[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)]
[Notices]
[Pages 47920-47921]
[FR Doc No: 2018-20555]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC18-147-000.
    Applicants: Avista Corporation.
    Description: Supplement to August 31, 2018 Application for
Authorization Under Section 203 of the Federal Power Act, et al. of
Avista Corporation.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5067.
    Comments Due: 5 p.m. ET 10/5/18.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER18-2009-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: Deficiency Response--Revisions to
Enhance Regulation Deployment of DVERs to be effective 12/18/2018.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5101.
    Comments Due: 5 p.m. ET 10/5/18.

    Docket Numbers: ER18-2421-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2018-09-13 Dynamic Transfer
Balancing Authority Operating Agmt with Nevada Power to be effective
10/27/2018.
    Filed Date: 9/13/18.
    Accession Number: 20180913-5089.
    Comments Due: 5 p.m. ET 10/4/18.

    Docket Numbers: ER18-2422-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2018-09-13 Amendment No. 4
to ABAOA with Nevada Power Company to be effective 11/13/2018.
    Filed Date: 9/13/18.
    Accession Number: 20180913-5090.
    Comments Due: 5 p.m. ET 10/4/18.

    Docket Numbers: ER18-2423-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2018-09-14_SA 3145 Heartland
Wind-NSPM E&P (J432) to be effective 9/15/2018.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5009.
    Comments Due: 5 p.m. ET 10/5/18.

    Docket Numbers: ER18-2424-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2018-09-14_SA 3147 MMPA-NSP
TSR CPA (F115) to be effective 8/14/2018.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5033.
    Comments Due: 5 p.m. ET 10/5/18.

    Docket Numbers: ER18-2425-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Sec.  205(d) Rate Filing: DEP-Fayetteville PWC PSCA
Amendment to be effective 11/13/2018.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5035.
    Comments Due: 5 p.m. ET 10/5/18.

    Docket Numbers: ER18-2426-000.
    Applicants: The Potomac Edison Company, PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Potomac submits IA SA No.
4452 to be effective 11/13/2018.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5038.
    Comments Due: 5 p.m. ET 10/5/18.

    Docket Numbers: ER18-2427-000.
    Applicants: Nevada Power Company.
    Description: Sec.  205(d) Rate Filing: NPC Concurrence to CAISO
SA4819 to be effective 9/13/2018.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5084.
    Comments Due: 5 p.m. ET 10/5/18.

    Docket Numbers: ER18-2428-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 2018-09-14 Ministerial
Revisions-Att O-PSCo Tbl 35, Sch 16 to be effective 4/16/2016.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5102.
    Comments Due: 5 p.m. ET 10/5/18.

    Docket Numbers: ER18-2429-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2018-09-14 First Amendment
to MEEA between CAISO and SMUD--Sutter Energy to be effective 9/15/
2018.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5110.
    Comments Due: 5 p.m. ET 10/5/18.

    Docket Numbers: ER18-2429-001.
    Applicants: California Independent System Operator Corporation.
    Description: Tariff Amendment: 2018-09-14 Second Amendment to MEEA
between CAISO and SMUD--Sutter Energy to to be effective 11/29/2018.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5142.
    Comments Due: 5 p.m. ET 10/5/18.

    Docket Numbers: ER18-2430-000.
    Applicants: Otter Tail Power Company.
    Description: Tariff Cancellation: Notice of Termination of
Fibrominn CASOT Service Agreement to be effective 11/13/2018.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5116.
    Comments Due: 5 p.m. ET 10/5/18.

    Docket Numbers: ER18-2431-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 2198R26 Kansas Power Pool
NITSA NOA to be effective 9/1/2018.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5159.
    Comments Due: 5 p.m. ET 10/5/18.

    Docket Numbers: ER18-2432-000.
    Applicants: ISO New England Inc., Central Maine Power Company.
    Description: Sec.  205(d) Rate Filing: Second Revised LGIA-ISONE/
CMP-08-01 under Schedule 22 of ISO-NE OATT to be effective 8/16/2018.
    Filed Date: 9/14/18.

    Accession Number: 20180914-5160.
    Comments Due: 5 p.m. ET 10/5/18.

    Take notice that the Commission received the following public
utility holding company filings:

    Docket Numbers: PH18-14-000.
    Applicants: CMS Energy Corporation.
    Description: CMS Energy Corporation submits FERC 65-B Notice of
Material Change.
    Filed Date: 9/14/18.
    Accession Number: 20180914-5076.
    Comments Due: 5 p.m. ET 10/5/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 14, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-20555 Filed 9-20-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Rules and Regulations]
[Pages 41665-41667]
[FR Doc No: 2011-17576]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0307; Directorate Identifier 2010-NM-111-AD;
Amendment 39-16747; AD 2011-14-12]
RIN 2120-AA64

Airworthiness Directives; Saab AB, Saab Aerosystems Model SAAB
2000 Airplanes

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

ACTION: Final rule.

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

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

    A report has been received of an incident where one of the two
bolts attaching the actuator mounting bracket to the MLG [main
landing gear] Shock Strut was found loose, leading to failure of the
other attachment bolt, subsequently resulting in failure of the
bracket.
    This condition, if not detected and corrected, could prevent the
MLG to extend to the full down-and-locked position, possibly
resulting in MLG collapse upon landing or during roll-out, with
consequent damage to the aeroplane and injury to the occupants.
* * * * *
We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective August 19, 2011.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 1,
2011.

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

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

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on April 8, 2011 (76 FR
19719). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    A report has been received of an incident where one of the two
bolts attaching the actuator mounting bracket to the MLG Shock Strut
was found loose, leading to failure of the other attachment bolt,
subsequently resulting in failure of the bracket.
    This condition, if not detected and corrected, could prevent the
MLG to extend to the full down-and-locked position, possibly
resulting in MLG collapse upon landing or during roll-out, with
consequent damage to the aeroplane and injury to the occupants.
    To correct this potentially unsafe condition, SAAB has published
Service Bulletin (SB) 2000-32-073, describing a [detailed]
inspection of the attachment bolts [and nuts] to detect any loose
bolts [and nuts], follow-up corrective action(s), depending on
findings, and the installation of the correct number of washers.
    For the reasons described above, this EASA AD requires the
accomplishment of the actions described in SAAB SB 2000-32-073.

Required actions, if any loose parts are found, include replacing the
bolt with a new bolt, and then doing a detailed inspection of the bolts
for uniform or fretting corrosion; a detailed inspection of the
actuator mounting bracket and shock struts for damage, cracks, and
signs of corrosion; and doing corrective actions if necessary.
Corrective actions include removing corrosion, replacing affected bolts
with new bolts, tightening loose nuts, repairing, and installing the
correct number of washers. You may obtain further information by
examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    We estimate that this AD will affect about 8 products of U.S.
registry. We also estimate that it will take about 1 work-hour per
product to comply with the basic requirements of this AD. The average
labor rate is $85 per work-hour. Required parts will cost about $1,039
per product. Where the service information lists required parts costs
that are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $8,992, or $1,124 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 10 work-hours and require parts costing $1,039, for a cost
of $1,889 per

product. We have no way of determining the number of products that may
need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ''significant regulatory action'' under Executive Order
12866;
    2. Is not a ''significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2011-14-12 Saab AB, Saab Aerosystems: Amendment 39-16747. Docket No.
FAA-2011-0307; Directorate Identifier 2010-NM-111-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective August
19, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Saab AB, Saab Aerosystems Model SAAB
2000 airplanes, certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 32: Landing
gear.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    A report has been received of an incident where one of the two
bolts attaching the actuator mounting bracket to the MLG [main
landing gear] Shock Strut was found loose, leading to failure of the
other attachment bolt, subsequently resulting in failure of the
bracket.
    This condition, if not detected and corrected, could prevent the
MLG to extend to the full down-and-locked position, possibly
resulting in MLG collapse upon landing or during roll-out, with
consequent damage to the aeroplane and injury to the occupants.
* * * * *

Compliance

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

Inspection

    (g) Within 12 months after the effective date of this AD, do a
detailed inspection for any loose top bolt and nut of the shock
strut actuator mounting bracket of both the left-hand and right-hand
main landing gear (MLG), in accordance with paragraph 2.B. of the
Accomplishment Instructions of Saab Service Bulletin 2000-32-073,
Revision 01, dated October 20, 2009.

Corrective Actions

    (h) If any loose bolt or nut is found during the inspection
required by paragraph (g) of this AD, before further flight, replace
the bolt with a new bolt and accomplish paragraphs (h)(1) and (h)(2)
of this AD, in accordance with paragraph 2.C. of the Accomplishment
Instructions of Saab Service Bulletin 2000-32-073, Revision 01,
dated October 20, 2009.
    (1) Do a detailed inspection of the bottom bolts for uniform or
fretting corrosion. If any corrosion is found, before further
flight, accomplish all applicable corrective actions, in accordance
with the Accomplishment Instructions of Saab Service Bulletin 2000-
32-073, Revision 01, dated October 20, 2009.
    (2) Do a detailed inspection for damage, cracks, and other signs
of deterioration of the actuator mounting bracket and shock strut.
If signs of damage, cracks, or other signs of deterioration are
found on the actuator mounting bracket or the shock strut, before
further flight, repair in accordance with a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA, or the European Aviation Safety Agency (EASA) (or
its delegated agent).
    (i) Within 12 months after the effective date of this AD, unless
already accomplished in accordance with paragraph (h) of this AD,
install the correct number of washers for both the top and bottom
bolts of the shock strut actuator mounting bracket of both MLG, in
accordance with paragraph 2.C. of the Accomplishment Instructions of
Saab Service Bulletin 2000-32-073, Revision 01, dated October 20,
2009.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (j) Actions accomplished before the effective date of this AD in
accordance with Saab Service Bulletin 2000-32-073, dated June 26,
2009, are considered acceptable for compliance with the
corresponding actions specified in this AD.

FAA AD Differences

    Note 1:  This AD differs from the MCAI and/or service
information as follows:
    No differences.

Other FAA AD Provisions

    (k) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International 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 International Branch, send it
to ATTN: Shahram Daneshmandi, Aerospace Engineer, International
Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind
Avenue, SW., Renton, Washington 98057-

3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may
be e-mailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (l) Refer to MCAI EASA Airworthiness Directive 2010-0069, dated
April 14, 2010; and Saab Service Bulletin 2000-32-073, Revision 01,
dated October 20, 2009; for related information.

Material Incorporated by Reference

    (m) You must use Saab Service Bulletin 2000-32-073, Revision 01,
dated October 20, 2009, to do the actions required by this AD,
unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact Saab
AB, Saab Aerosystems, SE-581 88, Link[ouml]ping, Sweden; telephone
+46 13 18 5591; fax +46 13 18 4874; e-mail
<EMAIL_ADDRESS>Internet http://www.saabgroup.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on July 1, 2011.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-17576 Filed 7-14-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 175 (Tuesday, September 10, 2019)]
[Notices]
[Page 47504]
[FR Doc No: 2019-19473]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP19-1505-001.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Tariff Amendment: Amendment to Filing in Docket No.
RP19-1505-000 to be effective 9/1/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5077.
    Comments Due: 5 p.m. ET 9/16/19.

    Docket Numbers: RP19-1534-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Capacity Release
Agreements--9/1/2019 to be effective 9/1/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5008.
    Comments Due: 5 p.m. ET 9/16/19.

    Docket Numbers: RP19-1535-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts
(Gulfport 34939, 35446 to Eco-Energy 38193, 38194) to be effective 9/1/
2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5074.
    Comments Due: 5 p.m. ET 9/16/19.

    Docket Numbers: RP19-1536-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Amendment to Neg Rate Agmt
(Colorado Bend 46260) to be effective 9/1/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5075.
    Comments Due: 5 p.m. ET 9/16/19.

    Docket Numbers: RP19-1537-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmt
(Constellation 51462 to Exelon 51517) to be effective 9/1/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5076.
    Comments Due: 5 p.m. ET 9/16/19.

    Docket Numbers: RP19-1538-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rate 2019-09-03 Encana to
be effective 9/1/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5129.
    Comments Due: 5 p.m. ET 9/16/19.

    Docket Numbers: RP19-1539-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: New Firm and Interruptible
Lateral Service (Rate Schedules FLS and ILS) to be effective 10/4/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5137.
    Comments Due: 5 p.m. ET 9/16/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 4, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-19473 Filed 9-9-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 51 (Friday, March 15, 2019)]
[Notices]
[Pages 9530-9531]
[FR Doc No: 2019-04883]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1574]

Medical Devices Containing Materials Derived From Animal Sources
(Except for In Vitro Diagnostic Devices); Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Medical Devices
Containing Materials Derived from Animal Sources (Except for In Vitro
Diagnostic Devices).'' FDA is issuing this guidance to update the
policy regarding the use of animal-derived material in medical device
manufacturing. These animal-derived materials may carry a risk of
transmitting infectious disease when improperly collected, stored, or
manufactured. The guidance describes the information manufacturers
should document at the manufacturing facility and include in any
premarket submissions.

DATES: The announcement of the guidance is published in the Federal
Register on March 15, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-D-1574 for ``Medical Devices Containing Materials Derived from
Animal Sources (Except for In Vitro Diagnostic Devices).'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Medical Devices Containing Materials Derived from Animal Sources
(Except for In Vitro Diagnostic Devices)'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Anjana Jain, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G450, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Scott McNamee, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3416,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance entitled ``Medical Devices Containing Materials
Derived From Animal Sources (Except for In Vitro Diagnostic Devices)''
updates the November 6, 1998, guidance of the same name regarding the
use of animal-derived material in medical device manufacturing. The
1998 guidance addressed ways to reduce the potential for exposure to
bovine spongiform encephalopathy. The revised guidance continues to
focus on the control of

transmissible disease and contains recommendations for documenting the
source of animal tissue, conducting viral inactivation validation
studies, as well as recommendations about the role of careful animal
husbandry in ensuring safe tissue sources. The revised guidance also
includes recommendations related to viral pathogens and all
transmissible spongiform encephalopathies.
    The information in this guidance is applicable to all medical
devices that contain or are exposed to animal-derived materials (e.g.,
bovine, ovine, porcine, avian materials) with the exception of in vitro
diagnostic devices and materials generally recognized to be safe based
on their method of manufacture. This guidance provides: (1) Information
that FDA believes is important to document the safe and consistent
manufacture of medical devices containing animal tissue; (2)
information that should be included in a premarket submission for
products within the scope of this guidance; (3) recommendations
regarding how specific aspects of the Quality System (QS) Regulation
should be applied to control and document the safe and consistent
manufacture of medical devices containing animal tissue; and (4)
additional information on specific approaches for determining the
ability of manufacturing methods to eliminate viral contamination in
the final product. Consideration of these items should aid in reducing
the risk of infectious disease transmission by medical devices. FDA
considered comments received on the draft guidance that appeared in the
Federal Register of January 23, 2014 (79 FR 3826). FDA revised the
guidance as appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on medical devices containing materials derived
from animal sources (except for in vitro diagnostic devices). It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Medical Devices
Containing Materials Derived from Animal Sources (Except for In Vitro
Diagnostic Devices)'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 2206 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA
             form                       Topic           OMB control No.
------------------------------------------------------------------------
807, subpart E................  Premarket                      0910-0120
                                 notification.
814, subparts A through E.....  Premarket approval...          0910-0231
814, subpart H................  Humanitarian Device            0910-0332
                                 Exemption.
812...........................  Investigational                0910-0078
                                 Device Exemption.
``De Novo Classification        De Novo                        0910-0844
 Process (Evaluation of          classification
 Automatic Class III             process.
 Designation)''.
``Requests for Feedback on      Q-submissions........          0910-0756
 Medical Device Submissions:
 The Pre-Submission Program
 and Meetings with Food and
 Drug Administration Staff''.
820...........................  Current Good                   0910-0073
                                 Manufacturing
                                 Practice (CGMP);
                                 Quality System (QS)
                                 Regulation.
------------------------------------------------------------------------

    Dated: March 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04883 Filed 3-14-19; 8:45 am]
BILLING CODE 4164-01-P