7 CFR 622.10 - Sponsors.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AGRICULTURE WATER RESOURCES WATERSHED PROJECTS Qualifications § 622.10 Sponsors. (a) Watershed projects are sponsored by one or more local organizations qualifying as sponsors. All watershed plans shall be sponsored...

7 CFR 622.10 - Sponsors.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AGRICULTURE WATER RESOURCES WATERSHED PROJECTS Qualifications § 622.10 Sponsors. (a) Watershed projects are sponsored by one or more local organizations qualifying as sponsors. All watershed plans shall be sponsored...

7 CFR 622.10 - Sponsors.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AGRICULTURE WATER RESOURCES WATERSHED PROJECTS Qualifications § 622.10 Sponsors. (a) Watershed projects are sponsored by one or more local organizations qualifying as sponsors. All watershed plans shall be sponsored...

7 CFR 622.10 - Sponsors.

Code of Federal Regulations, 2014 CFR

2014-01-01

... AGRICULTURE WATER RESOURCES WATERSHED PROJECTS Qualifications § 622.10 Sponsors. (a) Watershed projects are sponsored by one or more local organizations qualifying as sponsors. All watershed plans shall be sponsored...

7 CFR 654.14 - Duration of sponsor(s)' responsibility.

Code of Federal Regulations, 2010 CFR

2010-01-01

... performed by force account, division of work, or performance of work methods, the sponsor(s)' O&M responsibilities begin on the date the work or portion thereof is completed as determined by NRCS, except for completed work located on Federal lands which are subject to special-use permits. The O&M agreement shall...

The Sponsored Film.

ERIC Educational Resources Information Center

Klein, Walter J.

For public relations professionals and would-be sponsors of films, this book provides guidelines for understanding the film medium and its potential as a persuasive force in industry, government, organizations, and religious orders. For filmmakers, it brings together practical information needed to survive in the sponsored-film industry and to…

The financial implications of employer-sponsored health insurance.

PubMed

Natvig, Deborah; Tolbert, Sam

2005-01-01

The purpose of this study was to analyze utilization and costs of employer-sponsored health insurance in select businesses in a rural community in South Carolina. The study was conducted under the auspices of the HR Roundtable of the local Chamber of Commerce, composed of human resources directors from the larger area businesses. Twenty one companies were invited to participate and eight submitted information that was sufficiently complete to analyze. The participating companies employed 6,265 people, of which 5,712 were insured. The data represents a total of 13,057 covered lives. Although the findings cannot be generalized to a broader population, the descriptive data was sufficient to generate a discussion about health care issues for this community and for the group to make preliminary recommendations for collaborative work that may affect the costs of health care coverage for this community.

77 FR 46612 - New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Azaperone; Miconazole, Polymyxin...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-06

... 524 [Docket No. FDA-2012-N-0002] New Animal Drugs; Change of Sponsor; Change of Sponsor Address.... ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen...

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

PubMed

Tersmette, Derek Gideon; Engberts, Dirk Peter

2017-01-01

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

UNION-SPONSORED RETRAINING PROGRAMS.

ERIC Educational Resources Information Center

HOOS, IDA R.

UNION-SPONSORED TRAINING PROGRAMS WERE PROVIDED IN THE SAN FRANCISCO BAY AREA TO UPGRADE SKILLS OF MARINE COOKS AND STEWARDS, SHIPS' RADIO OPERATORS, JOURNEYMAN PLUMBERS AND GASFITTERS, AND MEMBERS OF THE INTERNATIONAL BROTHERHOOD OF ELECTRICAL WORKERS (IBEW). THESE PROGRAMS WERE THE ONLY COHESIVE UNION SPONSORED CURRICULA IN THAT AREA. MAJOR…

48 CFR 970.3501-1 - Sponsoring agreements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Sponsoring agreements. 970... Sponsoring agreements. (a) The contract award document constitutes the sponsoring agreement between the... the purpose and mission of the FFRDC. (c) Other elements of the sponsoring agreement which shall be...

48 CFR 970.3501-1 - Sponsoring agreements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Sponsoring agreements. 970... Sponsoring agreements. (a) The contract award document constitutes the sponsoring agreement between the... the purpose and mission of the FFRDC. (c) Other elements of the sponsoring agreement which shall be...

48 CFR 970.3501-1 - Sponsoring agreements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Sponsoring agreements. 970... Sponsoring agreements. (a) The contract award document constitutes the sponsoring agreement between the... the purpose and mission of the FFRDC. (c) Other elements of the sponsoring agreement which shall be...

45 CFR 1226.12 - Sponsor employees.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Sponsor employees. 1226.12 Section 1226.12 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR NATIONAL AND COMMUNITY SERVICE PROHIBITIONS ON ELECTORAL AND LOBBYING ACTIVITIES Sponsor Employee Activities § 1226.12 Sponsor employees...

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees

PubMed Central

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-01-01

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. PMID:26811365

A Robust Open Ascending-price Multi-unit Auction Protocol against False-name Bids

NASA Astrophysics Data System (ADS)

Iwasaki, Atsushi; Yokoo, Makoto; Terada, Kenji

This paper develops a new ascending-price multi-unit auction protocol that has following characteristics: (i) it has an open format, (ii) sincere bidding is an equilibrium strategy even if the marginal utilities of each agent can increase and agents can submit false-name bids. False-name bids are bids submitted under fictitious names such as multiple e-mail addresses, which can be done easily in the Internet. This is the first protocol that has these two characteristics. We show that our new protocol outperforms an existing protocol, which satisfies (ii), with respect to the social surplus and the seller's revenue.

17 CFR 229.1104 - (Item 1104) Sponsors.

Code of Federal Regulations, 2010 CFR

2010-04-01

... describe the sponsor's form of organization. (b) Describe the general character of the sponsor's business... regarding the size, composition and growth of the sponsor's portfolio of assets of the type to be...

7 CFR 622.10 - Sponsors.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AGRICULTURE WATER RESOURCES WATERSHED PROJECTS Qualifications § 622.10 Sponsors. (a) Watershed projects are... the use of nonstructural or structural measures shall be sponsored by organizations that, individually... project cost and all operation and maintenance costs. (b) To receive Federal assistance for project...

Academic investigator-initiated trials and the challenge of sponsor responsibility: the Cologne Sponsor Model.

PubMed

Georgias, Christine; Grunow, Andrea; Olderog, Miriam; May, Alexander; Paulus, Ursula

2012-12-01

With the amendment to the German Drug Law in 2004, the conduct of clinical trials changed by at least two main aspects: (1) The principles of Good Clinical Practice (GCP) were implemented in the national legislation, and (2) for the first time, the function of the sponsor of a clinical trial and the clinical trial itself have become legally binding definitions. By that, legal differences between industrial and academic clinical trials no longer exist. Clinical trials initiated by investigators have to fulfil the same requirements while the entire sponsor responsibility has to be carried out by the Coordinating Investigator or his institution including implementation of a quality management system according to the GCP. The Cologne Sponsor Model is an effective approach with settings, structures, basic features, action, and reporting lines, as well as funding for clinical trials initiated in an academic environment. The University of Cologne assumes the sponsor responsibility for clinical trials organised by the university researchers according to law. Sponsor's duties are delegated to a central operational unit of the sponsor - the Clinical Trials Center Cologne - which further delegates duties to the Coordinating Investigator. Clinical Trials Center Cologne was established in 2002 to support the performance of clinical trials at the university by offering comprehensive advisory and practical services covering all aspects of study planning and conduct. Furthermore, a specialised division of its quality management department acts as an independent sponsor's Quality Assurance Unit. The Clinical Trials Center Cologne has established a quality management system consisting of different components (1) to enable a reasoned decision to subsequent delegation, (2) for risk-based surveillance of trial conduct (audits, monitoring-checks, and reports), and (3) support and training of the Coordinating Investigator. Double functions of persons and departments in the university

48 CFR 235.017-1 - Sponsoring agreements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 3 2012-10-01 2012-10-01 false Sponsoring agreements. 235.017-1 Section 235.017-1 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM... Sponsoring agreements. (c)(4) DoD-sponsoring FFRDCs that function primarily as research laboratories (C3I...

Benchmark Credentialing Results for NRG-BR001: The First National Cancer Institute-Sponsored Trial of Stereotactic Body Radiation Therapy for Multiple Metastases

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

Al-Hallaq, Hania A., E-mail: halhallaq@radonc.uchicago.edu; Chmura, Steven J.; Salama, Joseph K.

Purpose: The NRG-BR001 trial is the first National Cancer Institute–sponsored trial to treat multiple (range 2-4) extracranial metastases with stereotactic body radiation therapy. Benchmark credentialing is required to ensure adherence to this complex protocol, in particular, for metastases in close proximity. The present report summarizes the dosimetric results and approval rates. Methods and Materials: The benchmark used anonymized data from a patient with bilateral adrenal metastases, separated by <5 cm of normal tissue. Because the planning target volume (PTV) overlaps with organs at risk (OARs), institutions must use the planning priority guidelines to balance PTV coverage (45 Gy in 3 fractions) againstmore » OAR sparing. Submitted plans were processed by the Imaging and Radiation Oncology Core and assessed by the protocol co-chairs by comparing the doses to targets, OARs, and conformity metrics using nonparametric tests. Results: Of 63 benchmarks submitted through October 2015, 94% were approved, with 51% approved at the first attempt. Most used volumetric arc therapy (VMAT) (78%), a single plan for both PTVs (90%), and prioritized the PTV over the stomach (75%). The median dose to 95% of the volume was 44.8 ± 1.0 Gy and 44.9 ± 1.0 Gy for the right and left PTV, respectively. The median dose to 0.03 cm{sup 3} was 14.2 ± 2.2 Gy to the spinal cord and 46.5 ± 3.1 Gy to the stomach. Plans that spared the stomach significantly reduced the dose to the left PTV and stomach. Conformity metrics were significantly better for single plans that simultaneously treated both PTVs with VMAT, intensity modulated radiation therapy, or 3-dimensional conformal radiation therapy compared with separate plans. No significant differences existed in the dose at 2 cm from the PTVs. Conclusions: Although most plans used VMAT, the range of conformity and dose falloff was large. The decision to prioritize either OARs or PTV coverage varied considerably, suggesting

Benchmark Credentialing Results for NRG-BR001: The First National Cancer Institute-Sponsored Trial of Stereotactic Body Radiation Therapy for Multiple Metastases.

PubMed

Al-Hallaq, Hania A; Chmura, Steven J; Salama, Joseph K; Lowenstein, Jessica R; McNulty, Susan; Galvin, James M; Followill, David S; Robinson, Clifford G; Pisansky, Thomas M; Winter, Kathryn A; White, Julia R; Xiao, Ying; Matuszak, Martha M

2017-01-01

The NRG-BR001 trial is the first National Cancer Institute-sponsored trial to treat multiple (range 2-4) extracranial metastases with stereotactic body radiation therapy. Benchmark credentialing is required to ensure adherence to this complex protocol, in particular, for metastases in close proximity. The present report summarizes the dosimetric results and approval rates. The benchmark used anonymized data from a patient with bilateral adrenal metastases, separated by <5 cm of normal tissue. Because the planning target volume (PTV) overlaps with organs at risk (OARs), institutions must use the planning priority guidelines to balance PTV coverage (45 Gy in 3 fractions) against OAR sparing. Submitted plans were processed by the Imaging and Radiation Oncology Core and assessed by the protocol co-chairs by comparing the doses to targets, OARs, and conformity metrics using nonparametric tests. Of 63 benchmarks submitted through October 2015, 94% were approved, with 51% approved at the first attempt. Most used volumetric arc therapy (VMAT) (78%), a single plan for both PTVs (90%), and prioritized the PTV over the stomach (75%). The median dose to 95% of the volume was 44.8 ± 1.0 Gy and 44.9 ± 1.0 Gy for the right and left PTV, respectively. The median dose to 0.03 cm 3 was 14.2 ± 2.2 Gy to the spinal cord and 46.5 ± 3.1 Gy to the stomach. Plans that spared the stomach significantly reduced the dose to the left PTV and stomach. Conformity metrics were significantly better for single plans that simultaneously treated both PTVs with VMAT, intensity modulated radiation therapy, or 3-dimensional conformal radiation therapy compared with separate plans. No significant differences existed in the dose at 2 cm from the PTVs. Although most plans used VMAT, the range of conformity and dose falloff was large. The decision to prioritize either OARs or PTV coverage varied considerably, suggesting that the toxicity outcomes in the trial could be affected. Several

Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor.

PubMed

Flacco, Maria Elena; Manzoli, Lamberto; Boccia, Stefania; Capasso, Lorenzo; Aleksovska, Katina; Rosso, Annalisa; Scaioli, Giacomo; De Vito, Corrado; Siliquini, Roberta; Villari, Paolo; Ioannidis, John P A

2015-07-01

To map the current status of head-to-head comparative randomized evidence and to assess whether funding may impact on trial design and results. From a 50% random sample of the randomized controlled trials (RCTs) published in journals indexed in PubMed during 2011, we selected the trials with ≥ 100 participants, evaluating the efficacy and safety of drugs, biologics, and medical devices through a head-to-head comparison. We analyzed 319 trials. Overall, 238,386 of the 289,718 randomized subjects (82.3%) were included in the 182 trials funded by companies. Of the 182 industry-sponsored trials, only 23 had two industry sponsors and only three involved truly antagonistic comparisons. Industry-sponsored trials were larger, more commonly registered, used more frequently noninferiority/equivalence designs, had higher citation impact, and were more likely to have "favorable" results (superiority or noninferiority/equivalence for the experimental treatment) than nonindustry-sponsored trials. Industry funding [odds ratio (OR) 2.8; 95% confidence interval (CI): 1.6, 4.7] and noninferiority/equivalence designs (OR 3.2; 95% CI: 1.5, 6.6), but not sample size, were strongly associated with "favorable" findings. Fifty-five of the 57 (96.5%) industry-funded noninferiority/equivalence trials got desirable "favorable" results. The literature of head-to-head RCTs is dominated by the industry. Industry-sponsored comparative assessments systematically yield favorable results for the sponsors, even more so when noninferiority designs are involved. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Tax-exempt bonds and sponsored research.

PubMed

Ballard, Frederic L

2003-01-01

"Sponsored research," wherein a business corporation or the government pays a portion of the cost of research activities carried out by a university or hospital, is increasingly important both for state institutions and for Section 510(c)(3) organizations. Sponsored research arrangements that are not properly structured can jeopardize the status of tax-exempt bonds issued to finance the facility at which the sponsored research occurs. While these rules have been difficult to apply in practice, properly structured agreements can provide funding for research without undue risk. This Article discusses the multiple pieces of guidance put forth by the Internal Revenue Service to clarify the many issues and tiers of analysis necessary to ensure a properly-structured sponsored research agreement.

Team sponsors in community-based health leadership programs.

PubMed

Patterson, Tracy Enright; Dinkin, Donna R; Champion, Heather

2017-05-02

Purpose The purpose of this article is to share the lessons learned about the role of team sponsors in action-learning teams as part of community-based health leadership development programs. Design/methodology/approach This case study uses program survey results from fellow participants, action learning coaches and team sponsors to understand the value of sponsors to the teams, the roles they most often filled and the challenges they faced as team sponsors. Findings The extent to which the sponsors were perceived as having contributed to the work of the action learning teams varied greatly from team to team. Most sponsors agreed that they were well informed about their role. The roles sponsors most frequently played were to provide the teams with input and support, serve as a liaison to the community and serve as a sounding board, motivator and cheerleader. The most common challenges or barriers team sponsors faced in this role were keeping engaged in the process, adjusting to the role and feeling disconnected from the program. Practical implications This work provides insights for program developers and community foundations who are interested in building the capacity for health leadership by linking community sponsors with emerging leaders engaged in an action learning experience. Originality/value This work begins to fill a gap in the literature. The role of team sponsors has been studied for single organization work teams but there is a void of understanding about the role of sponsors with multi-organizational teams working to improve health while also learning about leadership.

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

PubMed

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-04-01

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

AGU Sponsors Two Congressional Science Fellows

NASA Astrophysics Data System (ADS)

Chell, Kaitlin

2010-06-01

AGU will sponsor not one, but two Congressional Science Fellows (CSF) for the 2010-2011 fellowship term. Beginning in September, Jason Day and Ilya Fischhoff each will spend a year working in the congressional office of a U.S. senator or representative or in the office of a congressional committee. Both fellows were selected in March by AGU's Committee on Public Affairs after a competitive interview process. Their terms will mark the 33rd year AGU has sponsored a CSF and the first year AGU has ever sponsored two CSFs at one time.

Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: Study protocol for prospective, randomized, controlled trial

PubMed Central

2012-01-01

Background The use of botulinum toxin A (BT-A) for the treatment of lower limb spasticity is common in children with cerebral palsy (CP). Following the administration of BT-A, physical therapy plays a fundamental role in potentiating the functionality of the child. The balance deficit found in children with CP is mainly caused by muscle imbalance (spastic agonist and weak antagonist). Neuromuscular electrical stimulation (NMES) is a promising therapeutic modality for muscle strengthening in this population. The aim of the present study is to describe a protocol for a study aimed at analyzing the effects of NMES on dorsiflexors combined with physical therapy on static and functional balance in children with CP submitted to BT- A. Methods/Design Protocol for a prospective, randomized, controlled trial with a blinded evaluator. Eligible participants will be children with cerebral palsy (Levels I, II and III of the Gross Motor Function Classification System) between five and 12 years of age, with independent gait with or without a gait-assistance device. All participants will receive BT-A in the lower limbs (triceps surae). The children will then be randomly allocated for either treatment with motor physical therapy combined with NMES on the tibialis anterior or motor physical therapy alone. The participants will be evaluated on three occasions: 1) one week prior to the administration of BT-A; 2) one week after the administration of BT-A; and 3) four months after the administration of BT-A (end of intervention). Spasticity will be assessed by the Modified Ashworth Scale and Modified Tardieu Scale. Static balance will be assessed using the Medicapteurs Fusyo pressure platform and functional balance will be assessed using the Berg Balance Scale. Discussion The aim of this protocol study is to describe the methodology of a randomized, controlled, clinical trial comparing the effect of motor physical therapy combined with NMES on the tibialis anterior muscle or motor

Lipid profiles of follicular fluid from cows submitted to ovarian superstimulation.

PubMed

Santos, P H; Fontes, P K; Franchi, F F; Nogueira, M F G; Belaz, K R A; Tata, A; Eberlin, M N; Sudano, M J; Barros, C M; Castilho, A C S

2017-05-01

Ovarian superstimulation with exogenous gonadotropins has been extensively used to produce in vivo-derived embryos for embryo transfer in cattle. This process modifies the antral follicle microenvironment and affects oocyte and embryo quality as well the differentiation of granulosa cells. Lipids play significant roles in the cell, such as energy storage, cell structure, and fine-tuning of the physical properties and functions of biological membranes. The phospholipid (PL) contents as well as the effects of superstimulatory treatments on the PL profile of follicular fluid from cows, however, remain unknown. Therefore, to gain insight into the effects of superstimulation with follicle-stimulating hormone (FSH; P-36 protocol) or FSH combined with equine chorionic gonadotropin (eCG; P-36/eCG protocol) on the profile and abundance of PL from cows submitted or not submitted to superstimulatory protocols, were treated with these two superstimulatory protocols. As a control, non-superstimulated cows were only submitted to estrous synchronization. The follicular fluid was aspirated, the remaining cells removed and the follicular fluid stored at -80 °C until extraction. The lipid screening was performed by matrix-assisted laser desorption ionization mass spectrometry (MALDI-MS) and this technique allowed the identification of sphingomyelins (SM) and phosphatidylcholines (PC) and phosphoethanolamines (PE). The relative abundance of the ions observed in the three experimental groups was analyzed by multivariate and univariate statistical models. The phospholipid SM (16:0) and PC (36:4) and/or PC (34:1) were less (P < 0.05) abundant in the P-36 group compared to the control or P-36/eCG groups. However, the PC (34:2) was more (P < 0.05) abundant in both group of superstimulated cows compared to the control. In summary, ovarian superstimulation seems to modulate the PL content of bovine follicular fluid with a significant increase in PC (34:2), which jointly with others

Diffusion-Weighted Imaging Outside the Brain: Consensus Statement From an ISMRM-Sponsored Workshop

PubMed Central

Taouli, Bachir; Beer, Ambros J.; Chenevert, Thomas; Collins, David; Lehman, Constance; Matos, Celso; Padhani, Anwar R.; Rosenkrantz, Andrew B.; Shukla-Dave, Amita; Sigmund, Eric; Tanenbaum, Lawrence; Thoeny, Harriet; Thomassin-Naggara, Isabelle; Barbieri, Sebastiano; Corcuera-Solano, Idoia; Orton, Matthew; Partridge, Savannah C.; Koh, Dow-Mu

2016-01-01

The significant advances in magnetic resonance imaging (MRI) hardware and software, sequence design, and postprocessing methods have made diffusion-weighted imaging (DWI) an important part of body MRI protocols and have fueled extensive research on quantitative diffusion outside the brain, particularly in the oncologic setting. In this review, we summarize the most up-to-date information on DWI acquisition and clinical applications outside the brain, as discussed in an ISMRM-sponsored symposium held in April 2015. We first introduce recent advances in acquisition, processing, and quality control; then review scientific evidence in major organ systems; and finally describe future directions. PMID:26892827

Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

PubMed

Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

2016-08-01

Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers

14 CFR 151.37 - Sponsor eligibility.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Sponsor eligibility. 151.37 Section 151.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRPORTS... particular airport a sponsor must— (a) Be a public agency, which includes for the purposes of this part only...

14 CFR 151.37 - Sponsor eligibility.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Sponsor eligibility. 151.37 Section 151.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRPORTS... particular airport a sponsor must— (a) Be a public agency, which includes for the purposes of this part only...

Evaluating alcoholics anonymous sponsor attributes using conjoint analysis.

PubMed

Stevens, Edward B; Jason, Leonard A

2015-12-01

Alcoholics Anonymous (AA) considers sponsorship an important element of the AA program, especially in early recovery. 225 adult individuals who had experience as either a sponsor, sponsee, or both, participated in a hypothetical sponsor ranking exercise where five attributes were varied across three levels. Conjoint analysis was used to compute part-worth utility of the attributes and their levels for experience, knowledge, availability, confidentiality, and goal-setting. Differences in utilities by attribute were found where confidentiality had the greatest overall possible impact on utility and sponsor knowledge had the least. These findings suggest qualitative differences in sponsors may impact their effectiveness. Future research on AA should continue to investigate sponsor influence on an individual's overall recovery trajectory. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Clinical safety data management in company non-sponsored trials].

PubMed

Saito, Akiko; Sakai, Junko; Kurihara, Masaaki; Kami, Masahiro; Kanda, Yoshinobu; Mori, Shin-ichiro; Takaue, Yoichi; Ohashi, Yasuo

2003-09-01

There is currently no harmonized way in Japan to manage safety data which are obtained during clinical trials supported by Government funds. There are two types of clinical trials, 'sponsored trials(sponsored by industrial companies)' and 'non-sponsored trials(funded by the Government, etc.)'. The Japanese Ministry of Health and Welfare has issued many of pharmaceutical laws(GCP, GPMSP etc.) for the regulation of sponsored trials, while none has ever established for non-sponsored trials, thus leaving the most important quality control/assurance unregulated. In this manuscript we discuss that the simple application of pharmaceutical laws to government-sponsored trials can not be a proper answer because of the different nature of the two types of trials.

A False-name-Proof Double Auction Protocol for Arbitrary Evaluation Values

NASA Astrophysics Data System (ADS)

Sakurai, Yuko; Yokoo, Makoto

We develop a new false-name-proof double auction protocol called the Generalized Threshold Price Double auction (GTPD) protocol. False-name-proofness generalizes strategy-proofness by incorporating the possibility of false-name bids, e.g., bids submitted using multiple e-mail addresses. An existing protocol called TPD protocol is false-name-proof but can handle only the cases where marginal utilities of each agent always decrease, while our new GTPD protocol can handle arbitrary evaluation values. When marginal utilities can increase, some bids cannot be divided into a single unit (e.g., an all-or-nothing bid). Due to the existence of such indivisible bids, meeting supply/demand becomes difficult. Furthermore, a seller/buyer can submit a false-name-bid by pretending to be a potential buyer/seller to manipulate allocations and payments. In the GTPD protocol, the auctioneer is required to absorb the supply-demand imbalance up to a given upper-bound. Also, the GTPD incorporate a new false-name-proof one-sided auction protocol that is guaranteed to sell/buy a certain number of units. Simulation results show that when the threshold price is set appropriately, this protocol can obtain a good social surplus, and the number of absorbed units is much smaller than the given upper-bound.

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2015-12-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

PubMed Central

Chan, An-Wen; Tetzlaff, Jennifer M.; Altman, Douglas G.; Laupacis, Andreas; Gøtzsche, Peter C.; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A.; Doré, Caroline J.; Parulekar, Wendy R.; Summerskill, William S.M.; Groves, Trish; Schulz, Kenneth F.; Sox, Harold C.; Rockhold, Frank W.; Rennie, Drummond; Moher, David

2016-01-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders. PMID:23295957

SPIRIT 2013 statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Doré, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2013-02-05

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

45 CFR 233.51 - Eligibility of sponsored aliens.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 2 2011-10-01 2011-10-01 false Eligibility of sponsored aliens. 233.51 Section... CONDITIONS OF ELIGIBILITY IN FINANCIAL ASSISTANCE PROGRAMS § 233.51 Eligibility of sponsored aliens... affidavit(s) of support or similar agreement on behalf of an alien (who is not the child of the sponsor or...

45 CFR 233.51 - Eligibility of sponsored aliens.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 2 2012-10-01 2012-10-01 false Eligibility of sponsored aliens. 233.51 Section... CONDITIONS OF ELIGIBILITY IN FINANCIAL ASSISTANCE PROGRAMS § 233.51 Eligibility of sponsored aliens... affidavit(s) of support or similar agreement on behalf of an alien (who is not the child of the sponsor or...

45 CFR 233.51 - Eligibility of sponsored aliens.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 2 2010-10-01 2010-10-01 false Eligibility of sponsored aliens. 233.51 Section... CONDITIONS OF ELIGIBILITY IN FINANCIAL ASSISTANCE PROGRAMS § 233.51 Eligibility of sponsored aliens... affidavit(s) of support or similar agreement on behalf of an alien (who is not the child of the sponsor or...

Ethos and Vision Realization in Sponsored Academy Schools

ERIC Educational Resources Information Center

Gibson, Mark T.

2015-01-01

This article investigates the realization of ethos and vision in the early stages of sponsored academy schools in England. It is a qualitative nested case study of ten academies. Nineteen key actors were interviewed, including principals and sponsor representatives. The nests were organized by sponsor type. Key themes are discussed within the…

45 CFR 233.51 - Eligibility of sponsored aliens.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 2 2014-10-01 2012-10-01 true Eligibility of sponsored aliens. 233.51 Section 233... CONDITIONS OF ELIGIBILITY IN FINANCIAL ASSISTANCE PROGRAMS § 233.51 Eligibility of sponsored aliens... affidavit(s) of support or similar agreement on behalf of an alien (who is not the child of the sponsor or...

45 CFR 233.51 - Eligibility of sponsored aliens.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 2 2013-10-01 2012-10-01 true Eligibility of sponsored aliens. 233.51 Section 233... CONDITIONS OF ELIGIBILITY IN FINANCIAL ASSISTANCE PROGRAMS § 233.51 Eligibility of sponsored aliens... affidavit(s) of support or similar agreement on behalf of an alien (who is not the child of the sponsor or...

14 CFR 152.103 - Sponsors: Airport development.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Sponsors: Airport development. 152.103 Section 152.103 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... Sponsors: Airport development. (a) To be eligible to apply for a project for airport development with...

14 CFR 152.103 - Sponsors: Airport development.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Sponsors: Airport development. 152.103 Section 152.103 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... Sponsors: Airport development. (a) To be eligible to apply for a project for airport development with...

45 CFR 1226.13 - Obligations of sponsors.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Obligations of sponsors. 1226.13 Section 1226.13 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR NATIONAL AND COMMUNITY SERVICE PROHIBITIONS ON ELECTORAL AND LOBBYING ACTIVITIES Sponsor Employee Activities § 1226.13...

48 CFR 35.017-1 - Sponsoring agreements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Sponsoring agreements. 35... CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 35.017-1 Sponsoring agreements. (a) In order... mission, and ensure a periodic reevaluation of the FFRDC, a written agreement of sponsorship between the...

48 CFR 35.017-1 - Sponsoring agreements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Sponsoring agreements. 35... CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 35.017-1 Sponsoring agreements. (a) In order... mission, and ensure a periodic reevaluation of the FFRDC, a written agreement of sponsorship between the...

48 CFR 35.017-1 - Sponsoring agreements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Sponsoring agreements. 35... CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 35.017-1 Sponsoring agreements. (a) In order... mission, and ensure a periodic reevaluation of the FFRDC, a written agreement of sponsorship between the...

14 CFR 152.103 - Sponsors: Airport development.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Sponsors: Airport development. 152.103... (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.103 Sponsors: Airport development. (a) To be eligible to apply for a project for airport development with...

14 CFR 152.103 - Sponsors: Airport development.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Sponsors: Airport development. 152.103... (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.103 Sponsors: Airport development. (a) To be eligible to apply for a project for airport development with...

14 CFR 152.103 - Sponsors: Airport development.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Sponsors: Airport development. 152.103... (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.103 Sponsors: Airport development. (a) To be eligible to apply for a project for airport development with...

42 CFR 423.401 - General requirements for PDP sponsors.

Code of Federal Regulations, 2010 CFR

2010-10-01

... with State Law and Preemption by Federal Law § 423.401 General requirements for PDP sponsors. (a... sponsor is organized and licensed under State law as a risk bearing entity eligible to offer health... otherwise licensed, the sponsor obtains certification from the State that the organization meets a level of...

Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov.

PubMed

Stretton, Serina; Lew, Rebecca A; Ely, Julie A; Snape, Mark J; Carey, Luke C; Haley, Cassandra; Woolley, Mark J; Woolley, Karen L

2016-01-01

We investigated whether sponsor-imposed publication restrictions for ClinicalTrials.gov trials were reasonable, based on consistency with Good Publication Practice 2 (GPP2). ClinicalTrials.gov trial record data were electronically imported (October 7, 2012) and screened for eligibility (phase 2-4, interventional, recruitment closed, results available, first received for registration after November 10, 2009, any sponsor type, investigators not sponsor employees). Two authors categorized restrictions information as consistent or not consistent with GPP2, resolving discrepancies by consensus. Of the eligible trials (388/484, n = 81,768 participants), 80.7% (313/388) had restrictions disclosed, and 92.5% (311/388) were industry-sponsored. Significantly more trials had restrictions that were consistent with GPP2 than not (74.1% [232/313], n = 55,280 participants vs. 25.9% [81/313], n = 19,677 participants; P < .001). Reasons for inconsistency were insufficient, unclear, or ambiguous information (48.1%, 39/81), sponsor-required approval for publication (35.8%, 29/81), sponsor-required text changes (8.6%, 7/81), and outright bans (7.4%, 6/81). Follow-up of trials with insufficient information and a contact email (response rate, 46.9% [15/32]) revealed 2 additional bans. A total of 776 participants had consented to trials that had publication bans. Many, but not all, sponsor-imposed publication restrictions disclosed on ClinicalTrials.gov may be considered reasonable. Sponsors should ensure restrictions are appropriately disclosed. Volunteers should be alerted to any restrictions before consenting to participate in a clinical trial.

Effect of using reporting guidelines during peer review on quality of final manuscripts submitted to a biomedical journal: masked randomised trial

PubMed Central

Cortés, J; Ribera, J M; Cardellach, F; Selva-O’Callaghan, A; Kostov, B; García, L; Cirugeda, L; Altman, D G; González, J A; Sànchez, J A; Miras, F; Urrutia, A; Fonollosa, V; Rey-Joly, C; Vilardell, M

2011-01-01

hypothesised and not definitively demonstrated. Authors adhere more to suggestions from conventional reviews than to those from additional reviews, showing difficulties in adhering to high methodological standards at the latest research phases. To boost paper quality and impact, authors should be aware of future requirements of reporting guidelines at the very beginning of their study. Trial registration and protocol Although registries do not include trials of peer review, the protocol design was submitted to sponsored research projects (Instituto de Salud Carlos III, PI081903). PMID:22108262

7 CFR 225.12 - Claims against sponsors.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 4 2010-01-01 2010-01-01 false Claims against sponsors. 225.12 Section 225.12 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.12 Claims against sponsors. (a) The State agency...

Can the ministry collaborate to form the "next generation" of sponsors?

PubMed

Stanley, Teresa

2007-01-01

In looking to the future of sponsored ministry of Catholic institutions, the formation of future sponsors--both religious and lay alike--is an important issue. As this ministry continues to evolve, and sponsoring groups determine how best to prepare new sponsors, might it not be time to think about how to pool the ministry's collective wisdom on formation? Sponsors act not only in the name of the health care institution (or other ministry) but on behalf of the faith community engaged in continuing the compassionate healing ministry of Jesus. In Catholic ministry, and particularly health care ministry, sponsors carry out their responsibilities through a multiplicity of organizational relationships. Just as structures differ, so too do criteria that guide who will be called to join a sponsoring group. There are several core elements that are incorporated in the majority of sponsor competency sets. Elements identified by a committee of ministry members, and reviewed by hundreds of sponsors and other ministry leaders are: mission oriented, animated, theologically grounded, collaborative, church related, and accountable. If one is looking at the potential for convening dialogues about possible areas of collaboration in formation, these core elements, with examples of how they are lived out, may offer an outline of areas new sponsors might need to learn more about for their personal and professional development. Our Catholic health ministry depends on leaders who can create and steward organizational cultures that incarnate Jesus' healing. The possibilities for collaboration in the formation of future sponsors are endless, but there are challenges. If you are a member of a sponsor body/council/corporate member in Catholic health care, and are interested in nominating potential persons to take part in a representative group that would discuss possibilities for collaboration in sponsor formation, please go to www.chausa.org/sponsorformation and complete all sections of the

Benefits of Addressing HFCs under the Montreal Protocol 2014

EPA Pesticide Factsheets

The United States, Canada, and Mexico together submitted a proposal in April 2015 to phase-down production and consumption of hydrofluorocarbons (HFCs) under the Montreal Protocol. This paper presents an analysis of the potential benefits of such action.

22 CFR 211.5 - Obligations of cooperating sponsor.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Standards promulgated by the International Organization of Supreme Audit Institutions or International... provisions of this regulation. (c) Audits—(1) By nongovernmental cooperating sponsors. A nongovernmental cooperating sponsor shall arrange for periodic audits to be conducted in accordance with OMB Circular A-133...

22 CFR 211.5 - Obligations of cooperating sponsor.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Standards promulgated by the International Organization of Supreme Audit Institutions or International... provisions of this regulation. (c) Audits—(1) By nongovernmental cooperating sponsors. A nongovernmental cooperating sponsor shall arrange for periodic audits to be conducted in accordance with OMB Circular A-133...

22 CFR 211.5 - Obligations of cooperating sponsor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Standards promulgated by the International Organization of Supreme Audit Institutions or International... provisions of this regulation. (c) Audits—(1) By nongovernmental cooperating sponsors. A nongovernmental cooperating sponsor shall arrange for periodic audits to be conducted in accordance with OMB Circular A-133...

22 CFR 211.5 - Obligations of cooperating sponsor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Standards promulgated by the International Organization of Supreme Audit Institutions or International... provisions of this regulation. (c) Audits—(1) By nongovernmental cooperating sponsors. A nongovernmental cooperating sponsor shall arrange for periodic audits to be conducted in accordance with OMB Circular A-133...

22 CFR 211.5 - Obligations of cooperating sponsor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Standards promulgated by the International Organization of Supreme Audit Institutions or International... provisions of this regulation. (c) Audits—(1) By nongovernmental cooperating sponsors. A nongovernmental cooperating sponsor shall arrange for periodic audits to be conducted in accordance with OMB Circular A-133...

Should Sponsors and DSMBs Share Interim Results Across Trials?

PubMed Central

Shah, Seema K.; Dawson, Liza; Dixon, Dennis O.; Lie, Reidar K.

2011-01-01

Increasing numbers of multinational clinical trials have generated new ethical obligations of research sponsors and their DSMBs. Although sponsors and DSMBs clearly have ethical obligations to protect subjects in their trials, future patients, and the integrity of their trial, the obligations they have to protect subjects in other trials have been overlooked. When interim results from clinical trials can significantly affect the conduct of other trials and the welfare of the subjects in those trials, sponsors and DSMBs may have obligations to disclose results to the relevant parties. We propose that sponsors and DSMBs routinely work together in advance to develop a plan for disclosing relevant information in cases where it is necessary to protect the welfare of subjects in other trials. Channels of communication between sponsors, DSMBs, IRBs, and others involved in similar and concurrent trials will better protect both research participants and the integrity of the research enterprise. PMID:21937922

45 CFR 149.600 - Sponsor's duty to report data inaccuracies.

Code of Federal Regulations, 2014 CFR

2014-10-01

... HEALTH CARE ACCESS REQUIREMENTS FOR THE EARLY RETIREE REINSURANCE PROGRAM Disclosure of Data Inaccuracies § 149.600 Sponsor's duty to report data inaccuracies. A sponsor is required to disclose any data... 45 Public Welfare 1 2014-10-01 2014-10-01 false Sponsor's duty to report data inaccuracies. 149...

45 CFR 149.600 - Sponsor's duty to report data inaccuracies.

Code of Federal Regulations, 2012 CFR

2012-10-01

... HEALTH CARE ACCESS REQUIREMENTS FOR THE EARLY RETIREE REINSURANCE PROGRAM Disclosure of Data Inaccuracies § 149.600 Sponsor's duty to report data inaccuracies. A sponsor is required to disclose any data... 45 Public Welfare 1 2012-10-01 2012-10-01 false Sponsor's duty to report data inaccuracies. 149...

Government-Sponsored Programs on Structures Technology

NASA Technical Reports Server (NTRS)

Noor, Ahmed K. (Compiler); Malone, John B. (Compiler)

1997-01-01

This document contains the presentations from the joint UVA/AIAA workshops on Government-Sponsored Programs on Structures Technology, held on April 6, 1997 in Kissimmee, Florida and on September 4, 1997 in Hampton, Virginia. Workshop attendees were the Members and Friends of the AIAA Structures Technical Committee. The objectives of the workshops were to: (a) provide a forum for discussion of current government-sponsored programs in the structures area; (b) identify high-potential research areas for future aerospace systems; and (c) initiate suitable interaction mechanisms with the managers of structures programs.

The Sponsors of Literacy. Report Series 7.12.

ERIC Educational Resources Information Center

Brandt, Deborah

Intuitively, "sponsors" seems a fitting term for the figures who turned up most typically in people's memories of literacy learning: older relatives, teachers, priests, supervisors, military officers, editors, influential authors. The concept of sponsors helps to explain a range of human relationships and ideological pressures that turn…

Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials.

PubMed

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time. We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry-sponsored international trials. 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry-sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry-sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry-sponsored trials (from 42.4% to 37.2%). Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry-sponsored clinical research. Only 3% of academic trials but 30% of industry trials are

Differential Globalization of Industry- and Non-Industry–Sponsored Clinical Trials

PubMed Central

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Background Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry–sponsored clinical trials and its evolution over time. Methods We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry–sponsored international trials. Results 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry–sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry–sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry–sponsored trials (from 42.4% to 37.2%). Conclusions Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry–sponsored clinical research. Only 3% of

Employer-Sponsored Child Care Models and Related Issues.

ERIC Educational Resources Information Center

Renfroe, Martha Lou

This study was designed to describe the different models of Employer-Sponsored Child Care (ESCC) available to employers and child care professionals. Examples of specific child care programs sponsored by employers are described, and five ESCC models are identified: on-site and off-site centers for a single employer, off-site centers for multiple…

An Exploratory Investigation of Important Qualities and Characteristics of Alcoholics Anonymous Sponsors.

PubMed

Stevens, Edward B; Jason, Leonard A

Alcoholics Anonymous recommends members to have sponsors, especially those early in their recovery, yet little research has been done on the qualities of an effective sponsor. 245 adults (117 females, 128 males) currently in substance use disorder recovery participated. 231 of these individuals had experience as a sponsor, sponsee or both (109 had experience as a sponsor). Qualitative results suggest effective sponsors are currently engaged in the program on a personal level, are trustworthy, and are available although a wide variety of attributes were cited. In a choice and ranking exercise, 12- step engagement and qualities of character were also most often ranked highly. No significant differences were found between genders or sponsor/sponsee roles. Implications based on breadth of responses and dominant themes are discussed as well as the need for further research on sponsor/sponsee characteristics, satisfaction, and recovery outcomes.

An Experiential Social Media Project: Comparing Client-Sponsored and Non-Client-Sponsored Alternatives

ERIC Educational Resources Information Center

Vinuales, Gema; Harris, Judy

2017-01-01

Students implemented social media campaigns to raise awareness and funds for nonprofit organizations. Teams in one section of the course worked on a designated client-sponsored project (CSP), while teams in another section chose their own nonprofit organizations. Although both the CSPs and non-CSPs were evaluated favorably, students who worked on…

42 CFR 423.510 - Termination of contract by the Part D sponsor.

Code of Federal Regulations, 2010 CFR

2010-10-01

... to the Part D plan sponsor ends as of the first day of the month after the last month for which the... 42 Public Health 3 2010-10-01 2010-10-01 false Termination of contract by the Part D sponsor. 423... Procedures and Contracts with Part D plan sponsors § 423.510 Termination of contract by the Part D sponsor...

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan

Unfulfilled translation opportunities in industry sponsored clinical trials.

PubMed

Smed, Marie; Getz, Kenneth A

2013-05-01

Knowledge generated by site representatives through their participation in clinical trials is valuable for testing new products in use and obtaining final market approval. The leverage of this important knowledge is however challenged as the former direct relationships between in-house staff in the industry and site representatives are changing. The process of clinical trials has increased in complexity over the years, resulting in additional management layers. Besides an increase in internal management layers, sponsors often also outsource various tasks related to clinical trials to a CRO (Contract Research Organization) and thereby adding another link in the relationships between site and sponsor. These changes are intended to optimize the time-consuming and costly trial phases; however, there is a need to study whether valuable knowledge and experience is compromised in the process. Limited research exists on the full range of clinical practice insights obtained by investigators during and after clinical trials and how well these insights are transferred to study sponsors. This study explores the important knowledge-transfer processes between sites and sponsors and to what extent sites' knowledge gained in clinical trials is utilized by the industry. Responses from 451 global investigative site representatives are included in the study. The analysis of the extensive dataset reveals that the current processes of collaboration between sites and the industry restrict the leverage of valuable knowledge gained by physicians in the process of clinical trials. These restrictions to knowledge-transfer between site and sponsor are further challenged if CRO partners are integrated in the trial process. Copyright © 2013 Elsevier Inc. All rights reserved.

21 CFR 660.6 - Samples; protocols; official release.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Hepatitis B Surface Antigen § 660.6 Samples; protocols; official release. (a) Samples. (1) For the purposes... of official release is no longer required under paragraph (c)(2) of this section. (ii) One sample at... required under paragraph (c)(2) of this section. The sample submitted at the 90-day interval shall be from...

21 CFR 660.6 - Samples; protocols; official release.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Hepatitis B Surface Antigen § 660.6 Samples; protocols; official release. (a) Samples. (1) For the purposes... of official release is no longer required under paragraph (c)(2) of this section. (ii) One sample at... required under paragraph (c)(2) of this section. The sample submitted at the 90-day interval shall be from...

21 CFR 660.6 - Samples; protocols; official release.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Hepatitis B Surface Antigen § 660.6 Samples; protocols; official release. (a) Samples. (1) For the purposes... of official release is no longer required under paragraph (c)(2) of this section. (ii) One sample at... required under paragraph (c)(2) of this section. The sample submitted at the 90-day interval shall be from...

IMPACT OF BODY WEIGHT CHANGE ON THE EDSTAC TIER 1 MALE AND FEMALE PUBERTAL PROTOCOLS

EPA Science Inventory

IMPACT OF BODY WEIGHT CHANGE ON THE EDSTAC TIER I MALE AND FEMALE PUBERTAL PROTOCOLS. R.L. Cooper, T.E. Stoker, K. McElroy, J. Ferrell, K. Leffler, K. Bremser and S.C. Laws. Endocrinology Branch, Reproductive Toxicology Division, NHEERL, ORD, USEPA, RTP, NC. Sponsor: R.J. Kavl...

42 CFR 440.350 - Employer-sponsored insurance health plans.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Employer-sponsored insurance health plans. 440.350 Section 440.350 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... Benchmark-Equivalent Coverage § 440.350 Employer-sponsored insurance health plans. (a) A State may provide...

42 CFR 440.350 - Employer-sponsored insurance health plans.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Employer-sponsored insurance health plans. 440.350 Section 440.350 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... Benchmark-Equivalent Coverage § 440.350 Employer-sponsored insurance health plans. (a) A State may provide...

Diabetes in employer-sponsored health insurance.

PubMed

Peele, Pamela B; Lave, Judith R; Songer, Thomas J

2002-11-01

To examine medical and mental health care expenditures for large numbers of individuals with diabetes enrolled in employment-sponsored insurance plans. Health insurance billing data for approximately 1.3 million individuals enrolled in health insurance plans sponsored by 862 large self-insured employers nationwide were used to examine employer expenditures and consumer out-of-pocket payments for 20,937 people identified with diabetes. These expenditures were compared with expenditures for individuals with other chronic illnesses. Main outcome measures were covered charges, insurance plan reimbursements, and estimated consumer out-of-pocket payments for both medical and mental health services. A total of 1.7% of enrollees were identified as having diabetes and approximately 11% of those used at least one mental health service during 1996. Health care expenditures were three times higher for those with diabetes compared with all health care consumers in these insurance plans, but when compared with individuals with other chronic illnesses such as heart disease, HIV/AIDS, cancer, and asthma, those with diabetes were not more expensive for employers' insurance plans. Diabetes accounts for 6.5% of total health plan expenditures. Diabetes is not more expensive for either consumers or their employer-sponsored insurance plans than other chronic illnesses.

Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation.

PubMed

Psaty, Bruce M; Kronmal, Richard A

2008-04-16

. The data submitted by the sponsor to the FDA in a Safety Update Report in July 2001 used on-treatment analysis methods and reported 29 deaths (2.7%) among 1067 rofecoxib patients and 17 deaths (1.6%) among 1075 placebo patients. This on-treatment approach to reporting minimized the appearance of any mortality risk. In December 2001, when the FDA raised safety questions about the submitted safety data, the sponsor did not bring these issues to an institutional review board for review and revealed that there was no data and safety monitoring board for the protocol 078 study. The findings from this case study suggest that additional protections for human research participants, including new approaches for the conduct, oversight, and reporting of industry-sponsored trials, are necessary.

Characteristics of NIH- and industry-sponsored head and neck cancer clinical trials.

PubMed

Devaiah, Anand; Murchison, Charles

2016-09-01

Compare U.S. clinical trials sponsored by the National Institutes of Health (NIH) and industry, especially with regard to trial design, interventions studied, and results reporting rates. U.S. head and neck cancer clinical trials. We used information from ClinicalTrials.gov to compare NIH- and industry-sponsored head and neck cancer clinical trials, specifically analyzing differences in trial design and interventions studied. We examined publication rates and positive results rates using PubMed.gov. About 50% of NIH- and industry-sponsored clinical trials have their results reported in peer-reviewed literature. Industry-sponsored trials had higher rates of positive results than NIH-sponsored trials. NIH- and industry-sponsored clinical trials had similar trial designs, although industry-sponsored trials had significantly lower rates of randomization. Industry trials utilized radiation in 19% of trials and surgery in 2% of trials. NIH trials also had low utilization of both radiation and surgery (27% and 12% of trials, respectively). NIH- and industry-sponsored trials published their results in journals with comparable impact factors. There is significant underreporting of results in U.S. head and neck cancer clinical trials, whether sponsored by NIH or industry. Industry trials have significantly higher rates of positive results, although it is unclear what contributes to this. Both NIH- and industry-sponsored trials underutilize surgery and radiation as treatment modalities, despite the fact that these are standard-of-care therapies for head and neck cancer. We recommend that the NIH and industry report all results from clinical trials and use surgery and radiation as treatment arms in order to arrive at more balanced therapeutic recommendations. N/A. Laryngoscope, 126:E300-E303, 2016. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

14 CFR 151.113 - Advance planning proposals: Sponsor eligibility.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Engineering Proposals § 151.113 Advance planning proposals: Sponsor eligibility. The sponsor of an advance planning and engineering proposal must be a public agency, as defined in § 151.37(a), and must be legally... agreement; (c) Provide enough funds to pay all estimated proposal costs not borne by the United States; and...

14 CFR 151.113 - Advance planning proposals: Sponsor eligibility.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Engineering Proposals § 151.113 Advance planning proposals: Sponsor eligibility. The sponsor of an advance planning and engineering proposal must be a public agency, as defined in § 151.37(a), and must be legally... agreement; (c) Provide enough funds to pay all estimated proposal costs not borne by the United States; and...

76 FR 2807 - New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone AGENCY...) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug... currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, Sec...

The State-Sponsored Student Entrepreneur

ERIC Educational Resources Information Center

Mars, Matthew M.; Slaughter, Sheila; Rhoades, Gary

2008-01-01

This paper introduces the emergent role of the state-sponsored student entrepreneur within the academic capitalist knowledge/learning regime. Drawing on two clarifying cases of such entrepreneurship, the study explores the shifting boundaries between public and private sectors, the creation of new circuits of knowledge, and the entrepreneurial…

Emergency medicine leadership in industry-sponsored clinical trials.

PubMed

Newgard, Craig D; Kim, Sunghye; Camargo, Carlos A

2003-02-01

To identify and characterize emergency medicine (EM) researchers who, since 1990, have served on a steering committee (SC) or as overall principal investigator (PI) of an industry-sponsored, multicenter clinical trial involving a pharmaceutical or device. North American EM research directors (RDs) and other prominent EM investigators (for those hospitals without a RD) were identified from eight sources, including the Society for Academic Emergency Medicine RD Interest Group and the Multicenter Airway Research Collaboration (MARC) database. The identified investigators were sent a screening survey requesting information regarding industry-sponsored clinical research at their site. The individual EM investigators identified by this screening survey were then interviewed by telephone (validation survey) to further explore their leadership experience in industry-sponsored clinical trials. Of 153 identified RDs and prominent EM researchers, 138 responded to the screening survey (90% response rate). Eighty-five EM investigators reportedly had served on a SC or as overall PI for an industry-sponsored clinical trial. Of these 85 North American EM investigators, 77 were available for a structured telephone interview (91% response rate). Although 41 (53%) of the investigators confirmed their leadership role, 36 (47%) had not served in either role. Among the 41 confirmed investigators, 19 (25%) had served as a SC member, 10 (13%) had served as overall PI, and 12 (16%) had experience in both roles. Individual responses provided suggestions for pursuing such leadership positions. These data suggest the opportunity to expand EM leadership in industry-sponsored clinical trials and demonstrate the need for validation of reports obtained by a departmental research contact. The suggestions from EM researchers who have attained these leadership roles may provide strategies for investigators interested in pursuing these positions.

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.

PubMed

Engel, Pierre; Almas, Mariana Ferreira; De Bruin, Marieke Louise; Starzyk, Kathryn; Blackburn, Stella; Dreyer, Nancy Ann

2017-04-01

To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages. During the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. To the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines. © 2016 The British Pharmacological Society.

45 CFR 2552.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false May a sponsor serve as a volunteer station? 2552... NATIONAL AND COMMUNITY SERVICE FOSTER GRANDPARENT PROGRAM Responsibilities of a Volunteer Station § 2552.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2551.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false May a sponsor serve as a volunteer station? 2551... NATIONAL AND COMMUNITY SERVICE SENIOR COMPANION PROGRAM Responsibilities of a Volunteer Station § 2551.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2552.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false May a sponsor serve as a volunteer station? 2552... NATIONAL AND COMMUNITY SERVICE FOSTER GRANDPARENT PROGRAM Responsibilities of a Volunteer Station § 2552.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2552.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false May a sponsor serve as a volunteer station? 2552... NATIONAL AND COMMUNITY SERVICE FOSTER GRANDPARENT PROGRAM Responsibilities of a Volunteer Station § 2552.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2551.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false May a sponsor serve as a volunteer station? 2551... NATIONAL AND COMMUNITY SERVICE SENIOR COMPANION PROGRAM Responsibilities of a Volunteer Station § 2551.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2551.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false May a sponsor serve as a volunteer station? 2551... NATIONAL AND COMMUNITY SERVICE SENIOR COMPANION PROGRAM Responsibilities of a Volunteer Station § 2551.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2551.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false May a sponsor serve as a volunteer station? 2551... NATIONAL AND COMMUNITY SERVICE SENIOR COMPANION PROGRAM Responsibilities of a Volunteer Station § 2551.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2551.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false May a sponsor serve as a volunteer station? 2551... NATIONAL AND COMMUNITY SERVICE SENIOR COMPANION PROGRAM Responsibilities of a Volunteer Station § 2551.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2552.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false May a sponsor serve as a volunteer station? 2552... NATIONAL AND COMMUNITY SERVICE FOSTER GRANDPARENT PROGRAM Responsibilities of a Volunteer Station § 2552.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2552.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false May a sponsor serve as a volunteer station? 2552... NATIONAL AND COMMUNITY SERVICE FOSTER GRANDPARENT PROGRAM Responsibilities of a Volunteer Station § 2552.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

"Food company sponsors are kind, generous and cool": (mis)conceptions of junior sports players.

PubMed

Kelly, Bridget; Baur, Louise A; Bauman, Adrian E; King, Lesley; Chapman, Kathy; Smith, Ben J

2011-09-05

Children's exposure to unhealthy food marketing influences their food knowledge, preferences and consumption. Sport sponsorship by food companies is widespread and industry investment in this marketing is increasing. This study aimed to assess children's awareness of sport sponsors and their brand-related attitudes and purchasing intentions in response to this marketing. Sports clubs known to have food sponsors and representing the most popular sports for Australian children across a range of demographic areas were recruited. Interview-based questionnaires were conducted at clubs with children aged 10-14 years (n = 103) to examine their recall of local sports club and elite sport sponsors, and their attitudes towards sponsors and sponsorship activities. Most children (68%) could recall sponsors of their sports club, naming a median of two sponsors, including a median of one food company sponsor each. Almost half (47%) of children could recall any sponsors of their favourite elite sporting team. Children aged 10-11 years were more likely than older children to report that they thought about sponsors when buying something to eat or drink (P < 0.01); that they liked to return the favour to sponsors by buying their products (P < 0.01); and that sponsors were 'cool' (P = 0.02). Most children had received a voucher or certificate from a food or beverage company to reward sport performance (86% and 76%, respectively). Around one-third of children reported liking the company more after receiving these rewards. Children's high recall of food and beverage company sport sponsors and their positive attitudes towards these sponsors and their promotions is concerning as this is likely to be linked to children's food preferences and consumption. Limiting children's exposure to this marketing is an important initiative to improve children's nutrition.

"Food company sponsors are kind, generous and cool": (Mis)conceptions of junior sports players

PubMed Central

2011-01-01

Background Children's exposure to unhealthy food marketing influences their food knowledge, preferences and consumption. Sport sponsorship by food companies is widespread and industry investment in this marketing is increasing. This study aimed to assess children's awareness of sport sponsors and their brand-related attitudes and purchasing intentions in response to this marketing. Methods Sports clubs known to have food sponsors and representing the most popular sports for Australian children across a range of demographic areas were recruited. Interview-based questionnaires were conducted at clubs with children aged 10-14 years (n = 103) to examine their recall of local sports club and elite sport sponsors, and their attitudes towards sponsors and sponsorship activities. Results Most children (68%) could recall sponsors of their sports club, naming a median of two sponsors, including a median of one food company sponsor each. Almost half (47%) of children could recall any sponsors of their favourite elite sporting team. Children aged 10-11 years were more likely than older children to report that they thought about sponsors when buying something to eat or drink (P < 0.01); that they liked to return the favour to sponsors by buying their products (P < 0.01); and that sponsors were 'cool' (P = 0.02). Most children had received a voucher or certificate from a food or beverage company to reward sport performance (86% and 76%, respectively). Around one-third of children reported liking the company more after receiving these rewards. Conclusions Children's high recall of food and beverage company sport sponsors and their positive attitudes towards these sponsors and their promotions is concerning as this is likely to be linked to children's food preferences and consumption. Limiting children's exposure to this marketing is an important initiative to improve children's nutrition. PMID:21888675

Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

PubMed Central

Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

2017-01-01

Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

PubMed

Spelsberg, Angela; Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

2017-02-07

 To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act.  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.  Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions.  Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals.  Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the

78 FR 25279 - Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

... abbreviated new animal drug applications submitted to the Center for Veterinary Medicine, FDA. DATES: Submit....) Although over the last 5 fiscal years all sponsors chose to submit traditional ANADAs, some sponsors did...

Understanding the reporting practices of CAHPS sponsors.

PubMed

Teleki, Stephanie S; Kanouse, David E; Elliott, Marc N; Hiatt, Liisa; de Vries, Han; Quigley, Denise D

2007-01-01

This article examines the reporting of Consumer Assessment of Healthcare Providers and Systems (CAHPSO) consumer experience data by sponsors, those that fund data collection and decide how information is summarized and disseminated. We found that sponsors typically publicly reported comparative data to consumers, employers, and/or purchasers. They presented health plan-level data in print and online at least annually, usually in combination with non-CAHPS information. Many provided trend data, comparisons to individual plans, and summary scores. Most shared information consistent with known successful reporting practices. Areas meriting attention include: tailoring reports to specific audiences, assessing literacy, planning dissemination, educating vendors, and evaluating products and programs.

14 CFR 152.105 - Sponsors and planning agencies: Airport planning.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Sponsors and planning agencies: Airport... TRANSPORTATION (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.105 Sponsors and planning agencies: Airport planning. (a) To be eligible to apply for a project for...

14 CFR 152.105 - Sponsors and planning agencies: Airport planning.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Sponsors and planning agencies: Airport... TRANSPORTATION (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.105 Sponsors and planning agencies: Airport planning. (a) To be eligible to apply for a project for...

14 CFR 152.105 - Sponsors and planning agencies: Airport planning.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Sponsors and planning agencies: Airport... TRANSPORTATION (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.105 Sponsors and planning agencies: Airport planning. (a) To be eligible to apply for a project for...

14 CFR 152.105 - Sponsors and planning agencies: Airport planning.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Sponsors and planning agencies: Airport... TRANSPORTATION (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.105 Sponsors and planning agencies: Airport planning. (a) To be eligible to apply for a project for...

45 CFR 2552.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2010 CFR

2010-10-01

... § 2552.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Foster Grandparent Program as specified...

45 CFR 2552.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2013 CFR

2013-10-01

... § 2552.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Foster Grandparent Program as specified...

45 CFR 2552.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2014 CFR

2014-10-01

... § 2552.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Foster Grandparent Program as specified...

45 CFR 2552.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2012 CFR

2012-10-01

... § 2552.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Foster Grandparent Program as specified...

45 CFR 2552.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2011 CFR

2011-10-01

... § 2552.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Foster Grandparent Program as specified...

31 CFR 1030.210 - Anti-money laundering programs for housing government sponsored enterprises.

Code of Federal Regulations, 2014 CFR

2014-07-01

... activities. The program must be approved by senior management. A housing government sponsored enterprise... housing government sponsored enterprises. 1030.210 Section 1030.210 Money and Finance: Treasury... TREASURY RULES FOR HOUSING GOVERNMENT SPONSORED ENTERPRISES Programs § 1030.210 Anti-money laundering...

Robust Multi-unit Auction Protocol against False-name Bids

NASA Astrophysics Data System (ADS)

Yokoo, Makoto; Sakurai, Yuko; Matsubara, Shigeo

This paper presents a new multi-unit auction protocol (IR protocol) that is robust against false-name bids. Internet auctions have become an integral part of Electronic Commerce and a promising field for applying agent and Artificial Intelligence technologies. Although the Internet provides an excellent infrastructure for executing auctions, the possibility of a new type of cheating called false-name bids has been pointed out. A false-name bid is a bid submitted under a fictitious name. A protocol called LDS has been developed for combinatorial auctions of multiple different items and has proven to be robust against false-name bids. Although we can modify the LDS protocol to handle multi-unit auctions, in which multiple units of an identical item are auctioned, the protocol is complicated and requires the auctioneer to carefully pre-determine the combination of bundles to obtain a high social surplus or revenue. For the auctioneer, our newly developed IR protocol is easier to use than the LDS, since the combination of bundles is automatically determined in a flexible manner according to the declared evaluation values of agents. The evaluation results show that the IR protocol can obtain a better social surplus than that obtained by the LDS protocol.

14 CFR 152.105 - Sponsors and planning agencies: Airport planning.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Sponsors and planning agencies: Airport planning. 152.105 Section 152.105 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....105 Sponsors and planning agencies: Airport planning. (a) To be eligible to apply for a project for...

45 CFR 2551.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2010 CFR

2010-10-01

... § 2551.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Senior Companion Program as specified in...

45 CFR 2551.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2011 CFR

2011-10-01

... § 2551.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Senior Companion Program as specified in...

45 CFR 2551.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2014 CFR

2014-10-01

... § 2551.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Senior Companion Program as specified in...

45 CFR 2551.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2012 CFR

2012-10-01

... § 2551.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Senior Companion Program as specified in...

45 CFR 2551.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2013 CFR

2013-10-01

... § 2551.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Senior Companion Program as specified in...

78 FR 27859 - New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 558... Purina Mills, Inc., to Purina Nutrition LLC, and a change of sponsor for a new animal drug application (NADA) from Land O'Lakes Purina Feed LLC to Purina Nutrition LLC. The regulations are also being amended...

The evolution of Japanese employer-sponsored retirement plans.

PubMed

Rajnes, David

2007-01-01

This article examines the development of Japanese voluntary employer-sponsored retirement plans with an emphasis on recent trends. Until 2001, companies in Japan offered retirement benefits as lump-sum severance payments and/or benefits from one of two types of defined benefit (DB) pension plans. One type of DB plan was based on the occupational pension model used in the United States before the adoption of the Employee Retirement Income Security Act of 1974 (ERISA), but lacked the funding, vesting, and other protective features contained in ERISA. The other type of DB plan allowed companies to opt out of the earnings-related portion of social security, commonly referred to as "contracting out." Landmark laws passed in 2001 introduced a new generation of occupational retirement plans to employers and employees. One law increased funding requirements and enhanced employee protections for employer-sponsored DB plans, while a second law introduced defined contribution (DC) plans for several reasons, chiefly to increase retirement savings and help boost Japanese financial markets. These laws complemented earlier changes in the tax code and financial accounting standards already affecting employer-sponsored retirement plans. As a result, new retirement plan designs will replace most prereform era company retirement plans by 2012. In 2001, the experience of 401(k) plans in the United States, where 42 million participants had accumulated more than $1.8 trillion in assets over 20 years, attracted considerable attention among Japanese lawmakers finalizing provisions of the DC pension law. Even with government support and encouragement from the financial services industry, Japanese companies have not adopted these new DC plans in large numbers. As a result, occupational retirement plans in Japan have remained predominantly DB-a surprising development in light of the shift in a number of countries from DB to DC plans observed in recent decades. However, recent proposals to

Academic Internship Program: Sponsor's Handbook.

ERIC Educational Resources Information Center

Charlotte-Mecklenburg Public Schools, Charlotte, NC.

Since its beginning in 1975 at the West Charlotte High School in North Carolina, the Academic Internship Program has joined over 6,000 high school students in partnerships with more than 600 sponsors from the business community. The program is intended to: (1) provide opportunities for high school students to explore areas of academic, career, or…

The Complex Dynamics of Sponsored Search Markets

NASA Astrophysics Data System (ADS)

Robu, Valentin; La Poutré, Han; Bohte, Sander

This paper provides a comprehensive study of the structure and dynamics of online advertising markets, mostly based on techniques from the emergent discipline of complex systems analysis. First, we look at how the display rank of a URL link influences its click frequency, for both sponsored search and organic search. Second, we study the market structure that emerges from these queries, especially the market share distribution of different advertisers. We show that the sponsored search market is highly concentrated, with less than 5% of all advertisers receiving over 2/3 of the clicks in the market. Furthermore, we show that both the number of ad impressions and the number of clicks follow power law distributions of approximately the same coefficient. However, we find this result does not hold when studying the same distribution of clicks per rank position, which shows considerable variance, most likely due to the way advertisers divide their budget on different keywords. Finally, we turn our attention to how such sponsored search data could be used to provide decision support tools for bidding for combinations of keywords. We provide a method to visualize keywords of interest in graphical form, as well as a method to partition these graphs to obtain desirable subsets of search terms.

45 CFR 149.600 - Sponsor's duty to report data inaccuracies.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Sponsor's duty to report data inaccuracies. 149.600 Section 149.600 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH CARE ACCESS REQUIREMENTS FOR THE EARLY RETIREE REINSURANCE PROGRAM Disclosure of Data Inaccuracies § 149.600 Sponsor's duty to report data...

Tribal Resource Institute in Business, Engineering, and Science (T.R.I.B.E.S.). Part I, TRIBES Energy and Resource Management Simulation. Part II, Creative Writing--Essays submitted by the T.R.I.B.E.S. Students.

ERIC Educational Resources Information Center

Veirs, Val; And Others

The expository and creaive writing of Native American high school students enrolled in a summer program at Colorado College sponsored by TRIBES (Tribal Resource Institute in Business, Engineering, and Science) is featured in this document. Part 1 presents a simulation problem in energy and resource management followed by reports submitted by 28…

45 CFR 2553.61 - When may a sponsor serve as a volunteer station?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false When may a sponsor serve as a volunteer station... FOR NATIONAL AND COMMUNITY SERVICE THE RETIRED AND SENIOR VOLUNTEER PROGRAM Responsibilities of a Volunteer Station § 2553.61 When may a sponsor serve as a volunteer station? The sponsor may function as a...

45 CFR 2553.61 - When may a sponsor serve as a volunteer station?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false When may a sponsor serve as a volunteer station... FOR NATIONAL AND COMMUNITY SERVICE THE RETIRED AND SENIOR VOLUNTEER PROGRAM Responsibilities of a Volunteer Station § 2553.61 When may a sponsor serve as a volunteer station? The sponsor may function as a...

45 CFR 2553.61 - When may a sponsor serve as a volunteer station?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false When may a sponsor serve as a volunteer station... FOR NATIONAL AND COMMUNITY SERVICE THE RETIRED AND SENIOR VOLUNTEER PROGRAM Responsibilities of a Volunteer Station § 2553.61 When may a sponsor serve as a volunteer station? The sponsor may function as a...

45 CFR 2553.61 - When may a sponsor serve as a volunteer station?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false When may a sponsor serve as a volunteer station... FOR NATIONAL AND COMMUNITY SERVICE THE RETIRED AND SENIOR VOLUNTEER PROGRAM Responsibilities of a Volunteer Station § 2553.61 When may a sponsor serve as a volunteer station? The sponsor may function as a...

45 CFR 2553.61 - When may a sponsor serve as a volunteer station?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false When may a sponsor serve as a volunteer station... FOR NATIONAL AND COMMUNITY SERVICE THE RETIRED AND SENIOR VOLUNTEER PROGRAM Responsibilities of a Volunteer Station § 2553.61 When may a sponsor serve as a volunteer station? The sponsor may function as a...

Asthma: NIH-Sponsored Research and Clinical Trials | NIH MedlinePlus the Magazine

MedlinePlus

... turn Javascript on. Feature: Asthma Asthma: NIH-Sponsored Research and Clinical Trials Past Issues / Fall 2011 Table of Contents NIH-Sponsored Research Asthma in the Inner City: Recognizing that asthma ...

SU-E-P-03: Implementing a Low Dose Lung Screening CT Program Meeting Regulatory Requirements

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

LaFrance, M; Marsh, S; O'Donnell, G

Purpose: To provide information pertaining to IROC Houston QA Center's (RPC) credentialing process for institutions participating in NCI-sponsored clinical trials. Purpose: Provide guidance to the Radiology Departments with the intent of implementing a Low Dose CT Screening Program using different CT Scanners with multiple techniques within the framework of the required state regulations. Method: State Requirements for the purpose of implementing a Low Dose CT Lung Protocol required working with the Radiology and Pulmonary Department in setting up a Low Dose Screening Protocol designed to reduce the radiation burden to the patients enrolled. Radiation dose measurements (CTDIvol) for various CTmore » manufacturers (Siemens16, Siemens 64, Philips 64, and Neusoft128) for three different weight based protocols. All scans were reviewed by the Radiologist. Prior to starting a low dose lung screening protocol, information had to be submitted to the state for approval. Performing a Healing Arts protocol requires extensive information. This not only includes name and address of the applicant but a detailed description of the disease, the x-ray examination and the population to be examined. The unit had to be tested by a qualified expert using the technique charts. The credentials of all the operators, the supervisors and the Radiologists had to be submitted to the state. Results: All the appropriate documentation was sent to the state for review. The measured results between the Low Dose Protocol versus the default Adult Chest Protocol showed that there was a dose reduction of 65% for small (100-150 lb.) patient, 75% for the Medium patient (151-250 lbs.), and a 55% reduction for the Large patient ( over 250 lbs.). Conclusion: Measured results indicated that the Low Dose Protocol indeed lowered the screening patient's radiation dose and the institution was able to submit the protocol to the State's regulators.« less

[Criminal implication of sponsoring in medicine: legal ramifactions and recommendations].

PubMed

Mahnken, A H; Theilmann, M; Bolenz, M; Günther, R W

2005-08-01

As a consequence of the so-called "Heart-Valve-Affair" in 1994, the German public became aware of the potential criminal significance of industrial sponsoring and third-party financial support in medicine. Since 1997, when the German Anti-Corruption Law came into effect, the penal regulations regarding bribery and benefits for public officers were tightened. Due to the lack of explicit and generally accepted guidelines in combination with regional differences of jurisdiction, there is a lingering uncertainty regarding the criminal aspects of third-party funding and industrial sponsoring. The aim of this review is to summarize the penal and professional implications of third-party funding and sponsoring in medicine including recent aspects of jurisdiction. The currently available recommendations on this issue are introduced.

34 CFR 668.137 - Deadlines for submitting documentation and the consequences of failure to submit documentation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 3 2010-07-01 2010-07-01 false Deadlines for submitting documentation and the consequences of failure to submit documentation. 668.137 Section 668.137 Education Regulations of the Offices... documentation and the consequences of failure to submit documentation. (a) A student shall submit before a...

14 CFR 151.51 - Performance of construction work: Sponsor force account.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Performance of construction work: Sponsor force account. 151.51 Section 151.51 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... Development Projects § 151.51 Performance of construction work: Sponsor force account. (a) Before undertaking...

14 CFR 151.51 - Performance of construction work: Sponsor force account.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Performance of construction work: Sponsor force account. 151.51 Section 151.51 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... Development Projects § 151.51 Performance of construction work: Sponsor force account. (a) Before undertaking...

14 CFR 151.51 - Performance of construction work: Sponsor force account.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Performance of construction work: Sponsor force account. 151.51 Section 151.51 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... Development Projects § 151.51 Performance of construction work: Sponsor force account. (a) Before undertaking...

14 CFR 151.51 - Performance of construction work: Sponsor force account.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Performance of construction work: Sponsor force account. 151.51 Section 151.51 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... Development Projects § 151.51 Performance of construction work: Sponsor force account. (a) Before undertaking...

14 CFR 151.51 - Performance of construction work: Sponsor force account.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Performance of construction work: Sponsor force account. 151.51 Section 151.51 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... Development Projects § 151.51 Performance of construction work: Sponsor force account. (a) Before undertaking...

Sponsored Research & the Freedom of Publication.

ERIC Educational Resources Information Center

Packham, David

This paper examines conflicts and collaboration between industry and universities regarding sponsored research and freedom of publication, particularly in the United Kingdom. An opening section notes that the values of the market and the university are in fundamental conflict which presents problems for institutions attempting to work in…

17 CFR 229.1104 - (Item 1104) Sponsors.

Code of Federal Regulations, 2011 CFR

2011-04-01

... regarding the size, composition and growth of the sponsor's portfolio of assets of the type to be... representation or warranty, provide in the body of the prospectus for the prior three years, the information...

29 CFR 4043.29 - Change in contributing sponsor or controlled group.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the plan's contributing sponsor before the effective date of the transaction is a public company, 30... the structure of Company Q's controlled group. On the effective date of the sale, Company R will... become effective, Company Q has the reporting obligation. If the change in the contributing sponsor has...

21 CFR 1271.21 - When do I register, submit an HCT/P list, and submit updates?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false When do I register, submit an HCT/P list, and... Listing § 1271.21 When do I register, submit an HCT/P list, and submit updates? (a) You must register and submit a list of every HCT/P that your establishment manufactures within 5 days after beginning...

21 CFR 1271.21 - When do I register, submit an HCT/P list, and submit updates?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false When do I register, submit an HCT/P list, and... Listing § 1271.21 When do I register, submit an HCT/P list, and submit updates? (a) You must register and submit a list of every HCT/P that your establishment manufactures within 5 days after beginning...

21 CFR 1271.21 - When do I register, submit an HCT/P list, and submit updates?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false When do I register, submit an HCT/P list, and... Listing § 1271.21 When do I register, submit an HCT/P list, and submit updates? (a) You must register and submit a list of every HCT/P that your establishment manufactures within 5 days after beginning...

76 FR 79064 - New Animal Drugs; Change of Sponsor; Zinc Gluconate

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... [Docket No. FDA-2011-N-0003] New Animal Drugs; Change of Sponsor; Zinc Gluconate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for zinc...

75 FR 66304 - New Animal Drugs; Change of Sponsor; Monensin Blocks

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-28

... [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor; Monensin Blocks AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal... animal drug regulations as a sponsor of an approved application. Accordingly, Sec. 510.600 is being...

Reporting of Navy Sponsor Owned Material Stored at the Naval Air Systems Command Activities

DTIC Science & Technology

2007-04-23

Who Should Read This Report and Why? Navy personnel responsible for reporting the amount and value of Sponsor Owned Material stored at Navy facilities should read this report. It discusses the financial reporting and control of Sponsor Owned Material stored by Naval Air Systems Command activities. Background. The Department of the Navy reported $58.8 billion of Operating Materials and Supplies on its first quarter FY 2006 financial statements. This included a sub-category of supplies and materials termed Sponsor Owned Material. The Navy defines Sponsor

Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement.

PubMed

Moher, David; Shamseer, Larissa; Clarke, Mike; Ghersi, Davina; Liberati, Alessandro; Petticrew, Mark; Shekelle, Paul; Stewart, Lesley A

2015-01-01

Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.

Summer Food Service Program for Children. 1991 Sponsor's Handbook. (Revised Edition).

ERIC Educational Resources Information Center

Food and Nutrition Service (USDA), Washington, DC.

This handbook is a reference for sponsors of food service programs for children during school vacation periods. It is not applicable to academic year operations. Issues relating to planning a food service program are discussed. These include sponsor eligibility, the determination of the need of recipient children, requirements of kinds and amounts…

21 CFR 822.14 - May I reference information previously submitted instead of submitting it again?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false May I reference information previously submitted..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.14 May I reference information previously submitted instead of submitting it again? Yes...

Effects of Disclosing Sponsored Content in Blogs

PubMed Central

van Reijmersdal, Eva A.; Fransen, Marieke L.; van Noort, Guda; Opree, Suzanna J.; Vandeberg, Lisa; Reusch, Sanne; van Lieshout, Floor; Boerman, Sophie C.

2016-01-01

This article presents two studies examining the effects of disclosing online native advertising (i.e., sponsored content in blogs) on people’s brand attitude and purchase intentions. To investigate the mechanisms underlying these effects, we integrated resistance theories with the persuasion knowledge model. We theorize that disclosures activate people’s persuasion knowledge, which in turn evokes resistance strategies that people use to cope with the persuasion attempt made in the blog. We tested our predications with two experiments (N = 118 and N = 134). We found that participants indeed activated persuasion knowledge in response to disclosures, after which they used both cognitive (counterarguing) and affective (negative affect) resistance strategies to decrease persuasion. The obtained insights do not only advance our theoretical understanding of how disclosures of sponsored blogs affect persuasion but also provide valuable insights for legislators, advertisers, and bloggers. PMID:27721511

What Teachers Want from Sponsored Films.

ERIC Educational Resources Information Center

Modern Talking Picture Service, New Hyde Park, NY.

This collection of six pamphlets reports the results of a survey intended to supply information about what teachers in various fields desire in classroom films to sponsors and producers of 16mm motion pictures. A separate pamphlet is included for each of the following fields: (1) vocational agriculture, (2) physical education, (3) home economics,…

Informal and formal trail monitoring protocols and baseline conditions: Acadia National Park

USGS Publications Warehouse

Marion, Jeffrey L.; Wimpey, Jeremy F.; Park, L.

2011-01-01

At Acadia National Park, changing visitor use levels and patterns have contributed to an increasing degree of visitor use impacts to natural and cultural resources. To better understand the extent and severity of these resource impacts and identify effective management techniques, the park sponsored this research to develop monitoring protocols, collect baseline data, and identify suggestions for management strategies. Formal and informal trails were surveyed and their resource conditions were assessed and characterized to support park planning and management decision-making.

The GLOBE Contrail Protocol: Initial Analysis of Results

NASA Technical Reports Server (NTRS)

Chambers, Lin; Duda, David

2004-01-01

The GLOBE contrail protocol was launched in March 2003 to obtain surface observer reports of contrail occurrence to complement satellite and model studies underway at NASA Langley, among others. During the first year, more than 30,000 ground observations of contrails were submitted to GLOBE. An initial analysis comparing the GLOBE observations to weather prediction model results for relative humidity at flight altitudes is in progress. This paper reports on the findings to date from this effort.

A Compilation of Articles Reporting Research Sponsored by the Office of Naval Research

DTIC Science & Technology

1980-07-01

i-A /VGR P Technical Reports Nos 378,379,380,381 and 382 A COMPILATION OF ARTICLES REPORTING RESEARCH SPONSORED BY THE OFFICE OF NAVAL RESEARCH...SPONSORED BY ( THE OFFICE OF NAVAL RESEARCH#’ "I ZIP Office o ---- Contract JINY(601-Z.7-OO502IProject N 1 __ terge C, Anderson Associate Chairman for...SPONSORED BY THE OFFICE OF NAVAL RESEARCH TECHNICAL REPORT NO. 378 The Depth Variability of Meridional Gradients of Temperature, Salinity and Sound

Clock Scan Protocol for Image Analysis: ImageJ Plugins.

PubMed

Dobretsov, Maxim; Petkau, Georg; Hayar, Abdallah; Petkau, Eugen

2017-06-19

The clock scan protocol for image analysis is an efficient tool to quantify the average pixel intensity within, at the border, and outside (background) a closed or segmented convex-shaped region of interest, leading to the generation of an averaged integral radial pixel-intensity profile. This protocol was originally developed in 2006, as a visual basic 6 script, but as such, it had limited distribution. To address this problem and to join similar recent efforts by others, we converted the original clock scan protocol code into two Java-based plugins compatible with NIH-sponsored and freely available image analysis programs like ImageJ or Fiji ImageJ. Furthermore, these plugins have several new functions, further expanding the range of capabilities of the original protocol, such as analysis of multiple regions of interest and image stacks. The latter feature of the program is especially useful in applications in which it is important to determine changes related to time and location. Thus, the clock scan analysis of stacks of biological images may potentially be applied to spreading of Na + or Ca ++ within a single cell, as well as to the analysis of spreading activity (e.g., Ca ++ waves) in populations of synaptically-connected or gap junction-coupled cells. Here, we describe these new clock scan plugins and show some examples of their applications in image analysis.

Specification, Synthesis, and Verification of Software-based Control Protocols for Fault-Tolerant Space Systems

DTIC Science & Technology

2016-08-16

Force Research Laboratory Space Vehicles Directorate AFRL /RVSV 3550 Aberdeen Ave, SE 11. SPONSOR/MONITOR’S REPORT Kirtland AFB, NM 87117-5776 NUMBER...Ft Belvoir, VA 22060-6218 1 cy AFRL /RVIL Kirtland AFB, NM 87117-5776 2 cys Official Record Copy AFRL /RVSV/Richard S. Erwin 1 cy... AFRL -RV-PS- AFRL -RV-PS- TR-2016-0112 TR-2016-0112 SPECIFICATION, SYNTHESIS, AND VERIFICATION OF SOFTWARE-BASED CONTROL PROTOCOLS FOR FAULT-TOLERANT

NASA-sponsored containerless processing experiments

NASA Technical Reports Server (NTRS)

Hofmeister, William H.

1990-01-01

An outline is presented of containerless processing and facilities at Intersonics which is sponsored by NASA. There are electromagnetic, acoustic, and aerodynamic levitation facilities. There are also laser beam and arc lamp heating systems along with state of the art noncontact temperature and optical property measurement facilities. Nonintrusive diagnostic techniques with Laser Induced Fluorescence and mass spectrometer are also available. Controlled atmosphere processing, gas quenching, and proven microgravity processing technology is part of the Intersonics capabilities.

Committees and sponsors

NASA Astrophysics Data System (ADS)

2011-10-01

International Advisory Committee Richard F CastenYale, USA Luiz Carlos ChamonSão Paulo, Brazil Osvaldo CivitareseLa Plata, Argentina Jozsef CsehATOMKI, Hungary Jerry P DraayerLSU, USA Alfredo Galindo-UribarriORNL & UT, USA James J KolataNotre Dame, USA Jorge López UTEP, USA Joseph B NatowitzTexas A & M, USA Ma Esther Ortiz IF-UNAM Stuart PittelDelaware, USA Andrés SandovalIF-UNAM Adam SzczepaniakIndiana, USA Piet Van IsackerGANIL, France Michael WiescherNotre Dame, USA Organizing Committee Libertad Barrón-Palos (Chair)IF-UNAM Roelof BijkerICN-UNAM Ruben FossionICN-UNAM David LizcanoININ Sponsors Instituto de Ciencias Nucleares, UNAMInstituto de Física, UNAMInstituto Nacional de Investigaciones NuclearesDivisión de Física Nuclear de la SMFCentro Latinoamericano de Física

Description of the Protocols for Randomized Controlled Trials on Cancer Drugs Conducted in Spain (1999–2003)

PubMed Central

Bonfill, Xavier; Ballesteros, Mónica; Gich, Ignasi; Serrano, María Antonia; García López, Fernando; Urrútia, Gerard

2013-01-01

Objective To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols. Methods We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed. Results We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). Of all protocols, 10.6% intended to include more than 1000 patients (mean: 2442, SD: 2724). Compared with their national counterparts, internationally-based studies were significantly larger (p<0.001) and were more likely to implement centralized randomization (p<0.001), blinding of the intervention (p<0.001), and survival as primary outcome (p<0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7%) was lower. Conclusion RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide on

14 CFR 60.7 - Sponsor qualification requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false Sponsor qualification requirements. 60.7 Section 60.7 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.7...

14 CFR 60.7 - Sponsor qualification requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Sponsor qualification requirements. 60.7 Section 60.7 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.7...

14 CFR 60.7 - Sponsor qualification requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Sponsor qualification requirements. 60.7 Section 60.7 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.7...

14 CFR 60.7 - Sponsor qualification requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Sponsor qualification requirements. 60.7 Section 60.7 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.7...

76 FR 40229 - Oral Dosage Form New Animal Drugs; Change of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-08

.... FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Virbac AH...

7 CFR 225.12 - Claims against sponsors.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 4 2013-01-01 2013-01-01 false Claims against sponsors. 225.12 Section 225.12 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.12 Claims...

7 CFR 225.12 - Claims against sponsors.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 4 2011-01-01 2011-01-01 false Claims against sponsors. 225.12 Section 225.12 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.12 Claims...

7 CFR 225.12 - Claims against sponsors.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 4 2014-01-01 2014-01-01 false Claims against sponsors. 225.12 Section 225.12 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.12 Claims...

7 CFR 225.12 - Claims against sponsors.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 4 2012-01-01 2012-01-01 false Claims against sponsors. 225.12 Section 225.12 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.12 Claims...

22 CFR 42.31 - Family-sponsored immigrants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Family-sponsored immigrants. 42.31 Section 42.31 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF IMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Immigrants Subject to Numerical Limitations § 42.31 Family...

Quality assurance of research protocols conducted in the community: the National Institute on Drug Abuse Clinical Trials Network experience.

PubMed

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-04-01

Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. : QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. The lessons learned from the CTN's experience include the need

Quality assurance of research protocols conducted in the community: The National Institute on Drug Abuse Clinical Trials Network Experience

PubMed Central

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-01-01

Background: Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. Purpose: This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. Methods: The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Results: Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. Limitations: QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. Conclusions

ACR/NEMA Digital Image Interface Standard (An Illustrated Protocol Overview)

NASA Astrophysics Data System (ADS)

Lawrence, G. Robert

1985-09-01

The American College of Radiologists (ACR) and the National Electrical Manufacturers Association (NEMA) have sponsored a joint standards committee mandated to develop a universal interface standard for the transfer of radiology images among a variety of PACS imaging devicesl. The resulting standard interface conforms to the ISO/OSI standard reference model for network protocol layering. The standard interface specifies the lower layers of the reference model (Physical, Data Link, Transport and Session) and implies a requirement of the Network Layer should a requirement for a network exist. The message content has been considered and a flexible message and image format specified. The following Imaging Equipment modalities are supported by the standard interface... CT Computed Tomograpy DS Digital Subtraction NM Nuclear Medicine US Ultrasound MR Magnetic Resonance DR Digital Radiology The following data types are standardized over the transmission interface media.... IMAGE DATA DIGITIZED VOICE HEADER DATA RAW DATA TEXT REPORTS GRAPHICS OTHERS This paper consists of text supporting the illustrated protocol data flow. Each layer will be individually treated. Particular emphasis will be given to the Data Link layer (Frames) and the Transport layer (Packets). The discussion utilizes a finite state sequential machine model for the protocol layers.

Institutionalizing Entrepreneurship: A History of Sponsored Research at the University of Michigan

ERIC Educational Resources Information Center

DeGraff, Staney

2006-01-01

This paper examines the history of sponsored research and industrial relationships at the University of Michigan. For the purposes of this paper, sponsored research is defined as research performed by the university that is funded by an outside constituent. Although this paper covers events from the start of the twentieth century, it concentrates…

Employer-Sponsored Training: Current Status, Future Possibilities.

ERIC Educational Resources Information Center

Vaughan, Roger J.; Berryman, Sue E.

This document summarizes the conclusions of research papers and participant discussions at a conference on employer-sponsored training in 1988. Following an introduction, the first section offers support for the statement that employers invest heavily in training their best-educated and trained employees. The following are among the conclusions…

Recycling: Establishing a Citizen-Sponsored Reclamation Center.

ERIC Educational Resources Information Center

Keep America Beautiful, Inc., New York, NY.

This booklet applies the Clean Community System (CCS) of Keep America Beautiful, Inc. to the development of citizen-sponsored recycling projects. Six initial steps in establishing a reclamation center are given and include information gathering, market analysis, legal requirements, and site location. Suggestions are included for recruiting staff…

The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study.

PubMed

Decullier, Evelyne; Lhéritier, Véronique; Chapuis, François

2005-10-17

Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Retrospective cohort of 976 protocols approved by a representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14-17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25-53) and 37 (95% CI: 27-46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees.

7 CFR 226.12 - Administrative payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2012 CFR

2012-01-01

... (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS CHILD AND ADULT... organization's budget, or (3) the sum of the products obtained by multiplying each month the sponsoring... administrative budget detailing the costs which the sponsoring organization shall incur, document, and claim...

7 CFR 226.12 - Administrative payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2013 CFR

2013-01-01

... (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS CHILD AND ADULT... organization's budget, or (3) the sum of the products obtained by multiplying each month the sponsoring... administrative budget detailing the costs which the sponsoring organization shall incur, document, and claim...

7 CFR 226.12 - Administrative payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2014 CFR

2014-01-01

... (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS CHILD AND ADULT... organization's budget, or (3) the sum of the products obtained by multiplying each month the sponsoring... administrative budget detailing the costs which the sponsoring organization shall incur, document, and claim...

7 CFR 226.12 - Administrative payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2010 CFR

2010-01-01

... (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS CHILD AND ADULT... organization's budget, or (3) the sum of the products obtained by multiplying each month the sponsoring... administrative budget detailing the costs which the sponsoring organization shall incur, document, and claim...

7 CFR 226.12 - Administrative payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2011 CFR

2011-01-01

... (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS CHILD AND ADULT... organization's budget, or (3) the sum of the products obtained by multiplying each month the sponsoring... administrative budget detailing the costs which the sponsoring organization shall incur, document, and claim...

Marital status, spousal coverage, and the gender gap in employer-sponsored health insurance.

PubMed

Buchmueller, T C

Not only do men who work full time earn more than women, but they are more likely to receive employer-sponsored health benefits. This paper provides evidence on the gender gap in employer-sponsored health insurance. The results indicate that the gap is driven largely by the tendency of married women to decline employer-sponsored insurance in favor of being covered through their husbands. Indeed, among single workers, women are more likely than men to be offered insurance. These findings call into question the conclusion made by previous researchers that employers discriminate against women in the provision of health insurance.

7 CFR 226.16 - Sponsoring organization provisions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... a meals times rates payment system. In those States which implement this optional method of reimbursement, such disbursements may not exceed the rates times the number of meals documented at each facility...-time staff person for each 50 to 150 day care homes it sponsors. As part of its management plan, a...

7 CFR 226.16 - Sponsoring organization provisions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... a meals times rates payment system. In those States which implement this optional method of reimbursement, such disbursements may not exceed the rates times the number of meals documented at each facility...-time staff person for each 50 to 150 day care homes it sponsors. As part of its management plan, a...

Remote Sensing and the Kyoto Protocol: A Workshop Summary

NASA Technical Reports Server (NTRS)

Rosenqvist, Ake; Imhoff, Marc; Milne, Anthony; Dobson, Craig

2000-01-01

The Kyoto Protocol to the United Nations Framework Convention on Climate Change contains quantified, legally binding commitments to limit or reduce greenhouse gas emissions to 1990 levels and allows carbon emissions to be balanced by carbon sinks represented by vegetation. The issue of using vegetation cover as an emission offset raises a debate about the adequacy of current remote sensing systems and data archives to both assess carbon stocks/sinks at 1990 levels, and monitor the current and future global status of those stocks. These concerns and the potential ratification of the Protocol among participating countries is stimulating policy debates and underscoring a need for the exchange of information between the international legal community and the remote sensing community. On October 20-22 1999, two working groups of the International Society for Photogrammetry and Remote Sensing (ISPRS) joined with the University of Michigan (Michigan, USA) to convene discussions on how remote sensing technology could contribute to the information requirements raised by implementation of, and compliance with, the Kyoto Protocol. The meeting originated as a joint effort between the Global Monitoring Working Group and the Radar Applications Working Group in Commission VII of the ISPRS, co-sponsored by the University of Michigan. Tile meeting was attended by representatives from national government agencies and international organizations and academic institutions. Some of the key themes addressed were: (1) legal aspects of transnational remote sensing in the context of the Kyoto Protocol; (2) a review of the current and future and remote sensing technologies that could be applied to the Kyoto Protocol; (3) identification of areas where additional research is needed in order to advance and align remote sensing technology with the requirements and expectations of the Protocol; and 94) the bureaucratic and research management approaches needed to align the remote sensing

Pullout bond strength of fiber posts luted to different depths and submitted to artificial aging.

PubMed

Macedo, V C; Souza, N A Y; Faria e Silva, A L; Cotes, C; da Silva, C; Martinelli, M; Kimpara, E T

2013-01-01

The extension of fiber post cementation often does not seem to influence the fracture resistance of restorations. This study evaluated the effects of cementation depths on the retention of fiber posts submitted to artificial aging. One hundred and sixty bovine incisors were selected to assess post retention. Following endodontic treatment, the canals were flared with diamonds burs. Postholes were prepared in lengths of 5 or 10 mm, after which fiber posts were relined with composite resin and luted with RelyX ARC or RelyX Unicem. The samples were then submitted to thermal and/or mechanical cycling before testing their pullout bond strengths. Absence of cycling was used as a control. The results of each cement were submitted to two-way and post hoc Tukey tests (α=0.05). Independent of the aging protocol, a depth of 10 mm showed higher pullout bond strength than did 5 mm, except for RelyX Unicem without cycling. For RelyX ARC, thermomechanical cycling resulted in lower values than in the absence of cycling. Mechanical cycling alone promoted the highest bond strength when the posts were luted with RelyX Unicem. The effect of artificial aging on the pullout bond strength is dependent on the type of material and the depth.

The University Campus: Why Military Sponsored Research.

ERIC Educational Resources Information Center

Messing, Aubrey E.

Military-sponsored research on the university campus has been a major issue during the past several years. Opposition has come from radicals, who wish to destroy the university itself, to critics, who feel such activities take needed funds and personnel from the more important task of solving our nation's social problems. These viewpoints and the…

20 CFR 416.1204 - Deeming of resources of the sponsor of an alien.

Code of Federal Regulations, 2014 CFR

2014-04-01

... alien. 416.1204 Section 416.1204 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... of the sponsor of an alien. The resources of an alien who first applies for SSI benefits after September 30, 1980, are deemed to include the resources of the alien's sponsor for 3 years after the alien's...

20 CFR 416.1204 - Deeming of resources of the sponsor of an alien.

Code of Federal Regulations, 2011 CFR

2011-04-01

... alien. 416.1204 Section 416.1204 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... of the sponsor of an alien. The resources of an alien who first applies for SSI benefits after September 30, 1980, are deemed to include the resources of the alien's sponsor for 3 years after the alien's...

20 CFR 416.1204 - Deeming of resources of the sponsor of an alien.

Code of Federal Regulations, 2010 CFR

2010-04-01

... alien. 416.1204 Section 416.1204 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... of the sponsor of an alien. The resources of an alien who first applies for SSI benefits after September 30, 1980, are deemed to include the resources of the alien's sponsor for 3 years after the alien's...

20 CFR 416.1204 - Deeming of resources of the sponsor of an alien.

Code of Federal Regulations, 2013 CFR

2013-04-01

... alien. 416.1204 Section 416.1204 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... of the sponsor of an alien. The resources of an alien who first applies for SSI benefits after September 30, 1980, are deemed to include the resources of the alien's sponsor for 3 years after the alien's...

20 CFR 416.1204 - Deeming of resources of the sponsor of an alien.

Code of Federal Regulations, 2012 CFR

2012-04-01

... alien. 416.1204 Section 416.1204 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... of the sponsor of an alien. The resources of an alien who first applies for SSI benefits after September 30, 1980, are deemed to include the resources of the alien's sponsor for 3 years after the alien's...

A protocol proposition of cell therapy for the treatment of chronic obstructive pulmonary disease.

PubMed

Ribeiro-Paes, J T; Stessuk, T; Marcelino, M; Faria, C; Marinelli, T; Ribeiro-Paes, M J

2014-01-01

The main feature of pulmonary emphysema is airflow obstruction resulting from the destruction of the alveolar walls distal to the terminal bronchioles. Existing clinical approaches have improved and extended the quality of life of emphysema patients. However, no treatment currently exists that can change the disease course and cure the patient. The different therapeutic approaches that are available aim to increase survival and/or enhance the quality of life of emphysema patients. In this context, cell therapy is a promising therapeutic approach with great potential for degenerative pulmonary diseases. In this protocol proposition, all patients will be submitted to laboratory tests, such as evaluation of heart and lung function and routine examinations. Stem cells will be harvested by means of 10 punctures on each anterior iliac crest, collecting a total volume of 200mL bone marrow. After preparation, separation, counting and labeling (optional) of the mononuclear cells, the patients will receive an intravenous infusion from the pool of Bone Marrow Mononuclear Cells (BMMC). This article proposes a rational and safe clinical cellular therapy protocol which has the potential for developing new projects and can serve as a methodological reference for formulating clinical application protocols related to the use of cellular therapy in COPD. This study protocol was submitted and approved by the Brazilian National Committee of Ethics in Research (CONEP - Brazil) registration number 14764. It is also registered in ClinicalTrials.gov (NCT01110252). Copyright © 2013 Sociedade Portuguesa de Pneumologia. Published by Elsevier España. All rights reserved.

Sponsorship, ambushing, and counter-strategy: effects upon memory for sponsor and event.

PubMed

Humphreys, Michael S; Cornwell, T Bettina; McAlister, Anna R; Kelly, Sarah J; Quinn, Emerald A; Murray, Krista L

2010-03-01

Corporate sponsorship of sports, causes, and the arts has become a mainstream communications tool worldwide. The unique marketing opportunities associated with major events also attract nonsponsoring companies seeking to form associations with the event (ambushing). There are strategies available to brands and events which have been ambushed; however, there is only limited information about the effects of those strategies on attainment of sponsorship objectives. In Experiment 1, university staff and students participated by studying paragraphs linking a sponsor to a novel event. Relative to each sponsor-event pair, they then studied one of three different messages about a competitor. Results find a message which linked the competitor and the event increased competitor recall given the event as a cue and event recall given the competitor as a cue. These effects were moderated if there was information about the competitor not being the sponsor. In Experiment 2 ambushing and counter-ambushing information was presented over 2 days. Both types of messages increased competitor recall given the event as a cue and event recall given the competitor as a cue. In addition, "not sponsor" information was not always used even when it should have been recallable. The results can be explained if participants are using three cues: a specific cue such as a brand name, a contextual cue, and a category cue, such as the concept of an event. Findings suggest to sponsoring firms and event properties that counter-ambushing communications may have the unintended effect of strengthening an ambusher-event relationship in memory.

Use and Misuse of Industry Sponsored Materials.

ERIC Educational Resources Information Center

DuVall, Charles R.; Krepel, Wayne J.

A review of educational research reveals that free and inexpensive materials are used today to a much greater extent than they had been in the past. Two studies, sponsored by the American Iron and Steel Institute, are evidence of the producer's interest in determining the strengths and weaknesses of the materials being sent into classrooms and…

A review of NASA-sponsored technology assessment projects

NASA Technical Reports Server (NTRS)

Mascy, A. C.; Alexander, A. D., III; Wood, R. D.

1978-01-01

Recent technology assessment studies sponsored by NASA are reviewed, and a summary of the technical results as well as a critique of the methodologies are presented. The reviews include Assessment of Lighter-Than-Air Technology, Technology Assessment of Portable Energy RDT&P, Technology Assessment of Future Intercity Passenger Transportation Systems, and Technology Assessment of Space Disposal of Radioactive Nuclear Waste. The use of workshops has been introduced as a unique element of some of these assessments. Also included in this report is a brief synopsis of a method of quantifying opinions obtained through such group interactions. Representative of the current technology assessments, these studies cover a broad range of socio-political factors and issues in greater depth than previously considered in NASA sponsored studies. In addition to the lessons learned through the conduct of these studies, a few suggestions for improving the effectiveness of future technology assessments are provided.

The Emmanuel Schools Foundation: Sponsoring and Leading Transformation at England's Most Improved Academy

ERIC Educational Resources Information Center

Pike, Mark A.

2009-01-01

The Emmanuel Schools Foundation (ESF) has so far sponsored four schools in England. Beginning with Emmanuel College in Gateshead in 1990 (which remains a City Technology College) the Foundation sponsors the King's Academy in Middlesbrough, which opened in 2003, and Trinity Academy in Thorne near Doncaster, which opened in 2005. The Foundation's…

7 CFR 225.9 - Program assistance to sponsors.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.9 Program... of the sponsor's approved administrative budget. The amount of the start-up payment shall be deducted...

7 CFR 225.9 - Program assistance to sponsors.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.9 Program... of the sponsor's approved administrative budget. The amount of the start-up payment shall be deducted...

7 CFR 225.9 - Program assistance to sponsors.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.9 Program... of the sponsor's approved administrative budget. The amount of the start-up payment shall be deducted...

7 CFR 225.9 - Program assistance to sponsors.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.9 Program... of the sponsor's approved administrative budget. The amount of the start-up payment shall be deducted...

Effect of a cryopreservation protocol on the proliferation of stem cells from human exfoliated deciduous teeth.

PubMed

Ginani, Fernanda; Soares, Diego Moura; Rabêlo, Luciana Maria; Rocha, Hugo Alexandre Oliveira; de Souza, Lélia Batista; Barboza, Carlos Augusto Galvão

2016-11-01

The aim of the present study was to evaluate the influence of a cryopreservation protocol on the proliferation and viability of stem cells from human exfoliated deciduous teeth (SHEDs). Cells from the pulp of three deciduous teeth were isolated and characterized to confirm their stem cell nature. In second passage, part of the cells were submitted to normal conditions of cell culture (Control group), while part of the cells were maintained in 10% DMSO diluted in foetal bovine serum and submitted to the following cryopreservation protocol: 2 h at 4 °C, 18 h at -20 °C and then at -80 °C for two intervals (30 days - Cryopreservation I; and 180 days Cryopreservation II). Cell proliferation and cell cycle were evaluated at intervals of 24, 48 and 72 h after plating, and apoptosis-related events were analyzed at 72 h. All groups exhibited an increase in the number of cells, and no significant differences between the cryopreserved and control groups were observed (p > .05). The distribution of cells in the cell cycle phases was consistent with cell proliferation, and the percentage of viable cells was higher than 99% in all groups, indicating that cell viability was not affected by the cryopreservation protocol throughout the experiment. The proposed cryopreservation protocol is adequate for the storage of SHED, permitting their use in future experimental studies.

Biochemical and oxidative stress markers in the liver and kidneys of rats submitted to different protocols of anabolic steroids.

PubMed

Dornelles, Guilherme Lopes; Bueno, Andressa; de Oliveira, Juliana Sorraila; da Silva, Aleksandro Schafer; França, Raqueli Teresinha; da Silva, Cássia Bagolin; Machado, Márcia Silveira Netto; Petry, Letícia do Santos; Abdalla, Fátima Husein; Lhamas, Cibele Lima; de Andrade, Cinthia Melazzo

2017-01-01

The objective of this study was to evaluate the effects of different protocols (P1, P2, and P3) of boldenone undecylenate (BU) and stanozolol (ST) on markers of liver and kidney function and variables of oxidative stress in these organs. For this, 54 male Wistar rats were divided into nine groups of six animals each. Each animal received intramuscularly 5.0 mg kg -1 of BU or ST once a week for 4 weeks (P1); 2.5 mg kg -1 of BU or ST once a week for 8 weeks (P2); and 1.25 mg kg -1 of BU or ST once a week for 12 weeks (P3). For each protocol, a control group was used, and they received 0.1 ml of olive oil intramuscularly. Blood and fragments of liver and kidney were collected for alanine aminotransferase activity (ALT), alkaline phosphatase, albumin, creatinine, cholesterol, total protein, triglycerides, urea, reactive oxygen species, thiobarbituric acid reactive substances, total thiols, and glutathione evaluation. The results show that the BU in doses of 5 (day 30) and 2.5 mg kg -1 (day 60) changes the ALT seric activity, possibly showing a hepatotoxic effect. High doses of BU may lead to increased levels of cholesterol (protocol P1) possibly due to inhibition of the normal steroid biosynthesis process. All protocols used caused changes in the redox balance of the organs studied (except in the liver, protocol P2), which indicates that these drugs might be harmful even at low doses.

Map of biomedical research in Cameroon; a documentary review of approved protocols from 1997 to 2012.

PubMed

Walter, Ebile Akoh; Jerome, Ateudjieu; Marceline, Djuidje Ngounoue; Yakum, Martin Ndinakie; Pierre, Watcho

2017-11-21

Over the last decade, there has been a rapid increase in biomedical research in Cameroon. However, the question of whether these research projects target major health priorities, vulnerable populations and geographic locations at risk remains to be answered. The aim of this paper is to describe the state of biomedical research in Cameroon which is a key determinant that would guide future health care policies and promote equitable access to healthcare. A documentary review of all approved protocols (proposals) of biomedical research projects, from 1997 through 2012, at the Cameroon National Ethics Committee. Protocols were reviewed systematically by independent reviewers and data were extracted on a grid. Data were analyzed by calculating proportions at 95% confidence interval, chi-square test (chi2) and p-values. Two thousand one hundred seventy two protocols were reviewed for data extraction. One thousand three hundred ninety-five (64.7%) were student projects, 369 (17.0%) projects had international sponsors, and 1528 (72.4%) were hospital-based studies. The most targeted domain was the fight against diseases 1323 (61.3%); mostly HIV 342 (25.8%) and Malaria 136 (10.3%). Over half of the studies were concentrated in the Centre region 1242 (57.2%), with the least projects conducted in the Northern region 15 (0.7%). There was strong evidence that international and local sponsors would influence the research site (p-value = 0.01) and population targets (p-value = 0.00). Although biomedical research targets some important diseases that pose a great burden to Cameroonians, the most vulnerable populations are excluded from research. Biomedical research scarcely addresses other components of the health system and emerging diseases of vital public health importance. We recommend that the government should play a central role, between researchers from academic institutions, sponsors, NGOs and research institutions, to ensure that biomedical research addresses the

A protocol of rope skipping exercise for primary school children: A pilot test

NASA Astrophysics Data System (ADS)

Radzi, A. N. M.; Rambely, A. S.; Chellapan, K.

2014-06-01

This paper aims to investigate the methods and sample used in rope skipping as an exercise approach. A systematic literature review was approached in identifying skipping performance in the related researches. The methods were compared to determine the best methodological approach for the targeted skipping based research measure. A pilot test was performed among seven students below 12 years old. As the outcome of the review, a skipping protocol design has been proposed for 10 years old primary school students. The proposed protocol design is to be submitted to PPUKM Ethical Committee for approval prior to its implementation in investigation memory enhancement in relation to designed skipping activities.

Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

PubMed

Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira

2010-01-01

To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (p<0.05). Multiple logistic regressions detected no negative correlation between placement in other countries when compared to Brazil. Trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in Brazil. No clear direct competition between Brazil and other emerging countries was detected. South Korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.

SeaWiFS technical report series. Volume 5: Ocean optics protocols for SeaWiFS validation

NASA Technical Reports Server (NTRS)

Mueller, James L.; Austin, Roswell W.; Hooker, Stanford B. (Editor); Firestone, Elaine R. (Editor)

1992-01-01

Protocols are presented for measuring optical properties, and other environmental variables, to validate the radiometric performance of the Sea-viewing Wide Field-of-view Sensor (SeaWiFS), and to develop and validate bio-optical algorithms for use with SeaWiFS data. The protocols are intended to establish foundations for a measurement strategy to verify the challenging SeaWiFS accuracy goals of 5 percent in water-leaving radiances and 35 percent in chlorophyll alpha concentration. The protocols first specify the variables which must be measured, and briefly review rationale. Subsequent chapters cover detailed protocols for instrument performance specifications, characterizing and calibration instruments, methods of making measurements in the field, and methods of data analysis. These protocols were developed at a workshop sponsored by the SeaWiFS Project Office (SPO) and held at the Naval Postgraduate School in Monterey, California (9-12 April, 1991). This report is the proceedings of that workshop, as interpreted and expanded by the authors and reviewed by workshop participants and other members of the bio-optical research community. The protocols are a first prescription to approach unprecedented measurement accuracies implied by the SeaWiFS goals, and research and development are needed to improve the state-of-the-art in specific areas. The protocols should be periodically revised to reflect technical advances during the SeaWiFS Project cycle.

Drug company-sponsored patient assistance programs: a viable safety net?

PubMed

Choudhry, Niteesh K; Lee, Joy L; Agnew-Blais, Jessica; Corcoran, Colleen; Shrank, William H

2009-01-01

Drug company-sponsored patient assistance programs (PAPs) provide access to brand-name medications at little or no cost and have been advocated as a safety net for inadequately insured patients. Yet little is known about these programs. We surveyed drug company-sponsored PAPs and found much variability in their structures and application processes. Most cover one or two drugs. Only 4 percent disclosed how many patients they had directly helped, and half would not disclose their income eligibility criteria. A better understanding of PAPs might clarify their role in improving access to medications, the adequacy of existing public programs, and their impact on cost-effective medication use.

Consumer Perceptions of Sponsors of Disease Awareness Advertising

ERIC Educational Resources Information Center

Hall, Danika V.; Jones, Sandra C.; Iverson, Donald C.

2011-01-01

Purpose: In many countries there is emerging concern regarding alliances between the pharmaceutical industry and health non-profit organizations (NPOs), and the increase of co-sponsored marketing activities such as disease awareness advertising. The current study aims to explore Australian women's perceptions of disease awareness advertising with…

A Planning Model for American-Sponsored Overseas Schools.

ERIC Educational Resources Information Center

Baron, Mark A.

The main reason for the establishment of American-Sponsored Overseas Schools (ASOS) was to offer the dependents of Americans living abroad educational opportunities similar to what was available at home. ASOS have several general characteristics, including being privately controlled, nonprofit, nonsectarian, and American or binational in…

14 CFR 152.309 - Availability of sponsor's records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Accounting and Reporting Requirements § 152.309 Availability of... the purposes of accounting and audit. (b) The sponsor or planning agency shall allow appropriate FAA...-term retention value, the FAA may require transfer of custody of those records to the FAA. ...

Characteristics of project management at institutions sponsoring National Library of Medicine MedlinePlus Go Local*

PubMed Central

Olney, Cynthia A.; Backus, Joyce E. B.; Klein, Lori J.

2010-01-01

Objectives: Through interviews with the National Library of Medicine's MedlinePlus Go Local collaborators, an evaluation team sought to identify process characteristics that are critical for long-term sustainability of Go Local projects and to describe the impact that Go Local projects have on sponsoring institutions. Methods: Go Local project coordinators (n = 44) at 31 sponsor institutions participated in semi-structured interviews about their experiences developing and maintaining Go Local sites. Interviews were summarized, checked for accuracy by the participating librarians, and analyzed using a general inductive methodology. Results: Institutional factors that support Go Local projects were identified through the interviews, as well as strategies for staffing and partnerships with external organizations. Positive outcomes for sponsoring institutions also were identified. Conclusions: The findings may influence the National Library of Medicine team's decisions about improvements to its Go Local system and the support it provides to sponsoring institutions. The findings may benefit current sponsoring institutions as well as those considering or planning a Go Local project. PMID:20098657

[Analysis of projects of schistosomiasis sponsored by National Science Foundation of China].

PubMed

Wen-di, Zhou; Liang, Shi; Xue-Dan, Ke; Jie, Wang

2017-07-27

To summarize the present development by analysis of projects in schistosomiasis funded by National Science Foundation of China (NSFC). Based on the ISIS database of NFSC, the projects in the studies of schistosomiasis from 2005 to 2016 were analyzed. The distributions of sponsored numbers, amounts, types, agencies, disciplines and changes in research topics by means of network profiles were described. During the study period, 198 projects were funded by NSFC totally with 76.05 million yuan in which the general and youth projects were main types. The main sponsored agencies were research institutes and medical colleges. The top three fields sponsored were medical pathogenic microbes and infection, veterinary and medical immunology. The funding on schistosomiasis researches has a downward trend, but studies are continuing in depth. In this situation, innovative and interdisciplinary researches need to be encouraged to promote the development of schistosomiasis.

78 FR 68056 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

...The Environmental Protection Agency has submitted an information collection request (ICR), ``NSPS for Stationary Gas Turbines (Renewal)'' (EPA ICR No. 1071.11, OMB Control No. 2060-0028), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq). This is a proposed extension of the ICR, which is currently approved through December 31, 2013. Public comments were previously requested via the Federal Register (78 FR 33409) on June 4, 2013, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Undergraduates with Employer-Sponsored Aid: Comparing Group Differences

ERIC Educational Resources Information Center

Faulk, Dagney G.; Wang, Zhenlei

2014-01-01

Tuition assistance offered by employers is an understudied area of financial aid research. The purpose of this study is to compare the demographic, socioeconomic, academic and financial aid characteristics of college students who receive employer-sponsored financial aid with students who receive traditional financial aid (institutional, state, or…

7 CFR 226.13 - Food service payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2010 CFR

2010-01-01

... day care homes. 226.13 Section 226.13 Agriculture Regulations of the Department of Agriculture... CARE FOOD PROGRAM Payment Provisions § 226.13 Food service payments to sponsoring organizations for day care homes. (a) Payments shall be made only to sponsoring organizations operating under an agreement...

Rationale of technical requirements for NRG-BR001: The first NCI-sponsored trial of SBRT for the treatment of multiple metastases.

PubMed

Al-Hallaq, Hania A; Chmura, Steven; Salama, Joseph K; Winter, Kathryn A; Robinson, Clifford G; Pisansky, Thomas M; Borges, Virginia; Lowenstein, Jessica R; McNulty, Susan; Galvin, James M; Followill, David S; Timmerman, Robert D; White, Julia R; Xiao, Ying; Matuszak, Martha M

In 2014, the NRG Oncology Group initiated the first National Cancer Institute-sponsored, phase 1 clinical trial of stereotactic body radiation therapy (SBRT) for the treatment of multiple metastases in multiple organ sites (BR001; NCT02206334). The primary endpoint is to test the safety of SBRT for the treatment of 2 to 4 multiple lesions in several anatomic sites in a multi-institutional setting. Because of the technical challenges inherent to treating multiple lesions as their spatial separation decreases, we present the technical requirements for NRG-BR001 and the rationale for their selection. Patients with controlled primary tumors of breast, non-small cell lung, or prostate are eligible if they have 2 to 4 metastases distributed among 7 extracranial anatomic locations throughout the body. Prescription and organ-at-risk doses were determined by expert consensus. Credentialing requirements include (1) irradiation of the Imaging and Radiation Oncology Core phantom with SBRT, (2) submitting image guided radiation therapy case studies, and (3) planning the benchmark. Guidelines for navigating challenging planning cases including assessing composite dose are discussed. Dosimetric planning to multiple lesions receiving differing doses (45-50 Gy) and fractionation (3-5) while irradiating the same organs at risk is discussed, particularly for metastases in close proximity (≤5 cm). The benchmark case was selected to demonstrate the planning tradeoffs required to satisfy protocol requirements for 2 nearby lesions. Examples of passing benchmark plans exhibited a large variability in plan conformity. NRG-BR001 was developed using expert consensus on multiple issues from the dose fractionation regimen to the minimum image guided radiation therapy guidelines. Credentialing was tied to the task rather than the anatomic site to reduce its burden. Every effort was made to include a variety of delivery methods to reflect current SBRT technology. Although some simplifications

Computerized Management Information and Reporting Systems for Sponsored Projects.

ERIC Educational Resources Information Center

Rodman, John A.; Peters, Carl M.

1980-01-01

The effective management of the university depends on the research office providing usable, accurate, timely, and accessible information regarding sponsored programs. The utilization of automated systems to store, access, and manage information is seen as essential. (MLW)

42 CFR 403.806 - Sponsor requirements for eligibility for endorsement.

Code of Federal Regulations, 2013 CFR

2013-10-01

... provides customer telephone service, including to pharmacists, in accordance with standard business..., such as pharmacist services. (j) Grievance process. An endorsed sponsor must establish and maintain a...

42 CFR 403.806 - Sponsor requirements for eligibility for endorsement.

Code of Federal Regulations, 2012 CFR

2012-10-01

... provides customer telephone service, including to pharmacists, in accordance with standard business..., such as pharmacist services. (j) Grievance process. An endorsed sponsor must establish and maintain a...

42 CFR 403.806 - Sponsor requirements for eligibility for endorsement.

Code of Federal Regulations, 2011 CFR

2011-10-01

... provides customer telephone service, including to pharmacists, in accordance with standard business..., such as pharmacist services. (j) Grievance process. An endorsed sponsor must establish and maintain a...

42 CFR 403.806 - Sponsor requirements for eligibility for endorsement.

Code of Federal Regulations, 2014 CFR

2014-10-01

... provides customer telephone service, including to pharmacists, in accordance with standard business..., such as pharmacist services. (j) Grievance process. An endorsed sponsor must establish and maintain a...

42 CFR 403.806 - Sponsor requirements for eligibility for endorsement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... provides customer telephone service, including to pharmacists, in accordance with standard business..., such as pharmacist services. (j) Grievance process. An endorsed sponsor must establish and maintain a...

Forest bird monitoring protocol for strategic habitat conservation and endangered species management on O'ahu Forest National Wildlife Refuge, Island of O'ahu, Hawai'i

USGS Publications Warehouse

Camp, Richard J.; Gorresen, P. Marcos; Banko, Paul C.

2011-01-01

This report describes the results of a pilot forest bird survey and a consequent forest bird monitoring protocol that was developed for the O'ahu Forest National Wildlife Refuge, O'ahu Island, Hawai'i. The pilot survey was conducted to inform aspects of the monitoring protocol and to provide a baseline with which to compare future surveys on the Refuge. The protocol was developed in an adaptive management framework to track bird distribution and abundance and to meet the strategic habitat conservation requirements of the Refuge. Funding for this research was provided through a Science Support Partnership grant sponsored jointly by the U.S. Geological Survey (USGS) and the U.S. Fish and Wildlife Service (USFWS).

The use of tranexamic acid in patients submitted to primary total hip arthroplasty: an evaluation of its impact in different administration protocols.

PubMed

Melo, Gustavus Lemos Ribeiro; Lages, Daniel Souza; Madureira Junior, João Lopo; Pellucci, Guilherme de Paula; Pellucci, João Wagner Junqueira

2017-01-01

There is still no consensus as to the best form and dosages of use of tranexamic acid. The aim of this study was to evaluate the use of tranexamic acid in total hip arthroplasty, in order to reduce blood loss and decrease hemoglobin, taking into account different administration protocols. 42 patients submitted to total hip arthroplasty were divided into three groups. The study was prospective and randomized. Group 1 received a venous dose of tranexamic acid of 15 mg/kg, 20 min prior to bolus incision. Group 2 received an intravenous dose of 15 mg/kg bolus, 20 min before the incision, and an extra dose of 10 mg/kg by infusion pump during the duration of the surgical procedure. Patients in group 3 did not receive tranexamic acid, being the control group. Pre- and post-operative hemoglobin levels were measured and blood loss was measured 24 h after surgery using a Portovac drain. There was a significant reduction in the amount of bleeding through the Portovac drain and reduction in postoperative hemoglobin drop in patients who used tranexamic acid. There was neither significant difference in hemoglobin drop between groups 1 and 2, nor was there a need for hemotransfusion. Two patients in group 3 required blood transfusion. The findings demonstrated that the use of intravenous tranexamic acid in total hip arthroplasty reduced postoperative bleeding rates and significantly reduced serum hemoglobin without increasing thromboembolic effects. The bolus and bolus + infusion pump methods were shown to have a similar influence on hemoglobin and need for blood transfusion.

The Importance of Employer-Sponsored Job-Related Training.

ERIC Educational Resources Information Center

Medoff, James L.

Employer-sponsored, job-related training as a means of satisfying labor demands has potentially profound implications for the operation of the nation's economic system. The alternatives of bidding for desired workers and downgrading job requirements tend to increase inflation and lessen productivity. Since the end of the 1960's, the ability of…

Tax Exempt Organizations and Commercially Sponsored Scientific Research.

ERIC Educational Resources Information Center

Kertz, Consuelo Lauda

1982-01-01

Several related tax issues important to both the commercial sponsors and tax-exempt recipients of research funding are addressed: what type of activity qualified as scientific research; how acceptance of commercial funding affects tax-exempt status; and when the receipt of such funding generates a liability for tax on unrelated business income.…

7 CFR 225.6 - State agency responsibilities.

Code of Federal Regulations, 2010 CFR

2010-01-01

... sponsor's application to participate is denied, the official making the determination of denial must... application submitted by new sponsors and by sponsors which, in the determination of the State agency, have... information sheet for new sponsors and new sites, and for sponsors and sites which, in the determination of...

77 FR 69631 - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-20

...://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances...] Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the... IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of...

42 CFR 475.102 - Eligibility of physician-sponsored organizations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS QUALITY IMPROVEMENT ORGANIZATIONS Utilization and Quality Control Quality Improvement Organizations § 475.102 Eligibility of physician-sponsored..., during the contract evaluation process, a set number of bonus points. [49 FR 7207, Feb. 27, 1984...

Screening protocol for dysphagia in adults: comparison with videofluoroscopic findings.

PubMed

Sassi, Fernanda C; Medeiros, Gisele C; Zilberstein, Bruno; Jayanthi, Shri Krishna; de Andrade, Claudia R F

2017-12-01

To compare the videofluoroscopic findings of patients with suspected oropharyngeal dysphagia with the results of a clinical screening protocol. A retrospective observational cohort study was conducted on all consecutive patients with suspected oropharyngeal dysphagia between March 2015 and February 2016 who were assigned to receive a videofluoroscopic assessment of swallowing. All patients were first submitted to videofluoroscopy and then to the clinical assessment of swallowing. The clinical assessment was performed within the first 24 hours after videofluoroscopy. The videofluoroscopy results were analyzed regarding penetration/aspiration using an 8-point multidimensional perceptual scale. The accuracy of the clinical protocol was analyzed using the sensitivity, specificity, likelihood ratios and predictive values. The selected sample consisted of 50 patients. The clinical protocol presented a sensitivity of 50% and specificity of 95%, with an accuracy of 88%. "Cough" and "wet-hoarse" vocal quality after/during swallowing were clinical indicators that appeared to correctly identify the presence of penetration/aspiration risk. The clinical protocol used in the present study is a simple, rapid and reliable clinical assessment. Despite the absence of a completely satisfactory result, especially in terms of the sensitivity and positive predictive values, we suggest that lower rates of pneumonia can be achieved using a formal dysphagia screening method.

A zero-knowledge protocol for nuclear warhead verification

NASA Astrophysics Data System (ADS)

Glaser, Alexander; Barak, Boaz; Goldston, Robert J.

2014-06-01

The verification of nuclear warheads for arms control involves a paradox: international inspectors will have to gain high confidence in the authenticity of submitted items while learning nothing about them. Proposed inspection systems featuring `information barriers', designed to hide measurements stored in electronic systems, are at risk of tampering and snooping. Here we show the viability of a fundamentally new approach to nuclear warhead verification that incorporates a zero-knowledge protocol, which is designed in such a way that sensitive information is never measured and so does not need to be hidden. We interrogate submitted items with energetic neutrons, making, in effect, differential measurements of both neutron transmission and emission. Calculations for scenarios in which material is diverted from a test object show that a high degree of discrimination can be achieved while revealing zero information. Our ideas for a physical zero-knowledge system could have applications beyond the context of nuclear disarmament. The proposed technique suggests a way to perform comparisons or computations on personal or confidential data without measuring the data in the first place.

Science Innovation Through Industry Partnership: Lessons from AMPERE in Bridging the Federal Sponsor/Private Corporation Divide

NASA Astrophysics Data System (ADS)

Anderson, B. J.; Korth, H.; Erlandson, R. E.

2017-12-01

The Active Magnetosphere and Planetary Electrodynamics Response Experiment (AMPERE) was made possible by harnessing an fortuitous capability of the Iridium Communications constellation of 70 polar orbiting satellites. In 1996 it was realized that the attitude magnetometers on-board the Iridium satellites, then in fabrication, could potentially be used to obtain the first ever global and continuous measurements of the Birkeland currents with a sufficiently short re-sampling cadence (10 minutes) to track the dynamic evolution of the large-scale currents. The experience of taking this idea from 1996 through various research grant supported efforts, mission of opportunity proposal attempts, and finally through funding and implementation as a National Science Foundation geospace facility, revealed a number of challenges both in proposing innovative solutions to existing sponsor programs and also in working between the federal sponsor community and the private commercial space environment. Implementing AMPERE required a code change to on-board software on the Iridium satellites and it proved necessary to engage NASA to adjust the solicitation language to allow AMPERE. For NASA proposals we also encountered a conflict with respect to federal sponsorship such that the original business configuration of Iridium could not accept the accounting regime implied by a sub-contract derived from a federal contract acquisition. Subsequent mission of opportunity efforts encountered various other challenges including the cancellation of an explorer to fund the exploration initiative in 2001. The facilities proposal to NSF was almost not submitted owing a funding vehicle disparity between the preferred proposer structure (contract) vs NSF's requirement to fund only grants and a final hurdle concerned the structure of the contract with Iridium which was initially a sub-contract but was changed to a fixed-price data purchase due to NSF's limitations on funding fee-bearing engineering

78 FR 43878 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-22

...The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Stationary Combustion Turbines (40 CFR Part 63, Subpart YYYY) (Renewal)'' (EPA ICR No. 1967.05, OMB Control No. 2060-0540) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq). This is a proposed extension of the ICR, which is currently approved through September 30, 2013. Public comments were previously requested via the Federal Register (77 FR 63813) on October 17, 2012, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Student experimenter and sponsor display SE83-9 "Chix in Space" incubator

NASA Image and Video Library

1988-08-13

S88-44514 (13 Aug 1988) --- Student experimenter John C. Vellinger, left, explains components of an incubator used in his experiment to be carried onboard the Discovery for NASA's STS-29 mission next year. Mark S. Deusser, representing the sponsoring organization, holds up the incubator for inspection by members of the STS-29 crew who will monitor in-space operation of the experiment, titled "Chicken Embryo Development in Space." Astronaut Robert C. Springer is partially visible in lower right foreground. The student's sponsor is Kentucky Fried Chicken.

Student experimenter and sponsor display SE83-9 'Chix in Space' incubator

NASA Technical Reports Server (NTRS)

1988-01-01

Student experimenter John C. Vellinger (left) explains components of an incubator for his Student Experiment (SE) 83-9 Chicken Embryo Development in Space or 'Chix in Space' to be carried onboard STS-29 Discovery, Orbiter Vehicle (OV) 103. Mark S. Deusser, representing the sponsoring organization, holds up the incubator for inspection by STS-29 crewmembers who will monitor in-space operation of the experiment. Mission Specialist (MS) Robert C. Springer is partially visible in the lower right foreground. The student's sponsor is Kentucky Fried Chicken (KFC).

Oral-motor and electromyographic characterization of patients submitted to open a nd closed reductions of mandibular condyle fracture.

PubMed

Silva, Amanda Pagliotto da; Sassi, Fernanda Chiarion; Andrade, Claudia Regina Furquim de

To characterize the oral-motor system of adults with mandibular condyle facture comparing the performance of individuals submitted to open reduction with internal fixation (ORIF) and closed reduction with mandibulomaxillary fixation (CRMMF). Study participants were 26 adults divided into three groups: G1 - eight individuals submitted to ORIF for correction of condyle fracture; G2 - nine individuals submitted to CRMMF for correction of condyle fracture; CG - nine healthy volunteers with no alterations of the orofacial myofunctional system. All participants underwent the same clinical protocol: assessment of the orofacial myofunctional system; evaluation of the mandibular range of motion; and surface electromyography (sEMG) of the masticatory muscles. Results indicated that patients with condyle fractures from both groups presented significant differences compared with those from the control group in terms of mobility of the oral-motor organs, mastication, and deglutition. Regarding the measures obtained for mandibular movements, participants with facial fractures from both groups showed significant differences compared with those from the control group, indicating greater restrictions in mandibular motion. As for the analysis of sEMG results, G1 patients presented more symmetrical masseter activation during the task of maximal voluntary teeth clenching. Patients with mandibular condyle fractures present significant deficits in posture, mobility, and function of the oral-motor system. The type of medical treatment does not influence the results of muscle function during the first six months after fracture reduction. Individuals submitted to ORIF of the condyle fracture present more symmetrical activation of the masseter muscle.

Industry sponsored anti-smoking ads and adolescent reactance: test of a boomerang effect.

PubMed

Henriksen, L; Dauphinee, A L; Wang, Y; Fortmann, S P

2006-02-01

To examine whether adolescents' exposure to youth smoking prevention ads sponsored by tobacco companies promotes intentions to smoke, curiosity about smoking, and positive attitudes toward the tobacco industry. A randomised controlled experiment compared adolescents' responses to five smoking prevention ads sponsored by a tobacco company (Philip Morris or Lorillard), or to five smoking prevention ads sponsored by a non-profit organisation (the American Legacy Foundation), or to five ads about preventing drunk driving. A large public high school in California's central valley. A convenience sample of 9th and 10th graders (n = 832) ages 14-17 years. Perceptions of ad effectiveness, intention to smoke, and attitudes toward tobacco companies measured immediately after exposure. As predicted, adolescents rated Philip Morris and Lorillard ads less favourably than the other youth smoking prevention ads. Adolescents' intention to smoke did not differ as a function of ad exposure. However, exposure to Philip Morris and Lorillard ads engendered more favourable attitudes toward tobacco companies. This study demonstrates that industry sponsored anti-smoking ads do more to promote corporate image than to prevent youth smoking. By cultivating public opinion that is more sympathetic toward tobacco companies, the effect of such advertising is likely to be more harmful than helpful to youth.

Comparison of Cryopreservation Protocols (Single and Two-steps) and Thawing (Fast and Slow) for Canine Sperm.

PubMed

Brito, Maíra M; Lúcio, Cristina F; Angrimani, Daniel S R; Losano, João Diego A; Dalmazzo, Andressa; Nichi, Marcílio; Vannucchi, Camila I

2017-01-02

In addition to the existence of several cryopreservation protocols, no systematic research has been carried out in order to confirm the suitable protocol for canine sperm. This study aims to assess the effect of adding 5% glycerol during cryopreservation at 37°C (one-step) and 5°C (two-steps), in addition of testing two thawing protocols (37°C for 30 seconds, and 70°C for 8 seconds). We used 12 sperm samples divided into four experimental groups: Single-Step - Slow Thawing Group; Two-Step - Slow Thawing Group; Single-Step - Fast Thawing Group; and Two-Step - Fast Thawing Group. Frozen-thawed samples were submitted to automated analysis of sperm motility, evaluation of plasmatic membrane integrity, acrosomal integrity, mitochondrial activity, sperm morphology, sperm susceptibility to oxidative stress, and sperm binding assay to perivitellinic membrane of chicken egg yolk. Considering the comparison between freezing protocols, no statistical differences were verified for any of the response variables. When comparison between thawing protocols was performed, slow thawing protocol presented higher sperm count bound to perivitelline membrane of chicken egg yolk, compared to fast thawing protocol. Regardless of the freezing process, the slow thawing protocol can be recommended for the large scale cryopreservation of canine semen, since it shows a consistent better functional result.

The frequency of company-sponsored alcohol brand-related sites on Facebook™-2012.

PubMed

Nhean, Siphannay; Nyborn, Justin; Hinchey, Danielle; Valerio, Heather; Kinzel, Kathryn; Siegel, Michael; Jernigan, David H

2014-06-01

This research provides an estimate of the frequency of company-sponsored alcohol brand-related sites on Facebook™. We conducted a systematic overview of the extent of alcohol brand-related sites on Facebook™ in 2012. We conducted a 2012 Facebook™ search for sites specifically related to 898 alcohol brands across 16 different alcoholic beverage types. Descriptive statistics were produced using Microsoft SQL Server. We identified 1,017 company-sponsored alcohol-brand related sites on Facebook™. Our study advances previous literature by providing a systematic overview of the extent of alcohol brand sites on Facebook™.

Evaluation of results obtained with corifollitropin alfa after poor ovarian response in previous cycle using recombinant follicular stimulating hormone in the long-term protocol.

PubMed

Salgueiro, Lister L; Rolim, Juliana R; Moura, Bernardo R L; Machado, Suelen P P; Haddad, Carolina

2016-08-01

This study evaluated the use of Corifollitropin alfa in patients with previous poor response to recombinant follicle stimulating hormone in long-term protocols using gonadotropin-releasing hormone. Twenty-seven poor responders to previous treatment with the long term protocol using the recombinant follicle stimulating hormone (Group 1) were selected and then submitted to a second attempt using the same long term protocol with Corifollitropin alfa instead of the recombinant follicle stimulating hormone (Group 2).Ovarian down-regulation was achieved using subcutaneous administration of Leuprolide Acetate. Ovarian stimulation was performed with recombinant follicle stimulating hormone until the administration of human chorionic gonadotropin, followed by follicular aspiration (Group 1). Group 2 was submitted to this same protocol using Corifollitropin alfa instead of recombinant follicle stimulating hormone. There were significant differences in the number of aspirated oocytes, percentage of mature oocytes, amount of injected oocytes and transferred embryos - with all of these parameters being increased in the Corifollitropin alfa group. In addition, the rates of pregnancy and ongoing pregnancy were also significantly higher in the Corifollitropin alfa group. The present study demonstrated that the use of Corifollitropin alfa in the long-term protocol could be a highly effective alternative for patients with poor ovarian response, who were unsuccessful in a previous treatment with In Vitro Fertilization - Intracytoplasmic Sperm Injection.

Building a protocol expressway: the case of Mayo Clinic Cancer Center.

PubMed

McJoynt, Terre A; Hirzallah, Muhanad A; Satele, Daniel V; Pitzen, Jason H; Alberts, Steven R; Rajkumar, S Vincent

2009-08-10

Inconsistencies and errors resulting from nonstandard processes, together with redundancies, rework, and excess workload, lead to extended time frames for clinical trial protocol development. This results in dissatisfaction among sponsors, investigators, and staff and restricts the availability of novel treatment options for patients. A team of experts from Mayo Clinic formed, including Protocol Development Unit staff and management from the three Mayo Clinic campuses (Florida, Minnesota, and Arizona), a systems and procedures analyst, a quality office analyst, and two physician members to address the identified deficiencies. The current-state process was intensively reviewed, and improvement steps were taken to accelerate the development and approval of cancer-related clinical trials. The primary goal was to decrease the time from receipt of a new protocol through submission to an approving authority, such as the National Cancer Institute or institutional review board. Using the Define, Measure, Analyze, Improve, Control (DMAIC) framework infused with Lean waste-reduction methodologies, areas were identified for improvement, including enhancing first-time quality and processing new studies on a first-in/first-out basis. The project was successful in improving the mean turnaround time for internally authored protocols (P < .001) from 25.00 weeks (n = 41; range, 3.43 to 94.14 weeks) to 10.15 weeks (n = 14; range, 4.00 to 22.14 weeks). The mean turnaround time for externally authored protocols was improved (P < .001) from 20.61 weeks (n = 85; range, 3.29 to 108.57 weeks) to 7.79 weeks (n = 50; range, 2.00 to 20.86 weeks). DMAIC framework combined with Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes.

Hydrofluorocarbon (HFC) Scenarios, Climate Effects and the Montreal Protocol

NASA Astrophysics Data System (ADS)

Velders, G. J. M.; Fahey, D. W.; Daniel, J. S.

2016-12-01

The Montreal Protocol has reduced the use of ozone-depleting substances by more than 95% from its peak levels in the 1980s. As a direct result the use of hydrofluorocarbons (HFCs) as substitute compounds has increased significantly. National regulations to limit HFC use have been adopted recently in the European Union, Japan and USA, and four proposals have been submitted to amend the Montreal Protocol to substantially reduce growth in HFC use. The Parties of the Montreal Protocol have discussed these proposals during their meetings in 2016. The effects of the national regulations and Montreal Protocol amendment proposals on climate forcings and surface temperatures will be presented. Global scenarios of HFC emissions reach 4.0-5.3 GtCO2-eq yr-1 in 2050, which corresponds to a projected growth from 2015 to 2050 which is 9% to 29% of that for CO2 over the same time period. In 2050, in percent of global HFC emissions, China ( 30%), India and the rest of Asia ( 25%), Middle East and northern Africa ( 10%), and USA ( 10%) are the principal source regions; and refrigeration and stationary air conditioning are the major use sectors. Calculated baseline emissions are reduced by 90% in 2050 by implementing the North America Montreal Protocol amendment proposal. This corresponds to a reduction in surface temperature attributed to HFCs from 0.1 oC to 0.04 oC in 2050 and from 0.3-0.4 oC to 0.02 oC in 2100.

Ocean Optics Protocols for Satellite Ocean Color Sensor Validation. Volume 1; Revised

NASA Technical Reports Server (NTRS)

Mueller, James L. (Editor); Fargion, Giulietta (Editor); Mueller, J. L.; Trees, C.; Austin, R. W.; Pietras, C.; Hooker, S.; Holben, B.; McClain, Charles R.; Clark, D. K.;

Ocean Optics Protocols for Satellite Ocean Color Sensor Validation. Volume 2; Revised

NASA Technical Reports Server (NTRS)

Mueller, James L. (Editor); Fargion, Giulietta S. (Editor); Trees, C.; Austin, R. W.; Pietras, C. (Editor); Hooker, S.; Holben, B.; McClain, Charles R.; Clark, D. K.; Yuen, M.

2002-01-01

This document stipulates protocols for measuring bio-optical and radiometric data for the SIMBIOS Project. It supersedes the earlier version, and is organized into four parts: Introductory Background, Instrument Characteristics, Field Measurements and Data Analysis, Data Reporting and Archival. Changes in this revision include the addition of three new chapters: (1) Fundamental Definitions, Relationships and Conventions; (2) MOBY, A Radiometric Buoy for Performance Monitoring and Vicarious Calibration of Satellite Ocean Color Sensors: Measurement and Data Analysis Protocols; and (3) Normalized Water-Leaving Radiance and Remote Sensing Reflectance: Bidirectional Reflectance and Other Factors. Although the present document represents another significant, incremental improvement in the ocean optics protocols, there are several protocols that have either been overtaken by recent technological progress, or have been otherwise identified as inadequate. Revision 4 is scheduled for completion sometime in 2003. This technical report is not meant as a substitute for scientific literature. Instead, it will provide a ready and responsive vehicle for the multitude of technical reports issued by an operational Project. The contributions are published as submitted, after only minor editing to correct obvious grammatical or clerical errors.

Protocol Coordinator | Center for Cancer Research

Cancer.gov

CCR, NCI and NIH policies Collaborates with investigators to resolve any protocol/data issues Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI Institutional Review Board (IRB) and the clinical trial sponsor or the FDA Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Attends and prepares minutes for the Branch Protocol Review Committees For protocols that are performed with other research centers: contacts coordinators at other centers to obtain review committee approvals at these centers, maintains records of these approvals at the outside centers in the protocol files, and sends protocol amendments and other reports to the participating centers Maintains a schedule of all review committee submission deadline dates and meeting dates Assists clinical investigators in understanding and complying with the entire review process Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document management and tracking system for NCI protocols Converts protocols from Word format to PDF with bookmarks Maintains the PDF version of the most current approved version of each active clinical protocol on a central server    This position has the option to be located in Frederick or Rockville, Maryland.

Informal trail monitoring protocols: Denali National Park and Preserve. Final Report, October 2011

USGS Publications Warehouse

Marion, Jeffrey L.; Wimpey, Jeremy F.

2011-01-01

Managers at Alaska?s Denali National Park and Preserve (DENA) sponsored this research to assess and monitor visitor-created informal trails (ITs). DENA is located in south-central Alaska and managed as a six million acre wilderness park. This program of research was guided by the following objectives: (1) Investigate alternative methods for monitoring the spatial distribution, aggregate lineal extent, and tread conditions of informal (visitor-created) trails within the park. (2) In consultation with park staff, develop, pilot test, and refine cost-effective and scientifically defensible trail monitoring procedures that are fully integrated with the park?s Geographic Information System. (3) Prepare a technical report that compiles and presents research results and their management implications. This report presents the protocol development and field testing process, illustrates the types of data produced by their application, and provides guidance for their application and use. The protocols described provide managers with an efficient means to document and monitor IT conditions in settings ranging from pristine to intensively visited.

A Guide to Orientation Materials for Refugees and their Sponsors. A Selected, Annotated Bibliography Supplement.

ERIC Educational Resources Information Center

Center for Applied Linguistics, Washington, DC. Language and Orientation Resource Center.

An annotated bibliography of materials for the orientation of refugees and their sponsors is a supplement to "A Guide to Orientation Materials for Indochinese Refugees and their Sponsors," and includes 40 entries for materials pertinent to many other, non-Indochinese refugee groups. The materials are grouped alphabetically by the…

77 FR 31722 - New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-30

... 558 [Docket No. FDA-2012-N-0002] New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate.... ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new...

The Administration of Sponsored Programs. Handbook for Developing and Managing Research Activities and Other Projects.

ERIC Educational Resources Information Center

Beasley, Kenneth L.; And Others

Designed as a standard reference and training resource for administrators and project managers, this handbook discusses how to plan, organize, and manage sponsored projects in any organizational setting. It provides detailed, how-to-do-it information and many resources for: negotiating grants, awards, and contracts; organizing a sponsored projects…

14 CFR 60.9 - Additional responsibilities of the sponsor.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Additional responsibilities of the sponsor. 60.9 Section 60.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.9...

14 CFR 60.9 - Additional responsibilities of the sponsor.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Additional responsibilities of the sponsor. 60.9 Section 60.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.9...

14 CFR 60.9 - Additional responsibilities of the sponsor.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false Additional responsibilities of the sponsor. 60.9 Section 60.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.9...

14 CFR 60.9 - Additional responsibilities of the sponsor.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Additional responsibilities of the sponsor. 60.9 Section 60.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.9...

14 CFR 60.9 - Additional responsibilities of the sponsor.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Additional responsibilities of the sponsor. 60.9 Section 60.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.9...

Employer-Sponsored Career Development Programs. Information Series No. 231.

ERIC Educational Resources Information Center

Lancaster, Anita Sklare; Berne, Richard R.

This monograph presents an overview of employer-sponsored career development programs. It is divided into four sections. The "Adult Development" and "Adult Career Development" sections review pertinent theories and research (basic concepts, task model, transition model, theme model, adult career stages, career anchors approach, career development…

41. March 18, 1939 Oakland, California Launching party with sponsor ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

41. March 18, 1939 Oakland, California Launching party with sponsor Miss Harriet Biota Mason (holding flowers) at the Moore Dry Dock Company. - U.S. Coast Guard Cutter FIR, Puget Sound Area, Seattle, King County, WA

Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine".

PubMed

O'Reilly, Erin K; Blair Holbein, M E; Berglund, Jelena P; Parrish, Amanda B; Roth, Mary-Tara; Burnett, Bruce K

2013-12-01

This study highlights Warning Letter (WL) findings issued to sponsor-investigators (S-Is) by the Food and Drug Administration (FDA). The online index of WLs issued from October 1, 2007 through September 30, 2012 was reviewed [1]. Through a manual screening process, letters were evaluated if specifically issued to 'clinical investigators', 'sponsors' or 'sponsor-investigators'. A particular focus was given to S-Is at Academic Health Centres (AHCs). Each letter was scored for the presence of violations in 40 general regulatory categories. A review of FDA WLs issued over a five-year period (FDA Fiscal Years 2008-2012) revealed that WLs to S-Is represent half of the WLs issued to all sponsors (16 of 32 letters). A review of these letters indicates that S-Is are not aware of, or simply do not meet, their regulatory responsibilities as either investigators or sponsors. In comparing total sponsor letters to those of S-Is, the most cited violation was the same: a lack of monitoring. A review of publicly available inspection data indicates that these 16 letters merely represent the tip of the iceberg. This review of the WL database reveals the potential for serious regulatory violations among S-Is at AHCs. Recent translational funding initiatives may serve to increase the number of S-Is, especially among Academic Health Centres (AHCs) [2]; thus, AHCs must become aware of this S-I role and work to support investigators who assume both roles in the course of their research.

Protocol Coordinator | Center for Cancer Research

Cancer.gov

forms. Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies. Collaborates with investigators to resolve any protocol/data issues. Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA. Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events. Attends and prepares minutes for the Branch Protocol Review Committees. Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers, maintains records of these approvals and sends protocol amendments and other reports to the participating centers. Maintains a schedule of all review committee submission deadline dates and meeting dates. Assists clinical investigators in understanding and complying with the entire review process. Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document and tracking system for NCI protocols. Converts protocols from Word format to .pdf with bookmarks. Maintains the .pdf version of the most current approved version of each active clinical protocol on a central server. This position is located in Rockville, Maryland.

78 FR 12759 - Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

...--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting Hepatitis C Virus... sponsors in submitting hepatitis C virus (HCV) clinical virology data, which are important for supporting...

76 FR 2807 - New Animal Drugs; Change of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 510 [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

78 FR 17595 - New Animal Drugs; Changes of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 529, and 558 [Docket No. FDA-2013-N-0002] New Animal Drugs; Changes of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is...

Industry sponsored anti‐smoking ads and adolescent reactance: test of a boomerang effect

PubMed Central

Henriksen, L; Dauphinee, A L; Wang, Y; Fortmann, S P

2006-01-01

Objective To examine whether adolescents' exposure to youth smoking prevention ads sponsored by tobacco companies promotes intentions to smoke, curiosity about smoking, and positive attitudes toward the tobacco industry. Design A randomised controlled experiment compared adolescents' responses to five smoking prevention ads sponsored by a tobacco company (Philip Morris or Lorillard), or to five smoking prevention ads sponsored by a non‐profit organisation (the American Legacy Foundation), or to five ads about preventing drunk driving. Setting A large public high school in California's central valley. Subjects A convenience sample of 9th and 10th graders (n  =  832) ages 14–17 years. Main outcome measures Perceptions of ad effectiveness, intention to smoke, and attitudes toward tobacco companies measured immediately after exposure. Results As predicted, adolescents rated Philip Morris and Lorillard ads less favourably than the other youth smoking prevention ads. Adolescents' intention to smoke did not differ as a function of ad exposure. However, exposure to Philip Morris and Lorillard ads engendered more favourable attitudes toward tobacco companies. Conclusions This study demonstrates that industry sponsored anti‐smoking ads do more to promote corporate image than to prevent youth smoking. By cultivating public opinion that is more sympathetic toward tobacco companies, the effect of such advertising is likely to be more harmful than helpful to youth. PMID:16436398

A Case Study of Teaching Marketing Research Using Client-Sponsored Projects: Method, Challenges, and Benefits

ERIC Educational Resources Information Center

Bove, Liliana L.; Davies, W. Martin

2009-01-01

This case study outlines the use of client-sponsored research projects in a quantitative postgraduate marketing research subject conducted in a 12-week semester in a research-intensive Australian university. The case study attempts to address the dearth of recent literature on client-sponsored research projects in the discipline of marketing.…

Screening Protocol for Early Identification of Brazilian Children at Risk for Dyslexia

PubMed Central

Germano, Giseli D.; César, Alexandra B. P. de C.; Capellini, Simone A.

2017-01-01

Early identification of students at risk of dyslexia has been an educational challenge in the past years. This research had two main goals. First, we aimed to develop a screening protocol for early identification of Brazilian children at risk for dyslexia; second, we aimed to identify the predictive variables of this protocol using Principal Component Analysis. The major step involved in developing this protocol was the selection of variables, which were chosen based on the literature review and linguistic criteria. The screening protocol was composed of seven cognitive-linguistic skills: Letter naming; Phonological Awareness (which comprises the following subtests: Rhyme production, Rhyme identification, Syllabic segmentation, Production of words from a given phoneme, Phonemic Synthesis, and Phonemic analysis); Phonological Working memory, Rapid naming Speed; Silent reading; Reading of words and non-words; and Auditory Comprehension of sentences from pictures. A total of 149 children, aged from 6 years to 6 and 11, of both genders who were enrolled in the 1st grade of elementary public schools were submitted to the screening protocol. Principal Component Analysis revealed four factors, accounting for 64.45% of the variance of the Protocol variables: first factor (“pre-reading”), second factor (“decoding”), third factor (“Reading”), and fourth factor “Auditory processing.” The factors found corroborate those reported in the National and International literature and have been described as early signs of dyslexia and reading problems. PMID:29163246

78 FR 21058 - New Animal Drugs; Change of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 526, 529, and 558 [Docket No. FDA-2013-N-0002] New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is...

42 CFR 423.520 - Prompt payment by Part D sponsors.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Construction. A determination under this section that a claim submitted by a network pharmacy is a clean claim... respect to all clean claims, as defined in paragraph (b) of this section, submitted by network pharmacies... claim is received, as defined in paragraph (a)(2)(i) of this section, for an electronic claim; or (ii...

42 CFR 423.520 - Prompt payment by Part D sponsors.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) Construction. A determination under this section that a claim submitted by a network pharmacy is a clean claim... respect to all clean claims, as defined in paragraph (b) of this section, submitted by network pharmacies... claim is received, as defined in paragraph (a)(2)(i) of this section, for an electronic claim; or (ii...

42 CFR 423.520 - Prompt payment by Part D sponsors.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) Construction. A determination under this section that a claim submitted by a network pharmacy is a clean claim... respect to all clean claims, as defined in paragraph (b) of this section, submitted by network pharmacies... claim is received, as defined in paragraph (a)(2)(i) of this section, for an electronic claim; or (ii...

42 CFR 423.520 - Prompt payment by Part D sponsors.

Code of Federal Regulations, 2012 CFR

2012-10-01

...) Construction. A determination under this section that a claim submitted by a network pharmacy is a clean claim... respect to all clean claims, as defined in paragraph (b) of this section, submitted by network pharmacies... claim is received, as defined in paragraph (a)(2)(i) of this section, for an electronic claim; or (ii...

[Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

PubMed

Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

2018-01-01

 Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

[Analysis of projects of infectious disease epidemiology sponsored by National Natural Science Foundation of China].

PubMed

Jian-Ming, Wang; Yan-Kai, Xia; Hui-Juan, Zhu; Feng, Chen; Hong-Bing, Shen

2016-05-10

To analyze the projects on the infectious disease epidemiology sponsored by the National Natural Science Foundation of China (NSFC), explore the hotspot and development trend, and offer a reference for researchers in this field. Based on the NSFC database, the projects on the infectious disease epidemiology (H2609) sponsored from 1987 to 2014 were analyzed. The changes of fund numbers, amounts and research fields were described. During the study period, NSFC sponsored 373 projects, including 228 general projects (61.1%), 78 youth projects (20.9%) and 67 other projects (18.0%). The average amount of the grant was 358.2 thousand Yuan (20 thousand-8 million). The main sponsored research fields were mechanisms of pathogen and immunity (36.2%) and population-based epidemiological studies (33.0%). The top three diseases were hepatitis, HIV/AIDS and tuberculosis. The amount of funding on researches of infectious disease epidemiology has increased continuously, which has played an important role in training scientific talents in the field of prevention and control of infectious diseases.

76 FR 68808 - Exchange Visitor Program-Cap on Current Participant Levels and Moratorium on New Sponsor...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... Levels and Moratorium on New Sponsor Applications for Summer Work Travel Program AGENCY: Department of State. ACTION: Notice Regarding the Summer Work Travel Program. SUMMARY: Effective January 1, 2012, the... moratorium on designation of new Summer Work Travel sponsor organizations. FOR FURTHER INFORMATION CONTACT...

PrimateLit Database: Submit Literature for Indexing

Science.gov Websites

Access PrimateLit Using this Site About the Project Submit Literature for Indexing Copyright Info Center WI Regional Primate Resource Center Submit Literature for Indexing PrimateLit has not been

School-Sponsored Health Insurance: Planning for a New Reality

ERIC Educational Resources Information Center

Liang, Bryan A.

2010-01-01

Health care reform efforts in both the Clinton and Obama administrations have attempted to address college and university health. Yet, although the world of health care delivery has almost universally evolved to managed care, school health programs have not. In general, school-sponsored health plans do little to improve access and have adopted…

A Commentary on Literacy Narratives as Sponsors of Literacy

ERIC Educational Resources Information Center

Brandt, Deborah

2015-01-01

This brief commentary first clarifies Brandt's concept of sponsors of literacy in light of the way the concept has been taken up in writing studies. Then it treats Brandt's methods for handling accounts of literacy learning in comparison with other ways of analyzing biographical material. Finally it takes up Lawrence's argument about literacy…

Fitness, Friendship, and Fun: University Sponsored Community PE Program

ERIC Educational Resources Information Center

Stanley, Wendi Wilcox; De Marco, George Mario Paul; Laubach, Lloyd L.; Daprano, Corinne M.

2006-01-01

The purpose of this article is to describe that program, called Fitness, Friendship, and Fun. It is only one of a series of community based, physical education service learning programs. These programs are sponsored by the University of Dayton Health and Sport Science Department in collaboration with a neighboring professional development school,…

Immigrants and Employer-Sponsored Health Insurance

PubMed Central

Buchmueller, Thomas C; Lo Sasso, Anthony T; Lurie, Ithai; Dolfin, Sarah

2007-01-01

Objective To investigate the factors underlying the lower rate of employer-sponsored health insurance coverage for foreign-born workers. Data Sources 2001 Survey of Income and Program Participation. Study Design We estimate probit regressions to determine the effect of immigrant status on employer-sponsored health insurance coverage, including the probabilities of working for a firm that offers coverage, being eligible for coverage, and taking up coverage. Data Extraction Methods We identified native born citizens, naturalized citizens, and noncitizen residents between the ages of 18 and 65, in the year 2002. Principal Findings First, we find that the large difference in coverage rates for immigrants and native-born Americans is driven by the very low rates of coverage for noncitizen immigrants. Differences between native-born and naturalized citizens are quite small and for some outcomes are statistically insignificant when we control for observable characteristics. Second, our results indicate that the gap between natives and noncitizens is explained mainly by differences in the probability of working for a firm that offers insurance. Conditional on working for such a firm, noncitizens are only slightly less likely to be eligible for coverage and, when eligible, are only slightly less likely to take up coverage. Third, roughly two-thirds of the native/noncitizen gap in coverage overall and in the probability of working for an insurance-providing employer is explained by characteristics of the individual and differences in the types of jobs they hold. Conclusions The substantially higher rate of uninsurance among immigrants is driven by the lower rate of health insurance offers by the employers of immigrants. PMID:17355593

List of Organizing Committees and Sponsors

NASA Astrophysics Data System (ADS)

2012-03-01

Organizers DIRECTORS Maria L CalvoPresident of International Commission for Optics, Spain Aram V PapoyanDirector of Institute for Physical Research of NAS, Armenia HEADS OF PROJECT Tigran Dadalyan YSU, Armenia Artsrun MartirosyanIPR, Armenia COORDINATOR Narine GevorgyanIPR, Armenia / ICTP, Italy MANAGERS Paytsar MantashyanIPR, Armenia Karen VardanyanIPR, Armenia INTERNATIONAL ADVISORY COMMITTEE Marcis AuzinshLatvia Roland AvagyanArmenia Tapash ChakrabortyCanada Yuri ChilingaryanArmenia Eduard KazaryanArmenia Albert KirakosyanArmenia Radik KostanyanArmenia Avinash PandeyIndia Marat SoskinUkraine INTERNATIONAL PROGRAM COMMITTEE David Sarkisyan (Chair)Armenia Roman AlaverdyanArmenia Dan ApostolRomania Levon AslanyanArmenia Aranya BhattacherjeeIndia Gagik BuniatyanArmenia Vigen ChaltykyanArmenia Roldao Da RochaBrazil Miltcho DanailovItaly Vladimir GerdtRussia Samvel GevorgyanArmenia Gayane GrigoryanArmenia Rafik HakobyanArmenia Takayuki MiyaderaJapan Levon MouradianArmenia Atom MuradyanArmenia Simon RochesterUSA Hayk SarkisyanArmenia Aleksandr VardanyanArmenia LOCAL ORGANIZING COMMITTEE Narek AghekyanArmenia Anahit GogyanArmenia Melanya GrigoryanArmenia Armen HovhannisyanArmenia Lilit HovhannisyanArmenia Tatevik KhachatryanArmenia Astghik KuzanyanArmenia Satenik KuzanyanArmenia Vladimir LazarevRussia Lilit MantashyanArmenia Hripsime MkrtchyanArmenia Pavel MuzhikyanArmenia Wahi NarsisianArmenia Sahak OrdukhanyanArmenia Anna ReymersArmenia Narine TorosyanArmenia The Symposium was organized by YSU & NAS SPIE Armenian Student Chapter Institute for Physical Research (IPR) of National Academy of Sciences (NAS) Russian-Armenian (Slavonic) University (RAU) LT-PYRKAL cjsc Yerevan State University (YSU) Official Sponsors of the Symposium LT-PYRKAlRussian ArmenianSPIE LT-PYRKAL cjscRussian-Armenian UniversityYSU & NAS SPIE Student Chapter Further sponsors NFSATICTPSCSADevout Generation National Foundation of Science and Advanced TechnologiesThe Abdus Salam International Centre

Does industry-sponsored education foster overdiagnosis and overtreatment of depression, osteoporosis and over-active bladder syndrome? An Australian cohort study.

PubMed

Mintzes, Barbara; Swandari, Swestika; Fabbri, Alice; Grundy, Quinn; Moynihan, Ray; Bero, Lisa

2018-02-13

To investigate patterns of industry-sponsored educational events that focus on specific health conditions for which there are concerns about overdiagnosis and overtreatment. This retrospective cohort study examines publicly reported industry-sponsored events in Australia from October 2011 to September 2015 for three conditions potentially subject to overdiagnosis and overtreatment: depression, osteoporosis and overactive bladder. We used a database of transparency reports to identify events with a focus on depression, osteoporosis and overactive bladder and compared these with other sponsored events. We hypothesised that companies marketing treatments for each condition would sponsor related events and that target audiences would mainly work in primary care, reflecting a broad patient population. Event and attendee characteristics, sponsoring companies, related marketed treatments, cost-effectiveness ratings and dispensing rates. Over the study period, we identified 1567 events focusing on depression, 1375 on osteoporosis and 190 on overactive bladder (total n=3132, with 96 660 attendees). These events were attended by primary care doctors more often than sponsored events without a focus on these three conditions: relative risk (RR)=3.06 (95% CI 2.81 to 3.32) for depression, RR=1.48 (95% CI 1.41 to 1.55) for osteoporosis and RR=2.59 (95% CI 2.09 to 3.21) for overactive bladder. Servier, which markets agomelatine and AstraZeneca (quetiapine) sponsored 51.2% and 23.0% of depression events, respectively. Amgen and GlaxoSmithKline, which co-market denosumab, sponsored 49.5% of osteoporosis events and Astellas and Commonwealth Serum Laboratories (CSL) (mirabegron and solifenacin) sponsored 80.5% of overactive bladder events. This 4-year overview of industry-sponsored events on three overdiagnosed and overtreated conditions found that primary care clinicians were often targeted, dinner was often provided and that a few companies sponsored most events. In most cases

Low-Income Working Families With Employer-Sponsored Insurance Turn To Public Insurance For Their Children.

PubMed

Strane, Douglas; French, Benjamin; Eder, Jennifer; Wong, Charlene A; Noonan, Kathleen G; Rubin, David M

2016-12-01

Many families rely on employer-sponsored health insurance for their children. However, the rise in the cost of such insurance has outpaced growth in family income, potentially making public insurance (Medicaid or the Children's Health Insurance Plan) an attractive alternative for affordable dependent coverage. Using data for 2008-13 from the Medical Expenditure Panel Survey, we quantified the coverage rates for children from low- or moderate-income households in which a parent was offered employer-sponsored insurance. Among families in which parents were covered by such insurance, the proportion of children without employer-sponsored coverage increased from 22.5 percent in 2008 to 25.0 percent in 2013. The percentage of children with public insurance when a parent was covered by employer-sponsored insurance increased from 12.1 percent in 2008 to 15.2 percent in 2013. This trend was most pronounced for families with incomes of 100-199 percent of the federal poverty level, for whom the share of children with public insurance increased from 22.8 percent to 29.9 percent. Among families with incomes of 200-299 percent of poverty, uninsurance rates for children increased from 6.0 percent to 9.2 percent. These findings suggest a movement away from employer-sponsored insurance and toward public insurance for children in low-income families, and growth in uninsurance among children in moderate-income families. Project HOPE—The People-to-People Health Foundation, Inc.

20 CFR 416.1166a - How we deem income to you from your sponsor if you are an alien.

Code of Federal Regulations, 2013 CFR

2013-04-01

... if you are an alien. 416.1166a Section 416.1166a Employees' Benefits SOCIAL SECURITY ADMINISTRATION... income to you from your sponsor if you are an alien. Before we deem your sponsor's income to you if you are an alien, we determine how much earned and unearned income your sponsor has under § 416.1161(b...

20 CFR 416.1166a - How we deem income to you from your sponsor if you are an alien.

Code of Federal Regulations, 2014 CFR

2014-04-01

... if you are an alien. 416.1166a Section 416.1166a Employees' Benefits SOCIAL SECURITY ADMINISTRATION... income to you from your sponsor if you are an alien. Before we deem your sponsor's income to you if you are an alien, we determine how much earned and unearned income your sponsor has under § 416.1161(b...

20 CFR 416.1166a - How we deem income to you from your sponsor if you are an alien.

Code of Federal Regulations, 2012 CFR

2012-04-01

... if you are an alien. 416.1166a Section 416.1166a Employees' Benefits SOCIAL SECURITY ADMINISTRATION... income to you from your sponsor if you are an alien. Before we deem your sponsor's income to you if you are an alien, we determine how much earned and unearned income your sponsor has under § 416.1161(b...

20 CFR 416.1166a - How we deem income to you from your sponsor if you are an alien.

Code of Federal Regulations, 2011 CFR

2011-04-01

... if you are an alien. 416.1166a Section 416.1166a Employees' Benefits SOCIAL SECURITY ADMINISTRATION... income to you from your sponsor if you are an alien. Before we deem your sponsor's income to you if you are an alien, we determine how much earned and unearned income your sponsor has under § 416.1161(b...

Building a Protocol Expressway: The Case of Mayo Clinic Cancer Center

PubMed Central

McJoynt, Terre A.; Hirzallah, Muhanad A.; Satele, Daniel V.; Pitzen, Jason H.; Alberts, Steven R.; Rajkumar, S. Vincent

2009-01-01

Purpose Inconsistencies and errors resulting from nonstandard processes, together with redundancies, rework, and excess workload, lead to extended time frames for clinical trial protocol development. This results in dissatisfaction among sponsors, investigators, and staff and restricts the availability of novel treatment options for patients. Methods A team of experts from Mayo Clinic formed, including Protocol Development Unit staff and management from the three Mayo Clinic campuses (Florida, Minnesota, and Arizona), a systems and procedures analyst, a quality office analyst, and two physician members to address the identified deficiencies. The current-state process was intensively reviewed, and improvement steps were taken to accelerate the development and approval of cancer-related clinical trials. The primary goal was to decrease the time from receipt of a new protocol through submission to an approving authority, such as the National Cancer Institute or institutional review board. Results Using the Define, Measure, Analyze, Improve, Control (DMAIC) framework infused with Lean waste-reduction methodologies, areas were identified for improvement, including enhancing first-time quality and processing new studies on a first-in/first-out basis. The project was successful in improving the mean turnaround time for internally authored protocols (P < .001) from 25.00 weeks (n = 41; range, 3.43 to 94.14 weeks) to 10.15 weeks (n = 14; range, 4.00 to 22.14 weeks). The mean turnaround time for externally authored protocols was improved (P < .001) from 20.61 weeks (n = 85; range, 3.29 to 108.57 weeks) to 7.79 weeks (n = 50; range, 2.00 to 20.86 weeks). Conclusion DMAIC framework combined with Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes. PMID:19564529

Publication bias in the medical literature: a review by a Canadian Research Ethics Board.

PubMed

Hall, Richard; de Antueno, Cecilia; Webber, Adam

2007-05-01

We reviewed the publication record of all protocols submitted to the Capital District Health Authority Research Ethics Board (REB) in Halifax, Nova Scotia, for the period 1995-1996. Because of a heightened awareness of the issue, we hypothesized that there would be less publication bias (a failure to report negative results) and a higher publication rate from completed studies, than previously reported. Closed studies were identified from the REB database. Publications were identified by the investigators, requests from sponsors, and a literature review. For each publication, we identified authors, title, journal, number of subjects enrolled, and whether or not the publication was a report of a randomized clinical trial. Comparisons were done using a Student's t test, the Chi-square statistic, or Fisher's exact test as appropriate. From the database of closed studies, 106 remained unpublished, while completed investigations resulted in 84 publications (44% publication rate). The median time to publication was 32.5 months. Publication of statistically significant results occurred in 71/84 trials. Publication of protocols submitted by departments ranged from 91% (anesthesia; 10/11) to 25% [nursing; 2/8 (P<0.05)]. Trials investigating new drugs in Phase 3 or 4 studies were more likely to be published than trials investigating agents in Phase 1 or 2 (P<0.05), and were less likely to be published if sponsored by a pharmaceutical company (P<0.05). Publication bias continues to be a problem, particularly for early phase investigative studies. Our results suggest that a different approach is required to reduce publication bias. The role that REBs and peer-reviewed journals might play requires further exploration.

The Benefits and Challenges of Registered Apprenticeship: The Sponsors' Perspective

ERIC Educational Resources Information Center

Lerman, Robert; Eyster, Lauren; Chambers, Kate

2009-01-01

The Employment and Training Administration (ETA) of the U.S. Department of Labor oversees the registered apprenticeship system by issuing standards, monitoring state agencies, and promoting registered apprenticeship. Registered apprenticeship program "sponsors" are individual employers or groups of employers (sometimes in collaboration with…

Medical malpractice reform and employer-sponsored health insurance premiums.

PubMed

Morrisey, Michael A; Kilgore, Meredith L; Nelson, Leonard Jack

2008-12-01

Tort reform may affect health insurance premiums both by reducing medical malpractice premiums and by reducing the extent of defensive medicine. The objective of this study is to estimate the effects of noneconomic damage caps on the premiums for employer-sponsored health insurance. Employer premium data and plan/establishment characteristics were obtained from the 1999 through 2004 Kaiser/HRET Employer Health Insurance Surveys. Damage caps were obtained and dated based on state annotated codes, statutes, and judicial decisions. Fixed effects regression models were run to estimate the effects of the size of inflation-adjusted damage caps on the weighted average single premiums. State tort reform laws were identified using Westlaw, LEXIS, and statutory compilations. Legislative repeal and amendment of statutes and court decisions resulting in the overturning or repealing state statutes were also identified using LEXIS. Using a variety of empirical specifications, there was no statistically significant evidence that noneconomic damage caps exerted any meaningful influence on the cost of employer-sponsored health insurance. The findings suggest that tort reforms have not translated into insurance savings.

[Buccal manifestations in patients submitted to chemotherapy].

PubMed

Hespanhol, Fernando Luiz; Tinoco, Eduardo Muniz Barretto; Teixeira, Henrique Guilherme de Castro; Falabella, Márcio Eduardo Vieira; Assis, Neuza Maria de Souza Picorelli

2010-06-01

Several changes in the oral cavity due to chemotherapy can be observed and can lead to important systemic complications, increasing the time of the patient in hospital and the costs of the treatment as well as affect the quality of life of the patients. The aim of this study was to assess the oral manifestation in patients treated with chemotherapy according to sex, age and tumor type. Data was collected in an oncology hospital in Juiz de Fora, Minas Gerais State, from patients' records that were submitted to oncologic treatment. It was possible to verify that mucositis, associated or not to other type of lesions, was the most common lesion in both sex of all ages (15.5%). Xerostomia and other lesions, such as Candida infection and aphthous lesions, were also present. It is possible to improve the quality of life of the patient during and after anti-neoplastic therapies through a protocol of odontological assistance that includes changes of the oral environment previous to chemotherapy such as profilaxis, caries removal, treatment of periodontal and periapical lesions, oral hygiene instructions, diet orientation and laser therapy. It is very important the insertion of the dentist in the oncologic medical team for the early diagnosis of the oral manifestation and follow-up during treatment time.

How to Submit a Risk Management Plan (RMP) to EPA

EPA Pesticide Factsheets

RMP*eSubmit software is the only way to submit RMPs. After you have prepared your plan using RMP*eSubmit, you may also re-submit, correct, or withdraw an RMP. Another electronic tool, RMP*Comp, performs the required off-site consequence analysis.

The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

PubMed

Homedes, Núria; Ugalde, Antonio

2015-06-01

To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

77 FR 43345 - Agency Information Collection Activities: Sponsor's Notice of Change of Address, Form I-865...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-24

...-0076] Agency Information Collection Activities: Sponsor's Notice of Change of Address, Form I-865...: Sponsor's Notice of Change of Address. (3) Agency form number, if any, and the applicable component of the.... During this 60-day period, USCIS will be evaluating whether to revise the Form I-865. Should USCIS decide...

Practices of Boundary-Work in the Collaboration between Principals and Private Sponsors in England's Academy Schools

ERIC Educational Resources Information Center

Papanastasiou, Natalie

2017-01-01

This article presents one of the few qualitative studies to empirically examine the collaboration between private sponsors and principals in the context of England's academy schools policy. It uses the concept of boundary-work to illuminate the multiple dynamics involved in the collaboration between principals and business sponsors. By analysing…

14 CFR 1214.306 - Payload specialist relationship with sponsoring institutions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Payload specialist relationship with sponsoring institutions. 1214.306 Section 1214.306 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT Payload Specialists for Space Transportation System (STS) Missions § 1214.306 Payload...

14 CFR 1214.306 - Payload specialist relationship with sponsoring institutions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Payload specialist relationship with sponsoring institutions. 1214.306 Section 1214.306 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT Payload Specialists for Space Transportation System (STS) Missions § 1214.306 Payload...

14 CFR 1214.306 - Payload specialist relationship with sponsoring institutions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Payload specialist relationship with sponsoring institutions. 1214.306 Section 1214.306 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT Payload Specialists for Space Transportation System (STS) Missions § 1214.306 Payload...

14 CFR 1214.306 - Payload specialist relationship with sponsoring institutions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Payload specialist relationship with sponsoring institutions. 1214.306 Section 1214.306 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT Payload Specialists for Space Transportation System (STS) Missions § 1214.306 Payload...

45 CFR 2553.25 - What are a sponsor's administrative responsibilities?

Code of Federal Regulations, 2011 CFR

2011-10-01

... operate the project successfully. (b) Provide levels of staffing and resources appropriate to accomplish the purposes of the project and carry out its project management responsibilities. (c) Employ a full... staff positions in the sponsor organization and/or project service area. (f) Establish risk management...

45 CFR 2553.25 - What are a sponsor's administrative responsibilities?

Code of Federal Regulations, 2014 CFR

2014-10-01

... operate the project successfully. (b) Provide levels of staffing and resources appropriate to accomplish the purposes of the project and carry out its project management responsibilities. (c) Employ a full... staff positions in the sponsor organization and/or project service area. (f) Establish risk management...

45 CFR 2553.25 - What are a sponsor's administrative responsibilities?

Code of Federal Regulations, 2012 CFR

2012-10-01

... operate the project successfully. (b) Provide levels of staffing and resources appropriate to accomplish the purposes of the project and carry out its project management responsibilities. (c) Employ a full... staff positions in the sponsor organization and/or project service area. (f) Establish risk management...

45 CFR 2553.25 - What are a sponsor's administrative responsibilities?

Code of Federal Regulations, 2013 CFR

2013-10-01

... operate the project successfully. (b) Provide levels of staffing and resources appropriate to accomplish the purposes of the project and carry out its project management responsibilities. (c) Employ a full... staff positions in the sponsor organization and/or project service area. (f) Establish risk management...

A Process Manual: Staff Development in American-Sponsored Overseas Schools.

ERIC Educational Resources Information Center

Anderson, Carrel M.; Schaffer, Raymond, Jr.

This manual is written for those responsible for staff development in American-sponsored overseas schools (ASOS). Program management for staff development planning is divided into seven categories: (1) mission statement preparation; (2) needs assessment survey; (3) goal statements preparation; (4) staff objectives preparation; (5) activities…

77 FR 32897 - New Animal Drugs; Change of Sponsor's Name

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-04

.... FDA-2012-N-0002] New Animal Drugs; Change of Sponsor's Name AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug... 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and...

SeaWiFS technical report series. Volume 25: Ocean optics protocols for SeaWiFS validation, revision 1

NASA Technical Reports Server (NTRS)

Hooker, Stanford B. (Editor); Firestone, Elaine R. (Editor); Acker, James G. (Editor); Mueller, James L.; Austin, Roswell W.

1995-01-01

This report presents protocols for measuring optical properties, and other environmental variables, to validate the radiometric performance of the Sea-viewing Wide Field-of-view Sensor (SeaWiFS), and to develop and validate bio-optical algorithms for use with SeaWiFS data. The protocols are intended to establish foundations for a measurement strategy to verify the challenging SeaWiFS uncertainty goals of 5 percent in water-leaving radiances and 35 percent in chlorophyll alpha concentration. The protocols first specify the variables which must be measured, and briefly review the rationale for measuring each variable. Subsequent chapters cover detailed protocols for instrument performance specifications, characterizing and calibrating instruments, methods of making measurements in the field, and methods of data analysis. These protocols were developed at a workshop sponsored by the SeaWiFS Project Office (SPO) and held at the Naval Postgraduate School in Monterey, California (9-12 April 1991). This report began as the proceedings of the workshop, as interpreted and expanded by the authors and reviewed by workshop participants and other members of the bio-optical research community. The protocols are an evolving prescription to allow the research community to approach the unprecedented measurement uncertainties implied by the SeaWiFS goals; research and development are needed to improve the state-of-the-art in specific areas. These protocols should be periodically revised to reflect technical advances during the SeaWiFS Project cycle. The present edition (Revision 1) incorporates new protocols in several areas, including expanded protocol descriptions for Case-2 waters and other improvements, as contributed by several members of the SeaWiFS Science Team.

Fate of protocols submitted to a French national funding scheme: a cohort study.

PubMed

Decullier, Evelyne; Huot, Laure; Chapuis, François R

2014-01-01

The fate of clinical research projects funded by a grant has been investigated, but there is no information on the projects which did not receive funding. The fate of these projects is not known: do they apply for and/or receive funding from other sources or are they carried out without specific funding? The aim of the study was to describe all clinical research projects submitted to a French national funding scheme (PHRC 2000) and to assess project initiation, completion and publication status taking into account whether or not they received funding. This study is a retrospective cohort. The initial project characteristics were retrieved from the submission files and follow-up information was collected from the primary investigator. The percentages of projects started, completed and published were studied. A total of 481 projects were studied. Follow-up information was obtained for 366. Overall, 185 projects were initiated (51%); 139 of them were funded by the PHRC 2000 or other sources. The most commonly cited reason for not initiating a project was a lack of funding. Subsequently, 121 of the projects initiated were completed (65%). Accrual difficulties were the main reason cited to explain why studies were stopped prematurely or were still ongoing. Finally, 88 of the completed projects were published (73%). Amongst the completed projects, the only factor explaining publication was the statistical significance of the results. Obtainment of funding was a determining factor for project initiation. However, once initiated, the funding did not influence completion or publication.

Prevalence and Determinants of Physician Participation in Conducting Pharmaceutical-sponsored Clinical Trials and Lectures

PubMed Central

Ashar, Bimal H; Miller, Redonda G; Getz, Kelly J; Powe, Nell R

2004-01-01

BACKGROUND The relationship between physicians and the pharmaceutical industry is controversial because of the potential for conflicts of interest. However, little empirical evidence exists on the extent of physician participation in activities sponsored by pharmaceutical companies. OBJECTIVES To determine the prevalence of participation of internal medicine physicians in clinical trials and lectures sponsored by pharmaceutical companies and to describe factors that are associated with such participation. DESIGN, SETTING, AND PARTICIPANTS We conducted a cross-sectional regional survey of 1,000 Maryland internal medicine physicians between February 2000 and January 2001 in order to measure the prevalence of physician participation in pharmaceutical-sponsored clinical trials and lectures. We also collected economic and demographic information to examine potential associations between physician characteristics and engagement in such activities. RESULTS Of 835 eligible physicians 444 (53%) responded, of whom 37% reported engaging in pharmaceutical-sponsored clinical trials and/or lectures to supplement their incomes. In our multivariable analysis, subspecialists versus generalist physicians (odds ratio [OR], 1.85; 95% confidence interval [CI], 1.14 to 2.99), physicians in private group-single specialty and academic practice versus physicians in solo practice (OR, 2.30; 95% CI, 1.19 to 4.44 and OR, 2.56; 95% CI, 1.17 to 5.61, respectively), and physicians with higher versus lower annual incomes (OR, 1.22; 95% CI, 1.04 to 1.44) had a greater odds of participation in these activities. Additionally, physicians dissatisfied with their income had a 140% greater odds of participation (OR, 2.36; 95% CI, 1.45 to 3.83) than those who were satisfied with their income. CONCLUSIONS A substantial number of internists engage in pharmaceutical industry-sponsored clinical trials and/or lectures in an effort to supplement their incomes. Physician dissatisfaction with income appears to

The future of employer-sponsored retiree medical plans.

PubMed

Rappaport, A M; Kalman, R W

1987-01-01

Complex issues cloud the economic security of people who are covered by employer-sponsored retiree medical plans. The future stability of these plans is especially confusing. In their paper, the authors carefully analyze the current structure of retiree medical plans, including the effect of certain laws. Their clarifications are objective and concise. Of particular timeliness and practicality--particularly for public policy markers--is the authors' four-point strategy to help stabilize the future.

[Constraints on publication rights in industry-initiated clinical trials--secondary publication].

PubMed

Gøtzsche, Peter C; Hróbjartsson, Asbjørn; Johansen, Helle Krogh; Haahr, Mette T; Altman, Douglas G; Chan, An-Wen

2006-06-19

In 22 of 44 industry-initiated clinical trial protocols from 1994-95, it was noted that the sponsor either owned the data or needed to approve the manuscript; another 18 protocols had other constraints. Furthermore, in 16 trials, the sponsor had access to accumulating data, and in an additional 16 trials the sponsor could stop the trial at any time, for any reason. These facts were not noted in any of the trial reports. We found similar constraints on publication rights in 44 protocols from 2004. This tight sponsor control over industry-initiated trials should be changed.

45 CFR 2551.25 - What are a sponsor's administrative responsibilities?

Code of Federal Regulations, 2014 CFR

2014-10-01

... project and carry out its project management responsibilities. (c) Employ a full-time project director to... the sponsor organization and/or project service area. (f) Establish risk management policies and... responsibility for securing maximum and continuing community financial and in-kind support to operate the project...

45 CFR 2551.25 - What are a sponsor's administrative responsibilities?

Code of Federal Regulations, 2012 CFR

2012-10-01

... project and carry out its project management responsibilities. (c) Employ a full-time project director to... the sponsor organization and/or project service area. (f) Establish risk management policies and... responsibility for securing maximum and continuing community financial and in-kind support to operate the project...

45 CFR 2551.25 - What are a sponsor's administrative responsibilities?

Code of Federal Regulations, 2013 CFR

2013-10-01

... project and carry out its project management responsibilities. (c) Employ a full-time project director to... the sponsor organization and/or project service area. (f) Establish risk management policies and... responsibility for securing maximum and continuing community financial and in-kind support to operate the project...

45 CFR 2551.25 - What are a sponsor's administrative responsibilities?

Code of Federal Regulations, 2011 CFR

2011-10-01

... project and carry out its project management responsibilities. (c) Employ a full-time project director to... the sponsor organization and/or project service area. (f) Establish risk management policies and... responsibility for securing maximum and continuing community financial and in-kind support to operate the project...

21 CFR 316.22 - Permanent-resident agent for foreign sponsor.

Code of Federal Regulations, 2010 CFR

2010-04-01

....22 Section 316.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Designation of an Orphan Drug § 316.22 Permanent..., orders, decisions, requirements, and other communications may be made on behalf of the sponsor...

45 CFR 149.600 - Sponsor's duty to report data inaccuracies.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Sponsor's duty to report data inaccuracies. 149.600 Section 149.600 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH CARE ACCESS REQUIREMENTS FOR THE EARLY RETIREE REINSURANCE PROGRAM Disclosure of Data Inaccuracies...

45 CFR 149.600 - Sponsor's duty to report data inaccuracies.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Sponsor's duty to report data inaccuracies. 149.600 Section 149.600 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH CARE ACCESS REQUIREMENTS FOR THE EARLY RETIREE REINSURANCE PROGRAM Disclosure of Data Inaccuracies...

Changing dynamics in employer-sponsored health insurance. One market's perspective.

PubMed

Draper, D A; Thompson, J M; Hurley, R E

1999-01-01

Using their sponsored health benefits as a mechanism for change, employers have been able to exert significant influence over the nation's health care system. By examining how employers design, purchase and manage these programs, much insight can be gained. Twenty-five mid- to large-sized companies in a Middle-Atlantic metropolitan area were interviewed during May-July 1998. The study was modeled after a similar effort conducted in 1991, the results of which were published in this journal in 1993. The study found that many of the dynamics in employer-sponsored health insurance are changing. The findings suggest that a more distanced relationship between employers and employees is the major factor underlying the evolution, an intentional change to force a shift in medical care decision-making and responsibility to more of a shared process between the employee and the employer. These trends have important implications for local markets relevance and the national situation.

Does industry-sponsored education foster overdiagnosis and overtreatment of depression, osteoporosis and over­active bladder syndrome? An Australian cohort study

PubMed Central

Mintzes, Barbara; Swandari, Swestika; Fabbri, Alice; Grundy, Quinn; Moynihan, Ray; Bero, Lisa

2018-01-01

Objectives To investigate patterns of industry-sponsored educational events that focus on specific health conditions for which there are concerns about overdiagnosis and overtreatment. Design and setting This retrospective cohort study examines publicly reported industry-sponsored events in Australia from October 2011 to September 2015 for three conditions potentially subject to overdiagnosis and overtreatment: depression, osteoporosis and overactive bladder. We used a database of transparency reports to identify events with a focus on depression, osteoporosis and overactive bladder and compared these with other sponsored events. We hypothesised that companies marketing treatments for each condition would sponsor related events and that target audiences would mainly work in primary care, reflecting a broad patient population. Main outcome measures Event and attendee characteristics, sponsoring companies, related marketed treatments, cost-effectiveness ratings and dispensing rates. Results Over the study period, we identified 1567 events focusing on depression, 1375 on osteoporosis and 190 on overactive bladder (total n=3132, with 96 660 attendees). These events were attended by primary care doctors more often than sponsored events without a focus on these three conditions: relative risk (RR)=3.06 (95% CI 2.81 to 3.32) for depression, RR=1.48 (95% CI 1.41 to 1.55) for osteoporosis and RR=2.59 (95% CI 2.09 to 3.21) for overactive bladder. Servier, which markets agomelatine and AstraZeneca (quetiapine) sponsored 51.2% and 23.0% of depression events, respectively. Amgen and GlaxoSmithKline, which co-market denosumab, sponsored 49.5% of osteoporosis events and Astellas and Commonwealth Serum Laboratories (CSL) (mirabegron and solifenacin) sponsored 80.5% of overactive bladder events. Conclusions This 4-year overview of industry-sponsored events on three overdiagnosed and overtreated conditions found that primary care clinicians were often targeted, dinner was often

Health Risk Reduction Programs in Employer-Sponsored Health Plans: Part I—Efficacy

PubMed Central

Rothstein, Mark A.; Harrell, Heather L.

2011-01-01

Objective We sought to determine whether workplace health risk reduction programs (HRRPs) using health risk assessments (HRAs), individually focused risk reduction, and financial incentives succeeded in improving employee health and reducing employer health benefit costs. Methods We reviewed the proprietary HRA available to us and conducted a literature review to determine the efficacy of HRRPs using HRAs, individualized employee interventions, and financial incentives for employee participation. Results There is some evidence that HRRPs in employer-sponsored programs improve measures of employee health, but the results of these studies are somewhat equivocal. Conclusion Employer-sponsored HRRPs may have some benefits, but problems in plan design and in the studies assessing their efficacy complicate drawing conclusions. PMID:19625972

Developing the revised NICE appraisal technical guidance to manufacturers and sponsors: opportunity or threat?

PubMed

Taylor, Rod S; Hutton, John; Culyer, Anthony J

2002-01-01

One of the principal roles of the National Institute for Clinical Excellence (NICE) is to appraise selected existing and emerging healthcare technologies and, as a result, produce guidance for the National Health Service (NHS) in England and Wales. A central part of this appraisal is the potential for manufacturers and sponsors to make a data submission. This paper describes the process of development of the second edition of technical guidance to manufacturers and sponsors for submission to NICE. The revision process took place during the period May 2000 and January 2001 and involved a number of key steps -- establishment of a guidance steering committee, review of current international guidelines of clinical and cost effectiveness, drafting of the guidance, detailed consultation with stakeholders, revision of the guidance and, finally, publication. The lessons learnt from revision of the NICE guidance for manufacturers and sponsors and some main issues for its future development are discussed.

A Guide for Setting Up a Church-Sponsored Nursery School.

ERIC Educational Resources Information Center

Hostrawser, Sara

This document provides a guide for setting up a church-sponsored nursery school. Chapter One outlines the verbal-cognitive model of preschool education which emphasizes interaction between teacher and child. Perceptual, motor, cognitive, social, emotional, and language objectives are indicated. Chapter Two covers aspects of school management such…

77 FR 4224 - New Animal Drugs; Change of Sponsor's Name

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-27

.... FDA-2011-N-0003] New Animal Drugs; Change of Sponsor's Name AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug.... 801-808. List of Subjects in 21 CFR Part 510 Administrative practice and procedure, Animal drugs...

18 CFR 154.302 - Previously submitted material.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Previously submitted material. 154.302 Section 154.302 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Filed With Changes § 154.302 Previously submitted material. (a) If all, or any portion, of the...

18 CFR 154.302 - Previously submitted material.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Previously submitted material. 154.302 Section 154.302 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Filed With Changes § 154.302 Previously submitted material. (a) If all, or any portion, of the...

18 CFR 154.302 - Previously submitted material.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Previously submitted material. 154.302 Section 154.302 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Filed With Changes § 154.302 Previously submitted material. (a) If all, or any portion, of the...

18 CFR 154.302 - Previously submitted material.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Previously submitted material. 154.302 Section 154.302 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Filed With Changes § 154.302 Previously submitted material. (a) If all, or any portion, of the...

A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital.

PubMed

Shah, Pruthak C; Panchasara, Ashwin K; Barvaliya, Manish J; Tripathi, C B

2016-09-01

Application form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC). To check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital. The application forms of research projects submitted to the Institutional Review Board (IRB), Government Medical College, Bhavnagar, Gujarat, India from January 2014 to June 2015 were analysed for completeness and errors, with respect to the following - type of study, information about study investigators, sample size, study participants, title of the studies, signatures of all investigators, regulatory approval, recruitment procedure, compensation to study participants, informed consent process, information about sponsor, declaration of conflict of interest, plans for storage and maintenance of data, patient information sheet, informed consent forms and study related documents. Total 100 application forms were analysed. Among them, 98 were academic and 2 were industrial studies. Majority of academic studies were of basic science type. In 63.26% studies, type of study was not mentioned in title. Age group of subjects was not mentioned in 8.16% application forms. In 34.6% informed consent, benefits of the study were not mentioned. Signature of investigators/co-investigators/Head of the Department was missing in 3.06% cases. Our study recommends that the efficiency and speed of review will increase if investigator will increase vigilance regarding filling of application forms. Regular meetings will be helpful to solve the problems related to content of application forms. The uniformity in functioning of EC can be achieved if common application form for all ECs is there.

Economic benefits of sponsored clinical trials on pharmaceutical expenditures at a medical center in Taiwan.

PubMed

Shen, Li-Jiuan; Chou, Hua; Huang, Chih-Fen; Chou, Guann-Miaw; Chan, Wing Kai; Wu, Fe-Lin Lin

2011-07-01

Concerns exist regarding the additional cost of patient care when patients are enrolled in clinical trials at hospitals. To assess the avoidance of drug costs by conducting sponsored clinical trials, a retrospective analysis evaluating drug cost avoidance in all sponsored clinical trials was conducted in 2008 at the most prominent medical center in Taiwan. The National Health Insurance (NHI) reimbursement prices of either the investigated drugs or the standardized drug therapy for each specific disease were used to calculate the cost avoidance. Drug cost avoidance from sponsored clinical trials per year, per trial, per patient, in different therapeutic areas, and in different phases was analyzed. Three quarters of the cost avoidance in drug expenditures from 194 sponsored clinical trials were estimated. All cost values are in US Dollars. Around $11.2 million was avoided at the center in 2008. The average value of cost avoidance was $58,000/trial-year or $3,900/participant-year. The early-phase trials and phase III trials accounted for 25% and 56% of all trials, respectively, while they constituted 32% and 49% of the total costs avoided, respectively. The most frequently conducted and highest cost-avoiding trials were those for antineoplastic agents, especially targeted therapy which accounted for 85% of the total cost avoidance of anti-cancer trials. This study demonstrates the profoundly positive economic impact on the healthcare system in Taiwan by sponsored clinical trials. To understand the trend of economic benefits of the trials on pharmaceutical expenditure, it would be important to analyze the cost avoidance of trials regularly in an institution. Copyright © 2011 Elsevier Inc. All rights reserved.

32 CFR Appendix C to Part 282 - Submitting a Claim

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 2 2010-07-01 2010-07-01 false Submitting a Claim C Appendix C to Part 282.... 282, App. C Appendix C to Part 282—Submitting a Claim (a) Who May Submit a Claim. Any person (“claimant”) may submit a claim who has a demand for money or property against the Government under 31 U.S.C...

The Effect of Massachusetts' Health Reform on Employer-Sponsored Insurance Premiums.

PubMed

Cogan, John F; Hubbard, R Glenn; Kessler, Daniel

2010-01-01

In this paper, we use publicly available data from the Medical Expenditure Panel Survey - Insurance Component (MEPS-IC) to investigate the effect of Massachusetts' health reform plan on employer-sponsored insurance premiums. We tabulate premium growth for private-sector employers in Massachusetts and the United States as a whole for 2004 - 2008. We estimate the effect of the plan as the difference in premium growth between Massachusetts and the United States between 2006 and 2008-that is, before versus after the plan-over and above the difference in premium growth for 2004 to 2006. We find that health reform in Massachusetts increased single-coverage employer-sponsored insurance premiums by about 6 percent, or $262. Although our research design has important limitations, it does suggest that policy makers should be concerned about the consequences of health reform for the cost of private insurance.

Are All Clinical Studies Sponsored by Industry Not Valid?

PubMed Central

Heinemann, Lutz

2008-01-01

Industry-sponsored studies have such a bad reputation that some journals require an additional statistical analysis by an independent statistician. This commentary discusses some of the reasons why academic people tend to believe that “academic” science is better than industry-driven science. Most likely, when it comes to publications, the risk of fraud exists in both worlds as the pressure to publish “significant” data is prevalent in both worlds. In contrast to the academic world, the level of control by regulatory bodies for industry-sponsored studies is much higher. Therefore, the quality of industry-driven studies is high, at least when it comes to the quality of data. One of the main reasons why academic people are so skeptical about the pharmaceutical industry is a lack of knowledge about the work done in industry. It is as demanding and scientific as in other industries. In turn, many physicians working in the pharmaceutical industry have low self-esteem. Also, the pharmaceutical industry should improve its self-presentation adequately to get rid of its bad image. There is a clear need for more communication between both worlds in order to better understand the mutual difficulties and needs. PMID:19885307

Medical Malpractice Reform and Employer-Sponsored Health Insurance Premiums

PubMed Central

Morrisey, Michael A; Kilgore, Meredith L; Nelson, Leonard (Jack)

2008-01-01

Objective Tort reform may affect health insurance premiums both by reducing medical malpractice premiums and by reducing the extent of defensive medicine. The objective of this study is to estimate the effects of noneconomic damage caps on the premiums for employer-sponsored health insurance. Data Sources/Study Setting Employer premium data and plan/establishment characteristics were obtained from the 1999 through 2004 Kaiser/HRET Employer Health Insurance Surveys. Damage caps were obtained and dated based on state annotated codes, statutes, and judicial decisions. Study Design Fixed effects regression models were run to estimate the effects of the size of inflation-adjusted damage caps on the weighted average single premiums. Data Collection/Extraction Methods State tort reform laws were identified using Westlaw, LEXIS, and statutory compilations. Legislative repeal and amendment of statutes and court decisions resulting in the overturning or repealing state statutes were also identified using LEXIS. Principal Findings Using a variety of empirical specifications, there was no statistically significant evidence that noneconomic damage caps exerted any meaningful influence on the cost of employer-sponsored health insurance. Conclusions The findings suggest that tort reforms have not translated into insurance savings. PMID:18522666

76 FR 48714 - New Animal Drugs; Change of Sponsor; Moxidectin

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 522, and 524 [Docket No. FDA-2011-N-0003] New Animal Drugs; Change of Sponsor; Moxidectin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal...

45 CFR 2552.45 - Is a Foster Grandparent a federal employee, an employee of the sponsor or of the volunteer station?

Code of Federal Regulations, 2014 CFR

2014-10-01

... employee of the sponsor or of the volunteer station? 2552.45 Section 2552.45 Public Welfare Regulations... federal employee, an employee of the sponsor or of the volunteer station? Foster Grandparents are volunteers, and are not employees of the sponsor, the volunteer station, the Corporation, or the Federal...

45 CFR 2552.45 - Is a Foster Grandparent a federal employee, an employee of the sponsor or of the volunteer station?

Code of Federal Regulations, 2010 CFR

2010-10-01

... employee of the sponsor or of the volunteer station? 2552.45 Section 2552.45 Public Welfare Regulations... federal employee, an employee of the sponsor or of the volunteer station? Foster Grandparents are volunteers, and are not employees of the sponsor, the volunteer station, the Corporation, or the Federal...

45 CFR 2551.45 - Is a Senior Companion a federal employee, an employee of the sponsor or of the volunteer station?

Code of Federal Regulations, 2012 CFR

2012-10-01

... employee of the sponsor or of the volunteer station? 2551.45 Section 2551.45 Public Welfare Regulations... federal employee, an employee of the sponsor or of the volunteer station? Senior Companions are volunteers, and are not employees of the sponsor, the volunteer station, the Corporation, or the Federal...

45 CFR 2552.45 - Is a Foster Grandparent a federal employee, an employee of the sponsor or of the volunteer station?

Code of Federal Regulations, 2013 CFR

2013-10-01

... employee of the sponsor or of the volunteer station? 2552.45 Section 2552.45 Public Welfare Regulations... federal employee, an employee of the sponsor or of the volunteer station? Foster Grandparents are volunteers, and are not employees of the sponsor, the volunteer station, the Corporation, or the Federal...

45 CFR 2551.45 - Is a Senior Companion a federal employee, an employee of the sponsor or of the volunteer station?

Code of Federal Regulations, 2011 CFR

2011-10-01

... employee of the sponsor or of the volunteer station? 2551.45 Section 2551.45 Public Welfare Regulations... federal employee, an employee of the sponsor or of the volunteer station? Senior Companions are volunteers, and are not employees of the sponsor, the volunteer station, the Corporation, or the Federal...

45 CFR 2552.45 - Is a Foster Grandparent a federal employee, an employee of the sponsor or of the volunteer station?

Code of Federal Regulations, 2012 CFR

2012-10-01

... employee of the sponsor or of the volunteer station? 2552.45 Section 2552.45 Public Welfare Regulations... federal employee, an employee of the sponsor or of the volunteer station? Foster Grandparents are volunteers, and are not employees of the sponsor, the volunteer station, the Corporation, or the Federal...

45 CFR 2551.45 - Is a Senior Companion a federal employee, an employee of the sponsor or of the volunteer station?

Code of Federal Regulations, 2013 CFR

2013-10-01

... employee of the sponsor or of the volunteer station? 2551.45 Section 2551.45 Public Welfare Regulations... federal employee, an employee of the sponsor or of the volunteer station? Senior Companions are volunteers, and are not employees of the sponsor, the volunteer station, the Corporation, or the Federal...

45 CFR 2551.45 - Is a Senior Companion a federal employee, an employee of the sponsor or of the volunteer station?

Code of Federal Regulations, 2014 CFR

2014-10-01

... employee of the sponsor or of the volunteer station? 2551.45 Section 2551.45 Public Welfare Regulations... federal employee, an employee of the sponsor or of the volunteer station? Senior Companions are volunteers, and are not employees of the sponsor, the volunteer station, the Corporation, or the Federal...

45 CFR 2552.45 - Is a Foster Grandparent a federal employee, an employee of the sponsor or of the volunteer station?

Code of Federal Regulations, 2011 CFR

2011-10-01

... employee of the sponsor or of the volunteer station? 2552.45 Section 2552.45 Public Welfare Regulations... federal employee, an employee of the sponsor or of the volunteer station? Foster Grandparents are volunteers, and are not employees of the sponsor, the volunteer station, the Corporation, or the Federal...

Histomorphometric assessment of bone necrosis produced by two cryosurgery protocols using liquid nitrogen: an experimental study on rat femurs.

PubMed

Costa, Fábio Wildson Gurgel; Brito, Gerly Anne de Castro; Pessoa, Rosana Maria Andrade; Studart-Soares, Eduardo Costa

2011-01-01

The aim of this study was to evaluate the effects of liquid nitrogen cryosurgery on the femoral diaphysis of rats. The femoral diaphyses of 42 Wistar rats were exposed to three local and sequential applications of liquid nitrogen for 1 or 2 min, intercalated with periods of 5 min of passive thawing. The animals were sacrificed after 1, 2, 4 and 12 weeks and the specimens obtained were processed and analyzed histomorphometrically. The depth and extent of peak bone necrosis were 124.509 µm and 2087.094 µm for the 1-min protocol, respectively, and 436.424 µm and 12046.426 µm for the 2-min protocol. Peak necrosis was observed in the second experimental week with both cryotherapy protocols. The present results indicate that the 2-min protocol produced more marked bone necrosis than the 1-min protocol. Although our results cannot be entirely extrapolated to clinical practice, they contribute to the understanding of the behavior of bone tissue submitted to different cycles of liquid nitrogen freezing and may serve as a basis for new studies.

13 CFR 120.830 - Reports a CDC must submit.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false Reports a CDC must submit. 120.830... Company Loan Program (504) Requirements for Cdc Certification and Operation § 120.830 Reports a CDC must submit. A CDC must submit the following reports to SBA: (a) An annual report within one hundred-eighty...

13 CFR 120.830 - Reports a CDC must submit.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Reports a CDC must submit. 120.830... Company Loan Program (504) Requirements for Cdc Certification and Operation § 120.830 Reports a CDC must submit. A CDC must submit the following reports to SBA: (a) An annual report within one hundred-eighty...

13 CFR 120.830 - Reports a CDC must submit.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Reports a CDC must submit. 120.830... Company Loan Program (504) Requirements for Cdc Certification and Operation § 120.830 Reports a CDC must submit. A CDC must submit the following reports to SBA: (a) An annual report within one hundred-eighty...

13 CFR 120.830 - Reports a CDC must submit.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Reports a CDC must submit. 120.830... Company Loan Program (504) Requirements for Cdc Certification and Operation § 120.830 Reports a CDC must submit. A CDC must submit the following reports to SBA: (a) An annual report within one hundred-eighty...

A Distance Bounding Protocol for Location-Cloaked Applications

PubMed Central

Molina-Martínez, Cristián; Galdames, Patricio

2018-01-01

Location-based services (LBSs) assume that users are willing to release trustworthy and useful details about their whereabouts. However, many location privacy concerns have arisen. For location privacy protection, several algorithms build a cloaking region to hide a user’s location. However, many applications may not operate adequately on cloaked locations. For example, a traditional distance bounding protocol (DBP)—which is run by two nodes called the prover and the verifier—may conclude an untight and useless distance between these two entities. An LBS (verifier) may use this distance as a metric of usefulness and trustworthiness of the location claimed by the user (prover). However, we show that if a tight distance is desired, traditional DBP can refine a user’s cloaked location and compromise its location privacy. To find a proper balance, we propose a location-privacy-aware DBP protocol. Our solution consists of adding some small delays before submitting any user’s response. We show that several issues arise when a certain delay is chosen, and we propose some solutions. The effectiveness of our techniques in balancing location refinement and utility is demonstrated through simulation. PMID:29701641

A Distance Bounding Protocol for Location-Cloaked Applications.

PubMed

Molina-Martínez, Cristián; Galdames, Patricio; Duran-Faundez, Cristian

2018-04-26

Location-based services (LBSs) assume that users are willing to release trustworthy and useful details about their whereabouts. However, many location privacy concerns have arisen. For location privacy protection, several algorithms build a cloaking region to hide a user’s location. However, many applications may not operate adequately on cloaked locations. For example, a traditional distance bounding protocol (DBP)—which is run by two nodes called the prover and the verifier—may conclude an untight and useless distance between these two entities. An LBS (verifier) may use this distance as a metric of usefulness and trustworthiness of the location claimed by the user (prover). However, we show that if a tight distance is desired, traditional DBP can refine a user’s cloaked location and compromise its location privacy. To find a proper balance, we propose a location-privacy-aware DBP protocol. Our solution consists of adding some small delays before submitting any user’s response. We show that several issues arise when a certain delay is chosen, and we propose some solutions. The effectiveness of our techniques in balancing location refinement and utility is demonstrated through simulation.

Comparison of noninferiority margins reported in protocols and publications showed incomplete and inconsistent reporting.

PubMed

Dekkers, Olaf M; Cevallos, Myriam; Bührer, Jonas; Poncet, Antoine; Ackermann Rau, Sabine; Perneger, Thomas V; Egger, Matthias

2015-05-01

To compare noninferiority margins defined in study protocols and trial registry records with margins reported in subsequent publications. Comparison of protocols of noninferiority trials submitted 2001 to 2005 to ethics committees in Switzerland and The Netherlands with corresponding publications and registry records. We searched MEDLINE via PubMed, the Cochrane Controlled Trials Register (Cochrane Library issue 01/2012), and Google Scholar in September 2013 to identify published reports, and the International Clinical Trials Registry Platform of the World Health Organization in March 2013 to identify registry records. Two readers recorded the noninferiority margin and other data using a standardized data-abstraction form. The margin was identical in study protocol and publication in 43 (80%) of 54 pairs of study protocols and articles. In the remaining pairs, reporting was inconsistent (five pairs, 9%), or the noninferiority margin was either not reported in the publication (five pairs, 9%) or not defined in the study protocol (one pair). The confidence interval or the exact P-value required to judge whether the result was compatible with noninferior, inferior, or superior efficacy was reported in 43 (80%) publications. Complete and consistent reporting of both noninferiority margin and confidence interval (or exact P-value) was present in 39 (72%) protocol-publication pairs. Twenty-nine trials (54%) were registered in trial registries, but only one registry record included the noninferiority margin. The reporting of noninferiority margins was incomplete and inconsistent with study protocols in a substantial proportion of published trials, and margins were rarely reported in trial registries. Copyright © 2015 Elsevier Inc. All rights reserved.

42 CFR 423.636 - How a Part D plan sponsor must effectuate standard redeterminations, reconsiderations, or decisions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false How a Part D plan sponsor must effectuate standard... How a Part D plan sponsor must effectuate standard redeterminations, reconsiderations, or decisions. (a) Reversals by the Part D plan sponsor—(1) Requests for benefits. If, on redetermination of a...

The Consortium for Plant Biotechnology Research, Inc. Semi-Annual Technical Report for April 1, 2000 - September 30, 2000

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

NONE

2000-10-02

Scientific progress reports submitted by university researchers conducting projects funded through CPBR and metrics reports submitted by industry sponsors that provided matching funds to the projects.

ANDRO-IVF: a novel protocol for poor responders to IVF controlled ovarian stimulation

PubMed Central

Bercaire, Ludmila; Nogueira, Sara MB; Lima, Priscila CM; Alves, Vanessa R; Donadio, Nilka; Dzik, Artur; Cavagna, Mario; Fanchin, Renato

2018-01-01

Objective This study aimed to assess a novel protocol designed to improve poor ovarian response through intra-ovarian androgenization. The endpoints were: number of oocytes and mature oocytes retrieved, fertilization, cancellation and pregnancy rates. Methods This prospective crossover study enrolled poor responders from previous ovarian stimulation cycles submitted to a novel protocol called ANDRO-IVF. The protocol included pretreatment with transdermal AndroGel(r) (Besins) 25 mg, oral letrozole 2.5 mg and subcutaneous hCG 2500 IU; cycle control was performed with estradiol valerate and micronized progesterone; ovarian stimulation was attained with gonadotropins FSH/LH 450 IU, GnRH antagonist and hCG 5000 IU. Results Fourteen poor responders were enrolled. One patient did not meet the inclusion criteria. Thirteen patients previously summited to the standard protocol were offered the ANDRO-IVF Protocol.-Standard Protocol: Mean age: 35.30 years; cancellation rate: 61.53%; mean number of MII oocytes retrieved per patient: 1.8; fertilization rate: 33.33%. Only two patients had embryo transfers, and none got pregnant.-ANDRO-IVF Protocol: Mean age: 35.83 years; cancellation rate: 7.69%; mean number of oocytes retrieved per patient: 5.58, MII oocytes: 3.91. ICSI was performed in 84.61% of the patients and a mean of 1.5 embryos were transferred per patient. Fertilization rate: 62.5%; cumulative pregnancy rate: 16.66%; mean duration of stimulation: 9.77 days. Conclusion ANDRO-IVF allows intra-ovarian androgenization by increasing serum and intra-follicular androgen levels and preventing androgen aromatization. This protocol apparently improved clinical outcomes of poor responders in parameters such as number of oocytes retrieved and clinical pregnancy rates. Further randomized controlled trials are needed to confirm these findings. PMID:29303236

42 CFR 423.586 - Opportunity to submit evidence.

Code of Federal Regulations, 2010 CFR

2010-10-01

... limited by the short timeframe for making a decision. Therefore, the Part D plan sponsor must inform the... (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Grievances, Coverage Determinations...

Surgeon Training, Protocol Compliance, and Technical Outcomes From Breast Cancer Sentinel Lymph Node Randomized Trial

PubMed Central

Ashikaga, Takamaru; Harlow, Seth P.; Skelly, Joan M.; Julian, Thomas B.; Brown, Ann M.; Weaver, Donald L.; Wolmark, Norman

2009-01-01

Background The National Surgical Adjuvant Breast and Bowel Project B-32 trial was designed to determine whether sentinel lymph node resection can achieve the same therapeutic outcomes as axillary lymph node resection but with fewer side effects and is one of the most carefully controlled and monitored randomized trials in the field of surgical oncology. We evaluated the relationship of surgeon trial preparation, protocol compliance audit, and technical outcomes. Methods Preparation for this trial included a protocol manual, a site visit with key participants, an intraoperative session with the surgeon, and prerandomization documentation of protocol compliance. Training categories included surgeons who submitted material on five prerandomization surgeries and were trained by a core trainer (category 1) or by a site trainer (category 2). An expedited group (category 3) included surgeons with extensive experience who submitted material on one prerandomization surgery. At completion of training, surgeons could accrue patients. Two hundred twenty-four surgeons enrolled 4994 patients with breast cancer and were audited for 94 specific items in the following four categories: procedural, operative note, pathology report, and data entry. The relationship of training method; protocol compliance performance audit; and the technical outcomes of the sentinel lymph node resection rate, false-negative rate, and number of sentinel lymph nodes removed was determined. All statistical tests were two-sided. Results The overall sentinel lymph node resection success rate was 96.9% (95% confidence interval [CI] = 96.4% to 97.4%), and the overall false-negative rate was 9.5% (95% CI = 7.4% to 12.0%), with no statistical differences between training methods. Overall audit outcomes were excellent in all four categories. For all three training groups combined, a statistically significant positive association was observed between surgeons’ average number of procedural errors and their false

45 CFR 2551.111 - Under what conditions can an agency or organization sponsor a Senior Companion project without...

Code of Federal Regulations, 2010 CFR

2010-10-01

... organization sponsor a Senior Companion project without Corporation funding? 2551.111 Section 2551.111 Public... SENIOR COMPANION PROGRAM Non-Corporation Funded SCP Projects § 2551.111 Under what conditions can an agency or organization sponsor a Senior Companion project without Corporation funding? An eligible agency...

76 FR 58074 - 30-Day Notice of Proposed Information Collection: DS-7001 and DS-7005, DOS-Sponsored Academic...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-19

...-7001 and DS- 7005, DOS-Sponsored Academic Exchange Program Application, OMB Control Number 1405-0138.... Title of Information Collection: DOS-Sponsored Academic Exchange Program Application. OMB Control Number... Academic Exchange Program. Estimated Number of Respondents: 7160 (For DS-7001, 3842 estimated; for DS-7005...

Secure and Efficient Network Fault Localization

DTIC Science & Technology

2012-02-27

ORGANIZATION NAME(S) AND ADDRESS (ES) Carnegie Mellon University,School of Computer Science,Computer Science Department,Pittsburgh,PA,15213 8. PERFORMING...ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS (ES) 10. SPONSOR/MONITOR’S ACRONYM(S) 11. SPONSOR/MONITOR’S REPORT...efficiency than previously known protocols for fault localization. Our proposed fault localization protocols also address the security threats that

42 CFR 423.520 - Prompt payment by Part D sponsors.

Code of Federal Regulations, 2011 CFR

2011-10-01

... sponsor will issue, mail, or otherwise transmit payment with respect to all clean claims, as defined in... pharmacies) within— (i) 14 days after the date on which the claim is received, as defined in paragraph (a)(2)(i) of this section, for an electronic claim; or (ii) 30 days after the date on which the claim is...

Outsourcing ethical obligations: should the revised common rule address the responsibilities of investigators and sponsors?

PubMed

Shah, Seema K

2013-01-01

The Common Rule creates a division of moral labor in research. It implies that investigators and sponsors can outsource their ethical obligations to IRBs and participants, thereby fostering a culture of compliance, rather than one of responsibility. The proposed revisions to the Common Rule are likely to exacerbate this problem. To harness the expressive power of the law, I propose the Common Rule be revised to include the ethical responsibilities of investigators and sponsors. © 2013 American Society of Law, Medicine & Ethics, Inc.

76 FR 25733 - 60-Day Notice of Proposed Information Collection: DS-7001 and DS-7005, DOS-Sponsored Academic...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-05

... and DS- 7005, DOS-Sponsored Academic Exchange Program Application, OMB Control Number 1405-0138 ACTION... Collection: DOS-Sponsored Academic Exchange Program Application. OMB Control Number: 1405-0138. Type of... Cultural Affairs, ECA/A/E/EUR. Form Number: DS-7001, DS-7005. Respondents: Applicants for the Academic...

15 CFR 734.11 - Government-sponsored research covered by contract controls.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 2 2010-01-01 2010-01-01 false Government-sponsored research covered by contract controls. 734.11 Section 734.11 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) BUREAU OF INDUSTRY AND SECURITY, DEPARTMENT OF COMMERCE EXPORT...

47 CFR 1.10017 - How can I submit additional information?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false How can I submit additional information? 1... International Bureau Filing System § 1.10017 How can I submit additional information? In response to an official request for information from the International Bureau, you can submit additional information...

25 CFR 170.176 - Where can tribes get scholarships and tuition for Indian LTAP-sponsored education and training?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 25 Indians 1 2011-04-01 2011-04-01 false Where can tribes get scholarships and tuition for Indian... tribes get scholarships and tuition for Indian LTAP-sponsored education and training? Tribes can get tuition and scholarship assistance for Indian LTAP-sponsored education and training from the following...

25 CFR 170.176 - Where can tribes get scholarships and tuition for Indian LTAP-sponsored education and training?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false Where can tribes get scholarships and tuition for Indian... tribes get scholarships and tuition for Indian LTAP-sponsored education and training? Tribes can get tuition and scholarship assistance for Indian LTAP-sponsored education and training from the following...

25 CFR 170.176 - Where can tribes get scholarships and tuition for Indian LTAP-sponsored education and training?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false Where can tribes get scholarships and tuition for Indian... tribes get scholarships and tuition for Indian LTAP-sponsored education and training? Tribes can get tuition and scholarship assistance for Indian LTAP-sponsored education and training from the following...

25 CFR 170.176 - Where can tribes get scholarships and tuition for Indian LTAP-sponsored education and training?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 25 Indians 1 2012-04-01 2011-04-01 true Where can tribes get scholarships and tuition for Indian... tribes get scholarships and tuition for Indian LTAP-sponsored education and training? Tribes can get tuition and scholarship assistance for Indian LTAP-sponsored education and training from the following...

25 CFR 170.176 - Where can tribes get scholarships and tuition for Indian LTAP-sponsored education and training?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false Where can tribes get scholarships and tuition for Indian... tribes get scholarships and tuition for Indian LTAP-sponsored education and training? Tribes can get tuition and scholarship assistance for Indian LTAP-sponsored education and training from the following...

40 CFR 35.105 - Time frame for submitting an application.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Time frame for submitting an application. 35.105 Section 35.105 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GRANTS AND OTHER....105 Time frame for submitting an application. An applicant should submit a complete application to EPA...

40 CFR 35.506 - Time frame for submitting an application.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Time frame for submitting an application. 35.506 Section 35.506 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GRANTS AND OTHER... Application § 35.506 Time frame for submitting an application. An applicant should submit a complete...

29 CFR 1956.21 - Procedures for submitting changes.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Procedures for submitting changes. 1956.21 Section 1956.21 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION..., Change, Evaluation and Withdrawal of Approval Procedures § 1956.21 Procedures for submitting changes. The...

45 CFR 2551.24 - What are a sponsor's responsibilities for securing community participation?

Code of Federal Regulations, 2010 CFR

2010-10-01

...? (a) A sponsor shall secure community participation in local project operation by establishing an Advisory Council or a similar organizational structure with a membership that includes people: (1...

45 CFR 2552.24 - What are a sponsor's responsibilities for securing community participation?

Code of Federal Regulations, 2010 CFR

2010-10-01

...? (a) A sponsor shall secure community participation in local project operation by establishing an Advisory Council or a similar organizational structure with a membership that includes people: (1...

Discrepancies in employer-sponsored health insurance among Hispanics, blacks, and whites: the effects of sociodemographic and employment factors.

PubMed

Seccombe, K; Clarke, L L; Coward, R T

1994-01-01

Using a nationally representative sample of employed adults from the 1987 National Medical Expenditure Survey (NMES), this research explores differences in the incidence and predictors of employer-sponsored health insurance among Hispanics, blacks, and whites. The data suggest that: 1) whites are most likely, and Hispanics are least likely, to have employer-sponsored medical insurance in their own name, or in the name of another individual; 2) Hispanics are most likely, and whites are least likely, to be completely uninsured; and 3) the factors which increase the odds of receiving employer-sponsored coverage in one's own name are relatively similar across racial groups, though they differ substantially in magnitude.

30 CFR 210.203 - How do I submit sales contracts?

Code of Federal Regulations, 2010 CFR

2010-07-01

... royalty terms. (b) When to submit. (1) For coal and metal production, you must submit the required... MANAGEMENT FORMS AND REPORTS Production and Royalty Reports-Solid Minerals § 210.203 How do I submit sales..., and phosphate production, and production from any other lease with ad valorem royalty terms, you must...

29 CFR 4043.29 - Change in contributing sponsor or controlled group.

Code of Federal Regulations, 2013 CFR

2013-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.29 Change in contributing sponsor or controlled group. (a) Reportable event. A reportable event occurs for a plan when there is a transaction that results, or will result, in one or more persons...

29 CFR 4043.29 - Change in contributing sponsor or controlled group.

Code of Federal Regulations, 2012 CFR

2012-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.29 Change in contributing sponsor or controlled group. (a) Reportable event. A reportable event occurs for a plan when there is a transaction that results, or will result, in one or more persons...

29 CFR 4043.29 - Change in contributing sponsor or controlled group.

Code of Federal Regulations, 2014 CFR

2014-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.29 Change in contributing sponsor or controlled group. (a) Reportable event. A reportable event occurs for a plan when there is a transaction that results, or will result, in one or more persons...

29 CFR 4043.29 - Change in contributing sponsor or controlled group.

Code of Federal Regulations, 2011 CFR

2011-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.29 Change in contributing sponsor or controlled group. (a) Reportable event. A reportable event occurs for a plan when there is a transaction that results, or will result, in one or more persons...

21 CFR 500.84 - Conditions for approval of the sponsored compound.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Conditions for approval of the sponsored compound. 500.84 Section 500.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Regulation of Carcinogenic Compounds...

21 CFR 500.84 - Conditions for approval of the sponsored compound.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Conditions for approval of the sponsored compound. 500.84 Section 500.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Regulation of Carcinogenic Compounds...

21 CFR 500.84 - Conditions for approval of the sponsored compound.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Conditions for approval of the sponsored compound. 500.84 Section 500.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Regulation of Carcinogenic Compounds...

21 CFR 500.84 - Conditions for approval of the sponsored compound.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Conditions for approval of the sponsored compound. 500.84 Section 500.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Regulation of Carcinogenic Compounds...

21 CFR 500.84 - Conditions for approval of the sponsored compound.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Conditions for approval of the sponsored compound. 500.84 Section 500.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Regulation of Carcinogenic Compounds...

42 CFR 102.43 - Deadlines for submitting documentation.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Deadlines for submitting documentation. 102.43 Section 102.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES VACCINES SMALLPOX COMPENSATION PROGRAM Procedures for Filing Request Packages § 102.43 Deadlines for submitting...

42 CFR 102.43 - Deadlines for submitting documentation.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Deadlines for submitting documentation. 102.43 Section 102.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES VACCINES SMALLPOX COMPENSATION PROGRAM Procedures for Filing Request Packages § 102.43 Deadlines for submitting...

42 CFR 102.43 - Deadlines for submitting documentation.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Deadlines for submitting documentation. 102.43 Section 102.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES VACCINES SMALLPOX COMPENSATION PROGRAM Procedures for Filing Request Packages § 102.43 Deadlines for submitting...

42 CFR 102.43 - Deadlines for submitting documentation.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Deadlines for submitting documentation. 102.43 Section 102.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES VACCINES SMALLPOX COMPENSATION PROGRAM Procedures for Filing Request Packages § 102.43 Deadlines for submitting...

42 CFR 102.43 - Deadlines for submitting documentation.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Deadlines for submitting documentation. 102.43 Section 102.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES VACCINES SMALLPOX COMPENSATION PROGRAM Procedures for Filing Request Packages § 102.43 Deadlines for submitting...

45 CFR 2553.24 - What are a sponsor's responsibilities for securing community participation?

Code of Federal Regulations, 2010 CFR

2010-10-01

... community participation? (a) A sponsor shall secure community participation in local project operation by establishing an Advisory Council or a similar organizational structure with a membership that includes people...

12 CFR 516.110 - Who may submit a written comment?

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Who may submit a written comment? 516.110 Section 516.110 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY APPLICATION PROCESSING PROCEDURES Comment Procedures § 516.110 Who may submit a written comment? Any person may submit a...

25 CFR 183.15 - Must the Tribe submit any reports?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false Must the Tribe submit any reports? 183.15 Section 183.15... SAN CARLOS APACHE TRIBE DEVELOPMENT TRUST FUND AND SAN CARLOS APACHE TRIBE LEASE FUND Reports § 183.15 Must the Tribe submit any reports? Yes. The Tribe must submit the following reports after receiving...

25 CFR 183.15 - Must the Tribe submit any reports?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false Must the Tribe submit any reports? 183.15 Section 183.15... SAN CARLOS APACHE TRIBE DEVELOPMENT TRUST FUND AND SAN CARLOS APACHE TRIBE LEASE FUND Reports § 183.15 Must the Tribe submit any reports? Yes. The Tribe must submit the following reports after receiving...

25 CFR 183.15 - Must the Tribe submit any reports?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 25 Indians 1 2012-04-01 2011-04-01 true Must the Tribe submit any reports? 183.15 Section 183.15... SAN CARLOS APACHE TRIBE DEVELOPMENT TRUST FUND AND SAN CARLOS APACHE TRIBE LEASE FUND Reports § 183.15 Must the Tribe submit any reports? Yes. The Tribe must submit the following reports after receiving...

25 CFR 183.15 - Must the Tribe submit any reports?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false Must the Tribe submit any reports? 183.15 Section 183.15... SAN CARLOS APACHE TRIBE DEVELOPMENT TRUST FUND AND SAN CARLOS APACHE TRIBE LEASE FUND Reports § 183.15 Must the Tribe submit any reports? Yes. The Tribe must submit the following reports after receiving...

25 CFR 183.15 - Must the Tribe submit any reports?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 25 Indians 1 2011-04-01 2011-04-01 false Must the Tribe submit any reports? 183.15 Section 183.15... SAN CARLOS APACHE TRIBE DEVELOPMENT TRUST FUND AND SAN CARLOS APACHE TRIBE LEASE FUND Reports § 183.15 Must the Tribe submit any reports? Yes. The Tribe must submit the following reports after receiving...

14 CFR § 1214.306 - Payload specialist relationship with sponsoring institutions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Payload specialist relationship with sponsoring institutions. § 1214.306 Section § 1214.306 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT Payload Specialists for Space Transportation System (STS) Missions § 1214.306 Payload...

NICBR-Sponsored Spring Research Festival Set for May 8 and 9 | Poster

Cancer.gov

By Ashley DeVine, Staff Writer For the first time, the Spring Research Festival (SRF), scheduled for May 8 and 9, will be sponsored by all of the agencies that are part of the National Interagency Confederation for Biological Research (NICBR).

Optical engineering capstone design projects with industry sponsors

NASA Astrophysics Data System (ADS)

Bunch, Robert M.; Leisher, Paul O.; Granieri, Sergio C.

2014-09-01

Capstone senior design is the culmination of a student's undergraduate engineering education that prepares them for engineering practice. In fact, any engineering degree program that pursues accreditation by the Engineering Accreditation Commission of ABET must contain "a major design experience based on the knowledge and skills acquired in earlier course work and incorporating appropriate engineering standards and multiple realistic constraints." At Rose-Hulman, we offer an interdisciplinary Optical Engineering / Engineering Physics senior design curriculum that meets this requirement. Part of this curriculum is a two-course sequence where students work in teams on a design project leading to a functional prototype. The students begin work on their capstone project during the first week of their senior year. The courses are deliverable-driven and the students are held accountable for regular technical progress through weekly updates with their faculty advisor and mid-term design reviews. We have found that client-sponsored projects offer students an enriched engineering design experience as it ensures consideration of constraints and standards requirements similar to those that they will encounter as working engineers. Further, client-sponsored projects provide teams with an opportunity for regular customer interactions which help shape the product design. The process that we follow in both soliciting and helping to scope appropriate industry-related design projects will be described. In addition, an outline of the capstone course structure as well as methods used to hold teams accountable for technical milestones will be discussed. Illustrative examples of past projects will be provided.

The utilization of unified protocols in behavioral cognitive therapy in transdiagnostic group subjects: A clinical trial.

PubMed

de Ornelas Maia, Ana Claudia Corrêa; Nardi, Antonio Egidio; Cardoso, Adriana

2015-02-01

The practicing of protocols based on behavioral cognitive therapy (CBT) have been frequently used in the last decades and adapted to better manage the necessities of patients and providers. The goal is to build a treatment that is evidence-based - for that reason the unified protocol for multiple emotional disorders (transdiagnostics) have been utilized to simplify treatment - without losing scientific traits. The main goal of this study is to evaluate the unified protocol in groups of patients with depression and anxiety disorders. In a pool of 48 subjects, divided in two groups, one was submitted to 12 intervention sessions of the unified protocol while the other was solely given medication. MINI, BAI and BDI were the instruments used at the beginning and at the end of treatment. The results were highly significant (p<0.001) in as much as with the improvement of anxiety and depressive disorders as it was in the group which was treated with the unified protocol compared with the group which was only given medication Limitations of this study were the number of sample participants and the non-randomization of subjects in both groups. Group therapy has not been largely implemented though it is deemed very useful for treatments when the unified protocol is used in transdiagnostic patients. Not only does it allow for emotional stabilizing and socialization but it also enables subjects with an altruistic feeling amongst themselves. Copyright © 2014 Elsevier B.V. All rights reserved.

77 FR 5700 - New Animal Drugs; Change of Sponsor; Chlortetracycline Powder

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 520... in the animal drug regulations as a sponsor of an approved application. Accordingly, 21 CFR 510.600... subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects 21 CFR Part 510...

Undergraduates' Perceptions of Conflict of Interest in Industry-Sponsored Research

ERIC Educational Resources Information Center

Perry, Heather Brodie

2018-01-01

The prevalence of industry-sponsored research has led to significant concerns about financial conflicts of interest and the impact on research findings. This case study sought to examine how students considered conflict of interest when establishing the cognitive authority of a journal article. The case study used a mixed methods pretest and…

24 CFR 902.62 - Failure to submit data.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 4 2013-04-01 2013-04-01 false Failure to submit data. 902.62... DEVELOPMENT PUBLIC HOUSING ASSESSMENT SYSTEM PHAS Scoring § 902.62 Failure to submit data. (a) Failure to... receive a presumptive rating of failure for its unaudited information and shall receive zero points for...

24 CFR 902.62 - Failure to submit data.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 4 2012-04-01 2012-04-01 false Failure to submit data. 902.62... DEVELOPMENT PUBLIC HOUSING ASSESSMENT SYSTEM PHAS Scoring § 902.62 Failure to submit data. (a) Failure to... receive a presumptive rating of failure for its unaudited information and shall receive zero points for...

24 CFR 902.62 - Failure to submit data.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 4 2014-04-01 2014-04-01 false Failure to submit data. 902.62... DEVELOPMENT PUBLIC HOUSING ASSESSMENT SYSTEM PHAS Scoring § 902.62 Failure to submit data. (a) Failure to... receive a presumptive rating of failure for its unaudited information and shall receive zero points for...

30 CFR 285.607 - How do I submit my SAP?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false How do I submit my SAP? 285.607 Section 285.607... Assessment Plan and Information Requirements for Commercial Leases § 285.607 How do I submit my SAP? You must submit one paper copy and one electronic version of your SAP to MMS at the address listed in § 285.110(a). ...

Provider-sponsored HMOs: make, buy, or joint venture?

PubMed

Clay, S B

1997-03-01

Providers can sponsor their own HMOs in one of three ways: by creating their own HMO, by joint venturing with an existing HMO, or by purchasing an existing HMO. When selecting the best option, providers must consider various market conditions. Managed care penetration in the area, potential competitive responses of existing HMOs, market demand, provider reputation, and provider marketing ability will all influence the feasibility of each option. Providers also must examine their own organizational identity, their ability to raise the necessary capital to start an HMO, their managed care expertise and risk contracting experience, and their information systems capabilities.

A Checklist for Submitting Your Risk Management Plan (RMP)

EPA Pesticide Factsheets

Important information about 2014 submissions and a checklist to consider in preparing and resubmitting a 5-year update, as required by 40 CFR part 68. Use the RMP*eSubmit software application, which replaced RMP*Submit.

Sponsorshaping: How a Teacher Used Sponsors of Literacy for Pedagogical Purposes

ERIC Educational Resources Information Center

Dippre, Ryan

2016-01-01

Historically, the actions of classroom teachers have had a massive impact on the implementation of top-down reform efforts. However, a pedagogically-friendly construct for considering this impact has been lacking in studies of teacher practice. In this article, I draw on Deborah Brandt's concept of sponsors of literacy to build a construct for…

Evaluation of a new chest tube removal protocol using digital air leak monitoring after lobectomy: a prospective randomised trial.

PubMed

Brunelli, Alessandro; Salati, Michele; Refai, Majed; Di Nunzio, Luca; Xiumé, Francesco; Sabbatini, Armando

2010-01-01

The objective of this randomised trial was to assess the effectiveness of a new fast-track chest tube removal protocol taking advantage of digital monitoring of air leak compared to a traditional protocol using visual and subjective assessment of air leak (bubbles). One hundred and sixty-six patients submitted to pulmonary lobectomy for lung cancer were randomised in two groups with different chest tube removal protocols: (1) in the new protocol, chest tube was removed based on digitally recorded measurements of air leak flow; (2) in the traditional protocol, the chest tube removal was based on an instantaneous assessment of air leak during daily rounds. The two groups were compared in terms of chest tube duration, hospital stay and costs. The two groups were well matched for several preoperative and operative variables. Compared to the traditional protocol, the new digital recording protocol showed mean reductions in chest tube duration (p=0.0007), hospital stay (p=0.007) of 0.9 day, and a mean cost saving of euro 476 per patient (p=0.008). In the new chest tube removal protocol, 51% of patients had their chest tube removed by the second postoperative day versus only 12% of those in the traditional protocol. The application of a chest tube removal protocol using a digital drainage unit featuring a continuous recording of air leak was safe and cost effective. Although future studies are warranted to confirm these results in other settings, the use of this new protocol is now routinely applied in our practice. Copyright 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

42 CFR 405.809 - Opportunity to submit evidence.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Opportunity to submit evidence. 405.809 Section 405.809 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Appeals Under the Medicare Part B Program § 405.809 Opportunity to submit...

76 FR 40612 - New Animal Drugs; Change of Sponsor's Name and Address

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-11

.... FDA-2011-N-0003] New Animal Drugs; Change of Sponsor's Name and Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal... Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements...

42 CFR 403.822 - Reimbursement of transitional assistance and associated sponsor requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Reimbursement of transitional assistance and associated sponsor requirements. 403.822 Section 403.822 Public Health CENTERS FOR MEDICARE & MEDICAID... Prescription Drug Discount Card and Transitional Assistance Program § 403.822 Reimbursement of transitional...

7 CFR 225.14 - Requirements for sponsor participation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... an unanticipated school closure during the period from October through April (or at any time of the..., from submitting a new application if they have participated in the program at any time during the... and have the capability and the facilities to provide the meal service planned for the number of...

7 CFR 225.14 - Requirements for sponsor participation.

Code of Federal Regulations, 2011 CFR

2011-01-01

... an unanticipated school closure during the period from October through April (or at any time of the..., from submitting a new application if they have participated in the program at any time during the... and have the capability and the facilities to provide the meal service planned for the number of...

Gulf Regional Planning Commission scenario planning workshop : sponsored by the Federal Highway Administration

DOT National Transportation Integrated Search

2016-03-01

This report summarizes noteworthy practices shared during a scenario planning workshop, hosted by the Gulf Regional Planning Commission, on March 15-16, 2016, in Biloxi, Mississippi. The Federal Highway Administration (FHWA) sponsored this event as p...

RMP*eSubmit User's Manual

EPA Pesticide Factsheets

RMP*eSubmit facilitates secure online Risk Management Plan updates/resubmissions, required at least every 5 years. Reporting requirements have not changed since 2004, but the 2012 version of North American Industry Classification System has been integrated

Participants in School-Sponsored and Independent Sports: Perceptions of Self and Family.

ERIC Educational Resources Information Center

Browne, Beverly A.; Francis, Sally K.

1993-01-01

Examined perceptions of social competence and family dynamics among adolescent participants in school-sponsored and independent sports (baseball and skateboarding). Findings from 271 adolescents revealed that perceptions of social competence were differentially related to degree of sports involvement and perceived skill but were not related to…

"To Teach and To Sell": Irna Phillips and Her Sponsors, 1930-1954.

ERIC Educational Resources Information Center

Seiter, Ellen

1989-01-01

Examines the relationships between Irna Phillips, the most powerful woman in soap opera production from the 1930s through the 1960s, and the sponsors of her radio soap operas. Explores how Phillips represented women both in her scripts and in her public relations efforts. (MM)

75 FR 54016 - New Animal Drugs; Change of Sponsor's Name and Address

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

.... FDA-2010-N-0002] New Animal Drugs; Change of Sponsor's Name and Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal... in 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and...

Industrial Sponsor Perspective on Leveraging Capstone Design Projects to Enhance Their Business

ERIC Educational Resources Information Center

Weissbach, Robert S.; Snyder, Joseph W.; Evans, Edward R., Jr.; Carucci, James R., Jr.

2017-01-01

Capstone design projects have become commonplace among engineering and engineering technology programs. These projects are valuable tools when assessing students, as they require students to work in teams, communicate effectively, and demonstrate technical competency. The use of industrial sponsors enhances these projects by giving these projects…

27 CFR 73.31 - May I submit forms electronically to TTB?

Code of Federal Regulations, 2014 CFR

2014-04-01

...; ELECTRONIC SUBMISSION OF FORMS Electronic Filing of Documents with TTB § 73.31 May I submit forms... above; (c) You submit the electronic form to an electronic document receiving system that we have... submit the form through an electronic document receiving system that TTB has designated for the receipt...

Pharmaceutical Industry-Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries.

PubMed

DeJong, Colette; Aguilar, Thomas; Tseng, Chien-Wen; Lin, Grace A; Boscardin, W John; Dudley, R Adams

2016-08-01

The association between industry payments to physicians and prescribing rates of the brand-name medications that are being promoted is controversial. In the United States, industry payment data and Medicare prescribing records recently became publicly available. To study the association between physicians' receipt of industry-sponsored meals, which account for roughly 80% of the total number of industry payments, and rates of prescribing the promoted drug to Medicare beneficiaries. Cross-sectional analysis of industry payment data from the federal Open Payments Program for August 1 through December 31, 2013, and prescribing data for individual physicians from Medicare Part D, for all of 2013. Participants were physicians who wrote Medicare prescriptions in any of 4 drug classes: statins, cardioselective β-blockers, angiotensin-converting enzyme inhibitors and angiotensin-receptor blockers (ACE inhibitors and ARBs), and selective serotonin and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs). We identified physicians who received industry-sponsored meals promoting the most-prescribed brand-name drug in each class (rosuvastatin, nebivolol, olmesartan, and desvenlafaxine, respectively). Data analysis was performed from August 20, 2015, to December 15, 2015. Receipt of an industry-sponsored meal promoting the drug of interest. Prescribing rates of promoted drugs compared with alternatives in the same class, after adjustment for physician prescribing volume, demographic characteristics, specialty, and practice setting. A total of 279 669 physicians received 63 524 payments associated with the 4 target drugs. Ninety-five percent of payments were meals, with a mean value of less than $20. Rosuvastatin represented 8.8% (SD, 9.9%) of statin prescriptions; nebivolol represented 3.3% (7.4%) of cardioselective β-blocker prescriptions; olmesartan represented 1.6% (3.9%) of ACE inhibitor and ARB prescriptions; and desvenlafaxine represented 0.6% (2.6%) of

Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.

PubMed

Mello, Michelle M; Clarridge, Brian R; Studdert, David M

2005-01-01

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.

Barriers to Employer Sponsored Training in Ontario. Results of a Field Study.

ERIC Educational Resources Information Center

Harvey, Edward B.

Results of a field survey of Canadian companies, trade unions, employer associations, educational establishments, and government agencies regarding the extent and possibilities of employer-sponsored training for workers are compiled in this report. Concentrating on the forty-nine companies in the survey sample, with collateral data from the…

78 FR 44432 - New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 522, and 524 [Docket No. FDA-2013-N-0002] New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection AGENCY..., NADA 141-337 for RECUVYRA (fentanyl) Transdermal Solution to Elanco Animal Health, A Division of Eli...

The Perceived Influence of Industry-Sponsored Credentials in the Information Technology Industry.

ERIC Educational Resources Information Center

Bartlett, Kenneth R.

A study investigated the influence of information technology (IT)-industry-sponsored credentials from both organizational and individual perspectives. A senior-level human resource (HR) executive from each of 33 organizations with 500 or more employees completed a paper-and-pencil questionnaire (response rate=66% of the 50 organizations comprising…

Rights-Based Education for South Asian Sponsored Wives in International Arranged Marriages

ERIC Educational Resources Information Center

Merali, Noorfarah

2008-01-01

The Family Class Category of Canada's Immigration Policy exists with the key objective of family unification. Among Canada's second largest immigrant group, the South Asians, the cultural practice of arranged marriage is applied across international borders, leading to spousal sponsorship. Existing research on South Asian sponsored wives suggests…

25 CFR 224.54 - How must a tribe submit an application?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false How must a tribe submit an application? 224.54 Section... Obtaining Tribal Energy Resource Agreements Processing Applications § 224.54 How must a tribe submit an application? A tribe must submit an application and all supporting documents in written and electronic form to...

25 CFR 224.54 - How must a tribe submit an application?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false How must a tribe submit an application? 224.54 Section... Obtaining Tribal Energy Resource Agreements Processing Applications § 224.54 How must a tribe submit an application? A tribe must submit an application and all supporting documents in written and electronic form to...

25 CFR 224.54 - How must a tribe submit an application?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 25 Indians 1 2011-04-01 2011-04-01 false How must a tribe submit an application? 224.54 Section... Obtaining Tribal Energy Resource Agreements Processing Applications § 224.54 How must a tribe submit an application? A tribe must submit an application and all supporting documents in written and electronic form to...

24 CFR 598.300 - Procedure for submitting a nomination.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 3 2014-04-01 2013-04-01 true Procedure for submitting a nomination. 598.300 Section 598.300 Housing and Urban Development Regulations Relating to Housing and Urban... DESIGNATIONS Designation Process § 598.300 Procedure for submitting a nomination. (a) Establishment of...

24 CFR 598.300 - Procedure for submitting a nomination.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 3 2013-04-01 2013-04-01 false Procedure for submitting a nomination. 598.300 Section 598.300 Housing and Urban Development Regulations Relating to Housing and Urban... DESIGNATIONS Designation Process § 598.300 Procedure for submitting a nomination. (a) Establishment of...

24 CFR 598.300 - Procedure for submitting a nomination.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 3 2012-04-01 2012-04-01 false Procedure for submitting a nomination. 598.300 Section 598.300 Housing and Urban Development Regulations Relating to Housing and Urban... DESIGNATIONS Designation Process § 598.300 Procedure for submitting a nomination. (a) Establishment of...

Ancillary Care in South African HIV Vaccine Trials: Addressing Needs, Drafting Protocols, and Engaging Community

PubMed Central

Slack, Catherine M.

2014-01-01

There has been debate about sponsor-investigator ethical responsibilities to address participants’ medical needs in trials in resource-constrained contexts. Certain ethical guidelines make detailed recommendations. This study explored whether ethical guideline recommendations for care in HIV vaccine trials were being met, and whether stakeholders were facing difficulties addressed by guidelines. It sampled key stakeholders involved in two trials across five sites in South Africa, and reviewed relevant documentation. It concluded that sites were largely meeting guideline recommendations for addressing needs, with some exceeding these. Recommendations for writing protocols were only partially achieved. Recommendations for engaging participating community were mostly met, except for “moral negotiation” recommendations. Suggestions are made to strengthen practices, and to improve guidelines so they address empirical concerns. PMID:24572086

Ancillary care in South African HIV vaccine trials: addressing needs, drafting protocols, and engaging community.

PubMed

Slack, Catherine M

2014-02-01

There has been debate about sponsor-investigator ethical responsibilities to address participants' medical needs in trials in resource-constrained contexts. Certain ethical guidelines make detailed recommendations. This study explored whether ethical guideline recommendations for care in HIV vaccine trials were being met, and whether stakeholders were facing difficulties addressed by guidelines. It sampled key stakeholders involved in two trials across five sites in South Africa, and reviewed relevant documentation. It concluded that sites were largely meeting guideline recommendations for addressing needs, with some exceeding these. Recommendations for writing protocols were only partially achieved. Recommendations for engaging participating community were mostly met, except for "moral negotiation" recommendations. Suggestions are made to strengthen practices, and to improve guidelines so they address empirical concerns.

45 CFR 149.320 - Universe of claims that must be submitted.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Universe of claims that must be submitted. 149.320 Section 149.320 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH... Universe of claims that must be submitted. (a) Claims submitted for an early retiree, as defined in § 149.2...

45 CFR 149.320 - Universe of claims that must be submitted.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Universe of claims that must be submitted. 149.320 Section 149.320 Public Welfare Department of Health and Human Services REQUIREMENTS RELATING TO HEALTH... Universe of claims that must be submitted. (a) Claims submitted for an early retiree, as defined in § 149.2...

45 CFR 149.320 - Universe of claims that must be submitted.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Universe of claims that must be submitted. 149.320 Section 149.320 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH... Universe of claims that must be submitted. (a) Claims submitted for an early retiree, as defined in § 149.2...

45 CFR 149.320 - Universe of claims that must be submitted.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Universe of claims that must be submitted. 149.320 Section 149.320 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH... Universe of claims that must be submitted. (a) Claims submitted for an early retiree, as defined in § 149.2...

25 CFR 224.54 - How must a tribe submit an application?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 25 Indians 1 2012-04-01 2011-04-01 true How must a tribe submit an application? 224.54 Section 224... Obtaining Tribal Energy Resource Agreements Processing Applications § 224.54 How must a tribe submit an application? A tribe must submit an application and all supporting documents in written and electronic form to...

30 CFR 218.580 - When do I submit Form MMS-4444?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false When do I submit Form MMS-4444? 218.580 Section 218.580 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR MINERALS REVENUE... Correspondence § 218.580 When do I submit Form MMS-4444? Initially, you must submit MMS Form-4444 by November 29...

Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners.

PubMed Central

Wise, P.; Drury, M.

1996-01-01

OBJECTIVE: To assess the outcome of 100 general practice based, multicentre research projects submitted to the ethics committee of the Royal College of General Practitioners by pharmaceutical companies or their agents between 1984 and 1989. DESIGN: Analysis of consecutive submitted protocols for stated objectives, study design, and outcomes; detailed review of committee minutes and correspondence in relation to amendment and approval; assessment of final reports submitted at conclusion of studies. SUBJECTS: 82 finally approved protocols, embracing 34,523 proposed trial subjects and 1195 proposed general practice investigators. MAIN OUTCOME MEASURES: Success at enrolling subjects and investigators; commencement and completion data; validity of final report's assessment of efficacy, safety, tolerability, and acceptability; and method of use and dissemination of findings. RESULTS: 18 studies were not approved and 45 had to be amended. Randomised controlled trials comprised 46 of the original submissions. Remuneration considerations, inadequate information or consent sheets, pregnancy safety, the need to discontinue existing therapy, and suboptimal scientific content were major reasons for rejecting studies or asking for amendments. Of the 82 approved studies 8 were not started. Shortfalls of investigators (of 39%) and trial subjects (of 37%) and an overall 23% withdrawal rate were responsible for a significant incidence of inconclusive results. Within the six year follow up interval, only 19 of the studies had been formally published. CONCLUSIONS: This audit identified substantial ethical concerns in the process of approving multicentre general practice pharmaceutical research. PMID:8939118

Requesting Different Nodes Types When Submitting Jobs on the Peregrine

Science.gov Websites

System | High-Performance Computing | NREL Requesting Different Nodes Types When Submitting Jobs on the Peregrine System Requesting Different Nodes Types When Submitting Jobs on the Peregrine

The Perceived Influence of Industry-Sponsored Credentials on the Recruitment Process in the Information Technology Industry: Employer and Employee Perspectives

ERIC Educational Resources Information Center

Bartlett, Kenneth R.; Horwitz, Sujin K.; Ipe, Minu; Liu, Yuwen

2005-01-01

The increase in the number of industry-sponsored credential programs raises many questions for career and technical education. This study investigated the perceived influence of industry-sponsored credentials on the recruitment process in the information technology (IT) field. Influence is examined from the perspective of Human Resource (HR)…

Bridging the age gap in breast cancer: evaluation of decision support interventions for older women with operable breast cancer: protocol for a cluster randomised controlled trial

PubMed Central

Collins, Karen; Reed, Malcolm; Lifford, Kate; Burton, Maria; Edwards, Adrian; Ring, Alistair; Brain, Katherine; Harder, Helena; Robinson, Thompson; Cheung, Kwok Leung; Morgan, Jenna; Audisio, Riccardo; Ward, Susan; Richards, Paul; Martin, Charlene; Chater, Tim; Pemberton, Kirsty; Nettleship, Anthony; Murray, Christopher; Walters, Stephen; Bortolami, Oscar; Armitage, Fiona; Leonard, Robert; Gath, Jacqui; Revell, Deirdre; Green, Tracy; Wyld, Lynda

2017-01-01

Introduction While breast cancer outcomes are improving steadily in younger women due to advances in screening and improved therapies, there has been little change in outcomes among the older age group. It is inevitable that comorbidities/frailty rates are higher, which may increase the risks of some breast cancer treatments such as surgery and chemotherapy, many older women are healthy and may benefit from their use. Adjusting treatment regimens appropriately for age/comorbidity/frailty is variable and largely non-evidence based, specifically with regard to rates of surgery for operable oestrogen receptor-positive disease and rates of chemotherapy for high-risk disease. Methods and analysis This multicentre, parallel group, pragmatic cluster randomised controlled trial (RCT) (2015-18) reported here is nested within a larger ongoing ‘Age Gap Cohort Study’ (2012-18RP-PG-1209-10071), aims to evaluate the effectiveness of a complex intervention of decision support interventions to assist in the treatment decision making for early breast cancer in older women. The interventions include two patient decision aids (primary endocrine therapy vs surgery/antioestrogen therapy and chemotherapy vs no chemotherapy) and a clinical treatment outcomes algorithm for clinicians. Ethics and dissemination National and local ethics committee approval was obtained for all UK participating sites. Results from the trial will be submitted for publication in international peer-reviewed scientific journals. IRAS reference 115550. Trial registration number European Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2015-004220-61;Pre-results. Sponsor's Protocol Code Number Sheffield Teaching Hospitals STH17086. ISRCTN 32447*. PMID:28760787

77 FR 11555 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-27

... either http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinical...] Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Continuing Review After Clinical Investigation Approval; Availability AGENCY: Food and Drug Administration...

Patient perspectives on physician conflict of interest in industry-sponsored clinical trials for multiple sclerosis therapeutics.

PubMed

Solomon, Andrew J; Klein, Eran P; Corboy, John R; Bernat, James L

2015-10-01

Pharmaceutical industry financial support of physicians, physician practices, and academic departments involved in multicenter industry-sponsored clinical trials of novel therapeutic agents is a relatively new and infrequently acknowledged source of potential physician conflict of interest. Detailed disclosure of these relationships to study participants is not uniformly a part of informed consent and documentation practices. To understand attitudes of patients with multiple sclerosis concerning disclosure of potential physician-industry conflicts of interest created by clinical trials and how such disclosures may influence study participation An anonymous online instrument was developed. 597 people with multiple sclerosis participated in the study. The study found that detailed disclosure of conflicts of interest is important to potential participants in industry-sponsored clinical trials for multiple sclerosis therapies and that the presence of these conflicts of interest may influence patients' decisions to participate in these studies. Findings from this study support a call for uniform guidelines regarding disclosure of physician-industry relationships to prospective research participants for industry-sponsored clinical trials. © The Author(s), 2015.

21 CFR 516.22 - Permanent-resident U.S. agent for foreign sponsor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.22 Permanent-resident U.S. agent..., decisions, requirements, and other communications may be made on behalf of the sponsor. Notifications of...

21 CFR 516.22 - Permanent-resident U.S. agent for foreign sponsor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.22 Permanent-resident U.S. agent..., decisions, requirements, and other communications may be made on behalf of the sponsor. Notifications of...

49 CFR 579.6 - Address for submitting reports and other information.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., submissions under subpart B of this part must be submitted to [email protected]gov and submissions under § 579.5 must be submitted to [email protected]gov. (b)(1) Information, documents and reports that are submitted to NHTSA... identified on NHTSA's Web page http://www-odi.nhtsa.dot.gov/ewr/ewr.cfm. A manufacturer shall use the...

30 CFR 1218.580 - When do I submit Form ONRR-4444?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 3 2014-07-01 2014-07-01 false When do I submit Form ONRR-4444? 1218.580... Service of Official Correspondence § 1218.580 When do I submit Form ONRR-4444? Initially, you must submit Form ONRR-4444 by November 29, 2006, and subsequently, within 2 weeks of any change of your address. ...

30 CFR 1218.580 - When do I submit Form MMS-4444?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 3 2012-07-01 2012-07-01 false When do I submit Form MMS-4444? 1218.580... Service of Official Correspondence § 1218.580 When do I submit Form MMS-4444? Initially, you must submit Form MMS-4444 by November 29, 2006, and subsequently, within 2 weeks of any change of your address. ...

30 CFR 1218.580 - When do I submit Form MMS-4444?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 3 2011-07-01 2011-07-01 false When do I submit Form MMS-4444? 1218.580... Service of Official Correspondence § 1218.580 When do I submit Form MMS-4444? Initially, you must submit Form MMS-4444 by November 29, 2006, and subsequently, within 2 weeks of any change of your address. ...

30 CFR 1218.580 - When do I submit Form ONRR-4444?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 3 2013-07-01 2013-07-01 false When do I submit Form ONRR-4444? 1218.580... Service of Official Correspondence § 1218.580 When do I submit Form ONRR-4444? Initially, you must submit Form ONRR-4444 by November 29, 2006, and subsequently, within 2 weeks of any change of your address. ...

30 CFR 210.51 - Who must submit royalty reports?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Who must submit royalty reports? 210.51 Section 210.51 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR MINERALS REVENUE MANAGEMENT FORMS AND REPORTS Royalty Reports-Oil, Gas, and Geothermal Resources § 210.51 Who must submit...

Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin.

PubMed

Vedula, S Swaroop; Li, Tianjing; Dickersin, Kay

2013-01-01

Details about the type of analysis (e.g., intent to treat [ITT]) and definitions (i.e., criteria for including participants in the analysis) are necessary for interpreting a clinical trial's findings. Our objective was to compare the description of types of analyses and criteria for including participants in the publication (i.e., what was reported) with descriptions in the corresponding internal company documents (i.e., what was planned and what was done). Trials were for off-label uses of gabapentin sponsored by Pfizer and Parke-Davis, and documents were obtained through litigation. For each trial, we compared internal company documents (protocols, statistical analysis plans, and research reports, all unpublished), with publications. One author extracted data and another verified, with a third person verifying discordant items and a sample of the rest. Extracted data included the number of participants randomized and analyzed for efficacy, and types of analyses for efficacy and safety and their definitions (i.e., criteria for including participants in each type of analysis). We identified 21 trials, 11 of which were published randomized controlled trials, and that provided the documents needed for planned comparisons. For three trials, there was disagreement on the number of randomized participants between the research report and publication. Seven types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including ITT and six others. The protocol or publication described ITT using six different definitions, resulting in frequent disagreements between the two documents (i.e., different numbers of participants were included in the analyses). Descriptions of analyses conducted did not agree between internal company documents and what was publicly reported. Internal company documents provide extensive documentation of methods planned and used, and trial findings, and should be publicly accessible. Reporting standards

Protocol for the management of psychiatric patients with psychomotor agitation.

PubMed

Vieta, Eduard; Garriga, Marina; Cardete, Laura; Bernardo, Miquel; Lombraña, María; Blanch, Jordi; Catalán, Rosa; Vázquez, Mireia; Soler, Victòria; Ortuño, Noélia; Martínez-Arán, Anabel

2017-09-08

Psychomotor agitation (PMA) is a state of motor restlessness and mental tension that requires prompt recognition, appropriate assessment and management to minimize anxiety for the patient and reduce the risk for escalation to aggression and violence. Standardized and applicable protocols and algorithms can assist healthcare providers to identify patients at risk of PMA, achieve timely diagnosis and implement minimally invasive management strategies to ensure patient and staff safety and resolution of the episode. Spanish experts in PMA from different disciplines (psychiatrists, psychologists and nurses) convened in Barcelona for a meeting in April 2016. Based on recently issued international consensus guidelines on the standard of care for psychiatric patients with PMA, the meeting provided the opportunity to address the complexities in the assessment and management of PMA from different perspectives. The attendees worked towards producing a consensus for a unified approach to PMA according to the local standards of care and current local legislations. The draft protocol developed was reviewed and ratified by all members of the panel prior to its presentation to the Catalan Society of Psychiatry and Mental Health, the Spanish Society of Biological Psychiatry (SEPB) and the Spanish Network Centre for Research in Mental Health (CIBERSAM) for input. The final protocol and algorithms were then submitted to these organizations for endorsement. The protocol presented here provides guidance on the appropriate selection and use of pharmacological agents (inhaled/oral/IM), seclusion, and physical restraint for psychiatric patients suspected of or presenting with PMA. The protocol is applicable within the Spanish healthcare system. Implementation of the protocol and the constituent algorithms described here should ensure the best standard of care of patients at risk of PMA. Episodes of PMA could be identified earlier in their clinical course and patients could be managed in

31 CFR 356.14 - What are the requirements for submitting bids for customers?

Code of Federal Regulations, 2010 CFR

2010-07-01

... submitting bids for customers? 356.14 Section 356.14 Money and Finance: Treasury Regulations Relating to... requirements for submitting bids for customers? (a) Institutions that may submit bids for customers. Only depository institutions or dealers may submit bids for customers (see definitions at § 356.2), or for...

44 CFR 65.3 - Requirement to submit new technical data.

Code of Federal Regulations, 2011 CFR

2011-10-01

... available, a community shall notify the Administrator of the changes by submitting technical or scientific... IDENTIFICATION AND MAPPING OF SPECIAL HAZARD AREAS § 65.3 Requirement to submit new technical data. A community's...

10 CFR 600.504 - Information an applicant must submit.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Information an applicant must submit. 600.504 Section 600... Information an applicant must submit. (a) Any applicant for financial assistance under a covered program shall... United States of products resulting from a technology developed with financial assistance or to procure...

10 CFR 600.504 - Information an applicant must submit.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Information an applicant must submit. 600.504 Section 600... Information an applicant must submit. (a) Any applicant for financial assistance under a covered program shall... United States of products resulting from a technology developed with financial assistance or to procure...

10 CFR 600.504 - Information an applicant must submit.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Information an applicant must submit. 600.504 Section 600... Information an applicant must submit. (a) Any applicant for financial assistance under a covered program shall... United States of products resulting from a technology developed with financial assistance or to procure...

40 CFR 98.5 - How is the report submitted?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false How is the report submitted? 98.5 Section 98.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING General Provision § 98.5 How is the report submitted? Each GHG report and...

7 CFR 3406.21 - Intent to submit a proposal.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Submission of a Teaching or Research Proposal § 3406.21 Intent to submit a proposal. To assist CSREES in... 7 Agriculture 15 2010-01-01 2010-01-01 false Intent to submit a proposal. 3406.21 Section 3406.21 Agriculture Regulations of the Department of Agriculture (Continued) COOPERATIVE STATE RESEARCH, EDUCATION...

40 CFR 60.4915 - What reports must I submit?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Electronic Reporting Tool (ERT) (see http://www.epa.gov/ttn/chief/ert/ert_tool.html/) or other compatible... Sludge Incineration Units Recordkeeping and Reporting § 60.4915 What reports must I submit? You must... reporting period specified in paragraph (d)(3) of this section. You must submit your first annual compliance...

40 CFR 60.4915 - What reports must I submit?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Electronic Reporting Tool (ERT) (see http://www.epa.gov/ttn/chief/ert/ert_tool.html/) or other compatible... Sludge Incineration Units Recordkeeping and Reporting § 60.4915 What reports must I submit? You must... reporting period specified in paragraph (d)(3) of this section. You must submit your first annual compliance...

7 CFR 3405.12 - Intent to submit a proposal.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 15 2012-01-01 2012-01-01 false Intent to submit a proposal. 3405.12 Section 3405.12 Agriculture Regulations of the Department of Agriculture (Continued) NATIONAL INSTITUTE OF FOOD AND AGRICULTURE HIGHER EDUCATION CHALLENGE GRANTS PROGRAM Submission of a Proposal § 3405.12 Intent to submit a...

7 CFR 3405.12 - Intent to submit a proposal.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 15 2013-01-01 2013-01-01 false Intent to submit a proposal. 3405.12 Section 3405.12 Agriculture Regulations of the Department of Agriculture (Continued) NATIONAL INSTITUTE OF FOOD AND AGRICULTURE HIGHER EDUCATION CHALLENGE GRANTS PROGRAM Submission of a Proposal § 3405.12 Intent to submit a...

7 CFR 3405.12 - Intent to submit a proposal.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 15 2014-01-01 2014-01-01 false Intent to submit a proposal. 3405.12 Section 3405.12 Agriculture Regulations of the Department of Agriculture (Continued) NATIONAL INSTITUTE OF FOOD AND AGRICULTURE HIGHER EDUCATION CHALLENGE GRANTS PROGRAM Submission of a Proposal § 3405.12 Intent to submit a...

7 CFR 3405.12 - Intent to submit a proposal.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 15 2011-01-01 2011-01-01 false Intent to submit a proposal. 3405.12 Section 3405.12 Agriculture Regulations of the Department of Agriculture (Continued) NATIONAL INSTITUTE OF FOOD AND AGRICULTURE HIGHER EDUCATION CHALLENGE GRANTS PROGRAM Submission of a Proposal § 3405.12 Intent to submit a...