[Federal Register Volume 87, Number 130 (Friday, July 8, 2022)]
[Rules and Regulations]
[Pages 40714-40717]
[FR Doc No: 2022-14391]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0296; Project Identifier MCAI-2021-01064-E;
Amendment 39-22103; AD 2022-13-17]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
(Type Certificate Previously Held by Rolls-Royce plc) Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2021-15-01
for all Rolls-Royce Deutschland Ltd & Co KG (RRD) Trent XWB-75, Trent
XWB-79, Trent XWB-79B, Trent XWB-84, and Trent XWB-97 model turbofan
engines. AD 2021-15-01 required revisions to the airworthiness
limitations section (ALS) of the Rolls-Royce (RR) Trent XWB time limits
manual (TLM) and the operator's existing approved aircraft maintenance
program (AMP). Since the FAA issued AD 2021-15-01, the manufacturer has
revised the TLM life limits and updated mandatory inspection intervals
of certain critical rotating parts. This AD requires revisions to the
ALS of the RR Trent XWB TLM and the operator's existing approved AMP,
as specified in a European Union Aviation Safety Agency (EASA) AD,
which is incorporated by reference. The FAA is issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective August 12, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 12,
2022.

ADDRESSES: For material incorporated by reference in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221
8999 000; email: [email protected]. You may find this material on the
EASA website at https://ad.easa.europa.eu. You may view this material
at the FAA, Airworthiness Products Section, Operational Safety Branch,
1200 District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is
also available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0296. For the material identified in this
AD that is not incorporated by reference, contact Rolls-Royce plc,
Corporate Communications, P.O. Box 31, Derby, DE24 8BJ, United Kingdom;
phone: +44 (0)1332 242424; fax: +44 (0)1332 249936; website: https://www.rolls-royce.com/contact-us.aspx.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0296; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this AD, the EASA AD,
any comments received, and other information. The address for Docket
Operations is U.S. Department of Transportation, Docket Operations, M-
30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Sungmo Cho, Aviation Safety Engineer,
ECO Branch, FAA, 1200 District

Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0217, dated September 23, 2021
(EASA AD 2021-0217), to address an unsafe condition for all RRD Trent
XWB-75, Trent XWB-79, Trent XWB-79B, Trent XWB-84, and Trent XWB-97
model turbofan engines.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2021-15-01, Amendment 39-21648 (86 FR
36487, July 12, 2021), (``AD 2021-15-01''). AD 2021-15-01 applied to
all RRD Trent XWB-75, Trent XWB-79, Trent XWB-79B, Trent XWB-84, and
Trent XWB-97 model turbofan engines. The NPRM published in the Federal
Register on March 28, 2022 (87 FR 17209). The NPRM was prompted by the
manufacturer revising the TLM to introduce new instructions for repairs
to the low-pressure compressor blades and fan blade inspections. In the
NPRM, the FAA proposed to require accomplishing the actions specified
in EASA AD 2021-0217, except for any differences identified as
exceptions in the regulatory text of this AD and except as discussed
under ``Differences Between this Proposed AD and the EASA AD.'' The FAA
is issuing this AD to address the unsafe condition on these products.
See EASA AD 2021-0217 for additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from two commenters. The commenters were
Air Line Pilots Association, International (ALPA) and Delta Air Lines,
Inc (DAL). The following presents the comments received on the NPRM and
the FAA's response to each comment.

Request To Clarify Recording Requirement

    DAL requested that the FAA revise paragraph (h)(6), Exceptions to
EASA AD 2021-0217, of this AD to read as follows: ``This AD does not
require compliance with paragraph (5), Recording AD Compliance, of EASA
AD 2021-0217. This AD also does not require that after revising the
AMP, as required by paragraph (3) of EASA AD 2021-0217, that
accomplishment of individual actions is recorded for demonstration of
AD compliance.'' DAL noted that paragraph (5) of EASA AD 2021-0217
states that it is not necessary to record the accomplishment of
individual actions in order to demonstrate AD compliance. DAL indicated
that the proposed language in paragraph (h)(6) of the NPRM would negate
that action, and make the recording of individual actions a requirement
for AD compliance.
    The FAA disagrees with revising paragraph (h)(6) of this final
rule. As stated in this AD, this AD does not require compliance with
paragraph (5), Recording AD Compliance, of EASA AD 2021-0217.
Additionally, this AD does not mandate that operators not comply with
paragraph (5), Recording AD Compliance, of EASA AD 2021-0217. The FAA
notes, for purposes of clarification, that this AD only requires
compliance with paragraph (3) of EASA AD 2021-0217, and that paragraph
(3) of EASA AD 2021-0217 does not specify recording of individual
actions in order to demonstrate AD compliance. The FAA did not change
this AD as a result of this comment.

Request To Incorporate by Reference EASA AD 2021-0217

    DAL requested that the FAA add paragraph (k), Material Incorporated
by Reference, to this final rule and include EASA AD 2021-0217 in that
paragraph. DAL noted that using EASA ADs as the primary source of
information for compliance with requirements for corresponding FAA ADs
has improved the efficiency of the FAA's AD process and operator's AD
process. DAL also noted that one of the efficiencies of incorporating
EASA AD 2021-0217 by reference is that the Ref. Publications section
would allow for the use of later approved revisions of the TLM.
    The FAA notes that EASA AD 2021-0217 was proposed for incorporation
by reference under 1 CFR part 51 in the NPRM, which lists the material
to be incorporated by reference in this final rule. Additionally, while
not typically included in an NPRM, the ``Material Incorporated by
Reference'' paragraph exists in the final rule published for FAA ADs.
The FAA did not change this AD as a result of the comments.

Support for the AD

    ALPA expressed support for the AD as written.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting the AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for minor editorial changes, this
AD is adopted as proposed in the NPRM. None of the changes will
increase the economic burden on any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed European Union Aviation Safety Agency (EASA) AD
2021-0217, dated September 23, 2021. EASA AD 2021-0217 describes
actions for the incorporation of revised life limits and updated
mandatory inspection intervals of certain critical rotating parts into
the ALS of the RR Trent XWB TLM, as applicable to each engine model,
and the operator's existing approved AMP. This material is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in
ADDRESSES.

Other Related Service Information

    The FAA reviewed Rolls-Royce Airworthiness Limitations (Mandatory
parts lives), TRENTXWB-A-05-10-01-00A01-030A-D, Revision 016, dated May
1, 2021, of the Rolls-Royce Trent XWB TLM TRENTXWB-K0680-TIME0-01;
Rolls-Royce Airworthiness Limitations (Mandatory Parts Lives),
TRENTXWB-B-05-10-01-00A01-030A-D, Revision 003, dated April 19, 2021,
of the Rolls-Royce Trent XWB TLM TRENTXWB-K0680-TIME0-01; Rolls-Royce
Airworthiness Limitations (Mandatory inspections), TRENTXWB-A-05-20-01-
00A01-030A-D, Revision 015, dated May 1, 2021, of the Rolls-Royce Trent
XWB TLM TRENTXWB-K0680-TIME0-01; and Rolls-Royce Airworthiness
Limitations (Mandatory inspections), TRENTXWB-B-05-20-01-00A01-030A-D,
Revision 008, dated April 19, 2021, of the Rolls-Royce Trent XWB TLM
TRENTXWB-K0680-TIME0-01. These sections of the TLM specify inspection
intervals and life limits, differentiated by engine model, for critical
rotating parts.

Costs of Compliance

    The FAA estimates that this AD affects 30 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Revise the ALS of the RR Trent XWB TLM  1 work-hour x $85 per                 $0             $85          $2,550
 and the operator's existing approved    hour = $85.
 AMP.
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is 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

    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) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

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:
0
a. Removing Airworthiness Directive 2021-15-01, Amendment 39-21648 (86
FR 36487, July 12, 2021); and
0
b. Adding the following new airworthiness directive:

2022-13-17 Rolls-Royce Deutschland Ltd & Co KG (Type Certificate
previously held by Rolls-Royce plc): Amendment 39-22103; Docket No.
FAA-2022-0296; Project Identifier MCAI-2021-01064-E.

(a) Effective Date

    This airworthiness directive (AD) is effective August 12, 2022.

(b) Affected ADs

    This AD replaces AD 2021-15-01, Amendment 39-21648 (86 FR 36487,
July 12, 2021).

(c) Applicability

    This AD applies to Rolls-Royce Deutschland Ltd & Co KG Trent
XWB-75, Trent XWB-79, Trent XWB-79B, Trent XWB-84, and Trent XWB-97
model turbofan engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7200, Engine
Turbine/Turboprop.

(e) Unsafe Condition

    This AD was prompted by the manufacturer revising the time
limits manual (TLM) to incorporate revised life limits and updated
mandatory inspection intervals of certain critical rotating parts.
The FAA is issuing this AD to prevent the failure of critical
rotating parts. The unsafe condition, if not addressed, could result
in failure of one or more engines, loss of thrust control, and loss
of the airplane.

(f) Compliance

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

(g) Required Actions

    Except as specified in paragraph (h) of this AD: Perform all
required actions within the compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0217, dated September 23, 2021 (EASA AD 2021-0217).

(h) Exceptions to EASA AD 2021-0217

    (1) Where EASA AD 2021-0217 defines the AMP as the approved
Aircraft Maintenance Programme on the basis of which the operator or
the owner ensures the continuing airworthiness of each operated
engine, this AD defines the AMP as the existing Aircraft Maintenance
Program on the basis of which the operator or the owner ensures the
continuing airworthiness of each operated airplane.
    (2) Where EASA AD 2021-0217 requires revising the approved
aircraft maintenance program (AMP) within 12 months after the
effective date of EASA AD 2021-0217, this AD requires revising the
existing approved AMP and airworthiness limitations section (ALS)
within 120 days after the effective date of this AD.
    (3) This AD does not require compliance with paragraph (1),
Mandatory Inspections and Replacement of Life Limited Parts, of EASA
AD 2021-0217.
    (4) This AD does not require compliance with paragraph (2),
Corrective Action(s), of EASA AD 2021-0217.
    (5) This AD does not require compliance with paragraph (4),
Credit, of EASA AD 2021-0217.
    (6) This AD does not require compliance with paragraph (5),
Recording AD Compliance, of EASA AD 2021-0217.
    (7) This AD does not require compliance with the ``Remarks''
section of EASA AD 2021-0217.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, 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
certification office, send it to the attention of the person
identified in paragraph (j)(1) of this AD and email to: [email protected].
    (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.

(j) Related Information

    (1) For more information about this AD, contact Sungmo Cho,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; email:
[email protected].
    (2) For service information identified in this AD that is not
incorporated by reference, contact Rolls-Royce plc, Corporate
Communications, P.O. Box 31, Derby, DE24 8BJ, United Kingdom; phone:
+44 (0)1332

242424; fax: +44 (0)1332 249936; website: https://www.rolls-royce.com/contact-us.aspx. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

(k) 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 this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0217,
dated September 23, 2021.
    (ii) [Reserved]
    (3) For more information about EASA AD 2021-0217, contact EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999
000; email: [email protected]. You may find this material on the
EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. This material may be found
in the AD docket at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0296.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email:
[email protected], or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 17, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-14391 Filed 7-7-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48838-48839]
[FR Doc No: 2017-22839]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2017-0879]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0072

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval for
reinstatement, without change, of the following collection of
information: 1625-0072, Waste Management Plans, Refuse Discharge Logs,
Letters of Instruction for Certain Persons-in-Charge (PIC) and Great
Lakes Dry Cargo Residue Recordkeeping. Our ICR describes the
information we seek to collect from the public. Before submitting this
ICR to OIRA, the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before December 19,
2017.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2017-0879] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703

Martin Luther King Jr. Ave. SE., Stop 7710, Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek
reinstatement of the Collection. We will consider all comments and
material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2017-0879], and
must be received by December 19, 2017.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: Waste Management Plans, Refuse Discharge Logs, Letters of
Instruction for Certain Persons-in-Charge (PIC) and Great Lakes Dry
Cargo Residue Recordkeeping.
    OMB Control Number: 1625-0072.
    Summary: This information is needed to ensure that: (1) Certain
U.S. oceangoing vessels develop and maintain a waste management plan;
(2) certain U.S. oceangoing vessels maintain refuse discharge records;
(3) certain individuals that act as person-in-charge of the transfer of
fuel receive a letter of instruction, for prevention of pollution; and
(4) certain Great Lakes vessels comply with dry cargo residue
requirements.
    Need: This collection of information is needed as part of the Coast
Guard's pollution prevention compliance program.
    Forms: None.
    Respondents: Owners, operators, masters, and persons-in-charge of
vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from
65,696 hours to 116,095 hours a year due to an estimated increase in
the annual number of respondents.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter
35, as amended.

    Dated: October 16, 2017.
James D. Roppel,
U.S. Coast Guard, Acting Chief, Office of Information Management.
[FR Doc. 2017-22839 Filed 10-19-17; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: October 20, 2010 (Volume 75, Number 202)]
[Proposed Rules]
[Page 64681-64683]
[DOCID:fr20oc10-17]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0998; Directorate Identifier 2010-NE-29-AD]
RIN 2120-AA64

Airworthiness Directives; General Electric Company (GE) CF6-45
Series and CF6-50 Series Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for GE CF6-45 and CF6-50 series turbofan engines. This proposed AD
would require performing a fluorescent penetrant inspection (FPI) of
the stage 3 low-pressure turbine (LPT) rotor at every shop visit at
which the LPT module is separated from the engine. This proposed AD
results from seven

reports of uncontained failures of LPT stage 3 disks and eight reports
of cracked LPT stage 3 disks found during shop visit inspections. We
are proposing this AD to prevent LPT rotor separation, which could
result in an uncontained engine failure and damage to the airplane.

DATES: We must receive any comments on this proposed AD by December 20,
2010.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Christopher J. Richards, Aerospace
Engineer, Engine Certification Office, FAA, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, MA 01803; e-
mail<EMAIL_ADDRESS>phone:<PHONE_NUMBER>; fax: (781)
238-7199.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send us any written relevant data, views, or
arguments regarding this proposal. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2010-0998; Directorate
Identifier 2010-NE-29-AD'' in the subject line of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of the proposed AD. We will consider
all comments received by the closing date and may amend the proposed AD
in light of 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
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

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 this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

Discussion

    Since July 2008, we have received seven reports of uncontained
failures of LPT stage 3 rotor disks and eight reports of cracked LPT
rotor stage 3 disks found during shop visit inspections. Our
investigation revealed that certain part number LPT stage 3 rotor disks
might fail due to circumferential cracking of the forward cone body
(forward spacer arm) of the LPT stage 3 disk when exposed to core
engine (N2) vibrations. On June 4, 2010, we issued AD 2010-12-10 that
requires a separate set of corrective actions. Those actions, along
with this proposed AD, reduce the likelihood of further uncontained
engine failures. This condition, if not corrected, could result in
critical life-limited rotating engine part failure, which could result
in an uncontained engine failure and damage to the airplane.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other products
of this same type design. We are proposing this AD, which would require
performing a fluorescent penetrant inspection at every shop visit when
the LPT module is separated from the engine.

Interim Action

    These actions are interim actions and we may take further
rulemaking actions in the future.

Costs of Compliance

    We estimate that this proposed AD would affect 387 engines
installed on airplanes of U.S. registry. We also estimate that it would
take about 7 work-hours per engine to perform the proposed actions, and
that the average labor rate is $85 per work-hour. No parts would be
required. Based on these figures, we estimate the total cost of the
proposed AD to U.S. operators to be $230,265.

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 have 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 that the proposed 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); and
    3. Would 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. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Under the authority delegated to me by the Administrator, the
Federal

Aviation Administration 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
airworthiness directive:

General Electric Company: Docket No. FAA-2010-0998; Directorate
Identifier 2010-NE-29-AD.

Comments Due Date

    (a) The Federal Aviation Administration (FAA) must receive
comments on this airworthiness directive (AD) action by December 20,
2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to General Electric Company (GE) CF6-45A,
CF6-45A2, CF6-50A, CF6-50C, CF6-50CA, CF6-50C1, CF6-50C2, CF6-50C2B,
CF6-50C2D, CF6-50C2-F, CF6-50C2-R, CF6-50E, CF6-50E1, and CF6-50E2
series turbofan engines, with a low-pressure turbine (LPT) rotor
stage 3 disk that has a part number (P/N) listed in Table 1 of this
AD installed:

                  Table 1--LPT Rotor Stage 3 Disk P/Ns
------------------------------------------------------------------------

------------------------------------------------------------------------
     1473M90P01         1473M90P02        1473M90P03        1473M90P04
     1479M75P01         1479M75P02        1479M75P03        1479M75P04
     1479M75P05         1479M75P06        1479M75P07        1479M75P08
     1479M75P09         1479M75P11        1479M75P13        1479M75P14
     9061M23P06         9061M23P07        9061M23P08        9061M23P09
     9061M23P10         9061M23P12        9061M23P14        9061M23P15
     9061M23P16         9224M75P01
------------------------------------------------------------------------

    These engines are installed on, but not limited to, Boeing 747-
200B series, -200C series, and -200F series, 747-300 series
airplanes; McDonnell Douglas DC-10-15, -30, and -30F, MD-10-30, KC-
10A, and KDC-10 airplanes; and Airbus A300 series airplanes.

Unsafe Condition

    (d) This AD results from seven reports of uncontained failures
of LPT stage 3 disks and eight reports of cracked LPT stage 3 disks
found during shop visit inspections. We are issuing this AD to
prevent LPT rotor separation, which could result in an uncontained
engine failure and damage to the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed at each shop visit after the effective date of this AD,
at which the LPT module is separated from the engine.

Cleaning the LPT Stage 3 Disk

    (f) Clean the LPT stage 3 disk, using a wet-abrasive blast to
eliminate residual or background fluorescence. You can find guidance
on cleaning the disk in the cleaning procedure of CF6-50 Engine
Manual, GEK 50481 72-57-02.

Inspecting the LPT Stage 3 Disk

    (g) Perform a fluorescent penetrant inspection (FPI) of the
inner diameter of the forward cone body (forward spacer arm) of the
LPT stage 3 disk. You can find guidance on performing the FPI in the
CF6-50 Engine Manual, GEK 50481 72-57-02.
    (h) If a crack or a band of fluorescence is present, remove the
disk from service.

Alternative Methods of Compliance

    (i) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Related Information

    (j) Contact Christopher J. Richards, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>; fax: (781)
238-7199, for more information about this AD.

    Issued in Burlington, Massachusetts, on October 8, 2010.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2010-26312 Filed 10-19-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)]
[Notices]
[Pages 16599-16600]
[FR Doc No: 2017-06701]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-3560]

Determination That CEDAX (Ceftibuten Dihydrate) for Oral
Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5
Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that CEDAX (ceftibuten dihydrate) for oral suspension, 90
milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
ceftibuten dihydrate for oral suspension, 90 mg/5 mL and 180 mg/5 mL,
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Anuj Shah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and
180 mg/5 mL, are the subject of NDA 050686, held by Pernix Therapeutics
LLC, and initially approved on December 20, 1995. CEDAX is indicated
for the treatment of individuals with mild-to-moderate infections
caused by susceptible strains of Haemophilus influenzae (including
[beta]-lactamase-producing strains), Moraxella catarrhalis (including
[beta]-lactamase-producing strains), or Streptococcus pneumoniae
(penicillin-susceptible strains only) in acute bacterial exacerbations
of chronic bronchitis; H. influenzae (including [beta]-lactamase-
producing strains), M. catarrhalis (including [beta]-lactamase-
producing strains), or S. pneumoniae (penicillin-susceptible strains
only) in acute bacterial otitis media; and S. pyogenes in pharyngitis
and tonsillitis.
    CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and
180 mg/5 mL, are currently listed in the ``Discontinued Drug Product
List'' section of the Orange Book.
    Orchid Healthcare (a division of Orchid Pharma, Ltd.) submitted a
citizen petition dated October 26, 2016 (Docket No. FDA-2016-P-3560),
under 21 CFR 10.30, requesting that the Agency determine whether CEDAX
(ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL,
were withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that CEDAX (ceftibuten dihydrate) for oral
suspension, 90 mg/5 mL and 180 mg/5 mL, were not withdrawn for reasons
of safety or effectiveness. The petitioner has identified no data or
other information suggesting that these drug products were withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of CEDAX (ceftibuten
dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, from sale.
We have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We have reviewed the available
evidence and determined that these drug products were not withdrawn
from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list CEDAX (ceftibuten
dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to these drug products
may be approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: March 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06701 Filed 4-4-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 27, 2009 (Volume 74, Number 100)]
[Notices]
[Page 25245-25246]
[DOCID:fr27my09-40]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0253]

Draft Guidance for Industry on Presenting Risk Information in
Prescription Drug and Medical Device Promotion; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Presenting
Risk Information in Prescription Drug and Medical Device Promotion.''
This guidance responds to stakeholder requests for specific guidance on
how FDA evaluates prescription drug and device promotional pieces to
determine whether they adequately present risk information. The
guidance describes and discusses the factors FDA considers when
evaluating prescription drug advertisements (ads), restricted device
ads, and prescription drug and device promotional labeling for their
compliance with the Federal Food, Drug, and Cosmetic Act (the act) and
relevant regulations. The guidance gives examples to illustrate FDA's
thinking on these factors and is intended to help regulated industry
gain a better understanding of what they should consider as they
develop the content and format of their promotional communications.

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 comments on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by August 25, 2009. General comments on agency guidance documents are
welcome at any time.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT:  Regarding human prescription drugs:
Kristin Davis, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 Hampshire Ave., Bldg. 22, Silver Spring, MD
20993,<PHONE_NUMBER>.
    Regarding prescription human biological products: Ele Ibarra-Pratt,
Center for Biologics Evaluation and Research (HFM-602), Food and Drug
Administration, 5515 Security Lane, Rockville, MD 20852-1448, 301-827-
3028.
    Regarding medical device products: Ann Simoneau, Center for Devices
and Radiological Health (HFZ-302), 2094 Gaither Rd., Rockville, MD
20850,<PHONE_NUMBER>.
    Regarding prescription animal drug products: Martine Hartogensis,
Center for Veterinary Medicine (HFV-216), 7519 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Presenting Risk Information in

Prescription Drug and Medical Device Promotion.'' FDA has
responsibility under the act for regulating promotional labeling for
prescription drugs and devices and advertising for prescription drugs
and restricted devices. As required by the act and regulations, FDA
evaluates the promotional materials for these products to determine
whether the promotional materials for the product convey an accurate
and nonmisleading net impression about the risks and benefits of the
product. The draft guidance describes factors FDA considers when
evaluating the risk information in promotional materials for these
products.
    FDA relies on an extensive body of knowledge regarding human
cognition in assessing which factors to consider in evaluating
promotional materials and making regulatory decisions about the
presentation of risk information. In this draft guidance, FDA discusses
both the content and format factors that are relevant to its
determination of whether promotional materials adequately present risk
information and provides numerous examples to illustrate FDA's thinking
on these factors. The agency also makes recommendations about how
manufacturers can develop the content and format of their promotional
materials to comply with the requirements. The recommendations in the
guidance apply to both consumer- and professional-directed promotional
materials.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on risk
information in prescription drug and medical device promotion. 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 document.
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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: May 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12255 Filed 5-26-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: March 31, 2010 (Volume 75, Number 61)]
[Notices]
[Page 16100]
[DOCID:fr31mr10-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PL10-4-000]

Enforcement of Statutes, Orders, Rules and Regulations; Notice of
Workshops on Penalty Guidelines

March 24, 2010.
    The staff of the Federal Energy Regulatory Commission (Commission)
will hold three workshops to provide a forum for interested
participants to ask questions on the interpretation and application of
the Policy Statement on Penalty Guidelines, which the Commission
recently issued on March 18, 2010.\1\ Staff will hold the first
workshop on April 7, 2010, from 9:30 a.m. to 12 p.m. Eastern Daylight
Time, in the Commission Meeting Room (2C) at the Commission's
Washington, DC headquarters, 888 First Street, NE. To accommodate
participants outside of Washington, DC, this workshop will be webcast,
but will not be transcribed. All interested parties are invited, and
there is no registration list or registration fee to attend.
---------------------------------------------------------------------------

    \1\ Enforcement of Statutes, Orders, Rules, and Regulations, 130
FERC ] 61,220 (2010).
---------------------------------------------------------------------------

    Staff will also hold similar workshops in Houston, Texas on April
14, 2010, and in San Francisco, California on April 15, 2010. The times
and locations of these later workshops will be provided in a subsequent
notice. These workshops will not be webcast.
    The purpose of the workshops will be to have staff discuss how the
Penalty Guidelines will be applied and to answer questions about the
Penalty Guidelines. In that regard, questions are being solicited from
the public in advance of the workshops. Please submit questions on the
Penalty Guidelines to Jeremy Medovoy, Attorney-Advisor, Office of
Enforcement, Division of Investigations, by e-mail at
<EMAIL_ADDRESS>Workshop participants will also have an
opportunity to ask questions at the workshops, but due to time
limitations, questions in advance are encouraged.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    Questions about the workshops may be directed to Jeremy Medovoy by
e-mail at<EMAIL_ADDRESS>or by telephone at<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-7140 Filed 3-30-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 22, 2007 (Volume 72, Number 120)]
[Notices]
[Page 34483-34485]
[DOCID:fr22jn07-83]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0055]

Construction Records for Rigging Equipment; Extension of the
Office of Management and Budget's (OMB) Approval of Information
Collection (Paperwork) Requirements

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

ACTION: Request for public comment.

-----------------------------------------------------------------------

SUMMARY: OSHA solicits public comment concerning its proposal to extend
OMB approval of the information collection requirements contained in
paragraphs (b)(1), (b)(6)(i), (b)(6)(ii), (c)(15)(ii), (e)(1)(i), (ii),
and (iii) and (f)(2) of the Rigging Equipment for Construction Standard
(29 CFR 1926.251). These paragraphs require affixing identification
tags or markings on rigging equipment, developing and maintaining
inspection records, and retaining proof-testing certificates.

DATES: Comments must be submitted (postmarked, sent, or received) by
August 20, 2007.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal

eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit three copies of your comments
and attachments to the OSHA Docket Office, Docket No. OSHA-2007-0055,
U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-2625, 200 Constitution Avenue, NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the ICR (OSHA-2007-0055). All comments, including any
personal information you provide, are placed in the public docket
without change, and may be made available online at http://www.regulations.gov
.

For further information on submitting comments see the ``Public
Participation'' heading in the section of this notice titled
SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at

the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;

however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Stewart
Burkhammer at the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Stewart Burkhammer, Directorate of
Construction, OSHA, U.S. Department of Labor, Room N-3468, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
2020.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of efforts in
obtaining information (29 U.S.C. 657).
    The following section identifies and describes the information
collection requirements contained in the Rigging Equipment in
Construction Standard (i.e., ``the Standard''). The purpose of each of
these requirements is to prevent employees from using defective or
deteriorated equipment, thereby reducing their risk of death or serious
injury caused by equipment failure during material handling.

 Alloy Steel Chains, Paragraph (b)

    Paragraph (b)(1) requires that alloy steel chains have permanently
affixed durable identification tags stating size, grade, rated capacity
and sling manufacturer. Paragraph (b)(6)(i) requires the employer to
make a thorough periodic inspection of alloy steel chain slings in use
on a regular basis, but at least once a year. Paragraph (b)(6)(ii)
requires the employer to make and maintain a record of the most recent
month in which each alloy steel chain was inspected and make the record
available for examination.

 End Attachments, Paragraph (c)

    Paragraph (c)(15)(ii) requires that all welded end attachments of
wire rope slings be proof-tested by the manufacturer at twice their
rated capacity prior to initial use, and that the employer retain a
certificate of the proof test and make it available for examination.

 Synthetic Webbing (Nylon, Polyester, and Polypropylene),
Paragraph (e)

    Paragraphs (e)(1)(i), (ii), and (iii) require that synthetic web
slings be marked or coded to show the manufacturer's name or trademark,
the rated capacity for the type of hitch and the type of synthetic
webbing material.

 Shackles and Hooks, Paragraph (f)

    Paragraph (f)(2) requires that all hooks for which no applicable
manufacturer's recommendations are available be tested twice before
they are put into use. The employer shall maintain a record of the
dates and results of the tests.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirements contained in the Rigging Equipment Standard (29
CFR 1926.251). The Agency will summarize the comments submitted in
response to this notice and will include this summary in the request to
OMB.
    Type of Review: Extension of currently approved information
collection requirements.
    Title: Rigging Equipment for Material Handling (29 CFR
1926.25(b)(1), (b)(6)(i), (b)(6)(ii), (c)(15)(ii), (e)(1)(i), (ii), and
(iii), and (f)(2).
    OMB Number: 1218-0233.
    Affected Public: Business or other for-profit.
    Number of Respondents: 1,327,370.
    Frequency: On occasion.
    Average Time Per Response: Average 3 minutes (.05 hour) for an
employer to maintain and disclose a certificate to 30 minutes (.50
hour) for an employer to acquire information and make a tag for a
sling.
    Estimated Total Burden Hours: 56,335.
    Estimated Cost (Operation and Maintenance): $-0-.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal

eRulemaking Portal; (2) by facsimile (FAX); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2007-0055). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>).

    Comments and submissions are posted without change at http://www.regulations.gov.
 Therefore, OSHA cautions commenters about

submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://www.regulations.gov
 index, some information (e.g., copyrighted

material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit

comments and access the docket is available at the Web site's ``User
Tips'' link. Contact the OSHA Docket Office for information about
materials not available through the Web site, and for assistance in
using the Internet to locate docket submissions.

V. Authority and Signature

    Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational
Safety and Health, directed the preparation of this notice. The
authority for this notice is the Paperwork Reduction Act of 1995 (44
U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 5-2002 (67 FR
65008).

    Signed at Washington, DC, on June 14, 2007.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor for Occupational Safety and Health.
 [FR Doc. E7-12050 Filed 6-21-07; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register Volume 76, Number 176 (Monday, September 12, 2011)]
[Notices]
[Pages 56189-56191]
[FR Doc No: 2011-23207]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12965-002]

Symbiotics, LLC; Notice of Application Accepted for Filing,
Soliciting Motions to Intervene and Protests, Ready for Environmental
Analysis, and Soliciting Comments, Recommendations, Preliminary Terms
and Conditions, and Preliminary Fishway Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original Major License.
    b. Project No.: 12965-002.
    c. Date filed: March 25, 2011.
    d. Applicant: Symbiotics, LLC.
    e. Name of Project: Wickiup Dam Hydroelectric Project.
    f. Location: The proposed project would be constructed at the
existing U.S. Bureau of Reclamation (Reclamation) Wickiup dam located
on the Deschutes River near LaPine in Deschutes County, Oregon. The
project would occupy 1.02 acres of federal

lands jointly managed by the U.S. Forest Service and Reclamation.
    g. Filed Pursuant to: Federal Power Act 16 USC 791 (a)--825(r).
    h. Applicant Contact: Brent L. Smith, Chief Operating Officer,
Symbiotics, LLC, 371 Upper Terrace, Suite 2, Bend, OR 97702; telephone
(541) 330-8779.
    i. FERC Contact: Matt Cutlip,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests, comments,
recommendations, preliminary terms and conditions, and preliminary
prescriptions: 60 days from the issuance date of this notice; reply
comments are due 105 days from the issuance date of this notice.
    Motions to intervene, protests, comments, recommendations,
preliminary terms and conditions, and preliminary fishway prescriptions
may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. Project Description: The proposed project would consist of the
following new facilities: (1) Two 8-foot-diameter, 75-foot-long steel
penstocks connecting to the existing twin outlet conduits above the
existing regulating tube valves combining into a 10-foot-diameter, 68-
foot-long penstock delivering flow to the powerhouse; (2) two 8-foot-
diameter isolation valves constructed within the 75-foot-long
penstocks; (3) a 50-foot by 50-foot concrete powerhouse located on the
northwest side of the existing concrete stilling basin with one
generating unit with a total installed capacity of 7.15 megawatts; (4)
a fish killing rotor system downstream of the powerhouse draft tube to
prevent non-native fish species from surviving Kaplan turbine passage
into the Deschutes River downstream of the project; (5) a tailrace
picket barrier downstream of the fish killing rotor system to protect
upstream migrating fish; (6) a 135-foot-long, 24.9-kilovolt buried
transmission line connecting to an existing power line; and (7)
appurtenant facilities.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Anyone may submit comments, a protest, or a motion to intervene
in accordance with the requirements of Rules of Practice and Procedure,
18 CFR 385.210, .211, .214. In determining the appropriate action to
take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) bear in all capital letters the title
``PROTEST'', ``MOTION TO INTERVENE'', ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``PRELIMINARY TERMS AND CONDITIONS,'' or
``PRELIMINARY FISHWAY PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. A copy of any protest or
motion to intervene must be served upon each representative of the
applicant specified in the particular application. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.
    o. Procedural Schedule: The application will be processed according
to the following revised Hydro Licensing Schedule. Revisions to the
schedule may be made as appropriate.

------------------------------------------------------------------------
                Milestone                           Target Date
------------------------------------------------------------------------
Filing of recommendations, preliminary    November 2011
 terms and conditions, and preliminary
 fishway prescriptions.
Commission issues Draft EA..............  May 2012
Comments on Draft EA....................  June 2012
Filing of modified terms and conditions.  July 2012
Commission issues Final EA..............  October 2012
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.
    q. A license applicant must file no later than 60 days following
the date of issuance of the notice of acceptance and ready for
environmental analysis provided for in 5.22: (1) A copy of the water
quality certification; (2) a copy of the request for certification,
including proof of the date on which the certifying agency received the
request; or (3) evidence of waiver of water quality certification.
    r. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application, or a notice of
intent to file such an application. Submission of a timely notice of
intent allows an interested person to file the competing development
application no later than 120 days after the specified intervention
deadline date. Applications for preliminary permits will not be
accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A

notice of intent must be served on the applicant(s) named in this
public notice.

    Dated: September 6, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-23207 Filed 9-9-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 25 (Wednesday, February 6, 2019)]
[Notices]
[Pages 2210-2211]
[FR Doc No: 2019-01189]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10684-000]

Lansing Board of Water and Light; Notice of Existing Licensee's
Failure To File a Notice of Intent To File a Subsequent License
Application, and Soliciting Notices of Intent To File a License
Application and Pre-Application Documents

    The current license for the Lansing Board of Water and Light's
Moores Park Project No. 10684 (Moores Park Project) was issued on
January 5, 1994, for a term of 30 years, ending December 31, 2023.\1\
The 600-kilowatt (kW) project is located on the Grand River in the City
of Lansing, in Ingham County, Michigan.
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    \1\ Lansing Board of Water and Light, 66 FERC 62,002 (1994).
---------------------------------------------------------------------------

    The principal project works consist of: (1) A 240-acre reservoir
with 2,000-acre-feet of storage at a normal water surface elevation of
833.6 feet National Geodetic Vertical Datum; (2) a 190-foot-long, 21-
foot-high reinforced concrete gravity dam divided into a 120-foot-long
flashboard-crested spillway section and a 70-foot-long, three-bay
Taintor-gate section, each gate measuring 20-foot-long by 10-foot-high;
(3) a 110-foot-long, 50- to 83-foot-wide, 61-foot-high integral water-
impounding powerhouse constructed of reinforced concrete and brick
masonry containing one horizontal axis turbine-generator unit rated at
600 kW; (4) a 200-foot-long, 4,160-volt underground transmission line
connected to a step-up transformer; and (5) appurtenant equipment and
facilities.
    At least five years before the expiration of a license for a minor
water power project in which sections 14 and 15 of the Federal Power
Act were waived, the Commission's regulations require the licensee to
file with the Commission a notice of intent (NOI) that contains an
unequivocal statement of the licensee's intention to file or not to
file an application for a subsequent license, details on the principal
project works and installed plant capacity, and other information.\2\
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    \2\ 18 CFR 16.19(b) (2018) (citing 18 CFR 16.6(b) (2018)).
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    If such a licensee does not inform the Commission that it intends
to file an application for, in this case, a subsequent license for the
project, the licensee may not file an application for a subsequent
license, either individually or in conjunction with an entity or

entities that are not currently licensees of the project.\3\
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    \3\ 18 CFR 16.24(b) (2018).
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    Because the existing license expires on December 31, 2023, the NOI
was due to be filed by the close of business on December 31, 2018. The
Lansing Board of Water and Light, the existing licensee for the Moores
Park Project, failed to file an NOI for the project by this date.\4\
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    \4\ 18 CFR 16.23(b) (2018).
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    Any party interested in filing a license application for the Moores
Park Project No. 10684 must first file a NOI \5\ and pre-application
document (PAD) \6\ pursuant to Part 5 of the Commission's regulations.
Although the integrated licensing process (ILP) is the default pre-
filing process, section 5.3(b) of the Commission's regulations allows a
potential license applicant to request to use the traditional licensing
process or alternative procedures when it files its NOI.\7\
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    \5\ 18 CFR 5.5 (2018).
    \6\ 18 CFR 5.6 (2018).
    \7\ 18 CFR 5.3(b) (2018).
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    This notice sets a deadline of 120 days from the date of this
notice for interested applicants, other than the existing licensee, to
file NOIs, PADs, and requests to use the traditional licensing process
or alternative procedures.
    Applications for a subsequent license from potential applicants
must be filed with the Commission at least 24 months prior to the
expiration of the existing license.\8\ Because the existing license
expires on December 31, 2023, applications for license for this project
must be filed by December 31, 2021.\9\
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    \8\ 18 CFR 16.20 (2018).
    \9\ To the extent an interested applicant files an NOI and PAD
and elects or is required to use the Commission's ILP, a process
plan will be issued within 180 days of this notice, which
accelerates the steps of the ILP to allow for filing a timely
subsequent license application by the December 31, 2021 deadline.
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    Questions concerning this notice should be directed to Lee Emery at
(202) 502-8379 or<EMAIL_ADDRESS>
    Dated: January 31, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-01189 Filed 2-5-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Rules and Regulations]
[Pages 44771-44773]
[FR Doc No: 2016-16351]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2016-N-1653]

Medical Devices; Neurological Devices; Classification of the
Thermal System for Insomnia

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
thermal system for insomnia into class II (special controls). The
special controls that will apply to the device are identified in this
order and will be part of the codified language for the thermal system
for insomnia's classification. The Agency is classifying the device
into class II (special controls) in order to provide a reasonable
assurance of safety and effectiveness of the device.

DATES: This order is effective July 11, 2016. The classification was
applicable on May 13, 2016.

FOR FURTHER INFORMATION CONTACT: Leigh Anderson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.

    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On October 17, 2014, Cer[ecirc]ve Inc. submitted a request for
classification of the Cer[ecirc]ve Sleep System under section 513(f)(2)
of the FD&C Act. The manufacturer recommended that the device be
classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, 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. FDA
classifies 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 to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the request, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on May 13, 2016, 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 882.5700.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a thermal
system for insomnia will need to comply with the special controls named
in this final order.
    The device is assigned the generic name thermal system for
insomnia, and it is identified as a prescription device for use in
patients with insomnia that is used to apply a specified temperature to
the skin surface.
    FDA has identified the following risks to health associated
specifically with this type of device, as well as the mitigation
measures required to mitigate these risks in table 1:

   Table 1--Thermal System for Insomnia Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation method
------------------------------------------------------------------------
Adverse skin reaction..................  Biocompatibility Assessment.
                                         Labeling.
Electromagnetic Interference with Other  Electromagnetic Compatibility
 Devices.                                 Testing.
                                         Labeling.
Electrical Safety (e.g., shock)........  Electrical Safety Testing.
                                         Labeling.
Thermal Injury.........................  Non-clinical Performance
                                          Testing.
                                         Software Verification,
                                          Validation, and Hazard
                                          Analysis.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness.
    Thermal systems for insomnia devices are not safe to use except
under the supervision of a practitioner licensed by law to direct the
use of the device. As such, the device is a prescription device and
must satisfy prescription labeling requirements (see 21 CFR 801.109
Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the thermal system for insomnia they
intend to market.

II. Analysis of Environmental Impact

    The Agency has 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.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. 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
part 807, subpart E, regarding premarket notification submissions, have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR part 801, regarding labeling, have been
approved under OMB control number 0910-0485.

IV. Reference

    The following reference is on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and is available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it
is also available electronically at http://www.regulations.gov.

1. DEN140032 De novo Request per 513(f)(2) from Cer[ecirc]ve, Inc.,
dated October 17, 2014.

List of Subjects in 21 CFR Part 882

    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
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

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

0
2. Add Sec.  882.5700 to subpart F to read as follows:

Sec.  882.5700  Thermal system for insomnia.

    (a) Identification. A thermal system for insomnia is a prescription
device for use in patients with insomnia that is

used to apply a specified temperature to the skin surface.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (2) Performance testing must demonstrate electromagnetic
compatibility and electrical safety.
    (3) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be evaluated:
    (i) Thermal performance of the device, including maintenance of the
target temperature, must be evaluated under simulated use conditions.
    (ii) Mechanical testing to demonstrate the device can withstand
forces under anticipated use conditions.
    (iii) Mechanical testing to demonstrate the device is resistant to
leakage under anticipated use conditions.
    (4) Software verification, validation, and hazard analysis must be
performed.
    (5) Patient labeling must be provided to convey information
regarding safe use of the device, including instructions for assembly.

    Dated: July 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16351 Filed 7-8-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Page 18583]
[FR Doc No: 2021-07272]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91474; File No. SR-FINRA-2020-031]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Designation of Longer Period for Commission
Action on Proceedings To Determine Whether To Approve or Disapprove a
Proposed Rule Change, as Modified by Amendment No. 1, To Adopt Proposed
Rule 6439 (Requirements for Member Inter-Dealer Quotation Systems) and
Rescind the Rules Related to the OTC Bulletin Board Service

April 5, 2021.
    On September 24, 2020, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'' or ``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to rescind the rules related to
the OTC Bulletin Board Service and cease its operation and to adopt new
requirements for member inter-dealer quotation systems that disseminate
quotations in equity securities traded over-the-counter (``OTC''). The
proposed rule change was published for comment in the Federal Register
on October 7, 2020.\3\ On November 4, 2020, pursuant to Section
19(b)(2) of the Act,\4\ the Commission designated a longer period
within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\5\ On December 21, 2020, FINRA
filed Amendment No. 1 to the proposed rule change.\6\ On December 30,
2020, the Commission published notice of Amendment No. 1 to solicit
comments and instituted proceedings to determine whether to approve or
disapprove the proposed rule change.\7\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Exchange Act Release No. 90067 (October 1, 2020), 85 FR
63314 (``Notice''). Comments on the proposed rule change can be
found at: https://www.sec.gov/comments/sr-finra-2020-031/srfinra2020031.htm.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Exchange Act Release No. 90335, 85 FR 218 (November 10,
2020).
    \6\ Amendment No. 1 may be found at: https://www.sec.gov/comments/sr-finra-2020-031/srfinra2020031.htm.
    \7\ See Exchange Act Release No. 90824 (January 6, 2021), 86 FR
653.
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    Section 19(b)(2) of the Act \8\ provides that, after initiating
proceedings, the Commission shall issue an order approving or
disapproving the proposed rule change not later than 180 days after the
date of publication of notice of filing of the proposed rule change.
The Commission may extend the period for issuing an order approving or
disapproving the proposed rule change, however, by not more than 60
days if the Commission determines that a longer period is appropriate
and publishes the reasons for such determination. The proposed rule
change was published for notice and comment in the Federal Register on
October 7, 2020.\9\ April 5, 2021 is 180 days from that date, and June
4, 2021 is 240 days from that date.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).
    \9\ See Notice, supra note 3.
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider the proposed
rule change, the issues raised in the comment letters that have been
submitted in connection therewith, and the Exchange's responses to
comments. Accordingly, the Commission, pursuant to Section 19(b)(2) of
the Act,\10\ designates June 4, 2021 as the date by which the
Commission should either approve or disapprove the proposed rule change
(File No. SR-FINRA-2020-031).
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    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(57).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-07272 Filed 4-8-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Proposed Rules]
[Pages 46747-46748]
[FR Doc No: 2014-18621]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2014-0142; FRL-9914-50-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Revision to the Maintenance Plans for the Richmond 1990 1-
Hour and Richmond-Petersburg 1997 8-Hour Ozone Maintenance Areas To
Remove the Stage II Vapor Recovery Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) proposes to approve
the State Implementation Plan (SIP) revision submitted by the
Commonwealth of Virginia (Commonwealth). The revision removes the Stage
II vapor recovery program (Stage II) from the maintenance plans for the
Richmond 1990 1-hour and Richmond-Petersburg 1997 8-hour ozone National
Ambient Air Quality Standard (NAAQS) Maintenance Areas (Richmond Area
or Area). The revision also includes an analysis that addresses the
impact of the removal of Stage II from subject gasoline dispensing
facilities (GDFs) in the Richmond Area. The analysis submitted by the
Commonwealth satisfies the requirements of section 110(l) of the Clean
Air Act (CAA). In the Final Rules section of this Federal Register, EPA
is approving the State's SIP submittal as a direct final rule without
prior proposal because the Agency views this as a noncontroversial
submittal and anticipates no adverse comments. A detailed rationale for
the approval is set forth in the direct final rule and the Technical
Support Document (TSD) prepared in support of this rulemaking action. A
detailed summary of EPA's review and rationale for proposing to approve
this SIP revision may be found in the TSD prepared in support of this
rulemaking action and is available on line at http://www.regulations.gov, Docket number EPA-R03-OAR-2014-0142. If no adverse
comments are received in response to this action, no further activity
is contemplated. If EPA receives adverse comments, the direct final
rule will be withdrawn and all public comments received will be
addressed in a subsequent final rule based on this proposed rule. EPA
will not institute a second comment period. Any parties interested in
commenting on this action should do so at this time.

DATES: Comments must be received in writing by September 10, 2014.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2014-0142 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2014-0142, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2014-0142. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise

protected through www.regulations.gov or email. The www.regulations.gov
Web site is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an email comment directly to EPA
without going through www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Virginia Department of Environmental Quality, 629
East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Asrah Khadr,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action, with the same title,
that is located in the ``Rules and Regulations'' section of this
Federal Register publication.

    Dated: July 11, 2014.
William C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2014-18621 Filed 8-8-14; 8:45 am]
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