BEE-spoke-data/govdocs1-by-extension huggingface dataset:
# Presentation: 873977

## Using caBIG for Improving Communication with FDA

- Randy Levin, M.D.
- Director, Office of Information Management
- Center for Drug Evaluation and Research
- Food and Drug Administration

- Cancer Biomedical Informatics Grid Conference
- February 20, 2004

## Objectives

- Improving communication between investigators, clinical trial sponsors and FDA increases
- Efficiency in data collection
- Ease of reporting
- Efficiency for review
- Initiatives to improve communication
- Study Data Tabulation standards
- Electronic IND submissions
- Clinical investigator registry

## Study Data Tabulation Standard

- Model for describing observations in clinical trials
- From Clinical Data Interchange Standard Consortium (CDISC) and Health Level Seven  (HL7)
- Benefits
- Improve exchange of data between groups
- Facilitate development of standard Case Report Forms for use between sponsors
- Facilitate use of electronic data capture
- Facilitate creation of a clinical data repository allowing evaluation of data across studies with user friendly tools

## Electronic IND Submissions

- Electronic exchange of IND related documents and data
- Standards from the International Conference on Harmonisation (ICH)
- Benefits
- Automated submission process of IND information
- Electronic submission of adverse event reports
- On line access to IND documents and data
- Tools for the creation of an up to date, cumulative table of contents for all information submitted to the IND

## Clinical Investigator Registry

- Central repository for investigator information
- such as curriculum vitae and FDA form 1572
- Benefits
- Sign and process investigator forms electronically
- Automated submission of information
- Reuse information previously submitted
- Potential use to match investigators and sponsors of clinical trials
# Presentation: 670341

## RESULTS & DISCUSSION

**Single vs Expanded SSR term and All vs First Service Only**
- Use of the expanded SSR term improved accuracy in both models by 3.5%
- Expanded terms must be fit as random rather than fixed to avoid bias
- No difference between linear and threshold models
- Use of all services increases accuracy by 7.5%
- All biases  0
**Accuracy (%) by CG Size and Number of Matings/bull**

|  |  | Herd CG Size |  |  |  |
| --- | --- | --- | --- | --- | --- |
| N. Matings | Model | 5 | 10 | 20 | 100 |
| 10 | Linear | 45.6 | 46.3 | 48.7 | 49.4 |
|  | Threshold | 45.5 | 46.3 | 48.6 | 49.3 |
| 1000 | Linear | 88.0 | 89.9 | 89.6 | 90.5 |
|  | Threshold | 88.0 | 89.9 | 89.6 | 90.5 |

- All biases  0
**Effect of Unknown SSR on Accuracy (%)**
- Two approaches for handling unknown SSR were compared
- 1) Delete the matings, 2) use unknown SSR ID

| % Unknown | Approach | Linear | Threshold |
| --- | --- | --- | --- |
| 1 | Delete | 86.3 | 86.3 |
|  | Unknown SSR ID | 86.3 | 86.4 |
| 10 | Delete | 84.2 | 84.2 |
|  | Unknown SSR ID | 84.5 | 84.5 |

**CONCLUSIONS**
- By far, the most important factor affecting accuracy is not the model but simply the number of matings
- Compared to use of first service only, use of all services increases accuracy by 7.5%
- Predictions from linear model as accurate as those from threshold model, even with small subclasses
- Use of expanded SSR term improves accuracy of prediction
- CG size has relatively minor impact on accuracy; magnitude of impact decreases as number of breedings per bull  increases. Small CG size does not introduce bias in either model
- 10% unknown/incorrect SSR ID reduces accuracy by about 2%
- Effect of unknown pregnancy status is relatively minor; when all unsuccessful last services were (erroneously) changed to successes accuracy was reduced 2 to 3%
- Only when mean CR was 10% did the threshold model show an advantage over the linear model; however, with mean US Holstein cow CR  35%, a linear model will provide predictions of bull fertility equal in accuracy to a threshold model
**FUTURE RESEARCH**
- Determine whether use of standard deviation of predictor in threshold model probability calculations improves accuracy of predictions for threshold model
- Introduce relationships amongst cows and compare linear animal and threshold sire models

- All biases  0
- Similar results for incorrect SSR
**Effect of Unknown Pregnancy Status on Accuracy (%)**
-  13.5% of last services were failed pregnancies; these were all re-coded  as successes to compare to accuracies when true outcomes were used

| Last Service | Linear | Threshold |
| --- | --- | --- |
| True Outcome | 85.7 | 85.7 |
| All successes | 83.0 | 82.8 |

**Effect of Population Mean CR on Accuracy (%)**

| Mean CR | Linear | Threshold |
| --- | --- | --- |
| 0.10 |  84.4* | 86.0 |
| 0.35 | 85.7 | 85.7 |
| 0.50 | 84.3 | 84.3 |

- * Linear model variance estimates  0; threshold model variance estimates used for linear model when  = 0.10
# Presentation: 531311

## Measurements of Field Fluctuations  Inside LHC Beam Screen

- Vladimir Shiltsev (Fermilab)

***bnl - fnal- lbnl - slac***

_**US LHC Accelerator Research Program**_

## Worrisome Tevatron 2000 results 
Worrysome LHC Tolerances
Worrysome LHC beam screen
No data... no idea...nothing... -also worrysome
Measurements proposed in Sep’05: 
Interest at CERN
Even enthusiasm (L.Bottura) 
CERN coils offered (need to be evaluated)
IR quadrupoles, too! (O.Bruening + student)
3 mos to set the program, results in 2006 (2007) 
5k$ for new coils +5k$ travel = 10k$ (if ADCs borrowed)

- Worrysome LHC Tolerances
- Worrysome LHC beam screen
- No data... no idea...nothing... -also worrysome
- Measurements proposed in Sep’05:
- Interest at CERN
- Even enthusiasm (L.Bottura)
- CERN coils offered (need to be evaluated)
- IR quadrupoles, too! (O.Bruening + student)
- 3 mos to set the program, results in 2006 (2007)
- 5k$ for new coils +5k$ travel = 10k$ (if ADCs borrowed)

**dB/B Measurements**

- LARP Collab Mtg 10/05/05 - V.Shiltsev

##  FNAL MTF (Proc.PAC’01)

- LARP Collab Mtg 10/05/05 - V.Shiltsev

##  Coil Calibration

- LARP Collab Mtg 10/05/05 - V.Shiltsev

##  Raw Coil Signal

- LARP Collab Mtg 10/05/05 - V.Shiltsev

## Raw Spectra

- LARP Collab Mtg 10/05/05 - V.Shiltsev

## Calculated dB/B

- LARP Collab Mtg 10/05/05 - V.Shiltsev

##  Bent Crystal: 1TeV Channeling 

- LARP Collab Mtg 10/05/05 - V.Shiltsev
# Presentation: 672515

## Interface Engine Development

- Building Interfaces Using HIE Cloverleaf®
**Yenshei Liu**

- 1998 Client Server Team Presentation: Interface Engine

- 1/9/98

## Project Goals

**Provide an interface between the medical information system (MIS) and ancillary systems (LAB, PHARMACY, EKG)**
**Populate the Clinical Data Repository**

- 1998 Client Server Team Presentation: Interface Engine

- 1/9/98

## Description

**HIE Cloverleaf® is a toolset used to solve communication problems between various systems. **
**In our case, it is used to transfer data between MIS and all other hospital systems such as the lab (SCC), transcription system (SoftMed), EKG, and Pharmacy.**

- 1998 Client Server Team Presentation: Interface Engine

- 1/9/98

## Building an Interface

**There are various components to the interface involved in building an engine.**
**The main GUIs used to build an engine in the HIE Cloverleaf® Toolset are: The Network Configurator, Translation Configurator, and HL7 Configurator. **

- 1998 Client Server Team Presentation: Interface Engine

- 1/9/98

## Network Configurator

**Allows you to define and modify the connections on your network.**
**Handles communication transactions flowing across network connections.**

- 1998 Client Server Team Presentation: Interface Engine

- 1/9/98

## Translation Configurator

**Defines how incoming records should be translated into outgoing records.**
**Handles translations between different kinds of layouts such as HL7, Flat Record Layout, X12, and UN/EDIFACT.**

- 1998 Client Server Team Presentation: Interface Engine

- 1/9/98

## HL7 Configurator

**Defines the standard message, segment, and data field layouts in the HL7 format.**
**Health Level 7 (HL7) is a standard for electronic data interchange in healthcare environments, with emphasis on hospitals**** **
**Allows you to define variants in HL7.**
**Used for variable length messages**

- 1998 Client Server Team Presentation: Interface Engine

- 1/9/98

## TCL (Tool Command Language)

**Used to affect and customize many aspects of the defined interface engine.**
**Helpful in parsing messages and formatting field data.**

- 1998 Client Server Team Presentation: Interface Engine

- 1/9/98

## Current Status

**Interface engines in progress:**
**ADT Messages from MIS to SCC & CDR**
**ADT Messages from flat file to SCC**
**Chemistry, Microbiology, Blood Bank, & Pathology Anatomy Orders from MIS to SCC & CDR**

- 1998 Client Server Team Presentation: Interface Engine

- 1/9/98

## Current Status

**Interface engines to be replaced:**
**ADT Messages to PYXIS**
**ADT Messages to CDR**
**EKG Orders from MIS to EKG & CDR**
**EKG Results to MIS & CDR**

- 1998 Client Server Team Presentation: Interface Engine

- 1/9/98

## Current Status

**Interface engines in planning:**
**Radiology Orders from MIS to SoftMed® & CDR**
**Radiology Transcribed Reports to MIS & CDR**
**Pharmacy Orders from MIS to CDR**
**ADT messages to Voice Recording Prototype System**

- 1998 Client Server Team Presentation: Interface Engine

- 1/9/98
# Presentation: 274536

## Strategies to Reduce Urban Heat Islands

## Outline    

- Heat island definition, causes, and impacts
- Key strategies to reduce heat islands
- EPA’s Heat Island Reduction Initiative (HIRI) Program

## UHI Definition, Causes, Impact

- Urban heat islands
- Warmer city compared to surrounding
- Mitigation strategies exist.  So do barriers to implementation.
- Causes
- Impact
- energy use
- air quality
- public health

**Notes:**
Background - Basic information - launch date, program goals, history (e.g., Energy Star was initially part of HIRI) 

Current Status - 

Next Steps (see next slide) note that we’ll be translating research into user friendly tools, policy and guidance.  Framework is more on working with cities to advance HI mitigation.

## Key Strategies to Reduce UHI

- Urban vegetation
- Cool roofing
- Cool pavements

## highly reflective surfaces
roofs and pavement
reflect incoming solar radiation

shade trees
block incoming radiation to keep buildings cooler
naturally cool the surrounding air

- roofs and pavement
- reflect incoming solar radiation
- shade trees
- block incoming radiation to keep buildings cooler
- naturally cool the surrounding air

- Key Strategies to Reduce UHI

**Notes:**

Part of behaviors hoping to change

As explained in “strategic value”, also how these measures are implemented/considered

Still will answer by whom and how we expect

part of #4

## Key Strategies Can Improve Local and Global Environment

## Urban Vegetation - Benefits

- Energy savings
- Air temperature reduction
- Air pollution removal
- VOC reductions - Shading parking lots
- CO2 reduction
- Stormwater management
- Beautification, property value increases

## Cool Roofing - Benefits

- Energy savings
- Temperature reduction
- Reduced air pollution and GHG emissions
- Indoor comfort
- Durability and waste minimization

## Cool Pavements - Benefits

- Higher reflectance reduces _pavement_ temperatures
- Higher reflectance reduces a_ir_ temperatures
- Theory = cooler pavements last longer and save energy

## EPA’s HIRI Program Implementation

- Outreach
- Website
- Conferences
- Conference calls
- Tools
- Heat island
- 	      reduction
-            strategies guidebook
- MIST
- Analysis

## Slide 11

## Heat Island Mitigation: Resources & Contact Info

- Resources
- EPA’s Heat Island Website: www.epa.gov/heatisland
- LBNL Heat Island Group: http://eetd.lbl.gov/heatisland
- ICLEI Heat Island Site: www.hotcities.org
- Contact
- Eva Wong (wong.eva@epa.gov)
- Niko Dietsch (dietsch.nikolaas@epa.gov)
# Presentation: 901816

## Science in Regulation

- A Visionary Overview
- Arthur Kibbe, Ph.D.

## The Regulation of Science??

- To look forward we must look back first
- Where have we been?
- USP 1817 Dr. Spalding of NYC – Quality of Drugs
- APhA – National Formulary 1888 – Quality of Compounded Prescriptions
- Industrial Self Regulation – E.R Squibb

## Government Regulation

- 1848 – Quinine –
- Food & Drug Act of 1906  - It is what is claims to be
- 1912 Misbranding
- 1938 Must be safe
- 1951 Dirham & Humphrey Rx & OTC
- 1962 Safe & Effective

## Cost of Drugs

- 1950’s Tetracycline 50 cents a capsule
- Average cost of Rx 1.75
- Waxman Hatch Act 1984
- Re-importation??

## What is Next

- New drugs not only safe & effective BUT better
- International regulation of Quality
- Control of Cost to Consumer
- Continuous Quality improvement
- PAT
- Federally funded efficacy testing

## Challenge to FDA

- Ensure Quality of Drug Products
- Improve Productivity of the Industry
- Maintain public confidence
- Avoid unnecessary political involvement
- Maintain International cooperation
- Decriminalize Grandma
# Presentation: 417373

## You Are Invited to Attend

***You Are Invited to Attend***

***A Special Evening of Art Display and Auction***

**Art and science will merge at the Gulf Coast Exploreum in Mobile, Ala., March 25-May 6, when a major exhibition, "Imaging the Gulf," will showcase university student artwork depicting the value of the Gulf of Mexico. **

**The exhibition is being held in conjunction with the Fourth Gulf of Mexico Symposium at the adjacent Convention Center. This year's April 9-12 symposium, "The Gulf of Mexico - a Resource for the New Millennium" will feature E. O. Wilson of Harvard, the Pulitzer-prize winning scientist who popularized the concept of biodiversity.  **
**To celebrate and recognize the Gulf of Mexico as a unique marine resource:**

**The Gulf of Mexico Foundation will sponsor**
**An “****Imaging**** ****the Gulf****” Art Auction of**
**the Entries of the University Student Artwork**

**"Imaging the Gulf" is sponsored by the Communications Committee of the Gulf of Mexico Program Partnership, headquartered at Stennis Space Center, Miss.**** **

**TIME**
**7:00 p.m.**
***during***
***“******An Evening***
***At the ***
***Exploreum”***
***5:30 p-9:00 p***

**DATE**
**4-11-00**

**PLACE**
**Gulf Coast**
**Exploreum**
**Mobile, AL**
# Presentation: 426877

## Proposed BCA Phase 2 Demonstration

**These are the ****Motorola CAs**

**These are the ****SPYRUS CAs**

- c=US

- o=U.S. Government

- ou=DoD

- cn= DoD Bridge

- cn= AF/DISA ICA

- cn= AF/DISA CA

- cn= Army/Navy ICA

- cn= Army/Navy CA

- ou=FBI

- ou=Army

- ou=Navy

- SPYRUS-certified users at VDA / Annapolis Junction

- Motorola-certified users at VDA / Annapolis Junction

- ou=Air Force

- ou=DISA

- Entrust-certified users at VDA / Annapolis Junction

- Entrust-certified users at CygnaCom / McLean

- SPYRUS-certified users at CygnaCom / McLean

- Motorola-certified users at CygnaCom / McLean

- cn= AF/DISA Root

- cn= Army/Navy Root

- Locations layer: ou=locations,
- l=Annapolis Junction or l=McLean (as appropriate)
*(used for end-entities, not used for CAs)*

- Directory Information Tree(version 4)

- ou= Coast Guard

- ou= FBI

**Example:** c=US, o=U.S. Government, ou=Law Enforcement, ou=FBI, ou=locations, l=McLean (Entrust), cn= FBI User 1

- ou=Coast Guard

- cn= DoD Bridge CA

**Example:** c=US, o=U.S. Government, ou=DoD, ou=Locations, l=Annapolis Junction (SPYRUS), cn=Army/Navy CA

**These are the Entrust CAs, stored in ****a CA attribute at this point in the DIT**

- ou=Law Enforcement

**Example:** c=US, o=U.S. Government, ou=DoD, ou=Air Force, ou=Locations, l=McLean (Motorola), cn=AF User 1

## BCA Phase 2 DemonstrationSummary PKI Graph

- Army/Navy Root

- Army/Navy ICA

- Army/Navy CA

- AF/DISA Root

- AF/DISA ICA

- AF/DISA CA

- LawEnforcementCA

- CoastGuardCA

- FBICA

- BCA Phase 2 DemonstrationSummary PKI Graph

- ENTRUST
- CAs

- Motorola
- CAs

- SPYRUS
- CAs
# Presentation: 192940

## University of Minnesota-Twin Cities MRSEC Timothy P. Lodge DMR-0212302 Silicon Nanocrystals with Quantum Yields Exceeding 60% (Proto-IRG)

- Silicon is widely used for microelectronics due to its excellent electrical properties.  Unfortunately, its optical properties are poor, which has so far prevented its application as light-emitting material.  The photophysical properties of small silicon crystals improve drastically when reduced in size to a few nanometers.  The proto-IRG has developed a plasma gas discharge approach to produce macroscopic amounts of high quality silicon nanocrystals.  Through proper functionalization of the nanocrystal surfaces by binding organic molecules to silicon surface atoms, the group achieved a so far unprecedented optical activity of silicon.  Efficient visible light emission from silicon nanocrystals was observed upon irradiation with ultraviolet (UV) light.  Quantum yields, defined as visible photons emitted per UV photons absorbed, of 67% were observed, bettering previous reports of ~30%.  This development may make silicon a suitable material for light-emitting devices in optical communications, display devices, and new applications in bio-imaging. [Jurbergs, D.*; Mangolini, L.; Rogojina, E.*; Kortshagen, U. Silicon Nanocrystals with Quantum Yields Exceeding 60%. Appl. Phys. Lett. 2005, submitted (*InnovaLight, Inc.)]

- Colloidal silicon nanocrystals sitting on an ultraviolet (UV) lamp.  Left: room light on, UV lamp off. Right: room light off, UV lamp on.
# Presentation: 177544

## Updates Since Spring 2004

**Nancy Kirkendall, Director **
**Statistics and Methods Group**
**October 28, 2004**

## Electric Power 
Revision Policy
EIA Survey Testing Methods
Estimation of  Weekly Other Oils Stocks

**Revision Policy**
**EIA Survey Testing Methods**
**Estimation of  Weekly Other Oils Stocks**

**Topics**

## Electric Power

**Doug Hale’s transmission paper**
**Finalized and about to be released**
**Focus Groups****	**
**Electric Power Package**
**EIA responding to OMB regarding industry comments on the Electric Power Package**

## Revision Policy

**Goal of EIA Standards**
**To minimize number of revisions**
**EIA presented new policy on revising data previously classified as final**
**Committee thought our proposal was fine**
**EIA has implemented the policy and has coordinated revisions to data on monthly coal production, MTBE consumption, and electricity direct use **

## EIA presented our approach for survey  development and redesign
Pre-survey Design Visits
Cognitive Interviews
Respondent Debriefings
Usability Testing

Asked for Committee assessment of our approach

**Pre-survey Design Visits**
**Cognitive Interviews**
**Respondent Debriefings**
**Usability Testing**
**Asked for Committee assessment of our approach**

**EIA Survey Testing Methods**

## Evaluating Survey Testing Methods

**Committee Advised **
**Current Methods Adequate**
**Conduct As Much Testing As Is Practical**
**Retest Form After Revisions Implemented**
**Separate Interviews With Management and Staff**

## Follow-up
Stan Freedman presented paper on methodology in Amsterdam

Stan invited by Lynda Carlson (NSF) to conduct workshop on EIA methods 

**Stan Freedman presented paper on methodology in Amsterdam**
**Stan invited by Lynda Carlson (NSF) to conduct workshop on EIA methods **

**Evaluating Survey Testing Methods**

## Estimating Weekly Other Oils Stocks

**Goal:  **
**To estimate weekly stocks of “Other Oils” excluding propane to obtain a weekly estimate for total petroleum**
**Available data:  **
**Weekly data for major petroleum products, monthly data for all products**
**Committee Suggestion: **
**Collaborate with other EIA offices**

## Where We Are

**Still collaborating **
**SMG selected best regression based models using monthly data**
**Compared to alternatives from Petroleum Supply using weekly data  **
**Will compare to alternative from Energy Markets and End Use**
**Will add price as independent variable.**
# Presentation: 845712

## MANX with various momentum muons

*K. Yonehara*

- MCTF Meeting

- August 24, 2006

## Geometry

-  = 1.6 m,  = 1.0
- Diameter of beam pipe = 0.8 m
- r of reference orbit = 255 mm
- pinitial = 0.22, 0.25, 0.275, 0.3 GeV/c
- Total length
- 1.6 m (0.22 GeV/c), 2.4 m (0.25 GeV/c), 3.2 m (0.275 GeV/c)
-     4.0 m (0.3 GeV/c)
- 0.14 GeV/c < Final pfinal < 0.15 GeV/c
- Use LHe as absorber
- Momentum cut at the end of HCC (±0.15 ×pfinal)

**2.4 m**

- MCTF Meeting

- August 24, 2006

## Emittance evolution in various p

- Initial / Final Cooling factor

- p=0.22 GeV/c, 71.13/50.88 = 1.40

**Matching**

**HCC**

- p=0.25 GeV/c, 75.29/48.53 = 1.55

- p=0.275 GeV/c, 85.02/45.61 = 1.86

- p=0.3 GeV/c, 85.42/41.49 = 2.06

- MCTF Meeting

- August 24, 2006

## Emittance evolution in various p

- Initial / Final Cooling factor

- p=0.22 GeV/c, 174.7/142.0 = 1.23

**Matching**

**HCC**

- p=0.25 GeV/c, 198.0/139.2 = 1.42

- p=0.275 GeV/c, 245.8/139.6 = 1.76

- p=0.3 GeV/c, 235.1/131.5 = 1.79

- MCTF Meeting

- August 24, 2006

## Emittance evolution in various p

- Initial / Final Cooling factor

- p=0.22 GeV/c, 750.2/353.7 = 2.12

**Matching**

**HCC**

- p=0.25 GeV/c, 931.6/330.5 = 2.82

- p=0.275 GeV/c, 1427/280.7 = 5.08

- p=0.3 GeV/c, 1371/215.7 = 6.36

- MCTF Meeting

- August 24, 2006

## Design matching section

- MCTF Meeting

- August 24, 2006

## Current matching design

-  3 m Matching section
-  2 mm Al window
-  4 m HCC
-  2 mm Al window
-  Now downstream matching available

- Solenoid

- Dipole

- Matching

- HCC

- MCTF Meeting

- August 24, 2006

## Current matching design

- Quadrupole

- Matching

- HCC

- MCTF Meeting

- August 24, 2006

## Current matching design

- MCTF Meeting

- August 24, 2006

## Current matching design

- 85.52/43.69 = 1.96

- 199.3/137.2 = 1.45

- 1340/281.4 = 4.76

- Initial / Final 

- MCTF Meeting

- August 24, 2006

## Non-linear motion inenergy loss process

- What is the difficulty to make a lower momentum HCC?

- MCTF Meeting

- August 24, 2006

## Non-linear effect in energy loss process (I)

-  The challenge here is how to build a lower momentum HCC.
-  A big difference between p=0.1 GeV/c and p=0.15 GeV/c (20 vs 600).
-   Dhat is the distance from theoretical Dhat+1st order energy loss correction.

**Cooling factor**

- MCTF Meeting

- August 24, 2006

## Non-linear effect in energy loss process (II)

- General definition

- Taylor expansion

- 1st order perturbation term

- 2nd order perturbation term

- 3rd order perturbation term

**B**

- *a*

- *p*

- *p*

- *a*

- MCTF Meeting

- August 24, 2006
# Presentation: 128358

## MNM Fatal 2004-14

- Powered Haulage
- July 24, 2004 (Oklahoma)
- Limestone
- Laborer
- 18 years old
- 8 days experience

## Overview

- The victim was seriously injured on July 24, 2004, when the lift assembly of the skid-steer loader he was operating pinned him against the cab of the machine.  He was attempting to position the bucket so he could replace a hinge pin that had fallen from the left lift arm.  He died on August 6, 2004.

## Victim was caught between the lifting arm cylinder pin assembly and the top front of the cab 

**Victim was caught between the lifting arm cylinder pin assembly and the top front of the cab **

**The pin was found on the ground just inside the left front tire.**
**The pin was missing from the left front arm of the lift where it attaches to the bucket.**
**The bucket was found turned up resting on the cutting edge.**

## The safety bar was found in the down position in the operator’s cab. 

- The safety bar was found in the down position in the operator’s cab.

## The pin was missing from the  point where the lift arm attaches to the bucket.  It was found just inside the left front tire lying on the ground.

## Why Did Accident Occur?

- The accident occurred because safe operating procedures were not followed when performing repairs to the skid-steer loader without shutting off the engine and blocking the loader against hazardous motion.

## Causal Factors

- Policies and administrative controls were inadequate because newly hired employees were not monitored to prohibit them from performing repair tasks by themselves.
- The operator of the skid-steer loader did not follow the manufacturer’s recommendations for operating the loader.  The task training provided did not include a review of the equipment operator’s manual.

## Best Practices

- Evaluate a task and identify any potential hazards (conduct a risk analysis) before performing any maintenance work. Establish safe work procedures that include removing the hazards before beginning any work.
- Train all personnel assigned to operate mobile equipment regarding the safe work procedures and the hazards associated with maintenance of the equipment.
- Position yourself in a safe location where you are not exposed to hazards.
- Before performing repairs or maintenance on equipment, turn the power off and block the machinery against hazardous motion.
- Monitor personnel routinely to determine that safe work procedures are followed.
# Presentation: 822777

## Corporate Infra

- Mapping Requirements to Implementation Design
- Sample Screens & Outputs
- Baseline for Managing Change

## Corporate Infra – Overview			2/24/03			

- Start Process – Main Menu Item
- Data entry/edit form
- Decision Point

- Format

## Create New Property

- GSA Installation Site

- Owned

-    GSA
- Assigned

- Rental Occupancy
- Agreement

- Property (Land/Feature)

- Property (Feature)

- Shared
- Space

- Inter Agency
- Agreement

- Property (Feature)

- Agreement

- Permit

- Property (Feature)

- Vendor
- Permit

- GSA Installation Site

- Leased

- Lease Mgt

- Property (Create or  update Land/Feature)

## GSA Installation Site

- Owned

- Property (Land/Feature)

## Slide 5

## Slide 6

## Slide 7

## Slide 8

## Slide 9

## GSA Installation Site

- Leased

- Lease Mgt

- Property (Create or  update Land/Feature)

## Slide 11

## Slide 12

## Slide 13

## Slide 14

## Slide 15

## Slide 16

## Manage ROA

- ROA

- Rent Items

- Compare Rents/ STARS

## Slide 18

## Slide 19

## Slide 20

## 1166 form

## Slide 22

## Shared 

- Shared
- Space

- Inter Agency
- Agreement

- Property (Feature)

- Agreement

## Slide 24

## Permit

- Property (Feature)

- Vendor

## Slide 26

## Slide 27

## Slide 28

##   Edit  

-   Edit
- Property

-    Perform
- Inventory or
- Inspection

- Appraise
- for future
- action

- Manage Property

-   Edit
- Land Unit

-   Edit
- Other
- Feature

-   Edit
- Building

- Leased, PP&E,
- Public Domain, ...

- Property (Feature)

- Feature Basic

- Link Properties (bldgs, admin sites, ...)

- Occupancy

- Security

- Heritage

- Historical

- Appraisal form

- Acctg – Value Streams
- Write off cap value
- & accum depr

- Inspection/Inventory

- Work items

- Dispose?

- Project
- Complete

- Acquisition

- Other

- Projects (**Disposal**)

##   Edit

-   Edit
- Land Unit

- Leased, PP&E,
- Public Domain, ...

- Link Properties (bldgs, admin sites, ...)

- Heritage

- Historical

## Slide 31

## Slide 32

## Slide 33

##   Edit

-   Edit
- Building

- Property (Feature)

- Occupancy

- Security

- Acquisition

- Other

## Slide 35

## Slide 36

## Slide 37

## Slide 38

## Slide 39

## Slide 40

## Slide 41

## Slide 42

## Slide 43

## Slide 44

## Slide 45

##    Perform 

-    Perform
- Inventory or
- Inspection

- Inspection/Inventory

- Work items

## Slide 47

## Slide 48

## Appraise

- for future
- action

- Appraisal form

## Slide 50

## Acctg – Value Streams

- Write off cap value
- & accum depr

- Dispose?

- Project
- Complete

- Projects (**Disposal**)

## Slide 52

## Slide 53

## Cash Flow/operational $

## Slide 55

## Manage Budget

- Define program budgets

- Summary cash flow analysis

## Slide 57

## Manage Projects

- Projects (Capital Improvements, Maintenance, Operations

## Slide 59

## Slide 60

## Manage Subledgers

- Real  Property Accounting

## To be continued....
# Presentation: 536899

##  
Review on a quarterly basis by site, the actual maintenance expenditures against the amounts reported for that purpose in the FY 2003 facilities and infrastructure crosscut budget exhibit.  Reports on the actual maintenance expenditures are requested not later than 45 days following the end of each fiscal year quarter.  Controller staff will work the actual reporting mechanism with PSO staffs. 

Review on a quarterly basis by site, the actual expenditures for disposition of excess facilities as compared to the amounts reported for that purpose in the FY 2003 facilities and infrastructure crosscut budget exhibit.  Reports on actual expenditures for disposition of excess facilities are requested not later than 45 days following the end of each fiscal year quarter.  

- Review on a quarterly basis by site, the actual maintenance expenditures against the amounts reported for that purpose in the FY 2003 facilities and infrastructure crosscut budget exhibit.  Reports on the actual maintenance expenditures are requested not later than 45 days following the end of each fiscal year quarter.  Controller staff will work the actual reporting mechanism with PSO staffs.
- Review on a quarterly basis by site, the actual expenditures for disposition of excess facilities as compared to the amounts reported for that purpose in the FY 2003 facilities and infrastructure crosscut budget exhibit.  Reports on actual expenditures for disposition of excess facilities are requested not later than 45 days following the end of each fiscal year quarter.

**Proposed Plan for Quarterly Reporting of Maintenance Expenditures**

## Proposed Plan for Quarterly Reporting of Maintenance Expenditures

- Ensure that the dollar amounts for each Lead Program Secretarial Officer as reported in the FY 2003 Integrated Facilities and Infrastructure crosscut budget be expended only for facility maintenance and disposition.  The use of these funds for any other purpose requires advance approval by the cognizant “?  TBD”.
- Review in conjunction with my office, the Department’s budget and reporting classification structure and accounting systems to identify improvements needed to facilitate visibility of facility and infrastructure maintenance expenditures against approved budgets.  This review will be completed by March 31, 2003.
# Presentation: 704479

## Thank you!

**Sponsors**
**Planning Members**
**Speakers**
**Chairs/co-Chairs**
**Moderators/Discussion Leaders**
**Participants**
**SCG**

## Follow Up

**Proceedings of the meeting to be communicated in “Metabolomics”**
**Executive summary  on the workshop website**
**Break out session Chairs and co-Chairs contacted at a later date**

## Contacts

**Padma Maruvada**
**	****(301) 496 3893**
**	**_[maruvadp@mail.nih.gov](mailto:maruvadp@mail.nih.gov)_
**Young S. Kim**
**	****(301) 496-0126**
**	**_[kimyoung@mail.nih.gov](mailto:kimyoung@mail.nih.gov)_
**Carolyn Swanson **
**	****SCG Corporation**
**	****(301) 670-4990 **
**	**_[cswanson@scgcorp.com](mailto:cswanson@scgcorp.com)_

## NCI Chemical Repository

- _[www.ncirepository.org](http://www.ncirepository.org/)_
- 1-816-753-7600 x 1510#
- ~3000 compounds
- Call or write with new requests
# Presentation: 858104

## Parvovirus B19Public Health Impact of Donor Notification and Counseling 

- Parvovirus B19Public Health Impact of Donor Notification and Counseling

- Edward Gomperts, M.D.
- Global Vice President, Medical Affairs
- Baxter BioScience
- For
- The Plasma Protein Therapeutics Association

## Parvovirus B19 Infection

- Acute, self-limiting disease without chronic sequelae in normal individuals.
- Normally transmitted via the respiratory route.
- Most infections are asymptomatic.  Where symptomatic, (fever, headache, malaise, myalgias, rash) the donor would be deferred.
- Antibodies to Parvovirus B19 confer life-long protective immunity.
- More significant sequelae are rare and usually occur in particularly susceptible non-donor populations with pre-existing conditions.
- 	Principles and Practice of Infectious Diseases: Mandell, Douglas, and Bennett. Fourth  Edition. 1995. pages 1440-1446.

## Parvovirus B19Infection

- Parvovirus B19 infections typically resolve with the appearance of neutralizing antibodies ~10 days post infection for IgM and ~17 days post infection for IgG.
- Period of viremia ~14 days.*
- Intense viremia develops approximately  one week after infection, and viremia usually lasts one week.
- Our screening will not detect the low NAT levels associated with chronic carriers.
- 	*In some cases it has been observed that individuals with low level viremia continue to produce Parvovirus B19 for a longer period of time.

## Donor Notification/Counseling

- Average resolution time for NAT testing ranges from 25-60 days.
- Time would be required to identify and communicate with the donor.
- Infected donor would have already cleared the virus and developed sufficient antibodies to confer a life-long immunity by the time notification occurred.

## Conclusions

- Donor notification/counseling lacks public health benefit.
- Non-chronic virus infection.
- NAT resolution times.
- Medical information could be provided to the donor, obviously, but would be nonactionable and irrelevant to the individual’s short or long term health status.
- Questionable ethics of notification of donors regarding nonactionable medical information.
- Medical information to the donor would not have any public health impact.
# Presentation: 657435

## Public Forum ForProposed Revisions to IRP Regulations

- Presented by Western Area Power Administration
- September 6, 2007

## Western’s IRP History

- Conservation and Renewable Energy contractually required for Western’s long term firm customers starting in 1981
- Integrated Resource Planning (IRP) requirement for customers proposed in Energy Planning and Management Program (EPAMP) in 1991
- Congress reinforced Western’s administrative IRP proposal in the Energy Policy Act (EPAct) of 1992
- Final EPAMP adopted in 1995
- Required customer IRP
- Allowed preparation of alternative plan for small customers
- IRP cooperatives allowed

## Western’s Existing Regulations

- Adopted in March of 2000
- Feature customer choice and flexibility
- Reflect the transition of the electric utility industry
- Streamlined requirements
- Alternatives allowed in lieu of IRP:
- Minimum Investment Report-complying with a defined level of investment in demand-side management/renewable energy, including a public benefits program
- Complying with mandated energy efficiency/renewable energy activities and related reporting requirements-limited to end use customers

## Ability to Change Regulations

- Congress authorizes Western to make program changes
- Regulations track language from EPAct 1992
- At appropriate intervals, Western may initiate a public process to determine if regulations should be revised to reflects changes in technology, needs, or other developments

## IRP Approval Proposal

- Given the large number of members of some member-based associations (MBAs) and the diversity of member’s interests, difficult to attain unanimous approval by all members
- MBA governing body serves the interests of each MBA member through the member’s representation on the board
- Western proposes to eliminate the requirement that each member of an MBA independently approve the IRP
- MBA board approval still required
- No other changes to the full public participation requirement are proposed

## Regional IRP Proposal

- Joint planning, particularly for transmission, is increasingly important
- Western wants to clarify its willingness to let customers plan together
- Move beyond the “resource planning decision block” examples outlined in the original IRP rule
- Regional approach is appropriate even if participating customers are not members of an MBA
- Advance approval by Western required
- Regional IRPs must be approved by each participating customer

## Public Access to IRPs Proposal

- Western has received feedback that IRPs prepared by Western’s customers are more difficult to obtain than investor-owned utility IRPs
- Consistent with the requirement for full public participation in IRP preparation, Western proposes to make customer IRPs more readily available to the public, such as by posting on the Internet
- Freedom of Information Act (FOIA) protection of sensitive information remains available

## Questions and Comments
# Presentation: 736844

## Minnesota Hydrography

- Mark Olsen
- Minnesota Pollution Control Agency
- 520 Lafayette Road N.
- St. Paul, MN  55155
- mark.olsen@pca.state.mn.us

- Presented by:

##  A Valued Resource

- Land of 10,000 (or so) lakes
- High public interest and concern
- Recreational and environmental issues
- Lake property values related to water quality
- Distributed authority
- Need to coordinate activities

## Minnesota Governor’s Council on Geographic Information

- 			_Hydrography Committee_
- Inventory legacy systems
- Standards – codified and defacto
- State coordination
- Distributed authority
- Voluntary cooperation
- Define the MN hydrography framework
- Enable exchange of information
- Definition / delineation / identification / track events
- Coordination with Federal activities

##  NHD Development

- MPCA participation in 100K NHD development
- MN DNR 24K linework
- Partnerships necessary to build 24K NHD
- USEPA, USGS, USFS, NPS
- MPCA, DNR, LMIC, St Cloud State, USGS/WRD

## Slide 5

## MPCA’s Perspective

- Increasing monitoring and assessment needs
- EPA reporting requirements
- Leveraging contributions of broad community
- Consistency between states

## NHD is framework for integration

- Reach indexing ties together our activities
- Standards
- “Perch Creek: T.116, 117, 118, R.39”
- Monitoring (STORET)
- Assessments
- Cross reference to state numbering standard (DOWNUM)
- Integrated assessments
- Permitted dischargers

## More Critical Infrastructure

- STORET
- Data loading accelerated using SIM
- Accumulated expertise
- Training, conferences and user groups
- Web-enabled data entry application
- Field checking
- Includes all mandatory fields
- allows user aliases for fields
- persistent so provider can use next time
- Data validation
- Extract
- produces SIM-ready file

## Applications

- Construction Storm Water
- Proximity to special or impaired waters
- Multi-media analyses
- Integration of regulatory and ambient data
- Math and Science Academy
- Development of local water studies course
- Environmental Data Access Initiative
- Public access to water quality data and information

## Water Quality Data Access

- Environmental Data Access Initiative
- Implementation of One Stop grant investments
- Ambient data integration strategy
- Start with surface water data
- Focus on use by local water planners
- Competent repository for surface water data
- Timely access to data
- Better use of local data
- GIS is primary tool

## Slide 11

## Slide 12

## Slide 13

## Thank You.
# Presentation: 668321

## Net Worth Ratios Remain Strong

| 1991 |   6.3% |
| --- | --- |
| 1995 |   9.2% |
| 1998 | 10.9% |
| 2003
2004 
 | 10.7%
10.9% |

## Loan-to-Share RatiosAre Slowly Recovering

| 2001 | 73.8% |
| --- | --- |
| 2002 | 70.8% |
| 2003

2004 | 71.2%

73.7% |

## Delinquency RatiosAre Improving

| 2001 | 0.82% |
| --- | --- |
| 2002 | 0.79% |
| 2003
2004
 | 0.76%
0.71% |

## Concerns for the Future

**1) Slow Membership Growth**
**2) Disappearance of**
**        ****Small Credit Unions**
**3) Reputation Risks**
**4) Taxation**
**5) Conversions to Mutual Savings Banks**

## 1) Slow Membership Growth

- _Assets_

| 2001 |  $502 Billion | 14.5% | 79.3 Million | 2.3% |
| --- | --- | --- | --- | --- |
| 2002 |  $557 Billion | 11.1% | 80.9 Million | 2.0% |
| 2003 |  $610 Billion |   9.5% | 82.4 Million | 1.8% |
| 2004 | $641 Billion |    6.8%*
* Annualized | 83.7 Million |   2.1%*
* Annualized |

- _Members_

- Dollars

- % Growth

- Total

- % Growth

## Slide 7

## Credit Union Membership from Different Ethnic Groups

**Sources: U.S. Census Bureau 2003 estimates, and CUNA Research Services, 2004 **

## Population Growth:New Markets

- Projected population growth through the year 2020:
**Asians: 80%**
**Latinos:  75%**
**African Americans:  28%**
- Caucasians:  9%
- (Before 2020, Caucasians will become a minority.)

## Slide 10

## Slide 11

## 3) Reputation RisksIndirect Lending

**Reliance on Third Parties**
**Accelerating Loan Losses**
**Volume out of Control***** ***

## Slide 13

## Indirect Lending Exposure

- (at credit unions making indirect loans)
-  14% of Assets
-  21% of All Loans
** ****133% of Net Worth**
* *

## “Bounce Protection” Risks

**Exploiting Least Creditworthy Members**
**Encouraging Irresponsible Behavior**
**Damaging CUs’ Pro-Consumer Reputation**

## 4) TaxationThreats to Tax Exemption

**Loss of Small Credit Unions**
**Large FOMs (Community Charters)**
**Lack of Consistent Documentation of Service to Underserved Areas**

## 5) Conversions toMutual Savings Banks

** ****New NCUA Regulation**
** ****Role for Leagues**

## Addressing These Concerns

**Small Credit Union Initiative**
**Partnering and Leadership Successes**
**	**** ****(PALS)**

## Small Credit Union Initiative

** ****Examiner Training**
** ****Credit Union Training**
** ****Partnering with Leagues**

## 24) PALS

** ****Free Workshops**
** ****Best Practices Website**
# Presentation: 752256

## QwikBoostTMMainstream Engineering CorporationRockledge, FL

**QwikBoost****TM*****Mainstream Engineering Corporation******Rockledge, FL***

**INNOVATION**
-       Developed QwikBoostTM, an additive for vapor compression refrigeration systems, air conditioners, and heat pumps that results in increased system performance (i.e., reduced overall energy consumption).
**ACCOMPLISHMENTS**
- QwikBoost works by increasing the cooling capacity of the refrigerant.
- QwikBoost circulates through the refrigeration system in a manner similar to the way the lubricant circulates.
- Has high affinity for liquid HFC and HCFC refrigerants and has a significant heat of solution when mixed with them.
- Solution heat increases the available cooling capacity (latent heat) of the refrigerant during evaporation, providing an increase in performance of the system.
- Remains active for the life of the system and does not need to be replaced once QwikBoost is introduced into a system.
**COMMERCIALIZATION**
- Commercialization of QwikBoost is underway.
- Anticipated sales of $1M in1999 for the auto air conditioning market.
- QwikBoost is packaged in a handy  3-ounce can and is available for automotive air conditioning.

**Goddard Space Flight Center**

- 1988 Phase 2; SS5-017; 9/21/98

**S****mall**
**B****usiness**
**I****nnovation**
**R****esearch**

**GOVERNMENT/SCIENCE APPLICATIONS**
- Vapor-compression thermal control systems for spacecraft, resulting in lower mass systems.
- Use in air conditioning and refrigeration systems at NASA facilities, resulting in annual energy savings.
- Air conditioning systems of NASA’s vehicle fleet would benefit from this technology in faster cool-down times on hot days.

- Points of Contact:
-   -  NASA - Ted Swanson; 301-286-8618
-   -  Mainstream - Larry Grzyll; 407-631-3550

*QwikBoost**TM** Installation*
# Presentation: 821836

## AESDirectHints & Tips

**AES User Meeting**

## AESDirect  - Hints & Tips

- Efficient Use of AES*Direct*
- Good Practices
- Useful Things to Know / Do

## AESDirect – Efficient Use

- Create New Shipment: Enter USPPI and Consignee Codes on first screen
- Use Shipment Retrieval to create new shipments whenever possible
- To retrieve a shipment – Just enter Shipment #
- Freight Forwarder Info: Most shipments do not need it entered
- Don’t enter what AES*Direct* does not need, e.g. Equipment Details

## AESDirect – Efficient Use 

- Navigate from Shipment Section to Section – Only go back to View SED to submit shipment
- Look-Ups: To initiate use “?AA..<tab key>” instead of “?<tab key>”
- Look-Ups: Avoid null Search – Creates long list/takes time
- Look-Ups: Cannot find Port of Unlading – Enter country name to obtain a list of all ports in that country

## AESDirect – Good Practices

- New users should take the tutorial & Quiz before providing access to filing account.  Give them the tutorial username
- Consignee Codes: Use your own or let AES*Direct* create them – don’t mix
- Consignee Codes: Pre-enter frequently occurring ones

## AESDirect – Good Practices

- Use a meaningful (for your company) Shipment Number
- Make use of specific help links: (SCAC, Commodity Code)
- To Delete a Section use the “Clear Section” button

## AESDirect – Useful Things to Know/Do

- Use XTN# on exemption statement not ITN#
- Once AES*Direct* accepts your shipment – move it
- Be aware of AES*Direct* Response, Look-up, and Help window minimization
- Use Multiple Browser sessions: USPPI Set-up, Shipment Reporting, Create/Retrieve
- Use the On-Line Help

## AESDirect – Useful Things to Know/Do

- If you take a break: Minimize, don’t close your browser, also lock it or use a screen saver
- Use AES*Direct* to e-mail a submission response to your logistics chain partners
- Tailor  Shipment Reporting Pre-Set Reports to suit your company’s business
- Various reports provide different sorts of your data - exporter, consignee, carrier

## For More Information

- Phone:	1-800-549-0595  or                                                		1-877-715-1159
- Fax: 		301-457-1159
- Email: 	ASKAES@census.gov
- Web Sites:
- AES*Direct*:  www.aesdirect.gov
- Customs AES Site: www.customs.gov/aes
- Census Site: www.census.gov/foreign-trade

## Reduce Exporting Stress with AES
# Presentation: 527424

## Establishing an In Vitro Diagnostic (IVD) Claim 

- Robert L. Becker, Jr, MD, PHD
- Director, Division of Immunology and Hematology Devices
- OIVD/CDRH/FDA

## Claims

- Analytical Performance
- Clinical Performance

## Risk

- High – PMA – “Safe and Effective”
- Moderate – Usually 510(k) – “Substantially Equivalent”
- Low – Usually exempt
- How many patients; impact per patient
- How reliable is the test, and how will the physician/provider use the result?

## Clinical Performance Claims

- Define disease state
- Detect a change in disease state
- Forecast disease state
- [Clinical study designs differ]

## Define Disease State

- Initial Diagnosis
- Screening setting
- Definitive diagnosis setting
- In-between setting
- Presence of Residual Disease

## Detect a Change in Disease State

- Recurrence
- Progression/Regression
- [Response to Therapy]

## Forecast Disease State

- Future Likelihood of Disease
- Prognosis
- _Depending on the test result_, the estimate of outcome for a class of patients
- “Natural” or other history
- Prediction
- _Depending on the test result_, the estimate of an intervention’s likely effect

## Setting for the Test

- Indication/Intended Use for the Test
- Intended Use Population
- Measurement Performed
- Use of the Test Result
- Stand-alone Use?
- Sensitivity/Specificity
- Adjunctive Use?
- Improved Sensitivity, Specificity or Both
- NOT “just another tool”

## Where Does the Test “Fit” in Patient Evaluation/Management?

- Schematic likely very useful – makes the intended use concrete
- Formulation of a testable hypothesis; hence, clear labeling
- No need to elucidate all possible uses of the test – _pick one_ for study and review

## Establishing a Diagnostic Claim for the Test – Study Designs

- Study set adequately representing the intended use population
- Gold standard to assess truth of test result – sensitivity and specificity
- Lesser standard to assess truth of test result – positive and negative concordance
- Defensible success criteria

## Establishing a Monitoring Claim for the Test – Study Designs

- Adequate reference for disease state (e.g. biopsy, RECIST)
- Longitudinal study
- Often multiple observations per patient
- Data analyses may be complex; please seek advice

## Establishing a Prognostic Claim for the Test – Study Designs

- Well characterized study population
- Well defined outcome variate
- If retrospective, carefully assess potential sources of bias and eliminate or mitigate/compensate for them

## Establishing a Predictive Claim for the Test – Study Designs

- Single-arm or only marker positive studies generally insufficient
- Coordination with CDER or CBER and OCP likely needed
- Marker by Treatment Interaction Design
- Marker-based Strategy Design
- See Sargent et al, J Clin Oncol 2005; 23:2020-2027

## Finding Help

- Regulatory Consultants
- OIVD Website – http://www.fda.gov/cdrh/oivd
- Device Advice
- IVD Guidances
- Many other links
- Pre-IDE Process