| Page Range | 5029-5174 | |
| FR Document |
| Page and Subject | |
|---|---|
| 83 FR 5173 - National African American History Month, 2018 | |
| 83 FR 5171 - American Heart Month, 2018 | |
| 83 FR 5099 - Sunshine Act Meeting | |
| 83 FR 5099 - Sunshine Act Notice | |
| 83 FR 5037 - General Information, Regulations, and Definitions | |
| 83 FR 5141 - Government in the Sunshine Act Meeting Notice | |
| 83 FR 5146 - Sunshine Act Meeting Notice | |
| 83 FR 5029 - Marketing Order Regulating the Handling of Spearmint Oil Produced in the Far West; Revision of the Salable Quantity and Allotment Percentage for Class 3 (Native) Spearmint Oil for the 2017-2018 Marketing Year | |
| 83 FR 5059 - Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance | |
| 83 FR 5086 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; SEA and LEA Self-Assessment and Monitoring Protocol | |
| 83 FR 5056 - Amendments to Fireworks Regulations; Notice of Opportunity for Oral Presentation of Comments | |
| 83 FR 5155 - Proposed Collection; Comment Request | |
| 83 FR 5156 - Proposed Collection; Comment Request | |
| 83 FR 5063 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Haines Ferry Terminal Modification Project | |
| 83 FR 5110 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings | |
| 83 FR 5111 - National Institute of Mental Health; Notice of Closed Meetings | |
| 83 FR 5110 - National Institute of Mental Health; Notice of Closed Meetings | |
| 83 FR 5114 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings | |
| 83 FR 5113 - National Cancer Institute Amended Notice of Meeting | |
| 83 FR 5053 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Non-American Fisheries Act Crab Vessels Operating as Catcher Vessels Using Pot Gear in the Western Regulatory Area of the Gulf of Alaska | |
| 83 FR 5099 - Appraisal Subcommittee; Notice of Meeting | |
| 83 FR 5076 - Applications for New Awards; Native American Career and Technical Education Program | |
| 83 FR 5118 - Notice of Issuance of Final Determinations Concerning Certain Pharmaceutical Products | |
| 83 FR 5139 - Notice of Issuance of Final Determination Concerning Certain Ethernet Switch Products | |
| 83 FR 5092 - Combined Notice of Filings | |
| 83 FR 5094 - Watterra Energy, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
| 83 FR 5090 - Hydrodyne Industries, LLC; Hydrodyne Energy, LLC; Notice of Transfer of Exemption | |
| 83 FR 5090 - Notice of Commissioner and Staff Attendance at North American Electric Reliability Corporation Meetings | |
| 83 FR 5096 - Grid Power Direct, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 83 FR 5104 - Submission for OMB Review; Comment Request | |
| 83 FR 5087 - Tests Determined To Be Suitable for Use in the National Reporting System for Adult Education | |
| 83 FR 5061 - Atlantic Highly Migratory Species; Atlantic Shark Management Measures; 2018 Research Fishery | |
| 83 FR 5052 - Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pollock in the Bering Sea and Aleutian Islands | |
| 83 FR 5107 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug Adverse Event Reporting and Recordkeeping | |
| 83 FR 5144 - Carbon and Certain Alloy Steel Wire Rod From South Africa and Ukraine; Supplemental Schedule for the Subject Investigations | |
| 83 FR 5076 - Agency Information Collection Activities; Comment Request; Teacher Education Assistance for College and Higher Education Grant Program (TEACH Grant Program) Agreement To Serve | |
| 83 FR 5147 - Submission for Review: Designation of Beneficiary (FERS), Standard Form 3102 | |
| 83 FR 5095 - Water Facilities Authority a Joint Power Agency; Notice of Application for Surrender of Exemption, Soliciting Comments, Motions To Intervene, and Protests | |
| 83 FR 5090 - Brookfield White Pine Hydro LLC; Notice of Intent To File License Application, Filing of Pre-Application Document (PAD), Commencement of Pre-Filing Process, and Scoping; Request for Comments on the PAD and Scoping Document, and Identification of Issues and Associated Study Requests | |
| 83 FR 5094 - Oklahoma Municipal Power Authority v. Oklahoma Gas and Electric Company; Notice of Complaint | |
| 83 FR 5096 - Combined Notice of Filings | |
| 83 FR 5092 - Combined Notice of Filings #1 | |
| 83 FR 5088 - Combined Notice of Filings #1 | |
| 83 FR 5073 - Agency Information Collection Activities; Proposed Collection; Comment Request; CPSC Playground Surfaces Survey | |
| 83 FR 5102 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 83 FR 5165 - Agency Information Collection Activity: VSO Access to VHA Electronic Health Records | |
| 83 FR 5167 - Agency Information Collection Activity Under OMB Review: Notice of Waiver of Compensation or Pension To Receive Military Pay and Allowances | |
| 83 FR 5164 - Agency Information Collection Activity Under OMB Review: Designation of Certifying Official | |
| 83 FR 5165 - Agency Information Collection Activity Under OMB Review: Application for Change of Permanent Plan-Medical | |
| 83 FR 5164 - Agency Information Collection Activity Under OMB Review: Application for Conversion | |
| 83 FR 5167 - Agency Information Collection Activity Under OMB Review: Insurance Deduction Authorization | |
| 83 FR 5166 - Agency Information Collection Activity under OMB Review: Application For Dependency and Indemnity Compensation by Parent(s) (Including Accrued Benefits and Death Compensation when Applicable) | |
| 83 FR 5113 - National Heart, Lung, and Blood Institute Notice of Meeting | |
| 83 FR 5074 - Proposed Collection; Comment Request | |
| 83 FR 5109 - Meetings Announcement for the Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) | |
| 83 FR 5060 - Raw Flexible Magnets From the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2016 | |
| 83 FR 5055 - Request for Information Regarding Bureau Rules of Practice for Adjudication Proceedings | |
| 83 FR 5075 - Policy and Procedural Guidance for Processing Requests To Alter U.S. Army Corps of Engineers Civil Works Projects Pursuant to Section 408 | |
| 83 FR 5103 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 83 FR 5101 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 83 FR 5037 - Migratory Bird Hunting; Migratory Bird Hunting Regulations on Certain Federal Indian Reservations and Ceded Lands for the 2017-18 Season | |
| 83 FR 5033 - Medical Devices; Neurological Devices; Classification of the Percutaneous Nerve Stimulator for Substance Use Disorders | |
| 83 FR 5146 - OMB Approval of Information Collection; Missing Participants | |
| 83 FR 5097 - Federal Advisory Committee Act; Technological Advisory Council | |
| 83 FR 5057 - Petitions for Reconsideration of Action in Rulemaking Proceeding | |
| 83 FR 5097 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 83 FR 5145 - Agency Information Collection Activities; Proposed Collection; Comments Requested; Fee Waiver Request | |
| 83 FR 5157 - 60-Day Notice of Proposed Information Collection: Advance Notification Form; Tourist and Other Non-Governmental Activities in the Antarctic Treaty Area | |
| 83 FR 5158 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Michelangelo and the Vatican: Masterworks From the Museo e Real Bosco di Capodimonte, Naples” Exhibition | |
| 83 FR 5159 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Icons of Style: A Century of Fashion Photography, 1911-2011” Exhibition | |
| 83 FR 5158 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Peacock in the Desert: The Royal Arts of Jodhpur, India” Exhibition | |
| 83 FR 5105 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIBERZI | |
| 83 FR 5168 - Veterans' Family, Caregiver, and Survivor Advisory Committee; Notice of Meeting | |
| 83 FR 5058 - Notice of Public Meeting of the Indiana Advisory Committee to the U.S. Commission on Civil Rights | |
| 83 FR 5114 - National Institute of Environmental Health Sciences; Amended Notice of Meeting | |
| 83 FR 5059 - Proposed Information Collection; Comment Request; Request for the Appointment of a Technical Advisory Committee | |
| 83 FR 5106 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability; Correction | |
| 83 FR 5145 - Meeting of the Judicial Conference Advisory Committee on Rules of Evidence | |
| 83 FR 5145 - Meeting of the Judicial Conference Advisory Committee on Rules of Criminal Procedure | |
| 83 FR 5142 - Certain Magnetic Tape Cartridges and Components Thereof; Notice of Request for Statements on the Public Interest | |
| 83 FR 5141 - Certain Graphics Processors and Products Containing the Same Institution of Investigation | |
| 83 FR 5143 - Rubber Bands From China, Sri Lanka, and Thailand; Institution of Antidumping and Countervailing Duty Investigations and Scheduling of Preliminary Phase Investigations | |
| 83 FR 5159 - U.S. Department of State Advisory Committee on Private International Law (ACPIL): Public Meeting in Advance of Meeting of United Nations Commission on International Trade Law (UNCITRAL) Working Group I-Micro, Small, and Medium-Sized Enterprises | |
| 83 FR 5158 - U.S. Department of State Advisory Committee on Private International Law (ACPIL): Public Meeting on Online Dispute Resolution | |
| 83 FR 5117 - Notice of Meeting | |
| 83 FR 5116 - Notice of Meeting | |
| 83 FR 5154 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Relocate the Consolidated Audit Trail Compliance Rules | |
| 83 FR 5151 - Gadsden ETF Trust and Gadsden, LLC | |
| 83 FR 5153 - Columbia Funds Series Trust, et al. | |
| 83 FR 5148 - Janney Montgomery Scott LLC; Notice of Application | |
| 83 FR 5062 - Submission for OMB Review; Comment Request | |
| 83 FR 5061 - Submission for OMB Review; Comment Request | |
| 83 FR 5099 - Notice to All Interested Parties of Intent To Terminate the Receivership of 10424, Charter National Bank and Trust, Hoffman Estates, Illinois | |
| 83 FR 5100 - Notice of Scoping Meeting and Intent To Prepare a Supplemental Environmental Impact Statement (SEIS) for the Madawaska-Edmundston International Bridge and New Land Port of Entry (LPOE) Project | |
| 83 FR 5051 - Pacific Island Fisheries; 2017 Hawaii Kona Crab Annual Catch Limit and Accountability Measure | |
| 83 FR 5159 - Notice of OFAC Sanctions Actions | |
| 83 FR 5147 - National Strategic Plan for Advanced Manufacturing | |
| 83 FR 5035 - Special Local Regulation; Black Warrior River; Tuscaloosa, AL | |
| 83 FR 5166 - Publication of Choice Act Section 201 Independent Assessments and Report-Change of Website Location | |
| 83 FR 5113 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting | |
| 83 FR 5112 - National Cancer Institute; Notice of Closed Meetings | |
| 83 FR 5110 - National Cancer Institute; Amended Notice of Meeting | |
| 83 FR 5111 - Center for Scientific Review; Notice of Closed Meetings | |
| 83 FR 5115 - Center for Scientific Review; Notice of Closed Meetings | |
| 83 FR 5112 - Center for Scientific Review; Amended Notice of Meeting | |
| 83 FR 5160 - Notice of OFAC Sanctions Actions | |
| 83 FR 5062 - Science Advisory Board | |
| 83 FR 5096 - Termination of Dormant Proceedings |
Agricultural Marketing Service
Economic Development Administration
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Engineers Corps
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
U.S. Customs and Border Protection
Fish and Wildlife Service
Pipeline and Hazardous Materials Safety Administration
Foreign Assets Control Office
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Agricultural Marketing Service, USDA.
Final rule.
This rule implements a recommendation from the Far West Spearmint Oil Administrative Committee (Committee) to revise the quantity of Class 3 (Native) spearmint oil that handlers may purchase from, or handle on behalf of, producers during the 2017-2018 marketing year, which began on June 1, 2017. This rule increases the Native spearmint oil salable quantity and the allotment percentage. This rule also contains formatting changes to subpart references to bring the language into conformance with the Office of Federal Register requirements.
Effective February 6, 2018.
Barry Broadbent, Marketing Specialist, or Gary D. Olson, Regional Director, Northwest Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (503) 326-2724, Fax: (503) 326-7440, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202)720-8938, or Email:
This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Order No. 985 (7 CFR part 985), as amended, regulating the handling of spearmint oil produced in the Far West (Washington, Idaho, Oregon, and designated parts of Nevada and Utah). Part 985 (referred to as “the Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Marketing Order and is comprised of spearmint oil producers operating within the area of production, and a public member.
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the provisions of the Order now in effect, salable quantities and allotment percentages may be established for classes of spearmint oil produced in the Far West. This rule increases the quantity of Native spearmint oil produced in the Far West that handlers may purchase from, or handle on behalf of, producers during the 2017-2018 marketing year, which ends on May 31, 2018.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This final rule revises the quantity of Native spearmint oil that handlers may purchase from, or handle on behalf of, producers during the 2017-2018 marketing year under the Order. The salable quantity and allotment percentage for Native spearmint oil was initially established at 1,075,051 pounds and 44 percent, respectively, in a final rule published May 25, 2017 (82 FR 24001). This rule increases the Native spearmint oil salable quantity from 1,075,051 pounds to 1,514,902 pounds and the allotment percentage from 44 percent to 62 percent.
Under the volume regulation provisions of the Order, the Committee meets each year to adopt a marketing policy for the ensuing year. When the Committee's marketing policy considerations indicate a need for limiting the quantity of spearmint oil available to the market to establish or maintain orderly marketing conditions, the Committee submits a recommendation to the Secretary of Agriculture for volume regulation.
Volume regulation under the Order is effectuated through the establishment of a salable quantity and allotment percentage applicable to each class of spearmint oil handled in the production area during a marketing year. The salable quantity is the total quantity of each class of oil that handlers may purchase from, or handle on behalf of, producers during a given marketing year. The allotment percentage for each class of oil is derived by dividing the salable quantity by the total industry allotment base for that same class of oil. The total industry allotment base is the aggregate of all allotment base held individually by producers. Producer allotment base is the quantity of each class of spearmint oil that the Committee has determined is
The full Committee met on October 19, 2016, to consider its marketing policy for the 2017-2018 marketing year. At that meeting, the Committee determined that marketing conditions indicated a need for volume regulation of both classes of spearmint oil for the 2017-2018 marketing year. The Committee recommended salable quantities of 774,645 pounds and 1,075,051 pounds, and allotment percentages of 36 percent and 44 percent, respectively, for Scotch and Native spearmint oil. A proposed rule to that effect was published in the
Pursuant to authority contained in §§ 985.50, 985.51, and 985.52, the full eight-member Committee met again on September 25, 2017, and October 25, 2017, to evaluate the current year's volume control regulation. At the meetings, the Committee assessed the current market conditions for spearmint oil in relation to the salable quantities and allotment percentages established for the 2017-2018 marketing year. The Committee considered a number of factors, including the current and projected supply, estimated future demand, production costs, and producer prices for all classes of spearmint oil. The Committee determined that the established salable quantity and allotment percentage in effect for Native spearmint oil for the 2017-2018 marketing year should be increased to take into account the unanticipated rise in market demand for that class of spearmint oil.
At the September 25, 2017, meeting, the Committee recommended increasing the 2017-2018 marketing year Native spearmint oil salable quantity from 1,075,051 pounds to 1,221,696 pounds and the allotment percentage from 44 percent to 50 percent. The recommendation to increase the salable quantity and allotment percentage passed with a vote of seven members in favor and one opposed. The member opposed to the recommendation favored increasing the Native spearmint oil salable quantity and allotment percentage for the 2017-2018 marketing year, but at an undetermined level lower than what was recommended.
At the October 25, 2017, meeting, the Committee met again to consider an additional increase to the 2017-2018 marketing year salable quantity and allotment percentage for Native spearmint oil. The Committee recommended further increasing the 2017-2018 marketing year Native spearmint oil salable quantity from 1,221,696 pounds to 1,514,902 pounds and the allotment percentage from 50 percent to 62 percent. The recommendation to further increase the salable quantity and allotment percentage passed with a unanimous vote.
This action makes additional amounts of Native spearmint oil available to the market by increasing the salable quantity and allotment percentage previously established under the Order for the 2017-2018 marketing year. This rule increases the Native spearmint oil salable quantity by 439,851 pounds, to 1,514,902 pounds, and raises the allotment percentage 18 percentage points, to 62 percent. Such additional oil will come from releasing Native spearmint oil held by producers in the reserve pool. As of May 31, 2017, the Committee records show that the reserve pool for Native spearmint oil contained 996,050 pounds of oil, an amount considered excessive relative to market conditions.
At both the September and October 2017 meetings, the Committee staff reported that demand for Native spearmint oil has been greater than previously anticipated. Committee records indicate that 2017-2018 marketing year sales to date (945,683 pounds) are tracking fairly closely to sales for the same period in the 2016-2017 marketing year (1,095,112 pounds). However, handlers reported to the Committee that an additional 345,446 pounds of Native spearmint oil are committed to be sold, which would leave a deficit of 216,078 pounds of oil (1,075,051 pounds salable quantity minus 945,683 pounds sold to date and 345,446 pounds committed) to supply the market until May 31, 2018. Another factor that contributed to the short supply was that only 143,011 pounds of salable product carried over from the 2016-2017 marketing year into the 2017-2018 marketing year, which was 46,809 pounds less than expected. The Committee initially estimated in October 2016 that the total available supply of Native spearmint oil for the 2017-2018 marketing year would be 1,264,871 pounds, but that amount was reduced to 1,218,158 when the smaller carry-in quantity is accounted for.
The Committee initially estimated the trade demand for Native spearmint oil for the 2017-2018 marketing year to be 1,250,000. At the September 25, 2017, meeting, the Committee revised the expected trade demand for the 2017-2018 marketing year to be 1,338,820. At the October 25, 2017, meeting, the Committee further revised the expected trade demand for the 2017-2018 marketing year to 1,600,000 pounds. If realized, trade demand would be 381,842 pounds above the quantity of Native spearmint oil available under the volume control levels implemented in May 2017 (1,218,158 pounds available prior to this rule minus 1,600,000 pounds estimated demand equals a deficit of 381,842 pounds). Without increasing the salable quantity and allotment percentage, the market for Native spearmint oil may be shorted. The increased quantity of Native spearmint oil (439,851 pounds) that will be made available to the market as a result of this rulemaking will ensure that market demand is fully satisfied in the current year and that there would be approximately 20,171 pounds of Native spearmint oil salable inventory available to the market for the start of the 2018-2019 marketing year, which begins on June 1, 2018.
In making the recommendation to increase the salable quantity and allotment percentage of Native spearmint oil, the Committee considered all currently available information on the price, supply, and demand of Native spearmint oil. The Committee also considered reports and other information from handlers and producers in attendance at the meeting. Lastly, the Committee manager presented information and reports that were provided to the Committee staff by handlers and producers.
This rule increases the 2017-2018 marketing year Native spearmint oil salable quantity by 439,851 pounds, to a total of 1,514,902 pounds. However, the Committee expects that not all producers have Native spearmint oil held in reserve. As such, the Committee calculates that 37,796 pounds of the Native spearmint oil salable quantity will go unfulfilled. Therefore, the total supply of Native spearmint oil that the Committee anticipates actually being available to the market over the course of the 2017-2018 marketing year will be increased to 1,620,117 pounds (2017-2018 marketing year salable quantity plus salable carry-in of 143,011 pounds
The Committee estimates that this action will result in 20,171 pounds of salable Native spearmint oil being carried into the 2018-2019 marketing year. While 20,171 pounds is a relatively low quantity of salable Native spearmint oil to end the marketing year, reserve pool oil could be released into the market under a future relaxation of the volume regulation should it be necessary to adequately supply the market prior to the beginning of the 2018-2019 marketing year. The Committee estimates that a total of 1,237,237 pounds of Native spearmint oil will be available from the reserve pool if needed.
As mentioned previously, when the original 2017-2018 marketing policy statement was drafted, handlers estimated the demand for Native spearmint oil for the 2017-2018 marketing year to be 1,250,000 pounds. The Committee's initial recommendation for the establishment of the Native spearmint oil salable quantity and allotment percentage for the 2017-2018 marketing year was based on that estimate. The Committee did not anticipate the increase in demand for Native spearmint oil that the market is currently experiencing and did not make allowances for it when the marketing policy was initially adopted.
At the September 25, 2017, meeting, the Committee revised its estimate of the current trade demand to 1,338,820 pounds, and further increased that estimate to 1,600,000 pounds at the October 25, 2017, meeting. The Committee now believes that the supply of Native spearmint oil available to the market under the initially established salable quantity and allotment percentage will be insufficient to satisfy the current level of demand for oil at reasonable price levels. The Committee further believes that the increase in the salable quantity and allotment percentage is vital to ensuring an adequate supply of Native spearmint oil is available to the market moving forward.
The Committee's stated intent in the use of the Order's volume control regulation is to keep adequate supplies available to meet market needs and to maintain orderly marketing conditions. With that in mind, the Committee developed its recommendation for increasing the Native spearmint oil salable quantity and allotment percentage for the 2017-2018 marketing year based on the information discussed above, as well as the summary data outlined below.
(A) Initial estimated 2017-2018 Native Allotment Base—2,443,297 pounds. This is the allotment base estimate on which the original 2017-2018 salable quantity and allotment percentage was based.
(B) Revised 2017-2018 Native Allotment Base—2,443,391 pounds. This is 94 pounds more than the initial estimated allotment base of 2,443,297 pounds. The difference is the result of annual adjustments made to the allotment base according to the provisions of the Order.
(C) Initial 2017-2018 Native Allotment Percentage—44 percent. This was unanimously recommended by the Committee on October 19, 2016.
(D) Initial 2017-2018 Native Salable Quantity—1,075,051 pounds. This figure is 44 percent of the original estimated 2017-2018 allotment base of 2,443,297 pounds.
(E) Adjusted Initial 2017-2018 Native Salable Quantity—1,075,092 pounds. This figure reflects the salable quantity actually available at the beginning of the 2017-2018 marketing year. This quantity is derived by applying the initial 44-percent allotment percentage to the revised allotment base of 2,443,391.
(F) Revision to the 2017-2018 Native Salable Quantity and Allotment Percentage:
(1) Increase in the Native Allotment Percentage—18 percent. The Committee recommended an increase of six percentage points at its September 25, 2017, meeting, and a further 12 percentage points at its October 25, 2017, meeting for a total increase of 18 percentage points over the initial Native allotment percentage.
(2) Revised 2017-2018 Native Allotment Percentage—62 percent. This number was derived by adding the increase of 18 percentage points to the initially established 2017-2018 allotment percentage of 44 percent.
(3) Revised 2017-2018 Native Salable Quantity—1,514,902 pounds. This amount is 62 percent of the revised 2017-2018 allotment base of 2,443,391 pounds.
(4) Computed Increase in the 2017-2018 Native Salable Quantity as a Result of the Revision—439,851 pounds. This figure represents 18 percent of the 2017-2018 revised allotment base.
(5) Expected Actual Increase in the Native Spearmint Oil Available to the Market for the 2017-2018 Marketing Year—402,055 pounds. This amount is based on the Committee's estimation of Native spearmint oil that is actually held by producers in the reserve pool that may enter the market as a result of this action. The Committee estimates that approximately 37,796 pounds of the computed increase will go unfulfilled due to producers who do not have sufficient Native spearmint oil in reserve to utilize their full allotted salable quantity.
Scotch spearmint oil is also regulated by the Order. As mentioned previously, a salable quantity and allotment percentage for Scotch spearmint oil was established in a final rule published in the
This rule relaxes the regulation of Native spearmint oil and allows producers to meet market demand while improving producer returns. In conjunction with the issuance of the proposed rule, the Committee's revised marketing policy statement for the 2017-2018 marketing year has been reviewed by USDA. The Committee's marketing policy statement, a requirement whenever the Committee recommends implementing volume regulations or recommends revisions to existing volume regulations, meets the intent of § 985.50. During its discussion of revisions to the 2017-2018 salable quantities and allotment percentages, the Committee considered: (1) The estimated quantity of salable oil of each class held by producers and handlers; (2) the estimated demand for each class of oil; (3) the estimated production of each class of oil; (4) the total of allotment bases of each class of oil for the current marketing year and the estimated total of allotment bases of each class for the ensuing marketing year; (5) the quantity of reserve oil, by class, in storage; (6) producer prices of oil, including prices for each class of oil; and (7) general market conditions for each class of oil, including whether the estimated season average price to producers is likely to exceed parity. Conformity with USDA's “Guidelines for Fruit, Vegetable, and Specialty Crop
The increase in the Native spearmint oil salable quantity and allotment percentage will account for the anticipated market needs for that class of oil. In determining anticipated market needs, the Committee considered changes and trends in historical sales, production, and demand.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are eight spearmint oil handlers subject to regulation under the Order, and approximately 41 producers of Scotch spearmint oil and approximately 94 producers of Native spearmint oil in the regulated production area. Small agricultural service firms are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000 (13 CFR 121.201).
Based on the SBA's definition of small entities, the Committee estimates that only two of the eight handlers regulated by the Order could be considered small entities. Most of the handlers are large corporations involved in the international trading of essential oils and the products of essential oils. In addition, the Committee estimates that 12 of the 39 Scotch spearmint oil producers and 31 of the 94 Native spearmint oil producers could be classified as small entities under the SBA definition. Thus, the majority of handlers and producers of Far West spearmint oil may not be classified as small entities.
The use of volume control regulation allows the spearmint oil industry to fully supply spearmint oil markets while avoiding the negative consequences of over-supplying these markets. Without volume control regulation, the supply and price of spearmint oil would likely fluctuate widely. Periods of oversupply could result in low producer prices and a large volume of oil stored and carried over to future crop years. Periods of undersupply could lead to excessive price spikes and drive end users to source flavoring needs from other markets, potentially causing long-term economic damage to the domestic spearmint oil industry. The Order's volume control provisions have been successfully implemented in the domestic spearmint oil industry since 1980 and provide benefits for producers, handlers, manufacturers, and consumers.
This final rule increases the quantity of Native spearmint oil that handlers may purchase from, or handle on behalf of, producers during the 2017-2018 marketing year, which ends May 31, 2018. The 2017-2018 Native spearmint oil salable quantity was initially established at 1,075,051 pounds and the allotment percentage initially set at 44 percent. This final rule increases the Native spearmint oil salable quantity to 1,514,902 pounds and the allotment percentage to 62 percent.
Based on the information and projections available at the September 25, 2017, and October 25, 2017, meetings, the Committee considered several alternatives to this increase. The Committee considered leaving the salable quantity and allotment percentage unchanged, and also considered other potential levels of increase. The Committee reached its recommendation to increase the salable quantity and allotment percentage for Native spearmint oil after careful consideration of all available information and input from all interested industry participants, and believes that the levels recommended will achieve the desired objectives. Without this increase, the Committee believes the industry will not be able to satisfactorily meet market demand.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178 (Generic Specialty Crops). No changes are necessary in those requirements as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.
This rule relaxes the volume regulation requirements established under the Order. Accordingly, this action will not impose any additional reporting or recordkeeping requirements on either small or large spearmint oil handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this final rule.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
In addition, the Committee's meeting was widely publicized throughout the Far West spearmint oil industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. The September 25, 2017, and October 25, 2017, meetings were public and all entities, both large and small, were able to express views on this issue.
A proposed rule concerning this action was published in the
Ten comments were received from nine commenters in response to the proposed rule. All ten comments were in support of the proposed increase in the salable quantity and allotment percentage. Two of the comments, in addition to supporting the action, also voiced strong interest in USDA effectuating this increase as soon as possible. Accordingly, no changes will be made to the rule as proposed, based on the comments received.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
It is further found that good cause exists for not postponing the effective date of this rule until 30 days after publication in the
Marketing agreements, Oils and fats, Reporting and recordkeeping requirements, Spearmint oil.
For the reasons set forth in the preamble, 7 CFR part 985 is amended as follows:
7 U.S.C. 601-674.
(b) Class 3 (Native) oil—a salable quantity of 1,514,902 pounds and an allotment percentage of 62 percent.
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA or we) is classifying the percutaneous nerve stimulator for substance use disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the percutaneous nerve stimulator for substance use disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
This order is effective February 5, 2018. The classification was applicable on November 15, 2017.
Eric Franca, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2684, Silver Spring, MD 20993-0002, 301-796-6285,
Upon request, FDA has classified the percutaneous nerve stimulator for substance use disorders as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On March 17, 2017, Innovative Health Solutions, Inc., submitted a request for De Novo classification of the NSS-2 BRIDGE. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on November 15, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.5896. We have named the generic type of device percutaneous nerve stimulator for substance use disorders, and it is identified as a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).
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 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 the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; 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.
Medical devices, Neurological devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
(3) Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Sterility testing of the percutaneous components of the device must be performed.
(6) Shelf life testing must be performed to demonstrate continued
(7) Labeling must include the following:
(i) A detailed summary of the device technical parameters;
(ii) A warning stating that the device is only for use on clean, intact skin;
(iii) Instructions for use, including placement of the device on the patient; and
(iv) A shelf life.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary special local regulation on the Black Warrior River extending the entire width of the river from mile marker 339.0 to mile marker 341.5 in Tuscaloosa, AL. The special local regulation is needed to protect the persons participating in the NCAA Collegiate Rowing Competition marine event. Entry into, transiting through, or exiting from this regulated area is prohibited unless specifically authorized by the Captain of the Port Sector Mobile, or a designated representative.
This rule is effective from 6 a.m. until noon on February 24, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Lieutenant Kyle D. Berry, Sector Mobile, Waterways Management Division, U.S. Coast Guard; telephone 251-441-5940, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The event sponsors have informed the U.S. Coast Guard that a marine event will occur on February 24, 2018. After gathering all necessary information, including safety needs related to this event, the Coast Guard determined that this special local regulation is necessary for this event. It is impracticable to publish an NPRM because we must establish this special local regulation by February 24, 2018 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The Captain of the Port Sector Mobile (COTP) has determined that potential hazards associated with the rowing event on February 24, 2018 will be a safety concern for anyone within the area of the Black Warrior River between mile markers 339.0 and 341.5. This rule is needed to protect participants, spectators, and other persons and vessels during the rowing event on navigable waters.
This rule establishes a special local regulation on February 24, 2018, which will be enforced between the 6 a.m. and noon. The special local regulation takes place on the Black Warrior River between mile markers 339.0 and 341.5, extending the entire width of the navigable channel. The duration of the regulation is intended to protect participants, spectators, and other persons and vessels before, during, and after the rowing event. No vessel or person will be permitted to enter into, transit through, or exist the regulated area without obtaining permission from the COTP or a designated representative.
The Coast Guard will patrol the regatta area under the direction of the COTP, or a designated representative. A designated representative may be a Coast Guard Patrol Commander (PATCOM). Patrol Commander (PATCOM) means a Coast Guard commissioned, warrant, or petty officer who has been designated by the COTP to monitor the rowing area, permit entry into the area, give legally enforceable orders to persons or vessels within the area, and take other actions authorized by the COTP. The PATCOM will be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The PATCOM may be contacted on Channel 16 (156.8 MHZ) by the call sign “Coast Guard Patrol Commander.”
All persons and vessels not registered with the event sponsor as participants or official patrol vessels are considered spectators. The “official patrol vessels” consist of any Coast Guard, state, or local law enforcement and sponsor provided vessels assigned or approved by the COTP to patrol the regulated area.
Spectator vessels desiring to enter, transit through or within, or exit the regulated area may request permission to do so from the COTP or a PATCOM. When permitted to transit the area vessels must follow restrictions within the regulated area as directed by the Coast Guard, and must operate at a minimum safe navigation speed in a manner which will not endanger participants in the regulated area or any other vessels.
No spectator vessel shall anchor, block, loiter, or impede the through transit of participants or official patrol vessels in the regulated area during the effective dates and times, unless cleared for entry by or through an official patrol vessel.
Any spectator vessel may anchor outside the regulated area, but may not anchor in, block, or loiter in a navigable channel. Spectator vessels may be moored to a waterfront facility within the regulated area in such a way that they shall not interfere with the progress of the event. Such mooring must be complete at least 30 minutes prior to the establishment of the regulated area and remain moored through the duration of the event.
The COTP or a designated representative may forbid and control the movement of all vessels in the regulated area. When hailed or signaled by an official patrol vessel, a vessel shall come to an immediate stop and comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both.
The COTP or a designated representative may terminate the event or the operation of any vessel at any time it is deemed necessary for the protection of life or property. The COTP or a designated representative will terminate enforcement of the special local regulations at the conclusion of the event.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration, and time-of-year of the regulation. The special local regulation will take place on a 2.5 mile stretch of the Black Warrior River between mile markers 339.0 and 341.5, during a short duration of six hours on February 24, 2018, which is a time of year experiencing lower than normal traffic. Moreover, the Coast Guard will issue Broadcast Notices to Mariners via VHF-FM marine channel 16 about the regulation so that waterway users may plan accordingly for transits during this restriction. The rule also allows vessels to seek permission from the COTP or a designated representative to enter the regulated area.
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 rule will 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 V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
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 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
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will 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 Executive Order 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 rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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 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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined 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 rule involves a special local regulation lasting only six hours on the Black Warrior River between mile markers 339.0 and 341.5. It is categorically excluded from further
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233; 33 CFR 1.05-1.
(a)
(b)
(c)
(2) All persons and vessels not registered with the event sponsor as participants or official patrol vessels are considered spectators. The “official patrol vessels” consist of any Coast Guard, state, or local law enforcement and sponsor provided vessels assigned or approved by the COTP to patrol the regulated area.
(3) Spectator vessels desiring to transit the regulated area may do so only with prior approval of the COTP or a designated representative and when so directed by that officer will be operated at a minimum safe navigation speed in a manner which will not endanger participants in the regulated area or any other vessels.
(4) No spectator vessel shall anchor, block, loiter, or impede the through transit of participants or official patrol vessels in the regulated area during the effective dates and times, unless cleared for entry by or through an official patrol vessel.
(5) Any spectator vessel may anchor outside the regulated area, but may not anchor in, block, or loiter in a navigable channel. Spectator vessels may be moored to a waterfront facility within the regulated area in such a way that they shall not interfere with the progress of the event. Such mooring must be complete at least 30 minutes prior to the establishment of the regulated area and remain moored through the duration of the event.
(6) The COTP or a designated representative may forbid and control the movement of all vessels in the regulated area. When hailed or signaled by an official patrol vessel, a vessel shall come to an immediate stop and comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both.
(7) The COTP or a designated representative may terminate the event or the operation of any vessel at any time it is deemed necessary for the protection of life or property.
(8) The COTP or a designated representative will terminate enforcement of the special local regulations at the conclusion of the event.
(d)
In Title 49 of the Code of Federal Regulations, Parts 100 to 177, revised as of October 1, 2017, on page 131, in § 171.8, reinstate the definition of “specification packaging” to read as follows:
Fish and Wildlife Service, Interior.
Final rule.
This rule prescribes special migratory bird hunting regulations for certain Tribes on Federal Indian reservations, off-reservation trust lands, and ceded lands. This rule responds to tribal requests for U.S. Fish and Wildlife Service (hereinafter Service or we) recognition of their authority to regulate hunting under established guidelines. This rule allows the establishment of season bag limits and, thus, harvest at levels compatible with populations and habitat conditions.
This rule takes effect on February 5, 2018.
You may inspect comments received on the special hunting regulations and Tribal proposals during normal business hours at U.S. Fish and Wildlife Headquarters, 5275 Leesburg
Ron W. Kokel, U.S. Fish and Wildlife Service, Department of the Interior, MS: MB, 5275 Leesburg Pike, Falls Church, VA 22041-3803; (703) 358-1967.
The Migratory Bird Treaty Act (MBTA) of July 3, 1918 (16 U.S.C. 703
In the August 22, 2017,
(1) On-reservation hunting by both tribal members and nonmembers, with hunting by nontribal members on some reservations to take place within Federal frameworks but on dates different from those selected by the surrounding State(s);
(2) On-reservation hunting by tribal members only, outside of usual Federal frameworks for season dates and length, and for daily bag and possession limits; and
(3) Off-reservation hunting by tribal members on ceded lands, outside of usual framework dates and season length, with some added flexibility in daily bag and possession limits. In all cases, the regulations established under the guidelines must be consistent with the March 10-September 1 closed season mandated by the 1916 Migratory Bird Treaty with Canada.
In the June 10, 2016,
(1) Harvest anticipated under the requested regulations;
(2) Methods that would be employed to measure or monitor harvest (such as bag checks, mail questionnaires, etc.);
(3) Steps that would be taken to limit level of harvest, where it could be shown that failure to limit such harvest would adversely impact the migratory bird resource; and
(4) Tribal capabilities to establish and enforce migratory bird hunting regulations.
No action is required if a tribe wishes to observe the hunting regulations established by the State(s) in which an Indian reservation is located. We have successfully used the guidelines since the 1985-86 hunting season. We finalized the guidelines beginning with the 1988-89 hunting season (August 18, 1988,
The final rule described here is the final in the series of proposed and final rulemaking documents for Migratory Bird Hunting Regulations on Certain Federal Indian Reservations and Ceded Lands for the 2017-18 Season. Because some tribal seasons began on September 1, before the close of the comment period and finalization of the August 22, 2017, proposed rule (82 FR 39716), we published an interim final rule on August 31, 2017 (82 FR 41344) to allow these tribes to conduct their hunting seasons. In compliance with the MBTA, this rule opened the seasons on the dates set forth in the rule portion of this document, thereby allowing individuals to legally partake in hunting on these lands. Without publication of the interim final rule, hunting of migratory birds on certain Tribal ceded lands as requested by the Tribes would have been prohibited until we concluded with this rulemaking process initiated by the August 22, 2017, proposed rule (82 FR 39716). This new final rule replaces the August 31, 2017, interim final rule.
This rule sets hunting seasons, hours, areas, and limits for migratory game bird species on reservations and ceded territories. This final rule is the culmination of the rulemaking process for the Tribal migratory game bird hunting seasons, which started with the August 22, 2017, proposed rule. This final rule sets the Migratory Bird Hunting Regulations on Certain Federal Indian Reservations and Ceded Lands for the 2017-18 Season.
Each year we publish various species status reports that provide detailed information on the status and harvest of migratory game birds, including information on the methodologies and results. These reports are available at the address indicated under
For the 2017-18 migratory bird hunting season, we proposed regulations for 24 Tribes or Indian groups that followed the 1985 guidelines and were considered appropriate for final rulemaking. We noted in the August 22 proposed rule that we were proposing seasons for six Tribes who have submitted proposals in past years but from whom we had not yet received proposals this year. We did not receive proposals from five of those Tribes and, therefore, have not included them in this final rule.
The comment period for the August 22 proposed rule closed on September 21, 2017. We received 21 comments on our August 22 proposed rule, which announced proposed seasons for migratory bird hunting by American Indian Tribes. Similar comments were combined and significant comments are addressed below.
Specifically, GLIFWC appreciated our support for an experimental application of electronic calls to harvest migratory birds and our willingness to approve an experimental application of non-mechanical hand-held nets and snares for the harvest of migratory birds within the 1837 and 1842 Ceded Territories. They pointed out that in order to evaluate the impact that these methods may have, the Tribes have agreed to
Lastly, GLIFWC addressed the timing of the rulemaking process. They recognized that due to circumstances that may have been out of the Service's control, the final rules may not be issued until the middle of the Tribes' migratory bird hunting season. This delay may foreclose the opportunity for some Tribes to benefit from the proposed rule changes. For example, if we do establish a tribal season for sandhill crane harvesting in the 1836 Ceded Territory, it will be unlikely that hunters will be afforded an opportunity to hunt sandhill cranes in the 2017-18 season, as the migration of sandhill cranes through the 1836 Ceded Territory is likely to have concluded by the time we publish the final rule. The Tribes hope that, in future years, the Service commits to publishing its final rule for Tribes prior to the start of the migratory bird hunting season, noting that the Service consistently issues regulations for State seasons on time.
I.
The ceded territory covers one-third of the State of Wisconsin and significant areas of public hunting areas and public waters of Michigan and Minnesota. The commenters believe that the use of electronic calls for waterfowl hunting by tribal hunters could attract waterfowl in a zone of influence that may put any non-tribal hunters within that zone in violation of the law because they are prohibited from being aided by electronic calls in waterfowl hunting. This could effectively close public waters and lands to non-tribal waterfowl hunting where tribal hunters are using electronic calls and create zones of exclusivity. Further, it would not be possible for a tribal hunter to know whether or not a non-tribal hunter would or could be present on a public water or property for waterfowl hunting since most waterfowl hunters find their locations before dawn. In addition to the Federal restrictions on use of electronic calls, Wisconsin waterfowl hunting regulations also prohibit hunting with the “aid” of electronic calls; thus, a non-tribal hunter would be in violation if a tribal hunter was hunting the same general area with electronic calls. Closing these public lands and waters to hunting when they are supported by Pittman-Robertson and State wildlife management funds is inconsistent with their purpose. This situation has the potential to increase conflict among the hunting public creating a safety concern and a challenging law enforcement environment.
II.
III.
I.
As we have stated over the last 6 final rules (76 FR 54676, September 1, 2011; 77 FR 54451, September 5, 2012; 78 FR 53218, August 28, 2013; 79 FR 52226, September 3, 2014; 80 FR 52663, September 1, 2015; 81 FR 62404, September 9, 2016), the issue of allowing electronic calls and other electronic devices for migratory game bird hunting has been highly debated and highly controversial over the last 40 years, similar to other prohibited hunting methods. Electronic calls,
In our previous responses on this issue, we have also discussed information stemming from the use of electronic calls during the special light-goose seasons and our conclusions as to its applicability to most other waterfowl species. Given available evidence on the effectiveness of electronic calls, we continue to be concerned about the large biological uncertainty surrounding any widespread use of electronic calls. Additionally, given the fact that tribal waterfowl hunting covered by this rule would occur on ceded lands that are not in the ownership of the Tribes, we remain concerned that the use of electronic calls to take waterfowl could lead to confusion on the part of the public, wildlife-management agencies, and law enforcement officials in implementing the requirements of 50 CFR part 20. Further, similar to the impacts of baiting, we have some concerns on the uncertain zone of influence range from the use of electronic calls which could potentially increase harvest from non-tribal hunters operating within areas that electronic calls are used during the dates of the general hunt. However, unlike baiting, once the electronic call is removed from an area, the attractant or lure is immediately removed with presumably little to no lingering effects.
Notwithstanding our above concerns, we understand and appreciate GLIFWC's position on this issue, their desire to increase tribal hunter opportunity, harvest, and participation, and the importance that GLIFWC has ascribed to these issues. We further appreciate GLIFWC's latest proposal on the issue. GLIFWC has proposed a limited use of electronic calls under an experimental design with up to only 50 Tribal hunters. Hunters would be required to obtain special permits and complete and submit a hunt diary for each hunt where electronic calls were used. In our recent consultations with them, they have willingly discussed our concerns and all the uncertainties and difficulties surrounding them. Further, given GLIFWC's extremely limited current and expected waterfowl harvest (less than 3,000 ducks and 600 geese) and hunter participation (limited to 50 hunters), our concerns for any potential biological impacts are significantly lessened. Therefore, we agree with the tribes that much of the large uncertainty surrounding any widespread use of electronic calls could be potentially controlled, or significantly lessened, by this very modest experiment.
In that light, we are approving GLIFWC's limited experimental approach with the hope of gaining additional information and knowledge about the use of electronic calls and their effects on waterfowl. Ideally, this limited approach includes utilizing electronic calls both for Canada geese (where they may already be used in some instances) and new efforts for ducks. Important data related to tribal hunter interest, participation, effects on targeted species, and harvest needs to be closely tracked and reported, as GLIFWC has agreed. We conclude that the experimental removal of the electronic call prohibition, with the proposed limited design, is consistent with helping address and answer some of our long-standing concerns, and thus we approve GLIFWC's proposal to allow the experimental use of electronic calls in the 1837 and 1842 Treaty Areas for any open season for a 3-year experimental period.
II.
Current regulations at 50 CFR part 20 do not allow the use of traps, nets, or snares to capture migratory game birds (see § 20.21(a)), and we are unaware of any current State regulations allowing the use of traps for the capture of resident game birds. While the use of traps or nets for birds is not generally considered a sport-hunting technique, we recognize that their use may be a customary and traditional hunting method by tribal members. Further, GLIFWC's netting and trapping proposal does not allow baiting (which could lead to concerns related to potential disease transmission) or the herding of waterfowl into traps when they are largely flightless, such as during the summer molt. Practices such as these would significantly increase our concerns. As such, and recognizing the importance GLIFWC has placed on this issue, we are not opposed to the trapping of migratory birds, especially given all the GLIFWC-proposed restrictions on their use and the fact that they will be monitored at all times. Thus, we agree with the GLIFWC proposal and conclude that the restrictions they have proposed are appropriate to begin a 3-year experimental evaluation.
III.
Having taken into account the zones of temperature and the distribution, abundance, economic value, breeding habits, and times and lines of flight of migratory game birds, we conclude that the hunting seasons provided for herein are compatible with the current status of migratory bird populations and long-term population goals. Additionally, we are obligated to, and do, give serious consideration to all information received as public comment. We continue to conclude that the current Flyway-Council system of migratory bird management is one of the longest, most successful examples of State-Federal cooperative management since its establishment in 1952. Likewise, the establishment of special tribal migratory bird hunting regulations has been a successful Federal-Tribal partnership since 1988. However, as always, we continue to seek new ways to improve the process.
This final rule is not subject to the requirements of Executive Order (E.O.) 13771 (82 FR 9339, February 3, 2017) because this final rule establishes annual harvest limits related to routine hunting or fishing.
The programmatic document, “Second Final Supplemental Environmental Impact Statement: Issuance of Annual Regulations Permitting the Sport Hunting of Migratory Birds (EIS 20130139),” filed with the Environmental Protection Agency (EPA) on May 24, 2013, addresses NEPA compliance by the Service for issuance of the annual framework regulations for hunting of migratory game bird species. We published a notice of availability in the
Section 7 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
E.O. 12866 provides that the Office of Information and Regulatory Affairs (OIRA) will review all significant rules. OIRA has reviewed this rule and has determined that this rule is significant because it would have an annual effect of $100 million or more on the economy.
E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.
An economic analysis was prepared for the 2013-14 season. This analysis was based on data from the 2011 National Hunting and Fishing Survey, the most recent year for which data are available (see discussion under
The annual migratory bird hunting regulations have a significant economic impact on substantial numbers of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This final rule is a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. For the reasons outlined above, this rule will have an annual effect on the economy of $100 million or more. However, because this rule establishes hunting seasons, we do not plan to defer the effective date under the exemption contained in 5 U.S.C. 808(1).
This rule does not contain any new information collection that requires approval under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
• 1018-0019—North American Woodcock Singing Ground Survey (expires 5/31/2018).
• 1018-0023—Migratory Bird Surveys (expires 8/31/2020). Includes Migratory Bird Harvest Information Program, Migratory Bird Hunter Surveys, Sandhill Crane Survey, and Parts Collection Survey.
We have determined and certify, in compliance with the requirements of the Unfunded Mandates Reform Act, 2 U.S.C. 1502
The Department, in promulgating this rule, has determined that this rule will not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of E.O. 12988.
In accordance with E.O. 12630, this rule, authorized by the Migratory Bird Treaty Act, does not have significant takings implications and does not affect any constitutionally protected property rights. This rule will not result in the physical occupancy of property, the physical invasion of property, or the regulatory taking of any property. In fact, this rule allows hunters to exercise otherwise unavailable privileges and, therefore, reduces restrictions on the use of private and public property.
E.O. 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. While this rule is a significant regulatory action under E.O. 12866, it is not expected to adversely affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action and no Statement of Energy Effects is required.
In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), E.O. 13175, and 512 DM 2, we have evaluated possible effects on federally recognized Indian tribes and have determined that there are no effects on Indian trust resources. We have consulted with Tribes affected by this rule.
Due to the migratory nature of certain species of birds, the Federal Government has been given responsibility over these species by the Migratory Bird Treaty Act. We annually prescribe frameworks from which the States make selections regarding the hunting of migratory birds, and we employ guidelines to establish special regulations on Federal Indian reservations and ceded lands. This process preserves the ability of the States and tribes to determine which seasons meet their individual needs. Any State or Indian tribe may be more restrictive than the Federal frameworks at any time. The frameworks are developed in a cooperative process with the States and the Flyway Councils. This process allows States to participate in the development of frameworks from which they will make selections, thereby having an influence on their own regulations. These rules do not have a substantial direct effect on fiscal capacity, change the roles or responsibilities of Federal or State governments, or intrude on State policy or administration. Therefore, in accordance with E.O. 13132, these regulations do not have significant federalism effects and do not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
The rulemaking process for migratory game bird hunting, by its nature, operates under a time constraint as seasons must be established each year or hunting seasons remain closed. However, we intend that the public be provided extensive opportunity for public input and involvement in compliance with Administrative Procedure Act requirements. Thus, when the preliminary proposed rulemaking was published, we established what we concluded were the
Accordingly, with each participating Tribe having had an opportunity to participate in selecting the hunting seasons desired for its reservation or ceded territory on those species of migratory birds for which open seasons are now prescribed, and consideration having been given to all other relevant matters presented, certain sections of title 50, chapter I, subchapter B, part 20, subpart K, are hereby amended as set forth below.
Exports, Hunting, Imports, Reporting and recordkeeping requirements, Transportation, Wildlife.
Accordingly, part 20, subchapter B, chapter I of title 50 of the Code of Federal Regulations is amended as follows:
16 U.S.C. 703
Unless specifically provided for below, all of the regulations contained in 50 CFR part 20 apply to the seasons listed herein.
(a) [Reserved.]
(b)
(c)
1. While hunting waterfowl, a tribal member must carry on his/her person a valid Ceded Territory License.
2. Shooting hours for migratory birds are one-half hour before sunrise to one-half hour after sunset.
3. Except as otherwise noted, tribal members will be required to comply with tribal codes that will be no less restrictive than the provisions of Chapter 10 of the Model Off-Reservation Code. Except as modified by the Service rules adopted in response to this proposal, these amended regulations parallel Federal requirements in 50 CFR part 20 as to hunting methods, transportation, sale, exportation, and other conditions generally applicable to migratory bird hunting.
4. Band members in each zone will comply with State regulations providing for closed and restricted waterfowl hunting areas.
5. There are no possession limits for migratory birds. For purposes of enforcing bag limits, all migratory birds in the possession or custody of band members on ceded lands will be considered to have been taken on those lands unless tagged by a tribal or State conservation warden as having been taken on-reservation. All migratory birds that fall on reservation lands will not count as part of any off-reservation bag or possession limit.
(d)
(e)
The 2017-18 waterfowl hunting season regulations apply to all treaty areas (except where noted):
Daily Bag and Possession Limits: 20, singly, or in the aggregate, 25.
A. All tribal members are required to obtain a valid tribal waterfowl hunting permit.
B. Except as otherwise noted, tribal members are required to comply with tribal codes that are no less restrictive than the model ceded territory conservation codes approved by Federal courts in the
C. Particular regulations of note include:
1. Nontoxic shot is required for all waterfowl hunting by tribal members.
2. Tribal members in each zone must comply with tribal regulations providing for closed and restricted waterfowl hunting areas. These regulations generally incorporate the same restrictions contained in parallel State regulations.
3. There are no possession limits, with the exception of 2 swans (in the aggregate) and 25 rails (in the aggregate). For purposes of enforcing bag limits, all migratory birds in the possession and custody of tribal members on ceded lands are considered to have been taken on those lands unless tagged by a tribal or State conservation warden as taken on reservation lands. All migratory birds that fall on reservation lands do not count as part of any off-reservation bag or possession limit.
4. There are no shell limit restrictions.
5. Hunting hours are from 30 minutes before sunrise to 30 minutes after sunset, except that, within the 1837 and 1842 ceded territories hunters may use non-mechanical nets or snares that are operated by hand to take those birds subject to an open hunting season at any time. Hunters shall be permitted to capture, without the aid of other devices (
6. An experimental application of electronic calls (e-calls) will be implemented in the 1837 and 1842 ceded territories. Up to 50 tribal hunters will be allowed to use e-calls. Individuals using e-calls will be required to obtain a special permit; they will be required to complete a hunt diary for each hunt where e-calls are used; and they will be required to submit the hunt diary to the Commission within two (2) weeks of the end of the season in order to be eligible to obtain an e-call permit for the following year. Required information will include the date, time and location of the hunt, number of hunters, the number of each species harvested per hunting event, if other hunters were in the area, any interactions with other hunters, and other information deemed appropriate. Diary results will be summarized and documented in a Commission report, which will be submitted to the Service. Barring unforeseen results, this experimental application would be replicated for 3 years, after which a full evaluation would be completed.
7. Within the 1837 and 1842 ceded territories, tribal members will be allowed to use non-mechanical hand-operated nets (
(f)
(g)
(h)
(i)
(j)
A. All tribal members will be required to obtain a valid tribal resource card and 2017-18 hunting license.
B. Except as modified by the Service rules adopted in response to this proposal, these amended regulations parallel all Federal regulations contained in 50 CFR part 20. Shooting hours will be from one-half hour before sunrise to sunset.
C. Particular regulations of note include:
(1) Nontoxic shot will be required for all waterfowl hunting by tribal members.
(2) Tribal members in each zone will comply with tribal regulations providing for closed and restricted waterfowl hunting areas. These regulations generally incorporate the same restrictions contained in parallel State regulations.
D. Tribal members hunting in Michigan will comply with tribal codes that contain provisions parallel to Michigan law regarding duck blinds and decoys.
E. Possession limits are twice the daily bag limits.
(k)
(l)
(m) [Reserved.]
(n)
All other Federal regulations contained in 50 CFR part 20 apply. The following restrictions also apply:
1. As per Makah Ordinance 44, only shotguns may be used to hunt any species of waterfowl. Additionally, shotguns must not be discharged within 0.25 miles of an occupied area.
2. Hunters must be eligible, enrolled Makah tribal members and must carry their Indian Treaty Fishing and Hunting Identification Card while hunting. No tags or permits are required to hunt waterfowl.
3. The Cape Flattery area is open to waterfowl hunting, except in designated wilderness areas, or within 1 mile of Cape Flattery Trail, or in any area that is closed to hunting by another ordinance or regulation.
4. The use of live decoys and/or baiting to pursue any species of waterfowl is prohibited.
5. Steel or bismuth shot only for waterfowl is allowed; the use of lead shot is prohibited.
6. The use of dogs is permitted to hunt waterfowl.
7. Shooting hours for all species of waterfowl are one-half hour before sunrise to sunset.
8. Open hunting areas are: GMUs 601 (Hoko), a portion of the 602 (Dickey) encompassing the area north of a line between Norwegian Memorial and east to Highway 101, and 603 (Pysht).
(o)
(p)
(q)
(r)
(s)
(t)
(u) [Reserved.]
(v) [Reserved.]
(w) [Reserved.]
(x)
(y)
(z)
(aa)
(bb)
(cc)
(dd)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Final specification.
In this final rule, NMFS specifies an annual catch limit (ACL) for 2017 of 3,500 lb for Hawaii Kona crab, and an accountability measure (AM) to correct or mitigate any overages of the catch limit. The ACL and AM support the long-term sustainability of fishery resources of the U.S. Pacific Islands.
The final specification is effective March 7, 2018. The final specification is applicable from January 1, 2017, through December 31, 2017.
The Fishery Ecosystem Plan for the Hawaiian Archipelago is available from the Western Pacific Fishery Management Council (Council), 1164 Bishop St., Suite 1400, Honolulu, HI 96813, tel 808-522-8220, fax 808-522-8226, or
Sarah Ellgen, NMFS PIR Sustainable Fisheries, 808-725-5173.
NMFS is specifying an ACL of 3,500 lb of Hawaii Kona crab for fishing year 2017. NMFS proposed this specification on December 20, 2017 (82 FR 60366), and the final specification does not differ from the proposed. The 2017 fishing year began on January 1 and ended on December 31.
The Council recommended the ACL based on a recommended acceptable biological catch of 3,500 lb from its Scientific and Statistical Committee, and the results of an October 2015 stock assessment. The stock assessment found that the Hawaii Kona crab stock had reached an overfished status (<50 percent of B
At a constant 7,000-lb annual commercial harvest rate, the assessment estimated that Kona crab biomass would increase above 50 percent of B
As an AM, NMFS will apply a 3-year average catch to evaluate fishery performance against the ACL. Specifically, NMFS will use the average catch of fishing years 2015, 2016, and 2017, to evaluate fishery performance against the 2017 ACL. If, after the end of the fishing year, NMFS and the Council determine that the 3-year average catch exceeded the specified ACL, NMFS and the Council will reduce the ACL for that fishery by the amount of the overage in the subsequent year. The Council recommended an AM based on multi-year average catch data to reduce the influence of inter-annual variability in catch estimates in evaluating fishery performance against the ACL.
You may review additional background information on this action in the preamble to the proposed specification (82 FR 60366; December 20, 2017); we do not repeat that information here.
The comment period for the proposed specification ended on January 4, 2018. NMFS received two public comments that were not relevant to this rulemaking.
There are no changes in the final specification from the proposed specification.
The Regional Administrator, NMFS PIR, determined that this action is necessary for the conservation and management of Pacific Island fisheries, and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small
This action is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule.
NMFS is reallocating the projected unused amounts of the Aleut Corporation's and the Community Development Quota pollock directed fishing allowances from the Aleutian Islands subarea to the Bering Sea subarea directed fisheries. These actions are necessary to provide opportunity for harvest of the 2018 total allowable catch of pollock, consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area.
Effective 1200 hrs, Alaska local time (A.l.t.), February 5, 2018, until the effective date of the final 2018 and 2019 harvest specifications for Bering Sea and Aleutian Islands (BSAI) groundfish, unless otherwise modified or superseded through publication of a notification in the
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council (Council) under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
In the Aleutian Islands subarea, the portion of the 2018 pollock total allowable catch (TAC) allocated to the Aleut Corporation's directed fishing allowance (DFA) is 14,700 metric tons (mt) and the Community Development Quota (CDQ) DFA is 1,900 mt as established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 26, 2017), and as adjusted by an inseason adjustment (82 FR 60329, December 20, 2017).
As of January 17, 2018, the Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that 12,200 mt of Aleut Corporation's DFA and 1,900 mt of pollock CDQ DFA in the Aleutian Islands subarea will not be harvested. Therefore, in accordance with § 679.20(a)(5)(iii)(B)(
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of AI pollock. Since the pollock fishery opened January 20, 2018, it is important to immediately inform the industry as to the final Bering Sea subarea pollock allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery; allow the industry to plan for the fishing season and avoid potential disruption to the fishing fleet as well as processors; and provide opportunity to harvest increased seasonal pollock allocations while value is optimum. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of January 26, 2018.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by non-American Fisheries Act (AFA) crab vessels that are subject to sideboard limits, and operating as catcher vessels (CVs) using pot gear, in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2018 Pacific cod sideboard limit established for non-AFA crab vessels that are operating as
Effective 1200 hours, Alaska local time (A.l.t.), February 1, 2018, through 1200 hours, A.l.t., June 10, 2018.
Obren Davis, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.
The A season allowance of the 2018 Pacific cod sideboard limit established for non-AFA crab vessels, and that are operating as CVs using pot gear in the Western Regulatory Area of the GOA, is 338 metric tons (mt), as established by the final 2017 and 2018 harvest specifications for groundfish of the GOA (82 FR 12032, February 27, 2017) and one inseason adjustment (82 FR 60327, December 20, 2017).
In accordance with § 680.22(e)(2)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the A season allowance of the 2018 Pacific cod sideboard limit established for non-AFA crab vessels that are operating as CVs using pot gear in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a sideboard directed fishing allowance of 328 mt, and is setting aside the remaining 10 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 680.22(e)(3), the Regional Administrator finds that this sideboard directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by non-AFA crab vessels that are operating as CVs using pot gear in the Western Regulatory Area of the GOA.
After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the sideboard directed fishing closure of Pacific cod for non-AFA crab vessels that are subject to sideboard limits, and that are operating as CVs using pot gear in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of January 30, 2018.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 680.22 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Bureau of Consumer Financial Protection.
Request for information.
The Bureau of Consumer Financial Protection (Bureau) is seeking comments and information from interested parties to assist the Bureau in considering whether and how to amend the Bureau's Rules of Practice for Adjudication Proceedings.
Comments must be received by April 6, 2018.
You may submit responsive information and other comments, identified by Docket No. CFPB-2018-0002, by any of the following methods:
•
•
•
•
All submissions in response to this request for information, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. Sensitive personal information, such as account numbers or Social Security numbers, or names of other individuals, should not be included. Submissions will not be edited to remove any identifying or contact information.
For general inquiries and submission process questions, please call Monica Jackson at (202) 435-7275.
The Consumer Financial Protection Act of 2010 (Act) required the Bureau to prescribe rules establishing such procedures as may be necessary to carry out hearings and adjudications conducted pursuant to 12 U.S.C. 5563. 12 U.S.C. 5563(e). On July 28, 2011, the Bureau published an interim final rule seeking comment and prescribing rules establishing such hearings and procedures, with the exception of rules relating to the issuance of a temporary cease-and-desist order (TCDO) pursuant to section 1053(c) of the Act. 76 FR 45338 (July 28, 2011). The Bureau responded to comments received and published a final rule on June 29, 2012. 77 FR 39058 (June 29, 2012). This rule was codified at 12 CFR part 1081, subparts A-D. The Bureau published an interim final rule seeking comment and prescribing rules on TCDOs on September 26, 2013. 78 FR 59163 (Sept. 26, 2013). The Bureau received a single comment on this rule. Following consideration of the comment, the Bureau adopted the interim final rule without change on June 18, 2014. 79 FR 34622 (June 18, 2014). This rule was codified at 12 CFR part 1081, subpart E. Collectively, the rules codified at 12 CFR part 1081 are titled “Rules of Practice for Adjudication Proceedings” (Rules).
The Rules pertain to the general conduct of administrative adjudication proceedings, the initiation of such proceedings and prehearing rules, hearings, decisions and appeals, and temporary cease-and-desist proceedings. To date, there have been eight administrative adjudication proceedings under the Rules that were not immediately resolved by the issuance of a consent order pursuant to 12 CFR 1081.200(d). Six of these proceedings were settled during the course of the adjudication, one proceeding is pending, and one proceeding has resulted in a final decision.
The Bureau is, as described below, issuing this request for information seeking public comment on whether and how it might improve its administrative adjudication processes, including the Rules, while continuing to achieve the Bureau's statutory purposes and objectives.
The Bureau is using this request for information to seek public input regarding the Rules. The Bureau encourages comments from all interested members of the public. The Bureau anticipates that the responding public may include entities that have participated in Bureau administrative adjudication proceedings or similar proceedings at other agencies, members of the bar who represent these entities, agencies that utilize an administrative adjudication process, individual consumers, consumer advocates, regulators, and researchers or members of academia.
Section 1053 of the Act authorizes the Bureau to conduct administrative adjudications. The Bureau in the past has brought cases in the administrative setting in accordance with applicable law. The Bureau understands, however, that the administrative adjudication process can result in undue burdens, impacts, or costs on the parties subject to these proceedings. Members of the public are likely to have useful information and perspectives on the benefits and impacts of the Bureau's use of administrative adjudications, as well as existing administrative adjudication processes and the Rules. The Bureau is especially interested in receiving suggestions for whether it should be availing itself of the administrative
To allow the Bureau to more effectively evaluate suggestions, the Bureau requests that, where possible, comments include:
• Specific discussion of the positive and negative aspects of the Bureau's administrative adjudication processes, including whether a policy of proceeding in Federal court in all instances would be preferable;
• Specific suggestions regarding any potential updates or modifications to the Bureau's administrative adjudication processes, including the Bureau's Rules, consistent with the Bureau's statutory purposes and objectives, and including, in as much detail as possible, the potential update or modification, supporting data or other information on impacts and costs, or information concerning alignment with the processes of other agencies; and
• Specific identification of any aspects of the Bureau's administrative adjudication processes, including the Bureau's Rules, that should not be modified, consistent with the Bureau's statutory purposes and objectives, and including, in as much detail as possible, supporting data or other information on impacts and costs, information related to consumer and public benefit resulting from these processes, or information concerning alignment with the processes of other agencies.
The following list of general areas represents a preliminary attempt by the Bureau to identify elements of Bureau processes related to administrative adjudications that may be deserving of more immediate focus. This non-exhaustive list is meant to assist in the formulation of comments and is not intended to restrict the issues that may be addressed. In addressing these questions or others, the Bureau requests that commenters identify with specificity the Bureau regulations or practices at issue, providing legal citations where appropriate and available. Please feel free to comment on some or all of the questions below, but please be sure to indicate on which area you are commenting.
The Bureau is seeking feedback on all aspects of its administrative adjudication process, including but not limited to:
1. Whether, as a matter of policy, the Bureau should pursue contested matters only in Federal court rather than through the administrative adjudication process;
2. The Rules' protection of the rights and interests of third parties;
3. 12 CFR 1081.200(b)'s requirements for the contents of the Bureau's notice of charges;
4. The policy, expressed in 12 CFR 1081.101 for administrative adjudication proceedings to be conducted expeditiously, including:
a. 12 CFR 1081.201(a)'s requirement that respondents file an answer to a notice of charges within 14 days;
b. 12 CFR 1081.115(b)'s requirement that the hearing officer in administrative adjudications strongly disfavor motions for extensions of time except upon a showing of substantial prejudice;
c. 12 CFR 1081.212(h)'s requirement that the hearing officer decide any motion for summary disposition within 30 days; and
d. the Bureau's implementation of the requirement in 12 U.S.C. 5563(b)(1)(B) that hearings take place within 30 to 60 days of the notice of charges, unless the respondent seeks an extension of that time period;
5. 12 CFR 1081.206's requirements that the Bureau make documents available for copying or inspection, including whether the Bureau should produce those documents in electronic form to respondents in the first instance, at the Bureau's expense;
6. 12 CFR 1081.208's requirements for issuing subpoenas, and whether counsel for a party should be entitled to issue subpoenas without leave of the hearing officer;
7. 12 CFR 1081.209(g)(3)'s provision that failure to object to a question or document at a deposition is, with some exception, not deemed a waiver of the objection;
8. 12 CFR 1081.210(b)'s limitation on the number of expert witnesses any party may call at a hearing, absent “extraordinary circumstances”;
9. 12 CFR 1081.210(c)'s requirements for expert reports, including whether that paragraph should expressly incorporate the requirements of the Federal Rules of Civil Procedure relating to the required disclosures of expert witnesses;
10. 12 CFR 1081.212(e)'s instruction that extensions of the length limitation for motions for summary disposition are disfavored;
11. 12 CFR 1081.303(b)'s rules pertaining to admissible evidence in administrative adjudications, including:
a. Whether, in general, the Bureau should expressly adopt the Federal Rules of Evidence; and
b. whether, if the Bureau does not expressly adopt the Federal Rules of Evidence, the acceptance of prior testimony hearsay evidence pursuant to 12 CFR 1081.303(b)(3) should comply with the requirements of Federal Rule of Evidence 804(b)(1);
12. The Rules' lack of authorization for parties to conduct certain discovery, including deposing fact witnesses or serving interrogatories; and
13. Whether respondents should be afforded the opportunity to stay a decision of the Director pending appeal by filing a supersedeas bond, consistent with Federal Rule of Civil Procedure 62(d).
12 U.S.C. 5511(c).
Consumer Product Safety Commission.
Notice of proposed rulemaking; opportunity for oral presentation of comments.
The Consumer Product Safety Commission (Commission or CPSC) will be holding a meeting to provide interested parties with an opportunity to present oral comments on the notice of
The meeting will begin at 10 a.m. Eastern Standard Time (EST) on March 7, 2018. The Office of the Secretary must receive requests to make oral presentations, along with the written text of the oral presentations, no later than 5 p.m. EST on February 28, 2018.
The meeting will be in the Hearing Room, on the 4th Floor of the Bethesda Towers Building, 4330 East-West Highway, Bethesda, MD 20814. Submit requests to make oral presentations and the written text of oral presentations to the Office of the Secretary, with the caption, “Fireworks NPR; Oral Presentation,” by email to
For information about the subject matter of this meeting, contact Rodney Valliere, Project Manager, Directorate for Laboratory Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone: (301) 987-2526. For information about the procedure to make an oral presentation, contact Rockelle Hammond, Office of the Secretary, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; telephone: (301) 504-7923.
On February 2, 2017, the Commission published an NPR in the
In the Request for Comments section of the NPR (82 FR 9029), the Commission sought information on specific topics, in addition to requesting comments on all aspects of the proposed rule. Comments on the topics listed in the NPR would be helpful at the public hearing. In particular, the Commission would find information and data on the following topics useful:
• The public safety need for the proposed chemical composition and pyrotechnic weight limits for ground devices;
• the public safety need for prohibiting hexachlorobenzene and lead tetroxide and other lead compounds in fireworks devices;
• the public safety need for the proposed test method to evaluate side ignition and the appropriateness of the proposed ignition-resistance period;
• the public safety need for the proposed ban of fireworks devices that project fragments when functioning; and
• the appropriate trace contamination allowance levels for prohibited chemicals.
Under the FHSA and the Administrative Procedure Act (5 U.S.C. 551-562), the Commission must provide interested parties with an opportunity to submit “written data, views, or arguments” regarding a proposed rule. 5 U.S.C. 553(c). Neither statute requires the Commission to provide an opportunity for oral comments about a rulemaking, but the Commission is providing this forum to give interested parties an additional opportunity to comment on the NPR.
To request the opportunity to make an oral presentation, see the information under the
Federal Communications Commission.
Petitions for reconsideration.
Petitions for Reconsideration (Petitions) have been filed in the Commission's rulemaking proceeding by Joseph A. Godles, on behalf of Iridium Constellation LLC et al., Brian D. Weimer, on behalf of WorldVu Satellites Limited, and John P. Janka, on behalf of Viasat, Inc.
Oppositions to the Petitions must be filed on or before February 20, 2018. Replies to an opposition must be filed on or before March 2, 2018.
Federal Communications Commission, 445 12th Street SW, Washington, DC 20554.
Clay DeCell, 202-418-0803,
This is a summary of the Commission's document, Report No. 3084, released January 26, 2018. The full text of the Petitions is available for viewing and copying at the FCC Reference Information Center, 445 12th Street SW, Room CY-A257, Washington, DC 20554. They also may be accessed online via the Commission's Electronic Comment Filing System at:
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Indiana Advisory Committee (Committee) will hold a meeting on Saturday February 17, 2018, from 11:30 a.m.-1:00 p.m. CST for the purpose of hearing public testimony on voting rights issues in the state.
The meeting will be held on Saturday, February 17, 2018, from 11:30 a.m.-1:00 p.m. CST
The community forum will take place at the Evansville Central Library, Browning Rooms A&B. 200 SE, Martin Luther King Jr. Blvd., Evansville, Indiana 47713.
Dial: 877-329-7568; Conference ID 3466041.
Melissa Wojnaroski, DFO, at
This meeting is free and open to the public. Members of the public may appear in person and participate. This meeting is also available to the public through the above listed toll free call in number (audio only). Members of the public will be invited to make a statement as time allows.
For those individuals who join by phone, the conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
This is the second in a series of public meetings the Committee will hold on this topic. The Committee will also meet on Monday February 12, 2018 via web conference, and in Indianapolis on Friday March 2, 2018 to hear additional testimony. Please consult the
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Indiana Advisory Committee (Committee) will hold a meeting via web conference on Monday February 12, 2018, from 3:00 p.m.-4:30 p.m. EST for the purpose of hearing public testimony on voting rights issues in the state.
The meeting will be held on Monday, February 12, 2018, at 3:00 p.m. EST.
Melissa Wojnaroski, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the above listed toll free number (audio only) and web access link (visual only). Please use both the call in number and the web access link in order to follow the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines,
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit Office, U.S. Commission on Civil Rights, 55 W Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
This is the first in a series of public meetings the Committee will hold on this topic. The Committee will also meet in Evansville, Indiana on Saturday February 17th, 2018; and in Indianapolis on Friday March 2, 2018 to hear additional testimony. Please consult the
Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstance of this Committee doing work on the FY 2018 statutory enforcement report.
Economic Development Administration, U.S. Department of Commerce.
Notice and opportunity for public comment.
The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of the firms contributed importantly to the total or partial separation of the firms' workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act of 1974, as amended.
Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.
Bureau of Industry and Security.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and
Written comments must be submitted on or before April 6, 2018.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Mark Crace, BIS ICB Liaison, (202) 482-8093 or at
This collection of information is required by the Export Administration Regulations and the Federal Advisory Committee Act. The Technical Advisory Committees (TACs) were established to advise and assist the U.S. Government on export control matters such as proposed revisions to export control lists, licensing procedures, assessments of the foreign availability of controlled products, and export control regulations. Under this collection, interested parties may submit a request to BIS to establish a new TAC. The Bureau of Industry and Security provides administrative support for these committees.
Submitted electronically or in paper form.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Enforcement and Compliance, International Trade Administrative, Department of Commerce.
The Department of Commerce (Commerce) is rescinding the administrative review of the countervailing duty order on raw flexible magnets from the People's Republic of China (China) covering the period January 1, 2016, through December 31, 2016.
Effective February 5, 2018.
Patricia Tran, AD/CVD Operations, Office III, Enforcement & Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1503.
On November 13, 2017, based on a timely request by Qwik Picz Photo Booth, LLC (Qwik Picz), Commerce published in the
Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the party that requested the review withdraws the request within 90 days of the date of publication of the notice of initiation of the requested review. Qwik Picz withdrew its review request by the 90-day deadline, and no other parties requested an administrative review of this order. Therefore, we are rescinding the administrative review of the countervailing duty order on raw flexible magnets from China covering the period January 1, 2016, to December 31, 2016, in its entirety.
Commerce will instruct U.S. Customs and Border Protection (CBP) to assess countervailing duties on all appropriate entries. Because Commerce is rescinding this administrative review in its entirety, the entries to which this administrative review pertains shall be assessed countervailing duties that are equal to the cash deposits of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP within 15 days after the publication of this notice in the
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).
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).
The National Ocean Service (NOS) proposes to collect information from wildlife watching operations to ascertain the market value of marine wildlife via the ocean recreational industry in the Stellwagen Bank/Gulf of Maine region.
Up-to-date socioeconomic data is needed to support the conservation and management goals of SBNMS to strengthen and improve conservation of marine wildlife, including whales, pinnipeds, seals, and seabirds within the jurisdiction of the sanctuary and to satisfy legal mandates.
SBNMS is currently in the process of updating the 2010 Management Plan, and has identified a lack of baseline socioeconomic information on ocean recreation businesses. The type of data targeted for this collection has not been updated since 2008 and there are no source so information that detail operators' perceptions and attitudes towards the industry and sanctuary. Thus, current information on the importance of marine wildlife to the local tourism industry and operators is required. The primary focus for the survey will be to gather data on the non-consumptive, person-days of marine wildlife viewing and operators' perceptions and attitudes. Specifically, researchers will collect data to help determine the contribution of marine wildlife watching operations to the economy in the Stellwagen Bank region. The number of person-days of wildlife viewing is necessary to estimate the economic value that the industry makes to the region.
This information collection request may be viewed at
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 of public meeting.
On November 3, 2017, NMFS published a notice inviting qualified commercial shark permit holders to submit applications to participate in the 2018 shark research fishery. The shark research fishery allows for the collection of fishery-dependent data for future stock assessments and cooperative research with commercial fishermen to meet the shark research objectives of the Agency. Every year, the permit terms and permitted activities (
A conference call will be held on February 16, 2018.
A conference call will be conducted. See
Karyl Brewster-Geisz or Guy DuBeck at (301) 427-8503 or Delisse Ortiz at (240) 681-9037.
The Atlantic shark fisheries are managed under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The 2006 Consolidated Highly Migratory species (HMS) Fishery Management Plan (FMP) is implemented by regulations at 50 CFR part 635.
The final rule for Amendment 2 to the 2006 Consolidated HMS FMP (73 FR 35778, June 24, 2008, corrected at 73 FR 40658, July 15, 2008) established, among other things, a shark research fishery to maintain time-series data for stock assessments and to meet NMFS' research objectives. The shark research fishery gathers important scientific data and allows selected commercial fishermen the opportunity to earn more revenue from selling the sharks caught, including sandbar sharks. Only the commercial shark fishermen selected to participate in the shark research fishery are authorized to land/harvest sandbar sharks subject to the sandbar quota available each year. The 2018 sandbar shark quota is 90.7 mt dw per year. The selected shark research fishery participants also have access to the research large coastal shark, small coastal shark, and pelagic shark quotas subject to retention limits and quotas per §§ 635.24 and 635.27, respectively.
On November 3, 2017 (82 FR 51218), NMFS published a notice inviting qualified commercial shark directed and
As with past years, the 2018 permit terms and permitted activities (
The conference call will be held on February 16, 2018, from 1:30 to 3:30 p.m. (EST). Participants and interested parties should call 1-888-942-9261 and use the passcode 8567825. Selected participants who do not attend will not be allowed to participate in the shark research fishery. While the conference call is mandatory for selected participants, other interested parties may call in and listen to the discussion.
Selected participants are encouraged to invite their captain, crew, or anyone else who may assist them in meeting the terms and conditions of the shark research fishery permit.
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).
The currently approved collection covers collection of data for the 2014-2016 operating years. The renewed approval will cover years 2017-2019. Data will be collected from all catcher vessels registered to a limited entry trawl endorsed permit, catcher processors registered to catcher processor permits, and motherships registered to mothership permits, first receivers, and shorebased processors that received round or head-and-gutted IFQ groundfish or whiting from a first receiver to provide the necessary information for analyzing the effects of the West Coast Groundfish Trawl Catch Share Program.
As stated in 50 CFR 660.114, the EDC forms due on September 1, 2018 will provide data for the 2017 operating year.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of renewal of charter.
Pursuant to the provisions of the Federal Advisory Committee Act (FACA), and after consultation with the General Services Administration, the Chief Financial Officer and Assistant Secretary for Administration have determined that renewal of the NOAA Science Advisory Board is in the public interest. The committee has been a successful undertaking and has provided advice to the Under Secretary for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. The committee will continue to provide such advice and recommendations in the future.
The structure and responsibilities of the Committee are unchanged from when it was originally established in September 1997. The Committee will continue to operate in accordance with the provisions of the Federal Advisory Committee Act.
Dr. Cynthia Decker, Executive Director, SSMC3, Room 11230, 1315 East-West Hwy., Silver Spring, MD 20910; Phone Number: 301-734-1156. Email:
This document was received for publication by the Office of the Federal Register on January 30, 2018.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; Issuance of Incidental Harassment Authorization.
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA), as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to the Alaska Department of Transportation and Public Facilities (ADOT&PF) to incidentally take, by Level A and/or Level B harassment, six species of marine mammals during the Haines Ferry Terminal Modification Project, Haines, Alaska.
The IHA is valid from October 1, 2018, through September 30, 2019.
Jaclyn Daly, Office of Protected Resources, NMFS, (301) 427-8401.
An electronic copy of the IHA and supporting documents, as well as a list of the references cited in this document, may be obtained online at:
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.
NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
NMFS has defined “unmitigable adverse impact” in 50 CFR 216.103 as an impact resulting from the specified activity:
(1) That is likely to reduce the availability of the species to a level insufficient for a harvest to meet subsistence needs by: (i) Causing the marine mammals to abandon or avoid hunting areas; (ii) directly displacing subsistence users; or (iii) placing physical barriers between the marine mammals and the subsistence hunters; and
(2) That cannot be sufficiently mitigated by other measures to increase the availability of marine mammals to allow subsistence needs to be met.
The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
On January 9, 2017, NMFS received a request from ADOT&PF for an IHA to take marine mammals incidental to the Haines Ferry Terminal Modification Project. ADOT&PF submitted a subsequent application on May 30, 2017, which we considered adequate and complete. On August 17, 2017, ADOT&PF indicated a change to the requested effective dates in the application to accommodate a delayed construction schedule. ADOT&PF's request is for harassment only and NMFS concurs that serious injury or mortality is not expected to result from this activity. Therefore, an IHA is appropriate.
NMFS has issued an IHA to ADOT&PF authorizing the take of humpback whales (
We provided a description of the specified activity in our
The Haines Ferry Terminal Modification Project involves constructing an AMHS End Berth Facility adjacent to the existing dock. The expansion is necessary because the current configuration does not allow for operation of the new Alaska Class vessels, which are expected to be operational in 2018. Activities which have the potential to harass marine mammals include include impact and vibratory pile driving and vibratory pile removal. The terminal is located in southeast Alaska in Lutak Inlet.
To construct the new infrastructure, ADOT&PF will install 37 new piles (22 30-in. piles and 15 36-in. piles). Each pile will require 45 to 60 minutes of vibratory driving (to account for proper
A notice of NMFS's proposal to issue an IHA to ADOT&PF was published in the
Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS Stock Assessment Reports (SAR;
We provided a description of the anticipated effects of the specified activity on marine mammals in our
The introduction of anthropogenic noise into the aquatic environment from pile driving and removal is the primary means by which marine mammals may be harassed from ADOT&PF's specified activity. The effects of pile driving noise on marine mammals are dependent on several factors, including, but not limited to, sound type (
In 2016, ADOT&PF documented observations of marine mammals during pile driving and down-hole drilling at the Kodiak Ferry Dock (as described in 80 FR 60636; October 7, 2015 [date]). In the marine mammal monitoring report for that project (ABR 2016), 1,281 Steller sea lions were observed within the Level B disturbance zone during pile driving or drilling (
We provided a description of the effect of specified activity on marine mammal habitat in our
Construction activities at the Haines Ferry terminal could have localized, temporary impacts on marine mammal habitat and their prey by increasing in-water sound pressure levels and slightly decreasing water quality. ADOT&PF will employ standard construction best management practices (BMPs; see section 9 and 11.1 in ADOT's application), thereby, reducing any impacts. Any impacts are anticipated to be localized, short-term, and minimal.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
NMFS has authorized the taking of six species of marine mammals, by Level A and B harassment, incidental to pile driving and removal. Authorized takes will primarily be by Level B harassment, as use of the impact and vibratory hammers has the potential to result in disruption of behavioral patterns and/or TTS for individual marine mammals. Impact pile driving may also result in auditory injury (Level A harassment) for mysticetes, high frequency cetaceans, and phocids based on modeled auditory injury zones if those species are exposed to certain noise levels generated from installing two piles per day. However, there are multiple hours between impact pile driving each pile; therefore, these zones are conservative as animals are not known to linger in the area. Therefore, PTS potential is low and, if occurs, would likely be minimal (
We estimated take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals may be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities.
Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).
NMFS predicts that marine mammals are likely to be behaviorally harassed in a manner we consider Level B harassment when exposed to underwater anthropogenic noise above received levels of 120 decibel (dB) re 1 microPascal (μPa) root mean square (rms) for continuous (
Level A harassment for non-explosive sources—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Technical Guidance, 2016) identifies dual criteria to assess auditory injury (Level A harassment) for five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive).
These thresholds were developed by compiling and synthesizing the best available science and soliciting input multiple times from both the public and peer reviewers to inform the final product, and are provided in Table 2. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2016 Technical Guidance, which may be accessed at:
Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds.
ADOT&PF prepared an acoustic modeling report that discusses their modeling approach and identifies modeled source levels and harassment zones for the Haines Ferry Terminal project (Quijano
To assess potential underwater noise exposure of marine mammals during pile driving, ADOT&PF used two models: a Pile Driving Source Model (PDSM) to estimate the sound radiation generated by the pile driver acting upon the pile (
To model sounds resulting from impact and vibratory pile driving of 30-in and 36-in cylindrical pipe pipes, the PDSM was used in conjunction with GRL Engineer's Wave Equation Analysis Program (GRLWEAP) pile driving simulation software to obtain an equivalent pile source signature (
Once the pile source signature was computed, the FWRAM sound propagation modeling code was used to determine received levels as a function of depth, range, and azimuth direction. FWRAM is a time-domain acoustic model that used, as input, the PDSM-generated array of point sources representing the pile and computes synthetic pressure waveforms. To exclude sound field outliers, NMFS uses the maximum range at which the given sound level was encountered after excluding 5 percent of the farthest such points (R
Steel cylindrical pipe piles 41 m (135 ft) long with
Modeled source levels and distances to NMFS acoustic thresholds based on these source levels and the sound propagation model are presented in Table 3 and 4.
The modeling approach described above and in ADOT&PF's application constitutes a new approach in that it models both source levels and propagation loss to estimate distances to NMFS harassment thresholds. Some preliminary data comparing measured sound levels to those produced by the models has been presented, but no peer reviewed analysis has been undertaken. To test the validity of the model, NMFS has included a proposed requirement that ADOT&PF conduct a source source verification (SSV) study upon the onset of pile driving to validate the model or, if necessary, adjust the harassment zones based on measured data. This SSV study will also provide the first measurements of sound levels generated by 36-in piles driven by ADOT&PF. ADOT&PF has prepared a draft acoustic
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.
The data on marine mammals in this area are diverse and fairly robust due mostly to ADF&G surveys. Strong seasonal occurrence of marine mammals in this area is well documented; therefore, density estimates for each species were calculated by month rather than averaged throughout the year. For example, we have already discussed the seasonality of Steller sea lions and how prey aggregations affect their abundance. Monthly Steller sea lion densities were calculated based on abundance surveys conducted at Gran Point (ADF&G, pers. comm). Considering the Steller sea lion data used to calculate density is from Gran Point, ADOT&PF used this location to mark the southern boundary of the action area. The area from Gran Point north that encompasses Lutak Inlet and Lynn Canal is 91.3 km
Here we describe how the information provided above is brought together to produce a quantitative take estimate.
The following equation was used to calculate potential Level A take per species per pile type:
Also for Level B takes, we only considered the vibratory zone of 21.1 km
As described above, there would be 19 days of pile driving and 2 days of pile removal for a total of 21 pile activity days. We used the June density because, when densities changed throughout the year, this is when the highest density of all species occurs in the project area within the project in-water work window (with the exception of Dall's porpoise-see below) and ADOT&PF could conduct activities during this month. Therefore, the resulting take estimates assume all work is conducted in June, producing conservative estimates.
ADOT&PF may take 1.9 humpback whales by Level A harassment when impact driving 30″ piles (
For killer whales, Level B takes from vibratory pile driving were calculated using June density and the full 21.1 km
For Dall's porpoise, we increased the number of groups that may be within the calculated Level A thresholds area from one group in the proposed IHA notice to two groups to account for the increase in estimated density. We also increase the number of groups potentially exposed to noise levels about the Level B threshold to four groups. For Level B take, calculated take between 10 and 20 animals; therefore, we assumed two groups of ten each may occur within the Level B zone and are proposing to authorize 20 Level B takes.
Harbor porpoise take estimates were based on a density of .054 porpoise/km
Harbor seals may linger in the area for multiple days; therefore, we conservatively estimate one harbor seal could be around the terminal on any given day for a total of 21 Level A takes. For Level B takes, we used the equation above using a density of 1.09 seals/km
For Steller sea lions, no Level A takes are authorized. Level B takes from vibratory pile driving were calculated using the most conservative June density (assuming worst case scenario that all work occurs in June) and the full 21.1 km
Table 6 includes the total proposed take levels, by species, manner of taking, and the percentage of stock potentially taken by harassment.
In order to issue an IHA under Section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat, as well as subsistence uses. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if
(2) the practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations, and, in the case of a military readiness activity, personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
The following mitigation measures are included in the IHA:
•
•
•
•
Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, we have determined that the proposed mitigation measures provide the means effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, Section 101(a)(5)(D) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
Monitoring would be conducted 30 minutes before, during, and 30 minutes after pile driving and removal activities. In addition, observers shall record all incidents of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven or removed. Pile driving activities include the time to install or remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than thirty minutes.
A primary PSO would be placed at the terminal where pile driving would occur and a second observer would be placed at Tanani Point, located approximately 1 mi (1.6 km) southeast of the terminal. This second observer is at an advantage to observe species prior to entering the Level A zone as they move up Chilkoot Inlet, covering a majority of the Level B zone. PSOs would scan the waters using binoculars, and/or spotting scopes, and would use a handheld GPS or range-finder device to verify the distance to each sighting from the project site. All PSOs would be trained in marine mammal identification and behaviors and are required to have no other project-related tasks while conducting monitoring. The following measures also apply to visual monitoring:
(1) Monitoring will be conducted by qualified observers, who will be placed at the best vantage point(s) practicable to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. Qualified observers are trained biologists, with the following minimum qualifications:
(a) Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;
(b) Advanced education in biological science or related field (undergraduate degree or higher required);
(c) Experience and ability to conduct field observations and collect data according to assigned protocols (this may include academic experience);
(d) Experience or training in the field identification of marine mammals, including the identification of behaviors;
(e) Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;
(f) Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates and times when in-water construction activities were suspended to avoid potential incidental injury from construction sound of marine mammals observed within a defined shutdown zone; and marine mammal behavior; and
(g) Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.
A draft marine mammal monitoring report would be submitted to NMFS within 90 days after the completion of pile driving and removal activities. It will include an overall description of work completed, a narrative regarding marine mammal sightings, and associated marine mammal observation data sheets. Specifically, the report must include:
• Date and time that monitored activity begins or ends;
• Construction activities occurring during each observation period;
• Weather parameters (
• Water conditions (
• Species, numbers, and, if possible, sex and age class of marine mammals;
• Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;
• Distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;
• Locations of all marine mammal observations; and
• Other human activity in the area.
If no comments are received from NMFS within 30 days, the draft final report will constitute the final report. If comments are received, a final report addressing NMFS comments must be submitted within 30 days after receipt of comments.
In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by the IHA (if issued), such as an injury, serious injury or mortality, ADOT&PF would immediately cease the specified activities and report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and the Alaska Regional Stranding Coordinator. The report would include the following information:
• Description of the incident;
• Environmental conditions (
• Description of all marine mammal observations in the 24 hours preceding the incident;
• Species identification or description of the animal(s) involved;
• Fate of the animal(s); and
• Photographs or video footage of the animal(s) (if equipment is available).
Activities would not resume until NMFS is able to review the circumstances of the prohibited take. NMFS would work with ADOT&PF to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. ADOT&PF would not be able to resume their activities until notified by NMFS via letter, email, or telephone.
In the event that ADOT&PF discovers an injured or dead marine mammal, and the lead PSO determines that the cause of the injury or death is unknown and the death is relatively recent (
In the event that ADOT&PF discovers an injured or dead marine mammal and the lead PSO determines that the injury or death is not associated with or related to the activities authorized in the IHA (
ADOT&PF relied on source level and sound propagation models to estimate Level A and harassment zones. To validate the outputs of these models, ADOT&PF will conduct acoustic monitoring during the first two days of pile driving. The acoustic monitoring plan is available for review at
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
The Level A harassment zones identified in Tables 3 and 4 are based upon an animal exposed to impact pile driving two piles per day. Considering duration of impact driving each pile (up to 15 minutes) and breaks between pile installations (to reset equipment and move pile into place), this means an animal would have to remain within the area estimated to be ensonified above the Level A harassment threshold for multiple hours. This is highly unlikely given marine mammal movement throughout the area. If an animal was exposed to accumulated sound energy, the resulting PTS would likely be small (
Behavioral responses of marine mammals to pile driving and removal at the Terminal, if any, are expected to be mild and temporary. Marine mammals within the Level B harassment zone may not show any visual cues they are disturbed by activities (as noted during modification to the Kodiak Ferry Dock) or could become alert, avoid the area, leave the area, or display other mild responses that are not observable such as changes in vocalization patterns. Given the short duration of noise-generating activities per day and that pile driving and removal would occur on 21 days across 4 months, any harassment would be temporary. In addition, ADOT&PF would not conduct pile driving or removal during the spring eulachon and herring runs as well as the fall salmon runs, when marine mammals are in greatest abundance and engaging in concentrated foraging behavior.
In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:
• No mortality is anticipated or authorized.
• ADOT&PF would avoid pile driving and removal during peak periods of marine mammals abundance and foraging (
• ADOT&PF would implement mitigation measures such as vibratory driving piles to the maximum extent practicable, soft-starts, use of sound attenuation devices, and shut downs.
• Monitoring reports from similar work in Alaska have documented little to no effect on individuals of the same species impacted by the specified activities.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS finds that the total marine mammal take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.
As noted above, only small numbers of incidental take may be authorized under Section 101(a)(5)(D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
The amount of take NMFS proposes to authorize is 0.03 to 12.3 percent of any stock's best population estimate. The 12.3 percent is based on the possibility all 30 takes of killer whales are from the West Coast Transient stock (population size 243) which is highly unlikely. The next lowest percent of stock is for the Steller sea lion eDPS at 6.7 percent; however, this is also conservative because it assumes all pile driving occurs in June which has the highest Steller sea lion density and assumes all takes are of individual animals which is likely not the case. Harbor seal takes represent 6.3 percent of the Lynn Canal/Stephens passage population while takes for the remaining five species, including the Steller sea lion wDPS, represent less than 1 percent of all stocks.
Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531
On October 20, 2017, NMFS Alaska Region issued a Biological Opinion to NMFS Office of Protected Resources and the Federal Highway Administration which concluded the Terminal Modification Project is not likely to jeopardize the continued existence of WDPS Steller sea lions or Mexico DPS humpback whales or adversely modify critical habitat because none exists within the action area.
NMFS has issued an IHA to ADOT&PF for the potential harassment of small numbers of six marine mammal species incidental to pile driving and removal activities in Lutak Inlet, provided the previously mentioned mitigation, monitoring and reporting requirements are incorporated.
Consumer Product Safety Commission.
Notice.
The Consumer Product Safety Commission (CPSC or Commission) is announcing an opportunity for public comment on a new proposed collection of information by the agency. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Submit written or electronic comments on the collection of information by April 6, 2018.
You may submit comments, identified by Docket No. CPSC-2018-0002, by any of the following methods:
Charu Krishnan, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; (301) 504-7221, or by email to:
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 surveys. 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
The Commission is authorized under section 5(a) of the Consumer Product Safety Act (CPSA), 15 U.S.C. 2054(a), to conduct studies and investigations relating to the causes and prevention of deaths, accidents, injuries, illnesses, other health impairments, and economic losses associated with consumer products. Section 5(b) of the CPSA, 15 U.S.C. 2054(b), further provides that the Commission may conduct research, studies, and investigations on the safety of consumer products or test consumer products and develop product safety test methods and testing devices.
The use of recycled tire material or “tire crumb” rubber is commonplace for many athletic fields, as well as children's playgrounds. Playground surfaces derived from recycled tires are a popular option due to their low maintenance, variety of colors and designs, and ability to reduce the impacts from falls. The CPSC has received numerous inquiries from consumers and stakeholders regarding the safety of playground surfaces derived from recycled tires. In February 2016, the CPSC, the Environmental Protection Agency (EPA), and the Centers for Disease Control and Prevention (CDC) launched the interagency Federal Research Action Plan on Recycled Tire Crumb Used on Playing Fields and Playgrounds (Plan). One of the Plan's objectives is to identify the potential hazardous chemical exposure to children derived from recycled tire material used regularly on playgrounds throughout the United States. The EPA and CDC will evaluate the chemical hazards of recycled tire materials on athletic playing fields, and the CPSC will assess the level of risk and the extent to which children may be exposed to potential hazard(s) related to recycled tires on playgrounds.
As a first step, in 2016, the CPSC conducted focus groups to gather data from a small sample of parents, childcare providers, and personnel responsible for the inspection and maintenance of playgrounds on their experiences and observations of how children interact with various types of playground surfaces, including those derived from recycled tires.
CPSC has contracted with the Fors Marsh Group, LLC (FMG) to design the survey. SSRS, LLC will program and administer the final survey. Trained interviewers will dial and conduct the survey using a computer-assisted telephone interview (CATI) system, in a secure location, to which only authorized personnel have access. Participants will be recruited by re-contacting respondents of the SSRS Omnibus. The SSRS Omnibus is a
Each telephone interview will take approximately 20 minutes to complete. We estimate the number of respondents to be 2,200. We estimate the total annual burden hours for respondents to be 726 hours. The monetized hourly cost is $35.28, as defined by the average total hourly cost to employers for employee compensation for employees across all occupations as of June 2017, reported by the Bureau of Labor Statistics. Accordingly, we estimate the total annual cost burden to all respondents to be $25,613. (726 hours × $35.28 = $25,613.28.). The total cost to the federal government for the contract to design and conduct the survey issued to FMG under contract number CPSC-D-16-0002 is $243,593.
The CPSC invites comments on these topics:
• Whether the proposed collection of information is necessary for the proper performance of CPSC's functions, including whether the information will have practical utility;
• The accuracy of CPSC's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, utility, and clarity of the information to be collected; and
• 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.
Defense Manpower Data Center, DoD.
60-Day information collection notice.
In compliance with the
Consideration will be given to all comments received by April 6, 2018.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Defense Manpower Data Center (DMDC), DoD Center Monterey Bay, DBIDS, ATTN: David Schwab, Seaside, CA 93955, or call DMDC, DBIDS, at 831-583-2500.
Respondents are those persons requiring access to DOD Installations who do not meet requirements to possess a DOD identification card. Their data is collected pursuant to DoD force protection measures and base security policy. Persons possessing a valid DOD identification card have their data automatically provided through system to system interfaces and are not considered burdened.
U.S. Army Corps of Engineers, DoD.
Notice.
The U.S. Army Corps of Engineers (USACE) is proposing to issue an Engineer Circular (EC), which is an agency policy document that will provide the policies and procedures related to how USACE will process certain requests by others to alter a USACE civil works project pursuant to Section 14 of the Rivers and Harbors Act of 1899, as amended (more commonly referred to as Section 408). This notice announces the availability of the draft EC for comment. The comment period on the draft document starts with the publication of this notice in the
Comments must be submitted on or before March 7, 2018.
You may submit comments identified by docket number COE-2018-0003 by any of the following methods:
Ms. Tammy Conforti at 202-761-4649, email
Section 14 of the Rivers and Harbors Act of 1899, as amended, and codified in 33 U.S.C. 408 (Section 408) provides that the Secretary of the Army may, upon the recommendation of the Chief of Engineers, grant permission to other entities for the permanent or temporary alteration or use of any USACE Civil Works project. This requires a determination by the Secretary that the requested alteration will not be injurious to the public interest and will not impair the usefulness of the USACE project.
USACE is proposing to issue Engineer Circular (EC) 1165-2-220, Policy and Procedural Guidance for Processing Requests to Alter U.S. Army Corps of Engineers Civil Works Projects Pursuant to 33 U.S.C. 408, to update processes related to how USACE will review certain requests by others to alter a USACE civil works project. For example, other entities may want to alter a Civil Works project to increase recreational opportunities; improve flood risk management; or construct a road, transmission line, or pipeline across a Civil Works project. The purpose of the Section 408 review is to ensure that the Congressionally-authorized purpose and benefits of a Civil Works project are protected and maintained (
The first comprehensive policy and procedures for evaluation of alterations under Section 408 was issued as EC 1165-2-216 on July 31, 2014. Based on lessons learned from implementing EC 1165-2-216, USACE began the process to revise and update its Section 408 process to clarify applicability, roles and responsibilities, and the basic requirements. From November 2016 through January 2018, USACE issued multiple interim guidance to improve the efficiency and effectiveness of the Section 408 review process while continuing to work on a full policy revision.
USACE has now completed a draft of a new policy document (EC 1165-2-220) to replace EC 1165-2-216. EC 1165-2-220 would expire two years from issuance, which will provide USACE time consider implementation experience to identify any necessary clarifications or changes. After two years, EC 1165-2-220 will either be revised, rescinded, or converted to an Engineer Regulation, which does not expire.
EC 1165-2-220 is intended to consolidate the interim guidance issued since 2016 and update procedures to facilitate a scalable approach to reviewing Section 408 requests in a timely manner while maintaining a national consistent approach to
EC 1165-2-220 has also been developed in accordance with requirements in Section 1007 of the Water Resources Reform and Development Act (WRRDA) of 2014 (Pub. L. 113-121) and Section 1156 of the Water Resources Development Act (WRDA) of 2016 (Title I of Pub. L. 114-322). USACE now invites all interested parties to review and provide comment on the draft of EC 1165-2-220 prior to final publication.
Following the comment period, USACE will consider all comments received, make revisions as needed, and publish the final EC 1165-2-220 as soon as possible. When the final EC is published, a notice will be placed in the
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before April 6, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Jon Utz, 202-377-4040.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Career, Technical, and Adult Education, Department of Education.
Notice.
The Department of Education (Department) is issuing a notice inviting applications for new awards for fiscal year (FY) 2018 for the Native American Career and Technical Education Program (NACTEP), Catalog of Federal Domestic Assistance (CFDA) number 84.101A.
Gwen Washington, U.S. Department of
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
Under section 116 of the Act, Bureau-funded schools (as defined in this notice) proposing to fund secondary programs are not eligible to receive an award directly from the Secretary. However, an Indian Tribe, Tribal organization, Alaska Native entity, or Bureau-funded school may use its award to assist a secondary school operated or supported by the U.S. Department of the Interior to carry out CTE programs. A Bureau-funded school that is not proposing a secondary program is eligible for assistance under NACTEP.
This priority is:
For the purposes of this invitational priority,
Computer science includes computer programming or coding as a tool to create software, including applications, games, websites, and tools to manage or manipulate data; or development and management of computer hardware and the other electronics related to sharing, securing, and using digital information.
In addition to coding, the expanding field of computer science also includes computational thinking and interdisciplinary problem-solving to equip students with the skills and abilities necessary to apply computation in our digital world.
Computer science does not include using a computer for everyday activities, such as browsing the internet; use of tools like word processing, spreadsheets, or presentation software; or using computers in the study and exploration of unrelated subjects.
The application requirements are:
(1) An eligible applicant (as determined by the Act) must include documentation in its application showing that it and, if appropriate, its consortium members are eligible to apply.
As defined in the Indian Self-Determination and Education Assistance Act (ISDEAA) (25 U.S.C. 5304(l)), the term “Tribal organization” means the recognized governing body of any Indian Tribe; any legally established organization of Indians which is controlled, sanctioned, or chartered by such governing body or which is democratically elected by the adult members of the Indian community to be served by such organization and which includes the maximum participation of Indians in all phases of its activities: Provided, That in any case where a contract is let or grant made to an organization to perform services benefiting more than one Indian Tribe, the approval of each such Indian Tribe shall be a prerequisite to the letting or making of such contract or grant. In accordance with this statutory definition, any Tribal organization proposing to provide NACTEP services for the benefit of more than one Indian Tribe must first obtain the approval of each Indian Tribe it proposes to serve and must submit documentation of such approval with its NACTEP application and that documentation of Tribal approval is a prerequisite to the awarding of a NACTEP grant to any Tribal organization proposing to serve more than one Indian Tribe.
(2) An applicant that is not proposing to provide CTE directly to its students and proposes instead to use NACTEP funds to pay one or more qualified educational entities to provide education to its students must include with its application a written CTE agreement between the applicant and that entity. The written agreement must describe the commitment between the applicant and each educational entity and must include, at a minimum, a statement of the responsibilities of the applicant and the entity. The agreement must be signed by the appropriate individuals on behalf of each party, such as the authorizing official or president of a Tribe or Tribal organization, a college president, or a college dean.
The program requirements are:
(a) Section 116(e) of the Act requires the Secretary to ensure that activities funded under NACTEP “will improve career and technical education programs” (20 U.S.C. 2326(e)). Therefore, under NACTEP the Assistant Secretary will award grants to carry out projects that—
(1) Propose organized educational activities offering a sequence of courses that—
(i) Provide individuals with coherent and rigorous content aligned with challenging academic standards and relevant technical knowledge and skills needed to prepare for further education and careers in current or emerging professions;
(ii) Provide technical skill proficiency, an industry-recognized credential, a certificate, or an associate degree; and
(iii) Include competency-based applied learning that contributes to the academic knowledge, higher-order reasoning and problem-solving skills, work attitudes, general employability skills, technical skills, and occupation-
(2) Develop new programs, services, or activities or improve or expand existing programs, services, or activities that are consistent with the purposes of the Act. In other words, the Department will support “expansions” or “improvements” that include, but are not limited to, the expansion of effective programs or practices; upgrading of activities, equipment, or materials; increasing staff capacity; adoption of new technology; modification of curriculum; or implementation of new policies to improve program effectiveness and outcomes.
(3) Fund a CTE program, service, or activity that—
(i) Is a new program, service, or activity that was not provided by the applicant during the instructional term (a defined period, such as a semester, trimester, or quarter, within the academic year) that preceded the request for funding under NACTEP;
(ii) Will improve or expand an existing CTE program; or
(iii) Inherently improves CTE.
A program, service, or activity “inherently improves CTE” if it—
(a) Develops new CTE programs of study that will be approved by the appropriate accreditation agency;
(b) Strengthens the rigor of the academic and career and technical components of funded programs;
(c) Uses curriculum that is aligned with industry-recognized standards and will result in students attaining industry-recognized credentials, certificates, or degrees;
(d) Integrates academics (other than remedial courses) with CTE programs through a coherent sequence of courses to ensure learning in the core academic and career and technical subjects;
(e) Links CTE at the secondary level with CTE at the postsecondary level and facilitates students' pursuit of a baccalaureate degree;
(f) Expands the scope, depth, and relevance of curriculum, especially content that provides students with a comprehensive understanding of all aspects of an industry and a variety of hands-on, job-specific experiences; and
(g) Offers—
(1) Work-related experience, internships, cooperative education, school-based enterprises, entrepreneurship, community service learning, and job shadowing that are related to CTE programs;
(2) Coaching/mentoring, support services, and extra help for students after school, on weekends, and/or during the summers, so they can meet higher standards;
(3) Career guidance and academic counseling for students participating in CTE programs;
(4) Placement services for students who have successfully completed CTE programs and attained a technical skill proficiency that is aligned with industry-recognized standards;
(5) Professional development programs for teachers, counselors, and administrators;
(6) Strong partnerships among grantees and local educational agencies, postsecondary institutions, community leaders, adult education providers, and, as appropriate, other entities, such as employers, labor organizations, parents, and local partnerships, to enable students to achieve State academic standards and career and technical skills;
(7) The use of student assessment and evaluation data to improve continually instruction and staff development with the goal of increasing student achievement in CTE programs; or
(8) Research, development, demonstration, dissemination, evaluation and assessment, capacity-building, and technical assistance, related to CTE programs.
(b) Assistance to Bureau-funded secondary schools. An Indian Tribe, a Tribal organization, or an Alaska Native entity that receives funds through a NACTEP grant or contract may use the funds to provide assistance to a secondary school operated or supported by the U.S. Department of the Interior to enable such school to carry out CTE programs. (Section 116(b)(3) of the Act)
To help ensure the high quality of NACTEP projects and the achievement of the goals and purposes of section 116 of the Act, each grantee must budget for and conduct an ongoing evaluation of the effectiveness of its NACTEP project. An independent evaluator must conduct the evaluation. The evaluation must be appropriate for the project and be both formative and summative in nature.
In accordance with section 116(c)(2) of the Act, a portion of an award under this program may be used to provide stipends (as defined in the Definitions section of this notice) to one or more students to help meet the students' costs of participation in a NACTEP project. A grantee must apply the following procedures for determining student eligibility for stipends and appropriate amounts to be awarded as stipends:
(1) To be eligible for a stipend a student must—
(i) Be enrolled in a CTE project funded under this program;
(ii) Be in regular attendance in a NACTEP project and meet the training institution's attendance requirement;
(iii) Maintain satisfactory progress in his or her program of study according to the training institution's published standards for satisfactory progress; and
(iv) Have an acute economic need that—
(A) Prevents participation in a project funded under this program without a stipend; and
(B) Cannot be met through a work-study program.
(2) The amount of a stipend is the greater of either the minimum hourly wage prescribed by State or local law or the minimum hourly wage established under the Fair Labor Standards Act.
(3) A grantee may only award a stipend if the stipend combined with other resources the student receives does not exceed the student's financial need. A student's financial need is the difference between the student's cost of attendance and the financial aid or other resources available to defray the student's cost of participating in a NACTEP project.
(4) To calculate the amount of a student's stipend, a grantee would multiply the number of hours a student actually attends CTE instruction by the amount of the minimum hourly wage that is prescribed by State or local law, or by the minimum hourly wage that is established under the Fair Labor Standards Act.
In accordance with applicable Department statutory requirements and administrative regulations, grantees must maintain records that fully support their decisions to award stipends and the amounts that are paid, such as proof of a student's enrollment in a NACTEP project, stipend applications, timesheets showing the number of attendance hours confirmed in writing by an instructor, student financial status information, and evidence that a student would not be able to participate in the NACTEP project without a stipend. (20 U.S.C. 1232f; 34 CFR 75.700-75.702; 75.730; and 75.731)
(5) An eligible student may receive a stipend when taking a course for the
(6) An applicant must include in its application the procedure it intends to use to determine student eligibility for stipends and stipend amounts, and its oversight procedures for the awarding and payment of stipends.
A grantee may provide direct assistance to students if the following conditions are met:
(1) The recipient of the direct assistance is an individual who is a member of a special population and who is participating in the grantee's NACTEP project.
(2) The direct assistance is needed to address barriers to the individual's successful participation in that project.
(3) The direct assistance is part of a broader, more generally focused program or activity to address the needs of an individual who is a member of a special population.
Direct assistance to individuals who are members of special populations is not, by itself, a “program or activity for special populations.”
(4) The grant funds used for direct assistance must be expended to supplement, and not supplant, assistance that is otherwise available from non-Federal sources. (20 U.S.C. 2391(a)). For example, generally, a postsecondary educational institution could not use NACTEP funds to provide child care for single parents if non-Federal funds previously were made available for this purpose, or if non-Federal funds are used to provide child care services for single parents participating in non-CTE programs and these services otherwise would have been available to CTE students in the absence of NACTEP funds.
(5) In determining how much of the NACTEP grant funds it will use for direct assistance to an eligible student, a grantee must consider whether the specific services to be provided are a reasonable and necessary cost of providing CTE programs for special populations. However, the Assistant Secretary does not envision a circumstance in which it would be a reasonable and necessary expenditure of NACTEP project funds for a grantee to use a majority of a project's budget to pay direct assistance to students, in lieu of providing the students served by the project with CTE.
Any applicant denied funding under this NACTEP competition may request a hearing to review the Secretary's decision not to make the award. The Secretary will implement the appeal process in accordance with the procedures set forth in 34 CFR 401.23. In accordance with those procedures, any applicant denied funding will have 30 calendar days to make a written request to the Secretary for a hearing to review the Secretary's decision. (25 U.S.C. 5321(b)).
Section 116(f) of the Act provides that a Tribe, Tribal organization, or Alaska Native entity receiving financial assistance under this program may integrate those funds with assistance received from related programs in accordance with the provisions of Public Law 102-477, the Indian Employment, Training and Related Services Demonstration Act of 1992 (25 U.S.C. 3401
For further information on the integration of grant funds under this and related programs contact Terrence Parks, the Division of Workforce Development, Office of Indian Services, Bureau of Indian Affairs, U.S. Department of the Interior, 1951 Constitution Avenue NW, Mailstop 20 SIB, Washington, DC 20245. Telephone: (202) 513-7625. Email:
Section 116(b)(2) of the Act provides that grants or contracts awarded under section 116 of the Act are subject to the terms and conditions of section 102 of the ISDEAA (25 U.S.C. 5321) and must be conducted in accordance with the provisions of sections 4, 5, and 6 of the Act of April 16, 1934 (25 U.S.C. 5345-5347), that are relevant to the programs administered under section 116(b) of the Act. Section 102 of the ISDEAA authorizes Indian Tribes to request self-determination contracts from the Department of Interior. Accordingly, an Indian Tribe or Tribal organization that has applied to the Secretary for financial assistance under NACTEP and has been notified of its selection to be a recipient of financial assistance may submit a request to both the Secretary of Education (via the contact person listed under
After successful applicants are selected under this NACTEP competition, the Secretary will review any requests to operate a project under an Indian self-determination contract pursuant to the ISDEAA. If a request for an Indian self-determination contract is approved, the Indian Tribe or Tribal organization submitting the request will be required, to the extent possible, to operate its project in accordance with the ISDEAA, relevant provisions in sections 4, 5, and 6 of the Act of April 16, 1934 (25 U.S.C. 5345-5347), the Act, and the non-statutory program requirements specified in this notice.
The CTE programs provided through an Indian self-determination contract would have to be essentially the same as were proposed in the initial application and approved by the Department. Any Indian Tribe or Tribal organization that is selected to receive funding under this competition, but whose request to operate the project under an Indian self-determination contract is denied, may appeal the denial to the Secretary. If you have questions about ISDEAA self-determination contracts, please contact the persons listed under
(a) Any Native, as so defined, either or both of whose adoptive parents are not Natives; and
(b) In the absence of proof of a minimum blood quantum, any citizen of the United States who is regarded as an Alaska Native by the Native village or Native group of which he or she claims to be a member and whose father or mother is (or, if deceased, was) regarded as Native by any village or group. Any decision of the Secretary of the Interior regarding eligibility for enrollment will be final. (20 U.S.C. 2326(a)(1); 43 U.S.C. 1602(b))
(a) A Bureau-operated elementary or secondary day or boarding school or Bureau-operated dormitory for students attending a school other than a Bureau school. (25 U.S.C. 2021(3) and (4));
(b) An elementary school, secondary school, or dormitory that receives financial assistance for its operation under a contract, grant, or agreement with the Bureau under section 102, 103(a), or 208 of the ISDEAA (25 U.S.C. 5321, 5322(a), or 5355) or under the Tribally Controlled Schools Act of 1988 (25 U.S.C. 2504
(c) A school for which assistance is provided under the Tribally Controlled Schools Act of 1988 (25 U.S.C. 2501
(a) Offer a sequence of courses that—
(1) Provides individuals with coherent and rigorous content aligned with challenging academic standards and relevant technical knowledge and skills needed to prepare for further education and careers in current or emerging professions;
(2) Provides technical skills proficiency, an industry-recognized credential, a certificate, or an associate degree; and
(3) May include prerequisite courses (other than a remedial course) that meet the requirements of this definition; and
(b) Include competency-based applied learning that contributes to the academic knowledge, higher-order reasoning and problem-solving skills, work attitudes, general employability skills, technical skills, and occupation-specific skills, and knowledge of all aspects of an industry, including entrepreneurship, of the individual. (20 U.S.C. 2302(5))
(a) An educational institution in any State that—
(1) Admits as regular students only persons having a certificate of graduation from a school providing secondary education, or the recognized equivalent of such a certificate;
(2) Is legally authorized within such State to provide a program of education beyond secondary education;
(3) Provides an educational program for which the institution awards a bachelor's degree or provides not less than a 2-year program that is acceptable for full credit toward such a degree, or awards a degree that is acceptable for admission to a graduate or professional degree program, subject to review and approval by the Secretary;
(4) Is a public or other nonprofit institution; and
(5) Is accredited by a nationally recognized accrediting agency or association or, if not so accredited, is an institution that has been granted pre-accreditation status by such an agency or association that has been recognized by the Secretary of Education for the granting of pre-accreditation status, and the Secretary of Education has determined that there is satisfactory assurance that the institution will meet the accreditation standards of such an agency or association within a reasonable time.
(b) The term also includes—
(1) Any school that provides not less than a 1-year program of training to prepare students for gainful employment in a recognized occupation and that meets the provisions of paragraphs (a)(1), (2), (4), and (5) of this definition.
(2) A public or nonprofit private educational institution in any State that, in lieu of the requirement in paragraph (a)(1) of this definition, admits as regular students persons who are beyond the age of compulsory school attendance in the State in which the institution is located. (20 U.S.C. 1001 and 2302(18))
(a) Individuals with disabilities;
(b) Individuals from economically disadvantaged families, including foster children;
(c) Individuals preparing for nontraditional fields;
(d) Single parents, including single pregnant women;
(e) Displaced homemakers; and
(f) Individuals with limited English proficiency. (20 U.S.C. 2302(29))
20 U.S.C. 2301,
The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian Tribes.
The Department is not bound by any estimates in this notice.
1.
(1) A federally recognized Indian Tribe.
(2) A Tribal organization.
(3) An Alaska Native entity.
(4) A Bureau-funded school, except for a Bureau-funded school proposing to use its award to support secondary school CTE programs.
(b) Any Tribe, Tribal organization, Alaska Native entity, or eligible Bureau-funded school may apply individually or as part of a consortium with one or more eligible Tribes, Tribal organizations, Alaska Native entities, or eligible Bureau-funded schools. (Eligible applicants seeking to apply for funds as a consortium must meet the requirements in 34 CFR 75.127-75.129, which apply to group applications.)
2. (a)
(b)
We caution applicants not to plan to use funds under NACTEP to replace otherwise available non-Federal funding for direct assistance to students and family assistance programs. For example, NACTEP funds must not be used to supplant Tribal and other non-Federal funds with Federal funds in order to pay the costs of students' tuition, dependent care, transportation, books, supplies, and other costs associated with participation in a CTE program.
Funds under NACTEP should not be used to replace Federal student financial aid. The Act does not authorize the Secretary to fund projects that serve primarily as entities through which students may apply for and receive tuition and other financial assistance.
(c)
1.
You may also obtain an application package via the internet from the following address:
If you use a TDD or a TTY, call the FRS, toll-free, at 1-800-877-8339.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2.
3.
A webinar for prospective applicants will be held for this competition shortly after this notice's publication date. The webinar is intended to provide technical assistance to all interested grant applicants. Information regarding the webinar can be found on the Perkins Collaborative Resource Network at
Applications for grants under this competition may be submitted electronically using the
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the persons listed under
4.
5.
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the System for Award Management (SAM), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet at the following website:
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.
The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.
Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through,
If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.
Information about SAM is available at
In addition, if you are submitting your application via
7.
Applications for grants under this program may be submitted electronically or in paper format by mail or hand delivery.
a.
We are participating as a partner in the Governmentwide
If you choose to submit your application electronically, you must use the Governmentwide
A
You may access the electronic grant application for NACTEP at
Please note the following:
• Your participation in
• Applications received by
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through
• You should review and follow the Education Submission Procedures for submitting an application through
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you submit your application in paper format.
• If you submit your application electronically, you must submit all documents electronically, including all information you typically provide on the following forms: the Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• If you submit your application electronically, you must upload any narrative sections and all other attachments to your application as files in a read-only, flattened Portable Document Format (PDF), meaning any fillable PDF documents must be saved as flattened, nonfillable files. Therefore, do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, flattened PDF (
• After you electronically submit your application, you will receive from
Once your application is successfully validated by
These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the persons listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the
b.
If you submit your application in paper format by mail (through the U.S. Postal Service or a commercial carrier), you must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.101A), LBJ Basement Level 1, 400 Maryland Avenue SW, Washington, DC 20202-4260.
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
We will not consider applications postmarked after the application deadline date.
c.
If you submit your application in paper format by hand delivery, you (or a courier service) must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.101A), 550 12th Street SW, Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
Note for Mail or Hand Delivery of Paper Applications: If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
The maximum score for each criterion is indicated in parentheses.
(a)
(b)
(1) The extent to which the services to be provided by the proposed project will create opportunities for students to receive an industry-recognized credential; become employed in high skill, high-wage, and high-demand occupations; or both. (Up to 20 points).
(2) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs, as evidenced by the applicant's description of programs and activities that align with the target population's needs. (Up to 10 points).
(3) The extent to which the proposed project will establish linkages with or will be coordinated with similar or related efforts, and with community, State, or Federal resources, where such opportunities and resources exist. (Up to 5 points).
(4) The extent to which the training or professional development services to be provided by the proposed project would be of sufficient quality, intensity, and duration to lead to improvements in practice among the project staff and instructors, including the extent to which the proposed training and professional development plans address ways in which learning gaps will be addressed and how continuous review of performance will be conducted to identify training needs. (Up to 5 points).
(c)
(1) The adequacy of support, including facilities, equipment, supplies, and other resources, from the applicant organization(s) and the Tribal entity or entities to be served. (Up to 5 points).
(2) The extent to which the budget is adequate and costs are reasonable in relation to the objectives of the proposed project. (Up to 5 points).
(3) The relevance and demonstrated commitment (
(4) The extent to which the project will use instructors who are certified to teach in the field in which they will provide instruction. (Up to 5 points).
(d)
(1) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and the milestones and performance standards for accomplishing project tasks. (Up to 10 points).
(2) The extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. (Up to 5 points).
(3) The extent to which the time commitments of the project director and other key project personnel are appropriate and adequate to meet the objectives of the proposed project. (Up to 5 points).
(4) The qualifications, including relevant training, expertise, and experience, of the project director, key personnel, and project consultants. (Up to 5 points).
(e)
(1) The extent to which the methods of evaluation proposed by the grantee are thorough, feasible, and include the use of objective performance measures that are clearly related to the intended outcomes of the project and the Government Performance and Results Act of 1993 (GPRA) performance measures. (Up to 5 points).
(2) The extent to which the methods of evaluation will provide performance feedback and continuous improvement toward achieving intended outcomes. (Up to 5 points).
2.
We will award—
(a) Up to 5 additional points to applications that propose exemplary approaches that involve, coordinate with, or encourage Tribal economic development plans; and
(b) Five points to applications from Tribally controlled colleges or universities that—
(1) Are accredited or are candidates for accreditation by a nationally recognized accreditation organization as an institution of postsecondary CTE; or
(2) Operate CTE programs that are accredited or are candidates for accreditation by a nationally recognized accreditation organization and issue certificates for completion of CTE programs (20 U.S.C. 2326(e)).
3.
In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
4.
5.
Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
4.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
5.
(a) At the secondary level: An increase in the percentage of CTE students who—
(1) Attain academic proficiency, as demonstrated by meeting academic content standards and student academic achievement standards that meet challenging State-defined academic standards for reading/language arts and mathematics;
(2) Attain career and technical skill proficiencies, including student achievement on technical assessments that are aligned with industry-recognized standards;
(3) Attain a secondary school diploma;
(4) If a credential, certificate, or degree is offered by the State in which the project operates, in conjunction with a secondary school diploma, attain a proficiency credential, certificate, or degree in conjunction with a secondary school diploma; or
(5) Are placed in—
(i) Postsecondary education or advanced training;
(ii) Military service; or
(iii) Employment.
(b) At the postsecondary level: An increase in the percentage of CTE students who—
(1) Attain challenging career and technical skill proficiencies, including student achievement on technical assessments that are aligned with industry-recognized standards;
(2) Attain an industry-recognized credential, a certificate, or a degree;
(3) Are retained in postsecondary education or transfer to a baccalaureate degree program;
(4) Are placed in—
(i) Military service; or
(ii) Apprenticeship programs; or
(5) Are placed or have been retained in employment, including in high-skill, high-wage, or high-demand occupations or professions.
(c) At the adult education level: An increase in the percentage of participating adult career and technical education students who—-
(1) Enroll in a postsecondary education or training program;
(2) Attain career and technical education skill proficiencies aligned with industry-recognized standards;
(3) Receive industry-recognized credentials or certificates; or
(4) Are placed in a job, upgraded in a job, or retain employment.
All grantees will be expected to submit an annual performance report addressing these performance measures, to the extent feasible and to the extent that they apply to each grantee's NACTEP project.
6.
In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
You may also access documents of the Department published in the
Office of Elementary and Secondary Education (OESE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.
Interested persons are invited to submit comments on or before March 7, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Patrick Carr, 202-708-8196.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Career, Technical, and Adult Education, Department of Education.
Notice.
The Secretary announces tests, test forms, and delivery formats that the Secretary determines to be suitable for use in the National Reporting System for Adult Education (NRS).
Jay LeMaster, Department of Education, 400 Maryland Avenue SW, Room 11-152, Potomac Center Plaza, Washington, DC 20202-7240. Telephone: (202) 245-6218 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
On January 14, 2008, we published in the
On December 13, 2016, the Secretary published in the
On September 7, 2017, the Secretary published in the
In addition to the tests identified in the December 2016 and September 2017 notices as determined to be suitable for use in the NRS through February 2, 2019, and September 7, 2024, respectively, the Secretary now announces another test and test forms that have been determined to be suitable for use in the NRS, in accordance with § 462.13. This test measures the NRS educational functioning levels for Literacy/English Language Arts at all Adult Basic Education (ABE) levels, as described in Appendix A of
Adult education programs must use only the approved forms and computer-based delivery formats for the tests published in this document. If a particular test form or computer delivery format is not explicitly specified for a test in the December 2016 notice, the September 2017 notice, or in this notice, it is not approved for use in the NRS.
The Secretary has determined that the following test is suitable for use in Literacy/English Language Arts at all ABE levels of the NRS for a period of seven years from the date of publication of this notice:
Under certain circumstances, the Secretary may revoke the determination that a test is suitable (see § 462.12(e)). If the Secretary revokes the determination of suitability, the Secretary announces through the
You may also access documents of the Department published in the
29 U.S.C. 3292.
Take notice that the Commission received the following electric rate filings:
Description: Compliance filing: Compliance Filing of Executed Coyote 1 Station Transmission Facilities Agreement to be effective 12/24/2017.
Take notice that the Commission received the following public utility holding company 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 the Commission received the following exempt wholesale generator 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:
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission and/or Commission staff may attend the following meetings:
Further information regarding these meetings may be found at:
The discussions at the meetings, which are open to the public, may address matters at issue in the following Commission proceedings:
For further information, please contact Jonathan First, 202-502-8529, or
1. By letter filed January 17, 2018, George S. Cook, Manager, Hydrodyne Industries, LLC, exemptee and Michael Rickly P.E., Manager, Hydrodyne Energy, LLC informed the Commission that the exemption from licensing for the Little River Hydroelectric Project No. 3932, originally issued May 4, 1982
2. Hydrodyne Energy, LLC is now the exemptee of the Little River Hydroelectric Project No. 3932. All correspondence should be forwarded to: Mr. Michael Rickly P.E., Manager, Hydrodyne Energy, LLC, 1700 Joyce Ave., Columbus, OH 43219, Phone: 614-297-9877, Cell: 614-648-2466, Fax: 614-297-9878, Email:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l. With this notice, we are designating White Pine Hydro as the Commission's non-federal representative for carrying out informal consultation, pursuant to section 7 of the Endangered Species Act and section 106 of the National Historic Preservation Act.
m. White Pine Hydro filed with the Commission a Pre-Application Document (PAD; including a proposed process plan and schedule), pursuant to 18 CFR 5.6 of the Commission's regulations.
n. A copy of the PAD is available for review at the Commission in the Public Reference Room, or may be viewed on the Commission's website (
Register online at
o. With this notice, we are soliciting comments on the PAD and Commission staff's Scoping Document 1 (SD1), as well as study requests. All comments on the PAD and SD1, as well as study requests should be sent to the address above in paragraph h. In addition, all comments on the PAD and SD1, study requests, requests for cooperating agency status, and all communications to and from Commission staff related to the merits of the potential application must be filed with the Commission. Documents may be filed electronically via the internet.
All filings with the Commission must include on the first page, the project name (Hiram Hydroelectric Project and number (P-2530-054), and bear the appropriate heading: “Comments on Pre-Application Document,” “Study Requests,” “Comments on Scoping Document 1,” “Request for Cooperating Agency Status,” or “Communications to and from Commission Staff.” Any individual or entity interested in submitting study requests, commenting on the PAD or SD1, and any agency requesting cooperating status must do so by March 30, 2018.
p. Although our current intent is to prepare an environmental assessment (EA), there is the possibility that an Environmental Impact Statement (EIS) will be required. Nevertheless, the meetings listed below will satisfy the NEPA scoping requirements, irrespective of whether an EA or EIS is issued by the Commission.
Commission staff will hold two scoping meetings in the vicinity of the project at the time and place noted below. The daytime meeting will focus on resource agency, Indian tribes, and non-governmental organization concerns, while the evening meeting is primarily for receiving input from the public. We invite all interested agencies, Indian tribes, organizations, and individuals to attend one or both of the meetings, and to assist staff in identifying particular study needs, as well as the scope of environmental issues to be addressed in the environmental document. The times and locations of these meetings are as follows:
SD1, which outlines the subject areas to be addressed in the environmental document, was mailed to the individuals and entities on the Commission's mailing list. Copies of SD1 will be available at the scoping meetings, or may be viewed on the web at
The potential applicant and Commission staff will conduct an Environmental Site Review of the project on Thursday, March 1, 2018, starting at 2:00 p.m. All participants should meet at White Pine Hydro's Hiram Dam, located at 45 Hiram Dam Road, Baldwin, ME 04091. All participants are responsible for their own transportation. Anyone with questions about the site visit should contact Mr. Frank Dunlap of White Pine Hydro at (207) 755-5603 on or before February 20, 2018.
Meeting participants should come prepared to discuss their issues and/or concerns. Please review the PAD in preparation for the scoping meetings. Directions on how to obtain a copy of the PAD and SD1 are included in item n. of this notice.
The meetings will be recorded by a stenographer. The transcripts will be placed in the public record for the project.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report 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 the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities 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 January 26, 2018, pursuant to section 206 and 306 of the Federal Power Act, 16 U.S.C. 824e, 825e, and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, .212, the Oklahoma Municipal Power Authority (Complainant) filed a formal complaint against Oklahoma Gas and Electric Company (Respondent) alleging that the formula rate used by Respondent to determine the charges for transmission service in Zone 7 of the Southwest Power Pool is unjust and unreasonable, all as more fully explained in the complaint.
Complainant certifies that copies of the complaint were served on the 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 Complainant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
On November 29, 2017, Watterra Energy, LLC, filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Sutton Dam Hydroelectric Project to be located at the U.S. Army Corps of Engineers' (Corps) Sutton Dam, on the Elk River, in Sutton, Braxton County, West Virginia. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of the following: (1) A new 70-foot-long, 55-foot-wide powerhouse containing three turbine-generator units with a total rated capacity of 14 megawatts; (2) a new multiple-port intake structure to be located at the upstream face of the Sutton dam; (3) a new 300-foot-long, 15-foot-diameter steel penstock; (4) a new 50-foot-long, 50-foot-wide switchyard; (5) a new 13.8-kilovolt, 500-foot-long transmission line; and (6) appurtenant facilities. The proposed project would have an annual generation of 47,200 megawatt-hours.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's website 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, interventions, and protests is February 28, 2018. The Commission strongly encourages electronic filing. Please file motions to intervene, protests and comments using the Commission's eFiling system at
k.
l. This filing may be viewed on the Commission's website 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.
o.
This is a supplemental notice in the above-referenced proceeding of Grid Power Direct, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 20, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report 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:
Federal Communications Commission.
Notice of availability.
In this document, the Consumer and Governmental Affairs Bureau announces the availability of the FCC order terminating, as dormant, certain docketed Commission proceedings.
The dockets are terminated as of February 5, 2018.
Micah Caldwell, Consumer and Governmental Affairs Bureau at (202) 418-1316 or by email at
The Commission's Order,
Federal Communications Commission.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC) Technological Advisory Council will hold a meeting.
Wednesday, March 7th, 2018 in the Commission Meeting Room, from 10:00 a.m. to 3:00 p.m.
Federal Communications Commission, 445 12th Street SW, Washington, DC 20554.
Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807;
This is the first meeting of the Technological Advisory Council for 2018. At its prior meeting on December 6th, 2017, the Council had discussed possible work initiatives for 2018. These initiatives have been discussed in the interim within the FCC, with the TAC chairman, as well as with individual TAC members. At the June meeting, the FCC Technological Advisory Council will discuss its proposed work program for 2018. The FCC will attempt to accommodate as many people as possible. However, admittance will be limited to seating availability. Meetings are also broadcast live with open captioning over the internet from the FCC Live web page 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, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. 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 OMB 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 OMB control number.
Written PRA comments should be submitted on or before April 6, 2018. 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 to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The information collection contained in Section 20.21(a)(2) affects individuals or households; thus, there are impacts under the Privacy Act. However, the government is not directly collecting this information and the R&O directs carriers to protect the information to the extent it is considered Customer Proprietary Network Information (CPNI).
Based upon the foregoing, the receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201. No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
Thursday, February 8, 2018 at 11:00 a.m.
999 E Street NW, Washington, DC (Ninth Floor).
This meeting will be open to the public.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Dayna C. Brown, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.
Thursday, February 8, 2018 at 10:00 a.m.
999 E Street NW, Washington, DC (Ninth Floor).
This hearing will be open to the public.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Dayna C. Brown, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.
Appraisal Subcommittee of the Federal Financial Institutions Examination Council
Notice of meeting.
If you plan to attend the ASC Meeting in person, we ask that you send an email to
Public Building Service (PBS), General Services Administration (GSA).
Notice of intent; announcement of meeting.
Pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA), the Council on Environmental Quality Regulations, and the GSA Public Buildings Service NEPA Desk Guide, GSA is issuing this notice to advise the public that a Supplemental Environmental Impact Statement (SEIS) will be prepared for the proposed construction of the Madawaska-Edmundston International Bridge and New Land Port of Entry (the Project).
Madawaska High School Cafeteria, 135 7th Avenue, Madawaska, Maine 04756. The session format includes a 30-minute Open House, followed by formal presentation and Question & Answer session.
Written comments can be submitted by either of the following methods:
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Alexas Kelly, Project Manager, GSA, New England Region, at email
The purpose of the Project is to provide for the long-term safe and efficient flow of current and projected traffic volumes, including the movement of goods and people between Edmundston, New Brunswick and Madawaska, Maine. The Project is needed because (1) the existing International Bridge is nearing the end of its useful life, and (2) the existing Madawaska Land Port of Entry is substandard, inhibiting the agencies assigned to the Port from adequately fulfilling their respective missions.
The existing Madawaska-Edmundston International Bridge, opened in 1921, and its design life has exceeded. Notable bridge deficiencies are (1) substandard geometry—roadway width & clearance, (2) foundation susceptible to undermining, (3) piers cracked and deteriorated, (4) significant steel corrosion, (5) bridge capacity is insufficient, and (6) deficiencies prompting the bridge posting on October 27, 2017, from 50 tons to 5 tons.
A Final Environmental Impact Statement (FEIS) and Record of Decision (ROD) were published in January 2007, which addressed the construction of a new Madawaska LPOE.
Built in 1959, the current LPOE suffers from facility, operational and site deficiencies, and does not meet current Customs and Border Protection (CBP) mission & operational requirements for an LPOE. A few noted deficiencies: (1) Lack of office and inspection areas, (2) deficient inbound and outbound passenger and commercial processing areas, (3) inadequate queuing space for vehicles, and (4) inability to meet the Architectural Barriers Act. In furtherance of the LPOE Project, GSA previously acquired approximately nine acres of land, but did not commence construction.
An SEIS is needed due to a change in circumstance, specifically the decision by MaineDOT and New Brunswick Department of Transportation and Infrastructure (NBTI), which requires the existing Edmundston/Madawaska International Bridge be replaced and removed. The SEIS will address changes to the Project, including an updated design in accordance with current GSA and CBP requirements, and a reconfigured International Bridge approach (the totality of which may require additional land acquisition).
Scoping will be accomplished through this public meeting, and direct mail correspondence, to appropriate Federal, state, and local agencies, and to private organizations and citizens who have previously expressed, or are known to have, an interest in the Project.
The primary purpose of the scoping process is for the public to assist GSA in developing the SEIS by identifying and determining the range and extent of relevant issues related to the Project. Alternatives will be developed with input from the local community through the scoping process. GSA will provide public notice of this and any subsequent public meetings in local newspapers, radio announcements, postings in prominent town locations, and other outreach actions.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) 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;
(b) 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;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) 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,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Implementing the 6|18 Initiative: Case Studies—New—Office of the Director (OD), Centers for Disease Control and Prevention (CDC).
Major trends in health care, such as alternative payment and delivery models, facilitate the delivery of greater comprehensive care and prevention. Public health departments have leveraged their resources to complement those of the health care sector, to impact population health.
In this context, CDC developed the CDC's 6|18 Initiative to provide health care purchasers, payers, and providers with rigorous evidence about high-burden health conditions and associated evidence-based interventions. With a focus on the greatest short-term health and potential cost impact (generally in less than five years), the evidence informs their coverage decisions.
The name “6|18” comes from the initial focus on six common, costly and preventable health conditions (tobacco use, high blood pressure, diabetes, asthma, healthcare-associated infections and unintended pregnancies) and 18 evidence-based interventions. For more information, please see
The 6|18 initiative links health care and public health by providing a shared focus across prevention interventions ranging from traditional clinical settings to care outside the clinical setting. Public health's strength in analyzing scientific evidence complements the purchaser, payer, and provider role of financing and delivering care.
Since public health-health care collaboration to improve population health is still not a standard practice, there are few or no case studies on public health-health care collaboration around increasing preventive service utilization. CDC intends to fill this gap through this data collection.
CDC and its partners provided technical assistance to 17 teams (
To document qualitative lessons learned related to the collaboration, CDC and its cooperative agreement sub-contractor, George Washington University, plan to conduct in-person and telephone semi-structured individual interviews with state Public Health Department and State Medicaid Agency officials.
Interview participants will have been directly involved in conceptualizing, planning, and/or implementing 6|18 Initiative-related activities, and will have participated in the cross-sector collaboration. CDC plans to engage up to 82 respondents (four to seven officials from each of the 17 state teams who participated in the 6|18 Initiative). The officials from each state team will be leadership and staff from public health agencies at the state, city, and tribal level. For each state, we will request interviews with: One Public Health Division Director, one to four Public Health Services Managers (one per health condition), one Medicaid Director, and one Medicaid Services Manager. When joining the 6|18 Initiative, each state selected one to four conditions from the list of 6|18 conditions, and assigned one public health manager to each condition.
CDC plans to administer the interviews from 2018 to 2021, to allow time for unanticipated delays; and to accommodate state team schedules, busy seasons, and holidays. All participants will speak in their official capacity as state public health department or Medicaid agency officials. Prior to granting public access to written products, CDC will provide participants the opportunity to review written products.
CDC anticipates using the interview findings: (1) To describe, disseminate, and scale best practices to participating and non-participating states, and (2) for program improvement of the CDC's 6|18 Initiative. CDC will disseminate findings via written products such as peer-reviewed manuscripts and in-depth written case studies. The written products, which will share lessons learned and effective approaches to collaboration, can inform and potentially accelerate related efforts by other state teams. In addition, 6|18 participants can use findings and written products to highlight their accomplishments to their stakeholders, such as their Medicaid leadership, and/or governors.
Participants will have a maximum estimated burden of one hour and 15 minutes: One hour for the interview, and fifteen minutes for any needed preparation. All interviews will be based on the same interview guide.
OMB approval is requested for three years. An annualized average of 29 interviews will be conducted per year. Participation is voluntary and respondents will not receive incentives for participation. There are no costs to
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled “Gonococcal Isolate Surveillance Project (GISP)”. The purpose of GISP is to monitor trends in antimicrobial resistance in N. gonorrhoeae strains in the United States in order to establish a scientific basis for the selection of gonococcal therapies and to allow proactive changes to treatment guidelines before widespread resistance and failures of treatment occur.
CDC must receive written comments on or before April 6, 2018.
You may submit comments, identified by Docket No. CDC-2018-0019 by any of the following methods:
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Submit all comments through the Federal eRulemaking portal (
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. 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;
2. 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;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. 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,
5. Assess information collection costs.
Gonococcal Isolate Surveillance Project (OMB Control Number 0920-0307, Expiration 2/28/2019)—Revision—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
The Gonococcal Isolate Surveillance Project (GISP) was created in 1986 to monitor trends in antimicrobial susceptibilities of N. gonorrhoeae strains in the United States. Data from GISP are used to establish a scientific basis for the selection of gonococcal therapies and to allow pro-active changes to treatment guidelines before widespread resistance and failures of treatment occur. To increase capacity to detect and monitor resistant gonorrhea and improve the specificity of GISP, this submission is a revision to include collection of additional isolates and data elements.
The Centers for Disease Control and Prevention has designated N. gonorrhoeae as one of three “urgent” antibiotic resistance threats in the United States. The CDC is requesting a three-year OMB approval for this revision, which directly responds to the
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled National Surveillance for Severe Adverse Events Among Persons on Treatment of Latent Tuberculosis Infection to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on August 22, 2017 to obtain comments from the public and affected agencies. CDC received one substantive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) 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,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
National Surveillance for Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection—(0920-0773, expiration 01/31/2018)—Extension—Division of Tuberculosis Elimination (DTBE), National Center for HIV, Viral Hepatitis, STD, and TB Prevention NCHHSTP), Centers for Disease Control and Prevention (CDC).
This project seeks a three-year extension to continue the passive reporting system for severe adverse events (SAEs) associated with therapy for Latent Tuberculosis Infection (LTBI). The system will rely on medical chart review and/or onsite investigations by TB control staff. In 2004, CDC began collecting reports of SAEs associated with any treatment regimen for LTBI. For surveillance purposes, an SAE was defined as any drug-associated reaction resulting in a patient's hospitalization or death after at least one treatment dose for LTBI. Reports of SAEs related to rifampicin plus pyrazinamide (RZ) and isoniazid (INH) INH have prompted a need for this project a national surveillance system of such events.
The objective of the project is to determine the annual number and temporal trends of SAEs associated with any treatment for LTBI in the United States. Surveillance of such events will provide data to support periodic evaluation or potential revision of guidelines for treatment of persons with LTBI.
Potential respondents are any of the 60 reporting areas for the national TB surveillance system (the 50 states, the District of Columbia, New York City, Puerto Rico, and 7 jurisdictions in the Pacific and Caribbean). Data will be collected using the data collection form for SAEs associated with LTBI treatment. The data collection form is completed by healthcare providers and health departments for each reported hospitalization or death related to treatment of LTBI and contains demographic, clinical, and laboratory information. Reporting of SAEs will be conducted through telephone, email, or during CDC site visits.
CDC will analyze and periodically publish reports summarizing national LTBI treatment adverse events statistics and will conduct special analyses for publication in peer-reviewed scientific journals to further describe and interpret these data.
In this extension request, CDC is requesting approval for approximately 60 burden hours annually. There is no cost to respondents.
OMB previously approved data collection under OMB Control Number 0970-0462 for: the HPOG 2.0 National and Tribal Evaluation (Approved August 2015); and the National Evaluation impact study; the National Evaluation descriptive study; and the Tribal Evaluation (All approved June 2017). The proposed data collection activities described in this
In subsequent requests for clearance, we will submit (1) additional data collection instruments to support the descriptive study of the 27 non-tribal grantees participating in the HPOG 2.0 National Evaluation, including grantee interview guides and participant interview guides; and (2) the second follow-up survey—the Intermediate Follow-up Survey—for the HPOG 2.0 National Evaluation impact study. The second follow-up survey is for collecting data from both treatment and control group members at the 27 non-tribal grantees, approximately 36 months after baseline data collection and random assignment. This submission will also include data collection necessary for the National Evaluation's cost benefit analysis.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VIBERZI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (in the
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 6, 2018. The
Submit electronic comments in the following way:
•
• 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:
•
• For written/paper comments submitted to the Dockets Management Staff, 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product VIBERZI (eluxadoline). VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea. Subsequent to this approval, the USPTO received patent term restoration applications for VIBERZI (U.S. Patent Nos. 7,741,356; 8,344,011; and 8,609,709) from Janssen Pharmaceutica, N.V., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated August 12, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of VIBERZI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for VIBERZI is 2,716 days. Of this time, 2,381 days occurred during the testing phase of the regulatory review period, while 335 days occurred during the approval phase. These periods of time were derived from the following dates:
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3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 428 days, 606 days, or 431 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice of availability; correction.
The Food and Drug Administration is correcting a notice entitled “Hazard Analysis and Risk-
Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.
In the
1. On page 3163, in the first column, in the header of the document, the docket number is corrected to read “FDA-2018-D-0388”.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by March 7, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
With regard to adverse events and product/manufacturing defects associated with approved new animal drugs, section 512(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(l)) requires applicants with approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) to establish and maintain records and reports of data relating to experience with uses of such drug, or with respect to animal feeds bearing or containing such drug, to facilitate a determination under section 512(e) as to whether there may be grounds for suspending or withdrawing approval of the NADA or ANADA under section 512(e) or 512(m)(4). Sections 571(e)(3) and 512(e)(2) of the FD&C Act (21 U.S.C. 360ccc(e)(3) and 360b(e)(2)) require that applicants with conditionally approved new animal drug applications (CNADAs) maintain adequate records and make reports in accordance with a regulation or order issued under section 512(l). Finally, section 512(m)(5) of the FD&C Act requires an applicant for a license to manufacture animal feeds bearing or containing new animal drugs to maintain adequate records and make reports “as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine” whether there may be grounds for suspending or withdrawing approval of the new animal drug under section 512(e) or a license to manufacture animal feeds bearing or containing new animal drugs under section 512(m)(4).
Section 514.80 of our regulations (21 CFR 514.80) sets forth the recordkeeping and reporting requirements for applicants and nonapplicants of approved NADAs and ANADAs. Section 510.301 of our regulations (21 CFR 510.301) sets forth the recordkeeping and reporting requirements for licensed medicated feed manufacturing facilities.
Since the consolidation of the 0910-0012 collection into this collection in 2004, we have included the estimated number of medicated feed adverse event reports as part of our estimate of the number of all mandatory adverse event reports for new animal drugs. To improve the clarity of our estimates, we have added a row to table 1, on which we separately report our estimates of medicated feed reports.
The continuous monitoring of approved NADAs, ANADAs, CNADAs, and animal feeds bearing or containing new animal drugs affords the primary means by which we obtain information regarding potential problems with the safety and efficacy of marketed approved new animal drugs, as well as potential product/manufacturing problems. Postapproval marketing surveillance is important because data previously submitted to us may not be adequate as animal drug effects can change over time and less apparent effects may take years to manifest.
In the
FDA estimates the burden of this collection of information as follows:
We base our reporting and recordkeeping estimates on our experience with adverse event reporting for approved new animal drugs and the number of reports received in the previous 3 years. Since the
The burden of this collection has changed. There was a slight increase in the estimated number of reports submitted to FDA under total annual responses (by 7.8 responses) and there was a slight overall decrease in burden hours (by 1.75 hours). This minor fluctuation in responses and hours is due to the normal variation in the submission of reports to FDA, the correction of mathematical errors, and a change in reporting methodology (addition of a new row to table 1 and table 2).
We continually strive to improve our systems for collecting and analyzing drug experience reports and adverse event reports. To that end, we have developed an electronic submission system by which Form FDA 2301 may be submitted to the Agency. For Form FDA 1932a, we have a fillable electronic form available online, which can be submitted by email to FDA Center for Veterinary Medicine. We specifically invite comment from respondents on the utility of these reporting forms. Electronic adverse event reporting for approved new animal drugs (including mandatory reporting under § 514.80(b) and voluntary reporting) has been approved under OMB control number 0910-0645. Reporting and recordkeeping associated with the index of legally marketed unapproved new animal drugs for minor species (21 CFR part 516) is approved under OMB control number 0910-0620.
Notice of public meetings.
This notice announces the 2018 meetings of the Physician-Focused Payment Model Technical Advisory Committee (hereafter referred to as “the Committee”) which will be held in Washington, DC. This meeting will include voting and deliberations on proposals for physician-focused payment models (PFPMs) submitted by members of the public. All meetings are open to the public.
The 2018 PTAC meetings will occur on the following dates:
Please note that times are subject to change. If the times change, registrants will be notified directly via email.
All PTAC meetings will be held in the Great Hall of the Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201.
Ann Page, Designated Federal Official, at the Office of Health Policy, Assistant Secretary for Planning and Evaluation (ASPE), U.S. Department of Health and Human Services, 200 Independence Ave. SW, Washington, DC 20201, (202) 690-6870.
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The following information is submitted when registering:
Name:
Company/organization name:
Postal address:
Email address:
A confirmation email will be sent to registrants shortly after completing the registration process.
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Additional material for this meeting can be found on the ASPE PTAC website. For updates and announcements, please use the link to subscribe to the ASPE PTAC email listserv.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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, 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.
Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, March 13, 2018, 4:00 p.m. to March 14, 2018, 5:00 p.m., Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852 which was published in the
This meeting notice is amended to change the meeting name from “TEP-1: Development of Software Tools for Post Radiation Therapy Surveillance” to
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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, 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.
Notice is hereby given of a change in the meeting of the Integrative Nutrition and Metabolic Processes Study Section, February 8, 2018, 8:00 a.m. to February 9, 2018, 1:00 p.m., Westin Grand, 2350 M Street NW, Washington, DC 20037 which was published in the
The meeting will be held on February 7, 2018, 5:00 p.m. and end on February 8, 2018, 6:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Molecular and Cellular Endocrinology Study Section, February 8, 2018, 8:00 a.m. to February 9, 2018, 5:00 p.m., Ritz-Carlton Hotel at Pentagon City, 1250 South Hayes Street, Arlington, VA 22202 which was published in the
This meeting will be held on February 7, 2018 at 5:30 p.m. and end February 8, 2018 8:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the National Cancer Advisory Board, February 13, 2018, 1:00 p.m. to February 13, 2018, 4:00 p.m., National Cancer Institute Shady Grove, Shady Grove, 9609 Medical Center Drive, TE 406, Rockville, MD 20850 which was published in the
The meeting notice is being amended to change the meeting times for the open and closed sessions. The open session will he held from 1:00 p.m. to 3:10 p.m. The closed session will be held from 3:25 p.m. to 4:25 p.m. The meeting is partially closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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, notice is hereby given of a meeting of the National Heart, Lung, and Blood Advisory Council.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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.
Contact Person: Laura K. Moen, Ph.D., Director, Division of Extramural Research Activities, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7100, Bethesda, MD 20892, 301-435-0260
This notice is being published less than 15 days prior to the meeting due to the timing
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Notice is hereby given of a change in the meeting of the National Advisory Environmental Health Sciences Council, February 12, 2018, 8:30 a.m. to February 13, 2018, 10:30 a.m., National Institute of Environmental Health Sciences, Building 101, Rodbell Auditorium, 111 T. W. Alexander Drive, Research Triangle Park, NC 27709, which was published in the
Due to the government operating under the strong possibility of the current Continuing Resolution ending before the original scheduled Council date, it would be difficult to reschedule the grant review within the given Council round. The institute made the decision to hold an abbreviated Closed session of Council via teleconference on Wednesday, February 7, 2018, 2:00 p.m. They were counseled to post this information on their IC website. This meeting is closed to the public.
The open session of the National Advisory Environmental Health Sciences Council will be held as originally scheduled on February 12, 2018, 8:30 a.m. to 6:00 p.m. at the National Institute of Environmental Health Sciences, Building 101, Rodbell Auditorium, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. This meeting is open to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 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, 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 Public Law 92-463, notice is hereby given of the combined meeting on February 15, 2018, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) four National Advisory Councils: The SAMHSA National Advisory Council (NAC), the Center for Mental Health Services NAC, the Center for Substance Abuse Prevention NAC, the Center for Substance Abuse Treatment NAC; and the two SAMHSA Advisory Committees: Advisory Committee for Women's Services (ACWS) and the Tribal Technical Advisory Committee (TTAC).
SAMHSA's National Advisory Councils were established to advise the
Under Section 501 of the Public Health Service Act, the ACWS is statutorily mandated to advise the SAMHSA Assistant Secretary for Mental Health and Substance Use and the Associate Administrator for Women's Services on appropriate activities to be undertaken by SAMHSA and its Centers with respect to women's substance abuse and mental health services.
Pursuant to Presidential Executive Order No. 13175, November 6, 2000, and the Presidential Memorandum of September 23, 2004, SAMHSA established the TTAC for working with Federally-recognized Tribes to enhance the government-to-government relationship, and honor Federal trust responsibilities and obligations to Tribes and American Indian and Alaska Natives. The SAMHSA TTAC serves as an advisory body to SAMHSA.
The meeting will include remarks from the Assistant Secretary for Mental Health and Substance Use; SAMHSA's priorities and updates by the Centers and Office Directors; a presentation on the Report to Congress on the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC); a presentation on SAMHSA's role in recent behavioral health responses to disasters; and a council discussion.
The meeting is open to the public and will be held at the Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, MD 20857. Attendance by the public will be limited to space available. Interested persons may present data, information, or views orally or in writing, on issues pending before the Council. Written submissions should be forwarded to the contact person by February 8, 2018. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations are encouraged to notify the contact by February 8, 2018. Five minutes will be allotted for each presentation.
The meeting may be accessed via telephone and web conferencing will be available. To attend on site: Obtain the call-in number, access code, and/or web access link; submit written or brief oral comments; or request special accommodations for persons with disabilities, please register on-line at:
Meeting information and a roster of Council members may be obtained either by accessing the SAMHSA Council's website at
Pursuant to Public Law 92-463, notice is hereby given of the meeting on February 16, 2018, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC).
The SAMHSA NAC was established to advise the Secretary, Department of Health and Human Services (HHS), and the Assistant Secretary for Mental Health and Substance Use, SAMHSA, to improve the provision of treatments and related services to individuals with respect to substance use and to improve prevention services, promote mental health, and protect legal rights of individuals with mental illness and individuals who are substance users.
The meeting will include remarks from the Assistant Secretary for Mental Health and Substance Use; updates from the Department of Health and Human Services' Operating Divisions; updates from the ex-officio members, and a council discussion.
The meeting is open to the public and will be held at the Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, MD 20857. Attendance by the public will be limited to space available. Interested persons may present data, information, or views orally or in writing, on issues pending before the Council. Written submissions should be forwarded to the contact person by February 8, 2018. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations must notify the contact person by February 8, 2017. Five minutes will be allotted for each presentation.
The meeting may be accessed via telephone. To attend on site; obtain the call-in number, access code, and/or web access link; submit written or brief oral comments; or request special accommodations for persons with disabilities, please register on-line at:
Meeting information and a roster of Council members may be obtained either by accessing the SAMHSA Council's website at
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of final determinations.
This document provides notice that U.S. Customs and Border Protection (“CBP”) has issued 11 final determinations concerning the country of origin of certain pharmaceutical products. Based upon the facts presented, CBP has concluded that the country of origin of the Rosuvastatin Calcium Tablets, Levofloxacin Tablets, Levetiracetam Tablets, Metoprolol Tartrate Tablets, Gabapentin Capsules, Carvedilol Tablets, Paroxetine Hydrochloride Tablets, Entecavir Tablets, Montelukast Sodium Tablets, Simvastatin Tablets, Donepezil Hydrochloride Tablets is India for purposes of U.S. Government procurement.
These final determinations were issued on January 30, 2018. Copies of the final determinations are attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of these final determinations within March 7, 2018.
Elif Eroglu, Valuation and Special Programs Branch, Regulations and Rulings, Office of Trade, (202) 325-0277.
Notice is hereby given that on January 30, 2018 CBP issued 11 final determinations concerning the country of origin of certain pharmaceutical products, which may be offered to the U.S. Government under an undesignated government procurement contract pursuant to subpart B of part 177, CBP Regulations (19 CFR part 177, subpart B). These final determinations (H289700, H289701, H289702, H289704, H289706, H289710, H289711, H289712, H289713, H289714, and H289715), were issued under procedures set forth at 19 CFR part 177, subpart B, which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-18). In the final determinations, CBP concluded that the processing in the United States does not result in a substantial transformation. Therefore, the country of origin for purposes of U.S. Government procurement of the pharmaceutical products is India, the country where the active pharmaceutical ingredient was produced.
Section 177.29, CBP Regulations (19 CFR 177.29), provides that a notice of final determination shall be published in the
This is in response to your correspondence of July 7, 2017, requesting a final determination on behalf of Acetris Health, (“Acetris”)
This final determination concerns the country of origin of the Rosuvastatin Calcium tablets. We note that Acetris is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination.
You have asked that certain information submitted in connection with this ruling request be treated as confidential. Inasmuch as this request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), the request for confidentiality is approved. The information contained within brackets in your request will not be released to the public and will be withheld from published versions of this ruling.
The merchandise at issue are Rosuvastatin Calcium tablets. You state that Acetris is a generic pharmaceutical distributor specializing in providing cost effective products to the U.S. Government. Acetris has its principal place of business in Allendale, NJ. Among the products Acetris sells to the U.S. Government are Rosuvastatin Calcium tablets, members of a family of statin drugs prescribed for the reduction of cholesterol and triglyceride levels and prevention of heart attacks and strokes.
You state that Acetris procures the Rosuvastatin Calcium tablets from Aurolife Pharma LLC (“Aurolife”), located in Dayton, NJ. Aurolife, which is a wholly-owned subsidiary of company X in India, is a generic pharmaceutical product manufacturer in the specialty and niche areas. Aurolife manufactures the Rosuvastatin Calcium tablets supplied to Acetris in a U.S. Food & Drug Administration (“FDA”) approved cGMP compliant manufacturing facility, located in Dayton, NJ, from several active and inactive ingredients procured domestically and abroad. The active pharmaceutical ingredient (“API”) of the Rosuvastatin Calcium tablets is Rosuvastatin Calcium, which Aurolife sources from company X in India.
You state that the Rosuvastatin Calcium tablets supplied to Acetris are the result of a complex production process that occurs in Aurolife's New Jersey facility involving the combination of the API with several inactive ingredients, including some intermediates that are mixed in order to aid the conversion of the multiple ingredients. The production of Rosuvastatin employs processes that convert these ingredients into finished, medically effective dosage tablets (5 mg, 10 mg, 20 mg, and 40 mg tablets). You state that this processing changes the properties and characteristics of the API, materially enhancing the pharmacokinetics of the resulting drug.
You state that the process of converting these multiple ingredients into the Rosuvastatin Calcium tablets occurs entirely within the United States. The ingredients processed in the United States are sourced from a variety of suppliers, both United States and foreign, as follows:
The processing that occurs in the United States includes the following:
• Microcrystalline cellulose, lactose monohydrate, and dibasic calcium phosphate anhydrous are added to the Rosuvastatin Calcium API as adjuvant to improve the bioavailability/absorption, leading to pharmacokinetic profiles equivalent to the brand product (Crestor®) for therapeutic equivalency. These four excipients are blended according to a set protocol and blending times to ensure proper mixing. Dibasic Calcium Phosphate anhydrous is a key ingredient, addition of which results in a drug product with a higher pH than the API, preventing the instability, variable potency and formation of hazardous degradation byproducts that otherwise are present in the API, significantly enhancing the stability of the finished product.
• Magnesium stearate is added to create a hydrophobic environment around particles which provides a lubrication effect during the production process. Lubricant mixing is carefully done to ensure that the drug releasing profile and pharmacokinetics are not influenced by this hydrophobic environment.
• Finally, different coloring agents and film coating are added to give each strength a distinct name and character. Film coating is performed using polymers which imparts a protective barrier for each strength of the drug and to mask the taste.
You submitted product labels for the Rosuvastatin Calcium tablets. You also submitted a shipping label and the Materials Safety Data Sheet (“MSDS”) for the API, Rosuvastatin Calcium. Additionally, you provided a manufacturing flow chart depicting the various steps which occur in the United States to make the final Rosuvastatin Calcium tablets.
What is the country of origin of the Rosuvastatin Calcium tablets for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. § 177.21
Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B):
In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations.
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact.
In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, in cases concerning pharmaceutical products, CBP has considered whether the API retained its chemical and physical properties as a result of the processing performed and whether the processing changed the medicinal use of the API.
In HQ H240193, dated July 29, 2013, which concerned the country of origin marking of the brand-name Crestor® (Rosuvastatin Calcium salt) tablets, CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients, and manufactured into tablet form in the United States.
HQ H267177, dated November 5, 2015, concerned Acyclovir, a pharmaceutical product used as a synthetic nucleoside analogue active against herpes viruses. The API was manufactured in China and India and shipped to the United States where it underwent five manufacturing steps including the sizing of the active and inactive ingredients, preparation of Acyclovir granules, preparation of the tablet blend, tablet compression, and packaging in high density polyethylene plastic bottles. CBP determined that the processing performed in the United States did not result in a change in the medicinal use of the finished product and the active ingredient. The active ingredient retained its chemical and physical properties and was merely put into dosage form and packaged for sale. The active ingredient did not undergo a change in name, character or use. Therefore, CBP held that no substantial transformation occurred in United States, and Acyclovir tablets were considered a product of the country in which the active ingredient was produced.
HQ H215656, dated January 11, 2013, concerned the country of origin of Rybix ODT, a pharmaceutical product used for the management of moderate to moderately severe pain in adults. The API, tramadol hydrochloride, manufactured in India, was shipped to France where it underwent four processes of manufacturing consisting of the preparation of the API, preparation of the tablet blend, tablet compression, and packaging in blister packs. CBP determined that the processing in France did not result in a change in the medicinal use of the finished product, and the API retained its chemical and physical properties and was merely put into dosage form and packaged. Accordingly, CBP held that no substantial transformation occurred in France.
HQ H233356, dated December 26, 2012, concerned the country of origin of Ponstel, a pharmaceutical product used for the relief of mild to moderate pain caused by primary dysmenorrhea. Mefenamic acid, which is the API in Ponstel, was manufactured in India, and imported into the United States, where it was blended with inactive ingredients and packaged into dosage form. CBP determined that this process did not substantially transform the mefenamic acid because its chemical character remained the same and, therefore, CBP found that the country of origin of the Ponstel capsules was India.
You state that the FDA requires that a unique National Drug Code (“NDC”) be assigned to every drug product such as Rosuvastatin Calcium tablets, but prohibits
This office consulted with CBP's Laboratories and Scientific Services Directorate concerning the instant case, which informed us that the imported API, Rosuvastatin Calcium, retains its chemical and physical properties upon processing in the United States. Increasing the stability of the API and standardizing its concentration do not change the API. Further, the processing performed in the United States does not affect the medicinal use of the API. Based on the information presented, the API does not undergo a change in name, character or use. Therefore, in accordance with the rulings cited, we find that no substantial transformation occurs in United States, and the Rosuvastatin Calcium tablets would be considered a product of India, where the API was produced, for purposes of U.S. government procurement.
In addition, you asked whether the Rosuvastatin Calcium tablets are “manufactured in the United States” within the meaning of the term “U.S.-made end products”, as set forth in Section 25.003 of the Federal Acquisition Regulations System, Title 48, Code of Federal Regulations (48 C.F.R. § 25.003), and implemented in 48 C.F.R. § 52.225-5. As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent with the Federal Acquisition Regulations (48 C.F.R. chapter 1). The definition of country of origin in subpart B, 19 C.F.R. § 177.22(a) has two rules (see above) as does 48 C.F.R. § 25.003. The term “manufactured in the United States” in 48 C.F.R. § 25.003 correlates to the first rule of 19 C.F.R. § 177.22(a) which provides that an article is a product of a country or instrumentality if “it is wholly the growth, product, or manufacture of that country or instrumentality”. Since the production of Rosuvastatin Calcium tablets partially occurs in India, we do not find that they are manufactured in the United States.
The country of origin of the Rosuvastatin Calcium tablets for U.S. Government procurement purposes is India.
Notice of this final determination will be given in the
This is in response to your correspondence of July 7, 2017 and supplemental submission of August 7, 2017, requesting a final determination on behalf of Acetris Health, (“Acetris”)
This final determination concerns the country of origin of the Levofloxacin tablets. We note that Acetris is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination.
You have asked that certain information submitted in connection with this ruling request be treated as confidential. Inasmuch as this request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), the request for confidentiality is approved. The information contained within brackets in your request will not be released to the public and will be withheld from published versions of this ruling.
The merchandise at issue are Levofloxacin tablets. You state that Acetris is a generic pharmaceutical distributor specializing in providing cost effective products to the U.S. Government. Acetris has its principal place of business in Allendale, NJ. Among the products Acetris sells to the U.S. Government are Levofloxacin tablets, which are a fluoroquinolone antibacterial used to treat mild, moderate, and severe infections.
You state that Acetris procures the Levofloxacin tablets from Aurolife Pharma LLC (“Aurolife”), located in Dayton, NJ. Aurolife, which is a wholly-owned subsidiary of company X in India, is a generic pharmaceutical product manufacturer in the specialty and niche areas. Aurolife manufactures the Levofloxacin tablets supplied to Acetris in a U.S. Food & Drug Administration (“FDA”) approved cGMP compliant manufacturing facility, located in Dayton, NJ, from several active and inactive ingredients procured domestically and abroad. The active pharmaceutical ingredient (“API”) of the Levofloxacin tablets is Levofloxacin, which Aurolife sources from company X in India.
You state that the Levofloxacin tablets supplied to Acetris are the result of a complex production process that occurs in Aurolife's New Jersey facility involving the combination of the API with multiple inactive ingredients, including some intermediates that are mixed in order to aid the conversion of the multiple ingredients. The production of Levofloxacin tablets employs processes that convert these ingredients into finished, medically effective dosage tablets (250 mg, 500 mg, and 750 mg tablets). You state that this processing changes the properties and characteristics of the API, materially enhancing the pharmacokinetics of the resulting drug.
You state that the process of converting these multiple ingredients into the Levofloxacin tablets occurs entirely within the United States. The ingredients processed in the United States are sourced from a variety of suppliers, both United States and foreign, as follows:
The processing that occurs in the United States includes the following:
• Croscarmellose sodium is added as a disintegrant to provide easy dispersion of the tablet when engulfed by the patient which indirectly enhances the drug release process and bioavailability/absorption leading to pharmacokinetic profiles equivalent to the brand product (Levaquin®) for therapeutic equivalency.
• Microcrystalline cellulose is added as a bulking agent for better manufacturability and to have suitable tablet weight so that the patient can easily take the medication.
• Hypromellose is added as a binder to aid formation of flowable granules during manufacturing thereby achieving the uniformity of the drug leading to therapeutic efficacy.
• Magnesium stearate is added to create a hydrophobic environment around particles which provides a lubrication effect during the production process. Lubricant mixing is carefully done to ensure that the drug releasing profile and pharmacokinetics are not influenced by this hydrophobic environment.
• Film coating is performed using polymers which imparts a protective barrier for the drug and to mask the taste.
• Finally, the tablets are packed into suitable containers which are capable of maintaining the overall integrity of the quality attributes and minimizing the formation of impurities thereby transforming it into a more stable drug product whose therapeutic effectiveness as a drug is sustainable.
You submitted product labels for the Levofloxacin tablets. You also submitted a shipping label and the Materials Safety Data Sheet (“MSDS”) for the API, Levofloxacin. Additionally, you provided a manufacturing flow chart depicting the various steps which occur in the United States to make the final Levofloxacin tablets.
What is the country of origin of the Levofloxacin tablets for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. § 177.21
Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B):
In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations.
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact.
In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, in cases concerning pharmaceutical products, CBP has considered whether the API retained its chemical and physical properties as a result of the processing performed and whether the processing changed the medicinal use of the API.
In HQ H240193, dated July 29, 2013, which concerned the country of origin marking of the brand-name Crestor® (Rosuvastatin Calcium salt) tablets, CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients, and manufactured into tablet form in the United States.
HQ H267177, dated November 5, 2015, concerned Acyclovir, a pharmaceutical product used as a synthetic nucleoside analogue active against herpes viruses. The API was manufactured in China and India and shipped to the United States where it underwent five manufacturing steps including the sizing of the active and inactive ingredients, preparation of Acyclovir granules, preparation of the tablet blend, tablet compression, and packaging in high density polyethylene plastic bottles. CBP determined that the processing performed in the United States did not result in a change in the medicinal use of the finished product and the active ingredient. The active ingredient retained its chemical and physical properties and was merely put into dosage form and packaged for sale. The active ingredient did not undergo a change in name, character or use. Therefore, CBP held that no substantial transformation occurred in United States, and Acyclovir tablets were considered a product of the country in which the active ingredient was produced.
HQ H215656, dated January 11, 2013, concerned the country of origin of Rybix ODT, a pharmaceutical product used for the management of moderate to moderately severe pain in adults. The API, tramadol hydrochloride, manufactured in India, was shipped to France where it underwent four processes of manufacturing consisting of the preparation of the API, preparation of the tablet blend, tablet compression, and packaging in blister packs. CBP determined that the processing in France did not result in a change in the medicinal use of the finished product, and the API retained its chemical and physical properties and was merely put into dosage form and packaged. Accordingly, CBP held that no substantial transformation occurred in France.
HQ H233356, dated December 26, 2012, concerned the country of origin of Ponstel, a pharmaceutical product used for the relief of mild to moderate pain caused by primary dysmenorrhea. Mefenamic acid, which is the API in Ponstel, was manufactured in India, and imported into the United States, where it was blended with inactive ingredients and packaged into dosage form. CBP determined that this process did not substantially transform the mefenamic acid because its chemical character remained the same and, therefore, CBP found that the country of origin of the Ponstel capsules was India.
You state that the FDA requires that a unique National Drug Code (“NDC”) be assigned to every drug product such as Levofloxacin tablets, but prohibits that same NDC from being associated with any API, such as Levofloxacin, that has not been demonstrated to be safe and effective and cannot be sold for the treatment of any human disease condition. You also state that the FDA requires the name of the drug product (Levofloxacin tablet) to appear on every drug product label and prohibits use of that name on the label for the API. Further, you state that Levofloxacin is intended only for use by producers for further processing or for research since it is unstable and not fit
This office consulted with CBP's Laboratories and Scientific Services Directorate concerning the instant case, which informed us that the imported API, Levofloxacin, retains its chemical and physical properties upon processing in the United States. Increasing the stability of the API and standardizing its concentration do not change the API. Further, the processing performed in the United States does not affect the medicinal use of the API. Based on the information presented, the API does not undergo a change in name, character or use. Therefore, in accordance with the rulings cited, we find that no substantial transformation occurs in United States, and the Levofloxacin tablets would be considered a product of India, where the API was produced, for purposes of U.S. government procurement.
In addition, you asked whether the Levofloxacin tablets are “manufactured in the United States” within the meaning of the term “U.S.-made end products”, as set forth in Section 25.003 of the Federal Acquisition Regulations System, Title 48, Code of Federal Regulations (48 C.F.R. § 25.003), and implemented in 48 C.F.R. § 52.225-5. As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent with the Federal Acquisition Regulations (48 C.F.R. chapter 1). The definition of country of origin in subpart B, 19 C.F.R. § 177.22(a) has two rules (see above) as does 48 C.F.R. § 25.003. The term “manufactured in the United States” in 48 C.F.R. § 25.003 correlates to the first rule of 19 C.F.R. § 177.22(a) which provides that an article is a product of a country or instrumentality if “it is wholly the growth, product, or manufacture of that country or instrumentality”. Since the production of Levofloxacin tablets partially occurs in India, we do not find that they are manufactured in the United States.
The country of origin of the Levofloxacin tablets for U.S. Government procurement purposes is India.
Notice of this final determination will be given in the
This is in response to your correspondence of July 7, 2017 and supplemental submission of August 7, 2017, requesting a final determination on behalf of Acetris Health, (“Acetris”)
This final determination concerns the country of origin of the Levetiracetam tablets. We note that Acetris is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination.
You have asked that certain information submitted in connection with this ruling request be treated as confidential. Inasmuch as this request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), the request for confidentiality is approved. The information contained within brackets in your request will not be released to the public and will be withheld from published versions of this ruling.
The merchandise at issue are Levetiracetam tablets. You state that Acetris is a generic pharmaceutical distributor specializing in providing cost effective products to the U.S. Government. Acetris has its principal place of business in Allendale, NJ. Among the products Acetris sells to the U.S. Government are Levetiracetam tablets which are anti-epileptic medications indicated in treatment of partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures.
You state that Acetris procures the Levetiracetam tablets from Aurolife Pharma LLC (“Aurolife”), located in Dayton, NJ. Aurolife, which is a wholly-owned subsidiary of company X in India, is a generic pharmaceutical product manufacturer in the specialty and niche areas. Aurolife manufactures the Levetiracetam tablets supplied to Acetris in a U.S. Food & Drug Administration (“FDA”) approved cGMP compliant manufacturing facility, located in Dayton, NJ, from several active and inactive ingredients procured domestically and abroad. The active pharmaceutical ingredient (“API”) of the Levetiracetam tablets is Levetiracetam, which Aurolife sources from company X in India.
You state that the Levetiracetam tablets supplied to Acetris are the result of a complex production process that occurs in Aurolife's New Jersey facility involving the combination of the API with multiple inactive ingredients, including some intermediates that are mixed in order to aid the conversion of the multiple ingredients. The production of Levetiracetam tablets employs processes that convert these ingredients into finished, medically effective dosage tablets (250 mg, 500 mg, 750 mg, and 1000 mg tablets). You state that this processing changes the properties and characteristics of the API, materially enhancing the pharmacokinetics of the resulting drug.
You state that the process of converting these multiple ingredients into the Levetiracetam tablets occurs entirely within the United States. The ingredients processed in the United States are sourced from a variety of suppliers, both United States and foreign, as follows:
The processing that occurs in the United States includes the following:
• Corn starch is added as a bulking agent for better manufacturability and to have a suitable tablet weight so that the patient can easily take the medication. Corn starch is mixed with the API, enhancing that the compressibility of the API, so that the product can be easily administered.
• Povidone is added as a binder to aid formation of flowable granules during manufacturing, thereby achieving the uniformity of the drug leading to therapeutic efficacy.
• Talc and Colloidal silicon dioxide are added to create a gliding property in the blend particles and to provide a lubrication effect during the manufacturing process.
• Magnesium stearate is added to create a hydrophobic environment around particles which provides a lubrication effect during the production process. Lubricant mixing is carefully done to ensure that the drug releasing profile and pharmacokinetics are not influenced by this hydrophobic environment.
• Coloring agents and film coating are added to give each tablet strength a distinct name and character. Film coating is performed, using polymers, which imparts a protective barrier to each strength of the drug and to mask the taste.
• Finally, the tablets are packed into suitable containers which maintain the overall integrity of the quality attributes, thereby producing a more stable drug product whose therapeutic effectiveness is sustainable.
You submitted product labels for the Levetiracetam tablets. You also submitted a shipping label and the Materials Safety Data Sheet (“MSDS”) for the API, Levetiracetam. Additionally, you provided a manufacturing flow chart depicting the various steps which occur in the United States to make final Levetiracetam tablets.
What is the country of origin of the Levetiracetam tablets for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. § 177.21
Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B):
In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations.
. . . an article that is mined, produced, or manufactured in the United States or that is substantially transformed in the United States into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed.
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact.
In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, in cases concerning pharmaceutical products, CBP has considered whether the API retained its chemical and physical properties as a result of the processing performed and whether the processing changed the medicinal use of the API.
In HQ H240193, dated July 29, 2013, which concerned the country of origin marking of the brand-name Crestor® (Rosuvastatin Calcium salt) tablets, CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients, and manufactured into tablet form in the United States.
HQ H267177, dated November 5, 2015, concerned Acyclovir, a pharmaceutical product used as a synthetic nucleoside analogue active against herpes viruses. The API was manufactured in China and India and shipped to the United States where it underwent five manufacturing steps including the sizing of the active and inactive ingredients, preparation of Acyclovir granules, preparation of the tablet blend, tablet compression, and packaging in high density polyethylene plastic bottles. CBP determined that the processing performed in the United States did not result in a change in the medicinal use of the finished product and the active ingredient. The active ingredient retained its chemical and physical properties and was merely put into dosage form and packaged for sale. The active ingredient did not undergo a change in name, character or use. Therefore, CBP held that no substantial transformation occurred in United States, and Acyclovir tablets were considered a product of the country in which the active ingredient was produced.
HQ H215656, dated January 11, 2013, concerned the country of origin of Rybix ODT, a pharmaceutical product used for the management of moderate to moderately severe pain in adults. The API, tramadol hydrochloride, manufactured in India, was shipped to France where it underwent four processes of manufacturing consisting of the preparation of the API, preparation of the tablet blend, tablet compression, and packaging in blister packs. CBP determined that the processing in France did not result in a change in the medicinal use of the finished product, and the API retained its chemical and physical properties and was merely put into dosage form and packaged. Accordingly, CBP held that no substantial transformation occurred in France.
HQ H233356, dated December 26, 2012, concerned the country of origin of Ponstel, a pharmaceutical product used for the relief of mild to moderate pain caused by primary dysmenorrhea. Mefenamic acid, which is the API in Ponstel, was manufactured in India, and imported into the United States, where it was blended with inactive ingredients and packaged into dosage form. CBP determined that this process did not substantially transform the mefenamic acid because its chemical character remained the same and, therefore, CBP found that the country of origin of the Ponstel capsules was India.
You state that the FDA requires that a unique National Drug Code (“NDC”) be assigned to every drug product such as Levetiracetam tablets, but prohibits that same NDC from being associated with any API, such as Levetiracetam, that has not been demonstrated to be safe and effective and cannot be sold for the treatment of any human disease condition. You also state that the FDA requires the name of the drug product (Levetiracetam tablet) to appear on every drug product label and prohibits use of that name on the label for the API. Further, you state that API is intended only for use by producers for further processing or for research since it is unstable and not fit for medical use and may not be sold to consumers. Additionally, you state that the API has a bitter taste and poor compressibility properties. For these reasons, you claim that extensive additional processing of the API, sourced in India, with other ingredients must occur to change the API's properties and make it into a stable drug product that achieves the targeted disintegration and dissolution, is more suitable and stable, and possesses the desired physicochemical properties.
This office consulted with CBP's Laboratories and Scientific Services Directorate concerning the instant case, which informed us that the imported API, Levetiracetam, retains its chemical and physical properties upon processing in the United States. Increasing the stability of the API and standardizing its concentration do
In addition, you asked whether the Levetiracetam tablets are “manufactured in the United States” within the meaning of the term “U.S.-made end products”, as set forth in Section 25.003 of the Federal Acquisition Regulations System, Title 48, Code of Federal Regulations (48 C.F.R. § 25.003), and implemented in 48 C.F.R. § 52.225-5. As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent with the Federal Acquisition Regulations (48 C.F.R. chapter 1). The definition of country of origin in subpart B, 19 C.F.R. § 177.22(a) has two rules (see above) as does 48 C.F.R. § 25.003. The term “manufactured in the United States” in 48 C.F.R. § 25.003 correlates to the first rule of 19 C.F.R. § 177.22(a) which provides that an article is a product of a country or instrumentality if “it is wholly the growth, product, or manufacture of that country or instrumentality”. Since the production of Levetiracetam tablets partially occurs in India, we do not find that they are manufactured in the United States.
The country of origin of the Levetiracetam tablets for U.S. Government procurement purposes is India.
Notice of this final determination will be given in the
This is in response to your correspondence of July 7, 2017 and supplemental submission of August 7, 2017, requesting a final determination on behalf of Acetris Health, (“Acetris”)
This final determination concerns the country of origin of the Metoprolol Tartrate tablets. We note that Acetris is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination.
You have asked that certain information submitted in connection with this ruling request be treated as confidential. Inasmuch as this request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), the request for confidentiality is approved. The information contained within brackets in your request will not be released to the public and will be withheld from published versions of this ruling.
The merchandise at issue are Metoprolol Tartrate tablets. You state that Acetris is a generic pharmaceutical distributor specializing in providing cost effective products to the U.S. Government. Acetris has its principal place of business in Allendale, NJ. Among the products Acetris sells to the U.S. Government are Metoprolol Tartrate tablets, which are used in the treatment of hypertension, angina pectoris and myocardial infarction.
You state that Acetris procures the Metoprolol Tartrate tablets from Aurolife Pharma LLC (“Aurolife”), located in Dayton, NJ. Aurolife, which is a wholly-owned subsidiary of company X in India, is a generic pharmaceutical product manufacturer in the specialty and niche areas. Aurolife manufactures the Metoprolol Tartrate tablets supplied to Acetris in a U.S. Food & Drug Administration (“FDA”) approved cGMP compliant manufacturing facility, located in Dayton, NJ, from several active and inactive ingredients procured domestically and abroad. The active pharmaceutical ingredient (“API”) of the Metoprolol Tartrate tablets is Metoprolol Tartrate, which Aurolife sources from company X in India.
You state that the Metoprolol Tartrate tablets supplied to Acetris are the result of a complex production process that occurs in Aurolife's New Jersey facility involving the combination of the API with multiple inactive ingredients, including some intermediates that are mixed in order to aid the conversion of the multiple ingredients. The production of Metoprolol Tartrate tablets employs processes that convert these ingredients into finished, medically effective dosage tablets (25 mg, 50 mg, and 100 mg tablets). You state that this processing changes the properties and characteristics of the API, materially enhancing the pharmacokinetics of the resulting drug.
You state that the process of converting these multiple ingredients into the Metoprolol Tartrate tablets occurs entirely within the United States. The ingredients processed in the United States are sourced from a variety of suppliers, both United States and foreign, as follows:
The processing that occurs in the United States includes the following:
• Microcrystalline cellulose and corn starch are added as bulking agents for better manufacturability and to have suitable tablet weight so that the patient can easily take the medication. The API is mixed with these diluents which alters the physical form of the API such that the compressibility of the API is enhanced and the product can be easily administered.
• Sodium starch glycolate is added as a disintegrant to provide easy dispersion of the tablet when ingested by the patient, which indirectly enhances the drug release process and bioavailability/absorption, leading to pharmacokinetic profiles equivalent to the brand product (Lopressor®) for therapeutic equivalency.
• Talc and colloidal silicon dioxide are added to create a gliding property in the blend particles, contributing to the unit-to-unit uniformity of the drug during the manufacturing process.
• Magnesium stearate is added to create a hydrophobic environment around particles which provides a lubrication effect during the production process. Lubricant mixing is carefully done to ensure that the drug releasing profile and pharmacokinetics are not influenced by this hydrophobic environment.
• Sodium Lauryl Sulfate is added as a wetting agent to enhance the solubilization process and bioavailability/absorption, leading to pharmacokinetic profiles equivalent to the brand product for therapeutic equivalency.
• Coloring agents and film coating are added to give each tablet strength a distinct name and character. Film coating is performed using polymers which imparts a protective barrier for each tablet strength and to mask the taste.
• Finally, the tablets are packed into suitable containers which are capable of retaining the overall integrity of the quality attributes and minimizing the formation of impurity, transforming it into a more stable product whose therapeutic effectiveness as a drug is sustainable.
You submitted product labels for the Metoprolol Tartrate tablets. You also submitted a shipping label and the Materials Safety Data Sheet (“MSDS”) for the API, Metoprolol Tartrate. Additionally, you provided a manufacturing flow chart depicting the various steps which occur in the United States to make the final Metoprolol Tartrate tablets.
What is the country of origin of the Metoprolol Tartrate tablets for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. § 177.21
Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B):
In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations.
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact.
In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, in cases concerning pharmaceutical products, CBP has considered whether the API retained its chemical and physical properties as a result of the processing performed and whether the processing changed the medicinal use of the API.
In HQ H240193, dated July 29, 2013, which concerned the country of origin marking of the brand-name Crestor® (Rosuvastatin Calcium salt) tablets, CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients, and manufactured into tablet form in the United States.
HQ H267177, dated November 5, 2015, concerned Acyclovir, a pharmaceutical product used as a synthetic nucleoside analogue active against herpes viruses. The API was manufactured in China and India and shipped to the United States where it underwent five manufacturing steps including the sizing of the active and inactive ingredients, preparation of Acyclovir granules, preparation of the tablet blend, tablet compression, and packaging in high density polyethylene plastic bottles. CBP determined that the processing performed in the United States did not result in a change in the medicinal use of the finished product and the active ingredient. The active ingredient retained its chemical and physical properties and was merely put into dosage form and packaged for sale. The active ingredient did not undergo a change in name, character or use. Therefore, CBP held that no substantial transformation occurred in United States, and Acyclovir tablets were considered a product of the country in which the active ingredient was produced.
HQ H215656, dated January 11, 2013, concerned the country of origin of Rybix ODT, a pharmaceutical product used for the management of moderate to moderately severe pain in adults. The API, tramadol hydrochloride, manufactured in India, was shipped to France where it underwent four processes of manufacturing consisting of the preparation of the API, preparation of the tablet blend, tablet compression, and packaging in blister packs. CBP determined that the processing in France did not result in a change in the medicinal use of the finished product, and the API retained its chemical and physical properties and was merely put into dosage form and packaged. Accordingly, CBP held that no substantial transformation occurred in France.
HQ H233356, dated December 26, 2012, concerned the country of origin of Ponstel, a pharmaceutical product used for the relief of mild to moderate pain caused by primary dysmenorrhea. Mefenamic acid, which is the API in Ponstel, was manufactured in India, and imported into the United States, where it was blended with inactive ingredients and packaged into dosage form. CBP determined that this process did not substantially transform the mefenamic acid because its chemical character remained the same and, therefore, CBP found that the country of origin of the Ponstel capsules was India.
You state that the FDA requires that a unique National Drug Code (“NDC”) be assigned to every drug product such as Metoprolol Tartrate tablets, but prohibits that same NDC from being associated with any API, such as Metoprolol Tartrate, that has not been demonstrated to be safe and effective and cannot be sold for the treatment of any human disease condition. You also state that the FDA requires the name of the drug product (Metoprolol Tartrate tablet) to appear on every drug product label and prohibits use of that name on the label for the API. Further, you state that Metoprolol Tartrate is intended only for use by producers for further processing or for research since it is unstable and not fit for medical use and may not be sold to consumers. Additionally, you state that the Metoprolol Tartrate degrades under hydrolysis and has poor flow properties. For these reasons, you claim that extensive additional processing of the API, sourced in India, with other ingredients must occur to change the API's properties and make it into a stable drug product with the desired pharmacokinetics, therapeutic efficacy and physicochemical properties.
This office consulted with CBP's Laboratories and Scientific Services Directorate concerning the instant case, which informed us that the imported API, Metoprolol Tartrate, retains its chemical and physical properties upon processing in the
In addition, you asked whether the Metoprolol Tartrate tablets are “manufactured in the United States” within the meaning of the term “U.S.-made end products”, as set forth in Section 25.003 of the Federal Acquisition Regulations System, Title 48, Code of Federal Regulations (48 C.F.R. § 25.003), and implemented in 48 C.F.R. § 52.225-5. As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent with the Federal Acquisition Regulations (48 C.F.R. chapter 1). The definition of country of origin in subpart B, 19 C.F.R. § 177.22(a) has two rules (see above) as does 48 C.F.R. § 25.003. The term “manufactured in the United States” in 48 C.F.R. § 25.003 correlates to the first rule of 19 C.F.R. § 177.22(a) which provides that an article is a product of a country or instrumentality if “it is wholly the growth, product, or manufacture of that country or instrumentality”. Since the production of Metoprolol Tartrate tablets partially occurs in India, we do not find that they are manufactured in the United States.
The country of origin of the Metoprolol Tartrate tablets for U.S. Government procurement purposes is India.
Notice of this final determination will be given in the
This is in response to your correspondence of July 7, 2017 and supplemental submission of August 7, 2017, requesting a final determination on behalf of Acetris Health, (“Acetris”)
This final determination concerns the country of origin of the Gabapentin capsules. We note that Acetris is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination.
You have asked that certain information submitted in connection with this ruling request be treated as confidential. Inasmuch as this request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), the request for confidentiality is approved. The information contained within brackets in your request will not be released to the public and will be withheld from published versions of this ruling.
The merchandise at issue are Gabapentin capsules. You state that Acetris is a generic pharmaceutical distributor specializing in providing cost effective products to the U.S. Government. Acetris has its principal place of business in Allendale, NJ. Among the products Acetris sells to the U.S. Government are Gabapentin capsules, which are used for the management and/or treatment of postherpetic neuralgia in adults and partial onset seizures.
You state that Acetris procures the Gabapentin capsules from Aurolife Pharma LLC (“Aurolife”), located in Dayton, NJ. Aurolife, which is a wholly-owned subsidiary of company X in India, is a generic pharmaceutical product manufacturer in the specialty and niche areas. Aurolife manufactures the Gabapentin capsules supplied to Acetris in a U.S. Food & Drug Administration (“FDA”) approved cGMP compliant manufacturing facility, located in Dayton, NJ, from several active and inactive ingredients procured domestically and abroad. The active pharmaceutical ingredient (“API”) of the Gabapentin capsules is Gabapentin, which Aurolife sources from company X in India.
You state that the Gabapentin capsules supplied to Acetris are the result of a complex production process that occurs in Aurolife's New Jersey facility involving the combination of the API with multiple inactive ingredients, including some intermediates that are mixed in order to aid the conversion of the multiple ingredients. The production of Gabapentin capsules employs processes that convert these ingredients into finished, medically effective dosage capsules (100 mg, 300 mg, and 400 mg capsules). You state that this processing changes the properties and characteristics of the API, materially enhancing the pharmacokinetics of the resulting drug.
You state that the process of converting these multiple ingredients into the Gabapentin capsules occurs entirely within the United States. The ingredients processed in the United States are sourced from a variety of suppliers, both United States and foreign, as follows:
The processing that occurs in the United States includes the following:
• The API exhibits poor flow property whereby it will affect the manufacturability. Hence, the particle size is tailored to have good flowability during the manufacturing process so that there is no unit-to-unit variability in the labeled quantity in each capsule.
• Corn starch is added as a bulking agent for better manufacturability and to have suitable fill weight so that the patient can easily take the medication. Corn starch is mixed with the gabapentin where the drug particles get coated with the said excipient, enhancing stability.
• Talc is added to create a gliding property in the blend particles and also provides a lubrication effect during the production process. Lubricant mixing is carefully done to ensure that the drug releasing profile and
• Finally, the blend is filled into hard gelatin shells to give each strength a distinct name and character. Encapsulation of the blend gives a protective barrier for each strength of the drug and masks the metallic taste of the drug particles.
You submitted product labels for the Gabapentin capsules. You also submitted a shipping label and the Materials Safety Data Sheet (“MSDS”) for the API, Gabapentin. Additionally, you provided a manufacturing flow chart depicting the various steps which occur in the United States to make the final the final Gabapentin capsules.
What is the country of origin of the Gabapentin capsules for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. § 177.21
Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B):
In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part C.F.R. § 177 consistent with Federal Acquisition Regulations.
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact.
In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, in cases concerning pharmaceutical products, CBP has considered whether the API retained its chemical and physical properties as a result of the processing performed and whether the processing changed the medicinal use of the API.
In HQ H240193, dated July 29, 2013, which concerned the country of origin marking of the brand-name Crestor® (Rosuvastatin Calcium salt) tablets, CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients, and manufactured into tablet form in the United States.
HQ H267177, dated November 5, 2015, concerned Acyclovir, a pharmaceutical product used as a synthetic nucleoside analogue active against herpes viruses. The API was manufactured in China and India and shipped to the United States where it underwent five manufacturing steps including the sizing of the active and inactive ingredients, preparation of Acyclovir granules, preparation of the tablet blend, tablet compression, and packaging in high density polyethylene plastic bottles. CBP determined that the processing performed in the United States did not result in a change in the medicinal use of the finished product and the active ingredient. The active ingredient retained its chemical and physical properties and was merely put into dosage form and packaged for sale. The active ingredient did not undergo a change in name, character or use. Therefore, CBP held that no substantial transformation occurred in United States, and Acyclovir tablets were considered a product of the country in which the active ingredient was produced.
HQ H215656, dated January 11, 2013, concerned the country of origin of Rybix ODT, a pharmaceutical product used for the management of moderate to moderately severe pain in adults. The API, tramadol hydrochloride, manufactured in India, was shipped to France where it underwent four processes of manufacturing consisting of the preparation of the API, preparation of the tablet blend, tablet compression, and packaging in blister packs. CBP determined that the processing in France did not result in a change in the medicinal use of the finished product, and the API retained its chemical and physical properties and was merely put into dosage form and packaged. Accordingly, CBP held that no substantial transformation occurred in France.
HQ H233356, dated December 26, 2012, concerned the country of origin of Ponstel, a pharmaceutical product used for the relief of mild to moderate pain caused by primary dysmenorrhea. Mefenamic acid, which is the API in Ponstel, was manufactured in India, and imported into the United States, where it was blended with inactive ingredients and packaged into dosage form. CBP determined that this process did not substantially transform the mefenamic acid because its chemical character remained the same and, therefore, CBP found that the country of origin of the Ponstel capsules was India.
You state that the FDA requires that a unique National Drug Code (“NDC”) be assigned to every drug product such as Gabapentin capsules, but prohibits that same NDC from being associated with any API, such as Gabapentin, that has not been demonstrated to be safe and effective and cannot be sold for the treatment of any human disease condition. You also state that the FDA requires the name of the drug product (Gabapentin capsule) to appear on every drug product label and prohibits use of that name on the label for the API. Further, you state that Gabapentin is intended only for use by producers for further processing or for research since it is unstable and not fit for medical use and may not be sold to consumers. Additionally, you state that Gabapentin has a tendency to degrade and has poor flow properties. For these reasons, you claim that extensive additional processing of the API, sourced in India, with other ingredients must occur to change the API's properties and make it into a stable drug product.
This office consulted with CBP's Laboratories and Scientific Services Directorate concerning the instant case, which informed us that the imported API, Gabapentin, retains its chemical and physical properties upon processing in the United States. Increasing the stability of the API and standardizing its concentration do not change the API. Further, the processing performed in the United States does not affect the medicinal use of the API. Based on the information presented, the API does not undergo a change in name, character or use. Therefore, in accordance with the rulings cited, we find that no substantial transformation occurs in United States, and the Gabapentin capsules would be considered a product of India, where the API was produced, for purposes of U.S. government procurement.
In addition, you asked whether the Gabapentin capsules are “manufactured in the United States” within the meaning of the term “U.S.-made end products”, as set forth in Section 25.003 of the Federal Acquisition Regulations System, Title 48, Code of Federal Regulations (48 C.F.R. § 25.003), and implemented in 48 C.F.R. § 52.225-5. As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent with the Federal Acquisition Regulations (48 C.F.R. chapter 1). The definition of country of origin in subpart B, 19 C.F.R. § 177.22(a) has two rules (see above) as does 48 C.F.R. § 25.003. The term “manufactured in the United States” in 48 C.F.R. § 25.003 correlates to the first rule of 19 C.F.R. § 177.22(a) which provides that an article is a product of a country or instrumentality if “it is wholly the growth, product, or manufacture of that country or instrumentality”. Since the
The country of origin of the Gabapentin capsules for U.S. Government procurement purposes is India.
Notice of this final determination will be given in the
This is in response to your correspondence of July 7, 2017 and supplemental submission of August 7, 2017, requesting a final determination on behalf of Acetris Health, (“Acetris”)
This final determination concerns the country of origin of the Carvedilol tablets. We note that Acetris is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination.
You have asked that certain information submitted in connection with this ruling request be treated as confidential. Inasmuch as this request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), the request for confidentiality is approved. The information contained within brackets in your request will not be released to the public and will be withheld from published versions of this ruling.
The merchandise at issue are Carvedilol tablets. You state that Acetris is a generic pharmaceutical distributor specializing in providing cost effective products to the U.S. Government. Acetris has its principal place of business in Allendale, NJ. Among the products Acetris sells to the U.S. Government are Carvedilol tablets, members of a family of drugs prescribed for treating mild to severe chronic heart failure, left ventricular dysfunction following myocardial infarction, and hypertension.
You state that Acetris procures the Carvedilol tablets from Aurolife Pharma LLC (“Aurolife”), located in Dayton, NJ. Aurolife, which is a wholly-owned subsidiary of company X in India, is a generic pharmaceutical product manufacturer in the specialty and niche areas. Aurolife manufactures the Carvedilol tablets supplied to Acetris in a U.S. Food & Drug Administration (“FDA”) approved cGMP compliant manufacturing facility, located in Dayton, NJ, from several active and inactive ingredients procured domestically and abroad. The active pharmaceutical ingredient (“API”) of the Carvedilol tablets is Carvedilol, which Aurolife sources from company X in India.
You state that the Carvedilol tablets supplied to Acetris are the result of a complex production process that occurs in Aurolife's New Jersey facility involving the combination of the API with multiple inactive ingredients, including some intermediates that are mixed in order to aid the conversion of the multiple ingredients. The production of Carvedilol tablets employs processes that convert these ingredients into finished, medically effective dosage tablets (3.125 mg, 6.25 mg, 12.5 mg, and 25 mg tablets). You state that this processing changes the properties and characteristics of the API, materially enhancing the pharmacokinetics of the resulting drug.
You state that the process of converting these multiple ingredients into the Carvedilol tablets occurs entirely within the United States. The ingredients processed in the United States are sourced from a variety of suppliers, both United States and foreign, as follows:
The processing that occurs in the United States includes the following:
• Lactose monohydrate is added as a bulking agent for better manufacturability and to have suitable tablet weight so that the patient can easily take the medication. The API is mixed with these diluents to achieve uniformity of the API, so that the product can be easily administered.
• Crospovidone is added as a disintegrant to provide easy dispersion of the tablet when ingested by the patient which enhances the drug release process, bioavailability and absorption leading to pharmacokinetic profiles equivalent to the brand product (Coreg®) for therapeutic equivalency.
• Povidone and sucrose are added as binders to aid formation of flowable granules during production, thereby achieving the uniformity of the drug leading to therapeutic efficacy.
• Colloidal silicon dioxide is added to create a gliding property in the blend particles, thereby contributing to the unit-to-unit uniformity of the drug during the manufacturing process.
• Magnesium stearate is added to create a hydrophobic environment around particles which provides a lubrication effect during the production process. Lubricant mixing is carefully done to ensure that the drug releasing profile and pharmacokinetics are not influenced by this hydrophobic environment.
• Coloring and film coating agents are added. Film coating is performed using polymers which imparts a protective barrier for each tablet strength and to mask the taste.
• Finally, the tablets are packed into suitable containers which are capable of retaining the overall integrity of the quality attributes and minimizing the formation of impurities thereby producing a more stable drug product whose therapeutic effectiveness as a drug is sustainable.
You submitted product labels for the Carvedilol tablets. You also submitted a shipping label and the Materials Safety Data Sheet (“MSDS”) for the API, Carvedilol. Additionally, you provided a manufacturing flow chart depicting the various steps which occur in the United States to make the final Carvedilol tablets.
What is the country of origin of the Carvedilol tablets for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. § 177.21
Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B):
In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations.
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact.
In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, in cases concerning pharmaceutical products, CBP has considered whether the API retained its chemical and physical properties as a result of the processing performed and whether the processing changed the medicinal use of the API.
In HQ H240193, dated July 29, 2013, which concerned the country of origin marking of the brand-name Crestor® (Rosuvastatin Calcium salt) tablets, CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients, and manufactured into tablet form in the United States.
HQ H267177, dated November 5, 2015, concerned Acyclovir, a pharmaceutical product used as a synthetic nucleoside analogue active against herpes viruses. The API was manufactured in China and India and shipped to the United States where it underwent five manufacturing steps including the sizing of the active and inactive ingredients, preparation of Acyclovir granules, preparation of the tablet blend, tablet compression, and packaging in high density polyethylene plastic bottles. CBP determined that the processing performed in the United States did not result in a change in the medicinal use of the finished product and the active ingredient. The active ingredient retained its chemical and physical properties and was merely put into dosage form and packaged for sale. The active ingredient did not undergo a change in name, character or use. Therefore, CBP held that no substantial transformation occurred in United States, and Acyclovir tablets were considered a product of the country in which the active ingredient was produced.
HQ H215656, dated January 11, 2013, concerned the country of origin of Rybix ODT, a pharmaceutical product used for the management of moderate to moderately severe pain in adults. The API, tramadol hydrochloride, manufactured in India, was shipped to France where it underwent four processes of manufacturing consisting of the preparation of the API, preparation of the tablet blend, tablet compression, and packaging in blister packs. CBP determined that the processing in France did not result in a change in the medicinal use of the finished product, and the API retained its chemical and physical properties and was merely put into dosage form and packaged. Accordingly, CBP held that no substantial transformation occurred in France.
HQ H233356, dated December 26, 2012, concerned the country of origin of Ponstel, a pharmaceutical product used for the relief of mild to moderate pain caused by primary dysmenorrhea. Mefenamic acid, which is the API in Ponstel, was manufactured in India, and imported into the United States, where it was blended with inactive ingredients and packaged into dosage form. CBP determined that this process did not substantially transform the mefenamic acid because its chemical character remained the same and, therefore, CBP found that the country of origin of the Ponstel capsules was India.
You state that the FDA requires that a unique National Drug Code (“NDC”) be assigned to every drug product such as Carvedilol tablets, but prohibits that same NDC from being associated with any API, such as Carvedilol, that has not been demonstrated to be safe and effective and cannot be sold for the treatment of any human disease condition. You also state that the FDA requires the name of the drug product (Carvedilol tablet) to appear on every drug product label and prohibits use of that name on the label for the API. Further, you state that API is intended only for use by producers for further processing or for research since it is unstable and not fit for medical use and may not be sold to consumers. Additionally, you state that the API has poor flow quality and is susceptible to inadequate content uniformity. For these reasons, you claim that extensive additional processing of the API, sourced in India, with other ingredients must occur to change the API's properties and make it into a stable drug product.
This office consulted with CBP's Laboratories and Scientific Services Directorate concerning the instant case, which informed us that the imported API, Carvedilol, retains its chemical and physical properties upon processing in the United States. Increasing the stability of the API and standardizing its concentration do not change the API. Further, the processing performed in the United States does not affect the medicinal use of the API. Based on the information presented, the API does not undergo a change in name, character or use. Therefore, in accordance with the rulings cited, we find that no substantial transformation occurs in United States, and the Carvedilol tablets would be considered a product of India, where the API was produced, for purposes of U.S. government procurement.
In addition, you asked whether the Carvedilol tablets are “manufactured in the United States” within the meaning of the term “U.S.-made end products”, as set forth in Section 25.003 of the Federal Acquisition Regulations System, Title 48, Code of Federal Regulations (48 C.F.R. § 25.003), and implemented in 48 C.F.R. § 52.225-5. As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent with the Federal Acquisition Regulations (48 C.F.R. chapter 1). The definition of country of origin in subpart B, 19 C.F.R. § 177.22(a) has two rules (see above) as does 48 C.F.R. § 25.003. The term “manufactured in the United States” in 48 C.F.R. § 25.003 correlates to the first rule of 19 C.F.R. § 177.22(a) which provides that an article is a product of a country or instrumentality if “it is wholly the growth, product, or manufacture of that country or instrumentality”. Since the production of Carvedilol tablets partially occurs in India, we do not find that they are manufactured in the United States.
The country of origin of the Carvedilol tablets for U.S. Government procurement purposes is India.
Notice of this final determination will be given in the
This is in response to your correspondence of July 7, 2017 and supplemental submission of August 7, 2017, requesting a final determination on behalf of Acetris Health, (“Acetris”)
This final determination concerns the country of origin of the Paroxetine Hydrochloride tablets. We note that Acetris is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination.
You have asked that certain information submitted in connection with this ruling request be treated as confidential. Inasmuch as this request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), the request for confidentiality is approved. The information contained within brackets in your request will not be released to the public and will be withheld from published versions of this ruling.
The merchandise at issue are Paroxetine Hydrochloride tablets. You state that Acetris is a generic pharmaceutical distributor specializing in providing cost effective products to the U.S. Government. Acetris has its principal place of business in Allendale, NJ. Among the products Acetris sells to the U.S. Government are Paroxetine Hydrochloride tablets, which are psychotropic drugs used in the treatment of major depressive disorder, obsessive compulsive disorder, pain disorder, social anxiety disorder, generalized anxiety disorder, and post-traumatic stress disorder.
You state that Acetris procures the Paroxetine Hydrochloride tablets from Aurolife Pharma LLC (“Aurolife”), located in Dayton, NJ. Aurolife, which is a wholly-owned subsidiary of company X in India, is a generic pharmaceutical product manufacturer in the specialty and niche areas. Aurolife manufactures the Paroxetine Hydrochloride tablets supplied to Acetris in a U.S. Food & Drug Administration (“FDA”) approved cGMP compliant manufacturing facility, located in Dayton, NJ, from several active and inactive ingredients procured domestically and abroad. The active pharmaceutical ingredient (“API”) of the Paroxetine Hydrochloride tablets is Paroxetine Hydrochloride, which Aurolife sources from company X in India.
You state that the Paroxetine Hydrochloride tablets supplied to Acetris are the result of a complex production process that occurs in Aurolife's New Jersey facility involving the combination of the API with multiple inactive ingredients, including some intermediates that are mixed in order to aid the conversion of the multiple ingredients. The production of Paroxetine Hydrochloride tablets employs processes that convert these ingredients into finished, medically effective dosage tablets (10mg, 20mg, 30mg, and 40mg tablets). You state that this processing changes the properties and characteristics of the API, materially enhancing the pharmacokinetics of the resulting drug.
You state that the process of converting these multiple ingredients into the Paroxetine Hydrochloride tablets occurs entirely within the United States. The ingredients processed in the United States are sourced from a variety of suppliers, both United States and foreign, as follows:
The processing that occurs in the United States includes the following:
• Dibasic calcium phosphate dihydrate and dibasic calcium phosphate anhydrous are non-hygroscopic hydrophobic diluents added to the paroxetine hydrochloride to improve drug stability.
• Lactose monohydrate is added as a bulking agent for better manufacturability and to have suitable tablet weight so that the patient can easily take the medication.
• Sodium starch glycolate is added as a disintegrant to provide easy dispersion of the tablet when ingested by the patient, which enhances the drug release process, bioavailability and absorption leading to pharmacokinetic profiles equivalent to the brand product (Paxil®) for therapeutic equivalency.
• Magnesium stearate is added to create a hydrophobic environment around particles which provides a lubrication effect during the production process. Lubricant mixing is carefully done to ensure that the drug releasing profile and pharmacokinetics are not influenced by this hydrophobic environment.
• Coloring agents and film coating are added to give each strength a distinct name and character. Film coating is performed using polymers which imparts a protective barrier for each strength of the drug and to mask the taste.
• Finally, the tablets are packed into suitable containers which are capable of retaining the overall integrity of the quality attributes and minimizing discoloration, thereby permitting a more stable product whose therapeutic effectiveness as a drug is sustainable.
You submitted product labels for the Paroxetine Hydrochloride tablets. You also submitted a shipping label and the Materials Safety Data Sheet (“MSDS”) for the API, Paroxetine Hydrochloride. Additionally, you provided a manufacturing flow chart depicting the various steps which occur in the United States to make the API and other ingredients into the final Paroxetine Hydrochloride tablets.
What is the country of origin of the Paroxetine Hydrochloride tablets for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the
Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B):
In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations.
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact.
In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, in cases concerning pharmaceutical products, CBP has considered whether the API retained its chemical and physical properties as a result of the processing performed and whether the processing changed the medicinal use of the API.
In HQ H240193, dated July 29, 2013, which concerned the country of origin marking of the brand-name Crestor® (Rosuvastatin Calcium salt) tablets, CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients, and manufactured into tablet form in the United States.
HQ H267177, dated November 5, 2015, concerned Acyclovir, a pharmaceutical product used as a synthetic nucleoside analogue active against herpes viruses. The API was manufactured in China and India and shipped to the United States where it underwent five manufacturing steps including the sizing of the active and inactive ingredients, preparation of Acyclovir granules, preparation of the tablet blend, tablet compression, and packaging in high density polyethylene plastic bottles. CBP determined that the processing performed in the United States did not result in a change in the medicinal use of the finished product and the active ingredient. The active ingredient retained its chemical and physical properties and was merely put into dosage form and packaged for sale. The active ingredient did not undergo a change in name, character or use. Therefore, CBP held that no substantial transformation occurred in United States, and Acyclovir tablets were considered a product of the country in which the active ingredient was produced.
HQ H215656, dated January 11, 2013, concerned the country of origin of Rybix ODT, a pharmaceutical product used for the management of moderate to moderately severe pain in adults. The API, tramadol hydrochloride, manufactured in India, was shipped to France where it underwent four processes of manufacturing consisting of the preparation of the API, preparation of the tablet blend, tablet compression, and packaging in blister packs. CBP determined that the processing in France did not result in a change in the medicinal use of the finished product, and the API retained its chemical and physical properties and was merely put into dosage form and packaged. Accordingly, CBP held that no substantial transformation occurred in France.
HQ H233356, dated December 26, 2012, concerned the country of origin of Ponstel, a pharmaceutical product used for the relief of mild to moderate pain caused by primary dysmenorrhea. Mefenamic acid, which is the API in Ponstel, was manufactured in India, and imported into the United States, where it was blended with inactive ingredients and packaged into dosage form. CBP determined that this process did not substantially transform the mefenamic acid because its chemical character remained the same and, therefore, CBP found that the country of origin of the Ponstel capsules was India.
You state that the FDA requires that a unique National Drug Code (“NDC”) be assigned to every drug product such as Paroxetine Hydrochloride tablets, but prohibits that same NDC from being associated with any API, such as Paroxetine Hydrochloride, that has not been demonstrated to be safe and effective and cannot be sold for the treatment of any human disease condition. You also state that the FDA requires the name of the drug product (Paroxetine Hydrochloride tablet) to appear on every drug product label and prohibits use of that name on the label for the API. Further, you state that Paroxetine Hydrochloride is intended only for use by producers for further processing or for research since it is unstable and not fit for medical use and may not be sold to consumers. Additionally, you state that Paroxetine Hydrochloride experiences degradation. For these reasons, you claim that extensive additional processing of the API, sourced in India, with other ingredients must occur to change the API's properties and make it into a stable drug product whose medical effectiveness as a drug is sustainable.
This office consulted with CBP's Laboratories and Scientific Services Directorate concerning the instant case, which informed us that the imported API, Paroxetine Hydrochloride, retains its chemical and physical properties upon processing in the United States. Increasing the stability of the API and standardizing its concentration do not change the API. Further, the processing performed in the United States does not affect the medicinal use of the API. Based on the information presented, the API does not undergo a change in name, character or use. Therefore, in accordance with the rulings cited, we find that no substantial transformation occurs in United States, and the Paroxetine Hydrochloride tablets would be considered a product of India, where the API was produced, for purposes of U.S. government procurement.
In addition, you asked whether the Paroxetine Hydrochloride tablets are “manufactured in the United States” within the meaning of the term “U.S.-made end products”, as set forth in Section 25.003 of the Federal Acquisition Regulations System, Title 48, Code of Federal Regulations (48 C.F.R. § 25.003), and implemented in 48 C.F.R. § 52.225-5. As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent with the Federal Acquisition Regulations (48 C.F.R. chapter 1). The definition of country of origin in subpart B, 19 C.F.R. § 177.22(a) has two rules (see above) as does 48 C.F.R. § 25.003. The term “manufactured in the United States” in 48 C.F.R. § 25.003 correlates to the first rule of 19 C.F.R. § 177.22(a) which provides that an article is a product of a country or instrumentality if “it is wholly the growth, product, or manufacture of that country or instrumentality”. Since the production of Paroxetine Hydrochloride tablets partially occurs in India, we do not find that they are manufactured in the United States.
The country of origin of the Paroxetine Hydrochloride tablets for U.S. Government procurement purposes is India.
Notice of this final determination will be given in the
This is in response to your correspondence of July 7, 2017 and supplemental submission of August 7, 2017, requesting a final determination on behalf of Acetris Health, (“Acetris”)
This final determination concerns the country of origin of the Entecavir tablets. We note that Acetris is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination.
You have asked that certain information submitted in connection with this ruling request be treated as confidential. Inasmuch as this request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), the request for confidentiality is approved. The information contained within brackets in your request will not be released to the public and will be withheld from published versions of this ruling.
The merchandise at issue are Entecavir tablets. You state that Acetris is a generic pharmaceutical distributor specializing in providing cost effective products to the U.S. Government. Acetris has its principal place of business in Allendale, NJ. Among the products Acetris sells to the U.S. Government are Entecavir tablets for treating the Hepatitis B virus (HBV).
You state that Acetris procures the Entecavir tablets from Aurolife Pharma LLC (“Aurolife”), located in Dayton, NJ. Aurolife, which is a wholly-owned subsidiary of company X in India, is a generic pharmaceutical product manufacturer in the specialty and niche areas. Aurolife manufactures the Entecavir tablets supplied to Acetris in a U.S. Food & Drug Administration (“FDA”) approved cGMP compliant manufacturing facility, located in Dayton, NJ, from several active and inactive ingredients procured domestically and abroad. The active pharmaceutical ingredient (“API”) of the Entecavir tablets is Entecavir, which Aurolife sources from company X in India.
You state that the Entecavir tablets supplied to Acetris are the result of a complex production process that occurs in Aurolife's New Jersey facility involving the combination of the API with multiple inactive ingredients, including some intermediates that are mixed in order to aid the conversion of the multiple ingredients. The production of Entecavir tablets employs processes that convert these ingredients into finished, medically effective dosage tablets (0.5 mg and 1 mg tablets). You state that this processing changes the properties and characteristics of the API, materially enhancing the pharmacokinetics of the resulting drug.
You state that the process of converting these multiple ingredients into the Entecavir tablets occurs entirely within the United States. The ingredients processed in the United States are sourced from a variety of suppliers, both United States and foreign, as follows:
The processing that occurs in the United States includes the following:
• Lactose monohydrate and microcrystalline cellulose are added as bulking agents for better manufacturability and to have suitable tablet weight so that the patient can easily take the medication. These diluents also aid in achieving the desired uniformity with the help of processing steps like co-sifting.
• Crospovidone is added as a disintegrant to provide easy dispersion of the tablet when ingested by the patient which enhances the drug release process, bioavailability and absorption leading to pharmacokinetic profiles equivalent to the brand product (Baraclude®) for therapeutic equivalency.
• Magnesium stearate is added to create a hydrophobic environment around particles, which provides a lubrication effect during the production process. Lubricant mixing is carefully done to ensure that the drug releasing profile and pharmacokinetics are not influenced by this hydrophobic environment.
• Film coating agent is added to give each strength a distinct character. Film coating is performed using polymers which imparts a protective barrier for each strength of the drug, making it appropriate for patient use.
• Finally, the tablets are packed into suitable containers which are capable of retaining the overall integrity of the quality attributes, thereby producing a more stable drug product whose therapeutic effectiveness as a drug is sustainable.
You submitted product labels for the Entecavir tablets. You also submitted a shipping label and the Materials Safety Data Sheet (“MSDS”) for the API, Entecavir. Additionally, you provided a manufacturing flow chart depicting the various steps which occur in the United States to make the final Entecavir tablets.
What is the country of origin of the Entecavir tablets for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. § 177.21
Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B):
In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations.
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact.
In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, in cases concerning pharmaceutical products, CBP has considered whether the API retained its chemical and physical properties as a result of the processing performed and whether the processing changed the medicinal use of the API.
In HQ H240193, dated July 29, 2013, which concerned the country of origin marking of the brand-name Crestor® (Rosuvastatin Calcium salt) tablets, CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients, and manufactured into tablet form in the United States.
HQ H267177, dated November 5, 2015, concerned Acyclovir, a pharmaceutical product used as a synthetic nucleoside analogue active against herpes viruses. The API was manufactured in China and India and shipped to the United States where it underwent five manufacturing steps including the sizing of the active and inactive ingredients, preparation of Acyclovir granules, preparation of the tablet blend, tablet compression, and packaging in high density polyethylene plastic bottles. CBP determined that the processing performed in the United States did not result in a change in the medicinal use of the finished product and the active ingredient. The active ingredient retained its chemical and physical properties and was merely put into dosage form and packaged for sale. The active ingredient did not undergo a change in name, character or use. Therefore, CBP held that no substantial transformation occurred in United States, and Acyclovir tablets were considered a product of the country in which the active ingredient was produced.
HQ H215656, dated January 11, 2013, concerned the country of origin of Rybix ODT, a pharmaceutical product used for the management of moderate to moderately severe pain in adults. The API, tramadol hydrochloride, manufactured in India, was shipped to France where it underwent four processes of manufacturing consisting of the preparation of the API, preparation of the tablet blend, tablet compression, and packaging in blister packs. CBP determined that the processing in France did not result in a change in the medicinal use of the finished product, and the API retained its chemical and physical properties and was merely put into dosage form and packaged. Accordingly, CBP held that no substantial transformation occurred in France.
HQ H233356, dated December 26, 2012, concerned the country of origin of Ponstel, a pharmaceutical product used for the relief of mild to moderate pain caused by primary dysmenorrhea. Mefenamic acid, which is the API in Ponstel, was manufactured in India, and imported into the United States, where it was blended with inactive ingredients and packaged into dosage form. CBP determined that this process did not substantially transform the mefenamic acid because its chemical character remained the same and, therefore, CBP found that the country of origin of the Ponstel capsules was India.
You state that FDA requires that a unique National Drug Code (“NDC”) be assigned to every drug product such as Entecavir tablets, but prohibits that same NDC from being associated with any API, such as Entecavir, that has not been demonstrated to be safe and effective and cannot be sold for the treatment of any human disease condition. You also state that the FDA requires the name of the drug product (Entecavir tablet) to appear on every drug product label and prohibits use of that name on the label for the API. Further, you state that API is intended only for use by producers for further processing or for research since it is unstable and not fit for medical use and may not be sold to consumers. Additionally, you state that the API is susceptible to inadequate content uniformity and undergoes oxidative degradation. For these reasons, you claim that extensive additional processing of the API, sourced in India, with other ingredients must occur to change the API's properties and make it into a stable drug product that achieves the targeted disintegration and dissolution and exhibits appropriate physicochemical properties, the desired pharmacokinetics and therapeutic efficacy.
This office consulted with CBP's Laboratories and Scientific Services Directorate concerning the instant case, which informed us that the imported API, Entecavir, retains its chemical and physical properties upon processing in the United States. Increasing the stability of the API and standardizing its concentration do not change the API. Further, the processing performed in the United States does not affect the medicinal use of the API. Based on the information presented, the API does not undergo a change in name, character or use. Therefore, in accordance with the rulings cited, we find that no substantial transformation occurs in United States, and the Entecavir tablets would be considered a product of India, where the API was produced, for purposes of U.S. government procurement.
In addition, you asked whether the Entecavir tablets are “manufactured in the United States” within the meaning of the term “U.S.-made end products”, as set forth in Section 25.003 of the Federal Acquisition Regulations System, Title 48, Code of Federal Regulations (48 C.F.R. § 25.003), and implemented in 48 C.F.R. § 52.225-5. As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent with the Federal Acquisition Regulations (48 C.F.R. chapter 1). The definition of country of origin in subpart B, 19 C.F.R. § 177.22(a) has two rules (see above) as does 48 C.F.R. § 25.003. The term “manufactured in the United States” in 48 C.F.R. § 25.003 correlates to the first rule of 19 C.F.R. § 177.22(a) which provides that an article is a product of a country or instrumentality if “it is wholly the growth, product, or manufacture of that country or instrumentality”. Since the production of Entecavir tablets partially occurs in India, we do not find that they are manufactured in the United States.
The country of origin of the Entecavir tablets for U.S. Government procurement purposes is India.
Notice of this final determination will be given in the
This is in response to your correspondence of July 7, 2017 and supplemental submission of August 7, 2017, requesting a final determination on behalf of Acetris Health, (“Acetris”)
This final determination concerns the country of origin of the Montelukast Sodium tablets. We note that Acetris is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination.
You have asked that certain information submitted in connection with this ruling request be treated as confidential. Inasmuch as this request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), the request for confidentiality is approved. The information contained within brackets in your request will not be released to the public and will be withheld from published versions of this ruling.
The merchandise at issue are Montelukast Sodium tablets. You state that Acetris is a generic pharmaceutical distributor specializing in providing cost effective products to the U.S. Government. Acetris has its principal place of business in Allendale, NJ. Among the products Acetris sells to the U.S. Government are Montelukast Sodium tablets, which are drugs prescribed for the prevention and/or treatment of asthma, bronchoconstriction and allergic rhinitis.
You state that Acetris procures the Montelukast Sodium tablets from Aurolife Pharma LLC (“Aurolife”), located in Dayton, NJ. Aurolife, which is a wholly-owned subsidiary of company X in India, is a generic pharmaceutical product manufacturer in the specialty and niche areas. Aurolife manufactures the Montelukast Sodium tablets supplied to Acetris in a U.S. Food & Drug Administration (“FDA”) approved cGMP compliant manufacturing facility, located in Dayton, NJ, from several active and inactive ingredients procured domestically and abroad. The active pharmaceutical ingredient (“API”) of the Montelukast Sodium tablets is Montelukast Sodium, which Aurolife sources from company Y in India.
You state that the Montelukast Sodium tablets supplied to Acetris are the result of a complex production process that occurs in Aurolife's New Jersey facility involving the combination of the API with multiple inactive ingredients, including some intermediates that are mixed in order to aid the conversion of the multiple ingredients. The production of Montelukast Sodium tablets employs processes that convert these ingredients into finished, medically effective dosage tablets (10 mg tablets). You state that this processing changes the properties and characteristics of the API, materially enhancing the pharmacokinetics of the resulting drug.
You state that the process of converting these multiple ingredients into the Montelukast Sodium tablets occurs entirely within the United States. The ingredients processed in the United States are sourced from a variety of suppliers, both United States and foreign, as follows:
The processing that occurs in the United States includes the following:
• Lactose monohydrate, microcrystalline cellulose are added as bulking agents for better manufacturability so that the patient can easily take the medication.
• Hydroxyproyl cellulose is added as a binder to aid formation of flowable granules during manufacturing, thereby achieving the uniformity of the drug leading to therapeutic efficacy.
• Croscarmellose sodium is added as a disintegrant to provide easy dispersion of the tablet when ingested by the patient, which enhances the drug release process, bioavailability and absorption leading to pharmacokinetic profiles equivalent to the brand product (Singular®) for therapeutic equivalency.
• Colloidal silicon dioxide is added to create a gliding property in the blend particles, thereby contributing to the unit-to-unit uniformity of the drug during the manufacturing process.
• Magnesium stearate is added to create a hydrophobic environment around particles which provides a lubrication effect during the production process. Lubricant mixing is carefully done to ensure that the drug releasing profile and pharmacokinetics are not influenced by this hydrophobic environment.
• Coloring agent and film coating are added to give an aesthetic appearance. Film coating is performed using polymers which imparts a protective barrier for the drug and to mask the taste.
• Finally, the tablets are packed into suitable containers which are capable of retaining the overall integrity of the quality attributes and minimizing the formation of sulfoxide impurity, thereby transform it into a more stable product whose therapeutic effectiveness as a drug is sustainable.
You submitted product labels for the Montelukast Sodium tablets. You also submitted a shipping label and the Materials Safety Data Sheet (“MSDS”) for the API, Montelukast Sodium. Additionally, you provided a manufacturing flow chart depicting the various steps which occur in the United States to make the final Montelukast Sodium tablets.
What is the country of origin of the Montelukast Sodium tablets for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. § 177.21
Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B):
In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations.
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact.
In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, in cases concerning pharmaceutical products, CBP has considered whether the API retained its chemical and physical properties as a result of the processing performed and whether the processing changed the medicinal use of the API.
In HQ H240193, dated July 29, 2013, which concerned the country of origin marking of the brand-name Crestor® (Rosuvastatin Calcium salt) tablets, CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients, and manufactured into tablet form in the United States.
HQ H267177, dated November 5, 2015, concerned Acyclovir, a pharmaceutical product used as a synthetic nucleoside analogue active against herpes viruses. The API was manufactured in China and India and shipped to the United States where it underwent five manufacturing steps including the sizing of the active and inactive ingredients, preparation of Acyclovir granules, preparation of the tablet blend, tablet compression, and packaging in high density polyethylene plastic bottles. CBP determined that the processing performed in the United States did not result in a change in the medicinal use of the finished product and the active ingredient. The active ingredient retained its chemical and physical properties and was merely put into dosage form and packaged for sale. The active ingredient did not undergo a change in name, character or use. Therefore, CBP held that no substantial transformation occurred in United States, and Acyclovir tablets were considered a product of the country in which the active ingredient was produced.
HQ H215656, dated January 11, 2013, concerned the country of origin of Rybix ODT, a pharmaceutical product used for the management of moderate to moderately severe pain in adults. The API, tramadol hydrochloride, manufactured in India, was shipped to France where it underwent four processes of manufacturing consisting of the preparation of the API, preparation of the tablet blend, tablet compression, and packaging in blister packs. CBP determined that the processing in France did not result in a change in the medicinal use of the finished product, and the API retained its chemical and physical properties and was merely put into dosage form and packaged. Accordingly, CBP held that no substantial transformation occurred in France.
HQ H233356, dated December 26, 2012, concerned the country of origin of Ponstel, a pharmaceutical product used for the relief of mild to moderate pain caused by primary dysmenorrhea. Mefenamic acid, which is the API in Ponstel, was manufactured in India, and imported into the United States, where it was blended with inactive ingredients and packaged into dosage form. CBP determined that this process did not substantially transform the mefenamic acid because its chemical character remained the same and, therefore, CBP found that the country of origin of the Ponstel capsules was India.
You state that the FDA requires that a unique National Drug Code (“NDC”) be assigned to every drug product such as Montelukast Sodium tablets, but prohibits that same NDC from being associated with any API, such as Montelukast Sodium, that has not been demonstrated to be safe and effective and cannot be sold for the treatment of any human disease condition. You also state that the FDA requires the name of the drug product (Montelukast Sodium tablet) to appear on every drug product label and prohibits use of that name on the label for the API. Further, you state that API is intended only for use by producers for further processing or for research since it is unstable and not fit for medical use and may not be sold to consumers. Additionally, you state that the API degrades in potency, has poor flow qualities, and has a bitter taste. For these reasons, you claim that extensive additional processing of the API, sourced in India, with other ingredients must occur to change the API's properties and make it into a stable drug product whose medical effectiveness as a drug is sustainable.
This office consulted with CBP's Laboratories and Scientific Services Directorate concerning the instant case, which informed us that the imported API, Montelukast Sodium, retains its chemical and physical properties upon processing in the United States. Increasing the stability of the API and standardizing its concentration do not change the API. Further, the processing performed in the United States does not affect the medicinal use of the API. Based on the information presented, the API does not undergo a change in name, character or use. Therefore, in accordance with the rulings cited, we find that no substantial transformation occurs in United States, and the Montelukast Sodium tablets would be considered a product of India, where the API was produced, for purposes of U.S. government procurement.
In addition, you asked whether the Montelukast Sodium tablets are “manufactured in the United States” within the meaning of the term “U.S.-made end products”, as set forth in Section 25.003 of the Federal Acquisition Regulations System, Title 48, Code of Federal Regulations (48 C.F.R. § 25.003), and implemented in 48 C.F.R. § 52.225-5. As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent with the Federal Acquisition Regulations (48 C.F.R. chapter 1). The definition of country of origin in subpart B, 19 C.F.R. § 177.22(a) has two rules (see above) as does 48 C.F.R. § 25.003. The term “manufactured in the United States” in 48 C.F.R. § 25.003 correlates to the first rule of 19 C.F.R. § 177.22(a) which provides that an article is a product of a country or instrumentality if “it is wholly the growth, product, or manufacture of that country or instrumentality”. Since the production of Montelukast Sodium tablets partially occurs in India, we do not find that they are manufactured in the United States.
The country of origin of the Montelukast Sodium tablets for U.S. Government procurement purposes is India.
Notice of this final determination will be given in the
This is in response to your correspondence of July 7, 2017 and supplemental submission of August 7, 2017, requesting a final determination on behalf of Acetris Health, (“Acetris”)
This final determination concerns the country of origin of the Simvastatin tablets. We note that Acetris is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination.
You have asked that certain information submitted in connection with this ruling request be treated as confidential. Inasmuch as this request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), the request for confidentiality is approved. The information contained within brackets in your request will not be released to the public and will be withheld from published versions of this ruling.
The merchandise at issue are Simvastatin tablets. You state that Acetris is a generic pharmaceutical distributor specializing in providing cost effective products to the U.S.
You state that Acetris procures the Simvastatin tablets from Aurolife Pharma LLC (“Aurolife”), located in Dayton, NJ. Aurolife, which is a wholly-owned subsidiary of company X in India, is a generic pharmaceutical product manufacturer in the specialty and niche areas. Aurolife manufactures the Simvastatin tablets supplied to Acetris in a U.S. Food & Drug Administration (“FDA”) approved cGMP compliant manufacturing facility, located in Dayton, NJ, from several active and inactive ingredients procured domestically and abroad. The active pharmaceutical ingredient (“API”) of the Simvastatin tablets is Simvastatin, which Aurolife sources from company X in India.
You state that the Simvastatin tablets supplied to Acetris are the result of a complex production process that occurs in Aurolife's New Jersey facility involving the combination of the API with multiple inactive ingredients, including some intermediates that are mixed in order to aid the conversion of the multiple ingredients. The production of Simvastatin tablets employs processes that convert these ingredients into finished, medically effective dosage tablets (5 mg, 10 mg, 20 mg, 40 mg, and 80 mg tablets). You state that this processing changes the properties and characteristics of the API, materially enhancing the pharmacokinetics of the resulting drug.
You state that the process of converting these multiple ingredients into the Simvastatin tablets occurs entirely within the United States. The ingredients processed in the United States are sourced from a variety of suppliers, both United States and foreign, as follows:
The processing that occurs in the United States includes the following:
• Butylated hydroxyanisole, ascorbic acid, and citric acid are added to the Simvastatin API to improve drug stability. BHA and ascorbic acid are included in the tablets as antioxidants. Citric acid is added because it has chelation properties with metal ions, which, in the absence of the citric acid, could catalyze the oxidation process and make the drug unstable. These three excipients are added according to a proprietary set of protocols with specified blending times to ensure proper mixing throughout the blend. Butylated hydroxyanisole, ascorbic acid, and citric acid are the key ingredients which create a protective environment for enhancing the stability of the finished product.
• Lactose monohydrate, microcrystalline cellulose are added as bulking agents for better manufacturability and to have suitable tablet weight so that the patient can easily take the medication.
• Pregelatinized starch is added as a disintegrant to provide easy dispersion of the tablet when engulfed by the patient which indirectly enhances the drug release process.
• Magnesium stearate is added to create a hydrophobic environment around particles which provides a lubrication effect during the production process. Lubricant mixing is carefully done to ensure that the drug releasing profile and pharmacokinetics are not influenced by this hydrophobic environment.
• Finally, different coloring agents and film coating are added to give each tablet strength a distinct name and character. Film coating is performed using polymers which imparts a protective barrier for each strength of the drug and to mask the taste.
You submitted product labels for the Simvastatin tablets. You also submitted a shipping label and the Materials Safety Data Sheet (“MSDS”) for the API, Simvastatin. Additionally, you provided a manufacturing flow chart depicting the various steps which occur in the United States to make the final Simvastatin tablets.
What is the country of origin of the Simvastatin tablets for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. § 177.21
Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B):
In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations.
. . . an article that is mined, produced, or manufactured in the United States or that is substantially transformed in the United States into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed.
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact.
In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, in cases concerning pharmaceutical products,
In HQ H240193, dated July 29, 2013, which concerned the country of origin marking of the brand-name Crestor® (Rosuvastatin Calcium salt) tablets, CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients, and manufactured into tablet form in the United States.
HQ H267177, dated November 5, 2015, concerned Acyclovir, a pharmaceutical product used as a synthetic nucleoside analogue active against herpes viruses. The API was manufactured in China and India and shipped to the United States where it underwent five manufacturing steps including the sizing of the active and inactive ingredients, preparation of Acyclovir granules, preparation of the tablet blend, tablet compression, and packaging in high density polyethylene plastic bottles. CBP determined that the processing performed in the United States did not result in a change in the medicinal use of the finished product and the active ingredient. The active ingredient retained its chemical and physical properties and was merely put into dosage form and packaged for sale. The active ingredient did not undergo a change in name, character or use. Therefore, CBP held that no substantial transformation occurred in United States, and Acyclovir tablets were considered a product of the country in which the active ingredient was produced.
HQ H215656, dated January 11, 2013, concerned the country of origin of Rybix ODT, a pharmaceutical product used for the management of moderate to moderately severe pain in adults. The API, tramadol hydrochloride, manufactured in India, was shipped to France where it underwent four processes of manufacturing consisting of the preparation of the API, preparation of the tablet blend, tablet compression, and packaging in blister packs. CBP determined that the processing in France did not result in a change in the medicinal use of the finished product, and the API retained its chemical and physical properties and was merely put into dosage form and packaged. Accordingly, CBP held that no substantial transformation occurred in France.
HQ H233356, dated December 26, 2012, concerned the country of origin of Ponstel, a pharmaceutical product used for the relief of mild to moderate pain caused by primary dysmenorrhea. Mefenamic acid, which is the API in Ponstel, was manufactured in India, and imported into the United States, where it was blended with inactive ingredients and packaged into dosage form. CBP determined that this process did not substantially transform the mefenamic acid because its chemical character remained the same and, therefore, CBP found that the country of origin of the Ponstel capsules was India.
You state that the FDA requires that a unique National Drug Code (“NDC”) be assigned to every drug product such as Simvastatin tablets, but prohibits that same NDC from being associated with any API, such as Simvastatin, that has not been demonstrated to be safe and effective and cannot be sold for the treatment of any human disease condition. You also state that the FDA requires the name of the drug product (Simvastatin tablet) to appear on every drug product label and prohibits use of that name on the label for the API. Further, you state that Simvastatin is intended only for use by producers for further processing or for research since it is unstable and not fit for medical use and may not be sold to consumers. For these reasons, you claim that extensive additional processing of the API, sourced in India, with other ingredients must occur to change the API's properties and make it into a stable drug product whose medical effectiveness as a drug is sustainable.
This office consulted with CBP's Laboratories and Scientific Services Directorate concerning the instant case, which informed us that the imported API, Simvastatin, retains its chemical and physical properties upon processing in the United States. Increasing the stability of the API and standardizing its concentration do not change the API. Further, the processing performed in the United States does not affect the medicinal use of the API. Based on the information presented, the API does not undergo a change in name, character or use. Therefore, in accordance with the rulings cited, we find that no substantial transformation occurs in United States, and the Simvastatin tablets would be considered a product of India, where the API was produced, for purposes of U.S. government procurement.
In addition, you asked whether the Simvastatin tablets are “manufactured in the United States” within the meaning of the term “U.S.-made end products”, as set forth in Section 25.003 of the Federal Acquisition Regulations System, Title 48, Code of Federal Regulations (48 C.F.R. § 25.003), and implemented in 48 C.F.R. § 52.225-5. As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent with the Federal Acquisition Regulations (48 C.F.R. chapter 1). The definition of country of origin in subpart B, 19 C.F.R. § 177.22(a) has two rules (see above) as does 48 C.F.R. § 25.003. The term “manufactured in the United States” in 48 C.F.R. § 25.003 correlates to the first rule of 19 C.F.R. § 177.22(a) which provides that an article is a product of a country or instrumentality if “it is wholly the growth, product, or manufacture of that country or instrumentality”. Since the production of Simvastatin tablets partially occurs in India, we do not find that they are manufactured in the United States.
The country of origin of the Simvastatin tablets for U.S. Government procurement purposes is India.
Notice of this final determination will be given in the
This is in response to your correspondence of July 7, 2017 and supplemental submission of August 7, 2017, requesting a final determination on behalf of Acetris Health, (“Acetris”)
This final determination concerns the country of origin of the Donepezil Hydrochloride tablets. We note that Acetris is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination.
You have asked that certain information submitted in connection with this ruling request be treated as confidential. Inasmuch as this request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), the request for confidentiality is approved. The information contained within brackets in your request will not be released to the public and will be withheld from published versions of this ruling.
The merchandise at issue are Donepezil Hydrochloride tablets. You state that Acetris is a generic pharmaceutical distributor specializing in providing cost effective products to the U.S. Government. Acetris has its principal place of business in Allendale, NJ. Among the products Acetris sells to the U.S. Government are Donepezil Hydrochloride tablets, members of a family of drugs prescribed for the treatment of dementia of the Alzheimer's type.
You state that Acetris procures the Donepezil Hydrochloride tablets from Aurolife Pharma LLC (“Aurolife”), located in Dayton, NJ. Aurolife, which is a wholly-owned subsidiary of company X in India, is a generic pharmaceutical product manufacturer in the specialty and niche
You state that the Donepezil Hydrochloride tablets supplied to Acetris are the result of a complex production process that occurs in Aurolife's New Jersey facility involving the combination of the API with multiple inactive ingredients, including some intermediates that are mixed in order to aid the conversion of the multiple ingredients. The production of Donepezil Hydrochloride tablets employs processes that convert these ingredients into finished, medically effective dosage tablets (5 mg and 10 mg tablets). You state that this processing changes the properties and characteristics of the API, materially enhancing the pharmacokinetics of the resulting drug.
You state that the process of converting these multiple ingredients into the Donepezil Hydrochloride tablets occurs entirely within the United States. The ingredients processed in the United States are sourced from a variety of suppliers, both United States and foreign, as follows:
The processing that occurs in the United States includes the following:
• The particle size of the API is tailored to have a good flowability during the production process so that there is no unit-to-unit variability in the labeled quantity in each tablet.
• Lactose monohydrate and microcrystalline cellulose directly compressible grades are added as bulking agents for better flowability, manufacturability and to have suitable tablet weight so that the patient can easily take the medication.
• Pregelatinized starch and low substituted hydroxyproyl cellulose are added as disintegrants to provide easy dispersion of the tablet when ingested by the patient, which enhances the release process, bioavailability and absorption leading to pharmacokinetic profiles equivalent to the brand product (Aricept®) for therapeutic equivalency.
• Magnesium stearate is added to create a hydrophobic environment around particles which provides a lubrication effect during the production process. Lubricant mixing is carefully done to ensure that the drug releasing profile and pharmacokinetics are not influenced by this hydrophobic environment.
• Coloring agents and film coating are added to give an aesthetic appearance. Film coating is performed using polymers which imparts a protective barrier for the drug.
• Finally the tablets are packed into suitable containers which are capable of retaining the overall integrity of the quality attributes and minimizing the formation of oxidative impurity, thereby transforming it into a more stable product whose therapeutic effectiveness as a drug is sustainable.
You submitted product labels for the Donepezil Hydrochloride tablets. You also submitted a shipping label and the Materials Safety Data Sheet (“MSDS”) for the API, Donepezil Hydrochloride. Additionally, you provided a manufacturing flow chart depicting the various steps which occur in the United States to make the final Donepezil Hydrochloride tablets.
What is the country of origin of the Donepezil Hydrochloride tablets for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. § 177.21
Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B):
In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations.
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact.
In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, in cases concerning pharmaceutical products, CBP has considered whether the API retained its chemical and physical properties as a result of the processing performed and whether the processing changed the medicinal use of the API.
In HQ H240193, dated July 29, 2013, which concerned the country of origin marking of the brand-name Crestor® (Rosuvastatin Calcium salt) tablets, CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients, and manufactured into tablet form in the United States.
HQ H267177, dated November 5, 2015, concerned Acyclovir, a pharmaceutical product used as a synthetic nucleoside analogue active against herpes viruses. The API was manufactured in China and India and shipped to the United States where it underwent five manufacturing steps including the sizing of the active and inactive ingredients, preparation of Acyclovir granules, preparation of the tablet blend, tablet compression, and packaging in high density polyethylene plastic bottles. CBP determined that the processing performed in
HQ H215656, dated January 11, 2013, concerned the country of origin of Rybix ODT, a pharmaceutical product used for the management of moderate to moderately severe pain in adults. The API, tramadol hydrochloride, manufactured in India, was shipped to France where it underwent four processes of manufacturing consisting of the preparation of the API, preparation of the tablet blend, tablet compression, and packaging in blister packs. CBP determined that the processing in France did not result in a change in the medicinal use of the finished product, and the API retained its chemical and physical properties and was merely put into dosage form and packaged. Accordingly, CBP held that no substantial transformation occurred in France.
HQ H233356, dated December 26, 2012, concerned the country of origin of Ponstel, a pharmaceutical product used for the relief of mild to moderate pain caused by primary dysmenorrhea. Mefenamic acid, which is the API in Ponstel, was manufactured in India, and imported into the United States, where it was blended with inactive ingredients and packaged into dosage form. CBP determined that this process did not substantially transform the mefenamic acid because its chemical character remained the same and, therefore, CBP found that the country of origin of the Ponstel capsules was India.
You state that the FDA requires that a unique National Drug Code (“NDC”) be assigned to every drug product such as Donepezil Hydrochloride tablets, but prohibits that same NDC from being associated with any API, such as Donepezil Hydrochloride, that has not been demonstrated to be safe and effective and cannot be sold for the treatment of any human disease condition. You also state that the FDA requires the name of the drug product (Donepezil Hydrochloride tablet) to appear on every drug product label and prohibits use of that name on the label for the API. Further, you state that Donepezil Hydrochloride is intended only for use by producers for further processing or for research since it is unstable and not fit for medical use and may not be sold to consumers. Additionally, you state that the API is poisonous and has poor flow properties. For these reasons, you claim that extensive additional processing of the API, sourced in India, with other ingredients must occur to change the API's properties and make it into a stable drug product.
This office consulted with CBP's Laboratories and Scientific Services Directorate concerning the instant case, which informed us that the imported API, Donepezil Hydrochloride, retains its chemical and physical properties upon processing in the United States. Increasing the stability of the API and standardizing its concentration do not change the API. Further, the processing performed in the United States does not affect the medicinal use of the API. Based on the information presented, the API does not undergo a change in name, character or use. Therefore, in accordance with the rulings cited, we find that no substantial transformation occurs in United States, and the Donepezil Hydrochloride tablets would be considered a product of India, where the API was produced, for purposes of U.S. government procurement.
In addition, you asked whether the Donepezil Hydrochloride tablets are “manufactured in the United States” within the meaning of the term “U.S.-made end products”, as set forth in Section 25.003 of the Federal Acquisition Regulations System, Title 48, Code of Federal Regulations (48 C.F.R. § 25.003), and implemented in 48 C.F.R. § 52.225-5. As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent with the Federal Acquisition Regulations (48 C.F.R. chapter 1). The definition of country of origin in subpart B, 19 C.F.R. § 177.22(a) has two rules (see above) as does 48 C.F.R. § 25.003. The term “manufactured in the United States” in 48 C.F.R. § 25.003 correlates to the first rule of 19 C.F.R. § 177.22(a) which provides that an article is a product of a country or instrumentality if “it is wholly the growth, product, or manufacture of that country or instrumentality”. Since the production of Donepezil Hydrochloride tablets partially occurs in India, we do not find that they are manufactured in the United States.
The country of origin of the Donepezil Hydrochloride tablets for U.S. Government procurement purposes is India.
Notice of this final determination will be given in the
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of final determination.
This document provides notice that U.S. Customs and Border Protection (“CBP”) has issued a final determination concerning the country of origin of certain ethernet switch products known as Nyquist Ethernet Switches. Based upon the facts presented, CBP has concluded that the country of origin of the Nyquist Ethernet Switches is Mexico for purposes of U.S. Government procurement.
The final determination was issued on January 30, 2018. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within March 7, 2018.
Yuliya A. Gulis, Valuation and Special Programs Branch, Regulations and Rulings, Office of Trade, at (202) 325-0042.
Notice is hereby given that on January 30, 2018 pursuant to subpart B of part 177, U.S. Customs and Border Protection Regulations (19 CFR part 177, subpart B), CBP issued a final determination concerning the country of origin of certain ethernet switch products known as Nyquist Ethernet Switches, which may be offered to the U.S. Government under an undesignated government procurement contract. This final determination, HQ H282390, was issued under procedures set forth at 19 CFR part 177, subpart B, which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-18). In the final determination, CBP concluded that the last substantial transformation took place in Mexico. Therefore, the country of origin of the Nyquist Ethernet Switches is Mexico for purposes of U.S. Government procurement.
Section 177.29, CBP Regulations (19 CFR 177.29), provides that a notice of final determination shall be published in the
This is in response to your letter, dated May 6, 2016, on behalf of Cisco Systems, Inc. (“Cisco”), requesting a final determination concerning the country of origin of Cisco's Nyquist Ethernet Switch (“NES”), pursuant to subpart B of Part 177, U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR § 177.21,
Cisco plans to import the NES from Mexico. The NES is designed to interconnect devices on a computer network, while offering new capabilities, such as enabling new applications, differentiated security, dense wireless, and simplified and diverse network architecture. Each NES consists of one or more printed circuit board assemblies (“PCBA”), two power supplies, an uplink module, a protective metal housing, and ancillary devices to support additional features. The NES is configured with Cisco's configuration data. The configuration data programs the logic gates of the hardware components on the PCBA, which imparts physical changes to the patterns of interconnections in the hardware circuitry, defining the behavior of each component. The NES operates using Cisco's Polaris Operating System Software (“Polaris OS”).
In China, PCBAs are manufactured using: application specific integrated circuit (“ASIC”) components, which are assembled to final form in Korea incorporating materials from Taiwan and Japan in a process that takes between 12 and 25 weeks; central processing unit (“CPU”) components from Taiwan; synchronous dynamic random access memory (“SDRAM”) components from Taiwan or Korea; and, flash components from Korea and China. The PCBAs are tested to ensure that the PCBA components can properly interact with one another, and they are packaged and shipped to Mexico.
In Mexico, the following operations take place:
1. One or more PCBAs are installed into the NES chassis.
2. Two power supplies are installed in the NES chassis.
3. One uplink module is installed in the NES chassis.
4. Ancillary devices that support additional NES features are installed into the chassis.
5. A metal housing is added to complete the NES chassis assembly.
6. The power-on and bootloader initialization take place to activate the power system and fan modules of the NES, followed by the activation and preliminary testing of the CPU, ASIC, and ancillary devices.
7. The Polaris OS and configuration data developed in the United States are loaded onto a non-volatile flash memory, and then pushed out to the components of the PCBA.
8. The NES is tested to ensure the product functions as designed.
Cisco states that the Polaris OS and configuration data are downloaded onto the NES using in-circuit programming. According to Cisco, traditionally, each component of a PCBA (
According to Cisco, the PCBAs will have no commercial functionality when exported from China to Mexico because without the configuration data and the Polaris OS, the NES cannot function as intended. Cisco states that the NES will have large quantities of configurable elements, which require the configuration data to provide the firmware, modes and configuration settings, timing parameters, and physical properties for the components to function in the NES. Cisco states that the Polaris OS will provide I/O processor, route processor, and forwarding processor capabilities to the hardware, allowing the components to communicate with each other. Cisco notes that approximately 95 percent of the configuration data and 70 to 80 percent of the software code that will be loaded onto the NES in Mexico will be completely new and tailored based on customer needs and specifications.
What is the country of origin of the NES for purposes of U.S. Government procurement?
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 CFR § 177.21
Under the rule of origin set forth under 19 U.S.C. 2518(4)(B):
In
Accordingly, the programming of a device that defines its use generally constitutes substantial transformation.
Cisco argues that the country of origin of the NES will be Mexico because the final assembly of the NES and installation of the Polaris OS and configuration data onto the NES in Mexico will substantially transform the PCBA into the NES. While the configuration data is specific to the NES,
Cisco cites HQ 563012, dated May 4, 2004, in support of its position. In HQ 563012, CBP held that the PCBA and casing that were manufactured for a switch in China, were substantially transformed in the United States or Hong Kong, where U.S.-origin software was loaded, and the PCBA was further assembled with a power supply, fans, and an A/C filter of various origins to form the final fabric switch. CBP noted that in addition to the actual assembly, the configuration and software download operations performed in either Hong Kong or in the United States transformed the switch from a non-functional device into a fabric switch that was capable of performing various storage network functions.
Similar to the scenario in HQ 563012, where Hong Kong was found to be the origin, in this case, the major components of the NES, particularly the PCBA comprised of the ASIC, CPU, SDRAM, and flash components, will be manufactured in China, and then shipped to another country where the final assembly (adding the casing, power supply, uplink modules, and ancillary devices to the PCBA), software loading, configuration, and testing take place. Here, the other country is Mexico, which is different from the country where the U.S.-origin software is developed. While CBP has normally focused on where the origin of the software and where the programming took place, applying CBP's precedent in HQ 563012 to Cisco's manufacturing operations in Mexico, we find that the PCBAs from China will be substantially transformed by the final assembly, software loading, configuration, and testing operations in Mexico, and thus the country of origin for purposes of U.S. Government procurement will be Mexico.
Based on the facts provided, the PCBAs from China will be substantially transformed into the NES by the processes that take place in Mexico. As such, the NES will be considered a product of Mexico for purposes of U.S. Government procurement.
Notice of this final determination will be given in the
United States International Trade Commission.
February 9, 2018 at 11:00 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 701-TA-592 and 731-TA-1400 (Preliminary) (Plastic Decorative Ribbons from China). The Commission is currently scheduled to complete and file its determinations on February 12, 2018; views of the Commission are currently scheduled to be completed and filed on February 20, 2018.
5.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission:
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on December 29, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of ZiiLabs Inc., Ltd. of Bermuda. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain graphics processors and products containing the same by reason of infringement of certain claims of U.S. Patent No. 6,181,355 (“the ‘355 Patent”); U.S. 6,900,800 (“the ‘800 Patent”); U.S. Patent No. 8,144,156 (“the ‘156 Patent”); and U.S. Patent No. 8,643,659 (“the ‘659 Patent). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute.
The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-
Katherine Hiner, the Office of the Secretary, Docket Services, U.S. International Trade Commission, telephone (202) 205-1802.
The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2017).
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain graphics processors and products containing the same by reason of infringement of one or more of claims 1-11 of the ‘355 Patent; claims 1, 2, 6, 7, and 11-19 of the ‘800 Patent; claims 1-16 of the ‘156 Patent; and claims 1-10 and 15-20 of the ‘659 Patent; and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is: ZiiLabs Inc., Ltd., Clarendon House, 2 Church Street, Hamilton, HM11, Bermuda.
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not participate as a party in this investigation.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the presiding administrative law judge has issued a Final Initial Determination on Section 337 Violation and a Recommended Determination on Remedy and Bonding in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief, should the Commission find a violation, specifically a limited exclusion order (“LEO”) against certain magnetic tape cartridges and components thereof, which are imported, sold for importation, and/or sold after importation by Respondents Fujifilm Holdings Corporation of Tokyo, Japan; Fujifilm Corporation of Tokyo, Japan; Fujifilm Holdings America Corporation of Valhalla, New York; and Fujifilm Recording Media U.S.A., Inc. of Bedford, Massachusetts (collectively “Fujifilm” or “Respondents”); and a cease and desist order (“CDO”) against Respondents. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to Commission rules.
Cathy Chen, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2392. The public version of the complaint can be accessed on the Commission's electronic docket (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server (
Section 337 of the Tariff Act of 1930 (“Section 337”) provides that if the Commission finds a violation it shall exclude the articles concerned from the United States:
The Commission is interested in further development of the record on the public interest in these investigations. Accordingly, parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4). In addition, members of the public are hereby invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the administrative law judge's Recommended Determination on Remedy and Bonding issued in this investigation on January 25, 2018. Comments should address whether issuance of the LEO and CDO in this investigation, should the Commission find a violation, would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the recommended orders are used in the United States;
(ii) Identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) Identify like or directly competitive articles that complainants, their licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) Indicate whether complainants, complainants' licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the recommended exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) Explain how the LEO and CDO would impact consumers in the United States.
Written submissions from the public must be filed no later than by close of business on Thursday, March 1, 2018.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-1036”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.50 of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.50).
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-598-600 and 731-TA-1408-1410 (Preliminary) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of rubber bands from China, Sri Lanka, and Thailand, provided for in subheading 4016.99.35 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Governments of China, Sri Lanka, and Thailand. Unless the Department of Commerce extends the time for initiation, the Commission must reach preliminary determinations in antidumping and countervailing duty investigations in 45 days, or in this case by March 16, 2018. The Commission's views must be transmitted to Commerce within five business days thereafter, or by March 23, 2018.
January 30, 2018.
Mary Messer (202-205-3193) or Amanda Lawrence (202-205-3185), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B
In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.12 of the Commission's rules.
By order of the Commission.
United States International Trade Commission.
Notice.
January 30, 2018.
Douglas Corkran (202-205-3057), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
Effective September 5, 2017, the Commission established a general schedule for the conduct of the final phase of its investigations on carbon and certain alloy steel wire rod,
The Commission's supplemental schedule is as follows: The deadline for filing supplemental party comments on Commerce's final determinations is February 2, 2018; the staff report in the final phase of these investigations will be placed in the nonpublic record on February 9, 2018; and a public version will be issued thereafter.
Supplemental party comments may address only Commerce's final determinations regarding of carbon and certain alloy steel wire rod from South Africa and Ukraine. These supplemental final comments may not contain new factual information and may not exceed five (5) pages in length.
For further information concerning these investigations see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules.
By order of the Commission.
Judicial Conference of the United States, Advisory Committee on Rules of Criminal Procedure.
Notice of open meeting.
The Advisory Committee on Rules of Criminal Procedure will hold a meeting on April 24, 2018. The meeting will be open to public observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at:
April 24, 2018.
Thurgood Marshall Federal Judiciary Building, Mecham Conference Center, Administrative Office of the United States Courts, One Columbus Circle NE, Washington, DC 20544.
Rebecca A. Womeldorf, Rules Committee Secretary, Rules Committee Staff, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502-1820.
Advisory Committee on Rules of Evidence, Judicial Conference of the United States.
Notice of open meeting.
The Advisory Committee on Rules of Evidence will hold a meeting on April 27, 2018. The meeting will be open to public observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at:
April 27, 2018
Time: 9:00 a.m. to 5:00 p.m.
Thurgood Marshall Federal Judiciary Building, Mecham Conference Center, Administrative Office of the United States Courts, One Columbus Circle NE, Washington, DC 20544.
Rebecca A. Womeldorf, Rules Committee Secretary, Rules Committee Staff, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502-1820.
Executive Office for Immigration Review, Department of Justice.
30-day notice.
The Department of Justice (DOJ), Executive Office for Immigration Review (EOIR), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for an additional 30 days until March 7, 2018.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Jean King, General Counsel, Executive Office for Immigration Review, U.S. Department of Justice, Suite 2600, 5107 Leesburg Pike, Falls Church, Virginia 22041; telephone: (703) 305-0470. Written comments and/or suggestions can also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information collection:
1.
2.
3.
4.
5.
6.
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405B, Washington, DC 20530.
Weeks of February 5, 12, 19, 26, March 5, 12, 2018.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of February 12, 2018.
There are no meetings scheduled for the week of February 19, 2018.
There are no meetings scheduled for the week of February 26, 2018.
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of March 12, 2018.
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
Pension Benefit Guaranty Corporation.
Notice of OMB approval of new information collection.
The Office of Management and Budget has approved a new collection of information under the Pension Benefit Guaranty Corporation's regulations on Missing Participants.
Stephanie Cibinic (
Pursuant to regulation under the Paperwork Reduction Act of 1995 (PRA) for information collections contained in a rulemaking, 5 CFR 1320.11(k), the Pension Benefit Guaranty Corporation is publishing this notice to inform the public that the Office of Management and Budget (OMB) has approved a new collection of information.
On December 22, 2017 (at 82 FR 60800), PBGC published a final rule amending its regulations on Missing Participants (29 CFR part 4050). This final rule expands PBGC's Missing Participants Program for terminated single-employer defined benefit pension plans covered by PBGC's insurance program to most defined contribution plans, multiemployer defined benefit pension plans, and small professional service defined benefit pension plans not covered by PBGC. The rule was effective on January 22, 2018, and applicable to plans that terminate on or after January 1, 2018.
PBGC submitted the new collection of information to OMB for review under
Issued in Washington DC.
Office of Personnel Management.
30-Day notice and request for comments.
The Retirement Operations, Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on a revised information collection, Designation of Beneficiary (FERS), Standard Form 3102.
Comments are encouraged and will be accepted until March 7, 2018.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
A copy of this information collection, with applicable supporting documentation, may be obtained by contacting the Retirement Services Publications Team, Office of Personnel Management, 1900 E Street NW, Room 3316-L, Washington, DC 20415, Attention: Cyrus S. Benson, or sent via electronic mail to
As required by the Paperwork Reduction Act of 1995 OPM is soliciting comments for this collection. The information collection (OMB No. 3206-0173) was previously published in the
1. 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;
2. 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;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. 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,
Standard Form 3102 is used by an employee or an annuitant covered under the Federal Employees Retirement System to designate a beneficiary to receive any lump sum due in the event of his/her death.
Office of Science and Technology Policy (OSTP).
Notice of Request for Information.
On behalf of the National Science and Technology Council, Committee on Technology, Subcommittee on Advanced Manufacturing, the Office of Science and Technology Policy (OSTP) requests input from all interested parties on the development of a National Strategic Plan for Advanced Manufacturing. Through this Request for Information (RFI), OSTP seeks input from the public on ways to improve government coordination and on long-term guidance for Federal programs and activities in support of United States manufacturing competitiveness, including advanced manufacturing research and development that will create jobs, grow the economy across multiple industrial sectors, strengthen national security, and improve healthcare. The public input provided in response to this RFI will inform OSTP and NSTC as they work with Federal agencies and other stakeholders to develop the strategic plan.
Responses are due by March 7, 2018.
Responses should be submitted online at
Said Jahanmir, 301-975-8324,
Public Law 113-235, The Consolidated and Further Continuing Appropriations Act 2015, incorporating the Revitalize American Manufacturing and Innovation Act of 2014 revised 42
Advanced manufacturing refers to a family of activities relating to the use and coordination of information, automation, computation, software, sensing, networking, and interoperability to manufacture existing products in new ways, or to manufacture new products emerging from the use of new technologies.
NSTC has commenced the development of the Plan and, pursuant to 42 U.S.C. 6622, is soliciting public input through this RFI to obtain recommendations from a wide range of stakeholders, including representatives from diverse manufacturing companies, academia, and other relevant organizations and institutions. The public input provided in response to this RFI will inform OSTP and NSTC as they work with Federal agencies and other stakeholders to develop the Plan.
Through this RFI, OSTP seeks responses to the following questions to improve government coordination and provide long-term guidance for Federal programs and activities in support of United States manufacturing competitiveness, including advanced manufacturing R&D. Responses should clearly indicate which question(s) is being addressed.
1. In priority order, what should be the near-term and long-term objectives for advanced manufacturing, including R&D objectives, the anticipated time frame for achieving the objectives, and the metrics for use in assessing progress toward the objectives?
2. How can Federal agencies and federally funded R&D centers supporting advanced manufacturing R&D foster the transfer of R&D results into new manufacturing technologies and United States-based manufacturing of new products and processes for the benefit of society to ensure national, energy, and economic security? What role can public-private partnerships play, and how should they be structured for maximum impact?
3. What innovative tools, platforms, technologies are needed for advances in manufacturing? Of those that already exist, what are the barriers to their adoption?
4. How can such Federal agencies and centers develop and strengthen all levels of manufacturing education and training programs to ensure an adequate, well-trained U.S. workforce for the new advanced manufacturing jobs of the future?
5. How can such Federal agencies and centers assist small and medium-sized manufacturers in developing and implementing new products and processes?
6. How would you assess the state of the following factors and how they impact innovation and competitiveness for United States advanced manufacturing?
(a) technology transfer and commercialization activities;
(b) the adequacy of the national security industrial base;
(c) the capabilities of the domestic manufacturing workforce;
(d) export opportunities and trade policies;
(e) financing, investment, and taxation policies and practices;
(f) federal regulations;
(g) emerging technologies and markets;
(h) advanced manufacturing research and development undertaken by competing nations; and
(i) the capabilities of the manufacturing workforce of competing nations.
7. Is there any additional information related to advanced manufacturing in the United Stated, not requested above, that you believe OSTP should consider?
Securities and Exchange Commission (“Commission”).
Notice of application for an exemptive order under section 206A of the Investment Advisers Act of 1940 (“Advisers Act”) providing an exemption from the written disclosure and consent requirements of section 206(3).
Janney Montgomery Scott LLC (“Applicant”).
Exemption requested under section 206A from the written disclosure and consent requirements of section 206(3).
The Applicant requests that the Commission issue an order under section 206A exempting it and Future Advisers (as defined below) from the written disclosure and consent requirements of section 206(3) with respect to principal transactions with nondiscretionary advisory client accounts.
The application was filed on November 22, 2017.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving the Applicant with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on February 26, 2018, and should be accompanied by proof of service on the Applicant, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Advisers Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090. Applicant, c/o Laura E. Flores and Monica L. Parry, Morgan, Lewis & Bockius LLP, 1111 Pennsylvania Ave. NW, Washington, DC 20004.
Laura L. Solomon, Senior Counsel, at (202) 551-6915, or Robert Shapiro, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's website at
The Applicant seeks relief from the written disclosure and consent
1. The Applicant is registered as an investment adviser with the Commission and is a registered broker-dealer. The Applicant offers the Partners Advisory Program (the “Program”), a nondiscretionary advisory program.
2. The Applicant established the Program in 1999. Prior to December 31, 2016, the Applicant relied on the Rule to engage in principal transactions with its clients in the Program.
3. As of December 31, 2016, the Applicant had a total of 23,428 client accounts enrolled in the Program with aggregate assets of $7,318,704,000. On the same date, 1,491 client accounts had consented to principal transactions in their Program accounts in reliance on the Rule. In 2016, 4,527 trades were effected in reliance on the Rule in the Program. Approximately 90 percent of the trades done in reliance on the Rule in this period were purchases by client accounts; the average purchase was approximately $29,228. Approximately 10 percent of the trades done in reliance on the Rule in this period were sales from client accounts; the average sale was approximately $30,011.
4. The Applicant acknowledges that the Order, if granted, would not be construed as relieving in any way the Applicant from acting in the best interests of an advisory client, including fulfilling the duty to seek the best execution for the particular transaction for the advisory client; nor shall it relieve the Applicant from any obligation that may be imposed by sections 206(1) or (2) of the Advisers Act or by other applicable provisions of the federal securities laws or applicable Financial Industry Regulatory Authority (“FINRA”) rules.
1. Section 206(3) provides that it is unlawful for any investment adviser, directly or indirectly, acting as principal for its own account, knowingly to sell any security to or purchase any security from a client, without disclosing to the client in writing before the completion of the transaction the capacity in which the adviser is acting and obtaining the client's consent to the transaction. The Rule deemed an investment adviser to be in compliance with the provisions of section 206(3) of the Advisers Act when the investment adviser, or a person controlling, controlled by, or under common control with the investment adviser, acting as principal for its own account, sold to or purchased from an advisory client any security, provided that the investment adviser complied with the conditions of the Rule.
2. The Rule required, among other things, that the investment adviser obtain a client's written, revocable consent prospectively authorizing the adviser, directly or indirectly, acting as principal for its own account, to sell any security to or purchase any security from the client. The consent was required to be obtained after the adviser provided the client with written disclosure about: (i) The circumstances under which the investment adviser may engage in principal transactions with the client; (ii) the nature and significance of the conflicts the investment adviser has with its client's interests as a result of those transactions; and (iii) how the investment adviser addresses those conflicts. The investment adviser also was required to provide trade-by-trade disclosure to the client, before the execution of each principal transaction, of the capacity in which the adviser may act with respect to the transaction, and obtain the client's consent (which may be written or oral) to the transaction. The Rule was available only to an investment adviser that was also a broker-dealer registered under section 15 of the Securities Exchange Act of 1934 (“Exchange Act”) and could only be relied upon with respect to a nondiscretionary account that was a brokerage account subject to the Exchange Act, and the rules thereunder, and the rules of the self-regulatory organization(s) of which it is a member. The Rule was not available for principal transactions if the investment adviser or a person who controlled, was controlled by, or was under common control with the adviser (“control person”) was the issuer or an underwriter of the security (except that an investment adviser could rely on the Rule for trades in which the investment adviser or a control person was an underwriter of non-convertible investment-grade debt securities).
3. The Rule also required the investment adviser to provide to the client a trade confirmation that, in addition to the requirements of rule 10b-10 under the Exchange Act, included a conspicuous, plain English statement informing the client that the investment adviser disclosed to the client before the execution of the transaction that the investment adviser may act as principal in connection with the transaction, that the client authorized the transaction, and that the investment adviser sold the security to or bought the security from the client for its own account. The investment adviser also was required to deliver to the client, at least annually, a written statement listing all transactions that were executed in the account in reliance on the Rule, including the date and price of each transaction.
4. The Rule expired on December 31, 2016. Absent the requested relief, the Applicant would be required to provide trade-by-trade written disclosure to each nondiscretionary advisory client with whom the Applicant sought to engage in a principal transaction in accordance with section 206(3). The Applicant submits that its nondiscretionary clients have had access to the Applicant's inventory through principal transactions with the Applicant for a number of years, and expect to continue to have such access in the future. The Applicant believes that engaging in principal transactions with its clients provides certain benefits to its clients, including access to securities of limited availability, such as municipal bonds, and that the written disclosure and client consent requirements of section 206(3) act as an operational barrier to its ability to engage in principal trades with its clients, especially when the transaction involves securities of limited availability.
5. Unless the Applicant is provided an exemption from the written disclosure and client consent requirements of section 206(3), the Applicant believes that it will be unable to provide the same range of services and access to the same types of securities to its nondiscretionary advisory clients as it was able to provide to its clients under the Rule.
6. The Applicant notes that, if the requested relief is granted, it will remain subject to the fiduciary duties that are generally enforceable under sections 206(1) and 206(2) of the Advisers Act, which, in general terms, require the Applicant to: (i) Disclose material facts about the advisory relationship to its clients; (ii) treat each client fairly; and (iii) act only in the best interests of its client, disclosing conflicts of interest when present and obtaining client consent to arrangements that present such conflicts.
7. The Applicant further notes that, in its capacity as a broker-dealer with respect to these accounts, it will remain subject to a comprehensive set of Commission and FINRA regulations that apply to the relationship between a broker-dealer and its customer in
8. The Applicant requests that the Commission issue an Order pursuant to section 206A exempting it from the written disclosure and consent requirements of section 206(3) only with respect to client accounts in the Program and any similar nondiscretionary program to be created in the future. The Applicant also requests that the Commission's Order apply to future investment advisers controlling, controlled by, or under common control with the Applicant (“Future Advisers”). Any Future Adviser relying on any Order granted pursuant to the application will comply with the terms and conditions stated in the application.
The Applicant agrees that any Order granting the requested relief will be subject to the following conditions:
1. The Applicant will exercise no “investment discretion” (as such term is defined in section 3(a)(35) of the Exchange Act), except investment discretion granted by the advisory client on a temporary or limited basis,
2. The Applicant will not trade in reliance on this Order any security for which the Applicant or any person controlling, controlled by, or under common control with the Applicant is the issuer, or, at the time of the sale, an underwriter (as defined in section 202(a)(20) of the Advisers Act).
3. The Applicant will not directly or indirectly require the client to consent to principal trading as a condition to opening or maintaining an account with the Applicant.
4. The advisory client has executed a written revocable consent prospectively authorizing the Applicant directly or indirectly to act as principal for its own account in selling any security to or purchasing any security from the advisory client. The advisory client's written consent must be obtained through a signature or other positive manifestation of consent that is separate from or in addition to the signature indicating the client's consent to the advisory agreement. The separate or additional signature line or alternative means of expressing consent must be preceded immediately by prominent, plain English disclosure containing either: (a) An explanation of: (i) The circumstances under which the Applicant directly or indirectly may engage in principal transactions; (ii) the nature and significance of conflicts with its client's interests as a result of the transactions; and (iii) how the Applicant addresses those conflicts; or (b) a statement explaining that the client is consenting to principal transactions, followed by a cross-reference to a specific document provided to the client containing the disclosure in (a)(i)-(iii) above and to the specific page or pages on which such disclosure is located; provided, however, that if the Applicant requires time to modify its electronic systems to provide the specific page cross-reference required by clause (b), the Applicant may, while updating such electronic systems, and for no more than 90 days from the date of the Order, instead provide a cross-reference to a specific document provided to the client containing the disclosure in (a)(i)-(iii) above and to the specific section in such document in which such disclosure is located.
5. The Applicant, prior to the execution of each transaction in reliance on this Order, will: (a) Inform the advisory client, orally or in writing, of the capacity in which it may act with respect to such transaction; and (b) obtain consent from the advisory client, orally or in writing, to act as principal for its own account with respect to such transaction.
6. The Applicant will send a written confirmation at or before completion of each such transaction that includes, in addition to the information required by rule 10b-10 under the Exchange Act, a conspicuous, plain English statement informing the advisory client that the Applicant: (a) Disclosed to the client prior to the execution of the transaction that the Applicant may be acting in a principal capacity in connection with the transaction and the client authorized the transaction; and (b) sold the security to, or bought the security from, the client for its own account.
7. The Applicant will send to the client, no less frequently than annually, written disclosure containing a list of all transactions that were executed in the client's account in reliance upon this Order, and the date and price of each such transaction.
8. The Applicant is a broker-dealer registered under section 15 of the Exchange Act and each account for which the Applicant relies on this Order is a brokerage account subject to the Exchange Act, and the rules thereunder, and the rules of the self-regulatory organization(s) of which it is a member.
9. Each written disclosure required as a condition to this Order will include a conspicuous, plain English statement that the client may revoke the written consent referred to in Condition 4 above without penalty at any time by written notice to the Applicant in accordance with reasonable procedures established by the Applicant, but in all cases such revocation must be given effect within 5 business days of the Applicant's receipt thereof.
10. The Applicant will maintain records sufficient to enable verification of compliance with the conditions of this Order. Such records will include,
11. The Applicant will adopt written compliance policies and procedures reasonably designed to ensure, and the Applicant's chief compliance officer will monitor, the Applicant's compliance with the conditions of this Order. The Applicant's chief compliance officer will, on at least a quarterly basis, conduct testing reasonably sufficient to verify such compliance. Such written policies and procedures, monitoring and testing will address,
For the Commission, by the Division of Investment Management, under delegated authority.
Securities and Exchange Commission (“Commission”).
Notice.
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and 12(d)(1)(B) of the Act. The requested order would permit (a) actively-managed series of certain open-end management investment companies (“Funds”) to issue shares redeemable in large aggregations only (“Creation Units”); (b) secondary market transactions in Fund shares to occur at negotiated market prices rather than at net asset value (“NAV”); (c) certain Funds to pay redemption proceeds, under certain circumstances, more than seven days after the tender of shares for redemption; (d) certain affiliated persons of a Fund to deposit securities into, and receive securities from, the Fund in connection with the purchase and redemption of Creation Units; (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the Funds (“Funds of Funds”) to acquire shares of the Funds; and (f) certain Funds (“Feeder Funds”) to create and redeem Creation Units in-kind in a master-feeder structure.
Gadsden ETF Trust (“Trust”), a Delaware statutory trust that will be registered under the Act as an open-end management investment company with multiple series, and Gadsden, LLC (“Initial Adviser”), a Delaware limited liability company that will be registered as an investment adviser under the Investment Advisers Act of 1940.
The application was filed on December 26, 2017.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on February 23, 2018, and should be accompanied by proof of service on applicants, in the form of an affidavit, or for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090; Applicants: Eight Tower Bridge, 161 Washington Street, Suite 580, Conshohocken, PA 19428.
Bruce R. MacNeil, Senior Counsel, at (202) 551-6817, or David J. Marcinkus, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at
1. Applicants request an order that would allow Funds to operate as actively-managed exchange traded funds (“ETFs”).
2. Each Fund will consist of a portfolio of securities and other assets and investment positions (“Portfolio Instruments”). Each Fund will disclose on its website the identities and quantities of the Portfolio Instruments that will form the basis for the Fund's calculation of NAV at the end of the day.
3. Shares will be purchased and redeemed in Creation Units and generally on an in-kind basis. Except where the purchase or redemption will include cash under the limited circumstances specified in the application, purchasers will be required to purchase Creation Units by depositing specified instruments (“Deposit Instruments”), and shareholders redeeming their shares will receive specified instruments (“Redemption Instruments”). The Deposit Instruments and the Redemption Instruments will each correspond pro rata to the positions in the Fund's portfolio (including cash positions) except as specified in the application.
4. Because shares will not be individually redeemable, applicants request an exemption from section 5(a)(1) and section 2(a)(32) of the Act that would permit the Funds to register as open-end management investment companies and issue shares that are redeemable in Creation Units only.
5. Applicants also request an exemption from section 22(d) of the Act and rule 22c-1 under the Act as secondary market trading in shares will take place at negotiated prices, not at a current offering price described in a Fund's prospectus, and not at a price based on NAV. Applicants state that (a) secondary market trading in shares does not involve a Fund as a party and will not result in dilution of an investment in shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants represent that share market prices will be disciplined by arbitrage opportunities, which should prevent shares from trading at a material discount or premium from NAV.
6. With respect to Funds that hold non-U.S. Portfolio Instruments and that effect creations and redemptions of Creation Units in kind, applicants request relief from the requirement imposed by section 22(e) in order to allow such Funds to pay redemption proceeds within fifteen calendar days following the tender of Creation Units for redemption. Applicants assert that the requested relief would not be inconsistent with the spirit and intent of section 22(e) to prevent unreasonable, undisclosed or unforeseen delays in the actual payment of redemption proceeds.
7. Applicants request an exemption to permit Funds of Funds to acquire Fund shares beyond the limits of section 12(d)(1)(A) of the Act; and the Funds, and any principal underwriter for the Funds, and/or any broker or dealer registered under the Exchange Act, to sell shares to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act. The application's terms and conditions are designed to, among other things, help prevent any potential (i) undue influence over a Fund through control or voting power, or in connection with certain services, transactions, and underwritings, (ii) excessive layering of fees, and (iii) overly complex fund structures, which are the concerns underlying the limits in sections 12(d)(1)(A) and (B) of the Act.
8. Applicants request an exemption from sections 17(a)(1) and 17(a)(2) of the Act to permit a person who is an affiliated person, as defined in section 2(a)(3) of the Act (“Affiliated Person”), or an affiliated person of an Affiliated Person (“Second-Tier Affiliate”), of the Funds, solely by virtue of certain ownership interests, to effectuate purchases and redemptions in-kind. The deposit procedures for in-kind purchases of Creation Units and the redemption procedures for in-kind redemptions of Creation Units will be the same for all purchases and redemptions and Deposit Instruments and Redemption Instruments will be valued in the same manner as those Portfolio Instruments currently held by the Funds. Applicants also seek relief from the prohibitions on affiliated transactions in section 17(a) to permit a Fund to sell its shares to and redeem its shares from a Fund of Funds, and to engage in the accompanying in-kind transactions with the Fund of Funds.
9. Applicants also request relief to permit a Feeder Fund to acquire shares of another registered investment company managed by the Adviser having substantially the same investment objectives as the Feeder Fund (“Master Fund”) beyond the limitations in section 12(d)(1)(A) and permit the Master Fund, and any principal underwriter for the Master Fund, to sell shares of the Master Fund to the Feeder Fund beyond the limitations in section 12(d)(1)(B).
10. Section 6(c) of the Act permits the Commission to exempt any persons or transactions from any provision of the Act if such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities, or transactions, from any provision of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors. Section 17(b) of the Act authorizes the Commission to grant an order permitting a transaction otherwise prohibited by section 17(a) if it finds that (a) the terms of the proposed transaction are fair and reasonable and do not involve overreaching on the part of any person concerned; (b) the proposed transaction is consistent with the policies of each registered investment company involved; and (c) the proposed transaction is consistent with the general purposes of the Act.
For the Commission, by the Division of Investment Management, under delegated authority.
Securities and Exchange Commission (“Commission”).
Notice.
Notice of an application for an order pursuant to: (a) Section 6(c) of the Investment Company Act of 1940 (“Act”) granting an exemption from sections 18(f) and 21(b) of the Act; (b) section 12(d)(1)(J) of the Act granting an exemption from section 12(d)(1) of the Act; (c) sections 6(c) and 17(b) of the Act granting an exemption from sections 17(a)(1), 17(a)(2) and 17(a)(3) of the Act; and (d) section 17(d) of the Act and rule 17d-1 under the Act to permit certain joint arrangements and transactions. Applicants request an order that would permit certain registered open-end management investment companies to participate in a joint lending and borrowing facility.
Columbia Funds Series Trust, Columbia Funds Series Trust I, Columbia Funds Series Trust II, Columbia Funds Variable Insurance Trust, Columbia Funds Variable Series Trust II, Columbia ETF Trust I and Columbia ETF Trust II (each a “Trust” and collectively, the “Trusts”), each registered under the Act as open-end management investment companies with one or more series, and Columbia Management Investment Advisers, LLC (“Columbia Management”), registered as an investment adviser under the Investment Advisers Act of 1940.
The application was filed on November 9, 2017.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on February 26, 2018 and should be accompanied by proof of service on the applicants, in the form of an affidavit, or, for lawyers, a certificate of service. Pursuant to Rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090; Applicants: c/o Brian D. McCabe, Esq. and Nathan D. Somogie, Esq., Rope & Gray LLP, Prudential Tower, 800 Boylston Street, Boston, MA 02199.
Hae-Sung Lee, Attorney-Adviser, at (202) 551-7345 or Robert H. Shapiro, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or an applicant using the Company name box, at
1. Applicants request an order that would permit the applicants to participate in an interfund lending facility where each Fund could lend money directly to and borrow money directly from other Funds to cover unanticipated cash shortfalls, such as unanticipated redemptions or trade fails.
2. Applicants anticipate that the proposed facility would provide a borrowing Fund with a source of liquidity at a rate lower than the bank borrowing rate at times when the cash position of the Fund is insufficient to meet temporary cash requirements. In addition, Funds making short-term cash loans directly to other Funds would earn interest at a rate higher than they otherwise could obtain from investing their cash in repurchase agreements or certain other short term money market instruments. Thus, applicants assert that the facility would benefit both borrowing and lending Funds.
3. Applicants agree that any order granting the requested relief will be subject to the terms and conditions stated in the Application. Among others, the Adviser, through a designated committee, would administer the facility as a disinterested fiduciary as part of its duties under the investment management and administrative agreements with the Funds and would receive no additional fee as compensation for its services in connection with the administration of the facility. The facility would be subject to oversight and certain approvals by the Funds' Board, including, among others, approval of the interest rate formula and of the method for allocating loans across Funds, as well as review of the process in place to evaluate the liquidity implications for the Funds. A Fund's aggregate outstanding interfund loans will not exceed 15% of its net assets, and the Fund's loans to any one Fund will not exceed 5% of the lending Fund's net assets.
4. Applicants assert that the facility does not raise the concerns underlying section 12(d)(1) of the Act given that the Funds are part of the same group of investment companies and there will be no duplicative costs or fees to the Funds.
5. Applicants also believe that the limited relief from section 18(f)(1) of the Act that is necessary to implement the facility (because the lending Funds are not banks) is appropriate in light of the conditions and safeguards described in the application and because the Funds would remain subject to the requirement of section 18(f)(1) that all borrowings of a Fund, including combined interfund loans and bank borrowings, have at least 300% asset coverage.
6. Section 6(c) of the Act permits the Commission to exempt any persons or transactions from any provision of the Act if such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities, or transactions, from any provision of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors. Section 17(b) of the Act authorizes the Commission to grant an order permitting a transaction otherwise prohibited by section 17(a) if it finds that (a) the terms of the proposed transaction are fair and reasonable and do not involve overreaching on the part of any person concerned; (b) the proposed transaction is consistent with the policies of each registered investment company involved; and (c) the proposed transaction is consistent with the general purposes of the Act. Rule 17d-1(b) under the Act provides that in passing upon an application filed under the rule, the Commission will consider whether the participation of the registered investment company in a joint enterprise, joint arrangement or profit sharing plan on the basis proposed is consistent with the provisions, policies and purposes of the Act and the extent to which such participation is on a basis different from or less advantageous than that of the other participants.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to relocate the Consolidated Audit Trail Compliance rules (“CAT Rules”), currently under the 6800 Series (Rules 6810 through 6896), to General 7, Sections 1 through 13 in the Exchange's rulebook's (“Rulebook”) shell structure.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to relocate the CAT Rules, currently under the 6800 Series, Rules 6810 through 6896, to General 7, Sections 1 through 13 of the Rulebook's shell structure.
The Exchange adopted the CAT Rules to implement a consolidated audit trail in order to capture customer and order event information to comply with the provisions of the National Market System Plan Governing the Consolidated Audit Trail.
The relocation of the CAT Rules is part of the Exchange's continued effort to promote efficiency and conformity of its processes with those of its Affiliated Exchanges.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes do not impose a burden on competition because, as previously stated, they (i) are of a non-substantive nature, (ii) are intended to harmonize the Exchange's rules with those of its Affiliated Exchanges, and (iii) are intended to organize the Rulebook in a way that it will ease the Members' navigation and reading of the rules across the Affiliated Exchanges.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 35d-1 (17 CFR 270.35d-1) under the Investment Company Act of 1940 (15 U.S.C. 80a-1
The Commission estimates that there are approximately 9,939 open-end and closed-end funds that have names that are covered by the rule. The Commission estimates that of these 9,939 funds, approximately 33 will provide prior notice to shareholders pursuant to a policy adopted in accordance with this rule per year. The Commission estimates that the annual burden associated with the notice to shareholders requirement of the rule is 20 hours per response, for annual total of 660 hours per year.
Estimates of average burden hours are made solely for the purposes of the Paperwork Reduction Act and are not derived from a comprehensive or even representative survey or study of the costs of Commission rules and forms. The collection of information under rule 35d-1 is mandatory. The information provided under rule 35d-1 will not be kept confidential. 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.
Written comments are invited on: (a) 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; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE, Washington, DC 20549; or send an email to:
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 17g-3 contains certain reporting requirements for NRSROs including financial statements and information concerning its financial condition that the Commission, by rule, may prescribe as necessary or appropriate in the public interest or for the protection of investors. Currently, there are 10 credit rating agencies registered as NRSROs with the Commission. The Commission estimates that the total burden for respondents to comply with Rule 17g-3 is 3,650 hours.
Written comments are invited on: (a) 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; (b) the accuracy of the Commission's estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information on respondents; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
The Commission 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.
Please direct your written comments to: Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F St NE, Washington, DC 20549 or send an email to:
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 17g-10 contains certain certification requirements for third-party due diligence service providers that are employed by an NRSRO, an issuer, or an underwriter, which must be made on Form ABS Due Diligence-15E. The Commission estimates that the total burden for respondents to comply with Rule 17g-10 is 238 hours.
Written comments are invited on: (a) 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; (b) the accuracy of the Commission's estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information on respondents; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
The Commission 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.
Please direct your written comments to: Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F St NE, Washington, DC 20549 or send an email to:
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up to April 6, 2018.
You may submit comments by any of the following methods:
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You must include the DS form number, DS-4131; information collection title, ADVANCE NOTIFICATION FORM: Tourist and Other Non-Governmental Activities in the Antarctic Treaty Area; and the OMB control number, 1405-0181, in any correspondence.
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, may be submitted to Peter Ganser, Office of Ocean and Polar Affairs, Room 2665, Bureau of Oceans and International Environmental and Scientific Affairs, U.S. Department of State, 2201 C Street NW, Washington, DC 20520. He may be reached on 202-647-0237.
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Information solicited on the Advance Notification Form (DS-4131) provides the U.S. Government with information on tourist and other non-governmental expeditions to the Antarctic Treaty area. The U.S. Government needs this information to comply with Article VII(5)(a) of the Antarctic Treaty and associated documents.
Information will be submitted by organizers of tourist and other non-governmental expeditions to Antarctica. Copies should be submitted via email, although signed originals are also valid.
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Peacock in the Desert: The Royal Arts of Jodhpur, India,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Museum of Fine Arts, Houston, in Houston, Texas, from on or about March 4, 2018, until on or about August 12, 2018, at the Seattle Art Museum, Seattle, Washington, from on or about October 11, 2018, until on or about January 13, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest.
Elliot Chiu in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
The Office of the Assistant Legal Adviser for Private International Law, Department of State, hereby gives notice that the APCIL will hold a public meeting via teleconference to discuss a pending proposal on online dispute resolution (ODR) in the Asia Pacific Economic Cooperation forum (APEC). This is not a meeting of the full Advisory Committee.
In February 2017, the APEC Economic Committee endorsed a work plan on development of an APEC-wide cooperative framework for ODR for Micro, Small, and Medium Sized Enterprises (MSMEs) in business-to-business (B2B) transactions, which is currently co-sponsored by thirteen member economies (namely, Australia, Chile, Canada, Hong Kong, China, Indonesia, Japan, Mexico, New Zealand, Papua New Guinea, Peru, Russia, Chinese Taipei and the United States).
MSMEs have gained unprecedented access to international trade via the global supply chain and cross-border e-commerce, but to effectively reach global markets these businesses need a legal environment which enables the quick resolution of disputes and creates confidence in cross-border e-commerce. The use of ODR could be an effective means to solve this problem. ODR is a way of resolving disputes using traditional methods such as negotiation, mediation, and arbitration, but with the help of technology and without the need for a physical presence at a meeting or hearing.
At its most recent meeting in August 2017, the APEC Economic Committee endorsed a revised work plan on ODR that includes calls to inter alia “build a pilot in conjunction with platform host/ODR provider via outreach to regional arbitration/mediation centers to determine possible partners for hosting ODR platform.” Additionally, the scope of the project was expanded to include “Use of Modern Technology for Dispute Resolution and Electronic Agreement Management” with the explanation that “it is also worthwhile to explore the use of other modern technology such as block chain, automated or smart contracts for contract management or enforcement and prevention of disputes.” The APEC Economic Committee has approved a two-day workshop for the first Economic Committee meeting next February to discuss the work plan and the pilot proposal.
This conference call will be a continuation of the conference call meeting that was held on November 1, 2017.
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Michelangelo and the Vatican: Masterworks from the Museo e Real Bosco di Capodimonte, Naples,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit objects at the Museum of Fine Arts, Houston, in Houston, Texas, from on or about March 11, 2018, until on or about June 10, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.
Elliot Chiu in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
The Office of the Assistant Legal Adviser for Private International Law, Department of State, hereby gives notice that the Micro, Small, and Medium-Sized Enterprises (MSMEs) study group of the Advisory Committee on Private International Law (ACPIL) will hold a public meeting via teleconference to discuss the next session of the UNCITRAL Working Group I scheduled for March 12-16 in New York. This is not a meeting of the full Advisory Committee.
UNCITRAL has established a working group aimed at reducing the legal obstacles faced by MSMEs throughout their life cycle, and in particular those in developing countries. UNCITRAL further directed that the work should start with a focus on the legal issues surrounding the simplification of registration and incorporation. At its upcoming session, the UNCITRAL Working Group I will attempt to complete consideration of a draft legislative guide on key principles of business registration (UN Doc. A/CN.9/WG.I/WP.106) and an introductory paper prepared by the Secretariat entitled “Reducing the legal obstacles faced by MSMEs” (UN Doc. A/CN.9/WG.I/WP.107). Once those tasks had been completed, the Working Group would resume its consideration of the draft legislative guide on an UNCITRAL Limited Liability Organization found in documents A/CN.9/WG.I/WP.99 and A/CN.9/WG.I/WP.99/Add.1. Draft texts, along with the reports of earlier sessions of the Working Group will be available at
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Icons of Style: A Century of Fashion Photography, 1911-2011,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The J. Paul Getty Museum at the Getty Center, Los Angeles, California, from on or about June 26, 2018, until on or about October 21, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.
Elliot Chiu in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The list of Specially Designated Nationals and Blocked Persons (SDN List) and additional information concerning OFAC sanctions programs are available on OFAC's website (
On January 30, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority listed below.
1. WEI, Zhao (a.k.a. CHIO, Wai; a.k.a. HWEI, Jao; a.k.a. SAECHOU, Thanchai; a.k.a. WAI, Chio; a.k.a. WEI, Chao; a.k.a. WEI, Jiao; a.k.a. WEI, Zhang), Flat G, 19 FL Maple Mansion, Taikoo Shing, Quarry Bay, Hong Kong; Room 2410, 24/F, Block Q, Kornhill, Quarry Bay, Hong Kong; DOB 16 Sep 1952; POB Heilongjiang Province, China; alt. POB Liaoning Province, China; nationality China; Gender Male; Passport MA0269785 (Macau); alt. Passport M0178952 (China); alt. Passport MA0162634 (China); National ID No. 12756003 (Macau) (individual) [TCO] (Linked To: ZHAO WEI TCO). Designated pursuant to section 1(a)(ii)(B) of Executive Order 13581 of July 24, 2011, “Blocking Property of Transnational Criminal Organizations” (E.O. 13581), for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, the ZHAO WEI TCO. Also designated pursuant to section 1(a)(ii)(C) of E.O. 13581 for having acted or purported to act for or on behalf of, directly or indirectly, the ZHAO WEI TCO.
2. SU, Guiqin (a.k.a. SU, Gui Qin; a.k.a. SU, Madame; a.k.a. SU, Zhao; a.k.a. WEI, Su), Flat G, 19 FL Maple Mansion, Taikoo Shing, Quarry Bay, Hong Kong; DOB 03 Dec 1959; POB Liaoning Province, China; nationality China; Gender Female; Passport G55408772 (China); alt. Passport G42695702 (China); alt. Passport E03807847 (China); National ID No. R9733840 (China) (individual) [TCO] (Linked To: ZHAO WEI TCO). Designated pursuant to section 1(a)(ii)(B) of E.O. 13581 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, the ZHAO WEI TCO. Also designated pursuant to section 1(a)(ii)(C) of E.O. 13581 for having acted or purported to act for or on behalf of, directly or indirectly, the ZHAO WEI TCO.
3. EBERAHIM, Abbas (a.k.a. BASU), 43 Walana Cres, Kooringal, NSW 2650, Australia; Golden Triangle Special Economic Zone, Bokeo, Laos; 292 Moo 1 Wiang, Chiang Saen District, Chiang Rai 57150, Thailand; DOB 11 Sep 1949; POB Malaysia; nationality Australia; Gender Male; Passport N2315963 (Australia) (individual) [TCO] (Linked To: ZHAO WEI TCO). Designated pursuant to section 1(a)(ii)(B) of E.O. 13581 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, the ZHAO WEI TCO. Also designated pursuant to section 1(a)(ii)(C) of E.O. 13581 for having acted or purported to act for or on behalf of, directly or indirectly, the ZHAO WEI TCO.
4. RUNGTAWANKHIRI, Nat (a.k.a. RUNGTAWANKEEREE, Nat), 100 (20) Mu. 2, Tambon Mae Salong Nai, Mae Fah Luang District, Chiang Rai, Thailand; DOB 01 Jan 1977; nationality Thailand; Gender Male; National ID No. 5-5715-00025-50-6 (Thailand) (individual) [TCO] (Linked To: ZHAO WEI TCO). Designated pursuant to section 1(a)(ii)(B) of E.O. 13581 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, the ZHAO WEI TCO. Also designated pursuant to section 1(a)(ii)(C) of E.O. 13581 for having acted or purported to act for or on behalf of, directly or indirectly, the ZHAO WEI TCO.
1. ZHAO WEI TCO (a.k.a. KINGS ROMANS CASINO; a.k.a. KINGS ROMANS GROUP; a.k.a. ZHAO WEI NARCOTICS TRAFFICKING GROUP), Laos; Thailand; Burma; China [TCO]. Designated pursuant to section 1(a)(ii)(A) of E.O. 13581 because it is a foreign person that constitutes a significant transnational criminal organization.
2. KINGS ROMANS INTERNATIONAL (HK) CO., LIMITED (a.k.a. DOK NGEW KHAM CASINO CO. LTD.; a.k.a. DOK NGIEO KHAM COMPANY; a.k.a. DOK NGIU KHAM KING ROMAN CASINO; a.k.a. DOK NGIU KHAM KING ROMAN GROUP; a.k.a. DOKNGIEWKHAM COMPANY; a.k.a. DONG NGIEW KHAM GROUP; a.k.a. GOLDEN KAPOK; a.k.a. JIN MU MIAN; a.k.a. JING MU MIANG COMPANY; a.k.a. KING ROMANS GROUP COMPANY LTD; a.k.a. KINGS ROMAN INTERNATIONAL COMPANY, LIMITED; a.k.a. KINGS ROMAN RESORT AND CASINO; a.k.a. KINGS ROMANS CASINO; a.k.a. KINGS ROMANS GROUP; a.k.a. MYANMAR MACAU LUNDUN; a.k.a. WEI TA LEE COMPANY), Rm 3605, 36/F Wu Chung Hse, 213 Queens Rd E, Wan Chai, Hong Kong Island, Hong Kong; Registration ID 51510606 (Hong Kong); Certificate of Incorporation Number 1396649 (Hong Kong) [TCO] (Linked To: WEI, Zhao; Linked To: SU, Guiqin). Designated pursuant to section 1(a)(ii)(C) of E.O. 13581 for being owned or controlled by, or having acted or purported to act for or on behalf of, directly or indirectly, Zhao WEI and Guiqin SU.
3. KINGS ROMANS INTERNATIONAL INVESTMENT CO. LIMITED (a.k.a. DOK NGEW KHAM CASINO CO. LTD.; a.k.a. DOK NGIEO KHAM COMPANY; a.k.a. DOK NGIU KHAM KING ROMAN CASINO; a.k.a. DOK NGIU KHAM KING ROMAN GROUP; a.k.a. DOKNGIEWKHAM COMPANY; a.k.a. DONG NGIEW KHAM GROUP; a.k.a. GOLDEN KAPOK; a.k.a. JIN MU MIAN; a.k.a. JING MU MIANG COMPANY; a.k.a. KING ROMANS GROUP COMPANY LTD; a.k.a. KINGS ROMAN RESORT AND CASINO; a.k.a. KINGS ROMANS CASINO; a.k.a. KINGS ROMANS GROUP; a.k.a. MYANMAR MACAU LUNDUN; a.k.a. WEI TA LEE COMPANY), Rm C, 15/F, Full Win Coml Ctr, 573 Nathan Rd, Mongkok, Kowloon, Hong Kong; Rm 3605, 36FL, Wu Chung House, 213 Queen's Road East, Wan Chai, Wan Chai, Hong Kong; Registration ID 38620903 (Hong Kong); Certificate of Incorporation Number 1184117 (Hong Kong) [TCO] (Linked To: WEI, Zhao). Designated pursuant to section 1(a)(ii)(C) of E.O. 13581 for being owned or controlled by, or having acted or purported to act for or on behalf of, directly or indirectly, Zhao WEI.
4. KING ROMANS COMPANY LIMITED, 292, Wiang, Chiang Saen, 57150 Chiang Rai, Thailand; 292 Mu. 1, Tambon Wiang, Chiang Saen District, Chiang Rai, Thailand; 422/44 Chang Khlan Road, Tambon Chang Khlang, Mueang District, Chiang Mai, Thailand; Registration ID 0575552000132 (Thailand) [TCO] (Linked To: WEI, Zhao; Linked To: RUNGTAWANKHIRI, Nat). Designated pursuant to section 1(a)(ii)(C) of E.O. 13581 for being owned or controlled by, or having acted or purported to act for or on behalf of, directly or indirectly, Zhao WEI and Nat RUNGTAWANKHIRI.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them. Additionally, OFAC is publishing an update to the identifications under the Sectoral Sanctions Identification List.
See Supplementary Information section.
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The list of Specially Designated Nationals and Blocked Persons (SDN List) and additional information concerning OFAC sanctions programs
On January 26, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority listed below.
1. ANTIPOV, Igor Yurievich (a.k.a. ANTIPOV, Ihor), 23 Prospect Mayakovskogo, Apt. 110, Donetsk, Ukraine; 26 Ulitsa Turbinnaya, Donetsk, Ukraine; DOB 26 May 1961; Gender Male (individual) [UKRAINE-EO13660] (Linked To: DONETSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(v) of Executive Order 13660 of March 6, 2014, “Blocking Property of Certain Persons Contributing to the Situation in Ukraine” (E.O. 13660) for having acted or purported to act for or on behalf of, directly or indirectly, the so-called “DONETSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
2. GRANOVSKY, Aleksey Ivanovich, 41 Ulitsa Malakhova, Donetsk, Donetsk Region, Ukraine; DOB 03 Nov 1973; Gender Male (individual) [UKRAINE-EO13660] (Linked To: DONETSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(ii) of E.O. 13660 for having asserted governmental authority over any part or region of Ukraine without the authorization of the Government of Ukraine.
Also designated pursuant to section 1(a)(v) of E.O. 13660 for having acted or purported to act for or on behalf of, directly or indirectly, the so-called “DONETSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
3. KOSTENKO, Elena Nikolaevna (a.k.a. KOSTENKO, Olena Mykolaivna), Novoannivka Street, No. 9, Krasnodonsky District, Luhansk Region, Ukraine; DOB 13 Nov 1968; POB Krasnodonsky, Ukraine; Gender Female (individual) [UKRAINE-EO13660]. Designated pursuant to section 1(a)(ii) of E.O. 13660 for having asserted governmental authority over any part or region of Ukraine without the authorization of the Government of Ukraine.
4. MALAKHOVA, Svetlana Anatolievna (a.k.a. MALAKHOVA, Svetlana Anatolyevna; a.k.a. MALAKHOVA, Svitlana Anatoliivna), 2A Levanevsky Street, Luhansk, Luhansk Region, Ukraine; DOB 27 Aug 1964; Gender Female (individual) [UKRAINE-EO13660]. Designated pursuant to section 1(a)(ii) of E.O. 13660 for having asserted governmental authority over any part or region of Ukraine without the authorization of the Government of Ukraine.
5. MALGIN, Pavel Vladimirovich (a.k.a. MALGIN, Pavlo Volodymirovich; a.k.a. MALHIN, Pavlo), Quarter Koshevogo 37, Apt. 28, Molodogvardeysk, Ukraine; Lenin Street 3, Apt. 1, Sorokino Krasnodon, Ukraine; DOB 30 Mar 1968; POB Krasnodon, Ukraine; Gender Male (individual) [UKRAINE-EO13660]. Designated pursuant to section 1(a)(ii) of E.O. 13660 for having asserted governmental authority over any part or region of Ukraine without the authorization of the Government of Ukraine.
6. MATYUSHCHENKO, Ekaterina Sergeevna (a.k.a. MATIUSHCHENKO, Ekaterina Sergeevna; a.k.a. MATYUSHCHENKO, Kateryna), 20 Ulitsa Novosadovaya, Apt. 41, Donetsk, Donetsk Region, Ukraine; DOB 01 Feb 1979; Gender Female (individual) [UKRAINE-EO13660] (Linked To: DONETSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(ii) of E.O. 13660 for having asserted governmental authority over any part or region of Ukraine without the authorization of the Government of Ukraine.
Also designated pursuant to section 1(a)(v) of E.O. 13660 for having acted or purported to act for or on behalf of, directly or indirectly, the so-called “DONETSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
7. MELNYCHUK, Oleksandr (a.k.a. MELNICHUK, Aleksandr Aleksandrovich), Ukraine; DOB 17 Jan 1965; POB Rovenki, Ukraine; Gender Male (individual) [UKRAINE-EO13660] (Linked To: LUHANSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(iv) of E.O. 13660 for having materially assisted, sponsored, or provided financial, material, technological support for, or goods or services to or in support of, the so-called “LUHANSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
8. MELNYCHUK, Serhiy (a.k.a. MELNICHUK, Sergey; a.k.a. MELNYCHUK, Sergiy Oleksandrovich), Ukraine; DOB 30 Sep 1976; POB Rovenki, Ukraine; Gender Male (individual) [UKRAINE-EO13660] (Linked To: LUHANSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(iv) of E.O. 13660 for having materially assisted, sponsored, or provided financial, material, technological support for, or goods or services to or in support of, the so-called “LUHANSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
9. NIKONOROVA, Natalya Yurievna, 7 Ulitsa Dneprodzerzhinskaya, Apt. 142, Donetsk, Donetsk Region, Ukraine; DOB 28 Sep 1984; Gender Female (individual) [UKRAINE-EO13660] (Linked To: DONETSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(ii) of E.O. 13660 for having asserted governmental authority over any part or region of Ukraine without the authorization of the Government of Ukraine. Also designated pursuant to section 1(a)(v) of E.O. 13660 for having acted or purported to act for or on behalf of, directly or indirectly, the so-called “DONETSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
10. OVSYANNIKOV, Dmitry Vladimirovich (Cyrillic: ОВСЯННИКОВ, ДМИТРИЙ ВЛАДИМИРОВИЧ), Sevastopol, Crimea, Ukraine; DOB 21 Feb 1977; POB Omsk, Russia; Gender Male (individual) [UKRAINE-EO13660]. Designated pursuant to section 1(a)(i)(B) of E.O. 13660 for being responsible for or complicit in, or having engaged in, directly or indirectly, actions or policies that threaten the peace, security, stability, sovereignty, or territorial integrity of Ukraine.
11. PASHKOV, Vladimir Igorevich, Russia; Ukraine; DOB 1961; POB Bratsk, Russia; Gender Male (individual) [UKRAINE-EO13660] (Linked To: DONETSK PEOPLE'S REPUBLIC; Linked To: LUHANSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(v) of E.O. 13660 for having acted or purported to act for or on behalf of, directly or indirectly, the so-called “DONETSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
Also designated pursuant to section 1(a)(v) of E.O. 13660 for having acted or purported to act for or on behalf of, directly or indirectly, the so-called “LUHANSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
12. PAVLENKO, Vladimir Nikolaevich (a.k.a. PAVLENKO, Volodymyr Mykolaiovych), Ukraine; Gender Male; Minister of State Security of the so-called Donetsk People's Republic (individual) [UKRAINE-EO13660] (Linked To: DONETSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(v) of E.O. 13660 for having acted or purported to act for or on behalf of, directly or indirectly, the so-called “DONETSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
13. RADOMSKAYA, Elena Vladimirovna (a.k.a. RADOMSKA, Olena; a.k.a. RADOMSKAYA, Yelena), 211 Ulitsa Kuibysheva, Apt. 65, Donetsk, Donetsk Region, Ukraine; DOB 15 Nov 1974; Gender Female (individual) [UKRAINE-EO13660] (Linked To: DONETSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(ii) of E.O. 13660 for having asserted governmental authority over any part or region of Ukraine without the authorization of the Government of Ukraine.
Also designated pursuant to section 1(a)(v) of E.O. 13660 for having acted or purported to act for or on behalf of, directly or indirectly, the so-called “DONETSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
14. TIMOFEEV, Aleksandr Yurievich (a.k.a. TIMOFEYEV, Aleksandr Yuryevich; a.k.a. TYMOFEEV, Oleksandr Yuriyovich), 134 Ulitsa Petrovskogo, Apt. 98, Donetsk, Ukraine; DOB 15 May 1971; Gender Male (individual) [UKRAINE-EO13660] (Linked To: DONETSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(v) of E.O. 13660 for having acted or purported to act for or on behalf of, directly or indirectly, the so-called “DONETSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
15. CHEREZOV, Andrey Vladimirovich (a.k.a. CHEREZOV, Andrei; a.k.a. CHEREZOV, Andrey), Russia; DOB 12 Oct 1967; POB Salair, Kemerovsakya Oblast, Russia; nationality Russia; Gender Male; Deputy Minister of Energy in the Department
16. GRABCHAK, Evgeniy Petrovich (a.k.a. GRABCHAK, Evgeniy; a.k.a. GRABCHAK, Evgeny), Russia; DOB 18 Jul 1981; POB Ust-Labinsk, Krasnodar Region, Russia; nationality Russia; Gender Male; Head of the Department of Operational Control and Management in the Electric Power Industry in the Energy Ministry of the Russian Federation (individual) [UKRAINE-EO13661]. Designated pursuant to section 1(a)(ii)(A) of E.O. 13661 for being an official of the Government of the Russian Federation.
17. KOLOSOV, Bogdan Valeryevich (a.k.a. KOLOSOV, Bogdan), House 177, Apt. 64, Izhevsk, Udmurtskaya Respublika 426060, Russia; DOB 06 May 1985; Gender Male (individual) [UKRAINE-EO13661] (Linked To: KALASHNIKOV CONCERN). Designated pursuant to section 1(a)(ii)(C)(2) of E.O. 13661 for having acted or purported to act for or on behalf of, directly or indirectly, KALASHNIKOV CONCERN, a person determined to be subject to E.O. 13661.
Also designated pursuant to section 1(a)(ii)(D)(2) of E.O. 13661 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, KALASHNIKOV CONCERN, a person determined to be subject to E.O. 13661.
18. PENTYA, Aleksandr Yevgenyevich (a.k.a. PENTYA, Alexander), St. Petersburg, Russia; DOB 07 Sep 1985; Gender Male (individual) [UKRAINE-EO13661] (Linked To: CJSC ABR MANAGEMENT). Designated pursuant to section 1(a)(ii)(C)(2) of E.O. 13661 for acting or purporting to act for or on behalf of, directly or indirectly, CJSC ABR MANAGEMENT, a person determined to be subject to E.O. 13661.
19. ABRAMOV, Valeri Vyacheslavovich (a.k.a. ABRAMOV, Valerii Vyacheslavovich), St. Petersburg, Russia; 133, ul. Chernyshevskogo, Vologda, Vologodskaya Obl 160019, Russia; 122 Grazhdanskiy Prospect, Suite 5, Liter A, St. Petersburg 195267, Russia; DOB 06 Jan 1963; POB Tula, Russia; Gender Male; Tax ID No. 780201346432 (Russia); General Director (individual) [UKRAINE-EO13685] (Linked To: VAD, AO). Designated pursuant to section 2(a)(iii) of Executive Order 13685 of December 19, 2014, “Blocking Property of Certain Persons and Prohibiting Certain Transactions With Respect to the Crimea Region of Ukraine” (E.O. 13685) for having acted or purported to act for or on behalf of, directly or indirectly, VAD, AO, a person determined to be subject to E.O. 13685.
20. PEREVALOV, Viktor Pavlovich, St. Petersburg, Russia; 133, ul. Chernyshevskogo, Vologda, Vologodskaya Obl 160019, Russia; 122 Grazhdanskiy Prospect, Suite 5, Liter A, St. Petersburg 195267, Russia; DOB 27 Jun 1963; Gender Male; Tax ID No. 780201527164 (Russia); First Deputy General Director (individual) [UKRAINE-EO13685] (Linked To: VAD, AO). Designated pursuant to section 2(a)(iii) of E.O. 13685 for having acted or purported to act for or on behalf of, directly or indirectly, VAD, AO, a person determined to be subject to E.O. 13685.
21. TOPOR-GILKA, Sergey Anatolyevich, Russia; DOB 17 Feb 1970; Gender Male;
Director General of Limited Liability Company Foreign Economic Association Technopromexport (individual) [UKRAINE-EO13685] (Linked To: LIMITED LIABILITY COMPANY FOREIGN ECONOMIC ASSOCIATION TECHNOPROMEXPORT). Designated pursuant to section 2(a)(iii) of E.O. 13685 for having acted or purported to act for or on behalf of, directly or indirectly, LIMITED LIABILITY COMPANY FOREIGN ECONOMIC ASSOCIATION TECHNOPROMEXPORT, a person determined to be subject to E.O. 13685.
Also designated pursuant to section 2(a)(iii) of E.O. 13685 for having acted or purported to act for or on behalf of, directly or indirectly, OTKRYTOE AKTSIONERNOE OBSHCHESTVO VNESHNEEKONOMICHESKOE OBEDINENIE TEKHNOPROMEKSPORT, a person determined to be subject to E.O. 13685.
1. DONCOALTRADE SP Z O O, Ul. Barbary 21, Katowice, woj. Slaskie, pow. M. Katowice 40-053, Poland; Registration ID 0000421465 (Poland) [UKRAINE-EO13660] (Linked To: MELNYCHUK, Oleksandr). Designated pursuant to section 1(a)(v) of E.O. 13660 for being owned or controlled by Oleksandr MELNYCHUK, a person determined to be subject to E.O. 13660.
2. KOMPANIYA GAZ-ALYANS, OOO (a.k.a. COMPANY GAZ-ALLIANCE LLC; a.k.a. OBSHCHESTVO S OGRANICHENNOI OTVETSTVENNOSTYU KOMPANIYA GAZ-ALYANS), 15 Ul. Svobody, Nizhni Novgorod, Nizhegorodskaya Obl. 603003, Russia; Registration ID 1142311010885 (Russia) [UKRAINE-EO13660] (Linked To: DONETSK PEOPLE'S REPUBLIC; Linked To: LUHANSK PEOPLE'S REPUBLIC; Linked To: ZAO VNESHTORGSERVIS). Designated pursuant to section 1(a)(iv) of E.O. 13660 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, ZAO VNESHTORGSERVIS, a person determined to be subject to E.O. 13660.
Also designated pursuant to section 1(a)(iv) of E.O. 13660 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, the so-called “DONETSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
Also designated pursuant to section 1(a)(iv) of E.O. 13660 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, the so-called “LUHANSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
3. UGOLNYE TEKHNOLOGII, OOO (a.k.a. COAL TECHNOLOGIES; a.k.a. OBSHCHESTVO S OGRANICHENNOI OTVETSTVENNOSTYU “UGOLNYE TEKHNOLOGII”), d. 25 ofis 13, 14, per. Avtomobilny, Rostov-on-Don, Rostovskaya Oblast 344038, Russia; Registration ID 1146164002621 [UKRAINE-EO13660] (Linked To: DONETSK PEOPLE'S REPUBLIC; Linked To: LUHANSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(iv) of E.O. 13660 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, the so-called “DONETSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
Also designated pursuant to section 1(a)(iv) of E.O. 13660 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, the so-called “LUHANSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
4. ZAO VNESHTORGSERVIS, 1 Geroyev Street, Tskhinval, South Ossetia, Georgia [UKRAINE-EO13660] (Linked To: DONETSK PEOPLE'S REPUBLIC; Linked To: LUHANSK PEOPLE'S REPUBLIC). Designated pursuant to section 1(a)(v) of E.O. 13660 for having acted or purported to act for or on behalf of, directly or indirectly, the so-called “DONETSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
Also designated pursuant to section 1(a)(v) of E.O. 13660 for having acted or purported to act for or on behalf of, directly or indirectly, the so-called “LUHANSK PEOPLE'S REPUBLIC,” a person determined to be subject to E.O. 13660.
5. EVRO POLIS LTD. (a.k.a. EVRO POLIS, OOO; a.k.a. OBSHCHESTVO S OGRANICHENNOI OTVETSTVENNOSTYU EVRO POLIS), d. 1A pom. 9.1A, Shosse Ilinskoe, Krasnogorsk, Krasnogorski Raion, Moskovskaya Obl. 143409, Russia; Registration ID 1165024055613 [UKRAINE-EO13661] (Linked To: PRIGOZHIN, Yevgeniy Viktorovich). Designated pursuant to section 1(a)(ii)(C)(2) of E.O. 13661 for being owned or controlled by Yevgeniy PRIGOZHIN, a person determined to be subject to E.O. 13661.
6. INSTAR LODZHISTIKS, OOO (a.k.a. INSTAR LOGISTICS), d. 20 str., 7 ofis 102V, ul. Elektrozavodskaya, Moscow 1072023, Russia; Registration ID 1027739429981 (Russia); Tax ID No. 7714136948 (Russia); Government Gazette Number 18631592 (Russia) [UKRAINE-EO13661]. Designated pursuant to section 1(a)(ii)(C)(2) of E.O. 13661 for having acted or purported to act for or on behalf of, directly or indirectly, KALASHNIKOV CONCERN, a person determined to be subject to E.O. 13661.
Also designated pursuant to section 1(a)(ii)(D)(2) of E.O. 13661 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, KALASHNIKOV CONCERN, a person determined to be subject to E.O. 13661.
7. PJSC POWER MACHINES (a.k.a. OPEN JOINT STOCK COMPANY POWER MACHINES—ZTL, LMZ, ELECTROSILA, ENERGOMACHEXPORT; a.k.a. PUBLICHNOE AKTSIONERNOE OBSHCHESTVO SILOVYE MASHINY—ZTL, LMZ, ELEKTROSILA, ENERGOMASHEKSPORT; a.k.a. SILOVYE
Also designated pursuant to section 2(a)(iv) of E.O. 13685 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, OTKRYTOE AKTSIONERNOE OBSHCHESTVO VNESHNEEKONOMICHESKOE OBEDINENIE TEKHNOPROMEKSPORT, a person determined to be subject to E.O. 13685.
8. LIMITED LIABILITY COMPANY FOREIGN ECONOMIC ASSOCIATION TECHNOPROMEXPORT (a.k.a. OBSCHESTVO S OGRANICHENNOI OTVESTVENNOSTYU VNESHNEEKONOMICHESKOE OBEDINENIE TEKHNOPROMEKSPORT; a.k.a. OOO VO TECHNOPROMEXPORT; a.k.a. OOO VO TPE), Novyi Arbat Str. 15, Building 2, Moscow 119019, Russia; Registration ID 1147746527279 (Russia); Tax ID No. 7704863782e (Russia) [UKRAINE-EO13685]. Designated pursuant to section 2(a)(i) of E.O. 13685 for operating in the Crimea region of Ukraine.
9. VAD, AO (a.k.a. AKTSIONERNOE OBSHCHESTVO VAD; a.k.a. AO, VAD; a.k.a. CJSC VAD; a.k.a. JOINT STOCK COMPANY VAD; a.k.a. JSC VAD; a.k.a. ZAO VAD; a.k.a. “HIGH-QUALITY HIGHWAYS”), 133, ul. Chernyshevskogo, Vologda, Vologodskaya Obl 160019, Russia; 122 Grazhdanskiy Prospect, Suite 5, Liter A, St. Petersburg 195267, Russia; website
On January 26, 2018, OFAC determined SURGUTNEFTEGAS owns, directly or indirectly, a 50 percent or greater interest in the entities listed below. As a result of such ownership, these entities are subject to the prohibitions of Directive 4 (as amended) of October 31, 2017, issued pursuant to E.O. 13662, 31 CFR 589.406 and 589.802, and following the Secretary of the Treasury's determination of July 16, 2014 pursuant to section l(a)(i) of E.O. 13662 with respect to the energy sector of the Russian Federation economy. These entities are being identified in the Sectoral Sanctions Identification List:
1. KALININGRADNEFTEPRODUKT OOO (a.k.a. KALININGRADNEFTEPRODUKT LLC; a.k.a. LIMITED LIABILITY COMPANY KALININGRADNEFTEPRODUCT; a.k.a. LLC KALININGRADNEFTEPRODUCT), 22-b Komsomolskaya Ulitsa, Central District, Kaliningrad, Russia; Email Address
2. KINEF OOO (a.k.a. KINEF, LLC; a.k.a. LIMITED LIABILITY COMPANY PRODUCTION ASSOCIATION KIRISHINEFTEORGSINTEZ; a.k.a. LLC KINEF), d. 1 Shosse Entuziastov, Kirishi, Leningradskaya Oblast 187110, Russia; website
3. KIRISHIAVTOSERVIS OOO (a.k.a. LIMITED LIABILITY COMPANY KIRISHIAVTOSERVIS; a.k.a. LLC KIRISHIAVTOSERVIS), Lit A, 12 Smolenskaya Ulitsa, St. Petersburg 196084, Russia; website
4. LENGIPRONEFTEKHIM OOO (a.k.a. INSTITUT PO PROEKTIROVANIYU PREDPRIYATY NEFTEPERERABATYVAYUSCHEY I NEFTEKHIMICHESKOY PROMYSHLENNOSTI, LIMITED LIABILITY COMPANY; a.k.a. LIMITED LIABILITY COMPANY OIL REFINING AND PETROCHEMICAL FACILITIES DESIGN INSTITUTE; a.k.a. LLC LENGIPRONEFTEKHIM), D. 94, Obvodnogo Kanala, nab, St. Petersburg 196084, Russia; Email Address
5. MEDIA-INVEST OOO (a.k.a. LIMITED LIABILITY COMPANY MEDIA-INVEST; a.k.a. LLC MEDIA-INVEST), 17, Bld 1, Zubovsky Boulevard, Moscow 119847, Russia; Executive Order 13662 Directive Determination—Subject to Directive 4; Nationality of Registration Russia; Registration ID 1077762407580 (Russia); Tax ID No. 7704667322 (Russia); For more information, please reference the following link:
6. NOVGORODNEFTEPRODUKT OOO (a.k.a. LIMITED LIABILITY COMPANY NOVGORODNEFTEPRODUCT; a.k.a. LLC NOVGORODNEFTEPRODUCT; a.k.a. NOVGORODNEFTEPRODUKT LLC), d. 20 Germana Ulitsa, Veliky Novgorod, Novgorodskaya Oblast 173002, Russia; Email Address
7. PSKOVNEFTEPRODUKT OOO (a.k.a. LIMITED LIABILITY COMPANY MARKETING ASSOCIATION PSKOVNEFTEPRODUCT; a.k.a. LLC PSKOVNEFTEPRODUCT), 4 Oktyabrsky Prospekt, Pskov 180000, Russia; website
8. SNGB AO (a.k.a. CLOSED JOINT STOCK COMPANY SURGUTNEFTEGASBANK (ZAO SNGB); a.k.a. JOINT STOCK COMPANY SURGUTNEFTEGASBANK; a.k.a. JSC BANK SNGB), 19 Kukuyevitskogo Street, Surgut 628400, Russia; website
9. SO TVERNEFTEPRODUKT OOO (a.k.a. LIMITED LIABILITY COMPANY MARKETING ASSOCIATION TVERNEFTEPRODUCT; a.k.a. LLC MA TVERNEFTEPRODUCT), 6 Novotorzhskaya Ulitsa, Tver, Russia; website
10. SOVKHOZ CHERVISHEVSKI PAO (a.k.a. OJSC SOVKHOZ CHERVISHEVSKY; a.k.a. OPEN JOINT STOCK COMPANY SOVKHOZ CHERVISHEVSKY; a.k.a. SOVKHOZ CHERVISHEVSKY, JSC), d. 81 Sovetskaya Ulitsa, S. Chervichevsky, Tyumensky Rayon, Tyumenskaya Oblast 625519, Russia; Email Address
11. STRAKHOVOVE OBSHCHESTVO SURGUTNEFTEGAZ OOO (a.k.a. INSURANCE COMPANY SURGUTNEFTEGAS, LLC; a.k.a. LIMITED LIABILITY COMPANY INSURANCE COMPANY SURGUTNEFTEGAS; a.k.a. LLC INSURANCE COMPANY SURGUTNEFTEGAS), 9/1 Lermontova Ulitsa, Surgut 628418, Russia; website
12. SURGUTMEBEL OOO (a.k.a. LIMITED LIABILITY COMPANY SYRGUTMEBEL; a.k.a. LLC SURGUTMEBEL; a.k.a. LLC SYRGUTMEBEL; a.k.a. SURGUTMEBEL, LLC), Vostochnaya Industrial 1 Territory 2, Poselok Barsovo, Surgutsky District, Yugra, Khanty-Mansiysky Autonomous Okrug, Russia; website
Veterans Benefits Administration, Department of Veterans Affairs.082
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before March 7, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or email
44 U.S.C. 3501-21.
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. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before March 7, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or email
Public Law 96-342.
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. The
By direction of the Secretary:
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before March 7, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or email
44 U.S.C. 3501-21.
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. The
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
Veterans Health Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before April 6, 2018.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Brian McCarthy at (202) 615-9241.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (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
38 U.S.C. Parts 51 and 52.
The information will be used by VHA Office of Health Information Governance and/or contractors to create accounts in the VistA computer system for VSO's. The information collected is used for a national roll-out of a project targeted at providing more efficient benefits processing services to veterans. The VistA system requires a minimal set of data to create an account, which has been reflected on the form. After the initial roll-out, the burden to the government will be minimal, only involving VSO staff turnover.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before March 7, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Office of Quality, Privacy and Risk, Department of Veterans Affairs, 811 Vermont Avenue, Floor 5, Area 368, Washington, DC 20420, (202) 461-5870 or email
38 U.S.C. 1121, 1310, 5121.
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. The
By direction of the Secretary.
Department of Veterans Affairs.
Notice.
This
The Independent Assessment Report is now available on the following website:
Laura Bowman, Program Analyst, Veterans Health Administration, 810 Vermont Avenue NW, Washington, DC 20420 Telephone: (202) 461-7100. (This is not a toll-free number).
Section 201 of the Choice Act required the Secretary to contract with a private entity to conduct an independent assessment of VA health care. Within 60 days of completing the assessment, the private entity was required to submit a report of its findings and recommendations. The Secretary was then required to publish the report in
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before March 7, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 811 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or email
44 U.S.C. 3501-21.
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. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before March 7, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or email
44 U.S.C. 3501-21.
An agency may not conduct or sponsor, and a person is not required to
By direction of the Secretary.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the Veterans' Family, Caregiver, and Survivor Advisory Committee will meet on March 1-2, 2018. On March 1, the Committee will meet in open session at 11301 Wilshire Boulevard, Building 500, Room 1281, Los Angeles, CA, from 9:00 a.m. to 5:00 p.m. On March 2, the Committee will be touring the VA facility and breaking into small groups to participate in discussions and listening sessions with facility staff, families, caregivers, and survivors. Tours of VA facilities are closed, to protect from disclosure Veterans' information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Therefore, on March 2, the meeting will be closed to the public.
The purpose of the Committee is to advise the Secretary of Veterans Affairs on matters related to: Veterans' families, caregivers, and survivors across all generations, relationships, and Veterans status; the use of VA care and benefits services by Veterans' families, caregivers, and survivors, and possible expansion of such care and benefits services; Veterans' family, caregiver, and survivor experiences; VA policies, regulations, and administrative requirements related to the transition of Servicemembers from the Department of Defense (DoD) to enrollment in VA that impact Veterans' families, caregivers, and survivors; and factors that influence access to, quality of, and accountability for services and benefits for Veterans' families, caregivers, and survivors.
On March 1, the agenda will include information briefings on VA's Veterans Experience Office, Caregiver Support Office, VA's Choose Home Initiative, and community partners. The Committee's subcommittees on Education and Awareness, Access and Eligibility, and Gaps and Innovation will report out on activities since the last meeting. Public comments will be received at 4:15 p.m. on March 1, 2018.
Individuals wishing to make a public comment should contact Laureen Barone at
Any member of the public seeking additional information should contact Ms. Barone at (716) 364-3639 or at
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |