on second-year students in Benha Faculty of Medicine. A structured self-administered questionnaire was used to compare students' knowledge, attitude, limitations, and suggestions toward computer usage in medical education before and after the computer course to evaluate the change in students' responses. The majority of students were familiar with use of the mouse and keyboard, basic word processing, internet and web searching, and e-mail both before and after the computer course. The proportion of students who were familiar with software programs other than the word processing and trouble-shoot software/hardware was significantly higher after the course (P<0.001). There was a significant increase in the proportion of students who agreed on owning a computer (P=0.008), the inclusion of computer skills course in medical education, downloading lecture handouts, and computer-based exams (P<0.001) after the course. After the course, there was a significant increase in the proportion of students who agreed that the lack of central computers limited the inclusion of computer in medical education (P<0.001). Although the lack of computer labs, lack of Information Technology staff mentoring, large number of students, unclear course outline, and lack of internet access were more frequently reported before the course (P<0.001), the majority of students suggested the provision of computer labs, inviting Information Technology staff to support computer teaching, and the availability of free Wi-Fi internet access covering several areas in the university campus; all would support computer-assisted medical education. Medical students in Benha University are computer literate, which allows for computer-based medical education. Staff training, provision of computer labs, and internet access are essential requirements for enhancing computer usage in medical education in the university.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0465] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... guidance document will serve as the special control for rTMS systems. Section 513(f)(2) of the Federal Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-02
... Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research... CDRH and CBER and have been compiled into checklists for use by FDA review staff. In the Federal... do so by using the Internet. A search capability for all CDRH guidance documents is available at http...
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Advantage and choice: social relationships and staff assistance in assisted living.
Burge, Stephanie; Street, Debra
2010-05-01
OBJECTIVES. To understand how "cumulative inequality" (CI), expressed as individual advantage and choice, and "external social supports" contribute to the quality of social relationships and perceptions of staff assistance for older individuals in different assisted living (AL) settings. Data are from 429 cognitively intact AL residents aged 60 years and older interviewed for the Florida Study of Assisted Living. Bivariate and multivariate statistical analyses show how individual advantage and choice and external social networks influence respondents' social relationships and staff assistance in AL. Controlling for resident and facility characteristics, being able to pay privately enhances resident satisfaction with staff assistance and having control over the move to AL is positively associated with perceptions of staff relationships and assistance. Maintaining contact with pre-AL friends predicts quality of coresident relationships, as does family contact. Regular contact with family buffers some of the disadvantages associated with CI for perceptions of staff relationships but not perceptions of staff assistance. Discussion. Individual advantage and choice influence the quality of staff relationships and assistance for AL residents but matter little for coresident relationships. External social relationships buffer some of the risks associated with CI for perceptions of staff relationships but not perceived quality of staff assistance. Findings highlight outcomes associated with CI, including predictable risks that disadvantaged elders face in particular types of AL settings, differential advantages others enjoy that influence positive perceptions of staff relationships and staff assistance, and the enduring importance of supportive social relationships.
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Computer and Software Abuse Policies. Microcomputing Working Paper Series A 84-7.
ERIC Educational Resources Information Center
Smith, Shirley C.
This document was designed to assist computer users with the ethical issues created by the widespread use of microcomputers at Drexel University, where there were over 5,000 Macintosh microcomputers in use on the campus as of the fall of 1984. It explains to faculty, students, and staff what the university expects and the law demands in regard to…
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ERIC Educational Resources Information Center
Jordan, Jim
1988-01-01
Summarizes how infograhics are produced and how they provide information graphically in high school publications. Offers suggestions concerning information gathering, graphic format, and software selection, and provides examples of computer/student designed infographics. (MM)
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The Center for Devices and Radiological health: an update.
Donawa, M
2001-12-01
At a recent medical device conference, Dr. David Feigal, the Director of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) stated that one-third of the CDRH staff will retire in five years. This is only one of many challenges that the Center faces.This article discusses key factors shaping current FDA device policies and programmes, the CDRH strategic plan, the continuing importance of the standards programme, and CDRH harmonisation activities.
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32 CFR 700.330 - The Staff Assistants.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 32 National Defense 5 2011-07-01 2011-07-01 false The Staff Assistants. 700.330 Section 700.330 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY UNITED STATES NAVY REGULATIONS... Office of the Secretary of the Navy/the Staff Assistants § 700.330 The Staff Assistants. The Staff...
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32 CFR 700.330 - The Staff Assistants.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 32 National Defense 5 2010-07-01 2010-07-01 false The Staff Assistants. 700.330 Section 700.330 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY UNITED STATES NAVY REGULATIONS... Office of the Secretary of the Navy/the Staff Assistants § 700.330 The Staff Assistants. The Staff...
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32 CFR 700.330 - The Staff Assistants.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 32 National Defense 5 2014-07-01 2014-07-01 false The Staff Assistants. 700.330 Section 700.330 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY UNITED STATES NAVY REGULATIONS... Office of the Secretary of the Navy/the Staff Assistants § 700.330 The Staff Assistants. The Staff...
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32 CFR 700.330 - The Staff Assistants.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 32 National Defense 5 2012-07-01 2012-07-01 false The Staff Assistants. 700.330 Section 700.330 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY UNITED STATES NAVY REGULATIONS... Office of the Secretary of the Navy/the Staff Assistants § 700.330 The Staff Assistants. The Staff...
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32 CFR 700.330 - The Staff Assistants.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 32 National Defense 5 2013-07-01 2013-07-01 false The Staff Assistants. 700.330 Section 700.330 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY UNITED STATES NAVY REGULATIONS... Office of the Secretary of the Navy/the Staff Assistants § 700.330 The Staff Assistants. The Staff...
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NASA Astrophysics Data System (ADS)
Wagner, Robert F.; Beiden, Sergey V.; Campbell, Gregory; Metz, Charles E.; Sacks, William M.
2003-05-01
The dialog among investigators in academia, industry, NIH, and the FDA has grown in recent years on topics of historic interest to attendees of these SPIE sub-conferences on Image Perception, Observer Performance, and Technology Assessment. Several of the most visible issues in this regard have been the emergence of digital mammography and modalities for computer-assisted detection and diagnosis in breast and lung imaging. These issues appear to be only the "tip of the iceberg" foreshadowing a number of emerging advances in imaging technology. So it is timely to make some general remarks looking back and looking ahead at the landscape (or seascape). The advances have been facilitated and documented in several forums. The major role of the SPIE Medical Imaging Conferences i well-known to all of us. Many of us were also present at the Medical Image Perception Society and co-sponsored by CDRH and NCI in September of 2001 at Airlie House, VA. The workshops and discussions held at that conference addressed some critical contemporary issues related to how society - and in particular industry and FDA - approach the general assessment problem. A great deal of inspiration for these discussions was also drawn from several workshops in recent years sponsored by the Biomedical Imaging Program of the National Cancer Institute on these issues, in particular the problem of "The Moving Target" of imaging technology. Another critical phenomenon deserving our attention is the fact that the Fourth National Forum on Biomedical Imaging in Oncology was recently held in Bethesda, MD., February 6-7, 2003. These forums are presented by the National Cancer Institute (NCI), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the National Electrical Manufacturers Association (NEMA). They are sponsored by the National Institutes of Health/Foundation for Advanced Education in the Sciences (NIH/FAES). These forums led to the development of the NCI"s Interagency Council on Biomedical Imaging in Oncology (ICBIO) about two and a half years ago. The purpose of the ICBIO is to assist developers of new imaging technologies for cancer screening and diagnosis to find a coherent way to interface with government agencies with responsibilities in these areas. A recent product of these activities was an overview paper written by the present authors and published this year in the Journal Academic Radiology (2). The paper includes a summary of some of the major developments in assessment methodology in recent years and includes several case studies from the public forum of the FDA"s Center for Devices & Radiological Health (CDRH). We will include a brief sketch of some of the key issues of that paper in this review.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
De Volpi, A.; Fenrick, M. R.; Stanford, G. S.
1980-10-01
Documentation often is a primary residual of research and development. Because of this important role and because of the large amount of time consumed in generating technical reports, particularly those containing formulas and graphics, an existing data-processing computer system has been adapted so as to provide text-processing of technical documents. Emphasis has been on accuracy, turnaround time, and time savings for staff and secretaries, for the types of reports normally produced in the reactor development program. The computer-assisted text-processing system, called TXT, has been implemented to benefit primarily the originator of technical reports. The system is of particular value tomore » professional staff, such as scientists and engineers, who have responsibility for generating much correspondence or lengthy, complex reports or manuscripts - especially if prompt turnaround and high accuracy are required. It can produce text that contains special Greek or mathematical symbols. Written in FORTRAN and MACRO, the program TXT operates on a PDP-11 minicomputer under the RSX-11M multitask multiuser monitor. Peripheral hardware includes videoterminals, electrostatic printers, and magnetic disks. Either data- or word-processing tasks may be performed at the terminals. The repertoire of operations has been restricted so as to minimize user training and memory burden. Spectarial staff may be readily trained to make corrections from annotated copy. Some examples of camera-ready copy are provided.« less
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FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster
By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.
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Turnover Among Air Force Nurses.
1987-03-01
Statistics. - The U. S. Air Force Institute of Technology, Civilian Institutions , Allied Health Branch, for their assistance and partial financial support...The University of Utah, Computer Center, for their financial support and use of computer equipment used in the statistical analysis. xiv The following...retain the nurses currently employed (Decker, et al., 19S2; Weisman, 1982). White (1980) concludes that nursina staff is a considerable [ financial
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ERIC Educational Resources Information Center
Garcia, Thais Pousada; Loureiro, Javier Pereira; Gonzalez, Betania Groba; Riveiro, Laura Nieto; Sierra, Alejandro Pazos
2011-01-01
The purpose of the study was to determine the use of computers and assistive devices amongst children with cerebral palsy (CP) and establish the satisfaction level of both users and educational staff. The study was carried out with 30 children with cerebral palsy. A questionnaire was designed to characterize the use of new technologies and…
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ERIC Educational Resources Information Center
Godsall, R. A.
1974-01-01
A management simulation course has been designed by Dunchurch Industrial Staff College (DISC) that is management oriented rather than marketing oriented. The computer assisted program has been successful in allowing managers to experience immediately the effects of their decisions and also to experience each other's jobs and problems. (DS)
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21 CFR 807.22 - How and where to register establishments and list devices.
Code of Federal Regulations, 2010 CFR
2010-04-01
... use of the device. In lieu of form FDA-2892, tapes for computer input or hard copy computer output may by submitted if equivalent in all elements of information as specified in form FDA-2892. All formats...
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Reed, Terrie L; Kaufman-Rivi, Diana
2010-01-01
The broad array of medical devices and the potential for device failures, malfunctions, and other adverse events associated with each device creates a challenge for public health device surveillance programs. Coding reported events by type of device problem provides one method for identifying a potential signal of a larger device issue. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) Event Problem Codes that are used to report adverse events previously lacked a structured set of controls for code development and maintenance. Over time this led to inconsistent, ambiguous, and duplicative concepts being added to the code set on an ad-hoc basis. Recognizing the limitation of its coding system the FDA set out to update the system to improve its usefulness within FDA and as a basis of a global standard to identify important patient and device outcomes throughout the medical community. In 2004, FDA and the National Cancer Institute (NCI) signed a Memorandum of Understanding (MOU) whereby NCI agreed to provide terminology development and maintenance services to all FDA Centers. Under this MOU, CDRH's Office of Surveillance and Biometrics (OSB) convened a cross-Center workgroup and collaborated with staff at NCI Enterprise Vocabulary Service (EVS) to streamline the Patient and Device Problem Codes and integrate them into the NCI Thesaurus and Meta-Thesaurus. This initiative included many enhancements to the Event Problem Codes aimed at improving code selection as well as improving adverse event report analysis. LIMITATIONS & RECOMMENDATIONS: Staff resources, database concerns, and limited collaboration with external groups in the initial phases of the project are discussed. Adverse events associated with medical device use can be better understood when they are reported using a consistent and well-defined code set. This FDA initiative was an attempt to improve the structure and add control mechanisms to an existing code set, improve analysis tools that will better identify device safety trends, and improve the ability to prevent or mitigate effects of adverse events associated with medical device use.
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1999-05-14
The Food and Drug Administration (FDA) is announcing the availability of a new compliance policy guide (CPG) entitled "Year 2000 (Y2K) Computer Compliance" (section 160-800). This guidance document represents the agency's current thinking on the manufacturing and distribution of domestic and imported products regulated by FDA using computer systems that may not perform properly before, or during, the transition to the year 2000 (Y2K). The text of the CPG is included in this notice. This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG, and it will be included in the next printing of the Compliance Policy Guides Manual. This CPG is intended for FDA personnel, and it is available electronically to the public.
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Protocol Coordinator | Center for Cancer Research
PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator II: Provides comprehensive clinical and administrative support to the Brain Tumor Trial Collaborative, Neuro-Oncology Branch, NCI, National Institutes of Health Serves as a liaison with Principal Investigators (PIs), the associated study teams and a variety of offices associated with protocol development and approvals Orchestrates meetings with investigators and other key medical staff to identify required support Coordinates the writing and regulatory review processes that occur in tandem, facilitates the bi-directional dialogue and feedback between various teams, and assists investigators and medical writers on the production/revision of clinical research protocols Assists research staff in coordinating/navigating requirements for special circumstances and facilitates access to necessary services Facilitates initiation of intramural research by providing assistance in obtaining required approvals Coordinates with investigators and medical writers to ensure Institutional Review Board (IRB) and Food and Drug Administration (FDA) stipulations are appropriately addressed in a timely manner Provides consultation and assistance for all aspects of the protocol lifecycle including initial Investigational New Drug (IND) submission, IRB submission, continuing review applications, protocol amendments, annual reports, and protocol inactivation with IRB and FDA Tracks a portfolio of protocols through each lifecycle step; processes and tracks appropriate approvals (e.g., IRB, Data and Safety Monitoring Board, Radiation Safety, Office of Protocol Services, etc.) Provides administrative support to Scientific Review Committees (SRC), reviews proposed protocol documents to ensure they are complete, distributes to reviewers, documents meeting minutes, enters data into the IRIS database, facilitates processes to obtain approval to initiate and continue clinical research Creates, maintains and queries an IRB database of approved amendment descriptions Maintains records of the current protocol(s) version, current Informed Consent document(s), FDA Safe to Proceed designation, etc. for each IND Provides expertise in data management including data collection and analysis Develops procedural manuals for clinical trials protocols Participates in quality improvement and assurance involving International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines This position is located at the National Institutes of Health (NIH) in Bethesda, Maryland.
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Real-World Evidence, Public Participation, and the FDA.
Schwartz, Jason L
2017-11-01
For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.
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76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-22
...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.
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US FDA perspective on regulatory issues affecting circulatory assist devices.
Sapirstein, Wolf; Chen, Eric; Swain, Julie; Zuckerman, Bram
2006-11-01
There has been a rapid development in mechanical circulatory support systems in the decade since the US FDA first approved a mechanical device to provide the circulatory support lacking from a failing heart. Devices are presently approved for marketing by the FDA to replace a failing ventricle, the Ventricular Assist Device or the entire heart, Total Artificial Heart. Contemporaneous with, and permitted by, improvement in technology and design, devices have evolved from units located extracorporeally to paracorporeal systems and totally implanted devices. Clinical studies have demonstrated a parallel improvement in the homeostatic adequacy of the circulatory support provided. Thus, while the circulatory support was initially tolerated for short periods to permit recovery of cardiac function, this technology eventually provided effective circulatory support for increasing periods that permitted the FDA to approve devices for bridging patients in end-stage cardiac failure awaiting transplant and eventually a device for destination therapy where patients in end-stage heart failure are not cardiac transplant candidates. The approved devices have relied on displacement pumps that mimic the pulsatility of the physiological system. Accelerated development of more compact devices that rely on alternative pump mechanisms have challenged both the FDA and device manufacturers to assure that the regulatory requirements for safety and effectiveness are met for use of mechanical circulatory support systems in expanded target populations. An FDA regulatory perspective is reviewed of what can be a potentially critical healthcare issue.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-29
... document describes FDA's recommendations concerning 510(k) submissions for various types of in vitro.... SUPPLEMENTARY INFORMATION: I. Background This draft guidance includes recommendations concerning 510(k...
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76 FR 51039 - Statement of Organizations, Functions, and Delegations of Authority
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-17
... Bioequivalence II, Division of Microbiology, Division of Clinical Review, and Division of Chemistry IV. In...FDA/ReportsManualsForms/StaffManualGuides/default.htm . Dated: August 10, 2011. Leslie Kux, Acting...
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Yang, Tubao; Walker, Mark C; Krewski, Daniel; Yang, Qiuying; Nimrod, Carl; Garner, Peter; Fraser, William; Olatunbosun, Olufemi; Wen, Shi Wu
2008-03-01
To estimate the frequency of exposure to prescription Food and Drug Administration (FDA) category C, D, and X drugs in pregnant women, and to analyze the maternal characteristics associated with such an exposure. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 was chosen for the study. The rate of exposure to FDA category C, D, or X drugs recorded in the pharmacist database was estimated. Associations of exposure to FDA category C, D, and X drugs with maternal characteristics were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 575 women were included in this study. Among them, 3604 (19.4%) had exposure to one or more FDA category C, D, and X drugs during pregnancy. Category C drugs were the most frequently used drugs (15.8%), followed by D drugs (5.2%), and X drugs (3.9%). Women with chronic health conditions had fourfold at increased risk of exposure than women without. Regardless of health status, women who were <20 years of age, who had a parity > or =3, and who were on social assistance plan were at increased risk of pregnancy exposure to these drugs. About 19.4% pregnant women are exposed to FDA C, D or X drugs during pregnancy. Women with chronic diseases, younger age, increased parity, and under social assistance are at increased risk of exposure to FDA C, D, or X drugs. Copyright 2008 John Wiley & Sons, Ltd.
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Hearing Aids and Personal Sound Amplifiers: Know the Difference
... Devices and Personal Sound Amplification Products - Guidance for Industry and FDA Staff (PDF - 42KB) More in Consumer Updates Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products ...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-07
... and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov/MedicalDevices... ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' from CDRH you may...
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NASA Astrophysics Data System (ADS)
Agrawal, Anant; Gavrielides, Marios A.; Weininger, Sandy; Chakrabarti, Kish; Pfefer, Joshua
2008-02-01
For a number of years, phantoms have been used to optimize device parameters and validate performance in the primary medical imaging modalities (CT, MRI, PET/SPECT, ultrasound). Furthermore, the FDA under the Mammography Quality Standards Act (MQSA) requires image quality evaluation of mammography systems using FDA-approved phantoms. The oldest quantitative optical diagnostic technology, pulse oximetry, also benefits from the use of active phantoms known as patient simulators to validate certain performance characteristics under different clinically-relevant conditions. As such, guidance provided by the FDA to its staff and to industry on the contents of pre-market notification and approval submissions includes suggestions on how to incorporate the appropriate phantoms in establishing device effectiveness. Research at the FDA supports regulatory statements on the use of phantoms by investigating how phantoms can be designed, characterized, and utilized to determine critical device performance characteristics. These examples provide a model for how novel techniques in the rapidly growing field of optical diagnostics can use phantoms during pre- and post-market regulatory testing.
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1988-03-14
focused application of decision aids. These decision aids must incorporate standardized processes, computer assisted artificial intelligence, linkage...Theater Planning. A Strategic-Operational Perspective,’ by COL MIke ,or i n Olesak, John, LTC Office of the Deputy Chief of Staff, Inteligence , U S
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Adult Career Counseling Center. Fifteenth Annual Report, September 1997-June 1998.
ERIC Educational Resources Information Center
Goodman, Jane
The Adult Career Counseling Center (ACCC) at Oakland University provides career exploration and planning opportunities to community adults at no cost; trains faculty, staff, and students in the use of computer-assisted career guidance programs; and supports research efforts for a better understanding of career development resources. Clients…
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Computer Literacy: Handbook to Accompany VESL Vocabulary Cards.
ERIC Educational Resources Information Center
Siefer, Nancy; Lenhart, Debra
This manual is one of four self-contained components of a larger handbook designed to assist secondary and postsecondary instructors and support staff in meeting the needs of limited-English-proficiency (LEP) students in vocational training programs. Together with an accompanying set of vocational English as a second language (VESL) vocabulary…
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ERIC Educational Resources Information Center
Demski, Jennifer
2009-01-01
This article describes how centralized presentation control systems enable IT support staff to monitor equipment and assist end users more efficiently. At Temple University, 70 percent of the classrooms are equipped with an AMX touch panel, linked via a Netlink controller to an in-classroom computer, projector, DVD/VCR player, and speakers. The…
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Chor, Julie; Lyman, Phoebe; Ruth, Jean; Patel, Ashlesha; Gilliam, Melissa
2018-01-01
Balancing the need to provide individual support for patients and the need for an efficient clinic can be challenging in the abortion setting. This study explores physician, staff, and specially trained abortion doula perspectives on doula support, one approach to patient support. We conducted separate focus groups with physicians, staff members, and doulas from a high-volume, first-trimester aspiration abortion clinic with a newly established volunteer abortion doula program. Focus groups explored 1) abortion doula training, 2) program implementation, 3) program benefits, and 4) opportunities for improvement. Interviews were transcribed and computer-assisted content analysis was performed; salient findings are presented. Five physicians, 5 staff members, and 4 abortion doulas participated in separate focus group discussions. Doulas drew on both their prior personal skills and experiences in addition to their abortion doula training to provide women with support at the time of abortion. Having doulas in the clinic to assist with women's emotional needs allowed physicians and staff to focus on technical aspects of the procedure. In turn, both physicians and staff believed that introducing doulas resulted in more patient-centered care. Although staff did not experience challenges to integrating doulas, physicians and doulas experienced initial challenges in incorporating doula support into the clinical flow. Staff and doulas reported exchanging skills and techniques that they subsequently used in their interactions with patients. Physicians, clinic staff, and doulas perceive abortion doula support as an approach to provide more patient-centered care in a high-volume aspiration abortion clinic. © 2018 by the American College of Nurse-Midwives.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-02
... in an IND. In addition, organizational and editorial revisions were made to improve clarity. The...). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights...
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Osilla, Karen Chan; Kennedy, David P; Hunter, Sarah B; Maksabedian, Ervant
2016-09-07
Social networks play positive and negative roles in the lives of homeless people influencing their alcohol and/or other drug (AOD) and HIV risk behaviors. We developed a four-session computer-assisted social network motivational interviewing intervention for homeless adults transitioning into housing. We examined the acceptability of the intervention among staff and residents at an organization that provides permanent supportive housing through iterative rounds of beta testing. Staff were 3 men and 3 women who were residential support staff (i.e., case managers and administrators). Residents were 8 men (7 African American, 1 Hispanic) and 3 women (2 African American, 1 Hispanic) who had histories of AOD and HIV risk behaviors. We conducted a focus group with staff who gave input on how to improve the delivery of the intervention to enhance understanding and receptivity among new residents. We conducted semi-structured qualitative interviews and collected self-report satisfaction data from residents. Three themes emerged over the course of the resident interviews. Residents reported that the intervention was helpful in discussing their social network, that seeing the visualizations was more impactful than just talking about their network, and that the intervention prompted thoughts about changing their AOD use and HIV risk networks. This study is the first of its kind that has developed, with input from Housing First staff and residents, a motivational interviewing intervention that targets both the structure and composition of one's social network. These results suggest that providing visual network feedback with a guided motivational interviewing discussion is a promising approach to supporting network change. ClinicalTrials.gov Identifier NCT02140359.
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1 CFR 15.3 - Staff assistance.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 1 General Provisions 1 2011-01-01 2011-01-01 false Staff assistance. 15.3 Section 15.3 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS SERVICES TO FEDERAL AGENCIES General § 15.3 Staff assistance. The staff of the Office of the...
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1 CFR 15.3 - Staff assistance.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 1 General Provisions 1 2013-01-01 2012-01-01 true Staff assistance. 15.3 Section 15.3 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS SERVICES TO FEDERAL AGENCIES General § 15.3 Staff assistance. The staff of the Office of the...
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1 CFR 15.3 - Staff assistance.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 1 General Provisions 1 2012-01-01 2012-01-01 false Staff assistance. 15.3 Section 15.3 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS SERVICES TO FEDERAL AGENCIES General § 15.3 Staff assistance. The staff of the Office of the...
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1 CFR 15.3 - Staff assistance.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 1 General Provisions 1 2014-01-01 2012-01-01 true Staff assistance. 15.3 Section 15.3 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS SERVICES TO FEDERAL AGENCIES General § 15.3 Staff assistance. The staff of the Office of the...
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1 CFR 15.3 - Staff assistance.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 1 General Provisions 1 2010-01-01 2010-01-01 false Staff assistance. 15.3 Section 15.3 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS SERVICES TO FEDERAL AGENCIES General § 15.3 Staff assistance. The staff of the Office of the...
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A roundtable discussion: home healthcare-not a hospital in the home.
Logan, Mary K; Parker, Chuck; Gardner-Bonneau, Daryle; Treu, Denny; Keller, James; Winstel, Lisa; Weick-Brady, Mary; Kramer, Nancy; Cyrus, Reginald; Thiel, Scott; Lewis, Vicki R; Rogers, Wendy
2013-01-01
Home healthcare is vital for a large percentage of the population. According to data from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), 7 million people in the United States receive home healthcare annually. The use of medical devices in the home and other nonclinical environments is increasing dramatically. By the year 2050, an estimated 27 million people will need continuing care in the home or in the community and not in a controlled clinical environment. 1 The FDA recently announced its Home Use Devices Initiative and issued the document, "Draft Guidance for Industry and FDA Staff-Design Considerations for Devices Intended for Home Use" on Dec. 12, 2012. 2 The Center for Devices and Radiological Health (CDRH) regulates medical devices, but that regulatory authority alone is not enough to ensure safe and effective use of devices in the home. To address these and other issues, AAMI and FDA will co-host a summit on healthcare technology in nonclinical settings Oct. 9-10, 2013.
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76 FR 12975 - Determination of Regulatory Review Period for Purposes of Patent Extension; CERVARIX
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-09
... in situ; and cervical intraepithelial neoplasia grade 1. Subsequent to this approval, the Patent and... testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for...) from MedImmune, LLC., and the Patent and Trademark Office requested FDA's assistance in determining...
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Linking Project Procedure Manual for Using Dumb-Barcode Linking on GEAC.
ERIC Educational Resources Information Center
Condron, Lyn
This procedure manual is designed to assist cataloging staff members at a university library through the 10-step process of barcoding and linking books classified by the Library of Congress system to the library's GEAC online computer system. A brief introduction provides background information on the project. The procedures involved in each…
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Assessing the Efficacy of a Student Expectations Questionnaire
ERIC Educational Resources Information Center
Warwick, Jon
2012-01-01
This article uses Rasch analysis to explore the efficacy of a questionnaire designed to assist university teaching staff in identifying those Level 4 students most in need of mathematics support. The students were all taking a mathematics module as part of their first year Computing curriculum, and the questionnaire explores the students' previous…
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Delivery of Hardware for Syracuse University Faculty Loaner Program.
ERIC Educational Resources Information Center
Jares, Terry
This paper describes the Faculty Assistance and Computing Education Services (FACES) loaner program at Syracuse University and the method used by FACES staff to deliver and keep track of hardware, software, and documentation. The roles of the various people involved in the program are briefly discussed, i.e., the administrator, who handles the…
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Reaching Out: Challenges and Opportunities of Recruiting a Diverse Staff of Resident Assistants
ERIC Educational Resources Information Center
Healea, C. Daryl; Hale, Patrick J.
2016-01-01
Recruiting a diverse staff of resident assistants at an institution of American higher education involves both challenges and opportunities. This study employed the theoretical framework of multicultural organizational development to explore how diversity was cultivated in a resident assistant staff and why that staff exhibited a particular form…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-08
... for Devices and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov...'' from CDRH, you may either send an email request to [email protected] to receive an electronic copy of...
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The use of cimetidine in hospitalized patients.
Kopala, L
1984-01-01
Cimetidine is the most commonly prescribed drug in North America. A clinical review was conducted to identify physicians' prescribing habits. From September 1, 1981 to March 31, 1982, the charts were reviewed of 50 patients receiving cimetidine in an isolated coastal community hospital in British Columbia. It was discovered that physicians prescribed the drug for reasons approved by the Food and Drug Administration (FDA) only 14% of the time. The FDA guidelines approve cimetidine for duodenal ulcer, Zollinger-Ellison syndrome, and other hypersecretory states. A literature review was conducted, and guidelines on prescribing cimetidine were given to all members of the hospital's medical staff.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0804... Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)) and the... sheet form, assists respondents in categorizing administrative 510(k) information for submission to FDA...
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Moran, Anna; Nancarrow, Susan A; Enderby, Pamela
2015-07-01
This research aims to describe the factors associated with successful employment of allied health and social care assistants in community-based rehabilitation services (CBRS) in England. The research involved the thematic analysis of interviews and focus groups with 153 professionally qualified and assistant staff from 11 older people's interdisciplinary community rehabilitation teams. Data were collected between November 2006 and December 2008. Assistants were perceived as a focal point for care delivery and conduits for enabling a service to achieve goals within interdisciplinary team structures. Nine mechanisms were identified that promoted the successful employment of assistants: (i) Multidisciplinary team input into assistant training and support; (ii) Ensuring the timely assessment of clients by qualified staff; (iii) Establishing clear communication structures between qualified and assistant staff; (iv) Co-location of teams to promote communication and skill sharing; (v) Removing barriers that prevent staff working to their full scope of practice; (vi) Facilitating role flexibility of assistants, while upholding the principles of reablement; (vii) Allowing sufficient time for client-staff interaction; (viii) Ensuring an appropriate ratio of assistant to qualified staff to enable sufficient training and supervision of assistants; and (ix) Appropriately, resourcing the role for training and reimbursement to reflect responsibility. We conclude that upholding these mechanisms may help to optimise the efficiency and productivity of assistant and professionally qualified staff in CBRS. © 2014 John Wiley & Sons Ltd.
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Wu, Wei-Tao; Yang, Fang; Wu, Jingchun; Aubry, Nadine; Massoudi, Mehrdad; Antaki, James F.
2016-01-01
Continuous flow ventricular assist devices (cfVADs) provide a life-saving therapy for severe heart failure. However, in recent years, the incidence of device-related thrombosis (resulting in stroke, device-exchange surgery or premature death) has been increasing dramatically, which has alarmed both the medical community and the FDA. The objective of this study was to gain improved understanding of the initiation and progression of thrombosis in one of the most commonly used cfVADs, the Thoratec HeartMate II. A computational fluid dynamics simulation (CFD) was performed using our recently updated mathematical model of thrombosis. The patterns of deposition predicted by simulation agreed well with clinical observations. Furthermore, thrombus accumulation was found to increase with decreased flow rate, and can be completely suppressed by the application of anticoagulants and/or improvement of surface chemistry. To our knowledge, this is the first simulation to explicitly model the processes of platelet deposition and thrombus growth in a continuous flow blood pump and thereby replicate patterns of deposition observed clinically. The use of this simulation tool over a range of hemodynamic, hematological, and anticoagulation conditions could assist physicians to personalize clinical management to mitigate the risk of thrombosis. It may also contribute to the design of future VADs that are less thrombogenic. PMID:27905492
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Enhancing the incorporation of the patient's voice in drug development and evaluation.
Chalasani, Meghana; Vaidya, Pujita; Mullin, Theresa
2018-01-01
People living with a condition are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the Patient-Focused Drug Development (PFDD) initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. PFDD meetings are unique among FDA public meetings, with a format designed to engage patients and elicit their perspectives on two topic areas: (1) the most significant symptoms of their condition and the impact of the condition on daily life; and, (2) their current approaches to treatment. FDA has conducted 24 disease-specific PFDD meetings to date. The lessons learned from PFDD meetings range from experiences common across rare diseases to more disease specific experiences that matter most to patients. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps in information on the patient perspective. Patient-focused drug development is an ongoing effort and FDA looks forward to the next steps in advancing the science and the utilization of patient input throughout drug development and evaluation. The U.S. Food and Drug Administration (FDA) has multiple mechanisms for its regulators and staff to interact with patients -- but none quite like its novel Patient-Focused Drug Development (PFDD) initiative. FDA established the PFDD initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. Since the initiative's inception in 2012, FDA has held 24 PFDD meetings, covering a range of disease areas and hearing directly from thousands of patients and caregivers. FDA's PFDD meetings have also provided key stakeholders, including patient advocates, researchers, drug developers, healthcare providers, and other government officials, an opportunity to hear the patient's voice. The lessons learned include but are not limited to specific experiences that matter most to patients, patient perspectives on meaningful treatment benefits and how patients want to be engaged in the drug development process. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps in information on the patient perspective. Further enhancing the incorporation of the patient's voice in drug development and evaluation continues to be a priority for FDA.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0776] Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification... staff who: (1) Are familiar with the requirements for submission of a reclassification petition, (2...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-12
... opportunity to meet with NIC project staff and ask questions about the project and the application procedures. Attendance at the conference is optional. Provisions will be made using WebEx technology (telephone and computer-based conferencing). The WebEx session requires applicants to have access to a telephone and...
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Breast tumor malignancy modelling using evolutionary neural logic networks.
Tsakonas, Athanasios; Dounias, Georgios; Panagi, Georgia; Panourgias, Evangelia
2006-01-01
The present work proposes a computer assisted methodology for the effective modelling of the diagnostic decision for breast tumor malignancy. The suggested approach is based on innovative hybrid computational intelligence algorithms properly applied in related cytological data contained in past medical records. The experimental data used in this study were gathered in the early 1990s in the University of Wisconsin, based in post diagnostic cytological observations performed by expert medical staff. Data were properly encoded in a computer database and accordingly, various alternative modelling techniques were applied on them, in an attempt to form diagnostic models. Previous methods included standard optimisation techniques, as well as artificial intelligence approaches, in a way that a variety of related publications exists in modern literature on the subject. In this report, a hybrid computational intelligence approach is suggested, which effectively combines modern mathematical logic principles, neural computation and genetic programming in an effective manner. The approach proves promising either in terms of diagnostic accuracy and generalization capabilities, or in terms of comprehensibility and practical importance for the related medical staff.
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How Much Do We Know about the Most Common Medicines Used during Pregnancy?
... some medications taken during pregnancy. Technical expertise: CDC works with staff from the U.S. Food and Drug Administration (FDA) and other professionals to help conduct studies on the effects of medication use during pregnancy and ways to prevent harmful effects. ...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug...
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Applied Operations Research: Augmented Reality in an Industrial Environment
NASA Technical Reports Server (NTRS)
Cole, Stuart K.
2015-01-01
Augmented reality is the application of computer generated data or graphics onto a real world view. Its use provides the operator additional information or a heightened situational awareness. While advancements have been made in automation and diagnostics of high value critical equipment to improve readiness, reliability and maintenance, the need for assisting and support to Operations and Maintenance staff persists. AR can improve the human machine interface where computer capabilities maximize the human experience and analysis capabilities. NASA operates multiple facilities with complex ground based HVCE in support of national aerodynamics and space exploration, and the need exists to improve operational support and close a gap related to capability sustainment where key and experienced staff consistently rotate work assignments and reach their expiration of term of service. The initiation of an AR capability to augment and improve human abilities and training experience in the industrial environment requires planning and establishment of a goal and objectives for the systems and specific applications. This paper explored use of AR in support of Operation staff in real time operation of HVCE and its maintenance. The results identified include identification of specific goal and objectives, challenges related to availability and computer system infrastructure.
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The Use of Cimetidine in Hospitalized Patients
Kopala, Lili
1984-01-01
Cimetidine is the most commonly prescribed drug in North America. A clinical review was conducted to identify physicians' prescribing habits. From September 1, 1981 to March 31, 1982, the charts were reviewed of 50 patients receiving cimetidine in an isolated coastal community hospital in British Columbia. It was discovered that physicians prescribed the drug for reasons approved by the Food and Drug Administration (FDA) only 14% of the time. The FDA guidelines approve cimetidine for duodenal ulcer, Zollinger-Ellison syndrome, and other hypersecretory states. A literature review was conducted, and guidelines on prescribing cimetidine were given to all members of the hospital's medical staff. PMID:21283494
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0258] Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-28
... Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug... for 11 neurological and physical medicine devices. FDA is reopening the comment period to allow... announcing the availability of draft special controls guidance documents for 11 neurological and physical...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-07
... assessment. In some cases, a PMA may include multiple studies designed to answer different scientific... designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles...
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21 CFR 21.41 - Processing of requests.
Code of Federal Regulations, 2010 CFR
2010-04-01
... PRIVACY Procedures for Notification of and Access to Records in Privacy Act Record Systems § 21.41... consult with the individual concerning the appropriate treatment of the request. (c) The FDA Privacy Act Coordinator (HFI-30) in the Freedom of Information Staff shall be responsibile for the handling of Privacy Act...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1558... Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-25
... things, dated copies of advertisements, dated catalog pages, and dated promotional material. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices... manufacturer provide evidence that may include, among other things, dated copies of advertisements, dated...
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Feasibility of a web-based dementia feeding skills training program for nursing home staff.
Batchelor-Murphy, Melissa; Amella, Elaine J; Zapka, Jane; Mueller, Martina; Beck, Cornelia
2015-01-01
Nursing home (NH) staff do not receive adequate training for providing feeding assistance to residents with dementia who exhibit aversive feeding behaviors (e.g., clamping mouth shut). The result is often low meal intake for these residents. This feasibility study tested a web-based dementia feeding skills program for staff in two United States NHs. Randomly assigned, the intervention staff received web-based dementia feeding skills training with coaching. Both groups participated in web-based pre-/post-tests assessing staff knowledge and self-efficacy; and meal observations measured NH staff and resident feeding behaviors, time for meal assistance, and meal intake. Aversive feeding behaviors increased in both groups of residents; however, the intervention NH staff increased the amount of time spent providing assistance and meal intake doubled. In the control group, less time was spent providing assistance and meal intake decreased. This study suggests that training staff to use current clinical practice guidelines improves meal intake. Copyright © 2015 Elsevier Inc. All rights reserved.
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Getting It Going--Keeping It Running: A Handbook for Career Information Systems.
ERIC Educational Resources Information Center
Clyde, John S.
This handbook was designed as a tool to assist school and agency staff in management and in-service training needed in implementing a comprehensive Career Information System (CIS). The background, goals, and organization of CIS are given briefly. An explanation of the System which is computer-based yet also employs a manual needle-sort system is…
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NASA Technical Reports Server (NTRS)
1987-01-01
The NASA Lewis Research Center's research and technology accomplishments for fiscal year 1987 are summarized. It comprises approximately 100 short articles submitted by staff members of the technical directorates and is organized into four sections: aeronautics, aerospace technology (which includes space communications), space station systems, and computational support. A table of contents by subject was developed to assist the reader in finding articles of special interest.
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Applied Operations Research: Operator's Assistant
NASA Technical Reports Server (NTRS)
Cole, Stuart K.
2015-01-01
NASA operates high value critical equipment (HVCE) that requires trouble shooting, periodic maintenance and continued monitoring by Operations staff. The complexity HVCE and information required to maintain and trouble shoot HVCE to assure continued mission success as paper is voluminous. Training on new HVCE is commensurate with the need for equipment maintenance. LaRC Research Directorate has undertaken a proactive research to support Operations staff by initiation of the development and prototyping an electronic computer based portable maintenance aid (Operator's Assistant). This research established a goal with multiple objectives and a working prototype was developed. The research identified affordable solutions; constraints; demonstrated use of commercial off the shelf software; use of the US Coast Guard maintenance solution; NASA Procedure Representation Language; and the identification of computer system strategies; where these demonstrations and capabilities support the Operator, and maintenance. The results revealed validation against measures of effectiveness and overall proved a substantial training and capability sustainment tool. The research indicated that the OA could be deployed operationally at the LaRC Compressor Station with an expectation of satisfactorily results and to obtain additional lessons learned prior to deployment at other LaRC Research Directorate Facilities. The research revealed projected cost and time savings.
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Computer-assisted instruction: a library service for the community teaching hospital.
McCorkel, J; Cook, V
1986-04-01
This paper reports on five years of experience with computer-assisted instruction (CAI) at Winthrop-University Hospital, a major affiliate of the SUNY at Stony Brook School of Medicine. It compares CAI programs available from Ohio State University and Massachusetts General Hospital (accessed by telephone and modem), and software packages purchased from the Health Sciences Consortium (MED-CAPS) and Scientific American (DISCOTEST). The comparison documents one library's experience of the cost of these programs and the use made of them by medical students, house staff, and attending physicians. It describes the space allocated for necessary equipment, as well as the marketing of CAI. Finally, in view of the decision of the National Board of Medical Examiners to administer the Part III examination on computer (the so-called CBX) starting in 1988, the paper speculates on the future importance of CAI in the community teaching hospital.
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From computer-assisted intervention research to clinical impact: The need for a holistic approach.
Ourselin, Sébastien; Emberton, Mark; Vercauteren, Tom
2016-10-01
The early days of the field of medical image computing (MIC) and computer-assisted intervention (CAI), when publishing a strong self-contained methodological algorithm was enough to produce impact, are over. As a community, we now have substantial responsibility to translate our scientific progresses into improved patient care. In the field of computer-assisted interventions, the emphasis is also shifting from the mere use of well-known established imaging modalities and position trackers to the design and combination of innovative sensing, elaborate computational models and fine-grained clinical workflow analysis to create devices with unprecedented capabilities. The barriers to translating such devices in the complex and understandably heavily regulated surgical and interventional environment can seem daunting. Whether we leave the translation task mostly to our industrial partners or welcome, as researchers, an important share of it is up to us. We argue that embracing the complexity of surgical and interventional sciences is mandatory to the evolution of the field. Being able to do so requires large-scale infrastructure and a critical mass of expertise that very few research centres have. In this paper, we emphasise the need for a holistic approach to computer-assisted interventions where clinical, scientific, engineering and regulatory expertise are combined as a means of moving towards clinical impact. To ensure that the breadth of infrastructure and expertise required for translational computer-assisted intervention research does not lead to a situation where the field advances only thanks to a handful of exceptionally large research centres, we also advocate that solutions need to be designed to lower the barriers to entry. Inspired by fields such as particle physics and astronomy, we claim that centralised very large innovation centres with state of the art technology and health technology assessment capabilities backed by core support staff and open interoperability standards need to be accessible to the wider computer-assisted intervention research community. Copyright © 2016. Published by Elsevier B.V.
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FY02 CBNP Annual Report Input: Bioinformatics Support for CBNP Research and Deployments
DOE Office of Scientific and Technical Information (OSTI.GOV)
Slezak, T; Wolinsky, M
2002-10-31
The events of FY01 dynamically reprogrammed the objectives of the CBNP bioinformatics support team, to meet rapidly-changing Homeland Defense needs and requests from other agencies for assistance: Use computational techniques to determine potential unique DNA signature candidates for microbial and viral pathogens of interest to CBNP researcher and to our collaborating partner agencies such as the Centers for Disease Control and Prevention (CDC), U.S. Department of Agriculture (USDA), Department of Defense (DOD), and Food and Drug Administration (FDA). Develop effective electronic screening measures for DNA signatures to reduce the cost and time of wet-bench screening. Build a comprehensive system formore » tracking the development and testing of DNA signatures. Build a chain-of-custody sample tracking system for field deployment of the DNA signatures as part of the BASIS project. Provide computational tools for use by CBNP Biological Foundations researchers.« less
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FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology.
Grant, Evita V
Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.
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The current status and future prospects of computer-assisted hip surgery.
Inaba, Yutaka; Kobayashi, Naomi; Ike, Hiroyuki; Kubota, So; Saito, Tomoyuki
2016-03-01
The advances in computer assistance technology have allowed detailed three-dimensional preoperative planning and simulation of preoperative plans. The use of a navigation system as an intraoperative assistance tool allows more accurate execution of the preoperative plan, compared to manual operation without assistance of the navigation system. In total hip arthroplasty using CT-based navigation, three-dimensional preoperative planning with computer software allows the surgeon to determine the optimal angle of implant placement at which implant impingement is unlikely to occur in the range of hip joint motion necessary for daily activities of living, and to determine the amount of three-dimensional correction for leg length and offset. With the use of computer navigation for intraoperative assistance, the preoperative plan can be precisely executed. In hip osteotomy using CT-based navigation, the navigation allows three-dimensional preoperative planning, intraoperative confirmation of osteotomy sites, safe performance of osteotomy even under poor visual conditions, and a reduction in exposure doses from intraoperative fluoroscopy. Positions of the tips of chisels can be displayed on the computer monitor during surgery in real time, and staff other than the operator can also be aware of the progress of surgery. Thus, computer navigation also has an educational value. On the other hand, its limitations include the need for placement of trackers, increased radiation exposure from preoperative CT scans, and prolonged operative time. Moreover, because the position of a bone fragment cannot be traced after osteotomy, methods to find its precise position after its movement need to be developed. Despite the need to develop methods for the postoperative evaluation of accuracy for osteotomy, further application and development of these systems are expected in the future. Copyright © 2016 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-15
... availability of the draft guidance document entitled ``Factors to Consider When Making Benefit-Risk... versus its probable risk. This draft guidance sets out the factors FDA considers when making this... factors to consider when making benefit-risk determinations in medical device premarket review. It does...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-20
... enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology... profiles and for which it believes 510(k) review is not necessary to assure safety and effectiveness. While FDA intends to exempt these devices from the 510(k) requirement through rulemaking that would...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-05
... Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION... controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft... stimulator device achieves ``aesthetic effects through physical change to the structure of the body'' as well...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-18
... facilities into commercial sites and academic sites, and questioned whether the data are a fair... dedicated to regulatory compliance, whereas the individual sites, like the academic labs, must perform the same functions with a much smaller staff. The comment said that FDA's burden estimates for academic...
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41 CFR 101-42.1102-5 - Drugs, biologicals, and reagents other than controlled substances.
Code of Federal Regulations, 2012 CFR
2012-07-01
... UTILIZATION AND DISPOSAL 42-UTILIZATION AND DISPOSAL OF HAZARDOUS MATERIALS AND CERTAIN CATEGORIES OF PROPERTY... are subject to the provisions of § 101-42.1102-3. (a) Utilization requirements. Excess drugs... Scientific Coordination Staff, ACFA-CF-30, located in the appropriate FDA district office, of surplus...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-13
... for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave... INFORMATION CONTACT: For information concerning the guidance as it relates to devices regulated by CDRH: Mary... Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/Medical...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-23
... test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls... devices into class II (special controls) because special controls, in addition to general controls, will...
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ERIC Educational Resources Information Center
Sikorska-Simmons, Elzbieta
2006-01-01
Purpose: This study examines the relationship between resident satisfaction and staff perceptions of the work environment in assisted living. Staff perceptions were assessed at the facility level, using aggregate measures of staff job satisfaction, organizational commitment, and views of organizational culture. Design and Methods: The sample…
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Conger, Robin L.; Spanner, Gary E.
2011-11-02
The businesses that have utilized PNNL's Technology Assistance Program were sent a survey to solicit feedback about the program and to determine what, if any, outcomes resulted from the assistance provided. As part of its small business outreach, Pacific Northwest National Laboratory (PNNL) offers technology assistance to businesses with fewer than 500 employees throughout the nation and to businesses of any size in the 2 counties that contain the Hanford site. Upon request, up to 40 staff-hours of a researcher's time can be provided to address technology issues at no charge to the requesting firm. During FY 2011, PNNL completedmore » assistance for 54 firms. Topics of the technology assistance covered a broad range, including environment, energy, industrial processes, medical, materials, computers and software, and sensors. In FY 2011, PNNL's Technology Assistance Program (TAP) was funded by PNNL Overheads. Over the past 16 years, the Technology Assistance Program has received total funding of nearly $2.8 million from several federal and private sources.« less
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MO-F-16A-08: Have An Impact On More Patients From Your Ideas And Inventions
DOE Office of Scientific and Technical Information (OSTI.GOV)
Morton, R
Purpose: To inform physicists how to obtain an FDA 510(k) clearance for the innovations they use in their facility and to make those ideas widely available to patients throughout the U.S. Methods: Give advice from 20 years experience of assisting in well over 100 successful 510(k) clearances. Results: Learn how to develop a 510(k) submission. Conclusion: Many physicists, physicians and radiation therapists have developed innovations that that are helpful to the patients in their institution. But, many of these innovations deserve to be made available to patients throughout the United States. The author, a Certified Radiological Physicist and former FDAmore » employee, has consulted for over twenty years for inventors, start-ups and established medical device manufacturers to bring new devices to market in the U.S. and to assist them to established FDA compliant quality systems for manufacturing. In this presentation the audience will learn the important points for deciding to go forward with obtaining a Premarket Notification clearance [also known as a 510(k) clearance] to legally market a medical device in the United States. The FDA has published guidelines for submitting a 510(k) application. However, the methods used to efficiently develop the documentation for submission and to obtain clearance in the shortest possible time comes from the author's experience in assisting well over one hundred successful 510(k) clearances.Whether you want to start your own company or to market your idea to an established medical device manufacturer, the value of your innovation increases with a documented 510(k) clearance from FDA.« less
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A telephone survey of cancer awareness among frontline staff: informing training needs
Cook, N; Hart, A; Nuttall, K; Simpson, K; Turnill, N; Grant-Pearce, C; Damms, P; Allen, V; Slade, K; Dey, P
2011-01-01
Background: Studies have shown limited awareness about cancer risk factors among hospital-based staff. Less is known about general cancer awareness among community frontline National Health Service and social care staff. Methods: A cross-sectional computer-assisted telephone survey of 4664 frontline community-based health and social care staff in North West England. Results: A total of 671 out of 4664 (14.4%) potentially eligible subjects agreed to take part. Over 92% of staff recognised most warning signs, except an unexplained pain (88.8%, n=596), cough or hoarseness (86.9%, n=583) and a sore that does not heal (77.3%, n=519). The bowel cancer-screening programme was recognised by 61.8% (n=415) of staff. Most staff agreed that smoking and passive smoking ‘increased the chance of getting cancer.' Fewer agreed about getting sunburnt more than once as a child (78.0%, n=523), being overweight (73.5%, n=493), drinking more than one unit of alcohol per day (50.2%, n=337) or doing less than 30 min of moderate physical exercise five times a week (41.1%, n=276). Conclusion: Cancer awareness is generally good among frontline staff, but important gaps exist, which might be improved by targeted education and training and through developing clearer messages about cancer risk factors. PMID:21750554
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Fekete, Szabolcs; Fekete, Jeno; Molnár, Imre; Ganzler, Katalin
2009-11-06
Many different strategies of reversed phase high performance liquid chromatographic (RP-HPLC) method development are used today. This paper describes a strategy for the systematic development of ultrahigh-pressure liquid chromatographic (UHPLC or UPLC) methods using 5cmx2.1mm columns packed with sub-2microm particles and computer simulation (DryLab((R)) package). Data for the accuracy of computer modeling in the Design Space under ultrahigh-pressure conditions are reported. An acceptable accuracy for these predictions of the computer models is presented. This work illustrates a method development strategy, focusing on time reduction up to a factor 3-5, compared to the conventional HPLC method development and exhibits parts of the Design Space elaboration as requested by the FDA and ICH Q8R1. Furthermore this paper demonstrates the accuracy of retention time prediction at elevated pressure (enhanced flow-rate) and shows that the computer-assisted simulation can be applied with sufficient precision for UHPLC applications (p>400bar). Examples of fast and effective method development in pharmaceutical analysis, both for gradient and isocratic separations are presented.
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OpenFDA: an innovative platform providing access to a wealth of FDA's publicly available data.
Kass-Hout, Taha A; Xu, Zhiheng; Mohebbi, Matthew; Nelsen, Hans; Baker, Adam; Levine, Jonathan; Johanson, Elaine; Bright, Roselie A
2016-05-01
The objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). Using cutting-edge technologies deployed on FDA's new public cloud computing infrastructure, openFDA provides open data for easier, faster (over 300 requests per second per process), and better access to FDA datasets; open source code and documentation shared on GitHub for open community contributions of examples, apps and ideas; and infrastructure that can be adopted for other public health big data challenges. Since its launch on June 2, 2014, openFDA has developed four APIs for drug and device adverse events, recall information for all FDA-regulated products, and drug labeling. There have been more than 20 million API calls (more than half from outside the United States), 6000 registered users, 20,000 connected Internet Protocol addresses, and dozens of new software (mobile or web) apps developed. A case study demonstrates a use of openFDA data to understand an apparent association of a drug with an adverse event. With easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved.
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Validation of gamma irradiator controls for quality and regulatory compliance
NASA Astrophysics Data System (ADS)
Harding, Rorry B.; Pinteric, Francis J. A.
1995-09-01
Since 1978 the U.S. Food and Drug Administration (FDA) has had both the legal authority and the Current Good Manufacturing Practice (CGMP) regulations in place to require irradiator owners who process medical devices to produce evidence of Irradiation Process Validation. One of the key components of Irradiation Process Validation is the validation of the irradiator controls. However, it is only recently that FDA audits have focused on this component of the process validation. What is Irradiator Control System Validation? What constitutes evidence of control? How do owners obtain evidence? What is the irradiator supplier's role in validation? How does the ISO 9000 Quality Standard relate to the FDA's CGMP requirement for evidence of Control System Validation? This paper presents answers to these questions based on the recent experiences of Nordion's engineering and product management staff who have worked with several US-based irradiator owners. This topic — Validation of Irradiator Controls — is a significant regulatory compliance and operations issue within the irradiator suppliers' and users' community.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-06
...] Center for Devices and Radiological Health; Standard Operating Procedures for Network of Experts; Request... procedures (SOPs) for a new ``Network of Experts.'' The draft SOPs describe a new process for staff at the... FDA is announcing the availability of two draft SOPs, one entitled, ``Network of Experts--Expert...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-23
...: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS... assessment score test system into class II (special controls) under section 513(f)(2) of the Federal Food... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-28
... ``Center for Devices and Radiological Health (CDRH) Appeals Processes.'' This document describes the processes available to outside stakeholders to request additional review of decisions and actions by CDRH... submit related requests to CDRH and FDA. This draft guidance is not final nor is it in effect at this...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-20
... Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this... search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html... CDRH and CBER are implementing this provision of the law and providing public notice as required. The...
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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...
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Gulliver, Amelia; Farrer, Louise; Bennett, Kylie; Ali, Kathina; Hellsing, Annika; Katruss, Natasha; Griffiths, Kathleen M
2018-06-01
University students experience high levels of mental health problems; however, very few seek professional help. Teaching staff within the university are well placed to assist students to seek support. To investigate university teaching staff experiences of, and training needs around, assisting students with mental health problems. A total of 224 teaching staff at the Australian National University completed an anonymous online survey (16.4% response rate from n ∼ 1370). Data on mental health training needs, and experiences of assisting students with mental health problems were described using tabulation. Qualitative data were analysed using thematic analysis. Most teaching staff (70.1-82.2%) reported at least moderate confidence in their ability to provide emotional support for students. However, many staff (60.0%) felt under-equipped overall to deal with student mental health problems; almost half (49.6%) reported they did not have access to formal training. Specific actions described in assisting students included referrals, offering support, or consulting others for advice. Given the high rates of students who approach staff about mental health problems, there is a critical need to provide and promote both formal mental health response training and explicit guidelines for staff on when, how, and where to refer students for help.
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Logistics Automation Master Plan (LAMP). Better Logistics Support through Automation.
1983-06-01
office micro-computers, positioned throughout the command chain , by providing real time links between LCA and all users: 2. Goals: Assist HQDA staff in...field i.e., Airland Battle 2000. IV-27 Section V: CONCEPT OF EXECUTION Suply (Retail) A. SRstem Description. I. The Division Logistics Property Book...7. Divisional Direct Support Unit Automated Supply System (DDASS)/Direct pport Level Suply Automation (DLSA). DDASS and DLSA are system development
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Predictors of Organizational Commitment among Staff in Assisted Living
ERIC Educational Resources Information Center
Sikorska-Simmons, Elzbieta
2005-01-01
Purpose: This study examines the role of organizational culture, job satisfaction, and sociodemographic characteristics as predictors of organizational commitment among staff in assisted living. It is particularly important to examine organizational commitment, because of its close links to staff turnover. Design and Methods: Data were collected…
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Haglund, K; von Knorring, L; von Essen, L
2006-04-01
To describe nurses' and mental health nurse assistants' perceptions of advantages and disadvantages about working on a psychiatric ward with a locked entrance door. Psychiatric staff sometimes needs to protect patients from harming themselves or others. To keep the entrance door locked may help staff to achieve this goal. How locked entrance doors at psychiatric wards are experienced by staff, working on these wards, has been investigated to a very limited extent. The study was explorative and descriptive. Audio taped, semi-structured interviews with open-ended questions about advantages and disadvantages about working on a psychiatric ward with a locked entrance door, were conducted with 20 nurses and 20 mental health nurse assistants. Data were analyzed with content analysis. A content analysis revealed eight categories of advantages and 18 categories of disadvantages. Most advantages mentioned by nurses and mental health nurse assistants were categorized as providing staff with control over patients, providing patients with a secure and efficient care and protecting patients and staff against 'the outside'. Most disadvantages mentioned by nurses were categorized as causing extra work for staff, making patients feel confined, making patients feel dependent and creating a non-caring environment. Most disadvantages mentioned by mental health nurse assistants were categorized as causing extra work for staff, making patients feel confined, causing emotional problems for patients, making staff's power obvious and forcing patients to adapt to other patients' needs. Nurses and mental health nurse assistants mentioned more disadvantages than advantages and nurses mentioned more disadvantages than mental health nurse assistants. Nurses and mental health nurse assistants perceive a number of advantages and disadvantages for themselves, patients and significant others with a locked door at a psychiatric ward. Most of these concern patients' experiences. It is important for staff working within psychiatric care to reflect upon the fact that a locked entrance door is connected with a range of negative as well as positive perceptions and to minimize patient and own concerns connected to the locked door.
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Robot-assisted surgery: the future is here.
Gerhardus, Diana
2003-01-01
According to L. Wiley Nifong, director of robotic surgery at East Carolina University's Brody School of Medicine, "Nationally, only one-fourth of the 15 million surgeries performed each year are done with small incisions or what doctors call 'minimally invasive surgery'." Robots could raise that number substantially (Stark 2002). Currently, healthcare organizations use robot technology for thoracic, abdominal, pelvic, and neurological surgical procedures. Minimally invasive surgery reduces the amount of inpatient hospital days, and the computer in the system filters any hand tremors a physician may have during the surgery. The use of robot-assisted surgery improves quality of care because the patient experiences less pain after the surgery. Robot-assisted surgery demonstrates definite advantages for the patient, physician, and hospital; however, healthcare organizations in the United States have yet to acquire the technology because of implementation costs and the lack of FDA (Food and Drug Administration) approval for using the technology for certain types of heart procedures. This article focuses on robot-assisted surgery advantages to patients, physicians, and hospitals as well as on the disadvantages to physicians. In addition, the article addresses implementation costs, which creates financial hurdles for most healthcare organizations; offers recommendations for administrators to embrace this technology for strategic positioning; and enumerates possible roles for robots in medicine.
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The Need for Caregiver Education and Training in the Assisted Living Industry
ERIC Educational Resources Information Center
Falk-Huzar, Erica
2017-01-01
Assisted living is dedicated to serving individuals with a wide array of disabilities. Training and education are vital for staff and residents in assisted-living facilities because resident care depends on staff knowledge to provide for their safety and welfare. However, little research has been conducted on assisted-living facilities, let alone…
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Mentored Research | Cancer Prevention Fellowship Program
The major activity for Cancer Prevention Fellows is mentored research. All fellows are expected to develop original scientific projects and to report their findings at scientific meetings and in leading journals. Fellows select preceptors, who guide and enrich the fellow’s experience, from skilled investigators across all NCI divisions or participating FDA centers. Over 100 NCI staff members have served as preceptors.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-27
... effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5... departments, and manufacturers of enteral feeding tubes regarding luer lock misconnections. FDA advised... for Enteral Applications,'' you may either send an email request to [email protected] to receive an...
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Preceptorships | Cancer Prevention Fellowship Program
The major activity for Cancer Prevention Fellows is mentored research. All fellows are expected to develop original scientific projects and to report their findings at scientific meetings and in leading journals. Preceptors who serve to guide and enrich each fellow's experience are selected from skilled investigators across all NCI divisions, participating FDA centers, or local academic institutions. Over 100 NCI staff members have served as preceptors.
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Simmons, Sandra F; Hollingsworth, Emily K; Long, Emily A; Liu, Xulei; Shotwell, Matthew S; Keeler, Emmett; An, Ruopeng; Silver, Heidi J
2017-02-01
To determine the effect and cost-effectiveness of training nonnursing staff to provide feeding assistance for nutritionally at-risk nursing home (NH) residents. Randomized, controlled trial. Five community NHs. Long-stay NH residents with an order for caloric supplementation (N = 122). Research staff provided an 8-hour training curriculum to nonnursing staff. Trained staff were assigned to between-meal supplement or snack delivery for the intervention group; the control group received usual care. Research staff used standardized observations and weighed-intake methods to measure frequency of between-meal delivery, staff assistance time, and resident caloric intake. Fifty staff (mean 10 per site) completed training. The intervention had a significant effect on between-meal caloric intake (F = 56.29, P < .001), with the intervention group consuming, on average, 163.33 (95% CI = 120.19-206.47) calories per person per day more than the usual care control group. The intervention costs were $1.27 per person per day higher than usual care (P < .001). The incremental cost-effectiveness ratio for the intervention was 134 kcal per dollar. The increase in cost was due to the higher frequency and number of snack items given per person per day and the associated staff time to provide assistance. It is cost effective to train nonnursing staff to provide caloric supplementation, and this practice has a positive effect on residents' between-meal intake. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.
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Real-Time, Wide Area Dispatch of Mobil Tank Trucks
1987-01-01
human dispatchers it assists. Using CAD, Mobil has substantially re- duced costs and staff while improving customer service. I n the spring of 1985, a...process by establishing the Mobil order response center (MORC). To use MORC, the customer dials a toll-free number, available 24 hours a day, seven...MATS Figwe 3: Mobil light products order and dispatch information flow. Customers call an audio re- sponse computer system named MORC ( Mobil order
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FDA publishes checklist of Y2K high-risk devices.
1999-09-01
Key points. The federal Food and Drug Administration (FDA) has developed a list of types of medical devices that have the potential for the most serious consequences for patients should they fail because of Y2K-related problems. This list of computer-controlled potentially high-risk devices can provide a guide to health care facilities regarding the types of devices that should receive priority in their assessment and remediation of medical devices. The list may change as the FDA receives comments on the types of devices included in the list.
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Zuck, T F; Cumming, P D; Wallace, E L
2001-12-01
The safety of blood for transfusion depends, in part, on the reliability of the health history given by volunteer blood donors. To improve reliability, a pilot study evaluated the use of an interactive computer-based audiovisual donor interviewing system at a typical midwestern blood center in the United States. An interactive video screening system was tested in a community donor center environment on 395 volunteer blood donors. Of the donors using the system, 277 completed surveys regarding their acceptance of and opinions about the system. The study showed that an interactive computer-based audiovisual donor screening system was an effective means of conducting the donor health history. The majority of donors found the system understandable and favored the system over a face-to-face interview. Further, most donors indicated that they would be more likely to return if they were to be screened by such a system. Interactive computer-based audiovisual blood donor screening is useful and well accepted by donors; it may prevent a majority of errors and accidents that are reportable to the FDA; and it may contribute to increased safety and availability of the blood supply.
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78 FR 10180 - Annual Computational Science Symposium; Conference
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-13
...] Annual Computational Science Symposium; Conference AGENCY: Food and Drug Administration, HHS. ACTION... Computational Science Symposium.'' The purpose of the conference is to help the broader community align and share experiences to advance computational science. At the conference, which will bring together FDA...
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Evaluation of Computer-Based Training for Health Workers in Echocardiography for RHD.
Engelman, Daniel; Okello, Emmy; Beaton, Andrea; Selnow, Gary; Remenyi, Bo; Watson, Caroline; Longenecker, Chris T; Sable, Craig; Steer, Andrew C
2017-03-01
The implementation of screening for rheumatic heart disease at a population-scale would require a considerable increase in human resources. Training nonexpert staff in echocardiography requires appropriate methods and materials. This pre/post study aims to measure the change in the knowledge and confidence of a group of health workers after a computer-assisted training intervention in basic echocardiography for rheumatic heart disease. A syllabus of self-guided, computer-based modules to train nonexpert health workers in basic echocardiography for rheumatic heart disease was developed. Thirty-eight health workers from Uganda participated in the training. Using a pre/post design, identical test instruments were administered before and after the training intervention, assessing the knowledge (using multiple-choice questions) and confidence (using Likert scale questions) in clinical science and echocardiography. The mean total score on knowledge tests rose from 44.8% to 85.4% (mean difference: 40.6%, 95% confidence interval [CI]: 35.4% to 45.8%), with strong evidence for an increase in scores across all knowledge theme areas (p < 0.001). Increased confidence with each key aspect was reported, and there was strong evidence for an increase in the mean score for confidence scales in clinical science (difference: 7.1, 95% CI: 6.2 to 8.0; p < 0.001) and echocardiography (difference: 18.3, 95% CI: 16.6 to 20.0; p < 0.001). The training program was effective at increasing knowledge and confidence for basic echocardiography in nonexpert health workers. Use of computer-assisted learning may reduce the human resource requirements for training staff in echocardiography. Copyright © 2016 World Heart Federation (Geneva). Published by Elsevier B.V. All rights reserved.
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Animal models for acute radiation syndrome drug discovery.
Singh, Vijay K; Newman, Victoria L; Berg, Allison N; MacVittie, Thomas J
2015-05-01
Although significant scientific advances have been made over the past six decades in developing safe, nontoxic and effective radiation/medical countermeasures (MCMs) for acute radiation syndrome (ARS), no drug has been approved by the US FDA. The availability of adequate animal models is a prime requisite under the criteria established by the FDA 'animal rule' for the development of novel MCMs for ARS and the discovery of biomarkers for radiation exposure. This article reviews the developments of MCMs to combat ARS, with particular reference to the various animal models (rodents: mouse and rat; canine: beagle; minipigs and nonhuman primates [NHPs]) utilized for the in-depth evaluation. The objective, pathways and challenges of the FDA Animal Efficacy Rule are also discussed. There are a number of well-defined animal models, the mouse, canine and NHP, that are being used for the development of MCMs. Additional animal models, such as the minipig, are under development to further assist in the identification, efficacy testing and approval of MCMs under the FDA Animal Efficacy Rule.
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Vostal, Jaroslav G; Buehler, Paul W; Gelderman, Monique P; Alayash, Abdu I; Doctor, Alan; Zimring, James C; Glynn, Simone A; Hess, John R; Klein, Harvey; Acker, Jason P; Spinella, Philip C; D'Alessandro, Angelo; Palsson, Bernhard; Raife, Thomas J; Busch, Michael P; McMahon, Timothy J; Intaglietta, Marcos; Swartz, Harold M; Dubick, Michael A; Cardin, Sylvain; Patel, Rakesh P; Natanson, Charles; Weisel, John W; Muszynski, Jennifer A; Norris, Philip J; Ness, Paul M
2018-01-01
The US Food and Drug Administration (FDA) held a workshop on red blood cell (RBC) product regulatory science on October 6 and 7, 2016, at the Natcher Conference Center on the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop was supported by the National Heart, Lung, and Blood Institute, NIH; the Department of Defense; the Office of the Assistant Secretary for Health, Department of Health and Human Services; and the Center for Biologics Evaluation and Research, FDA. The workshop reviewed the status and scientific basis of the current regulatory framework and the available scientific tools to expand it to evaluate innovative and future RBC transfusion products. A full record of the proceedings is available on the FDA website (http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm507890.htm). The contents of the summary are the authors' opinions and do not represent agency policy. © 2017 AABB.
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Hefelfinger, Jenny; Patty, Alice; Ussery, Ann; Young, Walter
2013-10-24
This study assessed the value of technical assistance provided by state health department expert advisors and by the staff of the National Association of Chronic Disease Directors (NACDD) to community groups that participated in the Action Communities for Health, Innovation, and Environmental Change (ACHIEVE) Program, a CDC-funded health promotion program. We analyzed quantitative and qualitative data reported by community project coordinators to assess the nature and value of technical assistance provided by expert advisors and NACDD staff and the usefulness of ACHIEVE resources in the development and implementation of community action plans. A grounded theory approach was used to analyze and categorize phrases in text data provided by community coordinators. Open coding placed conceptual labels on text phrases. Frequency distributions of the quantitative data are described and discussed. The most valuable technical assistance and program support resources were those determined to be in the interpersonal domain (ie, interactions with state expert advisors, NACDD staff, and peer-to-peer support). The most valuable technical assistance events were action institutes, coaches' meetings, webinars, and technical assistance conference calls. This analysis suggests that ACHIEVE communities valued the management and training assistance provided by expert advisors and NACDD staff. State health department expert advisors provided technical guidance and support, including such skills or knowledge-based services as best-practice strategies, review and discussion of community assessment data, sustainability planning, and identification of possible funding opportunities. NACDD staff led development and implementation of technical assistance events.
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FDA Benchmark Medical Device Flow Models for CFD Validation.
Malinauskas, Richard A; Hariharan, Prasanna; Day, Steven W; Herbertson, Luke H; Buesen, Martin; Steinseifer, Ulrich; Aycock, Kenneth I; Good, Bryan C; Deutsch, Steven; Manning, Keefe B; Craven, Brent A
Computational fluid dynamics (CFD) is increasingly being used to develop blood-contacting medical devices. However, the lack of standardized methods for validating CFD simulations and blood damage predictions limits its use in the safety evaluation of devices. Through a U.S. Food and Drug Administration (FDA) initiative, two benchmark models of typical device flow geometries (nozzle and centrifugal blood pump) were tested in multiple laboratories to provide experimental velocities, pressures, and hemolysis data to support CFD validation. In addition, computational simulations were performed by more than 20 independent groups to assess current CFD techniques. The primary goal of this article is to summarize the FDA initiative and to report recent findings from the benchmark blood pump model study. Discrepancies between CFD predicted velocities and those measured using particle image velocimetry most often occurred in regions of flow separation (e.g., downstream of the nozzle throat, and in the pump exit diffuser). For the six pump test conditions, 57% of the CFD predictions of pressure head were within one standard deviation of the mean measured values. Notably, only 37% of all CFD submissions contained hemolysis predictions. This project aided in the development of an FDA Guidance Document on factors to consider when reporting computational studies in medical device regulatory submissions. There is an accompanying podcast available for this article. Please visit the journal's Web site (www.asaiojournal.com) to listen.
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Hope, Laughter, and Humor in Residents and Staff at an Assisted Living Facility.
ERIC Educational Resources Information Center
Westburg, Nancy G.
2003-01-01
Assesses and compares hope levels and laughter and humor experiences of 24 elderly residents and 21 staff at an assisted living facility. Residents and staff reported numerous benefits from humor and laughing, but differences arose between the two groups about the source and frequency of humor and laughter. Implications for mental health…
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Hauser, Robert G.; Katsiyiannis, William T.; Gornick, Charles C.; Almquist, Adrian K.; Kallinen, Linda M.
2010-01-01
Aims An estimated 10 000–15 000 pacemaker and implantable cardioverter–defibrillator (ICD) leads are extracted annually worldwide using specialized tools that disrupt encapsulating fibrous tissue. Additional information is needed regarding the safety of the devices that have been approved for lead extraction. The aim of this study was to determine whether complications due to device-assisted lead extraction might be more hazardous than published data suggest, and whether procedural safety precautions are effective. Methods and results We searched the US Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database from 1995 to 2008 using the search terms ‘lead extraction and death’ and ‘lead extraction and injury’. Additional product specific searches were performed for the terms ‘death’ and ‘injury’. Between 1995 and 2008, 57 deaths and 48 serious cardiovascular injuries associated with device-assisted lead extraction were reported to the FDA. Owing to underreporting, the FDA database does not contain all adverse events that occurred during this period. Of the 105 events, 27 deaths and 13 injuries occurred in 2007–2008. During these 2 years, 23 deaths were linked with excimer laser or mechanical dilator sheath extractions. The majority of deaths and injuries involved ICD leads, and most were caused by lacerations of the right atrium, superior vena cava, or innominate vein. Overall, 62 patients underwent emergency surgical repair of myocardial perforations and venous lacerations and 35 (56%) survived. Conclusion These findings suggest that device-assisted lead extraction is a high-risk procedure and that serious complications including death may not be mitigated by emergency surgery. However, skilled standby cardiothoracic surgery is essential when performing pacemaker and ICD lead extractions. Although the incidence of these complications is unknown, the results of our study imply that device-assisted lead extractions should be performed by highly qualified physicians and their teams in specialized centres. PMID:19946113
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OpenFDA: an innovative platform providing access to a wealth of FDA’s publicly available data
Kass-Hout, Taha A; Mohebbi, Matthew; Nelsen, Hans; Baker, Adam; Levine, Jonathan; Johanson, Elaine; Bright, Roselie A
2016-01-01
Objective The objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). Materials and Methods Using cutting-edge technologies deployed on FDA’s new public cloud computing infrastructure, openFDA provides open data for easier, faster (over 300 requests per second per process), and better access to FDA datasets; open source code and documentation shared on GitHub for open community contributions of examples, apps and ideas; and infrastructure that can be adopted for other public health big data challenges. Results Since its launch on June 2, 2014, openFDA has developed four APIs for drug and device adverse events, recall information for all FDA-regulated products, and drug labeling. There have been more than 20 million API calls (more than half from outside the United States), 6000 registered users, 20,000 connected Internet Protocol addresses, and dozens of new software (mobile or web) apps developed. A case study demonstrates a use of openFDA data to understand an apparent association of a drug with an adverse event. Conclusion With easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products. PMID:26644398
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Shrestha, Priyanka; Abbott, Katherine M
2018-02-01
The current study explored the contribution of non-clinical professionals, such as housekeepers and maintenance mechanics, in promoting person-centered care (PCC) for older adults residing in assisted living. Semi-structured face-to-face interviews with staff (n = 8), concierge (n = 2), maintenance mechanics (n = 2), housekeepers (n = 3), and an administrative assistant (n = 1) from an assisted living organization were conducted. Interviews were audiorecorded, transcribed, and reviewed for accuracy. The comments from the staff were coded based on prior PCC themes (i.e., promoting decision making, meaningful living, pleasurable living, and personhood). Results show that non-clinical staff play an important role in facilitating PCC in their everyday tasks with residents. A new sub-theme was added regarding how non-clinical staff help residents in assisted living navigate the organization. Findings suggest that all tasks, no matter how routine, can be performed in a person-centered manner, contributing to the quality of life of older adults in assisted living. The authors recommend including all staff who have direct contact with residents in person-centered education and training efforts as they support the PCC goals of an organization. [Journal of Gerontological Nursing, 44(2), 9-13.]. Copyright 2018, SLACK Incorporated.
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2016-06-23
The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.
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Everett, Kay D.; Conway, Claire; Desany, Gerard J.; Baker, Brian L.; Choi, Gilwoo; Taylor, Charles A.; Edelman, Elazer R.
2016-01-01
Endovascular stents are the mainstay of interventional cardiovascular medicine. Technological advances have reduced biological and clinical complications but not mechanical failure. Stent strut fracture is increasingly recognized as of paramount clinical importance. Though consensus reigns that fractures can result from material fatigue, how fracture is induced and the mechanisms underlying its clinical sequelae remain ill-defined. In this study, strut fractures were identified in the prospectively maintained Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience Database (MAUDE), covering years 2006–2011, and differentiated based on specific coronary artery implantation site and device configuration. These data, and knowledge of the extent of dynamic arterial deformations obtained from patient CT images and published data, were used to define boundary conditions for 3D finite element models incorporating multimodal, multi-cycle deformation. The structural response for a range of stent designs and configurations was predicted by computational models and included estimation of maximum principal, minimum principal and equivalent plastic strains. Fatigue assessment was performed with Goodman diagrams and safe/unsafe regions defined for different stent designs. Von Mises stress and maximum principal strain increased with multimodal, fully reversed deformation. Spatial maps of unsafe locations corresponded to the identified locations of fracture in different coronary arteries in the clinical database. These findings, for the first time, provide insight into a potential link between patient adverse events and computational modeling of stent deformation. Understanding of the mechanical forces imposed under different implantation conditions may assist in rational design and optimal placement of these devices. PMID:26467552
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Everett, Kay D; Conway, Claire; Desany, Gerard J; Baker, Brian L; Choi, Gilwoo; Taylor, Charles A; Edelman, Elazer R
2016-02-01
Endovascular stents are the mainstay of interventional cardiovascular medicine. Technological advances have reduced biological and clinical complications but not mechanical failure. Stent strut fracture is increasingly recognized as of paramount clinical importance. Though consensus reigns that fractures can result from material fatigue, how fracture is induced and the mechanisms underlying its clinical sequelae remain ill-defined. In this study, strut fractures were identified in the prospectively maintained Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience Database (MAUDE), covering years 2006-2011, and differentiated based on specific coronary artery implantation site and device configuration. These data, and knowledge of the extent of dynamic arterial deformations obtained from patient CT images and published data, were used to define boundary conditions for 3D finite element models incorporating multimodal, multi-cycle deformation. The structural response for a range of stent designs and configurations was predicted by computational models and included estimation of maximum principal, minimum principal and equivalent plastic strains. Fatigue assessment was performed with Goodman diagrams and safe/unsafe regions defined for different stent designs. Von Mises stress and maximum principal strain increased with multimodal, fully reversed deformation. Spatial maps of unsafe locations corresponded to the identified locations of fracture in different coronary arteries in the clinical database. These findings, for the first time, provide insight into a potential link between patient adverse events and computational modeling of stent deformation. Understanding of the mechanical forces imposed under different implantation conditions may assist in rational design and optimal placement of these devices.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Valerio, Luis G.; Arvidson, Kirk B.; Chanderbhan, Ronald F.
2007-07-01
Consistent with the U.S. Food and Drug Administration (FDA) Critical Path Initiative, predictive toxicology software programs employing quantitative structure-activity relationship (QSAR) models are currently under evaluation for regulatory risk assessment and scientific decision support for highly sensitive endpoints such as carcinogenicity, mutagenicity and reproductive toxicity. At the FDA's Center for Food Safety and Applied Nutrition's Office of Food Additive Safety and the Center for Drug Evaluation and Research's Informatics and Computational Safety Analysis Staff (ICSAS), the use of computational SAR tools for both qualitative and quantitative risk assessment applications are being developed and evaluated. One tool of current interest ismore » MDL-QSAR predictive discriminant analysis modeling of rodent carcinogenicity, which has been previously evaluated for pharmaceutical applications by the FDA ICSAS. The study described in this paper aims to evaluate the utility of this software to estimate the carcinogenic potential of small, organic, naturally occurring chemicals found in the human diet. In addition, a group of 19 known synthetic dietary constituents that were positive in rodent carcinogenicity studies served as a control group. In the test group of naturally occurring chemicals, 101 were found to be suitable for predictive modeling using this software's discriminant analysis modeling approach. Predictions performed on these compounds were compared to published experimental evidence of each compound's carcinogenic potential. Experimental evidence included relevant toxicological studies such as rodent cancer bioassays, rodent anti-carcinogenicity studies, genotoxic studies, and the presence of chemical structural alerts. Statistical indices of predictive performance were calculated to assess the utility of the predictive modeling method. Results revealed good predictive performance using this software's rodent carcinogenicity module of over 1200 chemicals, comprised primarily of pharmaceutical, industrial and some natural products developed under an FDA-MDL cooperative research and development agreement (CRADA). The predictive performance for this group of dietary natural products and the control group was 97% sensitivity and 80% concordance. Specificity was marginal at 53%. This study finds that the in silico QSAR analysis employing this software's rodent carcinogenicity database is capable of identifying the rodent carcinogenic potential of naturally occurring organic molecules found in the human diet with a high degree of sensitivity. It is the first study to demonstrate successful QSAR predictive modeling of naturally occurring carcinogens found in the human diet using an external validation test. Further test validation of this software and expansion of the training data set for dietary chemicals will help to support the future use of such QSAR methods for screening and prioritizing the risk of dietary chemicals when actual animal data are inadequate, equivocal, or absent.« less
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The impact of individual factors on healthcare staff's computer use in psychiatric hospitals.
Koivunen, Marita; Välimäki, Maritta; Koskinen, Anita; Staggers, Nancy; Katajisto, Jouko
2009-04-01
The study examines whether individual factors of healthcare staff are associated with computer use in psychiatric hospitals. In addition, factors inhibiting staff's optimal use of computers were explored. Computer applications have developed the content of clinical practice and changed patterns of professional working. Healthcare staff need new capacities to work in clinical practice, including the basic computers skills. Computer use amongst healthcare staff has widely been studied in general, but cogent information is still lacking in psychiatric care. Staff's computer use was assessed using a structured questionnaire (The Staggers Nursing Computer Experience Questionnaire). The study population was healthcare staff working in two psychiatric hospitals in Finland (n = 470, response rate = 59%). The data were analysed with descriptive statistics and manova with main effects and two-way interaction effects of six individual factors. Nurses who had more experience of computer use or of the implementation processes of computer systems were more motivated to use computers than those who had less experience of these issues. Males and administrative personnel who were younger had also participated more often than women in implementation processes of computer systems. The most significant factor inhibiting the use of computers was lack of interest in them. In psychiatric hospitals, more direct attention should focus on staff's capacities to use computers and to increase their understanding of the benefits in clinical care, especially for women and ageing staff working in psychiatric hospitals. To avoid exclusion amongst healthcare personnel in information society and to ensure that they have capacities to guide patients on how to use computers or to evaluate the quality of health information on the web, staff's capacities and motivation to use computers in mental health and psychiatric nursing should be ensured.
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21 CFR 10.80 - Dissemination of draft Federal Register notices and regulations.
Code of Federal Regulations, 2010 CFR
2010-04-01
... may discuss orally or in writing with an interested person ideas and recommendations for notices or regulations. FDA welcomes assistance in developing ideas for, and in gathering the information to support...
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21 CFR 10.80 - Dissemination of draft Federal Register notices and regulations.
Code of Federal Regulations, 2011 CFR
2011-04-01
... may discuss orally or in writing with an interested person ideas and recommendations for notices or regulations. FDA welcomes assistance in developing ideas for, and in gathering the information to support...
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Glasgow, Russell E; Nutting, Paul A; Toobert, Deborah J; King, Diane K; Strycker, Lisa A; Jex, Marleah; O'Neill, Caitlin; Whitesides, Holly; Merenich, John
2006-03-01
There is a need for practical, efficient and broad-reaching diabetes self-management interventions that can produce changes in lifestyle behaviours such as healthy eating and weight loss. The objective of this study was to evaluate such a computer-assisted intervention. Type 2 diabetes primary care patients (n=335) from fee-for-service and health maintenance organization settings were randomized to social cognitive theory-based tailored self-management (TSM) or computer-aided enhanced usual care (UC). Intervention consisted of computer-assisted self-management assessment and feedback, tailored goal-setting, barrier identification, and problem-solving, followed by health counsellor interaction and follow-up calls. Outcomes were changes in dietary behaviours (fat and fruit/vegetable intake), haemoglobin Alc (HbA1c), lipids, weight, quality of life, and depression. TSM patients reduced dietary fat intake and weight significantly more than UC patients at the 2-month follow-up. Among patients having elevated levels of HbA1c, lipids or depression at baseline, there were consistent directional trends favouring intervention, but these differences did not reach significance. The intervention proved feasible and was implemented successfully by a variety of staff. This relatively low-intensity intervention appealed to a large, generally representative sample of patients, was well implemented, and produced improvement in targeted behaviours. Implications of this practical clinical trial for dissemination are discussed.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-29
... request, or fax your request to CDRH to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for... capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/Device... Responses Response Total hours CDRH 3601 110 1 110 2 220 CBER 3601 4 1 4 2 8 Total Hours 228 \\1\\ There are...
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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...
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Virtual reality surgical simulators- a prerequisite for robotic surgery.
Rajanbabu, Anupama; Drudi, Laura; Lau, Susie; Press, Joshua Z; Gotlieb, Walter H
2014-06-01
The field of computer assisted minimally invasive surgery is rapidly expanding worldwide, including in India. With more hospitals in India contemplating the acquisition of a robotic platform, training of robotic surgeons is becoming essential. Virtual reality simulators can be used for surgeons to become acquainted with the robotic console prior to live surgery. Our aim was to evaluate the amount of simulator training required before a surgeon first operates on the da Vinci® Surgical System. Simulations were conducted on the Intuitive Surgical's da Vinci® Robot Skill Simulator using the software obtained from Mimic Technologies. Participants included attending staff surgeons experienced in robotic surgery and novices. A set of seven activities were chosen for each participant. Based on the mean exercise score from the first attempt, staff surgeons outperformed the novices in all exercises. However, the difference in score between the staff and the novices decreased after the participants repeated the exercises and by the sixth attempt most of the novices obtained similar scores to the staff, suggesting that this might be at present the minimum set of repetitions indicated (or required) prior to performing life robotic surgery.
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Research Projects, Technical Reports and Publications
NASA Technical Reports Server (NTRS)
Oliger, Joseph
1996-01-01
The Research Institute for Advanced Computer Science (RIACS) was established by the Universities Space Research Association (USRA) at the NASA Ames Research Center (ARC) on June 6, 1983. RIACS is privately operated by USRA, a consortium of universities with research programs in the aerospace sciences, under contract with NASA. The primary mission of RIACS is to provide research and expertise in computer science and scientific computing to support the scientific missions of NASA ARC. The research carried out at RIACS must change its emphasis from year to year in response to NASA ARC's changing needs and technological opportunities. A flexible scientific staff is provided through a university faculty visitor program, a post doctoral program, and a student visitor program. Not only does this provide appropriate expertise but it also introduces scientists outside of NASA to NASA problems. A small group of core RIACS staff provides continuity and interacts with an ARC technical monitor and scientific advisory group to determine the RIACS mission. RIACS activities are reviewed and monitored by a USRA advisory council and ARC technical monitor. Research at RIACS is currently being done in the following areas: Advanced Methods for Scientific Computing High Performance Networks During this report pefiod Professor Antony Jameson of Princeton University, Professor Wei-Pai Tang of the University of Waterloo, Professor Marsha Berger of New York University, Professor Tony Chan of UCLA, Associate Professor David Zingg of University of Toronto, Canada and Assistant Professor Andrew Sohn of New Jersey Institute of Technology have been visiting RIACS. January 1, 1996 through September 30, 1996 RIACS had three staff scientists, four visiting scientists, one post-doctoral scientist, three consultants, two research associates and one research assistant. RIACS held a joint workshop with Code 1 29-30 July 1996. The workshop was held to discuss needs and opportunities in basic research in computer science in and for NASA applications. There were 14 talks given by NASA, industry and university scientists and three open discussion sessions. There were approximately fifty participants. A proceedings is being prepared. It is planned to have similar workshops on an annual basis. RIACS technical reports are usually preprints of manuscripts that have been submitted to research 'ournals or conference proceedings. A list of these reports for the period January i 1, 1996 through September 30, 1996 is in the Reports and Abstracts section of this report.
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32 CFR 2800.6 - Delegation of classification and declassification authority.
Code of Federal Regulations, 2010 CFR
2010-07-01
.... 12065: (i) Staff Security Officer/Top Secret Control Officer. (ii) Assistant Staff Security Officer/Assistant Top Secret Control Officer. ... to originally classify and declassify information as “SECRET” and/or “CONFIDENTIAL”: (a) Chief of...
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Developing a self-learning training program for RIS computer skills.
Stike, R; Olivi, P
2000-01-01
The demonstration of competency by healthcare professionals remains a priority for hospital administrators, as well as for the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Unfortunately, staff members who have to complete competency exercises often describe the process as a burden. Ineffective training processes may be the culprit. Our teaching hospital developed a training program for the radiology information system (RIS) computer system used by an imaging department of more than 200 staff members. The emphasis of our training program was on the design phase and the contribution of subject-matter experts (SMEs) to the content and testing of training materials, which included a computer-assisted, self-learning manual (SLM) and a pocket guide. The first step in the design process was to identify subject matter experts (SMEs) within the imaging department. Seven SMEs were shadowed by the IT educator. The role of the SME was to demonstrate current practices with RIS, to state principles involved and to serve as a reference for questions during training development. The steps that followed planning and design were: training delivery, evaluation and ongoing training. These steps were implemented in a series of workshops, which included soliciting feedback about the training program. Feedback was used to revise the SLM. The RIS SLM training project was a huge success for everyone involved. The average score for the core-skills test was higher than 90 percent. Seventy-five percent of the current staff was trained in the first phase, including radiology students. Our yearly cost savings using SLM workshops instead of on-the-job training will be about $35,000. We attribute the success of this project to a detailed timeline, SME contributions, the pilot testing phase, and the positive attitude of the imaging staff.
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Hefelfinger, Jenny; Patty, Alice; Ussery, Ann
2013-01-01
Introduction This study assessed the value of technical assistance provided by state health department expert advisors and by the staff of the National Association of Chronic Disease Directors (NACDD) to community groups that participated in the Action Communities for Health, Innovation, and Environmental Change (ACHIEVE) Program, a CDC-funded health promotion program. Methods We analyzed quantitative and qualitative data reported by community project coordinators to assess the nature and value of technical assistance provided by expert advisors and NACDD staff and the usefulness of ACHIEVE resources in the development and implementation of community action plans. A grounded theory approach was used to analyze and categorize phrases in text data provided by community coordinators. Open coding placed conceptual labels on text phrases. Frequency distributions of the quantitative data are described and discussed. Results The most valuable technical assistance and program support resources were those determined to be in the interpersonal domain (ie, interactions with state expert advisors, NACDD staff, and peer-to-peer support). The most valuable technical assistance events were action institutes, coaches’ meetings, webinars, and technical assistance conference calls. Conclusion This analysis suggests that ACHIEVE communities valued the management and training assistance provided by expert advisors and NACDD staff. State health department expert advisors provided technical guidance and support, including such skills or knowledge-based services as best-practice strategies, review and discussion of community assessment data, sustainability planning, and identification of possible funding opportunities. NACDD staff led development and implementation of technical assistance events. PMID:24157078
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Quality assurance for respiratory care services: a computer-assisted program.
Elliott, C G
1993-01-01
At present, the principal advantage of computer-assisted quality assurance is the acquisition of quality assurance date without resource-consuming chart reviews. A surveillance program like the medical director's alert may reduce morbidity and mortality. Previous research suggests that inadequate oxygen therapy or failures in airway management are important causes of preventable deaths in hospitals. Furthermore, preventable deaths tend to occur among patients who have lower severity-of-illness scores and who are not in ICUs. Thus, surveillance of the entire hospital, as performed by the HIS medical director's alert, may significantly impact hospital mortality related to respiratory care. Future research should critically examine the potential of such computerized systems to favorably change the morbidity and mortality of hospitalized patients. The departments of respiratory care and medical informatics at LDS Hospital have developed a computer-assisted approach to quality assurance monitoring of respiratory care services. This system provides frequent and consistent samples of a variety of respiratory care data. The immediate needs of patients are addressed through a daily surveillance system (medical director's alert). The departmental quality assurance program utilizes a separate program that monitors clinical indicators of staff performance in terms of stated departmental policies and procedures (rate-based clinical indicators). The availability of an integrated patient database allows these functions to be performed without labor-intensive chart audits.
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1991-01-01
(1) The number of endoscopic examinations performed is rising. Epidemiological data and the workload of well developed units show that annual requirements per head of population are approaching: Upper gastrointestinal 1 in 100 Flexible sigmoidoscopy 1 in 500 Colonoscopy 1 in 500 ERCP 1 in 2000 (2) Open access endoscopy to general practitioners is desirable and increasingly sought. For a district general hospital serving a population of 250,000, this workload entails about 3500 procedures annually, performed during 10 half day routine sessions plus emergency work. (3) High standards of training and experience are needed by all staff, who must work in purpose built accommodation designed to promote efficient and safe practice. (4) The endoscopy unit should be adjacent to day care facilities and near the x ray department. There should be easy access to wards. (5) An endoscopy unit needs at least two endoscopy rooms; a fully ventilated cleaning/disinfection area; rooms for patient reception, preparation, and recovery; and accommodation for administration, storage, and staff amenities. (6) The service should be consultant based. At least 10 clinical sessions are required, made up of six or more consultant sessions and two to four clinical assistant, hospital practitioner, or staff specialist sessions. Each consultant should be expected to commit at least two sessions weekly to endoscopy. Extra consultant sessions may be needed to provide an efficient service. (7) A specially trained nursing sister (grade G or H) and five other endoscopy nurses are needed to care for the patients; their work may be supplemented by care assistants. (8) A new post of endoscopy department assistant (analogous to an operating department assistant) is proposed to maintain and prepare instruments, and to give technical assistance during procedures. (9) A full time secretary should be employed. Records, appointments, and audit should be computer based. (10) ERCP needs the collaboration of an interventional radiologist working with high quality x ray equipment in a specially prepared radiology screening room. This facility may need to serve more than one hospital. (11) A gastrointestinal measurement laboratory can conveniently be combined with the endoscopy unit. In some hospitals one or more gastrointestinal measurement technicians may staff this laboratory. (12) An endoscopy unit is a service department analogous to a radiology department. It needs an annual budget.
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21 CFR 207.40 - Establishment registration and drug listing requirements for foreign establishments.
Code of Federal Regulations, 2011 CFR
2011-04-01
... part 312 of this chapter, or the investigational new animal drug use provisions in part 511 of this... agent shall assist FDA in communications with the foreign drug establishment, respond to questions...
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21 CFR 207.40 - Establishment registration and drug listing requirements for foreign establishments.
Code of Federal Regulations, 2010 CFR
2010-04-01
... part 312 of this chapter, or the investigational new animal drug use provisions in part 511 of this... agent shall assist FDA in communications with the foreign drug establishment, respond to questions...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-26
...; (Formerly FDA-2007D-0393)] Guidance for Industry: Blood Establishment Computer System Validation in the User... Industry: Blood Establishment Computer System Validation in the User's Facility'' dated April 2013. The... document entitled ``Guidance for Industry: Blood Establishment Computer System Validation in the User's...
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Embi, Peter J; Acharya, Prasad; McCuistion, Mark; Kishman, Charles P; Haag, Doris; Marine, Stephen
2006-09-06
Information about drug withdrawals may not reach patients in a timely manner, and this could result in adverse events. Increasingly, the public turns to consumer health websites for health information, but such sites may not update their content for days or weeks following important events like Food and Drug Administration (FDA) drug withdrawal actions. There is no recognized standard for how quickly consumer health websites should respond to such events, and reports addressing this issue are lacking. The objective of this study was to develop and implement an approach to enhance the efficiency with which a consumer health website (NetWellness.org) responds to FDA drug withdrawal actions. Evaluation of the current approach used by NetWellness staff to update content affected by FDA action revealed a slow process driven by the goal of performing thorough and comprehensive review and editing. To achieve our desired goal of accurately updating affected content within 24 hours of FDA action, we developed a strategy that included rapid updating of affected Web pages with warning boxes and hyperlinks to the information about the withdrawal. With the next FDA withdrawal event, that of valdecoxib (Bextra) on April 7, 2005, we applied this new approach, observed the time and resource requirements, and monitored the rate at which consumers viewed the updated information to gauge its potential impact. Application of the new approach allowed one person to modify the affected Web pages in less than 1 hour and within 18 hours of the FDA announcement. Using the old strategy, response to a similar event, the withdrawal of rofecoxib (Vioxx) 6 months earlier, had taken over 3 weeks and the efforts of several personnel. Updated valdecoxib content received 188 hits within the first month and 4285 hits within 1 year. Rapid updating of a consumer health website's content in response to an FDA drug withdrawal event was easily accomplished by applying the approach described. This allowed consumers to view accurate information regarding the withdrawn drug much sooner than would otherwise have been the case. Given that consumers increasingly turn to websites for their health information, adoption of a rapid response standard for important health events like FDA drug withdrawals should be considered by the consumer health informatics community.
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Zimmerman, Sheryl; Cohen, Lauren W.; Reed, David; Gwyther, Lisa P.; Washington, Tiffany; Cagle, John C.; Beeber, Anna S.; Sloane, Philip D.
2013-01-01
Nursing homes and residential care/assisted living settings provide care to 2.4 million individuals. Few studies compare the experience of and relationships between family and staff in these settings, despite ongoing family involvement and evidence that relationships are problematic. Data from 488 families and 397 staff in 24 settings examined family involvement and family and staff burden, depressive symptoms, and perceptions; and staff absenteeism and turnover. There were few differences across setting types. While conflict rarely occurred, there was room for improvement in family-staff relations; this area, and preparing family for their caregiving roles, are appropriate targets for social work intervention. PMID:23869592
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Implementing Computer-Based Training for Library Staff.
ERIC Educational Resources Information Center
Bayne, Pauline S.; And Others
1994-01-01
Describes a computer-based training program for library staff developed at the University of Tennessee, Knoxville, that used HyperCard stacks on Macintosh computers. Highlights include staff involvement; evaluation of modules; trainee participation and feedback; staff recognition; administrative support; implementation plan; supervisory…
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Agency perspectives on food safety for the products of animal biotechnology.
Howard, H J; Jones, K M; Rudenko, L
2012-08-01
Animal biotechnology represents one subset of tools among a larger set of technologies for potential use to meet increasing world demands for food. Assisted reproductive technologies (ART) such as artificial insemination and embryo transfer continue to make positive contributions in food animal production. The US Food and Drug Administration (FDA) performed a comprehensive risk assessment to identify potential food consumption or animal health risks associated with animal cloning, an emerging ART. At that time, FDA concluded that animal cloning posed no unique risks either to animal health or to food consumption, and food from animal clones and their sexually reproduced offspring required no additional federal regulation beyond that applicable to conventionally bred animals of the species examined. At this time, no new information has arisen that would necessitate a change in FDA's conclusions on food from animal clones or their sexually reproduced offspring. Use of recombinant DNA technologies to produce genetically engineered (GE) animals represents another emerging technology with potential to impact food animal production. In its regulation of GE animals, FDA follows a cumulative, risk-based approach to address scientific questions related to the GE animals. FDA evaluates data and information on the safety, effectiveness and stability of the GE event. FDA carries out its review at several levels (e.g. molecular biology, animal safety, food safety, environmental safety and claim validation). GE animal sponsors provide data to address risk questions for each level. This manuscript discusses FDA's role in evaluation of animal cloning and GE animals. © 2012 Blackwell Verlag GmbH.
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Perceptions of a hospital-based animal assisted intervention program: An exploratory study.
Abrahamson, Kathleen; Cai, Yun; Richards, Elizabeth; Cline, Krista; O'Haire, Marguerite E
2016-11-01
Research has shown that there are multiple benefits of animal assisted interventions for patients. However, the impact of interaction with these animals in staff is understudied, particularly in the acute care setting, and is thus a novel contribution to the literature on human-animal interaction. The purpose of this qualitative pilot study was to contribute to the body of knowledge surrounding the experiences and perceptions of hospital staff who have participated in a hospital-based animal assisted intervention program. Nine face-to-face semi-structured interviews were conducted (4 staff nurses, 3 support staff members, and 2 hospital volunteers). Five themes emerged from the respondent interviews: (1) descriptions of the therapy dogs; (2) contacts with the dogs at work; (3) connection with the dogs outside of work; (4) benefits; (5) drawbacks. Our findings reflect abundantly positive hospital staff experiences. Copyright © 2016 Elsevier Ltd. All rights reserved.
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Predictors of organizational commitment among staff in assisted living.
Sikorska-Simmons, Elzbieta
2005-04-01
This study examines the role of organizational culture, job satisfaction, and sociodemographic characteristics as predictors of organizational commitment among staff in assisted living. It is particularly important to examine organizational commitment, because of its close links to staff turnover. Data were collected from 317 staff members in 61 facilities, using self-administered questionnaires. The facilities were selected from licensed assisted living programs and were stratified into small, traditional, and new-model homes. Staff questionnaires were distributed by a researcher during 1-day visits to each facility. Organizational commitment was measured by the extent of staff identification, involvement, and loyalty to the organization. Organizational culture, job satisfaction, and education were strong predictors of commitment, together explaining 58% of the total variance in the dependent variable. Higher levels of organizational commitment were associated with more favorable staff perceptions of organizational culture and greater job satisfaction. In addition, more educated staff members tended to report higher levels of organizational commitment. Other than education, sociodemographic characteristics failed to account for a significant amount of variance in organizational commitment. Because job satisfaction and organizational culture were strong predictors of commitment, interventions aimed at increasing job satisfaction and creating an organizational culture that values and respects staff members could be most effective in producing higher levels of organizational commitment.
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Broering, N C
1983-01-01
Georgetown University's Library Information System (LIS), an integrated library system designed and implemented at the Dahlgren Memorial Library, is broadly described from an administrative point of view. LIS' functional components consist of eight "user-friendly" modules: catalog, circulation, serials, bibliographic management (including Mini-MEDLINE), acquisitions, accounting, networking, and computer-assisted instruction. This article touches on emerging library services, user education, and computer information services, which are also changing the role of staff librarians. The computer's networking capability brings the library directly to users through personal or institutional computers at remote sites. The proposed Integrated Medical Center Information System at Georgetown University will include interface with LIS through a network mechanism. LIS is being replicated at other libraries, and a microcomputer version is being tested for use in a hospital setting. PMID:6688749
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OLIO+: an osteopathic medicine database.
Woods, S E
1991-01-01
OLIO+ is a bibliographic database designed to meet the information needs of the osteopathic medical community. Produced by the American Osteopathic Association (AOA), OLIO+ is devoted exclusively to the osteopathic literature. The database is available only by subscription through AOA and may be accessed from any data terminal with modem or IBM-compatible personal computer with telecommunications software that can emulate VT100 or VT220. Apple access is also available, but some assistance from OLIO+ support staff may be necessary to modify the Apple keyboard.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-27
... of harvesting surfclams and ocean quahogs from the Atlantic surfclam and ocean quahog Georges Bank... endorsed by the U.S. Food and Drug Administration (FDA). The Assistant Regional Administrator has also made...
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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.
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FDA's perspectives on cardiovascular devices.
Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G
2009-06-01
The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.
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1993-04-15
philosophy, the level of detail and leader involvement, and the standards of the process will assist future commanders and staff officers prepare for their...and the threat diminished in size but grew in scope, the national strategy , as well as USAREUR’s mission and focus, and staff officers is to...drawdown philosophy, the level of detail and leader involvement, and the standards of the process will assist future commanders and staff officers
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2014-01-01
Background The current paper presents a pilot study of interactive assessment using information and communication technology (ICT) to evaluate the knowledge, skills and abilities of staff with no formal education who are working in Swedish elderly care. Methods Theoretical and practical assessment methods were developed and used with simulated patients and computer-based tests to identify strengths and areas for personal development among staff with no formal education. Results Of the 157 staff with no formal education, 87 began the practical and/or theoretical assessments, and 63 completed both assessments. Several of the staff passed the practical assessments, except the morning hygiene assessment, where several failed. Other areas for staff development, i.e. where several failed (>50%), were the theoretical assessment of the learning objectives: Health, Oral care, Ergonomics, hygiene, esthetic, environmental, Rehabilitation, Assistive technology, Basic healthcare and Laws and organization. None of the staff passed all assessments. Number of years working in elderly care and staff age were not statistically significantly related to the total score of grades on the various learning objectives. Conclusion The interactive assessments were useful in assessing staff members’ practical and theoretical knowledge, skills, and abilities and in identifying areas in need of development. It is important that personnel who lack formal qualifications be clearly identified and given a chance to develop their competence through training, both theoretical and practical. The interactive e-assessment approach analyzed in the present pilot study could serve as a starting point. PMID:24742168
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Tsuda, Shawn; Oleynikov, Dmitry; Gould, Jon; Azagury, Dan; Sandler, Bryan; Hutter, Matthew; Ross, Sharona; Haas, Eric; Brody, Fred; Satava, Richard
2015-10-01
The da Vinci(®) Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) is a computer-assisted (robotic) surgical system designed to enable and enhance minimally invasive surgery. The Food and Drug Administration (FDA) has cleared computer-assisted surgical systems for use by trained physicians in an operating room environment for laparoscopic surgical procedures in general, cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures. There are substantial numbers of peer-reviewed papers regarding the da Vinci(®) Surgical System, and a thoughtful assessment of evidence framed by clinical opinion is warranted. The SAGES da Vinci(®) TAVAC sub-committee performed a literature review of the da Vinci(®) Surgical System regarding gastrointestinal surgery. Conclusions by the sub-committee were vetted by the SAGES TAVAC Committee and SAGES Executive Board. Following revisions, the document was evaluated by the TAVAC Committee and Executive Board again for final approval. Several conclusions were drawn based on expert opinion organized by safety, efficacy, and cost for robotic foregut, bariatric, hepatobiliary/pancreatic, colorectal surgery, and single-incision cholecystectomy. Gastrointestinal surgery with the da Vinci(®) Surgical System is safe and comparable, but not superior to standard laparoscopic approaches. Although clinically acceptable, its use may be costly for select gastrointestinal procedures. Current data are limited to the da Vinci(®) Surgical System; further analyses are needed.
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Nestle, M
1998-01-01
The Procter & Gamble Company spent 30 years and an estimated $500 million to bring its non-digestible fat substitute, olestra, to market. The Food and Drug Administration approved olestra as a food additive but requires products containing olestra to carry a warning statement about its potential effects on gastrointestinal function. In obtaining approval for olestra, P&G conducted a lengthy, persistent, and comprehensive campaign to enlist support from members of Congress; FDA staff; and food, nutrition, and health professionals. This campaign raises larger questions about corporate influence on government policies, and the relationships of corporations to health professionals. To address these larger concerns, the author reviews the history of olestra's approval; describes P&G's campaign to obtain support from FDA and Congress, to defend olestra against critics, and to market it to professionals, the press, and consumers; and suggests implications for public health policies.
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44 CFR 5.25 - Available materials.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Available materials. 5.25 Section 5.25 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF... are not published in the Federal Register. (c) Administrative staff manuals and instructions to staff...
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32 CFR 651.4 - Responsibilities.
Code of Federal Regulations, 2014 CFR
2014-07-01
...) The Assistant Secretary of the Army (Acquisition, Logistics, and Technology) (ASA(AL&T)). ASA(AL&T... of Staff for Logistics (DCSLOG). (e) The Assistant Chief of Staff for Installation Management (ACSIM... NEPA requirements, and develop and execute programs and initiatives to address problem areas. (8...
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32 CFR 651.4 - Responsibilities.
Code of Federal Regulations, 2012 CFR
2012-07-01
...) The Assistant Secretary of the Army (Acquisition, Logistics, and Technology) (ASA(AL&T)). ASA(AL&T... of Staff for Logistics (DCSLOG). (e) The Assistant Chief of Staff for Installation Management (ACSIM... NEPA requirements, and develop and execute programs and initiatives to address problem areas. (8...
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32 CFR 651.4 - Responsibilities.
Code of Federal Regulations, 2013 CFR
2013-07-01
...) The Assistant Secretary of the Army (Acquisition, Logistics, and Technology) (ASA(AL&T)). ASA(AL&T... of Staff for Logistics (DCSLOG). (e) The Assistant Chief of Staff for Installation Management (ACSIM... NEPA requirements, and develop and execute programs and initiatives to address problem areas. (8...
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31 CFR 1.20 - Purpose and scope of regulation.
Code of Federal Regulations, 2013 CFR
2013-07-01
... retrieved by an individual's name or personal identifier. They do not relate to those personnel records of... official, including immediate staff; (6) Assistant Secretary (International Economics and Development) and all offices reporting to such official, including immediate staff; (7) Assistant Secretary (Financial...
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31 CFR 1.20 - Purpose and scope of regulation.
Code of Federal Regulations, 2011 CFR
2011-07-01
... retrieved by an individual's name or personal identifier. They do not relate to those personnel records of... official, including immediate staff; (6) Assistant Secretary (International Economics and Development) and all offices reporting to such official, including immediate staff; (7) Assistant Secretary (Financial...
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31 CFR 1.20 - Purpose and scope of regulation.
Code of Federal Regulations, 2012 CFR
2012-07-01
... retrieved by an individual's name or personal identifier. They do not relate to those personnel records of... official, including immediate staff; (6) Assistant Secretary (International Economics and Development) and all offices reporting to such official, including immediate staff; (7) Assistant Secretary (Financial...
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31 CFR 1.20 - Purpose and scope of regulation.
Code of Federal Regulations, 2014 CFR
2014-07-01
... retrieved by an individual's name or personal identifier. They do not relate to those personnel records of... official, including immediate staff; (6) Assistant Secretary (International Economics and Development) and all offices reporting to such official, including immediate staff; (7) Assistant Secretary (Financial...
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13 CFR 120.824 - Professional management and staff.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Professional management and staff. 120.824 Section 120.824 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS..., management, marketing, packaging, processing, closing, servicing or liquidation services provided by...
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ERIC Educational Resources Information Center
Vancouver Community Coll., British Columbia.
These course outlines are intended to assist instructors in the development of curricula for college programs to train medical-dental health clerical support staff. The course outlines consist of a combined profile and four occupational profiles--dental receptionist, hospital clerical worker, medical office assistant, and medical stenographer.…
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Williams, W R; Latif, A H; Cater, L
2003-05-01
School-accident reports document incidents that have resulted in children requiring assistance from staff in the education and healthcare sectors. This study was undertaken to investigate the collection and use of data by agencies concerned with the school-accident problem. Our aim was to determine if the annual collection and use of such a large body of data might be improved through better management procedures. Interviews were conducted with primary and secondary school staff in one education authority. Interviewees completed a questionnaire on accident activity and accident reporting in their school. In the healthcare sector, staff from the Schools' Office and the ambulance unit servicing the schools provided information on their collection and use of data. Our survey found that accident activity is usually a private matter for individual schools, shared to varying degrees with the education authority. Playgrounds, children's behaviour and footwear carried much of the blame for the injuries sustained. Staff generally accepted the current accident rates. The compilation of accident data by the Schools' Office, accident and emergency department, and ambulance service were compromised by deficiencies in computerization and computer software. The management and utilization of school-accident data could be improved by better collaboration within and between the education and healthcare agencies.
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Taylor, Janice; Sims, Jane; Haines, Terry P
2014-12-01
To explore mobility care as provided by care staff in nursing homes. Care staff regularly assist residents with their mobility. Nurses are increasingly reliant on such staff to provide safe and quality mobility care. However, the nature of care staff decision-making when providing assistance has not been fully addressed in the literature. A focused ethnography. The study was conducted in four nursing homes in Melbourne, Australia. Non-participant observations of residents and staff in 2011. Focus groups with 18 nurses, care and lifestyle staff were conducted at three facilities in 2012. Thematic analysis was employed for focus groups and content analysis for observation data. Cognitive Continuum Theory and the notion of 'situation awareness' assisted data interpretation. Decision-making during mobility care emerged as a major theme. Using Cognitive Continuum Theory as a guide, nursing home staff's decision-making was described as ranging from system-aided, through resident- and peer-aided, to reflective and intuitive. Staff seemed aware of the need for resident-aided decision-making consistent with person-centred care. Habitual mobility care based on shared mental models occurred. It was noted that levels of situation awareness may vary among staff. Care staff may benefit from support via collaborative and reflective practice to develop decision-making skills, situation awareness and person-centred mobility care. Further research is required to explore the connection between staff's skills in mobility care and their decision-making competence as well as how these factors link to quality mobility care. © 2014 John Wiley & Sons Ltd.
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THPdb: Database of FDA-approved peptide and protein therapeutics.
Usmani, Salman Sadullah; Bedi, Gursimran; Samuel, Jesse S; Singh, Sandeep; Kalra, Sourav; Kumar, Pawan; Ahuja, Anjuman Arora; Sharma, Meenu; Gautam, Ankur; Raghava, Gajendra P S
2017-01-01
THPdb (http://crdd.osdd.net/raghava/thpdb/) is a manually curated repository of Food and Drug Administration (FDA) approved therapeutic peptides and proteins. The information in THPdb has been compiled from 985 research publications, 70 patents and other resources like DrugBank. The current version of the database holds a total of 852 entries, providing comprehensive information on 239 US-FDA approved therapeutic peptides and proteins and their 380 drug variants. The information on each peptide and protein includes their sequences, chemical properties, composition, disease area, mode of activity, physical appearance, category or pharmacological class, pharmacodynamics, route of administration, toxicity, target of activity, etc. In addition, we have annotated the structure of most of the protein and peptides. A number of user-friendly tools have been integrated to facilitate easy browsing and data analysis. To assist scientific community, a web interface and mobile App have also been developed.
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Library workshops for special audiences: secretaries, research assistants, and other support staff.
Mularski, C A; Bradigan, P S
1988-04-01
Reports on library workshops for nonlibrary support staff, conducted by health sciences and other libraries, are reviewed. In 1985-86, similar workshops for secretaries, research assistants, and other support staff were offered at the Ohio State University Health Sciences Library. Evaluations made by participants immediately after the workshops and six to twenty months later have provided valuable input on the usefulness of subjects discussed and on recommendations for changes.
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Library workshops for special audiences: secretaries, research assistants, and other support staff.
Mularski, C A; Bradigan, P S
1988-01-01
Reports on library workshops for nonlibrary support staff, conducted by health sciences and other libraries, are reviewed. In 1985-86, similar workshops for secretaries, research assistants, and other support staff were offered at the Ohio State University Health Sciences Library. Evaluations made by participants immediately after the workshops and six to twenty months later have provided valuable input on the usefulness of subjects discussed and on recommendations for changes. PMID:3285936
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FDA use of international standards in the premarket review process.
Rechen, E; Barth, D J; Marlowe, D; Kroger, L
1998-01-01
"This is an exciting time," says Eric Rechen, policy analyst in the U.S. Food and Drug Administration's (FDA) Office of Device Evaluation (ODE). "We're entering an era in which standards will have a more prominent role in the review of medical devices than ever before." During the past 10 years, there has been significant growth in the importance of standards in regulatory processes, as Donald J. Barth, regulatory staff manager for the Medical Products Group at Hewlett Packard Company, notes in setting the stage for discussion of the latest developments. Donald Marlowe, director of the FDA's Office of Science and Technology, and Rechen explain the use of standards in the regulatory review process as part of FDA efforts to ensure public safety in a time of shrinking agency resources. Marlowe discusses provisions of the FDA Modernization Act of 1997 that allow manufacturers to submit a declaration of conformity to a standard to satisfy premarket review requirements. A guidance on the recognition and use of consensus standards, a list of recognized standards, and a list of frequently asked questions are available at the Web site of the Center for Devices and Radiological Health (CDRH) at www.fda.gov/cdrh and via the AAMI Web site at www.aami.org. The information is also available by telephone via CDRH Facts on Demand at 800-899-0381. Rechen provides details about the two new approaches for premarket notifications available under the new 510(k) paradigm. Manufacturers may demonstrate substantial equivalence through special and abbreviated 510(k)s in addition to traditional 510(k)s. A copy of the new 510(k) paradigm is available at the AAMI and CDRH Web sites and through Facts on Demand. As the FDA and many manufacturers enter the new world of abbreviated and special 510(k)s, Larry Kroger, GE Medical Systems, provides his comments based on the 4 years of experience manufacturers of diagnostic x-ray products have had with simplified 510(k)s. A comparison of the European conformity assessment procedures with the new 510(k) paradigm will appear in an upcoming issue of BI&T.
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7 CFR 1700.27 - Chief of Staff.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 7 Agriculture 11 2014-01-01 2014-01-01 false Chief of Staff. 1700.27 Section 1700.27 Agriculture... GENERAL INFORMATION Agency Organization and Functions § 1700.27 Chief of Staff. The Chief of Staff aids and assists the Administrator and the Deputy Administrator. The Chief of Staff advises the...
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7 CFR 1700.27 - Chief of Staff.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 7 Agriculture 11 2012-01-01 2012-01-01 false Chief of Staff. 1700.27 Section 1700.27 Agriculture... GENERAL INFORMATION Agency Organization and Functions § 1700.27 Chief of Staff. The Chief of Staff aids and assists the Administrator and the Deputy Administrator. The Chief of Staff advises the...
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7 CFR 1700.27 - Chief of Staff.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 7 Agriculture 11 2011-01-01 2011-01-01 false Chief of Staff. 1700.27 Section 1700.27 Agriculture... GENERAL INFORMATION Agency Organization and Functions § 1700.27 Chief of Staff. The Chief of Staff aids and assists the Administrator and the Deputy Administrator. The Chief of Staff advises the...
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7 CFR 1700.27 - Chief of Staff.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 7 Agriculture 11 2013-01-01 2013-01-01 false Chief of Staff. 1700.27 Section 1700.27 Agriculture... GENERAL INFORMATION Agency Organization and Functions § 1700.27 Chief of Staff. The Chief of Staff aids and assists the Administrator and the Deputy Administrator. The Chief of Staff advises the...
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7 CFR 1700.27 - Chief of Staff.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 7 Agriculture 11 2010-01-01 2010-01-01 false Chief of Staff. 1700.27 Section 1700.27 Agriculture... GENERAL INFORMATION Agency Organization and Functions § 1700.27 Chief of Staff. The Chief of Staff aids and assists the Administrator and the Deputy Administrator. The Chief of Staff advises the...
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Roberts, Helen C; De Wet, Sanet; Porter, Kirsty; Rood, Gemma; Diaper, Norma; Robison, Judy; Pilgrim, Anna L; Elia, Marinos; Jackson, Alan A; Cooper, Cyrus; Aihie Sayer, Avan; Robinson, Sian
2014-11-01
To determine the feasibility and acceptability of using trained volunteers as mealtime assistants for older hospital inpatients. Poor nutrition among hospitalised older patients is common in many countries and associated with poor outcomes. Competing time pressures on nursing staff may make it difficult to prioritise mealtime assistance especially on wards where many patients need help. Mixed methods evaluation of the introduction of trained volunteer mealtime assistants on an acute female medicine for older people ward in a teaching hospital in England. A training programme was developed for volunteers who assisted female inpatients aged 70 years and over on weekday lunchtimes. The feasibility of using volunteers was determined by the proportion recruited, trained, and their activity and retention over one year. The acceptability of the training and of the volunteers' role was obtained through interviews and focus groups with 12 volunteers, nine patients and 17 nursing staff. Fifty-nine potential volunteers were identified: 38 attended a training session, of whom 29 delivered mealtime assistance, including feeding, to 3911 (76%) ward patients during the year (mean duration of assistance 5·5 months). The volunteers were positive about the practical aspects of training and ongoing support provided. They were highly valued by patients and ward staff and have continued to volunteer. Volunteers can be recruited and trained to help acutely unwell older female inpatients at mealtimes, including feeding. This assistance is sustainable and is valued. This paper describes a successful method for recruitment, training and retention of volunteer mealtime assistants. It includes a profile of those volunteers who provided the most assistance, details of the training programme and role of the volunteers and could be replicated by nursing staff in other healthcare units. © 2014 John Wiley & Sons Ltd.
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40 CFR 45.130 - Evaluation of applications.
Code of Federal Regulations, 2010 CFR
2010-07-01
... ASSISTANCE TRAINING ASSISTANCE § 45.130 Evaluation of applications. (a) Consistent with 40 CFR 30.301, the appropriate EPA program office staff will review training applications in accordance with the following... technical merit; (2) Competency of the proposed staff in relation to the type of project proposed; (3...
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Ottrey, Ella; Palermo, Claire; Huggins, Catherine E; Porter, Judi
2018-04-01
To explore multiple perspectives and experiences of volunteer and visitor involvement and interactions at hospital mealtimes. In addition, to understand how the volunteer and visitor role at mealtimes is perceived within the hospital system. Mealtime assistance can improve patients' food intake and mealtime experience. Barriers to providing mealtime assistance include time pressures, staff availability and inadequate communication. Volunteers and visitors can encourage and assist patients at mealtimes. There is a lack of evidence on the relationship between hospital staff, volunteers and visitors. A qualitative, ethnographic approach. Sixty-seven hours of fieldwork were conducted on two subacute wards within an Australian healthcare network in 2015. Mealtime practices and interactions of hospital staff, volunteers and visitors were observed. Sixty-one staff, volunteers and visitors were interviewed in 75 ethnographic and semi-structured interviews. Data were inductively and thematically analysed. Three key themes emerged as follows: "help"-volunteers and visitors were considered helpful when they assisted patients at mealtimes, supported well-being and aided staff-patient communication; "hindrance"-staff perceived visitors as negative presences when they inhibited patient progress and impacted staff work practices; and "reality of practice"-visiting hours, visitor engagement in patient therapy and communication between staff, volunteers and visitors were important practical considerations of mealtime involvement. The findings show how and why volunteers and visitors can be helpful and unhelpful at hospital mealtimes on subacute wards. More research on the role and contribution of volunteers and visitors on hospital wards will inform future practice in healthcare settings. This healthcare organisation should continue to encourage volunteer and visitor involvement at hospital mealtimes. More effort is needed to educate visitors about patients' therapeutic goals and the importance of nutrition. The working relationship between hospital staff, volunteers and visitors should be strengthened to improve nutritional care. © 2018 John Wiley & Sons Ltd.
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17 CFR 200.16 - Executive Assistant to the Chairman.
Code of Federal Regulations, 2010 CFR
2010-04-01
..., executive direction, and authority for staff studies and reports bearing on the Commission's administration of the laws and its relations with the public, industry, and the Congress. The Executive Assistant is... Commission, members of the staff, and/or representatives of the public on matters arising with regard to...
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38 CFR 14.600 - Federal Tort Claims Act-general.
Code of Federal Regulations, 2010 CFR
2010-07-01
... Network (VISN) Directors, and VA Medical Facility Directors; with respect to any claim for $2,500 or less..., Deputy General Counsel, and Assistant General Counsel (Professional Staff Group I) or those authorized to... Justice. (3) To the Regional Counsels and the Deputy Assistant General Counsel (Professional Staff Group I...
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Energy information directory 1995
DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
1995-10-01
The National Energy Information Center provides energy information and referral assistance to Federal, State, and local governments, the academic community, business and industrial organizations, and the general public. This Energy Information Directory is used to assist the Center staff as well as other DOE staff in directing inquires to the proper offices.
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18 CFR 388.104 - Informal advice from Commission staff.
Code of Federal Regulations, 2012 CFR
2012-04-01
... Commission staff. 388.104 Section 388.104 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Commission staff. (a) The Commission staff provides informal advice and assistance to the general public and... expressed by the staff do not represent the official views of the Commission, but are designed to aid the...
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18 CFR 388.104 - Informal advice from Commission staff.
Code of Federal Regulations, 2013 CFR
2013-04-01
... Commission staff. 388.104 Section 388.104 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Commission staff. (a) The Commission staff provides informal advice and assistance to the general public and... expressed by the staff do not represent the official views of the Commission, but are designed to aid the...
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18 CFR 388.104 - Informal advice from Commission staff.
Code of Federal Regulations, 2014 CFR
2014-04-01
... Commission staff. 388.104 Section 388.104 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Commission staff. (a) The Commission staff provides informal advice and assistance to the general public and... expressed by the staff do not represent the official views of the Commission, but are designed to aid the...
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18 CFR 388.104 - Informal advice from Commission staff.
Code of Federal Regulations, 2011 CFR
2011-04-01
... Commission staff. 388.104 Section 388.104 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Commission staff. (a) The Commission staff provides informal advice and assistance to the general public and... expressed by the staff do not represent the official views of the Commission, but are designed to aid the...
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18 CFR 388.104 - Informal advice from Commission staff.
Code of Federal Regulations, 2010 CFR
2010-04-01
... Commission staff. 388.104 Section 388.104 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Commission staff. (a) The Commission staff provides informal advice and assistance to the general public and... expressed by the staff do not represent the official views of the Commission, but are designed to aid the...
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Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena
2015-01-01
Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.
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Lezin, B; Thouin, A; Besnehard, J; Lobbedez, T; Ollivier, C; Ryckelynck, J P
1999-08-01
Even though computerized workstations bring undisputed benefits in nursing units, introducing them is still hard when most of the staff members have to share the workstation. We took advantage of the implementation of the drug prescription software SAUPHIX in a nephrology department to better define the encountered difficulties. The workstation described in this paper is shared by physicians who enter their prescriptions (proprietary names, doses, routes of administration), nurses who use dosage schedules for drug administration, and the chemist who has authority to control prescription orders. Six months after the implementation of the workstation, physicians and nurses had to fill out an anonymous questionnaire aimed at assessing each function of the software. Prescriptions proved to be more accurate and legible, while management of drugs was more precise. However, interns complained that entering data was time consuming. Furthermore, they raised objections to control of prescription orders. Nurses criticized dosage schedules, the primary reason being that they had to change their practice. The convenience of notebooks was questioned by both physicians and nurses who would have preferred a greater number of desktop computers at their disposition. The implementation of a computerized workstation requires information, diplomacy and negotiations to obtain real implication of the staff. Tasks and schedules must be specified for everybody. The system has to be carefully customized, according to the requirement of the unit. Computers must be properly chosen and allocated in sufficient number. Finally, appropriate preparation, staff training and follow-up of the computerized system are essential.
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JPRS Report, Science & Technology Europe
1988-09-08
with good temperature dependence. In the use of the 1B2B balance code, the average value of the optical power emitted by the photodiode equals one...Workers Clerical staff Total 9.7 6.6 18.8 10.3 28.8 8.4 9.4 General facilities 8.0 Table 2. MANPOWER ( Average staff in 1986) 170 180...Propulsion and High Temperatures Scientific Assistant Technical Assistant Special Assistant, Gas Turbines Modeling and Numerical Simulation in
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Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D
2007-01-01
Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.
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Wright, M. Jerry; Valentine, Gerald
2017-01-01
Objective The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) created unprecented enabling conditions for establishing national regulatory policy that reduces the burden of public health and societal problems associated with tobacco product use. The Center for Tobacco Products (CTP), created by the FDA to implement the TCA, developed a first-of-its-kind FDA/National Institutes of Health (NIH) collaborative program to fund Tobacco Centers of Regulatory Science (TCORS). Methods To assist the TCORS with addressing research priorites, working groups (WGs) comprised of FDA-CTP liasions and TCORS investigators were formed. Under the direction of the Center for Evaluation and Coordination of Trainin and Research (CECTR), the TCORS WGs seek to develop tangible work products in their respective areas of focus. Results The focus of the behavioral pharmacology WG evolved from publishing a narrow paper on behavioral methods in electronic cigarette research to a collection of papers on advances in behavioral laboratory methods that may inform tobacco regulatory science. Conclusion This Special Issue contains articles that address all of the CTP research priorities and demonstrates how advances in behavioral laboratory methods made by TCORS investigators can inform FDA efforst to regulate tobacco products. PMID:29152546
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Software Tools for Emittance Measurement and Matching for 12 GeV CEBAF
DOE Office of Scientific and Technical Information (OSTI.GOV)
Turner, Dennis L.
2016-05-01
This paper discusses model-driven setup of the Continuous Electron Beam Accelerator Facility (CEBAF) for the 12GeV era, focusing on qsUtility. qsUtility is a set of software tools created to perform emittance measurements, analyze those measurements, and compute optics corrections based upon the measurements.qsUtility was developed as a toolset to facilitate reducing machine configuration time and reproducibility by way of an accurate accelerator model, and to provide Operations staff with tools to measure and correct machine optics with little or no assistance from optics experts.
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Bonte, W; Bonte, I
1989-01-01
In 1985 we reported about the usefulness of a simple home computer (here: Commodore C 64) for scientific work. This paper will demonstrate, that such an instrument also can be an appropriate tool for the entire accountancy of a medicolegal institute. Presented were self-designed programs which deal with the following matters: complication of monthly performance reports, calculation of services for clinical care, typing of analytical results and brief interpretations, typing of liquidations, clearing of proceeds from written expertises and autopsies against administration and staff.
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Staff Directory: About Us: Smithsonian Marine Station (SMS) at Fort Pierce
Advanced Search SMS Home About Us Ecosystems Exhibit Education & Fellowships Research Online Resources lastnamefirstinitial@si.edu. Resident Research Staff Benthic Ecology Program * Dr. Jessica Lunt Biologist, 772-462-0973 * Katrina Bayliss Research Assistant * Michelle Stephens Research Assistant, 772-462-0992 Caribbean Coral
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Employment and Roles of Counselors in Employee Assistance Programs.
ERIC Educational Resources Information Center
Hosie, Thomas W.; And Others
1993-01-01
Studied employment and roles of master's-level counselors in employee assistance programs (EAPs). Counselors were found to be similar to those with Master's of Social Work degrees in employment rate and percentage of EAP staff. Both groups were most frequently employed and constituted greatest percentage of professional mental health staff in…
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Organizational Hierarchy, Employee Status, and Use of Employee Assistance Programs.
ERIC Educational Resources Information Center
Gerstein, Lawrence; And Others
1993-01-01
Examined role of organizational hierarchy and staff status in number of Employee Assistance Program (EAP) referrals made by potential helpers and relationship of these variables to personal EAP use among 157 supervisors and 232 employees. Supervisors suggested more EAP referrals than did employees. Middle level staff received EAP services more…
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Dong, Zhongqi; Ekins, Sean; Polli, James E
2013-03-04
The hepatic bile acid uptake transporter sodium taurocholate cotransporting polypeptide (NTCP) is less well characterized than its ileal paralog, the apical sodium dependent bile acid transporter (ASBT), in terms of drug inhibition requirements. The objectives of this study were (a) to identify FDA approved drugs that inhibit human NTCP, (b) to develop pharmacophore and Bayesian computational models for NTCP inhibition, and (c) to compare NTCP and ASBT transport inhibition requirements. A series of NTCP inhibition studies were performed using FDA approved drugs, in concert with iterative computational model development. Screening studies identified 27 drugs as novel NTCP inhibitors, including irbesartan (Ki = 11.9 μM) and ezetimibe (Ki = 25.0 μM). The common feature pharmacophore indicated that two hydrophobes and one hydrogen bond acceptor were important for inhibition of NTCP. From 72 drugs screened in vitro, a total of 31 drugs inhibited NTCP, while 51 drugs (i.e., more than half) inhibited ASBT. Hence, while there was inhibitor overlap, ASBT unexpectedly was more permissive to drug inhibition than was NTCP, and this may be related to NTCP possessing fewer pharmacophore features. Findings reflected that a combination of computational and in vitro approaches enriched the understanding of these poorly characterized transporters and yielded additional chemical probes for possible drug-transporter interaction determinations.
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Large eddy simulation of the FDA benchmark nozzle for a Reynolds number of 6500.
Janiga, Gábor
2014-04-01
This work investigates the flow in a benchmark nozzle model of an idealized medical device proposed by the FDA using computational fluid dynamics (CFD). It was in particular shown that a proper modeling of the transitional flow features is particularly challenging, leading to large discrepancies and inaccurate predictions from the different research groups using Reynolds-averaged Navier-Stokes (RANS) modeling. In spite of the relatively simple, axisymmetric computational geometry, the resulting turbulent flow is fairly complex and non-axisymmetric, in particular due to the sudden expansion. The resulting flow cannot be well predicted with simple modeling approaches. Due to the varying diameters and flow velocities encountered in the nozzle, different typical flow regions and regimes can be distinguished, from laminar to transitional and to weakly turbulent. The purpose of the present work is to re-examine the FDA-CFD benchmark nozzle model at a Reynolds number of 6500 using large eddy simulation (LES). The LES results are compared with published experimental data obtained by Particle Image Velocimetry (PIV) and an excellent agreement can be observed considering the temporally averaged flow velocities. Different flow regimes are characterized by computing the temporal energy spectra at different locations along the main axis. Copyright © 2014 Elsevier Ltd. All rights reserved.
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Schnelle, John F; Bertrand, Rosanna; Hurd, Donna; White, Alan; Squires, David; Feuerberg, Marvin; Hickey, Kelly; Simmons, Sandra F
2009-10-01
Guidelines written for government surveyors who assess nursing home (NH) compliance with federal standards contain instructions to observe the quality of mealtime assistance. However, these instructions are vague and no protocol is provided for surveyors to record observational data. This study compared government survey staff observations of mealtime assistance quality to observations by research staff using a standardized protocol that met basic standards for accurate behavioral measurement. Survey staff used either the observation instructions in the standard survey process or those written for the revised Quality Improvement Survey (QIS). Trained research staff observed mealtime care in 20 NHs in 5 states during the same time period that survey staff evaluated care in the same facilities, although it could not be determined if survey and research staff observed the same residents during the same meals. Ten NHs were evaluated by government surveyors using the QIS survey instructions and 10 NHs were evaluated by surveyors using the standard survey instructions. Research staff observations using a standardized observation protocol identified a higher proportion of residents receiving inadequate feeding assistance during meals relative to survey staff using either the standard or QIS survey instructions. For example, more than 50% of the residents who ate less than half of their meals based on research staff observation were not offered an alternative to the served meal, and the lack of alternatives, or meal substitutions, was common in all 20 NHs. In comparison, the QIS survey teams documented only 2 instances when meal substitutes were not offered in 10 NHs and the standard survey teams documented no instances in 10 NHs. Standardized mealtime observations by research staff revealed feeding assistance care quality issues in all 20 study NHs. Surveyors following the instructions in either the standard or revised QIS surveys did not detect most of these care quality issues. Survey staff instructions for observation of nutritional care are not clearly written; thus, these instructions do not permit accurate behavioral measurement. These instructions should be revised in consideration of basic principles that guide accurate behavioral measurement and shared with NH providers to enable them to effectively implement quality improvement programs.
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Verbal and physical aggression directed at nursing home staff by residents.
Lachs, Mark S; Rosen, Tony; Teresi, Jeanne A; Eimicke, Joseph P; Ramirez, Mildred; Silver, Stephanie; Pillemer, Karl
2013-05-01
Little research has been conducted on aggression directed at staff by nursing home residents. To estimate the prevalence of resident-to-staff aggression (RSA) over a 2-week period. Prevalent cohort study. Large urban nursing homes. Population-based sample of 1,552 residents (80 % of eligible residents) and 282 certified nursing assistants. Measures of resident characteristics and staff reports of physical, verbal, or sexual behaviors directed at staff by residents. The staff response rate was 89 %. Staff reported that 15.6 % of residents directed aggressive behaviors toward them (2.8 % physical, 7.5 % verbal, 0.5 % sexual, and 4.8 % both verbal and physical). The most commonly reported type was verbal (12.4 %), particularly screaming at the certified nursing assistant (9.0 % of residents). Overall, physical aggression toward staff was reported for 7.6 % of residents, the most common being hitting (3.9 % of residents). Aggressive behaviors occurred most commonly in resident rooms (77.2 %) and in the morning (84.3 %), typically during the provision of morning care. In a logistic regression model, three clinical factors were significantly associated with resident-to-staff aggression: greater disordered behavior (OR = 6.48, 95 % CI: 4.55, 9.21), affective disturbance (OR = 2.29, 95 % CI: 1.68, 3.13), and need for activities of daily living morning assistance (OR = 2.16, 95 % CI: 1.53, 3.05). Hispanic (as contrasted with White) residents were less likely to be identified as aggressors toward staff (OR = 0.57, 95 % CI: 0.36, 0.91). Resident-to-staff aggression in nursing homes is common, particularly during morning care. A variety of demographic and clinical factors was associated with resident-to-staff aggression; this could serve as the basis for evidence-based interventions. Because RSA may negatively affect the quality of care, resident and staff safety, and staff job satisfaction and turnover, further research is needed to understand its causes and consequences and to develop interventions to mitigate its potential impact.
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FDA Food Safety Modernization Act
Rep. Sutton, Betty [D-OH-13
2009-06-08
01/04/2011 Became Public Law No: 111-353. (TXT | PDF) (All Actions) Notes: H.R.2751 was introduced and first passed the House as the Consumer Assistance to Recycle and Save Act. Tracker: This bill has the status Became LawHere are the steps for Status of Legislation:
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Fagan, Pebbles; Pokhrel, Pallav; Herzog, Thaddeus A; Guy, Mignonne C; Sakuma, Kari-Lyn K; Trinidad, Dennis R; Cassel, Kevin; Jorgensen, Dorothy; Lynch, Tania; Felicitas-Perkins, Jamie Q; Palafox, Sherilyn; Hamamura, Faith; Maloney, Sarah; Degree, Kaylah; Sterling, Kymberle; Moolchan, Eric; Clanton, Mark S; Eissenberg, Thomas
2017-05-18
Prior to the Food and Drug Administration's (FDA) regulation of electronic cigarettes and warning statements related to nicotine addiction, there was no critical examination of manufacturer/distributor voluntary practices that could potentially inform FDA actions aimed to protect consumers. This study examined the content of warning statements and safety characteristics of electronic cigarette liquid bottles using a national sample. Research staff randomly selected four electronic cigarette liquid manufacturers/distributors from four U.S. geographic regions. Staff documented the characteristics of product packaging and content of warning statements on 147 electronic cigarette liquids (0-30 mg/ml of nicotine) purchased online from 16 manufacturers/distributors in April of 2016. Data showed that 97.9% of the electronic cigarette liquid bottles included a warning statement, most of which focused on nicotine exposure rather than health. Only 22.4% of bottles used a warning statement that indicated the product "contained nicotine". Of bottles that advertised a nicotine-based concentration of 12 mg/ml, 26% had a warning statements stated that the product "contains nicotine". None of the statements that indicated that the product "contained nicotine" stated that nicotine was "addictive". All bottles had a safety cap and 12% were in plastic shrink-wrap. Fifty-six percent of the websites had a minimum age requirement barrier that prevented under-aged persons from entering. Most manufacturers/distributors printed a warning statement on electronic cigarette liquid bottles, but avoided warning consumers about the presence and the addictiveness of nicotine. Studies are needed to examine manufacturer/distributor modifications to product packaging and how packaging affects consumer behaviors. These data can inform future FDA requirements related to the packaging and advertising of e-cigarette liquids; regulation related to the content of warning statements, including exposure warning statements, which are not currently mandated; and requirements on websites or language on packaging to help manufacturers adhere to the minimum age of purchase regulation. The data can also be used to help FDA develop additional guidance on the framing of statements on packaging that helps consumers make informed decisions about purchasing the product or protecting young people from use or unintentional exposure to the product. © The Author 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Robotic Assisted Microsurgery - RAMS FY'97
NASA Technical Reports Server (NTRS)
1997-01-01
JPL and Microdexterity Systems collaborated to develop new surgical capabilities. They developed a Robot Assisted Microsurgery (RAM) tool for surgeons to use for operating on the eye, ear, brain, and blood vessels with unprecedented dexterity. A surgeon can hold the surgical instrument with motions of 6 degrees of freedom with an accuracy of 25 microns in a 70 cu cm workspace. In 1996 a demonstration was performed to remove a microscopic particle from a simulated eyeball. In 1997, tests were performed at UCLA to compare telerobotics with mechanical operations. In 5 out of 7 tests, the RAM tool performed with a significant improvement of preciseness over mechanical operation. New design features include: (1) amplified forced feedback; (2) simultaneous slave robot instrumentation; (3) index control switch on master handle; and (4) tool control switches. Upgrades include: (1) increase in computational power; and (2) installation of hard disk memory storage device for independent operation and independent operation of forceps. In 1997 a final demonstration was performed using 2 telerobotics simultaneously in a microsurgery suture procedure to close a slit in a thin sheet of latex rubber which extended the capabilities of microsurgery procedures. After completing trials and demonstrations for the FDA the potential benefits for thousands of operations will be exposed.
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13 CFR 120.824 - Professional management and staff.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Professional management and staff... management and staff. A CDC must have full-time professional management, including an Executive Director (or the equivalent) managing daily operations. It must also have a full-time professional staff qualified...
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Code of Federal Regulations, 2014 CFR
2014-01-01
... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false Staff. 500.105 Section 500.105... LOAN PROGRAM Board Procedures § 500.105 Staff. (a) Executive Director. The Executive Director of the... direction with respect to the administration of the Board's actions, directs the activities of the staff...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Staff. 500.105 Section 500.105... LOAN PROGRAM Board Procedures § 500.105 Staff. (a) Executive Director. The Executive Director of the... direction with respect to the administration of the Board's actions, directs the activities of the staff...
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Code of Federal Regulations, 2012 CFR
2012-01-01
... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Staff. 1310.6 Section 1310.6 Aeronautics... GUARANTEED LOAN § 1310.6 Staff. (a) Executive Director. The Executive Director advises and assists the Board... administration of the Board's actions, directs the activities of the staff, and performs such other duties as the...
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Code of Federal Regulations, 2012 CFR
2012-01-01
... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Staff. 500.105 Section 500.105... LOAN PROGRAM Board Procedures § 500.105 Staff. (a) Executive Director. The Executive Director of the... direction with respect to the administration of the Board's actions, directs the activities of the staff...
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Code of Federal Regulations, 2013 CFR
2013-01-01
... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Staff. 400.105 Section 400.105... Board Procedures § 400.105 Staff. (a) Executive Director. The Executive Director of the Board advises... with respect to the administration of the Board's actions, directs the activities of the staff, and...
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Code of Federal Regulations, 2011 CFR
2011-01-01
... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Staff. 400.105 Section 400.105... Board Procedures § 400.105 Staff. (a) Executive Director. The Executive Director of the Board advises... with respect to the administration of the Board's actions, directs the activities of the staff, and...
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Code of Federal Regulations, 2011 CFR
2011-01-01
... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Staff. 500.105 Section 500.105... LOAN PROGRAM Board Procedures § 500.105 Staff. (a) Executive Director. The Executive Director of the... direction with respect to the administration of the Board's actions, directs the activities of the staff...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Staff. 1310.6 Section 1310.6 Aeronautics... GUARANTEED LOAN § 1310.6 Staff. (a) Executive Director. The Executive Director advises and assists the Board... administration of the Board's actions, directs the activities of the staff, and performs such other duties as the...
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13 CFR 120.824 - Professional management and staff.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Professional management and staff... management and staff. A CDC must have full-time professional management, including an Executive Director (or the equivalent) managing daily operations. It must also have a full-time professional staff qualified...
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Code of Federal Regulations, 2014 CFR
2014-01-01
... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false Staff. 400.105 Section 400.105... Board Procedures § 400.105 Staff. (a) Executive Director. The Executive Director of the Board advises... with respect to the administration of the Board's actions, directs the activities of the staff, and...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Staff. 400.105 Section 400.105... Board Procedures § 400.105 Staff. (a) Executive Director. The Executive Director of the Board advises... with respect to the administration of the Board's actions, directs the activities of the staff, and...
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Code of Federal Regulations, 2013 CFR
2013-01-01
... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Staff. 1310.6 Section 1310.6 Aeronautics... GUARANTEED LOAN § 1310.6 Staff. (a) Executive Director. The Executive Director advises and assists the Board... administration of the Board's actions, directs the activities of the staff, and performs such other duties as the...
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Code of Federal Regulations, 2013 CFR
2013-01-01
... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Staff. 500.105 Section 500.105... LOAN PROGRAM Board Procedures § 500.105 Staff. (a) Executive Director. The Executive Director of the... direction with respect to the administration of the Board's actions, directs the activities of the staff...
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13 CFR 120.824 - Professional management and staff.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false Professional management and staff... management and staff. A CDC must have full-time professional management, including an Executive Director (or the equivalent) managing daily operations. It must also have a full-time professional staff qualified...
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13 CFR 120.824 - Professional management and staff.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Professional management and staff... management and staff. A CDC must have full-time professional management, including an Executive Director (or the equivalent) managing daily operations. It must also have a full-time professional staff qualified...
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Code of Federal Regulations, 2012 CFR
2012-01-01
... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Staff. 400.105 Section 400.105... Board Procedures § 400.105 Staff. (a) Executive Director. The Executive Director of the Board advises... with respect to the administration of the Board's actions, directs the activities of the staff, and...
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An insight to the molecular interactions of the FDA approved HIV PR drugs against L38L↑N↑L PR mutant
NASA Astrophysics Data System (ADS)
Sanusi, Zainab K.; Govender, Thavendran; Maguire, Glenn E. M.; Maseko, Sibusiso B.; Lin, Johnson; Kruger, Hendrik G.; Honarparvar, Bahareh
2018-03-01
The aspartate protease of the human immune deficiency type-1 virus (HIV-1) has become a crucial antiviral target in which many useful antiretroviral inhibitors have been developed. However, it seems the emergence of new HIV-1 PR mutations enhances drug resistance, hence, the available FDA approved drugs show less activity towards the protease. A mutation and insertion designated L38L↑N↑L PR was recently reported from subtype of C-SA HIV-1. An integrated two-layered ONIOM (QM:MM) method was employed in this study to examine the binding affinities of the nine HIV PR inhibitors against this mutant. The computed binding free energies as well as experimental data revealed a reduced inhibitory activity towards the L38L↑N↑L PR in comparison with subtype C-SA HIV-1 PR. This observation suggests that the insertion and mutations significantly affect the binding affinities or characteristics of the HIV PIs and/or parent PR. The same trend for the computational binding free energies was observed for eight of the nine inhibitors with respect to the experimental binding free energies. The outcome of this study shows that ONIOM method can be used as a reliable computational approach to rationalize lead compounds against specific targets. The nature of the intermolecular interactions in terms of the host-guest hydrogen bond interactions is discussed using the atoms in molecules (AIM) analysis. Natural bond orbital analysis was also used to determine the extent of charge transfer between the QM region of the L38L↑N↑L PR enzyme and FDA approved drugs. AIM analysis showed that the interaction between the QM region of the L38L↑N↑L PR and FDA approved drugs are electrostatic dominant, the bond stability computed from the NBO analysis supports the results from the AIM application. Future studies will focus on the improvement of the computational model by considering explicit water molecules in the active pocket. We believe that this approach has the potential to provide information that will aid in the design of much improved HIV-1 PR antiviral drugs.
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Students Combine Studies with Stethoscopes | Poster
By Nancy Parrish, Staff Writer Janine Bahsali and Esther Shafer are Middletown High School seniors who go to school in the morning and spend their afternoons taking blood pressure, assisting with physical exams, learning how to draw a blood sample and stitch a wound closed, and generally assisting the staff of Occupational Health Services (OHS), a health care department
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ERIC Educational Resources Information Center
Hacienda La Puente Unified School District, City of Industry, CA. Outreach and Technical Assistance Network.
The Outreach and Technical Assistance Network (OTAN) was developed to disseminate resources to California adult educators. During the project's third year, staff development and information services were provided to 321 funded agencies. In collaboration with the Educational Telecommunications Network, OTAN staff organized the Adult Learning…
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Professional and collegiate team assistance programs: services and utilization patterns.
McDuff, David R; Morse, Eric D; White, Robert K
2005-10-01
Elite professional and collegiate athletes underuse stress control, mental health, and substance abuse treatment services. Behavioral health services use can be increased by establishing on-site, sports-specific services. Like Employee Assistance Programs of industry and government, Team Assistance Programs (TAPs) address critical issues such as substance abuse prevention, tobacco cessation, stress recognition, mental illness management, injury rehabilitation, performance enhancement, and cultural support. Strong links with the team's medical and conditioning staff can ensure a steady stream of TAP referrals and build trust with players and team staff. This article describes nine years of operation for two professional TAPs and three years for one college TAP. Use patterns and linkage strategies with team physicians, trainers, strength staff, chiropractors, and nutritionists are discussed.
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NASA Astrophysics Data System (ADS)
Zhang, Zhen; Chen, Siqing; Zheng, Huadong; Sun, Tao; Yu, Yingjie; Gao, Hongyue; Asundi, Anand K.
2017-06-01
Computer holography has made a notably progress in recent years. The point-based method and slice-based method are chief calculation algorithms for generating holograms in holographic display. Although both two methods are validated numerically and optically, the differences of the imaging quality of these methods have not been specifically analyzed. In this paper, we analyze the imaging quality of computer-generated phase holograms generated by point-based Fresnel zone plates (PB-FZP), point-based Fresnel diffraction algorithm (PB-FDA) and slice-based Fresnel diffraction algorithm (SB-FDA). The calculation formula and hologram generation with three methods are demonstrated. In order to suppress the speckle noise, sequential phase-only holograms are generated in our work. The results of reconstructed images numerically and experimentally are also exhibited. By comparing the imaging quality, the merits and drawbacks with three methods are analyzed. Conclusions are given by us finally.
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Roberts, Helen C; De Wet, Sanet; Porter, Kirsty; Rood, Gemma; Diaper, Norma; Robison, Judy; Pilgrim, Anna L; Elia, Marinos; Jackson, Alan A; Cooper, Cyrus; Sayer, Avan Aihie; Robinson, Sian
2014-01-01
Aims and objectives To determine the feasibility and acceptability of using trained volunteers as mealtime assistants for older hospital inpatients. Background Poor nutrition among hospitalised older patients is common in many countries and associated with poor outcomes. Competing time pressures on nursing staff may make it difficult to prioritise mealtime assistance especially on wards where many patients need help. Design Mixed methods evaluation of the introduction of trained volunteer mealtime assistants on an acute female Medicine for Older People ward in a teaching hospital in England. Methods A training programme was developed for volunteers who assisted female inpatients aged 70 years and over on weekday lunchtimes. The feasibility of using volunteers was determined by the proportion recruited, trained, and their activity and retention over 1 year. The acceptability of the training and of the volunteers’ role was obtained through interviews and focus groups with 12 volunteers, 9 patients and 17 nursing staff. Results 59 potential volunteers were identified: 38 attended a training session of whom 29 delivered mealtime assistance, including feeding, to 3,911 (76%) ward patients during the year (mean duration of assistance 5.5 months). The volunteers were positive about the practical aspects of training and on-going support provided. They were highly valued by patients and ward staff and have continued to volunteer. Conclusions Volunteers can be recruited and trained to help acutely unwell older female inpatients at mealtimes, including feeding. This assistance is sustainable and is valued. Relevance to clinical practice This paper describes a successful method for recruitment, training and retention of volunteer mealtime assistants. It includes a profile of those volunteers who provided the most assistance, details of the training programme and role of the volunteers, and could be replicated by nursing staff in other healthcare units. PMID:24666963
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USDA-ARS?s Scientific Manuscript database
The 17a-methyltestosterone Target Animal Safety study with tilapia was completed early this summer and we are finalizing the QA audit with an ‘in-life study’ report. We are also assisting AADAP with compiling a draft of the Final Study Report for FDA. We will present findings with respect to acute...
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76 FR 80378 - Federal Property Suitable as Facilities To Assist the Homeless
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-23
... sq. ft.; current use: explosive testing; needs extensive repairs; possible asbestos and lead base... asbestos and mold Bldg. 1197 Ft. Knox Ft. Knox KY 40121 Landholding Agency: Army Property Number... lead base paint, asbestos, and mold Rhode Island FDA Davisville Site 113 Bruce Boyer Street North...
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Peer Review for EPA’s Biologically Based Dose-Response (BBDR) Model for Perchlorate
EPA is developing a regulation for perchlorate in drinking water. As part the regulatory process EPA must develop a Maximum Contaminant Level Goal (MCLG). FDA and EPA scientists developed a biologically based dose-response (BBDR) model to assist in deriving the MCLG. This mode...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-23
... Act) established requirements for nutrition labeling of standard menu items for restaurants and..., pending promulgation of regulations. FDA is issuing this notice to assist restaurants and similar retail... INFORMATION: I. Background Section 4205 of the Affordable Care Act (Public Law 111-148) requires restaurants...
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21 CFR 60.10 - FDA assistance on eligibility.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) Verifying whether the product was subject to a regulatory review period before its commercial marketing or... whether the permission for commercial marketing or use of the product after the regulatory review period is the first permitted commercial marketing or use of the product either: (i) Under the provision of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-25
...] Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability AGENCY: Food and... Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic products. This guidance is intended to assist industry in...
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Scandurra, I; Hägglund, M; Koch, S; Lind, M
2008-01-01
Using participatory design, we developed and deployed a mobile Virtual Health Record (VHR) on a personal digital assistant (PDA) together with experienced homecare staff. To assess transferability to a second setting and usability when used by novice users with limited system education the application was tested in a usability lab. Eight participants from another homecare district performed tasks related to daily homecare work using the VHR. Test protocols were analyzed with regard to effectiveness, potential usability problems and user satisfaction. Usability problems having impact on system performance and contextual factors affecting system transferability were uncovered. Questionnaires revealed that the participants frequently used computers, but never PDAs. Surprisingly there were only minor differences in input efficiency between novice and experienced users. The participants were overall satisfied with the application. However, transfer to another district can not be performed, unless by means of careful field observations of contextual differences. PMID:19415140
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Tazawa, Yoshiaki
2016-01-01
On July 1st, 2013, the Ministry of Health, Labor and Welfare (MHLW) issued an official notification regarding the co-development of companion diagnostics (CDx) with a drug which requires any exclusive diagnostic test or medical device to predict efficacy or adverse reactions to the drug. The main frame and contents in the MHLW's notification are quite similar to the summaries in the final guidance issued by the US Food and Drug Administration (FDA) on August 6th, 2014 Guidance for Industry and Food and Drug Administration Staff (In Vitro Companion Diagnostic Devices, [2014] ), and these recommend industries to develop, study and submit CDx and the corresponding drug contemporaneously as much as possible. Following the MHLW's notification, the Pharmaceutical and Medical Device Agency (PMDA) notified on December 26th, 2013, "the technical guidance for co-development of CDx and the drug" that mentioned the regulatory requirements for clinical trial of the drug and CDx as well as analytical validity of CDx required for the trials. These official notifications from the Ministry and the Agency may be useful for pharmaceutical and diagnostics makers to understand how they should co-develop and validate CDx for clinical trials and regulatory submission. However, since the most anticipated technologies such as the next generation sequencer (NGS) are more complex and its medical risks could be high level, the existing regulatory system focusing on only diagnostics reagents and devices that are developed and manufactured by in vitro diagnostics (IVD) makers may be no longer suitable for the characteristics of CDx for the future.As an increase of clinical needs for multiple biomarkers assay by DNA sequencer, on November 19th, 2013, the FDA cleared 510 K for NGS and its universal kit. On October 3rd, 2014, moreover, the agency notified two drafts of guidance (Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), [2014]; Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDT), [2014]) for oversight of laboratory developed tests (LDTs) with medium or high medical risks. These FDA's strategic decisions and new regulatory frameworks may allow the clinical laboratories to develop and perform more easily NGS-based CDx under the certification of Clinical Laboratory Improvement Amendments (CLIA). However, neither law nor regulated quality management system similar to the CLIA exists in Japan. To effectively validate LDTs and NGS for medical practice, Japan should learn more the current regulatory changes and initiatives in the US, as well as to reform the regulatory frameworks and create any regulated quality management system for clinical laboratory testing to be reimbursed.
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44 CFR 353.5 - Average cost per FEMA professional staff-hour.
Code of Federal Regulations, 2014 CFR
2014-10-01
... professional staff-hour. 353.5 Section 353.5 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT... cost per FEMA professional staff-hour. Fees for FEMA services rendered will be calculated based upon the costs for such services using a professional staff rate per hour equivalent to the sum of the...
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44 CFR 353.5 - Average cost per FEMA professional staff-hour.
Code of Federal Regulations, 2010 CFR
2010-10-01
... professional staff-hour. 353.5 Section 353.5 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT... cost per FEMA professional staff-hour. Fees for FEMA services rendered will be calculated based upon the costs for such services using a professional staff rate per hour equivalent to the sum of the...
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44 CFR 353.5 - Average cost per FEMA professional staff-hour.
Code of Federal Regulations, 2011 CFR
2011-10-01
... professional staff-hour. 353.5 Section 353.5 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT... cost per FEMA professional staff-hour. Fees for FEMA services rendered will be calculated based upon the costs for such services using a professional staff rate per hour equivalent to the sum of the...
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Code of Federal Regulations, 2014 CFR
2014-01-01
... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Staff. § 1310.6 Section § 1310.6... OF GUARANTEED LOAN § 1310.6 Staff. (a) Executive Director. The Executive Director advises and assists... to the administration of the Board's actions, directs the activities of the staff, and performs such...
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Code of Federal Regulations, 2011 CFR
2011-01-01
... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Staff. 1310.6 Section 1310.6 Aeronautics and... GUARANTEED LOAN § 1310.6 Staff. (a) Executive Director. The Executive Director advises and assists the Board... administration of the Board's actions, directs the activities of the staff, and performs such other duties as the...
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Integration of new technology into clinical practice after FDA approval.
Govil, Ashul; Hao, Steven C
2016-10-01
Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.
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A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves.
Yoganathan, Ajit P; Fogel, Mark; Gamble, Susan; Morton, Michael; Schmidt, Paul; Secunda, Jeff; Vidmar, Sara; Del Nido, Pedro
2013-10-01
Congenital heart valve disease is one of the most common abnormalities in children. There are limited technological solutions available for treating children with congenital heart valve diseases. The aim of this study is to provide the details of the consensus reached in terms of pediatric definitions, design approach, in vitro testing, and clinical trials, which may be used as guidance for developing prosthetic heart valves for the pediatric indication. In stark contrast to the various designs of adult-sized replacement valves available in the market, there are no Food and Drug Administration (FDA)-approved prosthetic heart valves available for use in the pediatric population. There is a pressing need for FDA-approved pediatric valve devices in the United States. The pediatric patient population has been typically excluded from replacement heart valve trials for several reasons. In January 2010, heart valve manufacturers and pediatric clinicians collaborated with academicians and FDA staff in a workshop to suggest ways to successfully evaluate pediatric prosthetic valves and conduct pediatric clinical trials to provide acceptable heart valve replacement options for this patient population. Recommendations, derived from ISO 5840:2005 and the 2010 FDA Draft Replacement Heart Valve Guidance, are provided for hydrodynamic, durability, and fatigue testing. The article specifically addresses in vitro and premarket and postmarket approval clinical studies that should be considered by a heart valve manufacturer for obtaining regulatory approval of pediatric sizes of prosthetic heart valve designs that are already approved for adult clinical use. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.
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Smith, Jeffrey K
2013-04-01
Regulatory administrative database systems within the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) are essential to supporting its core mission, as a regulatory agency. Such systems are used within FDA to manage information and processes surrounding the processing, review, and tracking of investigational and marketed product submissions. This is an area of increasing interest in the pharmaceutical industry and has been a topic at trade association conferences (Buckley 2012). Such databases in CBER are complex, not for the type or relevance of the data to any particular scientific discipline but because of the variety of regulatory submission types and processes the systems support using the data. Commonalities among different data domains of CBER's regulatory administrative databases are discussed. These commonalities have evolved enough to constitute real database convergence and provide a valuable asset for business process intelligence. Balancing review workload across staff, exploring areas of risk in review capacity, process improvement, and presenting a clear and comprehensive landscape of review obligations are just some of the opportunities of such intelligence. This convergence has been occurring in the presence of usual forces that tend to drive information technology (IT) systems development toward separate stovepipes and data silos. CBER has achieved a significant level of convergence through a gradual process, using a clear goal, agreed upon development practices, and transparency of database objects, rather than through a single, discrete project or IT vendor solution. This approach offers a path forward for FDA systems toward a unified database.
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Code of Federal Regulations, 2014 CFR
2014-07-01
..., including immediate staff; (D) The Executive Secretary of the Treasury and all offices reporting to such official, including immediate staff; (E) Under Secretary (International Affairs) and all offices reporting... Development) and all offices reporting to such official, including immediate staff; (G) Assistant Secretary...
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Code of Federal Regulations, 2013 CFR
2013-07-01
..., including immediate staff; (D) The Executive Secretary of the Treasury and all offices reporting to such official, including immediate staff; (E) Under Secretary (International Affairs) and all offices reporting... Development) and all offices reporting to such official, including immediate staff; (G) Assistant Secretary...
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Code of Federal Regulations, 2012 CFR
2012-07-01
..., including immediate staff; (D) The Executive Secretary of the Treasury and all offices reporting to such official, including immediate staff; (E) Under Secretary (International Affairs) and all offices reporting... Development) and all offices reporting to such official, including immediate staff; (G) Assistant Secretary...
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ERIC Educational Resources Information Center
Thoreson, Richard W., Ed.; Hosokawa, Elizabeth P., Ed.
The promotion of employee assistance programs (EAP) in higher education is considered in 24 chapters, with an emphasis on enhancing resources and the academic environment for faculty and staff. Seven topical areas are addressed: history of EAP; characteristics of higher education; alcoholism and other risks in the academic life-style; EAP models…
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Models and Management of Student Employees in an Australian University Library
ERIC Educational Resources Information Center
O'Neil, Frances; Comley, Jenny
2010-01-01
Since 2008, Victoria University (VU) Library has employed 20 or more Student Assistants annually who work on a casual basis for up to 12 hours per week during terms/semesters to staff the Library in Study Hall mode (where there is self-service access to PCs and collections and limited staff assistance). This initiative appears to have been highly…
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Cerveri, Pietro; Marchente, Mario; Bartels, Ward; Corten, Kristoff; Simon, Jean-Pierre; Manzotti, Alfonso
2010-09-01
The femoral shaft (FDA) and transepicondylar (TA), anterior-posterior (WL) and posterior condylar (PCL) axes are fundamental quantities in planning knee arthroplasty surgery. As an alternative to the TA, we introduce the anatomical flexion axis (AFA). Obtaining such axes from image data without any manual supervision remains a practical objective. We propose a novel method that automatically computes the axes of the distal femur by processing the femur mesh surface. Surface data were processed by exploiting specific geometric, anatomical and functional properties. Robust ellipse fitting of the two-dimensional (2D) condylar profiles was utilized to determine the AFA alternative to the TA. The repeatability of the method was tested upon 20 femur surfaces reconstructed from CT scans taken on cadavers. At the highest surface resolutions, the relative median error in the direction of the FDA, AFA, PCL, WL and TA was < 0.50 degrees, 1.20 degrees, 1.0 degrees, 1.30 degrees and 1.50 degrees, respectively. As expected, at the lowest surface resolution, the repeatability decreased to 1.20 degrees, 2.70 degrees, 3.30 degrees, 3.0 degrees and 4.70 degrees, respectively. The computed directions of the FDA, PCL, WL and TA were in agreement (0.60 degrees, 1.55 degrees, 1.90 degrees, 2.40 degrees) with the corresponding reference parameters manually identified in the original CT images by medical experts and with the literature. The proposed method proved that: (a) the AFA can be robustly computed by a geometrical analysis of the posterior profiles of the two condyles and can be considered a useful alternative to the TA; (b) higher surface resolutions leads to higher repeatability of all computed quantities; (c) the TA is less repeatable than the other axes. Copyright 2010 John Wiley & Sons, Ltd.
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Dong, Zhongqi; Ekins, Sean; Polli, James E.
2013-01-01
The hepatic bile acid uptake transporter Sodium Taurocholate Cotransporting Polypeptide (NTCP) is less well characterized than its ileal paralog, the Apical Sodium Dependent Bile Acid Transporter (ASBT), in terms of drug inhibition requirements. The objectives of this study were a) to identify FDA approved drugs that inhibit human NTCP, b) to develop pharmacophore and Bayesian computational models for NTCP inhibition, and c) to compare NTCP and ASBT transport inhibition requirements. A series of NTCP inhibition studies were performed using FDA approved drugs, in concert with iterative computational model development. Screening studies identified 27 drugs as novel NTCP inhibitors, including irbesartan (Ki =11.9 μM) and ezetimibe (Ki = 25.0 μM). The common feature pharmacophore indicated that two hydrophobes and one hydrogen bond acceptor were important for inhibition of NTCP. From 72 drugs screened in vitro, a total of 31 drugs inhibited NTCP, while 51 drugs (i.e. more than half) inhibited ASBT. Hence, while there was inhibitor overlap, ASBT unexpectedly was more permissive to drug inhibition than was NTCP, and this may be related to NTCP’s possessing fewer pharmacophore features. Findings reflected that a combination of computational and in vitro approaches enriched the understanding of these poorly characterized transporters and yielded additional chemical probes for possible drug-transporter interaction determinations. PMID:23339484
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Staff Development: Finding the Right Fit
ERIC Educational Resources Information Center
Standerfer, Leslie
2005-01-01
Three years ago, when the author joined the staff of Agua Fria High School in Phoenix, Arizona, as an assistant principal, she was excited to find that the students' school day started an hour and a half later than normal each Wednesday to provide staff development time for the teaching staff. That first year, however, neither the principal, Bryce…
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ERIC Educational Resources Information Center
Palmini, Cathleen C.
1994-01-01
Describes a survey of Wisconsin academic library support staff that explored the effects of computerization of libraries on work and job satisfaction. Highlights include length of employment; time spent at computer terminals; training; computer background; computers as timesavers; influence of automation on effectiveness; and job frustrations.…
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A Comparison of Computer-based and Instructor-led Training for Long-term Care Staff.
ERIC Educational Resources Information Center
Harrington, Susan S.; Walker, Bonnie L.
2002-01-01
Fire safety training was provided to long-term care staff by computer (n=47) or a print-based, instructor-led program (n=47). Compared to 47 controls, both treatment groups significantly increased knowledge. The computer-trained staff were enthusiastic about the learning method and expressed greater interest in additional safety topics. (SK)
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A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus.
Ekins, Sean; Freundlich, Joel S; Coffee, Megan
2014-01-01
We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.
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A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus
Ekins, Sean; Freundlich, Joel S.; Coffee, Megan
2014-01-01
We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested. PMID:25653841
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2011-01-01
Background The nursing staff working in psychiatric care have a demanding work situation, which may be reflected in how they view their psychosocial work environment and the ward atmosphere. The aims of the present study were to investigate in what way different aspects of the ward atmosphere were related to the psychosocial work environment, as perceived by nursing staff working in psychiatric in-patient care, and possible differences between nurses and nurse assistants. Methods 93 nursing staff working at 12 general psychiatric in-patient wards in Sweden completed two questionnaires, the Ward Atmosphere Scale and the QPSNordic 34+. Data analyses included descriptive statistics, the Mann-Whitney U-test, Spearman rank correlations and forward stepwise conditional logistic regression analyses. Results The data revealed that there were no differences between nurses and nurse assistants concerning perceptions of the psychosocial work environment and the ward atmosphere. The ward atmosphere subscales Personal Problem Orientation and Program Clarity were associated with a psychosocial work environment characterized by Empowering Leadership. Program Clarity was related to the staff's perceived Role Clarity, and Practical Orientation and Order and Organization were positively related to staff perceptions of the Organizational Climate. Conclusions The results from the present study indicate that several ward atmosphere subscales were related to the nursing staff's perceptions of the psychosocial work environment in terms of Empowering Leadership, Role Clarity and Organizational Climate. Improvements in the ward atmosphere could be another way to accomplish improvements in the working conditions of the staff, and such improvements would affect nurses and nurse assistants in similar ways. PMID:21679430
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FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.
Wilson, Carolyn A; Simonyan, Vahan
2014-01-01
Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and bioinformatics tools to be able to store and analyze large amounts of data. To address this need, we have developed the High-performance Integrated Virtual Environment, or HIVE. HIVE uses a combination of distributed cloud storage and distributed cloud computations to provide a platform that is both rapid and responsive to support the growing and increasingly diverse scientific and regulatory needs of FDA scientists in their evaluation of NGS in research and ultimately for evaluation of NGS data in regulatory submissions. © PDA, Inc. 2014.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-12
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0124] Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: To assist the Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-15
... Necessary Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... Evaluation and Research's (CDER's) intended approach to assist in avoiding drug product shortages that may... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0568...
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CASE tools and UML: state of the ART.
Agarwal, S
2001-05-01
With increasing need for automated tools to assist complex systems development, software design methods are becoming popular. This article analyzes the state of art in computer-aided software engineering (CASE) tools and unified modeling language (UML), focusing on their evolution, merits, and industry usage. It identifies managerial issues for the tools' adoption and recommends an action plan to select and implement them. While CASE and UML offer inherent advantages like cheaper, shorter, and efficient development cycles, they suffer from poor user satisfaction. The critical success factors for their implementation include, among others, management and staff commitment, proper corporate infrastructure, and user training.
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Perioperative nurse training in cardiothoracic surgical robotics.
Connor, M A; Reinbolt, J A; Handley, P J
2001-12-01
The exponential growth of OR technology during the past 10 years has placed increased demands on perioperative nurses. Proficiency is required not only in patient care but also in the understanding, operating, and troubleshooting of video systems, computers, and cutting edge medical devices. The formation of a surgical team dedicated to robotically assisted cardiac surgery requires careful selection, education, and hands-on practice. This article details the six-week training process undertaken at Sarasota Memorial Hospital, Sarasota, Fla, which enabled staff members to deliver excellent patient care with a high degree of confidence in themselves and the robotic technology.
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Students Combine Studies with Stethoscopes | Poster
By Nancy Parrish, Staff Writer Janine Bahsali and Esther Shafer are Middletown High School seniors who go to school in the morning and spend their afternoons taking blood pressure, assisting with physical exams, learning how to draw a blood sample and stitch a wound closed, and generally assisting the staff of Occupational Health Services (OHS), a health care department serving more than 2,000 employees at NCI at Frederick.
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Staff members' perceived training needs regarding sexuality in residential aged care facilities.
Villar, Feliciano; Celdrán, Montserrat; Fabà, Josep; Serrat, Rodrigo
2017-01-01
The purpose of the article is to ascertain if staff members of residential aged care facilities (RACF) perceive the need for training regarding residents' sexuality, and what, if any, benefits from the training were perceived, and to compare perceived benefits of training between care assistants and professional/managerial staff. Interviews were conducted with 53 staff members of five different RACF in Spain. Their responses to two semistructured questions were transcribed verbatim and submitted to content analysis. Results show that most interviewees said they lacked training about sexuality and aging. Two potential highlighted benefits of the training are knowledge/attitudinal (countering negative attitudes regarding sexuality) and procedural (developing common protocols and tools to manage situations related to sexuality). Care assistants and professional staff agreed on the need for training, though the former emphasized the procedural impact and the latter the knowledge/attitudinal benefits. The results suggest that RACF staff should have an opportunity to receive training on residents' sexuality, as sexual interest and behavior is a key dimension of residents' lives.
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Palliative care for advanced dementia: Knowledge and attitudes of long-term care staff.
Chen, I-Hui; Lin, Kuan-Yu; Hu, Sophia H; Chuang, Yeu-Hui; Long, Carol O; Chang, Chia-Chi; Liu, Megan F
2018-02-01
To investigate the knowledge of and attitudes towards palliative care for advanced dementia and their associations with demographics among nursing staff, including nurses and nursing assistants, in long-term care settings. Nursing facilities are places where persons with dementia die; therefore, providing quality end-of-life care to residents with advanced dementia is crucial. To date, little attention has been paid to palliative care practice for patients with advanced dementia. A descriptive, cross-sectional, survey design was used. In total, a sample of 300 nurses (n = 125) and nursing assistants (n = 175) working in long-term care settings in Taiwan participated in this study. Two instruments were administered: demographic characteristics and responses to the Questionnaire of Palliative Care for Advanced Dementia. Descriptive statistics and multiple regression were used for data analysis. Overall, the nurses and nursing assistants had moderate mean scores for both knowledge of and attitudes regarding palliative care for advanced dementia. Additionally, nursing staff who were nurses with greater work experience and those who had received palliative care and hospice training had greater knowledge of palliative care. In addition, nursing staff who had received dementia care training and who had worked in nursing homes had higher levels of positive attitudes towards palliative care. This study indicates the need to provide nurses and nursing assistants with more information about palliative care practice for people with advanced dementia. Particularly, providing education to those who are nursing assistants, who have less working experience, who have not received palliative and dementia care training, and who have not worked in nursing homes can improve overall nursing staff knowledge of and attitudes towards palliative care. Continuing education in principles of palliative care for advanced dementia is necessary for currently practicing nursing staff and should be developed according to their educational background and needs. © 2017 John Wiley & Sons Ltd.
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Cimino, Nina M; Lockman, Kashelle; Grant, Marian; McPherson, Mary Lynn
2016-05-01
In long-term care and assisted living facilities, many groups of health care professionals contribute to the work of the health care team. These staff members perform essential, direct patient care activities. An educational needs assessment was conducted to determine the learning needs and preferences of staff members related to providing care for patients with life-limiting illnesses. Staff members placed importance on understanding topics such as principles of palliative care, pain assessment, pain management, and nonpain symptom management. The majority of survey respondents were also interested in learning more about these topics. The results of this educational needs analysis suggest staff members would benefit from a course tailored to these identified educational needs and designed to overcome previously identified educational barriers. © The Author(s) 2014.
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Resident aggression toward staff at a center for the developmentally disabled.
West, Christine A; Galloway, Ellen; Niemeier, Maureen T
2014-01-01
Few studies have examined factors contributing to nonfatal assaults to staff working in residential care facilities. The authors evaluated resident assaults toward direct care/nursing staff at an intermediate Care Facility for Individuals with Mental Retardation (ICF/MR), which included observations of work areas, employee interviews, calculation of injury and assault rates for 2004 to 2007 from Occupational Safety and Health Administration Logs, and review of state ICP/MR guidelines. Most staff interviewed reported having been injured during physical restraint of a resident and the average rate of injury from assault at the center evaluated was higher than the average national rates for the health care and social assistance sector for the same time period. The center lacked policies and developing a post-incident response and evaluation program to assist staff in coping with the consequences of assault and/or occupational injury.
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Preston, Nick; Weightman, Andrew; Gallagher, Justin; Holt, Raymond; Clarke, Michael; Mon-Williams, Mark; Levesley, Martin; Bhakta, Bipinchandra
2016-01-01
We investigated the feasibility of using computer-assisted arm rehabilitation (CAAR) computer games in schools. Outcomes were children's preference for single player or dual player mode, and changes in arm activity and kinematics. Nine boys and two girls with cerebral palsy (6-12 years, mean 9 years) played assistive technology computer games in single-user mode or with school friends in an AB-BA design. Preference was determined by recording the time spent playing each mode and by qualitative feedback. We used the ABILHAND-kids and Canadian Occupational Performance Measure to evaluate activity limitation, and a portable laptop-based device to capture arm kinematics. No difference was recorded between single-user and dual-user modes (median daily use 9.27 versus 11.2 min, p = 0.214). Children reported dual-user mode was preferable. There were no changes in activity limitation (ABILHAND-kids, p = 0.424; COPM, p = 0.484) but we found significant improvements in hand speed (p = 0.028), smoothness (p = 0.005) and accuracy (p = 0.007). School timetables prohibit extensive use of rehabilitation technology but there is potential for its short-term use to supplement a rehabilitation program. The restricted access to the rehabilitation games was sufficient to improve arm kinematics but not arm activity. Implications for Rehabilitation School premises and teaching staff present no obstacles to the installation of rehabilitation gaming technology. Twelve minutes per day is the average amount of time that the school time table permits children to use rehabilitation gaming equipment (without disruption to academic attendance). The use of rehabilitation gaming technology for an average of 12 minutes daily does not appear to benefit children's functional performance, but there are improvements in the kinematics of children's upper limb.
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Nestle, M
1998-01-01
The Procter & Gamble Company spent 30 years and an estimated $500 million to bring its non-digestible fat substitute, olestra, to market. The Food and Drug Administration approved olestra as a food additive but requires products containing olestra to carry a warning statement about its potential effects on gastrointestinal function. In obtaining approval for olestra, P&G conducted a lengthy, persistent, and comprehensive campaign to enlist support from members of Congress; FDA staff; and food, nutrition, and health professionals. This campaign raises larger questions about corporate influence on government policies, and the relationships of corporations to health professionals. To address these larger concerns, the author reviews the history of olestra's approval; describes P&G's campaign to obtain support from FDA and Congress, to defend olestra against critics, and to market it to professionals, the press, and consumers; and suggests implications for public health policies. Images p508-a p509-a p510-a p511-a p512-a p513-a p515-a p516-a p517-a PMID:9847922
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Risk management through staff education.
Seisser, M A; Epstein, A L
1998-01-01
The staff members of a healthcare organization are recognized as students of risk management. The risk manager, through application of the fundamentals of andragogy (i.e., learning strategies specific to adult learners), is in an advantageous position to assist staff in successfully applying risk management thought processes and related actions.
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Code of Federal Regulations, 2014 CFR
2014-07-01
... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Staff. 600.5 Section 600.5 Judicial Administration OFFICES OF INDEPENDENT COUNSEL, DEPARTMENT OF JUSTICE GENERAL POWERS OF SPECIAL COUNSEL § 600.5 Staff. A Special Counsel may request the assignment of appropriate Department employees to assist the...
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Code of Federal Regulations, 2010 CFR
2010-07-01
... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Staff. 600.5 Section 600.5 Judicial Administration OFFICES OF INDEPENDENT COUNSEL, DEPARTMENT OF JUSTICE GENERAL POWERS OF SPECIAL COUNSEL § 600.5 Staff. A Special Counsel may request the assignment of appropriate Department employees to assist the...
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Code of Federal Regulations, 2013 CFR
2013-07-01
... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Staff. 600.5 Section 600.5 Judicial Administration OFFICES OF INDEPENDENT COUNSEL, DEPARTMENT OF JUSTICE GENERAL POWERS OF SPECIAL COUNSEL § 600.5 Staff. A Special Counsel may request the assignment of appropriate Department employees to assist the...
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Code of Federal Regulations, 2011 CFR
2011-07-01
... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Staff. 600.5 Section 600.5 Judicial Administration OFFICES OF INDEPENDENT COUNSEL, DEPARTMENT OF JUSTICE GENERAL POWERS OF SPECIAL COUNSEL § 600.5 Staff. A Special Counsel may request the assignment of appropriate Department employees to assist the...
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Code of Federal Regulations, 2012 CFR
2012-07-01
... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Staff. 600.5 Section 600.5 Judicial Administration OFFICES OF INDEPENDENT COUNSEL, DEPARTMENT OF JUSTICE GENERAL POWERS OF SPECIAL COUNSEL § 600.5 Staff. A Special Counsel may request the assignment of appropriate Department employees to assist the...
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32 CFR 701.4 - Responsibility and authority.
Code of Federal Regulations, 2012 CFR
2012-07-01
...; develops a Navy-wide FOIA training program and serves as training oversight manager; conducts staff... provide recommended changes/comments to CNO (N09B30). (iv) Routinely conduct random staff assistance...; Director, Naval Nuclear Propulsion Program (NOON); Director, Navy Staff (N09B); Head, DON PA/FOIA Policy...
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32 CFR 701.4 - Responsibility and authority.
Code of Federal Regulations, 2011 CFR
2011-07-01
...; develops a Navy-wide FOIA training program and serves as training oversight manager; conducts staff... provide recommended changes/comments to CNO (N09B30). (iv) Routinely conduct random staff assistance...; Director, Naval Nuclear Propulsion Program (NOON); Director, Navy Staff (N09B); Head, DON PA/FOIA Policy...
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32 CFR 701.4 - Responsibility and authority.
Code of Federal Regulations, 2014 CFR
2014-07-01
...; develops a Navy-wide FOIA training program and serves as training oversight manager; conducts staff... provide recommended changes/comments to CNO (N09B30). (iv) Routinely conduct random staff assistance...; Director, Naval Nuclear Propulsion Program (NOON); Director, Navy Staff (N09B); Head, DON PA/FOIA Policy...
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32 CFR 701.4 - Responsibility and authority.
Code of Federal Regulations, 2013 CFR
2013-07-01
...; develops a Navy-wide FOIA training program and serves as training oversight manager; conducts staff... provide recommended changes/comments to CNO (N09B30). (iv) Routinely conduct random staff assistance...; Director, Naval Nuclear Propulsion Program (NOON); Director, Navy Staff (N09B); Head, DON PA/FOIA Policy...
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Lucey, C
2006-11-01
This article briefly recounts the 21st July 2005, Blood Products Advisory Committee (BPAC) meeting concerning recommendations for management of donors and units testing positive for hepatitis B virus (HBV) DNA. The author attended the meeting. The United States Food and Drug Administration (FDA) web site was used for meeting materials, and handouts were collected at the meeting to provide narrative information. Two European experts assisted with HBV subject matter. The proceedings of the advisory committee, the issue briefing materials, and testing algorithms are presented. BPAC voted concurrence with the FDA algorithm for Management of Donors and Units Testing Positive for Hepatitis B Virus DNA.
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75 FR 23667 - Trade Adjustment Assistance for Farmers
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-04
... DEPARTMENT OF AGRICULTURE Foreign Agricultural Service Trade Adjustment Assistance for Farmers... accepted a petition, and began review of a petition, for trade adjustment assistance by the Prune...-0876. FOR FURTHER INFORMATION CONTACT: Trade Adjustment Assistance Staff, FAS, USDA, at (202) 720-0638...
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Blood Glucose Monitoring Devices
... of interferences ability to transmit data to a computer cost of the meter cost of the test ... Performance FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment ...
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Frey, Catherine A; Remington, Patrick L; Lengerich, Eugene
2003-01-01
To identify effective strategies for improving epidemiology capacity in state chronic disease programs, staff epidemiologists and program directors from 25 states were interviewed using a structured questionnaire by phone or in person. Respondents reported three chief barriers to chronic disease epidemiology capacity: lack of institutional commitment and support for chronic disease epidemiology; lack of professional opportunities to engage with peers, colleagues, and scientists; and lack of trained epidemiology staff and resources to support chronic disease functions and activities. Epidemiology capacity in states would be improved by expanding the role and scope of staff placement programs; assisting states in establishing formal collaborations with academic institutions; and providing technical assistance to staff currently employed in states through training, consultation, and networking.
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Staff Differentiation. An Annotated Bibliography.
ERIC Educational Resources Information Center
Marin County Superintendent of Schools, Corte Madera, CA.
This annotated bibliography reviews selected literature focusing on the concept of staff differentiation. Included are 62 items (dated 1966-1970), along with a list of mailing addresses where copies of individual items can be obtained. Also a list of 31 staff differentiation projects receiving financial assistance from the U.S. Office of Education…
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What Residence Hall Staff Need to Know about Dealing with Death.
ERIC Educational Resources Information Center
Jacobs, Bonita; Towns, James E.
1984-01-01
Emphasizes the responsibility for residence hall staff to understand the grief process. An adaptation of Kubler-Ross's stages of death has produced helpful techniques for successfully accepting the death. Through understanding these principles, staff can become aware of the grief process and can assist residents. (JAC)
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29 CFR 553.11 - Exclusion for elected officials and their appointees.
Code of Federal Regulations, 2011 CFR
2011-07-01
... secretary to an assistant. (c) In order to qualify as personal staff members or officials in policymaking... employment of employees under civil service, except for cause, is provided. In addition, such personal staff... voters of their jurisdictions. Also excluded under this provision are personal staff members and...
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29 CFR 553.11 - Exclusion for elected officials and their appointees.
Code of Federal Regulations, 2013 CFR
2013-07-01
... secretary to an assistant. (c) In order to qualify as personal staff members or officials in policymaking... employment of employees under civil service, except for cause, is provided. In addition, such personal staff... voters of their jurisdictions. Also excluded under this provision are personal staff members and...
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29 CFR 553.11 - Exclusion for elected officials and their appointees.
Code of Federal Regulations, 2012 CFR
2012-07-01
... secretary to an assistant. (c) In order to qualify as personal staff members or officials in policymaking... employment of employees under civil service, except for cause, is provided. In addition, such personal staff... voters of their jurisdictions. Also excluded under this provision are personal staff members and...
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29 CFR 553.11 - Exclusion for elected officials and their appointees.
Code of Federal Regulations, 2010 CFR
2010-07-01
... secretary to an assistant. (c) In order to qualify as personal staff members or officials in policymaking... employment of employees under civil service, except for cause, is provided. In addition, such personal staff... voters of their jurisdictions. Also excluded under this provision are personal staff members and...
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29 CFR 553.11 - Exclusion for elected officials and their appointees.
Code of Federal Regulations, 2014 CFR
2014-07-01
... secretary to an assistant. (c) In order to qualify as personal staff members or officials in policymaking... employment of employees under civil service, except for cause, is provided. In addition, such personal staff... voters of their jurisdictions. Also excluded under this provision are personal staff members and...
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20 CFR 1001.142 - Stationing of DVOP staff.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 20 Employees' Benefits 4 2014-04-01 2014-04-01 false Stationing of DVOP staff. 1001.142 Section 1001.142 Employees' Benefits OFFICE OF THE ASSISTANT SECRETARY FOR VETERANS' EMPLOYMENT AND TRAINING... Veterans Outreach Program (DVOP) § 1001.142 Stationing of DVOP staff. DVOP specialists shall be stationed...
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20 CFR 1001.141 - Functions of DVOP staff.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Functions of DVOP staff. 1001.141 Section 1001.141 Employees' Benefits OFFICE OF THE ASSISTANT SECRETARY FOR VETERANS' EMPLOYMENT AND TRAINING... Veterans Outreach Program (DVOP) § 1001.141 Functions of DVOP staff. Each DVOP specialist shall carry out...
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20 CFR 1001.141 - Functions of DVOP staff.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Functions of DVOP staff. 1001.141 Section 1001.141 Employees' Benefits OFFICE OF THE ASSISTANT SECRETARY FOR VETERANS' EMPLOYMENT AND TRAINING... Veterans Outreach Program (DVOP) § 1001.141 Functions of DVOP staff. Each DVOP specialist shall carry out...
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20 CFR 1001.141 - Functions of DVOP staff.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 20 Employees' Benefits 4 2013-04-01 2013-04-01 false Functions of DVOP staff. 1001.141 Section 1001.141 Employees' Benefits OFFICE OF THE ASSISTANT SECRETARY FOR VETERANS' EMPLOYMENT AND TRAINING... Veterans Outreach Program (DVOP) § 1001.141 Functions of DVOP staff. Each DVOP specialist shall carry out...
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20 CFR 1001.142 - Stationing of DVOP staff.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 20 Employees' Benefits 4 2013-04-01 2013-04-01 false Stationing of DVOP staff. 1001.142 Section 1001.142 Employees' Benefits OFFICE OF THE ASSISTANT SECRETARY FOR VETERANS' EMPLOYMENT AND TRAINING... Veterans Outreach Program (DVOP) § 1001.142 Stationing of DVOP staff. DVOP specialists shall be stationed...
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20 CFR 1001.142 - Stationing of DVOP staff.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Stationing of DVOP staff. 1001.142 Section 1001.142 Employees' Benefits OFFICE OF THE ASSISTANT SECRETARY FOR VETERANS' EMPLOYMENT AND TRAINING... Veterans Outreach Program (DVOP) § 1001.142 Stationing of DVOP staff. DVOP specialists shall be stationed...
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20 CFR 1001.142 - Stationing of DVOP staff.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Stationing of DVOP staff. 1001.142 Section 1001.142 Employees' Benefits OFFICE OF THE ASSISTANT SECRETARY FOR VETERANS' EMPLOYMENT AND TRAINING... Veterans Outreach Program (DVOP) § 1001.142 Stationing of DVOP staff. DVOP specialists shall be stationed...
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20 CFR 1001.142 - Stationing of DVOP staff.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Stationing of DVOP staff. 1001.142 Section 1001.142 Employees' Benefits OFFICE OF THE ASSISTANT SECRETARY FOR VETERANS' EMPLOYMENT AND TRAINING... Veterans Outreach Program (DVOP) § 1001.142 Stationing of DVOP staff. DVOP specialists shall be stationed...
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20 CFR 1001.141 - Functions of DVOP staff.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Functions of DVOP staff. 1001.141 Section 1001.141 Employees' Benefits OFFICE OF THE ASSISTANT SECRETARY FOR VETERANS' EMPLOYMENT AND TRAINING... Veterans Outreach Program (DVOP) § 1001.141 Functions of DVOP staff. Each DVOP specialist shall carry out...
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20 CFR 1001.141 - Functions of DVOP staff.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 20 Employees' Benefits 4 2014-04-01 2014-04-01 false Functions of DVOP staff. 1001.141 Section 1001.141 Employees' Benefits OFFICE OF THE ASSISTANT SECRETARY FOR VETERANS' EMPLOYMENT AND TRAINING... Veterans Outreach Program (DVOP) § 1001.141 Functions of DVOP staff. Each DVOP specialist shall carry out...
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Zicko, Cdr Jennifer M; Schroeder, Lcdr Rebecca A; Byers, Cdr William S; Taylor, Lt Adam M; Spence, Cdr Dennis L
2017-10-01
Staff members working on our nonmental health (non-MH) units (i.e., medical-surgical [MS] units) were not educated in recognizing or deescalating behavioral emergencies. Published evidence suggests a behavioral emergency response team (BERT) composed of MH experts who assist with deescalating behavioral emergencies may be beneficial in these situations. Therefore, we sought to implement a BERT on the inpatient non-MH units at our military treatment facility. The objectives of this evidence-based practice process improvement project were to determine how implementation of a BERT affects staff and patient safety and to examine nursing staffs' level of knowledge, confidence, and support in caring for psychiatric patients and patients exhibiting behavioral emergencies. A BERT was piloted on one MS unit for 5 months and expanded to two additional units for 3 months. Pre- and postimplementation staff surveys were conducted, and the number of staff assaults and injuries, restraint usage, and security intervention were compared. The BERT responded to 17 behavioral emergencies. The number of assaults decreased from 10 (pre) to 1 (post); security intervention decreased from 14 to 1; and restraint use decreased from 8 to 1. MS staffs' level of BERT knowledge and rating of support between MH staff and their staff significantly increased. Both MS and MH nurses rated the BERT as supportive and effective. A BERT can assist with deescalating behavioral emergencies, and improve staff collaboration and patient and staff safety. © 2017 Sigma Theta Tau International.
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NASA Technical Reports Server (NTRS)
1995-01-01
This report selectively summarizes the NASA Lewis Research Center's research and technology accomplishments for the fiscal year 1994. It comprises approximately 200 short articles submitted by the staff members of the technical directorates. The report is organized into six major sections: Aeronautics, Aerospace Technology, Space Flight Systems, Engineering and Computational Support, Lewis Research Academy, and Technology Transfer. A table of contents and author index have been developed to assist the reader in finding articles of special interest. This report is not intended to be a comprehensive summary of all research and technology work done over the past fiscal year. Most of the work is reported in Lewis-published technical reports, journal articles, and presentations prepared by Lewis staff members and contractors. In addition, university grants have enabled faculty members and graduate students to engage in sponsored research that is reported at technical meetings or in journal articles. For each article in this report a Lewis contact person has been identified, and where possible, reference documents are listed so that additional information can be easily obtained. The diversity of topics attests to the breadth of research and technology being pursued and to the skill mix of the staff that makes it possible.
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Code of Federal Regulations, 2010 CFR
2010-01-01
... (CONTINUED) TECHNICAL ASSISTANCE GRANTS Technical Assistance and Training Grants § 1775.35 Eligibility. (a... provide technical assistance and/or training on a regional basis to associations as provided in § 1775.33... resources to provide technical assistance and/or training to associations in rural areas through its staff...
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Electrosurgical injuries during robot assisted surgery: insights from the FDA MAUDE database
NASA Astrophysics Data System (ADS)
Fuller, Andrew; Vilos, George A.; Pautler, Stephen E.
2012-02-01
Introduction: The da Vinci surgical system requires the use of electrosurgical instruments. The re-use of such instruments creates the potential for stray electrical currents from capacitive coupling and/or insulation failure with subsequent injury. The morbidity of such injuries may negate many of the benefits of minimally invasive surgery. We sought to evaluate the rate and nature of electrosurgical injury (ESI) associated with this device. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database is administered by the US Food and Drug Administration (FDA) and reports adverse events related to medical devices in the United States. We analyzed all incidents in the context of robotic surgery between January 2001 and June 2011 to identify those related to the use of electrosurgery. Results: In the past decade, a total of 605 reports have been submitted to the FDA with regard to adverse events related to the da Vinci robotic surgical platform. Of these, 24 (3.9%) were related to potential or actual ESI. Nine out of the 24 cases (37.5%) resulted in additional surgical intervention for repair. There were 6 bowel injuries of which only one was recognized and managed intra-operatively. The remainder required laparotomy between 5 and 8 days after the initial robotic procedure. Additionally, there were 3 skin burns. The remaining cases required conservative management or resulted in no harm. Conclusion: ESI in the context of robotic surgery is uncommon but remains under-recognized and under-reported. Surgeons performing robot assisted surgery should be aware that ESI can occur with robotic instruments and vigilance for intra- and post-operative complications is paramount.
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Job satisfaction of practice assistants in general practice in Germany: an observational study.
Goetz, Katja; Campbell, Stephen; Broge, Bjoern; Brodowski, Marc; Steinhaeuser, Jost; Wensing, Michel; Szecsenyi, Joachim
2013-08-01
Job satisfaction of practice staff is important for optimal health care delivery and for minimizing the turnover of non-medical professions. To document the job satisfaction of practice assistants in German general practice and to explore associations between job satisfaction, staff characteristics and culture in general practice organizations. The study was based on data from the European Practice Assessment accreditation scheme for general practices and used an observational design. The study population consisted of 1158 practice assistants from 345 general practices across Germany. Job satisfaction was measured with the 10-item Warr-Cook-Wall questionnaire. Organizational culture was evaluated with four items. A linear regression analysis was performed in which each of the job satisfaction items was handled as dependent variable. Out of 1716 staff member questionnaires handed out to practice assistants, 1158 questionnaires were completed (response rate: 67.5%). Practice assistants were most satisfied with their colleagues and least satisfied with their income. Higher job satisfaction was associated with issues of organizational culture, particularly a good working atmosphere, opportunities to suggest and influence areas for improvement and clear responsibilities within the practice team. Prioritizing initiatives to maintain high levels of, or to improve the job satisfaction of practice assistants, is important for recruitment and retention. It will also help to improve working conditions for both practice assistants and GPs and create an environment to provide better quality care.
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Communication in Assisted Living*
Williams, Kristine N.; Warren, Carol A.B.
2009-01-01
This study of communication in an Assisted Living Facility (ALF) focuses on staff’s interpretive frameworks and situational tactics for managing elderly residents. It is based on interviews with staff and residents in an ALF together with ethnographic fieldwork. As in other quasi-total institutions, staff members engage in control as well as care, monitoring residents for compliance with rules and directives. Residents, aware of the threat of being moved to a nursing home, also monitor their own behavior and cognition in comparison to other residents. Other communication issues include the infantilization of the elderly by staff, and the race, class, and ethnic prejudices of residents. PMID:20107612
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-16
... label to assist that office in processing your request, or fax your request to 301-847-8149. See the.... Clarifying that original or lossless compressed digital image files may be acceptable for record transfer; 3... be acceptable to FDA; 4. Deleting the question and answer dealing with image labeling; 5. Modifying...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-10
... the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355, for the substance. 21 U.S.C. 811(h... Institute on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in carrying out the Assistant... grounds for his determination that it is [[Page 61993
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-26
... test data in the studies: Obtained positive skin tests in index cases by either skin prick or... 20852- 1448. Send one self-addressed adhesive label to assist the office in processing your requests... list of reviewed literature associated with each product. FDA's approach to creating this data file was...
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Staff members' perceptions of an animal-assisted activity.
Bibbo, Jessica
2013-07-01
To examine the perceptions of staff members toward the implementation of an animal-assisted activity (AAA) in an outpatient regional cancer center. Quasi-experimental, post-test design. An adult outpatient regional cancer center in northern California. 34 facility staff members. Self-report questionnaire following four weeks of AAA visitation. Visits took place three times a week for a total of 12 visits. Perceptions of the AAA. Previous perceptions toward AAA influenced the perceptions of the visitation's efficacy. Direct and indirect interaction with the visiting AAA teams was positively associated with perceptions of the AAA. A disagreement occurred that the AAA had caused extra stress or work for staff. Enjoyment of interacting with the dog handler was not significantly different from interacting with the dog; however, it was more positively correlated to acceptance of the AAA. The study provided evidence that the AAA was generally accepted by staff members. Individual staff members' perceptions of dogs and AAAs can influence their receptivity to AAA interventions. Interaction with AAA teams should be voluntary and available for patients and staff members. AAA may be introduced into facilities without creating the perception of extra stress or work for staff members. Providing staff the opportunity to interact with visiting AAA teams may be beneficial for the success of such programs. The human handler in AAA teams may play a vital role in the staff acceptance of such programs.
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ERIC Educational Resources Information Center
Flora, Bethany H.
2007-01-01
In the US, graduate assistants are an integral part of a university's educational and operational climate. Graduate assistants provide teaching, research or administrative services to the educational enterprise in exchange for professional experience and a financial stipend. Recent strikes of graduate teaching assistants at New York University…
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ERIC Educational Resources Information Center
Behr, Shirley K.; And Others
A project to provide technical assistance to staffs of two demonstration programs for preschool handicapped children and their families is described. The focus was technical assistance developed and exercised by the Technical Assistance Development System (TADS), which assisted in the development of the Handicapped Children's Early Education…
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Designing Health Information Technology Tools to Prevent Gaps in Public Health Insurance.
Hall, Jennifer D; Harding, Rose L; DeVoe, Jennifer E; Gold, Rachel; Angier, Heather; Sumic, Aleksandra; Nelson, Christine A; Likumahuwa-Ackman, Sonja; Cohen, Deborah J
2017-06-23
Changes in health insurance policies have increased coverage opportunities, but enrollees are required to annually reapply for benefits which, if not managed appropriately, can lead to insurance gaps. Electronic health records (EHRs) can automate processes for assisting patients with health insurance enrollment and re-enrollment. We describe community health centers' (CHC) workflow, documentation, and tracking needs for assisting families with insurance application processes, and the health information technology (IT) tool components that were developed to meet those needs. We conducted a qualitative study using semi-structured interviews and observation of clinic operations and insurance application assistance processes. Data were analyzed using a grounded theory approach. We diagramed workflows and shared information with a team of developers who built the EHR-based tools. Four steps to the insurance assistance workflow were common among CHCs: 1) Identifying patients for public health insurance application assistance; 2) Completing and submitting the public health insurance application when clinic staff met with patients to collect requisite information and helped them apply for benefits; 3) Tracking public health insurance approval to monitor for decisions; and 4) assisting with annual health insurance reapplication. We developed EHR-based tools to support clinical staff with each of these steps. CHCs are uniquely positioned to help patients and families with public health insurance applications. CHCs have invested in staff to assist patients with insurance applications and help prevent coverage gaps. To best assist patients and to foster efficiency, EHR based insurance tools need comprehensive, timely, and accurate health insurance information.
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Preston, Nick; Weightman, Andrew; Gallagher, Justin; Levesley, Martin; Mon-Williams, Mark; Clarke, Mike; O'Connor, Rory J
2016-10-01
To evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on arm function of children with spastic cerebral palsy. A single-blind randomized controlled trial design. Power calculations indicated that 58 children would be required to demonstrate a clinically important difference. Intervention was home-based; recruitment took place in regional spasticity clinics. A total of 15 children with cerebral palsy aged five to 12 years were recruited; eight to the device group. Both study groups received 'usual follow-up treatment' following spasticity treatment with botulinum toxin; the intervention group also received a rehabilitation gaming device. ABILHAND-kids and Canadian Occupational Performance Measure were performed by blinded assessors at baseline, six and 12 weeks. An analysis of covariance showed no group differences in mean ABILHAND-kids scores between time points. A non-parametric analysis of variance on Canadian Occupational Performance Measure scores showed a statistically significant improvement across time points (χ 2 (2,15) = 6.778, p = 0.031), but this improvement did not reach minimal clinically important difference. Mean daily device use was seven minutes. Recruitment did not reach target owing to unanticipated staff shortages in clinical services. Feedback from children and their families indicated that the games were not sufficiently engaging to promote sufficient use that was likely to result in functional benefits. This study suggests that computer-assisted arm rehabilitation gaming does not benefit arm function, but a Type II error cannot be ruled out. © The Author(s) 2015.
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ERIC Educational Resources Information Center
Quick, R. C.; And Others
1987-01-01
Outlines Cornell University's Employee Assistance Education and Research Program, which uses an academic curriculum and field experience to further develop the Employee Assistance Program (EAP) profession. Addresses the dilemma of personnel executives in ensuring quality in EAP programs and staff. (JOW)
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Web-based technical assistance and training to promote community tobacco control policy change.
Young, Walter F; Montgomery, Debbie; Nycum, Colleen; Burns-Martin, Lavon; Buller, David B
2006-01-01
In 1998 the tobacco industry was released of claims that provided monetary relief for states. A significant expansion of tobacco control activity in many states created a need to develop local capacity. Technical assistance and training for new and experienced staff became a significant challenge for tobacco control leadership. In Colorado, this challenge was addressed in part through the development of a technical assistance and training Web site designed for local tobacco control staff and coalition members. Researchers, technical Web site development specialists, state health agency, and state tobacco control coalition staff collaborated to develop, promote, and test the efficacy of this Web site. The work group embodied a range of skills including tobacco control, Web site technical development, marketing, training, and project management. Persistent marketing, updating of Web site content, and institutionalizing it as a principal source of information and training were key to use by community coalition members.
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Food and Drug Administration Regulation of Diabetes-Related mHealth Technologies
Brooke, M. Jason; Thompson, Bradley Merrill
2013-01-01
mHealth smartphone applications (apps) offer great promise for managing people with diabetes, as well as those with prediabetes. But to realize that potential, industry needs to get clarity from the U.S. Food and Drug Administration (FDA) regarding the scope of its regulatory oversight. Certain smartphone apps, when properly understood, simply help people live healthier lives, assisting with dietary choices, monitoring exercise, and recording other factors important to overall health. The manufacturers of such apps, in an effort to promote their products but also to educate customers, might wish to explain how using the app can help reduce the risk of developing diabetes. Right now, though, the mere mention of the disease “diabetes” would cause the app to be regulated by the FDA. Such regulation, we submit, discourages the kind of education and motivational messages that our country needs to stem the tide of this disease. Further, should the app simply receive data from a blood glucose meter and graph that data for easier comprehension by the patient, the app would become a class II medical device that requires FDA clearance. Again, we submit that such simple software functionality should not be so discouraged. In this article, we identify the issues that we believe need to be clarified by the FDA in order to unleash the potential of mHealth technology in the diabetes space. PMID:23566984
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-24
... enhancements to extend the model predictions from red blood cell units to other blood components, such as...] Use of Computer Simulation of the United States Blood Supply in Support of Planning for Emergency...: Notice of public workshop. The Food and Drug Administration (FDA) is announcing a public workshop...
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A Secure Cloud-Assisted Wireless Body Area Network in Mobile Emergency Medical Care System.
Li, Chun-Ta; Lee, Cheng-Chi; Weng, Chi-Yao
2016-05-01
Recent advances in medical treatment and emergency applications, the need of integrating wireless body area network (WBAN) with cloud computing can be motivated by providing useful and real time information about patients' health state to the doctors and emergency staffs. WBAN is a set of body sensors carried by the patient to collect and transmit numerous health items to medical clouds via wireless and public communication channels. Therefore, a cloud-assisted WBAN facilitates response in case of emergency which can save patients' lives. Since the patient's data is sensitive and private, it is important to provide strong security and protection on the patient's medical data over public and insecure communication channels. In this paper, we address the challenge of participant authentication in mobile emergency medical care systems for patients supervision and propose a secure cloud-assisted architecture for accessing and monitoring health items collected by WBAN. For ensuring a high level of security and providing a mutual authentication property, chaotic maps based authentication and key agreement mechanisms are designed according to the concept of Diffie-Hellman key exchange, which depends on the CMBDLP and CMBDHP problems. Security and performance analyses show how the proposed system guaranteed the patient privacy and the system confidentiality of sensitive medical data while preserving the low computation property in medical treatment and remote medical monitoring.
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Headless spermatozoa in infertile men.
Sha, Y-W; Ding, L; Wu, J-X; Lin, S-B; Wang, X; Ji, Z-Y; Li, P
2017-10-01
Spermatozoa morphology, an important parameter in a semen specimen's potential fertility evaluation, is a significant factor for in vitro fertilisation in assisted reproductive technology. Eleven sterile men with headless spermatozoa, a type of human teratozoospermia, are presented. Their ejaculates' headless spermatozoa percentages were high with rare normal spermatozoa forms. Additionally, abnormal morphology (e.g. round-headed or microcephalic spermatozoa) was also found. Spermatozoa motility was somewhat affected, potentially because of the missing mitochondrial sheath at the sperm tail base. Patients who underwent assisted reproductive technology treatment experienced adverse pregnancy outcomes. Work types and corresponding environments seemed irrelevant, but specific family history may have prompted its genetic origin. Computer-assisted semen analysis systems easily mistake headless spermatozoa as oligozoospermia because of nonrecognition of the loose head. However, morphological testing, especially with an electronic microscope, clearly identifies abnormal spermatozoa. Future exploration requires more methods investigating the frequency and percentage of this morphological abnormality in different populations with varied fertility levels. Such research would estimate the probable correlation of the abnormality with other semen parameters and examine the potential developmental or genetic origins. During clinical work, medical staff should detect these cases, avoid misdiagnosis and provide proper consultation about diagnosis and assisted reproductive technology treatment. © 2016 Blackwell Verlag GmbH.
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Kossover, Rachel A; Chi, Carolyn J; Wise, Matthew E; Tran, Alvin H; Chande, Neha D; Perz, Joseph F
2014-01-01
Assisted living facilities (ALFs) provide housing and care to persons unable to live independently, and who often have increasing medical needs. Disease outbreaks illustrate challenges of maintaining adequate resident protections in these facilities. Describe current state laws on assisted living admissions criteria, medical oversight, medication administration, vaccination requirements, and standards for infection control training. We abstracted laws and regulations governing assisted living facilities for the 50 states using a structured abstraction tool. Selected characteristics were compared according to the time period in which the regulation took effect. Selected state health departments were queried regarding outbreaks identified in assisted living facilities. Of the 50 states, 84% specify health-based admissions criteria to assisted living facilities; 60% require licensed health care professionals to oversee medical care; 88% specifically allow subcontracting with outside entities to provide routine medical services onsite; 64% address medication administration by assisted living facility staff; 54% specify requirements for some form of initial infection control training for all staff; 50% require reporting of disease outbreaks to the health department; 18% specify requirements to offer or require vaccines to staff; 30% specify requirements to offer or require vaccines to residents. Twelve states identified approximately 1600 outbreaks from 2010 to 2013, with influenza or norovirus infections predominating. There is wide variation in how assisted living facilities are regulated in the United States. States may wish to consider regulatory changes that ensure safe health care delivery, and minimize risks of infections, outbreaks of disease, and other forms of harm among assisted living residents. Published by Elsevier Inc.
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Managing Staff Development in Adult and Community Learning: Reflection to Practice.
ERIC Educational Resources Information Center
Ewens, David
This document is intended to assist individuals responsible for managing staff development in adult and community learning (ACL) in the United Kingdom. The guide presents step-by-step advice for designing and implementing an approach based on the belief that staff development should do the following things: (1) relate holistically to the…
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ERIC Educational Resources Information Center
Reybold, L. Earle; Halx, Mark D.; Jimenez, Anne L.
2008-01-01
This study examined administrative staff perceptions of professional ethics in a student affairs division at one university. In-depth interviews were conducted with 12 staff members (six assistant/associate vice presidents and six directors) and analyzed using the constant comparative method. Participants described three dimensions of professional…
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Ochs, R.
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less
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TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities
DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less
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Deploying Embodied AI into Virtual Worlds
NASA Astrophysics Data System (ADS)
Burden, David J. H.
The last two years have seen the start of commercial activity within virtual worlds. Unlike computer games where Non-Player-Character avatars are common, in most virtual worlds they are the exception — and until recently in Second Life they were non-existent. However there is real commercial scope for Als in these worlds — in roles from virtual sales staff and tutors to personal assistants. Deploying an embodied AI into a virtual world offers a unique opportunity to evaluate embodied Als, and to develop them within an environment where human and computer are on almost equal terms. This paper presents an architecture being used for the deployment of chatbot driven avatars within the Second Life virtual world, looks at the challenges of deploying an AI within such a virtual world, the possible implications for the Turing Test, and identifies research directions for the future.
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Excel-based scheduling for reallocation of nursing staff.
2016-10-19
Outi Annelli Tuominen and colleagues write in Nursing Management about the use of an Excel-based scheduling system for reallocation of nursing staff, which was trialled on ward managers and assistant ward managers.
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ERIC Educational Resources Information Center
Richardson, M. D.; Flanigan, J. L.
The assistant principalship may not be the most productive ground for future principals. Assistant principals have traditionally been disciplinarians or building managers isolated from the realities of the principalship and the school's instructional program. Some researchers have advocated dividing the assistant principalship into two roles: one…
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Resident Aggression Toward Staff at a Center for the Developmentally Disabled
West, Christine A.; Galloway, Ellen; Niemeier, Maureen T.
2015-01-01
Few studies have examined factors contributing to nonfatal assaults to staff working in residential care facilities. The authors evaluated resident assaults toward direct care/nursing staff at an Intermediate Care Facility for Individuals with Mental Retardation (ICF/MR), which included observations of work areas, employee interviews, calculation of injury and assault rates for 2004 to 2007 from Occupational Safety and Health Administration Logs, and review of state ICF/MR guidelines. Most staff interviewed reported having been injured during physical restraint of a resident and the average rate of injury from assault at the center evaluated was higher than the average national rates for the health care and social assistance sector for the same time period. The center lacked policies for a safe workplace. The authors recommended review and maintenance of workplace violence prevention policies and developing a post-incident response and evaluation program to assist staff in coping with the consequences of assault and/or occupational injury. PMID:24571051
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The impact of OSHA regulations on nursing care cost and compliance.
Raltz, S; Kozarek, R A; Kim-Deobald, J; Pethigal, P; Moorhouse, M A
1994-01-01
The Occupational Safety and Health Administration (OSHA) requires health care facilities to protect employees from bloodborne pathogens. One of the mandates is to provide personal protective equipment (PPE) to employees at no cost to the employee. In this article, the authors explore the cost and compliance of implementing the new OSHA regulations for nursing staff assisting with colonoscopies over a 6-month period. The data were collected on a total of 461 procedures. The cost of implementing PPE for the nursing staff was $2.98 per procedure. The PPE available for the nursing staff included goggles, splash-proof gown, face mask, shoe covers, and latex gloves. The total cost of implementing the new regulations for the nursing staff assisting with colonoscopies was $2,747.56 and was projected to cost approximately $50,000 yearly if implemented for all GI procedures in the institution. Staff compliance rates for the five pieces of PPE ranged from 6.5 to 97.8%.
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Decision support environment for medical product safety surveillance.
Botsis, Taxiarchis; Jankosky, Christopher; Arya, Deepa; Kreimeyer, Kory; Foster, Matthew; Pandey, Abhishek; Wang, Wei; Zhang, Guangfan; Forshee, Richard; Goud, Ravi; Menschik, David; Walderhaug, Mark; Woo, Emily Jane; Scott, John
2016-12-01
We have developed a Decision Support Environment (DSE) for medical experts at the US Food and Drug Administration (FDA). The DSE contains two integrated systems: The Event-based Text-mining of Health Electronic Records (ETHER) and the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment (PANACEA). These systems assist medical experts in reviewing reports submitted to the Vaccine Adverse Event Reporting System (VAERS) and the FDA Adverse Event Reporting System (FAERS). In this manuscript, we describe the DSE architecture and key functionalities, and examine its potential contributions to the signal management process by focusing on four use cases: the identification of missing cases from a case series, the identification of duplicate case reports, retrieving cases for a case series analysis, and community detection for signal identification and characterization. Published by Elsevier Inc.
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Hallum-Montes, Rachel; Senter, Lindsay; D'Souza, Rohan; Gates-Ferris, Kathryn; Hurlbert, Marc; Anastario, Michael
2014-01-01
This study compares rates of completion of client intake forms (CIFs) collected via three interview modes: audio computer-assisted self-interview (ACASI), face-to-face interview (FFI), and self-administered paper-based interview (SAPI). A total of 303 clients served through the Avon Breast Health Outreach Program (BHOP) were sampled from three U.S. sites. Clients were randomly assigned to complete a standard CIF via one of the three interview modes. Logistic regression analyses demonstrated that clients were significantly more likely to complete the entire CIF via ACASI than either FFI or SAPI. The greatest observed differences were between ACASI and SAPI; clients were almost six times more likely to complete the CIF via ACASI as opposed to SAPI (AOR = 5.8, p < .001). We recommend that where feasible, ACASI be utilized as an effective means of collecting client-level data in healthcare settings. Adoption of ACASI in health centers may translate into higher completion rates of intake forms by clients, as well as reduced burden on clinic staff to enter data and review intake forms for completion. © 2013 National Association for Healthcare Quality.
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García de Diego, Laura; Cuervo, Marta; Martínez, J. Alfredo
2015-01-01
Computer assisted instruction (CAI) is an effective tool for evaluating and training students and professionals. In this article we will present a learning-oriented CAI, which has been developed for students and health professionals to acquire and retain new knowledge through the practice. A two-phase pilot evaluation was conducted, involving 8 nutrition experts and 30 postgraduate students, respectively. In each training session, the software developed guides users in the integral evaluation of a patient’s nutritional status and helps them to implement actions. The program includes into the format clinical tools, which can be used to recognize possible patient’s needs, to improve the clinical reasoning and to develop professional skills. Among them are assessment questionnaires and evaluation criteria, cardiovascular risk charts, clinical guidelines and photographs of various diseases. This CAI is a complete software package easy to use and versatile, aimed at clinical specialists, medical staff, scientists, educators and clinical students, which can be used as a learning tool. This application constitutes an advanced method for students and health professionals to accomplish nutritional assessments combining theoretical and empirical issues, which can be implemented in their academic curriculum. PMID:25978456
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Salloum, Alison; Crawford, Erika A; Lewin, Adam B; Storch, Eric A
2015-01-01
Computer-assisted cognitive behavioral therapy (CCBT) programs for childhood anxiety are being developed, although research about factors that contribute to implementation of CCBT in community mental health centers (CMHC) is limited. The purpose of this mixed-methods study was to explore consumers' and providers' perceptions of utilizing a CCBT for childhood anxiety in CMHC in an effort to identify factors that may impact implementation of CCBT in CMHC. Focus groups and interviews occurred with 7 parents, 6 children, 3 therapists, 3 project coordinators and 3 administrators who had participated in CCBT for childhood anxiety. Surveys of treatment satisfaction and treatment barriers were administered to consumers. RESULTS suggest that both consumers and providers were highly receptive to participation in and implementation of CCBT in CMHC. Implementation themes included positive receptiveness, factors related to therapists, treatment components, applicability of treatment, treatment content, initial implementation challenges, resources, dedicated staff, support, outreach, opportunities with the CMHC, payment, and treatment availability. As studies continue to demonstrate the effectiveness of CCBT for childhood anxiety, research needs to continue to examine factors that contribute to the successful implementation of such treatments in CMHC.
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García de Diego, Laura; Cuervo, Marta; Martínez, J Alfredo
2015-01-01
Computer assisted instruction (CAI) is an effective tool for evaluating and training students and professionals. In this article we will present a learning-oriented CAI, which has been developed for students and health professionals to acquire and retain new knowledge through the practice. A two-phase pilot evaluation was conducted, involving 8 nutrition experts and 30 postgraduate students, respectively. In each training session, the software developed guides users in the integral evaluation of a patient's nutritional status and helps them to implement actions. The program includes into the format clinical tools, which can be used to recognize possible patient's needs, to improve the clinical reasoning and to develop professional skills. Among them are assessment questionnaires and evaluation criteria, cardiovascular risk charts, clinical guidelines and photographs of various diseases. This CAI is a complete software package easy to use and versatile, aimed at clinical specialists, medical staff, scientists, educators and clinical students, which can be used as a learning tool. This application constitutes an advanced method for students and health professionals to accomplish nutritional assessments combining theoretical and empirical issues, which can be implemented in their academic curriculum.
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Evaluation of freeway motorist assist : staff summary, February 2010.
DOT National Transportation Integrated Search
2010-02-01
This research document builds on the previous Return on Investment (ROI) Study of Motorist Assist (1994) that evaluated the St. Louis Motor Assist program to establish and update current benefits of this program. The following is a summary of finding...
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Science and Technology for the Future Force. FY2006 Summer Study
2007-03-01
Panel Members Co-Chairs • Allen Adler • Gil Herrera • Charley Otstott Staff Assistant • Oscar Valent, ASA(ALT) Government Advisors • LTC(P) Keith Edwards...measures to cross- train/ educate personnel Transitioning Technology is a Contact Sport Technology transition from the S&T community to the acquisition...Members Co-Chairs • Allen Adler • Gil Herrera • Charley Otstott Staff Assistant • Oscar Valent, ASA(ALT) Government Advisors • LTC(P) Keith Edwards, ARCIC
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2013-03-01
annual targets between fiscal years 2008 and 2011 for the number of individuals in Yemen benefiting from food donations. However, reports to Congress...annual performance targets three times for the number of individuals in Yemen benefiting from food donations, reports to Congress about the program...security to several hundred locally employed staff. However, the embassy has deemed other steps proposed by locally employed staff, including telework and
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Schmidt, B.
Thesis. Appropriate measures to decrease radiation exposure of medical- technical assistants and nursing staff of hospitals with radiotherapy departments require personnel dose measurements during the different working operations. The measured values were in all cases below the maximum permissible doses; they are presented in tabular form for the various operations. Proposals are made for a further reduction of radiation exposure in particular fields of application. (GE)
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Introducing Hospital Staff to Computer Concepts: An Educational Program
Kaplan, Bonnie
1981-01-01
An in-house computer education program for hospital staff ran for two years at a large, metropolitan hospital. The program drew physicians, administrators, department heads, secretaries, technicians, and data managers to courses, seminars, and workshops on medical computing. Two courses, an introduction to computer concepts and a programming course, are described and evaluated.
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Understanding the motivations of the multigenerational physician assistant workforce.
Lopes, John E; Delellis, Nailya O
2013-10-01
Physician assistants (PAs) are more frequently finding themselves in positions where they are responsible for staff recruitment and retention. Staff turnover is associated with significant financial costs for organizations. Motivational theories focusing on job design indicate that paying attention to a combination of factors related to the work itself, in addition to the environment where the work is performed, increases satisfaction. This study asked a convenience sample of practicing PAs to rate the importance of a number of work-related factors known to influence job satisfaction. The results may be used as a basis for designing an environment to increase job satisfaction and improve recruitment and retention of highly qualified staff.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-23
... articles of food for which the Secretary believes that there is a reasonable probability that the use of or... there is a reasonable probability that the use of or exposure to an article of food, and any other... are needed to assist FDA in determining whether there is a reasonable probability that the use of or...
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Template-assisted fabrication of protein nanocapsules
NASA Astrophysics Data System (ADS)
Dougherty, Shelley A.; Liang, Jianyu; Kowalik, Timothy F.
2009-02-01
Bionanomaterials have recently begun to spark a great amount of interest and could potentially revolutionize biomedical research. Nanoparticles, nanocapsules, and nanotubular structures are becoming attractive options in drug and gene delivery. The size of the delivery vehicles greatly impacts cellular uptake and makes it highly desirable to precisely control the diameter and length of nanocarriers to make uniform nanoparticles at low cost. Carbon nanotubes have shown great potential within the field of drug and gene delivery. However, their insolubility and cytotoxicity could severely delay FDA approval. A desirable alternative would be to fabricate nanostructures from biomaterials such as proteins, peptides, or liposomes, which are already FDA approved. In this article we demonstrate the preparation of protein nanocapsules with both ends sealed using a template-assisted alternate immersion method combined with controlled cleaving. Glucose oxidase nanocapsules with controllable diameter, wall thickness, and length were fabricated and characterized with SEM and TEM. The biochemical activity of glucose oxidase in the form of nanocapsules after processing was confirmed using UV spectrometry. Our future work will explore proteins suitable for drug encapsulation and cellular uptake and will focus on optimizing the cleaving process to gain precise control over the length of the nanocapsules.
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Staff perspectives of relationships in aged care: A qualitative approach.
Jones, Cindy; Moyle, Wendy
2016-09-01
To explore aged care staff perceptions and experience of their relationships with co-workers, older people and families via pragmatic exploratory interviews. Thirty-nine direct care staff from seven residential age care facilities and 12 community organisations were interviewed. Staff felt that their capacity to develop therapeutic relationships with older people and families was impeded by care tasks and concerns regarding professional boundaries. Positive relationships between staff-family and staff-staff are hindered by staff perceptions of undue care demands, high family expectations, and staff-staff conflict within a hierarchical context and between work shifts. A relationship-centred approach to care as well as staff training and education should be encouraged to assist the development of therapeutic relationships and the management of professional boundaries. © 2016 AJA Inc.
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ERIC Educational Resources Information Center
Kommalage, Mahinda; Gunawardena, Sampath
2011-01-01
As a peer-assisted learning process, minilectures on physiology were conducted by students. During this process, students lecture to their colleagues in the presence of faculty staff members. These lectures were evaluated by faculty staff and students simultaneously. The aim of this study was to compare feedback from faculty members and students…
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Yaghmaie, Farideh; Jayasuriya, Rohan
2004-01-01
There have been many changes made to information systems in the last decade. Changes in information systems require users constantly to update their computer knowledge and skills. Computer training is a critical issue for any user because it offers them considerable new skills. The purpose of this study was to measure the effects of 'subjective computer training' and management support on attitudes to computers, computer anxiety and subjective norms to use computers. The data were collected from community health centre staff. The results of the study showed that health staff trained in computer use had more favourable attitudes to computers, less computer anxiety and more awareness of others' expectations about computer use than untrained users. However, there was no relationship between management support and computer attitude, computer anxiety or subjective norms. Lack of computer training for the majority of healthcare staff confirmed the need for more attention to this issue, particularly in health centres.
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A Quality Improvement System to Manage Feeding Assistance Care in Assisted-Living.
Simmons, Sandra F; Coelho, Chris S; Sandler, Andrew; Schnelle, John F
2018-03-01
To describe a feasible quality improvement system to manage feeding assistance care processes in an assisted living facility (ALF) that provides dementia care and the use of these data to maintain the quality of daily care provision and prevent unintentional weight loss. Supervisory ALF staff used a standardized observational protocol to assess feeding assistance care quality during and between meals for 12 consecutive months for 53 residents receiving dementia care. Direct care staff received feedback about the quality of assistance and consistency of between-meal snack delivery for residents with low meal intake and/or weight loss. On average, 78.4% of the ALF residents consumed more than one-half of each served meal and/or received staff assistance during meals to promote consumption over the 12 months. An average of 79.7% of the residents were offered snacks between meals twice per day. The prevalence of unintentional weight loss averaged 1.3% across 12 months. A quality improvement system resulted in sustained levels of mealtime feeding assistance and between-meal snack delivery and a low prevalence of weight loss among ALF residents receiving dementia care. Given that many ALF residents receiving dementia care are likely to be at risk for low oral intake and unintentional weight loss, ALFs should implement a quality improvement system similar to that described in this project, despite the absence of regulations to do so. Copyright © 2018 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.
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ERIC Educational Resources Information Center
Behr, Shirley K.; And Others
The interim report presents an evaluation of TADS (Technical Assistance Development System) through case studies of TADS technical assistance to the staffs of two demonstration programs for preschool handicapped children and their families. Purposes of the study included obtaining indepth descriptions of the technical assistance process to…
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42 CFR 485.631 - Condition of participation: Staffing and staff responsibilities.
Code of Federal Regulations, 2014 CFR
2014-10-01
... physician assistants, nurse practitioners, or clinical nurse specialists. (2) Any ancillary personnel are... conjunction with the physician assistant and/or nurse practitioner member(s), participates in developing...) In conjunction with the physician assistant and/or nurse practitioner members, periodically reviews...
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42 CFR 485.631 - Condition of participation: Staffing and staff responsibilities.
Code of Federal Regulations, 2012 CFR
2012-10-01
... physician assistants, nurse practitioners, or clinical nurse specialists. (2) Any ancillary personnel are... conjunction with the physician assistant and/or nurse practitioner member(s), participates in developing...) In conjunction with the physician assistant and/or nurse practitioner members, periodically reviews...
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42 CFR 485.631 - Condition of participation: Staffing and staff responsibilities.
Code of Federal Regulations, 2013 CFR
2013-10-01
... physician assistants, nurse practitioners, or clinical nurse specialists. (2) Any ancillary personnel are... conjunction with the physician assistant and/or nurse practitioner member(s), participates in developing...) In conjunction with the physician assistant and/or nurse practitioner members, periodically reviews...
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Results of a field test and follow-up study of a restorative care training program.
Walker, Bonnie L; Harrington, Susan S
2013-09-01
To implement restorative care in assisted living facilities, staff and administrators need to understand the philosophy and learn methods to help residents maintain optimal function. In this study, researchers investigated the use of a Web-based training program to improve the restorative care knowledge, attitudes, and practices of assisted living administrators and staff. The study design was one group repeated measure to consider the impact of the training program on participant's knowledge of restorative care and restorative care techniques, attitudes toward restorative care, and self-reported practices. Participants included 266 administrators and 203 direct care staff from assisted living facilities in eight states. Measurements were done at baseline (pretest), following the instruction (posttest), and one month later (follow-up). Researchers found that participants (n=469) significantly improved their scores from pre- to posttest. In a follow-up study (n=244), over half of participants reported making changes at their facility as a result of the restorative care training. Most of the changes are related to care practices, such as an emphasis on encouraging, motivating, and offering positive feedback to residents. Researchers concluded that there is a need for restorative care training for both administrators and staff of assisted living facilities. The study also demonstrates that a brief training session (2h or less) can bring about significant change in the learner's knowledge of facts, attitudes, and practices. It demonstrates that much of that change continues for at least 1 month after the training. It also demonstrates the loss of knowledge and points out the need for training to be followed up with continuing education and administrator encouragement. Furthermore, this study demonstrates that the Web is a feasible method of delivering restorative care training to assisted living facility administrators and staff. Copyright © 2012 Elsevier Ltd. All rights reserved.
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Computer Training for Staff and Patrons.
ERIC Educational Resources Information Center
Krissoff, Alan; Konrad, Lee
1998-01-01
Describes a pilot computer training program for library staff and patrons at the University of Wisconsin-Madison. Reviews components of effective training programs and highlights core computer competencies: operating systems, hardware and software basics and troubleshooting, and search concepts and techniques. Includes an instructional outline and…
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Intermediate Command and Staff Course (Maritime)--a guide to preparation.
Butterworth, S; Rawlinson, K
2014-01-01
The Intermediate Command and Staff Course (Maritime) is an eight-week residential course held at the Joint Services Command and Staff College, Shrivenham. It is designed to prepare mid-late-seniority Lieutenants and newly-promoted Lieutenant Commanders of the Royal Navy for command, charge and staff appointments, and also to assess their suitability for further staff training. This paper aims to assist officers in the Royal Navy Medical Services in their preparation for attending this course, and also to familiarise them with aspects of the course.
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Developing Crash-Resistant Electronic Services.
ERIC Educational Resources Information Center
Almquist, Arne J.
1997-01-01
Libraries' dependence on computers can lead to frustrations for patrons and staff during downtime caused by computer system failures. Advice for reducing the number of crashes is provided, focusing on improved training for systems staff, better management of library systems, and the development of computer systems using quality components which…
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Ellis, Julie M; Rawson, Helen
2015-07-01
This article presents findings from a study that explored nurses' and personal care assistants' role in improving the relocation of older people into a nursing home. Suggestions for improving the relocation process for older people moving into a nursing home have been the outcomes of studies that have interviewed residents and their families. However, the views of nurses and personal care assistants working in nursing homes have not been previously explored. An exploratory, descriptive qualitative research design. Individual interviews were conducted with 20 care staff (seven registered nurses, five enrolled nurses and eight personal care assistants) employed at four nursing homes. Using thematic analysis, two key themes were identified: 'What it's like for them' - highlighted staffs' awareness of the advantages, disadvantages and meaning of relocation, and focused on staffing and nursing care; other services provided and the environment. The second theme - 'We can make it better', revealed suggestions for improving the relocation process, and included spending time with new residents and the importance of a person-centred approach to care. Care staff have an important role in improving the relocation process of older people into a nursing home, as well as contributing to the discussion on this important clinical topic. Challenging care staff to acknowledge the importance of their role in helping older people settle into a nursing home is a key requirement of nursing practice in aged care. Nursing practice guidelines, with a focus on person-centred care, on how to manage the relocation process for an older person and their family are required for this aspect of nursing home care. Education of staff on relocation policies and procedures is essential to ensure that residents and their families are supported through this process. © 2015 John Wiley & Sons Ltd.
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75 FR 59682 - Trade Adjustment Assistance for Farmers
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-28
... Service (FAS) has denied petitions (No.'s 2011006-2011011, 2011028) for trade adjustment assistance for..., Farm Service Agency, Agricultural Marketing Service, and FAS. After a review, the Administrator... Adjustment Assistance for Farmers Program Staff, Office of Trade Programs, FAS, USDA; or by phone at (202...
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75 FR 62759 - Trade Adjustment Assistance for Farmers
Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-13
... Service (FAS), denied a petition (No. 2011019) for trade adjustment assistance (TAA) for Tilapia filed..., and FAS. After a review, the Administrator determined that the petition was unable to demonstrate the... INFORMATION CONTACT: Trade Adjustment Assistance for Farmers Program Staff, Office of Trade Programs, FAS...
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Barriers to vocational effectiveness in ACT: staff perspectives.
Waynor, William R; Pratt, Carlos W
2011-01-01
Assertive community treatment (ACT), for persons with serious mental illness, includes a vocational focus as an important aspect of community integration. Nevertheless, research suggests that ACT does not assist significant numbers of consumers in achieving employment goals. A two-step survey of New Jersey ACT team members was designed to identify the key issues that hinder ACT staff members in assisting consumers with obtaining employment. Survey items were categorized into three sections: (a) staff attitudes, (b) consumer barriers, and (c) staff barriers to working on employment. The initial survey asked staff members to rate items in each of these categories. Highly rated items were used in a subsequent paired comparison survey to determine the relative importance of each. This method highlighted the following issues: four staff attitude items-(a) returning to work is positive, (b) employment is key to recovery, (c) abstinence from substance abuse is needed to work, and (d) consumers are too ill to work; four consumer barrier items-(a) fear of loss of Social Security Administration benefits, (b) symptoms related to the illness, (c) lack of motivation, and (d) poor social skills; and three barriers to working on employment issues items-(a) clinical issues take priority, (b) other case management issues takes priority, and (c) too many emergencies. The implications for staff training are discussed.
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Face detection assisted auto exposure: supporting evidence from a psychophysical study
NASA Astrophysics Data System (ADS)
Jin, Elaine W.; Lin, Sheng; Dharumalingam, Dhandapani
2010-01-01
Face detection has been implemented in many digital still cameras and camera phones with the promise of enhancing existing camera functions (e.g. auto exposure) and adding new features to cameras (e.g. blink detection). In this study we examined the use of face detection algorithms in assisting auto exposure (AE). The set of 706 images, used in this study, was captured using Canon Digital Single Lens Reflex cameras and subsequently processed with an image processing pipeline. A psychophysical study was performed to obtain optimal exposure along with the upper and lower bounds of exposure for all 706 images. Three methods of marking faces were utilized: manual marking, face detection algorithm A (FD-A), and face detection algorithm B (FD-B). The manual marking method found 751 faces in 426 images, which served as the ground-truth for face regions of interest. The remaining images do not have any faces or the faces are too small to be considered detectable. The two face detection algorithms are different in resource requirements and in performance. FD-A uses less memory and gate counts compared to FD-B, but FD-B detects more faces and has less false positives. A face detection assisted auto exposure algorithm was developed and tested against the evaluation results from the psychophysical study. The AE test results showed noticeable improvement when faces were detected and used in auto exposure. However, the presence of false positives would negatively impact the added benefit.
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Does race influence conflict between nursing home staff and family members of residents?
Abrahamson, Kathleen; Pillemer, Karl; Sechrist, Jori; Suitor, Jill
2011-11-01
This study examines the influence of race on perceived similarity and conflict between nursing home staff and family members of residents. Despite evidence that the caregiving experience varies by race for both family and professional caregivers, little is known about how race plays a role in staff conflict with residents' family members. We used a representative sample of Certified Nursing Assistants (CNAs) to test relationships between race, treatment from family members, similarity to family members in expectations for care by CNAs, and conflicts with family members concerning aspects of resident care. Results of structural equation modeling indicated that race was not a predictor of staff perception of conflict with family members or of poor treatment from residents' families. However, Black nursing assistants were more likely to perceive that their own expectations of nursing care are dissimilar from those of residents' family members. Dissimilarity predicted reports of poor treatment from family members, and poor treatment was a positive predictor of perception of conflict. The personal long-term nature of nursing home care necessitates a high level of connectedness between family caregivers and nursing home staff. Results highlight the importance of establishing organizational pathways for communication of expectations between nursing staff and residents' families.
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Code of Federal Regulations, 2010 CFR
2010-07-01
... Intelligence) and all offices reporting to such official, including immediate staff; (N) Assistant Secretary... Secretary (Intelligence and Analysis) and all offices reporting to such official, including immediate staff... Supervision. (viii) Bureau of Engraving and Printing. (ix) United States Mint. (x) Financial Crimes...
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Kash, Bita A; Castle, Nicholas G; Naufal, George S; Hawes, Catherine
2006-10-01
We examined the effects of facility and market-level characteristics on staffing levels and turnover rates for direct care staff, and we examined the effect of staff turnover on staffing levels. We analyzed cross-sectional data from 1,014 Texas nursing homes. Data were from the 2002 Texas Nursing Facility Medicaid Cost Report and the Area Resource File for 2003. After examining factors associated with staff turnover, we tested the significance and impact of staff turnover on staffing levels for registered nurses (RNs), licensed vocational nurses (LVNs) and certified nursing assistants (CNAs). All three staff types showed strong dependency on resources, such as reimbursement rates and facility payor mix. The ratio of contracted to employed nursing staff as well as RN turnover increased LVN turnover rates. CNA turnover was reduced by higher administrative expenditures and higher CNA wages. Turnover rates significantly reduced staffing levels for RNs and CNAs. LVN staffing levels were not affected by LVN turnover but were influenced by market factors such as availability of LVNs in the county and women in the labor force. Staffing levels are not always associated with staff turnover. We conclude that staff turnover is a predictor of RN and CNA staffing levels but that LVN staffing levels are associated with market factors rather than turnover. Therefore, it is important to focus on management initiatives that help reduce CNA and RN turnover and ultimately result in higher nurse staffing levels in nursing homes.
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Weatherization Assistance Program Technical Assistance Center
DOE Office of Scientific and Technical Information (OSTI.GOV)
Robert Adams
2009-01-07
The following is a synopsis of the major achievements attributed to the operation of the Weatherization Assistance Program Technical Assistance Center (WAPTAC) by the National Association for State Community Services Programs (NASCSP). During the past five years, the WAPTAC has developed into the premier source for information related to operating the Weatherization Assistance Program (WAP) at the state and local levels. The services provide through WAPTAC include both virtual technical support as well as hands-on training and instruction in classroom and in the field. The WAPTAC achieved several important milestones during its operation including the establishment of a national Weatherizationmore » Day now celebrated in most states, the implementation of a comprehensive Public Information Campaign (PIC) to raise the awareness of the Program among policy makers and the public, the training of more than 150 new state managers and staff as they assume their duties in state offices around the country, and the creation and support of a major virtual information source on the Internet being accessed by thousands of staff each month. The Weatherization Assistance Program Technical Assistance Center serves the Department of Energy's (DOE) Office of Weatherization and Intergovernmental Program as a valuable training and technical assistance resource for the network of 54 direct state grantees (50 states, District of Columbia and three Native American tribes) and the network of 900 local subgrantees (comprised of community action agencies, units of local government, and other non-profit organizations). The services provided through WAPTAC focus on standardizing and improving the daily management of the WAP. Staff continually identify policies changes and best practices to help the network improve its effectiveness and enhance the benefits of the Program for the customers who receive service and the federal and private investors. The operations of WAPTAC are separated into six distinct areas: (1) Orientation for New WAP State Directors and Staff; (2) Pollution Occurrence Insurance Project; (3) Public Information Campaign; (4) State Management Training Project; (5) System for Integrating and Reviewing Technologies and Techniques; and (6) WAPTAC Services.« less
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Computer-Based Training for Library Staff: From Demonstration to Continuing Program.
ERIC Educational Resources Information Center
Bayne, Pauline S.
1993-01-01
Describes a demonstration project developed at the University of Tennessee (Knoxville) libraries to train nonprofessional library staff with computer-based training using HyperCard that was created by librarians rather than by computer programmers. Evaluation methods are discussed, including formative and summative evaluation; and modifications…
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Pain control and chaplaincy in Aotearoa New Zealand.
Carey, Lindsay B; Polita, Carla; Marsden, Candace Renee; Krikheli, Lillian
2014-10-01
This paper summarizes the results of 100 New Zealand health care chaplains with regard to their involvement in issues concerning pain control within the New Zealand health care context. Both quantitative (via survey) and qualitative methods (in-depth interviewing) were utilized. The findings of this study indicated that approximately 52 % of surveyed hospital chaplains had provided some form of pastoral intervention directly to patients and/or their families dealing with issues concerning pain and that approximately 30 % of hospital chaplains had assisted clinical staff with issues concerning pain. NZ chaplaincy personnel involved in pain-related issues utilized a number of pastoral interventions to assist patients, their families and clinical staff. Differences of involvement between professionally stipended hospital chaplains and their volunteer chaplaincy assistants are noted, as are the perspectives of interviewed chaplains about their pastoral interventions with issues relating to pain. Some implications of this study with respect to chaplaincy utility, training and collaboration with clinical staff are noted, as are comparisons with international findings.
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ERIC Educational Resources Information Center
Holmes, Manford L.
This paper describes the nature of the relationships developed between the technical assistance team of the Documentation and Technical Assistance (DTA) Project and members of a Chicago (Illinois) school district staff with whom the DTA worked. First, the methodology with which the technical assistance work was studied is described, as is the…
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MIT Laboratory for Computer Science Progress Report 27
1990-06-01
because of the natural, yet unexploited, concurrence that characterizes contemporary and prospective applications from business to sensory computing...432. 14 Advanced Network Architecture Academic Staff D. Clark, Group Leader D. Tennenhouse J. Saltzer Research Staff J. Davin K. Sollins Graduate...Murray Hill, NJ, July 1989. 23 24 Clinical Decision Making Academic Staff R. Patil P. Szolovits, Group Leader G. Rennels Collaborating Investigators M
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All Together Now: Measuring Staff Cohesion in Special Education Classrooms
Kratz, Hilary E.; Locke, Jill; Piotrowski, Zinnia; Ouellette, Rachel R.; Xie, Ming; Stahmer, Aubyn C.; Mandell, David S.
2015-01-01
This study sought to validate a new measure, the Classroom Cohesion Survey (CCS), designed to examine the relationship between teachers and classroom assistants in autism support classrooms. Teachers, classroom assistants, and external observers showed good inter-rater agreement on the CCS and good internal consistency for all scales. Simple factor structures were found for both teacher- and classroom assistant–rated scales, with one-factor solutions for both scales. Paired t tests revealed that on average, classroom assistants rated classroom cohesion stronger than teachers. The CCS may be an effective tool for measuring cohesion between classroom staff and may have an important impact on various clinical and implementation outcomes in school settings. PMID:26213443
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Mitchell, Shannon Gwin; Monico, Laura B; Gryczynski, Jan; O'Grady, Kevin E; Schwartz, Robert P
2015-01-01
The use of computers for identifying and intervening with stigmatized behaviors, such as drug use, offers promise for underserved, rural areas; however, the acceptability and appropriateness of using computerized brief intervention (CBIs) must be taken into consideration. In the present study, 12 staff members representing a range of clinic roles in two rural, federally qualified health centers completed semi-structured interviews in a qualitative investigation of CBI vs. counselor-delivered individual brief intervention (IBI). Thematic content analysis was conducted using a constant comparative method, examining the range of responses within each interview as well as data across interview respondents. Overall, staff found the idea of providing CBIs both acceptable and appropriate for their patient population. Acceptability by clinic staff centered on the ready availability of the CBI. Staff also believed that patients might be more forthcoming in response to a computer program than a personal interview. However, some staff voiced reservations concerning the appropriateness of CBIs for subsets of patients, including older patients, illiterate individuals, or those unfamiliar with computers. Findings support the potential suitability and potential benefits of providing CBIs to patients in rural health centers.
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Differences in the Language and Design of Four PPIs for Valium. Technical Assistance Report No. 1.
ERIC Educational Resources Information Center
Redish, Janice C.
As part of the evaluation of four different versions of a patient package insert (PPI) for diazepam (Valium) created by the Food and Drug Administration (FDA), the content, organization, language, and design of the PPIs were compared. One PPI was a short prose piece with clear organization that did not particularly highlight warnings or, indeed,…
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2010-10-01
and Consumer Assistance at its loll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/ cdrh /industrv/support...21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH , Office of Device
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75 FR 59682 - Trade Adjustment Assistance for Farmers
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-28
... Service (FAS) has denied petitions (Nos. 2011023-2011027) for trade adjustment assistance for wool filed... Economist, Farm Service Agency, Agricultural Marketing Service, and FAS. After a review, the Administrator... Adjustment Assistance for Farmers Program Staff, Office of Trade Programs, FAS, USDA; or by phone at (202...
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40 CFR 1.37 - Office of External Affairs.
Code of Federal Regulations, 2012 CFR
2012-07-01
... Activities. The Office of Federal Activities is headed by a Director who reports to the Assistant... serves as chief spokesperson for the Agency and as a principal adviser, along with the Assistant... of interest to the Congress. The Office works closely with the staffs of various Assistant...
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75 FR 23227 - Trade Adjustment Assistance for Farmers
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-03
... cost and cash benefits. FOR FURTHER INFORMATION CONTACT: Trade Adjustment Assistance Staff, FAS, USDA... in cash receipts for lilies compared to the average of the 3 preceding marketing years. If a...
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Moore, Thomas J; Furberg, Curt D; Mattison, Donald R; Cohen, Michael R
2016-06-01
Adverse drug event reports to the US Food and Drug Administration (FDA) remain the primary tool for identifying serious drug adverse effects without adequate existing warnings. We assessed the completeness of reports the FDA received in 2014. Serious adverse drug event reports were evaluated for whether they included age, gender, event date, and at least one medical term describing the event in computer excerpts. Report sources were direct reports to the FDA, manufacturer expedited reports about events without adequate warnings, and manufacturer periodic reports about events with existing warnings. In 2014, the FDA received 528,192 new case reports indicating a serious or fatal outcome, 25,038 (4.7%) directly from health professionals and consumers, and 503,154 (95.3%) from drug manufacturers. Overall, 21,595 (86.2%) of serious reports submitted directly to the FDA provided data for all four completeness variables, compared with 271,022 (40.4%) of manufacturer expedited reports and 24,988 (51.3%) of periodic reports. Among manufacturer serious reports, 37.9% lacked age and 46.9% had no event date. Performance by 25 manufacturers submitting 5000 or more reports varied from 24.4% complete on all variables to 67% complete. Patient death cases had the lowest completeness scores in all categories. By these measures, report completeness from drug manufacturers was poor compared with direct submissions to the agency. The FDA needs to update reporting requirements and compliance policies to help industry capture better adverse event information from new forms of manufacturer interactions with health professionals and consumers. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.
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Cummings, Greta G; Doupe, Malcolm; Ginsburg, Liane; McGregor, Margaret J; Norton, Peter G; Estabrooks, Carole A
2017-06-01
To (a) describe A Scheduled Shifts Staffing measure (ASSiST) to derive care aide worked hours per resident day (HCA WHRD) at facility and unit levels in nursing homes, (b) report reliability through comparisons to administrative staffing data; (c) report validity by examining associations between HCA WHRD, staff outcomes (job satisfaction, emotional exhaustion), and resident quality indicators (QIs) (e.g. falls, delirium, stage 2+ pressure ulcers), and (d) explore intrafacility variation in staffing intensity levels related to unit-level variation in resident and staff outcomes. We used data from 40 care units in 12 Canadian nursing homes between 2007 and 2012. Descriptive statistics and tests of association and difference described relationships of two measures of staffing with resident and staff outcomes. Annualized rates of HCA WHRD from both data sources compared well at the facility level (Pearson Product Correlation; R = 0.847, p < .001), and were correlated similarly to staff work life and many QIs. Using ASSiST data, we show that staffing levels can vary by up to 40% at the unit-level within nursing homes. ASSiST is easy to collect, more timely to retrieve than administrative data, has good criterion and construct validity, and reflects intrafacility variation in health care aide staffing levels. © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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National resource for computation in chemistry, phase I: evaluation and recommendations
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1980-05-01
The National Resource for Computation in Chemistry (NRCC) was inaugurated at the Lawrence Berkeley Laboratory (LBL) in October 1977, with joint funding by the Department of Energy (DOE) and the National Science Foundation (NSF). The chief activities of the NRCC include: assembling a staff of eight postdoctoral computational chemists, establishing an office complex at LBL, purchasing a midi-computer and graphics display system, administering grants of computer time, conducting nine workshops in selected areas of computational chemistry, compiling a library of computer programs with adaptations and improvements, initiating a software distribution system, providing user assistance and consultation on request. This reportmore » presents assessments and recommendations of an Ad Hoc Review Committee appointed by the DOE and NSF in January 1980. The recommendations are that NRCC should: (1) not fund grants for computing time or research but leave that to the relevant agencies, (2) continue the Workshop Program in a mode similar to Phase I, (3) abandon in-house program development and establish instead a competitive external postdoctoral program in chemistry software development administered by the Policy Board and Director, and (4) not attempt a software distribution system (leaving that function to the QCPE). Furthermore, (5) DOE should continue to make its computational facilities available to outside users (at normal cost rates) and should find some way to allow the chemical community to gain occasional access to a CRAY-level computer.« less
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Meehan, Thomas P; Qazi, Daniel J; Van Hoof, Thomas J; Ho, Shih-Yieh; Eckenrode, Sheila; Spenard, Ann; Pandolfi, Michelle; Johnson, Florence; Quetti, Deborah
2015-08-01
To describe and evaluate the impact of quality improvement (QI) support provided to skilled nursing facilities (SNFs) by a Quality Improvement Organization (QIO). Retrospective, mixed-method, process evaluation of a QI project intended to decrease preventable hospital readmissions from SNFs. Five SNFs in Connecticut. SNF Administrators, Directors of Nursing, Assistant Directors of Nursing, Admissions Coordinators, Registered Nurses, Certified Nursing Assistants, Receptionists, QIO Quality Improvement Consultant. QIO staff provided training and technical assistance to SNF administrative and clinical staff to establish or enhance QI infrastructure and implement an established set of QI tools [Interventions to Reduce Acute Care Transfers (INTERACT) tools]. Baseline SNF demographic, staffing, and hospital readmission data; baseline and follow-up SNF QI structure (QI Committee), processes (general and use of INTERACT tools), and outcome (30-day all-cause hospital readmission rates); details of QIO-provided training and technical assistance; QIO-perceived barriers to quality improvement; SNF leadership-perceived barriers, accomplishments, and suggestions for improvement of QIO support. Success occurred in establishing QI Committees and targeting preventable hospital readmissions, as well as implementing INTERACT tools in all SNFs; however, hospital readmission rates decreased in only 2 facilities. QIO staff and SNF leaders noted the ongoing challenge of engaging already busy SNF staff and leadership in QI activities. SNF leaders reported that they appreciated the training and technical assistance that their institutions received, although most noted that additional support was needed to bring about improvement in readmission rates. This process evaluation documented mixed clinical results but successfully identified opportunities to improve recruitment of and provision of technical support to participating SNFs. Recommendations are offered for others who wish to conduct similar projects. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. All rights reserved.
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40 CFR 57.803 - Issuance of tentative determination; notice.
Code of Federal Regulations, 2013 CFR
2013-07-01
... determination. (1) The EPA staff shall formulate and prepare: (i) A “Staff Computational Analysis,” using the... Computational Analysis, discussing the estimated cost of interim controls, and assessing the effect upon the...
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40 CFR 57.803 - Issuance of tentative determination; notice.
Code of Federal Regulations, 2012 CFR
2012-07-01
... determination. (1) The EPA staff shall formulate and prepare: (i) A “Staff Computational Analysis,” using the... Computational Analysis, discussing the estimated cost of interim controls, and assessing the effect upon the...