83_FR_15
Page Range | 3059-3259 | |
FR Document |
Page and Subject | |
---|---|
83 FR 3114 - Biodiesel From the Republic of Argentina and the Republic of Indonesia: Countervailing Duty Orders | |
83 FR 3189 - Bulk Manufacturer of Controlled Substances Application: Organix, Inc. | |
83 FR 3190 - Sunshine Act Meeting; National Science Board | |
83 FR 3239 - Sunshine Act Meetings | |
83 FR 3190 - Regular Board of Directors Meeting; Sunshine Act | |
83 FR 3190 - Sunshine Act Meeting Notice | |
83 FR 3110 - Sunshine Act Meeting Notice | |
83 FR 3068 - Rules and Regulations Under the Textile Fiber Products Identification Act | |
83 FR 3256 - Agency Information Collection: Activity Under OMB Review: Report of Financial and Operating Statistics for Large Certificated Air Carriers | |
83 FR 3257 - Agency Information Collection; Activity Under OMB Review; Report of Financial and Operating Statistics for Small Aircraft Operators | |
83 FR 3108 - Fisheries off West Coast States; Highly Migratory Fisheries; Amendment 4 to Fishery Management Plan for West Coast Highly Migratory Species Fisheries (HMS FMP); Revisions to the Biennial Management Cycle | |
83 FR 3140 - Notice of Filing of Complaint and Assignment | |
83 FR 3152 - Medicare and Medicaid Programs; Application by The Compliance Team for Continued CMS Approval of Its Rural Health Clinic Accreditation Program | |
83 FR 3192 - Entergy Nuclear Operations, Inc.; Vermont Yankee Nuclear Power Station, Independent Spent Fuel Storage Installation | |
83 FR 3154 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
83 FR 3059 - Federal Employees Health Benefits Program: Removal of Eligible and Ineligible Individuals From Existing Enrollments | |
83 FR 3071 - Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder | |
83 FR 3067 - Amendment of Class E Airspace; Kane, PA | |
83 FR 3077 - Civil Monetary Penalty Inflation Adjustment | |
83 FR 3189 - Labor Certification Process for the Temporary Employment of Aliens in Non-Agricultural Employment in the United States | |
83 FR 3101 - Air Plan Approval; AK: Fine Particulate Matter Infrastructure Requirements | |
83 FR 3253 - Administrative Declaration Amendment of Disaster for the State of Arizona | |
83 FR 3177 - 30-Day Notice of Proposed Information Collection: Veterans Housing Rehabilitation and Modification Program | |
83 FR 3178 - 60-Day Notice of Proposed Information Collection: Rent Reform Demonstration: 36-Month Follow-Up Survey and Comprehensive Impact Analysis | |
83 FR 3111 - Notice of Public Meeting of the Oregon Advisory Committee | |
83 FR 3111 - Notice of Public Meeting of the Arizona Advisory Committee | |
83 FR 3187 - Large Diameter Welded Pipe From Canada, China, Greece, India, Korea, and Turkey; Institution of Antidumping and Countervailing Duty Investigations and Scheduling of Preliminary Phase Investigations | |
83 FR 3185 - Global Digital Trade 2: The Business-to-Business Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; and Global Digital Trade 3: The Business-to-Consumer Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; Scheduling of Hearing | |
83 FR 3188 - Certain Consumer Electronic Devices, Including Televisions, Gaming Consoles, Mobile Phones and Tablets, and Network-Enabled DVD and Blu-Ray Players; Termination of Investigation on the Basis of Settlement | |
83 FR 3137 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
83 FR 3141 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
83 FR 3120 - Countervailing Duty Investigation of Fine Denier Polyester Staple Fiber From the People's Republic of China: Final Affirmative Determination | |
83 FR 3122 - Countervailing Duty Investigation of Fine Denier Polyester Staple Fiber From India: Final Affirmative Determination | |
83 FR 3145 - Agency Information Collection Activities; Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
83 FR 3171 - Meeting of the Tick-Borne Disease Working Group | |
83 FR 3126 - Certain Plastic Decorative Ribbon From the People's Republic of China: Initiation of Less-Than-Fair-Value Investigation | |
83 FR 3114 - Certain Plastic Decorative Ribbon From the People's Republic of China: Initiation of Countervailing Duty Investigation | |
83 FR 3118 - Stainless Steel Flanges From India: Preliminary Affirmative Countervailing Duty Determination, Preliminary Affirmative and Alignment of Final Determination With Final Antidumping Duty Determination | |
83 FR 3124 - Countervailing Duty Investigation of Stainless Steel Flanges From the People's Republic of China: Preliminary Affirmative Determination | |
83 FR 3193 - Civil Monetary Penalty Inflation Adjustment | |
83 FR 3172 - Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 | |
83 FR 3172 - Meeting of the National Vaccine Advisory Committee | |
83 FR 3112 - Approval of Subzone Status; Plaza Warehousing & Realty Corporation; Caguas, Puerto Rico | |
83 FR 3155 - Submission for OMB Review; Comment Request | |
83 FR 3191 - Advisory Committee on the Medical Uses of Isotopes; Meeting Notice | |
83 FR 3085 - Income Level for Individuals Eligible for Assistance | |
83 FR 3255 - Agency Information Collection Activities: Request for Comments for a New Information Collection | |
83 FR 3110 - Public Quarterly Meeting of the Board of Directors | |
83 FR 3255 - Agency Information Collection Activities: Notice of Request for Extension of Currently Approved Information Collection | |
83 FR 3140 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
83 FR 3146 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
83 FR 3254 - Eighty Seventh RTCA SC-147 Plenary Session | |
83 FR 3188 - Certain Wireless Audio Systems and Components Thereof; Commission Determination Not To Review an Initial Determination Terminating Investigation Based on Settlement and License Agreements | |
83 FR 3179 - Species Proposals for Consideration at the Eighteenth Regular Meeting of the Conference of the Parties to the Convention on International Trade in Endangered Species of Wild Fauna and Flora | |
83 FR 3086 - Endangered and Threatened Wildlife and Plants; Removing the Eastern Puma (=Cougar) From the Federal List of Endangered and Threatened Wildlife | |
83 FR 3163 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability | |
83 FR 3253 - Notice of Proposed Changes to the Slate of Industry Trade Advisory Committees | |
83 FR 3165 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and “Lookback” | |
83 FR 3164 - The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period | |
83 FR 3158 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Modified Risk Tobacco Product Applications | |
83 FR 3156 - Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
83 FR 3161 - Electronic Study Data Submission; Data Standards; Timetable for Updates to the Food and Drug Administration Data Standards Catalog for Study Data Submitted Electronically Under the Federal Food, Drug, and Cosmetic Act | |
83 FR 3157 - Watson Laboratories, Inc.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen | |
83 FR 3151 - Solicitation of Nominations for Appointment to the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC) | |
83 FR 3151 - Request for Nominations of Potential Reviewers To Serve on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP) | |
83 FR 3146 - Proposed Agency Information Collection Activities; Comment Request | |
83 FR 3148 - Proposed Agency Information Collection Activities; Comment Request | |
83 FR 3134 - Transcontinental Gas Pipe Line Company, LLC; Notice of Schedule for Environmental Review of the Rivervale South to Market Project | |
83 FR 3135 - Ampersand Moretown Hydro, LLC; Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving Use of the Traditional Licensing Process | |
83 FR 3133 - Powder River Crude Services, LLC; Notice of Petition for Declaratory Order | |
83 FR 3183 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Verification of Indian Preference for Employment in BIA and IHS | |
83 FR 3184 - Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Application for Admission to Haskell Indian Nations University and to Southwestern Indian Polytechnic Institute | |
83 FR 3182 - Agency Information Collection Activities; Sovereignty in Indian Education Grant Program | |
83 FR 3183 - Agency Information Collection Activities; Bureau of Indian Education Adult Education Program | |
83 FR 3258 - Agency Information Collection Activity: VA Cooperative Studies Program | |
83 FR 3135 - Combined Notice of Filings | |
83 FR 3136 - Combined Notice of Filings #1 | |
83 FR 3062 - Special Conditions: Preferred Improvements, LLC, Boeing Model DC3C Airplanes; Rechargeable Lithium Batteries | |
83 FR 3149 - Agency Forms Undergoing Paperwork Reduction Act Review | |
83 FR 3133 - Pacific Fishery Management Council; Public Meetings and Hearings | |
83 FR 3239 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Bats EDGX Exchange, Inc.; BOX Options Exchange LLC; C2 Options Exchange, Incorporated; Chicago Board Options Exchange, Incorporated; Financial Industry Regulatory Authority, Inc.; International Securities Exchange, LLC; Investors Exchange LLC; Miami International Securities Exchange LLC; MIAX PEARL, LLC; The NASDAQ Stock Market LLC; NASDAQ BX, Inc.; NASDAQ PHLX LLC; New York Stock Exchange LLC; NYSE Arca, Inc.; NYSE MKT LLC; Notice of Withdrawal of Proposed Rule Changes, as Modified by Amendments Thereto, To Eliminate Requirements That Will Be Duplicative of CAT | |
83 FR 3196 - Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Market Maker Orders | |
83 FR 3205 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing of Amendment No. 1 and Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To Introduce Cboe Market Close, a Closing Match Process for Non-BZX Listed Securities Under New Exchange Rule 11.28 | |
83 FR 3199 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Market Maker Orders | |
83 FR 3194 - Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Harmonize the Definition of Non-Professional User in Its Fee Schedule With That of Its Affiliates | |
83 FR 3233 - Self-Regulatory Organizations; CBOE EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Harmonize the Definition of Non-Professional User in Its Fee Schedule With That of Its Affiliates | |
83 FR 3203 - Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Harmonize the Definition of Non-Professional User in Its Fee Schedule With That of Its Affiliates | |
83 FR 3242 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Harmonize the Definition of Non-Professional User in Its Fee Schedule With That of Its Affiliates | |
83 FR 3235 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Market Maker Orders | |
83 FR 3240 - Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Harmonize the Definition of Non-Professional User in Its Fee Schedule With That of Its Affiliates | |
83 FR 3085 - Privacy of Information; Adding Clarifying Language Concerning the Purpose of a Contract or Interagency Agreement | |
83 FR 3138 - Pleading Cycle Established for Comment on Applications for State Certification for the Provision of Telecommunications Relay Service | |
83 FR 3173 - Office of the Secretary; Notice of Meeting | |
83 FR 3176 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings | |
83 FR 3176 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings | |
83 FR 3175 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
83 FR 3177 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
83 FR 3174 - Center for Scientific Review; Notice of Closed Meeting | |
83 FR 3174 - Center for Scientific Review; Notice of Closed Meetings | |
83 FR 3139 - Filing Dates for the Ohio Special Election in the 12th Congressional District | |
83 FR 3132 - Proposed Information Collection; Comment Request; Assessment of the Social and Economic Impact of Hurricanes and Other Climate Related Natural Disasters on Commercial and Recreational Fishing Industries in the Eastern, Gulf Coast and Caribbean Territories of the United States | |
83 FR 3131 - Proposed Information Collection; Comment Request; Highly Migratory Species Dealer Reporting Family of Forms | |
83 FR 3224 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Advance Notice Concerning Updates to and Formalization of OCC's Recovery and Orderly Wind-Down Plan | |
83 FR 3244 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Advance Notice Concerning Enhanced and New Tools for Recovery Scenarios | |
83 FR 3075 - Repeal of Regulatory Amendment and Restoration of Former Regulatory Language Governing Service of Official Correspondence | |
83 FR 3193 - National Nanotechnology Initiative Meetings | |
83 FR 3099 - Pacific Island Fisheries; 2018 Northwestern Hawaiian Islands Lobster Harvest Guideline | |
83 FR 3064 - Airworthiness Directives; Piper Aircraft, Inc. | |
83 FR 3112 - Certain Cased Pencils From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016 | |
83 FR 3100 - Proposed Amendment of Class D and Class E Airspace; Atwater, CA | |
83 FR 3079 - Subsistence Management Regulations for Public Lands in Alaska-2017-18 and 2018-19 Subsistence Taking of Fish Regulations | |
83 FR 3149 - Request for Medicare Payment Advisory Commission Nominations |
Forest Service
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Fish and Wildlife Service
Indian Affairs Bureau
Office of Natural Resources Revenue
Drug Enforcement Administration
Employment and Training Administration
Federal Aviation Administration
Federal Highway Administration
Transportation Statistics Bureau
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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Office of Personnel Management.
Final rule.
The United States Office of Personnel Management (OPM) is issuing a final rule amending Federal Employees Health Benefits (FEHB) Program regulations to provide a process for removal of certain identified individuals who are found not to be eligible as family members from FEHB enrollments. This process would apply to individuals for whom there is a failure to provide adequate documentation of eligibility when requested. This action also amends Federal Employees Health Benefits (FEHB) Program regulations to allow certain eligible family members to be removed from existing self and family or self plus one enrollments.
This rule is effective February 22, 2018.
Marguerite Martel at
The Federal Employees Health Benefits (FEHB) Program is administered by the Office of Personnel Management (OPM) in accordance with Title 5, Chapter 89 of the United States Code and our implementing regulations at title 5, part 890 of the Code of Federal Regulations. The statute establishes the basic rules for benefits, enrollment, and participation. OPM contracts with health benefits plans to provide coverage under the statute. OPM is authorized to prescribe regulations to govern the time, manner and conditions under which an employee can enroll in a health benefits plan under the FEHB Program and the beginning and end dates of coverage for annuitants and family members.
The Federal Employees Health Benefits (FEHB) Program provides health insurance to about 8.2 million Federal employees, retirees, and their dependents each year. It is the largest employer-sponsored health insurance program in the country providing more than $53 billion in health care benefits annually. Coverage options available to eligible individuals include self only, self plus one or self and family coverage in an approved health benefits plan. Eligible family members include the spouse of an employee or annuitant and a child under 26 years of age, including adopted children, stepchildren or foster children or a child regardless of age who is incapable of self-support because of mental or physical disability which existed before age 26.
On December 1, 2016, OPM published a proposed rule (81 FR 86902) to 1) provide that proof of family member eligibility may be required for coverage under an FEHB Program self plus one or self and family enrollment and 2) to establish the circumstances under which individuals covered under an existing self plus one or self and family FEHB enrollment will be removed from such enrollment and the processes for removal, where the enrollee does not provide adequate documentation of eligibility. Previously, under 5 CFR 890.302, all eligible family members are covered under a self and family enrollment. The regulations did not address the removal of an erroneously-covered ineligible individual from an existing self plus one or self and family enrollment.
On the same date, the Office of Personnel Management (OPM) published a Notice of Proposed Rulemaking (NPRM) (81 FR 86898) allowing certain eligible family members to be removed from self plus one and self and family enrollments in limited circumstances. This would change the current provision at 5 CFR 890.302, which provides that all family members that are eligible according to the FEHB Act (5 U.S.C. 8901) are automatically covered under a self and family enrollment.
This regulation merges and finalizes these two proposed regulations. The proposed regulations were published separately, but have now been merged for regulatory efficiency as both proposed regulations address title 5, Code of Federal Regulations, §§ 890.302, Coverage of Family Members, and 890.308, Disenrollment.
Both proposed regulations had 60-day comment periods. The regulations concerning ineligible family members received four comments: One from an interested citizen, one from an agency HR employee and one from a trade group representing FEHB Program plans with one duplicate comment. Two of the comments were supportive of the proposed rule and none objected to the proposed regulation. The proposed rule concerning eligible family members received three comments: one from an interested citizen, one from an agency HR employee and one from a trade group representing FEHB Program plans. Two of the comments were supportive of the proposed rules and none objected to the change in policy.
One commenter requested that OPM specify whether a submission of a reconsideration request delays the effective date of the initial removal. The provisions added in § 890.308(e) and (f) mirror the processes outlined in § 890.308(a) for disenrollment of employees. That provision does not provide a delayed effective date for reconsideration and so we are not adding one to this section. If an enrollee or the removed individual seeks reconsideration and the agency or OPM finds the family member to be eligible, the family member will receive retroactive coverage.
One commenter asked whether OPM is now requesting that agencies to track family members. This regulation does not require agencies to track family members, but forthcoming sub-regulatory guidance may require agencies to collect proof of eligibility in certain circumstances. The regulations amend § 890.302 to provide that proof of family member eligibility must be provided upon request by a carrier, employing office, or OPM.
Two commenters asked how an FEHB Program carrier would be aware of an initial determination of ineligibility under proposed § 890.308(f)(1) and requested further guidance on all required methods of notification to FEHB Program carriers. Section 890.308(f)(1) states that the employing office or OPM, as applicable, will direct the carrier to remove the individual if proof of eligibility is not provided by the enrollee. OPM will publish a Benefits Administration Letter (available at
One commenter suggested that OPM add an effective date for a removal under § 890.308(f)(3) and (e)(3) where fraud or intentional misrepresentation are found. OPM has updated the final regulation to specify that if fraud or intentional misrepresentation of material fact is found, the effective date of the removal is the date of loss of eligibility.
One commenter suggested that OPM add examples to § 890.308(g) to clarify how temporary continuation of coverage (TCC), conversion and extension of coverage rules will operate under the regulations. An example has been added to clarify that an individual will not be eligible to receive TCC, conversion or an extension of coverage unless the removal is effectuated within the time limit currently required under existing regulations.
One commenter asked who will be responsible for collecting documentation and determining proof of eligibility status and whether that information will need to be forwarded to FEHB Program carriers. The proposed rule provided and the final rule maintains that employing offices will be responsible for collecting documentation and determining proof of eligibility status and that the information will be sent to FEHB Program carriers. Two commenters asked that OPM specify how this information should be provided to carriers and how it should be maintained and tracked. OPM plans to publish a Benefits Administration Letter and a Carrier Letter to employing offices and FEHB Program carriers following the publication of this regulation including a process for agencies to inform carriers of changes in covered family members and documentation that needs to be collected to effectuate a change.
One commenter requested that OPM change the proposed effective date of removals. The proposed rule makes the removal effective on the first day of the pay period following a notarized request received from the family member at issue and on the first day of the second pay period following a request to remove a child received from the enrollee. The commenter requested that the effective date be the first day of the third pay period for enrollees who pay premiums bi-weekly and the second pay period for enrollees who pay premiums monthly as the effective date for either type of family member removal. OPM agrees that this avoids unnecessary benefit overpayments and ensures that a family member has sufficient time to obtain replacement health benefits coverage. The final rule makes this change.
We have also made minor, non-substantive editorial changes to the regulation for editorial consistency and to improve clarity. In addition, we have updated the regulation to clarify that either the enrollee or the removed individual can provide proof of eligibility or request reconsideration of the initial decision.
The FEHB Program currently has a total of 262 health plan options for employees to choose from for their health benefits coverage. Historically, about 18,000 of FEHB participants switch health care plans in any given year. There are approximately 4 million family members covered under FEHB Program. While this rule may lower costs to the FEHB Program by reducing the number of eligible and ineligible family members, OPM does not have data available to calculate specific rates. However, OPM has found anecdotal evidence which estimates between 1-3 percent of spouses and 4-12 percent of children in commercial health plans are ineligible for coverage. So, we anticipate this rule will not have widespread applicability across the Program.
Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). 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 been designated a “significant regulatory action,” under Executive Order 12866.
This final rule is not subject to the requirements of E.O. 13771 (82 FR 9339, February 3, 2017) because it is related to agency organization, management, or personnel.
I certify that this regulation will not have a significant economic impact on a substantial number of small entities.
We have examined this rule in accordance with Executive Order 13132, Federalism, and have determined that this rule will not have any negative impact on the rights, roles, and responsibilities of State, local, or Tribal governments.
The Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35; see 5 CFR part 1320) requires that the U.S. Office of Management and Budget (OMB) approve all collections of information by a Federal agency from the public before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number. OPM is not proposing any additional collections in this rule. This rule involves an OMB approved collection of information subject to the PRA—OMB No. 3206-0160, Health Benefits Election Form. The public reporting burden for this collection is estimated to average 30 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. The total burden hour estimate for this form is 9,000 hours. The systems of record notice for this collection is: OPM/Central 1 Civil Service Retirement and Insurance Records, available at
Administrative practice and procedure, Government employees, Health insurance.
For the reasons set forth in the preamble, OPM amends 5 CFR part 890 as follows:
5 U.S.C. 8913; Sec. 890.301 also issued under sec. 311 of Pub. L. 111-03, 123 Stat. 64; Sec. 890.111 also issued under section 1622(b) of Pub. L. 104-106, 110 Stat. 521; Sec. 890.112 also issued under section 1 of Pub. L. 110-279, 122 Stat. 2604; 5 U.S.C. 8913; Sec. 890.803 also issued under 50 U.S.C. 403p, 22 U.S.C. 4069c and 4069c-1; subpart L also issued under sec. 599C of 101, 104 Stat. 2064, as amended; Sec. 890.102 also issued under sections 11202(f), 11232(e), 11246(b) and (c) of Pub. L. 105-33, 111 Stat. 251; and section 721 of Pub. L. 105-261, 112 Stat. 2061; Pub. L. 111-148, as amended by Pub. L. 111-152.
(a)(1)
The revisions and additions read as follows:
(a)
(b)
(c)
(d)
(e)
(2) Appropriate documentation includes, but is not limited to, copies of birth certificates, marriage certificates, and, if applicable, other proof including that the individual lives with the enrollee and the enrollee is the individual's primary source of financial support.
(3) The effective date of a removal shall be prospective unless the record shows that the enrollee or the removed individual has committed fraud or made an intentional misrepresentation of material fact as prohibited by the terms of the plan. If fraud or intentional misrepresentation of material fact is found, the effective date of the removal is the date of loss of eligibility.
(4) A request for reconsideration of the carrier's initial decision must be filed by the enrollee or the removed individual with the enrollee's employing office within 60 calendar days after the date of the carrier's initial decision. The employing office must notify the carrier when a request for reconsideration of the decision to remove the individual from the enrollment is made. The time limit for filing may be extended if the enrollee or the removed shows that he or she was not notified of the time limit and was not otherwise aware of it, or that he or she was prevented by circumstances beyond his or her control from making the request within the time limit. The request for reconsideration must be made in writing and must include the enrollee's name, address, Social Security Number or other personal identification number, individual's name, the name of the enrollee's carrier, reason(s) for the request, and, if applicable, the enrollee's retirement claim number.
(5) The employing office must issue a written notice of its final decision to the enrollee, and notify the carrier of the decision, within 30 days of receipt of the request for reconsideration. The notice must fully set forth the findings and conclusions on which the decision was based.
(6) If an enrollee or the removed individual provides acceptable proof of eligibility of an individual subsequent to removal, coverage under the enrollment shall be reinstated retroactively so that there is no gap in coverage, as appropriate.
(f)
(2) Appropriate documentation includes, but is not limited to, copies of birth certificates, marriage certificates, and, if applicable, other proof including that the individual lives with the enrollee and that the enrollee is the individual's primary source of financial support.
(3) The effective date of the removal shall be prospective unless the record shows that the enrollee or the removed individual has committed fraud or made an intentional misrepresentation of material fact as prohibited by the terms of the plan. If fraud or intentional misrepresentation of material fact is found, the effective date of the removal is the date of loss of eligibility.
(4) The enrollee or the removed individual may request reconsideration of an employing office or OPM's decision to remove the individual from the enrollment within 60 days of an employing office or OPM's initial decision. The enrollee or the removed individual may request reconsideration of an employing office decision to the employing office or an OPM decision to OPM. The employing office or OPM, as applicable, must notify the carrier when a request for reconsideration of the decision to remove the individual from the enrollment is made. The time limit for filing may be extended if the enrollee or the removed individual shows that he or she was not notified of the time limit and was not otherwise aware of it, or that he or she was prevented by circumstances beyond his or her control from making the request within the time limit. The request for reconsideration must be made in writing and must include the enrollee's name, address, Social Security Number or other personal identification number, the individual's name, the name of the enrollee's carrier, reason(s) for the request, and, if applicable, the enrollee's retirement claim number.
(5) The employing office or OPM, as applicable, must issue a written notice of its final decision to the enrollee, and notify the carrier of the decision within 30 days of receipt of the request for reconsideration. The notice must fully set forth the findings and conclusions on which the decision was based.
(6) If an enrollee or the removed individual provides acceptable proof of eligibility of an individual subsequent to removal, coverage under the enrollment shall be reinstated retroactively so that there is no gap in coverage, as appropriate.
(g)
(1)
(2) [Reserved]
(h)
(i) In the case of a spouse, if the enrollee and his or her spouse provide a notarized request for removal.
(ii) In the case of a child who has reached the age of majority in the child's state of residence (the enrollee's state of residence if the child's is not known), if the enrollee provides proof that the child is no longer his or her dependent as described under § 890.302(b). The enrollee shall also provide the last known contact information for the child.
(iii) In the case of a child who has reached the age of majority in the child's state of residence, if the child provides a notarized request for removal to the employing office.
(2) For removals under paragraph (h)(1) of this section the effective date is the first day of the third pay period following the date the request is approved by the employing office for employees who pay bi-weekly and the second pay period following the date that the request is approved by the employing office for enrollees who pay premiums monthly.
(3) The family member's removal under this paragraph (h) is considered a cancellation under § 890.304(d) and removed family members are not eligible for temporary extension of coverage and conversion under § 890.401 or temporary continuation of coverage under § 809.1103.
(4) If an eligible family member is removed under this paragraph (h), he or she may only regain coverage under the applicable self plus one or self and family enrollment if requested by the enrollee during the annual open season or within 60 days of the family member losing other health insurance coverage. The enrollee must also provide written consent to reinstatement of coverage from the family member and demonstrate eligibility of the spouse or child as a family member to the employing office.
(5) If an employing office approves a request for removal, the employing office must notify the enrollee and the carrier of the removal immediately. For removals under paragraph (h)(1)(ii) of this section, the employing office must also immediately notify the child of the removal using the last known contact provided by the enrollee.
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued for Boeing Model DC3C airplanes as modified by Preferred Improvements, LLC. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is rechargeable lithium ion backup battery packs installed on the airplanes. The applicable airworthiness regulations do not contain adequate or appropriate
This action is effective on Preferred Improvements, LLC, on January 23, 2018. Send your comments by March 9, 2018.
Send comments identified by docket number FAA-2018-0035 using any of the following methods:
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Nazih Khaouly, Airplane & Flight Crew Interface Section, AIR-671, Transport Standards Branch, Policy & Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 1601 Lind Avenue SW, Renton, Washington 98057-3356; telephone (425) 227-2432; facsimile (425) 227-1320; email
The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions is impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected airplanes.
In addition, the substance of these special conditions has been published in the
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.
On February 1, 2017, Preferred Improvements, LLC, applied for a supplemental type certificate to install a Saab Grintek Impi II tracking system on Boeing Model DC3C airplanes. The tracking system sends altitude and speed information to a ground station via a modem, which contains a rechargeable lithium ion battery.
The Boeing Model DC3C airplane is a narrow-body transport category airplane powered by twin-turbine/piston wing-mounted engines. The airplane has a maximum takeoff weight of 26,900 pounds with seating for 2 crewmembers and 32 passengers.
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Preferred Improvements, LLC, must show that the Boeing Model DC3C airplanes, as changed, continue to meet the applicable provisions of the regulations listed in Type Certificate No. A669, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the models for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other models included on the same type certificates to incorporate the same novel or unusual design feature, these special conditions would also apply to the other models under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, Boeing Model DC3C airplanes, as modified by Preferred Improvements, LLC, must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34, and the noise certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.
Boeing Model DC3C airplanes, as modified by Preferred Improvements, LLC, will incorporate the following novel or unusual design feature: airplane tracking system with a modem containing a rechargeable lithium ion battery.
The battery system consists of the battery, battery charger, and any protective, monitoring, and alerting circuitry or hardware inside or outside of the battery. It also includes vents (where necessary) and packaging. For the purpose of these special conditions, a battery and battery system are referred to as a battery.
Rechargeable lithium batteries are considered to be a novel or unusual design feature in transport category airplanes, with respect to the requirements in § 25.1353. This type of battery has certain failure, operational, and maintenance characteristics that differ significantly from those of the nickel-cadmium and lead-acid rechargeable batteries currently approved for installation on transport category airplanes. These batteries introduce higher energy levels into airplane systems through new chemical compositions in various battery-cell sizes and construction. Interconnection of these cells in battery packs introduces failure modes that require unique design considerations, such as provisions for thermal management.
Special Condition 1 requires that each individual cell within a rechargeable lithium battery be designed to maintain safe temperatures and pressures. Special Condition 2 addresses these same issues but for the entire battery. Special Condition 2 requires the battery be designed to prevent propagation of a thermal event, such as self-sustained, uncontrolled increases in temperature or pressure from one cell to adjacent cells.
Special Conditions 1 and 2 are intended to ensure that the cells and battery are designed to eliminate the potential for uncontrollable failures. However, a certain number of failures will occur due to various factors beyond the control of the designer. Therefore, other special conditions are intended to protect the airplane and its occupants if failure occurs.
Special Conditions 3, 7, and 8 are self-explanatory.
Special Condition 4 clarifies that the flammable fluid fire-protection requirements of § 25.863 apply to rechargeable lithium battery installations. Section 25.863 is applicable to areas of the airplane that could be exposed to flammable fluid leakage from airplane systems. Rechargeable lithium batteries contain electrolyte that is a flammable fluid.
Special Condition 5 requires each rechargeable lithium battery installation to not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more severe failure condition. Special Condition 6 requires each rechargeable lithium battery installation to have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells. The means of meeting special conditions 5 and 6 may be the same, but they are independent requirements addressing different hazards. Special Condition 5 addresses corrosive fluids and gases, whereas Special Condition 6 addresses heat.
Special Condition 9 requires rechargeable lithium batteries to have “automatic” means due to the fast acting nature of lithium battery chemical reactions. Manual intervention would not be timely or effective in mitigating the hazards associated with these batteries.
These conditions apply to all rechargeable lithium battery installations in lieu of § 25.1353(b)(1) through (4) at amendment 25-123, or § 25.1353(c)(1) through (4) at earlier amendments. These regulations will remain in effect for other battery installations on these airplanes.
These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these special conditions are applicable to Boeing Model DC3C airplanes as modified by Preferred Improvements, LLC. Should Preferred Improvements, LLC, apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A699 to incorporate the same novel or unusual design feature, these special conditions would apply to those models as well.
This action affects only a certain novel or unusual design feature on one model of airplane. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Boeing Model DC3C airplanes as modified by Preferred Improvements, LLC.
In lieu of § 25.1353(b)(1) through (4) at amendment 25-123, or § 25.1353(c)(1) through (4) at earlier amendments, each rechargeable lithium battery installation must:
1. Be designed to maintain safe cell temperatures and pressures under all foreseeable operating conditions to prevent fire and explosion.
2. Be designed to prevent the occurrence of self-sustaining, uncontrollable increases in temperature or pressure, and automatically control the charge rate of each cell to protect against adverse operating conditions, such as cell imbalance, back charging, overcharging and overheating.
3. Not emit explosive or toxic gases, either in normal operation or as a result of its failure that may accumulate in hazardous quantities within the airplane.
4. Meet the requirements of § 25.863.
5. Not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more-severe failure condition.
6. Have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells.
7. Have a failure sensing and warning system to alert the flight crew if its failure affects safe operation of the airplane.
8. If its function is required for safe operation of the airplane, have a monitoring and warning feature that alerts the flight crew when its charge state falls below acceptable levels.
9. Have a means to automatically disconnect from its charging source in the event of an over-temperature condition, cell failure or battery failure.
A battery system consists of the battery, battery charger and any protective, monitoring and alerting circuitry or hardware inside or outside of the battery. It also includes vents (where necessary) and packaging. For the purpose of this special condition, a battery and battery system are referred to as a battery.
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for certain Piper Aircraft, Inc. Models PA-28-140, PA-28-150, PA-28-151, PA-28-160, PA-28-161, PA-28-180, PA-28-181,
This AD is effective February 7, 2018.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of February 7, 2018.
We must receive comments on this AD by March 9, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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•
•
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For service information identified in this final rule, contact Piper Aircraft, Inc., 2926 Piper Drive, Vero Beach, FL 32960; telephone: (772) 567-4361; internet:
You may examine the AD docket on the internet at
Ronald Segall, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: (404) 474-5541; fax: (404) 474-5506; email:
We received a report from Piper Aircraft, Inc., that they had a quality control issue that resulted in the installation of fuel tank selector covers with the placement of the left and right fuel tank selector placards installed in reverse on certain Piper Aircraft, Inc. Models PA-28-140, PA-28-150, PA-28-151, PA-28-160, PA-28-161, PA-28-180, PA-28-181, PA-28-236, PA-28-201T, PA-28R-180, PA-28R-200, PA-28R-201, PA-28R-201T, PA-28RT-201, and PA-28RT-201T airplanes. This condition, if not addressed, could result in fuel management errors resulting in fuel starvation and loss of engine power in flight. We are issuing this AD to address the unsafe condition on these products.
We reviewed Piper Aircraft, Inc. Service Bulletin No. 1309, dated October 10, 2017. The service bulletin describes procedures for inspecting the fuel tank selector cover to verify the left and right fuel tank selector placards are located at the 12:00 and 3:00 clock positions, respectively, and replacing those that are improperly located with new placards. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This AD requires accomplishing the actions specified in the service information described previously.
An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because improper fuel selection could result in fuel starvation and loss of engine power in flight. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason stated above, we find that good cause exists for making this amendment effective in less than 30 days.
This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We estimate that this AD affects 17,957 airplanes, of U.S. registry.
We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary replacements that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need this replacements:
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, and domestic business jet transport airplanes and associated appliances to the Director of the Policy and Innovation Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have 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.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective February 7, 2018.
None.
This AD applies to the following Piper Aircraft, Inc. airplane models and serial numbers (S/Ns) that are certificated in any category:
Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 11, Placard and Markings.
This AD was prompted by a quality control issue at the manufacturer that resulted in the installation of fuel tank selector covers with the left and right fuel tank selector placards improperly located. We are issuing this AD to prevent fuel management error. The unsafe condition, if not addressed, could result in fuel starvation and loss of engine power in flight.
Comply with this AD within the compliance times specified, unless already done.
Before further flight after February 7, 2018 (the effective date of this AD), inspect the left and right fuel selector cover placards for proper installation using Part I of Piper Aircraft, Inc. (Piper) Service Bulletin (SB) No. 1309, dated October 10, 2017. If the fuel selectors placards are properly installed, no further action is required.
If improper (reversed clock positions) installation of the left and right fuel selector placards is found during the inspection required in paragraph (g) of this AD, before further flight, fabricate and install temporary left and right fuel selector placards using Part II of Piper SB No. 1309, dated October 10, 2017. In lieu of installing the temporary placards required by this paragraph, you may install the permanent placards specified in paragraph (i) of this AD.
Within the next 100 hours time-in-service (TIS) after February 7, 2018 (the effective date of this AD), replace the temporary placard installed in paragraph (h) of this AD with permanent left and right fuel selector placards using Part III of Piper SB No. 1309, dated October 10, 2017, unless already done in lieu of installing the temporary placards specified in paragraph (h) of this AD.
A special flight permit is allowed for this AD per 14 CFR 39.23 with the following limitations: Flights are not to exceed a total of 100 hours TIS with temporary placards installed.
(1) The Manager, Atlanta ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in Related Information, paragraph (l), of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact Ronald Segall, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: (404) 474-5541; fax: (404) 474-5506; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Piper Aircraft, Inc. Service Bulletin No. 1309, dated October 10, 2017.
(ii) Reserved.
(3) For Piper Aircraft, Inc. service information identified in this AD, contact Piper Aircraft, Inc., 2926 Piper Drive, Vero Beach, FL 32960; telephone: (772) 567-4361; internet:
(4) You may view this service information at FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule; technical amendment.
This action amends the legal description of the Class E airspace extending upward from 700 feet above the surface at Kane Community Hospital Heliport, Kane, PA, by correcting the geographic coordinates of the heliport and point in space coordinates. This action does not affect the boundaries or operating requirements of the airspace.
Effective 0901 UTC, March 29, 2018. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11.B Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it makes a clerical correction to the geographic coordinates of Kane Community Hospital Heliport, Kane, PA.
The FAA Aeronautical Information Services branch found the Class E airspace extending upward from 700 feet above the surface at Kane Community Hospital Heliport, Kane, PA, along with the related point in space coordinates, were incorrect as published in FAA Order 7400.11B, Airspace Designations and Reporting Points. The latitude degree for the heliport and the longitude degree for the point in space coordinates were incorrect in the Order.
A clerical amendment in the legal description also is made to the airspace designation, removing the name of the town listed before the airport name description.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by correcting the geographic coordinates of the heliport reference point and point in space coordinates of Kane Community Hospital Heliport in Class E airspace extending upward from 700 feet above the surface to be in concert with the FAA's aeronautical database.
This is an administrative change and does not affect the boundaries, or operating requirements of the airspace, therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6-mile radius of the Point in Space coordinates serving Kane Community Hospital Heliport.
Federal Trade Commission (“FTC” or “Commission”).
Final rule.
The Commission amends the Rules and Regulations Under the Textile Fiber Products Identification Act (“Textile Rules”) to delete the
Effective on February 22, 2018.
Jock Chung, (202) 326-2984, Attorney, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
The Textile Fiber Products Identification Act (“Textile Act”)
In a Notice of Proposed Rulemaking published on June 28, 2017,
As discussed below, based on the record, the Commission has determined to amend the Textile Rules to delete the requirement trademark owners furnish the FTC with a copy of the mark's USPTO registration before using the mark on labels. Based on the comments received, however, the Commission declines to eliminate the provision allowing only trademarks used as house marks.
In particular, the record indicates that it can be difficult to find the identity of a specific registrant using a word trademark, rather than a house mark. Word trademarks that are not house marks can be registered for specific goods or services, and identical word trademarks can be registered numerous times for different goods or services.
RN numbers also already provide a free, convenient alternative to names for marketers that do not own house marks. The Commission has recently revised the RN Database at
Accordingly, the Commission will continue to allow only owners of registered word trademarks who use these trademarks as house marks to disclose such trademarks in lieu of their names.
The Textile Rules contain various “collection of information” (
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires that the Commission provide an Initial Regulatory Flexibility Analysis (IRFA) with a Proposed Rule, and a Final Regulatory Flexibility Analysis (FRFA) with the final Rule, unless the Commission certifies that the Rule will not have a significant economic impact on a substantial number of small entities.
The Commission anticipates that the final amendment will not have a significant economic impact on a substantial number of small entities. In the Commission's view, the amendment should not increase the costs of small entities that manufacture or import textile fiber products, but may reduce costs associated with furnishing a copy of a registered word trademark used as a house mark to the FTC. Therefore, based on available information, the Commission certifies that amending the Textile Rules will not have a significant economic impact on a substantial number of small businesses. Although the Commission certifies under the RFA that the amendment will not have a significant impact on a substantial number of small entities, the Commission has determined, nonetheless, that it is appropriate to publish a Final Regulatory Flexibility Analysis to inquire into the impact of the proposed amendment on small entities. Therefore, the Commission has prepared the following analysis:
Although the Commission has certified under the RFA that the amendments would not have a significant impact on a substantial number of small entities, the Commission has determined, nonetheless, that it is appropriate to publish an FRFA in order to explain the impact of the amendments on small entities as follows:
The Commission is amending the Rules to provide greater flexibility in complying with the Rules' disclosure requirements by permitting textile fiber product marketers to use registered house marks to identify themselves without sending registration copies to the Commission.
The Commission did not receive any comments specifically related to the impact of the final amendment on small businesses. In addition, the Commission did not receive any comments filed by the Chief Counsel for Advocacy of the Small Business Administration.
Under the Small Business Size Standards issued by the Small Business Administration, textile apparel manufacturers qualify as small businesses if they have 500 or fewer employees. Clothing wholesalers qualify as small business if they have 100 or fewer employees. The Commission's staff has estimated that approximately 22,642 textile fiber product manufacturers and importers are covered by the Textile Rules' disclosure requirements.
The amendment deletes a filing requirement, thus providing greater flexibility to companies covered by the Textile Rules. The amendment is not expected to increase any reporting, recordkeeping, or other requirements associated with the Textile Rules, and is expected to decrease reporting requirements.
The Commission did not propose any specific small entity exemption or other significant alternatives because the amendment is expected to decrease reporting requirements and will not impose any new requirements or compliance costs. No comments identified any new compliance costs, and several comments argued the amendment will reduce compliance costs.
Advertising, Labeling, Recordkeeping, Textile fiber products.
For the reasons discussed in the preamble, the Commission amends part
15 U.S.C. 70
(a) The name required by the Act to be used on labels shall be the name under which the person is doing business. Where a person has a word trademark, used as a house mark, registered in the United States Patent Office, such word trademark may be used on labels in lieu of the name otherwise required. No trademark, trade names, or other names except those provided for above shall be used for required identification purposes.
By direction of the Commission.
Drug Enforcement Administration, Department of Justice.
Final rule.
The Comprehensive Addiction and Recovery Act (CARA) of 2016, which became law on July 22, 2016, amended the Controlled Substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Separately, the Department of Health and Human Services, by final rule effective August 8, 2016, increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA for that purpose. The Drug Enforcement Administration (DEA) is hereby amending its regulations to incorporate these statutory and regulatory changes.
Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
It has been determined this is a major rule within the meaning of the Congressional Review Act (CRA). 5 U.S.C. 804(2). Major rules generally cannot take effect until 60 days after the date on which the rule is published in the
On July 22, 2016, the President signed the Comprehensive Addiction and Recovery Act (CARA) into law as Public Law 114-198. Section 303 of the CARA amended certain provisions of 21 U.S.C. 823(g)(2), which is the subsection of the Controlled Substance Act (CSA) that sets forth the conditions under which a practitioner may, without being separately registered under subsection 823(g)(1), dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Maintenance treatment is the dispensing of a narcotic drug, in excess of twenty-one days, for the treatment of dependence upon heroin or other morphine-like drugs (21 U.S.C. 802(29)). A detoxification treatment is the term given when a narcotic drug is dispensed in decreasing doses, not exceeding one hundred and eighty days, “to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug,” with the ultimate goal of bringing a patient to a narcotic drug-free state (21 U.S.C. 802(30)).
Specifically, section 303 of the CARA temporarily expands the types of practitioners who may dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment without being separately registered as a narcotic treatment program. Whereas prior to the CARA, only qualified
(I) The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain;
(II) The nurse practitioner or physician assistant must complete not fewer than 24 hours of initial training.
(III) The nurse practitioner or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner or physician assistant is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician; and
The Secretary determines in collaboration with, a qualifying physician, if the nurse practitioner or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner can treat and manage opiate-dependent patients. The Secretary may, by regulation, revise the requirements for being qualifying other practitioner.
This section of the CARA further provides that the Secretary of Health and Human Services (HHS) may, by regulation, revise the foregoing
The CARA also makes some technical revisions to 21 U.S.C. 823(g)(2) that do not materially alter the meaning of this subsection. Nonetheless, because the DEA regulations currently contain the older statutory language, DEA is hereby revising this part of the regulations to reflect the new statutory language.
Under the CSA, the Secretary of HHS may, by regulation, increase the maximum number of patients that a practitioner may treat pursuant to 21 U.S.C. 823(g)(2). 21 U.S.C. 823(g)(2)(B)(iii)(III). On July 8, 2016, the Secretary issued a final rule increasing this number to 275. 81 FR 44712. As stated therein, to be eligible for the patient limit of 275, the practitioner must possess a current waiver to treat up to 100 patients under 21 U.S.C. 823(g)(2) and meet additional criteria set forth in 42 CFR 8.610-8.625.
As indicated, this final rule amends the DEA regulations only to the extent necessary to be consistent with current federal law (as modified by the CARA) and current federal regulations issued by HHS. The qualifying practitioner amendments in the CARA alter the provisions of the CSA that DEA previously implemented in its regulations, and DEA is therefore obligated to update those regulations. With respect to the HHS regulations, the CSA gives sole authority to HHS to change the maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA is obligated to apply that number. As a result, DEA has no discretion not to amend its regulations as is being done in this final rule. Indeed, the new provisions issued under this final rule are already in effect by virtue of the CARA and the HHS final rule regarding patient limits. This final rule simply updates the DEA regulations to reflect these new provisions. Public comment on these amendments to the DEA regulations would therefore serve no purpose. Because notice and public comment are unnecessary, DEA finds there is good cause within the meaning of the Administrative Procedure Act (APA) to issue these amendments as a final rule without notice and comment, because these amendments merely conform the implementing regulations with recent amendments to the CSA contained in CARA that have already taken effect (
As explained above, DEA is obligated to issue this final rule to revise its regulations so that they are consistent with the provisions of the CSA that were amended by the CARA and the HHS final rule increasing the patient limit under 21 U.S.C. 823(g)(2). In issuing this final rule, DEA has not gone beyond the statutory text enacted by Congress or the final rule issued by HHS. Thus, DEA would have to issue this final rule regardless of the outcome of the agency's regulatory analysis. Nonetheless, DEA conducted this analysis as discussed below.
This final rule was developed in accordance with the principles of Executive Orders 12866 and 13563. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866. Executive Order 12866 classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
1. The DEA expects that this final rule will have an annual effect on the economy of $100 million or more in at least one year and therefore is an economically significant regulatory action. The analysis of benefits and costs is below.
2. This regulatory action is not likely to result in a rule that may create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. This final rule amends the DEA regulations only to the extent necessary to be consistent with current federal law (as modified by the CARA) and current federal regulations issued by HHS. The qualifying practitioner amendments in the CARA alter the provisions of the CSA that DEA previously implemented in its regulations, and DEA is therefore obligated to update those regulations. With respect to the HHS regulations, the CSA gives sole authority to HHS to change the maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA is obligated to apply that number.
3. This regulatory action is not likely to result in a rule that may materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof. The Diversion Control Fee Account, which the DEA administers and which involves registration fees, is not directly affected. This regulatory action temporarily expanding the types of practitioners and increasing the maximum number of patients that a practitioner may treat as described in detail above represents a minor modification to the registration procedures within the Diversion Control Program and does not necessitate a change in registration fees.
4. This regulatory action is not likely to result in a rule that may raise novel
The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined and it has been determined to be a significant regulatory action under Executive Order 12866, and therefore, has been submitted to the OMB for review.
On July 22, 2016, the Comprehensive Addiction and Recovery Act of 2016 (CARA) became law. One section of the CARA amended the Controlled Substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Separately, the Department of Health and Human Services (HHS), by final rule effective August 8, 2016, increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA for that purpose. The DEA is amending its regulations to incorporate these statutory and regulatory changes.
In addition to the legal requirement to implement the statute, this rule also implements one of the objectives of the statute; expand availability of medication-assisted treatment (MAT) for opioid addiction. As supported by research, there is a gap between those who need treatment for opioid addition and treatment providers (“treatment gap”). An increase in treatment availability is expected to result in more patients treated.
Substance Abuse and Mental Health Services Administration (SAMHSA) independently researched the issue of the treatment gap in its recent rule: Medication Assisted Treatment for Opioid Use Disorders, 81 FR 44712, 44729 (July 8, 2016). SAMHSA found that “. . . there is significant unmet need for MAT treatment among individuals with opioid use disorders . . . Evidence suggests that utilization of buprenorphine is limited directly by the existence of treatment limits.” A research article in American Journal of Public Health concluded that there are significant gaps between treatment need and capacity at the state and national levels, with 96% of states and District of Columbia having opioid abuse or dependence rates higher than their buprenorphine treatment capacity rates.
This final rule amends the DEA regulations only to the extent necessary to be consistent with current federal law (as modified by the CARA) and current federal regulations issued by HHS. The qualifying practitioner amendments in the CARA alter the provisions of the CSA that DEA previously implemented in its regulations, and DEA is therefore obligated to update those regulations. With respect to the HHS regulations, the CSA gives sole authority to HHS to change the maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA is obligated to apply that number. As a result, DEA has no discretion not to amend its regulations as is being done in this final rule. Indeed, the new provisions issued under this final rule are already in effect by virtue of the CARA and the HHS final rule regarding patient limits. This final rule simply updates the DEA regulations to reflect these new provisions; thus, no alternative approaches are possible.
This analysis is limited to the provisions associated with the section of the CARA that amended the CSA to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. The HHS rule that increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA was promulgated under HHS' authority; therefore, that section of the CARA was excluded from this analysis. This is a summary; a detailed economic analysis of the proposed rule can be found in the rulemaking docket at
Benefits, in the form of economic burden (health care costs, criminal justice costs, and lost productivity costs) reductions, are expected to be generated from the expansion of the categories of practitioners who may dispense a narcotic drug in schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. The DEA anticipates the expansion of the categories of practitioners will lead to an increase in the number of treatment providers, which will lead to an increase in the number of patients (who did not have access to treatment prior to this rule) treated, resulting in the reduction in the economic burden due to opioid abuse.
Cost of the rule is associated with treatment cost and the cost to practitioners of obtaining authority to dispense a narcotic drug in schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. While these costs are not directly attributable to this rule, obtaining dispensing authority and treating patients are required to generate the benefits of the rule, and thus, included in this analysis. Although the new treatment providers in the expanded category, qualifying other practitioners, will also need to comply with treatment-specific recordkeeping requirements, the cost of compliance is included in the estimated cost of treatment. Finally, there is potential for added risk of diversion from more
The DEA estimates the total benefit (economic burden reduction) is $208 million, $374 million, $467 million, $560 million, and $654 million in years 1, 2, 3, 4, and 5, respectively; the total cost of treatment is $133 million, $238 million, $298 million, $358 million, and $417 million in years 1, 2, 3, 4, and 5, respectively; and the total cost of obtaining DATA-waived status is $7 million and $4 million in years 1 and 2, respectively; resulting in a net benefit of $68 million, $132 million, $169 million, $202 million, and $237 million in years 1, 2, 3, 4, and 5, respectively. The table below contains the summary of benefits and costs.
At 3% discount rate, the present value of benefits is $2,044 million, the present value of costs is $1,315 million and the net present value (NPV) is $729 million. At 7% discount rate, the present value of benefits is $1,796 million, the present value of costs is $1,156 million and the NPV is $640 million.
This final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.
This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The final rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.
This final rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities between the Federal Government and Indian tribes.
This final rule is considered an E.O. 13771 deregulatory action. The rule is an enabling rule which expands the options for opioid treatment. Details on the expected economic effects of this rule can be found in the rule's economic impact analysis.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As explained above, the DEA determined that there was good cause to exempt this final rule from notice and comment. Consequently, the RFA does not apply to this final rule.
This final rule will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532.
This rule is a major rule as defined by the Congressional Review Act. 5 U.S.C. 804. This rule will result in an annual effect on the economy of $100 million or more as a result of economic burden reductions. However, it will not cause a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the United States-based companies to compete with foreign based companies in domestic and export markets. The DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.
This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521
Administrative practice and procedure, Drug traffic control, Exports, Imports, Security measures.
For the reasons set out above, the DEA amends 21 CFR part 1301 as follows:
21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.
(b)(1) * * *
(i) The individual practitioner is registered under § 1301.13 as an individual practitioner and is a “qualifying physician” as defined in section 303(g)(2)(G)(ii) of the Act (21
(ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the individual practitioner has the capacity to provide directly, by referral, or in such other manner as determined by the Secretary of Health and Human Services:
(A) All drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including for maintenance, detoxification, overdose reversal, and relapse prevention; and
(B) Appropriate counseling and other appropriate ancillary services.
(iii)(A) The total number of patients to whom the individual practitioner will provide narcotic drugs or combinations of narcotic drugs under this section at any one time will not exceed the applicable number. Except as provided in paragraphs (b)(1)(iii)(B) and (C) of this section, the applicable number is 30.
(B) The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of Health and Human Services of the need and intent of the practitioner to treat up to 100 patients.
(C) The applicable number is 275 for a practitioner who has been approved by the Secretary of Health and Human Services under 42 CFR part 8 to treat up to 275 patients at any one time, and provided further that the practitioner has renewed such approval to the extent such renewal is required under this part of the HHS regulations.
Office of the Secretary, Office of Natural Resources Revenue, Interior.
Final rule.
The Office of Natural Resources Revenue (ONRR) is publishing this rule to repeal a 2013 direct final rule and restore the former regulatory language governing service of official correspondence.
This rule is effective January 23, 2018.
For questions on procedural issues, contact Luis Aguilar, Regulatory Specialist, at (303) 231-3418 or by email to
ONRR's “official correspondence” includes significant documents we send to industry, such as invoices, notices of audit, orders, and notices of enforcement. Historically, Department of the Interior (Department) regulations authorized ONRR to serve official correspondence by conventional means—U.S. mail, personal delivery, or private mailing service, such as FedEx or U.P.S. On August 23, 2013, ONRR published in the
The 2013 direct final rule provided for a 30-day public comment period. In the 2013 direct final rule, we stated that if we received significant adverse comment during that period, we would withdraw the rule. During the public comment period, we received significant adverse comments. We attempted to withdraw the 2013 direct final rule before it went into effect on October 22, but had insufficient time to do so due to the October 2013 government shutdown. Because the rule should have been withdrawn, we consider the rule legally defective, and we have not enforced it. We would withdraw the 2013 direct final rule now, but the time limit for withdrawal has expired. Instead, we are publishing this rule to repeal the defective 2013 direct final rule and restore the former regulatory language governing service of official correspondence.
Because this rule makes no changes to the legal obligations or rights of non-governmental entities, the Department finds that good cause exists under 5 U.S.C. 553(d)(3) to make this rule effective immediately upon publication in the
This is a final rulemaking with no request for comments. Under section 553(b), ONRR generally publishes a rule in a proposed form and solicits public comment on it before issuing the final rule. However, section 553(b)(3)(B) provides an exception to the public comment requirement if the agency finds good cause to omit advance notice and public participation. Good cause is shown when public comment is “impracticable, unnecessary, or contrary to the public interest.” We find that in this case, because we are simply restoring the former noncontroversial regulatory language, public comment is unnecessary.
This rule repeals the direct final rule (78 FR 52431) and restores the former regulatory language governing service of official correspondence in sections 1218.540(a) and (d) of title 30 of the
Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in OMB will review all significant rules. OIRA has determined that this rule is not significant. Also, this rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.
Executive Order 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. Executive Order 13563 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. Executive Order 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 developed this rule in a manner consistent with these requirements.
The Regulatory Flexibility Act (RFA) requires an agency to prepare a regulatory flexibility analysis for all rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule. See 5 U.S.C. 603(a) and 604(a). This rule will impact large and small entities but will not have a significant economic effect on either because this is a technical rule restoring the original service of official correspondence regulation language. Thus, the RFA does not apply to this rulemaking.
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:
a. Does not have an annual effect on the economy of $100 million or more.
b. Will not cause a major increase in costs or prices for consumers; individual industries; Federal, State, local government agencies; or geographic regions.
c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises.
This is only a technical rule restoring the original service of official correspondence regulation language.
This rule does not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. This rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. Therefore, we are not required to provide a statement containing the information that the Unfunded Mandates Reform Act (2 U.S.C. 1531
Under the criteria in section 2 of E.O. 12630, this rule does not have any significant takings implications. This rule will not impose conditions or limitations on the use of any private property. Therefore, this rule does not require a takings implication assessment.
Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient Federalism implications to warrant the preparation of a Federalism summary impact statement. Therefore, as a technical rule, it does not require a Federalism summary impact statement.
This rule complies with the requirements of E.O. 12988. Specifically, this rule:
a. Meets the criteria of section 3(a), which requires that we review all regulations to eliminate errors and ambiguity and to write them to minimize litigation.
b. Meets the criteria of section 3(b)(2), which requires that we write all regulations in clear language using clear legal standards.
The Department strives to strengthen its government-to-government relationship with the Indian Tribes through a commitment to consultation with the Indian Tribes and recognition of their right to self-governance and Tribal sovereignty. Under the Department's consultation policy and the criteria in E.O. 13175, we evaluated this technical rule and determined that it will have no substantial direct effects on Federally-recognized Indian Tribes and does not require consultation.
This rule:
(a) Does not contain any new information collection requirements.
(b) Does not require a submission to OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
This rule does not constitute a major Federal action, significantly affecting the quality of the human environment. We are not required to provide a detailed statement under NEPA because this rule qualifies for categorical exclusion under 43 CFR 46.210(i) in that this rule is “. . .
This rule is not a significant energy action under the definition in E.O. 13211 and, therefore, does not require a Statement of Energy Effects.
Continental shelf, Electronic funds transfers, Geothermal energy, Indians—lands, Mineral royalties, Oil and gas exploration, Public lands—mineral resources, Reporting and recordkeeping requirements, Service of official correspondence.
For the reasons discussed in the preamble, ONRR amends 30 CFR part 1218 as set forth below:
5 U.S.C. 301
The revisions read as follows:
(a) * * *
(2) Personal delivery made pursuant to the law of the State in which the service is effected; or
(3) Private mailing service (such as the United Parcel Service or Federal Express), with signature and date upon delivery acknowledging the addressee of record's receipt of the official correspondence document.
(d)
(1) The addressee of record has moved without filing a forwarding address;
(2) The forwarding order has expired;
(3) Delivery was expressly refused; or
(4) The document was unclaimed and the attempt to deliver it is substantiated by:
(i) The U.S. Postal Service;
(ii) A private mailing service, as described in this section; or
(iii) The person who attempted to make delivery using some other method of service.
Under Secretary of Defense (Comptroller), Department of Defense.
Final rule.
The Department of Defense is issuing this final rule to adjust each of its statutory civil monetary penalties (CMP) to account for inflation. The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), requires the head of each agency to adjust for inflation its CMP levels in effect as of November 2, 2015, under a revised methodology that was effective for 2016 and for each year thereafter.
This rule is effective January 23, 2018 and is applicable beginning on January 12, 2018.
Brian Banal, 703-571-1652.
The Federal Civil Penalties Inflation Adjustment Act of 1990, Public Law 101-410, 104 Stat. 890 (28 U.S.C. 2461, note), as amended by the Debt Collection Improvement Act of 1996, Public Law 104-134, April 26, 1996, and further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), Public Law 114-74, November 2, 2015, required agencies to annually adjust the level of CMPs for inflation to improve their effectiveness and maintain their deterrent effect. The 2015 Act required that not later than July 1, 2016, and not later than January 15 of every year thereafter, the head of each agency must adjust each CMP within its jurisdiction by the inflation adjustment described in the 2015 Act. The inflation adjustment is determined by increasing the maximum CMP or the range of minimum and maximum CMPs, as applicable, for each CMP by the cost-of-living adjustment, rounded to the nearest multiple of $1. The cost-of-living adjustment is the percentage (if any) for each CMP by which the Consumer Price Index (CPI) for the month of October preceding the date of the adjustment (January 15), exceeds the CPI for the month of October in the previous calendar year.
The initial catch up adjustments for inflation to the Department of Defense's CMPs were published as an interim final rule in the
Pursuant to 5 U.S.C. 553(b)B, there is good cause to issue this rule without prior public notice or opportunity for public comment because it would be impracticable and unnecessary. The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Section 701(b)) requires agencies, effective 2017, to make annual adjustments for inflation to CMPs notwithstanding section 553 of title 5, United States Code. Additionally, the methodology used, effective 2017, for adjusting CMPs for inflation is established in statute, with no discretion provided to agencies regarding the substance of the adjustments for inflation to CMPs. The Department of Defense is charged only with performing ministerial computations to determine the dollar amount of adjustments for inflation to CMPs.
Further, there are no significant costs associated with the regulatory revisions that would impose any mandates on the Department of Defense, Federal, State or local governments, or the private sector. Accordingly, prior public notice and an opportunity for public comment are not required for this rule. The benefit of this rule is the Department of Defense anticipates that civil monetary penalty collections may increase in the future due to new penalty authorities and other changes in this rule. However, it is difficult to accurately predict the extent of any increase, if any, due to a variety of factors, such as budget and staff resources, the number and quality of civil penalty referrals or leads, and the length of time needed to investigate and resolve a case.
Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). 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,” because it does not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a section of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive Orders.
Executive Order 13771 requires that for every significant regulation promulgated, an agency must identify two for elimination and offset its costs. This rule is exempt from these requirements because it has been deemed not significant by the Office of Management and Budget.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule the mandates of which require spending in any year of $100 million in 1995 dollars, updated annually for inflation. In 2016, that threshold is approximately $146 million. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.
Because notice of proposed rulemaking and opportunity for comment are not required pursuant to 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601,
The Department of Defense determined that provisions of the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this rule because there are no new or revised recordkeeping or reporting requirements.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This final rule will not have a substantial effect on State and local governments.
Administrative practice and procedure, Penalties.
Accordingly, 32 CFR part 269 is amended as follows.
28 U.S.C. 2461 note.
(d)
Forest Service, Agriculture; Fish and Wildlife Service, Interior.
Final rule.
This final rule establishes regulations for seasons, harvest limits, methods, and means related to taking of fish for subsistence uses in Alaska during the 2017-2018 and 2018-2019 regulatory years. The Federal Subsistence Board (Board) completes the biennial process of revising subsistence hunting and trapping regulations in even-numbered years and subsistence fishing and shellfish regulations in odd-numbered years; public proposal and review processes take place during the preceding year. The Board also addresses customary and traditional use determinations during the applicable biennial cycle. This rule also revises fish customary and traditional use determinations.
This rule is effective January 23, 2018.
The Board meeting transcripts are available for review at the Office of Subsistence Management, 1011 East Tudor Road, Mail Stop 121, Anchorage, AK 99503, or on the Office of Subsistence Management website (
Chair, Federal Subsistence Board, c/o U.S. Fish and Wildlife Service, Attention: Eugene R. Peltola, Jr., Office of Subsistence Management; (907) 786-3888 or
Under Title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3111-3126), the Secretary of the Interior and the Secretary of Agriculture (Secretaries) jointly implement the Federal Subsistence Management Program. This program provides a preference for take of fish and wildlife resources for subsistence uses on Federal public lands and waters in Alaska. The Secretaries published temporary regulations to carry out this program in the
Consistent with subpart B of these regulations, the Secretaries established a Federal Subsistence Board to administer the Federal Subsistence Management Program. The Board comprises:
• A Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture;
• The Alaska Regional Director, U.S. Fish and Wildlife Service;
• The Alaska Regional Director, National Park Service;
• The Alaska State Director, Bureau of Land Management;
• The Alaska Regional Director, Bureau of Indian Affairs;
• The Alaska Regional Forester, USDA Forest Service; and
• Two public members appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture.
Through the Board, these agencies participate in the development of regulations for subparts C and D, which, among other things, set forth program eligibility and specific harvest seasons and limits.
In administering the program, the Secretaries divided Alaska into 10 subsistence resource regions, each of which is represented by a Federal Subsistence Regional Advisory Council (Council). The Councils provide a forum for rural residents with personal knowledge of local conditions and resource requirements to have a meaningful role in the subsistence management of fish and wildlife on Federal public lands in Alaska. The Council members represent varied geographical, cultural, and user interests within each region.
The Board addresses customary and traditional use determinations during the applicable biennial cycle. Section __.24 (customary and traditional use determinations) was originally published in the
The Departments published a proposed rule on February 22, 2016 (81 FR 8675), to amend the fish section of subparts C and D of 36 CFR part 242 and 50 CFR part 100. The proposed rule opened a comment period, which closed on April 1, 2016. The Departments advertised the proposed rule by mail, email, web page, social media, radio, and newspaper, and comments were submitted via
The 10 Councils met again, received public comments, and formulated their recommendations to the Board on proposals for their respective regions. The Councils had a substantial role in reviewing the proposed rule and making recommendations for the final rule. Moreover, a Council Chair, or a designated representative, presented each Council's recommendations at the Board's public meeting of January 10-12, 2017. These final regulations reflect Board review and consideration of Council recommendations, Tribal and Alaska Native corporation consultations, and public comments. The public received extensive opportunity to review and comment on all changes.
Of the 14 valid proposals, 10 were on the Board's regular agenda and 4 were on the consensus agenda. The consensus agenda is made up of proposals for which there is agreement among the affected Councils, a majority of the Interagency Staff Committee members, and the Alaska Department of Fish and Game concerning a proposed regulatory action. Anyone may request that the Board remove a proposal from the consensus agenda and place it on the non-consensus (regular) agenda. The Board votes en masse on the consensus agenda after deliberation and action on all other proposals.
Of the proposals on the consensus agenda, the Board adopted one; adopted two with modification; and rejected one. Analysis and justification for the action taken on each proposal on the consensus agenda are available for review at the Office of Subsistence Management, 1011 East Tudor Road, Mail Stop 121, Anchorage, AK 99503, or on the Office of Subsistence Management website (
The Board rejected, deferred, or took no action on three non-consensus proposals. The rejected proposals were recommended for rejection by one or more of the Councils unless noted below.
The Board rejected a proposal to allow for the harvest of early-run Chinook Salmon in sub-district 5D of the Yukon River based on conservation concerns and treaty obligations. This action was supported by three Councils and contrary to the recommendation of one Council.
The Board deferred action on one proposal to restructure the management plans, fishing schedules, and methods and means and allow for independent action to be taken by the in-season
The Board took no action on one proposal for the Kenai River. This decision was based on its earlier action on a similar proposal addressing a community gillnet.
The Board adopted or adopted with modification four non-consensus proposals. Modifications were suggested by the affected Council(s), developed during the analysis process, or developed during the Board's public deliberations. All of the adopted proposals were recommended for adoption by at least one of the Councils unless noted below.
The Board adopted a proposal to revise harvest limits to allow harvest once the mid-range of the interim management escapement goal and the total allowable catch goal are projected to be achieved on the Yukon River.
The Board adopted a proposal with modification to revise the methods and means for the use of gillnets in Racetrack Slough of the Koyukuk River and the sloughs of the Huslia River drainage.
The Board adopted a proposal with modification to revise the season dates for the experimental community gillnet fishery on the Kasilof River for the residents of Ninilchik.
The Board adopted a proposal to revise the season dates, reporting requirements, and household harvest limits, require the live release of Rainbow Trout and Dolly Varden, remove the requirement of an operational plan, and revise permit conditions for the community gillnet fishery on the Kenai River for the residents of Ninilchik.
These final regulations reflect Board review and consideration of Council recommendations, Tribal and Alaska Native corporation consultations, and public comments. Because this rule concerns public lands managed by an agency or agencies in both the Departments of Agriculture and the Interior, identical text will be incorporated into 36 CFR part 242 and 50 CFR part 100.
The Board has provided extensive opportunity for public input and involvement in compliance with Administrative Procedure Act requirements, including publishing a proposed rule in the
In the more than 25 years that the Program has been operating, no benefit to the public has been demonstrated by delaying the effective date of the subsistence regulations. A lapse in regulatory control could affect the continued viability of fish or wildlife populations and future subsistence opportunities for rural Alaskans, and would generally fail to serve the overall public interest. Therefore, the Board finds good cause pursuant to 5 U.S.C. 553(d)(3) to make this rule effective upon the date set forth in
A Draft Environmental Impact Statement that described four alternatives for developing a Federal Subsistence Management Program was distributed for public comment on October 7, 1991. The Final Environmental Impact Statement (FEIS) was published on February 28, 1992. The Record of Decision (ROD) on Subsistence Management for Federal Public Lands in Alaska was signed April 6, 1992. The selected alternative in the FEIS (Alternative IV) defined the administrative framework of an annual regulatory cycle for subsistence regulations.
The following
A 1997 environmental assessment dealt with the expansion of Federal jurisdiction over fisheries and is available at the office listed under
An ANILCA section 810 analysis was completed as part of the FEIS process on the Federal Subsistence Management Program. The intent of all Federal subsistence regulations is to accord subsistence uses of fish and wildlife on public lands a priority over the taking of fish and wildlife on such lands for other purposes, unless restriction is necessary to conserve healthy fish and wildlife populations. The final section 810 analysis determination appeared in the April 6, 1992, ROD and concluded that the Program, under Alternative IV with an annual process for setting subsistence regulations, may have some local impacts on subsistence uses, but will not likely restrict subsistence uses significantly.
During the subsequent environmental assessment process for extending fisheries jurisdiction, an evaluation of the effects of this rule was conducted in accordance with section 810. That evaluation also supported the Secretaries' determination that the rule will not reach the “may significantly restrict” threshold that would require notice and hearings under ANILCA section 810(a).
An agency may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. This rule does not contain any new collections of information that require OMB approval. OMB has reviewed and approved the collections of information associated with the subsistence regulations at 36 CFR part 242 and 50 CFR part 100, and assigned OMB Control Number 1018-0075, which expires June 30, 2019.
Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this rule is not significant.
Executive Order 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.
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601
Under the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801
Title VIII of ANILCA requires the Secretaries to administer a subsistence priority on public lands. The scope of this Program is limited by definition to certain public lands. Likewise, these regulations have no potential takings of private property implications as defined by Executive Order 12630.
The Secretaries have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502
The Secretaries have determined that these regulations meet the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988, regarding civil justice reform.
In accordance with Executive Order 13132, the rule does not have sufficient Federalism implications to warrant the preparation of a Federalism summary impact statement. Title VIII of ANILCA precludes the State from exercising subsistence management authority over fish and wildlife resources on Federal lands unless it meets certain requirements.
The Alaska National Interest Lands Conservation Act, Title VIII, does not provide specific rights to tribes for the subsistence taking of wildlife, fish, and shellfish. However, the Board provided Federally recognized Tribes and Alaska Native corporations opportunities to consult on this rule. Consultation with Alaska Native corporations are based on Public Law 108-199, div. H, Sec. 161, Jan. 23, 2004, 118 Stat. 452, as amended by Public Law 108-447, div. H, title V, Sec. 518, Dec. 8, 2004, 118 Stat. 3267, which provides that: “The Director of the Office of Management and Budget and all Federal agencies shall hereafter consult with Alaska Native corporations on the same basis as Indian tribes under Executive Order No. 13175.”
The Secretaries, through the Board, provided a variety of opportunities for consultation: Commenting on proposed changes to the existing rule; engaging in dialogue at the Council meetings; engaging in dialogue at the Board's meetings; and providing input in person, by mail, email, or phone at any time during the rulemaking process.
On April 12, 2016, the Board provided Federally recognized Tribes and Alaska Native Corporations a specific opportunity to consult on this rule prior to the start of its public regulatory meeting. Federally recognized Tribes and Alaska Native Corporations were notified by mail and telephone and were given the opportunity to attend in person or via teleconference.
This Executive Order requires agencies to prepare Statements of Energy Effects when undertaking certain actions. However, this rule is not a significant regulatory action under E.O. 13211, affecting energy supply, distribution, or use, and no Statement of Energy Effects is required.
Theo Matuskowitz drafted these regulations under the guidance of Eugene R. Peltola, Jr. of the Office of Subsistence Management, Alaska Regional Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Additional assistance was provided by:
• Daniel Sharp, Alaska State Office, Bureau of Land Management;
• Mary McBurney, Alaska Regional Office, National Park Service;
• Dr. Glenn Chen, Alaska Regional Office, Bureau of Indian Affairs;
• Carol Damberg, Alaska Regional Office, U.S. Fish and Wildlife Service; and
• Thomas Whitford, Alaska Regional Office, USDA Forest Service.
Administrative practice and procedure, Alaska, Fish, National forests, Public lands, Reporting and recordkeeping requirements, Wildlife.
Administrative practice and procedure, Alaska, Fish, National forests, Public lands, Reporting and recordkeeping requirements, Wildlife.
For the reasons set out in the preamble, the Federal Subsistence Board amends title 36, part 242, and title 50, part 100, of the Code of Federal Regulations, as set forth below.
16 U.S.C. 3, 472, 551, 668dd, 3101-3126; 18 U.S.C. 3551-3586; 43 U.S.C. 1733.
(a) * * *
(2) * * *
The additions and revisions read as follows:
(e) * * *
(3) * * *
(xiii) * * *
(B) In Subdistrict 5D you may take salmon once the mid-range of the Canadian interim management escapement goal and the total allowable catch goal are projected to be achieved.
(xv) * * *
(A) In Subdistrict 4A upstream from the mouth of Stink Creek, you may take Chinook salmon by drift gillnets less than 150 feet in length from June 10 through July 14, and chum salmon by drift gillnets after August 2; unless closed by the Federal In-season Manager; from June 10 through August 2, the Federal In-season Manager may open fishing periods during which chum salmon may be taken by drift gillnets.
(B) In Subdistrict 4A downstream from the mouth of Stink Creek, you may take Chinook salmon by drift gillnets less than 150 feet in length from June 10 through July 14; unless closed by the Federal In-season Manager; from June 10 through August 2, the Federal In-season Manager may open fishing periods during which chum salmon may be taken by drift gillnets.
(xvi) * * *
(F) In Racetrack Slough on the Koyukuk River and in the sloughs of the Huslia River drainage, from when each river is free of ice through June 15, the offshore end of the set gillnet may not be closer than 20 feet from the opposite bank except that sloughs 40 feet or less in width may have
(10) * * *
(iv) * * *
(I) Residents of Ninilchik may harvest sockeye, Chinook, coho, and pink salmon through an experimental community gillnet fishery in the Federal public waters of the upper mainstem of the Kasilof River from a Federal regulatory marker on the river below the outlet of Tustumena Lake downstream to the Tustumena Lake boat launch June 16-August 15. The experimental community gillnet fishery will expire 5 years after approval of the first operational plan.
(J) Residents of Ninilchik may harvest sockeye, Chinook, coho, and pink salmon in the Federal public waters of the Kenai River with a single gillnet to be managed and operated by the Ninilchik Traditional Council. Ninilchik residents may retain other species incidentally caught in the Kenai River except for rainbow trout and Dolly Varden; all rainbow trout and Dolly Varden must be released.
(13) * * *
(ix) Nets are prohibited in streams flowing across or adjacent to the roads on Wrangell and Mitkof islands, and in streams flowing across or adjacent to the road systems connected to the community of Sitka.
Postal Service
Final rule.
The Postal Service is adding language for clarification purposes to ensure that the purpose of a contract or interagency agreement complies with the Postal Reorganization Act and the Privacy Act of 1974.
Natalie A. Bonanno, Chief Counsel, Federal Compliance,
On October 11, 2017 (82 FR 47115), the Postal Service published its revised privacy regulations to implement numerous non-substantive editorial changes effective on the same date. These changes included renaming certain offices with privacy-related duties, modification of the roles of employees tasked with implementing aspects of the privacy regulations, and minor editorial changes to postal privacy policy to improve its consistency and clarity. The Postal Service is now adding clarifying language to ensure the purpose of a contract or interagency agreement complies with the Postal Reorganization Act and the Privacy Act of 1974.
Privacy.
For the reasons stated in the preamble, the Postal Service amends 39 CFR chapter I as follows:
5 U.S.C. 552a; 39 U.S.C. 401.
(b) * * *
(3) Under 39 U.S.C. 412(a), the Postal Service shall not make a mailing or other list of names or addresses (past or present) of postal patrons or other persons available to the public, unless such action is authorized by law. Consistent with this provision, the Postal Service may make such a list available as follows:
(i) In accordance with 39 U.S.C. 412(b), to the Secretary of Commerce for use by the Bureau of the Census;
(ii) As required by the terms of a legally enforceable contract entered into by the Postal Service under its authority contained in 39 U.S.C. 401(3) and when subject to a valid non-disclosure agreement. The purpose of the contract must comply with 5 U.S.C. 552a(n), which prohibits the sale or rental of an individual's name and address;
(iii) As required by the terms of a legally enforceable interagency agreement entered into by the Postal Service under its authority contained in 39 U.S.C. 411 and when subject to a valid non-disclosure agreement. The purpose of the interagency agreement must comply with 5 U.S.C. 552a(n), which prohibits the sale or rental of an individual's name and address;
(iv) In accordance with 5 U.S.C. 552a(b), the Postal Service may disclose a list of names and addresses of individuals pursuant to a written request by, or with the prior written consent of, each individual whose name and address is contained in such list, provided that such names and addresses are derived from records maintained by the Postal Service in a system of records as defined by 5 U.S.C. 552a(a); or
(v) As otherwise expressly authorized by federal law.
Legal Services Corporation.
Final rule.
The Legal Services Corporation (LSC) is required by law to establish maximum income levels for individuals eligible for legal assistance. This document updates the specified income levels to reflect the annual amendments to the Federal Poverty Guidelines issued by the U.S. Department of Health and Human Services (HHS).
Effective January 23, 2018.
Stefanie K. Davis, Assistant General Counsel, Legal Services Corporation, 3333 K St. NW, Washington, DC 20007; (202) 295-1563;
Section 1007(a)(2) of the Legal Services Corporation Act (Act), 42 U.S.C. 2996f(a)(2), requires LSC to establish maximum income levels for individuals eligible for legal assistance. Section 1611.3(c) of LSC's regulations establishes a maximum income level equivalent to 125% of the Federal Poverty Guidelines (Guidelines), which HHS is responsible for updating and issuing. 45 CFR 1611.3(c).
Each year, LSC updates Appendix A to 45 CFR part 1611 to provide client income eligibility standards based on the most recent Guidelines. The figures for 2018, set out below, are equivalent to 125% of the Guidelines published by HHS on January 18, 2018, 83 FR 2642.
In addition, LSC is publishing a chart listing income levels that are 200% of the Guidelines. This chart is for reference purposes only as an aid to recipients in assessing the financial eligibility of an applicant whose income is greater than 125% of the applicable Guidelines amount, but less than 200% of the applicable Guidelines amount (and who may be found to be financially eligible under duly adopted exceptions to the annual income ceiling in accordance with 45 CFR 1611.3, 1611.4, and 1611.5).
Except where there are minor variances due to rounding, the amount by which the guideline increases for each additional member of the household is a consistent amount.
Grant Programs—Law, Legal services.
For reasons set forth in the preamble, the Legal Services Corporation amends 45 CFR part 1611 as follows:
42 U.S.C. 2996g(e).
Fish and Wildlife Service, Interior.
Final rule.
We, the U.S. Fish and Wildlife Service (Service), determine the eastern puma (=cougar) (
This rule is effective February 22, 2018.
This final rule is available on the internet at
Martin Miller, Northeast Regional Office, telephone 413-253-8615, or Mark McCollough, Maine Field Office, telephone 207-902-1570. Individuals who are hearing or speech impaired may call the Federal Relay Service at 1-800-877-8337 for TTY assistance. General information regarding the eastern puma and the delisting process may also be accessed at:
The eastern puma (=cougar) was originally listed as an endangered species on June 4, 1973 (38 FR 14678). On June 17, 2015, the Service published a proposed rule (80 FR 34595) to remove the eastern puma from the List, with a comment period extending through August 17, 2015. The comment period for the proposed rule was subsequently reopened on June 28, 2016 (81 FR 41925). For more information on previous Federal actions concerning the eastern puma, refer to the proposed rule available at:
Here we summarize the biological and legal basis for delisting the eastern puma. For more detailed information, refer to the proposed rule and supplemental documents available at:
The eastern puma (
The eastern puma has a long and varied taxonomic history, as described in the Service's 5-year status review of this subspecies (USFWS 2011, pp. 29-35). Until recently, standard practice was to refer to the puma species as
There is little basis for believing that the ecology of eastern pumas was significantly different from puma ecology elsewhere on the continent. Therefore, in lieu of information specific to eastern pumas, our biological understanding of this subspecies relies on puma studies conducted in various regions of North America and, to the extent possible, from eastern puma historical records and museum specimens. This information is detailed in the 2011 status review for the eastern puma (USFWS 2011, pp. 6-8).
Details regarding historical eastern puma abundance and distribution are provided in USFWS 2011 (pp. 8-29, 36-56). Although records indicate that the eastern puma was formerly wide-ranging and apparently abundant at the time of European settlement, only 26 historical specimens from seven eastern States and one Canadian province reside in museums or other collections. Based on this evidence, Young and Goldman (1946) and the 1982 recovery plan for the eastern cougar (USFWS 1982, pp. 1-2) generally described the eastern puma's historical range as southeastern Ontario, southern Quebec, and New Brunswick in Canada, and a region bounded from Maine to Michigan, Illinois, Kentucky, and South Carolina in the Eastern United States. The most recently published assessment of the eastern puma in Canada, conducted by the Committee on the Status of Endangered Wildlife in Canada (COSEWIC), described the subspecies' range as Ontario, Quebec, and eastern Canada (Scott 1998, pp. v, 10, 29-30). Scott (1998, p. v, 29) indicated that “Manitoba is the easternmost part of
The historical literature indicates that puma populations were considered largely extirpated in Eastern North America (except for Florida and perhaps the Smoky Mountains) by the 1870s and in the Midwest by 1900. Their disappearance was attributed primarily to persecution stemming from fear of large predators, competition with game species, and occasional depredation of livestock. Other causes of eastern puma losses during the late 1800s included declining habitat conditions and the near-extirpation of their primary prey base, white-tailed deer. By 1929, eastern pumas were believed to be “virtually extinct,” and Young and Goldman (1946) concurred that “they became extinct many years ago.”
Conversely, puma records from New Brunswick in 1932 and Maine in 1938 suggest that a population may have persisted in northernmost New England and eastern Canada. In the Service's 1976 status review (Nowak 1976), R.M. Nowak professed his belief that the large number of unverified sightings of pumas constituted evidence that some populations had either survived or become reestablished in the central and eastern parts of the continent and may have increased in number since the 1940s. Similarly, R.L. Downing, as stated in the Eastern Cougar Recovery Plan (USFWS 1982, pp. 4, 7), had thought it possible that a small population may have persisted in the southern Appalachians into the 1920s; however, his investigations during preparation of the recovery plan led him to conclude that “no breeding cougar populations have been substantiated within the former range of
Thus, the most recent confirmed eastern puma sightings date from the mid-1800s to around 1930. Confirmed reports of pumas in Eastern North America (outside Florida) since then have been shown to be either western puma dispersers, as in Missouri, or released or escaped animals, as in Newfoundland.
Although habitat conditions now appear to be suitable for puma presence in various portions of the historical range described for the eastern puma, the many decades of both habitat and prey losses belie the sustained survival and reproduction of this subspecies over that time. A more detailed discussion of the historical status, current confirmed and unconfirmed puma sightings, potential habitat, and legal protection of the eastern puma in the States and provinces is provided in the 5-year status review (USFWS 2011, pp. 8-26).
We have not made substantive changes from the proposed rule (80 FR 34595, June 17, 2015). In this final rule, we have added or corrected text to clarify information and respond to input received during the public and peer review comment periods regarding the proposal. These changes have been incorporated into this final rule as presented below.
In the proposed rule (80 FR 34595, June 15, 2015), we requested that all interested parties submit written comments on the proposal by August 17, 2015. We also solicited peer review of the scientific basis for the proposal by reopening the comment period on June 28, 2016 (81 FR 41925). As appropriate, Federal and State agencies, tribes, scientific organizations, and other interested parties were contacted directly and invited to comment on the proposal. Press releases inviting general public comment were widely distributed, and notices were placed on Service websites.
We did not receive any requests for a public hearing. During the two public comment periods, a total of 75 letters submitted from organizations or individuals addressed the proposed delisting of the eastern puma. Attached to one letter was an appeal containing 2,730 names and addresses of individuals opposed to removing the eastern puma from the List. Many letters contained applicable information, which has been incorporated into this final rule as appropriate. Substantive public comments and peer review comments, with our responses, are summarized below.
In commenting on the ecological importance of pumas as apex predators, several reviewers noted that ungulate populations (like white-tailed deer) have overpopulated in their absence. Ungulate overpopulation may cause overbrowsing, “trophic cascades,” and reduced biodiversity (Goetch et al. 2011). It may also lead to declines in mast production (McShea et al. 2007), understory recruitment of certain tree species, and reduced ground-nesting bird habitat (Rawinsky 2008) across the eastern deciduous forest. In addition to maintaining biodiversity and ecosystem functioning (Ripple et al. 2014), restoring pumas would reduce risk to the public from vehicle collisions with deer and other large ungulates (Gilbert et al. 2016) and would reduce human health issues associated with deer ticks as a vector for Lyme disease (Kilpatrick et al. 2014). Some commenters noted that restoring pumas to unoccupied portions of their historical range would be similar to the Service's restoration of wolves to unoccupied portions of their historical range.
Finally, some commenters argued that the reestablishment or reintroduction of other puma subspecies into the historical range of the eastern puma should not be considered until the status of the eastern puma as extinct is officially recognized through removal of the subspecies from the List. They indicated that delisting the eastern puma could eliminate complications associated with Federal listing and open the door for State restoration projects.
The Service recognizes that within the historical range of the eastern puma there are large, intact areas of habitat with suitable prey resources and little human disturbance that could support puma populations (USFWS 2011, pp. 8, 11-25). Scientific articles published before and after our 2011 review conclude that potential habitat for pumas occurs in the Southeast (Keddy 2009), Georgia (Anco 2011), the Midwest (Smith et al. 2015), the Adirondack region of New York (Laundre 2013), numerous locations in New England (Glick 2014), and the Great Lakes region (O'Neil et al. 2014). Some authors predict that pumas will continue to expand their range eastward and naturally recolonize some areas of Eastern North America (LaRue and Nielsen 2014).
Despite the apparent opportunities for puma recolonizations or reintroductions, the Service does not have the authority under the Act to pursue establishment of other puma subspecies within the historical range of the eastern puma. Furthermore, while the purpose of the Act is to provide a means whereby the ecosystems upon which endangered and threatened species depend may be conserved, the Act gives the Service the authority to pursue ecosystem conservation only to the extent necessary to recover listed species. Thus, the Service cannot maintain the extinct eastern puma subspecies on the List for the purpose of facilitating restoration of other, nonlisted puma subspecies, whether to address overpopulation of deer and other ungulates or to achieve any other objective.
Delisting the eastern puma subspecies, in and of itself, would not foreclose future opportunities to reestablish pumas in Eastern North America. Although extinction of the eastern puma obviously precludes reintroduction of this particular subspecies, we concur that officially recognizing the eastern puma as extinct by removing it from the List could eliminate any perceived complications associated with the establishment of other, nonlisted puma populations into the historical range of the eastern puma. We note that authority over the establishment of nonlisted puma populations resides with the States.
A few commenters asserted that, based on the widespread acceptance of genetic information leading to the recommendation to revise the taxonomy to recognize all pumas in North America as a single subspecies, the Service should delist the eastern puma subspecies on the basis of original data error rather than extinction. They also stated that, were the Service to determine that delisting is called for due to data error, we must withdraw the proposed rule and publish a new proposal explaining our rationale.
Finally, some commenters suggested that, to resolve these taxonomic questions, the Service should conduct a complete taxonomic review and analysis of the subspecies status of North American pumas, including genetic, morphological, ecological, and behavioral considerations, prior to making a listing determination.
The 2011 status review recognized that more-recent genetic information introduced “significant ambiguities” in the species taxonomy that Young and Goldman had outlined in 1946. However, rather than recommending delisting as a result of those ambiguities, the status review recommended that a full taxonomic analysis be conducted to determine whether the taxonomy should be revised (p. 35). Since completion of our eastern puma status review in 2011, there appears to have been increasing acceptance of scientific nomenclature indicating a single subspecies,
• The Smithsonian Institution's Museum of Natural History documents current taxonomy (
• The Federal government's Interagency Taxonomic Information System (ITIS,
• In 2009, the Convention for the International Trade of Endangered Species of Wild Flora and Fauna (CITES) received a proposal from Canada to review the taxonomy and classification of the genus
• The IUCN now recognizes one subspecies of cougar (
• The Global Biodiversity Information Facility (GBIF,
• NatureServe currently acknowledges several subspecies, including
Although some authorities indicate acceptance of a taxonomy identifying a single North American puma subspecies (USFWS 2011, pp. 29-35), others continue to recognize the eastern puma as a separate subspecies. This has created an ambiguous situation that does not clearly replace Young and Goldman as the best scientific and commercial data available on puma taxonomy. We conclude that, despite its deficiencies, Young and Goldman (1946) remains the best available taxonomic information for the puma. We anticipate that in our status assessment for the Florida panther, now underway, we will complete a comprehensive taxonomic treatment that considers all other available scientific information—including morphological, ecological, and behavioral factors, in addition to genetics.
Notwithstanding the commenters' questions about the taxonomy of the species, we continue to base the delisting of the eastern puma on extinction for several reasons. First, although the Act and its implementing regulations at 50 CFR 424.11(d) allow for species to be delisted for reasons of recovery, extinction, or error in the original data for classification, neither the Act nor the implementing regulations compel the Service to choose one basis for delisting over another when more than one basis is available.
Second, the eastern puma's existence has been questioned for decades—long before its listing as an endangered species under the Act. We therefore place importance on officially acknowledging our finding, through this rulemaking, that the listed entity is extinct. Clear recognition of this finding should also forestall any speculation that we have discovered evidence of the existence of eastern pumas, a perception that could be triggered by changing the basis for delisting from extinction to original data error.
Third, because the eastern puma has likely been extinct since the early to mid-1900s, and because its existence had not been confirmed at the time of listing, delisting due to extinction in this case could be considered a delisting due to original data error that is more precisely described as “prior extinction.” And because the eastern puma's existence was questioned long before listing, while new information bringing its taxonomy into doubt did not appear until well after listing, original data error based on prior extinction reasonably has precedence over original data error based on a more-recent taxonomic understanding.
Fourth, although delisting the eastern puma due to taxonomic error would have no immediate effect on the listed status of the Florida panther, it could presuppose the taxonomic status of
Finally, accepting that all pumas in North America are a single subspecies would not fully address the question as to whether the eastern puma is a listable entity. When a vertebrate animal is found not to be a valid species or subspecies, a determination that it is not a listable entity requires that it further be found not to be a “distinct population segment” (DPS) of a vertebrate species as defined in the Act and in the 1996 Interagency Distinct Population Segment policy (61 FR 4722, February 7, 1996). The eastern puma does not qualify as a DPS because it is extinct (see also our response to comment 5). Extinction, therefore, is the most fundamental basis for delisting, because it is justified whether or not the eastern puma ever constituted a taxonomically listable entity.
In sum, while the best available scientific information provides some evidence that North American pumas constitute a single subspecies, taxonomic revision awaits full resolution and does not constitute the most fundamental basis for delisting the eastern puma. The best available information also indicates that the entity described as the eastern puma was extirpated throughout its historical range long before its listing, and that this is a primary and sufficiently proven basis for delisting.
We note that the consequences of delisting the eastern puma with regard to Federal protection of dispersing western pumas are the same whether delisting were to be based on extinction or taxonomic error (see our response to comment 3, above). Western pumas dispersing into the historical range of the eastern puma subspecies currently lack protection under the Act and would not receive protection under either delisting scenario. Dispersing western pumas receive, and will continue to receive, those protections afforded by individual States.
The Service's 2014 SPR policy (79 FR 37577, July 1, 2014) states that listing considerations are based solely on the status of the species in its current range. Regardless of the status of our 2014 SPR policy, the Service maintains this position. Because we have determined that the eastern puma subspecies is extinct—that is, that it does not exist in any part of its range and, therefore, has no current range—it cannot be considered endangered or threatened throughout all of its range or in any portion of its range. Therefore, a continued listing of the eastern puma based on endangered or threatened status within a significant portion of its range is not possible.
Commenters cited Cumberland and Demsey (1994), Cardoza and Langlois (2002), Maehr et al. (2003), Bertrand et al. (2006), Rosatte (2011), Mallory et al. (2012), Lang et al. (2013), and Glick (2014) as corroborating documentation for the occurrence of extant puma populations in eastern Canada. Our review of these sources found that Cumberland and Demsey (1994) documented a single puma (from tracks) in New Brunswick in 1992, concluding that “these data lend little support to the existence of a remnant Eastern Cougar population. It is possible that the animal responsible for the tracks could have been an escaped or released animal.” Bertrand et al. (2006) documented hair samples from two pumas in Fundy National Park in New Brunswick in 2003. One of these was from South America, indicative of an escaped or released pet, and there has been no further evidence confirming the existence of pumas in New Brunswick since 2003. Lang et al. (2013) collected 19 confirmed puma hair samples in eastern Canada from scratching post stations from 2001 to 2012. Several of these samples likely were from the same animal. Two samples were shown to be from the same pumas reported by Bertrand et al. (2006), while six were Central and South American haplotypes (assumed to be released pets), and 10 were of North American origin (whether captive or wild was undetermined). They also evaluated the origin of three known mortalities from 1992 to 2002. One was of South American origin, one was of North American origin (uncertain whether captive origin or wild), and one was of unknown origin. From these data, Lang et al. (2013) concluded that pumas have been present in eastern Canada but provide no confirmation of the existence of the eastern puma or evidence of any breeding population of pumas. Rosatte (2011) documented 21 puma occurrences with a high degree of certainty in Ontario from 1998 to 2010, including 15 confirmed tracks, 1 hair sample consistent with pumas, genetic confirmation of 2 scats, and 3 photographs “consistent with a cougar.” Mallory et al. (2012) collected eight “potential” puma hairs (Sudbury, Ontario) identified by hair scale pattern, and reanalyzed a scat collected in 2004 from Wainfleet, Ontario, and reported in Rosatte (2011). Mallory et al. (2012) reported that trapping records from 1919 to 1984 contained no information on puma pelts sold in Ontario or in eastern Canada except for eight animals sold in Quebec from 1919 to 1920; the origin of these animals (Quebec or western Canada) cannot be confirmed. Finally, Rosatte et al. (2015) documented six additional occurrences in Ontario from 2012 to 2014, including one scat sample (North or South America haplotype not reported), three photographs, one set of tracks, one pregnant female shot (captive origin), and one young male captured (believed to be of captive origin).
Most of these authors (
Given the absence of trapping records and confirmed historical records in eastern Canada since the late 1800s, the best available information points to the extirpation of puma populations in this portion of the eastern puma's historical range. Areas of Canada most likely to have been historically occupied by eastern pumas (southern Ontario and Quebec, New Brunswick, and Nova Scotia) were extensively trapped and logged, and evidence of a small breeding population would, in all probability, have been noted. With no confirmation of breeding pumas in eastern Canada for many decades, the Service concludes that those puma populations were extirpated. Further, because there is no indication of breeding or the abundant evidence of presence typically associated with small, reproducing populations, the Service concludes that the individual pumas occasionally found in Eastern Canada and the Eastern United States (outside Florida) are escaped or released pets or animals that have dispersed from western populations (or, rarely, Florida); refer to Comment 16 below for more detail).
One commenter mistakenly indicated that, among other investigators, Cardoza and Langlois (2002) and Maehr et al. (2003) provide substantial scientific evidence that eastern pumas continue to exist. On the contrary, Cardoza and Langlois (2002) shared skepticism of the plethora of anecdotal reports and sightings, concluding that “the search for cougars in the East must be conducted as a scientific endeavor.” They encouraged the Service to delist the eastern puma if it is extinct or re-list it as a DPS if any populations exist. If the subspecies were to remain listed, they encouraged the Service to revise the recovery plan, because “agencies have failed to meet the objective of . . . having found or established . . .” at least three self-sustaining populations. Maehr et al. (2003) called for recovery of pumas in Eastern North America but provided no documentation of a persistent population outside of Florida.
Puma refugia in western North America are often characterized by remote, steep, mountainous terrain with little infrastructure for human access and relatively low ungulate populations (Stoner et al. 2013). In contrast, potential refugia for pumas in Eastern North America (
The IUCN Standards and Petitions Subcommittee (IUCN 2014) has established criteria to track the conservation status of species, and it is instructive to consider those criteria here. The “extinct” category is used by the IUCN when there is evidence beyond a reasonable doubt that the last individual of a taxon has died, recognizing that this is extremely difficult to detect. The IUCN designates a taxon as extinct only after adequate surveys have failed to record the species and local or unconfirmed reports have been investigated and discounted. Relevant types of evidence supporting an IUCN designation of extinct include the following (Butchart et al. 2006):
• For species with recent last records, the decline has been well documented;
• Severe threatening processes are known to have occurred (
• The species possesses attributes known to predispose taxa to extinction (
Such evidence should be balanced against the following opposing considerations (Butchart et al. 2006):
• Recent field work has been inadequate (surveys have been insufficiently intensive/extensive or inappropriately timed, or the species' range is inaccessible, remote, unsafe, or inadequately known);
• The species is difficult to detect (it is cryptic, inconspicuous, nocturnal, nomadic, or silent, or its vocalizations are unknown, identification is difficult, or the species occurs at low densities);
• There have been reasonably convincing recent local reports or unconfirmed sightings; and
• Suitable habitat (free of introduced predators and pathogens, if relevant) remains within the species' known range, and/or allospecies or congeners may survive despite similar threatening processes.
The IUCN has not issued a determination that the eastern puma subspecies,
Many decades have passed since documentation of the last credible eastern puma records, which are contained in the scientific literature and are documented for each State and province within the eastern puma's historical range in our 2011 status review. In addition, severe threats (indiscriminate shooting, trapping, poisoning, deforestation, and extirpation of ungulate prey in much of the range) were evident at the time eastern puma populations were extirpated. Further, pumas are prone to extirpation because of their relatively small population sizes and low population densities, large habitat area requirements, and relatively slow population growth traits (Purvis et al. 2000).
Service-sponsored surveys in the early 1980s in the southern (Downing 1994a, 1994b) and northern (Brocke and VanDyke 1985) parts of the eastern puma's historical range failed to detect any pumas, noting that while difficulty of detection may be expected in the South, it should not be particularly difficult to detect pumas in the North, where there is snow. Our 2011 review also describes numerous other wildlife surveys that did not detect a breeding population of pumas in Eastern North America outside of Florida, and negative survey data are available for many portions of the historical range that still have intact habitat. Despite suggestions that we conduct further surveys, we are not aware of areas within the historical range of the eastern puma with enough evidence of a breeding population to merit the additional effort.
In our 2011 status review, we acknowledged the thousands of reported puma sightings while noting that 90 to 95 percent of these sightings have been shown to be invalid (Brocke 1981, Downing 1984, Hamilton 2006); these invalid reports have generally involved instances of misidentification and, at times, deliberate hoaxes. With respect to increasing frequency of confirmed puma sightings in recent years, we recognize that suitable habitat is available within the historical range of the eastern puma (see our response to comment 3, above), that past threats have been largely eliminated (with some level of protection for dispersing pumas), and that, according to some biologists, western pumas will continue to expand their range eastward (
There is no regulatory requirement for the Service to conduct statistical analyses in order to draw conclusions about extinction. Both our 2011 status review and our review of scientific information that has become available since then point to overwhelming evidence that the eastern puma subspecies is extinct (see also our earlier responses to comments 2, 7, and 10). Given that the last eastern pumas that were assumed to have existed were killed in Maine (1938) and New Brunswick (1932), the preponderance of scientific evidence fully supports our conclusion that breeding populations of pumas in Eastern North America outside of Florida and, until recent decades, Manitoba have been absent for at least the past 80 years, and that pumas recently sighted within the historical range of the eastern puma are escaped or released pets and western (and, rarely, Florida) dispersers. This conclusion and our use of the best available scientific information were sustained by peer reviewers (see comment 20, below).
Manitoba biologists have documented 20 occurrences of pumas since 2002 (carcasses, tracks, photos), including 6 puma carcasses (3 male and 3 female) since 2004. However, there has been no conclusive evidence of kittens or lactating females, and thus breeding status is uncertain. Biologists are unsure whether an increased number of dispersing pumas in Manitoba is on the cusp of developing a breeding population or whether a small breeding population currently exists (W. Watkins, Manitoba Conservation and Water Stewardship, email dated February 1,
Nonetheless, as in most eastern States and provinces, there continue to be numerous reports of pumas in Michigan, the most credible of which are investigated by the MDNR following its response protocol. At the time of the 2011 review, the MDNR had confirmed one puma report from Alcona County (1998) and one “likely” occurrence in Menominee County (2004). Since then, additional confirmed occurrences have been documented in the Upper Peninsula of Michigan in Ontonagon County (two in 2011), Houghton County (one in 2011), Keweenaw County (three in 2011), Baraga County (one in 2011, two in 2012), Marquette County (four in 2012, two in 2013), Delta County (one in 2015), Menominee County (one in 2010, two in 2012, one in 2015), Schoolcraft County (one carcass in 2015), Luce County (one in 2013, one in 2014), Mackinac County (two in 2014), and Chippewa County (one in 2014).
Noting that many of these records could represent multiple confirmations of the same animal, the number of confirmed puma occurrences in the Upper of Peninsula of Michigan has totaled 27 since 2010. This is in marked contrast to the number of confirmed puma records in Nebraska (255 since 2010), with its small breeding population of about 25 pumas.
The overall record of pumas dispersing eastward has grown substantially since the 2011 status review, with 271 confirmed puma occurrences east of documented breeding areas in the Dakotas, Nebraska, Colorado, and Texas (
The take protections of the Act do not extend to nonlisted pumas, irrespective of their origin or the fact that they have been found within the eastern puma's historical range. However, despite the Act's inapplicability to these pumas, some States have enforced their respective wildlife laws to protect all pumas within their jurisdictions. In addition to the take prohibitions associated with some State endangered species laws, many States within the historical range have closed seasons on pumas, affording some level of protection, and similar provincial protections are provided to pumas that may disperse into eastern Canada. Florida panthers, wherever they occur, continue to be protected from take under the Act, and all other pumas occurring in Florida continue to be protected under a similarity of appearance designation (32 FR 4001, March 11, 1967).
We emphasize that the authority and responsibility for protection and management of pumas not listed under the Act resides with the States, and balancing a public interest in natural recolonization with the concern for public, pet, and livestock safety will be a challenging endeavor. Recent studies of public attitudes toward pumas recolonizing or being reintroduced in Eastern North America provide a good foundation for management plans, policy decisions, and educational initiatives (Davenport et al. 2010, Thornton and Quinn 2010, Jacobsen et al. 2012, Bruskotter and Wilson 2014, McGovern and Kretser 2014, Smith et al. 2015, McGovern and Kretzer 2015). These human dimension studies also identify the many social and political challenges associated with such initiatives.
There also continue to be costs associated with retaining the eastern puma on the List. Maintaining the eastern puma on the List obligates the Service to continue to compile information relating to puma science and reported sightings and to respond to reported sightings. The Service therefore expends considerable staff time addressing puma reports and questions, diverting limited resources from conservation efforts for listed species that still exist.
While many listed species have areas of unoccupied range, there is no precedent for listing a species when its entire range is unoccupied because the entity is extinct. It is important to recognize that under the Act the Service cannot list a “vacant” range—we can list only species, subspecies, and DPSs. Thus, if a species as defined by the Act is determined to be extinct, we can neither list it nor keep it listed. We acknowledge that this commenter could be implying that the eastern puma should remain listed because its entire unoccupied historical range represents a portion of the historical range of a higher-level taxon to which it belongs (
Almost 80 years have passed (including more than 40 years while listed under the Act) with no confirmation of the existence of the eastern puma. In addition to the effort and resources put into evaluating all available scientific evidence, this amount of time is sufficient to determine the extinction of an animal that is not difficult to detect wherever it exists as a breeding population—this reasoning satisfies the precautionary principle. See also our response to comment 8.
Section 4 of the Act authorizes the Service to develop recovery plans for species listed as endangered or threatened. With regard to listed pumas, recovery plans were developed for the eastern puma (
In some instances, the Service has promoted the development of multi-State conservation plans for species that are petitioned or are candidates for Federal listing (
In accordance with our 1994 peer review policy (59 FR 34270, July 1, 1994), we invited six independent scientists to comment on our proposed delisting proposal (81 FR 41925, June 28, 2016). These individuals are recognized for their expertise in large carnivore ecology and management, with particular knowledge in one or more of the following areas: puma population ecology, management, demographics, conservation, and population genetics. In response to our request, we received comments from five experts.
We reviewed all peer review comments for substantive issues and new information regarding the status of the eastern puma. With the exception of our position in the proposed rule on current North American puma taxonomy, the peer reviewers largely endorsed our methods and overall conclusions, and provided new information and suggestions to improve the final rule. Specific peer review comments are addressed below and incorporated as appropriate into this rule or into supplemental documents (such as references cited), available at:
One reviewer provided extensive comments and data concerning confirmed puma reports in Eastern North America. Based on this information, the reviewer surmised that there is not a breeding population of pumas within the historical range of the eastern puma. This reviewer also discussed published studies that suggest evidence of resident puma populations in Eastern North America (
Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing species, reclassifying species, and removing species from listed status. “Species” is defined by the Act as including any species or subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature (16 U.S.C. 1532(16)). To determine whether a species should be listed as endangered or threatened, we assess the likelihood of its continued existence using the five factors described in section 4(a)(1) of the Act (see Consideration of Factors Affecting the Species, below). A species may be reclassified or removed from the List on the same basis. With regard to delisting a species due to extinction, “a sufficient period of time must be allowed before delisting to indicate clearly that the species is extinct” (50 CFR 424.11(d)(1)). According to these dual standards, we must determine whether the eastern puma subspecies is a valid listed entity that remains extant in order to determine its appropriate listing status.
With regard to the validity of the eastern puma as a subspecies and, therefore, as a listable entity, we recognize that support for a single North American subspecies has gained wide acceptance in the scientific community. However, the Service has not yet conducted a comprehensive assessment of all available scientific information pertinent to North American puma taxonomy and therefore has not yet drawn a conclusion whether to accept the single North American subspecies taxonomy. Furthermore, the Service has determined that, because drawing a conclusion on the single North American subspecies taxonomy is not needed to delist the eastern puma based on extinction, we have no essential basis for withdrawing our proposal to delist due to extinction in order to consider delisting due to original data error. Therefore, for the purposes of this regulatory action, we continue to treat the eastern puma as a subspecies as originally listed under the Act.
With regard to a determination that the eastern puma subspecies is extinct, it is important to note that the continuing presence of pumas in Eastern North America is not debated. However, physical and genetic evidence indicates that pumas recently observed in Eastern North America are released or escaped captive animals, with the exception of some wild pumas that have dispersed from western populations or, rarely, Florida.
Most significantly, no evidence whatsoever has been found to show that either individuals or relict populations of the eastern puma subspecies remain extant. The most recent confirmed records of pumas native to Eastern North America are from Tennessee (1930), New Brunswick (1932), and Maine (1938). These records coincide with the extirpation of white-tailed deer in most of the eastern puma's range in the 1800s, with the exception of a few remaining large forest tracts, and a shift of eastern pumas toward the northern periphery of their historical range during that time. In contrast, areas throughout North America that still support extant populations of native pumas have had a long and continuous record of confirmed occurrences.
Given the puma's life span, generally thought to be 10 to 11 years, it is implausible that nonbreeding eastern pumas could have persisted in the wild without being detected for more than seven decades and under conditions of habitat loss and lack of their primary prey base. By the same token, it is highly improbable that a breeding population of the subspecies could have gone undetected for that long. Together with the complete lack of either a recent report or a long-term record of eastern puma presence, these factors are indicative of the long-term absence of this subspecies.
In summary, we find that pumas (except for single transients) are reasonably detectable, that no contemporary puma sightings in Eastern
As mentioned under Assessment of Species Status above, section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing, reclassifying, or removing species from listed status. When we evaluate whether a species should be listed as an endangered species or threatened species, we must consider the five listing factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of the species' habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting the species' continued existence. We must consider these same factors in reclassifying a species or removing it from the List. Discussion of these factors and their application to the eastern puma follows. The principal factors leading to the listing of the eastern puma were widespread persecution (via poisoning, trapping, hunting, and bounties) (factors B and D), decline of forested habitat (factor A), and near-extirpation of white-tailed deer populations during the 1800s (factor A). Other natural or manmade factors affecting the species' continued existence (factor E) and disease or predation (factor C) were not identified as threats. These impacts led to the extirpation of most eastern puma populations by 1900. However, because we have determined that all populations of pumas described as the eastern puma have been extirpated and no longer exist, analysis of the five factors under section 4(a)(1) of the Act, which apply to threats facing extant populations, is immaterial.
As stated above, given the period of time that has passed without verification of even a single eastern puma, the Service concludes that the last remaining members of this subspecies perished decades ago. Therefore, the eastern puma is no longer extant and cannot be evaluated as an endangered species or threatened species.
After a thorough review of all available information, we have determined that the subspecies
Conservation measures provided to species listed as endangered or as threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. However, because the Service has determined the eastern puma to be extinct, this final rule removes any Federal conservation measures for any individual eastern pumas as originally listed on June 4, 1973 (38 FR 14678) (
This final rule revises 50 CFR 17.11 by removing the eastern puma from the List of Endangered and Threatened Wildlife due to extinction. Upon the effective date of this rule, the prohibitions and conservation measures provided by the Act will no longer apply to this subspecies. There is no designated critical habitat for the eastern puma.
Section 4(g)(1) of the Act, added in the 1988 reauthorization, requires the Service to implement a program, in cooperation with the States, to monitor for not less than 5 years the status of all species that have recovered and been removed from the Lists of Endangered and Threatened Wildlife and Plants (50 CFR 17.11 and 17.12). Because we have determined that the eastern puma is extinct, post-delisting monitoring is not warranted.
We have determined that an environmental assessment or an environmental impact statement, as defined under the authority of the National Environmental Policy Act of 1969, need not be prepared in connection with regulations adopted pursuant to section 4(a) of the Act. We published a notice outlining our reasons for this determination in the
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 the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. Accordingly, the Service communicated with Tribes during the public comment period on the proposed rule and received no comments expressing concern about our conclusion that the eastern puma is extinct.
A complete list of references is available as a supplemental document at
The primary authors of this rule are the staff members of the Service's Maine Fish and Wildlife Service Complex, Ecological Services Maine Field Office, and the Hadley, Massachusetts, Regional Office (see
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notification of lobster harvest guideline.
NMFS establishes the annual harvest guideline for the commercial lobster fishery in the Northwestern Hawaiian Islands for calendar year 2018 at zero lobsters.
January 23, 2018.
Bob Harman, NMFS PIR Sustainable Fisheries, tel. 808-725-5170.
NMFS manages the Northwestern Hawaiian Islands (NWHI) commercial lobster fishery under the Fishery Ecosystem Plan for the Hawaiian Archipelago. The regulations at 50 CFR 665.252(b) require NMFS to publish an annual harvest guideline for lobster Permit Area 1, comprised of Federal waters around the NWHI.
Regulations governing the Papahanaumokuakea Marine National Monument in the NWHI prohibit the unpermitted removal of monument resources (50 CFR 404.7), and establish a zero annual harvest guideline for lobsters (50 CFR 404.10(a)). Accordingly, NMFS establishes the harvest guideline for the NWHI commercial lobster fishery for calendar year 2018 at zero lobsters. Harvest of NWHI lobster resources is not allowed.
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class D airspace, and Class E airspace extending upward from 700 feet above the surface at Castle Airport, Atwater, CA, to accommodate airspace redesign due to the decommissioning of the El Nido VHF Omnidirectional Range/Distance Measuring Equipment (VOR/DME) as the FAA transitions from ground-based to satellite-based navigation. Also, this action would update the airport's geographic coordinates to match the FAA's aeronautical database. This action also would make an editorial change to the Class D airspace legal description replacing “Airport/Facility Directory” with the term “Chart Supplement”. These actions are necessary for the safety and management of instrument flight rules (IFR) operations at the airport.
Comments must be received on or before March 9, 2018.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2017-1091; Airspace Docket No. 17-AWP-26, at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW, Renton, WA 98057; telephone (425) 203-4511.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class D and Class E airspace at Castle Airport, Atwater, CA, to accommodate airspace redesign in support of IFR operations at the airport.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (Docket No. FAA-2017-1091; Airspace Docket No. 17-AWP-26) and be submitted in triplicate to DOT Docket Operations (see
Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2017-1091/Airspace Docket No. 17-AWP-26.” The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 for airspace redesign by modifying Class D airspace to a 4.6-mile radius (from a 4.5-mile radius) of the airport from the airport 297° bearing clockwise to the airport 164° bearing, thence direct to the point of beginning. This modification would provide additional Class D airspace south of the airport and would remove Class D airspace southwest and northwest of the airport, thereby containing instrument IFR departure aircraft until reaching 700 feet above the surface, and removing airspace not required by IFR operations. Also, this action would remove the reference to the El Nido VOR/DME in the legal description due to its planned decommissioning as the FAA transitions from ground-based to satellite-based navigation.
Class E airspace extending upward from 700 feet above the surface would be modified to a 7.2-mile (from a 7-mile) radius of the airport, and would remove the 23-mile extension northwest of the airport.
Additionally, the airport's geographic coordinates would be updated to match the FAA's aeronautical database for the Class D and Class E airspace areas. An editorial change also would be made to the Class E surface area airspace legal description replacing “Airport/Facility Directory” with the term “Chart Supplement”.
These actions are necessary for the safety and management of IFR operations at this airport.
Class E airspace designations are published in paragraph 6002, and 6005, respectively, of FAA Order 7400.11B, dated August 3, 2017 and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface up to but not including 2,000 feet MSL within a 4.6-mile radius of Castle Airport beginning at the 297° bearing from the airport clockwise to the 164° bearing, thence to the point of beginning. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from 700 feet above the surface within a 7.2-mile radius of Castle Airport.
Environmental Protection Agency (EPA).
Proposed rule.
Whenever a new or revised National Ambient Air Quality Standard (NAAQS) is promulgated, the Clean Air Act (CAA) requires states to submit a plan for the implementation, maintenance, and enforcement of the standard, commonly referred to as infrastructure requirements. The Environmental Protection Agency (EPA) is proposing to approve the Alaska State Implementation Plan (SIP) as meeting specific infrastructure requirements for the fine particulate matter (PM
Comments must be received on or before February 22, 2018.
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2017-0597, at
Kristin Hall, Air Planning Unit, Office of Air and Waste (OAW-150), Environmental Protection Agency—Region 10, 1200 Sixth Ave, Seattle, WA 98101; telephone number: (206) 553-6357; email address:
Throughout this document wherever “we,” “us,” or “our” is used, it is intended to refer to the EPA.
On July 18, 1997, the EPA promulgated a new 24-hour and a new annual NAAQS for fine particulate matter (PM
After a new or revised NAAQS is promulgated, the CAA requires states to submit infrastructure SIPs to meet basic elements required to implement, maintain, and enforce the new or revised NAAQS. On March 10, 2016, the Alaska Department of Environmental Conservation (ADEC) submitted a SIP revision to meet the 2012 PM
• CAA section 110(a)(2)(A) through (M) for the 2012 PM
• CAA section 110(a)(2)(G) for the 2006 PM
• CAA section 110(a)(2)(G) for the 1997 PM
We note that Alaska's March 10, 2016, submission addresses other program areas, such as regional haze, transportation conformity, and nonattainment planning. In this action, we are proposing to approve the portion of the March 10, 2016, submission related to PM
CAA section 110(a)(1) provides the procedure and timing for SIP submissions after a new or revised NAAQS is promulgated. CAA section 110(a)(2) lists specific elements that states must meet related to a newly established or revised NAAQS. The EPA has issued guidance to help states address these requirements, most recently on September 13, 2013 (2013 Guidance).
• 110(a)(2)(A): Emission limits and other control measures.
• 110(a)(2)(B): Ambient air quality monitoring/data system.
• 110(a)(2)(C): Program for enforcement of control measures.
• 110(a)(2)(D): Interstate transport.
• 110(a)(2)(E): Adequate resources.
• 110(a)(2)(F): Stationary source monitoring system.
• 110(a)(2)(G): Emergency episodes.
• 110(a)(2)(H): Future SIP revisions.
• 110(a)(2)(I): Areas designated nonattainment and applicable requirements of part D.
• 110(a)(2)(J): Consultation with government officials; public notification; and Prevention of Significant Deterioration (PSD) and visibility protection.
• 110(a)(2)(K): Air quality modeling/data.
• 110(a)(2)(L): Permitting fees.
• 110(a)(2)(M): Consultation/participation by affected local entities.
The EPA's 2013 Guidance restated our interpretation that two elements are not governed by the three-year submission deadline in CAA section 110(a)(1) because SIPs incorporating necessary local nonattainment area controls are due on separate schedules, pursuant to CAA section 172 and the various pollutant-specific subparts 2 through 5 of part D. These are submissions required by: (i) CAA section 110(a)(2)(C), to the extent that subsection refers to a permit program as required in part D, title I of the CAA, and (ii) CAA section 110(a)(2)(I). As a result, this action does not address CAA section 110(a)(2)(C) with respect to nonattainment new source review (NSR) or CAA section 110(a)(2)(I). The EPA has also determined that the CAA section 110(a)(2)(J) provision on visibility is not triggered by a new NAAQS because the visibility requirements in part C, title I of the CAA are not changed by a new NAAQS.
The EPA is proposing to approve Alaska's March 10, 2016, submission as meeting certain PM
CAA section 110(a)(2)(A) requires SIPs to include enforceable emission limits and other control measures, means or techniques (including economic incentives such as fees, marketable permits, and auctions of emissions rights), as well as schedules and timetables for compliance, as may be necessary or appropriate to meet the applicable requirements of the CAA.
• 18 AAC 50.010: Ambient Air Quality Standards.
• 18 AAC 50.015: Air Quality Designations, Classifications, and Control Regions.
• 18 AAC 50.040: Federal Standards Adopted by Reference.
• 18 AAC 50.050: Incinerator Emission Standards.
• 18 AAC 50.055: Industrial Processes and Fuel Burning Equipment.
• 18 AAC 50.065: Open Burning.
• 18 AAC 50.070: Marine Vessel Visible Emission Standards.
• 18 AAC 50.075: Solid Fuel-Fired Heating Device Visible Emission Standards.
• 18 AAC 50.076: Solid Fuel-Fired Heating Device Fuel Requirements; Registration of Commercial Wood Sellers.
• 18 AAC 50.077: Standards for Wood-Fired Heating Devices.
• 18 AAC 50.301: Permit Continuity.
• 18 AAC 50.302: Construction Permits.
• 18 AAC 50.306: Prevention of Significant Deterioration (PSD) Permits.
• 18 AAC 50.345: Construction, Minor and Operating Permits: Standard Permit Conditions.
• 18 AAC 50.502: Minor Permits for Air Quality Protection.
• 18 AAC 50.508: Minor Permits Requested by the Owner or Operator.
• 18 AAC 50.540: Minor Permit: Application.
• 18 AAC 50.542: Minor Permit Review and Issuance.
• 18 AAC 50.544: Minor Permits: Content.
• 18 AAC 50.546: Minor Permits: Revisions.
• 18 AAC 50.560: General Minor Permits.
Alaska has no areas designated nonattainment for the 2012 PM
Alaska's major NSR permitting rules in 18 AAC Chapter 50, Article 3 for attainment and unclassifiable areas, generally rely on the federal PSD program regulations at 40 CFR 51.166 and 40 CFR 52.21, which are incorporated by reference into the Alaska SIP, to implement its SIP-approved PSD permitting program. The EPA most recently approved revisions to Alaska's PSD rules on August 28, 2017 (82 FR 40712). The current Alaska SIP-approved PSD program incorporates by reference specific regulations at 40 CFR 52.21 and 40 CFR 51.166 as of December 28, 2015.
Alaska regulates minor stationary sources of PM
In addition to permitting requirements, Alaska's SIP contains rules that limit particulate matter emissions. These controls include incinerator emission standards, emission limits for specific industrial processes and fuel burning equipment, open burning restrictions, visible emission limits on marine vessel emissions, and requirements for installing and operating solid fuel-fired devices. Therefore, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(A) for the 2012 PM
CAA section 110(a)(2)(B) requires SIPs to include provisions to provide for the establishment and operation of ambient air quality monitors, collecting and analyzing ambient air quality data, and making these data available to the EPA upon request.
The submission references ADEC's revised
CAA section 110(a)(2)(C) requires states to include a program providing for enforcement of all SIP measures and the regulation of construction of new or modified stationary sources, including a program to meet PSD and nonattainment NSR requirements.
With respect to construction of new and modified stationary sources, the submission points to ADEC's statutory authority established in AS 46.14
To generally meet the requirements of CAA section 110(a)(2)(C) for regulation of construction of new or modified stationary sources, states are required to have PSD, nonattainment NSR, and minor NSR permitting programs adequate to implement the 2012 PM
For the PSD portion of element 110(a)(2)(C) (as well as for the PSD portions of elements (D)(i)(II) and (J)) the EPA interprets the CAA to require an infrastructure submission that demonstrates a complete PSD permitting program meeting current requirements for all regulated NSR pollutants. Alaska has a SIP-approved PSD program that incorporates by reference certain federal PSD program requirements at 40 CFR 52.21 and 40 CFR 51.166. We most recently approved updates to the program on August 28, 2017 (82 FR 40712). The Alaska PSD rules meet current requirements for all regulated NSR pollutants—we are therefore proposing to approve element 110(a)(2)(C) for PSD.
Turning to the minor NSR requirement, the EPA originally approved Alaska's minor NSR program into the SIP on July 5, 1983 as meeting federal minor NSR requirements at 40 CFR 51.160 through 40 CFR 51.164 (48 FR 30623). Over the years, we have approved revisions to the program as consistent with the CAA and federal minor NSR requirements, most recently on August 28, 2017 (82 FR 40712). We have determined that the program regulates construction of new and modified minor sources for purposes of the 2012 PM
CAA section 110(a)(2)(D)(i) requires state SIPs to include provisions prohibiting any source or other type of emissions activity in one state from contributing significantly to nonattainment, or interfering with maintenance of the NAAQS in another state (CAA section 110(a)(2)(D)(i)(I)). Further, this section requires state SIPs to include provisions prohibiting any source or other type of emissions activity in one state from interfering with measures required to prevent significant deterioration (PSD) of air quality, or from interfering with measures required to protect visibility (
To address whether emissions from sources in Alaska interfere with any other state's required measures to protect visibility, the submission references the Alaska regional haze SIP, submitted on March 29, 2011, and approved by the EPA on February 14, 2013 (78 FR 10546). The EPA believes, as noted in the 2013 Guidance, that with respect to the 110(a)(2)(D)(i)(II), where a state's regional haze SIP has been approved as meeting all current obligations, a state may rely upon those provisions in support of its demonstration for the visibility sub-element. Because the Alaska regional haze SIP was found to meet federal requirements, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(D)(i)(II) as it applies to visibility for the 2012 PM
CAA section 110(a)(2)(D)(ii) requires SIPs to include provisions ensuring compliance with the applicable requirements of CAA sections 126 and 115 (relating to interstate and international pollution abatement). CAA section 126 requires notification to neighboring states of potential impacts from a new or modified major stationary source, and specifies how a state may petition the EPA when a major source or group of stationary sources in a state is thought to contribute to certain pollution problems in another state. CAA section 115 governs the process for addressing air pollutants emitted in the United States that cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare in a foreign country.
CAA section 110(a)(2)(E) requires each state to provide (i) necessary assurances that the state will have adequate personnel, funding, and authority under state law to carry out the SIP (and is not prohibited by any provision of federal or state law from carrying out the SIP or portion thereof), (ii) requirements that the state comply with the requirements respecting state boards under CAA section 128 and (iii) necessary assurances that, where the state has relied on a local or regional government, agency, or instrumentality for the implementation of any SIP provision, the state has responsibility for ensuring adequate implementation of such SIP provision.
With respect to CAA section 110(a)(2)(E)(ii), Alaska's regulations on conflict of interest are found in Title 2
With respect to CAA section 110(a)(2)(E)(iii) and assurances that the state has responsibility for ensuring adequate implementation of the plan where the state has relied on local or regional government agencies, the submission references statutory authority and requirements for establishing local air pollution control programs found at AS 46.14.400
The submission also states that ADEC provides technical assistance and regulatory oversight to the Municipality of Anchorage, Fairbanks North Star Borough, and other local jurisdictions to ensure that the State Air Quality Control Plan and SIP objectives are satisfactorily carried out. ADEC has a Memorandum of Understanding with the Municipality of Anchorage and Fairbanks North Star Borough that allows the local entities to operate air quality control programs in their respective jurisdictions. The South Central Clean Air Authority has been established to aid the Municipality of Anchorage and the Matanuska-Susitna Borough in pursuing joint efforts to control emissions and improve air quality in the air-shed common to the two jurisdictions.
CAA section 110(a)(2)(F) requires (i) the installation, maintenance, and replacement of equipment, and the implementation of other necessary steps, by owners or operators of stationary sources to monitor emissions from such sources, (ii) periodic reports on the nature and amounts of emissions and emissions-related data from such sources, and (iii) correlation of such reports by the state agency with any emission limitations or standards established pursuant to the CAA, which reports shall be available at reasonable times for public inspection.
Additionally, states are required to submit emissions data to the EPA for purposes of the National Emissions Inventory (NEI). The NEI is the EPA's central repository for air emissions data. All states are required to submit a comprehensive emissions inventory every three years and report emissions for certain larger sources annually through the EPA's online Emissions
CAA section 110(a)(2)(G) requires states to provide for authority to address activities causing imminent and substantial endangerment to public health, including contingency plans to implement the emergency episode provisions in their SIPs.
CAA section 110(a)(2)(H) requires that SIPs provide for revision of the plan (i) from time to time as may be necessary to take account of revisions of a national primary or secondary ambient air quality standard or the availability of improved or more expeditious methods of attaining the standard, and (ii), except as provided in paragraph 110(a)(3)(C), whenever the Administrator finds that the SIP is substantially inadequate to attain the NAAQS which it implements or to otherwise comply with any additional requirements under the CAA.
CAA section 110(a)(2)(J) requires states to provide a process for consultation with local governments and federal land managers with respect to NAAQS implementation requirements pursuant to section 121. CAA section 110(a)(2)(J) further requires states to notify the public if NAAQS are exceeded in an area and to enhance public awareness of measures that can be taken to prevent exceedances. Lastly, CAA section 110(a)(2)(J) requires states to meet applicable requirements of part C, title I of the CAA related to prevention of significant deterioration and visibility protection.
ADEC routinely coordinates with local governments, states, federal land managers and other stakeholders on air quality issues including transportation conformity and regional haze, and provides notice to appropriate agencies
Section 110(a)(2)(J) also requires the public to be notified if NAAQS are exceeded in an area and to enhance public awareness of measures that can be taken to prevent exceedances. ADEC is a partner in the EPA's AIRNOW and Enviroflash Air Quality Alert programs, which provide air quality information to the public for five major air pollutants regulated by the CAA: Ground-level ozone, particulate matter, carbon monoxide, sulfur dioxide, and nitrogen dioxide. Alaska also provides real-time air monitoring information to the public on the ADEC air quality website, in addition to air advisory information. During the summer months, the Fairbanks North Star Borough prepares a weekly Air Quality forecast for the Fairbanks area on its website. We are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(J) for public notification for the 2012 PM
Turning to the requirement in CAA section 110(a)(2)(J) that the SIP meet the applicable requirements of part C of title I of the CAA, we have evaluated this requirement in the context of CAA section 110(a)(2)(C) and permitting. The EPA most recently approved updates to Alaska's PSD program on August 28, 2017 (82 FR 40712). As discussed in section 110(a)(2)(C), the program meets current federal requirements. Therefore, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(J) for PSD for the 2012 PM
With respect to visibility protection under element (J), the EPA recognizes that states are subject to visibility and regional haze program requirements under part C of the CAA. In the event of the establishment of a new NAAQS, however, the visibility and regional haze program requirements under part C do not change. Thus we find that there is no new applicable requirement related to visibility triggered under CAA section 110(a)(2)(J) when a new NAAQS becomes effective. Based on the analysis above, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(J) for the 2012 PM
CAA section 110(a)(2)(K) requires that SIPs provide for (i) the performance of air quality modeling as the Administrator may prescribe for the purpose of predicting the effect on ambient air quality of any emissions of any air pollutant for which the Administrator has established a NAAQS, and (ii) the submission, upon request, of data related to such air quality modeling to the Administrator.
CAA section 110(a)(2)(L) directs SIPs to require each major stationary source to pay permitting fees to cover the cost of reviewing, approving, implementing and enforcing a permit.
In addition, Alaska SIP-approved regulations at 18 AAC 50.306(d)(2) and 18 AAC 50.311(d)(2) require fees for purposes of major new source permitting as specified in 18 AAC 50.400 through 18 AAC 50.499. Therefore, we are proposing to conclude that Alaska has satisfied the requirements of CAA section 110(a)(2)(L) for the 2012 PM
CAA section 110(a)(2)(M) requires states to provide for consultation and participation in SIP development by local political subdivisions affected by the SIP.
We are proposing to approve the Alaska SIP as meeting the following CAA section 110(a)(2) infrastructure elements for the 2012 PM
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this proposed action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because it does not involve technical standards; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability of an amendment to a fishery management plan; request for comments.
NMFS announces that the Pacific Fishery Management Council (Council) has submitted Amendment 4 to the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (HMS FMP) for review by the Secretary of Commerce. The intent of Amendment 4 is to bring descriptions of the management context for highly migratory species (HMS) fisheries up to date, better describe the Council's role in the process of making stock status determinations including evaluations of the best scientific information available (BSIA), and change the schedule of the Council's three-meeting biennial management cycle for HMS stocks. The amendment is administrative in nature and is not expected to affect activities authorized under the FMP or their harvest levels.
Comments on Amendment 4 must be submitted received by March 26, 2018 to be considered in the decision whether to approve, disapprove, or partially approve Amendment 4.
You may submit comments on this document, identified by NOAA-NMFS-2017-0138, by any of the following methods:
•
•
Copies of the draft Amendment 4 and other supporting documents are available via the Federal eRulemaking Portal:
Amber Rhodes, NMFS, 562-980-3231,
During the Council's 2016 biennial management cycle meetings for HMS and considerations for recent revisions to agency guidelines for National Standard 1 (81 FR 71858, October 18, 2016), key
The proposed changes to the HMS FMP are administrative in nature, do not involve the issuance of any permits, and are described in further detail below:
• The description of the stock status determination process in Chapter 4 of the current HMS FMP has been revised to account for the fact that the HMS management unit species are internationally assessed and that these stock assessments are not routinely subject to Scientific and Statistical Committee (SSC) review for purposes of determining BSIA, unlike assessments for domestically-managed stocks.
• Additionally, to better align the Council's biennial management schedule with the NMFS' process for conducting HMS stock status determinations, the schedule described in Chapter 5 of the FMP would be changed under the proposed amendment to the HMS FMP. The three-meeting biennial management cycle would take place during September, November, and March Council meetings instead of during June, September, and November meetings; however, the schedule would continue to start on even years.
• Chapters 1 and 6 in the FMP also have been substantially revised to better describe the management context (Chapter 1) and the types of measures available and in use to manage U.S. West Coast HMS fisheries (Chapter 6).
• Chapter 8 (Research and Data Needed for Management) is proposed to be deleted, because it is out of date. This information may be periodically updated and presented in the HMS Stock Assessment and Fishery Evaluation Report produced by the HMS Management Team and the Research and Data Needs Report produced periodically by the Council's SSC.
NMFS expects to publish and request public comment on proposed revisions to regulations to implement Amendment 4 in the near future. Public comments on the proposed rule must be received by the end of the comment period on Amendment 4 to be considered in the approval/disapproval decision on the amendment. All comments received during the comment period for Amendment 4, whether specifically directed to the amendment, or the proposed rule, will be considered in the decision whether to approve, disapprove, or partially approve Amendment 4.
16 U.S.C. 1801
United States African Development Foundation.
Notice of meeting.
The US African Development Foundation (USADF) will hold its quarterly meeting of the Board of Directors to discuss the agency's programs and administration.
The meeting date is Tuesday, February 6, 9:00 a.m. to 12:00 p.m.
The meeting location is USADF, 1400 I St. NW, Suite 1000, Washington, DC 20005.
Marie-Cécile Groelsema, 202-233-8883.
Public Law 96-533 (22 U.S.C. § 290h).
United States Commission on Civil Rights.
Notice of Commission public briefing.
Friday, February 2, 2018, 9:00 a.m. EST.
Marriott Crabtree Raleigh Durham, 4500 Marriott Drive, Raleigh, NC 27612.
Brian Walch, (202) 376-8371; TTY: (202) 376-8116;
The Commission will hold a public briefing as part of its ongoing assessment of federal enforcement of the Voting Rights Act (VRA). This meeting is open to the public. Testimony from this briefing will form an integral basis for our 2018 report to Congress, the President, and the American people regarding the state of voting rights across the nation.
Our Commissioners will receive testimony from current and former state and federal government officials, legal experts, academics, and civil society actors. Panelists will discuss voter access, including federal voting rights enforcement efforts after the 2006 reauthorization of the temporary provisions of the VRA, and the impact of the
We will also offer an open comment period in which members of the public will be able to address the Commission. Individuals who wish to participate should sign-up at the briefing. Each individual will have up to three (3) minutes to speak, with spots allotted on a first-come, first-serve basis; forty (40) spots will be available during the two-hour period. The first half of the available slots will be available for sign-up during the morning (10:40 a.m.) and lunch breaks (12:20 p.m.). The second half of the available slots will be available for sign-up during the afternoon break (2:50 p.m.), until all available slots are filled.
In addition, the Commission welcomes the submission of additional material for consideration as we prepare our report. Please submit such information to
The event will live-stream at
• Peyton McCrary, served as a historian in the Civil Rights Division of DOJ for over twenty-seven years, until his retirement in late 2016. Dr. McCrary does research on the factual issues in voting rights litigation and assist DOJ attorneys in identifying expert witnesses to retain for cases that the Department pursues. He also co-authored a book chapter that examines how the DOJ has administered Section 5 from 1965 to present.
• Vanita Gupta, President and CEO, The Leadership Conference on Civil and Human Rights. Ms. Gupta served in DOJ from October 2014-January 2017 as Principal Deputy Assistant Attorney General and head of the Civil Rights Division.
• J. Gerald Hebert, Senior Director, Voting Rights & Redistricting at Campaign Legal Center. Mr. Hebert served in several capacities at DOJ from 1973 to 1994, and served as chief counsel in over one hundred voting rights lawsuits.
• Justin Levitt, Professor of Law at Loyola Los Angeles Law School. Professor Levitt served as the Deputy Assistant Attorney General at DOJ from 2015-2017.
• Ezra Rosenberg, Co-Director of the Voting Rights Project at the Lawyers' Committee for Civil Rights under Law (LCCR).
• Nina Perales, Vice President of Litigation at the Mexican American Legal Defense and Educational Fund (MALDEF).
• Dale Ho, Director of Voting Rights Project at the American Civil Liberties Union (ACLU).
• E. Mark Braden, Counsel at Baker Hostetler.
• Dan Morenoff, Executive Director of the Equal Voting Rights Institute.
• Natalie Landreth, Senior Staff Attorney at the Native American Rights Fund.
• Michelle Bishop, Disability Advocacy Specialist for Voting Rights at the National Disability Rights Network.
• Michael J. Pitts, Professor of Law at Indiana University.
• Cleta Mitchell, Partner at Foley & Larder LLP.
• John Fund, Columnist for the
• Anita Earls, Former Executive Director at the Southern Coalition for Social Justice.
• John Merrill, Secretary of State of Alabama.
• John J Park Jr., Counsel at Strickland, Brockington, Lewis LLP.
• Judd Choate, President of the National Association of State Election Directors and Elections Director for the State of Colorado.
• Sherrilyn Ifill, President and Director-Counsel of the NAACP Legal Defense and Educational Fund.
• Lorraine Minnite, Professor of Political Science at Rutgers University.
• Jerry Vattamala, Director of the Democracy Program at Asian American Legal Defense and Educational Fund (AALDEF).
• Individuals who wish to participate in the open public comment period should sign-up at the briefing. Each individual will have up to three (3) minutes to speak, with spots allotted on a first-come, first-serve basis; forty (40) spots will be available during the two-hour period. The first half of the available slots will be available for sign-up during the morning (10:40 a.m.) and lunch breaks (12:20 p.m.) of the briefing. The second half of the available slots will be available for sign-up during the afternoon break (2:50 p.m.) until all available slots are filled.
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 (FACA) that a meeting of the Oregon Advisory Committee (Committee) to the Commission will be held at 1:00 p.m. (Pacific Time) Tuesday, February 6, 2018 and 1:00 p.m. (Pacific Time) Tuesday, March 6, 2018. The purpose of the meeting is for the Committee to continue planning to collect testimony focused on human trafficking in Oregon.
The meeting will be held on Tuesday, February 6, 2018 at 1:00 p.m. PT and Tuesday, March 6, 2018 at 1:00 p.m. PT.
Ana Victoria Fortes (DFO) at
This meeting is available to the public through the following toll-free call-in number: 888-298-3457, conference ID number: 6258443. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and 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 entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website,
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 (FACA) that a meetings of the Arizona Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Mountain Time) Wednesday, January 31, 2018. The purpose of the meetings is for the Committee to discuss logistics for March 9, 2018 briefing on voting rights.
The meeting will be held on Wednesday, January 31, 2018 at 12:00 p.m. MT.
Ana Victoria Fortes (DFO) at
This meetings are available to the public through the following toll-free call-in number: 877-419-6593, conference ID number: 1710920. Any interested member of the public may call this number and listen to the meetings. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-
Members of the public are entitled to make comments during the open period at the end of the meetings. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meetings at
On September 20, 2017, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Puerto Rico Trade and Export Company, grantee of FTZ 61, requesting subzone status subject to the existing activation limit of FTZ 61, on behalf of Plaza Warehousing & Realty Corporation, in Caguas, Puerto Rico.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 61T was approved on January 18, 2018, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 61's 1,821.07-acre activation limit.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On September 15, 2017, the Department of Commerce (Commerce) published in the
Applicable January 23, 2018.
Sergio Balbontin, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: 202-482-6478.
On September 15, 2017, Commerce published the
The merchandise subject to the order includes certain cased pencils from China. The subject merchandise is currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheading 9609.10.00. Although the HTSUS subheading is provided for convenience and customs purposes, the written product description is dispositive. A full description of the scope of the order is contained in the Issues and Decision Memorandum.
All issues raised in Prime Time's case brief are addressed in the accompanying Issues and Decision Memorandum.
In the
Commerce conducted this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act). In the
As noted in the
For a full description of the methodology underlying our conclusions,
Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Commerce intends to issue assessment instructions to CBP 15 days after the date of publication of these final results of review. With regard to Tianjin Tonghe and Ningbo Homey, we will instruct CBP to apply an assessment rate of 114.19 percent of the entered value of subject merchandise during the POR which was exported by those companies.
Additionally, consistent with its assessment practice in non-market economy (NME) cases, for the Wah Yuen entity which Commerce determined had no shipments of the subject merchandise, any suspended entries made under that exporter's case number (
The following cash deposit requirements will be effective upon publication of these final results of administrative review for shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Act: (1) For companies which have a separate rate, the cash deposit rate will be that established in these final results (except, if the rate is zero or
This notice also serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a 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 regulations and terms of an APO is a violation which is subject to sanction.
This determination is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(5).
In notice document 2017-28480, appearing on pages 522 through 523, in the issue of Thursday, January 4, 2018, make the following correction:
The table, on page 522, in the third column, eleven lines from the top, should read as set forth below.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable January 23, 2018.
Maliha Khan at (202) 482-0895, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
On December 27, 2017, the U.S. Department of Commerce (Commerce) received a countervailing duty (CVD) Petition concerning imports of certain plastic decorative ribbon (plastic decorative ribbon) from the People's Republic of China (China), filed in proper form on behalf of Berwick Offray, LLC (the petitioner).
On January 2, 2018, Commerce requested supplemental information pertaining to certain areas of the Petition.
In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that the Government of China (GOC) is providing countervailable subsidies, within the meaning of sections 701 and 771(5) of the Act, to imports of plastic decorative ribbon from China and that such imports are materially injuring, or threatening material injury to, the domestic industry producing plastic decorative ribbon in the United States. Also, consistent with section 702(b)(1) of the Act, the Petition is accompanied by information reasonably available to the petitioner supporting its allegations.
Commerce finds that the petitioner filed this Petition on behalf of the domestic industry because the petitioner is an interested party as defined in section 771(9)(C) of the Act. Commerce also finds that the petitioner demonstrated sufficient industry support with respect to the initiation of the CVD investigation that the petitioner is requesting.
Because the Petition was filed on December 27, 2017, the period of investigation for this investigation is January 1, 2016, through December 31, 2016.
The products covered by this investigation are plastic decorative ribbon from China. For a full description of the scope of this investigation,
During our review of the Petition, Commerce issued questions to, and received responses from, the petitioner pertaining to the proposed scope to ensure that the scope language in the Petition would be an accurate reflection of the products for which the domestic industry is seeking relief.
As discussed in the preamble to Commerce's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope).
Commerce requests that any factual information the parties consider relevant to the scope of the investigation be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the
All submissions to Commerce must be filed electronically using Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS).
Pursuant to sections 702(b)(4)(A)(i) and (ii) of the Act, Commerce notified representatives of the GOC of the receipt of the Petition, and provided them the opportunity for consultations with respect to the Petition.
Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers, as a whole, of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC must apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that plastic decorative ribbon, as defined in the scope, constitutes a single domestic like product, and we have analyzed industry support in terms of that domestic like product.
In determining whether the petitioner has standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” the Appendix to this notice. The petitioner provided its own 2016 production of the domestic like product, and compared this to the estimated total production of the domestic like product for the entire domestic industry.
Our review of the data provided in the Petition, General Issues and China CVD Supplement, and other information readily available to Commerce indicates that the petitioner has established industry support for the Petition.
Commerce finds that the petitioner filed the Petition on behalf of the domestic industry because it is an interested party as defined in section 771(9)(C) of the Act and it has demonstrated sufficient industry support with respect to the CVD investigation that it is requesting that Commerce initiate.
Because China is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from China materially injure, or threaten material injury to, a U.S. industry.
The petitioner alleges that imports of the subject merchandise are benefitting from countervailable subsidies and that such imports are causing, or threaten to cause, material injury to the U.S. industry producing the domestic like product. In addition, the petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
The petitioner contends that the industry's injured condition is illustrated by a significant and increasing volume of subject imports; reduced market share; underselling and price depression or suppression; lost sales and revenues; and a negative impact on the domestic industry's performance.
Based on the examination of the Petition, we find that the Petition meets the requirements of section 702 of the Act. Therefore, we are initiating a CVD investigation to determine whether imports of plastic decorative ribbon from China benefit from countervailable subsidies conferred by the GOC. In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.
Under the Trade Preferences Extension Act of 2015, numerous amendments to the AD and CVD laws were made.
Based on our review of the Petition, we find that there is sufficient information to initiate a CVD investigation on 24 alleged programs. For a full discussion of the basis for our decision to initiate on each program,
In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.
The petitioner named 51 producers/exporters of plastic decorative ribbon from China.
On January 17, 2018, Commerce plans to release CBP data under APO to all parties with access to information protected by APO. Interested parties wishing to comment regarding the CBP data and respondent selection must do so within three business days of the publication date of the notice of initiation of this CVD investigation. Commerce will not accept rebuttal comments regarding the CBP data or respondent selection.
Comments must be filed electronically using ACCESS. An electronically filed document must be received successfully, in its entirety, by ACCESS no later than 5:00 p.m. ET on the date noted above. We intend to finalize our decisions regarding respondent selection within 20 days of publication of this notice. Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on Commerce's website at
In accordance with section 702(b)(4)(A)(i) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the GOC
We will notify the ITC of our initiation, as required by section 702(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of plastic decorative ribbon from China are materially injuring or threatening material injury to a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). 19 CFR 351.301(b) requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and,
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Parties should review
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, Commerce published
This notice is issued and published pursuant to sections 702 and 777(i) of the Act.
The merchandise covered by this investigation is certain plastic decorative ribbon having a width (measured at the narrowest span of the ribbon) of less than or equal to four (4) inches in actual measurement, including but not limited to ribbon wound onto itself; a spool, a core or a tube (with or without flanges); attached to a card or strip; wound into a keg- or egg-shaped configuration; made into bows, bow-like items, or other shapes or configurations; and whether or not packaged or labeled for retail sale. The subject merchandise is typically made of substrates of polypropylene, but may be made in whole or in part of any type of plastic, including without limitation, plastic derived from petroleum products and plastic derived from cellulose products. Unless the context otherwise clearly indicates, the word “ribbon” used in the singular includes the plural and the plural “ribbons” includes the singular.
The subject merchandise includes ribbons comprised of one or more layers of substrates made, in whole or in part, of plastics adhered to each other, regardless of the method used to adhere the layers together, including without limitation, ribbons comprised of layers of substrates adhered to each other through a lamination process. Subject merchandise also includes ribbons comprised of (a) one or more layers of substrates made, in whole or in part, of plastics adhered to (b) one or more layers of substrates made, in whole or in part, of non-plastic materials, including, without limitation, substrates made, in whole or in part, of fabric.
The ribbons subject to this investigation may be of any color or combination of colors (including without limitation, ribbons that are transparent, translucent or opaque) and may or may not bear words or images, including without limitation, those of a holiday motif. The subject merchandise includes ribbons with embellishments and/or treatments, including, without limitation, ribbons that are printed, hot-stamped, coated, laminated, flocked, crimped, die-cut, embossed (or that otherwise have impressed designs, images, words or patterns), and ribbons with holographic, metallic, glitter or iridescent finishes.
Subject merchandise includes “pull-bows,” an assemblage of ribbons connected to one another, folded flat, and equipped with a means to form such ribbons into the shape of a bow by pulling on a length of material affixed to such assemblage, and “pre-notched” bows, an assemblage of notched ribbon loops arranged one inside the other with the notches in alignment and affixed to each other where notched, and which the end user forms into a bow by separating and spreading the loops circularly around the notches, which form the center of the bow. Subject merchandise includes ribbons that are packaged with non-subject merchandise, including ensembles that include ribbons and other products, such as gift wrap, gift bags, gift tags and/or other gift packaging products. The ribbons are covered by the scope of this investigation; the “other products”
Excluded from the scope of this investigation are the following: (1) Ribbons formed exclusively by weaving plastic threads together; (2) ribbons that have metal wire in, on, or along the entirety of each of the longitudinal edges of the ribbon; (3) ribbons with an adhesive coating covering
Further, excluded from the scope of the antidumping duty order are any products covered by the existing antidumping duty order on polyethylene terephthalate film, sheet, and strip (PET Film) from the People's Republic of China (China).
Merchandise covered by this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 3920.20.0015 and 3926.40.0010. Merchandise covered by this investigation also may enter under subheadings 3920.10.0000; 3920.20.0055; 3920.30.0000; 3920.43.5000; 3920.49.0000; 3920.62.0050; 3920.62.0090; 3920.69.0000; 3921.90.1100; 3921.90.1500; 3921.90.1910; 3921.90.1950; 3921.90.4010; 3921.90.4090; 3926.90.9996; 5404.90.0000; 9505.90.4000; 4601.99.9000; 4602.90.0000; 5609.00.3000; 5609.00.4000; and 6307.90.9889. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of stainless steel flanges from India. The period of investigation is January 1, 2016, through December 31, 2016.
Applicable January 23, 2018.
Ryan Mullen or Chelsey Simonovich, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5260 or (202) 482-2000, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on September 11, 2017.
The products covered by this investigation are stainless steel flanges from India. For a complete description of the scope of this investigation, see Appendix I.
In accordance with the preamble to Commerce's regulations,
Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
In making these findings, we relied, in part, on facts available and, because it finds that one or more respondents did not act to the best of their ability to respond to Commerce's requests for information, it drew an adverse inference where appropriate in selecting from among the facts otherwise available.
In accordance with section 703(e)(1) of the Act, Commerce preliminarily determines that critical circumstances exist with respect to imports of stainless steel flanges from India for Bebitz
As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final countervailing duty (CVD) determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of stainless steel flanges from India based on a request made by the petitioners.
Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and
Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance
Section 703(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. Commerce preliminarily finds that critical circumstances exist for imports of subject merchandise produced and/or exported by Bebitz Flanges Works, Echjay Forgings Private Limited, and all-other producers and exporters. In accordance with section 703(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of merchandise from the exporters/producers identified in this paragraph that were entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice.
Commerce intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of its public announcement, or if there is no public announcement, within five days of the date of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination.
This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).
The products covered by this investigation are certain forged stainless steel flanges, whether unfinished, semi-finished, or finished (certain forged stainless steel flanges). Certain forged stainless steel flanges are generally manufactured to, but not limited to, the material specification of ASTM/ASME A/SA182 or comparable domestic or foreign specifications. Certain forged stainless steel flanges are made in various grades such as, but not limited to, 304, 304L, 316, and 316L (or combinations thereof). The term “stainless steel” used in this scope refers to an alloy steel containing, by actual weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements.
Unfinished stainless steel flanges possess the approximate shape of finished stainless steel flanges and have not yet been machined to final specification after the initial forging or like operations. These machining processes may include, but are not limited to, boring, facing, spot facing, drilling, tapering, threading, beveling, heating, or compressing. Semi-finished stainless steel flanges are unfinished stainless steel flanges that have undergone some machining processes.
The scope includes six general types of flanges. They are: (1) Weld neck, generally used in butt-weld line connection; (2) threaded, generally used for threaded line connections; (3) slip-on, generally used to slide over pipe; (4) lap joint, generally used with stub-ends/butt-weld line connections; (5) socket weld, generally used to fit pipe into a machine recession; and (6) blind, generally used to seal off a line. The sizes and descriptions of the flanges within the scope include all pressure classes of ASME B16.5 and range from one-half inch to twenty-four inches nominal pipe size. Specifically excluded from the scope of this investigation are cast stainless steel flanges. Cast stainless steel flanges generally are manufactured to specification ASTM A351.
The country of origin for certain forged stainless steel flanges, whether unfinished, semi-finished, or finished is the country where the flange was forged. Subject merchandise includes stainless steel flanges as defined above that have been further processed in a third country. The processing includes, but is not limited to, boring, facing, spot facing, drilling, tapering, threading, beveling, heating, or compressing, and/or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the stainless steel flanges.
Merchandise subject to the investigation is typically imported under headings 7307.21.1000 and 7307.21.5000 of the Harmonized Tariff Schedule of the United States (HTS). While HTS subheadings and ASTM specifications are provided for convenience and customs purposes, the written description of the scope is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers and exporters of fine denier polyester staple fiber (fine denier PSF) from the People's Republic of China (China). The period of investigation is January 1, 2016, through December 31, 2016. For information on the estimated subsidy rates,
Applicable January 23, 2018.
Yasmin Bordas or Davina Friedmann, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-3813 or (202) 482-0698, respectively.
Commerce published the
In accordance with the Preliminary Scope Memorandum, Commerce provided parties an opportunity to provide comments on all issues regarding product coverage (
Commerce is conducting this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (Act). For each of the subsidy programs found to be countervailable, we determine that there is a subsidy (
The merchandise covered by this investigation is generally described as fine denier PSF from China. For a complete description of the scope of this investigation,
The subsidy programs under investigation, and the issues raised in the case and rebuttal briefs submitted by the parties, are discussed in the Issues and Decision Memorandum. A list of the issues that parties raised, and to which we responded in the Issues and Decision Memorandum, is attached to this notice at Appendix I.
For purposes of this final determination, we relied on facts available, and because certain respondents did not act to the best of their ability in responding to Commerce's requests for information, we drew an adverse inference, where appropriate, in selecting from among the facts otherwise available.
Based on our review and analysis of the comments received from parties, and minor corrections presented at verification, we made certain changes to the respondents' subsidy rate calculations since the
In accordance with section 705(c)(1)(B)(i) of the Act, we calculated an individual rate for each producer/exporter of the subject merchandise individually investigated.
In accordance with section 705(c)(5)(A) of the Act, for companies not individually investigated, we apply an “all-others” rate. Under section 705(c)(5)(A)(i) of the Act, the “all-others” rate excludes zero and
Pursuant to section 705(c)(5)(A)(i) of the Act, we have calculated the “all-others” rate using the subsidy rates of the two individually investigated respondents. However, we have not calculated the “all-others” rate by weight-averaging the rates because doing so risks disclosure of proprietary information. Therefore, and consistent with Commerce's practice, for the “all-others” rate, we calculated a simple average of the two mandatory respondents' subsidy
We intend to disclose to parties in this proceeding the calculations performed for this final determination within five days of the date of public announcement of our final determination, in accordance with 19 CFR 351.224(b).
As a result of our
If the U.S. International Trade Commission (the ITC) issues a final affirmative injury determination, we will issue a CVD order, will reinstate the suspension of liquidation under section 706(a) of the Act, and will require a cash deposit of estimated CVDs for such entries of subject merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.
In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Enforcement and Compliance.
In the event the ITC issues a final negative injury determination, this notice serves as the only reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). 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 regulations and terms of an APO is a violation subject to sanction.
This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.
The merchandise covered by this investigation is fine denier polyester staple fiber (fine denier PSF), not carded or combed, measuring less than 3.3 decitex (3 denier) in diameter. The scope covers all fine denier PSF, whether coated or uncoated. The following products are excluded from the scope:
(1) PSF equal to or greater than 3.3 decitex (more than 3 denier, inclusive) currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 5503.20.0045 and 5503.20.0065.
(2) Low-melt PSF defined as a bi-component polyester fiber having a polyester fiber component that melts at a lower temperature than the other polyester fiber component, which is currently classifiable under HTSUS subheading 5503.20.0015.
Fine denier PSF is classifiable under the HTSUS subheading 5503.20.0025. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigations is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers and exporters of fine denier polyester staple fiber (fine denier PSF) from India. The period of investigation is January 1, 2016, through December 31, 2016. For information on the estimated subsidy rates,
Applicable January 23, 2018.
Eli Lovely or Trisha Tran, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-1593 or (202) 482-4852, respectively.
On November 6, 2017, Commerce published the
In accordance with the Preliminary Scope Memorandum, Commerce provided parties an opportunity to provide comments on all issues regarding product coverage (
Commerce conducted this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable, we determine that there is a subsidy (
The merchandise covered by this investigation is fine denier PSF from India. For a complete description of the scope of this investigation,
The subsidy programs under investigation, and the issues raised in the case and rebuttal briefs submitted by the parties, are discussed in the Issues and Decision Memorandum. A list of the issues that parties raised, and to which we responded in the Issues and Decision Memorandum, is attached to this notice at Appendix I.
For purposes of this final determination, we relied on facts available, and because certain respondents did not act to the best of their ability in responding to Commerce's requests for information, we drew an adverse inference, where appropriate, in selecting from among the facts otherwise available.
Based on our review and analysis of the comments received from parties, and minor corrections presented at verification, we made certain changes to the respondents' sales figures and subsidy rate calculations since the
In accordance with section 705(c)(1)(B)(i) of the Act, we calculated an individual rate for each producer/exporter of the subject merchandise individually investigated.
In accordance with section 705(c)(5)(A) of the Act, for companies not individually investigated, we apply an “all-others” rate. Under section 705(c)(5)(A)(i) of the Act, the “all-others” rate excludes zero and
Pursuant to section 705(c)(5)(A)(i) of the Act, we have calculated the “all-others” rate using the subsidy rates of the two individually investigated respondents. The Department calculated the all-others' rate using a weighted average of the individual estimated subsidy rates calculated for the examined respondents using each company's publicly-ranged values for the merchandise under consideration.
We intend to disclose to parties in this proceeding the calculations performed for this final determination within five days of the date of public announcement of our final determination, in accordance with 19 CFR 351.224(b).
As a result of our
If the U.S. International Trade Commission (the ITC) issues a final affirmative injury determination, we will issue a CVD order, will reinstate the suspension of liquidation under section 706(a) of the Act, and will require a cash deposit of estimated CVDs for such entries of subject merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.
In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Enforcement and Compliance.
In the event the ITC issues a final negative injury determination, this notice serves as the only reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). 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 regulations and terms of an APO is a violation subject to sanction.
This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.
The merchandise covered by this investigation is fine denier polyester staple fiber (fine denier PSF), not carded or combed, measuring less than 3.3 decitex (3 denier) in diameter. The scope covers all fine denier PSF, whether coated or uncoated. The following products are excluded from the scope:
(1) PSF equal to or greater than 3.3 decitex (more than 3 denier, inclusive) currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 5503.20.0045 and 5503.20.0065.
(2) Low-melt PSF defined as a bi-component polyester fiber having a polyester fiber component that melts at a lower temperature than the other polyester fiber component, which is currently classifiable under HTSUS subheading 5503.20.0015.
Fine denier PSF is classifiable under the HTSUS subheading 5503.20.0025. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigations is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers/exporters of stainless steel flanges from the People's Republic of China (China). The period of investigation is January 1, 2016, through December 31, 2016. We invite interested parties to comment on this preliminary determination.
Applicable January 23, 2018.
Justin Neuman or Jerry Huang, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-0486 or (202) 482-4047, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (Act). Commerce published the notice of initiation of this investigation on September 11, 2017.
The products covered by this investigation are stainless steel flanges from China. For a complete description of the scope of this investigation, see Appendix I.
Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
In making these findings, Commerce relied totally on facts available, because neither the GOC nor any of the selected mandatory respondent companies responded to the questionnaire. Further,
Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and
Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance with section 703(d)(1)(B) and (d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination.
This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).
The products covered by this investigation are certain forged stainless steel flanges, whether unfinished, semi-finished, or finished (certain forged stainless steel flanges). Certain forged stainless steel flanges are generally manufactured to, but not limited to, the material specification of ASTM/ASME A/SA182 or comparable domestic or foreign specifications. Certain forged stainless steel flanges are made in various grades such as, but not limited to, 304, 304L, 316, and 316L (or combinations thereof). The term “stainless steel” used in this scope refers to an alloy steel containing, by actual weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements.
Unfinished stainless steel flanges possess the approximate shape of finished stainless steel flanges and have not yet been machined to final specification after the initial forging or like operations. These machining processes may include, but are not limited to, boring, facing, spot facing, drilling, tapering, threading, beveling, heating, or compressing. Semi-finished stainless steel flanges are unfinished stainless steel flanges that have undergone some machining processes.
The scope includes six general types of flanges. They are: (1) Weld neck, generally used in butt-weld line connection; (2) threaded, generally used for threaded line connections; (3) slip-on, generally used to slide over pipe; (4) lap joint, generally used with stub-ends/butt-weld line connections; (5) socket weld, generally used to fit pipe into a machine recession; and (6) blind, generally used to seal off a line. The sizes and descriptions of the flanges within the scope include all pressure classes of ASME B16.5 and range from one-half inch to twenty-four inches nominal pipe size. Specifically excluded from the scope of these orders are cast stainless steel flanges. Cast stainless steel flanges generally are manufactured to specification ASTM A351.
The country of origin for certain forged stainless steel flanges, whether unfinished, semi-finished, or finished is the country where the flange was forged. Subject merchandise includes stainless steel flanges as defined above that have been further processed in a third country. The processing includes, but is not limited to, boring, facing, spot facing, drilling, tapering, threading, beveling, heating, or compressing, and/or any other processing that would not otherwise remove the merchandise from the scope of the investigations if performed in the country of manufacture of the stainless steel flanges.
Merchandise subject to the investigation is typically imported under headings 7307.21.1000 and 7307.21.5000 of the Harmonized Tariff Schedule of the United
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable January 16, 2018.
Mark Hoadley at (202) 482-3148, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
On December 27, 2017, the U.S. Department of Commerce (Commerce) received an antidumping duty (AD) Petition concerning imports of certain plastic decorative ribbon (plastic decorative ribbon) from the People's Republic of China (China), filed in proper form on behalf of Berwick Offray, LLC (the petitioner).
On January 2, 2018, Commerce requested supplemental information pertaining to certain areas of the Petition.
In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that imports of plastic decorative ribbon from China are being, or are likely to be, sold in the United States at less than fair value within the meaning of section 731 of the Act, and that such imports are materially injuring, or threatening material injury to, the domestic industry producing plastic decorative ribbon in the United States. Consistent with section 732(b)(1) of the Act, the Petition is accompanied by information reasonably available to the petitioner supporting its allegations.
Commerce finds that the petitioner filed this Petition on behalf of the domestic industry because the petitioner is an interested party as defined in section 771(9)(C) and (F) of the Act. Commerce also finds that the petitioner demonstrated sufficient industry support with respect to the initiation of the AD investigation that the petitioner is requesting.
Because the Petition was filed on December 27, 2017, and China is a non-market economy (NME) country, pursuant to 19 CFR 351.204(b)(1), the POI for this investigation is April 1, 2017, through September 30, 2017.
The products covered by this investigation are plastic decorative ribbon from China. For a full description of the scope of this investigation,
During our review of the Petition, Commerce issued questions to, and received responses from, the petitioner pertaining to the proposed scope to ensure that the scope language in the Petition would be an accurate reflection of the products for which the domestic industry is seeking relief.
As discussed in the preamble to Commerce's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope).
Commerce requests that any factual information the parties consider relevant to the scope of the investigation be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact Commerce and request permission to submit the additional information. All such comments must be filed on the records of each of the concurrent AD and CVD investigations.
All submissions to Commerce must be filed electronically using Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS).
Commerce will provide interested parties an opportunity to comment on the appropriate physical characteristics of plastic decorative ribbon to be reported in response to Commerce's AD questionnaires. This information will be used to identify the key physical characteristics of the merchandise under consideration in order to report the relevant costs of production accurately as well as to develop appropriate product-comparison criteria.
Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) General product characteristics and (2) product-comparison criteria. We note that it is not always appropriate to use all product characteristics as product-comparison criteria. We base product-comparison criteria on meaningful commercial differences among products. In other words, although there may be some physical product characteristics utilized by manufacturers to describe plastic decorative ribbon, it may be that only a select few product characteristics take into account commercially meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, Commerce attempts to list the most important physical characteristics first and the least important characteristics last.
In order to consider the suggestions of interested parties in developing and issuing the AD questionnaire, all product characteristics comments must be filed by 5:00 p.m. ET on February 5, 2018. Any rebuttal comments must be filed by 5:00 p.m. ET on February 15, 2018. All comments and submissions to Commerce must be filed electronically using ACCESS, as explained above, on the record of the less-than-fair-value investigation.
Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC must apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that plastic decorative ribbon, as defined in the scope, constitutes a single domestic like product, and we have analyzed industry support in terms of that domestic like product.
In determining whether the petitioner has standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the Appendix to this notice. The petitioner provided its own 2016 production of the domestic like product, and compared this to the estimated total production of the domestic like product for the entire domestic industry.
Our review of the data provided in the Petition, General Issues and China AD Supplement, and other information readily available to Commerce indicates
Commerce finds that the petitioner filed the Petition on behalf of the domestic industry because it is an interested party as defined in section 771(9)(C) of the Act and it has demonstrated sufficient industry support with respect to the AD investigation that it is requesting that Commerce initiate.
The petitioner alleges that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at less than normal value (NV). In addition, the petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
The petitioner contends that the industry's injured condition is illustrated by a significant and increasing volume of subject imports; reduced market share; underselling and price depression or suppression; lost sales and revenues; and a negative impact on the domestic industry's performance.
The following is a description of the allegation of sales at less than fair value upon which Commerce based its decision to initiate the AD investigation of imports of plastic decorative ribbon from China. The sources of data for the petitioner's calculations relating to U.S. price and NV are discussed in greater detail in the initiation checklist.
The petitioner based U.S. price on export price (EP) using price quotes for sales of plastic decorative ribbon produced in and exported from China to unaffiliated U.S. customers.
Commerce considers China to be a non-market economy (NME) country.
The petitioner states that Thailand is an appropriate surrogate country for China, because it is a market economy country that is at a level of economic development comparable to that of China, it is a significant producer of comparable merchandise, and public information from Thailand is available to value all material input factors.
Interested parties will have the opportunity to submit comments regarding surrogate country selection and, pursuant to 19 CFR 351.301(c)(3)(i), will be provided an opportunity to submit publicly available information to value FOPs no later than 30 days before the scheduled date of the preliminary determination.
Because information regarding the volume of inputs consumed by Chinese producers/exporters is not available, the petitioner relied on its own production experience as a domestic producer of plastic decorative ribbon in the United States as an estimate of Chinese manufacturers' FOPs.
Based on the data provided by the petitioner, there is reason to believe that imports of plastic decorative ribbon from China are being, or are likely to be, sold in the United States at less than fair value. Based on comparisons of EP to NV in accordance with sections 772 and 773 of the Act, the estimated dumping margins for plastic decorative ribbon from China range from 74.34 percent to 370.04 percent.
Based upon the examination of the Petition, we find that the Petition meets the requirements of section 732 of the Act. Therefore, we are initiating this AD investigation to determine whether imports of plastic decorative ribbon from China are being, or are likely to be,
Under the Trade Preferences Extension Act of 2015, numerous amendments to the AD and CVD law were made.
The petitioner named 51 producers/exporters of plastic decorative ribbon from China.
Producers/exporters of plastic decorative ribbon from China that do not receive Q&V questionnaires by mail may still submit a response to the Q&V questionnaire and can obtain a copy of the Q&V questionnaire from Enforcement & Compliance's website. The Q&V response must be submitted by the relevant Chinese exporters/producers no later than 5:00 p.m. ET on January 30, 2018. All Q&V responses must be filed electronically via ACCESS.
In order to obtain separate-rate status in an NME investigation, exporters and producers must submit a separate-rate application.
Commerce will calculate combination rates for certain respondents that are eligible for a separate rate in an NME investigation. The Separate Rates and Combination Rates Bulletin states:
In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the government of China
We will notify the ITC of our initiation, as required by section 732(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of plastic decorative ribbon from China, are materially injuring or threatening material injury to a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). 19 CFR 351.301(b) requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Parties should review
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, Commerce published
This notice is issued and published pursuant to sections 732(c)(2) and 777(i) of the Act, and 19 CFR 351.203(c).
The merchandise covered by this investigation is certain plastic decorative ribbon having a width (measured at the narrowest span of the ribbon) of less than or equal to four (4) inches in actual measurement, including but not limited to ribbon wound onto itself; a spool, a core or a tube (with or without flanges); attached to a card or strip; wound into a keg- or egg-shaped configuration; made into bows, bow-like items, or other shapes or configurations; and whether or not packaged or labeled for retail sale. The subject merchandise is typically made of substrates of polypropylene, but may be made in whole or in part of any type of plastic, including without limitation, plastic derived from petroleum products and plastic derived from cellulose products. Unless the context otherwise clearly indicates, the word “ribbon” used in the singular includes the plural and the plural “ribbons” includes the singular.
The subject merchandise includes ribbons comprised of one or more layers of substrates made, in whole or in part, of plastics adhered to each other, regardless of the method used to adhere the layers together, including without limitation, ribbons comprised of layers of substrates adhered to each other through a lamination process. Subject merchandise also includes ribbons comprised of (a) one or more layers of substrates made, in whole or in part, of plastics adhered to (b) one or more layers of substrates made, in whole or in part, of non-plastic materials, including, without limitation, substrates made, in whole or in part, of fabric.
The ribbons subject to this investigation may be of any color or combination of colors (including without limitation, ribbons that are transparent, translucent or opaque) and may or may not bear words or images, including without limitation, those of a holiday motif. The subject merchandise includes ribbons with embellishments and/or treatments, including, without limitation, ribbons that are printed, hot-stamped, coated, laminated, flocked, crimped, die-cut, embossed (or that otherwise have impressed designs, images, words or patterns), and ribbons with holographic, metallic, glitter or iridescent finishes.
Subject merchandise includes “pull-bows” an assemblage of ribbons connected to one another, folded flat, and equipped with a means to form such ribbons into the shape of a bow by pulling on a length of material affixed to such assemblage, and “pre-notched” bows, an assemblage of notched ribbon loops arranged one inside the other with the notches in alignment and affixed to each other where notched, and which the end user forms into a bow by separating and spreading the loops circularly around the notches, which form the center of the bow. Subject merchandise includes ribbons that are packaged with non-subject merchandise, including ensembles that include ribbons and other products, such as gift wrap, gift bags, gift tags and/or other gift packaging products. The ribbons are covered by the scope of this investigation; the “other products” (
Excluded from the scope of this investigation are the following: (1) Ribbons formed exclusively by weaving plastic threads together; (2) ribbons that have metal wire in, on, or along the entirety of each of the longitudinal edges of the ribbon; (3) ribbons with an adhesive coating covering the entire span between the longitudinal edges of the ribbon for the entire length of the ribbon; (4) ribbon formed into a bow without a tab or other means for attaching the bow to an object using adhesives, where the bow has: (a) An outer layer that is either flocked or made of fabric, and (b) a flexible metal wire at the base that is suitable for attaching the bow to a Christmas tree or other object by twist-tying; (5) elastic ribbons, meaning ribbons that elongate when stretched and return to their original dimension when the stretching load is removed; (6) ribbons affixed as a decorative detail to non-subject merchandise, such as a gift bag, gift box, gift tin, greeting card or plush toy, or affixed (including by tying) as a decorative detail to packaging containing non-subject merchandise; (7) ribbons that are (a) affixed to non-subject merchandise as a working component of such non-subject merchandise, such as where the ribbon comprises a book marker, bag cinch, or part of an identity card holder, or (b) affixed (including by tying) to non-subject merchandise as a working component that holds or packages such non-subject merchandise or attaches packaging or labeling to such non-subject merchandise, such as a “belly band” around a pair of pajamas, a pair of socks or a blanket; (8) imitation raffia made of plastics having a thickness not more than one (1) mil when measured in an unfolded/untwisted state; and (9) ribbons in the form of bows having
Further, excluded from the scope of the antidumping duty investigation are any products covered by the existing antidumping duty order on polyethylene terephthalate film, sheet, and strip (PET Film) from the People's Republic of China (China).
Merchandise covered by this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 3920.20.0015 and 3926.40.0010. Merchandise covered by this investigation also may enter under subheadings 3920.10.0000; 3920.20.0055; 3920.30.0000; 3920.43.5000; 3920.49.0000; 3920.62.0050; 3920.62.0090; 3920.69.0000; 3921.90.1100; 3921.90.1500; 3921.90.1910; 3921.90.1950; 3921.90.4010; 3921.90.4090; 3926.90.9996; 5404.90.0000; 9505.90.4000; 4601.99.9000; 4602.90.0000; 5609.00.3000; 5609.00.4000; and 6307.90.9889. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this investigation is dispositive.
National Oceanic and Atmospheric Administration, Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before March 26, 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 Dianne Stephan, Atlantic Highly Migratory Species Management Division, National Marine Fisheries Service, 55 Great Republic Drive, Gloucester, MA 01930, (978) 281-9260 or
This request is for extension of a currently approved information collection.
Under the provisions of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801
This collection serves as a family of forms for Atlantic highly migratory species (HMS) dealer reporting, including purchases of HMS from domestic fishermen, and the import, export, and/or re-export of HMS, including federally managed tunas, sharks, and swordfish.
Transactions covered under this collection include purchases of Atlantic HMS from domestic fishermen; and the import/export of all bluefin tuna, frozen bigeye tuna, southern bluefin tuna or swordfish under the HMS International Trade Program, regardless of geographic area of origin. This information is used to monitor the harvest of domestic fisheries, and/or track international trade of internationally managed species.
The domestic dealer reporting covered by this collection includes weekly electronic landing reports and negative reports (
International trade tracking programs are required by both the International Commission for the Conservation of Atlantic Tunas (ICCAT) and the Inter-American Tropical Tuna Commission (IATTC) to account for all international trade of covered species. The U.S. is a member of ICCAT and IATTC and required by ATCA and the Tunas Convention Act (16 U.S.C. 951
Dealers who internationally trade Southern bluefin tuna are required to participate in a trade tracking program to ensure that imported Atlantic and Pacific bluefin tuna will not be intentionally mislabeled as “southern bluefin” to circumvent reporting requirements. This action is authorized under ATCA, which provides for the promulgation of regulations as may be necessary and appropriate to carry out ICCAT recommendations.
In addition to statistical document, catch document, and re-export certificate requirements, this collection includes biweekly reports to complement trade tracking statistical documents by summarizing statistical document data and collecting additional economic information.
Methods of submission include electronic, mail, fax, and tagging of fish.
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 shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be 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.
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.
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before March 26, 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 Lisa L. Colburn, (401) 782-3253 or
This request is for a new information collection.
The NOAA Fisheries Office of Science and Technology's Economics and Social Analysis Division seeks to conduct assessments of the social and economic impacts from hurricanes and other climate related natural disasters on commercial and recreational fishing industries in the eastern, gulf coast and Caribbean territories of the United States. It seeks to collect data on the immediate and long-term disruption and impediments to recovery of normal business practices to the commercial and recreational fishing industries. Data would be collected from commercial and recreational for hire fishermen, fish dealers, bait and tackle stores, marinas and other businesses dependent on the fishing industry for livelihood. The data will improve research and analysis of potential fishery management actions by understanding the immediate effects and/or long-term compounding effects of natural disasters on communities most dependent on commercial and recreational fishing. This data collection is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and essential for implementing National Standard 8, which calls for the sustained participation of fishing communities.
This information will be collected by telephone, on-line, and in person.
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 shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be 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.
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.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of opportunities to submit public comments.
The Pacific Fishery Management Council (Pacific Council) has announced its annual preseason management process for the 2018 ocean salmon fisheries. This notice informs the public of opportunities to provide comments on the 2018 ocean salmon management measures.
Written comments on the salmon management alternatives adopted by the Pacific Council at its March 2018 meeting, and described in Preseason Report II, received electronically or in hard copy by 5 p.m. Pacific Time, March 30, 2018, will be considered in the Pacific Council's final recommendation for the 2018 management measures.
Documents will be available from Mr. Phil Anderson, Chair, Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384, and posted on the Pacific Council website at
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• Comments can also be submitted via email to
Ms. Robin Ehlke, Pacific Council, telephone: 503-820-2280. For information on submitting comments via the Federal e-Rulemaking portal, contact Peggy Mundy, NMFS West Coast Region, telephone: 206-526-4323; email:
The Pacific Council has published its annual notice of availability of reports, public meetings, and hearings for the 2018 ocean salmon fisheries (82 FR 61268, December 27, 2017). The Pacific Council will adopt alternatives for 2018 ocean salmon fisheries at its March 8-14, 2018, meeting at the DoubleTree by Hilton Sonoma, Rohnert Park, CA. Details of this meeting are available on the Pacific Council's website (
All public hearings begin at 7 p.m. at the following locations:
• March 26, 2018: Chateau Westport, Fremont Room, 710 West Hancock, Westport, WA 98595, telephone 360-268-9101.
• March 26, 2018: Red Lion Hotel, South Umpqua Room, 1313 North Bayshore Drive, Coos Bay, OR 97420, telephone 541-267-4141.
• March 27, 2018: Laurel Inn & Conference Center, 801 West Laurel Drive, Salinas, CA 93906, telephone: 831-449-2474.
Comments on the alternatives the Pacific Council adopts at its March 2018 meeting, and described in Preseason Report II, may be submitted in writing or electronically as described under
16 U.S.C. 1801
Take notice that on January 10, 2018, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2017), Powder River Crude Services, LLC (Petitioner), filed a petition for a declaratory order seeking Commission approval of the rate framework, gathering agreements, and open season process that support a new crude and
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, 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. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
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 August 31, 2017, Transcontinental Gas Pipe Line Company, LLC (Transco) filed an application in Docket No. CP17-490-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities entirely within New Jersey. The proposed project is known as the Rivervale South to Market Project (Project), and would enable Transco to provide an additional 190 million cubic feet (MMcf) per day of firm transportation service to meet supply needs for the 2019/2020 winter heating season.
On September 15, 2017, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the Project. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the Project.
If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.
Transco proposes to construct, modify, upgrade, and operate various facilities in connection with its proposed Rivervale South to Market Project in Bergen, Hudson, and Union Counties, New Jersey. According to Transco, the Project would increase the firm delivery transportation capacity of its existing pipeline system by 190 MMcf per day of natural gas from the Rivervale interconnection to existing Compressor Station 210 in Mercer County and the Central Manhattan meter and regulation station (M&R) station in Hudson County. The Compressor Station 210 pooling point would receive 140 MMcf, and the Central Manhattan M&R would receive 50 MMcf.
The Project would consist of the following facilities:
• Construct 0.61 mile of 42-inch-diameter pipeline loop
• uprate 10.35 miles of the existing 24-inch-diameter North New Jersey Extension from the Paramus M&R station (Bergen County) to the Orange and Rockland M&R station (Bergen County). The North New Jersey Extension would be uprated from a maximum allowable operating pressure of 650 pounds per square inch gauge (“psig”) to 812 psig;
• upgrade the existing valves, including overpressure protection valves, and yard piping, and related activities at the Paramus, Central Manhattan, Orange and Rockland, and Emerson M&R stations; and
• construct additional facilities, such as mainline valves, cathodic protection, internal inspection device (pig
On October 19, 2017, the Commission issued a
In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This
Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (
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j. Ampersand Moretown Hydro, LLC filed its request to use the Traditional Licensing Process on November 20, 2017. Ampersand Moretown Hydro, LLC provided public notice of its request on November 30, 2017. In a letter dated January 17, 2018, the Director of the Division of Hydropower Licensing approved Ampersand Mortetown Hydro, LLC's request to use the Traditional Licensing Process.
k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR part 402; and NOAA Fisheries under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920. We are also initiating consultation with the Vermont State Historic Preservation Officer, as required by section 106 of the National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.
l. Ampersand Moretown Hydro, LLC filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
m. 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 (
n. The licensee states its unequivocal intent to submit an application for a subsequent license for Project No. 5944. Pursuant to 18 CFR 16.20, each application for a subsequent license and any competing license applications must be filed with the Commission at least 24 months prior to the expiration of the existing license. All applications for license for this project must be filed by November 30, 2020.
o. Register online at
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:
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:
Export-Import Bank of the United States.
Notice and request for public comments. Request for OMB review and extension of approval.
The Export-Import Banks of the United States (EXIM), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery,” for approval under the Paperwork Reduction Act (PRA). This collection was developed as part of the Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery. This is the notice of our intent to submit this collection to OMB for the extension of approval. We are soliciting comments on the specific aspects for the proposed information collection.
Comments must be received on or before March 26, 2018 to be assured of consideration.
Comments may be submitted electronically on
Comments submitted in response to this notice may be made available to the public through the
To request additional information, please contact Mia Johnson,
The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable. The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:
• The collections are voluntary;
• The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;
• The collections are non-controversial and do not raise issues of concern to other Federal agencies;
• Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;
• Personally identifiable information (PII) is collected only to the extent necessary and is not retained;
• Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency;
• Information gathered will not be used for the purpose of substantially informing influential policy decisions; and
• Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.
Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.
Below we provide projected average estimates for the next three years:
All written comments will be available for public inspection
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.
Federal Communications Commission.
Notice.
In this document, the Commission seeks public comment on state applications for renewal of the certification of their state telecommunications relay services (TRS) programs.
Interested parties may file comments no later than February 22, 2018. Reply comments may be filed no later than March 9, 2018.
Comments may be filed using the Commission's Electronic Comment Filing System (ECFS).
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• Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
• All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th Street SW, Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington, DC 20554.
Dana Wilson, Consumer and Governmental Affairs Bureau at: (202) 418-2247; email:
Interested parties may file comments on or before the dates indicated above in the Dates portion of this notice. All filings must reference CG Docket No. 03-123 and the relevant state identification number of the state application for which comments are being submitted.
To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to
Notice is hereby given that the states listed below have applied to the Commission for renewal of certification of their state TRS programs, for the five-year period from July 26, 2018 through July 25, 2023. Each state's application for certification must demonstrate that its TRS program complies with section 225 of the Communications Act and the Commission's rules governing the provision of TRS. This notice seeks public comment on the following state applications for certification, which can be found on the Commission's website at:
Federal Election Commission.
Notice of filing dates for special elections.
Ohio has scheduled special elections on May 8, 2018, and August 7, 2018, to fill the U.S. House of Representatives seat in the 12th Congressional District vacated by Representative Patrick J. Tiberi.
Committees required to file reports in connection with the Special Primary Election on May 8, 2018, shall file a 12-day Pre-Primary Report. Committees required to file reports in connection with both the Special Primary and Special General Election on August 7, 2018, shall file a 12-day Pre-Primary, 12-day Pre-General Report and a 30-day Post-General Report.
Ms. Elizabeth S. Kurland, Information Division, 999 E Street NW, Washington, DC 20463; Telephone: (202) 694-1100; Toll Free (800) 424-9530.
All principal campaign committees of candidates who participate in the Ohio Special Primary and Special General Elections shall file a 12-day Pre-Primary Report on April 26, 2018; a 12-day Pre-General Report on July 26, 2018; and a 30-day Post-General Report on September 6, 2018. (See charts below for the closing date for each report.)
All principal campaign committees of candidates participating
Political committees filing on a quarterly basis in 2018 are subject to special election reporting if they make previously undisclosed contributions or expenditures in connection with the Ohio Special Primary or Special General Elections by the close of books for the applicable report(s). (See charts below for the closing date for each report.)
Committees filing monthly that make contributions or expenditures in connection with the Ohio Special Primary or Special General Elections will continue to file according to the monthly reporting schedule.
Additional disclosure information in connection with the Ohio Special Elections may be found on the FEC website at
Principal campaign committees, party committees and Leadership PACs that are otherwise required to file reports in connection with the special elections must simultaneously file FEC Form 3L if they receive two or more bundled contributions from lobbyists/registrants or lobbyist/registrant PACs that aggregate in excess of the lobbyist bundling disclosure threshold during the special election reporting periods (See charts below for closing date of each period.) 11 CFR 104.22(a)(5)(v), (b).
The lobbyist bundling disclosure threshold for calendar year 2017 is $17,900. This threshold amount may increase in 2018 based upon the annual cost of living adjustment (COLA). Once the adjusted threshold amount becomes available, the Commission will publish it in the
On behalf of the Commission.
Notice is given that a complaint has been filed with the Federal Maritime Commission (Commission) by Tarik Afif Chaouch, hereinafter “Complainant,” against Demetrios Air Freight Co., Demetrios International Shipping Co., Inc., and Troy Container Line LTD., hereinafter “Respondents.” Complainant states it hired the Respondents to ship two cars to Algiers, Algeria.
Complainant alleges that due to an error the Respondents made on the bill of lading, the shipment was “. . . impounded in Algiers, Algeria for approximately four months . . .” Complainant alleges that this error resulted in costs for which Complainant would not have otherwise been responsible. Complainant alleges that it is “. . . subject to injury as a direct result of the violations by respondent of sections 46 U.S.C. code § 41104 and more specifically paragraphs 4 and 5.”
Complainant seeks reparations in the amount of $21,086.70, and other relief. The full text of the complaint can be found in the Commission's Electronic Reading Room at
This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by January 18, 2019, and the final decision of the Commission shall be issued by August 1, 2019.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than February 16, 2018.
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Board of Governors of the Federal Reserve System.
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Reporting, Recordkeeping, and Disclosure Requirements Associated with the Guidance on Response Programs for Unauthorized Access to Customer Information (FR 4100
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Board of Governors of the Federal Reserve System.
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to revise, without extension, the Annual Report of Foreign Banking Organizations (FR Y-7). The revisions to the mandatory FR Y-7 information collection are effective beginning with FR Y-7 reports for fiscal year-ends that end on or after March 1, 2018.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board
Final approval under OMB delegated authority of the revision of the following information collection:
The FR Y-7 is an annual information collection submitted by FBOs that are qualifying to update their financial and organizational information with the Federal Reserve. The FR Y-7 collects financial, organizational, shareholder, and managerial information. The Federal Reserve uses the information to assess an FBO's ability to be a continuing source of strength to its U.S. operations and to determine compliance with U.S. laws and regulations.
The FR Y-10 is an event-generated information collection submitted by FBOs; top-tier HCs; securities holding companies as authorized under Section 618 of the Dodd-Frank Act (12 U.S.C. 1850a(c)(1)); state member banks unaffiliated with a BHC; Edge and agreement corporations that are not controlled by a member bank, a domestic BHC, or an FBO; and nationally chartered banks that are not controlled by a BHC (with regard to their foreign investments only) to capture changes in their regulated investments and activities. The Federal Reserve uses the data to monitor structure information on subsidiaries and regulated investments of these entities engaged in banking and nonbanking activities.
The FR Y-10E is an event-driven supplement that may be used to collect additional structural information deemed to be critical and needed in an expedited manner.
FR Y-6: Section 5(c)(1)(A) of the Bank Holding Company Act (BHC Act) (12 U.S.C. 1844(c)(1)(A)); sections 8(a) and 13(a) of the International Banking Act (IBA) (12 U.S.C. 3106(a) and 3108(a)); sections 11(a)(1), 25, and 25A of the Federal Reserve Act (FRA) (12 U.S.C. 248(a)(1), 602, and 611a); and sections 113, 165, 312, 618, and 809 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) (12 U.S.C. 5361, 5365, 5412, 1850a(c)(1), and 5468(b)(1)).
FR Y-7: Sections 8(a) and 13(a) of the IBA (12 U.S.C. 3106(a) and 3108(a)); sections 113, 165, 312, 618, and 809 of the Dodd-Frank Act (12 U.S.C. 5361, 5365, 5412, 1850a(c)(1), and 5468(b)(1)).
FR Y-10 and FR Y-10E: Sections 4(k) and 5(c)(1)(A) of the BHC Act (12 U.S.C. 1843(k), and 1844(c)(1)(A)); section 8(a) of the IBA (12 U.S.C. 3106(a)); sections 11(a)(1), 25(7), and 25A of the FRA (12 U.S.C. 248(a)(1), 321, 601, 602, 611a, 615, and 625); sections 113, 165, 312, 618, and 809 of the Dodd-Frank Act (12 U.S.C. 5361, 5365, 5412, 1850a(c)(1), and 5468(b)(1)); and section 10(c)(2)(H) of the Home Owners' Loan Act (HOLA) (12 U.S.C. 1467a(c)(2)(H)).
Except as discussed below, the data collected in the FR Y-6, FR Y-7, FR Y-10, and FR Y-10E are generally not considered confidential. With regard to information that a banking organization may deem confidential, the institution may request confidential treatment of such information under one or more of the exemptions in the Freedom of Information Act (FOIA) (5 U.S.C. 552). The most likely case for confidential treatment will be based on FOIA exemption 4, which permits an agency to exempt from disclosure “trade secrets and commercial or financial information obtained from a person and privileged and confidential” (5 U.S.C. 552(b)(4)). To the extent an institution can establish the potential for substantial competitive harm, such information would be protected from disclosure under the standards set forth in
Section 165 of the Dodd-Frank Act directs the Board to establish enhanced prudential standards for BHCs and FBOs with total consolidated assets of $50 billion or more and nonbank financial companies that the Financial Stability Oversight Council has designated for supervision by the Board. In addition, the Dodd-Frank Act directs the Board to issue regulations applying certain standards to BHCs and FBOs with total consolidated assets of $10 billion or more. In particular, the Board is directed to require publicly traded BHCs and FBOs with total consolidated assets of $10 billion or more to establish risk committees.
In February of 2014, the Board adopted enhanced prudential standards for FBOs, including risk committee and stress testing requirements for FBOs with total consolidated assets of more than $10 billion. These standards are contained in the Board's Regulation YY, which applies different requirements to FBOs depending on their asset size. The risk committee and stress testing requirements are located in the following subparts:
• Subpart L establishes stress testing requirements for FBOs with total consolidated assets of more than $10 billion;
• Subpart M establishes risk committee requirements for publicly traded FBOs with total consolidated assets between $10-$50 billion;
• Subpart N establishes enhanced prudential standards (including risk committee and stress testing requirements) for FBOs with total consolidated assets of $50 billion or more but combined U.S. assets of less than $50 billion; and
• Subpart O establishes enhanced prudential standards (including risk committee and stress testing requirements) for FBOs with total consolidated assets of $50 billion or more and combined U.S. assets of $50 billion or more.
With regard to risk committee requirements, an FBO subject to subpart M or N of Regulation YY is required to certify that it has a risk committee that oversees the risk management practices of the combined U.S. operations of the company and has at least one member with appropriate risk expertise.
With regard to stress testing, an FBO subject to subpart L, N, or O of Regulation YY must be subject to a consolidated capital stress testing regime administered or reviewed by the FBO's home country supervisor, meet the home country supervisor's minimum standards, and, in some cases, provide information to the Board about the results of home country stress testing or face additional requirements in the United States. In particular, the U.S. branches and agencies of the FBO become subject to an asset maintenance requirement, and the FBO generally must conduct an annual stress test of its U.S. subsidiaries. An FBO subject to subpart O also must stress test any U.S. IHC.
The revisions to the FR Y-7 implement the U.S. risk committee certification requirement in Regulation YY and provide FBOs with a standardized way to indicate compliance with the home country stress testing requirements (and thus, avoid being subject to additional requirements in the U.S.). The revisions to the FR Y-7 also better describe the risk committee requirements in Regulation YY and the scope of applicability of the report to FBOs.
The following is a detailed discussion of the two comments received regarding the FR Y-7 proposal and the responses related to the changes in the FR Y-7 proposal. Although no comments were received on the reporting burden estimates, the Board has reconsidered the estimates given the clarifications provided to Regulation YY. Thus, the Board increased the estimated hourly burden from 4 hours to 6 hours per response.
A commenter requested a number of clarifications regarding the provisions in Regulation YY that require an FBO to maintain a committee of its global board of directors (or equivalent thereof) that oversees the risk-management policies of the combined U.S. operations of the FBO.
First, the commenter requested clarification on whether the committee that oversees U.S. risk must be composed entirely of members of the FBO's global board or may be configured in other ways that take into account the size, scale, and complexity of an FBO's combined U.S. operations and more effectively utilize the expertise of personnel familiar with the risk of these operations.
In response to this comment, to certify compliance with sections 252.132(a) and 252.144(a), the FBO is not required to form a special U.S. risk committee comprised of members of the FBO's board of directors. Rather, the FBO must ensure that the FBO's board of directors or a committee comprised of members of the FBO's board of directors has primary responsibility for oversight of the risks of the combined U.S. operations. The committee that oversees U.S. risk for an FBO subject to Regulation YY is not required to (though it may) directly administer the FBO's U.S. risk management policies; rather, the FBO may designate specific senior management officials from the FBO's U.S. operations to be responsible for administering the U.S. risk management policies and for providing regular reports directly to the FBO's board of directors or risk committee.
The same commenter requested clarification regarding how the requirement in Regulation YY for an FBO to have a committee that oversees U.S. risk would apply to an FBO with a two-tier board structure. The two-tier board structure is a common feature of FBOs in European countries, and generally consists of a supervisory board independent from management that sets the direction of the company and oversees the company's senior management, and a management/executive board that implements the company's strategies and risk management. The purpose of the risk committee requirements in Regulation YY is to ensure that the FBO parent is aware of and takes responsibility for the oversight of the risks of its combined U.S. operations. This oversight function can be integrated into various board structures that currently exist in different foreign countries. In a two-tier board structure, a committee of either the supervisory board or the management/executive board (or a combination thereof) could be considered a committee of the FBO board of directors for purposes of complying with the requirement under Regulation YY for an FBO to maintain a committee that oversees U.S. risk. Both tiers of a two-tier board are typically involved in evaluating risk management at an FBO with the same goals as those of a single board of directors in the United States.
The same commenter requested clarification regarding various requirements in Regulation YY relating to capital stress testing and liquidity stress testing.
Moreover, the same commenter requested clarification as to whether an FBO would meet the home country stress test requirements upon a satisfactory completion of an Internal Capital Adequacy Assessment Process (ICAAP). If an ICAAP satisfies the underlying requirements for a capital stress test, including all applicable information requirements in Regulation YY, satisfactory completion of the ICAAP would be sufficient to satisfy these requirements.
Regulation YY requires an FBO to report on an annual basis the results of an internal liquidity stress test for either the consolidated operations of the FBO or the FBO's combined U.S. operations. In either case, the liquidity stress test must incorporate three specified planning horizons. The same commenter requested guidance on how an FBO should report when the FBO's home country uses fewer or different planning horizons.
In the event that an FBO is not required to conduct an internal liquidity stress test for its consolidated operations using the three specified planning horizons in Regulation YY or chooses not to do so, the FBO may instead choose to provide an internal liquidity stress test for just the combined U.S. operations. Under Regulation YY, if an FBO does not comply with the internal liquidity stress testing reporting requirements, it must limit the net aggregate amount owed by the parent or other non-U.S. affiliates to the U.S. operations to 25 percent or less of the third party liabilities of the combined U.S. operations.
In addition, although Regulation YY does not prescribe the information that must be reported to the Board regarding the internal liquidity stress tests, given the diversity in liquidity reporting requirements across jurisdictions, FBOs are expected to provide sufficient information in the internal liquidity stress test to allow the Board to assess the liquidity position of the FBO.
The same commenter requested guidance on an FBO's compliance with the stress testing requirement when
The same commenter requested guidance on whether an FBO would be deemed to satisfy the requirement to report and certify compliance with its home country capital adequacy requirements by completing the FR Y-7Q. In addition, the commenter requested confirmation of the as-of date and frequency of the certification of the FR Y-7Q. Regulation YY requires an FBO to report compliance with capital adequacy measures that are consistent with the Basel Capital Framework (as defined in 12 CFR 252.143(a) and 252.154(a)) concurrently with filing the FR Y-7Q; however, Regulation YY does not specify the frequency or the as-of date for an FBO's certification of
A second commenter requested clarification on the definition of an inactive company when an entity is in the liquidation process. Respondents should refer to the definition of “Liquidation” in the Banking, Savings and Loan, and Nonbanking Schedules in the FR Y-10 instructions on how to classify an entity during the liquidation process. Specifically, the instructions state “liquidation refers to final distribution of assets, satisfaction of liabilities, and closing of capital accounts of a company, as opposed to sale or transfer of the company.”
The same commenter also requested that the instructions be expanded on reporting when a nonbanking company is a functionally regulated subsidiary since the mere registration with a functional regulator does not necessarily qualify a company as being functionally regulated for these purposes. In response to the commenter's request, the Board notes that respondents should refer to the definition of “Functionally Regulated Subsidiary” in the FR Y-10 instructions, which provides that certain companies may be required to be registered with one of the enumerated regulators without necessarily qualifying as being functionally regulated by that regulator; for example, publicly held companies may be required to be registered with the U.S. Securities and Exchange Commission (SEC) without necessarily qualifying as functionally regulated by the SEC as a securities broker-dealer, investment adviser, investment company, or company that engages in commodity futures trading.
Board of Governors of the Federal Reserve System.
The Board of Governors of the Federal Reserve System (Board or Federal Reserve) is adopting a proposal to extend for three years, with revision, the following mandatory reports:
(1) The Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies (FR Y-11; OMB No. 7100-0244),
(2) the Abbreviated Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies (FR Y-11S; OMB No. 7100-0244),
(3) the Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations (FR 2314; OMB No. 7100-0073), and
(4) the Abbreviated Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations (FR 2314S; OMB No. 7100-0073).
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than February 12, 2018.
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In addition,
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Board of Governors of the Federal Reserve System.
Notice, request for comment.
The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, with revision, the reports on Margin Credit (FR G-1, FR G-2, FR G-4; OMB No. 7100-0011. FR G-3; OMB No. 7100-0018. FR T-4; OMB No. 7100-0019. FR U-1; OMB No. 7100-0115).
Comments must be submitted on or before March 26, 2018.
You may submit comments, identified by
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All public comments are available from the Board's website at
Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public website at:
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.
The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposal.
The deregistration statement (FR G-2) is used by nonbank lenders to withdraw from regulation if their margin credit activities no longer exceed the regulatory threshold found in Regulation U. Under section 221.3(b)(2) of Regulation U, a registered nonbank lender may apply to terminate its registration if the lender has not, during the preceding six calendar months, had more than $200,000 of such credit outstanding.
The information submitted on the annual report (FR G-4) is required pursuant to Regulation U to enable the Federal Reserve to monitor the amount of credit that is secured by margin stock and that is extended by nonbank lenders.
The Board also proposes to consolidate all six Margin Credit Reports under one OMB control number, 7100-0011, which currently only includes the FR G-1, FR G-2, and FR G-4. This change is aimed at simplifying the tracking and clearance process for the Margin Credit Reports.
FR G-1 and FR G-4 collect financial information, including a balance sheet, from nonbank lenders subject to Regulation U. Some of these lenders may be individuals or nonbank entities that do not make this information publicly available; release could therefore cause substantial harm to the competitive position of the respondent or result in an unwarranted invasion of personal privacy. In those cases, the information could be withheld under exemption 4 or exemption 6 of the Freedom of Information Act (5 U.S.C. 552(b)(4) and (6)), respectively. Confidentiality determinations must be made on a case by case basis. Because FR G-3, FR T-4, and FR U-1 are not submitted to the Federal Reserve System and FR G-2 does not contain any information considered to be confidential, no confidentiality determination is necessary for these reports.
Board of Governors of the Federal Reserve System.
Notice, request for comment.
The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the Recordkeeping Requirements Associated with Limitations on Interbank Liabilities (Regulation F; OMB No. 7100-0331).
Comments must be submitted on or before March 26, 2018.
You may submit comments, identified by
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•
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All public comments are available from the Board's website at
Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public website at:
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is
The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposal prior to giving final approval.
The Board has updated its burden estimate for this information collection to account for all depository institutions insured by the Federal Deposit Insurance Corporation (FDIC), all of which are potential respondents. The Board's previous burden estimate accounted only for state member banks. The increase in burden reflects the update to correct the number of potential respondents, and is not due to a change in burden for individual institutions.
U.S. Government Accountability Office (GAO).
Request for letters of nomination and resumes.
The Balanced Budget Act of 1997 established the Medicare Payment Advisory Commission (MedPAC) and gave the Comptroller General responsibility for appointing its members. GAO is now accepting nominations for MedPAC appointments that will be effective in May 2018. Letters of nomination and resumes should be submitted no later than February 23, 2018 to ensure adequate opportunity for review and consideration of nominees prior to appointment of new members. Acknowledgement of submissions will be provided within a week of submission. Please contact Greg Giusto at (202) 512-8268 if you do not receive an acknowledgment.
Email:
Greg Giusto, 202-512-8268,
42 U.S.C. 1395b-6.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC)
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 Youth Tobacco Surveys (NYTS) 2018-2020 (OMB Control Number 0920-0621, expires 01/31/2018)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Tobacco use is the leading cause of preventable disease and death in the United States, and nearly all tobacco use begins during youth and young adulthood. A limited number of health-risk behaviors, including tobacco use, account for the overwhelming majority of immediate and long-term sources of morbidity and mortality. Because many health-risk behaviors are established during adolescence, there is a critical need for public health programs directed towards youth, and for information to support these programs.
Since 2004, the CDC has periodically collected information about tobacco use among adolescents (National Youth Tobacco Survey (NYTS) 2004, 2006, 2009, 2011, 2012, 2013-2017, OMB Control Number 0920-0621). This surveillance activity builds on previous surveys funded by the American Legacy Foundation in 1999, 2000, and 2002.
At present, the NYTS is the most comprehensive source of nationally representative tobacco data among students in grades 9-12, moreover, the NYTS is the only source of such data for students in grades 6-8. The NYTS has provided national estimates of tobacco use behaviors, information about exposure to pro- and anti-tobacco influences, and information about racial and ethnic disparities in tobacco-related topics. CDC uses the information collected through the NYTS to identify trends over time, to inform the development of tobacco cessation programs for youth, and to evaluate the effectiveness of existing interventions and programs.
CDC plans to request OMB approval to conduct additional cycles of the NYTS in 2018, 2019, and 2020. CDC will conduct the survey among nationally representative samples of students attending public and private schools in grades 6-12, and administer to students either as an optically scannable booklet of multiple-choice questions or as a digitally-based survey.
CDC will also collect information supporting the NYTS from state-, district-, and school-level administrators and teachers. During the 2018-2020 timeframe, changes will be incorporated that reflect CDC's ongoing collaboration with FDA and the need to measure progress toward meeting strategic goals established by the Family Smoking Prevention and Tobacco Control Act.
Information collection will occur annually and may include a number of new questions, as well as increased representation of minority youth.
The survey will examine the following topics: Use of cigarettes, cigars, smokeless tobacco, electronic cigarettes, hookahs, pipes, bidis, snus, and dissolvable tobacco products; knowledge and attitudes; media and advertising; access to tobacco products and enforcement of restrictions on access; secondhand smoke including e-cigarette aerosol exposure; provision of school- and community-based interventions, and cessation.
CDC will continue to use the results of the NYTS to inform and evaluate the National Comprehensive Tobacco Control Program; provide data to inform the Department of Health and Human Service's Tobacco Control Strategic Action Plan, and provide national benchmark data for state-level Youth Tobacco Surveys. CDC also expects the information collected through the NYTS to provide multiple measures and data for monitoring progress on six of the 20 tobacco-related objectives (TU-2, 3, 7, 11, 18, and 19) for Healthy People 2020.
CDC seeks a three-year OMB approval and estimates 18,537 burden hours for this project. There are no costs to respondents other than their time.
Notice.
The Centers for Disease Control and Prevention (CDC) is soliciting nominations for membership on the BCCEDCAC. The BCCEDCAC consists of 14 experts in fields associated with breast cancer, cervical cancer, medicine, public health, behavioral science, epidemiology, radiology, pathology, clinical medical care, health education, and surveillance. Two members may be representatives of the general public with personal experience in issues related to breast or cervical cancer early detection and control. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of breast cancer, cervical cancer, medicine, public health, behavioral science, epidemiology, radiology, pathology, clinical medical care, health education, and surveillance. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of BCCEDCAC objectives.
Nominations for membership on the BCCEDCAC must be received no later than February 23, 2018. Packages received after this time will not be considered for the current membership cycle.
All nominations should be mailed (regular, Express or Overnight Mail) to Ms. Jameka Reese Blackmon, MBA, CMP c/o BCCEDCAC Secretariat, CDC, 3719 North Peachtree Road, Building 100 Chamblee, Georgia 30341, electronic submissions (including attachments) to
Jameka Reese Blackmon, MBA, CMP, Designated Federal Officer, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Hwy. NE, Mailstop F76, Atlanta, Georgia 30341, Telephone (770) 488-4880; Fax (770) 488-4760; Email:
The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented, and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees, requiring the filing of financial disclosure reports at the beginning and annually during their terms. CDC reviews potential candidates for BCCEDCAC membership each year, and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in April 2018, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year.
Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items:
Current curriculum vitae, including complete contact information (telephone numbers, mailing address, email address).
At least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services. (Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency (
Nominations may be submitted by the candidate him- or herself, or by the person/organization recommending the candidate.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Notice.
The CDC is soliciting nominations for possible membership on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP) in the National
Nominations for membership on the NCIPC, NCEH and ATSDR SEPs must be received no later than June 30, 2018. Packages received after this time will not be considered for the current membership cycle.
All nominations should be mailed to NCIPC Extramural Program Office (ERPO): Centers for Disease Control and Prevention, 4770 Buford Highway, Mailstop F-63, Atlanta, GA 30341, emailed (recommended) to
Kenneth Roberts, Public Health Analyst, CDC/NCIPC/ERPO, 4770 Buford Highway, Mailstop F-63, Atlanta, GA 30341; Telephone: (404) 498-1427; Email:
The Disease, Disability, and Injury Prevention and Control Special Emphasis Panel provides advice and guidance to the Secretary, Department of Health and Human Services (HHS); the Director, Centers for Disease Control and Prevention (CDC), and the Administrator, Agency for Toxic Substances and Disease Registry (ATSDR) regarding the concept review, scientific and technical merit of grant and cooperative agreement assistance applications, and contract proposals relating to the causes, prevention, and control of diseases, disabilities, injuries, and impairments of public health significance; exposure to hazardous substances in the environment; health promotion and education; and other related activities that promote health and well-being. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishment of CDC SEP objectives. Reviewers with expertise in the following research fields for injury and violence prevention are sought to serve on the NCIPC SEPs, for research and evaluation related, but not limited to: child abuse and neglect, opioid overdose, intimate partner violence, motor vehicle injury, older adult falls, self-directed violence, sexual violence, traumatic brain injury, teen dating violence and youth violence (see
The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented, and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Reviewers appointed to the CDC SEPs are not considered Special Government Employees, and will not be required to file financial disclosure reports.
Nominees interested in serving as a potential reviewer on a CDC SEP for NCIPC, NCEH, or ATSDR programs should submit the following items:
• Current
Nomination materials must be postmarked by April 30, 2018 and sent by U.S. mail to: NCIPC Extramural Research Program Office (ERPO): Centers for Disease Control and Prevention, 4770 Buford Highway, Mailstop F-63, Atlanta, Georgia 30341 or to the ERPO electronic mailbox
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed notice with request for comment.
This proposed notice acknowledges the receipt of an application from The Compliance Team
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. February 22, 2018.
In commenting, refer to file code CMS-3351-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Christina Mister-Ward, (410) 786-2441.
Monda Shaver, (410) 786-3410.
Patricia Chmielewski, (410) 786-6899.
Under the Medicare program, eligible beneficiaries may receive covered services in a rural health clinic (RHC) provided certain requirements are met by the RHC. Section 1861(aa) and 1905(l)(1) of the Social Security Act (the Act), establish distinct criteria for facilities seeking designation as a RHC. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488, subpart A. The regulations at 42 CFR part 491, subpart A specify the conditions that a RHC must meet to participate in the Medicare program. The scope of covered services and the conditions for Medicare payment for RHCs are set forth at 42 CFR part 405, subpart X.
Generally, to enter into a provider agreement with the Medicare program, a RHC must first be certified by a state survey agency as complying with the conditions or requirements set forth in 42 CFR part 491. Thereafter, the RHC is subject to regular surveys by a state survey agency to determine whether it continues to meet these requirements.
There is an alternative, however, to surveys by state agencies. Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation.
If an accrediting organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accrediting organization applying for CMS approval of its accreditation program under 42 CFR part 488, subpart A, must provide us with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of accrediting organizations are set forth at § 488.5. Section 488.5(e)(2)(i) requires an accrediting organization to reapply for continued approval of its accreditation program every 6 years or as determined by CMS. The Compliance Team (TCT) current term of approval for its RHC accreditation program expires July 18, 2018.
Section 1865(a)(2) of the Act and § 488.5 require that our findings concerning review and approval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide us with the necessary data for validation.
Section 1865(a)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a
The purpose of this proposed notice is to inform the public of TCT's request for continued CMS approval of its RHC accreditation program. This notice also solicits public comment on whether TCT's requirements meet or exceed the Medicare conditions for certification for RHCs.
TCT submitted all the necessary materials to enable us to make a determination concerning its request for continued approval of its RHC accreditation program. This application was determined to be complete on November 24, 2017. Under section 1865(a)(2) of the Act and § 488.5 (Application and re-application procedures for national accrediting organizations), our review and evaluation of TCT will be conducted in accordance with, but not necessarily limited to, the following factors:
• The equivalency of TCT's standards for RHCs as compared with CMS's RHC conditions for certification.
• TCT's survey process to determine the following:
++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.
++ The comparability of TCT's processes to those of state agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.
++ TCT's processes and procedures for monitoring a RHC determined to be out of compliance with TCT's program requirements. These monitoring procedures are used only when TCT identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the state survey agency monitors corrections as specified at § 488.9(c).
++ TCT's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.
++ TCT's capacity to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process.
++ The adequacy of TCT's staff and other resources, and its financial viability.
++ TCT's capacity to adequately fund required surveys.
++ TCT's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.
++ TCT's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans).
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Because of the large number of public comments we normally receive on
Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by February 22, 2018.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' website address at website address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
William Parham at (410) 786-4669.
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. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C.
1.
This
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). At least one portion of the meeting will be closed to the public. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. FDA is establishing a docket for public comments on this document.
The meeting will be held on March 22, 2018, from 8:30 a.m. to 5:30 p.m.
FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-0045. The docket will close on March 23, 2018. Submit either electronic or written comments on this public meeting by that date. Please note that late, untimely comments will not be considered. The
Comments received on or before March 8, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA.
You may submit comments as follows:
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.” FDA 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
Marieann Brill, Office of the Commissioner, Food and Drug
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Marieann Brill (See,
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA and Agency) is withdrawing approval of an abbreviated new drug application (ANDA), held by Watson Laboratories, Inc. (Watson), for prescription pain medications that contain more than 325 milligrams (mg) of acetaminophen. Watson has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing.
Approval is withdrawn as of January 23, 2018.
Jane Baluss, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6278, Silver Spring, MD 20993-0002, 301-796-3469.
In the
In a letter dated November 22, 2016, Watson voluntarily requested that FDA withdraw approval of its ANDA 074699 for Pentazocine and Acetaminophen Tablets, 25 mg/650 mg, and waived its opportunity for a hearing. The letter also stated that the product was not manufactured or distributed after January 14, 2014.
Therefore, under § 314.150(d), approval of this ANDA, and all amendments and supplements thereto, is withdrawn (see
The safety issue discussed in this document and the January 14, 2011,
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by March 26, 2018.
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 March 26, 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
Amber Sanford, Office of Operations,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
In the
This draft guidance describes the information that the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires in an MRTPA submission as well as FDA's recommendations regarding the scientific evidence that should be contained in a MRTPA for FDA to make an assessment and conduct an ongoing review of modified risk tobacco products (MRTPs). The draft guidance also permits the filing of a single application for any MRTP that is also a new tobacco product under section 910 of the FD&C Act (21 U.S.C. 387k). The draft guidance discusses, among other things: (1) Who submits MRTPAs; (2) when to submit a MRTPA; (3) what information section 911 of the FD&C Act (21 U.S.C. 387j) requires applicants to submit in a MRTPA; (4) what scientific evidence FDA recommends applicants include in a MRTPA; (5) what information should be collected through postmarket surveillance and studies; and (6) how to organize and submit a MRTPA. The purpose of the proposed information collection is to allow FDA to collect statutorily mandated information regarding modified risk tobacco products and other information that will facilitate FDA's effective and efficient review of MRTPAs.
Modified risk tobacco products are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products (section 911(b)(1) of the FD&C Act). No person may introduce or deliver for introduction into interstate commerce any MRTP unless an order issued pursuant to section 911(g) is effective with respect to that product (section 911(a) of the FD&C Act).
Under section 911(d) of the FD&C Act, a MRTPA must contain:
• A description of the proposed product and any proposed advertising and labeling;
• The conditions for using the product;
• The formulation of the product;
• Sample product labels and labeling;
• All documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health-related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health;
• Data and information on how consumers actually use the tobacco product; and
• Such other information as the Secretary may require.
Further, FDA's regulation implementing the National Environmental Policy Act of 1969 requires that “[a]ll applications or petitions requesting agency action require the submission of an [environmental assessment] or a claim of categorical exclusion” (21 CFR 25.15(a)).
Section 911(g) of the FD&C Act describes the demonstrations applicants must make to obtain an order from FDA. Section 911(g)(1) and (2) of the FD&C Act set forth two bases for FDA to issue an order.
A “risk modification order” is an order permitting the introduction or delivery for introduction into interstate commerce of a tobacco product that FDA has found meets the criteria for an order under section 911(g)(1) of the FD&C Act. In order for FDA to issue a risk modification order under section 911(g)(1) of the FD&C Act, the applicant must demonstrate that the proposed modified risk tobacco product, as it is actually used by consumers, will:
• Significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and
• Benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.
An “exposure modification order” is an order permitting the introduction or delivery for introduction into interstate commerce of a tobacco product that reduces or eliminates exposure to a substance and for which the available scientific evidence suggests that a measurable and substantial reduction in morbidity and mortality is likely to be demonstrated in future studies. In order for FDA to issue an exposure modification order, the applicant must satisfy all of the criteria for issuance of an order under section 911(g)(2) of the FD&C Act.
FDA may issue an exposure modification order under section 911(g)(2) of the FD&C Act (the “special rule”) if it determines that the applicant has demonstrated that:
• Such an order would be appropriate to promote the public health;
• Any aspect of the label, labeling, and advertising for the product that would cause the product to be a MRTP is limited to an explicit or implicit representation that the tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke;
• Scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards for obtaining an order under section 911(g)(1); and
• The scientific evidence that is available without conducting long-term epidemiological studies demonstrates
Furthermore, for FDA to issue an exposure modification order, FDA must find that the applicant has demonstrated that:
• The magnitude of overall reductions in exposure to the substance or substances, which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances;
• The product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users;
• Testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product is or has been demonstrated to be less harmful, or presents or has been demonstrated to present less of a risk of disease than one or more other commercially marketed tobacco products; and
• Issuance of the exposure modification order is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products (section 911(g)(2)(B) of the FD&C Act).
In evaluating the benefit to health of individuals and of the population as a whole under section 911(g)(1) and (2) of the FD&C Act, FDA must take into account:
• The relative health risks the MRTP presents to individuals;
• The increased or decreased likelihood that existing tobacco product users who would otherwise stop using such products will switch to using the modified risk tobacco product;
• The increased or decreased likelihood that persons who do not use tobacco products will start using the modified risk tobacco product;
• The risks and benefits to persons from the use of the MRTP compared to the use of smoking cessation drug or device products approved by FDA to treat nicotine dependence; and
• Comments, data, and information submitted to FDA by interested persons (section 911(g)(4) of the FD&C Act).
Furthermore, FDA must ensure that the advertising and labeling of the MRTP enable the public to comprehend the information concerning modified risk and to understand the relative significance of such information in the context of total health and in relation to all of the tobacco-related diseases and health conditions (section 911(h)(1) of the FD&C Act).
FDA intends to determine whether it will issue an order under section 911(g) within 360 days after the receipt of a complete application and will issue such an order only if the application satisfies all the applicable requirements in section 911 of the FD&C Act.
A risk modification order issued under section 911(g)(1) will be effective for the period of time specified in the order issued by FDA (section 911(h)(4) of the FD&C Act). An applicant to whom a risk modification order is issued under section 911(g)(1) must conduct postmarket surveillance and studies (section 911(i)(1) of the FD&C Act).
An exposure modification order issued under section 911(g)(2) of the FD&C Act will be effective for a term of not more than 5 years. FDA may renew an exposure modification order if the applicant files a new application, and FDA finds that the requirements for such order under section 911(g)(2) continue to be satisfied (section 911(g)(2)(C)(i) of the FD&C Act). Further, an exposure modification order will be conditioned on the applicant's agreement to conduct postmarket surveillance and studies and to submit the results of such surveillance and studies to FDA annually (section 911(g)(2)(C)(ii) and (iii) of the FD&C Act).
The postmarket surveillance and studies that all applicants who receive orders are required to conduct are intended to determine the effect of issuance of an order on consumer perception, behavior, and health, and enable FDA to review the accuracy of the determinations upon which an order was based (section 911(g)(2)(C)(ii) and 911(i)(1) of the FD&C Act). An applicant who receives a risk modification order must also conduct postmarket surveillance and studies that provide information FDA determines is otherwise necessary regarding the use or health risks involving the tobacco product (section 911(i)(1) of the FD&C Act).
If the proposed MRTP is a new tobacco product within the meaning of section 910(a)(1), the new tobacco product must satisfy any applicable premarket review requirements under section 910 of the FD&C Act, in addition to any requirements under section 911 of the FD&C Act. A new tobacco product must be found to be substantially equivalent, exempt from the requirement to obtain a substantial equivalence determination, or have a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. The collections of information relating to premarket review described in the “Guidance for Industry: Section 905(j) Reports: Demonstrating Substantial Evidence for Tobacco Products” (OMB control number 0910-0673), 21 CFR part 1107 (“Establishment Registration, Product Listing, and Substantial Equivalence Reports”) (OMB control number 0910-0684), and “Deeming Tobacco Products To Be Subject to the FD&C Act ” (OMB control number 0910-0768) have been previously approved by OMB. An applicant may file the appropriate report or application to satisfy any applicable premarket review requirements and a separate application under section 911 of the FD&C Act. To the extent data or information contained in the premarket review portion of the application is also relevant to or required for the modified risk determination, FDA encourages the applicant to cross-reference that data or information rather than duplicate it in the modified risk portion of the application. Additionally, due to the many similarities between the content requirements of sections 910(b)(1) (for premarket tobacco applications (PMTAs)) and 911(d) (for MRTPAs) of the FD&C Act, we recommend submitting a single application to seek both a marketing order under section 910 of the FD&C Act and a modified risk order under section 911 of the FD&C Act. The single application must include the information required for premarket review under section 910(b) of the FD&C Act, as well as the information required to support issuance of an order under section 911(g) of the FD&C Act.
FDA estimates the burden of this collection of information as follows:
Table 1 describes the annual reporting burden as a result of submitting a MRTPA. FDA estimates that it will receive three MPRTAs annually and that it will take the applicant 10,000 hours per response to conduct studies and collect the information needed to support an MRTPA. FDA is also including an estimation of the burden associated with preparing environmental analyses. FDA estimates that it will take an additional 320 hours to prepare any environmental analyses. FDA encourages persons considering developing a MRTPA to meet with the Center for Tobacco Products to discuss MRTPA submission and investigational requirements. FDA anticipates that eight respondents considering developing MRTPAs may request meetings with FDA. FDA estimates it will take 40 hours per response to prepare a meeting request, including background information.
Section 911 of the FD&C Act requires applicants to whom FDA issues orders to conduct postmarket surveillance and studies and submit relevant information to FDA on an annual basis. Applicants must submit and receive FDA approval of surveillance protocols. FDA estimates that it will take 5,000 hours per response to collect and submit the protocol information to FDA, conduct the postmarket surveillance and studies and to submit results of postmarket surveillance and studies to FDA annually. FDA expects five respondents to carry out postmarket surveillance and studies annually.
Because orders issued under section 911(g) of the FD&C Act are valid for only a set number of years, FDA expects applicants will submit requests for renewal. Because the dates on which orders are issued and the length of the period for which the order is valid will vary, FDA expects one request for renewal annually. FDA estimates that it will take 1,000 hours to prepare the request for renewal.
The estimated total burden hours for this collection of information is estimated to be 57,280. These burden estimates were computed using FDA staff expertise and by reviewing comments received from recent FDA information collections for other tobacco-related initiatives. In addition, FDA notes that due to the many similarities between the content requirements of sections 910(b)(1) (from PMTAs) and 911(d) (for MRTPAs) of the FD&C Act, and the likelihood that many respondents will submit joint PMTAs and MRTPAs, or cross-reference the applications, that part of the collection of information burden for respondents submitting an MRTPA will be captured in the preparation of the PMTA.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). The initial implementation timetable for submitting standardized study data in electronic format was 24 months for NDAs, ANDAs, and applications, and 36 months for certain INDs after publication of the final guidance “Providing Regulatory Submissions in Electronic Format—Standardized Study” in December 2014. When future updates to study data standards listed in the FDA Data Standards Catalog (Catalog) occur, these updated standards will be required in studies with a start date no earlier than 12 months after a
You may submit comments as follows:
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
Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1115, Silver Spring, MD 20993-0002, 301-796-5333,
On December 17, 2014, FDA published final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Standardized Study Data” posted on FDA's Study Data Standards Resources web page at
When future version updates to supported study data standards and new study data standards are announced in the
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry #245 entitled “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.” This draft guidance document, when finalized, will help animal food facilities comply with the requirements for hazard analysis and risk-based preventive controls under our regulation “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.”
Submit either electronic or written comments on the draft guidance by July 23, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Jenny Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246,
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public (human and animal) health by helping to ensure the safety and security of the food supply. FSMA enables FDA to focus more on preventing animal food safety problems rather than relying primarily on reacting to problems after they occur.
Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d). We have established regulations to implement the hazard analysis and risk-based preventive controls requirements within part 507 (21 CFR part 507).
We are announcing the availability of a draft guidance for industry #245 entitled “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.” This multi-chapter draft guidance for industry is intended to
• Introduction
• Chapter One—The Food Safety Plan
• Chapter Two—Conducting a Hazard Analysis
• Chapter Three—Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Animal Food
• Chapter Four—Preventive Controls
• Chapter Five—Overview of Preventive Control Management Components
We intend to announce the availability for public comment of additional chapters of the draft guidance as we complete them.
This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on how to comply with the hazard analysis and risk-based preventive controls requirements for the regulation “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 507 have been approved under OMB control number 0910-0789.
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice of availability; extension of comment period.
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the
FDA is extending the comment period on the document published December 15, 2017 (82 FR 59623), by an additional 30 days. Submit either electronic or written comments on the draft guidance by March 15, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
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
Joshua Silverstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-796-5155; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
In the
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the Federal Food, Drug, and Cosmetic Act. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866.
The Agency has received a request for a 30-day extension of the comment period. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response.
FDA has considered the request and is extending the comment period for the notice of availability for 30 days, until March 15, 2018. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by March 26, 2018.
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 March 26, 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
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,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
All blood and blood components introduced or delivered for introduction into interstate commerce are subject to section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)). Section 351(a) requires that manufacturers of biological products, which include blood and blood components intended for further manufacturing into products, have a license, issued upon a demonstration that the product is safe, pure, and potent and that the manufacturing establishment meets all applicable standards, including those prescribed in the FDA regulations designed to ensure the continued safety, purity, and potency of the product. In addition, under section 361 of the PHS Act (42 U.S.C. 264), by delegation from the Secretary of Health and Human Services, FDA may make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.
Section 351(j) of the PHS Act states that the Federal Food, Drug, and Cosmetic Act (FD&C Act) also applies to biological products. Blood and blood components for transfusion or for further manufacturing into products are drugs, as that term is defined in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)). Because blood and blood components are drugs under the FD&C Act, blood and plasma establishments must comply with the provisions and related regulatory scheme of the FD&C Act. For example, under section 501 of the FD&C Act (21 U.S.C. 351(a)), drugs are deemed “adulterated” if the methods used in their manufacturing, processing, packing, or holding do not conform to CGMP and related regulations.
The CGMP regulations (part 606) (21 CFR part 606) and related regulations implement FDA's statutory authority to ensure the safety, purity, and potency of blood and blood components. The public health objective in testing human blood donations for evidence of relevant transfusion-transmitted infections and in notifying donors is to prevent the transmission of relevant transfusion-transmitted infections. For example, the “lookback” requirements are intended to help ensure the continued safety of the blood supply by providing necessary information to consignees of blood and blood components and appropriate notification of recipients of blood components that are at increased risk for transmitting human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
The information collection requirements in the CGMP, donation testing, donor notification, and “lookback” regulations provide FDA with the necessary information to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections.
The recordkeeping requirements serve preventive and remedial purposes. The third-party disclosure requirements identify various blood and blood components and important properties of the product, demonstrate that the CGMP requirements have been met, and facilitate the tracing of a product back to its original source. The reporting requirements inform FDA of certain information that may require immediate corrective action.
Under the reporting requirements, § 606.170(b), in brief, requires that facilities notify FDA's Center for Biologics Evaluation and Research
Section 610.40(g)(2) (21 CFR 610.40(g)(2)) requires an establishment to obtain written approval from FDA to ship human blood or blood components for further manufacturing use prior to completion of testing for evidence of infection due to relevant transfusion-transmitted infections.
Section 610.41(b) allows for a previously deferred donor to subsequently be found to be an eligible donor of blood and blood components by a requalification method or process found acceptable for such purposes by FDA.
Section 610.40(h)(2)(ii)(A), in brief, requires an establishment to obtain written approval from FDA to use or ship human blood or blood components found to be reactive by a screening test for evidence of infection due to a relevant transfusion-transmitted infection(s) or collected from a donor deferred under § 610.41(a).
In addition, § 630.35(b) (21 CFR 630.35(b)) allows for a previously deferred donor, deferred for reasons other than § 610.41(b) to become requalified for donation by a method or process found acceptable for such purpose by FDA.
Under the third-party disclosure requirements, § 606.145(c) requires transfusion services to notify certain blood collection establishments concerning bacterial contamination of platelets. In table 3, FDA estimates that for the approximately 4,961 transfusion services, there would be 1,400 total notifications per year to blood collection establishments (700 notifications that platelets are bacterially contaminated and 700 notifications per year concerning the identity or non-identity of the species of the contaminating organism).
Section 610.40(c)(1)(ii) in part 610, in brief, requires that each donation dedicated to a single identified recipient be labeled as required under § 606.121 and with a label containing the name and identifying information of the recipient. The information collection requirements under § 606.121 are part of usual and customary business practice.
Sections 610.40(h)(2)(ii)(C) and (D), in brief, require an establishment to label certain reactive human blood and blood components with the appropriate screening test results for evidence of infection due to the identified relevant transfusion-transmitted infection(s), and, if they are intended for further manufacturing use into products, to include a statement on the label indicating the exempted use specifically approved by FDA. Also, § 610.40(h)(2)(vi) requires each donation of human blood or blood components, excluding Source Plasma, that tests reactive by a screening test for syphilis and is determined to be a biological false positive to be labeled with both test results.
Section 610.42(a) requires a warning statement “indicating that the product was manufactured from a donation found to be reactive by a screening test for evidence of infection due to the identified relevant transfusion-transmitted infection(s)” in the labeling for medical devices containing human blood or a blood component found to be reactive by a screening test for evidence of infection due to a relevant transfusion-transmitted infection(s) or syphilis.
In addition, § 630.35(b) allows for a previously deferred donor, deferred for reasons other than § 610.41(b) to become requalified for donation by a method or process found acceptable for such purpose by FDA.
In brief, §§ 610.46 and 610.47 require blood collecting establishments to establish, maintain, and follow an appropriate system for performing HIV and HCV “lookback” when: (1) A donor tests reactive for evidence of HIV or HCV infection or (2) the collecting establishment becomes aware of other reliable test results or information indicating evidence of HIV or HCV infection (see §§ 610.46(a)(1) and 610.47(a)(1)). The requirement for “an appropriate system” requires the collecting establishment to design standard operating procedures (SOPs) to identify and quarantine all blood and blood components previously collected from a donor who later tests reactive for evidence of HIV or HCV infection, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection. Within 3 calendar days of the donor testing reactive by an HIV or HCV screening test or the collecting establishment becoming aware of other reliable test results or information, the collecting establishment must, among other things, notify consignees to quarantine all identified previously collected in-date blood and blood components (§§ 610.46(a)(1)(ii)(B) and 610.47(a)(1)(ii)(B)) and, within 45 days, notify the consignees of supplemental test results, or the results of a reactive screening test if there is no available supplemental test that is approved for such use by FDA (§§ 610.46(a)(3) and 610.47(a)(3)).
Consignees also must establish, maintain, and follow an appropriate system for performing HIV and HCV “lookback” when notified by the collecting establishment that they have received blood and blood components previously collected from donors who later tested reactive for evidence of HIV or HCV infection, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection in a donor (§§ 610.46(b) and 610.47(b)). This provision for a system requires the consignee to establish SOPs for, among other things, notifying transfusion recipients of blood and blood components, or the recipient's physician of record or legal representative, when such action is indicated by the results of the supplemental (additional, more specific) tests or a reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an investigational new drug application (IND) or an investigational device exemption (IDE), is exempted for such use by FDA. The consignee must make reasonable attempts to perform the notification within 12 weeks of receipt of the supplemental test result or receipt of a reactive screening test result when there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA (§§ 610.46(b)(3) and 610.47(b)(3)).
Section 630.40(a) requires an establishment to make reasonable attempts to notify any donor who has been deferred as required by § 610.41(a), or who has been determined not to be eligible as a donor. Section 630.40(d)(1) requires an establishment to provide certain information to the referring physician of an autologous donor who is deferred based on the results of tests as described in § 610.41.
Under the recordkeeping requirements, § 606.100(b), in brief, requires that written SOPs be maintained for all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components used for transfusion and further manufacturing purposes. Section 606.100(c) requires the review of all records pertinent to the lot or unit of blood prior to release or distribution. Any unexplained discrepancy or the failure of a lot or unit of final product
In brief, § 606.110(a) provides that the use of plateletpheresis and leukapheresis procedures to obtain a product for a specific recipient may be at variance with the additional standards for that specific product if, among other things, the physician determines and documents that the donor's health permits plateletpheresis or leukapheresis. Section 606.110(b) requires establishments to request prior approval from CBER for plasmapheresis of donors who do not meet donor requirements. The information collection requirements for § 606.110(b) are approved under OMB control number 0910-0338 and, therefore, are not reflected in the tables of this document.
Section 606.151(e) requires that SOPs for compatibility testing include procedures to expedite transfusion in life-threatening emergencies; records of all such incidents must be maintained, including complete documentation justifying the emergency action, which must be signed by a physician.
Section 606.171 requires establishments to establish and maintain procedures related to product deviations. The burden for the recordkeeping requirements under § 606.171 are included under § 606.100.
So that each significant step in the collection, processing, compatibility testing, storage, and distribution of each unit of blood and blood components can be clearly traced, § 606.160 requires that legible and indelible contemporaneous records of each such step be made and maintained for no less than 10 years. Section 606.160(b)(1)(viii) requires records of the quarantine, notification, testing and disposition performed under the HIV and HCV “lookback” provisions. Furthermore, § 606.160(b)(1)(x) requires a blood collection establishment to maintain records of notification of donors deferred or determined not to be eligible for donation, including appropriate followup. Section 606.160(b)(1)(xi) requires an establishment to maintain records of notification of the referring physician of a deferred autologous donor, including appropriate followup.
Section 606.165, in brief, requires that distribution and receipt records be maintained to facilitate recalls, if necessary.
Section 606.170(a) requires records to be maintained of any reports of complaints of adverse reactions arising as a result of blood collection or transfusion. Each such report must be thoroughly investigated, and a written report, including conclusions and followup, must be prepared and maintained. Section 606.170(a) also requires that when an investigation determines that the product caused the transfusion reaction, copies of all such written reports must be forwarded to and maintained by the manufacturer or collecting facility.
Section 610.40(g)(1) requires an establishment to appropriately document a medical emergency for the release of human blood or blood components prior to completion of required testing.
Under § 630.15(a)(1)(ii)(B), FDA requires that for a dedicated donation based on the intended recipient's documented exceptional medical need, the responsible physician determines and documents that the health of the donor would not be adversely affected by donating.
Under § 630.20(c), a collection establishment may collect blood and blood components from a donor who is determined to be not eligible to donate under any provision of § 630.10(e) and (f) or § 630.15(a), if the donation is restricted for use solely by a specific transfusion recipient based on documented exceptional medical need and the responsible physician determines and documents that the donor's health permits the collection procedure, and that the donation presents no undue medical risk to the transfusion recipient.
In addition to the CGMP regulations in part 606, there are regulations in part 630 that include requirements for blood and blood components intended for transfusion or further manufacturing use, and part 640 that require additional standards for certain blood and blood products as follows: Sections 630.5(b)(1)(i), 630.5(d), 630.10(c)(1) and (2), 630.10(f)(2) and (4), 630.10(g)(2)(i), 630.15(a)(1)(ii)(A) and (B), 630.15(b)(2), (b)(7)(i) and (iii), 630.20(a) and (b); 640.25(b)(4) and (c)(1); 640.21(e)(4); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 640.56(b) and (d); 630.15(b)(2); 640.65(b)(2)(i); 640.66; 640.71(b)(1); 640.72; 640.73; and 640.76(a) and (b). The information collection requirements and estimated burdens for these regulations are included in the part 606 burden estimates, as described in tables 1 and 2.
Respondents to this collection of information are licensed and unlicensed blood establishments that collect blood and blood components, including Source Plasma and Source Leukocytes, inspected by FDA, and transfusion services inspected by Centers for Medicare and Medicaid Services (CMS). Based on information received from CBER's database systems, there are approximately 569 licensed Source Plasma establishments and approximately 1,054 licensed blood collection establishments, for an estimated total of 1,623 (569 + 1,054) licensed blood collection establishments. Also, there are an estimated total of 680 unlicensed, registered blood collection establishments for an approximate total of 2,303 collection establishments (569 + 1,054 + 680 = 2,303 establishments). Of these establishments, approximately 901 perform plateletpheresis and leukopheresis. These establishments annually collect approximately 53.3 million units of Whole Blood and blood components, including Source Plasma and Source Leukocytes, and are required to follow FDA “lookback” procedures. In addition, there are another estimated 4,961 establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (formerly referred to as facilities approved for Medicare reimbursement) that transfuse blood and blood components.
The following reporting and recordkeeping estimates are based on information provided by industry, CMS, and FDA experience. Based on information from industry, we estimate that there are approximately 38.3 million donations of Source Plasma from approximately 2 million donors and approximately 15 million donations of Whole Blood and apheresis Red Blood Cells including approximately 34,500 (approximately 0.23 percent of 15 million) autologous donations, from approximately 10.9 million donors. Assuming each autologous donor makes an average of 1.1 donations, FDA estimates that there are approximately 31,364 autologous donors (34,500 autologous/1.1 average donations).
FDA estimates that approximately 0.19 percent (21,000/10,794,000) of the 72,000 donations that are donated specifically for the use of an identified recipient would be tested under the dedicated donors' testing provisions in § 610.40(c)(1)(ii).
Under §§ 610.40(g)(2) and (h)(2)(ii)(A), Source Leukocytes, a licensed product that is used in the manufacture of interferon, which requires rapid preparation from blood, is currently shipped prior to completion of testing for evidence of relevant transfusion-transmitted infections. Shipments of Source Leukocytes are approved under a biologics license application and each shipment does not have to be reported to the Agency.
According to CBER's database system, there are approximately 15 licensed manufacturers that ship known reactive human blood or blood components under §§ 610.40(h)(2)(ii)(C) and (D). FDA estimates that each manufacturer would ship an estimated 1 unit of human blood or blood components per month (12 per year) that would require two labels; one as reactive for the appropriate screening test under § 610.40(h)(2)(ii)(C), and the other stating the exempted use specifically approved by FDA under § 610.40(h)(2)(ii)(D).
Based on information received from industry, we estimate that approximately 7,544 donations that test reactive by a screening test for syphilis and are determined to be biological false positives by additional testing annually. These units would be labeled according to § 610.40(h)(2)(vi).
Human blood or a blood component with a reactive screening test, as a component of a medical device, is an integral part of the medical device,
FDA estimates that approximately 3,021 repeat donors will test reactive on a screening test for HIV. We also estimate that an average of three components was made from each donation. Under §§ 610.46(a)(1)(ii)(B) and (a)(3), this estimate results in 9,063 (3,012 × 3) notifications of the HIV screening test results to consignees by collecting establishments for the purpose of quarantining affected blood and blood components, and another 9,063 (3,021 × 3) notifications to consignees of subsequent test results.
We estimate that approximately 4,961 consignees will be required under § 610.46(b)(3) to notify transfusion recipients, their legal representatives, or physicians of record an average of 0.35 times per year resulting in a total number of 1,755 (585 confirmed positive repeat donors × 3) notifications. Also under § 610.46(b)(3), we estimate and include the time to gather test results and records for each recipient and to accommodate multiple attempts to contact the recipient.
Furthermore, we estimate that approximately 6,799 repeat donors per year would test reactive for antibody to HCV. Under §§ 610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments would notify the consignee 2 times for each of the 20,397 (6,799 × 3 components) components prepared from these donations, once for quarantine purposes and again with additional HCV test results for a total of 40,794 (2 × 20,397 notifications) as an annual ongoing burden. Under § 610.47(b)(3), we estimate that approximately 4,961 consignees would notify approximately 2,050 recipients or their physicians of record annually.
Based on industry estimates, approximately 14.3 percent of approximately 9 million potential donors (1,287,000 donors) who come to donate annually are determined not to be eligible for donation prior to collection because of failure to satisfy eligibility criteria. It is the usual and customary business practice of approximately 1,734 (1,054 + 680) blood collecting establishments to notify onsite and to explain why the donor is determined not to be suitable for donating. Based on such available information, we estimate that two-thirds (1,156) of the 1,734 blood collecting establishments provided onsite additional information and counseling to a donor determined not to be eligible for donation as usual and customary business practice. Consequently, we estimate that only approximately one-third, or 578 of the 1,734 blood collecting establishments would need to provide, under § 630.40(a), additional information and onsite counseling to the estimated 429,000 (one-third of approximately 1,287,000) ineligible donors.
It is estimated that another 4.5 percent of 10 million potential donors (450,000 donors) are deferred annually based on test results. We estimate that approximately 95 percent of the establishments that collect 99 percent of the blood and blood components notify donors who have reactive test results for HIV, Hepatitis B Virus, HCV, Human T-Lymphotropic Virus, and syphilis as usual and customary business practice. Consequently, 5 percent of the 1,623 licensed establishments (81) collecting 1 percent (4,050) of the deferred donors (405,000) would notify donors under § 630.40(a).
As part of usual and customary business practice, collecting establishments notify an autologous donor's referring physician of reactive test results obtained during the donation process required under § 630.40(d)(1). However, we estimate that approximately 5 percent of the 1,054 blood collection establishments (53) may not notify the referring physicians of the estimated 2 percent of 31,364 autologous donors with the initial reactive test results (627) as their usual and customary business practice.
The recordkeeping chart reflects the estimate that approximately 95 percent of the recordkeepers, which collect 99 percent of the blood supply, have developed SOPs as part of their customary and usual business practice. Establishments may minimize burdens associated with CGMP and related regulations by using model standards developed by industries' accreditation organizations. These accreditation organizations represent almost all registered blood establishments.
Under § 606.160(b)(1)(ix), we estimate the total annual records based on the approximately 1,287,000 donors determined not to be eligible to donate and each of the estimated 1,692,000 (1,287,000 + 405,000) donors deferred based on reactive test results for evidence of infection because of relevant transfusion-transmitted infections. Under § 606.160(b)(1)(xi), only the 1,734 registered blood establishments collect autologous donations and, therefore, are required to notify referring physicians. We estimate that 4.5 percent of the 31,364 autologous donors (1,411) will be deferred under § 610.41, which in turn will lead to the notification of their referring physicians.
Under § 610.41(b), FDA estimates that there would be 25 submissions for requalification of donors each requiring 7 hours per submission. In addition, FDA estimates that there would be only 3 notifications for requalification of donors under § 630.35(b) which would also require 7 hours for each submission.
FDA permits the shipment of untested or incompletely tested human blood or blood components in rare medical emergencies and when appropriately documented (§ 610.40(g)(1). We estimate the recordkeeping under § 610.40(g)(1) to be minimal with one or fewer occurrences per year. The reporting of test results to the consignee in § 610.40(g) is part of the usual and
The average burden per response (hours) and average burden per recordkeeping (hours) are based on estimates received from industry or FDA experience with similar reporting or recordkeeping requirements.
FDA estimates the burden of this collection of information as follows:
The burden for this information collection has changed since the last OMB approval. Because of a slight decrease in the number of blood establishments during the last 3 years, FDA has decreased our recordkeeping and third party disclosure burden estimates.
Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
The Department of Health and Human Services (HHS) announces the third meeting of the Tick-Borne Disease Working Group (Working Group) on February 12, 2018, from 12:00 p.m. to 4:00 p.m., Eastern Time. For this third meeting, the Working Group will focus on mapping out the work of the six Subcommittee Meeting Working Groups that were established on December 12, 2017. These subcommittees were established to assist the Working Group with the development of the report to Congress and the HHS Secretary as required by the 21st Century Cures Act. The subcommittees are:
1. Disease Vectors, Surveillance and Prevention (includes epidemiology of tick-borne diseases);
2. Pathogenesis, Transmission, and Treatment;
3. Testing and Diagnostics (including laboratory-based diagnoses and clinical-diagnoses);
4. Access to Care Services and Support to Patients;
5. Vaccine and Therapeutics; and
6. Other Tick-Borne Diseases and Co-infections.
February 12, 2018, from 12:00 p.m. to 4:00 p.m., Eastern Time.
This will be a virtual meeting that is held via webcast. Members of the public may attend the meeting via webcast and instructions for attending this virtual meeting will be posted one week prior to the meeting at:
James Berger, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services; via email at
At this meeting, the Working Group will also hear about one or more examples of other efforts that have been successfully undertaken to define a national or statewide approach to preventing, monitoring, diagnosing, and treating people with tick-borne diseases. In addition, federal resources, within and outside of HHS, that may be of use to the subcommittees as they do their work, such as the Department of Health and Human Services Internal Working Group on Lyme and Other Tick-Borne Diseases, will be presented.
The Working Group invites public comment on issues related to the Working Group's charge. Comments may be provided over the phone during the meeting or in writing. Persons who wish to provide comments by phone should review directions at
Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. This meeting will be held online via webinar and is open to the public. The Committee will discuss the nation's health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will develop recommendations regarding: Leading Health Indicators; the setting of targets for a more focused set of measurable, nationally representative objectives; the roles of health and well-being, health equity, and law in Healthy People 2030; and the creation of a logic model for communicating the role of Healthy People 2030, disease prevention, and health promotion. Pursuant to the Committee's charter, the Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.
The Committee will meet on February 28, 2018, from 2:00 p.m. to 5:00 p.m. Eastern Time (ET).
The meeting will be held online via webinar. To register to attend the meeting, please visit the Healthy People website at
Emmeline Ochiai, Designated Federal Official, Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health, Office of Disease Prevention and Health Promotion, 1101 Wootton Parkway, Room LL-100, Rockville, MD 20852, (240) 453-8280 (telephone), (240) 453-8281 (fax). Additional information is available on the Healthy People website at
The names and biographies of the Committee members are available at
To join the Committee meeting, individuals must pre-register at the Healthy People website at
42 U.S.C. 300u and 42 U.S.C. 217a. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 is governed by provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C., App.) which sets forth standards for the formation and use of federal advisory committees.
National Vaccine Program Office, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that a meeting is scheduled to be held for the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public; public comment sessions will be held during the meeting.
The meeting will be held on February 7 and 8, 2018. The meeting times and agenda will be posted on the NVAC website at
U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Great Hall, 200 Independence Avenue SW, Washington, DC 20201. The meeting can also be accessed through a live webcast on both days of the meeting. For more information, visit
Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or participate in the public comment session should register at
National Vaccine Program Office, U.S. Department of Health and Human Services, Room 715H, Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201. Phone: (202) 690-5566; email:
Pursuant to Section 2101 of the Public Health Service Act (42 U.S.C. 300aa-1), the Secretary of Health and Human Services was mandated to establish the National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The NVAC was established to provide advice and make recommendations to the Director of the National Vaccine Program on matters related to the Program's responsibilities. The Assistant Secretary for Health serves as Director of the National Vaccine Program. During the February 2018 NVAC meeting, sessions will consist of presentations on vaccine innovation, including the current status of adjuvants in vaccines, universal influenza, and an overview on the Secretary of the Department of Health and Human Services' Report to Congress on Vaccine Innovation in response to the 21st Century Cures Act; a report out on the recently approved Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria Report, “Incentivizing the Development of Vaccines, Therapeutics, and Diagnostics to Combat Antibiotic Resistant Bacteria”; disparities in adult immunizations; and an update on strategies to support improving coverage for human papillomavirus vaccine. Please note that agenda items will be related to the charge of the Committee and are subject to change as priorities dictate. Information on the final meeting agenda will be posted prior to the meeting on the NVAC website:
Public attendance at the meeting is limited to the available space. Individuals who plan to attend in person and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the National Vaccine Program Office at the address/phone number listed above at least one week prior to the meeting. For those unable to attend in person, a live webcast will be available. More information on registration and accessing the webcast can be found at
Members of the public will have the opportunity to provide comments at the NVAC meeting during the public comment periods designated on the agenda. Public comments made during the meeting will be limited to three minutes per person to ensure time is allotted for all those wishing to speak. Individuals are also welcome to submit their written comments. Written comments should not exceed three pages in length. Individuals submitting written comments should email their comments to the National Vaccine Program Office (
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the Task Force on Research Specific to Pregnant Women and Lactating Women.
The meetings will be open to the public, 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.
Public comments are welcome either by filing written comments and/or providing oral comments at the meeting. Oral comments from the public will be scheduled on February 26, 2018, from approximately 10:00 a.m.-10:45 a.m. Any member of the public interested in presenting oral comments on February 26, 2018, should submit a letter of intent, a brief description of the organization represented, and the oral presentation to Ms. Lisa Kaeser (
The submitted presentations and any written comments will be formatted to be posted on the PRGLAC website for the record. Only one representative of an organization may be allowed to present oral comments. Presentations will be limited to three to five minutes per speaker depending on the number of speakers to be accommodated within the allotted time. Speakers will be assigned a time to speak in the order of the date and time when their request to speak is received. Both printed and electronic copies are requested for the record.
Details and additional information about these meetings can be found at the NICHD website for the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)
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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
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 a meeting of the NHLBI Mentored Patient-Oriented Research Review Committee.
The meeting will be closed to the public in accordance with the provisions set forth in section 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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Clinical Trials Review Committee.
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.
Office of the Chief Information Officer, HUD.
Notice.
HUD submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax:202-395-5806, Email:
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A. The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) 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) The accuracy of the agency'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 those who are to respond: including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of Policy Development and Research, HUD.
Notice.
The Department of Housing and Urban Development (HUD) is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street, SW, Room 4176, Washington, DC 20410-5000; telephone (202) 402-5534 (this is not a toll-free number) or email at
Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410-5000; email Anna P. Guido at
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
(1) Lexington Housing Authority (LHA), Lexington, Kentucky;
(2) Louisville Metro Housing Authority (LMHA), Louisville, Kentucky;
(3) San Antonio Housing Authority (SAHA), San Antonio, Texas; and
(4) District of Columbia Housing Authority (DCHA), Washington, DC.
The impact evaluation's intent is to gain an understanding of the impact of the alternative rent system on the families as well as the administrative burden on Public Housing Agencies (PHAs). Data collection will include the families that are part of the treatment and control groups, as well as PHA staff. Data for this evaluation will be gathered through a variety of methods including informational interviews, direct observation, surveys, and analysis of administrative records. The work covered under this information request is for the 36-month follow-up survey that will document and contextualize administrative data findings related to employment, earnings, and hardship and study participants' experience with the demonstration.
This includes:
• Families with housing vouchers, remaining in the current rent system (control group): up to 3,350.
• Families with housing vouchers, enrolled in the alternative rent system (treatment group): up to 3,310.
All assumptions are reflected in the table below.
This notice solicits comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) 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) The accuracy of the agency'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 those who are to respond, including the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Fish and Wildlife Service, Interior.
Notice.
We (the U.S. Fish and Wildlife Service) invite you to provide us with information and recommendations on animal and plant species to be considered as candidates for U.S. proposals to amend Appendices I and II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES, or the Convention) at the upcoming eighteenth meeting of the Conference of the Parties (CoP18). Such amendments may concern the addition of species to Appendix I or II, the transfer of species from one Appendix to another, or the removal of species from Appendices. We also describe the U.S. approach to preparations for CoP18. We will publish a second
We will consider all information and comments we receive on or before March 26, 2018.
You may submit comments by one of the following methods:
•
•
Rosemarie Gnam, Chief, Division of Scientific Authority, 703-358-1708 (phone); 703-358-2276 (fax); or
We, the U.S. Fish and Wildlife Service, hereby notify you of the convening of 18th meeting of the Conference of the Parties (CoP18) of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES, or the Convention), which is scheduled to be held in Sri Lanka from 23 May to 3 June 2019. We invite you to provide us with information and recommendations on animal and plant species to be considered as candidates
The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES, or the Convention) is an international treaty designed to regulate international trade in certain animal and plant species that are now, or potentially may become, threatened with extinction. These species are included in the Appendices to CITES, which are available on the CITES Secretariat's website at
Currently there are 183 Parties to CITES, 182 countries, including the United States, and one regional economic integration organization, the European Union. The Convention calls for regular meetings of the Conference of the Parties (Conference, or CoP) every 2-3 years, unless the Conference decides otherwise. At these meetings, the Parties review the implementation of CITES, make provisions enabling the CITES Secretariat in Switzerland to carry out its functions, consider amendments to the list of species in Appendices I and II, consider reports presented by the Secretariat, and make recommendations for the improved effectiveness of CITES. Any Party to CITES may propose amendments to Appendices I and II, resolutions, decisions, and agenda items for consideration by all the Parties at the meeting.
This is our first in a series of
Priorities for U.S. submissions to CoP18 continue to be consistent with the overall objective of U.S. participation in the Convention: to maximize the effectiveness of the Convention in the conservation and sustainable use of species subject to international trade. With this in mind, we plan to consider the following factors in determining issues to submit for inclusion in the agenda at CoP18:
(1)
(2)
(3)
The purpose of this notice is to request information and recommendations that will help us identify species that the United States should propose for addition to, removal from, or reclassification in the CITES Appendices, or to identify issues warranting attention by the CITES specialists on zoological and botanical nomenclature. This request is not limited to species occurring in the United States. Any Party may submit proposals concerning animal or plant species occurring in the wild anywhere in the world. We encourage the submission of information on any species for possible inclusion in the Appendices if the species is subject to international trade that is, or may become, detrimental to the survival of the species. We also encourage you to keep in mind the U.S. approach to CoP18, described in this notice in the section U.S. Approach for the Conference of the Parties, when considering which species the United States should propose for inclusion in the Appendices.
We are not necessarily requesting complete proposals, but they are always welcome. However, we are asking you to submit convincing information describing: (1) The status of the species, especially trend information; (2) conservation and management programs for the species, including the effectiveness of enforcement efforts; and (3) the level of international as well as domestic trade in the species, especially trend information. You may also provide any other relevant information, and we appreciate receiving a list of references.
The term “species” is defined in CITES as “any species, subspecies, or
CITES specifies that international trade in any readily recognizable parts or derivatives of animals included in Appendices I or II, or plants included in Appendix I, is subject to the same conditions that apply to trade in the whole organisms. With certain standard exclusions formally approved by the Parties, the same applies to the readily recognizable parts and derivatives of most plant species included in Appendix II. Parts and derivatives often not included (
In 1994, the CITES Parties adopted criteria for inclusion of species in Appendices I and II (in Resolution Conf. 9.24 (Rev. CoP17)). These criteria apply to all listing proposals and are available from the CITES Secretariat's website at
To provide us with information and recommendations on species subject to international trade for possible proposals to amend the Appendices, please include as much of the following information as possible in your submission:
(1) Scientific name and common name;
(2) Population size estimates (including references if available);
(3) Population trend information;
(4) Threats to the species (other than trade);
(5) The level or trend of international trade (as specific as possible, but without a request for new searches of our records);
(6) The level or trend in total take from the wild (as specific as reasonable); and
(7) A short summary statement clearly presenting the rationale for inclusion in, or removal or transfer from, one of the Appendices, including which of the criteria in Resolution Conf. 9.24 (Rev. CoP17) are met.
If you wish to submit more complete proposals for us to consider, please consult Resolution Conf. 9.24 (Rev. CoP17) for the format for proposals and a detailed explanation of each of the categories. Proposals to transfer a species from Appendix I to Appendix II, or to remove a species from Appendix II, must also be in accordance with the precautionary measures described in Annex 4 of Resolution Conf. 9.24 (Rev. CoP17).
The information that you submit will help us decide if we should submit, or co-sponsor with other Parties, a proposal to amend the CITES Appendices. However, there may be qualifying species for which we may decide not to submit a proposal to CoP18. Our decision will be based on a number of factors, including available scientific and trade information; whether or not the species is native to the United States; and, for foreign species, whether or not a proposal is supported or co-sponsored by at least one range country for the species. These factors and others are included in the U.S. Approach for the Conference of the Parties section. We will carefully consider all factors of the U.S. approach when deciding which species the United States should propose for inclusion in the Appendices.
We will consult range countries for foreign species, and for species we share with other countries, after receiving and analyzing the information provided by the public in response to this notice as well as other information available to us.
One important function of the CITES Scientific Authority of each Party is monitoring the international trade in plant and animal species and ongoing scientific assessments of the impact of that trade on species. For native U.S. species included in Appendices I and II, we monitor trade and export permits authorized so that we can prevent overutilization and restrict exports if necessary. We also work closely with the States to ensure that species are correctly listed in the CITES Appendices (or not listed, if listing is not warranted). For these reasons, we actively seek information about U.S. and foreign species subject to international trade.
The next regular meeting of the Conference of the Parties (CoP18) is scheduled to be held in Sri Lanka 23 May to 3 June 2019. The United States must submit any proposals to amend Appendix I or II, or any draft resolutions, decisions, or agenda items for discussion at CoP18, to the CITES Secretariat at least 150 days prior to the start of the meeting. In order to meet this deadline and to prepare for CoP18, we have developed a tentative U.S. schedule.
We plan to publish a
Through a series of additional notices and website postings in advance of CoP18, we will inform you about preliminary negotiating positions on resolutions, decisions, and amendments to the Appendices proposed by other Parties for consideration at CoP18, and about how to obtain observer status
The procedures for developing U.S. documents and negotiating positions for a meeting of the Conference of the Parties to CITES are outlined in 50 CFR 23.87. As noted, we may modify or suspend the procedures outlined there if they would interfere with the timely or appropriate development of documents for submission to the CoP and of U.S. negotiating positions.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review; however, we cannot guarantee that we will be able to do so.
The primary author of this notice is Thomas E.J. Leuteritz, Division of Scientific Authority, U.S. Fish and Wildlife Service.
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Education (BIE) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before March 26, 2018.
Send your comments on this information collection request (ICR) by mail to the Dr. Maureen Lesky, Bureau of Indian Education, 1011 Indian School Road NW, Albuquerque, NM 87104; or by email to
To request additional information about this ICR, contact to Dr. Maureen Lesky by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIE; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIE enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIE minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
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 authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Education (BIE) are proposing to renew an information.
Interested persons are invited to submit comments on or before March 26, 2018.
Send your comments on this information collection request (ICR) by mail to Ms. Juanita Mendoza, Program Analyst, Bureau of Indian Education, U.S. Department of the Interior, 1849 C Street NW, MS 3609-MIB, Washington, DC 20240; or by email to
To request additional information about this ICR, contact Juanita Mendoza by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIE; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIE enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIE minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
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 authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Affairs (BIA) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before February 22, 2018.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact Ms. Laurel Iron Cloud by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A
We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIA; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIA enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIA minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
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 authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Education (BIE) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before February 22, 2018.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact Ms. Jacquelyn Cheek, phone: 202-631-4074. You may also view the ICR at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A
We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIE; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIE enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIE minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of
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 authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
United States International Trade Commission.
Scheduling of public hearing.
The Commission has scheduled a public hearing for March 6, 2018, in connection with the second and third of three investigations on global digital trade: Investigation No. 332-562,
All Commission offices, including the Commission's hearing rooms, are located in the United States International Trade Commission Building, 500 E Street SW, Washington, DC. All written submissions should be addressed to the Secretary, United States International Trade Commission, 500 E Street SW, Washington, DC 20436. The public file for these investigations may be reviewed on the Commission's electronic docket (EDIS) at
For information relating to
In his letter of January 13, 2017, the United States Trade Representative (USTR) requested that the Commission conduct three investigations and prepare three reports relating to global digital trade. The Commission delivered the first of these reports,
The Commission invites members of the public with an interest in the matter to participate in a hearing for the second and third investigations in this series and provide information that relates to the reports that the Commission has been asked to prepare. For the second report (
• Provide qualitative, and to the extent possible, quantitative analysis of measures in key foreign markets (identified in the first report) that affect the ability of U.S. firms to develop and/or supply business-to-business digital products and services abroad; and
• Assess, using case studies or other qualitative and quantitative methods, the impact of these measures on the competitiveness of U.S. firms engaged in the sale of digital products and services, as well as on international trade and investment flows associated with digital products and services related to significant business-to-business technologies.
The Commission expects to deliver this second report to the USTR by October 29, 2018.
For the third report (
• Provide qualitative, and to the extent possible, quantitative analysis of measures in key foreign markets (identified in the first report) that affect the ability of U.S. firms to develop and/or supply business-to-consumer digital products and services abroad; and
• Assess, using case studies or other qualitative and quantitative methods, the impact of these measures on the competitiveness of U.S. firms engaged in the sale of digital products and services, as well as on international trade and investment flows associated with digital products and services related to significant business-to-consumer technologies.
The Commission expects to deliver this third report to the USTR by March 29, 2019.
All information, including CBI, submitted in these two investigations may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel (a) for cybersecurity purposes or (b) in monitoring user activity on U.S. government classified networks. The Commission will not otherwise disclose any CBI in a manner that would reveal the operations of the firm supplying the information.
Notice of institution of the second and third investigations in this series was published in the
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-593-596 and 731-TA-1401-1406 (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 large diameter welded pipe from Canada, China, Greece, India, Korea, and Turkey, provided for in subheadings 7305.11, 7305.12, 7305.19, 7305.31, and 7305.39 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, India, Korea, and Turkey. Unless the Department of Commerce extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by March 5, 2018. The Commission's views must be transmitted to Commerce within five business days thereafter, or by March 12, 2018.
January 17, 2018.
Abu Kanu ((202) 205-2597), 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 (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207).
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.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 12) of the presiding administrative law judge (“ALJ”), granting a joint motion to terminate the above-captioned investigation based on settlement and license agreements.
Cathy Chen, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2392. Copies of non-confidential documents filed in connection with this investigation are or will be 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, Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
The Commission instituted this investigation on September 15, 2017, based on a complaint filed by Broadcom Limited of San Jose, California; and Avago Technologies General IP (Singapore) Pte. Ltd. of Singapore (collectively, “Broadcom”). 82 FR 43404 (Sep. 15, 2017). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain wireless audio systems and components thereof by reason of infringement of claim 20 of U.S. Patent No. 6,684,060. The complaint further alleges that an industry in the United States exists as required by 19 U.S.C. 1337(a)(2). The notice of investigation named DTS, Inc. of Calabasas, California; Phorus, Inc. of Calabasas, California; MartinLogan, Ltd. of Lawrence, Kansas; Paradigm Electronics Inc. of Ontario, Canada; Anthem Electronics, Inc. of Ontario, Canada; Wren Sound Systems, LLC of Phoenixville, Pennsylvania; McIntosh Laboratory, Inc. of Binghamton, New York; Definitive Technology of Owings Mills, Maryland; and Polk Audio Inc. of Vista, California, as respondents. The Office of Unfair Import Investigations is also a party in this investigation.
On December 18, 2017, Broadcom and Respondents filed a joint motion to terminate the investigation in its entirety on the basis of settlement and license agreements. The ALJ issued the subject ID granting the motion on December 20, 2017. The ALJ found that the motion complies with Commission Rules and termination of the investigation will not adversely affect the public interest. No petitions for review were filed.
The Commission has determined not to review the ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in Part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (“ALJ”) initial determination (“ID”) (Order No. 27), which terminated the investigation on the basis of settlement.
Sidney A. Rosenzweig, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 708-2532. Copies of non-confidential documents filed in connection with this investigation are or will be 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, Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
The Commission instituted this investigation on June 13, 2017, based upon a complaint filed by ARRIS Enterprises LLC of Sewanee, Georgia (“ARRIS”). 82 FR 27078 (June 13, 2017). The complaint alleged violations of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain consumer electronic devices, including televisions, gaming consoles, mobile phones and tablets, and network-enabled DVD and Blu-ray players by reason of the infringement of certain claims of U.S. Patent No. 6,473,858; U.S. Patent No. 6,934,148;
On December 15, 2017, ARRIS and Sony filed a joint motion to terminate the investigation in view of a patent cross license agreement between the parties that settles this investigation. On December 18, 2017, the Commission investigative attorney responded in support of the motion.
On December 20, 2017, the presiding ALJ granted the motion as the subject ID. The ID finds that the motion complies with Commission Rules, and that granting the motion is not contrary to the public interest. ID at 1-3;
No petitions for review of the ID were filed. The Commission has determined not to review the ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Notice document 2017-28180, appearing on page 539, in the issue of January 4, 2018 was inadvertently published in error and should not have appeared in the
Employment and Training Administration, Department of Labor.
Notice.
The Employment and Training Administration (ETA) of the Department of Labor (Department) is issuing this notice to announce to employers and other interested stakeholders about a process change to better assure fairness regarding the issuance of H-2B temporary labor certifications due to the unprecedented volume of applications received on January 1, 2018.
William W. Thompson, II, Administrator, Office of Foreign Labor Certification, Box #12-200, Employment & Training Administration, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210. Telephone number: 202-513-7350 (this is not a toll-free number).
Individuals with hearing or speech impairments may access the telephone number above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627.
The Immigration and Nationality Act (INA) sets the annual number of aliens who may be issued H-2B visas or otherwise provided H-2B nonimmigrant status by the Department of Homeland Security (DHS) to perform temporary non-agricultural work at 66,000. Up to 33,000 H-2B visas may be issued in the first half of a fiscal year (October 1 to March 31), and the remaining semi-annual allocation of 33,000 visas will be available for employers seeking to hire H-2B workers during the second half of the fiscal year (April 1 to September 30). This announcement concerns the processing of the H-2B temporary labor certification applications for the April 1-September 30, 2018 period of need.
The Employment and Training Administration's Office of Foreign Labor Certification (OFLC) process for obtaining an H-2B certification is a two-step process for employers. Employers must first file a complete and accurate
Because of the intense competition for H-2B visas in recent years, the semi-annual visa allocation, and the regulatory requirement that employers apply with OFLC for a temporary labor certification 75 to 90 days before the start date of work, employers who wish to obtain visas for their workers under the semi-annual allotment for periods of need beginning from April 1-September 30, 2018, must promptly apply for a temporary labor certification and then file a petition with USCIS before the cap is reached. As a result, OFLC typically experiences a significant “spike” in labor certification applications at the beginning of January for temporary or seasonal jobs during the U.S.'s early spring and summer weather months.
Thus, on January 1, 2017 (FY 2017), OFLC received 1,538 applications covering approximately 26,673 worker positions for a work start date of April 1, 2017; approximately 80% of the entire semi-annual visa allocation of 33,000. By contrast, on January 1, 2018, OFLC received approximately 4,498 applications covering 81,008 worker positions requesting an April 1, 2018, start date of work. This unprecedented level of employer requests for H-2B workers on January 1, 2018 is approximately three times greater than the number of applications received on January 1, 2017, and more than two and one-half times greater than the 33,000 semi-annual visa allotment for FY 2018 permitted under the INA. In previous years, OFLC processed applications as expeditiously as possible in a manner irrespective of the time of day the application was filed, only focusing on processing applications by the day they were filed. Although OFLC is working as expeditiously as possible to issue first actions, review responses to Notices of Deficiency, and issue Notices of Acceptance, the overwhelming workload this year has strained OFLC's processing system and resulted in delays for the majority of all applications filed on January 1. OFLC
Employers receiving Notices of Acceptance can proceed to meet the additional regulatory requirements, including recruitment of U.S. workers and submission of recruitment reports. Employers receiving Notices of Deficiency that are corrected, and who then receive a Notice of Acceptance, can also proceed to meet the additional regulatory requirements. In order to promote fairness for employers in accessing the H-2B program and due to the unprecedented volume of applications on January 1, OFLC is making a change to its process regarding the issuance of final labor certification decisions. This process change will better reflect the sequential order in which employers filed applications. Thus, OFLC will not begin releasing certified H-2B applications (Form ETA-9142B
As required, OFLC will grant temporary labor certification only after the employer's H-2B application has met all the requirements for approving labor certification under 20 CFR 655.50 and the subpart. In accordance with regulatory requirements, OFLC will send all certified H-2B applications to the employer, or the employer's authorized attorney or agent, by means normally assuring next day delivery.
The National Science Board, pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice of the scheduling of a teleconference for the transaction of National Science Board business, as follows:
Open meeting of the Executive Committee of the National Science Board, to be held Monday, January 29, 2018, from 4:00-5:00 p.m. EST.
This meeting will be held by teleconference at the National Science Foundation, 2415 Eisenhower Ave., Alexandria, VA 22314.
Open.
Committee Chair's Opening Remarks; approval of Executive Committee Minutes of October 10, 2017; discuss issues and topics for an agenda of the NSB Meeting scheduled for February 21-22, 2018.
Point of contact for this meeting is: James Hamos, 2415 Eisenhower Ave., Alexandria, VA 22314. Telephone: (703) 292-8000.
You may find meeting information and updates (time, place, subject matter or status of meeting) at
An audio listening line will be available for the public. Members of the public must contact the Board Office to request the number by sending an email to
1:00 p.m., Wednesday, February 14, 2018.
NeighborWorks America—Gramlich Boardroom, 999 North Capitol Street NE, Washington DC 20002.
Open (with the exception of Executive Sessions).
Rutledge Simmons, Acting EVP & General Counsel/Secretary, (202) 760-4105;
The General Counsel of the Corporation has certified that in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552(b)(2) and (4) permit closure of the following portion(s) of this meeting:
Weeks of January 22, 29, February 5, 12, 19, 26, 2018.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
This meeting will be webcast live at the Web address—
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of January 29, 2018.
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.
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
Nuclear Regulatory Commission.
Notice of Meeting.
The U.S. Nuclear Regulatory Commission (NRC) will convene a teleconference meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on February 15, 2018, to discuss the revised draft report of the ACMUI Nursing Mother Guidelines for the Medical Administration of Radioactive Materials and the revised draft report of the ACMUI Physical Presence Requirements for the Leksell Gamma Knife® Icon
The NRC will also convene another teleconference meeting on March 1, 2018, to discuss the draft report of the Standing ACMUI Training and Experience Subcommittee. This report will include the subcommittee's recommendation for the total number of training and experience hours for authorized users under title 10
The teleconference meetings will be held on Thursday, February 15, 2018, 9:00 a.m. to 11:00 a.m. Eastern Time and Thursday, March 1, 2018, 2:00 p.m. to 4:00 p.m. Eastern Time.
Sophie Holiday, email:
Dr. Philip Alderson, ACMUI Chairman, will preside over the meeting. Dr. Alderson will conduct the meeting in a manner that will facilitate the orderly conduct of business. The following procedures apply to public participation in the meeting:
1. Persons who wish to provide a written statement should submit an electronic copy to Ms. Holiday at the contact information listed above. All submittals must be received by February 12, 2018, and February 26, 2018, three business days prior to the February 15, 2018, meeting and the March 1, 2018, meeting, and must pertain to the topic(s) on the agenda for the meeting.
2. Questions and comments from members of the public will be permitted during the meetings, at the discretion of the Chairman.
3. The draft transcript and meeting summary will be available on ACMUI's website
This meeting will be held in accordance with the Atomic Energy Act of 1954, as amended (primarily Section 161a); the Federal Advisory Committee Act (5 U.S.C. App); and the Commission's regulations in 10 CFR part 7.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Environmental assessment and finding of no significant impact; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is considering an exemption request from Entergy Nuclear Operations, Inc. (ENO) to allow the Vermont Yankee Nuclear Power Station (VYNPS) to use a new regionalized loading pattern, load fuel that has been cooled for at least 2 years, and establish a per-cell maximum average burnup limit at 65,000 megawatt days per metric ton of uranium (MWD/MTU) in HI-STORM 100 multi-purpose canister (MPC)-68M using Certificate of Compliance (CoC) No. 1014, Amendment No. 10. The NRC prepared an environmental assessment (EA) documenting its finding. The NRC concluded that the proposed action would have no significant environmental impact. Accordingly, the NRC staff is issuing a finding of no significant impact (FONSI) associated with the proposed exemption.
The EA and FONSI referenced in this document are available on January 23, 2018.
Please refer to Docket ID NRC-2017-0134 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
Yen-Ju Chen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555; telephone: 301-415-1018; email:
The NRC is reviewing an exemption request from ENO, dated May 16, 2017 (ADAMS Accession No. ML17142A358), and supplemented by letters dated September 7, 2017 (ADAMS Accession No. ML17255A236) and December 7, 2017 (ADAMS Accession No. ML17346A685). ENO is requesting an exemption from the requirements of title 10 of the
Specifically, ENO is requesting an exemption from certain requirements in Amendment No. 10 of the Holtec International (Holtec) CoC No. 1014 for the HI-STORM 100 Cask System (ADAMS Accession No. ML16144A177) to allow VYNPS to use a new regionalized loading pattern as described in Figure 2.4-1 of the exemption request, to load fuel that has been cooled for at least 2 years, and to establish a per-cell maximum average burnup limit at 65,000 megawatt days per metric ton of uranium (MWD/MTU) in a HI-STORM 100 MPC-68M canister. This would allow VYNPS to load fuel assemblies which have not been cooled for at least 3 years, as approved in the current CoC, but have been cooled for 2 years, into the MPC-68M.
Under the requirements of §§ 51.21 and 51.30(a), the NRC staff developed an EA (ADAMS Accession No. ML17249A160) to evaluate the proposed action, which is for the NRC to grant an exemption to ENO to allow the use of a new regionalized loading pattern as described in Figure 2.4-1 of the exemption request, to load fuel that has been cooled for at least 2 years, and to establish a per-cell maximum average burnup limit at 65,000 MWD/MTU in a HI-STORM 100 MPC-68M at the VYNPS site.
The EA defines the NRC's proposed action (
This EA evaluates the potential environmental impacts of granting the exemption to allow the use of a new regionalized loading pattern as described in Figure 2.4-1 of the exemption request, loading fuel that has been cooled for at least 2 years, and establishing a per-cell maximum average burnup limit at 65,000 MWD/MTU in a HI-STORM 100 MPC-68M at the VYNPS site. The potential environmental impact of using NRC-approved storage casks was initially analyzed in the EA for the rulemaking to provide for the storage of spent fuel under a general license on July 18, 1990 (55
NRC staff finds that this exemption request is bounded by CoC No. 1014, Amendment No. 10, and that there will be no significant environmental impacts of the proposed action. The proposed action does not change the types or quantities of effluents that may be released offsite, and it does not increase occupational or public radiation exposure. Therefore, there are no significant radiological environmental impacts associated with the proposed action. There is no change to the non-radiological effluents. The proposed action will take place within the site boundary, and does not have other environmental impacts. Thus, the proposed action will not have a significant effect on the quality of the human environment. Therefore, the environmental impacts of the proposed
The NRC staff has prepared an EA and associated FONSI in support of the proposed action. The NRC staff has concluded that the proposed action, for the NRC to grant the exemption requested for VYNPS, allowing the use of a new regionalized loading pattern as described in Figure 2.4-1 of the exemption request, and to load fuel that has been cooled for at least 2 years, and establishing a per-cell maximum average burnup limit at 65,000 MWD/MTU in a HI-STORM 100 MPC-68M, will not significantly impact the quality of the human environment, and that the proposed action is the preferred alternative. The environmental impacts are bounded by the previous NRC EA for the rulemaking to add the HI-STORM 100, Amendment No. 10, cask system to 10 CFR 72.214.
The NRC provided the Vermont Department of Health with a draft copy of the EA for a 30-day review on October 16, 2017 (ADAMS Accession No. ML17289A422).
The NRC staff has determined that this exemption would have no impact on historic and cultural resources or ecological resources and therefore no consultations are necessary under Section 7 of the Endangered Species Act and Section 106 of the National Historic Preservation Act, respectively.
Therefore, the NRC finds that there are no significant environmental impacts from the proposed action, and that preparation of an environmental impact statement is not warranted. Accordingly, the NRC has determined that a FONSI is appropriate.
For the Nuclear Regulatory Commission.
Railroad Retirement Board.
Notice announcing updated penalty inflation adjustments for civil monetary penalties for 2018.
As required by Section 701 of the Bipartisan Budget Act of 2015, entitled the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, the Railroad Retirement Board (Board) hereby publishes its 2018 annual adjustment of civil penalties for inflation.
Marguerite P. Dadabo, Assistant General Counsel, Railroad Retirement Board, 844 North Rush Street, Chicago, IL 60611-2092, (312) 751-4945, TTD (312) 751-4701.
Section 701 of the Bipartisan Budget Act of 2015, Public Law 114-74 (Nov. 2, 2015), entitled the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (28 U.S.C. 2461 note) (Inflation Adjustment Act) to require agencies to publish regulations adjusting the amount of civil monetary penalties provided by law within the jurisdiction of the agency not later than July 1, 2016, and annual adjustments thereafter.
For the 2018 annual adjustment for inflation of the maximum civil penalty under the Program Fraud Civil Remedies Act of 1986, the Board applies the formula provided by the 2015 Act and the Board's regulations at title 20, Code of Federal Regulations, part 356. In accordance with the 2015 Act, the amount of the adjustment is based on the percent increase between the CPI-U for the month of October preceding the date of the adjustment and the CPI-U for the October one year prior to the October immediately preceding the date of the adjustment. If there is no increase, there is no adjustment of civil penalties. The percent increase between the CPI-U for October 2017 and October 2016, as provided by Office of Management and Budget Memorandum M-18-03 (December 15, 2017) is 1.02041 percent. Therefore, the new maximum penalty under the Program Fraud Civil Remedies Act is $11,181 (the 2017 maximum penalty of $10,957 multiplied by 1.02041, rounded to the nearest dollar). The new minimum penalty under the False Claims Act is $11,181 (the 2017 minimum penalty of $10,957 multiplied by 1.02041, rounded to the nearest dollar), and the new maximum penalty is $22,363 (the 2017 maximum penalty of $21,916 multiplied by 1.02041, rounded to the nearest dollar). The adjustments in penalties will be effective January 23, 2018.
For The Board.
Notice of public meetings.
The National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), will facilitate stakeholder discussion of targeted nanotechnology topics through workshops, webinars, and Community of Interest meetings between the publication date of this Notice and December 31, 2018.
The NNCO will hold one or more workshops, webinars, networks, and Community of Interest teleconferences between the publication date of this Notice and December 31, 2018.
Attendance information, including addresses, will be posted on nano.gov. For information about upcoming workshops and webinars, please visit
For information regarding this Notice, please contact Marlowe Newman at
These public meetings address the charge in the 21st Century Nanotechnology Research and Development Act for NNCO to provide “for public input and outreach . . . by the convening of regular and ongoing public discussions”. Workshop and webinar topics may include technical subjects; environmental, health, and safety issues related to nanomaterials (nanoEHS); business case studies; or other areas of potential interest to the nanotechnology community. Areas of focus for the Communities of Interest may include research on nanoEHS; nanotechnology education; nanomedicine; nanomanufacturing; or other areas of potential interest to the nanotechnology community. For example, the
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend the Market Data section of its fee schedule to harmonize the definition of “Non-Professional User” with that of its affiliates, Cboe Exchange, Inc. (“Cboe”) and Cboe C2 Exchange, Inc. (“C2”).
The text of the proposed rule change is available at 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 parts of such statements.
The Exchange proposes to amend the Market Data section of its fee schedule to harmonize the definition of “Non-Professional User” with that of its affiliates, Cboe and C2. In late 2016, the Exchange and its affiliates Cboe EDGA Exchange, Inc. (“EDGA”), Cboe BYX Exchange, Inc. (“BYX”), and Cboe BZX Exchange, Inc. (“BZX”) received approval to effect a merger (the “Merger”) of the Exchange's parent company, Bats Global Markets, Inc., the parent of EDGA, EDGX, BYX, and BZX with CBOE Holding, Inc. (now known as Cboe Global Markets, Inc.) the parent company of Cboe and C2.
The revised definition is substantially identical to the definition of “Non-Professional User' included within the Cboe and C2 fee schedules.
None of these differences impact the manner in which the Exchange would characterize a User and a Professional or Non-Professional. The harmonized definition would provide additional specificity while harmonizing the definition with that of its affiliates. Doing so would ensure consistent terms amongst the Exchange and its affiliates, thereby reducing the potential for confusion amongst market data subscribers regarding the type of User they may be considered by the Exchange.
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. The harmonized definition of Non-Professional User would have no impact on competition because it does not materially alter the definition.
The Exchange has neither solicited nor received written comments on the proposed rule change.
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
In its filing, the Exchange requested that the Commission waive the 30-day operative delay in order to enable the Exchange to immediately ensure consistent use of terms amongst the Exchange and its affiliates, thereby reducing the potential for confusion amongst market data subscribers regarding the type of User they may be considered by the Exchange. The Commission believes that such waiver is consistent with the protection of investors and the public interest. Therefore, the Commission designates the proposed rule change to be operative upon filing. For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation.
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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The text of the proposed rule change is set forth below. Proposed new language is
The Exchange proposes to amend MRX Rule 805 to permit Market Makers
(a)
(b)
(1) A market maker may enter all order types permitted to be entered by non-customer participants under the Rules to buy or sell options in classes of options listed on the Exchange to which the market maker is not appointed under Rule 802,
(i) and (ii) No change.
(2) and (3) No change.
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 purpose of this rule change is to permit Market Makers to enter principal orders to buy or sell options in the options classes to which they are appointed under Rule 802
Today, as noted in MRX Rule 805(a), a Market Maker may not place principal orders to buy or sell options in the options classes to which they are appointed under Rule 802, other than opening only orders,
Today, MRX Market Makers, who are appointed and non-appointed in a particular options class, may submit orders without limitation, unless otherwise restricted by the order type as discussed herein. The Exchange proposes to permit Market Makers to enter all order types, which are listed in MRX Rule 715, except for Stopped Orders, Reserve Orders and Customer Cross Orders. The Exchange notes that today Market Makers are not eligible to execute either Customer Cross Orders, which are Customer orders, or Stopped Orders, which are intended for the account of a customer.
Today, for the reasons noted above, the Exchange does not permit Market Makers to enter Reserve Orders in non-appointed options classes. However, the current rule text does not provide this limitation. The Exchange proposes to amend the current rule text at MRX Rule 805(b)(1) to codify this limitation.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange notes that previously, Nasdaq ISE, LLC prohibited non-customer trading by Electronic Access Members (“EAMs”) for principal or agent transactions.
The Exchange notes that these restrictions never existed on MRX. MRX believes that these restrictions should not exist today because there is no reason to restrict Market Makers in entering order types, except for the restriction related to Reserve Orders, in options classes in which they are appointed. Unlike other order types, the Reserve Order is a limit order that contains both a displayed portion and a non-displayed portion.
The Exchange is also amending MRX Rule 805(a) to detail the types of non-resting order types and their modifiers with respect to ISO Orders, All-Or-None Orders, Stop Orders, Qualified Contingent Cross Orders, Attributable Orders, Do-Not-Route Orders, Opening Sweep Orders, Cancel and Replace Orders, and Add Liquidity Orders. This rule change will detail and align the rule text with the system functionality and make clear which order types a Market Maker may submit in appointed options classes.
MRX Market Makers continue to be obligated to add liquidity on MRX. The Exchange also notes that MRX Rule 805(b)(2) and (3) restricts the number of contracts that a Market Maker may enter in an options class to which the Market Maker is not appointed.
The total number of contracts executed during a quarter by a Primary Market Maker in options classes to which it is not appointed may not exceed ten percent (10%) of the total number of contracts traded per each Primary Market Maker Membership.
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. Today, NYSE Arca and NYSE American place no limitation on the types of orders that can be entered by market makers in their appointed class.
Further, Market Makers, unlike other market participants, are required to abide by certain quoting requirements, in the options classes in which they are appointed pursuant to MRX Rule 802, in order to maintain the status of a Market Maker.
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 Brent J. Fields, 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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend ISE Rule 805 to permit Market Makers
The text of the proposed rule change is set forth below. Proposed new language is
(a)
(b)
(1) A market maker may enter all order types permitted to be entered by non-customer participants under the Rules to buy or sell options in classes of options listed on the Exchange to which the market maker is not appointed under Rule 802,
(i) and (ii) No change.
(2) and (3) No change.
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 purpose of this rule change is to permit Market Makers to enter principal orders to buy or sell options in the options classes to which they are appointed under Rule 802
Today, as noted in ISE Rule 805(a), a Market Maker may not place principal orders to buy or sell options in the options classes to which they are appointed under Rule 802, other than opening only orders,
Today, ISE Market Makers, who are appointed and non-appointed in a particular options class, may submit orders without limitation, unless otherwise restricted by the order type as discussed herein. The Exchange proposes to permit Market Makers to enter all order types, which are listed in ISE Rule 715, except for Stopped Orders, Reserve Orders and Customer Cross Orders. The Exchange notes that today Market Makers are not eligible to execute either Customer Cross Orders, which are Customer orders, or Stopped Orders, which are intended for the account of a customer.
Today, for the reasons noted above, the Exchange does not permit Market Makers to enter Reserve Orders in non-appointed options classes. However, the current rule text does not provide this limitation. The Exchange proposes to amend the current rule text at ISE Rule 805(b)(1) to codify this limitation.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange notes that previously, ISE prohibited non-customer trading by Electronic Access Members (“EAMs”) for principal or agent transactions.
The Exchange does not believe there is any reason to restrict Market Makers in entering order types, except for the restriction related to Reserve Orders, in options classes in which they are appointed. Unlike other order types, the Reserve Order is a limit order that contains both a displayed portion and a non-displayed portion.
The Exchange is also amending ISE Rule 805(a) to detail the types of non-resting order types and their modifiers with respect to ISO Orders, All-Or-None Orders, Stop Orders, Qualified Contingent Cross Orders, Attributable Orders, Do-Not-Route Orders, QCC with Stock Orders, Opening Sweep Orders, Cancel and Replace Orders, and Add Liquidity Orders. This rule change will detail and align the rule text with the system functionality and make clear which order types a Market Maker may submit in appointed options classes.
ISE Market Makers continue to be obligated to add liquidity on ISE. The Exchange also notes that ISE Rule 805(b)(2) and (3) restricts the number of contracts that a Market Maker may enter in an options class to which the Market Maker is not appointed.
The total number of contracts executed during a quarter by a Primary Market Maker in options classes to which it is not appointed may not exceed ten percent (10%) of the total number of contracts traded per each Primary Market Maker Membership.
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. Today, NYSE Arca and NYSE American place no limitation on the types of orders that can be entered by market makers in their appointed class.
Further, Market Makers, unlike other market participants, are required to abide by certain quoting requirements, in the options classes in which they are appointed pursuant to ISE Rule 802, in order to maintain the status of a Market Maker.
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 Brent J. Fields, 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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend the Market Data section of its fee schedule to harmonize the definition of “Non-Professional User” with that of its affiliates, Cboe Exchange, Inc. (“Cboe”) and Cboe C2 Exchange, Inc. (“C2”).
The text of the proposed rule change is available at 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 parts of such statements.
The Exchange proposes to amend the Market Data section of its fee schedule to harmonize the definition of “Non-Professional User” with that of its affiliates, Cboe and C2. In late 2016, the Exchange and its affiliates Cboe EDGX Exchange, Inc. (“EDGX”), Cboe BYX Exchange, Inc. (“BYX”), and Cboe BZX Exchange, Inc. (“BZX”) received approval to effect a merger (the “Merger”) of the Exchange's parent company, Bats Global Markets, Inc., the parent of EDGA, EDGX, BYX, and BZX with CBOE Holding, Inc. (now known as Cboe Global Markets, Inc.) the parent company of Cboe and C2.
The EDGX Option's fee schedule currently defines “Non-Professional User” as:
As amended, “Non-Professional User” would be defined as:
The revised definition is substantially identical to the definition of “Non-Professional User' included within the Cboe and C2 fee schedules.
None of these differences impact the manner in which the Exchange would characterize a User and a Professional or Non-Professional. The harmonized definition would provide additional specificity while harmonizing the definition with that of its affiliates. Doing so would ensure consistent terms amongst the Exchange and its affiliates, thereby reducing the potential for confusion amongst market data subscribers regarding the type of User they may be considered by the Exchange.
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. The harmonized definition of Non-Professional User would have no impact on competition because it does not materially alter the definition.
The Exchange has neither solicited nor received written comments on the proposed rule change.
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
In its filing, the Exchange requested that the Commission waive the 30-day operative delay in order to enable the Exchange to immediately ensure consistent use of terms amongst the Exchange and its affiliates, thereby reducing the potential for confusion amongst market data subscribers regarding the type of User they may be considered by the Exchange. The Commission believes that such waiver is consistent with the protection of investors and the public interest. Therefore, the Commission designates the proposed rule change to be operative upon filing. For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation.
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.
On May 5, 2017, Bats BZX Exchange, Inc. (now known as Cboe BZX Exchange, Inc.) (“BZX” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
As described in more detail in the Notice,
Members
At the MOC Cut-Off Time, the System would match for execution all buy and sell MOC orders entered into the System based on time priority.
The Exchange would utilize the official closing price published by the exchange designated by the primary listing market in the case where the primary listing market suffers an impairment and is unable to perform its closing auction process.
The Exchange states that it is proposing to adopt Cboe Market Close in response to requests from market participants, particularly buy-side firms, for an alternative to the primary listing markets' closing auctions that still provides an execution at a security's official closing price.
The Commission has carefully reviewed the proposal, including the comments received, and finds that approval of the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission received sixty-three comment letters from fifty-two commenters on the proposal, including four response letters from the Exchange.
The majority of commenters addressed the potential impacts of the proposal on price discovery in the closing auctions on the primary listing markets. Eight commenters stated that the proposal would not negatively impact price discovery in the primary listing markets' closing auctions.
Thirty-eight commenters stated that the proposal would further fragment the markets and harm price discovery in the closing auctions on the primary listing markets.
Specifically, Nasdaq expressed concern that the availability of Cboe Market Close could cause a reduction in the number of limit-on-close orders submitted to the primary listing markets' closing auctions, which Nasdaq asserted would harm price discovery at the market close.
Moreover, Nasdaq argued that even if the proposal only resulted in fewer market-on-close orders submitted to Nasdaq closing auctions, investors would be harmed because the official closing price could potentially represent a stale or undermined price.
NYSE similarly argued that even though Cboe Market Close would only accept MOC orders, it could materially impact official closing prices determined through a NYSE closing auction.
NYSE also argued that the proposal would detrimentally impact price discovery on the NYSE Arca and NYSE American automated closing auctions. NYSE stated that in the last six months there were 130 instances where the official closing price determined through a NYSE Arca closing auction was based entirely on paired-off market order volume.
In arguing that additional fragmentation of closing auction interest would detrimentally impact price discovery, both Nasdaq and NYSE distinguished the Cboe Market Close from competing closing auctions currently operated by Nasdaq and NYSE Arca for securities listed on other markets. Nasdaq stated that the BZX proposal is a price-matching order type and not a competitive single-priced
Nasdaq and NYSE further argued that competing closing auctions cause minimal fragmentation, as volumes in those auctions are “miniscule.”
Nasdaq and NYSE also addressed price-matching services in the over-the-counter market. Nasdaq stated that the proposal would introduce a new category of price-matching venues, which would exacerbate the harm caused by fragmentation.
In addition, NYSE stated that existing off-exchange matching services have a negative impact on the validity and integrity of price discovery in the closing auctions.
Several other commenters also discussed how the proposal may impact the integrity of official closing prices. In particular, GTS, a DMM on NYSE, argued that market-on-close orders are a vital component of closing prices and, should those orders be diverted away from the primary listing markets as a result of the proposal, it could undermine the official closing prices.
Multiple commenters stated that one of the benefits of a centralized closing auction conducted by the primary listing market is that it allows market participants to fairly assess supply and demand such that the closing prices reflect both market sentiment and total market participation.
In response to concerns regarding the impact of the proposal on the price discovery process, BZX argued that, because the proposal would only match MOC orders and would require the Exchange to publish the number of matched shares in advance of the primary listing markets' cut-off times, BZX believes it would avoid any impact on price discovery.
In particular, with regard to competing closing auctions, BZX argued that such competing auctions could not only pull all MOC interest away from the primary listing markets but could also divert all price-setting limit-on-close interest from those markets as well.
With regard to off-exchange matching processes, BZX stated that several off-exchange venues currently offer executions at the official closing price and therefore provide a forum to which participants may choose to send MOC orders in lieu of sending MOC or LOC orders to the primary listing market.
BZX also provided certain data regarding current trading volume at the close on venues other than primary listing exchanges to show that the proposal would “not introduce a new
In response to NYSE's data regarding the impact of off-exchange activity at the close on closing auction price formation, BZX presented several critiques of the analysis. First, BZX asserted that NYSE provided selective data that supported their conclusion that existing fragmentation at the close has a negative impact on price discovery in closing auctions. In particular, BZX stated that NYSE did not indicate the number of closing auctions included in its data set.
BZX further argued that it is possible that such low volume securities with severe imbalances would be subject to price variations between the last sale and the official closing price, regardless of the amount of off-exchange closing activity.
Furthermore, BZX stated that it conducted its own analysis of data from all primary auctions in NYSE-listed securities for which there was a closing auction and a last sale regular way trade, regardless of size, from January 2, 2017 through September 29, 2017.
In addition, BZX stated that it also found similar patterns “when it analyzed securities based on their ADV instead of auction size.”
In response to NYSE's arguments regarding the impact on a DMM's ability to price the close, BZX argued that this point highlights what it believes to be an additional benefit of allowing it to compete with NYSE's closing auction.
As the Commission stated in the OIP, it has consistently recognized the importance of the closing auctions of the primary listing markets.
Importantly, Cboe Market Close will only accept MOC orders and not LOC orders. Contrary to some commenters' assertions that MOC orders contribute to the closing price, the Commission
The Commission recognizes that several commenters made assertions that matched MOC order flow provides informational content regarding the depth of the market that indicates true supply and demand and contributes to market participants' decisions regarding order submission and ultimately price formation.
As discussed above, NYSE and Nasdaq argued that if the proposed rule change resulted in the removal of all MOC orders from the primary listing exchanges' closing auctions, that result would impact closing prices in instances where no auction could be held in accordance with their rules. In such scenarios, NYSE and Nasdaq assert that, pursuant to the primary listing exchanges' rules, the resulting closing price would be the consolidated last sale price.
Further, while the commenters' analyses examined price differentials in various contexts, differences in prices alone are not dispositive with respect to price discovery or efficiency. First, a large difference between a reference price (
Further, while NYSE and Nasdaq implied that use of the consolidated last sale price as the official closing price is inferior to the price discovery process of the closing auction, the use of the consolidated last sale price as the official closing price when a primary listing exchange does not conduct a closing auction is not mandated by the Act or rules thereunder, but rather is established by the rules of that exchange. Therefore, if a primary listing exchange believes that such prices no longer reflect an appropriate closing price in certain scenarios, it is within the exchange's discretion to reevaluate whether reliance on the last consolidated sale price is the appropriate means for determining the official closing price in such scenarios, and may file proposed rule changes to amend its rules to establish alternative methods of determining the official closing price should no auction be held that it believes to be more appropriate.
Some commenters also argued that the proposal would impact the submission of LOC orders to the primary listing markets. As BZX stated in its response letter, LOC orders provide price protection, whereas MOC orders are submitted by market participants who may be less price sensitive and who may prioritize other aspects of a closing execution over price. As such, the Commission does not believe that it is likely that market participants would be more inclined to assume the risk of submitting MOC orders to the Cboe Market Close in circumstances where they otherwise would have submitted price-protected LOC orders into the primary markets' closing auctions, solely to pay lower fees. As discussed above, Nasdaq and NYSE also asserted that the Cboe Market Close could discourage submission of orders in the continuous market and closing cross if there were a large amount of paired MOC orders in Cboe Market Close and a subsequent lack of imbalance information disseminated on the primary listing markets.
In addition, as discussed above, many commenters addressed the existence of fragmentation at the close today due to off-exchange matching processes and competing closing auctions. With regard to broker-dealer matching services, the Commission's consideration and analysis of whether BZX's proposal is consistent with the Act as an exchange is subject to differing requirements and standards than those that apply to broker-dealers under the Act. At the same time, how such existing off-exchange services impact closing auctions on the primary listing markets may provide some limited insight into the potential impact of the proposal on the price discovery function of the primary closing markets, particularly to the extent the proposed Cboe Market Close is similar to such off-exchange services.
The staff from the Commission's Division of Economic and Risk Analysis analyzed the relationship between the proportion of MOC orders executed off-exchange and closing price discovery and efficiency.
NYSE provided several critiques of the DERA Analysis' methodology and argued that the DERA Analysis' findings should not be interpreted as providing evidence that BZX's proposal would have no negative impact on price discovery or the efficiency of closing prices.
As discussed above, NYSE stated that because the bulk of the volume accounted for in the DERA Analysis is market maker volume crossed on behalf of clients, it may not be a good proxy for evaluating the potential impact of the proposal.
In criticizing the methodology of the DERA Analysis, NYSE further asserted that “widely accepted” alternative approaches for analyzing potential behavior and incentives under alternative market structures could be useful in considering the impact of BZX's proposal on closing price discovery and efficiency.
Concluding that the methodology used by the DERA Analysis does not provide meaningful evidence of the extent to which off-exchange MOC trading currently impacts the informational efficiency of the official closing price, NYSE discussed the metrics used in the DERA Analysis.
The Commission has considered the criticisms of NYSE with respect to the DERA Analysis. Importantly, the DERA Analysis was explicit regarding the limited scope of its analysis and does not assert that BZX's proposal would have no negative impact on price discovery of official closing prices. The DERA Analysis sought to explore the correlation of closing price discovery and efficiency with existing off-exchange MOC activity. It did not make any findings with respect to establishing a causal link between off-exchange MOC activity and closing price discovery and efficiency.
NYSE noted that the DERA Analysis “cites to two published papers by Barclay and Hendershott as support for using a regression-based approach to study the information content of the closing price. However, the DERA Analysis does not actually use the Barclay-Hendershott methodology.”
With respect to NYSE's critique of the Price Contribution metric, the DERA Analysis controlled for contemporaneous absolute price volatility to account for the precise concerns identified by NYSE. Accordingly, the regression utilized in the DERA Analysis sought to isolate variations in Price Contributions that were not merely “large arbitrary price swings” that happened to be correlated with off-exchange MOC activity.
Moreover, NYSE suggested that there are alternative approaches that would be useful in considering how market participants are likely to behave under alternative market structures and for analyzing how potential structures create incentives for market manipulation, as well as alternative measures that could provide pertinent information regarding price discovery at the close.
As discussed above, Nasdaq and NYSE concluded that existing over-the-counter price matching should not be considered a precedent for the proposal and described how they believed some over-the-counter MOC trades differed from those that would occur through Cboe Market Close.
With regard to competing closing auctions, BZX's proposed Cboe Market Close is not a closing auction and the Commission believes, as do some commenters, that there are certain fundamental differences between BZX's proposed Cboe Market Close and existing competing closing auctions, such as those identified by NYSE and Nasdaq regarding the price discovery mechanisms of their competing, single-priced closing auctions, which produce closing prices independent from those determined through the primary listing exchanges' closing auctions.
Several commenters stated that the proposal could harm issuers, particularly small and mid-cap companies.
In addition, one commenter, SPDJI, argued that the proposal may also impact confidence in the pricing of benchmark indices as confidence in closing prices is a prerequisite for market participants to maintain confidence in the pricing of benchmark indices.
Moreover, some commenters argued that the centralization of liquidity at the open and close of trading, and how primary listing markets perform during the opening and closing, are important factors for issuers in determining where to list their securities, and the additional risk posed to listed companies from an unreliable or unrepresentative closing price and/or process could impact an issuer's decision where to list and/or cause companies to forgo going public.
With regard to concerns about the impact of the proposal on issuers and their shareholders, BZX stated that the proposal “would not adversely impact the trading environment for issuers and their securities” because it “specifically designed the [p]roposal so that it would not impact the very important price discovery function performed by the primary listing markets' closing auction” by only matching paired MOC orders and not LOC orders and ensuring executions at the closing price.
The Commission believes that, because the proposal is reasonably designed to minimize any impact on the price discovery process, as described above, commenters' concerns regarding the effects on listed issuers, including small and mid-cap companies, are similarly mitigated. Commenters stated that the proposal would undermine the value and reliability of closing prices for securities and, as a result, the pricing of benchmark indices, and that decentralization of the closing auction would harm liquidity in their stock.
Several commenters addressed the potential impact of the proposal on market complexity and operational risk that could occur if the proposal resulted in increased market fragmentation. Some of these commenters believed that the proposal would not introduce significant additional complexity or operational risk. For example, two commenters argued that the proposal could enhance the resiliency of the closing auction process by providing market participants an additional mechanism through which to execute orders at the official closing price in the event of a disruption at a primary listing market.
In contrast, other commenters argued that the proposal would add unnecessary market complexity and operational risk. In particular, two commenters stated that the proposal would require market participants to monitor an additional data feed, the Bats Auction Feed, with one also stating that if additional exchanges adopted similar functionality to Cboe Market Close, it would require monitoring of even more data feeds.
In response, BZX argued that the proposal would not increase market complexity or operational risks.
In addition, BZX added that modern software can easily and simply add volume data disseminated by the primary listing markets regarding the closing auction and data regarding matched MOC orders from the Cboe Market Close.
The Cboe Market Close will offer market participants an additional venue to which they may send orders for execution at the official closing price and an additional data feed that some market participants may choose to monitor. However, as several commenters stated, many market participants already monitor multiple data feeds and the Commission believes that those market participants that would plan to monitor information disseminated by BZX relating to Cboe Market Close would likely already maintain systems and software that are able to aggregate such feeds.
Several commenters addressed the issue of whether the proposal would facilitate manipulation of both the closing auctions on the primary listing markets, as well as continuous trading during the final minutes of the trading day. Some commenters did not believe it would do so. For example, one commenter stated that incentives to manipulate the closing price already exist and it is unlikely the proposal would result in increased manipulation of the market close.
In contrast, several commenters asserted that the proposal raises a risk of manipulation, in part due to the asymmetry of information that would be disseminated, which would allow market participants to utilize informational advantages to their own benefit. For example, Nasdaq argued that information concerning the amount of orders matched through Cboe Market Close, would represent tradable information that market participants could use to “game” the closing crosses on the primary listing markets and undermine fair and orderly markets.
NYSE further asserted that the proposal could potentially provide some market participants, such as professional traders, with useful information that other market participants do not have, such as the direction of an imbalance, which could be used to influence the official closing price.
Although not citing concerns regarding manipulation specifically, T. Rowe Price similarly argued that the proposal would lead to information asymmetries that could result in changes in continuous trading behavior leading into the market close as some market participants could be trading on information gathered from Cboe Market Close pairing results.
In contrast, BZX argued that information asymmetries are inherent in trading, including the primary listing markets closing auctions.
The Commission believes that the proposed rule change is consistent with the requirement of Section 6(b)(5) of the Act that the rules of a national securities exchange be designed to prevent fraudulent and manipulative acts and practices. The Commission believes information asymmetries as those described by commenters exist today and are inherent in trading, including with respect to closing auctions. For example, any party to a trade gains valuable insight regarding the depth of the market when an order is executed or partially executed. Further, on NYSE, not only DMMs, but NYSE floor brokers have access to closing auction imbalance information that is not simultaneously available to other market participants, far in advance of the NYSE order entry cut-off time. Specifically, pursuant to NYSE rules, floor brokers receive the amount of, and any imbalance between, MOC and marketable LOC interest every fifteen seconds beginning at 2:00 p.m. until 3:45 p.m.
The Commission believes that the same arguments apply with respect to BZX's proposal. In particular, even if a market participant becomes aware of the direction of the imbalance for a security in Cboe Market Close as a result of receiving a cancellation of part or all of that participant's order, such information does not represent overall supply or demand for the security, is subject to change before the close, and is only one piece of information and likely less useful than other information regarding the close that would be available to market participants, such as the total matched amount of MOC shares that would be disseminated by BZX at 3:35 p.m. and available to all market participants on equal terms, as well as any imbalance information disseminated by the primary listing markets. While commenters argue that those who participate in Cboe Market Close would be able to discern the direction of an imbalance and use such information to manipulate the closing price, the Commission believes the utility of such gleaned information is limited. In particular, a market participant would only be able to determine the direction of the imbalance, and would have difficulty determining the magnitude of any imbalance, as it would only know the unexecuted size of its own order. In addition, the information would only be with regard to the pool of liquidity on BZX and would provide no insight into imbalances on the primary listing market, competing auctions, or off-exchange matching services which, as described above, can represent a significant portion of trading volume at the close. Likewise, while a market participant would be able to determine whether its own order made up a large or small percentage of the paired shares for a security in Cboe Market Close, it would not be able to determine the composition of same-side or contra-side MOC orders submitted to Cboe Market Close, nor would such information enable it to determine the composition of orders submitted to the primary listing market, competing auctions, or off-exchange matching services.
NYSE also argued that the proposal would increase potential manipulation for several reasons.
The Commission recognizes that, with or without Cboe Market Close, the potential exists that there may be market participants who may seek to engage in manipulative or illegal trading activity, including with respect to closing prices.
Lastly, Nasdaq stated that it and other exchanges would need to develop new cross-market surveillance systems in order to address these risks.
In response, BZX made several arguments as to why it does not believe that the proposal creates a potential for increased manipulation.
BZX also highlighted the cross-market surveillance that FINRA conducts on its behalf.
With respect to manipulative or illegal trading activity more broadly, self-regulatory organizations such as BZX and the primary listing markets have an obligation under the Act to surveil for manipulative activity on their markets. The Commission generally believes that existing self-regulatory organization surveillance and enforcement activity, and the measures that the Exchange has represented that it would take to surveil for and detect manipulative activity related to the proposal, would help to deter market participants who might otherwise seek to try and abuse Cboe Market Close or a closing auction on a primary listing exchange. The Commission expects that BZX will closely monitor Cboe Market Close and implement new or enhanced surveillance measures, as necessary, designed to identify potential manipulative behavior. Further, the Commission expects that potential violative conduct identified by BZX, FINRA, or any other national securities exchange would be investigated. With respect to NYSE's comment on the potential challenges posed that time differences or cross-market activity may pose in identifying manipulative activity,
A number of commenters addressed the proposal's impact on competition. Seven commenters supporting the proposal stated that it would increase competition among exchanges for executions of orders at the close.
In contrast, other commenters argued that the proposal would impose a burden on competition not necessary or appropriate in furtherance of the purposes of the Act, including by “free-riding” on the investments the primary listing markets have made in their closing auctions.
Nasdaq also argued that the proposal would impose a burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Specifically, Nasdaq believed that the proposal undermines intra-market competition, by removing orders from Nasdaq's auction book and prohibiting those orders from competing on Nasdaq, which Nasdaq argued is necessary for the exchange to arrive at the most accurate closing price.
In response to commenters' contentions about competition, BZX asserted that the proposal would enhance rather than burden competition.
BZX also challenged the assertion that it was “free-riding” on the primary listing exchanges' closing auctions.
Further, BZX asserted that the Commission has approved the operation of competing closing auctions, noting in particular the closing auctions on Nasdaq, NYSE Arca, and the American Stock Exchange.
The Commission believes that the proposal does not impose any burden on competition not necessary or appropriate in furtherance of the Act; rather, it provides an alternative venue to which market participants may submit closing interest and receive the official closing price. The Commission believes that while BZX would not be conducting the closing auction that would determine the execution price for orders executed in Cboe Market Close, the availability of Cboe Market Close will inject competition into the closing process to the ultimate benefit of market participants generally, which could include price and execution quality competition. The Commission further believes that implementation of Cboe Market Close could incent other venues, including the primary listing exchanges as well as off-exchange matching venues, to continue to innovate and compete to attract MOC orders to their closing auctions, which may include lowering transaction fees, to the benefit of market participants generally. The proposal would also provide an opportunity for market participants to assess and compare their experience in seeking to execute MOC orders on different national securities exchanges, which would foster competition and that may enhance the quality and efficiency of MOC order executions. Ultimately, the Commission believes that the success of the Cboe Market Close in competing with the primary listing exchanges and off-exchange matching venues for MOC orders will depend on a variety of factors, including the quality of the MOC order execution services, the attendant risks, and the costs associated with such executions.
While the primary listing markets and other commenters argue that BZX is “free riding” on investments of the primary listing markets in the development and maintenance of the closing auction process and thus impeding competition in a manner inconsistent with the Act, the Commission believes that this form of burden on competition must be evaluated against the potentially enhanced competition that the proposal also provides, as discussed above.
In addition, both NYSE and Nasdaq referenced the Commission's disapproval of Nasdaq's proposal to create a Benchmark Order as support that BZX has not sufficiently satisfied its obligation to justify that the proposal is consistent with the Act and not an inappropriate burden on competition. NYSE argued that BZX essentially proposes to compete with broker-dealer agency order matching services.
Likewise, SIFMA also referenced the Commission's disapproval of Nasdaq's proposal to create a Benchmark Order as support for its assertion that BZX is proposing to offer a function identical to that currently offered by broker-dealers, yet would benefit from regulatory immunity as well as the limits on liability contained in BZX Rule 11.16.
With respect to regulatory immunity, SIFMA asserted that both courts and the Commission have stated that regulatory immunity applies only in situations where an exchange is exercising its regulatory authority over its member, pursuant to the Act.
BZX argued that, rather than looking to compete with broker-dealer services, it is seeking to compete on price with the primary listing markets' closing auctions.
The Commission believes, as acknowledged by BZX, that it is possible that BZX's proposal could divert some MOC orders from off-exchange matching services operated by broker-dealers onto a regulated exchange.
Further, the Commission believes that the issues raised by commenters regarding the judicial doctrine of regulatory immunity and rule-based limitations on liability are part of a broader policy issue regarding the different regulatory structures for exchanges and broker-dealers, and do not materially impact the Commission's analysis or finding regarding whether this proposal poses an unnecessary or inappropriate burden on competition.
The Commission has taken the position that immunity from suit “is properly afforded to the exchanges when engaged in their traditional self-regulatory functions—where the exchanges act as regulators of their members,” including “the core adjudicatory and prosecutorial functions that have traditionally been accorded absolute immunity, as well as other functions that materially relate to the exchanges' regulation of their members,” but should not “extend to functions performed by an exchange itself in the operation of its own market, or to the sale of products and services arising out of those functions.”
For the foregoing reasons, the Commission finds that the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 806(e)(1) of Title VIII of the Dodd-Frank Wall Street Reform and Consumer Protection Act, entitled Payment, Clearing and Settlement Supervision Act of 2010 (“Clearing Supervision Act”)
This advance notice is filed in connection with a proposed change to formalize and update OCC's Recovery and Orderly Wind-Down Plan (“RWD Plan” or “Plan”), consistent with the requirement applicable to OCC in Rule 17Ad-22(e)(3)(ii).
The RWD Plan was included as confidential Exhibit 5 of the filing.
In its filing with the Commission, OCC included statements concerning the purpose of and basis for the advance notice and discussed any comments it received on the advance notice. The text of these statements may be examined at the places specified in Item IV below. OCC has prepared summaries, set forth in sections A and B below, of the most significant aspects of these statements.
Written comments were not and are not intended to be solicited with respect to the proposed rule change and none have been received. OCC will notify the Commission of any written comments received by OCC.
On September 28, 2016 the Commission adopted amendments to Rule 17Ad-22
OCC is defined as a covered clearing agency under the CCA rules, and therefore is subject to the requirements of the CCA rules, including Rule 17Ad-22(e)(3).
OCC is proposing to update, formalize and adopt its RWD Plan.
As discussed in greater detail below, in preparing the proposed Plan, OCC was informed by relevant guidance from not only from OCC's regulators, but also from certain international organizations. Within the framework of this guidance, OCC has drafted the proposed Plan to reflect OCC's specific characteristics, including its ownership, organizational, and operational structures, as well as OCC's size and systemic importance relative to the products that its clears.
The proposed RWD Plan consists of eight chapters. A description of each of the first seven chapters of the proposed Plan is provided below (Chapter 8 of the proposed plan consists of a series of appendices containing supporting material).
Chapter 1 of the RWD Plan would provide an executive summary and overview of the proposed Plan. Chapter 1 would begin by acknowledging OCC's
• The sections of the preamble to the Commission's adopting release for its CCA rules that address topics relating to recovery and orderly wind-down of a CCA;
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• Commodity Futures Trading Commission (“CFTC”) Staff Letter 16-61, published by the Division of Clearing and Risk of the CFTC;
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Chapter 1 would highlight OCC's designated Critical Services and would summarize the approach OCC used in preparing its “Stress Scenarios,” which are six detailed storyline scenarios that address OCC's possible response to one or more of the following stresses: Individual Clearing Member default, multiple successive Clearing Member defaults, disruption or failure of a bank or liquidity facility provider, inability to access another financial market infrastructure and general business and operational risks. The Stress Scenarios would be included in Appendix H of the Plan. Chapter 1 would restate each of the five qualitative “Recovery Trigger Events” that are identified in Chapter 5 of the RWD Plan (which constitutes OCC's “Recovery Plan”) and explain that the timeframe for OCC's recovery, based on the Stress Scenarios, could range from intraday to several months. Chapter 1 also would restate each of the six qualitative “W[ind-]D[own ]P[lan] Trigger Events,” which, if occurring during OCC's recovery efforts, could likely jeopardize the viability of OCC's recovery and signal that initiation of OCC's Wind-Down Plan (“WDP”) should be considered. Chapter 1 would explain that, given OCC's critical role as the sole clearing organization for all securities options exchanges in the U.S., OCC would seek to focus primarily on recovering from any severe stress scenario; however, in the extremely remote circumstance that that OCC experienced a stress severe enough to initiate the WDP, the ultimate goal of OCC's resolution would be to transfer ownership of OCC itself by the consummation of a consensual sale or similar transaction, in a manner ensuring the ongoing provision of OCC's Critical Services. Chapter 1 would conclude by summarizing OCC's assumptions for the duration of its resolution process and the estimated amount of operating capital needed to fund OCC's resolution.
Chapter 2 of the proposed RWD Plan is designed to impart information that OCC believes would be essential to relevant authorities for purposes of recovery and orderly wind-down planning, as well as to provide readers of the Plan with necessary context for the subsequent discussion and analysis of OCC's “Critical Services” and “Critical Support Functions” in Chapter 4 (discussed below) and of OCC's resolution process in Chapter 6 (discussed below). To accomplish this, Chapter 2 would provide a detailed description of OCC's business, summarizing the role that OCC plays in the options market and the services and products it provides to its clearing members and market participants. Chapter 2 also would describe the regulatory oversight to which OCC is subject, and give details on the basic structure and organization of OCC's Board of Directors and management. Chapter 2 also would provide OCC's financial statements and summarize the services OCC provides to its clearing members and other financial market utilities (“FMUs”). Chapter 2 would include details about OCC's internal and external interconnectedness, distinguishing as appropriate between financial, operational and external forms of interconnectedness. Chapter 2 would further provide an explanation of each of OCC's three lines of defense, which are employed to mitigate the various risks to which OCC is exposed,
In Chapter 3 of the proposed RWD Plan, OCC would identify each of its fourteen different internal support functions and provide a brief description of the activities performed by each such support function. Together, Chapters 2 and 3 of the proposed Plan are designed to provide foundational information about the organization and operation of OCC that might be essential to relevant authorities in the event of an orderly wind-down planning. Like Chapter 2, the
The primary purpose of Chapter 4 of the proposed RWD Plan would be to identify OCC's “Critical Services” and “Critical Support Functions.” A “Critical Service,” as defined in the proposed Plan, is a service provided by OCC that, if interrupted, would likely have a material negative impact on participants or significant third parties, give rise to contagion, or undermine the general confidence of markets the FMU serves.
Chapter 4 of the proposed Plan sets forth the framework that OCC has used to designate its “Critical Services” and provides the analysis that OCC employed such designation. As proposed, the framework for designating OCC's “Critical Services” enlists the following criteria to determine if failure or discontinuation of a particular its services would adversely impact financial and operational capabilities of OCC's clearing members, other FMUs, and/or the broader financial system:
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In proposed Chapter 4, OCC further reduces each criterion to between one and three “measurable indicators.” Each measureable indicator is assigned a “high,” “medium” or “low” rating relative to each of the services evaluated, and each rating assigned to a measurable indicator is given equal weight in OCC's designation analysis. OCC evaluated eight discreet services, five of which were assigned a “high” rating for at least one of the measurable indicators in each of the four selected criteria. In proposed Chapter 4, certain qualitative and quantitative characteristics of each of those five discreet services is further discussed in order to reach a conclusion about the service's criticality. In proposed Chapter 4, OCC designates several of its services as Critical Services on the basis of this final discussion; the services designated as Critical Services would include, but not be limited to, clearance services for listed options and clearance services for futures.
Proposed Chapter 4 derives OCC's Critical Support Functions from the Critical Services designations. In proposed Chapter 4, OCC inventories each of the fourteen support functions discussed in Chapter 3 and determines which are minimally necessary for the continued and orderly operation each of the services identified as Critical Services. On the basis of this identification process, proposed Chapter 4 identifies the eleven support functions as “Critical Support Functions.”
The final sections of Chapter 4 would discuss the critical vendors for each of the Critical Support Functions, as well as the critical external interconnections that OCC maintains with other FMUs, exchanges (including designated contract markets), clearing and settlement banks, custodian banks, letter of credit banks, clearing members and credit facility lenders. These sections would be supported by the materials in Appendix B (which identifies OCC's clearing members), Appendix C (which identifies OCC's settlement banks), Appendix D (which identifies OCC's custodial banks), Appendix E (which identifies OCC's letter of credit banks), Appendix F (which identifies OCC's key vendors and service providers) and Appendix G (which identifies key agreements to be maintained).
Chapter 5 of OCC's proposed Plan would constitute OCC's Recovery Plan. Consistent with the above-stated purpose of a recovery and orderly wind-down plan, the purpose of Chapter 5 would be to demonstrate that OCC has considered scenarios which may potentially prevent it from being able to provide its Critical Services as a going-concern and that, based on the scenarios considered, OCC has prepared appropriate plans for its recovery.
The Recovery Plan would begin by describing the approach OCC initially took in developing the stress scenarios and recovery scenarios in OCC's existing orderly recovery and wind-down plan. Proposed Chapter 5 would then describe the approach OCC took in refining existing scenarios and adding new scenarios to arrive at the six storyline Stress Scenarios in Appendix H of the proposed RWD Plan.
The Recovery Plan would next identify and discuss each of OCC's “Enhanced Risk Management Tools” and “Recovery Tools,” which together would form the tool set that OCC could deploy, as applicable facts and circumstances might warrant, in a stress scenario. With respect to the Enhanced Risk Management Tools and Recovery Tools, the Recovery Plan would provide an overview of the tool, and as appropriate for each tool, the Recovery Plan would include a discussion of the implementation of the tool (including the estimated time frame for implementation of the tool), the key risks associated with the tool, and the expected impact and incentives associated with use of the tool.
Proposed Chapter 5 would explain that OCC's Enhanced Risk Management Tools are designed to supplement OCC's existing processes and other existing tools in scenarios where OCC faces heightened stresses. Contrary to the Recovery Tools (which are described in greater detail below), the use of OCC's Enhanced Risk Management Tools
Descriptions of each of the Enhanced Risk Management Tools contained in the proposed Recovery Plan are provided below:
As stated in Section 5(d) of Article VIII of the By-Laws, use of OCC's current and/or retained earnings would require prior unanimous consent from the holders of OCC's Class A common stock and Class B common stock. Accordingly, the Recovery Plan would acknowledge that the utility of this particular tool is limited by the fact that the tool is dependent upon receipt of unanimous consent from OCC's existing stockholders (and therefore, the availability of the tool cannot be known in advance). The Recovery Plan would further acknowledge that because OCC's retained earnings presently amount to only a small fraction of OCC's existing prefunded Clearing Fund resources, the maximum utility of this particular tool may be realized in specific circumstances at either the beginning of OCC's loss waterfall (
With respect to OCC's discretionary authority to increase the minimum cash requirement, the proposal would allow OCC's Executive Chairman, Chief Administrative Officer (“CAO”), or Chief Operating Officer (“COO”), upon providing notice to the Risk Committee of OCC's Board of Directors (“Risk Committee”), to temporarily increase the amount of cash required to be maintained in the Clearing Fund up to an amount that includes the size of the Clearing Fund for the protection of OCC, clearing members or the general public. Any determination by the Executive Chairman, CAO and/or COO to implement a temporary increase in Clearing Fund size would (i) be based upon then-existing facts and circumstances, (ii) be in furtherance of the integrity of OCC and the stability of the financial system, and (iii) take into consideration the legitimate interests of Clearing Members and market participants. The proposal would require that any such temporary increase be reviewed by the Risk Committee as soon as practicable, but in any event within 20 calendar days of the increase. Clearing Members would be required to satisfy any such increase in their required cash contributions no later than one hour before the close of the Fedwire (
OCC's Recovery Plan would acknowledge that the process for initiating any increase to the minimum cash requirement would be driven by the preparation of a “Close-Out Action Plan,” which is an internal document prepared in accordance with OCC's Default Management Policy and Default Management Procedures that, among other things, takes into consideration the projected liquidity demands for successful management of a defaulted Clearing Member. The Recovery Plan recognizes that the expected impact of any increase to the minimum Clearing fund cash requirement could be the exacerbation of any ongoing liquidity constraints facing OCC's Clearing Members.
The Recovery Plan would acknowledge that the process for initiating any borrowing against the Clearing Fund would be driven by the preparation of a “Close-Out Action Plan” (in the event of a Clearing Member default), in accordance with the execution of OCC's “Settlement Bank Failure Procedure” (in the event of a disruption to or failure of a settlement bank), in accordance with the execution of OCC's “Linked FMI Disruption Procedure” (in the event of a disruption to a linked financial market infrastructure). The Recovery Plan would further acknowledge that a borrowing pursuant to a recommendation in a Close-Out Action Plan or under either of the Settlement Bank Failure Procedures or Linked FMI Disruption Procedures would occur in accordance with OCC's “Syndicated Credit Facility Procedure.” The Recovery Plan recognizes that a key risk of this particular tool would be that in a heightened stress scenario OCC's primary liquidity facilities already may be fully or partially utilized (and therefore, the availability of the tool cannot be known in advance).
The Recovery Plan would recognize that borrowings under the facility would occur in accordance with OCC's Syndicated Credit Facility Procedure. The Recovery Plan would further recognize that the key risk associated with the use of the facility is that a portion of the syndicate may not timely fund OCC's draw.
The Recovery Plan would recognize that borrowings under the facility would occur in accordance with OCC's “Non-Bank Facility Procedure.” The Recovery Plan would further recognize that the key risk associated with the use of the non-bank facility is that OCC's counterparty may not timely execute the transaction.
The Recovery Plan would acknowledge that, assuming one of the two necessary conditions exists, the process for initiating cash settlement would be driven by the preparation of a “Close-Out Action Plan,” which would recommend impacted options and single-stock futures be cash settled in lieu of physical delivery. The Recovery Plan would also acknowledge that execution of cash settlement would occur in accordance with OCC's “Alternative Cash Settlement of Cleared Contracts Procedure.” The Recovery Plan recognizes that a key risk of this particular tool would be the potentially detrimental impacts on Clearing Members and their customers, who would receive a cash settlement amount when they had anticipated receiving physical securities.
Proposed Chapter 5 would explain that OCC's Recovery Tools differ from OCC's Enhanced Risk Management Tools in that the use of each Recovery Tool is generally limited to a scenario in which a Recovery Trigger Event has occurred, and as discussed below, the sequence and timing of the deployment of each Recovery Tool is more structured than the sequence and timing for the deployment of the Enhanced Risk Management Tools. As noted below, each of the Recovery Tools is discussed in greater detail in a proposed rule change that has been filed with the Commission.
Descriptions of each of the Recovery Tools contained in the proposed Recovery Plan are provided below:
The Recovery Plan would discuss the mechanics for replenishment of the Clearing Fund, which is the mechanism by which assessments would be collected from Clearing Members.
The Recovery Plan would discuss the mechanics for voluntary payments and the estimated time frame for issuing a “Voluntary Payment Notice” and collecting voluntary payments (from several hours to overnight, depending on the timing of the event driving OCC's determination to call for voluntary payments).
The Recovery Plan anticipates that OCC's tear-up process—for both voluntary tear-ups as well as partial tear-ups—would be initiated on a date sufficiently in advance of the exhaustion of OCC's financial resources such that OCC would be expected to have adequate remaining resources to cover the amount it must pay to extinguish the positions of Clearing Members and customers without
After OCC has completed its tear-up process and re-established a matched book, OCC expects that holders of both voluntarily torn-up and mandatorily torn-up positions would be provided with a limited opportunity to re-establish positions in the contracts that were voluntarily or mandatorily extinguished. For the losses, costs or expenses imposed upon the holders of torn-up positions, proposed Rule 1111 would provide OCC with two separate and non-exclusive means of equitably re-allocating such losses costs or expenses.
In addition to discussing the above mechanics for voluntary tear-up and the estimated time frame for initiating and completing OCC's tear-up process, the Recovery Plan would acknowledge that the key risk associated with the ability to call for voluntary tear-ups is that non-defaulting Clearing Members and nonwould be unwilling, or unable, to participate.
As explained above, the Recovery Plan would anticipate that the process for implementing a partial tear-up would be intertwined with the process for implementing a voluntary tear-up. The Recovery Plan would also make clear that partially torn-up positions would be allocated to non-defaulting Clearing Members' accounts (and further allocated by Clearing Members to their non-defaulting customers' accounts) on a pro rata basis.
In addition to generally discussing each of the Enhanced Risk Management Tools and Recovery Tools as described above, the Recovery Plan also would provide a mapping of OCC's Enhanced Risk Management Tools and Recovery Tools against the types of financial market infrastructure (“FMI”) risk exposures identified in the Recovery Report.
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The Recovery Plan would include a short discussion of how the Enhanced Risk Management Tools and Recovery Tools would apply to each of the risk categories and failure scenarios identified in the Recovery Report.
After discussing the Enhanced Risk Management Tools and Recovery Tools, the Recovery Plan would identify five qualitative “Recovery Trigger Events” (events that—if occurring during OCC's risk management efforts—would indicate that OCC is facing an extreme stress event that potentially threatens OCC's viability). The Recovery Plan would specify that the occurrence of a Recovery Trigger Event shall require OCC personnel to notify the Commission and the CFTC (and the Federal Deposit Insurance Corporation, to the extent applicable), and such notice shall apprise the regulator(s) of the specific Recovery Trigger Event that has occurred and sufficient information to enable the regulator(s) to understand the nature of the occurrence of the Recovery Trigger Event. The Recovery Plan would further outline an escalation process for the occurrence of a Recovery Trigger Event. The escalation process would start with individual support function leads, who would be responsible for communicating the possible occurrence of a Recovery Trigger Event to other support functions within OCC. The escalation process would require OCC's Enterprise Risk Management and Financial Risk Management groups to be responsible for assessing the situation and providing recommendations regarding the potential use of Enhanced Risk Management Tools and Recovery Tools. The escalation process would identify that the Chief Executive Officer and Executive Chairman would be responsible for providing necessary approvals for the implementation of Enhanced Risk Management Tools and Recovery Tools, and that the Chief Risk Officer and the Management Committee would be responsible for overseeing the deployment of any Enhanced Risk Management Tools or Recovery Tools. The escalation process would identify OCC's Board and the Risk Committee of the Board as being responsible for generally overseeing OCC's recovery efforts.
Finally, the Recovery Plan would provide general descriptions of how OCC would anticipate deploying its Enhanced Risk Management and Recovery Tools in response to each of the six Stress Scenarios detailed in Appendix H. As described above, the six detailed Stress Scenarios would be grouped into the following categories of stresses: Individual Clearing Member default, multiple successive Clearing Member defaults, disruption or failure of a bank or liquidity facility provider, inability to access another financial market infrastructure and general business and operational risks.
Chapter 6 of OCC's proposed RWD Plan would constitute OCC's WDP. Consistent with the above-stated purpose of an orderly wind-down plan, Chapter 6 would demonstrate that OCC has considered scenarios which may potentially prevent it from being able to provide its Critical Services as a going-concern and that OCC has adequately evaluated plans for its orderly wind-down.
The WDP would state OCC's basic assumptions concerning the resolution process, including assumptions about the duration of the resolution process, the cost of the resolution process, OCC's capitalization through the resolution process, the maintenance of Critical Services and Critical Support Functions and the retention of personnel and contractual relationships. The WDP would further identify six “WDP Trigger Events” that—if occurring during OCC's recovery efforts—could likely jeopardize the viability of OCC's recovery and signal that initiation of the WDP should be considered. Upon the occurrence of any WDP Trigger Event, the WDP would require OCC personnel to notify the Commission and the CFTC (and the Federal Deposit Insurance Corporation, to the extent applicable), and such notice must apprise the regulator(s) of the specific WDP Trigger Event that has occurred and sufficient information to enable the regulator(s) to understand the nature of the occurrence of the WDP Trigger Event. Additionally, the WDP would prescribe for each WDP Trigger Event more tailored internal notification requirements. These more tailored notification requirements would designate OCC personnel in specific support functions (generally, the function whose area is most closely related to, or impacted by, the specific WDP Trigger Event) as responsible for identifying such WDP Trigger Event and for notifying OCC's senior management.
The WDP also would reference the importance of the critical external interconnections (discussed in Chapter 4) to the resolution process and highlight the key agreements that would be necessary to maintain throughout OCC's resolution (such agreements would be listed in Appendix G). The WDP would provide a discussion of the key actions that OCC (or a resolution authority) could take during the resolution process. The key actions discussed in the WDP would include the following: The decision by OCC's Board (informed by senior management) to abandon recovery and initiate OCC's resolution process; the potential institution of new or heightened requirements on clearing membership; the potential imposition of heightened capital requirements on clearing members (consistent with the existing requirements in Rule 301); the imposition of increased margin requirements for Clearing Members
The WDP also would identify potential transactions that could be entered to accomplish the objectives of wind-down (“WDP Transactions”), as well as discuss the possibility of ceasing operation of OCC's Critical Services. The WDP would state that the goal of OCC's resolution—and thusly of any WDP Transaction—would be to transfer ownership of OCC itself by the consummation or a consensual sale or similar transaction, in a manner that ensures the continuation of OCC's Critical Services. The WDP would examine the structure of three potential WDP Transactions, with a focus on the corporate, transactions, governance and regulatory issues relating to each structure. In order of preference based on OCC's examination, the first structure would be a “Stock Transaction,” meaning a sale by OCC's stockholder exchanges of all of their shares of stock to one or more new owners; the second structure would be a “Merger Transaction,” meaning a merger or consolidation of OCC with another entity (with the aim of OCC remaining as the surviving entity), and; the third structure would be an “Asset Transaction,” meaning that substantially all of OCC's assets and some or all of OCC's liabilities, including open positions in OCC-cleared contracts along with related Clearing Fund deposits and margin collateral, would be transferred to a third party.
With respect to the possibility of ceasing OCC's Critical Services, the WDP would consider taking a corporate action to consider institution of a bankruptcy or insolvency proceeding, which would have the effect of triggering the existing close-out netting provisions in Article VI, Section 27 of OCC's By-Laws.
Chapter 7 of OCC's proposed Plan would memorialize the prior governance for approval of the earlier drafts of OCC's recovery and orderly wind-down plan and would establish an internal governance process for the maintenance, review and approval of the proposed RWD Plan. The internal governance process for the approval of subsequent changes to OCC's proposed RWD Plan would initiate with an RWD Working Group, which would recommend any changes to OCC's Management Committee. OCC's Management Committee, in turn, would review and, as appropriate, approve and recommend any changes to OCC's Risk Committee. OCC's Risk Committee, in turn, would review and, as appropriate, approve and recommend any changes to OCC's Board. OCC's Board would have final responsibility for review and approval of subsequent changes to OCC's proposed RWD Plan.
OCC believes that the proposed change would reduce the nature and level of risk presented to OCC by formalizing a plans designed to enhance OCC's ability to address extreme stress events and minimize the risks of contagion to OCC's Clearing Members, market participants or to the wider financial system, including other FMIs. Specifically, the RP would seek to enhance OCC's ability to address extreme stresses or crises by establishing a framework that OCC could use to navigate the use its Enhanced Risk Management Tools and Recovery Tools, with the aim of maintaining OCC's viability as a going concern. In the event that OCC's recovery efforts are not successful, the WDP would seek to improve the possibility that a resolution of OCC's operations can be conducted in an orderly manner, thereby minimizing the disruption to Clearing Members and market participants and improving the likelihood of minimizing the risk of contagion to the broader financial system. In this regard, OCC believes its proposed RWD Plan improves the possibility of maintaining market and public confidence during a time of unprecedented stress.
The stated purpose of the Clearing Supervision Act is to mitigate systemic risk in the financial system and promote financial stability by, among other things, promoting uniform risk management standards for systemically important financial market utilities and strengthening the liquidity of systemically important financial market utilities.
• Promote robust risk management;
• promote safety and soundness;
• reduce systemic risks; and
• support the stability of the broader financial system.
The Commission has adopted risk management standards under Section 805(a)(2) of the Clearing Supervision Act and the Act in furtherance of these objectives and principles, including those standards adopted pursuant to the Commission rules cited below.
OCC believes that the proposed rule change is also consistent with Rule 17Ad-22(e)(3)(ii).
The proposed change may be implemented if the Commission does not object to the proposed change within 60 days of the later of (i) the date the proposed change was filed with the Commission or (ii) the date any additional information requested by the Commission is received. OCC shall not implement the proposed change if the Commission has any objection to the proposed change.
The Commission may extend the period for review by an additional 60 days if the proposed change raises novel or complex issues, subject to the Commission providing the clearing agency with prompt written notice of the extension. A proposed change may be implemented in less than 60 days from the date the advance notice is filed, or the date further information requested by the Commission is received, if the Commission notifies the clearing agency in writing that it does not object to the proposed change and authorizes the clearing agency to implement the proposed change on an earlier date, subject to any conditions imposed by the Commission.
OCC shall post notice on its website of proposed changes that are implemented.
The proposal shall not take effect until all regulatory actions required with respect to the proposal are completed.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the advance notice is consistent with the Clearing Supervision 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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly.
All submissions should refer to File Number SR-OCC-2017-810 and should be submitted on or before February 13, 2018.
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend the Market Data section of its fee schedule applicable to its equity options platform (“EDGX Options”) to harmonize the definition of “Non-Professional User” with that of its affiliates, Cboe Exchange, Inc. (“Cboe”) and Cboe C2 Exchange, Inc. (“C2”).
The text of the proposed rule change is available at 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 parts of such statements.
The Exchange proposes to amend the Market Data section of its fee schedule applicable to EDGX Options to harmonize the definition of “Non-Professional User” with that of its affiliates, Cboe and C2. In late 2016, the Exchange and its affiliates Cboe EDGA Exchange, Inc. (“EDGA”), Cboe BYX Exchange, Inc. (“BYX”), and Cboe BZX Exchange, Inc. (“BZX”) received approval to effect a merger (the
As amended, “Non-Professional User” would be defined as:
The revised definition is substantially identical to the definition of “Non-Professional User' included within the Cboe and C2 fee schedules.
None of these differences impact the manner in which the Exchange would characterize a User and a Professional or Non-Professional. The harmonized definition would provide additional specificity while harmonizing the definition with that of its affiliates. Doing so would ensure consistent terms amongst the Exchange and its affiliates, thereby reducing the potential for confusion amongst market data subscribers regarding the type of User they may be considered by the Exchange.
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. The harmonized definition of Non-Professional User would have no impact on competition because it does not materially alter the definition.
The Exchange has neither solicited nor received written comments on the proposed rule change.
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
In its filing, the Exchange requested that the Commission waive the 30-day operative delay in order to enable the Exchange to immediately ensure consistent use of terms amongst the Exchange and its affiliates, thereby reducing the potential for confusion
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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The text of the proposed rule change is set forth below. Proposed new language is
The Exchange proposes to amend GEMX Rule 805 to permit Market Makers
(a)
(b)
(1) A market maker may enter all order types permitted to be entered by non-customer participants under the Rules to buy or sell options in classes of options listed on the Exchange to which the market maker is not appointed under Rule 802,
(i) and (ii) No change.
(2) and (3) No change.
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 purpose of this rule change is to permit Market Makers to enter principal orders to buy or sell options in the options classes to which they are appointed under Rule 802
Today, as noted in GEMX Rule 805(a), a Market Maker may not place principal orders to buy or sell options in the options classes to which they are appointed under Rule 802, other than opening only orders,
Today, GEMX Market Makers, who are appointed and non-appointed in a particular options class, may submit orders without limitation, unless otherwise restricted by the order type as discussed herein. The Exchange proposes to permit Market Makers to enter all order types, which are listed in GEMX Rule 715, except for Stopped Orders, Reserve Orders and Customer Cross Orders. The Exchange notes that today Market Makers are not eligible to execute either Customer Cross Orders, which are Customer orders, or Stopped Orders, which are intended for the account of a customer.
Today, for the reasons noted above, the Exchange does not permit Market Makers to enter Reserve Orders in non-appointed options classes. However, the current rule text does not provide this limitation. The Exchange proposes to amend the current rule text at GEMX Rule 805(b)(1) to codify this limitation.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange notes that previously, Nasdaq ISE, LLC prohibited non-customer trading by Electronic Access Members (“EAMs”) for principal or agent transactions.
The Exchange notes that these restrictions never existed on GEMX. GEMX believes that these restrictions should not exist today because there is no reason to restrict Market Makers in entering order types, except for the restriction related to Reserve Orders, in options classes in which they are appointed. Unlike other order types, the Reserve Order is a limit order that contains both a displayed portion and a non-displayed portion.
The Exchange is also amending GEMX Rule 805(a) to detail the types of non-resting order types and their modifiers with respect to ISO Orders, All-Or-None Orders, Stop Orders, Qualified Contingent Cross Orders, Attributable Orders, Do-Not-Route Orders, Opening Sweep Orders, Cancel and Replace Orders, and Add Liquidity Orders. This rule change will detail and align the rule text with the system functionality and make clear which order types a Market Maker may submit in appointed options classes.
GEMX Market Makers continue to be obligated to add liquidity on GEMX. The Exchange also notes that GEMX Rule 805(b)(2) and (3) restricts the number of contracts that a Market Maker may enter in an options class to which the Market Maker is not appointed.
The total number of contracts executed during a quarter by a Primary Market Maker in options classes to which it is not appointed may not exceed ten percent (10%) of the total number of contracts traded per each Primary Market Maker Membership.
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. Today, NYSE Arca and NYSE American place no limitation on the types of orders that can be entered by market makers in their appointed class.
Further, Market Makers, unlike other market participants, are required to abide by certain quoting requirements, in the options classes in which they are appointed pursuant to GEMX Rule 802, in order to maintain the status of a Market Maker.
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 Brent J. Fields, 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.
To be Published.
Wednesday, January 24, 2018 at 2:00pm.
The Closed Meeting scheduled for Wednesday, January 24, 2018 at 2:00 p.m. has been changed to Wednesday, January 24, 2018 at 11:00 a.m.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact the Office of the Secretary at (202) 551-5400.
On May 15, 2017, Bats BZX Exchange, Inc. (“Bats BZX”) (n/k/a Cboe BZX Exchange, Inc.);
On June 1, 2017, the proposed rule changes submitted by Bats BZX, Bats EDGX, BOX, C2, CBOE, FINRA, IEX, ISE, MIAX, and PEARL; both proposed rule changes submitted by NYSE MKT; and one of the proposed rule changes submitted by NYSE Arca were published for comment in the
Four comments were submitted to File Number SR-FINRA-2017-013.
On June 22, 2017, each of NASDAQ, BX, ISE, and Phlx filed an amendment to its proposed rule change. On July 14,
On August 24, 2017, BOX submitted Amendment No. 1 to its proposed rule change, IEX submitted Amendment No. 1 to its proposed rule change, PEARL submitted Amendment No. 2 to its proposed rule change,
On August 30, 2017, the Commission instituted proceedings under Section 19(b)(2)(B) of the Act
On January 9, 2018, MIAX and PEAL withdrew their proposed rule changes (File Numbers SR-MIAX-2017-20; SR-PEARL-2017-23). On January 10, 2018, Bats BZX, Bats EDGX, C2, CBOE, and IEX withdrew their proposed rule changes (File Numbers SR-BatsBZX-2017-37; SR-BatsEDGX-2017-23; SR-C2-2017-018; SR-CBOE-2017-041; SR-IEX-2017-18). On January 11, 2018, BOX withdrew its proposed rule change (File Number SR-BOX-2017-17). On January 12, 2018, FINRA, ISE, NASDAQ, BX, and Phlx withdrew their proposed rule changes (File Numbers SR-FINRA-2017-013; SR-ISE-2017-46; SR-NASDAQ-2017-055; SR-BX-2017-027; SR-PHLX-2017-43). On January 16, 2018, NYSE withdrew its proposed rule change (File Number SR-NYSE-2017-23), and NYSE Arca and NYSE MKT each withdrew both of their proposed rule changes (File Numbers SR-NYSEArca-017-57; SR-NYSEArca-2017-59; SR-NYSEMKT-2017-29; SR-NYSEMKT-2017-30).
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend the Market Data section of its fee schedule to harmonize the definition of “Non-Professional User” with that of its affiliates, Cboe Exchange, Inc. (“Cboe”) and Cboe C2 Exchange, Inc. (“C2”).
The text of the proposed rule change is available at 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 Exchange proposes to amend the Market Data section of its fee schedule to harmonize the definition of “Non-Professional User” with that of its affiliate, Cboe and C2. In late 2016, the Exchange and its affiliates Cboe EDGA Exchange, Inc. (“EDGA”), Cboe EDGX Exchange, Inc. (“EDGX”), and Cboe BZX Exchange, Inc. (“BZX”) received approval to effect a merger (the “Merger”) of the Exchange's parent company, Bats Global Markets, Inc., the parent of EDGA, EDGX, BYX, and BZX with CBOE Holding, Inc. (now known as Cboe Global Markets, Inc.) the parent company of Cboe and C2.
The revised definition is substantially identical to the definition of “Non-Professional User” included within the Cboe and C2 fee schedules.
None of these differences impact the manner in which the Exchange would characterize a User and a Professional or Non-Professional. The harmonized definition would provide additional specificity while harmonizing the definition with that of its affiliates. Doing so would ensure consistent terms amongst the Exchange and its affiliates, thereby reducing the potential for confusion amongst market data subscribers regarding the type of User they may be considered by the Exchange.
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. The harmonized definition of Non-Professional User would have no impact on competition because it does not materially alter the definition.
The Exchange has neither solicited nor received written comments on the proposed rule change.
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
In its filing, the Exchange requested that the Commission waive the 30-day operative delay in order to enable the Exchange to immediately ensure consistent use of terms amongst the Exchange and its affiliates, thereby reducing the potential for confusion amongst market data subscribers regarding the type of User they may be considered by the Exchange. The Commission believes that such waiver is consistent with the protection of investors and the public interest. Therefore, the Commission designates the proposed rule change to be operative upon filing. For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation.
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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend the Market Data section of its fee schedule applicable to its equity options platform (“BZX Options”) to harmonize the definition of “Non-Professional User” with that of its affiliates, Cboe Exchange, Inc. (“Cboe”) and Cboe C2 Exchange, Inc. (“C2”).
The text of the proposed rule change is available at 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
The Exchange proposes to amend the Market Data section of its fee schedule applicable to BZX Options to harmonize the definition of “Non-Professional User” with that of its affiliates, Cboe and C2. In late 2016, the Exchange and its affiliates Cboe EDGA Exchange, Inc. (“EDGA”), Cboe BYX Exchange, Inc. (“BYX”), and Cboe EDGX Exchange, Inc. (“EDGX”) received approval to effect a merger (the “Merger”) of the Exchange's parent company, Bats Global Markets, Inc., the parent of EDGA, EDGX, BYX, and BZX with CBOE Holding, Inc. (now known as Cboe Global Markets, Inc.) the parent company of Cboe and C2.
The revised definition is substantially identical to the definition of “Non-Professional User' included within the Cboe and C2 fee schedules.
None of these differences impact the manner in which the Exchange would characterize a User and a Professional or Non-Professional. The harmonized definition would provide additional specificity while harmonizing the definition with that of its affiliates. Doing so would ensure consistent terms amongst the Exchange and its affiliates, thereby reducing the potential for confusion amongst market data subscribers regarding the type of User they may be considered by the Exchange.
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. The harmonized definition of Non-Professional User would have no impact on competition because it does not materially alter the definition.
The Exchange has neither solicited nor received written comments on the proposed rule change.
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
In its filing, the Exchange requested that the Commission waive the 30-day operative delay in order to enable the Exchange to immediately ensure consistent use of terms amongst the Exchange and its affiliates, thereby reducing the potential for confusion amongst market data subscribers regarding the type of User they may be considered by the Exchange. The Commission believes that such waiver is consistent with the protection of investors and the public interest. Therefore, the Commission designates the proposed rule change to be operative upon filing. For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation.
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.
Pursuant to Section 806(e)(1) of Title VIII of the Dodd-Frank Wall Street Reform and Consumer Protection Act, entitled Payment, Clearing and Settlement Supervision Act of 2010 (“Clearing Supervision Act”)
This advance notice is filed in connection with a proposed change to make certain revisions to OCC's Rules and By-Laws to enhance OCC's existing tools to address the risks of liquidity shortfalls and credit losses and to establish new tools by which OCC could re-establish a matched book following a default. Each of the tools proposed herein is contemplated to be deployed by OCC in an extreme stress event that has placed OCC into a recovery or orderly wind-down scenario.
The proposed changes to OCC's By-Laws and Rules were submitted as Exhibits 5A and 5B of the filing, and proposed changes to OCC's Default Management Policy were submitted as confidential Exhibit 5C of the filing.
In its filing with the Commission, OCC included statements concerning the purpose of and basis for the advance notice and discussed any comments it received on the advance notice. The text of these statements may be examined at the places specified in Item IV below. OCC has prepared summaries, set forth in sections A and B below, of the most significant aspects of these statements.
Written comments were not and are not intended to be solicited with respect to the proposed rule change and none have been received. OCC will notify the Commission of any written comments received by OCC.
The purpose of this proposed rule change is to make certain revisions to OCC's Rules and By-Laws Laws that are designed to enhance OCC's existing tools to address the risks of liquidity shortfalls and credit losses and to establish tools by which OCC could re-establish a matched book following a default. Each of the tools proposed herein is contemplated to be deployed by OCC in an extreme stress event that has placed OCC into a recovery or orderly wind-down scenario. Each of the proposed revisions also is designed to further OCC's compliance, in whole or in part, with the provisions of the Commission's rules identified immediately below.
On September 28, 2016, the Commission adopted amendments to Rule 17Ad-22
• Rule 17Ad-22(e)(3)(ii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [m]aintain a sound risk management framework for comprehensively managing legal, credit, liquidity, operational, general business, investment, custody, and other risks that arise in or are borne by the [CCA], which . . . [i]ncludes plans for the recovery and orderly wind-down of the [CCA] necessitated by credit losses, liquidity shortfalls, losses from general business risk, or any other losses.”
• Rule 17Ad-22(e)(4)(viii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [e]ffectively identify, measure, monitor, and manage its credit exposures to participants and those arising from its payment, clearing, and settlement processes, including by . . . [a]ddressing allocation of credit losses the [CCA] may face if its collateral and other resources are insufficient to fully cover its credit exposures, including the repayment of any funds the [CCA] may borrow from liquidity providers.”
• Rule 17Ad-22(e)(4)(ix) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [e]ffectively identify, measure, monitor, and manage its credit exposures to participants and those arising from its payment, clearing, and settlement processes, including by . . . [d]escribing the [CCA's] process to replenish any financial resources it may use following a default or other event in which use of such resources is contemplated.”
• Rule 17Ad-22(e)(7)(ix) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [e]ffectively measure, monitor, and manage the liquidity risk that arises in or is borne by the [CCA], including measuring, monitoring, and managing its settlement and funding flows on an ongoing and timely basis, and its use of intraday liquidity by, at a minimum, doing the following...[d]escribing the [CCA's] process to replenish any liquid resources that the clearing agency may employ during a stress event.”
• Rule 17Ad-22(e)(13) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [e]nsure the covered clearing agency has the authority and operational capacity to take timely action to contain losses and liquidity demands and continue to meet its obligations . . .”
• Rule 17Ad-22(e)(23)(i) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [p]ublicly disclos[e] all relevant rules and material procedures, including key aspects of its default rules and procedures.”
• Rule 17Ad-22(e)(23)(ii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [p]rovid[e] sufficient information to enable participants to identify and evaluate the risks, fees, and other material costs they incur by
OCC meets the definition of a CCA and is therefore subject to the requirements of the CCA rules, including new Rules 17Ad-22(e)(3)(ii), (e)(4)(viii), (e)(4)(ix), (e)(7)(ix), (e)(13), (e)(23)(i) and (e)(23)(ii).
In order to enhance OCC's existing tools to address the risks of liquidity shortfalls and credit losses and to establish new tools by which OCC could re-establish a matched book following a default, OCC is proposing to make the following revisions to its Rules and By-Laws:
(1) Revise the existing assessment powers in Section 6 of Article VIII of OCC's By-Laws, specifically to:
(a) Establish a rolling “cooling-off period” that would be triggered by the payment of a proportionate charge against the Clearing Fund (“triggering proportionate charge”), during which period the aggregate liability of a Clearing Member to replenish the Clearing Fund (inclusive of assessments) would be 200% of the Clearing Member's required contribution as of the time immediately preceding the triggering proportionate charge;
(b) Clarify that a Clearing Member that chooses to terminate its membership status during a cooling-off period will not be liable for replenishment of the Clearing Fund immediately following the expiration of such cooling-off period, provided that the withdrawing Clearing Member satisfies enumerated criteria, including providing notice of such termination by no later than the end of the cooling-off period and by closing-out and/or transferring of all its open positions with OCC by no later than the last day of the cooling-off period; and
(c) Delineate between the obligation of a Clearing Member to replenish its contributions to the Clearing Fund and its obligations to meet additional “assessments” that may be levied following a proportionate charge to the Clearing Fund.
(2) Adopt a new Rule 1009 that would provide OCC with discretionary authority to call for voluntary payments from non-defaulting Clearing Members in a circumstance where one or more Clearing Members has already defaulted and OCC has determined that it may not have sufficient resources to satisfy its obligations and liabilities resulting from such default. Rule 1009 also would establish that OCC would prioritize compensation of Clearing Members that made voluntary payments from any amounts recovered from the defaulted Clearing Members.
(3) Adopt a new Rule 1111 that would provide authority to:
(a) Allow OCC to call for voluntary tear-ups (“Voluntary Tear-Up,” as defined below) of non-defaulting Clearing Member and/or customer positions at any time following the suspension or default of a Clearing Member, with the scope of any such Voluntary Tear-Ups being determined by the Risk Committee of OCC's Board (“Risk Committee”);
(b) Allow OCC's Board to vote to tear-up the “Remaining Open Positions” (defined below) of a defaulted Clearing Member, as well as any “Related Open Positions” (defined below) in a circumstance where OCC has attempted one or more auctions of such defaulted Clearing Member's remaining open positions and OCC has determined that it may not have sufficient resources to satisfy its obligations and liabilities resulting from such default with the scope of any such tear-up (“Partial Tear-Up”) being determined by the Risk Committee; and
(c) Allow OCC's Board to vote to re-allocate losses, costs and fees imposed upon holders of positions extinguished in a Partial Tear-Up through a special charge levied against remaining non-defaulting Clearing Members.
(4) Revise the descriptions and authorizations in Article VIII of OCC's By-Laws concerning the use of the Clearing Fund to reflect the discretion of OCC to use remaining Clearing Fund contributions to re-allocate losses imposed on non-defaulting Clearing Members and customers from a Voluntary Tear-Up or a mandatory tear-up (“Partial Tear-Up,” as defined below).
Each of the proposed revisions to OCC's Rules and By-Laws is described in more detail in the following sub-sections:
OCC's current assessment powers are described in Section 6 of Article VIII of OCC's By-Laws. Section 6 establishes a general requirement for each Clearing Member to promptly make good any deficiency in its required contribution to the Clearing Fund whenever an amount is paid out of its Clearing Fund contribution (whether by proportionate charge or otherwise).
OCC proposes to amend Section 6 of Article VIII of OCC's By-Laws to make three primary modifications regarding its existing authority to assess proportionate charges against Clearing Members' contributions to the Clearing Fund. First, the proposal introduces an automatic minimum fifteen calendar day “cooling-off” period that begins
During a cooling-off period, each Clearing Member would have its aggregate liability to replenish the Clearing Fund capped at 200% of the Clearing Member's then-required contribution to the Clearing Fund. Once the cooling-off period ends each remaining Clearing Member would be required to replenish the Clearing Fund in the amount necessary to meet its then-required contribution. Once the cooling-off period ends, any remaining losses or expenses suffered by OCC as a result of any event described in clauses (i) through (iv) of Article VIII, Section 5(a) of OCC's By-Laws that occurred during such cooling-off period could not be charged against the amounts Clearing Members have contributed to replenish the Clearing Fund upon the expiration of the cooling-off period.
Second, in connection with the cooling-off period, the proposal would extend the time frame within which a Clearing Member may provide a termination notice to OCC to avoid liability for replenishment of the Clearing Fund after the cooling-off period and would modify the obligations of such a terminating Clearing Member for closing-out and transferring its remaining open positions. Specifically, to effectively terminate its status as a Clearing Member and not be liable for replenishing the Clearing Fund after the cooling-off period, a Clearing Member would be required to: (i) Notify OCC in writing of its intent to terminate not later than the last day of the cooling-off period, (ii) not initiate any opening purchase or opening writing transaction, and, if the Clearing Member is a Market Loan Clearing Member or a Hedge Clearing Member, not initiate any Stock Loan transaction, through any of its accounts, and (iii) close-out or transfer all of its open positions by no later than the last day of the cooling-off period. If a Clearing Member fails to satisfy all of these conditions by the end of a given cooling-off period, it would not have completed all of the requirements necessary to terminate its status as a Clearing Member under Article VIII, Section 6 of OCC's By-Laws and therefore it would remain subject to the obligation to replenish the Clearing Fund after the end of the cooling-off period.
Third, the proposal would clarify the distinction between “replenishment” of the Clearing Fund and a Clearing Member's obligation to answer “assessments.” In this context, the term “replenish” (and its variations) shall to refer to a Clearing Member's standing duty, following any proportionate charge against the Clearing Fund, to return its Clearing Fund contribution to the amount required from such Clearing Member for the month in question.
OCC proposes to add new Rule 1009, which will provide a framework by which OCC could receive voluntary payments in a circumstance where a Clearing Member has defaulted and OCC has determined that, notwithstanding the availability of any remaining resources under OCC Rules 707, 1001, 1104 through 1107, 2210 and 2211,
OCC proposes to add new Rule 1111, which, in relevant part, will establish a framework by which non-defaulting Clearing Members and non-defaulting customers of Clearing Members could be given an opportunity to voluntarily extinguish (
While Risk Committee approval is not needed to commence a voluntary tear-up, the Risk Committee would be responsible for determining the appropriate scope of each voluntary tear-up. To ensure OCC retains sufficient flexibility to effectively deploy this tool in an extreme stress event, proposed Rule 1111(c) is drafted to provide the Risk Committee with discretion to determine the appropriate
Once the Risk Committee has determined the scope of the Voluntary Tear-Up, OCC will initiate the call for voluntary tear-ups by issuing a “Voluntary Tear-Up Notice.” The Voluntary Tear-Up Notice shall inform all non-defaulting Clearing Members of the opportunity to participate in a Voluntary Tear-Up.
OCC is not proposing a tear-up process that would require the imposition of “gains haircutting” (
In OCC's proposed tear-up process, the holders of torn-up positions would be assigned a Tear-Up Price and OCC would draw on its remaining financial resources in order to extinguish the torn-up positions at the assigned Tear-Up Price without forcing a reduction in the amount unpaid gains on such positions. The proposed changes would provide OCC with two separate and non-exclusive means of equitably re-allocating the losses, costs or expenses imposed upon the holders of torn-up positions as a result of the tear-up(s). First, the proposed changes to Article VIII would provide OCC discretion to use remaining Clearing Fund contributions to re-allocate losses imposed on non-defaulting Clearing Members and customers from such tear-up(s). Second, Rule 1111(a) would provide that if OCC subsequently recovers from the defaulted Clearing Member or the estate(s) of the defaulted Clearing Member(s) and the amount of such recovery exceeds the amount OCC received in voluntary payments, then non-defaulting Clearing Members and non-defaulting customers that voluntarily tore-up open positions and incurred losses from such tear-ups would be repaid from the amount of the recovery in excess of the amount OCC received in voluntary payments.
With respect to Voluntary Tear-Ups, new Rule 1111(h) would clarify that no action or omission by OCC pursuant to and in accordance Rule 1111 shall constitute a default by OCC.
OCC proposes to add new Rule 1111, which, in relevant part, will provide the Board with discretion to extinguish the remaining open positions of any defaulted Clearing Member or customer of such defaulted Clearing Member(s) (such positions, “Remaining Open Positions”), as well as any related open positions as necessary to mitigate further disruptions to the markets affected by the Remaining Open Positions (such positions, “Related Open Positions”), in a circumstance where a Clearing Member has defaulted and OCC has determined that, notwithstanding the availability of any remaining resources under OCC Rules 707, 1001, 1104 through 1107, 2210 and 2211, OCC may not have sufficient resources to satisfy its obligations and liabilities resulting from such default (such tear-ups hereinafter collectively referred to as “Partial Tear-Ups”). Like the determination for Voluntary Tear-Ups, the Risk Committee shall determine the appropriate scope of each Partial Tear-Up and such determination shall (i) be based on then-existing facts and circumstances, (ii) be in furtherance of the integrity of OCC and the stability of the financial system, and (iii) take into consideration the legitimate interests of Clearing Members and market participants. Once the Risk Committee has determined the scope of the Partial Tear-Up, OCC will initiate the Partial Tear-Up process by issuing a “Partial Tear-Up Notice.” The Partial Tear-Up Notice shall (i) identify the Remaining Open Positions and Related Open Positions designated for tear-up, (ii) identify the open positions of non-defaulting Clearing Members and non-defaulting customers that will be subject to Partial Tear-Up (such positions, “Tear-Up Positions”), (iii) specify the termination price (“Partial Tear-Up Price”) for each position to be torn-up, and (iv) list the date and time as of which the Partial Tear-Up will occur.
The scope of any Partial Tear-Up will be determined in accordance with Rule 1111(e). With respect to the extinguishment of Remaining Open Positions, OCC will designate Tear-Up Positions in identical Cleared Contracts and Cleared Securities on the opposite side of the market and in an aggregate amount equal to that of the Remaining Open Positions. OCC will only designate Tear-Up Positions in the accounts of non-defaulting Clearing Members (inclusive of such Clearing Members' customer accounts) with an open position in the applicable Cleared Contract or Cleared Security and of non-defaulted customers of a defaulted Clearing Member. Tear-Up Positions shall be designated and applied by OCC on a pro rata basis across all the identical positions in Cleared Contracts and Cleared Securities on the opposite side of the market in the accounts of non-defaulted Clearing Members and non-defaulted customers (including the non-defaulted customers of defaulted Clearing Members).
Rule 1111(e)(iii) provides that every Partial Tear-Up position is automatically terminated upon and with effect from the Partial Tear-Up Time, without the need for any further step by any party to such Cleared Contract or Cleared Security, and that upon termination, either OCC or the relevant Clearing Member (as the case may be) shall be obligated to pay the other the applicable Partial Tear-Up Price. Rule 1111(e)(iii) further provides that the corresponding open position shall be deemed terminated at the Partial Tear-Up Price.
Rule 1111(g) provides that to the extent losses imposed upon non-defaulting Clearing Members and non-defaulting customers resulting from a Partial Tear-Up can reasonably be determined, the Board may elect to re-allocate such losses among all non-defaulting Clearing Members through a special charge to all non-defaulting Clearing Members in an amount corresponding to each such non-defaulting Clearing Member's proportionate share of the variable amount of the Clearing Fund at the time such Partial Tear-Up is conducted.
With respect to Partial Tear-Ups, new Rule 1111(h) would clarify that no action or omission by OCC pursuant to and in accordance Rule 1111 shall constitute a default by OCC.
OCC believes that the proposed changes would reduce the nature and level of risk presented to OCC in three primary ways: (i) By providing greater certainty regarding what financial resources will be available to OCC after a proportionate charge is assessed; (ii) by providing additional tools by which to allocate credit losses in excess of OCC's available financial resources; and (iii) by enhancing OCC's ability to re-establish a matched book. First, OCC believes the imposition of a 200% cap on OCC's assessment powers during any cooling-off period provides Clearing Members with greater certainty regarding their maximum liability with respect to the Clearing Fund during extreme stress events, which in turn, facilitates Clearing Members' management of their own risks, and to the extent applicable, regulatory capital considerations. Further, OCC believes that extending the window for Clearing Member withdrawal following a proportionate charge to be equivalent with the cooling-off period would afford a Clearing Member a more reasonable period in which to evaluate whether the withdrawal from clearing membership would be necessary to cap its liability for proportionate charges at 200% of its then-required Clearing Fund contributions. With this change, OCC believes the increased predictability would help it to more reliably understand the amount of Clearing Fund contributions that will likely be available to it after a proportionate charge is assessed. Second, the introduction of rules to allow for voluntary payments, Voluntary Tear-Ups and Partial Tear-Ups would provide OCC with three distinct tools that could be used to allocate any credit losses OCC may face in excess of collateral and other resources available to OCC. Finally, in the event that OCC believes its obligations and liabilities arising from remaining positions in the portfolio of a defaulted Clearing Member may exceed its remaining available financial resources, the proposed changes ultimately would enable OCC to extinguish those positions, thereby re-establishing a matched book.
The risks of a Partial Tear-Up are extremely remote; nonetheless, OCC believes that the express authority to conduct a Partial Tear-Up may be viewed as increasing Clearing Members' and customers' exposure to an extreme stress scenario. As explained above, the proposed Partial Tear-Up authority is consistent with regulatory requirements, as well as with the expectations of CCPs of various international organizations. OCC further believes that its proposed Partial Tear-Up authority strikes an appropriate balance between seeking to protect the interests of Clearing Members and customers and the need to have appropriate tools to stabilize a systemically important financial market utility and minimize the risk of disruption to the broader financial system. To address the potential impact of a Partial Tear-Up on Clearing Members and customers, OCC has proposed two tools that would enable it to equitably re-allocate the losses, costs and fees imposed upon holders of torn-up positions.
The stated purpose of the Clearing Supervision Act is to mitigate systemic risk in the financial system and promote financial stability by, among other
• Promote robust risk management;
• promote safety and soundness;
• reduce systemic risks; and
• support the stability of the broader financial system.
The Commission has adopted risk management standards under Section 805(a)(2) of the Clearing Supervision Act and the Act in furtherance of these objectives and principles, including those standards adopted pursuant to the Commission rules cited below.
In relevant part, Rule 17Ad-22(e)(3)(ii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . plan[ ] for the recovery and orderly wind-down of the [CCA] necessitated by credit losses, liquidity shortfalls, losses from general business risk, or any other losses.”
In relevant part, Rule 17Ad-22(e)(4)(viii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [a]ddress[ ] allocation of credit losses the [CCA] may face if its collateral and other resources are insufficient to fully cover its credit exposures . . .”
In relevant part, Rule 17Ad-22(e)(4)(ix) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [d]escrib[e] the [CCA's] process to replenish any financial resources it may use following a default or other event in which use of such resources is contemplated.”
OCC believes that the proposed approach improves predictability for
OCC believes that the relative certainty provided by the proposed cooling-off period and 200% cap on assessments ultimately could reduce the risks of successive or “cascading” defaults, in which the financial demands on remaining non-defaulting Clearing Members to continually replenish OCC's Clearing Fund (and similar guaranty funds at other CCPs to which such Clearing Members might belong) have the effect of further weakening such Clearing Members to the point of default. In this regard, the proposed changes are designed to provide OCC, Clearing Members and other stakeholders with sufficient time to manage the ongoing default(s) without further aggravating the extreme stresses facing market participants.
OCC recognizes that the proposed changes would limit the maximum amount of Clearing Fund resources that could be available to OCC in an extreme stress scenario, which introduces the possibility, however remote, that the proposed 200% cap ultimately could be reached. If during any cooling-off period the amount of aggregate proportionate charges against the Clearing Fund approaches the 200% cap, the amount remaining in the Clearing Fund may no longer be sufficient to comply with the applicable minimum regulatory financial resources requirements in the CCAs. In any such event, OCC's existing authority under Rule 603 would permit OCC to call on participants for additional initial margin, which could ensure that OCC's minimum financial resources remain in excess of applicable CCA requirements.
Given the products cleared by OCC and the composition of its clearing membership, OCC has determined that a minimum 15-calendar day cooling-off period, rolling up to a maximum of 20 calendar days, is likely to be a sufficient amount of time for OCC to manage the ongoing default(s) and take necessary steps in furtherance of stabilizing the clearing system. Further, through conversations with Clearing Members, OCC believes that the proposed cooling-off period is likely to be a sufficient amount for Clearing Members (and their customers) to orderly reduce or rebalance their positions, in an attempt to mitigate stress losses and exposure to potential initial margin increases as they navigate the stress event. Through conversations with Clearing Members, OCC also believes that the proposed cooling-off period is likely to be a sufficient amount for certain Clearing Members to orderly close-out their positions and transfer customer positions as they withdraw from clearing membership. OCC believes the proposed cooling-off period, coupled with the other proposed changes to OCC's assessment powers, is likely to provide Clearing Members with an adequate measure of stability and predictability as to the potential use of Clearing Fund resources, which OCC believes removes the existing incentive for Clearing Members to withdraw following a proportionate charge.
In light of the foregoing, OCC believes that the proposed changes would enhance and strengthen its process to replenish the Clearing Fund following a default or other event in which use of the Clearing Fund is contemplated, in accordance with Rule 17Ad-22(e)(4)(ix).
In relevant part, Rule 17Ad-22(e)(7)(ix) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [d]escrib[e] the [CCA's] process to replenish any liquid resources that the clearing agency may employ during a stress event.”
In relevant part, Rule 17Ad-22(e)(13) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [e]nsure the [CCA] has the authority and operational capacity to take timely action to contain losses and liquidity demands and continue to meet its obligations . . .”
In relevant part, Rule 17Ad-22(e)(23)(i) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [p]ublicly disclos[e] all relevant rules and material procedures, including key aspects of its default rules and procedures.”
In relevant part, Rule 17Ad-22(e)(23)(ii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [p]rovid[e] sufficient information to enable participants to identify and evaluate the risks, fees, and other material costs they incur by participating in the covered clearing agency.”
The proposed change may be implemented if the Commission does not object to the proposed change within 60 days of the later of (i) the date the proposed change was filed with the Commission or (ii) the date any additional information requested by the Commission is received. OCC shall not implement the proposed change if the Commission has any objection to the proposed change.
The Commission may extend the period for review by an additional 60 days if the proposed change raises novel or complex issues, subject to the Commission providing the clearing agency with prompt written notice of the extension. A proposed change may be implemented in less than 60 days from the date the advance notice is filed, or the date further information requested by the Commission is received, if the Commission notifies the clearing agency in writing that it does not object to the proposed change and authorizes the clearing agency to implement the proposed change on an earlier date, subject to any conditions imposed by the Commission.
OCC shall post notice on its website of proposed changes that are implemented.
The proposal shall not take effect until all regulatory actions required with respect to the proposal are completed.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the advance notice is consistent with the Clearing Supervision 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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly.
All submissions should refer to File Number SR-OCC-2017-809 and should be submitted on or before February 13, 2018.
By the Commission.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Administrative declaration of a disaster for the State of Arizona dated 08/03/2017.
Issued on 01/11/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of an Administrative declaration for the State of ARIZONA, dated 08/03/2017, is hereby amended to establish the incident closing date as 09/30/2017.
All other information in the original declaration remains unchanged.
Office of the United States Trade Representative.
Notice and request for comments.
The United States Trade Representative (Trade Representative) and the Secretary of Commerce (Secretary) plan to establish a new four-year charter term for the Industry Trade Advisory Committees (ITACs) beginning in February 2018. As part of the re-chartering process, the Secretary and the Trade Representative are proposing changes to the current slate of ITACs and invite interested parties to submit their view on these changes.
The deadline for submission of written comments is February 5, 2018 at midnight EST.
Submit comments electronically via email to
Gregory M. Walters, Assistant United States Trade Representative for Intergovernmental Affairs and Public Engagement at
Section 135 of the Trade Act of 1974, as amended (19 U.S.C. 2155), establishes a private-sector trade advisory system to ensure that U.S. trade policy and trade negotiation objectives adequately reflect U.S. commercial and economic interests. Section 135(c)(2) (19 U.S.C. 2155(c)(2)) directs the President to establish sectoral or functional trade advisory committees as appropriate, comprised of representatives of all industry, labor, agricultural, and services interests (including small business interests) in the sector or functional area. These committees provide detailed policy and technical advice, information, and recommendations regarding trade barriers, negotiation of trade agreements, and implementation of existing trade agreements affecting industry sectors, and perform other advisory functions relevant to U.S. trade policy matters as requested. In organizing such committees, the Trade Representative and the relevant Secretary are to consult with interested private organizations and to consider “(i) patterns of actual or potential competition between United States industry and agriculture and foreign enterprise in international trade, (ii) the character of the nontariff barriers and other distortions affecting such competition, (iii) the necessity for reasonable limits on the number of such advisory committees, (iv) the necessity that each committee be reasonably limited in size, and (v) in the case of each sectoral committee, that the product lines covered by each committee be reasonably related.”
Pursuant to this authority, the Secretary and the Trade Representative established the ITACs to provide detailed policy and technical advice, information, and recommendations to the Secretary and the Trade Representative on trade policy matters including: (1) Negotiating objectives and bargaining positions before entering into trade agreements; (2) the impact of the implementation of trade agreements on the relevant sector; (3) matters concerning the operation of any trade agreement once entered into; and (4) other matters arising in connection with the development, implementation, and administration of the trade policy of the United States. The nonpartisan, industry input provided by the ITACs is important in developing unified trade policy objectives and positions when the United States negotiates and implements trade agreements. The ITACs address market-access problems, trade barriers, tariffs, discriminatory foreign procurement practices, and information, marketing, and advocacy needs of their industry sector. With
The current ITACs expire in February 2018, and the Secretary and the Trade Representative intend to renew the ITACs as described below for a new four-year charter terms for the ITACs to begin in February 2018 and end in February 2022.
For the 2014-2018 charter term, the Secretary and Trade Representative chartered: Thirteen sectoral ITACs advising on issues that affect specific sectors of U.S. industry; three ITACs advising on crosscutting, functional issues that affect all industry sectors and include specifically appointed members along with non-voting members from the industry specific ITACs to represent a broad range of industry perspectives; and a Committee of Chairs of the ITACs as follows:
Industry Trade Advisory Committees on:
For the 2018-2022 charter term, after considering the statutory factors listed above, the Secretary and the Trade Representative propose to streamline the ITACs as follows based on the nature of the U.S. industry in various sectors, the level of interest in serving on an ITAC (using the number of members and applications for appointment during the 2014-2018 charter terms), the level of activity of each ITAC (using the number of meetings and recommendations submitted during the 2014-2018 charter terms), and constraints on the resources to support and engage with the ITACs.
• Combining the current ITACs on Distribution Services and on Services and Finance Industries into one ITAC on Services.
• Combining the current ITACs on Forest Products and on Building Materials, Construction, and Nonferrous Metals into one ITAC on Forest Products, Building Materials, Construction, and Nonferrous Metals.
• Changing the name of the ITAC on Information and Communications Technologies, Services, and Electronic Commerce to the ITAC on Digital Economy to reflect the innovation in and full scope of that industry sector.
• Discontinuing the Committee of Chairs of the ITACs to both preserve staff resources and to ensure that all ITAC members receive relevant, timely, and unfiltered information directly from appropriate government staff.
This streamlining would result in eleven sectoral ITACs and three functional ITACs for the new four-year charter term as follows:
Industry Trade Advisory Committees on:
In accordance with Section 135(c)(2)(A) (19 U.S.C. 2155(c)(2)) of the Trade Act, we invite written comments on the proposed changes to the slate of ITACs for the 2018-2022 charter term.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Eighty Seventh RTCA SC-147 Plenary Session.
The FAA is issuing this notice to advise the public of a meeting of Eighty Seventh RTCA SC-147 Plenary Session.
The meeting will be held March 08, 2018 9:00 a.m.-4:30 p.m.
The meeting will be held at: RTCA Headquarters, 1150 18th Street NW, Suite 910, Washington, DC 20036.
Al Secen at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Eighty Seventh RTCA SC-147 Plenary Session. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Highway Administration (FHWA), DOT.
Request for comments.
The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for a new information collection, which is summarized below under
Please submit comments by March 26, 2018.
You may submit comments identified by DOT Docket ID Number 2018-0001 by any of the following methods:
Mr. Chris Jaeschke, 703-404-6306, Planning and Programming (HFPP-15), Eastern Federal Lands Highway Division, Federal Highway Administration, Department of Transportation, 21400 Ridgetop Circle, Sterling, VA 20166. Office hours are from 7:30 a.m. to 4:00 p.m., Monday through Friday, except Federal holidays.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1.48.
Federal Highway Administration (FHWA), DOT.
Notice of request for extension of currently approved information collection.
The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for renewal of an existing information collection that is summarized below under
Please submit comments by March 26, 2018.
You may submit comments identified by DOT Docket ID Number 2018-0002 by any of the following methods:
Steven Jessberger, 202-366-5052, Federal Highway Administration, Department of Transportation, Office of Highway Policy Information, 1200 New Jersey Avenue SE, Washington, DC 20590, Monday through Friday, except Federal holidays.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1.48.
Office of the Assistant Secretary for Research and Technology (OST-R), Bureau of Transportation Statistics (BTS), DOT.
Notice.
In compliance with the Paperwork Reduction Act of 1995, Public Law 104-13, the Bureau of Transportation Statistics invites the general public, industry and other governmental parties to comment on the continuing need for and usefulness of BTS collecting financial data from large certificated air carriers. Large certificated air carriers are carriers that operate aircraft with 61 seats or more, aircraft with 18,001 pounds of payload capacity or more, or operate international air services.
Written comments should be submitted by March 26, 2018.
Jeff Gorham, Office of Airline Information, RTS-42, Room E34, OST-R, BTS, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, Telephone Number (202) 366-4406, Fax Number (202) 366-3383 or EMAIL
You may submit comments identified by DOT Docket ID Number DOT-OST-2014-0031 by any of the following methods:
You may access comments received for this notice at
The Department of Transportation sets and updates the international and mainline Alaska mail rates based on carrier aircraft operating expense, traffic and operational data. Form 41 cost data, especially fuel costs, terminal expenses, and line haul expenses are used in arriving at rate levels. DOT revises the established rates based on the percentage of unit cost changes in the carriers' operations. These updating procedures have resulted in the carriers receiving rates of compensation that more closely parallel their costs of providing mail service and contribute to the carriers' economic well-being.
As a party to the Convention on International Civil Aviation, the United States is obligated to provide the International Civil Aviation Organization with financial and statistical data on operations of U.S. air carriers. Over 99 percent of the data filed with ICAO is extracted from the carriers' Form 41 reports.
Fitness determinations are made for both new entrants and established U.S. domestic carriers proposing a substantial change in operations. A portion of these applications consists of an operating plan for the first year (14 CFR part 204) and an associated projection of revenues and expenses. The carrier's operating costs, included in these projections, are compared against the cost data in Form 41 for a carrier or carriers with the same aircraft type and similar operating characteristics. Such a review validates the reasonableness of the carrier's operating plan.
Form 41 reports, particularly balance sheet reports and cash flow statements play a major role in the identification of vulnerable carriers. Data comparisons are made between current and past periods in order to assess the current financial position of the carrier. Financial trend lines are extended into the future to analyze the continued viability of the carrier. DOT reviews three areas of a carrier's operation: (1) The qualifications of its management team, (2) its disposition to comply with laws and regulations, and (3) its financial posture. DOT must determine whether or not a carrier has sufficient financial resources to conduct its operations without imposing undue risk on the traveling public. Moreover, once a carrier is operating, DOT is required to monitor its continuing fitness.
Senior DOT officials must be kept fully informed as to all current and developing economic issues affecting the airline industry. In preparing financial conditions reports or status reports on a particular airline, financial and traffic data are analyzed. Briefing papers may use the same information.
The Confidential Information Protection and Statistical Efficiency Act of 2002 (44 U.S.C. 3501 note), requires a statistical agency to clearly identify information it collects for non-statistical purposes. BTS hereby notifies the respondents and the public that BTS uses the information it collects under this OMB approval for non-statistical purposes including, but not limited to, publication of both Respondent's identity and its data, submission of the information to agencies outside BTS for review, analysis and possible use in regulatory and other administrative matters.
Bureau of Transportation Statistics (BTS), DOT.
Notice.
In compliance with the Paperwork Reduction Act of 1995, Public Law 104-13, the Bureau of Transportation Statistics invites the general public, industry and other governmental parties to comment on the continuing need for and usefulness of BTS collecting financial, traffic and operating statistics from small certificated and commuter air carriers. Small certificated air carriers (operate aircraft with 60 seats or less or with 18,000 pounds of payload capacity or less) currently must file the two quarterly schedules listed below:
F-1
F-2
Commuter air carriers must file the Schedule F-1
Commenters should address whether BTS accurately estimated the reporting burden and if there are other ways to enhance the quality, utility, and clarity of the information collected.
Written comments should be submitted by March 26, 2018.
Marianne Seguin, Office of Airline Information, RTS-42, Room E32-105, OST-R, BTS, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, Telephone Number (202) 366-1457, Fax Number (202) 366-3383 or EMAIL
You may submit comments identified by DOT Docket ID Number DOT-OST-2014-0031 by any of the following methods:
The Department of Transportation sets and updates the Intra-Alaska Bush mail rates based on carrier aircraft operating expense, traffic, and operational data. Form 298-C cost data, especially fuel costs, terminal expenses, and line haul expenses are used in arriving at rate levels. DOT revises the established rates based on the percentage of unit cost changes in the carriers' operations. These updating procedures have resulted in the carriers receiving rates of compensation that more closely parallel their costs of providing mail service and contribute to the carriers' economic well-being.
DOT often has to select a carrier to provide a community's essential air service. The selection criteria include historic presence in the community, reliability of service, financial stability and cost structure of the air carrier.
Fitness determinations are made for both new entrants and established U.S. domestic carriers proposing a substantial change in operations. A portion of these applications consists of an operating plan for the first year (14 CFR part 204) and an associated projection of revenues and expenses. The carrier's operating costs, included in these projections, are compared against the cost data in Form 298-C for a carrier or carriers with the same aircraft type and similar operating characteristics. Such a review validates the reasonableness of the carrier's operating plan.
The quarterly financial submissions by commuter and small certificated air carriers are used in determining each carrier's continuing fitness to operate. Section 41738 of Title 49 of the United States Code requires DOT to find all commuter and small certificated air carriers fit, willing, and able to conduct passenger service as a prerequisite to providing such service to an eligible essential air service point. In making a fitness determination, DOT reviews three areas of a carrier's operation: (1) The qualifications of its management team, (2) its disposition to comply with laws and regulations, and (3) its financial posture. DOT must determine whether or not a carrier has sufficient financial resources to conduct its operations without imposing undue risk on the traveling public. Moreover, once a carrier begins conducting flight operations, DOT is required to monitor its continuing fitness.
Senior DOT officials must be kept fully informed and advised of all current and developing economic issues affecting the airline industry. In preparing financial condition reports or status reports on a particular airline, financial and traffic data are analyzed. Briefing papers prepared for senior DOT officials may use the same information.
The
Veterans Health Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health 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
Comments must be submitted on or before February 22, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Office of Quality, Privacy and Risk (OQPR), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or email
38 U.S.C. Part 1, Chapter 5, Section 527
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.
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 |