80 FR 50558 - Revisions to Auxiliary Installations, Replacement Facilities, and Siting and Maintenance Regulations
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission Federal Register Volume 80, Issue 161 (August 20, 2015)
Federal Energy Regulatory Commission
Federal Register Volume 80, Issue 161 (August 20, 2015)
| Page Range | 50558-50559 | |
| FR Document | 2015-20538 |
[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)] [Rules and Regulations] [Pages 50558-50559] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20538] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Parts 2 and 157 [Docket No. RM12-11-003; Order No. 790-B] Revisions to Auxiliary Installations, Replacement Facilities, and Siting and Maintenance Regulations AGENCY: Federal Energy Regulatory Commission. ACTION: Final rule, order on clarification; correction. ----------------------------------------------------------------------- SUMMARY: This document contains corrections to the final rule (RM12-11- 003) which was published in the Federal Register of Friday, July 24, 2015 (80 FR 43944). The final rule amended regulations to: provide pre- granted authority under a new paragraph to abandon or replace auxiliary facilities, subject to certain conditions; permit auxiliary facilities that cannot meet the conditions for the pre-granted abandonment authority in the new paragraph to be abandoned under the blanket certificate regulations, subject to those regulations' requirements; and permit replacement facilities constructed under the regulations to be abandoned under the blanket certificate regulations, subject to those regulations' requirements. DATES: Effective October 7, 2015. FOR FURTHER INFORMATION CONTACT: Katherine Liberty, Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502-6491, [email protected]. Gordon Wagner, Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502-8947, [email protected]. Howard Wheeler, Office of Energy Projects, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502-8688, [email protected]. Shannon Jones, Office of Energy Projects, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502-6410, [email protected]. SUPPLEMENTARY INFORMATION: Revisions to Auxiliary Installations, Replacement Facilities, and Siting and Maintenance Regulations Docket No. RM12-11-003 Errata Notice On July 16, 2015, the Commission issued a Final Rule in the above [[Page 50559]] captioned proceeding. Revisions to Auxiliary Installations, Replacement Facilities, and Siting and Maintenance Regulations, 152 FERC ] 61,049 (2015). This errata notice makes a correction to the Final Rule as issued. In FR Doc. 2015-17919 appearing on page 43949 in the Federal Register of Friday, July 24, 2015, the following correction is made: 1. On page 43949, in the second column, Sec. 157.216(b)(2)(i)(A) of the regulatory text is revised to read as follows: ``(A) Will not exceed the cost limit in Sec. 157.208(d) for activities under the prior notice provisions;'' Dated: August 14, 2015. Kimberly D. Bose, Secretary. [FR Doc. 2015-20538 Filed 8-19-15; 8:45 am] BILLING CODE 6717-01-P
![50558 Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Rules and Regulations
(d) Subject be accomplished using a method approved DEPARTMENT OF ENERGY
Air Transport Association (ATA) of by the Manager, New York ACO, ANE–170,
America Code 27, Flight Controls. FAA; or Transport Canada Civil Aviation Federal Energy Regulatory
(TCCA); or Bombardier, Inc.’s TCCA Design Commission
(e) Reason
Approval Organization (DAO). If approved by
This AD was prompted by reports of a the DAO, the approval must include the 18 CFR Parts 2 and 157
disconnect between the elevator lever and DAO-authorized signature.
control rod. We are issuing this AD to [Docket No. RM12–11–003; Order No. 790–
prevent a disconnect between the elevator (j) Related Information B]
lever and control rod, which could lead to (1) Refer to Mandatory Continuing
un-commanded elevator movement of the Revisions to Auxiliary Installations,
Airworthiness Information (MCAI) Canadian
associated control surface, a large difference Replacement Facilities, and Siting and
Airworthiness Directive CF–2014–44, dated
between the position of the left and the right Maintenance Regulations
elevator control surfaces, and consequent December 9, 2014, for related information.
reduced controllability of the airplane and This MCAI may be found in the AD docket AGENCY: Federal Energy Regulatory
degradation of the structural integrity of the on the Internet at http:// Commission.
horizontal stabilizer. www.regulations.gov/ ACTION: Final rule, order on
#!documentDetail;D=FAA-2015-0492-0002. clarification; correction.
(f) Compliance
(2) Service information identified in this
Comply with this AD within the AD that is not incorporated by reference is SUMMARY: This document contains
compliance times specified, unless already available at the addresses specified in corrections to the final rule (RM12–11–
done. 003) which was published in the
paragraphs (k)(3) and (k)(4) of this AD.
(g) Replacement of Elevator Lever Federal Register of Friday, July 24, 2015
Assemblies and Control Rods (k) Material Incorporated by Reference (80 FR 43944). The final rule amended
Within 9,200 flight hours or 5 years, (1) The Director of the Federal Register regulations to: provide pre-granted
whichever occurs first, after the effective date approved the incorporation by reference authority under a new paragraph to
of this AD: Replace the left and right fixed (IBR) of the service information listed in this abandon or replace auxiliary facilities,
control rods and lever assemblies of the paragraph under 5 U.S.C. 552(a) and 1 CFR subject to certain conditions; permit
elevator control system with newly designed part 51. auxiliary facilities that cannot meet the
control rods and lever assemblies, in (2) You must use this service information conditions for the pre-granted
accordance with the Accomplishment as applicable to do the actions required by abandonment authority in the new
Instructions of Bombardier Service Bulletin this AD, unless this AD specifies otherwise. paragraph to be abandoned under the
670BA–27–062, Revision C, dated February (i) Bombardier Service Bulletin 670BA–27– blanket certificate regulations, subject to
13, 2015.
062, Revision C, dated February 13, 2015. those regulations’ requirements; and
(h) Credit for Previous Actions (ii) Reserved. permit replacement facilities
This paragraph provides credit for actions (3) For service information identified in constructed under the regulations to be
required by paragraph (g) of this AD, if those this AD, contact Bombardier, Inc., 400 Côte abandoned under the blanket certificate
actions were performed before the effective Vertu Road West, Dorval, Québec H4S 1Y9, regulations, subject to those regulations’
date of this AD using Bombardier Service Canada; telephone: 514–855–5000; fax: 514– requirements.
Bulletin 670BA–27–062, dated December 12, 855–7401; email: thd.crj@ DATES: Effective October 7, 2015.
2013; Bombardier Service Bulletin 670BA– aero.bombardier.com; Internet http://
27–062, Revision A, dated April 1, 2014; or FOR FURTHER INFORMATION CONTACT:
www.bombardier.com.
Bombardier Service Bulletin 670BA–27–062, Katherine Liberty, Office of the General
(4) You may view this service information
Revision B, dated October 10, 2014. This Counsel, Federal Energy Regulatory
at the FAA, Transport Airplane Directorate,
service information is not incorporated by Commission, 888 First Street NE.,
1601 Lind Avenue SW., Renton, WA. For
reference in this AD. Washington, DC 20426, (202) 502–
information on the availability of this
(i) Other FAA AD Provisions 6491, katherine.liberty@ferc.gov.
material at the FAA, call 425–227–1221. Gordon Wagner, Office of the General
The following provisions also apply to this (5) You may view this service information Counsel, Federal Energy Regulatory
AD: that is incorporated by reference at the
Commission, 888 First Street NE.,
(1) Alternative Methods of Compliance National Archives and Records
(AMOCs): The Manager, New York Aircraft
Washington, DC 20426, (202) 502–
Administration (NARA). For information on
Certification Office (ACO), ANE–170, FAA, 8947, gordon.wagner@ferc.gov.
the availability of this material at NARA, call Howard Wheeler, Office of Energy
has the authority to approve AMOCs for this 202–741–6030, or go to: http://
AD, if requested using the procedures found Projects, Federal Energy Regulatory
www.archives.gov/federal-register/cfr/ibr- Commission, 888 First Street NE.,
in 14 CFR 39.19. In accordance with 14 CFR
locations.html. Washington, DC 20426, (202) 502–
39.19, send your request to your principal
inspector or local Flight Standards District Issued in Renton, Washington, on August 8688, howard.wheeler@ferc.gov.
Office, as appropriate. If sending information 10, 2015. Shannon Jones, Office of Energy
directly to the ACO, send it to ATTN: Projects, Federal Energy Regulatory
Michael Kaszycki,
Program Manager, Continuing Operational Commission, 888 First Street NE.,
Safety, FAA, New York ACO, 1600 Stewart Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service. Washington, DC 20426, (202) 502–
Avenue, Suite 410, Westbury, NY 11590;
telephone: 516–228–7300; fax: 516–794– [FR Doc. 2015–20366 Filed 8–19–15; 8:45 am]
6410, shannon.jones@ferc.gov.
5531. Before using any approved AMOC, SUPPLEMENTARY INFORMATION:
BILLING CODE 4910–13–P
notify your appropriate principal inspector, Revisions to Auxiliary Installations,
or lacking a principal inspector, the manager
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of the local flight standards district office/
Replacement Facilities, and Siting and
certificate holding district office. The AMOC Maintenance Regulations Docket No.
approval letter must specifically reference RM12–11–003
this AD. Errata Notice
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain corrective On July 16, 2015, the Commission
actions from a manufacturer, the action must issued a Final Rule in the above
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![Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Rules and Regulations 50559
captioned proceeding. Revisions to ADDRESSES: Submit electronic disease product application’’ and sets
Auxiliary Installations, Replacement comments on additional diseases forth criteria which, if met, enable those
Facilities, and Siting and Maintenance suggested for designation to who submit an application for a tropical
Regulations, 152 FERC ¶ 61,049 (2015). www.regulations.gov. Submit written disease product to be eligible to receive
This errata notice makes a correction to comments on additional diseases a PRV upon approval of that tropical
the Final Rule as issued. suggested for designation to the Division disease product application. To be
In FR Doc. 2015–17919 appearing on of Dockets Management (HFA–305), eligible for a PRV, the tropical disease
page 43949 in the Federal Register of Food and Drug Administration, 5630 product application must meet all of the
Friday, July 24, 2015, the following Fishers Lane, Rm. 1061, Rockville, MD following criteria:
correction is made: 20852. All comments should be • The application must be a ‘‘human
1. On page 43949, in the second identified with the docket number drug application,’’ as defined in section
column, § 157.216(b)(2)(i)(A) of the found in brackets in the heading of this 735(1) of the FD&C Act (21 U.S.C.
regulatory text is revised to read as document. 379g(1)).
follows: FOR FURTHER INFORMATION CONTACT: • The application must be for the
‘‘(A) Will not exceed the cost limit in Kristiana Brugger, Center for Drug ‘‘prevention or treatment of a tropical
§ 157.208(d) for activities under the Evaluation and Research, Food and disease,’’ as defined by statute.
prior notice provisions;’’ Drug Administration, 10903 New • The application must be deemed
Dated: August 14, 2015. Hampshire Ave., Bldg. 51, rm. 6262, eligible for priority review by the
Kimberly D. Bose, Silver Spring, MD 20993–0002, 301– Secretary of HHS.
Secretary. 796–3601; or Stephen Ripley, Center for • The application must be approved
[FR Doc. 2015–20538 Filed 8–19–15; 8:45 am] Biologics Evaluation and Research, after the date of enactment of FDAAA
BILLING CODE 6717–01–P Food and Drug Administration, 10903 (i.e., September 27, 2007) for use in the
New Hampshire Ave., Bldg. 71, rm. prevention, detection, or treatment of a
7301, Silver Spring, MD 20993–0002, tropical disease.
DEPARTMENT OF HEALTH AND 240–402–7911. • The application must be for ‘‘a
HUMAN SERVICES SUPPLEMENTARY INFORMATION: human drug, no active ingredient
(including any ester or salt of the active
Table of Contents ingredient) of which has been approved
Food and Drug Administration
I. Background: Priority Review Voucher in any other application under section
21 CFR Part 317 Program 505(b)(1) [21 U.S.C. 355(b)(1)] or section
II. Criteria for Expansion of the List of 351 of the [PHS Act].’’
[Docket No. FDA–2008–N–0567] Tropical Diseases Section 524(a)(4) of the FD&C Act. In
A. No Significant Market in Developed particular, the requirement that an
RIN 0910–AG37
Nations
B. Disproportionately Affects Poor and application must be eligible for priority
Designating Additions to the Current Marginalized Populations review demonstrates the PRV program’s
List of Tropical Diseases in the Federal III. Diseases Being Designated intent to reward tropical disease
Food, Drug, and Cosmetic Act A. Chagas Disease product applications that have the
B. Neurocysticercosis potential to demonstrate significant
AGENCY: Food and Drug Administration,
IV. Process for Requesting Additional improvements in safety or effectiveness
HHS. Diseases To Be Added to the List in the treatment or prevention of
ACTION: Final order. V. Paperwork Reduction Act
tropical diseases (Ref. 1).
VI. References
SUMMARY: The Federal Food, Drug, and FDA will award a PRV to the
Cosmetic Act (the FD&C Act) authorizes I. Background: Priority Review application holder upon the approval of
the Food and Drug Administration (FDA Voucher Program a qualifying tropical disease product
or Agency) to award priority review Much of the global burden of disease application that meets the criteria
vouchers (PRVs) to tropical disease falls on populations who lack the previously listed. The voucher entitles
product applicants when the resources to develop, encourage the holder to a priority review of a
applications meet certain criteria. The development of, or purchase disease human drug application, submitted
FD&C Act lists the diseases that are preventions or treatments. For this under section 505(b)(1) of the FD&C Act
considered to be tropical diseases for reason, many of the diseases afflicting or section 351 of the PHS Act, of the
purposes of obtaining PRVs, and also these populations do not receive the voucher holder’s choosing. Once
provides for Agency expansion of that same level of innovation investment as awarded to the application holder, the
list to include other diseases that satisfy diseases afflicting wealthier or more PRV may be transferred to another
the definition of ‘‘tropical diseases’’ as empowered populations. entity, and the original holder may
set forth in the FD&C Act. FDA has Section 524 of the FD&C Act (21 receive consideration (including
determined that Chagas disease and U.S.C. 360n), which was added by payment) for the transfer. To redeem the
neurocysticercosis satisfy this section 1102 of the Food and Drug voucher, a PRV holder must notify FDA
definition, and therefore is adding them Administration Amendments Act of of its intent to use the PRV at least 90
to the list of designated tropical diseases 2007 (FDAAA), is designed to address days prior to the submission of the
whose product applications may result the lack of treatment development application for which the PRV will be
in the award of PRVs. Sponsors incentives for such tropical diseases. It used. This notification constitutes a
submitting certain applications for the uses a PRV incentive to encourage the legally binding agreement to pay the
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treatment of Chagas disease and development of new drugs for user fee that must be applied to
neurocysticercosis may be eligible to prevention and treatment of certain applications using a PRV.
receive a PRV if such applications are diseases that, in the aggregate, affect Section 524(a)(3) of the FD&C Act lists
approved by FDA. millions of people throughout the the following diseases as tropical
DATES: This order is effective August 20, world. Specifically, section 524 of the diseases qualifying for a PRV:
2015. FD&C Act defines the term ‘‘tropical • Tuberculosis
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Document Created: 2015-12-15 11:08:33
Document Modified: 2015-12-15 11:08:33
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule, order on clarification; correction. | |
| Dates | Effective October 7, 2015. | |
| Contact | Katherine Liberty, Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502-6491, [email protected] Gordon Wagner, Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502-8947, [email protected] Howard Wheeler, Office of Energy Projects, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502-8688, [email protected] Shannon Jones, Office of Energy Projects, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502-6410, [email protected] | |
| FR Citation | 80 FR 50558 | |
| CFR Citation | 18
CFR
157 18 CFR 2 |
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