Unknown. Interim rule and request for comments

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--- schema: federal-register doc_type: fedreg source_file: FR-2016-08-08.xml --- 81 152 Monday, August 8, 2016 Contents Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Forest Service See Rural Housing Service Animal Animal and Plant Health Inspection Service RULES State and Zone Designations: California; Tuberculosis in Cattle and Bison, 52325-52326 2016-18428 Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 2017 Census Test, 52398-52401 2016-18722 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 52434-52438 2016-18710 2016-18746 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: State Annual Long-Term Care Ombudsman Report Revised Data Collection to the National Ombudsman Reporting System, 52438 2016-18736 Coast Guard Coast Guard RULES Drawbridge Operations: Umpqua River, Reedsport, OR, 52335 2016-18709 Safety Zones: 2016 Wings over Vermont Air Show, Lake Champlain, Burlington, VT, 52339-52341 2016-18535 Marine Events held in the Sector Long Island Sound Captain of the Port Zone, 52335-52339 2016-18641 Point to LaPointe Swim, Lake Superior, LaPointe, WI, 52339 2016-18480 Commerce Commerce Department See Census Bureau See Foreign-Trade Zones Board See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration Community Living Administration Community Living Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: National Maltreatment Reporting System, 52438-52439 2016-18731 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Bank Secrecy Act/Money Laundering Risk, 52521-52525 2016-18740 Education Department Education Department RULES Final Priorities: Enhanced Assessment Instruments Grant Program, 52341-52346 2016-18530 NOTICES Applications for New Awards: Enhanced Assessment Instruments Grant Program, 52424-52432 2016-18532 Federal Need Analysis Methodology for the 2016-17 Award Year:

Federal Pell Grant, Federal Perkins Loan, Federal Work-Study, Federal Supplemental Educational Opportunity Grant, William D. Ford Federal Direct Loan, Iraq and Afghanistan Service Grant and TEACH Grant Programs, 52418-52424 2016-18723 Energy Department Energy Department NOTICES Meetings: Biomass Research and Development Technical Advisory Committee, 52433 2016-18724 National Coal Council, 52432-52433 2016-18725 Environmental Protection Environmental Protection Agency RULES Denials of Petitions for Reconsideration:

Mercury and Air Toxics Standards and the Utility New Source Performance Standards Startup and Shutdown Provisions; Final Action, 52346-52347 2016-18684 Pesticide Tolerances: Flonicamid, 52348-52352 2016-18666 Technical Amendments to Performance Specification 18 and Procedure 6, 52348 2016-18682 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: South Dakota, Revisions to the Permitting Rules, 52388-52393 2016-18759 Review of the 2008 Lead Renovation, Repair, and Painting Program, 52393-52394 2016-18520 Federal Aviation Federal Aviation Administration PROPOSED RULES Class E Airspace;

Amendments: Blue Mesa, CO, 52369-52370 2016-18676 Federal Communications Federal Communications Commission RULES Improving Outage Reporting: Submarine Cables and Enhanced Submarine Outage Data, 52354-52363 2016-18610 Federal Deposit Federal Deposit Insurance Corporation NOTICES Terminations of Receivership: Home National Bank Blackwell, OK, 52433 2016-18766 Federal Emergency Federal Emergency Management Agency RULES Suspension of Community Eligibility, 52353-52354 2016-18510 Federal Motor Federal Motor Carrier Safety Administration NOTICES National Hazardous Materials Route Registry Revisions and Procedures, 52518-52521 2016-18729 Qualification of Drivers;

Exemption Applications: Diabetes Mellitus, 52505-52512 2016-18734 Implantable Cardioverter Defibrillators, 52512-52514 2016-18737 Vision, 52514-52518 2016-18733 2016-18735 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 52433-52434 2016-18691 Fish Fish and Wildlife Service RULES Subsistence Management Regulations for Public Lands in Alaska—2016-17 and 2017-18 Subsistence Taking of Wildlife Regulations, 52528-52582 2016-17832 Food and Drug Food and Drug Administration RULES Refusals to Accept Procedures for Premarket Tobacco Product Submissions, 52329-52335 2016-18534 Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products:

Confirmation of Effective Date, 52329 2016-18584 PROPOSED RULES Food Additive Petitions: Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council, 52370-52371 2016-18720 Refusals to Accept Procedures for Premarket Tobacco Product Submissions, 52371-52377 2016-18533 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Survey of Alumni Commissioner's Fellowship Program Fellows, 52439-52440 2016-18711 Determinations That Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: BENTYL Dicyclomine Hydrochloride Syrup, 52440-52441 2016-18707 Guidance for Industry and Staff: Deciding When to Submit a 510(k) for a Change to an Existing Device, 52443-52444 2016-18713 Deciding When to Submit a 510(k) for a Software Change to an Existing Device, 52441-52443 2016-18714 Guidance:

Ulcerative Colitis; Clinical Trial Endpoints, 52449-52450 2016-18716 Meetings: Stakeholders; Over-the-Counter Monograph User Fees: Reopening of Comment Period, 52444-52445 2016-18717 Retrospective Review of Premarket Approval Application Devices: Striking the Balance Between Premarket and Postmarket Data Collection, 52445-52449 2016-18672 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties: AL-JANABI, Nabil Abdullah, Beirut, Lebanon, 52526 2016-18696 Foreign Trade Foreign-Trade Zones Board NOTICES Reorganization and Expansion Applicationss under Alternative Site Framework:

Foreign-Trade Zone 193, Pinellas County, FL, 52401 2016-18782 Subzone Approvals: Barrett Distribution Centers, Inc., Franklin, MA, 52402 2016-18781 Subzone Expansions: Approvals: Premcor Refining Group Inc., Subzone 116C, Port Arthur, TX, 52401 2016-18785 Forest Forest Service RULES Subsistence Management Regulations for Public Lands in Alaska—2016-17 and 2017-18 Subsistence Taking of Wildlife Regulations, 52528-52582 2016-17832 NOTICES Meetings: Kistachie National Forest Resource Advisory Committee, 52397 2016-18719 Nicolet Resource Advisory Committee, 52397-52398 2016-18732 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Children and Families Administration See Community Living Administration See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health Health Resources Health Resources and Services Administration NOTICES Statements of Organization, Functions and Delegations of Authority, 52450-52451 2016-18730 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S.

Customs and Border Protection Indian Affairs Indian Affairs Bureau NOTICES Meetings: Advisory Board for Exceptional Children, 52457-52458 2016-18718 Industry Industry and Security Bureau RULES Export Administration Regulations to Add Targets for the Production of Tritium and Related Development and Production Technology to the List of 0Y521 Series; Amendments, 52326-52329 2016-18070 Interior Interior Department See Fish and Wildlife Service See Indian Affairs Bureau See National Park Service RULES Civil Penalties Inflation Adjustments;

Correction, 52352 2016-18643 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Aluminum Extrusions from the People's Republic of China, 52402-52403 2016-18788 Preserved Mushrooms from the People's Republic of China, 52403-52405 2016-18779 Export Trade Certificates of Review: Northwest Fruit Exporters; Application, 52405-52406 2016-18755 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Carbon Steel Butt-Weld Pipe Fittings from Brazil, China, Japan, Taiwan, and Thailand, 52460 2016-18742 Judicial Conference Judicial Conference of the United States NOTICES Meetings: Advisory Committee on Rules of Criminal Procedure, 52460 2016-18762 Justice Department Justice Department See Justice Programs Office NOTICES Proposed Consent Decrees under CERCLA, 52460-52461 2016-18712 Justice Programs Justice Programs Office PROPOSED RULES Formula Grant Program: Juvenile Justice and Delinquency Prevention Act, 52377-52388 2016-18371 Legal Legal Services Corporation NOTICES Agricultural Worker Population Estimates for Basic Field—Agricultural Worker/Migrant Grants, 52461-52464 2016-18753 Management Management and Budget Office NOTICES North American Industry Classification System:

Revision for 2017, 52584 2016-18774 Millenium Millennium Challenge Corporation NOTICES Compacts with the Republic of Niger, 52464-52466 2016-18756 National Credit National Credit Union Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Written Reimbursement Policy, 52466-52467 2016-18750 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 52452 2016-18689 Meetings:

Center for Scientific Review, 52453 2016-18687 National Cancer Institute, 52452-52453 2016-18686 National Institute on Alcohol Abuse and Alcoholism, 52451-52452 2016-18688 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Reallocation of Pollock in the Bering Sea and Aleutian Islands, 52367-52368 2016-18763 Fisheries of the Northeastern United States: Small-Mesh Multispecies Fishery; Adjustment to the Commercial Northern Red Hake Inseason Possession Limit, 52366-52367 2016-18715 Snapper-Grouper Fishery of the South Atlantic: 2016 Recreational Accountability Measure and Closure for the South Atlantic Other Jacks Complex, 52366 2016-18677 PROPOSED RULES Fisheries of the Exclusive Economic Zone Off Alaska:

Gulf of Alaska Management Area; Amendment 101, 52394-52396 2016-18745 NOTICES Meetings: Pacific Fishery Management Council, 52406-52407 2016-18692 Takes of Marine Mammals: Anchor Retrieval Program in the Chukchi and Beaufort Seas, 52407-52418 2016-18738 National Park National Park Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Community Harvest Assessments for Alaskan National Parks, Preserves, and Monuments, 52458-52459 2016-18727 National Park Service National Recreation Trails and National Water Trails System Applications, 52459-52460 2016-18741 National Science National Science Foundation NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 52467-52478 2016-18758 Nuclear Regulatory Nuclear Regulatory Commission NOTICES License Application; Amendments: Export Radioactive Waste, 52483-52484 2016-18752 Omaha Public Power District; Fort Calhoun Station, Unit No. 1, 52483 2016-18744 License Application; Renewals: Massachusetts Institute of Technology, 52478-52482 2016-18628 Meetings; Sunshine Act, 52478 2016-18831 Nuclear Waste Importation Licenses, 52484-52485 2016-18749 Presidential Documents Presidential Documents EXECUTIVE ORDERS Committees;

Establishment, Renewal, Termination, etc.: Africa, President's Advisory Council on Doing Business in; Amendment to Executive Order 13675 To Expand Membership (EO 13734), 52321-52322 2016-18872 ADMINISTRATIVE ORDERS Electrify Africa Act of 2015; Delegation of Authority (Memorandum of August 3, 2016), 52323 2016-18879 Export Control Regulations; Continuation of National Emergency (Notice of August 4, 2016), 52585-52587 2016-18943 Rural Housing Service Rural Housing Service NOTICES Solicitations of Applications:

Loans to Re-Lenders under the Community Facility Loan Program for Fiscal Year

(FY)2016; Correction, 52398 2016-18825 Securities Securities and Exchange Commission NOTICES Applications: American Independence Funds Trust, et al., 52493-52494 2016-18754 Managed Portfolio Series and Port Street Investments, LLC, 52490-52491 2016-18683 OSI ETF Trust, et al., 52485-52486 2016-18706 Self-Regulatory Organizations; Proposed Rule Changes: Bats BYX Exchange, Inc., 52503-52504 2016-18699 Bats BZX Exchange, Inc., 52494-52496, 52504-52505 2016-18697 2016-18698 Bats EDGA Exchange, Inc., 52491-52493 2016-18700 Bats EDGX Exchange, Inc., 52496-52498 2016-18701 C2 Options Exchange, Inc., 52498-52502 2016-18702 NASDAQ Stock Market, LLC, 52486-52490 2016-18703 Transportation Department Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration RULES Technical Amendment to Revise the Definition of Service Agent, 52364-52365 2016-18328 NOTICES Commuter Authority Applications: Trans Northern Airways LLC, 52521 2016-18728 Treasury Treasury Department See Comptroller of the Currency See Foreign Assets Control Office Customs U.S. Customs and Border Protection NOTICES National Customs Automation Program: Automated Commercial Environment Portal Accounts to Establish the Protest Filer Account, etc., 52453-52457 2016-18757 Separate Parts In This Issue Part II Agriculture Department, Forest Service, 52528-52582 2016-17832 Interior Department, Fish and Wildlife Service, 52528-52582 2016-17832 Part III Management and Budget Office, 52584 2016-18774 Part IV Presidential Documents, 52585-52587 2016-18943 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, 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. 81 152 Monday, August 8, 2016 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 77 [Docket No. APHIS-2016-0052] Tuberculosis in Cattle and Bison; State and Zone Designations; California AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Interim rule and request for comments. SUMMARY: We are amending the bovine tuberculosis regulations regarding State and zone classifications by reclassifying the State of California as accredited-free. We have determined that the State meets the criteria for accredited-free status. This action relieves certain restrictions on the interstate movement of cattle and bison from the State of California. DATES: This interim rule is effective August 8, 2016. We will consider all comments that we receive on or before October 7, 2016. ADDRESSES: You may submit comments by either of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0052.* • *Postal Mail/Commercial Delivery:* Send your comment to Docket No. APHIS-2016-0052, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Supporting documents and any comments we receive on this docket may be viewed at *http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0052* or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call

(202)799-7039 before coming. FOR FURTHER INFORMATION CONTACT: Dr. C. William Hench, Cattle Health Center Staff Veterinarian, Surveillance, Preparedness and Response Services, Veterinary Services, APHIS, 2150 Centre Avenue, Fort Collins, CO 80526-8117;

(970)494-7378. SUPPLEMENTARY INFORMATION: Background Bovine tuberculosis is a contagious and infectious granulomatous disease caused by the bacterium *Mycobacterium bovis.* Although commonly defined as a chronic debilitating disease, bovine tuberculosis can occasionally assume an acute, rapidly progressive course. While any body tissue can be affected, lesions are most frequently observed in the lymph nodes, lungs, intestines, liver, spleen, pleura, and peritoneum. Although cattle are considered to be the true hosts of *M. bovis,* the disease has been reported in several other species of both domestic and nondomestic animals, as well as in humans. At the beginning of the past century, tuberculosis caused more losses of livestock than all other livestock diseases combined. This prompted the establishment in the United States of the National Cooperative State/Federal Bovine Tuberculosis Eradication Program for tuberculosis in livestock. In carrying out the national eradication program, the Animal and Plant Health Inspection Service (APHIS) issues and enforces regulations. The regulations require the testing of cattle and bison for tuberculosis, define the Federal tuberculosis status levels for States or zones (accredited-free, modified accredited advanced, modified accredited, accreditation preparatory, and nonaccredited), provide the criteria for attaining and maintaining those status levels, and contain testing and movement requirements for cattle and bison leaving States or zones of a particular status level. These regulations are contained in 9 CFR part 77 and in the Bovine Tuberculosis Eradication Uniform Methods and Rules, 1999 (UMR), which is incorporated by reference into the regulations. The status of a State or zone is based on its prevalence of tuberculosis in cattle and bison, the effectiveness of the State's tuberculosis eradication program, and the degree of the State's compliance with standards for cattle and bison contained in the UMR. The regulations provide that a State may request partitioning into specific geographic regions or zones with different status designations (commonly referred to as split-State status) if bovine tuberculosis is detected in a portion of a State and the State demonstrates that it meets certain criteria with regard to zone classification. Request for Advancement of Modified Accredited Advanced Status In an interim rule effective and published in the **Federal Register** on September 18, 2008 (73 FR 54063-54065, Docket No. APHIS-2008-0067), we amended the tuberculosis regulations for cattle and bison by removing the State of California from the list of accredited-free States for bovine tuberculosis and reclassified the State as modified accredited advanced. Because two affected cattle herds had been detected in California since November 2007, the State no longer met our requirements for accredited-free status. That action was necessary to reduce the likelihood of the spread of bovine tuberculosis within the United States. As a result of that action, cattle or bison moved interstate from anywhere in California have had to meet the testing requirements that apply to animals from modified accredited advanced States or zones. The State of California has requested that the State be reclassified from modified accredited advanced to accredited-free. Based on the findings of a review of the tuberculosis eradication program in California conducted during the week of April 18 to 22, 2016, APHIS has determined that the State meets the criteria for advancement of status contained in the regulations. State animal health officials in California have demonstrated that the State enforces and complies with the provisions of the UMR. The State of California has demonstrated that it has zero percent prevalence of cattle and bison herds affected with tuberculosis and has had no findings of tuberculosis in any cattle or bison in the State since the last affected herd completed a test-and-remove herd plan and was released from quarantine in July 2014. Therefore, California has demonstrated that the State meets the criteria for accredited-free status as set forth in the definition of *accredited-free State* *or zone* in § 77.5 of the regulations. Based on our evaluation of California's request, we are classifying the entire State of California as accredited-free. Immediate Action Immediate action is warranted to relieve restrictions on the interstate movement of cattle and bison from the State of California. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this action effective less than 30 days after publication in the **Federal Register** . We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the **Federal Register** . The document will include a discussion of any comments we receive and any amendments we are making to the rule. Executive Order 12866 and Regulatory Flexibility Act This interim rule is subject to Executive Order 12866. However, for this action, the Office of Management and Budget has waived its review under Executive Order 12866. In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. The full analysis may be viewed on the *Regulations.gov* Web site (see ADDRESSES above for instructions for accessing *Regulations.gov* ) or obtained from the person listed under FOR FURTHER INFORMATION CONTACT . Tuberculosis testing, including veterinary fees, costs approximately $10 to $15 per head. Approximately 100,000 tuberculosis tests were conducted in California in 2015, to meet the import requirements imposed by other States. Based on this information, the annual cost savings associated with advancing the tuberculosis status of California from modified accredited advanced to accredited-free will range from $1 million to $1.5 million. We note that Federal interstate movement testing requirements for modified accredited advanced States were suspended by a Federal Order issued in April 2010. The $1 million to $1.5 million in savings that will be realized represents less than 0.02 percent of the approximately $10 billion earned from California's cattle and milk sales. Entities that may be affected by the interim rule fall into various categories of the North American Industry Classification System. The majority of the affected businesses are small entities. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.) Executive Order 12988 This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule has no retroactive effect and does not require administrative proceedings before parties may file suit in court challenging this rule. Paperwork Reduction Act This rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects in 9 CFR Part 77 Animal diseases, Bison, Cattle, Reporting and recordkeeping requirements, Transportation, Tuberculosis. Accordingly, we are amending 9 CFR part 77 as follows: PART 77—TUBERCULOSIS 1. The authority citation for part 77 continues to read as follows: Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4. 77.7 [Amended] 2. In § 77.7, paragraph

(a)is amended by adding the word “California,” after the word “Arkansas,”. 77.9 [Amended] 3. In § 77.9, paragraph

(a)is amended by removing the word “California” and adding the word “None” in its place. Done in Washington, DC, this 29th day of July 2016. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2016-18428 Filed 8-5-16; 8:45 am]

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