[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Proposed Rules]
[Pages 40286-40288]
[FR Doc No: 2011-17264]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0713; Directorate Identifier 2011-CE-023-AD]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de
Aeron[aacute]utica S.A. (EMBRAER) Model EMB-505 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    It has been found the possibility of free-play between the mass
balance weight and the elevator structure. This condition if not
corrected could lead to elevator flutter and possible loss of
airplane control.

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by August 22, 2011.

ADDRESSES: You may send comments 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 20590, 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., Phenom Maintenance Support, Av. Brig. Faria Lima, 2170,
Sao Jose dos Campos--SP, CEP: 12227-901--PO Box: 36/2, BRASIL;
telephone: ++55 12 3927-5383; fax: ++55 12 3927-2619; E-mail:
<EMAIL_ADDRESS>Internet: http://www.embraer.com.br.
You may review copies of the referenced service information at the FAA,
Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106.
For information on the availability of this material at the FAA, call
(816) 329-4148.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; 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 (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; 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-2011-0713; Directorate Identifier 2011-CE-023-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 http://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 AGENCIA NACIONAL DE AVIACAO CIVIL--BRAZIL (ANAC), which is the
aviation authority for Brazil, has issued AD No.: 2011-05-05, effective
date June 16, 2011 (referred to after this as ``the MCAI''), to correct
an unsafe condition for the specified products. The MCAI states:

    It has been found the possibility of free-play between the mass
balance weight and the elevator structure. This condition if not
corrected could lead to elevator flutter and possible loss of
airplane control.
    Since this condition may occur in other airplanes of the same
type and affects flight safety, a corrective action is required.
Thus, sufficient reason exists to request compliance with this AD in
the indicated time limit.

The MCAI requires replacement of the bolts that attach the balance mass
weights to the elevator structure. You may obtain further information
by examining the MCAI in the AD docket.

Relevant Service Information

    EMBRAER S.A. has issued PHENOM Service Bulletin No.: 505-55-0002,
dated January 14, 2011. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of the 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 this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the proposed AD.

Costs of Compliance

    We estimate that this proposed AD will affect 8 products of U.S.
registry. We also estimate that it would take about 38 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 $3,490 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $53,760, or $6,720 per product.
    According to the manufacturer, some 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.

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); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Empresa Brasileira de Aeron[aacute]utica S.A. (EMBRAER): Docket No.
FAA-2011-0713; Directorate Identifier 2011-CE-023-AD.

Comments Due Date

    (a) We must receive comments by August 22, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Empresa Brasileira de Aeron[aacute]utica
S.A. (EMBRAER) Model EMB-505 airplanes, all serial numbers (SN)
through 50500023, certificated in any category.

Subject

    (d) Air Transport Association of America (ATA) Code 27: Flight
Controls.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    It has been found the possibility of free-play between the mass
balance weight and the elevator structure. This condition if not
corrected could lead to elevator flutter and possible loss of
airplane control.
    Since this condition may occur in other airplanes of the same
type and affects flight safety, a corrective action is required.
Thus, sufficient reason exists to request compliance with this AD in
the indicated time limit.

The MCAI requires replacement of the bolts that attach the balance
mass weights to the elevator structure.

Actions and Compliance

    (f) Unless already done, within 12 calendar months after the
effective date of this AD, replace the bolts that attach the balance
mass weights to the elevator structure following EMBRAER S.A. PHENOM
Service Bulletin No.: 505-55-0002, dated January 14, 2011.

FAA AD Differences

    Note:  This AD differs from the MCAI and/or service information
as follows: The MCAI applies to SN 50500004 through 50500023. This
AD applies to all SN through 50500023.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using
any approved AMOC on any airplane to which the AMOC applies, notify
your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a Federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave., SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

Related Information

    (h) Refer to MCAI AG[Ecirc]NCIA NACIONAL DE
AVIA[Ccedil][Atilde]O CIVIL--BRAZIL (ANAC) AD No.: 2011-05-05,
effective date June 16, 2011; and EMBRAER S.A. PHENOM Service
Bulletin No.: 505-55-0002, dated January 14, 2011, for related
information. For service information related to this AD, contact
EMBRAER S.A., Phenom Maintenance Support, Av. Brig. Faria Lima,
2170, Sao Jose dos Campos--SP, CEP: 12227-901--PO Box: 36/2, BRASIL;
telephone: ++55 12 3927-5383; fax: ++55 12 3927-2619; E-mail:
<EMAIL_ADDRESS>Internet: http://www.embraer.com.br. You may review copies of the referenced service
information at the FAA, Small Airplane Directorate, 901 Locust,
Kansas City, Missouri 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri, on July 1, 2011.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2011-17264 Filed 7-7-11; 8:45 am]
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[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Page 57177]
[FR Doc No: 2021-22345]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3563-EM; Docket ID FEMA-2021-0001]

Rhode Island; Amendment No. 1 to Notice of an Emergency
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of Rhode Island (FEMA-3563-EM), dated August 21, 2021, and
related determinations.

DATES: This amendment was issued August 30, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective August 24, 2021.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22345 Filed 10-13-21; 8:45 am]
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[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Pages 57113-57114]
[FR Doc No: 2014-22681]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1352]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH
GL52); Draft Guidance for Industry on Bioequivalence: Blood Level
Bioequivalence Study; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (GFI 224)
entitled ``Draft Guidance for Industry, Bioequivalence: Blood Level
Bioequivalence Study'' (VICH GL52). This draft guidance has been
developed for veterinary use by the International Cooperation on
Harmonisation of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH). This draft VICH guidance document is
intended to harmonize the data recommendations associated with in vivo
blood level bioequivalence (BE) for veterinary pharmaceutical products.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 24, 2014.

ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marilyn Martinez, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
(GFI 224) entitled ``Draft Guidance for Industry,
Bioequivalence: Blood Level Bioequivalence Study'' (VICH GL52). In
recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote the
international harmonization of regulatory requirements. FDA has
participated in efforts to enhance harmonization and has expressed its
commitment to seek scientifically based harmonized technical procedures
for the development of pharmaceutical products. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies in
different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use for several years to develop harmonized
technical requirements for the approval of human pharmaceutical and
biological products among the European Union, Japan, and the United
States. The VICH is a parallel initiative for veterinary medicinal
products. The VICH is concerned with developing harmonized technical
requirements for the approval of veterinary medicinal products in the
European Union, Japan, and the United States, and includes input from
both regulatory and industry representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission; European Medicines Evaluation Agency;
European Federation of Animal Health; Committee on Veterinary Medicinal
Products; FDA; U.S. Department of Agriculture; the Animal Health
Institute; the Japanese Veterinary Pharmaceutical Association; the
Japanese Association of Veterinary Biologics; and the Japanese Ministry
of Agriculture, Forestry, and Fisheries.
    Six observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, one representative
from the industry of Canada, one representative from the government of
South Africa, and one representative from the industry of South Africa.
The VICH Secretariat, which coordinates the preparation of
documentation, is provided by the International Federation for Animal
Health (IFAH). An IFAH representative also participates in the VICH
Steering Committee meetings.

II. Draft Guidance on Bioequivalence: Blood Level Bioequivalence Study

    The VICH Steering Committee held a meeting in November 2013 and
agreed that the draft guidance document entitled ``Draft Guidance for
Industry, Bioequivalence: Blood Level Bioequivalence Study'' (VICH
GL52) should be made available for public comment. This draft VICH
guidance document is intended to harmonize the data recommendations
associated with in vivo blood level BE for veterinary pharmaceutical
products. To meet this objective, the draft guidance addresses the
following topics: A harmonized definition of BE, factors/variables that
should be considered when developing scientifically sound blood level
BE study designs, and information that should be included in a blood
level BE study report.
    FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.

III. Significance of Guidance

    This draft guidance, developed under the VICH process, has been
revised to conform to FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' In addition, guidance documents must not
include mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
    The draft guidance, when finalized, will represent the Agency's
current thinking on this topic. 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 applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Action of 1995 (44 U.S.C. 3501-3520). The
collections of information in this draft guidance have been approved
under OMB control numbers 0910-0032 and 0910-0669.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

VI. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: September 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22681 Filed 9-23-14; 8:45 am]
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