[Federal Register Volume 80, Number 229 (Monday, November 30, 2015)]
[Proposed Rules]
[Pages 74720-74722]
[FR Doc No: 2015-30224]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-6542; Directorate Identifier 2015-NM-038-AD]
RIN 2120-AA64

Airworthiness Directives; Embraer S.A. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Embraer S.A. Model ERJ 170 airplanes; and all Embraer S.A. Model ERJ
190-100 STD, -100 LR, -100 IGW, -200 STD, -200 LR, and -200 IGW
airplanes. This proposed AD was prompted by reports of cracks in
certain engine low-stage bleed check valves. This proposed AD would
require replacing the air management system (AMS) controller operation
program of the AMS controller processor boards, and replacement of the
current low-stage bleed check valve and associated seals. We are
proposing this AD to prevent failure of the low-stage bleed check
valve, which could result in dual engine in-flight shutdown.

DATES: We must receive comments on this proposed AD by January 14,
2016.

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 http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Embraer S.A., Technical Publications Section (PC 060), Av. Brigadeiro
Faria Lima, 2170-Putim-12227-901 S[atilde]o Jose dos Campos-SP-BRASIL;
telephone +55 12 3927-5852 or +55 12 3309-0732; fax +55 12 3927-7546;
email<EMAIL_ADDRESS>Internet http://www.flyembraer.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<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
6542; 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
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Ana Martinez Hueto, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-6542;
Directorate Identifier 2015-NM-038-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 based on those comments.
    We will post all comments we receive, without change, to http://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

    The Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC),
which is the aviation authority for Brazil, has issued Brazilian
Airworthiness Directive 2015-02-02, dated March 6, 2015 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for Embraer S.A. Model
ERJ 190-100 STD, -100 LR, -100 IGW, -200 STD, -200 LR, and -200 IGW
airplanes. The MCAI states:

    This [Brazilian] AD was prompted by reports of cracks in some
engine low-stage bleed check valves having part number (P[/]N)
1001447-6. Further analysis has determined that if a new (zero hour)
low-stage bleed check valve P/N 1001447-6 is installed in an
airplane already equipped with the Air Management System (AMS)
controller processor boards containing the AMS Controller
Operational Program version Black Label 13, or a later version,
premature cracking on the petals of the low-stage bleed check valve
is not expected to occur. We are issuing this [Brazilian] AD to
prevent the possibility of a dual engine in-flight shutdown due to
low-stage bleed check valve failure.

    The required action is replacement of the AMS controller operation
program of the AMS controller processor boards, and replacement of the
low-stage bleed check valves and associated seals. You may examine the
MCAI in the AD docket on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-6542.

Related Service Information Under 1 CFR Part 51

    Embraer has issued Service Bulletin 190-36-0023, Revision 03, dated
September 24, 2014, which describes procedures for replacing the engine
low-stage bleed check valves. Embraer has also issued Service Bulletin
190-21-0041, Revision 02, dated July 30, 2013, which describe
procedures for replacing the AMS controller operation program of the
AMS controller processor boards. This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section of this NPRM.

Differences Between the MCAI and This Proposed AD

    The applicability of paragraph (g) of this proposed AD is limited
to airplanes identified in Embraer Service Bulletin 190-21-0041,
Revision 02, dated July 30, 2013. The MCAI did not include this
limitation. We have included this limitation because Model ERJ 190
airplanes with serial number (S/N) 19000587, S/N 19000589, S/N 19000593
and subsequent have a modification incorporated at the factory
equivalent to the modification required by this AD.
    Also, this proposed AD includes all Embraer S.A. Model ERJ 170-100
LR, -100 STD, -100 SE, and -100 SU airplanes; and Model ERJ 170-200 LR,
-200 SU, and -200 STD airplanes, because of an additional proposed
requirement in paragraph (j)(1) of this AD, which is related to
installation of used low-stage bleed check valves having P/N 001447-6
on Model ERJ 170 airplanes. ANAC is considering future rulemaking to
include a similar requirement.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    We estimate that this proposed AD affects 197 airplanes of U.S.
registry.
    We also estimate that it would take about 4 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost about $638
per product. Based on these figures, we estimate the cost of this
proposed AD on U.S. operators to be $192,666, or $978 per product.

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):

Embraer S.A.: Docket No. FAA-2015-6542; Directorate Identifier 2015-
NM-038-AD.

(a) Comments Due Date

    We must receive comments by January 14, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1)
and (c)(2) of this AD, certificated in any category.
    (1) All Embraer S.A. Model ERJ 170-100 LR, -100 STD, -100 SE,
and -100 SU airplanes; and Model ERJ 170-200 LR, -200 SU, and -200
STD airplanes.
    (2) All Embraer S.A. Model ERJ 190-100 STD, -100 LR, -100 IGW, -
200 STD, -200 LR, and -200 IGW airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 36, Pneumatic.

(e) Reason

    This AD was prompted by reports of cracks in certain engine low-
stage bleed check valves. We are issuing this AD to prevent failure
of the low-stage bleed check valve, which could result in dual
engine in-flight shutdown.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Modification

    For Embraer S.A. Model ERJ 190 airplanes identified in Embraer
Service Bulletin 190-21-0041, Revision 02, dated July 30, 2013,
within 3 months after the effective date of this AD, replace the
Hamilton Sundstrand air management system (AMS) controller operation
program of the AMS controller processor boards, as specified in
paragraph (g)(1) or (g)(2) of this AD.
    (1) Replace with a new, improved program, in accordance with the
Accomplishment Instructions of Embraer Service Bulletin 190-21-0041,
Revision 02, dated July 30, 2013.
    (2) Replace with a version of the Hamilton Sundstrand AMS
controller operation program approved after August 31, 2012, using a
method approved by the Manager, International Branch, ANM-116,
Transport Airplane Directorate, FAA; Ag[ecirc]ncia Nacional de
Avia[ccedil][atilde]o Civil (ANAC); or ANAC's authorized Designee.

(h) Valve Replacement

    For Embraer S.A. Model ERJ 190 airplanes identified in Embraer
Service Bulletin 190-21-0041, Revision 02, dated July 30, 2013,
within 3 months after the effective date of this AD, and after
accomplishment of the actions required by paragraph (g) of this AD:
Replace the check valve and associated seals of the left-hand and
right-hand engine bleed system with a check valve identified in
paragraph (i) of this AD, and new seals, in accordance with the
Accomplishment Instructions of Embraer Service Bulletin 190-36-0023,
Revision 03, dated September 24, 2014.

(i) Allowed Valves

    When complying with paragraph (h) of this AD, the low-stage
bleed check valves having P/N 1001447-6, and associated seals, are
replaced with new ones (zero-hour). Low-stage bleed check valves
having P/N 1001447-6 that can be demonstrated with logged hours only
on ERJ-170 aircraft and/or on ERJ-190 aircraft equipped with the AMS
Controller Operational Program version Black Label 13, or a later
version, can be used instead of new ones (zero-hour).

(j) Parts Installation Limitation

    (1) For Model ERJ 170-100 STD, -100 LR, -100SU, -100SE, -200
STD, -200 LR, and -200 SU airplanes: No person may install on any
airplane a low-stage bleed check valve having P/N 1001447-6 that was
installed on any Model ERJ 190-100 STD, -100 LR, -100 IGW, -200 STD,
-200 LR, or -200 IGW airplane, any serial number except 190-00587,
190-00589, and 190-00593 and subsequent, prior to accomplishment of
paragraph (g) of this AD.
    (2) For Model ERJ 190-100 STD, -100 LR, -100IGW, -200 STD, -200
LR, and -200 IGW airplanes: No person may install on any airplane on
which the actions of paragraph (g) of this AD have been done, a low-
stage bleed check valve having P/N 1001447-6 that was previously
installed on any Model ERJ 190-100 STD, -100 LR, -100 IGW, -200 STD,
-200 LR, or -200 IGW airplane, any serial number except 190-00587,
190-00589, 190-00593 and subsequent, prior to accomplishment of
paragraph (g) of this AD.

(k) Credit for Previous Actions

    (1) This paragraph provides credit for actions required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using the service information identified
in paragraph (k)(1)(i) or (k)(1)(ii) of this AD. This service
information is not incorporated by reference in this AD.
    (i) Embraer Service Bulletin 190-21-0041, dated September 27,
2012.
    (ii) Embraer Service Bulletin 190-21-0041, Revision 01, dated
December 20, 2012.
    (2) This paragraph provides credit for actions required by
paragraph (h) of this AD, if those actions were performed before the
effective date of this AD using the service information identified
in paragraph (k)(2)(i), (k)(2)(ii), or (k)(2)(iii) of this AD. This
service information is not incorporated by reference in this AD.
    (i) Embraer Service Bulletin 190-36-0023, dated July 22, 2013.
    (ii) Embraer Service Bulletin 190-36-0023, Revision 01, dated
September 3, 2013.
    (iii) Embraer Service Bulletin 190-36-0023, Revision 02, dated
April 30, 2014.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Ana Martinez
Hueto, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or ANAC; or
ANAC's authorized Designee. If approved by the ANAC Designee, the
approval must include the Designee's authorized signature.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Brazilian Airworthiness Directive 2015-02-02, dated March 6,
2015, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2015-6542.
    (2) For service information identified in this AD, contact
Embraer S.A., Technical Publications Section (PC 060), Av.
Brigadeiro Faria Lima, 2170 - Putim - 12227-901 S[atilde]o Jose dos
Campos - SP - BRASIL; telephone +55 12 3927-5852 or +55 12 3309-
0732; fax +55 12 3927-7546; email<EMAIL_ADDRESS>Internet
http://www.flyembraer.com. You may view this 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<PHONE_NUMBER>.

    Issued in Renton, Washington, on November 20, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-30224 Filed 11-27-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: July 17, 2008 (Volume 73, Number 138)]
[Notices]
[Page 41089-41090]
[DOCID:fr17jy08-85]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1995-N-0054] (formerly Docket No. 1995N-0304)

Small Entity Compliance Guide: Final Rule Declaring Dietary
Supplements Containing Ephedrine Alkaloids Adulterated Because They
Present an Unreasonable Risk; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing
theavailability of a small entity compliance guide (SECG) for a final
rule published in the Federal Register of February 11, 2004 (69 FR
6788), entitled ``Final Rule Declaring Dietary Supplements Containing
Ephedrine Alkaloids Adulterated Because They Present an Unreasonable
Risk.'' This SECG is intended to set forth in plain language the
requirements of the regulation and to help small businesses understand
the regulation.

DATES: Submit written or electronic comments on the SECG at any time.

ADDRESSES: Submit written comments on the SECG to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
on the SECG to http://www.regulations.gov. Submit written requests for
single copies of the SECG to the Division of Dietary Supplement
Programs, Office of Nutrition, Labeling, and Dietary Supplements (HFS-
810), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or fax
your request to<PHONE_NUMBER>. Send one self-addressed adhesive label to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Center for Food
Safety and Applied Nutrition (HFS-810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 11, 2004, FDA issued a final
rule declaring dietary supplements containing ephedrine alkaloids
adulterated under the Federal Food,

Drug, and Cosmetic Act because they present an unreasonable risk of
illness or injury under the conditions of use recommended or suggested
in labeling, or if no conditions of use are suggested or recommended in
labeling, under ordinary conditions of use. This final rule became
effective April 12, 2004.
    FDA examined the economic implementation of the final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-602) and
determined that the final rule would have a significant economic impact
on a substantial number of small entities. In compliance with section
212 of the Small Business Regulatory Enforcement Fairness Act (Public
Law 104-121), FDA is making available this SECG stating in plain
language the requirements of the regulation.
    FDA is issuing this SECG as a level 2 guidance consistent with
FDA's good guidance practices regulation (21 CFR 10.115(c)(2)). The
SECG represents the agency's current thinking on this subject. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this SECG.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The SECG and received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.cfsan.fda.gov/guidance.html.

    Dated: July 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16396 Filed 7-16-08; 8:45 am]

BILLING CODE 4160-01-S