[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Contents]
[Pages III-VII]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]






                  CONTENTS



Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / 
Contents

[[Page iii]]




Army Department
See Engineers Corps


Centers for Disease Control and Prevention
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 42075-42080


Centers for Medicare & Medicaid Services
RULES
Medicaid and Children's Health Insurance Programs:
    Essential Health Benefits in Alternative Benefit Plans, Eligibility 
            Notices, Fair Hearing and Appeal Processes, and Premiums 
            and Cost Sharing; Exchanges: Eligibility and Enrollment, 
            42160-42322
NOTICES
Privacy Act; Computer Matching Programs, 42080-42081


Children and Families Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 42081-42082


Coast Guard
RULES
Drawbridge Operations:
    Delaware River, NJ, 42010-42011
    Isle of Wight (Sinepuxent) Bay, Ocean City, MD, 42010
    The Gut, South Bristol, ME, 42011-42012
    The Straights, Harkers Island, NC, 42011
Safety Zones and Regulated Navigation Areas:
    Chicago Sanitary and Ship Canal, Romeoville, IL, 42012-42015
Safety Zones:
    Discovery World Fireworks, Milwaukee Harbor, Milwaukee, WI, 42016-
            42018
PROPOSED RULES
Safety Zones:
    San Diego Bayfair; Mission Bay, San Diego, CA, 42027-42030
NOTICES
Solicitations for Membership:
    Boston Area Maritime Security Advisory Committee, 42101-42102
Termination of Radiotelephone Medium Frequency 2182 kHz Watchkeeping, 
          etc., 42102-42103


Commerce Department
See International Trade Administration
See National Oceanic and Atmospheric Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 42037-42038
Privacy Act; Systems of Records, 42038


Consumer Product Safety Commission
PROPOSED RULES
Petition for Rulemaking to Eliminate Accessible Cords on Window 
          Covering Products, 42026-42027


Corporation for National and Community Service
NOTICES
Corporation for National and Community Service Strategic Plan; Proposed 
          Revision, 42051


Defense Department
See Engineers Corps
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Federal Acquisition Regulation; Examination of Records by 
            Comptroller General and Contract Audit, 42074-42075
Arms Sales, 42051-42053
Cooperative Agreements:
    Office of Economic Adjustment for Research and Technical 
            Assistance, 42054-42056
Meetings:
    Board of Regents, Uniformed Services University of the Health 
            Sciences, 42053
    Military Family Readiness Council, 42053-42054


Drug Enforcement Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    National Clandestine Laboratory Seizure Report, 42108-42109


Education Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    FFEL/Direct Loan/Perkins Military Service Deferment/Post-Active 
            Duty Student Deferment Request, 42057
    Guaranty Agency Financial Report, 42056-42057
Meetings:
    National Assessment Governing Board, 42057-42059


Employee Benefits Security Administration
PROPOSED RULES
Pension Benefit Statements; Amendment, 42027


Energy Department
See Federal Energy Regulatory Commission


Engineers Corps
PROPOSED RULES
Reservoirs at Headwaters of the Mississippi River; Use and 
          Administration, 42030-42034


Environmental Protection Agency
RULES
Determinations Regarding Applicability of Clean Air Act Requirements:
    California; Attainment for the Sacramento Nonattainment Area for 
            the 2006 Fine Particle Standard, 42018-42021
NOTICES
Board of Directors for the National Environmental Education Foundation, 
          42069-42071

[[Page iv]]

Protective Action Guides Manual:
    Protective Action Guides and Planning Guidance for Radiological 
            Incidents; Update, 42071-42072


Export-Import Bank
NOTICES
Applications for Long-Term Loan or Financial Guarantee in Excess of 
          $100 Million, 42072


Federal Aviation Administration
RULES
Combined Drug and Alcohol Testing Programs, 41999-42006
Pilot Certification and Qualification Requirements for Air Carrier 
          Operations, 42324-42380


Federal Communications Commission
PROPOSED RULES
Extra Fees Levied on Inmate Calling Services, 42034-42036
Radio Broadcasting Services:
    Port Lions, AK, De Beque, CO, Benjamin, Cisco, Rule, and Shamrock, 
            TX, 42036
NOTICES
Meetings:
    Consumer Advisory Committee, 42072-42073


Federal Deposit Insurance Corporation
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Occasional Qualitative Surveys, 42073-42074


Federal Energy Regulatory Commission
NOTICES
Combined Filings, 42059-42061
Complaints:
    Chevron Products Co. v. Enterprise TE Products Pipeline Co., LLC, 
            42061-42062
Environmental Assessments; Availability, etc.:
    Columbia Gas Transmission, LLC; Proposed Smithfield III Expansion 
            Project, 42062-42064
Orders Approving Reliability Standards:
    North American Electric Reliability Corp., 42064-42068
Records Governing Off-the-Record Communications, 42068


Federal Highway Administration
NOTICES
Final Federal Agency Actions:
    Goethals Bridge Replacement Project in New York and New Jersey, 
            42151-42152


Federal Reserve System
NOTICES
Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 
          42074


Federal Retirement Thrift Investment Board
NOTICES
Meetings; Sunshine Act, 42074


Fish and Wildlife Service
NOTICES
Meetings:
    Wildlife and Hunting Heritage Conservation Council; Teleconference, 
            42104-42105


Food and Drug Administration
RULES
Oral Dosage Form New Animal Drugs:
    Nicarbazin; Oclacitinib; Zilpaterol, 42006-42008
PROPOSED RULES
Administrative Detention of Drugs Intended for Human or Animal Use, 
          42382-42386
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Agreement for Shipment of Devices for Sterilization, 42082-42083
Center for Drug Evaluation and Research Data Standards Program 
          Documents; Availability:
    Electronic Study Data Submission; Data Standard Support, 42084
Cooperative Agreements:
    World Trade Organization's Standards and Trade Development 
            Facility, 42084-42085
Draft Guidance for Industry and Staff:
    Circumstances that Constitute Delaying, Denying, Limiting, or 
            Refusing a Drug Inspection, 42387
Draft Guidance for Industry:
    Content of and Process for Submitting Initial Pediatric Study Plans 
            and Amended Pediatric Study Plans, 42085-42086
Draft Guidance for Industry; Availability:
    Arsenic in Apple Juice; Action Level, etc., 42086-42087
Meetings:
    Anesthetic and Analgesic Drug Products Advisory Committee; 
            Cancellation, 42088
    Risk Communications Advisory Committee, 42087-42088


General Services Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Federal Acquisition Regulation; Examination of Records by 
            Comptroller General and Contract Audit, 42074-42075


Health and Human Services Department
See Centers for Disease Control and Prevention
See Centers for Medicare & Medicaid Services
See Children and Families Administration
See Food and Drug Administration
See Health Resources and Services Administration
See National Institutes of Health
See Substance Abuse and Mental Health Services Administration
RULES
Medicaid and Children's Health Insurance Programs:
    Essential Health Benefits in Alternative Benefit Plans, Eligibility 
            Notices, Fair Hearing and Appeal Processes, and Premiums 
            and Cost Sharing; Exchanges: Eligibility and Enrollment, 
            42160-42322


Health Resources and Services Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 42088-42089
Statements of Organization, Functions and Delegations of Authority, 
          42089-42090


Homeland Security Department
See Coast Guard
See U.S. Customs and Border Protection

[[Page v]]




Indian Affairs Bureau
NOTICES
Meetings:
    Advisory Board for Exceptional Children, 42105


Interior Department
See Fish and Wildlife Service
See Indian Affairs Bureau


International Trade Administration
NOTICES
Antidumping Duty Administrative Reviews; Results, Extensions, 
          Amendments, etc.:
    Certain Hot-Rolled Carbon Steel Flat Products from the People's 
            Republic of China, 42039-42040
Trade Missions:
    Travel and Tourism to Taiwan, Japan, and Korea, 42041
    U.S. Healthcare to Russia; Cancellation, 42041


International Trade Commission
NOTICES
Full Five-year Reviews:
    Polyethylene Terephthalate Film, Sheet, and Strip from India and 
            Taiwan, 42105-42106
Investigations; Terminations, Modifications, Rulings, etc.:
    Certain TV Programs, Literary Works for TV Production and Episode 
            Guides Pertaining to Same, 42106-42107
Requests for Information:
    Certain Wireless Devices with 3G Capabilities and Components 
            Thereof; Statements on Public Interest, 42107-42108


Justice Department
See Drug Enforcement Administration
See Justice Programs Office
NOTICES
Consent Decrees under the Clean Water Act, 42108


Justice Programs Office
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Juvenile Justice Reform and Reinvestment Initiative Stakeholder 
            Survey, 42109-42110


Labor Department
See Employee Benefits Security Administration


Maritime Administration
NOTICES
Administrative Waivers of Coastwise Trade Laws:
    Vessel COMPASS ROSE, 42153
    Vessel OFF COURSE, 42152-42153


National Aeronautics and Space Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Federal Acquisition Regulation; Examination of Records by 
            Comptroller General and Contract Audit, 42074-42075
Meetings:
    NASA Advisory Council; Commercial Space Committee, 42111
    NASA Advisory Council; Education and Public Outreach Committee, 
            42110
    NASA Advisory Council; Human Exploration and Operations Committee, 
            42110-42111


National Highway Traffic Safety Administration
NOTICES
Certain Nonconforming Motor Vehicles Eligible for Importation, 42153-
          42155
Petitions for Inconsequential Noncompliance:
    BHC Investment Corp., 42155-42156


National Institutes of Health
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    NIH Office of Intramural Training and Education Application, 42090-
            42091
Meetings:
    National Cancer Institute; Amendment, 42091


National Oceanic and Atmospheric Administration
RULES
Atlantic Highly Migratory Species:
    Commercial Gulf of Mexico Aggregated Large Coastal Shark and Gulf 
            of Mexico Hammerhead Shark Management Groups, 42021-42022
Fisheries of the Exclusive Economic Zone Off Alaska:
    Atka Mackerel in the Bering Sea and Aleutian Islands Management 
            Area, 42023-42024
    Northern Rockfish and Dusky Rockfish in the Western Regulatory Area 
            of the Gulf of Alaska, 42024-42025
    Other Rockfish in the Western Regulatory Area of the Gulf of 
            Alaska, 42022-42023
NOTICES
Permits:
    Marine Mammals; File No. 17115, 42041-42042
Taking of Marine Mammals Incidental to Specified Activities:
    U.S. Marine Corps Training Exercises at Air Station Cherry Point, 
            42042-42050


National Science Foundation
NOTICES
Meetings:
    Advisory Committee for Mathematical and Physical Sciences; 
            Correction, 42111
Meetings; Sunshine Act, 42111-42112


Nuclear Regulatory Commission
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 42112
Facility Operating Licenses:
    San Onofre Nuclear Generating Station, Units 2 and 3; Applications 
            and Amendments, 42113


Pension Benefit Guaranty Corporation
RULES
Benefits Payable in Terminated Single-Employer Plans; Interest 
          Assumptions for Paying Benefits, 42009-42010


Securities and Exchange Commission
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 42113-42114
Applications:
    Bridge Builder Trust and Olive Street Investment Advisers, LLC, 
            42122-42125
    FlexShares Trust, et al., 42114-42115
    NGAM Advisors, LP, et al., 42115-42122
Meetings; Sunshine Act, 42125
Self-Regulatory Organizations; Changes to Operations:
    Options Clearing Corp., 42125-42127

[[Page vi]]

Self-Regulatory Organizations; Liquidity Deposits to Clearing Funds:
    National Securities Clearing Corp., 42127-42132
Self-Regulatory Organizations; Proposed Rule Changes:
    Chicago Board Options Exchange, Inc., 42132-42135
    Miami International Securities Exchange, LLC, 42138-42140
    National Securities Clearing Corp., 42140-42147
    NYSE MKT LLC, 42135-42138


Small Business Administration
NOTICES
Disaster Declarations:
    Illinois; Amendment 3, 42148
    Iowa, 42147-42148
    North Carolina, 42148
    Oklahoma, 42147
    South Dakota, 42147


State Department
NOTICES
Meetings:
    Advisory Committee on International Economic Policy, 42148-42149
Privacy Act; Systems of Records, 42149-42151


Substance Abuse and Mental Health Services Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 42091-42099
Stay Covered Challenge and Churn Marketing Research Methodology 
          Development Challenge; Requirements and Registrations, 42099-
          42101


Surface Transportation Board
NOTICES
Acquisition Exemptions:
    Sonoma-Marin Area Rail Transit District, Marin County, CA, 42156-
            42157


Transportation Department
See Federal Aviation Administration
See Federal Highway Administration
See Maritime Administration
See National Highway Traffic Safety Administration
See Surface Transportation Board


U.S. Customs and Border Protection
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    African Growth and Opportunity Act Certificate of Origin, 42103-
            42104


Veterans Affairs Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 42157

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



Separate Parts In This Issue
Part II
Health and Human Services Department, Centers for Medicare & Medicaid 
          Services, 42160-42322
Health and Human Services Department, 42160-42322


Part III
Transportation Department, Federal Aviation Administration, 42324-42380


Part IV
Health and Human Services Department, Food and Drug Administration, 
          42382-42387

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



Reader Aids

Consult the Reader Aids section at the end of this page for phone numbers, 
online resources, finding aids, reminders, and notice of recently enacted 
public laws.

To subscribe to the Federal Register Table of Contents LISTSERV electronic 
mailing list, go to http://listserv.access.gpo.gov and select Online 
mailing list archives, FEDREGTOC-L, Join or leave the list (or change 
settings); then follow the instructions.




      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.


Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / 
Contents

Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / 
Contents

Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / 
Contents

[[Page vii]]



                          14 CFR
61...................................................42324
120..................................................41999
121..................................................42324
135..................................................42324
141..................................................42324
142..................................................42324

                          16 CFR
Proposed Rules:
Ch. II...............................................42026

                          21 CFR
520..................................................42006
558..................................................42006
Proposed Rules:
1....................................................42382
16...................................................42382

                          29 CFR
4022.................................................42009
Proposed Rules:
2520.................................................42027

                          33 CFR
117 (4 documents).............................42010, 42011
165 (2 documents).............................42012, 42016
Proposed Rules:
165..................................................42027
207..................................................42030

                          40 CFR
52...................................................42018

                          42 CFR
431..................................................42160
435..................................................42160
436..................................................42160
438..................................................42160
440..................................................42160
447..................................................42160
457..................................................42160

                          45 CFR
155..................................................42160
156..................................................42160

                          47 CFR
Proposed Rules:
64...................................................42034
73...................................................42036

                          50 CFR
635..................................................42021
679 (3 documents)......................42022, 42023, 42024