Federal Register 2014-01-10: Vol 79 Iss 7

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Vol. 79
Iss. 7
JAN 10
2014

FEDERAL REGISTER
Vol. 79 Friday,
No. 7 January 10, 2014
Pages 1733-2074
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Ill
Contents
Federal Register
Vol. 79, No. 7
Friday, January 10, 2014
Agency for Healthcare Research and Quality See International Trade Administration
NOTICES See National Institute of Standards and Technology
Agency Information Collection Activities; Proposals, See National Oceanic and Atmospheric Administration
Submissions, and Approvals, 1868-1870 See National Telecommunications and Information
Administration
Agriculture Department
NOTICES
See Food Safety and Inspection Service Agency Information Collection Activities; Proposals,
See Forest Service Submissions, and Approvals, 1823
NOTICES
Agency Information Collection Activities; Proposals,
Committee for Purchase From People Who Are Blind or
Submissions, and Approvals, 1819-1821
Severely Disabled
Army Department NOTICES
See Engineers Corps Procurement List; Additions and Deletions, 1835-1836
Blind or Severely Disabled, Committee for Purchase From
Comptroller of the Currency
People Who Are
See Committee for Purchase From People Who Are Blind or NOTICES
Agency Information Collection Activities; Proposals,
Severely Disabled
Submissions, and Approvals:
Bureau of Consumer Financial Protection Securities Offering Disclosure Rules, 1914-1915
NOTICES
Consumer Information Publications; Availability, 1836- Defense Department
1837 See Engineers Corps
See Navy Department
Centers for Disease Control and Prevention
NOTICES
NOTICES Base Closure and Realignment, 1838
Environmental Impact Statements; Availability, etc.: Meetings:
Roybal Campus 2025 Master Plan; Public Hearing, 1870- Defense Business Board, 1839
1871 Draft Edition 3 of Standardization Agreement 4671,
1839-1840
Centers for Medicare & Medicaid Services
Response Systems to Adult Sexual Assault Crimes Panel,
RULES 1838-1839
Medicare Program:
Privacy Act; Systems of Records, 1840-1843
Hospital Inpatient Prospective Payment Systems for
Acute Care Hospitals and the Long-Term Care
Hospital Prospective Payment System and Fiscal Drug Enforcement Administration
Year 2014 Rates; etc.; Correction, 1741-1742 PROPOSED RULES
Prospective Payment System and Consolidated Billing for Schedules of Controlled Substances:
Skilled Nursing Facilities for FY 2014; Correction, Temporary Placement of Four Synthetic Cannabinoids
1742-1743 into Schedule I, 1776-1780
PROPOSED RULES NOTICES
Medicare Program: Importers of Controlled Substances; Applications:
Contract Year 2015 Policy and Technical Changes to the Cody Laboratories Inc., Cody, WY, 1888
Medicare Advantage and the Medicare Prescription Fresenius Kabi USA, LLC, 1888
Drug Benefit Programs, 1918-2073 Myoderm, 1887-1888
NOTICES Siegfried USA, LLC., 1887
Agency Information Collection Activities; Proposals, Importers of Controlled Substances; Registrations:
Submissions, and Approvals, 1871-1873 Fisher Clinical Services, Inc., 1889
Mylan Pharmaceuticals, Inc., Morgantown, WV, 1888-
Coast Guard 1889
RULES Manufacturers of Controlled Substances; Applications:
Drawbridge Operations: Cayman Chemical Co., 1889-1890
Upper Mississippi River, Sabula, lA, 1741 Cody Laboratories, Inc., Cody, WY, 1890
PROPOSED RULES Manufacturers of Controlled Substances; Registrations:
Marine Casualty Reporting on the Outer Continental Shelf, Organix, Inc., 1890-1891
1780-1789
Regulated Navigation Areas and Limited Access Areas
Waterway Management: Education Department
Apra Harbor, Guam, 1789-1791 NOTICES
Applications for New Awards:
Commerce Department Personnel Development to Improve Services and Results
See Industry and Security Bureau for Children with Disabilities, etc., 1846-1853
IV Federal Register/Vol. 79, No. 7/Friday, January 10, 2014/Contents
Employment and Training Administration Federal Reserve System
NOTICES NOTICES
Revised Determinations on Reconsideration: Agency Information Collection Activities; Proposals,
Belden, Inc., Horseheads, NY, 1891-1892 Submissions, and Approvals, 1862-1866
Worker Adjustment Assistance Eligibility; Investigations, Changes in Bank Control:
1892 Acquisitions of Shares of a Bank or Bank Holding
Worker Adjustment Assistance; Amended Certifications: Company, 1866
REC Silicon, Inc., et al., Moses Lake, WA, and Silver Formations of. Acquisitions by, and Mergers of Bank
Bow, MT, 1893 Holding Companies, 1866-1867
Worker Adjustment Assistance; Determinations, 1893-1896 Proposals to Engage in or to Acquire Companies Engaged in
Permissible Nonbanking Activities, 1867
Energy Department
Federal Transit Administration
NOTICES
Application to Export Electric Energy: NOTICES
Meetings:
NextEra Energy Power Marketing, LLC, 1853-1854
Regional Planning Effort to Improve Public
Environmental Impact Statements; Availability, etc.:
Transportation in Central Wasatch Mountains, Salt
Lake Charles Carbon Capture and Sequestration Project,
Lake and Summit Counties, UT, 1912-1914
1854-1861
Fish and Wildlife Service
Engineers Corps
PROPOSED RULES
NOTICES Endangered and Threatened Wildlife and Plants:
Environmental Impact Statements; Availability, etc.: Endangered Status for the Sierra Nevada Yellow-legged
Installation of a Terminal Groin Structure, Western End Frog and the Northern Distinct Population Segment
of South Beach, Bald Head Island, etc., Brunswick of the Mountain Yellow-legged Frog, and Threatened
County, NC, 1843-1844 Status for the Yosemite Toad and Designation of
Critical Habitat, 1805-1810
Environmental Protection Agency Subsistence Management Regulations for Public Lands in
PROPOSED RULES Alaska:
Air Quality State Implementation Plans; Approvals and Taking of Fish and Shellfish, 1791-1795
Promulgations:
Idaho, 1795-1799 Food and Drug Administration
Self-Certification Program Authorization: RULES
Oklahoma; Lead-Based Paint Renovation, etc., and Pre- Medical Devices; Pediatric Uses of Devices:
Renovation Education Activities in Target Housing Requirement for Submission of Information on Pediatric
and Child Occupied Facilities, 1799-1804 Subpopulations that Suffer from a Disease or
NOTICES Condition that a Device is Intended to Treat,
Environmental Impact Statements; Weekly Receipts, 1861- Diagnose, or Cure, 1735-1741
1862 NOTICES
Draft Guidances for Industry; Availability:
Executive Office of the President Commimity-Acquired Bacterial Pneumonia: Developing
See Management and Budget Office Drugs for Treatment, 1874-1875
Qualification of Exacerbations of Chronic Pulmonary
Federal Aviation Administration Disease Tool for Measurement of Symptoms of Acute
Bacterial Exacerbation of Chronic Bronchitis, etc.,
RULES
1873-1874
Airworthiness Directives:
Drugs for Human Use; Drug Efficacy Study Implementation:
Turbomeca S.A. Turboshaft Engines, 1733-1734
Certain Prescription Drugs Offered for Various
PROPOSED RULES
Indications; Final Resolution of Hearing Requests
Airworthiness Directives:
Under Dockets, 1875-1877
Austro Engine GmbH Engines, 1774-1776
Meetings:
Dowty Propellers Propellers, 1774
Characterizing and Communicating Uncertainty in the
The Boeing Company Airplanes, 1772-1774
Assessment of Benefits and Risks in Drug Regulatory
Decision-Making; Public Workshop, 1877-1879
Federal Housing Finance Agency
Unapproved and Misbranded Oral and Injectable Drugs
NOTICES
Labeled for Prescription Use Containing Codeine
Annual Adjustment of Cap on Average Total Assets that
Sulfate, Codeine Phosphate, or Dihydrocodeine
Defines Community Financial Institutions, 1862
Bitartrate; Enforcement Action Dates, 1879-1882
Federal Motor Carrier Safety Administration Food Safety and Inspection Service
NOTICES NOTICES
Exemption Applications; Qualification of Drivers: 2014 Rate Changes for the Basetime, Overtime, Holiday,
Vision, 1908-1912 and Laboratory Services Rates, 1821-1823
Federal Railroad Administration Forest Service
RULES PROPOSED RULES
Railroad Workplace Safety: Subsistence Management Regulations for Public Lands in
Adjacent-Track On-Track Safety for Roadway Workers, Alaska:
1743-1771 Taking of Fish and Shellfish, 1791-1795
Federal Register/Vol. 79, No. 7/Friday, January 10, 2014/Contents V
Government Accountability Office International Trade Commission
NOTICES NOTICES
Requests for Nominations; Antidumping Duty Administrative Reviews; Results,
Health Information Technology Policy Committee, 1867 Extensions, Amendments, etc.;
Steel Wire Garment Hangers from China, 1885-1886
Health and Human Services Department Investigations; Terminations, Modifications and Rulings;
See Agency for Healthcare Research and Quality Certain Wireless Communications Base Stations and
See Centers for Disease Control and Prevention Components, 1886
See Centers for Medicare & Medicaid Services
See Food and Drug Administration Justice Department
See Health Resources and Services Administration See Drug Enforcement Administration
See Indian Health Service See Justice Programs Office
See National Institutes of Health NOTICES
PROPOSED RULES Consent Judgments under the Resource Conservation and
National Vaccine Injury Compensation Program; Recovery Act, 1886-1887
Revisions to the Vaccine Injury Table, 1804-1805
NOTICES Justice Programs Office
Meetings;
National Vaccine Advisory Committee, 1868 NOTICES
Agency Information Collection Activities; Proposals,
Submissions, and Approvals;
Health Resources and Services Administration
2013 National Survey of Indigent Defense Systems, 1891
NOTICES
Statement of Organization, Functions and Delegations of
Authority, 1882 Labor Department
See Employment and Training Administration
Healthcare Research and Quality Agency
See Agency for Healthcare Research and Quality Land Management Bureau
NOTICES
Homeland Security Department Agency Information Collection Activities; Proposals,
See Coast Guard Submissions, and Approvals, 1884-1885
See U.S. Customs and Border Protection
Management and Budget Office
Housing and Urban Development Department
NOTICES
NOTICES List of Designated Federal Entities and Federal Entities;
Federal Properties Suitable as Facilities to Assist the Fiscal Year 2013 and 2014, 1896-1897
Homeless, 1884
National institute of Standards and Technology
Indian Health Service
See Indian Health Service NOTICES
Federally Funded Research and Development Center;
NOTICES
Proposed Establishment, 1831-1832
Organization, Function, and Delegations of Authority;
Part G; Proposed Functional Statement, 1882-1883
National Institutes of Health
Industry and Security Bureau NOTICES
Meetings;
NOTICES
Denials of Export Privileges Center for Scientific Review, 1883
3K Aviation Consulting & Logistics, etc., 1823-1824
National Oceanic and Atmospheric Administration
Interior Department PROPOSED RULES
See Fish and Wildlife Service Fisheries of the Northeastern United States; Specifications
See Land Management Bureau and Management Measures;
Atlantic Mackerel, Squid, and Butterfish Fisheries, 1813-
International Trade Administration 1818
NOTICES Fishing Restrictions for Pacific Bluefin Tuna in the Eastern
Antidumping Duty Administrative Reviews; Results, Pacific Ocean;
Extensions, Amendments, etc.; International Fisheries; Pacific Tuna Fisheries, 1810-1813
Certain Frozen Warmwater Shrimp from the Socialist NOTICES
Republic of Vietnam, 1824-1826 Meetings;
Polyethylene Terephthalate Film, Sheet, and Strip from Fisheries of the South Atlantic, Gulf of Mexico, and
Brazil, 1827-1828 Caribbean; Southeast Data, Assessment, and Review,
Purified Carboxymethylcellulose from Finland, 1826- 1833
1827 Pacific Fishery Management Council; Online Webinar,
Antidumping Duty Orders; Results, Extensions, 1832-1833
Amendments, etc.; Permit Applications;
Certain Steel Nails from the Peoples Republic of China, Marine Mammals; File No. 16479, 1833-1834
1830-1831 Permits;
Steel Wire Garment Hangers from the Peoples Republic of Marine Mammals; File No. 14514, 1834
China, 1829-1830 Marine Mammals; File No. 17429, 1834-1835
VI Federal Register/Vol. 79, No. 7/Friday, January 10, 2014/Contents
National Science Foundation Surface Transportation Board
NOTICES NOTICES
Meetings: Sunshine Act: Operation Exemptions:
National Science Board, 1897-1898 Union County Industrial Railroad Co.; SEDA-COG Joint
Rail Authority, 1914
National Telecommunications and Information
Administration Transportation Department
See Federal Aviation Administration
NOTICES See Federal Motor Carrier Safety Administration
National Environmental Policy Act Implementing See Federal Railroad Administration
Procedures and Categorical Exclusions: See Federal Transit Administration
First Responder Network Authority, 1835 See Surface Transportation Board
Navy Department
Treasury Department
NOTICES
See Comptroller of the Currency
Privacy Act; Systems of Records, 1844-1846
Nuclear Regulatory Commission U.S. Customs and Border Protection
NOTICES NOTICES
Agency Information Collection Activities; Proposals, Agency Information Collection Activities; Proposals,
Submissions, and Approvals, 1898 Submissions, and Approvals
Conceptual Example of a Proposed Risk Management Vessel Entrance or Clearance Statement, 1883-1884
Regulatory Framework Policy Statement, 1898-1899
Director’s Decisions: Veterans Affairs Department
Brunswick Steam Electric Plant Units 1 and 2, Duke NOTICES
Energy Progress, Inc., 1899-1900 Agency Information Collection Activities: Proposals,
Draft Interim Staff Guidances: Submissions, and Approvals:
Emergency Planning Exemption Requests for VA Request for Determination of Reasonable Value, 1915
Decommissioning Nuclear Power Plants, 1900-1901
License Exemptions; Issuances:
Oyster Creek Nuclear Generating Station, Exelon Separate Parts In This Issue
Generation Co., LLC, 1901-1903
License Renewal Interim Staff Guidance: Part II
Aging Management of Loss of Coating Integrity for Health and Human Services Department, Centers for
Internal Service Level III Coatings, 1904-1905 Medicare & Medicaid Services, 1918-2073
Office of Management and Budget
See Management and Budget Office
Reader Aids
Securities and Exchange Commission Consult the Reader Aids section at the end of this page for
phone numbers, online resources, finding aids, reminders,
RULES
Responsibilities of the General Counsel, 1734-1735 and notice of recently enacted public laws.
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Agency Information Collection Activities: Proposals, LISTSERV electronic mailing list, go to http://
Submissions, and Approvals, 1905-1906 listserv.access.gpo.gov and select Online mailing list
Self-Regulatory Organizations; Proposed Rule Changes: archives, FEDREGTOC-L, Join or leave the list (or change
NASDAQ OMX PHLX, LLC, 1906-1908 settings); then follow the instructions.
Federal Register/Vol. 79, No. 7/Friday, January 10, 2014/Contents VII
CFR PARTS AFFECTED IN THIS ISSUE
A cumulative list of the parts affected this month can be found in the
Reader Aids section at the end of this issue.
14 CFR
39.1733
Proposed Rules:
39 (3 documents) ....1772, 1774
17 CFR
200.1734
21 CFR
814.1735
Proposed Rules:
1308.1776
33 CFR
117.1741
Proposed Rules:
140.1780
146.1780
165.1789
36 CFR
Proposed Rules:
242.1791
40 CFR
Proposed Rules:
52.1795
745.1799
42 CFR
412 .1741
413 (2 documents).1741,
1742
414 .1741
419.1741
424 (2 documents).1741,
1742
482.1741
485.1741
489.1741
Proposed Rules:
100.1804
409.1918
417.1918
422 .1918
423 .1918
424 .1918
46 CFR
Proposed Rules:
4.1780
109.1780
49 CFR
214.1743
50 CFR
Proposed Rules:
17.1805
100.1791
300.1810
648.1813
1733
Rules and Regulations
Federal Register
Vol. 79, No. 7
Friday, January 10, 2014
This section of the FEDERAL REGISTER comments received, and other Conclusion
contains regulatory documents having general information. The street address for the
We reviewed the available data and
applicability and legal effect, most of which Docket Operations office (phone: 800-
determined that air safety and the
aFreed ekreayl eRd etgou alantdio cnosd, iwfiehdic hin itsh peu Cbloisdhee dof under 6se4c7t-io5n5.2 7C)o ims mpreonvtisd wedil li nb eth aev AaiDlaDbRlEeS iSnE S public interest require adopting this AD
50 titles pursuant to 44 U.S.C. 1510. with the changes described previously.
the AD docket shortly after receipt.
We determined that these changes will
The Code of Federal Regulations is sold by FOR FURTHER INFORMATION CONTACT: not increase the economic burden on
the Superintendent of Documents. Prices of Frederick Zink, Aerospace Engineer, any operator or increase the scope of
new books are listed in the first FEDERAL Engine Certification Office, FAA, Engine this AD.
REGISTER issue of each week.
& Propeller Directorate, 12 New England
Costs of Compliance
Executive Park, Burlington, MA 01803;
DEPARTMENT OF TRANSPORTATION phone: [phone]; fax: 781-238- We estimate that this AD will affect
7199; email: [email protected]. about 6 engines of U.S. registry. We also
Federal Aviation Administration estimate that it will take about 5 horn’s
SUPPLEMENTARY INFORMATION: per engine to comply with this AD. The
average labor rate is $85 per hour.
14CFR Part 39 Discussion
Required parts will cost about $6,560
[Docket No. FAA-2013-0575; Directorate We issued a notice of proposed per engine. Based on these figures, we
Identifier 2013-NE-21-AD; Amendment 39- rulemaking (NPRM) to amend 14 CFR estimate the cost of this AD on U.S.
17718; AD 2013-26-09] part 39 by adding an AD that would operators to be $41,910.
RIN 212&-AA64 apply to the specified products. The Authority for This Rulemaking
NPRM was published in the Federal
Airworthiness Directives; Turbomeca Register on August 6, 2013 (78 FR Title 49 of the United States Code
S.A. Turboshaft Engines 47581). The NPRM proposed to correct specifies the FAA’s authority to issue
an unsafe condition for the specified rules on aviation safety. Subtitle I,
AGENCY: Federal Aviation products. The MCAI states: section 106, describes the authority of
Administration (FAA), DOT.
the FAA Administrator. “Subtitle VII:
ACTION: Final rule. Some cracks have been reported on the Aviation Programs,” describes in more
second stage turbine disc of ASTAZOU XIV
detail the scope of the Agency’s
SUMMARY: We are adopting a new engines inducted into a Repair Centre. These
authority.
airworthiness directive (AD) for all cracks are located in the serrations of the
Turbomeca S.A. ASTAZOU XIV B and disc. The results of the technical We are issuing this rulemaking under
investigation concluded that the cracks were the authority described in “Subtitle VII,
XIV H engines. This AD was prompted
present on non-shot peened second stage Part A, Subpart III, Section 44701:
by reports of cracks on the 2nd-stage
turbine discs (discs on which AB 138 General requirements.” Under that
turbine disk. This AD requires
modification was not incorporated), and on section. Congress charges the FAA with
replacement of the 2nd-stage turbine
second stage turbine discs that were shot promoting safe flight of civil aircraft in
disk. We are issuing this AD to prevent
peened during their service life (discs on air commerce by prescribing regulations
disk cracking, uncontained 2nd-stage which AB 138 modification was incorporated for practices, methods, and procedures
turbine blade release, damage to the after initial service use without shot the Administrator finds necessary for
engine, and damage to the helicopter. peening). Until now, no crack has been
safety in air commerce. This regulation
DATES: This AD becomes effective reported on second stage turbine discs shot is within the scope of that authority
February 14, 2014. peened since new', these discs accounting for because it addresses an unsafe condition
more than half of all ASTAZOU XIV flight
ADDRESSES: The Docket Operations hours. It was not possible to clearly identify that is likely to exist or develop on
office is located at Docket Management what caused the cracks. products identified in this rulemaking
Facility, U.S. Department of This condition, if not corrected, could lead action.
Transportation, 1200 New Jersey to some events of disc serrations rupture, Regulatory Findings
Avenue SE., West Building Ground possibly resulting in uncontained second
Floor, Room Wl2-140, Washington, DC stage turbine blade release with consequent We determined that this AD will not
20590-0001. damage to, and reduced control of, the have federalism implications under
helicopter. Executive Order 13132. This AD will
Examining the AD Docket
not have a substantial direct effect on
You may examine the MCAI in the
You may examine the AD docket on the States, on the relationship between
the Internet at http:// AD docket on the Internet at http:// the national government and the States,
www.regulations.gov/
\^'ww.^egu}ations.govhy searching for or on the distribution of power and
and locating Docket No. FAA-2013- tt!documentDetail;D=FAA-2013-0575- responsibilities among the various
0575; or in person at the Docket 0002. levels of government.
Operations office between 9 a.m. and 5 We gave the public the opportunity to For the reasons discussed above, I
p.m., Monday through Friday, except participate in developing this AD. We certify this AD:
Federal holidays. The AD docket received no comments on the NPRM (78 (1) Is not a “significant regulatory
contains this AD, the mandatory FR 47581, August 6, 2013). However, we action” under Executive Order 12866,
continuing airworthiness information did make an editorial change to the (2) Is not a “significant rule” under
(MCAI), the regulatory evaluation, any preamble of this AD. the DOT Regulatory Policies and