Airworthiness Directives; the Boeing Company Airplanes, 37684-37687 [2014-15505]
Download as PDF
37684
Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Proposed Rules
(b) Affected ADs
None.
accordance with the procedures specified in
paragraph (k) of this AD.
information on the availability of this
material at the FAA, call 425–227–1221.
(c) Applicability
This AD applies to The Boeing Company
Model 767–200, –300, –300F, and –400ER
series airplanes; certificated in any category;
as identified in Boeing Service Bulletin 767–
28–0105, Revision 1, dated February 6, 2013.
(j) Credit for Previous Actions
Issued in Renton, Washington, on June 25,
2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
(d) Subject
Air Transport Association (ATA) of
America Code 28, Fuel.
(e) Unsafe Condition
This AD was prompted by reports
indicating that a standard access door was
located where an impact-resistant access
door was required, and stencils were missing
from some impact-resistant access doors. We
are issuing this AD to prevent foreign object
penetration of the fuel tank from uncontained
engine failure or tire debris, which could
cause a fuel leak near an ignition source (e.g.,
hot brakes or engine nozzle), consequently
leading to a fuel-fed fire.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
(g) Inspections
Within 72 months after the effective date
of this AD, do the actions specified in
paragraphs (g)(1) and (g)(2) of this AD, in
accordance with the Accomplishment
Instructions of Boeing Service Bulletin 767–
28–0105, Revision 1, dated February 6, 2013.
(1) Do either a general visual inspection or
ultrasonic non-destructive test of the left- and
right-hand wing fuel tank access doors to
determine whether impact-resistant access
doors are installed in the correct locations. If
any standard access door is found, before
further flight, replace with an impactresistant access door.
(2) Do a general visual inspection of the
left- and right-hand wing fuel tank impactresistant access doors to verify stencils and
index markers are applied. If a stencil or
index marker is missing, before further flight,
apply a stencil or index marker, as
applicable.
(h) Maintenance or Inspection Program
Revision
Within 60 days after the effective date of
this AD, revise the maintenance or inspection
program, as applicable, to incorporate critical
design configuration control limitation
(CDCCL) Task 57–AWL–01, ‘‘ImpactResistant Fuel Tank Access Door,’’ of Section
9, Airworthiness Limitations (AWLs) and
Certification Maintenance Requirements
(CMRs) of Boeing 767 Maintenance Planning
Data Document D622T001–9, Revision
January 2013.
(i) No Alternative Actions, Intervals, and/or
CDCCLs
After accomplishing the revision required
by paragraph (h) of this AD, no alternative
actions (e.g., inspections), intervals, and/or
CDCCLs may be used unless the actions,
intervals, and/or CDCCLs are approved as an
alternative method of compliance (AMOC) in
VerDate Mar<15>2010
14:15 Jul 01, 2014
Jkt 232001
This paragraph provides credit for the
actions required by paragraph (g) of this AD,
if those actions were performed before the
effective date of this AD using Boeing Service
Bulletin 767–28–0105, dated January 12,
2012, which is not incorporated by reference
in this AD.
(k) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Seattle Aircraft
Certification Office (ACO), FAA, has the
authority to approve AMOCs for this AD, if
requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the ACO, send it to the
attention of the person identified in
paragraph (l)(1) of this AD. Information may
be emailed to: 9-ANM-Seattle-ACO-AMOCRequests@faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(3) An AMOC that provides an acceptable
level of safety may be used for any repair
required by this AD if it is approved by the
Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has
been authorized by the Manager, Seattle
ACO, to make those findings. For a repair
method to be approved, the repair must meet
the certification basis of the airplane, and the
approval must specifically refer to this AD.
(4) AMOCs for ADs 2008–11–01 R1,
Amendment 39–16145 (74 FR 68515,
December 28, 2009); 2010–06–10,
Amendment 39–16234 (75 FR 15322, March
29, 2010); or 2011–25–05, Amendment 39–
16881 (77 FR 2442, January 18, 2012); that
meet the conditions specified in paragraphs
(k)(4)(i) and (k)(4)(ii) of this AD are approved
as AMOCs for the corresponding provisions
of paragraph (h) of this AD.
(i) AMOCs that are approved after
November 2, 2012.
(ii) AMOCS that include incorporation of
CDCCL Task 57–AWL–01, ‘‘Impact-Resistant
Fuel Tank Access Door.’’
(l) Related Information
(1) For more information about this AD,
contact Suzanne Lucier, Aerospace Engineer,
Propulsion Branch, ANM–140S, FAA, Seattle
Aircraft Certification Office, 1601 Lind
Avenue SW., Renton, WA 98057–3356;
phone: 425–917–6438; fax: 425–917–6590;
email: suzanne.lucier@faa.gov.
(2) For service information identified in
this AD, contact Boeing Commercial
Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H–65,
Seattle, WA 98124–2207; telephone 206–
544–5000, extension 1; fax 206–766–5680;
Internet https://www.myboeingfleet.com. You
may view this referenced service information
at the FAA, Transport Airplane Directorate,
1601 Lind Avenue SW., Renton, WA. For
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
[FR Doc. 2014–15530 Filed 7–1–14; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2014–0428; Directorate
Identifier 2014–NM–067–AD]
RIN 2120–AA64
Airworthiness Directives; the Boeing
Company Airplanes
Federal Aviation
Administration (FAA), DOT.
ACTION: Notice of proposed rulemaking
(NPRM).
AGENCY:
We propose to adopt a new
airworthiness directive (AD) for certain
The Boeing Company Model 787–8
airplanes. This proposed AD was
prompted by reports of deficiencies in
the flight control module (FCM)
software. This proposed AD would
require installing certain FCM software.
We are proposing this AD to correct
deficiencies in the FCM software,
which, if not corrected, could prevent
continued safe flight and landing.
DATES: We must receive comments on
this proposed AD by August 18, 2014.
ADDRESSES: You may send comments,
using the procedures found in 14 CFR
11.43 and 11.45, by any of the following
methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 202–493–2251.
• Mail: U.S. Department of
Transportation, Docket Operations, M–
30, West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.
• Hand Delivery: Deliver to Mail
address above between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays.
For service information identified in
this proposed AD, contact Boeing
Commercial Airplanes, Attention: Data
& Services Management, P.O. Box 3707,
MC 2H–65, Seattle, WA 98124–2207;
telephone 206–544–5000, extension 1;
fax 206–766–5680; Internet https://
www.myboeingfleet.com. You may view
this referenced service information at
SUMMARY:
E:\FR\FM\02JYP1.SGM
02JYP1
Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Proposed Rules
the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the
availability of this material at the FAA,
call 425–227–1221.
Examining the AD Docket
You may examine the AD docket on
the Internet at https://
www.regulations.gov by searching for
and locating Docket No. FAA–2014–
0428; or in person at the Docket
Management Facility between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket
contains this proposed AD, the
regulatory evaluation, any comments
received, and other information. The
street address for the Docket Office
(phone: 800–647–5527) is in the
ADDRESSES section. Comments will be
available in the AD docket shortly after
receipt.
FOR FURTHER INFORMATION CONTACT:
Marie Hogestad, Aerospace Engineer,
Systems and Equipment Branch, ANM–
130S, Seattle Aircraft Certification
Office (ACO), FAA, 1601 Lind Avenue
SW., Renton, WA 98057–3356; phone:
425–917–6418; fax: 425–917–6590;
email: marie.hogestad@faa.gov.
SUPPLEMENTARY INFORMATION:
Comments Invited
We invite you to send any written
relevant data, views, or arguments about
this proposal. Send your comments to
an address listed under the ADDRESSES
section. Include ‘‘Docket No. FAA–
2014–0428; Directorate Identifier 2014–
NM–067–AD’’ at the beginning of your
comments. We specifically invite
comments on the overall regulatory,
economic, environmental, and energy
aspects of this proposed AD. We will
consider all comments received by the
closing date and may amend this
proposed AD because of those
comments.
We will post all comments we
receive, without change, to https://
www.regulations.gov, including any
personal information you provide. We
will also post a report summarizing each
substantive verbal contact we receive
about this proposed AD.
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
Discussion
We have received reports of in-service
incidents and identified an indicating
system shortcoming due to deficiencies
in the FCM software, which have been
determined to be safety issues in Model
787–8 airplanes.
We have received several reports of
FCM airborne resets that occurred
VerDate Mar<15>2010
14:15 Jul 01, 2014
Jkt 232001
during trailing edge variable camber
operation which, due to a software
deficiency, incorrectly resulted in the
flaps being shut down and the ‘‘FLAPS
DRIVE’’ (caution) message, which
directs the flightcrew to execute a flaps
up landing. The flaps up landing
procedure requires a high speed landing
and, in combination with abnormal
landing conditions such as a short
runway or adverse weather conditions,
could result in a runway excursion.
Additionally, we received a report of
a single flap position sensor failure
which, due to a software deficiency,
incorrectly resulted in flap position data
being declared invalid. Invalid flap data
causes the primary flight controls to
transition to secondary mode, the
spoiler droop commands to default to
flaps up (i.e., no-droop) position, the
autopilot to disengage, the flaps to
remain in the last commanded position,
and loss of flap position on the displays.
This failure could prevent continued
safe flight and landing if it occurs
during final approach below
approximately 100 feet due to the
combination of high workload, the flight
control mode change, and the wing lift
loss, which may result in a high
airplane sink rate landing or a ground
impact short of the runway.
We have also determined that a single
spoiler failure requires an engine
indication and crew alerting system
(EICAS) alert because a single spoiler
failure with flaps down can result in
significant levels of buffet, which,
without annunciation, the flightcrew
might interpret either as a stall, landing
gear damage, structural damage, or other
external damage.
These conditions, if not corrected,
could prevent continued safe flight and
landing.
Relevant Service Information
We reviewed Boeing Alert Service
Bulletin B787–81205–SB270020–00,
Issue 001, dated February 6, 2014. For
information on the procedures and
compliance times, see this service
information at https://
www.regulations.gov by searching for
Docket No. FAA–2014–0428.
Concurrent Service Information
For certain airplanes, Boeing Alert
Service Bulletin B787–81205–
SB270020–00, Issue 001, dated February
6, 2014, specifies concurrent
accomplishment of the FCM software
installation specified in Boeing Alert
Service Bulletin B787–81205–
SB270017–00, Issue 001, dated
September 18, 2013. For information on
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
37685
the procedures, see Boeing Alert Service
Bulletin B787–81205–SB270017–00,
Issue 001, dated September 18, 2013, at
https://www.regulations.gov by searching
for Docket No. FAA–2014–0428.
FAA’s Determination
We are proposing this AD because we
evaluated all the relevant information
and determined the unsafe condition
described previously is likely to exist or
develop in other products of the same
type design.
Proposed AD Requirements
This proposed AD would require
installing certain FCM software as
specified in the service information
described previously.
Explanation of ‘‘RC’’ Steps in Service
Information
The FAA worked in conjunction with
industry, under the Airworthiness
Directives Implementation Aviation
Rulemaking Committee, to enhance the
AD system. One enhancement was a
new process for annotating which steps
in the service information are required
for compliance with an AD.
Differentiating these steps from other
tasks in the service information is
expected to improve an owner’s/
operator’s understanding of crucial AD
requirements and help provide
consistent judgment in AD compliance.
The actions specified in the service
information described previously
include steps that are labeled as RC
(required for compliance) because these
steps have a direct effect on detecting,
preventing, resolving, or eliminating an
identified unsafe condition.
As noted in the specified service
information, steps labeled as RC must be
done to comply with the proposed AD.
However, steps that are not labeled as
RC are recommended. Those steps that
are not labeled as RC may be deviated
from, done as part of other actions, or
done using accepted methods different
from those identified in the service
information without obtaining approval
of an alternative method of compliance
(AMOC), provided the steps labeled as
RC can be done and the airplane can be
put back in a serviceable condition. Any
substitutions or changes to steps labeled
as RC will require approval of an
AMOC.
Costs of Compliance
We estimate that this proposed AD
affects 11 airplanes of U.S. registry.
We estimate the following costs to
comply with this proposed AD:
E:\FR\FM\02JYP1.SGM
02JYP1
37686
Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Proposed Rules
ESTIMATED COSTS
Action
Labor cost
Parts cost
FCM BP3 software installation
Concurrent FCM BP2 software
installation (Group 1 airplanes).
2 work-hours × $85 per hour = $170 .....................................
2 work-hours × $85 per hour = $170 .....................................
According to the manufacturer, all of
the costs of this proposed AD may be
covered under warranty, thereby
reducing the cost impact on affected
individuals. We do not control warranty
coverage for affected individuals. As a
result, we have included all costs in our
cost estimate.
The parts cost for the FCM BP3
software installation is not included in
our cost estimate. It is considered
Boeing-provided loadable software,
which is referenced in Boeing Alert
Service Bulletin B787–81205–
SB270020–00, Issue 001, dated February
6, 2014, under ‘‘Parts & Materials
Supplied by the Operator.’’
(2) Is not a ‘‘significant rule’’ under
the DOT Regulatory Policies and
Procedures (44 FR 11034, February 26,
1979),
(3) Will not affect intrastate aviation
in Alaska, and
(4) Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
Authority for This Rulemaking
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. Subtitle VII:
Aviation Programs, describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in Subtitle VII,
Part A, Subpart III, Section 44701:
‘‘General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
Regulatory Findings
We determined that this proposed AD
would not have federalism implications
under Executive Order 13132. This
proposed AD would not have a
substantial direct effect on the States, on
the relationship between the national
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify this proposed regulation:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,
VerDate Mar<15>2010
14:15 Jul 01, 2014
Jkt 232001
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
The Proposed Amendment
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):
■
The Boeing Company: Docket No. FAA–
2014–0428; Directorate Identifier 2014–NM–
067–AD.
(a) Comments Due Date
We must receive comments by August 18,
2014.
(b) Affected ADs
None.
(c) Applicability
This AD applies to The Boeing Company
Model 787–8 airplanes, certificated in any
category, as identified in Boeing Alert
Service Bulletin B787–81205–SB270020–00,
Issue 001, dated February 6, 2014.
(d) Subject
Air Transport Association (ATA) of
America Code 27, Flight Controls.
(e) Unsafe Condition
This AD was prompted by reports of
deficiencies in the flight control module
(FCM) software. We are issuing this AD to
correct deficiencies in the FCM software,
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
$0
$630
Cost per
product
Cost on U.S.
operators
$170
$800
$1,870
$8,800
which, if not corrected, could prevent
continued safe flight and landing.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Flight Control Module (FCM) Software
Installation
Within 6 months after the effective date of
this AD: Use the onboard data load function
(ODLF) to install FCM operational program
software (OPS), FCM loadable diagnostic
information (LDI) database (DB) software,
and FCM air data reference function (ADRF)
DB software, in accordance with the
Accomplishment Instructions of Boeing Alert
Service Bulletin B787–81205–SB270020–00,
Issue 001, dated February 6, 2014.
(h) Concurrent Requirements
For Group 1 airplanes, as identified in
Boeing Alert Service Bulletin B787–81205–
SB270020–00, Issue 001, dated February 6,
2014: Prior to or concurrently with
accomplishing the actions required by
paragraph (g) of this AD, use the ODLF to
install FCM OPS, FCM LDI DB, and central
maintenance computer function (CMCF) LDI
DB software, in accordance with the
Accomplishment Instructions of Boeing Alert
Service Bulletin B787–81205–SB270017–00,
Issue 001, dated September 18, 2013.
(i) Parts Installation Prohibition
After installation of the new software
specified in paragraphs (g) and (h) of this AD,
no person may install any previous versions
of the FCM OPS, FCM LDI DB, FCM ADRF
DB, or CMCF LDI DB software, on any
airplane.
(j) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Seattle Aircraft
Certification Office (ACO), FAA, has the
authority to approve AMOCs for this AD, if
requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the ACO, send it to the
attention of the person identified in
paragraph (k)(1) of this AD. Information may
be emailed to: 9–ANM-Seattle-ACO–AMOCRequests@faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(3) If the service information contains steps
that are labeled as RC (Required for
E:\FR\FM\02JYP1.SGM
02JYP1
Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Proposed Rules
Compliance), those steps must be done to
comply with this AD; any steps that are not
labeled as RC are recommended. Those steps
that are not labeled as RC may be deviated
from, done as part of other actions, or done
using accepted methods different from those
identified in the specified service
information without obtaining approval of an
AMOC, provided the steps labeled as RC can
be done and the airplane can be put back in
a serviceable condition. Any substitutions or
changes to steps labeled as RC require
approval of an AMOC.
(k) Related Information
(1) For more information about this AD,
contact Marie Hogestad, Aerospace Engineer,
Systems and Equipment Branch, ANM–130S,
Seattle Aircraft Certification Office (ACO),
FAA, 1601 Lind Avenue SW., Renton, WA
98057–3356; phone: 425–917–6418; fax: 425–
917–6590; email: marie.hogestad@faa.gov.
(2) For service information identified in
this AD, contact Boeing Commercial
Airplanes, Attention: Data & Services
Management, P. O. Box 3707, MC 2H–65,
Seattle, WA 98124–2207; telephone 206–
544–5000, extension 1; fax 206–766–5680;
Internet https://www.myboeingfleet.com. You
may view this referenced service information
at the FAA, Transport Airplane Directorate,
1601 Lind Avenue SW., Renton, WA. For
information on the availability of this
material at the FAA, call 425–227–1221.
Issued in Renton, Washington, on June 24,
2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 2014–15505 Filed 7–1–14; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 216
[Docket No. FDA–1999–N–0194 (Formerly
99N–4490)]
RIN 0910–AH10
Additions and Modifications to the List
of Drug Products That Have Been
Withdrawn or Removed From the
Market for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
HHS.
Proposed rule; withdrawal of
previous proposed rule.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
proposing to amend its regulations to
revise the list of drug products that may
not be compounded under the
exemptions provided by the Federal
Food, Drug, and Cosmetic Act (the
SUMMARY:
VerDate Mar<15>2010
14:15 Jul 01, 2014
Jkt 232001
FD&C Act) because the drug products
have been withdrawn or removed from
the market after the drug products or
components of such drug products were
found to be unsafe or not effective.
Specifically, the proposed rule would
add 25 drug products to this list of drug
products and modify the description of
one drug product on this list to add an
exception. These revisions are necessary
because new information has come to
the Agency’s attention since March 8,
1999, when FDA published the original
list as a final rule. FDA is also
withdrawing the previous proposed rule
regarding additions to this list (see the
Federal Register of January 4, 2000).
DATES: Submit either electronic or
written comments on the proposed rule
by September 2, 2014. The January 4,
2000, proposed rule (65 FR 256) is
withdrawn as of July 2, 2014.
ADDRESSES: You may submit comments,
identified by Agency name and Docket
No. FDA–1999–N–0194 and/or
Regulatory Information Number (RIN)
number 0910–AH10, by any of the
following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• Mail/Hand delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Agency name, Docket
No. FDA–1999–N–0194, and RIN 0910–
AH10 for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Edisa Gozun, Center for Drug Evaluation
PO 00000
Frm 00018
Fmt 4702
Sfmt 4702
37687
and Research (HFD–310), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5199,
Silver Spring, MD 20993–0002, 301–
796–3110.
SUPPLEMENTARY INFORMATION:
I. Background
Section 503A of the FD&C Act (21
U.S.C. 353a) describes the conditions
that must be satisfied for human drug
products compounded by a licensed
pharmacist or licensed physician to be
exempt from the following three
sections of the FD&C Act: (1) Section
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B))
(concerning current good manufacturing
practice); (2) section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning the labeling of
drugs with adequate directions for use);
and (3) section 505 (21 U.S.C. 355)
(concerning the approval of drugs under
new drug applications (NDAs) or
abbreviated new drug applications
(ANDAs)).
One of the conditions that must be
satisfied to qualify for the exemptions
under section 503A of the FD&C Act is
that the licensed pharmacist or licensed
physician does not compound a drug
product that appears on a list published
by the Secretary in the Federal Register
of drug products that have been
withdrawn or removed from the market
because such drug products or
components of such drug products have
been found to be unsafe or not effective
(see section 503A(b)(1)(C) of the FD&C
Act).
A. Court Decisions Regarding the
Pharmacy Compounding Provisions of
the FD&C Act
As originally enacted, section 503A of
the FD&C Act included prohibitions on
the advertising and solicitation of
prescriptions for any particular
compounded drug, class of drug, or type
of drug. Seven compounding
pharmacies challenged the advertising
and solicitation provisions of section
503A of the FD&C Act as an
impermissible regulation of commercial
speech. In February 2001, the U.S. Court
of Appeals for the Ninth Circuit held
that the prohibition on advertising and
promotion in section 503A(c) and the
provision of section 503A(a) of the
FD&C Act that requires that the
prescription be ‘‘unsolicited,’’ were
unconstitutional restrictions on
commercial speech. (See Western States
Med. Ctr. v. Shalala, 238 F.3d 1090 (9th
Cir. 2001).) Furthermore, the Ninth
Circuit held that the advertising and
solicitation provisions could not be
severed from the rest of section 503A
and, as a result, found section 503A of
the FD&C Act to be invalid in its
E:\FR\FM\02JYP1.SGM
02JYP1
Agencies
[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Proposed Rules]
[Pages 37684-37687]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15505]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA-2014-0428; Directorate Identifier 2014-NM-067-AD]
RIN 2120-AA64
Airworthiness Directives; the Boeing Company Airplanes
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 787-8 airplanes. This proposed AD was
prompted by reports of deficiencies in the flight control module (FCM)
software. This proposed AD would require installing certain FCM
software. We are proposing this AD to correct deficiencies in the FCM
software, which, if not corrected, could prevent continued safe flight
and landing.
DATES: We must receive comments on this proposed AD by August 18, 2014.
ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
Fax: 202-493-2251.
Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com. You may view this referenced service information
at
[[Page 37685]]
the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call 425-227-1221.
Examining the AD Docket
You may examine the AD docket on the Internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0428; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.
FOR FURTHER INFORMATION CONTACT: Marie Hogestad, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, Seattle Aircraft Certification
Office (ACO), FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone:
425-917-6418; fax: 425-917-6590; email: marie.hogestad@faa.gov.
SUPPLEMENTARY INFORMATION:
Comments Invited
We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2014-0428;
Directorate Identifier 2014-NM-067-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
We will post all comments we receive, without change, to https://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.
Discussion
We have received reports of in-service incidents and identified an
indicating system shortcoming due to deficiencies in the FCM software,
which have been determined to be safety issues in Model 787-8
airplanes.
We have received several reports of FCM airborne resets that
occurred during trailing edge variable camber operation which, due to a
software deficiency, incorrectly resulted in the flaps being shut down
and the ``FLAPS DRIVE'' (caution) message, which directs the flightcrew
to execute a flaps up landing. The flaps up landing procedure requires
a high speed landing and, in combination with abnormal landing
conditions such as a short runway or adverse weather conditions, could
result in a runway excursion.
Additionally, we received a report of a single flap position sensor
failure which, due to a software deficiency, incorrectly resulted in
flap position data being declared invalid. Invalid flap data causes the
primary flight controls to transition to secondary mode, the spoiler
droop commands to default to flaps up (i.e., no-droop) position, the
autopilot to disengage, the flaps to remain in the last commanded
position, and loss of flap position on the displays. This failure could
prevent continued safe flight and landing if it occurs during final
approach below approximately 100 feet due to the combination of high
workload, the flight control mode change, and the wing lift loss, which
may result in a high airplane sink rate landing or a ground impact
short of the runway.
We have also determined that a single spoiler failure requires an
engine indication and crew alerting system (EICAS) alert because a
single spoiler failure with flaps down can result in significant levels
of buffet, which, without annunciation, the flightcrew might interpret
either as a stall, landing gear damage, structural damage, or other
external damage.
These conditions, if not corrected, could prevent continued safe
flight and landing.
Relevant Service Information
We reviewed Boeing Alert Service Bulletin B787-81205-SB270020-00,
Issue 001, dated February 6, 2014. For information on the procedures
and compliance times, see this service information at https://www.regulations.gov by searching for Docket No. FAA-2014-0428.
Concurrent Service Information
For certain airplanes, Boeing Alert Service Bulletin B787-81205-
SB270020-00, Issue 001, dated February 6, 2014, specifies concurrent
accomplishment of the FCM software installation specified in Boeing
Alert Service Bulletin B787-81205-SB270017-00, Issue 001, dated
September 18, 2013. For information on the procedures, see Boeing Alert
Service Bulletin B787-81205-SB270017-00, Issue 001, dated September 18,
2013, at https://www.regulations.gov by searching for Docket No. FAA-
2014-0428.
FAA's Determination
We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.
Proposed AD Requirements
This proposed AD would require installing certain FCM software as
specified in the service information described previously.
Explanation of ``RC'' Steps in Service Information
The FAA worked in conjunction with industry, under the
Airworthiness Directives Implementation Aviation Rulemaking Committee,
to enhance the AD system. One enhancement was a new process for
annotating which steps in the service information are required for
compliance with an AD. Differentiating these steps from other tasks in
the service information is expected to improve an owner's/operator's
understanding of crucial AD requirements and help provide consistent
judgment in AD compliance. The actions specified in the service
information described previously include steps that are labeled as RC
(required for compliance) because these steps have a direct effect on
detecting, preventing, resolving, or eliminating an identified unsafe
condition.
As noted in the specified service information, steps labeled as RC
must be done to comply with the proposed AD. However, steps that are
not labeled as RC are recommended. Those steps that are not labeled as
RC may be deviated from, done as part of other actions, or done using
accepted methods different from those identified in the service
information without obtaining approval of an alternative method of
compliance (AMOC), provided the steps labeled as RC can be done and the
airplane can be put back in a serviceable condition. Any substitutions
or changes to steps labeled as RC will require approval of an AMOC.
Costs of Compliance
We estimate that this proposed AD affects 11 airplanes of U.S.
registry.
We estimate the following costs to comply with this proposed AD:
[[Page 37686]]
Estimated Costs
----------------------------------------------------------------------------------------------------------------
Cost per Cost on U.S.
Action Labor cost Parts cost product operators
----------------------------------------------------------------------------------------------------------------
FCM BP3 software installation...... 2 work-hours x $85 per hour $0 $170 $1,870
= $170.
Concurrent FCM BP2 software 2 work-hours x $85 per hour $630 $800 $8,800
installation (Group 1 airplanes). = $170.
----------------------------------------------------------------------------------------------------------------
According to the manufacturer, all of the costs of this proposed AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.
The parts cost for the FCM BP3 software installation is not
included in our cost estimate. It is considered Boeing-provided
loadable software, which is referenced in Boeing Alert Service Bulletin
B787-81205-SB270020-00, Issue 001, dated February 6, 2014, under
``Parts & Materials Supplied by the Operator.''
Authority for This Rulemaking
Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
Regulatory Findings
We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed
regulation:
(1) Is not a ``significant regulatory action'' under Executive
Order 12866,
(2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
The Proposed Amendment
Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
PART 39--AIRWORTHINESS DIRECTIVES
0
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
0
2. The FAA amends Sec. 39.13 by adding the following new airworthiness
directive (AD):
The Boeing Company: Docket No. FAA-2014-0428; Directorate
Identifier 2014-NM-067-AD.
(a) Comments Due Date
We must receive comments by August 18, 2014.
(b) Affected ADs
None.
(c) Applicability
This AD applies to The Boeing Company Model 787-8 airplanes,
certificated in any category, as identified in Boeing Alert Service
Bulletin B787-81205-SB270020-00, Issue 001, dated February 6, 2014.
(d) Subject
Air Transport Association (ATA) of America Code 27, Flight
Controls.
(e) Unsafe Condition
This AD was prompted by reports of deficiencies in the flight
control module (FCM) software. We are issuing this AD to correct
deficiencies in the FCM software, which, if not corrected, could
prevent continued safe flight and landing.
(f) Compliance
Comply with this AD within the compliance times specified,
unless already done.
(g) Flight Control Module (FCM) Software Installation
Within 6 months after the effective date of this AD: Use the
onboard data load function (ODLF) to install FCM operational program
software (OPS), FCM loadable diagnostic information (LDI) database
(DB) software, and FCM air data reference function (ADRF) DB
software, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin B787-81205-SB270020-00, Issue 001,
dated February 6, 2014.
(h) Concurrent Requirements
For Group 1 airplanes, as identified in Boeing Alert Service
Bulletin B787-81205-SB270020-00, Issue 001, dated February 6, 2014:
Prior to or concurrently with accomplishing the actions required by
paragraph (g) of this AD, use the ODLF to install FCM OPS, FCM LDI
DB, and central maintenance computer function (CMCF) LDI DB
software, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin B787-81205-SB270017-00, Issue 001,
dated September 18, 2013.
(i) Parts Installation Prohibition
After installation of the new software specified in paragraphs
(g) and (h) of this AD, no person may install any previous versions
of the FCM OPS, FCM LDI DB, FCM ADRF DB, or CMCF LDI DB software, on
any airplane.
(j) Alternative Methods of Compliance (AMOCs)
(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k)(1) of this AD.
Information may be emailed to: 9-ANM-Seattle-ACO-AMOC-Requests@faa.gov.
(2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
(3) If the service information contains steps that are labeled
as RC (Required for
[[Page 37687]]
Compliance), those steps must be done to comply with this AD; any
steps that are not labeled as RC are recommended. Those steps that
are not labeled as RC may be deviated from, done as part of other
actions, or done using accepted methods different from those
identified in the specified service information without obtaining
approval of an AMOC, provided the steps labeled as RC can be done
and the airplane can be put back in a serviceable condition. Any
substitutions or changes to steps labeled as RC require approval of
an AMOC.
(k) Related Information
(1) For more information about this AD, contact Marie Hogestad,
Aerospace Engineer, Systems and Equipment Branch, ANM-130S, Seattle
Aircraft Certification Office (ACO), FAA, 1601 Lind Avenue SW.,
Renton, WA 98057-3356; phone: 425-917-6418; fax: 425-917-6590;
email: marie.hogestad@faa.gov.
(2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call 425-227-1221.
Issued in Renton, Washington, on June 24, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-15505 Filed 7-1-14; 8:45 am]
BILLING CODE 4910-13-P