New Fatigue Risk Management Approaches

Federal Aviation
Administration
New Fatigue Risk
Management
Approaches for U.S.
Flightcrew
Thomas E. Nesthus, Ph.D.
Engineering Research Psychologist
Civil Aerospace Medical Institute
Oklahoma City, OK
Buenos días desde CAMI
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Overview of Flightcrew FRM
• Recently developed fatigue risk
management approaches for U.S.
flightcrew
– Rulemaking background
– 14 CFR Part 117 Flightcrew Member
Duty and Rest Requirements
– Fatigue Risk Management Plans
(FRMP)
– Optional Fatigue Risk Management
System (FRMS)
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Rulemaking Background
• FAA considered revising 14 CFR part 121
flight, duty, and rest regulations in June 1992
• Aviation Rulemaking Advisory Committee
(ARAC) could not agree on recommendations
but FAA issued an NPRM in 1995
• Industry stated FAA lacked safety data to justify
the rulemaking, arguing that rules would be too
costly
• FAA never finalized the 1995 rulemaking
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Rulemaking Background
• Following Feb 2009 Colgan Air crash FAA
chartered an aviation rulemaking committee (ARC)
June 24, 2009
• The ARC provided its report to FAA on Sep 9, 2009
• FAA released NPRM on Sep 14, 2010
• FAA received over 8,000 comments
• Final Rule published Federal Register Jan 4, 2012
• 14 CFR part 117 implemented Jan 4, 2014
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New Regulation
• Underlying philosophy is that no single
element of the rule mitigates the risk of
fatigue to an acceptable level, thus
– Both carrier and pilot are responsible for
managing fatigue
– Carrier provides “environment”;
Crewmembers wisely utilize
“environment” for sleep & recovery
• Both parties must meet their respective
responsibilities in order to adequately
manage fatigue
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Federal Register / Vol. 77, No. 2 / Wednesday, January 4,
2012 / Rules and Regulations
III. Discussion of Public
Comments and Final Rule
A. Applicability
B. Definitions
C. Fitness for Duty
D. Fatigue Education and
Training
E. Fatigue Risk
Management System
F. Flight Duty Period—
Unaugmented
G. Flight Time Limitations
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H. Flight Duty Period—
Augmented
I. Schedule Reliability
J. Extensions of Flight Duty
Periods
K. Split Duty
L. Consecutive Nights
M. Reserve
N. Cumulative Limits
O. Rest
P. Deadhead Transportation
Q. Emergency & Government
Sponsored Operations
R. Miscellaneous Issues
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14 CFR Part 117 Overview
 Applicability
 Definitions
 Limitations
 Extensions
 Consecutive Nighttime Operations
 Mitigations
 Coffee Break
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Applicability
 All part 121 certificate holders conducting passengercarrying operations
All Cargo Operations
 Continue to operate all-cargo operations under part
121
 May opt to apply ALL of its all-cargo operations under
the limits of part 117
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Opting Into Part 117
 The carrier may NOT segregate those operations
between part 117 and 121
 Flight time and duty limits must be outlined in the
carrier’s FRMP
 Rest scheme must be consistent with the
applicable limits and must be outlined in the
carrier’s FRMP
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Definitions §117.3











Acclimation
Augmented flightcrew member
Deadhead transportation
Duty
Fit for Duty
Flight duty period
Physiological night’s rest
Rest facility (on-board Class 1, 2 or 3)
Rest period
Suitable accommodation (ground-based)
Theater (60 degrees longitude vs. time zone)
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Fitness for Duty §117.5
 Joint responsibility between the certificate holder and the
flightcrew member
 Must be fit to perform assigned duties
 Certificate holder may not assign and the flightcrew
member may not except an assignment if the flight
flightcrew member has reported to be too fatigued to
safely perform their assigned duties
 Once notified, the certificate holder may not allow the
flightcrew member to continue an assigned FDP
 Must attest fitness for duty prior to conducting each
segment
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FRMS §117.7
 Based on scientific principles
 A data-driven approach to fatigue mitigation
 An alternative method of compliance
 Targeted to a specific limitation(s)
 Must demonstrate an equivalent level of safety
against fatigue-related accidents and incidents,
as provided in the provisions of part 117
 Continuous data reporting requirements
 Must demonstrate continuous improvement
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Fatigue Education and Awareness Training
(FEAT) Program (§117.9)
 Must be FAA-approved
 Adopted the training standards required in Public Law
111-216, sec. 212(b)
 Required training for all covered employees
 Training frequency not to exceed 12 calendar months
 No grace month provided
 No AQP
 FEAT must be updated every 24 calendar months
 Update must be provided no later than 12 calendar
months after the date of the previous FEAT submission
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FEAT – Covered Employees
 All employees responsible for administering the
provisions of part 117
 Flightcrew members
 Dispatchers
 Individuals directly involved with scheduling
flightcrew members
 Individuals directly involved with operational
control
 Any employee providing direct management
oversight of those areas
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Flight Time Limits
May not accept or continue an assigned FDP if
the total flight time during that FDP will exceed
any of the following:
 Limits prescribed in Table A of part 117
(Unaugmented flightcrew)
 13 hours for a 3-pilot augmented crew
 17 hours for a 4-pilot augmented crew
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Table A of Part 117
TABLE A TO PART 117 – MAXIMUM
FLIGHT TIME LIMITS FOR
UNAUGMENTED OPERATIONS
Time of report
(acclimated)
Maximum flight time
(hours)
0000-0459
0500-1959
2000-2359
8
9
8
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Flight Time Extensions §117.11
 Post takeoff only
 Unforeseen operational circumstance must have
occurred
 May exceed the flight time limits of § 117.11(a)
and the cumulative flight time limits of § 117.23(b)
to the extent necessary to safely land at the next
destination or alternate airport
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Flight Time Extensions
 The certificate holder must report within 10 days
any flight time that exceeded the maximum flight
time limits permitted by §117.11(a) or cumulative
limits prescribed in §117.23(b).
 The report must contain a description of the
extended flight time limitation and the
circumstances surrounding the need for the
extension.
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FDP Limits – Unaugmented §117.13
 May not exceed the limits permitted in Table B of part 117
 Limits are based on the scheduled FDP time of start (local
time in the theater last acclimated) and the actual number
of segments flown
 Must reduce the applicable limit in Table B of part 117 by
30 minutes if the flightcrew member is not acclimated
 For the purposes of determining Table B FDP limits, a
diversion does not count as a segment.
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Table B of Part 117
TABLE B TO PART 117 – FLIGHT DUTY PERIOD:
Unaugmented Operations
Scheduled time
Maximum flight duty period (hours) for
of start
lineholders based on number of flight segments
(acclimated
1
2
3
4
5
6
7+
time)
0000-0359
9
9
9
9
9
9
9
0400-0459
10
10
10
10
9
9
9
0500-0559
12
12
12
12
11.5
11
10.5
0600-0659
13
13
12
12
11.5
11
10.5
0700-1159
14
14
13
13
12.5
12
11.5
1200-1259
13
13
13
13
12.5
12
11.5
1300-1659
12
12
12
12
11.5
11
10.5
1700-2159
12
12
11
11
10
9
9
2200-2259
11
11
10
10
9
9
9
2300-2359
10
10
10
9
9
9
9
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Split Duty §117.15
 Is a fatigue mitigation
 May only be applied to unaugmented operations
 Split duty rest must occur in a suitable accommodation
 Rest must be provided between 2200-0500 LOCAL
 Time in the suitable accommodation must be at least 3
hours beginning when the flightcrew member reaches the
suitable accommodation
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Split Duty
 Split duty rest must be scheduled prior to the flightcrew
member beginning the FDP in which the split duty rest will
be taken
 The actual rest opportunity taken may not be less than the
scheduled rest opportunity
 The flightcrew member must complete the first segment of
the FDP prior to taking the rest period
 The combined FDP time and the split duty rest may not
exceed 14 hours
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FDP Limits – Augmented §117.17
 May not exceed the maximum applicable limits
prescribed in Table C of part 117
 FDP limit is based on local time in the theater last
acclimated
 Must reduce the maximum applicable limit in
Table C by 30 minutes if not acclimated
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FDP Limits - Augmented
 Pilot making the last landing of the FDP must
have available a 2 consecutive hour in-flight rest
opportunity in the second half of the FDP
 Pilot monitoring the last landing of the FDP must
have 90 consecutive minutes available for in-flight
rest during that FDP
 FDP is limited to a maximum of 3 segments
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Table C of Part 117
TABLE C TO PART 117 – FLIGHT DUTY PERIOD:
Augmented Operations
Scheduled Maximum flight duty period (hours) based on rest
time of
facility and number of pilots
start
Class 1 rest
Class 2 rest
Class 3 rest
(acclimate
facility
facility
facility
d time) 3 pilots 4 pilots 3 pilots 4 pilots 3 pilots 4 pilots
0000-0559
0600-0659
0700-1259
1300-1659
1700-2359
15
16
17
16
15
17
18.5
19
18.5
17
14
15
16.5
15
14
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15.5
16.5
18
16.5
15.5
13
14
15
14
13
13.5
14.5
15.5
14.5
13.5
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FDP Extensions §117.19
 Pre-takeoff or a post takeoff condition
 Applies to unaugmented and augmented operations
 If an unforeseen operational circumstance occurs




Pre-takeoff circumstances
PIC and certificate holder may extend an FDP up to 2
hours above the maximum applicable FDP limit
PIC concurrence
30 minutes or less, and 31 minutes or greater
Cannot extend the FDP if it exceeds the FDP cumulative
limits
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FDP Extension
 30-hour rest requirement prior to accepting another
extension (§117.25(b))
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Reporting requirements
FDP extension of greater than 30 minutes
Report within 10 days of the extension
A description of the extension and circumstances
If within the control of the certificate holder, develop
corrective actions to minimize such occurrences
Implement corrective actions within 30 days of the
extension
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FDP Extensions




Post-Takeoff Conditions
PIC and certificate holder may extend the FDP limit to the
extent necessary to safely land the airplane at the next
destination or alternate airport
30-hour rest requirement prior to accepting another
extension (§117.25(b))
May exceed the cumulative FDP limits
Report within 10 days any FDP that exceeded the
cumulative FDP limits, or exceeded the maximum FDP
limits permitted by Tables B or C by more than 30
minutes. The report must contain a description of the
circumstances surrounding the affected FDP
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Consecutive Nighttime Operations §117.27
 Two or more consecutive FDPs that infringe on
the flightcrew members WOCL
 Limit with no mitigation: 3 consecutive nighttime
FDPs
 Limit with mitigation: 5 consecutive nighttime
FDPs.
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Mitigations
 Rest opportunity of at least 2 hours for each of the 4 or 5
nights
 Rest opportunity must occur between 2200-0500 LOCAL
 The rest opportunity provided must be scheduled prior to
beginning the FDP
 The length of the rest opportunity actually provided must
equal or exceed the scheduled rest opportunity
 The rest opportunity is not provided until the first segment
of the FDP is completed
 Any split duty rest that is provided in accordance with
§117.15 counts as part of a FDP
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QUESTIONS/COMMENTS?
Coffee Break?
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14 CFR Part 117 Overview (cont.)
 Cumulative Limitations
 Rest
 Part 117 for flight attendants in §121.467
 Application of FRMP and FRMS
 Appendix A-D
 Website location
 Associated Advisory Circulars
 Operations specifications
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Cumulative Limitations §117.23
 Includes all flying on behalf of any certificate
holder or part 91K program manager.
 Flight time:
100 hours in any 672 consecutive hours or
1,000 hours in any 365 consecutive calendar
day period.
 FDP hours:
60 FDP hours in any 168 consecutive hours, or
190 FDP hours in any 672 consecutive hours
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The Rest Test
How do I know if my assigned rest period was a rest
period?
 Prospectively scheduled
 The rest period is continuous
 Free from all restraint of the carrier, and free from
a present responsibility for work, should the
occasion arise
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Rest Period §117.25
 No duty or reserve assignment while on rest
 Before beginning any reserve or flight duty period
a flightcrew member must be given at least 30
consecutive hours free from all duty within the
past 168 consecutive hour period (Meets
§117.25(e) rest)
 36 consecutive hours (re-acclimation)
 Meets the 30-hour cumulative rest requirements
and the minimum rest requirements (§117.25(b))
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Rest Period
 A minimum of 56 consecutive hours rest upon return to
home base if the flightcrew member travels more than 60°
longitude during a FDP or a series of FDPs, and is away
from home base for more than 168 consecutive hours
during this travel.
 The 56 hours of rest must encompass three physiological
nights' rest based on local time
 (Minimum rest) 10 consecutive hours of rest opportunity
with an 8 consecutive hour sleep opportunity before
beginning any reserve or an FDP
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Rest Period
 If a flightcrew member determines that a rest period will
not provide eight uninterrupted hours of sleep opportunity,
the flightcrew member must notify the certificate holder.
 The flightcrew member cannot report for the assigned
FDP until they receive a rest period specified in § 17.25(e)
(measured from the release of duty)
 If a flightcrew member engaged in deadhead
transportation exceeds the applicable FDP limits in Table
B, the flightcrew member must be given a rest period
equal to the length of the deadhead transportation but not
less than the required rest in § 117.25(e) before beginning
a FDP.
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Part §121.467
 Part 117 amended §121.467 to reflect the option to apply
the part 117 limits to flight attendants
 If a certificate holder elects to apply the limits of part 117
to its flight attendants, the certificate holder must apply
ALL of the limits of part 117 to its flight attendants, except
the provisions for rest facilities
 If the certificate holder applies the limits of part 117 to its
flight attendants, it should be outlined in its FRMP
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Fatigue Risk Management Plans (FRMP)




Statutory requirement
Public Law (PL) 111-216, § 212(b)
Required by each part 121 air carrier
The FRMP describes how the air carrier will manage and
mitigate day-to-day pilot fatigue from within the applicable
regulatory structure
 Requires training every 12 calendar months
 Requires the carrier to update its FRMP at least once
every 24-calendar months
 Is an FAA-accepted document
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FRMP Objectives
• Primarily to mitigate and manage day-to-day
flightcrew member fatigue from within the
regulatory structure
• How?
– Develop and implement fatigue
management policies & procedures within
the air carrier’s operation
– Provide fatigue awareness & education to
improve alertness and reduce potential for
errors
– Continuously assess FRMP performance
& adjust with appropriate revisions
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FRMP Components
 Senior-level commitment
 FRMP polices and procedures
 Flight and duty limits
 Rest scheme consistent with limitations
 Fatigue education and awareness training
 Fatigue reporting policy
 Fatigue incident reporting
 Fatigue monitoring procedures
 FRMP evaluation process
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Generic Guidance for Fatigue Risk
Management Systems
• Must be data-driven and scientifically-based
• Must enable continuous monitoring and management
of safety risks associated with fatigue-related hazards
• Must provide a means of measuring, mitigating, and
reassessing fatigue risk
• Must include schedule assessment, data collection,
and systematic analysis
• Provides scientifically guided fatigue mitigations –
both proactive and reactive
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Fatigue Risk Management System (FRMS)
§ 117.7 describes an optional approach or an
alternate means of compliance (AMOC) to safely
conduct specific flight operations that are
currently limited under the rule
– Provides carrier with flexibilities not found in the
prescriptive regulations
– Implementation process will identify and reduce the
risk of fatigue relevant to specific operational
circumstances
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Fatigue Risk Management System (FRMS)
 Proposed FRMS AMOC must demonstrate an equivalent
level of safety (ELOS)
 Demonstrated by data analysis and must be validated by
FAA
Must Include:
 An FRMS management policy, training, fatigue reporting,
flight crew fatigue monitoring, incident reporting, and
performance evaluation
 Approved by the Administrator
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FRMS
§ 117.7 states:
(a) No certificate holder may exceed any provision of this part
unless approved by the FAA under a Fatigue Risk Management
System that provides at least an equivalent level of safety
against fatigue-related accidents or incidents as the other
provisions of this part
(b) The Fatigue Risk Management System must include:
(1) A fatigue risk management policy
(2) An education and awareness training program
(3) A fatigue reporting system
(4) A system for monitoring flightcrew fatigue
(5) An incident reporting process
(6) A performance evaluation
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FRMS Objectives
 An optional approach to fatigue mitigation
 FRMS is a data-driven system based upon scientific
principles
 An alternative method of compliance to the prescriptive
rule
 Targeted to specific limitation(s)
 FRMS must demonstrate at least an equivalent level of
safety against fatigue-related accidents or incidents
 Requires data collection and monitoring for continuous
improvement
 AC 120-103A Fatigue Risk Management Systems for
Aviation Safety
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Guidance for FRMS Authorization
Process
FAA AC 120-103A: FRMS for Aviation Safety
(1) Describes the basic concepts of Fatigue Risk Management Systems
(2) Provides detailed guidance on critical FRMS components
(3) Defines an operations-specific process for a certificate holder’s
particular flight operation need
a. What limitations of the regulation do they need relief from, e.g.,
extension of flight duty periods for ULR city-pair
(4) Provides details of the FRMS approval process, including the
required documentation, safety assurance processes, data collection
and analysis, evaluation and validation, OpSpec authorization, and
continuous monitoring and reporting
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Overview of FRMS Authorization Process
1. Pre-application, Planning, & Assessment
Assessment, Planning,
and Preparation
•Gates 1-4
Detailed FRM Process and
2. Formal Application
Procedure Development
•Gates 5 & 6
a. Data Collection Prep
3. Documentation & Data Collection Plan
•Gate 7
4. Demonstration & Validation
b. Petition for exemption
c. Data Collection
Data Analysis & Validation
•Gate 8
5. Authorization, Implementation & Monitoring
OpSpec Authorization
•Gate 9
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1. Preapplication, Planning, & Assessment
Objective: prepare to fully develop proposed FRMS and data
collection encompasses Gates 1-4
(1) Needs analysis defines specific flight ops requiring AMOC as
well as mitigations, procedures, policies, documentation,
resources, & communications
(2) Implementation plan including fatigue & incident reporting,
monitoring, & training
(3) Development of plans for data collection & analysis, and data
collection flight operations
(4) Development of flightcrew member operational procedures,
inflight rest, pre- & post-FDP rest, and a reactive hazard
identification and risk assessment
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2. Formal Application
Primary focus for the FAA will be to determine that the data
collection operation can be safely conducted
Secondly, the FAA will evaluate the effectiveness of the data
collection plan and the data analysis plan
Gates 5 & 6
(5) Formal documentation of all elements developed during
phase 1
(6) Review, evaluate, and validate:
– safety performance indicators
– predicted effectiveness of AMOC
– periodic evaluation
– feedback
– process documentation of training, communications, and
monitoring
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Overview of FRMS Authorization
Process
1. Preapplication, Planning, & Assessment
Assessment, Planning,
and Preparation
•Gates 1-4
Detailed FRM Process and
2. Formal Application
Procedure Development
•Gates 5 & 6
a. Data Collection Prep
3. Documentation & Data Collection Plan
•Gate 7
4. Demonstration & Validation
b. Petition for exemption
c. Data Collection
Data Analysis & Validation
•Gate 8
5. Authorization, Implementation & Monitoring
OpSpec Authorization
•Gate 9
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3. Documentation & Data Collection Plan
The FAA will evaluate FRMS plan and all documentation
supporting flight ops during data collection.
Gate 7
(7) Concerns all aspects of flight operations data collection,
including: modeling fatigue predictions/mitigations,
demonstration of an effective AMOC, another review of safety
performance indicators & data analysis methodology.
Lastly, determination of applicable exemptions with specific
limitations and conditions for data collection flights.
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Overview of FRMS Authorization
Process
1. Preapplication, Planning, & Assessment
Assessment, Planning,
and Preparation
•Gates 1-4
Detailed FRM Process and
2. Formal Application
Procedure Development
•Gates 5 & 6
a. Data Collection Prep
3. Documentation & Data Collection Plan
•Gate 7
4. Demonstration & Validation
b. Petition for exemption
c. Data Collection
Data Analysis & Validation
•Gate 8
5. Authorization, Implementation & Monitoring
OpSpec Authorization
•Gate 9
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4. Demonstration & Validation
Certificate holder will collect & analyze all data associated with
the FRMS proposal and submit an analysis package to FAA for
review/validation
Gate 8
(8) Certificate holder provides “…a complete review and
analysis of results…with specific emphasis on how the
data confirm that the alternative operation outside the
prescriptive rules provides an effective AMOC with safety
standards” to the FAA
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AMOC and Statistical Procedures
• Traditional ANOVA or t-tests look primarily at variability and
group differences
– However, we cannot conclude equivalence from a difference
test…Why?
• Because non-significance can be the result of a number of
things including small samples with inadequate power to
show differences
• Altman & Bland (1996) stated: “Absence of evidence is not
evidence of absence”
– This simply means that the data are inadequate to determine if
there is a difference
– A difference might still be found with a larger sample size
Altman, DG and Bland, JM. Absence of evidence is not
evidence of absence. BMJ 1995, Aug 19, 311(7003):485
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Statistical Procedures (cont.)
• But, there are methods to test group equivalency, and
should be implemented whenever this is the true goal of
the research question
– Since it is not possible to prove that two treatments are
identical, such as with generic vs original drug
formulations*, the aim is to show that they do not differ by
more than a specified and immaterial amount
• By using this analysis approach, you must determine
what a meaningful/practical difference is, even before
you start
*FDA (1992), “Bioavailability and Bioequivalence Requirements,” in U. S. Code of Federal
Regulations (vol. 21, chap. 320),Washington, DC: U. S. Government Printing Office
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Regular t-test vs. Two OneSided Tests (TOST) Approach
Wellek, S. (2010). Testing Statistical Hypotheses of
Equivalence and Noninferiority.
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Confidence Intervals and Practical
Differences Approach
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Overview of FRMS Authorization
Process
1. Preapplication, Planning, & Assessment
Assessment, Planning,
and Preparation
•Gates 1-4
Detailed FRM Process and
2. Formal Application
Procedure Development
•Gates 5 & 6
a. Data Collection Prep
3. Documentation & Data Collection Plan
•Gate 7
4. Demonstration & Validation
b. Petition for exemption
c. Data Collection
Data Analysis & Validation
•Gate 8
5. Authorization, Implementation & Monitoring
OpSpec Authorization
•Gate 9
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5. Authorization, Implementation &
Monitoring
Upon satisfactory completion of this process, the FAA may grant
authorization to operate in accordance with the FRMS flight
operation by issuance of OpsSpec A318
Gate 9
(9) Issues OpsSpec A318 with time restrictions and an
audit schedule along with an ongoing Safety Assurance
process to monitor the continued success of the FRMS
operation. Monitoring data will be provided to the FAA at
specified time intervals for evaluation.
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How Science Supplements the Flight
and Duty Time Rules
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How Science Supplements the Flight
and Duty Time Rules
Features of Rule
Science
Limitation
Data-driven Mitigation
Part 117 is a set
of fixed duty
limits and rest
requirements
People and
situations vary and
may combine on any
given day to reduce
performance below
the level normally
expected under the
fixed limits.
The crewmember must
certify fitness for duty prior to
each flight segment.
The PIC must accept FDP
extensions.
These two “data” driven
requirements mitigate
variability that could cause
fatigue or excessive duty
demands in actual
operations.
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How Science Supplements the Flight
and Duty Time Rules
Features of Rule
Science
Limitation
Data-driven Mitigation
Part 117 may
classify a
specific situation
as “safe” when,
in practice, it is
fatiguing
Not all fatiguing
situations can be
anticipated by a set
of static limits that
don’t model the
dynamic interaction
of factors or the
cumulative effects of
fatigue.
The FRMP process allows
for fatigue reports to identify
hazardous situations and
requires the operator to
conduct a root cause
analysis to mitigate such
unanticipated or complex
interactions that can cause
fatigue in practice, within the
regulatory limits.
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How Science Supplements the Flight
and Duty Time Rules
Features of Rule Science
Limitation
Part 117 may
classify a specific
situation as
“unsafe” when, in
fact, a set of
mitigations can be
arranged that would
make the situation
safe.
Some situations are
misclassified as
unsafe because the
rule does not
consider all
possibilities of
additional rest or
constrained duty that
would render the
situation safe.
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Data-driven Mitigation
The FRMS process allows the
carrier to demonstrate that such
situations constitute an
alternative means of
compliance by collecting data
that proves that the exception,
in combination with additional
mitigations (e.g. additional rest,
time of day limits, reduced
workload, etc.), is equivalent in
safety to operations performed
within the confines of Part 117.
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Summary
New U.S. approaches to flightcrew fatigue management
• FRMP mandated 2010 & remains within regulatory structure
• New part 117 implemented in 2014
− Integrated fatigue mitigations in the rule and FRMS is optional for
carriers to propose alternative means of compliance for certain flight
operations that exceed limitations
• Both approaches require monitoring & mitigating fatigue and
should include at least 4 practical procedures:
–
–
–
–
Fatigue-related data acquisition
Analysis
Determination/identification of fatigue risk
Application and management of fatigue mitigation strategies
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ICAO FRMS Guidance Materials
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Appendix A: Part 117 Website
 AGC-200 (FAA Office of the Chief Counsel)
 Repository for part 117 documents
 Guidance and regulatory documents
 Legal interpretations & Part 117 clarification
document
http://www.faa.gov/about/office_org/headquarters_o
ffices/agc/pol_adjudication/agc200/part117/
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Appendix B: Advisory Circulars
 117-1 Flightcrew Member Rest Facilities
 117-2 Fatigue Education and Awareness Training
Program
 117-3 Fitness for Duty
 120-100 Basics of Aviation Fatigue
 120-103A Fatigue Risk Management Systems for
Aviation Safety
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Appendix C: Operations Specifications
 A033 Flight and rest requirements (121.470,
121.480, 121.500)
 A117 Qualification of rest facilities
 A317 Acceptance of an FRMP
 A318 FRMS authorization
 A319 FEAT approval and required updates
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Appendix D: Equivalence References
Barker, Luman, McCauley, and Chu. Assessing Equivalence: An Alternative to
the Use of Difference Tests for Measuring Disparities in Vaccination Coverage.
Am J Epidemiol 2002;156:1056–1061.
Barker, Rolka, Rolka, and Brown. Equivalence Testing for Binomial Random
Variables: Which Test to Use? Am Stat 2001; 55(4): 279-87.
Bland and Altman. Comparing methods of measurement: why plotting difference
against standard method is misleading. Lancet 1995; 346:1085-87.
Farrington and Manning. Test statistics and sample size formulae for comparing
binomial trials with null hypothesis of non-zero difference or nonunity relative
risk. Stat Med 1990; 9:1447–54.
Jones B, Jarvis P, Lewis JA, et al. Trials to assess equivalence: the importance
of rigorous methods. BMJ 1996;313:36–9.
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Appendix D: Equivalence References
Richter S and Richter C. A Method for Determining Equivalence in Industrial
Applications. Quality Engineering, 14(3), 375–380 (2002).
Schuirmann, D.J. A comparison of the Two One-Sided Tests Procedure and the
Power Approach for assessing the equivalence of average bioavailability, J.
Pharmacokinetics and pharmacodynamics, 115: 1567, 1987.
Wellek, S. Testing Statistical Hypotheses of Equivalence and Noninferiority. 2nd
Ed, Chapman & Hall/CRC Press, 2010, ISBN: 978-1-4398-0818-4.
An intuitive discussion is available from Dr. Harvey Motulsky and the authors of
GraphPad Prism in an online Statistical Guide that outlines their approach to
equivalence testing:
http://www.graphpad.com/guides/prism/6/statistics/index.htm?stat_testing_for_e
quivalence_with_c.htm
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QUESTIONS/COMMENTS?
• Dale.e.roberts@faa.gov
• 202-267-5749
• Chester.piolunek@faa.gov
• 202-267-3711
• Tom.nesthus@faa.gov
• 405-954-6297
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