[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Rules and Regulations]
[Pages 52313-52315]
[FR Doc No: 2018-22694]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2018-N-3596]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Herpes Virus Nucleic Acid-Based Cutaneous and
Mucocutaneous Lesion Panel

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion
panel into class II (special controls). The special controls that apply
to the device type are identified in this order and will be part of the
codified language for the herpes virus nucleic acid-based cutaneous and
mucocutaneous lesion panel's classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.

DATES: This order is effective October 17, 2018. The classification was
applicable on May 13, 2014.

FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4676, Silver Spring, MD, 20993-0002, 301-
796-6217, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the herpes virus nucleic acid-
based cutaneous and mucocutaneous lesion panel as class II (special
controls), which we have determined will provide a reasonable assurance
of safety and effectiveness. In addition, we believe this action will
enhance patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application (PMA) to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on February 7, 2014, finding
the Lyra\TM\ Direct HSV 1 + 2/VZV Assay not substantially equivalent to
a predicate not subject to PMA. Thus, the device remained in class III
in accordance with section 513(f)(1) of the FD&C Act when we issued the
order.
    On February 21, 2014, Quidel Corporation submitted a request for De
Novo classification of the Lyra\TM\ Direct HSV 1 + 2/VZV Assay. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on May 13, 2014, FDA issued an order to the requestor
classifying the device into class II. FDA

is codifying the classification of the device by adding 21 CFR
866.3309. We have named the generic type of device herpes virus nucleic
acid-based cutaneous and mucocutaneous lesion panel, and it is
identified as a qualitative in vitro diagnostic device intended for the
simultaneous detection and differentiation of different herpes viruses
in cutaneous and mucocutaneous lesion samples from symptomatic patients
suspected of Herpetic infections. Negative results do not preclude
infection and should not be used as the sole basis for treatment or
other patient management decisions. The assay is not intended for use
in cerebrospinal fluid samples.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

  Table 1--Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous
               Lesion Panel Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Risk of false results..................  Special controls (1) (21 CFR
                                          866.3309(b)(1)), (2) (21 CFR
                                          866.3309(b)(2)), and (3) (21
                                          CFR 866.3309(b)(3)).
Failure to correctly interpret test      Special controls (4) (21 CFR
 results.                                 866.3309(b)(4)) and (5) (21
                                          CFR 866.3309(b)(5)).
Failure to correctly operate the         Special controls (6) (21 CFR
 instrument.                              866.3309(b)(6)) and (7) (21
                                          CFR 866.3309(b)(7)).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulations, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
parts 801 and 809, regarding labeling, have been approved under OMB
control number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics; Laboratories; Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 866 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  866.3309 to subpart D to read as follows:

Sec.  866.3309   Herpes virus nucleic acid-based cutaneous and
mucocutaneous lesion panel.

    (a) Identification. A herpes virus nucleic acid-based cutaneous and
mucocutaneous lesion panel is a qualitative in vitro diagnostic device
intended for the simultaneous detection and differentiation of
different herpes viruses in cutaneous and mucocutaneous lesion samples
from symptomatic patients suspected of Herpetic infections. Negative
results do not preclude infection and should not be used as the sole
basis for treatment or other patient management decisions. The assay is
not intended for use in cerebrospinal fluid samples.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must include detailed
documentation for the device description, including the device
components, ancillary reagents required but not provided, and a
detailed explanation of the methodology including primer design and
selection.
    (2) Premarket notification submissions must include detailed
documentation from the following analytical and clinical performance
studies: Analytical sensitivity (Limit of Detection), reactivity,
inclusivity, precision, reproducibility, interference, cross
reactivity, carry-over, and cross contamination.
    (3) Premarket notification submissions must include detailed
documentation of a clinical study using lesion samples in which Herpes
Simplex Virus 1, Herpes Simplex Virus 2, or Varicella Zoster Virus DNA
detection was requested. The study must compare the device performance
to an appropriate well established reference method.
    (4) A detailed explanation of the interpretation of results and
acceptance criteria must be included in the device's 21 CFR
809.10(b)(9) compliant labeling.
    (5) The device labeling must include a limitation statement that
reads: ``The device is not intended for use with cerebrospinal fluid or
to aid in the diagnosis of HSV or VZV infections of the central nervous
system (CNS).''
    (6) Premarket notification submissions must include quality
assurance protocols and a detailed documentation for device software,
including, but not limited to, standalone

software applications and hardware-based devices that incorporate
software.
    (7) The risk management activities performed as part of the
manufacturer's 21 CFR 820.30 design controls must document an
appropriate end user device training program that will be offered as
part of efforts to mitigate the risk of failure to correctly operate
the instrument.

    Dated: October 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22694 Filed 10-16-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77945-77947]
[FR Doc No: 2010-31267]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denials.

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SUMMARY: FMCSA announces its denial of 103 applications from
individuals who requested an exemption from the Federal vision standard
applicable to interstate truck and bus drivers and the reasons for the
denials. FMCSA has statutory authority to exempt individuals from the
vision requirement if the exemptions granted will not compromise
safety. The Agency has concluded that granting these exemptions does
not provide a level of safety that will be equivalent to, or greater
than, the level of safety maintained without the exemptions for these
commercial motor vehicle (CMV) drivers.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director Medical
Programs,<PHONE_NUMBER>, U.S. Department of Transportation, FMCSA, 1200
New Jersey Avenue, SE., Room W64-224, Washington, DC 20590-0001. Office
hours are from 8:30 a.m. to 5 p.m. Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal vision standard for a renewable 2-year period if it
finds ``such an exemption would likely achieve a level of safety that
is equivalent to, or greater than, the level that would be achieved
absent such an exemption.'' The procedures for requesting an exemption
are set forth in 49 CFR part 381.
    Accordingly, FMCSA evaluated 103 individual exemption requests on
their merit and made a determination that these applicants do not
satisfy the criteria eligibility or meet the terms and conditions of
the Federal exemption program. Each applicant has, prior to this
notice, received a letter of final disposition on the exemption
request. Those decision letters fully outlined the basis for the denial
and constitute final Agency action. The list published in this notice
summarizes the Agency's recent denials as required under 49 U.S.C.
31315(b)(4) by periodically publishing names and reasons for denial.
    The following 11 applicants lacked sufficient driving experience
during the 3-year period prior to the date of their applications:

Tonny Bailey             Randall S. Grauer        Wesley A. Roberson
Charles J. Dawber        Darrell A. Harmon        David M. Taylor
Richard C. Dickinson     Thomas W. Keel, Jr.      David M. Wcisel
Harold L. Elders         Jay Rider

    The following 7 applicants had no experience operating a CMV:

Floyd Aldridge           William Chisley          Keith M.Vanderhyde
Stanly J. Baumann        William Cusano
Janie Burford            Shelby B. Richardson

    The following 24 applicants did not have 3 years of experience
driving a CMV on public highways with the vision deficiency:

Dwight D. Andersen       Kenneth P. Littlefield   Michael R. Spieth
William M. Bell          Ricardo A. Montano       Troy M. Standifer
Barry Bunker             George Edward Mulherrin  Alan D. Strain
                          III
John P. Chuda            Mark Paugh               Ronald R. Sumpter
David L. Ellis           James Perusse            George G. Ulferts, Jr.
Darrel E. Graumann       Larry Robins             Michael S. Westervelt
Ronald Hutchins          Stanley W. Rowden        Michael P. Witkowski
James Jaramillo          Clayton Slone            Brian P. Wunn

    The following 6 applicants did not have 3 years of recent
experience driving a CMV with the vision deficiency:

Ronald C. Ashley         Anthony Chastain         Allen L. Segotta
John E. Cahall           Terrance J. Hurley       Kevin Weaver

    The following 18 applicants did not have sufficient driving
experience during the past 3 years under normal highway operating
conditions:

Raymond W. Anderson      Steve Garrett            Wayne A. LeClaire
Andres Castanon, Jr.     Marc D. Groszkrueger     Christopher J. McCulla
Dickie R. Clough         Darris Hardwidge         Darrell Rogers
Scott A. Cole            Shawn M. Hebert          Karl H. Strangfeld
Richard W. Futrell       Milan Jokic              Jacob E. Wadewitz
Carlos R. Galarza        Douglas Jones            Stephen H. Ward

    The following 3 applicants had more than 2 commercial motor vehicle
violations during the application process. Each applicant is only
allowed 2 moving citations:

Wesley M. Creamer        Gregory C. Simmons       Christopher J. Van
                                                   Dyke

    One applicant, William E. Woodhouse, has other medical conditions
making him unqualified under Federal Motor Carrier Safety Regulations.
All applicants must meet all other physical qualifications standards in
49 CFR 391.41(b)(1-13).
    Two applicants, Shorty Ellis and Charles J. Kruggel, had commercial
driver's license suspensions during the 3-year review period for moving
violations. Applicants do not qualify for an exemption with a
suspension during the 3-year period.
    One applicant, James F. Partin, did not have verifiable proof of
commercial driving experience over the past 3 years under normal
highway operating conditions that would serve as an adequate predictor
of future safe performance.
    The following 5 applicants were denied for miscellaneous/multiple
reasons:

Samuel Golden            Matthew B. Lairamore     John Thomas White, Jr.
David W. Herbert         Gerald Lord

    The following 16 applicants met the current federal vision
standards. Exemptions are not required for applicants who meet the
current regulations for vision:

Anthony Benally          Craig R. Gross           Gaylon Nelson
Larry D. Cooper          Ray O. Howell            Brian J. Ruzalski
Sid L. Crumpton          Ervin A. Kope            Travis Stroming
Gerald Davis             Fernando M. Magana       Todd M. Sucharda
Eric N. Fitzgerald       Ignacio V. Maldonado     Scott M. Tommen
Larry D. Cooper          Richard G. Myers

    One applicant, Thomas D. Laws, was issued a medical certificate for
3 months. Applicants with a medical certificate valid for less than 6
months do not meet the exemption program eligibility criteria.
    The following 7 applicants drove interstate while restricted to
intrastate driving:

John Gallagher           Steven R. Parker         Michael Watters
Derrick A. Hardy         Jay L. Pendergas
John F. Murphy           Mohammad Suhail

    Finally, one applicant, Wilford Mendoza, will not be driving
interstate, interstate commerce, or not required to carry a DOT medical
card.

    Issued on: December 6, 2010.
 Larry W. Minor,
Associate Administrator, Office of Policy.
[FR Doc. 2010-31267 Filed 12-13-10; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Notices]
[Pages 46278-46280]
[FR Doc No: 2014-18633]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2006-0042]

Canadian Standards Association: Grant of Renewal of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: This notice announces the Occupational Safety and Health
Administration's final decision granting renewal of recognition of
Canadian Standards Association, as a Nationally Recognized Testing
Laboratory (NRTL).

DATES: The renewal of recognition becomes effective on August 7, 2014.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, 200 Constitution Avenue
NW., Room N-3647, Washington, DC 20210; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. David Johnson,
Director,

Office of Technical Programs and Coordination Activities, Directorate
of Technical Support and Emergency Management, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue NW., Room N-3655, Washington, DC 20210; telephone: (202) 693-
2110; email<EMAIL_ADDRESS>OSHA's Web page includes
information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Background

    OSHA recognition of an NRTL signifies that the organization meets
the requirements specified by 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition, and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
properly approved by the NRTL to meet OSHA standards that require
testing and certification. OSHA maintains an informational Web site for
each NRTL at http://www.osha.gov/dts/otpca/nrtl/index.html that details
its scope of recognition.
    OSHA processes applications submitted by an NRTL for renewal of
recognition following requirements in Appendix A to 29 CFR 1910.7. OSHA
conducts renewals in accordance with the procedures in 29 CFR 1910.7,
App. A II.C. In accordance with these procedures, NRTLs submit a
renewal request to OSHA between nine months and one year before the
expiration date of its current recognition. A renewal request includes
a request for renewal and any additional information demonstrating its
continued compliance with the terms of its recognition and 29 CFR
1910.7. If OSHA has not conducted an on-site assessment of the NRTL
headquarters and any key sites within the past 18 to 24 months, it will
schedule the necessary on-site assessment prior to the expiration date
of the NRTL's recognition. Upon review of the submitted material and,
as necessary, the successful completion of the on-site assessment, OSHA
announces its preliminary decision to grant or deny renewal in the
Federal Register and solicits comments from the public. OSHA then
publishes a final Federal Register notice responding to any comments
and renewing the NRTL's recognition for a period of five years, or
denying the renewal of recognition.
    Canadian Standards Association (CSA) initially received OSHA
recognition as an NRTL on December 24, 1992 (57 FR 61452). The most
recent renewal for CSA was on July 3, 2001, for a five-year period
expiring on July 3, 2006. CSA submitted a timely request for renewal,
dated October 3, 2005 (see Ex. OSHA-2006-0042-0007), and retained its
recognition pending OSHA's final decision in this renewal process. The
current addresses of CSA facilities recognized by OSHA and included as
part of the renewal request are:
    1. CSA Toronto, 178 Rexdale Boulevard, Etobicoke, Ontario, Canada
M9W 1R3;
    2. CSA International Montreal, 865 Ellingham Street, Pointe-Claire,
Quebec, Canada H9R 5E8;
    3. CSA International Irvine, 2805 Barranca Parkway, Irvine,
California 92606;
    4. CSA International Edmonton, 1707-94th Street, Edmonton, Alberta,
Canada T6N 1E6;
    5. CSA International Vancouver, 13799 Commerce Parkway, Richmond,
British Columbia, Canada V6V 2N9; and
    6. CSA International Cleveland, 8501 East Pleasant Valley Road,
Cleveland, Ohio 44131.
    OSHA evaluated CSA's application for renewal and made a preliminary
determination that CSA can continue to meet the requirements prescribed
by 29 CFR 1910.7 for recognition. OSHA conducted audits of CSA's
headquarters, CSA Toronto, on March 24-25, 2011; of the CSA Montreal
site on March 21-22, 2011; of the CSA Edmonton site on September 23-24,
2009; and of the CSA Vancouver site on August 21-22, 2013, and found
non-conformances with the requirements of 29 CFR 1910.7. CSA addressed
these issues sufficiently to meet the applicable NRTL requirements.
Accordingly, OSHA determined that it did not need to conduct an on-site
review of CSA's facilities for this request for renewal based on its
evaluation of CSA's application and all other available information.
    OSHA published the preliminary notice announcing CSA's renewal
request in the Federal Register on February 24, 2014 (79 FR 10193). The
Agency requested comments by March 11, 2014, but received no comments
in response to this notice. OSHA now is proceeding with this final
notice to grant CSA's request for renewal of recognition.
    To obtain or review copies of all public documents pertaining to
the CSA's application, go to www.regulations.gov or contact the Docket
Office, Occupational Safety and Health Administration, U.S. Department
of Labor, 200 Constitution Avenue NW., Room N-2625, Washington, DC
20210. Docket No. OSHA-2006-0042 contains all materials in the record
concerning CSA's recognition.

II. Final Decision and Order

    Pursuant to the authority granted under 29 CFR 1910.7, OSHA hereby
gives notice of the renewal of recognition of CSA as an NRTL. OSHA NRTL
Program staff reviewed the renewal request for CSA and other pertinent
information. Based on this review of the renewal request for CSA and
other pertinent information, OSHA finds that CSA meets the requirements
of 29 CFR 1910.7 for renewal of its recognition, subject to the
specified limitation and conditions. OSHA limits the renewal of CSA's
recognition to include the terms and conditions of CSA's scope of
recognition. The scope of recognition for CSA is available in the
Federal Register notice dated December 24, 1992 (57 FR 61452), or on
OSHA's Web site at http://www.osha.gov/dts/otpca/nrtl/csa.html. This
renewal extends CSA's recognition for a period of five years from
August 7, 2014.

Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
CSA also must abide by the following conditions of recognition:
    1. CSA must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as an NRTL, and provide details of the
change(s);
    2. CSA must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. CSA must continue to meet the requirements for recognition,
including all previously published conditions on CSA's scope of
recognition, in all areas for which it has recognition.

III. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on August 1, 2014.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2014-18633 Filed 8-6-14; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Rules and Regulations]
[Pages 46946-46948]
[FR Doc No: 2012-18582]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0269; Directorate Identifier 2011-NM-105-AD;
Amendment 39-17140; AD 2012-15-11]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Dassault Aviation Model FALCON 7X airplanes. This AD was prompted by a
report that a passenger oxygen pipe at frame 10 was chafing against the
forward lavatory rear structure, raising the risk of the oxygen pipe
developing a crack. This AD requires modifying the routing of and, if
necessary, replacing, the oxygen pipe. We are issuing this AD to
prevent rupture of the oxygen pipe which, in case of a cabin
depressurization, would impair operation of the passenger oxygen
distribution system.

DATES: This AD becomes effective September 11, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
11, 2012.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on March 20, 2012 (77
FR 16186). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    Inspections of two aeroplanes during cabin completions have
shown that a passenger oxygen line at frame 10 was chafing with the
forward lavatory rear structure.
    Design review of the area confirmed a local low clearance value
which raises the risk of the oxygen line developing a crack.
    This condition, if not detected and corrected, could lead to
rupture of the oxygen line which, in case of a cabin
depressurization, would impair operation of the passengers' oxygen
distribution system.
    To address this unsafe condition, Dassault Aviation have
designed a modification with a new oxygen line routing.
    This AD requires an [general visual] inspection of the oxygen
line for interference or damage and, in case of discrepancies
[damage, or clearance less than 3 mm], accomplishment of the
modification [including general visual inspections, and, if
necessary, replacing the oxygen line/pipe] before next flight. It
requires as well accomplishment of the modification of the oxygen
line routing for the aeroplanes in which [clearance of 3 mm or more
but less than 12 mm] were identified.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (77 FR 16186, March 20,
2012) or on the determination of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed--except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 16186, March 20, 2012) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 16186, March 20, 2012).

Costs of Compliance

    We estimate that this AD will affect about 11 products of U.S.
registry. We also estimate that it will take about 11 work-hours per
product to comply with the basic requirements of this AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this AD to the U.S. operators to be $10,285, or $935 per
product.

    In addition, we estimate that any necessary follow-on actions would
take about 16 work-hours and require parts costing $655, for a cost of
$2,015 per product. We have no way of determining the number of
products that may need these actions.

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 AD will not have federalism implications
under Executive Order 13132. This AD will 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 that this AD:
    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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM 77 FR 16186, March 20, 2012),
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.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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 AD:

2012-15-11 Dassault Aviation: Amendment 39-17140. Docket No. FAA-
2012-0269; Directorate Identifier 2011-NM-105-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective September
11, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Dassault Aviation Model FALCON 7X airplanes,
certificated in any category, serial numbers 3, 10, 13, 18, 19, 20,
22, 23, 24, 26, 27, 29, 30, 31, 32, 33, 35, 36, 38, 41, 42, 43, 47,
48, 58, 63, 64, 66, 67, 68, 71, 76, 78, 79, 83, 84, 85, 86, 87, and
93; except for airplanes on which the Dassault Aviation modification
specified in Dassault Mandatory Service Bulletin 7X-174 has been
incorporated.

(d) Subject

    Air Transport Association (ATA) of America Code 35: Oxygen.

(e) Reason

    This AD was prompted by a report that a passenger oxygen pipe at
frame 10 was chafing against the forward lavatory rear structure,
raising the risk of the oxygen pipe developing a crack. We are
issuing this AD to prevent rupture of the oxygen pipe which, in case
of a cabin depressurization, would impair operation of the passenger
oxygen distribution system.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Inspection

    Within 2 months after the effective date of this AD, do a
boroscope inspection of the passenger oxygen pipe for clearance and
a general visual inspection for damage of the oxygen pipe, in
accordance with the Accomplishment Instructions of Dassault
Mandatory Service Bulletin 7X-174, dated March 10, 2011.

(h) Corrective Actions

    If during any inspection required by paragraph (g) of this AD
any damage is found or oxygen pipe clearance is less than 3
millimeters (mm) (0.12 inch): Before further flight, modify the
oxygen pipe routing, including doing a general visual inspection for
chafing of the pipe and doing all applicable replacements, in
accordance with the Accomplishment Instructions of Dassault
Mandatory Service Bulletin 7X-174, dated March 10, 2011.

(i) Oxygen Pipe Routing Modification

    If, during any inspection required by paragraph (g) of this AD,
oxygen pipe clearance is 3 mm (0.12 inch) or more but less than 12
mm (0.47 inch): Within 98 months or 4,000 flight cycles after the
effective date of this AD, whichever occurs first, modify the
routing of the passenger oxygen pipe, including doing a general
visual inspection for chafing of the pipe and doing all applicable
replacements, in accordance with the Accomplishment Instructions of
Dassault Mandatory Service Bulletin 7X-174, dated March 10, 2011.

(j) 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: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
Washington 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) 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.

(k) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2011-0070, dated April 18, 2011; and
Dassault Mandatory Service Bulletin 7X-174, dated March 10, 2011;
for related information.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Dassault Mandatory Service Bulletin 7X-174, dated March 10,
2011.
    (ii) Reserved.
    (3) For Dassault service information identified in this AD,
contact Dassault Falcon Jet, P.O. Box 2000, South Hackensack, New
Jersey 07606; telephone<PHONE_NUMBER>; Internet http://www.dassaultfalcon.com.
    (4) You may review copies of the 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>.
    (5) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on July 20, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-18582 Filed 8-6-12; 8:45 am]
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