Federal Register Vol. 81, No.29,
Federal Register Volume 81, Issue 29 (February 12, 2016)
Federal Register Volume 81, Issue 29 (February 12, 2016)
| Page Range | 7441-7693 | |
| FR Document |
Document Created: 2015-12-31 23:05:09
Document Modified: 2015-12-31 23:05:09
| Page and Subject | |
|---|---|
| 81 FR 7691 - Sequestration Order for Fiscal Year 2017 Pursuant to Section 251A of the Balanced Budget and Emergency Deficit Control Act, as Amended | |
| 81 FR 7685 - Establishment of the Federal Privacy Council | |
| 81 FR 7587 - Government in the Sunshine Act Meeting Notice | |
| 81 FR 7542 - Wireless Telecommunications Bureau Releases Updated List of Reserve-Eligible Nationwide Service Providers in Each PEA for the Broadcast Incentive Auction | |
| 81 FR 7493 - Trade Monitoring Procedures for Fishery Products; International Trade in Seafood; Permit Requirements for Importers and Exporters; Public Meeting; Correction | |
| 81 FR 7441 - Commission on Enhancing National Cybersecurity | |
| 81 FR 7504 - Notice of Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review: Drawn Stainless Steel Sinks From the People's Republic of China | |
| 81 FR 7500 - Citric Acid and Certain Citrate Salts From Canada: Preliminary Results of Antidumping Duty Administrative Review; 2014-2015 | |
| 81 FR 7503 - Light-Walled Rectangular Pipe and Tube From Turkey; Preliminary Results of Antidumping Duty Administrative Review; 2014-2015 | |
| 81 FR 7502 - Certain Magnesia Carbon Bricks From Mexico and the People's Republic of China: Continuation of Antidumping Duty Orders and Countervailing Duty Order | |
| 81 FR 7500 - Foreign-Trade Zone (FTZ) 279-Terrebonne Parish, Louisiana; Notification of Proposed Production Activity; Thoma-Sea Marine Constructors, L.L.C. (Shipbuilding); Houma, Louisiana | |
| 81 FR 7499 - Sunshine Act Meeting Notice | |
| 81 FR 7454 - Visas: Documentation of Nonimmigrants Under the Immigration and Nationality Act, as Amended | |
| 81 FR 7556 - Accreditation and Approval of Saybolt LP as a Commercial Gauger and Laboratory | |
| 81 FR 7553 - Accreditation and Approval of AmSpec Services, Llc, as a Commercial Gauger and Laboratory | |
| 81 FR 7536 - Agency Information Collection Activities: Information Collection Request (ICR) for On-Highway Motorcycle Certification and Compliance Program; EPA ICR Number 2535.01, OMB Control Number-2060-NEW | |
| 81 FR 7466 - Allocations of Cross-State Air Pollution Rule Allowances From New Unit Set-Asides for the 2015 Compliance Year | |
| 81 FR 7555 - Accreditation and Approval of AmSpec Services, LLC, as a Commercial Gauger and Laboratory | |
| 81 FR 7455 - Significant New Use Rule on Certain Chemical Substances | |
| 81 FR 7554 - Accreditation and Approval of Inspectorate America Corporation, As a Commercial Gauger and Laboratory | |
| 81 FR 7499 - Submission for OMB Review; Comment Request | |
| 81 FR 7510 - Procurement List, Proposed Additions And Deletion | |
| 81 FR 7566 - Agency Information Collection Activities: Petition for CNMI-Only Nonimmigrant Transitional Worker, Form I-129CW; Extension, Without Change, of a Currently Approved Collection. | |
| 81 FR 7510 - Procurement List Addition | |
| 81 FR 7508 - Procurement List Additions and Deletions | |
| 81 FR 7511 - Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Pertaining to Third Party Conformity Assessment Bodies | |
| 81 FR 7526 - 36(b)(1) Arms Sales Notification | |
| 81 FR 7538 - Environmental Impact Statements; Notice of Availability | |
| 81 FR 7588 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Manufacturers of Ammunition, Records and Supporting Data of Ammunition Manufactured and Disposed of | |
| 81 FR 7590 - Agency Information Collection Activities; Proposed eCollection eComments Requested; ATF Distribution Center Survey (ATF F 1370.4) | |
| 81 FR 7594 - National Industrial Security Program Policy Advisory Committee (NISPPAC) | |
| 81 FR 7507 - Pacific Fishery Management Council; Public Meeting | |
| 81 FR 7542 - Order Declares ACT Telecommunications, Inc.'s International Section 214 Authorization Terminated | |
| 81 FR 7625 - Arkansas Disaster #AR-00086 | |
| 81 FR 7624 - Oklahoma Disaster Number OK-00098 | |
| 81 FR 7624 - Arkansas Disaster # AR-00087 | |
| 81 FR 7623 - Michigan Disaster #MI-00054 Declaration of Economic Injury | |
| 81 FR 7497 - Request for Public Engagement in the Interagency Special Report `2nd State of the Carbon Cycle Report (SOCCR-2)' | |
| 81 FR 7533 - Idaho Power Company; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests | |
| 81 FR 7535 - Southern California Edison Company; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests | |
| 81 FR 7534 - Dominion Energy Marketing, Inc., Dominion Energy Manchester Street, Inc. v. ISO New England, Inc.; Notice of Complaint | |
| 81 FR 7535 - Combined Notice of Filings | |
| 81 FR 7534 - Combined Notice of Filings #1 | |
| 81 FR 7537 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Recordkeeping and Reporting Related to RFS2 Voluntary RIN Quality Assurance Program (Renewal) | |
| 81 FR 7539 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Proposed Information Collection Request; Landfill Methane Outreach Program (Renewal) | |
| 81 FR 7538 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; EPA's ENERGY STAR Program in the Commercial and Industrial Sectors (Revision) | |
| 81 FR 7528 - 36(b)(1) Arms Sales Notification | |
| 81 FR 7583 - Indian Gaming; Extension of Tribal-State Class III Gaming Compact (Crow Creek Sioux Tribe and the State of South Dakota) | |
| 81 FR 7565 - Agency Information Collection Activities: Immigrant Petition for Alien Worker, Form I-140; Extension, Without Change, of a Currently Approved Collection | |
| 81 FR 7585 - Certain Corrosion-Resistant Steel Products From China, India, Italy, Korea, and Taiwan; Scheduling of the Final Phase of Countervailing Duty and Antidumping Duty Investigations | |
| 81 FR 7567 - Additional Clarifying Guidance, Waivers and Alternative Requirements for Grantees in Receipt of Community Development Block Grant Disaster Recovery Funds Under Public Law 113-2 for the Submission of Expenditure Deadline Extension Requests and Urgent Need Certification Extensions and for the Provision of Interim Mortgage Assistance by the State of New York | |
| 81 FR 7557 - Proposed Flood Hazard Determinations | |
| 81 FR 7561 - Proposed Flood Hazard Determinations | |
| 81 FR 7588 - Agency Information Collection Activities; Proposed eCollection eComments Requested; FFL Out of Business Records Request (ATF F 5300.3A) | |
| 81 FR 7559 - Changes in Flood Hazard Determinations | |
| 81 FR 7558 - Notice of Adjustment of Statewide Per Capita Indicator for Recommending a Cost Share Adjustment | |
| 81 FR 7563 - Texas; Amendment No. 3 to Notice of a Major Disaster Declaration | |
| 81 FR 7543 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 81 FR 7513 - 36(b)(1) Arms Sales Notification | |
| 81 FR 7507 - National Oceanic and Atmospheric Administration | |
| 81 FR 7625 - Wisconsin Central Ltd.-Trackage Rights Exemption-Lines of Union Pacific Railroad Company and Illinois Central Railroad Company | |
| 81 FR 7540 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 81 FR 7541 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
| 81 FR 7477 - Broadcast Licensee-Conducted Contests | |
| 81 FR 7491 - Petitions for Reconsideration of Action in a Rulemaking Proceeding | |
| 81 FR 7589 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Voluntary Magazine Questionnaire for Agencies/Entities Who Store Explosive Materials | |
| 81 FR 7587 - Stainless Steel Wire Rod From Italy, Japan, Korea, Spain, and Taiwan; Revised Schedule for the Subject Reviews | |
| 81 FR 7626 - Hours of Service of Drivers: Farruggio's Express, Application for Exemption | |
| 81 FR 7571 - Endangered and Threatened Wildlife and Plants; Initiation of 5-Year Status Reviews of 76 Species in Hawaii, Oregon, Washington, Montana, and Idaho | |
| 81 FR 7583 - National Geospatial Advisory Committee; Charter Renewal | |
| 81 FR 7628 - Proposed Agency Information Collection Activities; Comment Request | |
| 81 FR 7524 - 36(b)(1) Arms Sales Notification | |
| 81 FR 7552 - Policy Letter: Guidance for Training of Deck Officers on Vessels Subject to the International Code for Ships Operating in the Polar Waters | |
| 81 FR 7549 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products | |
| 81 FR 7544 - Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards | |
| 81 FR 7547 - Government-Owned Inventions; Availability for Licensing; Influenza Virus Neuramindase | |
| 81 FR 7593 - Aerospace Safety Advisory Panel; Meeting | |
| 81 FR 7593 - NASA International Space Station Advisory Committee; Meeting | |
| 81 FR 7445 - Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972 | |
| 81 FR 7630 - West Los Angeles VA Medical Center; Draft Master Plan | |
| 81 FR 7546 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Samples and Protocols | |
| 81 FR 7548 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution | |
| 81 FR 7547 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration | |
| 81 FR 7543 - Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 81 FR 7452 - Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia | |
| 81 FR 7548 - Annual Computational Science Symposium; Conference | |
| 81 FR 7446 - Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure | |
| 81 FR 7623 - Florida Disaster #FL-00110 | |
| 81 FR 7623 - Florida Disaster #FL-00111 | |
| 81 FR 7624 - Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest | |
| 81 FR 7563 - Infrastructure Protection Gateway Facility Surveys | |
| 81 FR 7569 - Mortgage and Loan Insurance Programs Under the National Housing Act-Debenture Interest Rates | |
| 81 FR 7584 - Certain Stainless Steel Products, Certain Processes for Manufacturing or Relating to Same, and Certain Products Containing Same; Notice of Commission Determination To Review an Initial Determination Granting in Part a Motion for Default and Other Relief and, on Review, To Affirm the Default Finding; Schedule for Filing Written Submissions on the Issues Under Review and on Remedy, Public Interest, and Bonding | |
| 81 FR 7594 - NASA Advisory Council; Science Committee; Meeting. | |
| 81 FR 7582 - Agency Information Collection Activities: Comment Request | |
| 81 FR 7522 - 36(b)(1) Arms Sales Notification | |
| 81 FR 7587 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc. | |
| 81 FR 7516 - 36(b)(1) Arms Sales Notification | |
| 81 FR 7512 - Proposed Information Collection; Comment Request | |
| 81 FR 7506 - Views on the Framework for Improving Critical Infrastructure Cybersecurity | |
| 81 FR 7592 - Advisory Board on Toxic Substances and Worker Health Charter Amendment. | |
| 81 FR 7546 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting | |
| 81 FR 7595 - New Postal Product | |
| 81 FR 7596 - New Postal Product | |
| 81 FR 7549 - National Institute of General Medical Sciences; Notice of Closed Meeting | |
| 81 FR 7550 - National Institute of General Medical Sciences; Notice of Closed Meeting | |
| 81 FR 7552 - National Institute of General Medical Sciences; Notice of Closed Meeting | |
| 81 FR 7550 - National Institute of General Medical Sciences; Notice of Closed Meetings | |
| 81 FR 7551 - National Institute on Drug Abuse; Notice of Closed Meetings | |
| 81 FR 7550 - National Institute on Drug Abuse; Notice of Closed Meeting | |
| 81 FR 7520 - 36(b)(1) Arms Sales Notification | |
| 81 FR 7489 - Approval and Promulgation of Implementation Plans; Idaho: Interstate Transport Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standards | |
| 81 FR 7489 - Revisions to the California State Implementation Plan, San Joaquin Valley Unified Air Pollution Control District | |
| 81 FR 7483 - Air Plan Approval; Tennessee: Removal of I/M Program in Memphis and Revisions to the 1997 8-Hour Ozone Maintenance Plan for Shelby County, Tennessee | |
| 81 FR 7494 - Pacific Island Fisheries; Hawaii Bottomfish and Seamount Groundfish; Revised Essential Fish Habitat and Habitat Areas of Particular Concern | |
| 81 FR 7518 - 36(b)(1) Arms Sales Notification | |
| 81 FR 7609 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating To Adopting a Principles-Based Approach To Prohibit the Misuse of Material Nonpublic Information by Designated Primary Market-Makers (“DPMs”) and Lead Market-Makers (“LMMs”) | |
| 81 FR 7620 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Include NextShares in the Lead Market Maker Program | |
| 81 FR 7613 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Filing, as Modified by Amendment No. 1 Thereto, of Proposed Rule Change To Provide for the Clearance of Certain Asia-Pacific Credit Default Swap Contracts | |
| 81 FR 7599 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing of a Proposed Rule Change to Rule 14.11(i), Managed Fund Shares, To List and Trade Shares of the SPDR DoubleLine Short Term Total Return Tactical ETF of the SSgA Active Trust | |
| 81 FR 7597 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Retroactively Apply Recently-Reduced Port Fees | |
| 81 FR 7618 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delete Obsolete Rules 1000C-1009C | |
| 81 FR 7595 - Notice of Permits Issued Under the Antarctic Conservation Act of 1978 | |
| 81 FR 7619 - State Farm Associates' Funds Trust, et al.; Notice of Application | |
| 81 FR 7596 - Submission for OMB Review; Comment Request | |
| 81 FR 7616 - Submission for OMB Review; Comment Request | |
| 81 FR 7463 - Clean Air Act Title V Operating Permit Program Revision; West Virginia | |
| 81 FR 7591 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Contraband Cigarette Trafficking Act Delivery Sale Information Form-Schedule B (ATF Form 5200.26) | |
| 81 FR 7590 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Tobacco Inventory Report (ATF Form 5200.25) | |
| 81 FR 7592 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection Reporting and Recordkeeping for Digital Certificates | |
| 81 FR 7466 - Diflubenzuron; Pesticide Tolerances | |
| 81 FR 7473 - Benzyl acetate; Exemption From the Requirement of a Tolerance | |
| 81 FR 7481 - Special Local Regulation; Chesapeake Bay, Between Sandy Point and Kent Island, MD | |
| 81 FR 7454 - Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying Benefits | |
| 81 FR 7532 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
| 81 FR 7530 - State Energy Advisory Board (STEAB) | |
| 81 FR 7531 - Electricity Advisory Committee | |
| 81 FR 7653 - Medicare Program; Reporting and Returning of Overpayments | |
| 81 FR 7492 - Federal Motor Vehicle Safety Standards; Denial of Petition for Rulemaking | |
| 81 FR 7478 - Agriculture Acquisition Regulation, Fire Suppression and Liability | |
| 81 FR 7573 - Endangered Species; Issuance of Permits | |
| 81 FR 7631 - Federal Property Suitable as Facilities To Assist the Homeless | |
| 81 FR 7564 - Agency Information Collection Activities: H-2 Petitioner's Employment Related or Fee Related Notification, No Form; Extension, Without Change, of a Currently Approved Collection |
Issue
National Institute of Food and Agriculture
Rural Utilities Service
Foreign-Trade Zones Board
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Energy Information Administration
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
U.S. Citizenship and Immigration Services
U.S. Customs and Border Protection
Fish and Wildlife Service
Geological Survey
Indian Affairs Bureau
Drug Enforcement Administration
Workers Compensation Programs Office
Information Security Oversight Office
Federal Motor Carrier Safety Administration
Federal Railroad Administration
National Highway Traffic Safety Administration
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Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.
This rule is effective March 14, 2016.
For access to the docket to read background documents or comments received, go to
Jessica T. Walker, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972, because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972. These other statutory and regulatory authorities allow FDA to evaluate and monitor the safety and effectiveness of all biological products and authorize FDA to revoke a license for products because they are not safe and effective, or are misbranded.
The final rule removes §§ 601.25 and 601.26 (21 CFR 601.25 and 601.26), which prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972.
FDA is taking this action under the biological products provisions of the Public Health Service Act (the PHS Act), and the drugs and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Because this final rule would not impose any additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.
In the
Since establishing the procedures under §§ 601.25 and 601.26, FDA developed new regulations to assess and ensure the safety and efficacy of biological products. FDA issued the Current Good Manufacturing Practice (cGMP) regulations, which contain the minimum cGMP for preparation of drug products, including biological products. The cGMP regulations help FDA ensure that such products meet the requirements for product safety, effectiveness, and labeling. FDA also helps ensure the safety and effectiveness of biological products through application of other regulations, such as the reporting of biological product deviations by licensed manufacturers (see 21 CFR 600.14), postmarketing reporting of adverse experiences (21 CFR 600.80), and labeling regulations (for example, 21 CFR part 201). Biological products that do not meet the requirements under these regulations are subject to license revocation under 21 CFR 601.5, which allows FDA to revoke any biologics license for a product that fails to meet applicable standards and fails to comply with
In addition, FDA continues to help ensure the safety and effectiveness of licensed biological products through the development and application of additional standards and mechanisms. These mechanisms assist FDA in evaluating and monitoring the safety and effectiveness of biological products.
FDA did not receive any comments on the proposed rule.
The final rule removes §§ 601.25 and 601.26 of the regulations, which prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because these regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products.
FDA is issuing this regulation under the biological products provisions of the PHS Act (42 U.S.C. 262 and 264) and the drugs and general administrative provisions of the FD&C Act (sections 201, 301, 501, 502, 503, 505, 510, 701, and 704 (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371, and 374)). Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, and potent; and to prevent the introduction, transmission, and spread of communicable disease.
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule removes regulations that are obsolete and no longer necessary in light of other current statutory and regulatory authorities, FDA certifies that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in any 1-year expenditure that would meet or exceed this amount.
We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant adverse effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final rule contains no collection of information. Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required.
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that would have substantial direct effects 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. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
Administrative practice and procedure, Biologics, Confidential business information.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 601 is amended as follows:
15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note).
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA) is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to class II (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. A membrane lung device for long-term pulmonary support (>6 hours) refers to the oxygenator in an extracorporeal circuit used during long-term procedures, commonly referred to
This order is effective February 12, 2016.
Fernando Aguel, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1234, Silver Spring, MD 20993, 301-796-6326,
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).
Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.
Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification procedures (510(k)) to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a premarket approval application (PMA) until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval or until the device is subsequently reclassified into class I or class II.
On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126 Stat. 1056) amended section 513(e) of the FD&C Act, changing the mechanism for reclassifying a device from rulemaking to an administrative order.
Section 513(e) of the FD&C Act provides that FDA may, by administrative order, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify a preamendments device. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See,
Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available authority (see
FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information,
Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final reclassification order. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the
FDA published a proposed order to reclassify this device in the
As discussed in the proposed order, FDA considered the available information on these devices and concluded that these devices could be reclassified to class II, subject to the identified special controls. As required by section 513(e)(1) of the FD&C Act, FDA convened a meeting of a device classification panel described in section 513(b) of the FD&C Act with respect to the membrane lung devices for long-term pulmonary support on September 12, 2013, followed by a meeting on May 7, 2014. The deliberations of the device classification panels are discussed in section IV of this order. FDA received and has considered two comments on the January 8, 2013, proposed order, as discussed in section III. Therefore, FDA has met the requirements for issuing a final order under section 513(e)(1) of the FD&C Act.
FDA received two comments in response to the January 8, 2013, proposed order to reclassify membrane lung devices for long-term pulmonary support for conditions where imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery.
One comment supported FDA's reclassification proposal but requested that the Agency clarify the population covered and the conditions included in the reclassification. According to the commenter, it seemed that the membrane lung device could be used for long-term support in neonates and infants only when imminent death is threatened by cardiopulmonary failure, but for the remaining population (
Another comment disagreed with FDA's intent to reclassify membrane lung devices for long-term pulmonary support, stating that “ECMO devices must remain categorized as class III devices for all indications because they are life-sustaining devices for which clinical trials are necessary to provide reasonable assurance of safety and effectiveness.” FDA disagrees with this comment. According to section 513(a)(1)(C) of the FD&C Act, a class III device is defined as a device which: (1) Cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device; and (2) cannot be classified as a class II device because insufficient information exists to determine that the special controls would provide reasonable assurance of its safety and effectiveness; and (3) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health; or (4) presents a potential unreasonable risk of illness or injury.
Although FDA considers membrane lung devices for long-term pulmonary support to be life-supporting, a viewpoint that was supported by the panel members at the September 12, 2013 (2013 Panel), and May 7, 2014 (2014 Panel), device classification panel meetings, FDA believes that the available information supports FDA's determination that special controls, in addition to general controls, would be sufficient to provide a reasonable assurance of safety and effectiveness. Further, the 2013 and 2014 Panels largely supported reclassification of ECMO for use in patients with acute respiratory failure or acute cardiopulmonary failure as noted in section IV of this order. As mentioned previously and discussed further in section IV, ECMO is a tool which provides extracorporeal circulation and physiologic gas exchange of blood. The special controls identified in this final order, including clinical performance data, ensure that the device can function as intended to provide extracorporeal circulation and physiologic gas exchange of blood for the intended duration of device use. The Agency believes that the risks of ECMO devices are sufficiently understood based on valid scientific evidence and that the risks of ECMO devices can be mitigated with the special controls identified in this final order. The special controls mitigate the risks to health identified for the device as outlined in section IV, table 1. Therefore, FDA does not agree that membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure should remain a class III device.
The commenter also expressed concern that the reclassification of these devices would mean that companies manufacturing new versions of the device would not be required to show that their products are safe and effective. The commenter suggests that classification to class II (special controls) precludes FDA from requesting clinical data for these devices. FDA disagrees with this comment. FDA believes that the identified special controls provide a reasonable assurance of safety and effectiveness for membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. FDA has determined that by complying with the identified special controls, the currently legally marketed devices within this classification regulation will be reasonably safe and effective when used for acute respiratory failure or acute cardiopulmonary failure. Future devices claiming substantial equivalence to an available predicate(s) must demonstrate that they are substantially equivalent, as defined under section 513(i) of the FD&C Act, to the predicate device and comply with all applicable FDA regulations and with the special
The commenter further expressed concern that reclassification for some indications will reduce the incentive to undertake future studies for untested indications due to the availability of the devices for “off-label” use. FDA notes in response to this comment that, generally, FDA regulates the use of a device as indicated by the party offering the device for interstate commerce.
The commenter also sought assurance from FDA that membrane lung devices for long-term pulmonary support for indications not identified in the proposed order would remain in class III and therefore require the submission of a PMA. FDA notes that by identifying the intended uses covered by the revised classification regulation, uses that fall outside the definition would not be subject to the order but rather would be classified under section 513 of the FD&C Act.
As required by section 513(e)(1) of the FD&C Act, FDA convened a meeting of the Circulatory System Devices Panel to consider the existing valid scientific evidence to support reclassification to class II of membrane lung devices for long-term pulmonary support. One meeting was held on September 12, 2013 (2013 Panel), regarding pediatric uses for ECMO and another meeting was held on May 7, 2014 (2014 Panel), regarding adult uses for ECMO (Refs. 1 and 2).
On September 12, 2013, FDA presented the risks associated with use of the membrane lung device for long-term pulmonary support. The 2013 Panel mostly agreed that the risks to health were adequately captured as presented by FDA. Several 2013 Panel members discussed whether the list of risks to health should also include information on renal dysfunction, neurologic injury, disseminated intravascular coagulation, transfusion issues, and inflammatory responses. FDA explained that such effects are more appropriately characterized not as risks to health but rather as adverse events that may result from the risks to health. The 2013 Panel understood this distinction but requested that FDA consider expanding the definition of adverse tissue reaction to include inflammatory response. FDA considered the 2013 Panel's input when updating the risks to health for the 2014 Panel and this final order.
The 2013 Panel agreed that the available scientific evidence supported the safety and effectiveness for ECMO and its accessories for conditions where the subject is at threat of imminent death caused by acute reversible respiratory failure (
The 2013 Panel also agreed that the probable benefits to health from use of the extracorporeal circuit and its accessories for long-term pulmonary and cardiopulmonary support for these uses outweigh the probable risks. As noted previously, FDA has further considered all available information and has determined that the risks to health identified for ECMO are the same across neonatal, infant, pediatric, and adult populations. This is consistent with input from the 2013 and 2014 Panels, which found that the risks to health for the pediatric and adult populations do not differ. Further, FDA believes that the available safety and effectiveness information supports use of ECMO as a tool to provide extracorporeal circulation and physiologic gas exchange of blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. FDA is providing greater clarity in this final order by simplifying the identification of ECMO devices in the classification regulation to better reflect what an ECMO circuit performs, not specify patient populations or conditions to be treated. Specific indications for use for ECMO, including specific patient populations and/or conditions, are further discussed in this document.
In general, the 2013 Panel believed the special controls in the proposed order would mitigate the identified risks to health and provide reasonable assurance of safety and effectiveness of the extracorporeal circuit and its accessories. However, some 2013 Panel members recommended that compatibility of the various circuit accessories be evaluated to ensure that the circuit accessories can function together as intended. FDA believes that the special controls will be able to address the issue of circuit accessories' compatibility. Specifically, the following special controls from the classification regulation address this concern: (1) The design characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use; (2) non-clinical performance evaluation of the device must demonstrate substantial equivalence for performance characteristics on the bench, mechanical integrity, electromagnetic compatibility(where applicable), software, durability, and reliability; and (3) labeling must include a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility with other circuit accessories, and maintenance during a procedure.
The 2013 Panel unanimously agreed that the membrane lung device for long-term pulmonary support is life-supporting. The 2013 Panel further stated that the available scientific evidence and the proposed special controls, in conjunction with general controls, supported the reclassification to class II of membrane lung devices for long-term pulmonary/cardiopulmonary support in pediatric patients. The 2013 Panel expressed concern about not having had the opportunity to review data regarding use of the device in adults, given that use of ECMO in adults had increased significantly over the years. The 2013 Panel recommended that FDA convene another meeting to review the available literature regarding use of the membrane lung device for long-term pulmonary support in adults before finalizing the proposed reclassification.
On May 7, 2014, FDA convened the 2014 Panel to discuss the classification of the membrane lung for long-term support, specifically for adult pulmonary and cardiopulmonary indications. For both pulmonary and cardiopulmonary intended uses, the 2014 Panel believed that the list of risks to health presented by FDA were comprehensive and adequately captured. Of note, in response to the 2013 Panel's recommendation regarding risks to health, FDA expanded the definition of adverse tissue reaction to include inflammatory response.
The majority of the 2014 Panel believed that the available scientific evidence is adequate to support a
The 2014 Panel agreed that FDA's list of special controls were appropriate and comprehensive. The 2014 Panel further agreed that the special controls would mitigate the identified risks to health and provide reasonable assurance of safety and effectiveness for the device when used to provide long-term support in adults with acute respiratory failure or cardiopulmonary failure.
For both acute respiratory and acute cardiopulmonary indications in adults, the 2014 Panel unanimously agreed that the membrane lung device for long-term support is life-supporting. The 2014 Panel further believes that the available scientific evidence and the proposed special controls support the reclassification to class II of membrane lung devices for long-term support in adults with acute respiratory failure or acute cardiopulmonary failure.
After considering input from both the 2013 and 2014 Panels, FDA believes that the risks to health identified can be mitigated by the special controls as outlined in Table 1.
At both the 2013 Panel and 2014 Panel meetings, FDA provided a summary of information from the clinical literature regarding specific patient populations and conditions to be treated using ECMO (Refs.1 and 2). Of note, FDA has not cleared any ECMO devices that are indicated for specific patient populations or conditions. As such, FDA believes that the intended uses included in this final order should remain broad to reflect use of ECMO as a tool to provide extracorporeal circulation and physiologic gas exchange of blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. However, FDA believes that there are specific indications (patient populations and/or conditions) that would fall within this broader intended use and therefore be within the scope of this regulation as outlined in this document.
Specifically, FDA has reviewed the clinical literature and has determined that there are sufficient data available to support labeling ECMO devices for the following specific indications (patient populations and/or conditions) at this time: Meconium aspiration in neonates and infants; congenital diaphragmatic hernia in neonates and infants; pulmonary hypertension in neonates and infants; failure to wean from cardiopulmonary bypass following cardiac surgery in pediatric and adult patients; and ECMO-assisted cardiopulmonary resuscitation in adults.
FDA has further evaluated data from the clinical literature and determined that the data available do not support labeling ECMO devices for certain specific indications (patient populations and/or conditions) at this time without additional clinical data from sponsors to support such uses, consistent with the identified special controls, including but not limited to: High risk percutaneous coronary intervention; trauma resuscitation; failed heart or lung transplant; acute respiratory distress syndrome; and/or acute decompensation of chronic obstructive pulmonary disease.
For ECMO devices that have not been legally marketed prior to the effective date of the final order, or models (if any) that have been legally marketed but are required to submit a new 510(k) under § 807.81(a)(3) because the device is
Under section 513(e) of the FD&C Act, FDA is adopting its findings as published in the preamble to the proposed order (78 FR 1158) with modifications as discussed in section IV of this final order. FDA is issuing this final order to reclassify the membrane lung devices for long-term pulmonary support from class III to class II for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent, and to establish special controls. FDA is removing the regulation from 21 CFR part 868 (Anesthesiology Devices) and adding it to 21 CFR part 870 (Cardiovascular Devices) to better align this device type (and the review thereof) with other similar types of cardiovascular devices. The title and identification of § 870.4100 (21 CFR 870.4100) reflects the Agency's intent to regulate ECMO and the accessories used in ECMO under the same set of regulatory controls. However, an individual device or accessory in an ECMO circuit may already have its own classification regulation when intended for short-term use (≤6 hours) and, in those instances, such device or accessory is subject to the preexisting regulation(s).
Following the effective date of this final order, firms marketing membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent, must comply with the particular mitigation measures set forth in the special controls.
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the devices. FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent, and, therefore, this device type is not exempt from premarket notification requirements.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order refers to previously approved collections of information found in FDA regulations. 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 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subpart B, have been approved under OMB control number 0910-0231; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.
Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) of the FD&C Act as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this final order, we are revoking the requirements in 21 CFR 868.5610 related to the classification of membrane lung for long-term pulmonary support as class III devices and codifying under § 870.4100 the reclassification of membrane lung for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent into class II (special controls).
The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 868 and 870 are amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
(a)
(b)
(1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible;
(2) The devices and accessories in the circuit must be demonstrated to be biocompatible;
(3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories;
(4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability;
(5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and
(6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA) is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
This order is effective February 12, 2016. The classification was applicable on December 8, 2015.
Neil Ogden, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G414, Silver Spring, MD 20993-0002, 301-796-6397.
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1) of the FD&C Act. Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device.
On March 6, 2015, Target Health, Inc. (on behalf of Dignitana AB) submitted a request for classification of the DigniCap
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the
Therefore, on December 8, 2015, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding § 878.4360 (21 CFR 878.4360).
Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia will need to comply with the special controls named in this final order.
The device is assigned the generic name scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia, and it is identified as a scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used. The device is a prescription device.
FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks:
FDA believes that the special controls in § 878.4360(b)(1) through (6), in addition to the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness.
Scalp cooling systems to reduce the likelihood of chemotherapy-induced alopecia are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see 21 CFR 801.109 (
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia they intend to market.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. 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 part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use. This information must include testing to demonstrate accuracy of the temperature control mechanism.
(2) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of the device.
(3) Software verification, validation, and hazard analysis must be performed.
(4) The patient contacting components of the device must be demonstrated to be biocompatible. Material names must be provided.
(5) Labeling must include the following:
(i) A statement describing the potential risk of developing scalp metastasis.
(ii) Information on the patient population and chemotherapeutic agents/regimen for which the device has been demonstrated to be effective.
(iii) A summary of the non-clinical and/or clinical testing pertinent to use of the device.
(iv) A summary of the device technical parameters, including temperature cooling range and duration of cooling.
(v) A summary of the device- and procedure-related adverse events pertinent to use of the device.
(vi) Information on how the device operates and the typical course of treatment.
(6) Patient labeling must be provided and must include:
(i) Relevant contraindications, warnings, precautions, and adverse effects/complications.
(ii) Information on how the device operates and the typical course of treatment.
(iii) Information on the patient population for which there is clinical evidence of effectiveness.
(iv) The potential risks and benefits associated with use of the device.
(v) Postoperative care instructions.
(vi) A statement describing the potential risk of developing scalp metastasis.
Department of State.
Interim final rule; correction.
The Department of State published a
This correction is effective on February 19, 2016. Written comments must be received on or before April 4, 2016.
Paul-Anthony L. Magadia, U.S. Department of State, Visa Services, Legislation and Regulations Division, Washington, DC 20006, 202-485-7641; email:
The Department of State published an interim final rule on February 4, 2016 (81 FR 5906); this document corrects text in the
In the FR Doc 2016-02191, appearing on page 5906 in the
1. In the second column of page 5906, third item under
2. In the third column of page 5907, the first sentence of the discussion regarding “Executive Order 12866: Regulatory Review” is corrected to read: “The costs of this rulemaking are discussed in the companion DHS rule, RIN 1651-AB09, published in the
Pension Benefit Guaranty Corporation.
Final rule.
This final rule amends the Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single-Employer Plans to prescribe interest assumptions under the regulation for valuation dates in March 2016. The interest assumptions are used for paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.
Effective March 1, 2016.
Catherine B. Klion (
PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's Web site (
PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.
The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for March 2016.
The March 2016 interest assumptions under the benefit payments regulation will be 1.25 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for February 2016, these interest assumptions are unchanged.
PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.
Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during March 2016, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.
PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.
Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply.
Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.
In consideration of the foregoing, 29 CFR part 4022 is amended as follows:
29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.
Environmental Protection Agency (EPA).
Final rule.
EPA is finalizing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for three chemical substances that were the subject of premanufacture notices (PMNs). This action requires persons who intend to manufacture (including import) or process any of the chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs.
This final rule is effective April 12, 2016.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2013-0399, is available at
You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Manufacturers (including importers) or processors of one or more subject chemical substances (NAICS codes 325 and 324110),
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance to a proposed or final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
EPA is finalizing SNURs, under TSCA section 5(a)(2), for three very long chain chlorinated paraffin (vLCCPs—alkyl chain length of C
In the
EPA received several comments on the proposed rules for these three chemical substances, from a single commenter representing chlorinated paraffin (CP) manufacturers (including the submitter of the PMNs that are the subject of these SNURs). A full discussion of EPA's response to these comments is included in Unit V. of this document. After consideration of these comments, because the potential remains for increased exposure that formed the basis for the proposed SNURs, EPA is issuing the final rules as they were proposed for the chemical substances.
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors, listed in Unit IV. of this rule. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use. Persons who must report are described in § 721.5.
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the final rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the
During review of the PMNs submitted for the three chemical substances that are subject to these final SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health and environmental effects of the chemical substances. The basis for these findings is outlined in Unit IV of the proposed rule. Based on these findings, a TSCA section 5(e) consent order was negotiated with the PMN submitter that required manufacture of the substances at certain cumulative,
EPA is issuing final SNURs for three chemical substances described above to achieve the following objectives with regard to the significant new uses designated in this final rule:
• EPA will receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.
• EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
• EPA will be able to regulate prospective manufacturers or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at
Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the chemical substances listed in this final rule, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.
EPA received comments from the Chlorinated Paraffins Industry Association (CPIA), which represents the CP industry, including the submitter of the PMN substances that are the subject of these SNURs and other chlorinated paraffin manufacturers. CPIA's comments, and associated attachments, can be found in the public docket under ID EPA-HQ-OPPT-2013-0399-0198.
Nonetheless, EPA does have concern for these chemical substances because when released to the environment, vLCCPs are expected to rapidly partition to particulates and sediments where they are anticipated to persist in the environment with half-lives of months or greater. If they do degrade over time, these substances are expected to form shorter chain chlorinated chemicals. Based on the complex starting mixtures, lack of data on biological and abiotic reactions, and potential degradation products, there is high uncertainty regarding the fate and transport of these substances. Nevertheless, by analogy to medium chain chlorinated paraffins (MCCPs—alkyl chain length of C
MCCPs and LCCPs are expected to be PBT chemicals based on the following lines of evidence: (a) The available data on MCCPs, sediment core studies, environmental fate studies, and associated calculations, indicate transformation half-lives of months to years, depending on the environmental media. Even though there are limited data on the LCCPs, biodegradation data indicated increasing stability with increasing chain length. LCCPs are also expected to have transformation half-lives comparable to, or greater than MCCPs. Therefore, MCCPs and LCCPs are expected to be very persistent; (b)
EPA notes that its risk assessments for certain MCCP and LCCP PMNs have recently been made available for public comment in the
Regardless of the naming conventions raised by the commenter, in reviewing the studies submitted with the PMNs in this SNUR and other PMNs, and the scientific literature more broadly, EPA has concluded that that there is a continuum of effects linked to chain length and degree of chlorination. On the one end of the spectrum are SCCPs and MCCPs; more data are available on these chain lengths, and EPA has concluded that sufficient data exists to conclude that they may be PBTs. There are also some, albeit significantly less, data on the vLCCPs, most of which appear to point to a lack of effects, but the chemical composition of the test substances was poorly characterized. Ultimately, EPA is interested in specific fate and toxicity tests on vLCCPs that elucidate the relationship between degree of chlorination and alkyl chain length. The testing schema is designed to minimize the burden of testing of complex mixtures with numerous congeners.
To the extent that the commenter is suggesting that the predicted releases to surface water do not present a risk and thus do not support a significant new determination, EPA notes that a significant new use determination is not based on risk.
If uses begun after the proposed rule was published were considered ongoing rather than new, any person could defeat the SNUR by initiating the significant new use before the final rule was issued. Therefore EPA has designated the date of publication of the proposed rule as the cutoff date for determining whether the new use is ongoing. Consult the
Any person who began commercial manufacture or processing of the chemical substances identified in this rule for any of the significant new uses designated in the proposed SNUR after the date of publication of the proposed SNUR, must stop that activity before the effective date of the final rule. Persons who ceased those activities will have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires, before engaging in any activities designated as significant new uses. If a person were to meet the conditions of advance compliance under 40 CFR 721.45(h), the person would be considered to have met the
EPA recognizes that TSCA section 5 does not require the development of any particular test data before submission of a SNUN. The two exceptions are:
1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing.
Recommended testing that would address the criteria of concern of § 721.170 can be found in Unit IV. of the proposed rule. Descriptions of tests are provided only for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:
• Human exposure and environmental release that may result from the significant new use of the chemical substances.
• Potential benefits of the chemical substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in § 720.50. SNUNs must be on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in §§ 721.25 and 720.40. E-PMN software is available electronically at
EPA evaluated the potential costs of SNUN requirements for potential manufacturers and processors of the chemical substances in the rule. The Agency's complete Economic Analysis is available in the docket under docket ID number EPA-HQ-OPPT-2014-0390
The following is a listing of those documents used to prepare the preamble to this final rule. Additional information for this final rule can be located under docket ID number EPA-HQ-OPPT-2013-0399, which is available for inspection as specified under
This final rule establishes SNURs for chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “
According to PRA (44 U.S.C. 3501
The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the
Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601
1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost significantly more than $8,300.
A copy of that certification is available in the docket for this final rule.
This final rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit VIII. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:
• A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
• Submission of the SNUN would not cost any small entity significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this final rule. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501
This action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).
This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This final rule does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this final rule.
This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.
This action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.
In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Reporting and recordkeeping requirements.
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
7 U.S.C. 135
15 U.S.C. 2604, 2607, and 2625(c).
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving a revision to the Title V Operating Permits Program (found in West Virginia's regulations at 45CSR30) submitted by the State of West Virginia. The revision increases West Virginia's annual emission fees for its Title V Operating Permit Program to $28 per ton of emissions of a regulated pollutant from an individual source subject to the West Virginia Title V Operating Permit Program. EPA is approving the revision to West Virginia's Title V Operating Permit Program in accordance with the requirements of the Clean Air Act (CAA).
This final rule is effective on March 14, 2016.
EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2015-0594. All documents in the docket are listed in the
Paul Wentworth, (215) 814-2183, or by email at
On October 5, 2015 (80 FR 60110), EPA published a notice of proposed rulemaking (NPR) for the State of West Virginia. In the NPR, EPA proposed approval of a revision to the West Virginia Title V Operating Permit Program. The formal program revision was submitted by the State of West Virginia on June 17, 2015.
In the June 17, 2015 program revision submittal, West Virginia included revisions to 45CSR30.8 to increase West Virginia's annual emission fees for its Title V Operating Permit Program. West Virginia increased the annual fees to $28 per ton of emissions of a regulated pollutant from an individual source subject to the West Virginia Title V Operating Permit Program. The previous rate in 45CSR30.8 was $18 per ton of regulated pollutant. This revised fee per ton became effective on May 1, 2015 and replaced the prior fee, $18 per ton, which was effective July 1, 1995 through April 30, 2015.
Other specific requirements of the program revision and the rationale for the EPA's proposed action are explained in the NPR and will not be restated here.
The WVDEP comment letter corrects the EPA's error and clarifies that the correct fee per ton of regulated pollutant emitted by a Title V permitted source is $28 per ton. As noted previously, the revision to 45CSR30.8 increasing the permit fee from $18 per ton to $28 per ton of regulated pollutant emitted meets requirements in section 502 of the CAA and 40 CFR 70.9 for the collection of sufficient Title V fees to cover permit program implementation and oversight costs. The EPA's determination that West Virginia's Title V Operating Permit Program continues to meet obligations to collect sufficient fees to implement its Title V program is not altered by our inadvertent reference to $25 per ton of regulated pollutant emitted instead of $28 per ton emitted as our analysis was based on the revised 45CSR30.8 which listed the correct fee as $28 per ton.
The EPA also finds no further comment period is needed to address the inadvertent reference to the per ton fee increase. The EPA's finding that the revised fees in 45CSR30.8 meet requirements in section 502 of the CAA and 40 CFR 70.9 was explained in the NPR, and the specific finding that the $28 per ton meets requirements for Title V permit fees to fund a Title V program is a logical outgrowth of the proposed rule. No additional notice or opportunity to comment is necessary where, as here, the final rule is “in character with the original scheme,” and does not “substantially depart [] from the terms or substance” of the proposal.
Notwithstanding the NPR's erroneous description of the revised fee being $25 per ton of regulated pollutant, the EPA's determination about the sufficiency of this fee was in fact based on our evaluation of the slightly larger $28-per-ton fee. The NPR also cited the correct provision of West Virginia law, which also would have confirmed to potential commenters that the state's proposed fee increase was to $28 per ton. The docket similarly included information clarifying that the proposed revision
Accordingly, a supplemental notice clarifying the per-ton fee would not provide any commentators with a first occasion to offer any new or different criticisms of WVDEP's Title V permit fees. Nor would any such criticism convince EPA to alter our conclusion. As stated in the NPR, WVDEP found its permit fee of $18 per ton was insufficient to allow adequate implementation of its Title V Operating Permit Program. After internal analysis, WVDEP concluded it needed the additional revenue from permit fees at $28 per ton emitted to fund sufficiently its Title V Operating Permit Program, and EPA concurs with that conclusion. Further opportunity for comment would not provide any opportunity for criticism of West Virginia's new permit fee which the EPA would find convincing. Thus, our approval of West Virginia's Title V Operating Permits Program including the revision to 45CSR30.8 is final as a “logical outgrowth” of the proposed approval announced in the NPR.
EPA is approving the June 17, 2015 Title V Operating Permit Program revision submitted by the State of West Virginia to increase Title V permit fees paid by owners or operators of Title V sources in West Virginia from $18 per ton of regulated pollutant emitted to $28 per ton of regulated pollutant emitted. The revision meets requirements in section 503 of the CAA and of 40 CFR 70.9.
This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 12, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action which approves the June 17, 2015 program revision submittal by the State of West Virginia as a revision to the West Virginia Title V Operating Permits Program may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401,
(g) The West Virginia Department of Environmental Protection submitted a program revision on June 17, 2015; approval effective on May 1, 2015.
Environmental Protection Agency (EPA).
Final rule; notice of data availability (NODA).
The Environmental Protection Agency (EPA) is providing notice of emission allowance allocations to certain units under the new unit set-aside (NUSA) provisions of the Cross-State Air Pollution Rule (CSAPR) federal implementation plans (FIPs). EPA has completed final calculations for the second round of NUSA allowance allocations for the 2015 compliance year of the CSAPR NO
February 12, 2016.
Questions concerning this action should be addressed to Robert Miller at (202) 343-9077 or
Under the CSAPR FIPs, a portion of each state budget for each of the four CSAPR trading programs is reserved as a NUSA from which allowances are allocated to eligible units through an annual one- or two-round process. EPA has described the CSAPR NUSA allocation process in five NODAs previously published in the
EPA received no objections to the preliminary lists of new units eligible for second-round 2015 NUSA allocations of CSAPR NO
As described in the December 15 NODA, any allowances remaining in the CSAPR NO
Under 40 CFR 97.412(b)(10), 97.612(b)(10), and 97.712(b)(10), any allowances remaining in the CSAPR NO
The final unit-by-unit data and allowance allocation calculations are set forth in Excel spreadsheets titled “CSAPR_NUSA_2015_NOx_Annual_2nd_Round_Final_Data_New_Units”, “CSAPR_NUSA_2015_SO
Pursuant to CSAPR's allowance recordation timing requirements, the allocated NUSA allowances will be recorded in sources' AMS accounts by February 15, 2016. EPA notes that an allocation or lack of allocation of allowances to a given unit does not constitute a determination that CSAPR does or does not apply to the unit. EPA also notes that NUSA allocations of CSAPR NO
(Authority: 40 CFR 97.411(b), 97.611(b), and 97.711(b).)
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of diflubenzuron in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective February 12, 2016. Objections and requests for hearings must be received on or before April 12, 2016, and must be filed in accordance with the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0672, is available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0672 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 12, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0672, by one of the following methods:
•
•
•
In the
Based upon review of the data supporting the petition, EPA has modified the levels at which some of the tolerances are being established. The reason for these changes are explained in Unit IV.D.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for diflubenzuron including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with diflubenzuron follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
For diflubenzuron, the hemopoietic system is the target site with effects including increased sulfhemoglobin and/or methemoglobin levels in rat and dog studies. In subchronic and chronic feeding studies, the primary endpoint of concern was methemoglobinemia and/or sulfhemoglobinemia. These effects were evident in both sexes of mice, rats, and dogs and were produced by more than one route of administration in rats (
The toxicity data provide no indication of an increased susceptibility to rats or to rabbits from
The Agency concluded that diflubenzuron is not carcinogenic in humans based on lack of evidence of carcinogenicity in rats and mice. PCA, a plant metabolite of diflubenzuron, tested positive for splenic tumors in male rats and hepatocellular adenomas/carcinomas in male mice in a National Toxicology Program (NTP) study.
Therefore, EPA has classified PCA as a probable human carcinogen. CPU is the major degradate found in water and is a significant metabolite in milk. CPU is structurally related to monuron (
Specific information on the studies received and the nature of the adverse effects caused by diflubenzuron as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for diflubenzuron used for human risk assessment is discussed in Table 1 in Unit III.B. of the final rule published in the
1.
i.
ii.
iii.
iv.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.
• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
For the cancer dietary exposure analysis, the Agency estimated the PCT for existing uses as follows:
Soybeans (1%), peppers (2.5%), oranges (10%), tangerines (10%), grapefruit (25%), pear (5%), apricot (10%), peach (5%), almond, (10%), pecan (2.5%), rice (2.5%), wheat (1%), cotton (1%), artichoke (45%), peanut (10%), lemon (1%), plum (5%), and walnut (2.5%).
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 to 7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which diflubenzuron may be applied in a particular area.
2.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.
Based on the Surface Water Concentration Calculator model (SWCC) for surface water the Estimated Drinking Water Concentration (EDWC) of 1.3 microgram/Liter (μg/L) (including diflubenzuron and CPU) was used to assess chronic non-cancer dietary risk. Based on the Pesticide Root Zone Model-Groundwater (PRZM-GW) model for ground water the cancer risk for CPU was assessed using the EDWC of 8.02 μg/L.
3.
Diflubenzuron is not registered for any specific use patterns that would result in residential exposure.
4.
EPA has not found diflubenzuron to share a common mechanism of toxicity with any other substances, and diflubenzuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that diflubenzuron does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
1.
2.
3.
i. The toxicological database for diflubenzuron is adequate for risk assessment. The non-cancer toxicity of CPU and PCA is well understood. CPU is less toxic and does not affect methemoglobin. PCA does cause methemoglobin formation but is similar in potency to diflubenzuron. Therefore, assuming equal toxicity of CPU and PCA to diflubenzuron is health protective, additional toxicity studies are not required on the metabolites.
ii. There are no clear signs of neurotoxicity following subchronic or chronic dosing in multiple species in the diflubenzuron database; therefore, there is no need for any neurotoxicity studies.
iii. There is no evidence that diflubenzuron results in increased susceptibility in
iv. The dietary exposure assessment uses conservative assumptions which will not underestimate dietary exposure and EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to diflubenzuron in drinking water. These assessments will not underestimate the exposure and risks posed by diflubenzuron.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
Short- and intermediate-term adverse effects were identified; however, diflubenzuron is not registered for any use patterns that would result in short- or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for diflubenzuron.
4.
EPA generally considers cancer risks in the range of 10
Considering the precision with which cancer hazard can be estimated, the conservativeness of low-dose linear extrapolation, and the rounding procedure described above, cancer risk should generally not be assumed to exceed the benchmark level of concern of the range of 10
5.
Adequate enforcement analytical methods are available for the enforcement of tolerances for residues of diflubenzuron and its metabolites in crop and livestock commodities. Three enforcement methods for diflubenzuron are published in PAM, Vol. II as Methods I, II, and III. Method I is a GC/ECD method that determines diflubenzuron in plants as derivatized 4-chloroaniline (PCA). Method II is a GC/ECD method that can separately determine residues of diflubenzuron, 4-chlorophenylurea (CPU) and PCA in eggs, milk, and livestock tissues, each as derivatized PCA. Method III is an HPLC/UV method that determines diflubenzuron per se in eggs, milk, and livestock tissues. All three methods have undergone successful Agency validations.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has established MRLs for diflubenzuron in or on peach and nectarine at 0.5 ppm which is the same as the tolerance in the United States for the peach subgroup 12-12B at 0.50 ppm; a tolerance on plums at 0.5 ppm which is the same as the U.S. tolerance for the plum subgroup 12-12C at 0.5 ppm; and a tolerance on tree nuts at 0.2 ppm which is the same as the U.S. tolerance for the tree nut group 14-12 at 0.20 ppm, and which was raised to harmonize with Codex.
The Codex has established MRLs for diflubenzuron on chili peppers at 3 ppm, dried chili peppers at 20 ppm, and sweet peppers at 0.7 ppm which are different from the tolerances established in the U.S. for diflubenzuron on the pepper/eggplant subgroup 8-10B at 1.0 ppm. The pepper/eggplant subgroup 8-10B covers both bell and non-bell peppers and the Codex MRLs split them out into two separate tolerances which the U.S. does not do because the petition was for the entire subgroup. Based on the residue data submitted and reviewed for this action, it would not be appropriate for the U.S. tolerance to harmonize with either the chili pepper MRL of 3 ppm or the sweet pepper MRL of 0.7 ppm. Also, in regards to the dried chili pepper MRL, this is not expected to be an issue since the U.S. does not set tolerances on dried fruits and vegetables, but instead the processed food is considered to be the whole processed commodity after compensating for or reconstituting the commodity's normal moisture content.
One comment was received in response to the February 11, 2015 Notice of Filing, however, it related to a different chemical than diflubenzuron and therefore is not relevant to this action. Two comments were received in response to the December 2, 2015 Notice of Filing. One commenter opposed residues of this pesticide on food and argued that EPA should deny the petition. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework. The second comment stated that “without long term studies of its effects on the environment and the toxic effects on aquatic invertebrates, then there should be a slight reduction in ppm of diflubenzuron used on crops.” This comment is not relevant to the Agency's evaluation of safety of the diflubenzuron tolerances; section 408 of the FFDCA focuses on potential harms to human health and does not permit consideration of effects on the environment.
Based on an evaluation of the residue data, the Agency modified the levels at which tolerances were proposed for the existing tolerances for egg, poultry fat, and poultry meat byproducts. In addition, the Agency determined that a separate tolerance is not required for the commodity “plum, prune, dried” since residues are not found to concentrate on prunes. Lastly, some of the tolerances levels were modified to reflect the correct significant figures.
Therefore, tolerances are established, modified and removed for residues of diflubenzuron
Under 180.377(a)(1) a tolerance is established for the cottonseed subgroup 20C at 0.20 ppm; existing tolerances are changed for egg to 0.07 ppm; poultry, fat to 0.10 ppm; and poultry, meat byproducts to 0.08 ppm; and the existing tolerance for cotton, undelinted seed at 0.2 ppm is removed as unnecessary.
Under 180.377(a)(2), tolerances are established in or on the raw agricultural commodities carrot, roots at 0.20 ppm; peach subgroup 12-12B at 0.50 ppm; plum subgroup 12-12C at 0.50 ppm; nut, tree group 14-12 at 0.20 ppm; the pepper/eggplant subgroup 8-10 B at 1.0 ppm; and the following existing tolerances are removed as unnecessary: Fruit, stone, group 12, except cherry at 0.07 ppm; nut, tree, group 14 at 0.06 ppm; pistachio at 0.06 ppm; and pepper at 1.0 ppm.
Under 180.377(c) regional tolerances are established for the combined residues of diflubenzuron and its metabolites 4-chlorophenlyurea and 4-chloroaniline in or on the raw agricultural commodities alfalfa, forage at 6 ppm; alfalfa, hay at 20 ppm; and alfalfa, seed at 0.9 ppm.
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The additions and revision read as follows:
(a) General (1) * * *
(2) * * *
(c)
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of benzyl acetate (CAS Reg. No. 140-11-4), when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops only under 40 CFR 180.920. Technology Sciences Group, on behalf of the Huntsman Corporation, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of benzyl acetate.
This regulation is effective February 12, 2016. Objections and requests for hearings must be received on or before April 12, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0783, is available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0783 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 12, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0783, by one of the following methods:
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In the
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for benzyl acetate including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with benzyl acetate follows.
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by benzyl acetate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.
Benzyl acetate exhibits low levels of toxicity via the dermal route of exposure in rabbits and inhalation and oral routes of exposure in rats. It is mildly irritating to the skin and minimally irritating to the eyes in rabbits. It is not a skin sensitizer in guinea pigs.
In a 13-week feeding study in the rat, atrophic seminiferous tubules were observed in male rats at dose levels of 12,500 parts per millions (ppm) (equivalent to 900 milligrams/kilogram/day (mg/kg/day)). The NOAEL was identified as 6,250 ppm (460 mg/kg/day). In mice, following 13 weeks of exposure via the diet, decreased body weight and food consumption were observed at all doses. The LOAEL was 3,130 ppm (425 mg/kg/day). A NOAEL was not established.
In a developmental toxicity study in the rat, maternal and fetal toxicity were observed at 1,000 mg/kg/day. Maternal toxicity was manifested as decreased body weight and fetal toxicity was manifested as reduced body weights, increased incidence of dilation of the renal pelvis and skeletal variations. Although qualitative fetal susceptibility is observed, fetal effects occur in the presence of maternal toxicity and a clear NOAEL of 500 mg/kg/day was established for maternal and developmental toxicity.
The potential for benzyl acetate to be genotoxic was evaluated in a battery of
Evidence of neurotoxicity and neuronal degeneration was identified in the 13-week studies in rats and mice. Signs of neurotoxicity included tremors and ataxia that were associated with the degeneration of the glial cells in the cerebellum and hippocampus at the doses ≥12,500 ppm (≥2,000 mg/kg/day). Since these effects were induced at doses above the limit dose (1,000 mg/kg/day) and the established cRfD of 1.10 mg/kg/day, will be protective of these effects, the concern is low for these effects.
There is evidence that benzyl acetate suppresses immune function in mammalian systems in the rat however this effect occurs only at a dose that is lethal and well above the limit dose. In the 13-week feeding study in the rat, a decrease in the cellular components of the bone marrow, thymus and lymphoid follicles was observed at 50,000 ppm (3,900 mg/kg/day for males and 4,500 mg/kg/day for females), the highest dose tested and well above the limit dose. The NOAEL for this study was 12,500 ppm (900 mg/kg/day). The potential for immunotoxicity is not of concern because the effects occur well above the limit dose and the exposure to benzyl acetate through the proposed use is unlikely to occur at such a high dose.
The carcinogenicity of benzyl acetate in F
In metabolism studies approximately 90% of benzyl acetate is excreted as metabolites primarily in the urine after oral or percutaneous administration. None was detected in the adipose tissue, blood, kidney, liver, lung, muscle, skin or stomach. The major metabolite in the urine was hippuric acid and 95 to 99% of the excreted dose was in this form. Less than 4% remained in the carcass.
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
The point of departure for benzyl acetate is 110 mg/kg/day from the NTP 2-year carcinogenicity study in mice (dietary study) based on decreased in body weights in both sexes at the LOAEL of 345/375 mg/kg/day. There was no NOAEL observed in a 90-day toxicity study in mice based on the effects on body weights seen at all doses (lowest dose tested was 3,130 ppm; equal to 425 mg/kg/day); however, in a carcinogenicity study in mice no effects on body weight were seen at 110 mg/kg/day, therefore, the NOAEL for the carcinogenicity study would be protective of decreased body weights seen in a 90-day study in mice. Therefore, 90-day toxicity study in mice was not selected. This endpoint was used for all exposure scenarios. The dermal absorption and inhalation factors were 100%. The Agency applied an interspecies uncertainty factor (10X) and an intraspecies uncertainty factor (10X); the FQPA safety factor was reduced to 1X.
1.
An acute dietary risk assessment was not conducted because no endpoint of concern following a single exposure was identified in the available studies. A chronic dietary exposure assessment was completed and performed using the Dietary Exposure Evaluation Model DEEM-FCID
2.
3.
Based upon the requested use of benzyl acetate, the Agency does not expect non-occupational, non-dietary exposures. However, there is a potential for residential exposure via non-pesticidal uses such as use in cosmetics and other, pesticide uses, once it is approved. The residential exposure could occur via ingestion products containing benzyl acetate, and via dermal and inhalation routes of exposure through use of products containing benzyl acetate in residential settings. These residential pesticide exposures are considered short-term and intermediate-term in nature. Residential exposures to benzyl acetate as the result of its use as a cosmetic ingredient may be short-, intermediate- or long-term in nature. The aggregate-short term exposure assessment for benzyl acetate considers exposures from the pesticidal and nonpesticidal uses (
4.
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i. The toxicity database for benzyl acetate contains the following studies that are adequate to evaluate the potential toxicity of benzyl acetate for infants and children: A thirteen week feeding study in the rat, a 13-week feeding study in the mouse, a developmental toxicity study in the rat, several
ii. Evidence of neurotoxicity and neuronal degeneration seen in a thirteen-week study was determined not to exceed levels of concern since the effects occurred at doses that were well above the limit dose (1,000 mg/kg/day). The established cRfD is 1.10 mg/kg/day therefore is protective of these effects.
iii. Qualitative fetal susceptibility was observed in the developmental study in rats. Maternal (decrease in body weight) and fetal (reduced body weights, increased incidence of dilation of the renal pelvis and skeletal variations) toxicity were observed at 1,000 mg/kg/day, the limit dose. Since fetal toxicity occurs in the presence of maternal toxicity and a clear NOAEL of 500 mg/kg/day was established, the established cRfD (1.10 mg/kg/day) will be protective of these effects. The potential for reproduction toxicity was observed in the 13-week dietary study in rats. Atrophy of seminiferous tubules was observed in males at 12,500 ppm (900 mg/kg/day). However, the concern for reproductive toxicity is low since effects occurred at a high dose and a clear NOAEL of 6,250 ppm (460 mg/kg/day) was established.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to benzyl acetate in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by benzyl acetate.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
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Benzyl acetate is likely to be used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to benzyl acetate. Using the exposure assumptions described in this unit for screening-level short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 150 for children ages 1 to 2 and 260 for adults. Because EPA's level of concern for benzyl acetate is a MOE of 100 or below, these MOEs are not of concern.
4.
5.
6.
An analytical method is not required for enforcement purposes since the
Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for benzyl aceetate (CAS Reg. No. 140-11-4) when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops only.
This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
Federal Communications Commission.
Final rule; announcement of effective date.
In this document, the Federal Communications Commission (Commission) announces that the Office of Management and Budget (OMB) has approved, for a period of three years, information collection requirements adopted in the Commission's Report and Order relating to the Amendment of the Commission's Rules Related to Broadcast Licensee-Conducted Contests. This document is consistent with the Report and Order, which stated that the Commission would publish a document in the
The amendments to 47 CFR 73.1216, published at 80 FR 64354, October 23, 2015, are effective on February 12, 2016.
Cathy Williams by email at
This document announces that, on February 3, 2016, OMB approved information collection requirements contained in the Commission's Report and Order, FCC 15-118, published at 80 FR 64354. The OMB Control Number is 3060-1209. The Commission publishes this document as an announcement of the effective date of those information collection requirements.
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on February 3, 2016, for the information collection
The foregoing notification is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.
The total annual reporting burdens and costs for the respondents are as follows:
Office of Procurement and Property Management, U.S. Department of Agriculture
Final rule.
The Office of Procurement and Property Management (OPPM) of the U.S. Department of Agriculture (USDA) amends the Agriculture Acquisition Regulation (AGAR) by adding a new clause entitled “Fire Suppression and Liability.” Section 8205 of the Agricultural Act of 2014 (2014 Act) provided the USDA Forest Service with permanent authority for Stewardship End Result Contracting by adding a new Section 604 to the Healthy Forests Restoration Act of 2003. Section 8205 contains a requirement that the agency use a fire liability provision in all stewardship contracts and agreements that is in substantially the same form as the fire liability provisions contained in the integrated resource timber contract in Forest Service Contract Numbered 2400-13, Part H, Section H.4. This final rule establishes a new clause in the AGAR, the USDA supplement to the Federal Acquisition Regulation (FAR), for use in Integrated Resource Service Contracts (IRSC) subject to the FAR. This new AGAR clause addresses fire liability on stewardship contracts as required in the 2014 Agricultural Act.
Effective March 14, 2016.
Ms. Ismaela Ramirez, Senior Procurement Analyst, USDA, Office of Procurement and Property Management at (202) 730-7997.
The enactment of Section 8205 of the Agricultural Act of 2014 (Pub. L. 113-79) establishes permanent authority to conduct Stewardship End Result Contracting projects by adding a new Section 604 to the Healthy Forests Restoration Act of 2003 (HFRA) (16 U.S.C. 6591c). Section 8205 of the 2014 Agricultural Act contains a requirement that the agency use a fire liability provision in all stewardship contracts and agreements that is in substantially the same form as the fire liability provisions contained in the integrated resource timber contract in Forest Service Contract Numbered 2400-13, Part H, Section H.4 and timber sale contracts conducted pursuant to Section 14 of the National Forest Management Act of 1976 (16 U.S.C. 472a).
Beginning in 1998 with the enactment of Section 347 of the Department of the Interior and Related Agencies Appropriation Act, 1999, the Forest Service has been authorized to carry out Stewardship End Result Contracting Projects; first on a pilot basis and then, through a succession of subsequent amendments, this authority was expanded. The enactment of Section 8205 of the Agricultural Act of 2014 sets forth the permanent authority for conducting Stewardship End Resulting Contracting Projects by adding a new Section 604 to the Healthy Forests Restoration Act of 2003. Section 8205 contains a provision that “not later than 90 days after the date of enactment of this section, the Chief of the Forest Service and the Director of the Bureau of Land Management shall issue for use in all contracts and agreements under this section fire liability provisions that are in substantially the same form as the fire liability provisions contained in— (A) integrated resource timber contracts, as described in the Forest Service Contract Numbered 2400-13, Part H, Section H.4; and (B) timber sale contracts conducted pursuant to Section 14 of the National Forest Management Act of 1976 (16 U.S.C. 472a).”
This final rule establishes a new AGAR clause for use in stewardship contracts subject to the FAR. This clause addresses fire liability on Stewardship End Result Contracting, as required in the 2014 Agricultural Act. The text of the clause is closely specified in the law.
USDA solicited comments on the interim rule on May 22, 2014. USDA received two comments at the end of the
Both comments were received from the Federal Forest Resource Coalition (FFRC), a national trade association comprised of large and small companies, regional and state associations, county governments, and others concerned about the management of our National Forests and the landscape covered by Bureau of Land Management.
Both comments recommend changes to add clarity and consistency to the language in the regulations. The comments suggest that USDA follow the requirement of implementing a liability clause for IRSC contracts that mirrored Integrated Resource Timber Contracts (IRTC). The comments from FFRC are presented below, along with USDA's responses and are grouped by the Code of Federal Regulations (CFR) section numbers to which they apply.
As a result of public comments received on the interim rule, USDA will amend the CFR to add clarity and consistency that reflects the intention of the Farm Bill with regard to implementing a fire liability clause for IRSCs that mirrors current Timber Sales Contracts.
USDA certifies that this final rule will not have a significant impact on a substantial number of small entities, as defined in the Regulatory Flexibility Act, 5 U.S.C. 601,
The Paperwork Reduction Act does not apply because the final rule does not impose any record keeping or information collection requirements that require approval by the Office of Management and Budget.
The USDA has determined that this final rule falls within this category of actions and that no extraordinary circumstances exist that would require preparation of an environmental assessment or environmental impact statement.
This final rule has been reviewed under USDA procedures and Executive Order 12866 on Regulatory Planning and Review. It has been determined that this is not a significant rule. This rule would not have an annual effect of $100 million or more on the economy, nor would it adversely affect productivity, competition, jobs, the environment, public health and safety, or State or local governments. This final rule would not interfere with an action taken or planned by another agency, nor raise new legal or policy issues. Finally, this final rule would not alter the budgetary impact of entitlement, grant, user fee, or loan programs or the rights and obligations of beneficiaries of such programs. Accordingly, this final rule is not subject to Office of Management and Budget (OMB) review under Executive Order (E.O.) 12866.
The USDA has analyzed this final rule in accordance with the principles and criteria contained in E.O. 12630 and determined that the rule would not pose the risk of a taking of private property.
The USDA has reviewed this final rule under E.O. 12778, Civil Justice Reform. Under this rule, (1) all State and local laws and regulations that conflict with this rule or that impede its full implementation would be preempted; (2) no retroactive effect would be given to this final rule; and (3) it would require administrative proceedings before parties may file suit in court challenging its provisions.
The USDA has considered this final rule under the requirements of E.O. 13132 on Federalism and has determined that this rule conforms to the Federalism principles in the E.O. The rule would not impose any compliance costs on the States; and would not have any substantial direct effects on the States, the relationship between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government. Moreover, this final rule does not have tribal implications as defined by E.O. 13175, Consultation and Coordination with Indian Tribal Governments, and therefore advance consultation with tribes is not required.
The USDA has reviewed this final rule under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or use and has determined that this rule would not constitute a significant energy action as defined in the E.O.
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the USDA assessed the effects of this final rule on State, local, and tribal governments and the private sector. This rule would not compel the expenditure of $100 million or more by State, local, and tribal governments, or by the private sector. Therefore, a statement under Section 202 of the Act is not required.
Government procurement.
For the reasons set forth in the preamble, the U.S. Department of Agriculture amends 48 CFR Chapter 4, in the following manner:
5 U.S.C. 301 and 40 U.S.C. 121(c)
Insert the clause at 452.236-78,
5 U.S.C. 301 and 40 U.S.C. 121(c)
As prescribed in section 436.578, the following clause shall be inserted in Intergrated Resource Service Contracts (IRSC) awarded for the Forest Service.
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Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish special local regulations for certain waters of the Chesapeake Bay. This action is necessary to provide for the safety of life on these navigable waters located between Sandy Point, Anne Arundel County, MD and Kent Island, Queen Anne's County, MD, during a paddling event on May 14, 2016. This proposed rulemaking would prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Baltimore or Coast Guard Patrol Commander. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before March 14, 2016.
You may submit comments identified by docket number USCG-2015-1126 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Mr. Ronald Houck, U.S. Coast Guard Sector Baltimore, MD; telephone 410-576-2674, email
On December 28, 2015, ABC Events, Inc. notified the Coast Guard that it will be conducting the Bay Bridge Paddle from 8 a.m. until noon on May 14, 2016, to both showcase the kayak and stand up paddle board water sport for intermediate and elite paddlers, and benefit the Annapolis Chapter of the Foundation for Community Betterment and the Maryland Chapter of the Special Olympics. The paddle race is to be held under and between the north and south spans of the William P. Lane, Jr. (US-50/301) Memorial Bridges, located between Sandy Point, Anne Arundel County, MD and Kent Island, Queen Anne's County, MD. Elite paddlers will depart Sandy Point and proceed easterly along a 4.2-mile course toward Kent Island, turn around upon reaching a point near Kent Island, and proceed back to Sandy Point. Intermediate paddlers will depart Sandy Point and proceed easterly along the same 4.2-mile course toward Kent Island, however, they will turn around upon reaching the half way point (2.1 miles), and proceed back to Sandy Point. Hazards from the paddle race include event numerous event participants crossing designated shipping channels and interfering with vessels intending to operate within those channels. The COTP Baltimore has determined that potential hazards associated with the paddle race would be a safety concern for anyone intending to operate within certain waters of the Chesapeake Bay between Sandy Point and Kent Island, MD.
The purpose of this rulemaking is to protect event participants, spectators and transiting vessels on certain waters of the Chesapeake Bay before, during, and after the scheduled event.
The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1233, which authorize the Coast Guard to establish and define special local regulations.
The COTP Baltimore proposes to establish special local regulations from 7:30 a.m. until 12:30 p.m. on May 14, 2016, and, if necessary due to inclement weather, from 7:30 a.m. until 12:30 p.m. on May 15, 2016. The regulated area would cover all navigable waters of the Chesapeake Bay between and adjacent to the spans of the William P. Lane Jr. Memorial Bridges from shoreline to shoreline, bounded to the north by a line drawn parallel and 500 yards north of the north bridge span that originates from the western shoreline at latitude 39°00′36″ N., longitude 076°23′05″ W. and thence eastward to the eastern shoreline at latitude 38°59′14″ N., longitude 076°20′00″ W., and bounded to the south by a line drawn parallel and 500 yards south of the south bridge span that originates from the western shoreline at latitude 39°00′16″ N., longitude 076°24′30″ W. and thence eastward to the eastern shoreline at latitude 38°58′38.5″ N., longitude 076°20′06″ W. The duration of the regulated area is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 8 a.m. until noon paddle event. Except for Bay Bridge Paddle participants, no vessel or person would be permitted to enter the regulated area without obtaining permission from the COTP Baltimore or a designated representative. The regulatory text we are proposing appears at the end of this document.
We developed this proposed rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.
E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly,
This regulatory action determination is based on the size and duration of the regulated area, which would impact a small designated area of the Chesapeake Bay for 5 hours. The Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the status of the regulated area. Moreover, the rule would allow vessels to seek permission to enter the regulated area, and vessel traffic would be able to safely transit the regulated area once the Coast Guard Patrol Commander deems it safe to do so.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the regulated area may be small entities, for the reasons stated in section IV.A above this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under E.O. 13132, Federalism, if it has 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. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this proposed rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves implementation of regulations within 33 CFR part 100 applicable to organized marine events on the navigable waters of the United States that could negatively impact the safety of waterway users and shore side activities in the event area lasting for 5 hours. The category of water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, canoe and sail board racing. Normally such actions are categorically excluded from further review under paragraph 34(h) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary environmental analysis checklist and Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:
33 U.S.C. 1233.
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(2) Except for participants and vessels already at berth, mooring, or anchor, all persons and vessels within the regulated area at the time it is implemented are to depart the regulated area.
(3) Persons desiring to transit the regulated area must first obtain authorization from the Captain of the Port Baltimore or Coast Guard Patrol Commander. Prior to the enforcement period, to seek permission to transit the area, the Captain of the Port Baltimore can be contacted at telephone number 410-576-2693 or on Marine Band Radio, VHF-FM channel 16 (156.8 MHz). During the enforcement period, to seek permission to transit the area, the Coast Guard Patrol Commander can be contacted on Marine Band Radio, VHF-FM channel 16 (156.8 MHz) for direction.
(4) The Coast Guard may be assisted in the patrol and enforcement of the regulated area by other Federal, State, and local agencies. The Coast Guard Patrol Commander and official patrol vessels enforcing this regulated area can be contacted on marine band radio VHF-FM channel 16 (156.8 MHz) and channel 22A (157.1 MHz).
(5) The Coast Guard will publish a notice in the Fifth Coast Guard District Local Notice to Mariners and issue a marine information broadcast on VHF-FM marine band radio announcing specific event date and times.
(d)
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve the State of Tennessee's May 23, 2014, State Implementation Plan (SIP) revision, submitted through the Tennessee Department of Environment and Conservation (TDEC) on behalf of the Shelby County Health Department (SCHD), seeking to modify the SIP by removing the Inspection and Maintenance (I/M) program in the City of Memphis, Tennessee, and by incorporating Shelby County's revised maintenance plan for the 1997 8-hour ozone national ambient air quality standards (NAAQS). Among other things, the revised maintenance plan updates the emissions inventory estimates and the motor vehicle emissions budgets (MVEBs) for the years 2006 and 2021 and contains an emissions reduction measure to offset the emissions increase expected from the termination of City of Memphis I/M program. EPA has preliminarily determined that Tennessee's May 23, 2014, SIP revision is consistent with the applicable provisions of the Clean Air Act (CAA or Act).
Written comments must be received on or before March 14, 2016.
Submit your comments, identified by Docket ID Number EPA-R04-OAR-2014-0250 by one of the following methods:
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Richard Wong, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Mr. Wong may be reached by phone at (404) 562-8726 or via electronic mail at
EPA is proposing to approve Tennessee's May 23, 2014, SIP revision seeking to remove the City of Memphis I/M program from the SIP and to incorporate Shelby County's revised maintenance plan for the 1997 8-hour ozone NAAQS into the SIP.
Shelby County was designated as nonattainment for the carbon monoxide (CO) NAAQS on March 3, 1978.
On July 26, 1994 (59 FR 37939), EPA redesignated Shelby County to attainment for the CO standard and approved the initial 10-year CO maintenance plan for Shelby County. Subsequently, further improvements in automotive technology led to a consistent reduction in locally monitored levels of CO. On October 25, 2006, EPA approved the required second 10-year CO maintenance plan which demonstrated that I/M was no longer needed to maintain the CO NAAQS.
On April 30, 2004, EPA designated Shelby County, Tennessee, and Crittenden County, Arkansas, as nonattainment for the 1997 8-hour ozone NAAQS, with a classification of `moderate' (hereinafter collectively referred to as the “Memphis 1997 8-hour Ozone Area”).
Following the initial designations for the 1997 8-hour ozone standard, Shelby County, the State of Tennessee, Crittenden County, and the State of Arkansas adopted additional measures to control ozone-forming emissions in the region and petitioned EPA to use its discretion under CAA section 181(a)(4) to reclassify the area from moderate to marginal. On September 22, 2004, EPA granted the petition to reclassify the area, which removed the SIP planning requirements mandated of moderate ozone nonattainment areas, including the adoption of a mandatory I/M program, and reset the attainment deadline to June 15, 2007.
The end of the 2008 ozone monitoring season resulted in a design value for the Memphis 1997 8-hour Ozone Area that met the NAAQS. Tennessee, Mississippi, and Arkansas prepared separate, but coordinated, redesignation requests and maintenance plans for their respective portions of the Area. Tennessee, on behalf of Shelby County, submitted the redesignation request and maintenance plan for its portion of the 1997 8-hour Ozone Area to EPA on February 26, 2009, prior to the attainment plan SIP revision due date.
EPA approved Tennessee's redesignation request and maintenance plan on January 4, 2010.
On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of 0.075 parts per million (ppm).
Section 110(l) of the CAA requires that a revision to the SIP not interfere with any applicable requirement concerning attainment and reasonable further progress (RFP) (as defined in section 171), or any other applicable requirement of the Act. Tennessee's May 23, 2014, SIP revision includes a demonstration that the requested actions comply with section 110(l) of the CAA. EPA evaluates each section 110(l) noninterference demonstration on a case-by-case basis considering the circumstances of each SIP revision.
EPA interprets 110(l) as applying to SIP revisions for all areas of the country, whether attainment, nonattainment, unclassifiable, or maintenance for one or more of the six criteria pollutants.
In nonattainment areas, EPA will generally not approve a SIP revision under 110(l) that allows additional emissions of pollutants for which the area is designated nonattainment in the absence of equivalent emissions reductions or an attainment demonstration addressing the proposed changes to the SIP. “Equivalent” emissions reductions are reductions that are equal to or greater than those reductions achieved by the control measure approved in the SIP. To show that compensating emissions reductions are equivalent, adequate justification must be provided. The compensating, equivalent reductions must represent actual emissions reductions achieved in a contemporaneous time frame to the change of the existing SIP control measure in order to preserve the status quo level of air emissions. If the status quo is preserved, noninterference is demonstrated. In addition to being contemporaneous, the equivalent emissions reductions must also be permanent, enforceable, quantifiable, and surplus.
Section 193 of the CAA prohibits the modification of control measures in effect before November 15, 1990, in a nonattainment area for any air pollutant unless the modification insures equivalent or greater emission reductions of that pollutant. Shelby County included a section 193 analysis in its SIP revision because it requested removal of the I/M program from the SIP, because Shelby County is in a nonattainment area for the 2008 8-hour ozone NAAQS, and because I/M programs may impact ozone air quality.
Tennessee's May 23, 2014, SIP revision seeks to remove the City of Memphis I/M program from the SIP and incorporate Shelby County's revised maintenance plan for the 1997 8-hour ozone NAAQS. The maintenance plan includes, among other things, an emissions reduction measure to offset the emissions increase expected from the termination of City of Memphis I/M program as well as revised emission inventory estimates and revised MVEBs based upon new modeling associated with the requested removal of the I/M program and upon the inclusion of an offset measure.
Tennessee's SIP revision includes an evaluation of the impact that the requested removal of the City of Memphis I/M program would have on attainment and maintenance of the NAAQS for each criteria pollutant. This
The SIP revision quantifies the potential emissions increases in NO
The 2013 inputs for the MOVES model were developed by interpolating TDM results for 2011 and 2015 in order to use the model to estimate the emissions increases in 2013 associated with the termination of the Memphis I/M program. The results of this modeling are provided in Table 1:
The County's on-road mobile source modeling predicts that the termination of the City of Memphis I/M program will increase 2013 ozone season VOC by approximately 0.352 tons per ozone season day and will not increase NO
Tennessee's SIP revision seeks to incorporate the emissions reductions from the closure of the Cleo facility for use as offsets for the termination of the I/M program. The company ceased operation in 2011 and submitted a letter to Shelby County on January 4, 2012, requesting termination of its Title V air permit effective at the end of 2011, making the reductions permanent and enforceable. SCHD issued a Title V termination letter on April 3, 2012. Shelby County quantified the emissions reductions associated with the Cleo facility shutdown by averaging the certified annual emissions reported by the facility to the County in 2009 and 2010, the last two full years of operation. In 2009 and 2010, Cleo reported and paid air pollution fees on actual VOC emissions of 239.1 tons and 254.5 tons, respectively, resulting in an annual average of 246.8 tpy (0.676 tpd across the calendar year). During the same operational period, Cleo averaged 1.09 tpy of NO
Shelby County evaluated the potential for the requested removal of the I/M program to interfere with maintenance of the PM NAAQS in the County because studies have shown that VOCs can be a precursor to PM in certain chemical and meteorological circumstances. The County concluded that the termination of the I/M program would not interfere with attainment or maintenance of the PM
The revised maintenance plan included in Tennessee's SIP revision contains an updated emissions inventory with emissions projections that account for the termination of the I/M program and the closure of the Cleo facility. Shelby County emissions for 2021 remain the same as those provided in the Shelby County 1997 8-hour Ozone Maintenance Plan approved by EPA on January 4, 2010 (75 FR 56), with the exception of on-road mobile and point source emissions. On-road emissions for 2006 and 2021 in the revised maintenance plan were remodeled using MOVES2010b, and they replace the on-road emissions
Point source emissions for 2006 remain the same; however, Tennessee adjusted the 2021 point source emissions for VOCs and NO
Tennessee's May 23, 2014, maintenance plan revision updates the MVEBs for 2006 and 2021 using on-road mobile source emissions estimates from MOVES and removes the MVEBs for 2009 and 2017. The revised 2021 MVEB accounts for the termination of the I/M program and the shutdown of the Cleo facility. These budgets are used by transportation authorities to assure that transportation plans, programs, and projects are consistent with, and conform to, the maintenance of acceptable air quality in the Memphis 1997 8-hour Ozone Area.
Under section 176(c) of the CAA, new transportation plans, programs, and projects, such as the construction of new highways, must “conform” to (
Under the CAA, states are required to submit, at various times, control strategy SIPs and maintenance plans for nonattainment areas. These control strategy SIPs (including RFP and attainment demonstration) and maintenance plans create MVEBs for criteria pollutants and/or their precursors to address pollution from cars and trucks. Per 40 CFR part 93, a MVEB must be established for the last year of the maintenance plan. A state may adopt MVEBs for other years as well. The MVEB is the portion of the total allowable emissions in the maintenance demonstration that is allocated to highway and transit vehicle use and emissions.
According to 40 CFR 93.118, a maintenance plan must establish MVEBs for the last year of the maintenance plan (in this case, 2021). The updated MVEBs in the revised maintenance plan for the 1997 8-hour ozone NAAQS are for the base year (2006) and the last year of the first 10-year maintenance plan (2021). The 2021 MVEB reflects the total on-road mobile source emissions for 2021 plus an allocation from the available VOC and NO
The previously approved 1997 8-hour ozone maintenance plan for Shelby County contained interim MVEBs for years 2006, 2009, and 2017 in addition to the required maintenance year MVEB of 2021. The consensus formed during the interagency consultation process was that MVEBs should only be set for 2006 and 2021.
Under 40 CFR 93.101, the safety margin is the difference between the attainment level and the projected level, from all sources, of emissions in the maintenance plan. The attainment level of emissions is the level of emissions during one of the years in which Shelby County met the 1997 8-hour ozone NAAQS. The safety margin, in whole or in part, can be allocated to the transportation sector as long as total emissions from all categories remain below the attainment level.
For the revised 2021 MVEBs, Shelby County allocated ninety-five percent of the VOC and NO
The MVEB is constrained to assure that the total emissions from all source categories do not exceed the 2006 attainment year emissions. The MVEBs are consistent with the plan for maintaining total emissions from all source categories at or below the 2006 VOC and NO
EPA is proposing to approve Tennessee's May 23, 2014, SIP revision that seeks to remove the City of Memphis I/M program from the SIP and incorporate Shelby County's revised maintenance plan for the 1997 8-hour ozone NAAQS that includes an emission reduction measure to offset the emission increases associated with the requested removal of the I/M program from the SIP. The revised maintenance plan also contains updated attainment inventories and updated MVEBs for NO
Under the CAA, the Administrator is required to approve a SIP submittal that complies with the provisions of the Act and applicable Federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, October 7, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000) nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule; reopening of comment period.
The Environmental Protection Agency (EPA) issued a proposed rule in the
Any comments must arrive by February 29, 2016.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2015-0751 at
For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
Nicole Law, EPA Region IX, (415) 947-4126,
This document reopens the public comment period established in the proposed rule published in the
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a submittal by the Idaho Department of Environmental Quality (Idaho DEQ) demonstrating that the State Implementation Plan (SIP) meets certain interstate transport requirements of the Clean Air Act (CAA) for the National Ambient Air Quality Standards (NAAQS) promulgated for nitrogen dioxide (NO
Comments must be received on or before March 14, 2016.
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2015-0855 at
For information please contact John Chi at (206) 553-1185, or
Throughout this document wherever “we,” “us,” or “our” is used, it is intended to refer to the EPA.
On January 22, 2010, the EPA established a primary NO
CAA section 110(a)(2)(D)(i)(I) requires state SIPs to contain adequate provisions prohibiting any source or other type of emissions activity within a state from contributing significantly to nonattainment, or interfering with maintenance of the NAAQS in any other state.
In the December 24, 2015 submittal, the Idaho DEQ reviewed air quality monitoring data for the United States and found that all monitored areas in the country met the 2010 NO
In addition to reviewing Idaho's submittal, the EPA reviewed more recent monitoring data for NO
The EPA also reviewed regulatory provisions to control future new sources of nitrogen oxide emissions in Idaho. We note that on April 17, 2014, we approved Idaho's NO
Based on our review of the Idaho submittal, air quality monitoring data, and provisions in the current Federally-approved Idaho SIP regulating new sources, we believe it is reasonable to conclude that emissions from Idaho do not significantly contribute to nonattainment of the 2010 NO
The EPA has reviewed the December 24, 2015 submittal from the Idaho DEQ demonstrating that sources in Idaho do not significantly contribute to nonattainment, or interfere with maintenance, of the NO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because this action does not involve technical standards; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Reporting and recordkeeping requirements.
Federal Communications Commission.
Petition for reconsideration.
Petitions for Reconsideration (Petitions) have been filed in the Commission's Rulemaking proceeding by Howard S. Shapiro, on behalf of Audio-Technica U.S., Inc., Laura Stefani, on behalf of Sennheiser Electronic Corp., Paul Margie, on behalf of Google Inc., Paula Boyd, on behalf of Microsoft Corporation, Stephen E. Coran, on behalf of Wireless Internet Service Providers Association, Rick Kaplan, on behalf of National Association of Broadcasters, Lawrence J. Movshin, on behalf of WMTS Coalition, Catherine Wang, on behalf of Shure Incorporated, Ari Q. Fitzgerald, on behalf GE Healthcare, Gordon Moore, on behalf of Lectrosonics, Inc. and Telecommunications Law Professionals PLLC, on behalf of Carlson Wireless Technologies, Inc. and Cal.net, Inc.
Oppositions to the Petitions must be filed on or before February 29, 2016. Replies to an opposition must be filed on or before March 25, 2016.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Hugh Van Tuyl, Policy and Rules Division, Office of Engineering and Technology, (202) 418-7506, email:
This is a summary of Commission's document, Report No. 3037, released January 12, 2016. The full text of the Petitions is available for viewing and copying in Room CY-B402, 445 12th Street SW., Washington, DC or may be accessed online via the Commission's Electronic
Number of Petitions Filed: 12.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Denial of petition for rulemaking.
Based on the agency's evaluation, NHTSA denies a petition for rulemaking from Mr. David K. Aberizk, P.E., of Integrated Consultants Incorporated, who requests the development of safety standards for a driver-activated vehicle regenerative braking interface with distinct rear lighting indication. The petitioner claims that the recommended changes to the relevant safety standards would allow vehicle manufacturers to better utilize the regenerator technology to increase vehicle efficiency. NHTSA finds that some features of the suggested concept are not prohibited by existing Federal motor vehicle safety standards (FMVSS) and notes that Mr. Aberizk did not demonstrate how the other features address a motor vehicle safety need. FMVSS Nos. 108 and 135 currently specify performance requirements relevant to certain permitted technologies identified in the petition.
February 12, 2016.
Ms. Lisa Gavin, Office of Crash Avoidance Standards, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590.
On April 14, 2012, David K. Aberizk, P.E., petitioned NHTSA requesting development of safety standards for a driver-activated vehicle regenerative braking interface with a distinct rear indicator lamp.
Mr. Aberizk states that regenerator technology is currently integrated as a component of the conventional friction braking system in electric or hybrid electric motor vehicles, which limits the potential of the device to recover energy. He claims that hybrid and electric vehicles with driver-activated regenerative braking systems (RBS) increases overall efficiency by 6 percent over existing RBS.
Mr. Aberizk recommends that the agency establish a new safety standard for regenerator engagement to adopt performance requirements, which he believes will interest automakers in embracing increased efficiency concepts, such as his operator-initiated slowing design. Mr. Aberizk provided graphic illustrations showing potential locations for an activation control device on the steering wheel or gear selector, and an expanded center high-mounted stop lamp (CHMSL) assembly. In his first information submission, Mr. Aberizk refers the reader to the Integrated Consultants Incorporated Web site for additional details on the driver-activated RBS empirical test findings and his U.S. patent, Vehicle Regenerative Deceleration Actuator and Indicator System and Method.
In his supplemental submission, Mr. Aberizk states that current RBS technologies underutilize the potential of brake regenerators to increase vehicle efficiency. With an operator-initiated slowing feature added to existing RBSs, Mr. Aberizk claims that overall efficiency increases by 6 percent in hybrid and electric vehicles, and by at least 2.5 percent for mild-hybrid vehicles. As presented, the slowing concept relies on the driver to manually engage the regenerator to slow the vehicle, independent of the brake pedal application. Finally, Mr. Aberizk included a summary of the comment and the attachment he submitted to NHTSA's notice of proposed rulemaking (NPRM) to establish Corporate Average Fuel Economy (CAFE) Standards for model years 2017 and beyond.
Although the submission met the requirements to be accepted as a rulemaking petition, NHTSA does not endorse specific products, designs, or equipment, as Mr. Aberizk requests. NHTSA develops and issues Federal motor vehicle safety standards in order to reduce crashes, deaths and injuries resulting from motor vehicle crashes.
Mr. Aberizk requests that NHTSA define the location and geometric parameters for an operator activated slowing control device with a human-machine interface required for safe operation. Mr. Aberizk offers anecdotal observations and evaluations, but did not submit quantitative data. For vehicles configured with the slowing device, he claims a `noticeable' increase in range for test distances of 15 miles or greater, as well as a 50 to 75 percent reduction in brake pedal usage. The petition does not, however, assess how these factors, if accurate, would lead to safety benefits attributable to the driver-activated slowing concept. Additionally, NHTSA is not aware of any data that establish a correlation between
Perhaps more relevant, however, we note that a manually-enhanced feature to increase recovered braking energy is not prohibited by FMVSS No. 135, the light vehicle braking standard that includes requirements for the service brake system, associated parking brake system, and optional regenerative braking systems. FMVSS No. 135 defines RBS as an electrical energy system that is installed in an electric vehicle for recovering or dissipating kinetic energy and which uses the propulsion motor(s) as a retarder for partial braking of the electric vehicle while returning electrical energy to the propulsion battery(s) or dissipating electrical energy. FMVSS No. 135 expressly states that for an electric vehicle equipped with RBS, the RBS is considered to be part of the service brake system, if it is automatically activated by an application of the service brake control, if there is no means provided for the driver to disconnect or otherwise deactivate it, and if it is activated in all transmission positions, including neutral. For an electric vehicle that is equipped with antilock brake system (ABS) and RBS that is part of the service brake system, the ABS must control the RBS. A vehicle equipped with or without RBS must meet the stopping performance requirements of FMVSS No. 135.
Information compiled by the Federal government estimates the combined city/highway driving energy recovered by regenerative braking to be 5 to 9 percent.
In the petition, Mr. Aberizk also requests that NHTSA define the parameters for an additional rear lamp to signal vehicle slowing. Because we are denying the petition with respect to braking, we need not address the part of the petition related to lighting because without a new brake requirement, there is no need for a new lighting requirement.
In order for NHTSA to consider establishing a new safety standard, the agency must determine that a safety need exists and that the suggested concept will reduce the crash risk. For example, NHTSA completed rulemaking action to require center high mounted stop lamps as standard lighting equipment after extensive research that quantified the crash problem and estimated the safety impact and the effectiveness of the new equipment.
Finally, Mr Aberizk claims that development of safety standards will keep product liability of an operator-initiated slowing system neutral to the industry. Because NHTSA regulates motor vehicle safety and not tort liability, the agency refrains from drawing legal conclusions about Mr. Aberizk's operator-initiated slowing device.
In accordance with 49 CFR part 552, this completes the agency's review of the petition for rulemaking. NHTSA believes that the current requirements specified in FMVSS Nos. 108 and 135 do not prohibit certain features suggested in the petition. The petitioner did not demonstrate a safety need or substantiate claims of reduced crash risk associated with the petitioned concept. Therefore, NHTSA denies David K. Aberizk's petition.
49 U.S.C. 322, 30111, 30115, 30117 and 30166; delegation of authority at 49 CFR 1.95.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting; correction.
The National Marine Fisheries Service published a document in the
Mark Wildman, Office of International Affairs and Seafood Inspection; telephone: (301) 427-8350.
In the
The meeting will be held Wednesday, February 17, 2016, from 3 p.m. until 4 p.m. eastern standard time. Written comments on the proposed rule (December 29, 2015; 80 FR 81251) must be received by February 29, 2016.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability of fishery ecosystem plan amendment; request for comments.
NMFS announces that the Western Pacific Fishery Management Council (Council) proposes to amend the Fishery Ecosystem Plan for Fisheries of the Hawaiian Archipelago. If approved, Amendment 4 would revise the descriptions of essential fish habitat (EFH) and habitat areas of particular concern (HAPC) for 14 species of bottomfish and three species of seamount groundfish in the Hawaiian Archipelago. The proposed action considers the best available scientific, commercial, and other information about the fisheries, and supports the long-term sustainability of fishery resources.
NMFS must receive comments on the proposed amendment by April 12, 2016.
You may submit comments on this document, identified by NOAA-NMFS-2015-0056, by either of the following methods:
•
•
The Council prepared Amendment 4 that provides background information on the proposed action. The amendment is available from
Matt Dunlap, Sustainable Fisheries Division, NMFS PIR, 808-725-5177.
NMFS and the Council manage Hawaii fisheries under the Fishery Ecosystem Plan for Fisheries of the Hawaiian Archipelago. Typically, the Council recommends conservation and management measures for NMFS to implement under the authority of Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act (16 U.S.C. 1801
The Council and NMFS have improved their understanding of the life histories and specific habitat requirements of Hawaii bottomfish and seamount groundfish. After considering the new information, the Council recommended revising the EFH and HAPC designations in the FEP.
NMFS must receive comments on the proposed amendment by April 12, 2016 for consideration in the decision to approve, partially approve, or disapprove the amendment.
The current designation for overall EFH for Hawaii bottomfish is the “water column extending from the shoreline to the outer boundary of the 200-mile EEZ [Exclusive Economic Zone] to a depth of 400 m.” The current designation for HAPC is “all escarpments and slopes between 40-280 m and three known areas of juvenile
The overall EFH for Hawaii seamount groundfish is currently defined as the “water column and bottom habitat from 0-600 m in the EEZ, bounded by latitude 29°-35° N., and longitude 171° E.,-179° W.” The seamount groundfish EFH encompasses the Hancock Seamounts, part of the northern extent of the Hawaiian Ridge, located 1,500 miles northwest of Honolulu. Currently, there are no HAPC designations for Hawaii seamount groundfish (Table 1).
Under the changes proposed in Amendment 4, the overall EFH designation for Hawaii bottomfish would remain the same,
Under the changes proposed in Amendment 4, EFH for Hawaii seamount groundfish would be an area that overlaps the Hancock Seamounts Ecosystem Management area, or the waters within the EEZ north of 28° N. and west of 180° W. The proposed revisions to EFH for seamount groundfish involve distinctions over depth ranges at various life stages. The Council is proposing to designate the same area described for EFH above as HAPC for seamount groundfish (Table 2). Previously there were no HAPC designated for seamount groundfish in the Hawaiian archipelago.
16 U.S.C. 1801
National Institute of Food and Agriculture (NIFA) on behalf of the United States Global Change Research Program (USGCRP), Department of Agriculture.
Request for Public Comments on a Draft Report. Prospectus, Technical Input, and Nominations for Technical Contributors.
The U.S. Carbon Cycle Science Program and the Carbon Cycle Interagency Working Group (CCIWG), under the auspices of the U.S. Global Change Research Program (USGCRP), are initiating an Interagency Special Report entitled the 2nd State of the Carbon Cycle Report (referred to as “SOCCR-2” or “the Report” throughout this notice). The United States Department of Agriculture (USDA) has agreed to be lead agency for this report as it is relevant to USDA and USDA has experience in producing a similar highly successful report of Climate Change and Food Security. The focus of SOCCR-2 will be on U.S. and North American carbon cycle processes, stocks, and flows in the context of and interactions with global scale budgets and climate change impacts in managed and unmanaged systems. Carbon stocks and fluxes in soils, water (including oceans), vegetation, aquatic-terrestrial interfaces (
Written comments on the Draft Prospectus, technical information, and nominations for technical contributors must be received by 5:00 p.m., ET on March 14, 2016.
Comments on the Draft Prospectus, technical information, and nominations for technical contributors must be submitted electronically via
USGCRP Contact: Dr. Gyami Shrestha; telephone 202-223-6262; or email:
NIFA Contact: Dr. Nancy Cavallaro; telephone 202-401-5176; or email:
The Draft Prospectus describes the proposed plans for scoping, drafting, reviewing, producing, and disseminating SOCCR-2. Comments are specifically sought on the Draft Report outline (including the draft table of contents), proposed topics, and process as outlined in the Draft Prospectus. The Draft Prospectus and instructions to submit comments can be found at
The SOCCR-2 report is a synthesis and assessment focusing on U.S. and North American carbon cycle processes, stocks, and flows in the context of and interactions with global scale budgets and climate change impacts in managed and unmanaged systems.
Current status and near-term projections for each topic will be included. If and where possible, modeling and multi-model syntheses of the carbon cycle will be included. As appropriate, each chapter will address cross-cutting themes such as: Land use change, fluxes, feedbacks, historical context, indicators and trends, societal impacts, North American and global scales (based on the 2014 National Climate Assessment regions), carbon management, impacts of decisions, and research needs. The expanded draft table of contents can be found on
Preface—The Preface will explain the importance of the carbon cycle to climate, the scope and rationale for SOCCR-2, and key developments since SOCCR-1.
Chapter 1: Global carbon cycle overview—Chapter 1 will contain an overview of major elements of the coupled global carbon cycle (
Chapter 2: Carbon cycle at scales—Chapter 2 will provide an assessment of the North American carbon cycle (scaled down from the global system in chapter 1), including updated regional, and local perspectives on key carbon stocks and flows.
Chapter 3: Carbon in natural and anthropogenic systems—major stocks, flows, uncertainties, broader social
Chapter 4: Interactions/disturbance: Impacts to the carbon cycle—Chapter 4 will focus on the role of disturbances, such as fire, ocean acidification, pathogens, land use change, etc. on the carbon cycle.
Chapter 5: Carbon cycle information, management practices, tools and needs at various scales—Chapter 5 will assess the role of recent carbon management practices and highlight the current state of carbon data management, monitoring systems, tools, and carbon relevant modeling scenarios.
Chapter 6: Synthesis, conclusions, gaps in knowledge, and (near) future outlook—Chapter 6 will provide an overarching synthesis of the current state of the carbon cycle while identifying key knowledge gaps/opportunities and a near-term outlook on the North American Carbon cycle.
The audience includes scientists, decision-makers in the public and private sectors and the general interested community across the U.S., extending to North American and global regions. The report may ultimately be used to inform policies but will not prescribe or recommend them.
The SOCCR-2 Report will be a federal interagency report. Technical contributors may be federal employees, academic scientists, private and nonprofit sector representatives, and others as appropriate and in alignment with federal requirements. The technical contributors will be selected based on their scientific expertise; demonstrated accomplishments; academic interests and knowledge in the thematic areas specified in the draft outline; time availability; and technical capability to work in this type of broad interdisciplinary and cross-cutting scientific assessment setting. The main roles and responsibilities of the technical contributors may include compiling the necessary background literature; synthesizing, analyzing and interpreting the existing science; and contributing intellectual and technical input. The process for nominating technical contributors is provided in Section III below.
A Federal Steering Committee of the USGCRP's SOCCR-2 has been established to provide guidance and coordination to the report authors and staff. The Committee members represent CCIWG member departments and agencies including National Oceanic and Atmospheric Administration (NOAA), National Aeronautics and Space Administration (NASA), Department of Energy (DOE), United States Department of Agriculture (USDA), U.S. Geological Survey (USGS) and Environmental Protection Agency (EPA).
The USGCRP's 2nd State of the Carbon Cycle Report will use referenced materials derived primarily from the existing, peer-reviewed scientific literature and consistent with guidance regarding the use of other literature. This report will follow the USDA Information Quality Guidelines and administrative processes (
The written comments on the Draft Prospectus, technical information, and nominations for technical contributors called for in this notice are the first opportunities for public participation in the SOCCR-2 report process. Federal Steering committee will provide several opportunities for public engagement with the scientific community throughout the report scoping, planning and writing process via special presentations, sessions, town hall meetings and side-events at national and international scientific conferences. A public review period for the Draft SOCCR-2 will also be announced via a
SOCCR-2, with a likely release in 2017, is designed to inform the next quadrennial National Climate Assessment (due in 2018).
Interested parties are invited to assist in contributing, collecting and refining the scientific information base for this special report. To do so, parties are asked to submit recent, relevant scientific and/or technical research studies including observed, modeled and/or projected carbon cycle science information that have been peer reviewed and published or accepted for publication in scientific journals and/or government reports. All scientific literature submitted in response to this call for information must be received by 5:00 p.m., ET on March 14, 2016.
Submissions must be uploaded electronically via the link provided on
This notice seeks nominations for technical contributors to SOCCR-2 with pertinent subject matter expertise and scientific background. Potential technical contributors should be accomplished scholarly writers and have demonstrated scientific and technical expertise and academic proficiency in at least one of the carbon cycle science topics outlined in the prospectus (available via
Responses to this request must be received by 5:00 p.m., ET on March 14, 2016. Please follow instructions on
The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by March 14, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
United States Commission on Civil Rights.
Notice of Commission Briefing and Business Meeting.
Friday, February 19, 2016, at 9 a.m. EST.
Gerson Gomez, Media Advisor at telephone: (202) 376-8371, TTY: (202) 376-8116 or email:
This business meeting is open to the public. If you would like to listen to the briefing or business meeting, please contact the above for the call-in information.
Comments may also be submitted by email to
The Houma-Terrebonne Airport Commission, grantee of FTZ 279, submitted a notification of proposed production activity to the FTZ Board on behalf of Thoma-Sea Marine Constructors, L.L.C. (Thoma-Sea), located in Houma, Louisiana. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on February 3, 2016.
A separate request for subzone designation at the Thoma-Sea facilities is planned and will be processed under Section 400.31 of the FTZ Board's regulations. The facilities are used for the construction and repair of oceangoing vessels. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Thoma-Sea from customs duty payments on the foreign status components used in export production. On its domestic sales, Thoma-Sea would be able to choose the duty rate during customs entry procedures that applies to oceangoing vessels (free) for the foreign status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign status production equipment.
The components sourced from abroad include: plastic hoses; printed manuals; steel pipe fittings; doors; steel tanks; hatches/manholes; copper anodes; zinc rods; base metal mountings; outboard motors; parts of marine engines; parts of hydraulic pumps; hydraulic fluid pumps; compressors; portal/pedestal jib cranes; thruster parts; pressure-reducing valves; steel tank valves; vent check valves; machine parts of automated systems; electric motors; AC generators; speed drive controllers; power supplies; batteries; power cells; starter generators/motors; electric ignition starter parts; fuses; circuit boards; parts of electrical switching apparatus; insulated winding wire; liquid flow/level measuring instruments; parts of printed circuit assemblies; and, parts of measuring instruments (duty rate ranges from free to 5.7%).
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is March 23, 2016.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
For further information, contact Pierre Duy at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on citric acid and certain citrate salts (citric acid) from Canada. The period of review (POR) is May 1, 2014, through April 30, 2015. The review covers one producer/exporter of the subject merchandise, Jungbunzlauer Canada Inc. (JBL Canada). We preliminarily determine that sales of subject merchandise by JBL Canada were not made at prices below normal value (NV). We invite interested parties to comment on these preliminary results.
Rebecca Trainor or Katherine Johnson, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-4007 or (202) 482-4929, respectively.
The merchandise covered by this order is citric acid and certain citrate salts from Canada. The product is currently classified under subheadings 2918.14.0000, 2918.15.1000, 2918.15.5000, and 3824.90.9290 of the Harmonized Tariff System of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of merchandise subject to the scope is dispositive.
The Department is conducting this review in accordance with section 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act). Constructed export price is calculated in accordance with section 772 of the Act. NV is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions,
As a result of this review, the Department preliminarily determines that a weighted-average dumping margin of 0.00 percent exists for JBL Canada for the period May 1, 2014, through April 30, 2015.
We intend to disclose to interested parties the calculations performed in connection with these preliminary results within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Interested parties may submit case briefs not later than 30 days after the date of publication of this notice.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues parties intend to be discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined.
The Department intends to issue the final results of this administrative review, including the results of its analysis of issues raised in any written briefs, not later than 120 days after the date of publication of this notice, unless the deadline is extended.
Upon completion of the administrative review, the Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
We calculated importer-specific
We intend to issue instructions to CBP 41 days after the date of publication of the final results of this review.
The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for JBL Canada will be the rate established in the final results of this review, except if the rate is
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of the determinations by the Department of Commerce (“the Department”) and the International Trade Commission (“ITC”) that revocation of the antidumping duty (“AD”) orders on certain magnesia carbon bricks (“MCBs”) from Mexico and the People's Republic of China (“PRC”) and the countervailing duty (“CVD”) order on MCBs from the PRC would likely lead to a continuation or recurrence of dumping and countervailable subsidies and material injury to an industry in the United States, the Department is publishing a notice of continuation of the antidumping duty orders and the countervailing duty order.
Kenneth Hawkins, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-6491.
On August 3, 2015 the Department published a notice of initiation of the first sunset review of the AD orders on MCBs from Mexico and the PRC, and the CVD order on MCBs from the PRC, pursuant to section 751(c) of the Tariff Act of 1930, as amended (“the Act”).
Imports covered by the orders consist of certain chemically bonded (resin or pitch), MCBs with a magnesia component of at least 70 percent magnesia (“MgO”) by weight, regardless of the source of raw materials for the MgO, with carbon levels ranging from trace amounts to 30 percent by weight, regardless of enhancements, (for example, MCBs can be enhanced with coating, grinding, tar impregnation or coking, high temperature heat treatments, anti-slip treatments or metal casing) and regardless of whether or not anti-oxidants are present (for example, antioxidants can be added to the mix from trace amounts to 15 percent by weight as various metals, metal alloys, and metal carbides).
Certain MCBs that are the subject of this investigation are currently classifiable under subheadings 6902.10.1000, 6902.10.5000, 6815.91.0000, 6815.99.2000, and 6815.99.4000 of the Harmonized Tariff Schedule of the United States (“HTSUS”). While HTSUS subheadings are provided for convenience and customs purposes, the written description is dispositive.
As a result of the determinations by the Department and the ITC that revocation of the AD and CVD orders would likely lead to a continuation or recurrence of dumping and countervailable subsidies and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), the Department hereby orders the continuation of the AD orders on MCBs from Mexico and the PRC and the CVD order on MCBs from the PRC. U.S. Customs and Border Protection will continue to collect AD and CVD duty cash deposits at the rates in effect at the time of entry for all imports of subject merchandise.
The effective date of the continuation of the orders will be the date of publication in the
This five-year (“sunset”) review and this notice are in accordance with section 751(c) of the Act and published pursuant to section 777(i)(1) of the Act and 19 CFR 351.218(f)(4)
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily finds that Agir Haddecilik A.S. (Haddecilik) did not make sales at prices below normal value (NV) during the period of review (POR). The POR is May 1, 2014, through April 30, 2015. We invite interested parties to comment on these preliminary results.
Mark Flessner or Robert James, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-6312 or (202) 482-0649, respectively.
The merchandise covered by the order is certain welded carbon quality light-walled steel pipe and tube, of rectangular (including square) cross section, having a wall thickness of less than 4 millimeters. The merchandise subject to the order is classified in the Harmonized Tariff Schedule of the United States at subheadings 7306.61.50.00 and 7306.61.70.60.
For a full description of the scope of the order, see the memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, entitled “Light-Walled Rectangular Pipe and Tube From Turkey: Decision Memorandum for the Preliminary Results of Antidumping Duty Administrative Review; 2014-2015” (Preliminary Decision Memorandum), which is dated concurrently with this notice and is hereby incorporated by reference.
As explained in the memorandum from the Acting Assistant Secretary for Enforcement & Compliance, the Department has exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. All deadlines in this segment of the proceeding have been extended by four business days. The revised deadline for the preliminary results of this review is now February 5, 2016.
The Department is conducting this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act). Export price (EP) is calculated in accordance with section 772 of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.
As a result of this review, we preliminarily determine the following weighted-average dumping margin for the period May 1, 2014, through April 30, 2015:
The Department intends to disclose to interested parties the calculations performed in connection with these preliminary results within five days of the date of publication of this notice.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by 5:00 p.m. Eastern Standard Time within 30 days after the date of publication of this notice.
The Department intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in all written case briefs, within 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).
Upon completion of the administrative review, the Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries.
We intend to issue instructions to CBP 15 days after publication of the final results of this review.
The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of light-walled rectangular pipe and tube from Turkey entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for Haddecilik will be the weighted-average dumping margin established in the final results of this administrative review except if the rate is
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is initiating a changed circumstances review (CCR) of the antidumping duty (AD) order on drawn stainless steel sinks from the People's Republic of China (PRC) with regard to Ningbo Afa Kitchen and Bath Co., Ltd. (Ningbo). We preliminarily determine that Ningbo is the successor-in-interest to Yuyao Afa Kitchenware Co., Ltd. (Yuyao) for purposes of determining AD liability. Interested parties are invited to comment on these preliminary results.
Ross Belliveau or Brian Smith, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4952 or (202) 482-1766.
On April 11, 2013, the Department published in the
The products covered by the scope of this order are drawn stainless steel sinks with single or multiple drawn bowls, with or without drain boards, whether finished or unfinished, regardless of type of finish, gauge, or grade of stainless steel. Mounting clips, fasteners, seals, and sound-deadening pads are also covered by the scope of this order if they are included within the sales price of the drawn stainless steel sinks. For purposes of this scope definition, the term “drawn” refers to a manufacturing process using metal forming technology to produce a smooth basin with seamless, smooth, and rounded corners. Drawn stainless steel sinks are available in various shapes and configurations and may be
Excluded from the scope of the order are stainless steel sinks with fabricated bowls. Fabricated bowls do not have seamless corners, but rather are made by notching and bending the stainless steel, and then welding and finishing the vertical corners to form the bowls. Stainless steel sinks with fabricated bowls may sometimes be referred to as “zero radius” or “near zero radius” sinks.
The products covered by this order are currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under statistical reporting number 7324.10.0000 and 7324.10.0010. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope is dispositive.
Pursuant to section 751(b)(1)(A) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.216(d), the Department will conduct a CCR upon receipt of a request from an interested party for a review of an AD order which shows changed circumstances sufficient to warrant a review of the order. The information submitted by Ningbo supporting its claim that it is the successor-in-interest to Yuyao demonstrates changed circumstances sufficient to warrant such a review.
In accordance with the above-referenced regulation, the Department is initiating a CCR to determine whether Ningbo is the successor-in-interest to Yuyao. When it concludes that expedited action is warranted, the Department may publish the notice of initiation and preliminary results for a CCR concurrently.
In determining whether one company is the successor-in-interest to another, the Department examines a number of factors including, but not limited to, changes in management, production facilities, supplier relationships, and customer base.
In its December 22, 2015 submission, Ningbo provided information to demonstrate that it is the successor-in-interest to Yuyao. Ningbo states that the company's ownership, location/production facilities, management, and customer base have not changed as a result of the corporate name change. It states further that its suppliers have remained largely the same, with some suppliers added but none eliminated. To support its claims, Ningbo submitted the following documents: (1) A copy of Ningbo's old and new business licenses, issued on June 2, 2015, and November 19, 2015, respectively;
Based on the evidence on the record, we preliminarily find that Ningbo is the successor-in-interest to Yuyao. We find that Ningbo operates as the same business entity as Yuyao and that its ownership, management, production facilities, supplier relationships, and customers have not changed as a result of its name change. Thus, we preliminarily find that Ningbo should receive the same antidumping duty cash deposit rate with respect to the subject merchandise as Yuyao, its predecessor company.
Should our final results remain the same as these preliminary results, we will instruct U.S. Customs and Border Protection to suspend entries of subject merchandise exported by Ningbo at Yuyao's cash deposit rate, effective on the publication date of our final results.
Interested parties may submit case briefs and/or written comments not later than 14 days after the publication of this notice.
Interested parties that wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS, within 14 days of publication of this notice.
Consistent with 19 CFR 351.216(e), we intend to issue the final results of this changed circumstance review no later than 270 days after the date on which this review was initiated, or within 45 days of publication of these preliminary results if all parties agree to our preliminary finding.
We are issuing and publishing this finding and notice in accordance with sections 751(b)(1) and 777(i)(1) of the Act, and 19 CFR 351.216 and 351.221(c)(3)(ii).
National Institute of Standards and Technology, Commerce.
Notice; extension of comment period.
The National Institute of Standards and Technology (NIST) is extending the period for submitting comments relating to the “Framework for Improving Critical Infrastructure Cybersecurity” (the “Framework”) through February 23, 2016. In a Request for Information (RFI) that published in the
Comments must be received by 5:00 p.m. Eastern time on February 23, 2016. Comments received after February 9, 2016 and before publication of this notice are deemed to be timely.
Written comments may be submitted by mail to Diane Honeycutt, National Institute of Standards and Technology, 100 Bureau Drive, Stop 8930, Gaithersburg, MD 20899. Online submissions in electronic form may be sent to
All comments received in response to this RFI will be posted at
For questions about this RFI contact: Diane Honeycutt, National Institute of Standards and Technology, 100 Bureau Drive, Stop 8930, Gaithersburg, MD 20899 or
NIST is extending the comment period announced in the December 11, 2015 Request for Information (RFI) (80 FR 76934) through February 23, 2016. NIST is authorized by the Cybersecurity Enhancement Act of 2014
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Up-to-date socioeconomic data is needed to support the further development and improvement of Ocean Guardian Schools. These schools receive funding from the NOAA Office of Education and the Office of National Marine Sanctuaries. Schools may apply for funding up to five years. A number of schools have continued their Ocean Guardian School projects after the five years. From 2010-2015, the total funding received by 71 schools was $544,315.
Although the costs and sources of funding are known, there is limited information known about the economic value participants place on this program and the economic value created by these schools and their many activities. Currently, there is no information available that provides estimates of the value of education programs like Ocean Guardian to parents and teachers. Ocean Guardian Schools receive funding to develop projects to help protect the ocean in the future and promote ocean conservation and stewardship. Projects include recycling, beach clean-up days, installing rain barrels, installing wildlife structures, composting, and energy reduction.
The types of data targeted for this collection are: attitudes and preferences towards the projects and student involvement, importance of/satisfaction with the program and attributes of the program, extent of reach (are parents aware of their student's involvement and are they too learning about ocean stewardship), level of teacher, student, parent and administrative involvement, and teachers' and parents' willingness to pay. The primary focus for the survey will be to gather data on parents' and teachers' willingness to pay for this program. Specifically, researchers will collect data to determine the economic value teachers, administrators and parents place on this program. The information collected will help to inform Ocean Guardian Schools about areas for improvement and the value that their programs create for the community.
This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The Pacific Fishery Management Council's (Pacific Council) Groundfish Management Team (GMT) will hold two webinars that are open to the public.
The GMT webinars will be held on Tuesday, March 1, 2016, from 8:30 a.m. until 12 p.m. and on Monday, April 4, 2016, from 1:30 p.m. to 5 p.m.
To attend the webinars: (1) Join the meetings by visiting this link
Ms. Kelly Ames, Pacific Council, (503) 820-2426.
The purpose of the GMT webinars are to prepare for the March and April 2016 Pacific Council meetings. The GMT may also address other assignments relating to groundfish management. No management actions will be decided by the GMT. Public comment will be accommodated if time allows, at the discretion of the GMT Chair. The GMT's task will be to develop recommendations for consideration by the Pacific Council at its March 8-14, 2016 meeting in Sacramento, CA and its April 8-14, 2016 meeting in Vancouver, WA.
Although nonemergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section
The public listening station is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2425 at least 5 days prior to the meeting date.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and deletions from the procurement list.
This action adds products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products from the Procurement List previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On May 8, 2015 (80 FR 26548-26549) and November 16, 2015 (80 FR 70761-70762), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and service and impact of the additions on the current or most recent contractors, the Committee has determined that the products and service listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and service to the Government.
2. The action will result in authorizing small entities to furnish the products and service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products and service proposed for addition to the Procurement List.
Accordingly, the following products and service are added to the Procurement List:
The Committee for Purchase From People Who Are Blind or Severely Disabled (Committee) operates pursuant to statutory and regulatory requirements. Committee regulations state for a commodity or service to be suitable for addition to the Procurement List, each of the following criteria must be satisfied: The addition to the Procurement List must demonstrate a potential to generate employment of people who are blind or have other severe disabilities; the nonprofit agency proposing to provide the product or service to the Federal Government must be qualified to participate in the AbilityOne program as defined in separate Committee regulations; the nonprofit agency must prove itself capable to deliver the product or service at the quality standard and delivery schedule required by the Government; and the Committee reviews the level of impact on the current contractor for the commodity or service.
Federal Prison Industries (FPI) submitted a comment objecting to the proposed addition of the U.S. Army Combat Uniform Coat to the Procurement List. FPI asserts in its comments that, for items already listed on FPI's Schedule of Products like the proposed U.S. Army Combat Uniform Coat, a designated central nonprofit agency of the AbilityOne program must seek a waiver of FPI's purchase priority before requesting to add the same product to the Committee's Procurement List pursuant to 41 CFR 51-3.3. Normally, FPI products have a purchase priority over AbilityOne products, as stated in FAR subparts 8.002, 8.603 and 8.704.
However, 10 U.S.C. 2410n and DFARS subpart 208.602-70 provide that, if FPI's share for the particular product is greater than five percent of the Department of Defense (DOD) market, then DOD must use competitive and fair opportunity procedures in order to purchase additional quantities from FPI, permitting FPI to participate in such competitive process which establishes that FPI no longer has a
In fact, the FAR subparts 8.603 and 8.704 contemplate a purchasing priority “when identical supplies or services are on the Procurement List and the Schedule of Products issued by the Federal Prison Industries, Inc.” For this particular product, FPI has lost its priority by operation of law, but the AbilityOne priority remains effective.
Section 827 of National Defense Authorization Act for Fiscal Year 2008 (NDAA for FY2008, now 10 U.S.C. 2410n) and supplemental Defense Federal Acquisition Regulation 208.602-70 do not apply to the Javits-Wagner-O'Day (JWOD) Act purchase priority established in 41 U.S.C. 8504 and implemented in FAR subpart 8.7. As preset forth at 10 U.S.C. 2410n, if FPI provides a significant market share of a particular product to DOD, then, by statute, DOD procurement activities may purchase a product listed in the latest edition of the Federal Prison Industries catalog for which Federal Prison Industries has a significant market share [defined as greater than 5%]
In addition, the basis for both competitive and fair opportunity procurement procedures is the Competition in Contract Act (CICA) (10 U.S.C. 2304 or 41 U.S.C. 3304) and FAR Subpart 6. Both 10 U.S.C. 2304(c)(5) and FAR Subpart 6.302-5, the implementing regulation, provide that an Agency is not required to follow CICA when expressly required by another statute to use different procurement procedures. The JWOD purchase priority, set forth at 41 U.S.C. 8504, is listed in FAR Subpart 6.302-5 as an express exception to CICA and full and open competition. While FPI is precluded by law from exercising its purchase priority for DOD procurements when it already provides greater than 5% of the market share for a particular product, competition in accordance with the Competition in Contracting Act does not apply because the JWOD purchase priority is applicable. The JWOD Act states:
(a) In General.—An entity of the Federal Government intending to procure a product or service on the procurement list referred to in section 8503 of this title shall procure the product or service from a qualified nonprofit agency for the blind or a qualified nonprofit agency for other severely disabled in accordance with regulations of the Committee and at the price the Committee establishes if the product or service is available within the period required by the entity.
(b)
Pursuant to section 8504, an exception to the JWOD priority exists for procurement of a “product that is available” from FPI. When an FPI product reaches the market share of sales specified in section 2410n the product is no longer available from FPI on a priority basis pursuant to 18 U.S.C. 4124.
Therefore, if the same product is listed on the Procurement List, then Federal agencies must purchase from the designated nonprofit agencies (assuming nonprofits are able to deliver the substantially same product in the delivery window required), and cannot elect to pursue the competitive process outlined in section 2410n while ignoring the priorities set forth in the JWOD Act 41 U.S.C. 8504, and FAR subparts 8.002, 8.603 and 8.704.
On January 8, 2016 (81 FR 916-917), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products deleted from the Procurement List.
Accordingly, the following products are deleted from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Addition to the procurement list.
This action adds a service to the Procurement List that will be provided by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On December 18, 2015 (80 FR 79031-79032), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to furnish the service and impact of the additions on the current or most recent contractors, the Committee has determined that the service listed below is suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will provide the service to the Government.
2. The action will result in authorizing small entities to provide the service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service proposed for addition to the Procurement List.
Accordingly, the following service is added to the Procurement List:
The Committee finds good cause to dispense with the 30-day delay in the effective date normally required by the Administrative Procedure Act. 5 U.S.C. 553(d). This addition to the Committee's Procurement List is a reaction to the expiration of the U.S. Army help desk support services contract. The Federal customer contacted, and has worked with the AbilityOne Program since April 2015 to fulfill this service need under the AbilityOne Program. To avoid performance disruption, and the possibility that the U.S. Army will have no viable alternative but to procure this service, this addition must be effective on February 29, 2016, ensuring timely execution for a March 1, 2016, start date while still allowing 18 days for comment. Pursuant to its own regulation 41 CFR 51-2.4, the Committee has been in contact with one of the affected parties, the incumbent of the expiring contract, since May 2015 and determined that no severe adverse impact exists. The Committee also published a notice of proposed Procurement List addition in the
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed Additions to and Deletion from the Procurement List.
The Committee is proposing to add products to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes a product previously furnished by such agency.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products listed below from nonprofit
The following products are proposed for addition to the Procurement List for production by the nonprofit agencies listed:
The following product is proposed for deletion from the Procurement List:
Consumer Product Safety Commission.
Notice.
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Consumer Product Safety Commission (“CPSC” or “Commission”) requests comments on a proposed extension of approval of a collection of information under the requirements pertaining to third party conformity assessment bodies, approved previously under OMB Control No. 3041-0156. The Commission will consider all comments received in response to this notice before requesting an extension of this collection of information from the Office of Management and Budget (“OMB”).
Submit written or electronic comments on the collection of information by April 12, 2016.
You may submit comments, identified by Docket No. CPSC-2012-0026, by any of the following methods:
Robert H. Squibb, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7815, or by email to:
CPSC seeks to renew the following currently approved collection of information:
•
○ We estimate approximately 40 new applications from independent third party conformity assessment bodies will be submitted per year, taking an estimated 75 minutes to complete the initial application materials, with an estimated burden of 50 hours per year.
○ We estimate approximately 3 firewalled third party conformity assessment bodies will apply per year, taking an estimated 8.4 hours to complete the initial application materials, with an estimated burden of 25.2 hours per year.
○ We estimate approximately 4 governmental third party conformity assessment bodies will apply per year, taking an estimated 3 hours to complete the initial application materials, with an estimated burden of 12 hours per year.
•
○ We estimate that approximately 5 third party conformity assessment bodies will take 15 minutes to update information for only those elements of information that need updating, with an estimated burden of 1.35 hours per year.
•
○ We estimate that approximately 27 third party conformity assessment bodies will take 7 minutes to comply with the subcontracting recordkeeping requirement for an estimated 68,769 subcontract test, with an estimated of approximately 8,023 hours per year.
•
○ We estimate approximately 8 third party conformity assessment bodies will withdraw yearly, taking an estimated 30 minutes to create and submit the required documentation, with an estimated burden of 4 hours per year.
•
○ We estimate that approximately 228 independent third party conformity assessment bodies each year will be audited, taking approximately 4 minutes to resubmit their Form 223 and accreditation certificate, with an estimated burden of 15.2 hours per year.
○ We estimate that approximately 18 firewalled third party conformity assessment bodies will spend 226 minutes collecting and preparing the documentation to submit for an audit, with estimated burden of about 68 hours per year.
○ We estimate approximately 25 governmental third party conformity assessment bodies will spend 1 hour collecting and preparing the documentation to submit for an audit, with estimated burden of 25 hours per year.
•
Adding all of the annual estimated burden hours results in a total of 8,224 hours for third party conformity assessment bodies per year. At $38.78 per hour, the total cost of the recordkeeping associated with the Requirements Pertaining to Third Party Conformity Assessment Bodies is approximately $318,927 (8,224 hours × $38.78 = $318,927).
The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:
CNCS.
Notice.
The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce
Currently, CNCS is soliciting comments concerning its proposed renewal of the National Service Trust Voucher and Payment Request Form/National Service Trust Manual Payment Request Form (OMB #3045-0014); which is used to make payments to repay qualified student loans and to pay for the cost of attending eligible post-secondary educational institutions and approved School-to-Work programs. Prior to making the payments, CNCS will review information from the forms and compare it to information taken from the AmeriCorps members' education award account(s) to ensure that the payments meet the requirements of the law. This information collection is not required to be considered for obtaining grant funding support.
Copies of the information collection request can be obtained by contacting the office listed in the
Written comments must be submitted to the individual and office listed in the
You may submit comments, identified by the title of the information collection activity, by any of the following methods:
(1) By mail sent to: Corporation for National and Community Service, National Service Trust; Attention: Nahid Jarrett, Trust Officer, 250 E Street SW., Suite 300, Washington, DC, 20525.
(2) By hand delivery or by courier to the CNCS mailroom at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except Federal holidays.
(3) By fax to: 202-606-3484, Attention: Nahid Jarrett.
(4) Electronically through
Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8:00 a.m. and 8:00 p.m. Eastern Time, Monday through Friday.
Nahid Jarrett, 202-606-6753, or by email at
CNCS is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
CNCS supports programs that provide opportunities for individuals who want to become involved in national service. The service opportunities cover a wide range of activities over varying periods of time. Upon successfully completing an agreed-upon term of service in an approved AmeriCorps program, an AmeriCorps member receives an education award.
The National Service Trust is the office within CNCS that administers the education award program. This involves tracking the service for all AmeriCorps members, ensuring that certain requirements of CNCS enabling legislation are met, and processing school and loan payments that the members authorize both manually and electronically through the MyAmeriCorps portal. With this form AmeriCorps members request Segal Education Award payments, schools and lenders certify their eligibility, and both parties certify certain legal requirements.
CNCS seeks to renew the current information collection request.
After an AmeriCorps member completes a period of national service, the individual receives an education award that can be used to pay against qualified student loans or pay for current post-secondary educational expenses. The
The information collection will otherwise be used in the same manner as the existing application. CNCS also seeks to continue using the current application until the revised application is approved by OMB. The current application is due to expire on 03/31/2016.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Defense Security Cooperation Agency, DoD.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-05 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
(iii)
Thirteen (13) MK 15 Phalanx Block lB Baseline 2 Close-in Weapons System (CIWS) Guns
Eight (8) CIWS Block 1 Baseline 0 to Block 1B Baseline 2 upgrade kits
Two-hundred and sixty thousand (260,000) Rounds of 20mm MK 244 MOD 0 Armor-Piercing Discarding Sabots (APDS)
20mm dummy rounds; spares to support the installation, maintenance and operation of the MK 15 Phalanx Block l B Baseline 2 systems; classified and unclassified publications; software; training; technical assistance; installations; other technical assistance; and logistical support.
(iv)
(v)
TW-P-LFF, TW-P-LDA; P&A TW-PLHO, $320.2M, 10 October 2014.
(vi)
(vii)
(viii)
*as defined in Section 47(6) of the Arms Export Control Act.
The Taipei Economic and Cultural Representative Office in the United States has requested a possible sale of:
Thirteen (13) MK 15 Phalanx Block 1B Baseline 2 Close-in Weapons System (CIWS) Guns
Eight (8) CIWS Block 1 Baseline 0 to Block lB Baseline 2 upgrade kits
Two-hundred and sixty thousand (260,000) Rounds of 20mm MK 244 MOD 0 Armor Piercing Discarding Sabots (APDS)
Also included in this possible sale are: 20mm dummy rounds; spares to support the installation, maintenance and operation of the MK 15 Phalanx Block 1B Baseline 2 systems; classified and unclassified publications; software; training; technical assistance; installations; other technical assistance; and logistical support. The estimated cost is $416 million.
This sale is consistent with United States law and policy as expressed in Public Law 96-8.
This proposed sale serves U.S. national, economic, and security interests by supporting the recipient's continuing efforts to modernize its armed forces and enhance its defensive capability. The proposed sale will help improve the security of the recipient and assist in maintaining political stability, military balance, and economic progress in the region.
The proposed sale will improve the recipient's capability in current and future defensive efforts. The recipient will use the enhanced capability as a deterrent to regional threats and to strengthen homeland defense. The recipient will have no difficulty absorbing this equipment into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The prime contractor will be Raytheon Missile Systems Company in Tucson, Arizona. The purchaser has requested an offset of forty percent. At this time, agreements are undetermined and will be defined in negotiations between the purchaser and contractor.
Implementation of this proposed sale should not require the permanent assignment of additional U.S. Government or contractor representatives outside the United States.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. Purchaser currently has forty-two (42) MK 15 Phalanx Close-In Weapon Systems (CIWS) Guns of various configurations, including Block 0, Block 1 (Baselines 0, 1 and 2), Block 1A, and Block 1B Baseline 0. Purchaser will be upgrading eight (8) of its lower configurations as well as procuring thirteen (13) additional systems, all of which will have an end configuration of Block 1B Baseline 2 configuration. The main characteristics of the MK 15 Phalanx Block l B Baseline 2 CIWS Gun are:
a. A Radar Upgrade that provides increased sensitivity on sea-skimming threats and improved low-observable performance.
b. A stabilized thermal imager and an automatic acquisition video tracker that were introduced with the Block 1B Baseline 0 configuration. These components provide the capability to engage small, high speed, maneuvering surface craft and low, slow aircraft and helicopters. The thermal imager also improves performance against Anti-Ship Cruise Missiles by carrying out more accurate angle tracking information to the fire control computer. Purchaser has already been provided this capability with the Block 1B Baseline 0 previously procured via an FMS case.
c. The Optimized Gun Barrel that was also introduced with the Block l B Baseline 0 and provides improved dispersion performance of the ammunition when the system is fired. This gun barrel also permits use of the MK 244 ammunition, an enhanced lethal cartridge capable of penetrating harder warheads in use today. Purchaser has already been provided this capability with the Block l B Baseline 0 previously procured via an FMS case.
2. Although the MK 15 Phalanx Block 1B Baseline 2 CIWS Gun is considered state-of-the-art technology, there is no Critical Program Information associated with the MK 15 Phalanx CIWS hardware, technical documentation, or software. The highest classification of the hardware to be exported is UNCLASSIFIED. The highest classification of the technical documentation to be exported is CONFIDENTIAL; there is only one CONFIDENTIAL technical manual that will be exported, which is required for the operation of the MK 15 Phalanx CIWS. The highest classification of software to be exported is UNCLASSIFIED. The MK 15 Phalanx CIWS meets Anti-Tampering requirements. Only Organizational-Level and Intermediate-Level maintenance capability will be exported. The Maintenance Plan for the MK 15 CIWS limits Intermediate-Level maintenance to the system's Gun and Ammunition Handling System.
3. A determination has been made that the recipient country can provide the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is
4. All defense articles and services listed in this transmittal have been authorized for release and export to the recipient.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-06 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
(iii)
Major Defense Equipment (MDE) includes:
Non-MDE items included are Integrated Electronic Technical Manuals (IETMs), Government-Furnished Equipment, spare and repair parts, Telemeters, Range and Test Support, contractor technical support, contractor training, contractor engineering services, and contractor logistics services. Also included are consolidation, Total Package Fielding, Material Fielding Team, Field Service Representative (FSR), U.S. Government Technical Support, and other associated equipment and services.
(iv)
(v)
(vi)
(vii)
(viii)
* as defined in Section 47(6) of the Arms Export Control Act.
The Taipei Economic and Cultural Representative Office in the United States has requested a possible sale of two-hundred and fifty (250) Block I-92F MANPAD Stinger Missiles, four (4) Block I-92F MANPAD Stinger Fly-to-Buy Missiles, one (1) Captive Flight Trainer (CFT), forty two (42) Field Handling Trainers (FHTs), seventy (70) Gripstock Control Groups, seventy (70) Medium Thermal Weapon Sights (MTWS), forty-two (42) Tracking Head Trainers (THTs), four (4) Sierra Coolant Recharging Units (CRUs), one (1) Missile Go/No Go Test Set, four (4) MQM-170 Outlaw Target Drones, sixty-two (62) Identification Friend or Foe (IFF), IFF Development, one (1) Stinger Troop Proficiency Trainer (STPT). Also included are Integrated Electronic Technical Manuals (IETMs),Government Furnished Equipment, spare and repair parts, Telemeters, Range and Test Support, contractor technical support, contractor training, contractor engineering services, contractor logistics services, consolidation, Total Package Fielding, Material Fielding Team, Field Service Representative (FSR), U.S. Government Technical Support, and other associated equipment and services. The estimated value is $216,848,586.
This sale is consistent with United States law and policy as expressed in Public Law 96-8.
This proposed sale serves U.S. national, economic, and security interests by supporting the recipient's continuing efforts to modernize its armed forces and enhance its defensive capability. The proposed sale will help improve the security of the recipient and assist in maintaining political stability, military balance, and economic progress in the region.
The proposed sale will improve the recipient's capability in current and future defensive efforts. The recipient will use the enhanced capability as a deterrent to regional threats and to strengthen homeland defense.
The recipient intends to use these defense articles and services to modernize its armed forces and to expand its existing air defense architecture to counter threats posed by air attack. The recipient will have no difficulty absorbing this equipment into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractor involved in this program is Raytheon Missile Systems, Tucson, Arizona. The recipient normally requests industrial cooperation at forty percent, but at this time there are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will require visits to the recipient by twelve (12) U.S. Government or contractor representatives for a period of six (6) weeks (Non-concurrent).
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(viii)
1. The highest classification of the Stinger 92F Reprogrammable Micro-Processor (RMP) Block I Missile and Stinger Man-Portable Air Defense System (MANPADS) hardware is CONFIDENTIAL, and the highest classification of data and information is SECRET.
a. The Stinger RMP Block I Missile, hardware, embedded software object code and operating documentation contain sensitive technology and are classified CONFIDENTIAL. The guidance section of the missile and tracking head trainer contain highly sensitive technology and are classified CONFIDENTIAL. Missile System hardware components contain sensitive critical technologies. Stinger Block I critical technology is primarily in the area of design and production know-how and not end-items. This sensitive critical technology is inherent in the hybrid microcircuit assemblies; micro-processors; magnetic and amorphous metals; purification; firmware; printed circuit boards; laser roll rate sensor; dual detector assembly; detector filters; optical coatings; ultraviolet sensors; compounding and handling of electronic, electro-optic, and optical materials; test equipment operating instructions; energetic materials fabrication and loading technology; warhead components and seeker assembly. Information on countermeasures vulnerability to electronic countermeasures, system performance capabilities and effectiveness, simulation and test data and software source code are classified up to SECRET.
b. Loss of this hardware and/or data could permit development of information leading to the exploitation of countermeasures. Therefore, if a technologically capable adversary were to obtain missile hardware or associated development or production information, the missile system could be compromised through reverse engineering techniques which could defeat the weapon system's effectiveness.
2. All defense articles and services listed in this transmittal have been authorized for release and export to the recipient.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 15-27 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
* as defined in Section 47(6) of the Arms Export Control Act.
The Taipei Economic and Cultural Representative Office in the United States has requested the possible sale, refurbishment, and upgrade of two (2) Oliver Hazard Perry Class Frigates (FFG-7) being provided as Excess Defense Articles (EDA). Each vessel will be equipped with the MK-92 Mod 6 Fire Control System, the SQQ-89V(9) Anti-Submarine Warfare System, the MK-75 76mm Gun System, Phalanx 20mm Close-In-Weapon System (CIWS) (Block I B), MK-13 Guided Missile Launching System (GMLS), AN/SLQ-32 Electronic Warfare System, SPS-49 Radar, SQR-19 Towed Array Sonar, SQS-56 Sonar, spare and repair parts, publications and technical documentation, personnel training and training equipment, provisioning, system integration, U.S. Government and contractor logistics, engineering, and technical support services, and other related elements of logistics and program support. The estimated cost is $190 million.
This sale is consistent with United States law and policy as expressed in Public Law 96-8.
This proposed sale serves U.S. national, economic, and security interests by supporting the recipient's continuing efforts to modernize its armed forces and enhance its defensive capability. The proposed sale will help improve the security of the recipient and assist in maintaining political stability, military balance, and economic progress in the region.
The proposed sale will improve the recipient's capability in current and future defensive efforts. The recipient will use these ships to replace existing Knox Class destroyers which have reached the end of their useful service life. The EDA Oliver Hazard Perry Class Frigates (FFG-7) will be more sustainable, provide increased Anti-Submarine Warfare (ASW) capability as a deterrent to local threats, require less maintenance, and reduce life cycle support costs. The recipient will have no difficulty absorbing these ships and equipment into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractor will be selected through a competitive procurement conducted by the U.S. Government in accordance with the Federal Acquisition Regulation. The purchaser normally requests industrial cooperation at forty percent, but at this time there are no known offset agreements proposed in connection with this potential sale.
Implementation of this sale will not require the assignment of any additional U.S. Government personnel or contractor representatives to the recipient.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The equipment to be delivered with these Oliver Perry Class Frigates (FFG-7) is similar to the equipment currently on customer ships or in inventory. This includes Close-ln- Weapon System (CIWS) (Block IB), MK 75 76mm gun, MK 13 Guided Missile Launching System (GMLS) for their STANDARD Missile (SM-1) and Harpoon Block II missiles. MK 32 SVTT is an over-the-side launching system for light weight torpedoes. The Link 11 system provides data sharing capability with other platforms. Operational performance characteristics for CIWS, Harpoon, and the MK 75 gun are classified SECRET. With the exception of CIWS IB and Harpoon Block II, all other equipment being provided in this program is considered legacy technology within the U.S. Navy.
2. The SQQ-89V(9) Anti-Submarine Warfare (ASW) system is being introduced to customer inventory through this program. This system represents an upgrade in capability for the customer, which will enhance the recipient's ASW capabilities. The operating system software and operating manuals are both classified SECRET. Operational performance is classified SECRET. The technical and operational elements of this system, and any related data, are classified SECRET. The SQQ-89V(9) will result in the transfer of highly accurate ASW sensing and detection capability.
3. The technical and operational elements of these systems, and any related data, are classified to protect vulnerabilities, design and performance parameters, and similar critical information. Uncontrolled release of sensitive technological information on these systems could reveal capabilities and possible vulnerabilities.
4. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar advanced capabilities.
5. A determination has been made that the recipient can provide the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
6. All defense articles and services listed in this transmittal have been authorized for release and export to the recipient.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 15-44 with attached Policy Justification.
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
* as defined in Section 47(6) of the Arms Export Control Act.
The Taipei Economic and Cultural Representative Office in the United States has requested a possible sale of follow-on life cycle support to maintain the Multifunctional Information Distribution Systems Low Volume Terminals (MIDS/LVT-1) and Joint Tactical Information Distribution Systems (JTIDS) previously procured. The support will include spare and repair parts, support equipment, repair and return, publications and technical documentation, personnel training and training equipment, software and hardware updates, maintenance of a continental United States lab, U.S. Government and contracting engineering, logistics, and technical support services, and other related elements of program and logistics support. The estimated value is $120 million.
This sale is consistent with United States law and policy as expressed in Public Law 96-8.
This proposed sale serves U.S. national, economic, and security interests by supporting the recipient's continuing efforts to modernize its armed forces and enhance its defensive capability. The proposed sale will help improve the security of the recipient and assist in maintaining political stability, military balance, and economic progress in the region.
The proposed sale will enhance the recipient's operational readiness and maintenance of its existing systems. The support will improve and integrate the recipient's information flow and display of tactical aircraft, surface ships, and ground stations. The recipient will have no difficulty absorbing this support and equipment into its inventory.
The proposed sale of this equipment and support will not significantly alter the basic military balance in the region.
The principal contractor will be selected through a competitive procurement conducted by the U.S. Government in accordance with the Federal Acquisition Regulation. The purchaser normally requests industrial cooperation at forty percent, but at this time there are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will require multiple trips to the recipient involving U.S. Government and contractor representatives to participate in training, program management, and technical reviews.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 15-74 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
(iii)
Also included with this request are U.S. Government and contractor technical assistance, above the line transportation costs, and other related elements of logistics and program support.
(iv)
(v)
(vi)
(vii)
(viii)
* as defined in Section 47(6) of the Arms Export Control Act.
The Taipei Economic and Cultural Representative Office in the United States has requested a possible sale of two-hundred and eight (208) Javelin Guided Missiles; U.S. Government and contractor technical assistance, above the line transportation costs, and other related elements of logistics and program support. The estimated cost is $57 million.
This sale is consistent with United States law and policy as expressed in Public Law 96-8.
This proposed sale serves U.S. national, economic, and security interests by supporting the recipient's continuing efforts to modernize its armed forces and enhance its defensive capability. The proposed sale will help improve the security of the recipient and assist in maintaining political stability, military balance, and economic progress in the region.
The Javelin missile will provide the recipient with increased capacity to meet its coastal and homeland defense requirements. The recipient will have no difficulty absorbing this equipment into its armed forces.
The prime contractors will be Raytheon/Lockheed Martin Javelin Joint Venture of Orlando, Florida and Tucson, Arizona. The purchaser normally requests industrial cooperation at forty percent, but at this time there are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives to the recipient.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(viii)
1. The Javelin Weapon System is a medium-range, man-portable, shoulder-launched, fire-and-forget, anti-tank system for infantry, scouts, and combat engineers. It may also be mounted on a variety of platforms to include vehicles and watercraft. The system weighs 49.5 pounds and has a maximum range in excess of 2,500 meters. The system is highly lethal against tanks and other systems with conventional and reactive armors. The system possesses a secondary capability against bunkers.
2. Javelin's key technical feature is the use of fire-and-forget technology which allows the gunner to fire and immediately relocate or take cover. Additional special features are the top attack and/or direct fire modes, an advanced tandem warhead and imaging infrared seeker, target lock-on before launch, and soft launch from enclosures or covered fighting positions. The Javelin missile also has a minimum smoke motor thus decreasing its detection on the battlefield.
3. The missile is autonomously guided to the target using an imaging infrared seeker and adaptive correlation tracking algorithms.
4. The Javelin Missile System hardware and the documentation are UNCLASSIFIED. The missile software which resides in the Command Launch Unit (CLU) is considered sensitive. The sensitivity is primarily in the software programs which instruct the system how to operate in the presence of countermeasures. The overall hardware is also considered sensitive in that the infrared wavelengths could be useful in attempted countermeasure development. The benefits to be derived from the sale, as outlined in the policy justification of the notification, outweigh the potential damage that could result if sensitive technology was revealed to unauthorized persons.
5. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities. All defense articles and services listed in this transmittal have been authorized for release and export to the Taipei Economic and Cultural Representative Office in the United States.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-01 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
(iii)
Also included are the following non-MDE: Missile Support Equipment, Government-Furnished Equipment, Technical Manuals/Publications, Spare Parts, Tool and Test Equipment, Training, U.S. Government Technical
(iv)
(v)
(vi)
(vii)
(viii)
* as defined in Section 47(6) of the Arms Export Control Act.
The Taipei Economic and Cultural Representative Office in the United States has requested a possible sale of seven hundred sixty-nine (769) TOW 2B Aero Radio Frequency (RF) Missiles (BGM-71F-Series). This proposed sale also includes fourteen (14) Radio Frequency (RF) TOW 2B Aero (BGM-71F-Series) Fly-to-Buy Missiles for lot acceptance testing, forty-six (46) Improved Target Acquisition System (ITAS) Launchers, four (4) Improved Target Acquisition System (ITAS) Launcher spares, Missile support Equipment, Government-Furnished Equipment, Technical Manuals/Publications, Spare Parts, Tool and Test Equipment, Trainers, U.S. Government Technical Support/Integrated Logistical Support, Contractor Technical Support, and other associated equipment and services. The estimated cost is $268 million.
This sale is consistent with United States law and policy as expressed in Public Law 96-8.
This proposed sale serves U.S. national, economic, and security interests by supporting the recipient's continuing efforts to modernize its armed forces and enchance its defensive capability. The proposed sale will help improve the security of the recipient and assist in maintaining political stability, military, balance, and economic progress in the region.
The proposed sale of TOW 2B Missiles, ITAS Launchers, and technical support will advance the recipient's efforts to develop and integrated ground defense capability. A strong national defense and dedicated military force will assist the recipient in its efforts to maintain stability. The recipient will have no difficulty absorbing this equipment into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractor involved in this program is Raytheon Missile Systems (RMS) of Tucson, Arizona, and McKinney, Texas. The purchaser normally requests industrial cooperation at forty percent, but at this time there are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will require the U.S. Government or contractor representatives to travel to the recipient for multiple period of equipment de-processing/fielding, system checkout, and new equipment training. There will be no more than ten contractor personnel at any one time and all efforts will take less than 16 weeks in total.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The TOW 2B Aero Radio Frequency (RF) Missile (BGM-71F-3-RF) is a fly-over-shootdown missile designed to defeat armored vehicles. TOW missiles are fired from a variety of TOW Launchers in the U .S. Army, U.S. Marine Corps and Foreign Military Sales (FMS) customer forces. The TOW 2B Aero RF missile can be launched from the same launcher platforms as the existing wire-guided TOW 2B and TOW 2B Aero missiles without modification to the launcher. The TOW 2B missile (both wire & RF) contains two tracker beacons (xenon and thermal) for the launcher to track and guide the missile in flight. Guidance commands from the launcher are provided to the missile by an RF link contained within the missile case. Software for performance data, lethality penetration, and sensors are classified SECRET.
2. The Improved Target Acquisition System (ITAS) is designed to fire all existing versions of the TOW missile and consists of a Target Acquisition Subsystem (TAS), a Fire Control Subsystem (FCS), a Li-Ion Battery Box (LBB), a modified Traversing Unit (TU) plus the standard launch tube and tripod. The ITAS provides for the integration of both the direct view optics and a second generation Standard Advanced Dewar Assembly (SADA) II thermal sensor into a single housing; direct view optics that provide viewing the target scene in daylight and non-obscured conditions; introduction of both passive and active eye safe laser-ranging; development of embedded training and training sustainment; automatic bore sight which allows the gunner to align the night vision system with the direct view optics; insertion of advanced Built-In Test/Built-In Test Equipment (BIT/BITE) which provides fault detection and recognition and go/no go status for the gunner; and an Aided Target Tracker (ATT) that provides the capability to process infrared imagery into recognizable contour features used to assist the gunner's aim point.
3. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities. All defense articles and services listed in this transmittal have been authorized for release and export to the recipient.
Defense Security Cooperation Agency, DoD.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 15-72 with attached Policy Justification and Sensitivity of Technology.
(i)
Taipei Economic and Cultural Representative Office in the United States (TECRO)
(ii)
(iii)
Thirty-Six (36) Assault Amphibious Vehicles (AAVs)
Weapons
• Thirty (30) .50 Caliber M2 machine guns
• Six (6) 7.62mm M240 machine guns
Non-MDE included with this request are: Enhanced Armored Applique Kits (EAAK); spares; training; support and test equipment; publications; contractor engineering technical services; engineering technical services; logistical, training, engineering and program support; and other technical assistance.
(iv)
(v)
(vi)
(vii)
(viii)
The Taipei Economic and Cultural Representative Office in the United States has requested a possible sale of the following:
Thirty-Six (36) Assault Amphibious Vehicles (AAVs)
Weapons
• Thirty (30) .50 Caliber M2 machine guns
• Six (6) 7.62mm M240 machine guns
Non-MDE included with this request are: Enhanced Armored Applique Kits (EAAK); spares; weapons; training; support and test equipment; publications; contractor engineering technical services; engineering technical services; logistical, training, engineering and program support; and other technical assistance. The estimated MDE cost is $300 million. The total estimated cost is $375 million.
This sale is consistent with United States law and policy as expressed in Public Law 96-8.
This proposed sale serves U.S. national, economic, and security interests by supporting the recipient's continuing efforts to modernize its armed forces and enhance its defensive capability. The proposed sale will help improve the security of the recipient and assist in maintaining political stability, military balance, and economic progress in the region.
The proposed sale will improve the recipient's capability in current and future defensive efforts. The recipient will use these vehicles to augment existing vehicles and will have no difficulty absorbing these new vehicles into its armed forces.
The proposed sale of this equipment and support will not significantly alter the basic military balance in the region.
The prime contractor supporting the refurbishment has not been selected. The purchaser normally requests industrial cooperation at forty percent, but at this time there are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale should not require the permanent assignment of additional U.S. Government or contractor representatives to the recipient.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The Amphibious Assault Vehicles (AAV) Al Reliability Availability Maintainability (RAM) Rebuild to Standard (RS) Family of Vehicles (FOV) end items, trainers, and components are UNCLASSIFIED. The technical and operational elements of these systems, and any related data, are classified up to SECRET to protect vulnerabilities, design and performance parameters, and similar critical information.
2. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar advanced capabilities.
3. All defense articles and services listed in this transmittal have been authorized for release and export to the recipient.
Department of Defense, Defense Security Cooperation Agency.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 15-45 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
(iii)
Four (4) Multifunctional Information Distribution Systems (MIDS) On Ship Low Volume Terminals (LVTs)
Four (4) Command and Control Processor (C2P) units
Non-MDE items included are the installation and integration of Taiwan Advanced Tactical Data Link System (TATDLS) beyond line-of-sight datalink capability on six (6) Perry Class Frigates (PFG-2) and four (4) Lafayette Class (PFG-3) ships, up to ten (10) High Frequency Radios, and ten (10) Data Terminal Sets (DTSs). Also included are spare and repair parts; support equipment; communications equipment; maintenance support; personnel training and training equipment; publications and technical documentation; U.S. Government and contractor engineering and technical support services; and other related elements of logistics and program support.
(iv)
(v)
(vi)
(vii)
(viii)
*as defined in Section 47(6) of the Arms Export Control Act.
The Taipei Economic and Cultural Representative Office in the United States has requested a possible sale of four (4) Multifunctional Information Distribution Systems (MIDS) On Ship Low Volume Terminals (LVTs), and four (4) Command and Control Processor (C2P) units. Also included will be the installation and integration of Taiwan Advanced Tactical Data Link System (TATDLS) beyond line-of-sight datalink capability on six (6) Perry Class (PFG-2) and four (4) Lafayette Class (PFG-3) ships, up to ten (10) High Frequency Radios, ten (10) Data Terminal Sets (DTSs), spare and repair parts, support equipment, communications equipment, maintenance support, personnel training and training equipment, publications and technical documentation, U.S. Government and contractor engineering and technical support services, and other related elements of logistics and program support. The estimated value is $75 million.
This sale is consistent with United States law and policy as expressed in Public Law 96-8.
This proposed sale serves U.S. national, economic, and security interests by supporting the recipient's continuing efforts to modernize its armed forces and enhance its defensive capability. The proposed sale will help improve the security of the recipient and assist in maintaining political stability, military balance, and economic progress in the region.
The proposed sale will improve the recipient's capability in current and future defensive efforts. Under this case the recipient will update the existing Perry Class (PFG-2) (six ships) and Lafayette Class (PFG-3) (four ships) ships to match the configuration of ships updated under the Po Sheng and Syun An programs. Configuring the remaining ships to include TATDLS beyond line-of-sight datalink capability will allow data sharing capability with other platforms and improve the recipient's operational readiness for the systems provided under the previous Foreign Military Sales (FMS) cases. The recipient will have no difficulty absorbing this equipment into its armed forces.
The proposed sale of this equipment and support will not significantly alter the basic military balance in the region.
The principal contractor is unknown at this time and will be determined during contract negotiations. The purchaser normally requests industrial cooperation at forty percent, but at this time there are no known offset agreements proposed in connection with this potential sale.
It is estimated that during implementation of this proposed sale a number of U.S. Government and contractor representatives will be assigned to the recipient or travel there intermittently during the program.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The equipment to be delivered under this case has been provided previously under Po Sheng TW-P-GMK and Syun An TW-P-GNU and is currently used by the customer. The efforts under this case will lead to the remaining Perry Class (PFG-2) (six ships) and Lafayette Class (PFG-3) (four ships) ships having the same configuration as ships previously integrated under Po Sheng, TW-P-GMK and Syun An, TW-P-GNU cases. The ships will have Taiwan Advanced Tactical Data Link System (TATDLS) beyond line-of-sight datalink capability, which provides data sharing capability with other platforms. The equipment being provided under this case is considered legacy technology within the U.S. Navy.
2. The Multifunctional Information Distribution System (MIDS) On Ship Low Volume Terminal (LVT) hardware, publications, performance specifications, operational capability, parameters, vulnerabilities to countermeasures, and software documentation are classified CONFIDENTIAL. The classified information to be provided is necessary for the operation, maintenance, and repair (through intermediate level) of the data link terminal, installed systems, and related software. The recipient has previously received terminals under TW-P-GNU. Commercial Signal Message Processors (CSMPs) will be integrated into terminals provided. The operating system has CONFIDENTIAL software and operating elements; operating manuals are UNCLASSIFIED.
3. The Command and Control Processor (C2P) provided will be Model 4 or equivalent, which is considered legacy technology within the U.S. Navy. The operating system has CONFIDENTIAL software and operating elements; operating manuals are CONFIDENTIAL.
4. The technical and operational elements of these systems, and any related data, are classified to protect vulnerabilities, design and performance parameters, and similar critical information. Uncontrolled release of sensitive technological information on these systems could reveal capabilities and possible vulnerabilities, which could be detrimental to the U.S. Navy.
5. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar advanced capabilities.
6. All defense articles and services listed in this transmittal have been authorized for release and export to the recipient.
Energy Efficiency and Renewable Energy, Department of Energy.
Notice of Open Live Board Meeting.
This notice announces a Board meeting of the State Energy Advisory Board (STEAB). The Federal Advisory Committee Act (Public Law 92-463; 86 Stat. 770) requires that public notice of these meetings be announced in the
March 9th, 2016, 9:00 a.m. to 5:30 p.m.; March 10th, 2016, 9:00 a.m. to 3:30 p.m.
Renaissance Arlington Capital View Hotel, 2800 South Potomac Ave., Arlington, Virginia 22202 USA.
Michael Li, Policy Advisor, Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Ave. SW., Washington, DC 20585. Phone number 202-287-5189, and email
Office of Electricity Delivery and Energy Reliability, Department of Energy.
Notice of open meeting.
This notice announces an open meeting of the Electricity Advisory Committee. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the
Thursday, March 17, 2016 12:00 p.m.-6:00 p.m. EST.
Friday, March 18, 2016 8:00 a.m.-12:30 p.m. EST.
The meeting will be held at the National Rural Electric Cooperative Association, 4301 Wilson Blvd., Arlington, VA 22203.
Matthew Rosenbaum, Office of Electricity Delivery and Energy Reliability, U.S. Department of Energy, Forrestal Building, Room 8G-017, 1000 Independence Avenue SW., Washington, DC 20585; Telephone: (202) 586-1060 or Email:
The meeting agenda may change to accommodate EAC business. For EAC agenda updates, see the EAC Web site at:
You may submit comments, identified by “Electricity Advisory Committee Open Meeting,” by any of the following methods:
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•
•
•
The following electronic file formats are acceptable: Microsoft Word (.doc), Corel Word Perfect (.wpd), Adobe Acrobat (.pdf), Rich Text Format (.rtf), plain text (.txt), Microsoft Excel (.xls), and Microsoft PowerPoint (.ppt). If you submit information that you believe to be exempt by law from public disclosure, you must submit one complete copy, as well as one copy from which the information claimed to be exempt by law from public disclosure has been deleted. You must also explain the reasons why you believe the deleted information is exempt from disclosure.
DOE is responsible for the final determination concerning disclosure or nondisclosure of the information and for treating it in accordance with the DOE's Freedom of Information regulations (10 CFR 1004.11).
U.S. Energy Information Administration (EIA), Department of Energy.
30-Day Notice of Submission of Information Collection Approval from the Office of Management and Budget and Request for Comments.
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, EIA has submitted a Generic Information Collection Request (Generic ICR): “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'” to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
Comments must be submitted by March 14, 2016.
Written comments may be submitted to:
Requests for additional information should be directed to Jacob Bournazian, U.S. Energy Information Administration, 1000 Independence Avenue SW., Washington, DC 20585, phone: 202-586-5562, email:
Qualitative feedback means data that provide useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations. This feedback also provides an early warning of issues with service, or focuses attention on areas where communication, training or changes in operations might improve the accuracy of data reported on survey instruments or the delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.
Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
The 60-day notice was published in the
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.
Executive Order (EO) 13571, Streamlining Service Delivery and Improving Customer Service.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
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d.
e.
f.
g.
h.
i.
j. Deadline for filing comments, motions to intervene, and protests: March 8, 2015.
The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, or recommendations using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
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:
Take notice that on February 5, 2016, pursuant to sections 206 and 306 of the Federal Power Act
Dominion certifies that copies of the complaint were served on contacts for Respondent as listed on the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of answers, protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
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.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. Deadline for filing comments, motions to intervene, protests, and recommendations is March 9, 2016. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, or recommendations using the Commission's eFiling system at
k. Description of Request: The licensee requests Commission approval for a variance of the minimum pool requirement at Tioga Lake, which requires that the licensee maintain the lake level within two feet of the spillway or, in dry years, at its peak for the year from May 1 through September 30. In order to facilitate maintenance work on the grizzly and outlet works, the licensee requests Commission approval to begin draining the lake starting August 1, 2016, instead of the October 1 commencement date. The associated maintenance work would occur from September 6 to October 31, 2016, during which, the licensee would maintain natural flow through the outlet works.
l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE., Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's Web site at
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
o. Filing and Service of Responsive Documents: Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). All comments, motions to intervene, or protests should relate to project works which are the subject of the license surrender. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. If an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit an Information Collection Request (ICR) for on-highway motorcycle emissions certification and compliance” to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before April 12, 2016.
Submit your comments, referencing docket ID number OAR-2016-0027, to EPA online using EDOCKET (our preferred method), by email to
Julian Davis, Environmental Protection Agency, 2000 Traverwood, Ann Arbor MI 48105; telephone number: (734) 214-4029; fax number: (734) 214-4869; email address:
EPA has established a public docket for this ICR under Docket ID number OAR-2016-0027, which is available for public viewing at the Air and Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
(i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(ii) Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(iii) Enhance the quality, utility, and clarity of the information to be collected; and
(iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another
The current ICR for on-highway motorcycle emissions certification and compliance information is set to expire on September 30, 2016. This program was previously included under the current ICR for light-duty vehicle emissions certification and in-use testing [EPA ICR No. 0783.62, OMB Control No. 2060-0104].
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “Recordkeeping and Reporting Related to RFS2 Voluntary RIN Quality Assurance Program” (EPA ICR No. 2473.03, OMB Control No. 2060-0688)
Additional comments may be submitted on or before March 14, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2005-1121, to (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Geanetta Heard, Fuel Compliance Center, 64106J, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-343-9017; fax number: 202-565-2085; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Responsible Agency: Office of Federal Activities, General Information (202) 564-7146 or
Weekly receipt of Environmental Impact Statements (EISs), Filed 02/01/2016 Through 02/05/2016, Pursuant to 40 CFR 1506.9.
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “EPA's ENERGY STAR Program in the Commercial and Industrial Sectors” (EPA ICR No. 1772.07, OMB Control No. 2060-0347) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 14, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2006-0407, to (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Stephanie Klein, Climate Protection Partnerships Division, Mail Code: 6202A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-343-9144; fax number: 202-343-2204; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
To join ENERGY STAR, organizations are asked to complete a Partnership Letter or Agreement that establishes their commitment to energy efficiency. Partners agree to undertake efforts such as measuring, tracking, and benchmarking their organization's energy performance by using tools such as those offered by ENERGY STAR; developing and implementing a plan to improve energy performance in their facilities and operations by adopting a strategy provided by ENERGY STAR; and educating staff and the public about their Partnership with ENERGY STAR, and highlighting achievements with the ENERGY STAR, where available. In addition, Partners and any other interested party can evaluate the efficiency of their buildings using EPA's online tools (
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “Landfill Methane Outreach Program” (EPA ICR No. 1849.07 OMB Control No. 2060-0446) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 14, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2003-0078, to (1) EPA online
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Swarupa Ganguli, Climate Change Division, Office of Atmospheric Programs, 6207A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 343-9732; fax number: (202) 343-2342; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before April 12, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.
Office of the Secretary.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before April 12, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Frequency of Response: Recordkeeping requirement.
The amateur radio service governed by 47 CFR part 97 of the Commission's rules, provides spectrum for amateur radio service licensees to participate in a voluntary noncommercial communication service which provides emergency communications and allows experimentation with various radio techniques and technologies to further the understanding of radio use and the development of technologies.
The information collection is used to calculate the effective radiated power (ERP) that the station is transmitting to ensure that ERP does not exceed 100 W PEP.
Federal Communications Commission.
Notice.
In this document, the Commission declares the international section 214 authorization granted to ACT Telecommunications, Inc. (ACT) terminated given ACT's inability to comply with the express condition for holding the authorization. We also conclude that ACT failed to comply with those requirements of the Communications Act of 1934, as amended (the Act) and the Commission's rules that ensure that the Commission can contact and communicate with the authorization holder, which failures have prevented any way of addressing ACT's inability to comply with the condition of its authorization.
January 14, 2016.
Cara Grayer, Telecommunications and Analysis Division, International Bureau, at (202) 418-2960 or
This is a summary of the Commission's Order, DA 16-53, adopted and released January 14, 2016. On October 27, 2009, the International Bureau granted ACT an international section 214 authorization to provide global or limited global facility-based service and global or limited global resale service in accordance with section 63.18(e)(1) and 63.18(e)(2) of the Commission's rules. The International Bureau granted the application on the express condition that ACT abide by the commitments and undertakings contained in its Letter of Assurance (LOA) to the Department of Justice (DOJ) and the Department of Homeland Security (DHS, and with DOJ, the Executive Branch Agencies) dated October 20, 2009. On May 9, 2014, the Executive Branch Agencies notified the Commission of ACT's non-compliance with the conditions of its authorization and requested that the Commission terminate, and declare null and void and no longer in effect, the international section 214 authorization issued to ACT. We determine that ACT's international section 214 authorization to provide international services issued under File No. ITC-214-20081201-00519 has terminated for ACT's inability to comply with the LOA, an express condition for holding the section 214 international authorization. The International Bureau has provided ACT with notice and opportunity to respond to the allegations in the May 9, 2014 Executive Branch Letter concerning ACT's non-compliance with the condition of the grant. ACT has not responded to any of our multiple requests or requests from the Executive Branch Agencies. We find that ACT's failure to respond to our multiple requests demonstrates that it is unable to satisfy the LOA conditions concerning its 2012 and 2013 certifications, maintaining a current designated point of contact (POC), and providing timely notice of a change in ACT's POC status, upon which the Executive Branch Agencies gave their non-objection to the grant of the authorization to ACT, and which is a condition of the grant of its section 214 authorization.
Furthermore, after having received an international 214 authorization, a carrier “is responsible for the continuing accuracy of the certifications made in its application” and must promptly correct information no longer accurate, “and, in any event, within thirty (30) days.” ACT has failed to inform the Commission of any changes in its business status of providing international telecommunications services, as required by the rules. Nor is there any record of ACT having complied with section 413 of the Communications Act and the Commission's rules requiring it to designate an agent for service after receiving its authorization on October 27, 2009. Finally, as part of its authorization, ACT “must file annual international telecommunications traffic and revenue as required by section 43.62.” Section 43.62(b) states that “[n]ot later than July 31 of each year, each person or entity that holds an authorization pursuant to section 214 to provide international telecommunications service shall report whether it provided international telecommunications services during the preceding calendar year.” Our records indicate that ACT failed to file an annual international telecommunications traffic and revenue report indicating whether or not ACT provided services in 2014, as required by section 43.62(b) of the Commission's rules. In these circumstances, and in light of ACT's failure to respond to the Commission's rules designed to ensure its ability to communicate with the holder of the authorization also warrants termination wholly apart from demonstrating ACT's inability to satisfy the LOA conditions of its authorization.
By this Order, we grant the Executive Branch agencies' request to the extent set forth in this Order. A copy of this Order will be sent by return receipt requested to ACT at its last known addresses.
Further requests should be sent to Cara Grayer, Attorney, Telecommunications and Analysis Division, International Bureau via email at
Federal Communications Commission.
Notice.
In this document, the Federal Communications Commission's Wireless Telecommunications Bureau (Bureau) updated a list of nationwide providers qualified to bid on reserved spectrum in Auction 1002.
Kate Matraves, Wireless Telecommunications Bureau, 202-391-6272, email
This is a summary of the Bureau's Public Notice, DA No. 16-115, AU Docket No. 14-252, released February 2, 2016. The full text of this document, including the associated attachment, is available for inspection and copying from 8:00 a.m. to 4:30 p.m. ET Monday through Thursday or from 8:00 a.m. to 11:30 a.m. ET on Fridays in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. The complete text is also available on the Commission's Web site at
The
The Wireless Telecommunications Bureau is releasing the updated list as Attachment 1 to this Public Notice. These updates reflect recently approved transactions and certain corrections requested by Verizon Wireless and T-Mobile,
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than March 1, 2016.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
1.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices”. The guidance identifies the types of UHMWPE currently in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions for such devices. This draft guidance is not final nor is it in effect at this time.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 12, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• 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”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, 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.”
• 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
An electronic copy of the guidance document is available for download from the Internet. See the
Peter Allen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1512, Silver Spring, MD 20993-0002, 301-796-6402.
FDA is announcing the availability of a draft guidance for industry and FDA staff entitled “Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices”. FDA has developed this guidance document for members of industry who submit, and FDA staff who review, information regarding orthopedic devices using UHMWPE material. This guidance is intended to provide recommendations when finalized regarding the characterization and testing of orthopedic devices that use UHMWPE materials such as conventional UHMWPE, highly crosslinked UHMWPE, and highly crosslinked UHMWPE containing vitamin E. This document also outlines the information FDA recommends industry include in a submission to FDA to characterize the UHMWPE material (
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on UHMWPE used in orthopedic 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.
Persons interested in obtaining a copy of the draft 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
The guidance document “Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices” refers to previously approved information collections found in FDA regulations and guidance. 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 21 CFR part 807, subpart E, are approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 are approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814, subparts B and E, are approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H, are approved under OMB control number 0910-0332; and the collections of information in the guidance document entitled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” are approved under OMB control number 0910-0756.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an
Submit either electronic or written comments on the collection of information by April 12, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• 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”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, 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.”
• 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
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
In the
In the first year of implementing the program standards, the State program conducts a baseline self-assessment to determine if it meets the elements of each standard. The State program should use the worksheets and forms contained in the draft program standards; however, it can use alternate
FDA estimates the burden of this collection of information as follows:
The burden has been calculated as 750 hours per respondent. This burden was determined by capturing the average amount of time for each respondent to assess the current state of the program and work toward implementation of each of the 10 standards contained in MFRPS. The hours per respondent will change as accounted for in the continuing improvement and self-sufficiency of the program.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Request for Samples and Protocols” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On September 24, 2015, the Agency submitted a proposed collection of information entitled “Request for Samples and Protocols” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0206. The approval expires on December 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Cindy Hong at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On December 9, 2015, the Agency submitted a proposed collection of information entitled “Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0728. The approval expires on January 31, 2019. A copy of the supporting statement for this information collection is available on the Internet at
Food and Drug Administration, HHS.
Notice.
The invention listed in this document is owned by an Agency of the U.S. Government and is available for licensing in accordance with Federal regulations to achieve expeditious commercialization of results of Federally funded research and development.
Technology description.
The subject technology may offer an alternative to therapeutic NA inhibitors
• Prophylactic and therapeutic against influenza virus infections;
• Diagnostic tests for influenza virus infections; and
• Reagent to measure the potency of H1N1 NA in influenza virus vaccines.
• Monoclonal antibody demonstrated to be effective against circulating H1N1 influenza viruses;
• Monoclonal antibody binds a novel, conserved epitope spanning NA dimers; and
• Monoclonal antibody is well-suited for an antibody cocktail that includes anti-HA antibodies.
The Food and Drug Administration is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Parties interested in licensing or collaborative research activities for this technology should contact William Ronnenberg (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On July 8, 2015, the Agency submitted a proposed collection of information entitled “Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0045. The approval expires on December 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at
Food and Drug Administration, HHS.
Notice of public conference.
The Food and Drug Administration, in cosponsorship with the Pharmaceutical Users Software Exchange (PhUSE) is announcing a public conference entitled “The FDA/PhUSE Annual Computational Science Symposium.” The purpose of the conference is to help the broader community align and share experiences to advance computational science. At the conference, which will bring together FDA, industry, and academia, FDA will update participants on current initiatives, and collaborative project groups will address specific challenges in accessing and reviewing data to support product development. These project groups will focus on solutions and practical ways to implement them.
The meeting will be held on March 13, 2016, from 3 p.m. to 7 p.m., and March 14 to 15, 2016, from 9 a.m. to 5:30 p.m.
The meeting will be held at the Silver Spring Civic Building at Veterans Plaza, One Veterans Pl., Silver Spring, MD 20910, 1-240-777-5300.
Chris Decker, PhUSE FDA Liaison Director, Pharmaceutical Users Software Exchange (PhUSE), Kent Innovation Centre, Broadstairs, Kent CT10 2QQ, United Kingdom; 1-609-514-5105 (US),
Since 2008, the Office of Computational Science (formerly the Computational Science Center) of FDA's Center for Drug Evaluation and Research (CDER) has supported CDER's scientific community by offering innovative solutions that improve the scientific drug review process by integrating data, tools, services, and training. Since the first Computational Science Symposium four years ago, FDA has played an important part in the development and ongoing support of the conference and the associated PhUSE Computational Science Working Groups. The PhUSE Collaboration was formed to bring together experts from industry, FDA and other regulatory agencies, academia, and
All registrants (with the exception of a limited number of speakers and/or organizers who will have a complimentary registration) will pay a fee for this meeting to help defray the costs of facilities, materials, and food. Seats are limited, and registration will be on a first-come, first-served basis.
To register, please complete the registration form online at (
Government and nonprofit attendees and exhibitors will need an invitation code to register at the discounted rate. An invitation code can be obtained by sending an email to:
Attendees are responsible for their own hotel accommodations. Attendees making reservations at the DoubleTree by Hilton Silver Spring Hotel are eligible for a reduced rate of $189 not including applicable taxes. Those making reservations online should use the following link to receive the reduced rate:
If you need special accommodations because of disability, please contact Chris Decker (see
We expect that transcripts will be available approximately 30 days after the meeting. A transcript can be obtained either in hard copy or on CD-ROM, after submission of a Freedom of Information request. Send written requests to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Send faxed requests to 301-827-9267.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On October 21, 2015, the Agency submitted a proposed collection of information entitled “Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0429. The approval expires on December 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Coast Guard, DHS.
Notice of availability.
The Coast Guard announces the availability, in the docket, of a policy letter which provides voluntary guidance for the training of deck officers on vessels operating in polar waters. It recommends training measures that will achieve a higher level of safety for mariners working in this specialized polar environment. It is applicable to SOLAS vessels operating outside the boundary line and subject to the International Code for Ships Operating in Polar Waters (Polar Code). The draft policy letter and voluntary guidance would not apply to vessels on voyages that do not operate in areas subject to the Polar Code.
This policy letter is effective on February 12, 2016.
If you have questions about this document, contact Cathleen Mauro, Marine Personnel Qualifications Division (CG-OES-1), U.S. Coast Guard; telephone 202-372-1449, or
The policy letter is available in the docket and can be viewed by going to
Current shipping trends show an increase in the number of vessels regularly transiting remote polar areas. Vessels in polar waters experience unpredictable and poor weather conditions, degraded navigation tools, threats to operating equipment and increased stability concerns. In response to the challenges faced by these vessels and the concern for their safe operation, the International Maritime Organization (IMO) has adopted a mandatory code, the International Code for Ships Operating in Polar Waters, commonly referred to as the Polar Code. The Polar Code addresses safety and environmental requirements for vessels, as well as the level of training required for deck officers, and is expected to come into force on January 1, 2017.
In order to obtain input from U.S. stakeholders and to facilitate the development of the U.S. position at the IMO on the training requirements needed to support the Polar Code, the Merchant Marine Personnel Advisory Committee (MERPAC) chartered a working group in 2013 to address mariner training in support of the polar code. The working group developed a proposal that included the training competencies for U.S. mariners serving on ships operating in polar waters. The working group held multiple meetings and provided recommendations on minimum standards of competence, sea service, and recency requirements for polar training at the basic and advanced levels. The group also developed recommendations on how existing mariners with experience operating in polar waters would be grandfathered under the new requirements. MERPAC adopted the working group's recommendations, which provided the basis of the U.S. position regarding the relevant amendments to the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers (STCW Convention), 1978, as amended, and the Seafarers' Training, Certification and Watchkeeping Code (STCW Code). The STCW Convention and Code provide the international standards for seafarers.
Through the work of the IMO's Sub-committee on Human Element, Training and Watchkeeping (HTW), amendments to the STCW Convention and Code were developed to define the training requirements needed to support the implementation of the Polar Code. These amendments were approved by the Maritime Safety Committee on its Ninety Fifth Session (MSC 95), and are expected to be adopted by the IMO in July of 2016. The amendments are expected to enter into force on January 1, 2018.
Cognizant that there is a gap between the time the Polar Code enters into force on January 1, 2017 and the adoption of the amendments to the STCW Convention by IMO in July of 2016, the Coast Guard has developed a policy letter that recommends training guidelines for deck officers on vessels operating in polar waters. The Coast Guard is providing this guidance to
Recognizing that the operation of ships sailing in polar waters calls for specific education, training, experience and related qualifications for officers, Resolution 11 of the 2010 amendments to the STCW Convention included non-mandatory guidance on training for deck and engineer officers serving on ships operating in polar waters. The guidance is contained in Section B-V/g of the STCW Code. The training requirements of the Polar Code, however, go beyond what is addressed in Section B-V/g of the STCW Code, by utilizing a risk-assessment to addresses the applicability of different levels of training required for deck officers engaged on ships operating in polar waters. Chapter 12 of The Polar Code identifies the level of training required for deck officers on ships subject to the Polar Code taking into account the type of vessel and the ice conditions in the operating area. The levels of training are either Basic or Advanced Training for Ships Operating in Polar Waters. The interim guidance in this policy is based upon the amendments to the STCW Convention and Code supporting the mandatory training requirements in Chapter 12 of the Polar Code.
The requirements to meet the standards of competence for Basic or Advanced Training for Ships Operating in Polar Waters are defined in the STCW amendments supporting the Polar Code. A mariner may satisfy the standard of competence for Basic or Advanced Training in Polar Code Operations by meeting the respective sea service and training requirements prescribed in Enclosure (1) of the Policy Letter.
By meeting the basic or advanced training standard required by the Polar Code, mariners are also meeting the familiarization requirements of 46 CFR 15.405, which states that each credentialed mariner must be familiar with the relevant characteristics of the vessel appropriate to his or her duties and responsibilities prior to assuming those duties and responsibilities. On board a seagoing vessel, this responsibility rests with both the mariner and the employer as set forth in 46 CFR 15.1105, which requires mariners subject to STCW to complete familiarization training before performing any duty or being assigned any responsibility unless they are familiar with those duties and responsibilities and with all of the vessel's arrangements, installations, equipment, procedures, and characteristics relevant to his or her routine and emergency duties or responsibilities.
If training regulations are published, training completed to meet the requirements described in the policy letter may be evaluated on a case by case basis, and considered to meet part of the transitional provisions of the training requirements for Basic or Advanced Polar Waters Operations.
The guidance provided in this policy letter is voluntary, except where existing regulatory requirements are discussed. Although