| Page Range | 45193-45323 | |
| FR Document |
| Page and Subject | |
|---|---|
| 83 FR 45288 - Interim Storage Partner's Waste Control Specialists Consolidated Interim Storage Facility | |
| 83 FR 45321 - Strengthening Retirement Security in America | |
| 83 FR 45317 - Labor Day, 2018 | |
| 83 FR 45315 - National Preparedness Month, 2018 | |
| 83 FR 45313 - National Alcohol and Drug Addiction Recovery Month, 2018 | |
| 83 FR 45210 - Sunshine Act Meeting Notice | |
| 83 FR 45237 - Sunshine Act Meeting; Farm Credit Administration Board | |
| 83 FR 45285 - Sunshine Act Meeting | |
| 83 FR 45236 - Proposed Information Collection Request; Comment Request; NESHAP for Radionuclides (Renewal) | |
| 83 FR 45225 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Day of Service Project Collection Tool; Proposed Information Collection; Comment Request | |
| 83 FR 45235 - Notification of a Public Teleconference of the Chartered Science Advisory Board (SAB) | |
| 83 FR 45223 - Pacific Fishery Management Council; Public Meeting | |
| 83 FR 45222 - Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting | |
| 83 FR 45223 - Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Meetings | |
| 83 FR 45208 - Rural Development Cooperative Agreement Program; Correction. | |
| 83 FR 45288 - New Postal Products | |
| 83 FR 45249 - Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee | |
| 83 FR 45258 - Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee | |
| 83 FR 45251 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products | |
| 83 FR 45202 - Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in Statistical Area 610 in the Gulf of Alaska | |
| 83 FR 45254 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification | |
| 83 FR 45253 - Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee | |
| 83 FR 45308 - Open Meeting of the Federal Advisory Committee on Insurance | |
| 83 FR 45217 - President's Advisory Council on Doing Business in Africa | |
| 83 FR 45209 - Information Collection Activity; Comment Request | |
| 83 FR 45239 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 83 FR 45278 - Cedar Creek and Grove National Historical Park Advisory Commission Notice of Public Meeting | |
| 83 FR 45271 - Changes in Flood Hazard Determinations | |
| 83 FR 45211 - Light-Walled Rectangular Pipe and Tube From Mexico: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017 | |
| 83 FR 45215 - Certain Plastic Decorative Ribbon From the People's Republic of China: Amended Preliminary Affirmative Countervailing Duty Determination | |
| 83 FR 45217 - Rubber Bands From the People's Republic of China: Preliminary Affirmative Determination of Critical Circumstances, in Part, in the Countervailing Duty Investigation, and Amendment to the Scope of the Preliminary Determination in the Countervailing Duty Investigation | |
| 83 FR 45298 - Notice of Meeting of Advisory Committee on International Law | |
| 83 FR 45213 - Less-Than-Fair-Value Investigation of Rubber Bands From the People's Republic of China: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Preliminary Affirmative Determination of Critical Circumstances | |
| 83 FR 45220 - Rubber Bands From Thailand: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination, and Extension of Provisional Measures | |
| 83 FR 45263 - National Institute of Environmental Health Sciences: Notice of Meeting | |
| 83 FR 45268 - Changes in Flood Hazard Determinations | |
| 83 FR 45238 - Notice of Agreements Filed | |
| 83 FR 45266 - Information Collection Request to Office of Management and Budget; OMB Control Number: 625-0069 | |
| 83 FR 45267 - Information Collection Request to Office of Management and Budget | |
| 83 FR 45240 - Submission for OMB Review; Notarized Document Submittal for System for Award Management Registration | |
| 83 FR 45207 - Codex Alimentarius Commission: Meeting of the Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) | |
| 83 FR 45201 - Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in Statistical Area 620 in the Gulf of Alaska | |
| 83 FR 45262 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings | |
| 83 FR 45263 - National Institute of Dental and Craniofacial Research; Notice of Closed Meetings | |
| 83 FR 45261 - National Institute of Dental and Craniofacial Research; Notice of Closed Meetings | |
| 83 FR 45265 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
| 83 FR 45262 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 83 FR 45265 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 83 FR 45264 - National Center for Advancing Translational Sciences; Notice of Closed Meeting | |
| 83 FR 45264 - Center for Scientific Review: Notice of Closed Meetings | |
| 83 FR 45243 - Surgeon General's Call to Action: “Community Health and Prosperity” | |
| 83 FR 45266 - Center for Scientific Review; Notice of Closed Meetings | |
| 83 FR 45308 - Citizens Coinage Advisory Committee Public Meeting | |
| 83 FR 45275 - International Wildlife Conservation Council; Public Meeting | |
| 83 FR 45302 - Hazardous Materials: Notice of Applications for Special Permits | |
| 83 FR 45305 - Hazardous Materials: Notice of Applications for Special Permits | |
| 83 FR 45303 - Hazardous Materials: Notice of Applications for Special Permits | |
| 83 FR 45224 - Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Pacific Coast Groundfish Fishery; Applications for Exempted Fishing Permits (EFP) | |
| 83 FR 45306 - Senior Executive Service Performance Review Boards Membership | |
| 83 FR 45249 - Draft Guidances Relating to the Development of Human Gene Therapy Products; Availability; Extension of Comment Period | |
| 83 FR 45206 - Announcement of Intent To Establish the 2020 Dietary Guidelines Advisory Committee and Solicitation of Nominations for Membership | |
| 83 FR 45277 - Wild Horse and Burro Advisory Board Meeting | |
| 83 FR 45196 - Prohibition of Target Shooting on Public Lands in the Eastern Lake Mountains, Utah County, Utah | |
| 83 FR 45276 - Competitive Coal Lease Sale, North Dakota | |
| 83 FR 45244 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 83 FR 45241 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 83 FR 45246 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 83 FR 45203 - Alaska; Hunting and Trapping in National Preserves-Extension of Public Comment Period | |
| 83 FR 45194 - Air Plan Approval; Vermont; Infrastructure State Implementation Plan Requirements for the 2012 PM2.5 | |
| 83 FR 45284 - Whistleblower Protection; Public Meeting | |
| 83 FR 45283 - The Cadmium in General Industry Standard; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements | |
| 83 FR 45227 - Environmental Management Site-Specific Advisory Board, Northern New Mexico | |
| 83 FR 45226 - Environmental Management Site-Specific Advisory Board, Savannah River Site | |
| 83 FR 45227 - Environmental Management Site-Specific Advisory Board, Nevada | |
| 83 FR 45280 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
| 83 FR 45279 - Large Diameter Welded Pipe From Canada, China, Greece, India, Korea, and Turkey; Scheduling of the Final Phase of Countervailing Duty and Antidumping Duty Investigations | |
| 83 FR 45281 - U.S. SME Exports: Trade-Related Barriers Affecting Exports of U.S. Small- and Medium-Sized Enterprises to the United Kingdom; Institution of Investigation and Scheduling of Hearing | |
| 83 FR 45278 - Stainless Steel Flanges From India; Supplemental Schedule for the Subject Investigations | |
| 83 FR 45298 - In the Matter of the Designation of Jama'at Nusrat al-Islam wal-Muslimin (JNIM), aka Jamaat Nosrat al-Islam wal-Mouslimin, aka Group for the Support of Islam and Muslims, aka Group to Support Islam and Muslims, aka GSIM, aka GNIM, aka Nusrat al-Islam wal-Muslimeen, as a Foreign Terrorist Organization Pursuant to Section 219 of the Immigration and Nationality Act, as Amended | |
| 83 FR 45288 - Product Change-Priority Mail Negotiated Service Agreement | |
| 83 FR 45288 - Product Change-Priority Mail Express Negotiated Service Agreement | |
| 83 FR 45298 - In the Matter of the Designation of Jama'at Nusrat al-Islam wal-Muslimin (JNIM), aka Jamaat Nosrat al-Islam wal-Mouslimin, aka Group for the Support of Islam and Muslims, aka Group to Support Islam and Muslims, aka GSIM, aka GNIM, aka Nusrat al-Islam wal-Muslimeen, as a Specially Designated Global Terrorist | |
| 83 FR 45210 - Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance | |
| 83 FR 45231 - Notice of Institution of Section 206 Proceeding and Refund Effective Date: Citizens Sycamore-Penasquitos Transmission LLC | |
| 83 FR 45233 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization: Josco Energy USA, LLC | |
| 83 FR 45230 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization: Enel Green Power Rattlesnake Creek Wind Project, LLC | |
| 83 FR 45234 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization: Riverhead Solar Farm, LLC | |
| 83 FR 45229 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization: Heartland Divide Wind Project, LLC | |
| 83 FR 45229 - Combined Notice of Filings | |
| 83 FR 45228 - Combined Notice of Filings | |
| 83 FR 45230 - Combined Notice of Filings #1 | |
| 83 FR 45300 - Hours of Service of Drivers: American Concrete Pavement Association, Inc.; Application for Exemption | |
| 83 FR 45204 - Hours of Service | |
| 83 FR 45268 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Application for Community Disaster Loan (CDL) Program | |
| 83 FR 45247 - Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 83 FR 45259 - Allergic Rhinitis: Developing Drug Products for Treatment; Guidance for Industry; Availability | |
| 83 FR 45260 - Nonallergic Rhinitis: Developing Drug Products for Treatment; Guidance for Industry; Availability | |
| 83 FR 45285 - Exelon Generation Company, LLC: Peach Bottom Atomic Power Station, Units 2 and 3 | |
| 83 FR 45199 - Suspension of Community Eligibility | |
| 83 FR 45233 - Notice of Availability of the Environmental Assessment for the Proposed Columbia Gas Transmission, LLC Line 8000 Replacement Project | |
| 83 FR 45228 - Notice of Availability of Draft Environmental Assessment: New York Power Authority | |
| 83 FR 45289 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change Relating to the First Trust Senior Loan Fund of First Trust Exchange Traded Fund IV | |
| 83 FR 45289 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing of Proposed Rule Change To List and Trade Corporate Non-Convertible Bonds on Nasdaq | |
| 83 FR 45234 - Notice of Technical Conference and Environmental Site Review: Moon Lake Electric Association, Inc. | |
| 83 FR 45231 - Notice of Intent To Prepare an Environmental Assessment for the Proposed Gateway Project, and Request for Comments on Environmental Issues: Sendero Carlsbad Gateway, LLC | |
| 83 FR 45301 - Agency Information Collection Activity Under OMB Review | |
| 83 FR 45237 - Disability Advisory Committee; Announcement of Next Meeting | |
| 83 FR 45307 - Proposed Collection; Comment Request on Information Collection for Work Opportunity Credit | |
| 83 FR 45298 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “The Charterhouse of Bruges: Jan Van Eyck, Petrus Christus, and Jan Vos” Exhibition | |
| 83 FR 45239 - Impax Laboratories Oral Argument Before the Commission | |
| 83 FR 45238 - Petition of Orient Overseas Container Line Limited and OOCL (EUROPE) Limited for an Exemption; Notice of Filing and Request for Comments | |
| 83 FR 45299 - Environmental Impact Statement: Douglas County, Kansas | |
| 83 FR 45203 - Adjustment of Cable Statutory License Royalty Rates; Correction | |
| 83 FR 45193 - Air Plan Approval; Ohio; Cleveland, PM2.5 |
Rural Business-Cooperative Service
Rural Housing Service
Rural Utilities Service
The U.S. Codex Office
Economic Development Administration
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Agency for Toxic Substances and Disease Registry
Centers for Disease Control and Prevention
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Land Management Bureau
National Park Service
Occupational Safety and Health Administration
Copyright Royalty Board
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Transit Administration
Pipeline and Hazardous Materials Safety Administration
Internal Revenue Service
United States Mint
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Environmental Protection Agency (EPA).
Final rule.
On October 14, 2016, the Ohio Environmental Protection Agency (OEPA) submitted a State Implementation Plan (SIP) submission for the 2012 Fine Particle (PM
This final rule is effective on October 9, 2018.
EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2016-0644. All documents in the docket are listed in the
Francisco J. Acevedo, Mobile Source Program Manager, Control Strategies Section, Air Programs Branch (AR 18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312)886-6061,
Throughout this document, wherever “we”, “us” or “our” is used, we mean EPA.
On June 4, 2018, at 83 FR 25608, EPA proposed to approve a revision to the SIP for the 2012 PM
Our June 4, 2018, proposed rule provided a 30-day review and comment period. The comment period closed on July 5, 2018. EPA received comments from three parties during the public comment period but all comments were completely outside of the scope of this action and therefore are not being addressed as part of this final action.
EPA is approving a SIP revision submitted by Ohio EPA on October 14, 2016. Ohio's attainment demonstration modeling, and precursor analysis for both attainment planning RACM and nonattainment NNSR determined that VOCs and NH
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, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• 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 application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications 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).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 5, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(e) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of Vermont that addresses the infrastructure SIP requirements of the Clean Air Act (CAA or Act)—including the interstate transport provisions—for the 2012 fine particle (PM
This rule is effective on October 9, 2018.
EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2017-0696. All documents in the docket are listed on the
Alison C. Simcox, Air Quality Unit, U.S. Environmental Protection Agency, EPA Region 1, 5 Post Office Square—Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912, tel. (617) 918-1684, email
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
On June 29, 2018 (83 FR 30598), EPA published a Notice of Proposed Rulemaking (NPRM) for the State of Vermont.
In the NPRM, EPA proposed to approve an infrastructure SIP revision for the 2012 fine particle (PM
This submittal included an enclosure addressing the “Good Neighbor” (or “transport”) provisions of the Act for the 2012 PM
This rulemaking does not cover three substantive areas that are not integral to acting on a state's infrastructure SIP submission: (i) Existing provisions related to excess emissions during periods of start-up, shutdown, or malfunction at sources (“SSM” emissions) that may be contrary to the CAA and EPA's policies addressing such excess emissions; (ii) existing provisions related to “director's variance” or “director's discretion” that purport to permit revisions to SIP-approved emissions limits with limited public process or without requiring further approval by EPA, that may be contrary to the CAA (“director's discretion”); and, (iii) existing provisions for Prevention of Significant Deterioration (PSD) programs that may be inconsistent with current requirements of EPA's “Final New Source Review (NSR) Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Instead, EPA has the authority to address each of these substantive areas separately. A detailed history, interpretation, and rationale for EPA's approach to infrastructure SIP requirements can be found in EPA's May 13, 2014, proposed rule entitled, “Infrastructure SIP Requirements for the 2008 Lead NAAQS” in the section, “What is the scope of this rulemaking?”
The NPR includes the rationale for approval, and EPA will not restate it here. Three public comments were received on the NPRM.
EPA received three comments during the comment period. All comments discuss subjects outside the scope of an infrastructure SIP action, do not explain (or provide a legal basis for) how the proposed action should differ in any way, and, indeed, make no specific mention of the proposed action. Consequently, the three comments are not germane to this rulemaking and require no further response.
EPA is approving Vermont's October 2017 infrastructure SIP submission for the 2012 PM
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• This action is not an Executive Order 13771 regulatory action because this action is not significant 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 application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications 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).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 5, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(e) * * *
Bureau of Land Management, Interior.
Interim final supplementary rule.
The Bureau of Land Management (BLM) Utah State Director hereby establishes an interim final supplementary rule (rule) prohibiting target shooting within a 2,004-acre area on BLM-administered public lands in the Eastern Lake Mountains area of the Salt Lake Field Office, Eastern Lake Mountains, Utah County, Utah. The rule is necessary to implement and enforce this long-term prohibition to provide for public safety and historic properties (specifically Native American petroglyphs), as authorized in the Decision Record for the Eastern Lake Mountains Target Shooting Resource Management Plan Amendment (RMPA). The rule does not restrict other public activities in or access to or through the Lake Mountains, including legal hunting.
The rule is effective on September 6, 2018. You may submit comments to the BLM on or before November 5, 2018.
You may submit comments by any of the following methods:
The environmental assessment, Decision Record, and RMPA are available for public review at the mailing and NEPA Register website addresses in this section.
Matt Preston, BLM Salt Lake Field Manager, Bureau of Land Management at 801-977-4300. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual. The FRS
The BLM is establishing this rule under the authority of 43 Code of Federal Regulations (CFR) 8365.1-6, which allows State Directors to establish supplementary rules for the protection of persons, property, and the public lands and resources. This provision allows the BLM to issue rules of less than national effect by publishing the rule in the
This Notice and the map of the affected area can be obtained by visiting or contacting the Salt Lake Field Office (see
Please submit your written comments on issues related to this rule to one of the addresses shown in the
The BLM is not obligated to consider, or include in the Administrative Record for the rule, comments delivered to an address other than those listed above (see
The BLM will make your comments, including your name and address, available for public review at the Salt Lake Field Office address listed in
The rule is necessary to implement and enforce the long-term target shooting closure authorized in the Decision Record for the Eastern Lake Mountains Target Shooting RMPA. The long-term closure covers 2,004 acres of public lands in Utah County, Utah. This rule replaces and expands the previous target shooting closure orders implemented by the BLM in the Eastern Lake Mountains since 2012 (81 FR 90864, 79 FR 74111, 77 FR 75186). The expanded closure area identified in this supplementary rule is necessary in order to provide additional protection for public health and safety to those who may be endangered by target shooting and for protection of historic properties (specifically Native American petroglyphs) damaged by target shooting, outside the previous closure area.
The BLM determined that a long-term target shooting closure was necessary due to a variety of concerns, including: Several serious public safety incidents of errant gunfire endangering lives and property, the high incidence of target shooting-caused wildfires annually, documented and irreparable damage to historic properties (specifically Native American petroglyphs), and the large amounts of litter and hazardous waste that result from target shooting. In addition, the area is not considered safe for target shooting due to the lack of proper backstops in lower elevations, nearby homes, and its proximity to State Highway 68. Public outreach and education efforts to address these problems have not been successful.
The BLM has determined that this rule is necessary to allow immediate implementation of the long-term closure, thereby providing for public safety and protection of important historic and pre-historic properties.
In accordance with section 553(b)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(B)), the BLM finds good cause that publishing a proposed supplementary rule, accepting public comment on the proposed supplementary rule, and then, publishing a final supplementary rule are contrary to the public interest. The urgency and magnitude of the need to reduce the risks to public safety and health, and historic properties (specifically Native American petroglyphs) associated with target shooting in the Eastern Lake Mountains warrants expedited action. Furthermore, the planning process for the Eastern Lake Mountains Target Shooting RMPA offered extensive opportunities for public comment, including public notices, an extended scoping period, an extended comment period, a protest period on the proposed land use plan decision, and a Governor's consistency review.
Under section 553(d)(3) of the APA (5 U.S.C. 553(d)(3)), good cause also exists for making these rules effective immediately because a variety of government and public stakeholders have asked the BLM to take immediate and affirmative action to curtail the public safety risks and the damage to historic properties (specifically Native American petroglyphs) caused by the target shooting. The environmental assessment for the RMPA discussed the need to establish a supplementary rule, and thus, the public was on notice during that process that this supplementary rule would follow completion of the RMPA. A summary of the planning process, including public participation periods, is described below in Section III. Procedural Matters, National Environmental Policy Act (NEPA).
The BLM invites public comment on this interim final supplementary rule until November 5, 2018. If any substantive comments are received in response to this notice, the BLM will determine whether or not to modify this rule. The BLM will publish a Notice establishing the final supplementary rule only if substantive comments are received. If no substantive comments are received, the rule will become a final supplementary rule without another published notice.
The rule prohibits target shooting on a limited area of public lands in the Eastern Lake Mountains. The rule is not a significant regulatory action and is not subject to review by the Office of Management and Budget under Executive Order 12866 or 13563. The rule would not have an annual effect of $100 million or more on the economy; and it would not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments, or communities. The rule would not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; and it would not materially alter the budgetary effects of entitlements, grants, user fees, or loan programs, or the rights or obligations of their recipients; nor does it raise novel legal or policy issues. This rule
Executive Order 12866 requires each agency to write regulations that are simple and easy to understand. The BLM invites your comments on how to make this rule easier to understand, including answers to questions such as the following:
(1) Are the requirements in the rule clearly stated?
(2) Does the rule contain technical language or jargon that interferes with its clarity?
(3) Does the format of the rule (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce its clarity?
(4) Would the rule be easier to understand if it was divided into more (but shorter) sections?
(5) Is the description of the rule in the
Please send any comments you have on the clarity of the rule to one of the addresses specified in the
The rule implements a land use plan decision to prohibit target shooting on 2,004 acres to provide for public safety and protect historic properties (specifically Native American petroglyphs) as authorized in the Decision Record for the Eastern Lake Mountains Target Shooting RMPA (DOI-BLM-UT-W010-2015-0023-EA). The BLM analyzed and disclosed the environmental consequences of the long-term target shooting closure identified in an environmental assessment completed on December 14, 2016. The BLM found that the long-term target shooting closure, including the rule, would not have a significant individual or cumulative effect on the quality of the human environment under Section 102(2) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)).
The Eastern Lake Mountains Target Shooting RMPA was initiated under a Notice of Intent published in the
The environmental assessment, Decision Record, and RMPA are available for public review at the locations identified in the
Congress enacted the Regulatory Flexibility Act (RFA) of 1980, as amended (5 U.S.C. 601-612) to ensure that Government regulations do not unnecessarily or disproportionately burden small entities. The RFA requires a regulatory flexibility analysis if a rule would have a significant economic impact, either detrimental or beneficial, on a substantial number of small entities. This rule does not pertain specifically to commercial or governmental entities of any size, but to public recreational use of specific public lands. This rule establishes a rule of conduct for recreational use of certain public lands in the Eastern Lake Mountains. Therefore, the BLM has determined, under the RFA, that this rule would not have a significant economic impact on a substantial number of small entities.
This rule does not constitute a “major rule” as defined at 5 U.S.C 804(2). This rule establishes a rule of conduct for recreational use of certain public lands in the Eastern Lake Mountains and would not affect business, commercial, or industrial use of the public lands.
This rule would not impose an unfunded mandate on state, local, or tribal governments or the private sector, of more than $100 million per year; nor would it have a significant or unique effect on small governments. This rule would have no effect on governmental or tribal entities and would impose no requirements on any of these entities. This rule establishes a rule of conduct for recreational use of certain public lands in the Eastern Lake Mountains and does not affect business, commercial, or industrial use of these public lands. Therefore, the BLM is not required to prepare a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
This rule does not represent a Government action capable of interfering with constitutionally protected property rights. This rule does not address property rights in any form and does not cause the impairment of anyone's property rights. This rule establishes a rule of conduct for recreational use of certain public lands in the Eastern Lake Mountains. Therefore, the BLM has determined that this rule would not cause a “taking” of private property or require preparation of a takings assessment under this Executive Order.
This rule would not have a substantial direct effect on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. This rule applies to a limited area of land in only one State, Utah, and would not conflict with any Utah state statute or regulation. Therefore, in accordance with Executive Order 13132, the BLM has determined that this rule does not have sufficient Federalism implications to warrant preparation of a Federalism Assessment.
Under Executive Order 12988, the BLM has determined that this rule would not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of the Order.
In accordance with Executive Order 13175, the BLM consulted and coordinated with Indian tribal governments on this rule during the development of the Eastern Lake Mountains Target Shooting RMPA, which included an implementation-
The Salt Lake Field Manager sent project information and invited the initiation of formal consultation with the following Native American Tribes via certified letter dated June 29, 2015: Jemez Pueblo, Skull Valley Band of Goshute Indians of Utah, Confederated Tribes of the Goshute Reservation, Paiute Indian Tribe, Ute Indian Tribe, and Eastern Shoshone. The BLM contacted these same tribes via phone between July 1 and 7, 2015, to schedule telephone conferences with the Salt Lake Field Manager, if desired. The Paiute Indian Tribe requested a meeting and a presentation was made to the Paiute Tribal Council on July 16, 2015, at which the tribe expressed their support for the Eastern Lake Mountains Target Shooting RMPA. Additionally, these tribes received formal invitations to participate in the planning process as a consulting party and/or cooperating agency; none of the tribes accepted either role. These same tribes were included on the project mailing list and received notification of the scoping period and associated open houses, the public comment period and associated open house, and the protest period. Only the Paiute Indian Tribe of Utah submitted a comment letter during the public comment period expressing concern over preserving and protecting Native American petroglyphs. To discuss this in detail with the tribe, the BLM attended a Paiute Tribal Council meeting on November 1, 2016, in which the tribal leaders expressed their support for the Proposed RMPA.
The Salt Lake Field Manager and staff also attended the November 15, 2016 Utah Tribal Leaders Conference in Wendover, Nevada, at which time tribal leaders of the Confederated Tribes of the Goshute Reservation, Paiute, Ute, and Eastern Shoshone were informed of the Proposed RMPA and invited to make comments. Tribal leaders asked questions and made verbal comments in support of the Proposed RMPA. A final letter was mailed to these same tribes on December 14, 2016, inviting them to consult on the Proposed RMPA and associated environmental assessment. The BLM also contacted these tribes via telephone. No further comments were received.
Under Executive Order 13352, the BLM has determined that this rule would not impede the facilitation of cooperative conservation. This rule would take appropriate account of and consider the interests of persons with ownership or other legally recognized interests in land or other natural resources; properly accommodate local participation in the Federal decision-making process; and provide that the programs, projects, and activities are consistent with protecting public health and safety.
This rule does not constitute a “significant energy action,” as defined in Executive Order 13211. The rule would not have an adverse effect on energy supplies, production, or consumption and has no connection with energy policy.
This rule does not contain information collection requirements that the Office of Management and Budget must approve under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
For the reasons stated in the preamble, and under the authority of 43 CFR 8365.1-6, the State Director establishes a rule for 2,004 acres of public lands managed by the BLM in the Lake Mountains in Utah County, Utah, subject to the Pony Express Resource Management Plan, to read as follows:
Target shooting is prohibited within the area described below, including 2,004 acres, in Utah County, Utah.
The following persons are exempt from this rule: Any Federal, state, local, and/or military employees acting within the scope of their official duties; members of any organized rescue or fire fighting force performing an official duty; and persons who are expressly authorized or approved by the BLM.
The legal description of the affected public lands is:
The areas described contain approximately 2,004 acres.
Target shooting: The discharge or use of a firearm or other dangerous weapon (
Any person who violates this rule may be tried before a United States Magistrate and fined in accordance with 18 U.S.C. 3571, imprisoned no more than 12 months under 43 U.S.C. 1733(a) and 43 CFR 8360.0-7, or both. In accordance with 43 CFR 8365.1-7, State or local officials may also impose penalties for violations of Utah law.
Federal Emergency Management Agency, DHS.
Final rule.
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has
The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables.
If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Adrienne L. Sheldon, PE, CFM, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 400 C Street SW, Washington, DC 20472, (202) 212-3966.
The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the
In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.
Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.
Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is amended as follows:
42 U.S.C. 4001
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for pollock in Statistical Area 620 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the C season allowance of the 2018 total allowable catch of pollock for Statistical Area 620 in the GOA.
Effective 1200 hours, Alaska local time (A.l.t.), September 1, 2018, through 1200 hours, A.l.t., October 1, 2018.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The C season allowance of the 2018 total allowable catch (TAC) of pollock in Statistical Area 620 of the GOA is 10,441 metric tons (mt) as established by the final 2018 and 2019 harvest specifications for groundfish in the GOA (83 FR 8768, March 1, 2018) and inseason adjustment (83 FR 42609, August 23, 2018).
In accordance with § 679.20(d)(1)(i), the Regional Administrator has determined that the C season allowance of the 2018 TAC of pollock in Statistical Area 620 of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 10,241 mt and is setting aside the remaining 200 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for pollock in Statistical Area 620 of the GOA. While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for pollock in Statistical Area 620 of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 30, 2018.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for pollock in Statistical Area 610 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the C season allowance of the 2018 total allowable catch of pollock for Statistical Area 610 in the GOA.
Effective 1200 hours, Alaska local time (A.l.t.), September 3, 2018, through 1200 hours, A.l.t., October 1, 2018.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The C season allowance of the 2018 total allowable catch (TAC) of pollock in Statistical Area 610 of the GOA is 14,369 metric tons (mt) as established by the final 2018 and 2019 harvest specifications for groundfish in the GOA (83 FR 8768, March 1, 2018) and inseason adjustment (83 FR 42609, August 23, 2018).
In accordance with § 679.20(d)(1)(i), the Regional Administrator has determined that the C season allowance of the 2018 TAC of pollock in Statistical Area 610 of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 14,269 mt and is setting aside the remaining 100 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for pollock in Statistical Area 610 of the GOA. While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for pollock in Statistical Area 610 of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 30, 2018.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Park Service, Interior.
Proposed rule; extension of public comment period.
The National Park Service is extending the public comment period for the proposed rule to amend its regulations for sport hunting and trapping in National Preserves in Alaska. Extending the comment period will allow more time for the public to review the proposal and submit comments.
The comment period for the proposed rule published on May 22, 2018 (83 FR 23621), is extended. Comments must be received by 11:59 p.m. EST on November 5, 2018.
You may submit comments, identified by Regulation Identifier Number (RIN) 1024-AE38, by one of the following methods:
(1)
(2)
We request that you send comments only by the methods described above. Comments will not be accepted by fax, email, or in any way other than those specified above. We will post comments to
Herbert C. Frost, Regional Director, Alaska Regional Office, 240 West 5th Ave., Anchorage, AK 99501. Phone (907) 644-3510. Email:
On May 22, 2018, the National Park Service (NPS) published in the
Copyright Royalty Board, Library of Congress.
Proposed rule; correction and reopening of comment period.
The Copyright Royalty Judges (Judges) are correcting one of the references to a docket number in a proposed rule that appeared in the
The comment period for the modified proposed rule published July 30, 2018, at 83 FR 36509, is reopened. Comments should be received on or before September 12, 2018.
You may submit comments and objections, identified by docket number 15-CRB-0010-CA-S, by any of the following methods:
Anita Blaine, CRB Program Specialist, by telephone at (202) 707-7658 or email at
On Monday, July 30, 2018, the Judges published in the
In the
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of public listening session.
The FMCSA announces that it will hold a public listening session concerning potential changes to its hours-of-service (HOS) rules for truck drivers. On August 23, 2018, FMCSA published an Advance Notice of Proposed Rulemaking (ANPRM) seeking public comment on four specific aspects of the HOS rules for which the Agency is considering changes: The short-haul HOS limit; the HOS exception for adverse driving conditions; the 30-minute rest break provision; and the split-sleeper berth rule to allow drivers to split their required time in the sleeper berth. In addition, the Agency requested public comment on petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.org (TruckerNation). The Agency encourages vendors of electronic logging devices (ELDs) to participate to address potential implementation issues should changes to the HOS rules be made. The listening session will be held at the U.S. Department of Transportation in Washington, DC. The listening session will be webcast for the benefit of those not able to attend in person. The listening session will allow interested persons to present comments, views, and relevant research on topics mentioned above. All comments will be transcribed and placed in the rulemaking docket for the FMCSA's consideration.
The listening session will be September 14, 2018, in Washington, DC, at the U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590. The listening session will begin at 1 p.m. (EDT) and end at 3 p.m., or earlier, if all participants wishing to express their views have done so.
The September 14, 2018, meeting will be held at the U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590.
You may submit comments identified by Docket Number FMCSA-2018-0248 using any of the following methods:
•
•
•
•
•
To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the
For special accommodations for the HOS listening session, such as sign language interpretation, contact Ms. Shannon L. Watson, Senior Advisor to the Associate Administrator for Policy, (202) 385-2395 or at
If you submit a comment, please include the docket number for this ANPRM (Docket No. FMCSA-2018-0248), indicate the specific section of this document to which each section applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
FMCSA will consider all comments and material received during the comment period for the ANPRM. Late comments will be considered to the extent practicable.
Confidential Business Information (CBI) is commercial or financial information that is customarily not made available to the public by the submitter. Under the Freedom of Information Act, CBI is eligible for protection from public disclosure. If you have CBI that is relevant or responsive
FMCSA will consider all comments and material received during the comment period for the ANPRM.
To view comments, as well as any documents mentioned in this preamble as being available in the docket, go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to
On August 23, 2018 (83 FR 42631), FMCSA published an ANPRM concerning potential changes to its hours-of-service rules. The ANPRM indicated the Agency is considering changes in four areas of the HOS rules: The short-haul HOS limit [49 CFR 395.1(e)(1)(ii)(A)]; the HOS exception for adverse driving conditions [§ 395.1(b)(1)]; the 30-minute rest break provision [§ 395.3(a)(3)(ii)]; and the split-sleeper berth rule to allow drivers to split their required time in the sleeper berth [§ 395.1(g)(1)(i)(A) and (ii)(A)]. In addition, the Agency requested public comment on petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.org (TruckerNation). The ANPRM provides an opportunity for additional discussion of each of these topics. The listening session will provide interested persons to share their views on these topics with representatives of the Agency. The Agency encourages ELD vendors to participate to address potential implementation issues should changes to the HOS rules be made.
The listening session is open to the public. Speakers' remarks will be limited to 2 minutes each. The public may submit material to the FMCSA staff at the session for inclusion in the public docket, FMCSA-2018-0248. The session will be webcast in its entirety, providing the opportunity for remote participation via the internet. For information on participating in the live webcast, please go to
In preparing their comments, meeting participants should consider the questions posed in the ANPRM about the current HOS requirements. Answers to these questions should be based upon the experience of the participants and any data or information they can share with FMCSA.
Office of the Assistant Secretary for Health, U.S. Department of Agriculture (USDA), Food, Nutrition and Consumer Services (FNCS) and Research, Education and Economics (REE); and U.S. Department of Health and Human Services (HHS).
Notice.
The Departments of Agriculture and Health and Human Services announce the intent to establish a Dietary Guidelines Advisory Committee and invite nominations for the Committee.
Nominations must be submitted by midnight Eastern Time on October 9, 2018.
Nominations may be submitted by electronic mail to
Eve Stoody (telephone 703-305-7600), Center for Nutrition Policy and Promotion, 3101 Park Center Drive, Room 1034, Alexandria, Virginia 22302, or, Richard Olson (telephone 240-453-8280), Office of Disease Prevention and Health Promotion, 1101 Wootton Parkway, Suite LL100, Rockville, Maryland 20852. Additional information is available on the internet at
The 2020 Dietary Guidelines Advisory Committee (the Committee) shall be formed and governed under the 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 advisory committees. The Committee is established to provide independent, science-based advice and recommendations to be considered by USDA and HHS in the development of the 2020-2025 Dietary Guidelines for Americans. Formation of the Committee is necessary and in the public interest.
The Committee is expected to begin meeting during the Fall/Winter of 2018/2019; the Committee will meet approximately five times during the course of its operation. Pursuant to the FACA, all Committee meetings will be open to the public. The Committee will be established to accomplish a single, time-limited task. The Committee will develop a report of its recommendations that will be submitted to the Secretaries of USDA and HHS. Upon delivery of its report to the Secretaries or when the charter expires, the activities of the Committee will be terminated.
Expertise in human nutrition related to disease prevention and health promotion during different stages of life, such as pediatrics, obstetrics, and geriatrics, will be sought. Expertise in the topics and scientific questions identified by the Departments to be examined by the Committee also will be sought. Information on the topics and scientific questions is available at
Equal opportunity practices regarding membership appointments to the Committee will be aligned with USDA and HHS policies. To ensure that recommendations of the Committee take into account the needs of the diverse groups served by USDA and HHS, membership shall include, to the extent practicable, individuals who are minorities, women, and persons with disabilities.
Individuals will be appointed to serve as members of the Committee to represent balanced viewpoints of the scientific evidence, not to represent the viewpoints of any specific group.
Members of the Committee will be classified as Special Government Employees (SGEs) during their term of appointment on the Committee and, as such, are subject to the ethical standards of conduct for Federal employees. Upon entering the position and annually throughout the approximate 2-year term of appointment, members of the Committee will be required to complete and submit a report of their financial holdings.
The curriculum vitae should include the following information: (a) Education; (b) experience (current and former); (c) affiliations (food, nutrition, public health, and/or other relevant associations, including positions held); (d) memberships (expert panels, committees, or other relevant groups, including positions held); (e) peer-reviewed publications (for past 10 years); (f) oral presentations (for past 5 years); (g) editorials, opinion pieces, and blogs (for past 5 years); (h) grant funding (for past 15 years); (i) name of any corporation, professional society, association, panel, company, firm, government agency (Federal, state, and local), research organization, educational institution, or other organization or institution (government, private, and not-for-profit; domestic and foreign) in which the nominee's services have been, will be, or are expected to be provided, with or without compensation, including on a part-time or seasonal basis as an officer, medical staff, board member, owner, trustee, director, expert advisor, consultant, official spokesperson, member of speakers bureau, or expert witness (for past 5 years and upcoming); (j) other paid travel or honoraria received, not included above (for past 5 years). Web links to publications, presentations, and other materials available online are requested, when available. In all cases, a limited selection of earlier publications, presentations, affiliations, etc. applicable to the qualifications may also be included.
U.S. Codex Office.
Notice of public meeting and request for comments.
The U.S. Codex Office is sponsoring a public meeting on September 26, 2018. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States positions to be discussed at the 24th Session of the Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) of the Codex Alimentarius Commission (Codex), taking place in Brisbane, Australia, October 22-26, 2018. The U.S. Manager for Codex Alimentarius and the Under Secretary, Office of Trade and Foreign Agricultural Affairs, recognize the importance of providing interested parties the opportunity to obtain background information on the 24th Session of the CCFICS and to address items on the agenda.
The public meeting is scheduled for Wednesday, September 26, from 2:00 p.m. to 4 p.m.
The public meeting will take place at the United States Department of Agriculture (USDA), Jamie L. Whitten Building, 1400 Independence Avenue SW, Room 107-A, Washington, DC 20250.
Documents related to the 24th Session of the CCFICS will be accessible via the internet at the following address:
Mary Stanley, U.S. Delegate to the 24th Session of the CCFICS invites U.S. interested parties to submit their comments electronically to the following email address:
The participant code will be posted on the web page below:
Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.
The CCFICS is responsible for:
(a) Developing principles and guidelines for food import and export inspection and certification systems, with a view to harmonizing methods and procedures that protect the health of consumers, ensure fair trading practices, and facilitate international trade in foodstuffs;
(b) Developing principles and guidelines for the application of
(c) Developing guidelines for the utilization, as and when appropriate, of quality assurance systems to ensure that foodstuffs conform with requirements and to promote the recognition of these systems in facilitating trade in food products under bilateral/multilateral arrangements by countries;
(d) Developing guidelines and criteria with respect to format, declarations and language of such official certificates as countries may require with a view towards international harmonization;
(e) Making recommendations for information exchange in relation to food import/export control;
(f) Consulting as necessary with other international groups working on matters related to food inspection and certification systems; and
(g) Considering other matters assigned to it by the Commission in relation to food inspection and certification systems.
The CCFICS is hosted by Australia. The United States attends CCFICS as a member country of Codex.
The following items on the Agenda for the 24th Session of the CCFICS will be discussed during the public meeting:
Each issue listed will be fully described in documents distributed, or to be distributed by the Secretariat before to the Committee Meeting. Members of the public may access or request copies of these documents (see
At the September 26, 2018, public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Mary Stanley, U.S. Delegate for the 24th Session of the CCFICS (see
Public awareness of all segments of rulemaking and policy development is important. Consequently, the U.S. Codex Office will announce this
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at:
Send your completed complaint form or letter to USDA by mail, fax, or email.
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Rural Business-Cooperative Service, Rural Housing Service, and Rural Utilities Service, USDA.
Notice; correction.
This document corrects one item in the initial notice that published in the
Effective September 6, 2018.
Christine Sorensen, Regional Coordinator,
In FR Doc. 2018-17765 appearing on page 41046 in the
On page 41052 in the second column, third paragraph, section d. reads “The applicant will demonstrate how their proposal will utilize partnerships outside of RD . . . (10 points),” replace with “The applicant will demonstrate how their proposal will utilize partnerships outside of RD . . . (5 points).”
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the United States Department of Agriculture (USDA) Rural Utilities Service (RUS) invites comments on the following information collections for which the RUS intends to request approval from the Office of Management and Budget (OMB).
Comments on this notice must be received by November 5, 2018.
Michele Brooks, Team Lead, Rural Development Innovation Center—Regulatory Team, USDA, 1400 Independence Avenue SW, STOP 1522, Room 5162, South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Email
The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies information collections that USDA Rural Development is submitting to OMB for extension.
Comments are invited on: (a) Whether this collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including the validity of the methodology and assumptions used; (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 appropriate automated, electronic, mechanical or other technological collection techniques or other forms of information technology. Comments may be sent to: Michele Brooks, Team Lead, Rural Development Innovation Center—Regulatory Team, USDA, 1400 Independence Avenue SW, STOP 1522, Room 5162, South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Email
Copies of this information collection can be obtained from Kimble Brown, Innovation Center, at (202) 692-0043, or email:
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the Rural Utilities Service, an agency of the U.S. Department of Agriculture (USDA) Rural Development mission area, invites comments on this information collection for which approval from the Office of Management and Budget (OMB) will be requested.
Comments on this notice must be received by September 6, 2018.
Michele Brooks, Team Lead, Rural Development Innovation Center—Regulatory Team, USDA, 1400 Independence Avenue SW, STOP 1522, Room 5162, South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Email
The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that will be submitted to OMB for approval. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (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 those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Michele Brooks, Team Lead, Rural Development Innovation Center—Regulatory Team, USDA, 1400 Independence Avenue SW, STOP 1522, Room 5162, South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Email
Copies of this information collection can be obtained from Robin M. Jones, Innovation Center, at (202) 772-1172. Email:
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
United States Commission on Civil Rights.
Notice of Commission public business meeting.
Friday, September 14, 2018, 10:00 a.m. EST.
Place: National Place Building, 1331 Pennsylvania Ave. NW, 11th Floor, Suite 1150, Washington, DC 20245 (Entrance on F Street NW).
Brian Walch, phone: (202) 376-8371; TTY: (202) 376-8116; email:
This business meeting is open to the public. There will also be a call-in line for individuals who desire to listen to the presentations: 800-682-0995; Conference ID 4872955. The event will also live-stream at
Economic Development Administration, U.S. Department of Commerce.
Notice and opportunity for public comment.
The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of the firms contributed importantly to the total or partial separation of the firms' workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act of 1974, as amended.
Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that Maquilacero S.A. de C.V. (Maquilacero) and Regiomontana de Perfiles y Tubos S.A. de C.V. (Regiopytsa) made sales of subject merchandise at less than normal value during the period of review (POR) August 1, 2016, through July 31, 2017. Interested parties are invited to comment on these preliminary results.
Applicable September 6, 2018.
Madeline Heeren or Kent Boydston, 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) 482-9179 or (202) 482-5649, respectively.
On October 16, 2017, we published the notice of initiation for this administrative review.
The Preliminary Decision Memorandum is a public document and is on file electronically
The scope of this order covers certain welded carbon-quality light-walled steel pipe and tube, of rectangular (including square) cross section, having a wall thickness of less than 4 mm. The term carbon-quality steel includes both carbon steel and alloy steel which contains only small amounts of alloying elements. Specifically, the term carbon-quality includes products in which none of the elements listed below exceeds the quantity by weight respectively indicated; 1.80 percent of manganese, or 2.25 percent of silicon, or 1.00 percent of copper, or 0.50 percent of aluminum, or 1.25 percent of chromium, or 0.30 percent of cobalt, or 0.40 percent of lead, or 1.25 percent of nickel, or 0.30 percent of tungsten, or 0.10 percent of molybdenum, or 0.10 percent of niobium, or 0.15 percent of vanadium, or 0.15 percent of zirconium.
The description of carbon-quality is intended to identify carbon-quality products within the scope. The welded-carbon quality rectangular pipe and tube subject to the order is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7306.61.50.00 and 7306.61.70.60. This tariff classification is provided for convenience and Customs purposes; however, the written description of the scope of the order is dispositive.
Commerce is conducting this review in accordance with sections 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act). Export price was calculated in accordance with section 772 of the Act. Normal value was calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions,
We preliminarily determine that, for the period August 1, 2016, through July 31, 2017, the following weighted-average dumping margins exist:
We
Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days of the date of publication of this notice.
Unless extended, we intend to issue the final results of this administrative review, which will include the results of our analysis of all issues raised in the case and rebuttal briefs, within 120 days of publication of these preliminary results in the
Upon issuance of the final results, Commerce will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
Regarding entries of subject merchandise during the period of review that were produced by Maquilacero and Regiopytsa and for which they did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate un-reviewed entries at the all-others rate of 3.76 percent, as established in the less-than-fair-value investigation of the order, if there is no rate for the intermediate company(ies) involved in the transaction.
For the firms covered by this review, we intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review.
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Maquilacero and Regiopytsa and other companies listed above will be equal to the weighted-average dumping margin established in the final results of this administrative review; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which they were reviewed; (3) if the exporter is not a firm covered in this review, a prior review, or in the investigation but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be the all-others rate of 3.76 percent. These cash deposit requirements, when imposed, shall remain in effect until further notice.
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 review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that rubber bands from the People's Republic of China (China) are being or are likely to be sold in the United States at less than fair value (LTFV). The period of investigation (POI) is July 1, 2017, through December 31, 2017. Interested parties are invited to comment on this preliminary determination.
Applicable September 6, 2018.
Paul Stolz or Stephanie Berger, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4474 or (202) 482-2483, respectively.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). We published the notice of initiation of this investigation on February 27, 2018.
The products covered by this investigation are rubber bands from China. For a complete description of the scope of this investigation,
In accordance with the preamble to Commerce's regulations,
We are conducting this investigation in accordance with section 731 of the Act. Pursuant to section 776(a) and (b) of the Act, we have preliminarily relied upon facts otherwise available, with adverse inferences, for the China-wide entity because it did not respond to our requests for information. Specifically, all companies to which Commerce issued quantity and value (Q&V) questionnaires failed to respond.
On June 11, 2018, as revised on August 7, 2018, the petitioner timely filed a critical circumstances allegation, pursuant to section 733(e)(1) of the Act and 19 CFR 351.206, alleging that critical circumstances exist with respect to imports of rubber bands from China.
For a full description of the methodology and the results of Commerce's analysis,
We preliminarily determine that the following estimated weighted-average dumping margin exists:
In accordance with section 733(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of subject merchandise, as described in the scope of the investigation entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of subject 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 all imports of subject merchandise from China. In accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to all unliquidated entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice.
To determine the cash deposit rate, Commerce normally adjusts the estimated weighted-average dumping margin by the amount of domestic subsidy pass-through and export subsidies determined in a companion countervailing duty (CVD) proceeding when CVD provisional measures are in effect. Accordingly, where Commerce has made a preliminary affirmative determination for export subsidies, Commerce has offset the calculated estimated weighted-average dumping margin by the appropriate rate(s). Any such cash deposit rates may be found in the Preliminary Determination Section's chart of estimated weighted-average dumping margins above.
Should provisional measures in the companion CVD investigation expire prior to the expiration of provisional measures in this LTFV investigation, Commerce will direct CBP to begin collecting cash deposits at a rate equal to the estimated weighted-average dumping margin calculated in this preliminary determination unadjusted for the export subsidies at the time the CVD provisional measures expire. These suspension of liquidation instructions will remain in effect until further notice.
Normally, Commerce discloses to interested parties the calculations performed in connection with a preliminary determination within five days of its public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). However, because Commerce preliminarily applied AFA to companies in this investigation in accordance with section 776 of the Act, and the applied AFA rate is based solely on the petition, there are no calculations to disclose.
Because all respondents did not provide information requested by Commerce and we preliminarily determine that all respondents to have been uncooperative, verification will not be conducted.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 30 days after the date of publication of the preliminary determination, unless the Secretary alters the time limit. 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, we intend 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 733(f) of the Act, we notified the ITC of our preliminary affirmative determination of sales at LTFV and preliminary determination of critical circumstances. If the Commerce 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 whether imports of the subject merchandise are materially injuring, or threaten material injury to, the U.S. industry and whether critical circumstances exist.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The products subject to this investigation are bands made of vulcanized rubber, with a flat length, as actually measured end-to-end by the band lying flat, no less than
Excluded from the scope of this investigation are vulcanized rubber bands of various sizes with arrow shaped rubber protrusions from the outer diameter that exceeds at the anchor point a wall thickness of 0.125 inches and where the protrusion is used to loop around, secure and lock in place.
Excluded from the scope of this investigation are yarn/fabric-covered vulcanized rubber hair bands, regardless of size.
Merchandise covered by this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheading 4016.99.3510. Merchandise covered by the scope may also enter under HTSUS subheading 4016.99.6050. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On June 22, 2018, the Department of Commerce (Commerce) published in the
Applicable September 6, 2018.
Mark Hoadley, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3148.
On June 22, 2018, Commerce published in the
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
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 which permits attachment to an 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 a diameter of less than seven-eighths (
The scope of the investigation is not intended to include shredded plastic film or shredded plastic strip, in each case where the shred does not exceed 5 mm in width and does not exceed 18 inches in length, imported in bags.
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.
Pursuant to the
Commerce has previously set August 13, 2018, as the deadline for case briefs and August 20, 2018 as the deadline for rebuttal briefs regarding the CVD preliminary determination.
In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its amended preliminary determination. If Commerce's final determination is affirmative, the ITC will make its final determination before the later of 120 days after the date of this preliminary determination or 45 days after Commerce's final determination.
This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.
U.S. Department of Commerce, International Trade Administration.
Notice of an open meeting of the President's Advisory Council on Doing Business in Africa (PAC-DBIA or Council).
The President's Advisory Council on Doing Business in Africa will hold the final meeting of its term to deliberate and consider adopting a report containing recommendations to the President on actions the United States Government could take to mitigate obstacles that U.S. companies face in doing business in Africa, as well as findings from the Council's June 24-July 5, 2018 Fact-Finding Trip to Ethiopia, Kenya, Côte d'Ivoire and Ghana, countries the Council identified as holding particular promise of business opportunities for U.S. companies, that was led by Commerce Secretary Wilbur Ross and Under Secretary for International Trade Gil Kaplan. The recommendations in the Council's report may include updates to recommendations the Council previously adopted on April 18, 2018 for Ethiopia, Kenya, Côte d'Ivoire and Ghana, new recommendations that focus on those or other African countries, and recommendations that apply to the African region broadly.
The Secretary of Commerce extended the appointments of the members of the PAC-DBIA by 60 days, to expire on November 5, 2018, to allow the Council sufficient time to complete its final report following the Fact-Finding Trip.
The final agenda for the meeting will be posted at least one week in advance of the meeting on the Council's website at
September 26, 2018, 9:30 a.m.-11:30 a.m.
The President's Advisory Council on Doing Business in Africa meeting will be broadcast via live webcast on the internet at
Giancarlo Cavallo or Ashley Bubna, Designated Federal Officers, President's Advisory Council on Doing Business in Africa, Department of Commerce, 1401 Constitution Ave. NW, Room 22004, Washington, DC, 20230, telephone: 202-482-2091, email:
Submit statements electronically to Giancarlo Cavallo and Ashley Bubna, Designated Federal Officers, President's Advisory Council on Doing Business in Africa, via email:
Send paper statements to Giancarlo Cavallo and Ashley Bubna, Designated Federal Officers, President's Advisory Council on Doing Business in Africa, Department of Commerce, 1401 Constitution Ave. NW, Room 22004, Washington, DC, 20230.
Statements will be provided to the members in advance of the meeting for consideration and also will be posted on the Council website (
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) has preliminarily determined that critical circumstances exist with respect to imports of rubber bands from certain producers and exporters from the People's Republic of China (China). Further, Commerce has amended the scope of the countervailing duty (CVD) investigation on rubber bands from China.
Applicable September 6, 2018.
Kristen Johnson, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-4793.
On January 30, 2018, Commerce received a CVD petition concerning imports of rubber bands from China filed in proper form on behalf of Alliance Rubber Co. (the petitioner).
Commerce selected Graceful Imp. & Exp. Co., Ltd. (Graceful), Moyoung Trading Co., Ltd. (Moyoung), and Ningbo Syloon Imp & Exp Co., Ltd. (Ningbo Syloon) (collectively, the mandatory respondents) as the individually-examined respondents in
On June 11, 2018, the petitioner alleged that critical circumstances exist with respect to imports of rubber bands from China, pursuant to section 703(e)(1) of the Act and 19 CFR 351.206.
In accordance with 19 CFR 351.206(c)(1), if the petitioner submits an allegation of critical circumstances 30 days or more before the scheduled date of the final determination,
The POI is January 1, 2017, through December 31, 2017.
The products covered by this investigation are rubber bands from China. For a complete description of the scope of this investigation,
In accordance with the preamble to Commerce's regulations,
The petitioner alleges a massive increase of imports of rubber bands from China and provided monthly import data, sourced from the U.S. International Trade Commission's (ITC) Tariff and Trade DataWeb (DataWeb) for the period January 2017 through April 2018.
The petitioner also alleges that there is a reasonable basis to believe that there are subsidies in this investigation which are inconsistent with the Subsidies and Countervailing Measures Agreement (SCM Agreement).
Section 703(e)(1) of the Act provides that Commerce will preliminarily determine that critical circumstances exist if there is a reasonable basis to believe or suspect that: (A) The alleged countervailable subsidy is inconsistent with the SCM Agreement,
In determining whether there are “massive imports” over a “relatively short period,” pursuant to section 703(e)(1)(B) of the Act and 19 CFR 351.206(h) and (i), Commerce normally compares the import volumes of the subject merchandise for at least three months immediately preceding the filing of the petition (
Sections 776(a)(1) and (2) of the Act provide that Commerce shall, subject to section 782(d) of the Act, apply “facts otherwise available” if necessary information is not on the record or an interested party or any other person: (A) Withholds information that has been requested; (B) fails to provide information within the deadlines established, or in the form and manner requested by Commerce, subject to subsections (c)(1) and (e) of section 782 of the Act; (C) significantly impedes a proceeding; or (D) provides information that cannot be verified as provided by section 782(i) of the Act. Because the mandatory respondents decided to not participate in this investigation, we have made this preliminary determination with respect to critical circumstances on the basis of facts
Section 776(b) of the Act provides that Commerce may use an adverse inference in selecting from among the facts otherwise available when a party fails to cooperate by not acting to the best of its ability to comply with a request for information. Further, section 776(b)(2) of the Act states that an adverse inference may include reliance on information derived from the petition, the final determination from the investigation, a previous administrative review, or other information placed on the record. Because Graceful, Moyoung, and Ningbo Syloon did not cooperate to the best of their ability in this investigation, in selecting from the facts available, we find that an adverse inference is warranted, pursuant to section 776(b) of the Act, with respect to critical circumstances. As such, we are making an adverse inference that Graceful, Moyoung, and Ningbo Syloon each benefited from countervailable subsidies under the “Export Assistance Grants” program. As determined in Commerce's Initiation Checklist, the “Export Assistance Grants” program, alleged in the Petition and supported by information reasonably available to the petitioner, appears to be export contingent and thus inconsistent with the SCM Agreement.
Consistent with prior determinations, we have not imputed the adverse inference of massive imports that we applied to the mandatory respondents to the non-individually examined companies receiving the all-others rate.
The petitioner stated that it is not aware of any seasonal or consumption trends.
We obtained U.S. import value data from DataWeb for each month from January 2017 through June 2018.
We will make a final determination concerning critical circumstances for rubber bands from China when we make our final determination in this investigation, which is currently scheduled to be signed no later than November 13, 2018.
Interested parties may submit case briefs or other written comments with regard to this preliminary affirmative critical circumstances determination and the preliminary scope decision. Such submissions must be submitted to the Assistant Secretary for Enforcement and Compliance
Electronically filed documents must be received successfully in their entirety by 5:00 p.m. Eastern Time,
In accordance with section 703(e)(2)(A) of the Act, we are directing U.S. Customs and Border Protection (CBP) to suspend liquidation, with regard to Graceful, Moyoung, and Ningbo Syloon, of any unliquidated entries of subject merchandise from the China entered, or withdrawn from warehouse for consumption, on or after April 10, 2018, which is 90 days prior to the date of publication of the
In accordance with section 703(f) of the Act, we will notify the ITC of this preliminary determination of critical circumstances.
This determination is issued and published pursuant to sections 703(f) and 777(i)(1) of the Act.
The products subject to this investigation are bands made of vulcanized rubber, with a flat length, as actually measured end-to-end by the band lying flat, no less than
Excluded from the scope of this investigation are vulcanized rubber bands of various sizes with arrow shaped rubber protrusions from the outer diameter that exceeds at the anchor point a wall thickness of 0.125 inches and where the protrusion is used to loop around, secure and lock in place.
Excluded from the scope of this investigation are yarn/fabric-covered vulcanized rubber hair bands, regardless of size.
Merchandise covered by this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheading 4016.99.3510. Merchandise covered by the scope may also enter under HTSUS subheading 4016.99.6050. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that rubber bands from Thailand are being or are likely to be sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2017, through December 31, 2017. Interested parties are invited to comment on this preliminary determination.
Applicable September 6, 2018.
Laurel LaCivita or Stephanie Berger, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4243 or (202) 482-2483, respectively.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). We published the notice of initiation of this investigation on February 27, 2018.
The products covered by this investigation are rubber bands from Thailand. For a complete description of the scope of this investigation,
In accordance with the preamble to our regulations,
We are conducting this investigation in accordance with section 731 of the Act. We have calculated export prices in accordance with section 772(a) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary determination,
Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination we shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and
In this investigation, we preliminarily determined a zero rate for Liang Hah Heng International Rubber Co., Ltd. (Liang Hah Heng).
We preliminarily determine that the following estimated weighted-average dumping margins exist:
Consistent with section 733(b)(3) of the Act, we disregard
In accordance with section 733(d)(2) of the Act, we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
We normally adjust cash deposits for estimated antidumping duties by the amount of export subsidies countervailed in a companion countervailing duty (CVD) proceeding, when CVD provisional measures are in effect. Accordingly, where we preliminarily make an affirmative determination for countervailable export subsidies, we offset the estimated weighted-average dumping margin by the appropriate CVD rate.
However, in the companion CVD preliminary determination, we have preliminarily determined that no countervailable subsidies are being provided to the production or exportation of subject merchandise, and therefore, we did not direct CBP to suspend liquidation of any such entries.
We intend to disclose to interested parties the calculations and analysis performed in connection with this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, we intend to verify information relied upon in making our 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, we intend 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.
Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who
On July 31, 2018, and August 1, 2018, in accordance with 19 CFR 351.210(b)(2)(ii), Liang Hah Heng and U. Yong requested to postpone the final determination for a maximum of 135 days after the date of publication of the preliminary determination in the
In accordance with section 733(f) of the Act, we will notify the International Trade Commission (ITC) of our preliminary 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 whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The products subject to this investigation are bands made of vulcanized rubber, with a flat length, as actually measured end-to-end by the band lying flat, no less than
Excluded from the scope of this investigation are vulcanized rubber bands of various sizes with arrow shaped rubber protrusions from the outer diameter that exceeds at the anchor point a wall thickness of 0.125 inches and where the protrusion is used to loop around, secure and lock in place.
Excluded from the scope of this investigation are yarn/fabric-covered vulcanized rubber hair bands, regardless of size.
Merchandise covered by this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheading 4016.99.3510. Merchandise covered by the scope may also enter under HTSUS subheading 4016.99.6050. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigation is dispositive.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The Mid-Atlantic Fishery Management Council's Mackerel, Squid, and Butterfish Advisory Panel and Committee will hold a public meeting via webinar.
The meeting will be held on Monday September 24, 2018, from 10 a.m. to 12 p.m. See
The meeting will be held via webinar, which can be accessed at:
Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.
The Mid-Atlantic Fishery Management Council's
Background documents can be found on the Council's website (
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings (webinars).
The Pacific Fishery Management Council's (Pacific Council) Salmon Technical Team (STT) will hold a series of meetings via webinar to continue the discussion on the ongoing development of salmon rebuilding plans for Klamath River fall Chinook, Sacramento River fall Chinook, Strait of Juan de Fuca natural coho, Queets River natural coho, and Snohomish River natural coho. Each meeting is scheduled for two hours with either a morning or afternoon start time. These meetings are open to the public.
The STT webinar for Klamath River fall Chinook will be held Wednesday, September 26, 2018, from 9 a.m. to 11 a.m.
The STT webinar for Sacramento River fall Chinook will be held Wednesday, September 26, 2018, from 1 p.m. to 3 p.m.
The STT webinar for Strait of Juan de Fuca natural coho will be held Thursday, September 27, 2018, from 8 a.m. to 10 a.m.
The STT webinar for Queets River natural coho will be held Thursday, September 27, 2018, from 10:30 a.m. to 12:30 p.m.
The STT webinar for Snohomish River natural coho will be held Thursday, September 27, 2018, from 1 p.m. to 3 p.m.
The STT meetings will be held by webinar. To attend the webinars, (1) join the meeting by visiting this link
Ms. Robin Ehlke, Pacific Council; telephone: (503) 820-2410.
Three natural coho stocks (Queets coho, Strait of Juan de Fuca coho, and Snohomish coho) and two Chinook stocks (Sacramento River fall Chinook and Klamath River fall Chinook) were found to meet the criteria for being classified as overfished in the PFMC Review of 2017 Ocean Salmon Fisheries. Under the tenets of the Salmon Fishery Management Plan, the STT is required to develop a salmon rebuilding plan for each of these stocks and propose them to the Council within one year.
The STT, tribal, state, Federal, and other management entities are working together to develop the salmon rebuilding plans. These meetings are the third of a series of meetings, and will focus on the development of potential recommendations to be included in each rebuilding plan. Additional topics for discussion may include, but are not limited to, outstanding data needs, data analysis, and economic aspects to be included in each plan. One meeting will occur for each of the five stocks; additional meetings will be scheduled as needed. These meetings are open to the public. All meetings will have the same webinar ID and access code.
Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
The meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of meetings of the South Atlantic Fishery Management Council's
The South Atlantic Fishery Management Council (Council) will hold meetings of the following Citizen Science Advisory Panel Action Teams: Finance & Infrastructure; Volunteers; Projects/Topics Management; Data Management; and Communication/Outreach/Education via webinar.
The Finance & Infrastructure Team meeting will be held on Wednesday, September 26, 2018 at 1 p.m.; Volunteers Team on Thursday, September 27, 2018 at 2 p.m.; Projects/Topics Management Team will be held on Friday, September 28, 2018 at 10 a.m.; Data Management Team on Monday, October 1, 2018 at 10 a.m.; and Communication/Outreach/Education Team on Wednesday, October 3, 2018 at 2 p.m. Each meeting is scheduled to last approximately 90 minutes. Additional Action Team webinars and plenary webinar dates and times will publish in a subsequent issue in the
Amber Von Harten, Citizen Science Program Manager, SAFMC; phone: (843) 302-8433 or toll free (866) SAFMC-10; fax: (843) 769-4520; email:
The Council created a Citizen Science Advisory Panel Pool in June 2017. The Council appointed members of the Citizen Science Advisory Panel Pool to five Action Teams in the areas of Volunteers, Data Management, Projects/Topics Management, Finance, and Communication/Outreach/Education to develop program policies and operations for the Council's Citizen Science Program.
Each Action Team will meet to continue work on developing recommendations on program policies and operations to be reviewed by the Council's Citizen Science Committee. Public comment will be accepted at the beginning of the meeting.
Items to be addressed during these meetings:
These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments.
NMFS announces the receipt of three exempted fishing permit (EFP) applications. NMFS has made a preliminary determination that these EFP applications warrant further consideration. The applications, submitted by the San Francisco Community Fishing Association, Scott Cook, and Real Good Fish, request exemptions from prohibitions to fish for rockfish species in the non-trawl Rockfish Conservation Areas during the 2019-2020 fishing years. All three applicants request to test hook-and-line gear that selectively harvests underutilized, midwater rockfish species while avoiding bottom-dwelling, overfished rockfish species. NMFS requests public comment on these applications.
Comments must be received by October 9, 2018.
You may submit comments on this document, identified by NOAA-NMFS-2018-0093, by any of the following methods:
•
•
•
Lynn Massey, West Coast Region, NMFS, (562) 436-2462,
This action is authorized by the Pacific Coast Groundfish Fishery Management Plan and the regulations implementing the Magnuson-Stevens Fishery Conservation and Management Act at 50 CFR 600.745, which state that EFPs may be used to authorize fishing activities that would otherwise be prohibited.
At its June 2018 meeting, the Pacific Fishery Management Council (Council) made its final recommendation to NMFS on three EFP applications. The Council considered the EFP applications concurrently with the 2019-2020 biennial harvest specifications and management process because expected catch under each EFP is included in the catch limits for groundfish stocks. All three EFP applicants request to test hook-and-line gear that selectively targets underutilized, midwater rockfish species (
•
•
•
During the two-year period of EFP activities from 2019 to 2020, all applicants will adhere to EFP set-asides for targeted and incidental groundfish and other species, which were considered and approved by the Council at their June 2018 meeting. These EFP set-asides are off the top deductions from the 2019-2020 applicable annual catch limits (ACLs), meaning any landings and discards that occur under these EFPs would be accounted for within the applicable ACLs.
NMFS does not expect any impacts to the environment, essential fish habitat, or protected or prohibited species from this EFP beyond those analyzed for the groundfish fishery as a whole in applicable biological opinions
16 U.S.C. 1801
Corporation for National and Community Service.
Notice.
The Corporation for National and Community Service (CNCS) has submitted a public information collection request (ICR) entitled Day of Service Project Collection Tool for review and approval in accordance with the Paperwork Reduction Act.
Comments may be submitted, identified by the title of the information collection activity, by October 9, 2018.
Comments may be submitted, identified by the title of the information collection activity, to the Office of Information and Regulatory
(1)
(2)
Copies of this ICR, with applicable supporting documentation, may be obtained by calling the Corporation for National and Community Service, David Sherman, at 202-606-6986, or by email to
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions;
• Propose ways to enhance the quality, utility, and clarity of the information to be collected; and
• Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
A 60-day Notice requesting public comment was published in the
Office of Environmental Management, Department of Energy.
Notice of Open Meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Savannah River Site. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the
Monday, September 24, 2018, 1:00 p.m.-4:45 p.m.
Tuesday, September 25, 2018, 9:00 a.m.-5:00 p.m.
DoubleTree Hotel, 2100 Bush River Road, Columbia, SC 29210.
Amy Boyette, Office of External Affairs, Department of Energy, Savannah River Operations Office, P.O. Box A, Aiken, SC, 29802; Phone: (803) 952-6120.
Office of Environmental Management, Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the
Wednesday, September 26, 2018, 4:00 p.m.
Frank H. Rogers Science and Technology Building, 755 East Flamingo, Las Vegas, Nevada 89119.
Barbara Ulmer, Board Administrator, 232 Energy Way, M/S 167, North Las Vegas, Nevada 89030. Phone: (702) 630-0522; Fax: (702) 295-2025 or email:
Office of Environmental Management, Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the
Wednesday, September 26, 2018, 1:00 p.m.-5:15 p.m.
Sagebrush Inn Conference Center, 1508 Paseo del Pueblo Sur, Taos, New Mexico 87571.
Menice Santistevan, Northern New Mexico Citizens' Advisory Board (NNMCAB), 94 Cities of Gold Road, Santa Fe, NM 87506. Phone (505) 995-0393; Fax (505) 989-1752 or email:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the application for a new license for the Blenheim-Gilboa Pumped Storage Project, located on Schoharie Creek, in the Towns of Blenheim and Gilboa in Schoharie County, New York, and has prepared a draft Environmental Assessment (EA) for the project.
The draft EA contains staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the draft EA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
You may also register online at
Any comments should be filed within 30 days from the date of this notice.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
For further information, contact Andy Bernick at (202) 502-8660 or by email at
This is a supplemental notice in the above-referenced proceeding of Heartland Divide Wind Project, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 19, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing
This is a supplemental notice in the above-referenced proceeding Enel Green Power Rattlesnake Creek Wind Project, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 19, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Description: Baseline eTariff Filing: Market-Based Rate Tariff Application to be effective 8/30/2018.
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:
On August 30, 2018, the Commission issued an order in Docket No. EL18-193-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether Citizens Sycamore-Penasquitos Transmission LLC's proposed transmission owner tariff may be unjust and unreasonable.
The refund effective date in Docket No. EL18-193-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL18-193-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Gateway Project involving construction and operation of facilities by Sendero Carlsbad Gateway, LLC (Gateway) in Eddy County, New Mexico and Culberson County, Texas. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies about issues regarding the project. The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from its action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires the Commission to discover concerns the public may have about proposals. This process is referred to as “scoping.” The main goal of the scoping process is to focus the analysis in the EA on the important environmental issues. By this notice, the Commission requests public comments on the scope of the issues to address in the EA. To ensure that your comments are timely and properly recorded, please submit your comments so that the Commission receives them in Washington, DC on or before 5:00 p.m. Eastern Time on September 28, 2018.
You can make a difference by submitting your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. Commission staff will consider and address all filed comments during the preparation of the EA.
If you sent comments on this project to the Commission before the opening of this docket on August 9, 2018, you will need to file those comments in Docket No. CP18-538-000 to ensure they are considered as part of this proceeding.
This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.
If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The company would seek to negotiate a mutually acceptable easement agreement. You are not required to enter into an agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if you and the company do not reach an easement agreement, the pipeline company could initiate condemnation proceedings in court. In such instances, compensation would be determined by a judge in accordance with state law.
Gateway provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” This fact sheet addresses a number of typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. It is also available for viewing on the FERC website (
For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or
(1) You can file your comments electronically using the
(2) You can file your comments electronically by using the
(3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (CP18-538-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Gateway proposes to construct, operate, and maintain various facilities in connection with its proposed Gateway Project located in Eddy County, New Mexico and Culberson County, Texas. The Gateway Project would provide about 400 million standard cubic feet of natural gas per day from Gateway's newly expanded Carlsbad Plant (a cryogenic gas processing plant) to the Agua Blanca intrastate pipeline owned by White Water Midstream, LLC. According to Gateway, its project would help alleviate natural gas supply delivery constraints in southeast New Mexico and satisfy overall demand in the western region of the United States.
The Gateway Project would consist of the following facilities:
• Approximately 23 miles of 24-inch-diameter natural gas transmission pipeline;
• A new meter station (including a mainline block valve and pig
• A mainline block valve at milepost 15.0; and
• A pig receiver and mainline block valve at milepost 23.3 near a White Water Midstream, LLC meter station.
The general location of the project facilities is shown in appendix 1.
Construction of the proposed facilities would disturb about 334 acres of land for the aboveground facilities and the pipeline. Following construction, Gateway would maintain about 100 acres of land for permanent operation of the project's facilities; the remaining acreage would be restored and would revert to former uses. About 82 percent of the proposed pipeline route parallels existing pipeline, utility, or road rights-of-way.
The EA will discuss impacts that could occur as a result of the construction and operation of the proposed project under these general headings:
• Geology and soils;
• Land use;
• Water resources, fisheries, and wetlands;
• Cultural resources;
• Vegetation and wildlife;
• Air quality and noise;
• Endangered and threatened species;
• Public safety; and
• Cumulative impacts.
Commission staff will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.
The EA will present Commission staffs' independent analysis of the issues. The EA will be available in the public record through eLibrary,
With this notice, the Commission is asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate in the preparation of the EA.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, the Commission is using this notice to initiate consultation with the applicable State Historic Preservation Offices (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. Commission staff will update the environmental mailing list as the analysis proceeds to ensure that information related to this environmental review is sent to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.
If you need to make changes to your name/address, or if you would like to remove your name from the mailing list, please return the attached Mailing List Update Form (appendix 2).
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Finally, public sessions or site visits will be posted on the Commission's calendar located at
This is a supplemental notice in the above-referenced proceeding Josco Energy USA, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 19, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) for the Line 8000 Replacement Project (Project), proposed by Columbia Gas Transmission, LLC (Columbia) in the above-referenced docket. Columbia requests authorization to modernize and upgrade Columbia's Line 8000 pipeline system by replacing and abandoning existing pipeline and constructing new pipeline and appurtenant facilities in Mineral County, West Virginia and Allegany County, Maryland.
The EA assesses the potential environmental effects of the construction and operation of the Project in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that approval of the proposed project, with appropriate mitigating measures, would not constitute a major federal action significantly affecting the quality of the human environment.
The proposed Line 8000 Project would consist of:
• Replacement of a total of approximately 13.25 miles of existing 12-inch-diameter bare steel pipeline, with approximately 13.54 miles of new, coated 12-inch-diameter natural gas transmission pipeline in five sections and four modification points along Line 8000 and Lateral Line 8006;
• Replacement of a total of approximately 0.54 miles of existing 4-inch-diameter bare steel pipeline, with approximately 0.67 miles of new coated 4-inch-diameter natural gas transmission pipeline along two laterals (Lateral Lines 8225 and 8244);
• Installation of two new pig
• Modifications/abandonment of three existing mainline valves and three existing side tap valve sites and modification of tie-ins at two regulator stations; and
• Abandonment of 13 active residential taps and 109 inactive taps.
The FERC staff mailed copies of the EA to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; and newspapers and libraries in the project area. In addition, the EA is available for public viewing on the FERC's website (
Any person wishing to comment on the EA may do so. Your comments should focus on the EA's disclosure and discussion of potential environmental effects, reasonable alternatives, and
For your convenience, there are three methods you can use to file your comments to the Commission. In all instances, please reference the project docket number (CP18-13-000) with your submission. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or
(1) You can file your comments electronically using the eComment feature on the Commission's website (
(2) You can also file your comments electronically using the eFiling feature on the Commission's website (
(3) You can file a paper copy of your comments by mailing them to the following address: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214). Only intervenors have the right to seek rehearing or judicial review of the Commission's decision. The Commission may grant affected landowners and others with environmental concerns intervenor status upon showing good cause by stating that they have a clear and direct interest in this proceeding which no other party can adequately represent. Simply filing environmental comments will not give you intervenor status, but you do not need intervenor status to have your comments considered.
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
This is a supplemental notice in the above-referenced proceeding Riverhead Solar Farm, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 19, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
a.
b.
c.
d.
e. The technical conference will be recorded by a stenographer and will be placed in the public records of the project.
f. All local, state, and federal agencies, Indian tribes, and other interested parties are invited to participate either in person or by telephone. Please contact Quinn Emmering at (202) 502-6382 or by email at
g. In addition, Moon Lake Electric Association, Inc. (Moon Lake) and FERC staff will conduct an environmental site review of the project on Tuesday, September 25, 2018, starting at 9:00 a.m. (MDT). All interested individuals, organizations, and agencies are invited to attend. The Uintah Project is located approximately 15 miles north of Neola, Utah.
h. For the environmental site review, Moon Lake has made arrangements to provide transportation for participants from The Church of Jesus Christ of Latter-Day Saints parking lot located at 2062 W 9000N, Neola, Utah 84053 (at intersection with 2000W). Please note that the project tour is expected to take 4 hours, at minimum. No lunch is provided and food services in the Neola area are limited. Participants should make their own arrangements to bring food and beverages. Participants should dress appropriately for fall weather outdoors and wear hiking boots or similar footwear. Please RSVP Pat Corun at (435) 722-5406 or by email at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA), Science Advisory Board (SAB) Staff Office announces a public teleconference of the Chartered SAB to: Conduct two quality reviews of the draft SAB Review of EPA's Draft Toxicological Review of Ethyl Tertiary Butyl Ether and Draft Toxicological Review of tert-Butyl Alcohol; and the draft SAB review of the EPA's Framework for Assessing Biogenic CO
The teleconference will be held on Wednesday, September 26, 2018, from 1:00 p.m. to 5:00 p.m. (Eastern Time).
The public teleconference will be held by telephone only.
Any member of the public wishing to obtain information concerning the public teleconference may contact Mr. Thomas Carpenter, Designated Federal Officer (DFO), EPA Science Advisory Board Staff Office (1400R), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; by telephone/voice mail at (202) 564-4885 or at
The SAB was established pursuant to the Environmental Research, Development, and Demonstration Authorization Act (ERDDAA), codified at 42 U.S.C. 4365, to provide independent scientific and technical advice to the Administrator on the scientific and technical basis for Agency positions and regulations. The SAB is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. The SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. Pursuant to FACA and EPA policy, notice is hereby given that the SAB will hold a public teleconference to discuss and deliberate on the topics below.
Pursuant to FACA and EPA policy, notice is hereby given that the Chartered SAB will hold a public teleconference to discuss information provided by the EPA on these topics. The Chartered SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies.
Federal advisory committees and panels, including scientific advisory committees, provide independent advice to the EPA. Members of the public can submit comments for a federal advisory committee to consider as it develops advice for the EPA. Interested members of the public may submit relevant written or oral information on the topic of this advisory activity, and/or the group conducting the activity, for the SAB to consider during the advisory process. Input from the public to the SAB will have the most impact if it provides specific scientific or technical information or analysis for SAB to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should follow the instructions below to submit comments.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “NESHAP for Radionuclides (Renewal)” (EPA ICR No. 1100.16, OMB Control No. 2060-0191) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through March 31, 2019. 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.
Comments must be submitted on or before November 5, 2018.
Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2003-0085, online using
EPA's policy is that all comments received will be included in the public docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Jonathan P. Walsh, Radiation Protection Division, Office of Radiation and Indoor Air, Mail Code 6608T, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-343-9238; fax number: 202-343-2304; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of
Information collected is used by the EPA to ensure that public health continues to be protected from the hazards of airborne radionuclides by compliance with these standards. Compliance is demonstrated through emissions testing and dose calculation when appropriate.
Farm Credit Administration.
Notice, regular meeting.
Notice is hereby given, pursuant to the Government in the Sunshine Act, of the regular meeting of the Farm Credit Administration Board (Board).
The regular meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on September 13, 2018, from 9:00 a.m. until such time as the Board concludes its business.
Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090. Submit attendance requests via email to
Dale L. Aultman, Secretary to the Farm Credit Administration Board, (703) 883-4009, TTY (703) 883-4056,
Parts of this meeting of the Board will be open to the public (limited space available) and parts will be closed to the public. Please send an email to
Federal Communications Commission.
Notice.
In this document, the Commission announces and provides an agenda for the next meeting of the Disability Advisory Committee (DAC or Committee).
Wednesday, October 3, 2018. The meeting will come to order at 9:00 a.m. Eastern Time.
Federal Communications Commission, 445 12th Street SW, Washington, DC 20554, in the Commission Meeting Room.
Will Schell, Designated Federal Officer (DFO), at 202-418-0767 (voice) or
This meeting is open to members of the general public. The meeting will be webcast with open captioning at:
Notice is hereby given that Orient Overseas Container Line Limited and OOCL (Europe) Limited (“Petitioners”), have petitioned the Commission pursuant to 46 U.S.C. 40103(a) and 46 CFR 502.94, “. . . for an exemption from 46 U.S.C. 40703 so that they may reduce their tariff rates effective upon publication.”
The Petitioners allege this requested exemption “. . . would neither reduce competition nor be detrimental to commerce.” Petitioners state that “OOCL operates as an ocean common carrier in numerous trades between ports in the United States and ports in other countries.” Petitioners state that they are both entities classified as “. . . controlled carriers within the meaning of 46 U.S.C. 40102(8) and 46 CFR 565.2(a).” Petitioners “. . . are requesting an exemption from the requirement that it provide 30 days' notice of a reduction in its tariff rates” required of controlled carriers and allege that without this exemption “. . . the OOCL entities would be effectively prevented from competing for a measurable portion of the market.”
In order for the Commission to make a thorough evaluation of the exemption requested in the Petition, pursuant to 46 CFR 502.92, interested parties are requested to submit views or arguments in reply to the Petition no later than September 18, 2018. Replies shall be sent to the Secretary by email to
Non-confidential filings may be submitted in hard copy to the Secretary at the above address or by email as a PDF attachment to
The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary by email at
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 October 2, 2018.
1.
2.
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 October 1, 2018.
1.
Federal Trade Commission.
Oral Argument; open meeting.
The Federal Trade Commission (“FTC” or “Commission”) will meet on Thursday, October 11, 2018, in Room 532 of the Federal Trade Commission Building for an Oral Argument in In the Matter of Impax Laboratories, Inc. The public is invited to attend and observe the open portion of the meeting, which is scheduled to begin at 2:00 p.m. The remainder of the meeting will be closed to the public.
The Oral Argument is scheduled for October 11, 2018 at 2:00 p.m.
Federal Trade Commission Building, 600 Pennsylvania Avenue NW, Washington, DC 20580.
Donald S. Clark, Secretary, Office of the Secretary, 600 Pennsylvania Avenue NW, Washington, DC 20580, 202-326-2514.
(1) Oral Argument in In the Matter of Impax Laboratories, Inc., Docket No. 9373.
(2) Executive Session to follow the Oral Argument in In the Matter of Impax Laboratories, Inc., Docket No. 9373.
On August 22, 2018, Commissioners Simons, Phillips, Chopra, and Slaughter were recorded as voting in the affirmative to conduct Matter Number One in open session, and to close Matter Number Two, and to withhold from this meeting notice such information as is exempt from disclosure under 5 U.S.C. 552b(c). Commissioner Ohlhausen was recorded as not participating.
The Commission has determined that Matter Number Two may be closed under 5 U.S.C. 552b(c)(10), and that the
The General Counsel has certified that Matter Number Two may properly be closed, citing the following relevant exemptive provision: 5 U.S.C. 552b(c)(10).
Expected to attend the closed meeting are the Commissioners themselves, an advisor to one of the Commissioners, and such other Commission staff as may be appropriate.
By direction of the Commission, Commissioner Ohlhausen not participating.
Office of Acquisition Policy, General Services Administration (GSA).
Notice of request for comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an existing OMB clearance regarding a notarized document submittal for System for Award Management (SAM) Registration.
Submit comments on or before October 9, 2018.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
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Mr. Curtis E. Glover, Sr. Procurement Analyst, Federal Acquisition Policy Division, GSA, telephone number 202-501-1448, or via email to
A. Federal Acquisition Regulation (FAR) Subpart 4.11 prescribes policies and procedures for requiring contractor registration in the System for Award Management (SAM) database to: (1) Increase visibility of vendor sources (including their geographical locations) for specific supplies and services; and (2) establish a common source of vendor data for the Government.
In the past, the GSA Office of Inspector General (OIG) conducted an investigation into fraudulent activities discovered within SAM. Certain bad actors have, through electronic means, used public information to impersonate legitimate entities and established new entity registrations for those entities in SAM. By establishing fraudulent entity registrations, bad actors submitted bids in certain U.S. Government procurement systems or shipped deficient or counterfeit goods to the U.S. Government.
GSA established a new Information Collection Request (ICR) to collect additional information to support increased validation of entities registered and registering in the System for Award Management (SAM). This additional information is contained in a notarized letter in which an officer or other signatory authority of the entity formally appoints the Entity Administrator for the entity registering or recertifying in SAM. The original, signed letter is mailed to the Federal Service Desk for SAM prior to the registration's activation or re-registration.
The new ICR expires September 30, 2018, without authority for an extension. GSA is actively pursuing technical alternatives to the collection of this information for all non-federal entities. GSA seeks to refine the requirement and adopt a risk-based approach. This notice for an extension of the ICR lays the groundwork for the authority to continue collection of the information provided GSA is still pursuing the technical alternative beyond the ICR expiration date. In the interim, the collection of the notarized letter information is essential to GSA's acquisition mission to meet the needs of all federal agencies, as well as the needs of the grant community. A key element of GSA's mission is to provide efficient and effective acquisition solutions across the Federal Government. SAM is essential to the accomplishment of that mission. In addition to federal contracts, federal assistance programs also rely upon the integrity and security of the information in SAM. Without assurances that the information in SAM is protected and, is at minimal risk of compromise, GSA would risk losing the confidence of the federal acquisition and assistance communities which is serves. As a result, some entities may prefer not to do business with the Federal Government.
A 60-day notice was published in the
The information collection allows GSA to request the notarized letter, and apply this approach to new registrants (an average of 7,200 per month) and to existing SAM registrants (an average of 50,000 re-register per month).
Entities registered and registering in SAM are provided the template for the requirements of the notarized letter. It is estimated that the Entity Administrator will take on average 0.5 hour to create the letter and 0.25 hour to mail the hard copy letter. GSA proposes that an Entity Administrator equivalent to a GS-5, Step 5 Administrative Support person within the Government would perform these tasks. The estimated hourly rate of $24.70 (Base + Locality + Fringe) was used for the calculation.
Based on historical data of the ratio of small entities to other than small entities registering in SAM, GSA approximates 32,200 of the 57,200 new and existing entities (re-registrants) will have in-house resources to notarize documents. GSA proposes that the entities with in-house notaries will typically be large businesses where the projected salary of the executive or officer responsible for signing the notarized letter is on average approximately $150 per hour. The projected time for signature and notarizing the letter internally is 0.5 hour.
The other remaining 25,000 new and existing entities (re-registrants) per month are estimated to be small entities where the projected salary of the executive or officer responsible signing the notarized letter is on average approximately $100 per hour. These entities will more than likely have to obtain notary services from an outside source. The projected time for signature and notarizing the letter externally is 1 hour. The estimate includes a nominal fee ($5.00) usually charged by third- party notaries.
Public comments are particularly invited on: Whether this collection of information is necessary, whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).
Notice with comment period.
The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled “Prenatal Assessment of Environmental Risk (PAER)”. This web-based data collection will provide information on behavioral risks for environmental exposures for patients seeking preconception and prenatal care, and for their reproductive health care clinicians (RHCCs).
ATSDR must receive written comments on or before November 5, 2018.
You may submit comments, identified by Docket No. ATSDR-2018-0007 by any of the following methods:
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To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery M. Zirger, Information Collection Review Office, Centers for Disease Control and
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected;
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
5. Assess information collection costs.
Many environmental chemicals absorbed or ingested by pregnant women can cross the placenta to the fetus. The scientific evidence over the last 10 to 15 years has shown that exposure to toxic environmental agents before conception and during pregnancy can have significant and long-lasting adverse effects on the reproductive health of mothers, and on the long-term health of mothers and babies. Reducing exposure to toxic environmental agents is a critical area of intervention for reproductive health care professionals in the United States and worldwide. In 2013, the American College of Obstetricians and Gynecologists (ACOG) and other obstetrician-gynecologist professional societies called for timely action to identify and reduce exposure to toxic environmental agents while addressing the consequences of such exposure (ACOG, 2013; FIGO, 2105).
In support of this call to action, the Agency for Toxic Substances and Disease Registry (ATSDR) is requesting a three-year Paperwork Reduction Act (PRA) clearance for a new information collection request (ICR) entitled “Prenatal Assessment of Environmental Risk (PAER)”.
The long-term goal is for the PAER web-based information collection system to be widely adopted by obstetricians, gynecologists, and other reproductive health care professionals. Through PAER, practicing clinicians will have readily accessible and reliable information, and educational resources to counsel mothers-to-be on their potential environmental exposures and associated risks. This will facilitate reduction in harm to mothers-to-be and their babies. PAER environmental exposure assessment results will be suitable for incorporation into patients' electronic health records and maintenance within health care provider organizations.
Data collected will also establish an ongoing public health surveillance system that will provide an improved understanding of behaviors in daily life that put women of reproductive age and their babies at higher risk of exposure to environmental hazards. ATSDR will maintain only anonymous patient PAER survey responses and registration variables, including the PAER unique survey ID number, age, and zip code. Age and zip code will serve as the two variables for data analysis. Reported risk-based aggregate data will be at the zip code or higher geographic level, excluding zip code tabulation areas (ZTCAs) with 20,000 or fewer persons.
ATSDR plans to analyze the exposure risk data by geographic regions and over time. This data analysis will allow clinician and patient education on the most prevalent region-specific environmental exposures. ATSDR and partner organizations can use this information to shape educational initiatives and counseling guidance on ways women can lower environmental exposure risk.
The PAER survey is web-based, and includes 17 multiple-choice questions and one open-ended question. These questions are divided into five topic areas: Lifestyle; home; food and water; cans, bottles, and containers; and getting ready for the baby. The PAER survey focuses on 11 common types of environmental exposures: Air pollution, benzene, bisphenol A (BPA), flame retardants, lead, mercury, polychlorinated biphenyls (PCBs), pesticides, phthalates, smoking, and volatile organic compounds (VOCs).
There are two types of respondents who will participate in the PAER data collection, reproductive health care clinicians (RHCCs), and women of reproductive age who are seeking preconception or prenatal care. RHCCs will include obstetricians/gynecologists, family medicine physicians, nurse practitioners and physician assistants, and nurse midwives who are involved in the care of these women.
RHCCs (the first type of respondent) who choose to participate in the PAER process will be required to register with ATSDR, and gain approval to participate and establish credentials through CDC's Secure Access Management Services (SAMS). ATSDR will provide online training resources to instruct RHCCs how to register themselves and their clinic for PAER, to recruit patients, to utilize environmental histories and PAER resources for patient counseling, and to link PAER results to their patient health records. Online registration and training module components are estimated to take 30 minutes per RHCC.
Each RHCC who participates in PAER will also invite their patients to complete the environmental exposure survey by email or text, link their patients' survey response data with the invitations sent and health records, and provide counseling to individual patients to aid in modifying behavior to lower environmental exposure risks. These components are estimated to take RHCCs 30 minutes per patient.
Of note, ATSDR will not receive any information from the patients' electronic health records. RHCCs will invite their patients to participate outside of the PAER application, and will be responsible for protecting the patient information provided to them within PAER in accordance with the 1996 Health Insurance Portability and Accountability (HIPAA) guidelines.
Based on ACOG estimates, the number of practicing RHCCs in the U.S. is approximately 35,586. On average over the next three years, ATSDR estimates that up to 15 percent (n = 5,338) of these clinicians will participate in the PAER process each year through online registration and training. For purposes of estimation, ATSDR assumes the RHCCs represent the full effort of clinic staff. The
Women who receive preconception or prenatal care (the second type of respondents) may respond to the PAER environmental exposure history by accessing the online PAER survey through the application internet home page or through their RHCC's email/text invitation. ATSDR assumes that 5 percent of these women will participate in PAER over the next three years (or 1.67 percent per year). Using the 3,978,497 births reported in the 2015 U.S. Vital Statistics to represent the number women who receive preconception or prenatal care, 1.67 percent equals to 66,441 women who will take part in the PAER survey each year. Thus, each RHCCH is assumed to interact with 12 such patients per year (66,441/5,338 = 12). The time for women to respond to the survey is estimated at 10 minutes per patient.
Participation in the PAER process and survey is voluntary. There is no cost to respondents other than their time. The total annualized time burden requested is 45,772 hours. A summary of the estimated annualized burden hours is shown in the table that follows.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on an upcoming Surgeon General's document/Call to Action with a working title “
CDC is the lead agency to support the Office of the Surgeon General to publish a Call to Action that will be science-informed and actionable, outlining a conceptual framework with case examples and available evidence on the business case for investing in community health. The goal of the Call to Action is to: Clearly demonstrate that investments in community health have the potential to improve the health and prosperity of communities and issue a call to action to the private sector and local policy makers for investment in communities, unilaterally or as part of multi-sector or other consortium, to improve community health.
Written comments must be received before November 5, 2018.
You may submit comments, identified by Docket No. CDC-2018-0082 by any of the following methods:
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Martin J. Vincent, Office of the Associate Director for Policy, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mail Stop D-28, Atlanta, Georgia 30329. Telephone: 404-639-1455, Email:
Interested persons or organizations are invited to submit written views, recommendations, and data about how investing in communities can improve health and prosperity. Examples may include:
(1) Available data, evidence and/or experience(s) (a) that suggest private sector investments in community health have (directly or indirectly) improved health and prosperity of the workforce and communities; (b) that healthier communities help private sector businesses to be more efficient, profitable, successful, or competitive; (c) description of data systems and evaluation frameworks that might contribute to supporting community health investment decisions, evaluating success and impact; and (d) case studies, examples, reviews and meta-analyses, data linkages, promising and emerging ideas, and best practices;
(2) Types of investments the private sector and local policy makers can consider to improve health and wellness of employees and families, and community well-being and prosperity;
(3) Types of partners or coalitions that have invested in community health and the scope of their collaborations contributions;
(4) Descriptions of important barriers to and facilitators of success;
(5) Private sector and local policy maker rationales for making investments in community health; and
(6) Successful efforts by local policy makers to promote and sustain private sector investments in community health.
Please note that comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Comments will be posted at
America's prosperity is being hampered by preventable chronic diseases and behavioral health issues. Life expectancy at birth dropped in the United States for a second consecutive year in 2016. Preliminary data indicate that age-adjusted death rates continued to rise in 2017, which is likely to mark a third straight year of declining life expectancy. The U.S. lags behind comparable high-income countries on a range of health outcomes including life expectancy despite spending more on health care. About 6 in 10 American adults have at least one chronic health condition, and these people account for 90% of total health care spending. While chronic diseases affect all populations, they are not evenly distributed. Disease rates vary by race, ethnicity, education, geography and income level, with the most disadvantaged Americans often suffering the highest burden of disease.
However, only about 20% of the factors that influence a person's health can be addressed by health care and the remaining 80% reflect socioeconomic, environmental or behavioral factors. Focusing on strategies that address the social and community conditions could improve health, life expectancy, and quality of life, while also reducing related health care costs and productivity losses. Investing in communities to improve the health and well-being of people could also revitalize and improve economic opportunity, enhancing prosperity in the community and for its residents and businesses.
Although there are published literature and several ongoing public, private and philanthropic initiatives examining how investments in community health can enhance well-being and economic prosperity, there has not been a thorough assessment that compiles the evidence and best practices to illustrate benefits for the private sector and local policy makers. The Surgeon General's Call to Action is expected to bridge that gap and inspire more investments by the private sector and local policy makers in community health.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Capacity Building Assistance Program: Assessment and Quality Control. The purpose of this information collection is to assess how well the capacity building assistance (CBA) program meets the needs of health care staff from organizations funded directly or indirectly by the CDC, involved in HIV prevention service delivery. The program will assess customer satisfaction with CBA services and changes in capacity, knowledge, skills, and self-efficacy as a result of CBA service delivery.
CDC must receive written comments on or before November 5, 2018.
You may submit comments, identified by Docket No. CDC-2018-0080 by any of the following methods:
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To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery M. Zirger Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information,
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
5. Assess information collection costs.
Capacity Building Assistance Program: Assessment and Quality Control—Revision—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
The CDC is requesting the Office of Management and Budget (OMB) to grant a one year revision to collect data that comprises the Health Professional Application for Training, Training Follow-up Instrument, and the Technical Assistance Satisfaction Instrument. For this one year revision we will not collect any qualitative data (interviews) since we have gleaned valuable information that has been used to improve our service delivery and processes. The purpose of this information collection is to assess how well the CDC's Capacity Building Assistance (CBA) program meets the needs of its consumers in order to enhance its capacity building strategy over time. The PTCs and CBA providers are funded by CDC/Division of STD Prevention (DSTDP) and Division of HIV/AIDS Prevention (DHAP) over a five-year period to provide capacity building services that includes information, training, and technical assistance. CBA means the provision of free (not for fee) information, training, technical assistance, and technology transfer to individuals, organizations, and communities to improve their capacity in the delivery and effectiveness of evidence-based interventions and core public health strategies for HIV prevention. CBA is provided to support health departments, community-based organizations, and healthcare organizations in the implementation, monitoring and evaluation of evidence-based HIV prevention interventions and programs; building organizational infrastructure; and community mobilization to decrease stigma and increase HIV testing in high risk communities. CBA services are requested by health departments, community-based organizations, and healthcare organizations and also offered proactively. Under this project, there will be no duplication of information collection, because it builds on existing, OMB approved data collection activities. The PTCs and CBA providers offer classroom and experiential training, web-based training, clinical consultation, and capacity building assistance to maintain and enhance the capacity of healthcare professionals to control and prevent STDs and HIV. The CBA service recipients are healthcare professionals who work at community-based organizations (CBOs), health departments, and healthcare organizations, most of whom are funded directly or indirectly by the CDC, involved in HIV prevention service delivery. Their positions include HIV educator, clinical supervisor, HIV prevention specialist, clinician, outreach worker, case manager director, program coordinator, program manager, disease intervention specialist, partner services provider, physicians, nurses, and health educators, etc. CDC is requesting to use two web-based assessments that will be administered to recipients of CBA services: (1) Training Follow-Up Instrument and (2) Technical Assistance Satisfaction Instrument. The first quantitative assessment will be disseminated 90 days after a training event to agency staff who participated in a training activity. It takes approximately 12 minutes to complete. The purpose of this web-based assessment is to determine the training participants' satisfaction with the trainers, training materials, and the course pace, benefits from the training, and CBA needs, how relevant the training was to their work, and whether they were able to utilize the information gained from the training. The second quantitative assessment will be disseminated 45 days after a technical assistance event to agency staff who participated in a technical assistance. This instrument takes approximately 12 minutes to complete. The purpose of the second assessment is to assess participants' satisfaction with the technical assistance they received, intended or actual use of enhanced capacity, barriers and facilitators to use, and benefits of the technical assistance. The 7,400 respondents represent an average of the number of health professionals who receive training and technical assistance from the CBA and PTC grantees during the years 2010 and 2011. The data collection is necessary (a) to assess CBA consumers' (community-based organizations, health departments, and healthcare organizations) satisfaction with and short-term outcomes from the overall CBA program as well as specific elements of the CBA program; (b) to improve CBA services and enhance the Capacity Building Branch's national capacity building strategy over time; (c) to assess the performance of the grantees in delivering training and technical assistance and to standardize the registration processes across the two CBA programs (
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled “
CDC must receive written comments on or before November 5, 2018.
You may submit comments, identified by Docket No. CDC-2018-0081 by any of the following methods:
•
•
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
5. Assess information collection costs.
Assessment of Outcomes Associated with the Preventive Health and Health Services Block Grant—New—Office for State, Tribal, Local and Territorial Support (OSTLTS), Centers for Disease Control and Prevention (CDC).
For more than 35 years, the Preventive Health and Health Services Block Grant (PHHS Block Grant) has provided flexible funding for all 50 states, the District of Columbia, two American Indian tribes, five U.S. territories, and three freely associated states to address the unique public health needs of their jurisdictions in innovative and locally defined ways. First authorized by Congress in 1981 through the Public Health Service Act (Pub. L. 102-531), the fundamental and enduring purpose of the grant has been to provide grantees with flexibility and control to address their priority public health needs. In 1992, Congress amended the law to align PHHS Block Grant funding priorities with the 22 chapters specified in Healthy People (HP) 2000, a set of national objectives designed to guide health promotion and disease prevention efforts. Additional amendments included set-aside funds specifically dedicated to sex offense prevention and victim services, thus requiring grantees receiving this support to include related HP objectives and activities as part of their PHHS Block Grant-funded local programs.
CDC is establishing a comprehensive, standardized method to collect data to describe select outputs and outcomes and ensure the accountability of the PHHS Block Grant. The CDC PHHS Block Grant Measurement Framework is an innovative approach to assessing cross-cutting outputs and outcomes resulting from grantees' use of flexible grant funds. The framework defines four measures that enable CDC to standardize the collection of data on grantee achievements. The measures capture data on public health infrastructure improved (
The purpose of this information collection request (ICR) is to collect data that assess select cross-cutting outputs and outcomes of the grant (as defined by the framework measures) and that demonstrate the utility of the grant on a national level. This data collection will describe the outcomes of the PHHS Block Grant as a whole—not individual grantee activities or outcomes. Findings from this data collection will be used to: (1) Describe the outcomes and achievements of grantees' public health efforts and identify how the use of PHHS Block Grant funds contributed to
The respondent universe consists of 61 PHHS Block Grant coordinators, or their designees, across 61 health departments (50 states, the District of Columbia, two tribes, five US territories, and three freely associated states). The assessment will be administered to PHHS Block Grant coordinators electronically via a web-based questionnaire. A link to the assessment will be provided by email invitation. The survey will be completed once every two years. The total annualized estimated burden is 46 hours.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” This guidance document describes FDA's current approach to considering uncertainty in making benefit-risk determinations to support certain FDA premarket decisions for medical devices—premarket approval applications (PMAs), De Novo requests, and humanitarian device exemption (HDE) applications. This guidance document elaborates on the consideration of uncertainty as part of our overarching approach to a benefit-risk based framework that is intended to assure greater predictability, consistency, and efficiency through the application of least burdensome principles. This draft guidance also provides examples of how the principles for considering uncertainty could be applied in the context of clinical evidence and circumstances where greater uncertainty could be appropriate in premarket decisions, balanced by postmarket controls—PMAs for Breakthrough Devices and PMAs for devices for small patient populations. This draft guidance is not final nor is it in effect at this time.
Submit either electronic or written comments on the draft guidance by December 5, 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the
Sonja Fulmer, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5451, Silver Spring, MD 20993-0002, 240-402-5979.
The Medical Device Amendments of 1976 (Pub. L. 94-295) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) established a risk-based framework for the regulation of medical devices. The law established a three-tiered risk classification system based on the risk posed to patients should the device fail to perform as intended. Under this system, devices that pose greater risks to patients are subject to more regulatory controls and requirements. Generally, in premarket decision-making for devices, there exists some uncertainty around benefits and risks. The Agency generally provides marketing authorization for a device when it meets the applicable standards, including that its benefits outweigh its risks.
In 2015, following pilots conducted over 4 years, FDA established the Expedited Access Pathway Program as a voluntary program for certain medical devices that address an unmet need in the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Under this program, an eligible device subject to a PMA could be approved with greater uncertainty about the product's benefits and risks, provided that, among other requirements, the data still support a reasonable assurance of safety and effectiveness, including that the probable benefits of the device outweigh its risks for a patient population with unmet medical needs. For devices subject to PMA, the Agency has the authority to impose, when warranted, postmarket requirements, including post-approval studies and postmarket surveillance, as a condition of approval, which could be used to address this greater uncertainty.
This draft guidance provides further information on how FDA considers uncertainty in benefit-risk determinations for PMAs, De Novo requests, and HDE applications.
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 consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, De Novo classifications, and humanitarian device exemptions. 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.
Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
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 21 CFR part 801 have been approved under OMB control number 0910-0485; the collections of information for De Novo classification requests have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H, have been approved under OMB control number 0910-0332; and the collections of information in 21 CFR
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective with this notice.
FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Nominations received on or before November 5, 2018 will be given first consideration for membership on TEPRSSC. Nominations received after November 5, 2018 will be considered for nomination to the committee as later vacancies occur.
All nominations for membership should be sent electronically by accessing FDA's Advisory Committee Membership Nomination Portal at
Patricio G. Garcia, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993-0002, 301-796-6875, email:
FDA is requesting nominations for voting members on TEPRSSC that include three general public representatives.
The committee provides advice and consultation to the Commissioner of Food and Drugs (Commissioner) on the technical feasibility, reasonableness, and practicability of performance standards for electronic products to control the emission of radiation from such products, and may recommend electronic product radiation safety standards to the Commissioner for consideration.
The committee consists of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of science or engineering, applicable to electronic product radiation safety. Members will be invited to serve for overlapping terms of up to 4 years. Terms of more than 2 years are contingent upon the renewal of the committee by appropriate action prior to its expiration.
Any interested person may nominate one or more qualified individuals for membership on the committee. Self-nominations are also accepted. Nominations must include a current, complete résumé or curriculum vitae for each nominee, including current business address and/or home address, telephone number, and email address if available, and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Food and Drug Administration, HHS.
Notification; extension of comment period.
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notices of availability for six draft guidance documents relating to the development of human gene therapy products that appeared in the
FDA is extending the comment period on the six documents that published on July 12, 2018 (see
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 December 10, 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
Jenifer Stach, 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
The Agency has received requests for a 60-day extension of the comment period for the six draft guidance documents. These requests conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the draft guidance documents.
FDA has considered these requests and is extending the comment period for the six draft guidance documents for 60 days, until December 10, 2018. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments.
The following references are on display in the Dockets Management Staff (see
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 November 5, 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 November 5, 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, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
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.
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding, among other things, a chapter granting FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.
The FD&C Act, as amended by the Tobacco Control Act, requires that before a new tobacco product may be introduced or delivered for introduction into interstate commerce, the new tobacco product must undergo premarket review by FDA. FDA must issue an order authorizing the commercial distribution of the new tobacco product or find the product exempt from the requirements of substantial equivalence under section 910(a)(2)(A) of the FD&C Act, before the product may be introduced into commercial distribution (section 910 of the FD&C Act (21 U.S.C. 387j)).
FDA has issued a guidance document containing recommendations for preparing substantial equivalence reports (SE Reports) under section 905(j)(1)(A)(i). A tobacco product manufacturer must show that a new tobacco product is substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that it is in compliance with the requirements of the FD&C Act. The comparison product chosen by the tobacco product manufacturer is referred to by FDA as the predicate tobacco product.
The guidance document associated with this collection of information contains recommendations on preparing reports intended to demonstrate substantial equivalence to a predicate tobacco product and compliance with the FD&C Act as required under section 905(j)(1)(A)(i). Submission of a section 905(j)(1)(A)(i) report intended to demonstrate substantial equivalence and, in response, an order from the Agency finding that the new tobacco product is substantially equivalent to a predicate tobacco product and in compliance with the requirements of the FD& C Act, is one means for a new tobacco product to legally enter the market. FDA's guidance entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” (December 2016). This guidance may be accessed at
The Tobacco Control Act also gave FDA the authority to issue a regulation deeming all other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the FD&C Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10, 2016, FDA issued that rule, extending FDA's tobacco product authority to all products that meet the definition of tobacco product in the law (except for accessories of newly regulated tobacco products), including electronic nicotine delivery systems, cigars, hookah, pipe tobacco, nicotine gels, dissolvables that were not already subject to the FD&C Act, and other tobacco products that may be developed in the future (81 FR 28974 at 28976) (“the Deeming final rule”).
FDA estimates the burden of this collection of information as follows:
FDA's estimates are based on experience with SE Reports, initial updated deemed registration and listing data, interactions with the industry, and information related to other regulated products. The estimated number of SE Reports is expected to increase from an annual average of 979 to 1,570.
When groups of full or product quantity change SE Reports have identical content, they may be bundled; when a group of similar reports are bundled, the subsequent bundled reports are expected to take less time to prepare than the initial report.
FDA has based these estimates on information it now has available from interactions with the industry, information related to other regulated products, and FDA expectations regarding the tobacco industry's use of the section 905(j) pathway to market their products. Table 1 describes the annual reporting burden as a result of the implementation of the substantial equivalence requirements of sections 905(j)(1)(A)(i) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)) for an SE application.
FDA estimates that 683 respondents will prepare and submit 683 section 905(j)(1)(A)(i) SE Reports each year. In addition, anyone submitting an SE Report is required to submit an environmental assessment (EA) under 21 CFR 25.40. The burden for environmental reports has been included in the burden per response for each type of SE report. Based on FDA's experience with EAs for currently regulated tobacco products, we expect industry to spend 80 hours to prepare an environmental assessment for a SE Report. Thus, FDA estimates that it will take a manufacturer approximately 300 hours per report to prepare an SE Report and the EA for a new tobacco product, which is a total of 204,900 hours.
In addition, we estimate receiving 456 Full SE Bundled Reports at 90 hours per submission for a total of 41,040 hours.
FDA estimates that it will receive 239 Product Quantity Change SE Reports and that it will take a manufacturer approximately 87 hours to prepare this report for a total of 20,793 hours. This includes time to prepare the environmental assessment, which FDA believes will take less time due to the typically more limited modification(s) included in a Product Quantity Change SE Report. We estimate receiving 192 Product Quantity Change Bundled SE Reports at approximately 62 hours per submission for a total of 11,904 hours, this number excludes the time for the initial SE Report which was previously account for.
Therefore, FDA estimates the burden for submission of SE information will be 278,637 hours. This is an increase of 106,759 hours from the currently approved burden. We attribute this increase to an increase in the number of SE Reports we expect related to Deemed products (
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC or Committee) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice.
Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by October 9, 2018 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by October 9, 2018.
All statements of interest from industry organizations interested in participating in the selection process of nonvoting industry representative nomination should be sent to Margaret Ames (see
Margaret Ames, Division of Workforce Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, email:
The Agency is requesting nominations for nonvoting industry representatives to the panels listed in the table in this document.
The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. The panels engage in a number of activities to fulfill the functions the Federal Food, Drug, and Cosmetic Act (FD&C Act) envisions for device advisory panels. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises the Commissioner of Food and Drugs (the Commissioner) regarding recommended classification or reclassification of devices into one of three regulatory categories; advises on any possible risks to health associated with the use of devices; advises on formulation of product development protocols; reviews premarket approval applications for medical devices; reviews guidelines and guidance documents; recommends exemption of certain devices from the application of portions of the FD&C Act; advises on the necessity to ban a device; and responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Committee also provides recommendations to the Commissioner or designee on complexity categorization of in vitro diagnostics under the Clinical Laboratory Improvement Amendments of 1988.
Persons nominated for the device panels should be full-time employees of firms that manufacture products that would come before the panel, or consulting firms that represent manufacturers, or have similar appropriate ties to industry.
Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see
Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Nomination must include a current, complete résumé or curriculum vitae for each nominee including current business address and telephone number, email address if available, and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Committee Membership Nomination Portal (see
FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
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 November 5, 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 November 5, 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.”
•
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
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.
This information collection supports the previously captioned Agency guidance and associated Form FDA 3911. The Drug Supply Chain Security Act (DSCSA) (Title II of Pub. L. 113-54) added new section 582(h)(2) to the Federal Food, Drug, and Cosmetic Act (FD&C Act), requiring FDA to issue guidance to aid trading partners in identifying a suspect product and
Beginning January 1, 2015, section 582 of the FD&C Act requires certain trading partners, upon determining that a product in their possession or control is a suspect product, to quarantine the product while they promptly conduct an investigation to determine whether the product is an illegitimate product.
Under section 202 of the DSCSA, manufacturers, repackagers, wholesale distributors, and dispensers (
Under section 582(b)(4)(B)(ii)(I), (c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii) of the FD&C Act, as amended by the DSCSA, and beginning not later than January 1, 2015, a manufacturer, repackager, wholesale distributor, or dispenser who determines that a product in its possession or control is illegitimate must notify FDA of that determination not later than 24 hours after the determination is made. In addition, section 582(b)(4)(B)(ii)(II) of the FD&C Act requires manufacturers to notify FDA when a manufacturer determines that a product poses a high risk of illegitimacy.
We originally estimated that all manufacturers, repackagers, wholesale distributors, and dispensers would collectively submit 5,000 notifications per year. This estimate included the notifications by trading partners that have determined that illegitimate product is in their possession or control, as well as notifications by manufacturers that have determined a product poses a high risk of illegitimacy. As discussed in our
We are also combining the estimates for manufacturers and repackagers because FDA's establishment and drug product listing database indicates that many companies perform activities of both manufacturers and repackagers. Although the DSCSA specifically defines dispensers, for estimation purposes, we are using estimates for pharmacies in general terms based on those that must comply with the new requirements under section 582(d) of the FD&C Act.
Because manufacturers, repackagers, and wholesale distributors are collectively responsible for prescription drugs from the point of manufacturing through distribution in the drug supply chain, we assume that most notifications of illegitimate products are submitted by these three trading partners. The total number of respondents is comprised of 80 percent manufacturers (120), 15 percent wholesale distributors (22), and 5 percent pharmacies (8).
We estimate that the number of annual notifications will vary from 0 to 2 for manufacturers/repackagers, as well as from pharmacies, with the vast majority of companies making no notifications. Although FDA's establishment and drug product listing database currently contains registrations for approximately 6,500 manufacturers and repackagers, we estimate that approximately 120 manufacturers/repackagers will notify us of illegitimate products an average of one time per year. Although we estimate approximately 69,000 pharmacy sites in the United States, based on data from the National Association of Chain Drug Stores, the National Community Pharmacists Association, and the American Hospital Association, we estimate that approximately 8 pharmacies will notify FDA of illegitimate product an average of one time per year. According to the Healthcare Distribution Alliance (formerly known as Healthcare Distribution Management Association), approximately 30 wholesale distributors are responsible for over 90 percent of drug distributions; based on sales and because FDA is estimating that over 2,200 small wholesale distributors might be responsible for the remaining 10 percent of drug sales, we estimate that wholesale distributors will be responsible for making about an average of 1 notification per year to account for the estimated 22 notifications that FDA will receive regarding illegitimate product. Each notification should include information about the person or entity initiating the notification, the product determined to be illegitimate or having a high risk of illegitimacy, and a description of the circumstances surrounding the event that prompted
Under section 582(b)(4)(B)(ii)(I), (c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii) of the FD&C Act, a trading partner who determines that a product in its possession is illegitimate must also notify all immediate trading partners that they believe may have received such illegitimate product not later than 24 hours after the determination is made. In addition, under section 582(b)(4)(B)(ii)(II) of the FD&C Act, a manufacturer is required to notify all immediate trading partners that the manufacturer believes may possess a product manufactured by or purported to be manufactured by the manufacturer not later than 24 hours after the determination is made or being notified by FDA or a trading partner that the product has a high risk of illegitimacy.
Because the extent of distribution of any illegitimate product is likely to vary from one situation to another, we assume a wide distribution of each illegitimate product. We estimate that, for each notification made by a manufacturer or repackager to FDA, approximately 30 trading partners (based on the number of distributors) will also be notified. This results in approximately 3,600 notifications annually to trading partners of manufacturers/repackagers. This estimate includes the notifications by manufacturers and repackagers who have determined that illegitimate product is in their possession or control, as well as notifications by manufacturers that have determined that a product poses a high risk of illegitimacy.
We estimate that a large wholesale distributor may have up to 4,500 trading partners, but a small wholesale distributor may have 200 trading partners, for an average of approximately 2,350. We originally estimated that a wholesale distributor would notify all 2,350 trading partners for each of the illegitimate products identified. However, we are lowering our estimate as a result of our experience with the collection and informal feedback from industry to reflect that 22 respondents will make 1,175 disclosures for a total of 25,850 disclosures annually; and that each disclosure will require approximately 12 minutes, for a total of 5,170 hours annually.
We estimate that a pharmacy purchases prescription drugs from an average of two wholesale distributors. Therefore, a pharmacy would notify 2 trading partners for each of the 8 illegitimate products identified, resulting in approximately 16 notifications annually to pharmacy trading partners.
Manufacturers/repackagers, wholesale distributors, and pharmacies may notify their trading partners using existing systems and processes used for similar types of communications. Such communications may include, but are not limited to, posting notifications on a company website, sending an email, telephoning, or mailing or faxing a letter or notification. The information contained in the notification to the immediate trading partner should be the same as or based on the notification that was already submitted to FDA. We estimate that, for all trading partners, each notification of immediate trading partners will take approximately 0.2 hours (12 minutes). The estimated total burden hours that manufacturers/repackagers, wholesale distributors, and pharmacies will take to notify trading partners is approximately 5,893 hours annually, as reflected in table 2.
Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and (e)(4)(B)(iv) of the FD&C Act requires that a trading partner who determines, in consultation with FDA, that a notification made under section 582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), or (e)(4)(B)(ii) is no longer necessary must terminate the notification. The guidance for industry sets forth the process by which trading partners should consult with FDA to terminate notifications that are no longer necessary.
Each request for termination of notification must include information about the person or entity initiating the request for termination, the illegitimate product or product with a high risk of illegitimacy, the notification that was issued, and an explanation about what actions have taken place or what information has become available that make the notification no longer necessary. Trading partners should also include the FDA-assigned incident number associated with the initial notification on the request for termination. The request for a termination will be viewed as a request for consultation with FDA. We estimate that the same amount of time will be required to provide the information necessary to request termination as is required to make the notification. The time required to investigate and resolve an illegitimate product notification will vary, but we assume that each notification will eventually be terminated. We assume that the number of requests for termination of a notification per year will be the same as the original number of notifications for a given year. The estimated total burden hours of making requests for termination of notifications to FDA is 150 hours annually, as reflected in table 3.
Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and (e)(4)(B)(iv) of the FD&C Act requires that a trading partner who, in consultation with FDA, terminates a notification made under section 582(b)(4)(B)(ii)(I) or (II), (c)(4)(B)(ii), (d)(4)(B)(ii), or (e)(4)(B)(ii) must also promptly inform previously-notified immediate trading partners that the notification has been terminated. We estimate that the burden for notifying trading partners of an illegitimate product and the number of trading partners notified will be the same as the estimates for notification of termination. The estimated total burden hours of notifying trading partners that the notification is terminated is approximately 5,893 hours annually, as reflected in table 4.
FDA estimates the burden of this collection of information as follows:
Cumulatively, the total estimated burden is 12,086 annual hours, which reflects a significant decrease. We base this adjustment on our experience with the information collection since its establishment and implementation.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective with this notice.
FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Nominations received on or before November 5, 2018, will be given first consideration for membership on the National Mammography Quality
All nominations for membership should be submitted electronically by logging into the FDA Advisory Nomination Portal:
FDA is requesting nominations for voting members to fill upcoming vacancies on the National Mammography Quality Assurance Advisory Committee.
The National Mammography Quality Assurance Advisory Committee advises the Commissioner of Food and Drugs (the Commissioner) or designee on: (1) Developing appropriate quality standards and regulations for mammography facilities; (2) developing appropriate standards and regulations for bodies accrediting mammography facilities under this program; (3) developing regulations with respect to sanctions; (4) developing procedures for monitoring compliance with standards; (5) establishing a mechanism to investigate consumer complaints; (6) reporting new developments concerning breast imaging that should be considered in the oversight of mammography facilities; (7) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; (8) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (9) determining the costs and benefits of compliance with these requirements.
The committee consists of a core of 15 members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among physicians, practitioners, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years.
Any interested person may nominate one or more qualified persons for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete résumé or curriculum vitae for each nominee, including current business address, telephone number, and email address if available and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Allergic Rhinitis: Developing Drug Products for Treatment.” The purpose of this guidance is to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults. The guidance addresses issues of trial design, effectiveness, and safety for new products being developed for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). This guidance incorporates the comments received for and finalizes the draft guidance of the same name issued on February 16, 2016.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances 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
• 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 this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Stacy Chin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm., 3340, Silver Spring, MD 20993-0002, 240-402-5005.
FDA is announcing the availability of a guidance for industry entitled “Allergic Rhinitis: Developing Drug Products for Treatment.” The purpose of this guidance is to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults. The guidance addresses issues of trial design, effectiveness, and safety for new products being developed for the treatment of SAR and PAR. This guidance finalizes the draft guidance of the same name issued on February 16, 2016. All the public comments received on the draft guidance have been considered and the guidance has been revised as appropriate along with a few editorial changes.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Allergic Rhinitis: Developing Drug Products for Treatment. 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 guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.
Persons with access to the internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Nonallergic Rhinitis: Developing Drug Products for Treatment.” The purpose of this guidance is to assist applicants of new drug applications and biologics license applications in developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults. This guidance incorporates the comments received and finalizes the draft guidance of the same name issued on February 16, 2016.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances 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 this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Stacy Chin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3340, Silver Spring, MD 20993, 240-402-5005.
FDA is announcing the availability of a guidance for industry entitled “Nonallergic Rhinitis: Developing Drug Products for Treatment.” The purpose of this guidance is to assist applicants of new drug applications and biologics license applications in developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults. This guidance incorporates the comments received and finalizes the draft guidance of the same name issued on February 16, 2016 (81 FR 7811). All the public comments received on the draft guidance have been considered and the guidance has been revised primarily to update references and to clarify.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on developing drug products for treatment of nonallergic rhinitis. 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 guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.
Persons with access to the internet may obtain the guidance at either
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 Microbiology, Infectious Diseases and AIDS Initial Review Group Microbiology and Infectious Diseases B Subcommittee.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, NIEHS.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Environmental Health Sciences, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of 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.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0069, Ballast Water Management Reporting and Recordkeeping; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before November 5, 2018.
You may submit comments identified by Coast Guard docket number [USCG-2018-0789] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2018-0789], and must be received by November 5, 2018.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0035, Title 46 CFR Subchapter Q: Lifesaving, Electrical, Engineering and Navigation Equipment, Construction and Materials & Marine Sanitation Devices (33 CFR part 159); without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before November 5, 2018.
You may submit comments identified by Coast Guard docket number [USCG-2018-0792] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the internet at
Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2018-0792], and must be received by November 5, 2018.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Federal Emergency Management Agency, DHS.
Notice and request for comments.
The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (
Comments must be submitted on or before October 9, 2018.
Submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the Desk Officer for the Department of Homeland Security, Federal Emergency Management Agency, and sent via electronic mail to
Requests for additional information or copies of the information collection should be made to Director, Information Management Division, 500 C Street SW, Washington, DC 20472, email address
This proposed information collection previously published in the
Comments may be submitted as indicated in the
Federal Emergency Management Agency, DHS.
Notice.
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths,
Each LOMR was finalized as in the table below.
Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.
The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).
This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.
This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP and are used to calculate the appropriate flood insurance premium rates for new buildings, and for the contents in those buildings. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.
Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents.
Each LOMR was finalized as in the table below.
Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been
The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.
The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).
This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.
This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP and are used to calculate the appropriate flood insurance premium rates for new buildings, and for the contents in those buildings. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.
Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at
Fish and Wildlife Service, Interior.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the U.S. Fish and Wildlife Service announces a public meeting of the International Wildlife Conservation Council, which provides advice and recommendations to the Secretary of the Interior regarding the benefits that result from U.S. citizens traveling to foreign nations to engage in hunting.
September 26, 2018 from 1 p.m. to 5 p.m. (Eastern Time) and September 27, 2018 from 8:30 a.m. to 5:30 p.m. (Eastern Time). For deadlines and directions on registering to attend, submitting written material, and giving an oral presentation, please see Public Input under
The meeting will be held at the U.S. Fish and Wildlife Service's Headquarters Building, 5275 Leesburg Pike, Falls Church, VA 22041-3803.
Cade London, Policy Advisor, by email (preferred) at
In accordance with the Federal Advisory Committee Act (5 U.S.C. Appendix 2), we, the U.S. Fish and Wildlife Service, announce a public meeting of the International Wildlife Conservation Council (council). The council provides advice and recommendations to the Secretary of the Interior regarding the benefits that result from U.S. citizens traveling to foreign nations to engage in hunting.
Formed in December 2017, the council is an advisory body whose duties include, but are not limited to:
(a) Developing a plan for public engagement and education on the benefits of international hunting.
(b) Reviewing and making recommendations for changes, when needed, on all Federal programs and/or regulations, to ensure support of hunting as:
1. An enhancement to foreign wildlife conservation and survival, and
2. An effective tool to combat illegal trafficking and poaching.
(c) Recommending strategies to benefit the U.S. Fish and Wildlife Service's permit office in receiving timely country data and information so as to remove barriers that impact consulting with range states.
(d) Recommending removal of barriers to the importation into the United States of legally hunted wildlife.
(e) Ongoing review of import suspension/bans and providing recommendations that seek to resume the legal trade of those items, where appropriate.
(f) Reviewing seizure and forfeiture actions/practices, and providing recommendations for regulations that will lead to a reduction of unwarranted actions.
(g) Reviewing the Endangered Species Act's foreign listed species and interaction with the Convention on International Trade in Endangered Species of Wild Flora and Fauna, with the goal of eliminating regulatory duplications.
(h) Recommending methods for streamlining/expediting processing of import permits.
The council will convene to hear and discuss the following:
1. Presentations made by conservation and sport hunting experts and government officials,
2. Administrative topics, and
3. Public comment and response.
The final agenda will be posted on the internet at
If you plan to attend this meeting, you must register by close of business on the date listed in Public Input. Please submit your name, time of arrival, email address, and phone number to the Policy Advisor for International Affairs (see
Members of the public requesting reasonable accommodations, such as hearing interpreters, may contact Mr. London in writing (preferably by email), or via the Federal Relay Service at 1-800-877-8339 no later than September 19, 2018.
Interested members of the public may submit relevant information for the council to consider during the public meeting. Written statements must be received by the date in the table above so that the information may be made available to the council for consideration prior to the meeting. Submit written statements in the following formats: one hard copy with original signature, and/or one electronic copy via email (acceptable file formats are Adobe Acrobat PDF, MS Word, MS PowerPoint, or rich text file).
Requests to address the council during the public comment period will be accommodated in the order the requests are received. Interested parties must contact the Policy Advisor for International Affairs in writing (preferably via email; see
Written comments we receive become part of the administrative record associated with this action. 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 request in your comment that we withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.
Detailed minutes of the meeting will be available for public inspection within 90 days of the meeting. They will be posted on the internet at
5 U.S.C. Appendix 2.
Bureau of Land Management, Interior.
Notice of coal lease sale.
Notice is hereby given that coal resources in lands in Oliver County, North Dakota, will be offered for competitive lease by sealed bid in accordance with the provisions of the Mineral Leasing Act of 1920, as amended.
The lease sale will be held at 11 a.m. Mountain Time on October 10, 2018. Sealed bids must be submitted on or before 10 a.m., October 10, 2018.
The lease sale will be held in the 920 Conference Room of the Bureau of Land Management (BLM) Montana State Office, 5001 Southgate Drive, Billings, Montana 59101-4669. Sealed bids must be submitted to the Cashier, BLM Montana State Office, at this same address.
Gregory Fesko by telephone at 406-896-5080 or by email at
This sale is being held in response to a Lease-by- Application (LBA) filed by BNI Coal, Ltd. (BNI). The Federal coal resources to be offered are located in the following-described lands:
The 160-acre tract, located in Oliver County, North Dakota, contains an estimated 2.4 million tons of surface mineable Federal coal resources. The tract contains one mineable coal bed, the Hagel A bed. The Hagel A bed averages approximately 9.0 feet in thickness with an average overburden thickness of 43 feet. The coal quality for the Hagel A bed averages 6,729 BTUs per pound in heating value, 39.31 percent moisture, 5.74 percent ash, 0.76 percent sulfur, and 6.23 percent sodium-in-ash content.
The tract will be leased to the qualified bidder of the highest cash amount, provided that the high bid meets or exceeds the BLM's estimate of the fair-market value of the tract. The minimum bid for the tract is $100 per acre or fraction thereof. The minimum bid is not intended to represent fair-market value. The fair-market value will be determined by the authorized officer after the sale.
The sealed bids should be sent by certified mail, return receipt requested, or be hand delivered to the Cashier, BLM Montana State Office, at the address provided in the
A lease issued as a result of this offering will require payment of an annual rental of $3 per acre, or fraction thereof, and a royalty payable to the United States of 12.5 percent of the value of coal mined by surface methods. Bidding instructions for the tract offered and the terms and conditions of the proposed coal lease are included in the Detailed Statement of Lease Sale. Copies of the statement and the proposed coal lease are available at the Montana State Office. Casefile NDM 102083 is also available for public inspection at the Montana State Office.
43 CFR 3422.3-2
Bureau of Land Management, Interior.
Notice of advisory board meeting.
In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Wild Horse and Burro Advisory Board (Advisory Board) will meet as indicated below.
The Advisory Board will hold a public meeting Tuesday through Thursday, October 9-11, 2018; from 7 a.m. to 5 p.m. on Tuesday; and from 8 a.m. to 5 p.m. on Wednesday and Thursday. A public comment period will be held on Thursday, October 11, 2018, from 2 p.m. to 4:30 p.m. All times are in Mountain Daylight Time (MDT).
The Advisory Board will meet at the Courtyard Marriott Salt Lake City Downtown, 345 West 100 South, Salt Lake City, UT 84101; hotel website:
Written comments and statements must be mailed to the U.S. Department of the Interior, Bureau of Land Management, National Wild Horse and Burro Program, Attention: Dorothea Boothe WO-260, 20 M Street SE, Room 2134LM, Washington, DC 20003, or emailed to:
Dorothea Boothe, Wild Horse and Burro Program Coordinator, at 202-912-7654, or by email at
The Advisory Board advises the Secretary of the Interior, through the BLM Director, and the Secretary of Agriculture, through the Chief of the U.S. Forest Service, on matters pertaining to the management and protection of wild, free-roaming horses and burros on the Nation's public lands. The Advisory Board operates under the authority of 43 CFR part 1780, subpart 1784. The tentative agenda for the meeting is:
(The field tour is open to limited public attendance with advanced sign-up on a first-come, first-served basis. Attendees must provide for their own transportation (high-clearance vehicle recommended) and personal needs. Field tour attendees will depart from the Courtyard Marriott at 7:00 a.m. To sign up, contact Dorothea Boothe by email at
The detailed final agenda will be posted 48 hours in advance of the meeting at
The meeting will be live-streamed at
On Thursday, October 11, 2018, members of the public will have the opportunity to make comments to the Board on the Wild Horse and Burro Program. Persons wishing to make comments during the public comment period should register in person with the BLM by 2:00 p.m. (MDT) on October 11, 2018, at the meeting location. Depending on the number of commenters, the Advisory Board may limit the length of comments. At previous meetings, comments have been limited to 2 minutes in length; however, this time may vary. Speakers are requested to submit a written copy of their statement to the address listed in the
Participation in the Advisory Board meeting is not required to submit written comments. The BLM invites written comments from all interested parties. Your written comments should be specific and explain the reason for any recommendation. The BLM considers comments that are either supported by quantitative information or studies or those that include citations to and analysis of applicable laws and regulations to be the most useful and likely to influence the BLM's decisions
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 in your comment that the BLM withhold your personal identifying information from public review, the BLM cannot guarantee that it will be able to do so.
National Park Service, Interior.
Meeting notice.
In accordance with the Federal Advisory Committee Act of 1972, the National Park Service is hereby giving notice that the Cedar Creek and Belle Grove National Historical Park Advisory Commission (Commission) will meet as indicated below.
The meeting will be held on Thursday, September 20, 2018, from 9:00 a.m. to 11:00 a.m. (Eastern).
The meeting will be held at the Strasburg Town Hall Council Chambers, 174 East King Street, Strasburg, VA 22657.
Further information concerning the meeting may be obtained from Karen Beck-Herzog, Site Manager, Cedar Creek and Belle Grove National Historical Park, P.O. Box 700, Middletown, Virginia 22645, telephone (540) 868-9176, or visit the park website:
The Commission was designated by Congress to provide advice to the Secretary of the Interior on the preparation and implementation of the park's general management plan and to advise on land protection (16 U.S.C. 410iii-7). Individuals who are interested in the park, the implantation of the plan, or the business of the Commission are encouraged to attend the meeting. Interested members of the public may present, either orally or through written comments, information for the Commission to consider during the public meeting. Attendees and those wishing to provide comment are strongly encouraged to preregister through the contact information provided. A detailed final agenda will be posted 48 hours in advance of the meeting on the Commission's website at
5 U.S.C. Appendix 2.
United States International Trade Commission.
Notice.
August 29, 2018.
Celia Feldpausch (202-205-2387), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
Effective January 23, 2018, the Commission established a general schedule for the conduct of the final phase of its investigations on stainless steel flanges from China and India,
This supplemental schedule is as follows: The deadline for filing supplemental party comments on Commerce's final determinations is September 4, 2018. Supplemental party comments may address only Commerce's final determinations regarding imports of stainless steel flanges from India. These supplemental final comments may not contain new factual information and may not exceed five (5) pages in length. The supplemental staff report in the final phase of these investigations regarding subject imports from India will be placed in the nonpublic record on September 7, 2018; and a public version will be issued thereafter.
For further information concerning these investigations see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of the final phase of antidumping and countervailing duty investigation Nos. 701-TA-593-596 and 731-TA-1401-1406 (Final) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether 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 (LDWP) from Canada, China, Greece, India, Korea, and Turkey, provided under subheadings 7305.11.1030, 7305.11.1060, 7305.11.5000, 7305.12.1030, 7305.12.1060, 7305.12.5000, 7305.19.1030, 7305.19.1060, 7305.19.5000, 7305.31.4000, 7305.31. 6010, 7305.31.6090, 7305.39.1000, and 7305.39.5000 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce (“Commerce”) to be subsidized and/or sold at less-than-fair-value.
August 27, 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 this phase of the investigations, hearing procedures, 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 C (19 CFR part 207).
Additional written submissions to the Commission, including requests pursuant to § 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with §§ 201.16(c) and 207.3 of the Commission's 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 § 207.21 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 received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Autel Robotics USA LLC on August 30, 2018. The complaint alleges violations of section 337 of the Tariff Act of 1930 (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 unmanned aerial vehicles and components thereof. The complaint names as respondents: SZ DJI Technology Co., Ltd. of China; DJI Europe B. V. of the Netherlands; DJI Technology Inc. of Burbank, CA; iFlight Technology Co., Ltd. of Hong Kong; DJI Baiwang Technology Co. Ltd of China; DJI Research LLC of Palo Alto, CA; DJI service LLC of Cerritos, CA; and DJI Creative Studio LLC of Burbank, CA. The complainant requests that the Commission issue a limited exclusion order and a cease and desist order and
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) Identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) Identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) Indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) Explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3335) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
United States International Trade Commission.
Institution of investigation and scheduling of public hearing.
Following receipt of a request from the U.S. Trade Representative (USTR) on August 3, 2018, under section 332(g) of the Tariff Act of 1930, the U.S. International Trade Commission has instituted investigation No. 332-569,
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 record for this investigation may be viewed on the Commission's electronic docket (EDIS) at
Project Leader Mahnaz Khan (202-205-
In addition, USTR asked that the Commission base its report on available information, including information furnished by SMEs and interested parties following the Commission's notice of investigation. The USTR said that the Commission, to the extent applicable, should provide qualitative distinctions among the identified trade-related barriers. Additionally, the letter said that the report may include suggestions gathered from SMEs or the relevant literature for actions that would help address some of the identified barriers and enhance the participation of U.S. SMEs in U.S.-UK trade. As requested, the Commission expects to transmit its report to the USTR by July 31, 2019.
In his request letter, the USTR stated that his office intends to make the Commission's report available to the public in its entirety, and asked that the Commission not include any CBI or national security classified information in the report that it delivers to the USTR. All information, including CBI, submitted in this investigation 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 for cybersecurity purposes. The Commission will not otherwise disclose any CBI in a manner that would reveal the operations of the firm supplying the information.
By order of the Commission.
Occupational Safety and Health Administration (OSHA), Labor.
Request for public comments.
OSHA solicits public comments concerning the proposal to extend OMB approval of the information collection requirements contained in the Cadmium in General Industry Standard.
Comments must be submitted (postmarked, sent, or received) by November 5, 2018.
Thomas Mockler or Christie Garner, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor, telephone (202) 693-2222.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (
OSHA has a particular interest in comments on the following issues:
• Whether the proposed information collection requirements are necessary for the proper performance of the agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply—for example, by using automated or other technological information collection and transmission techniques.
The information collection requirements specified in the Cadmium in General Industry Standard protect workers from the adverse health effects that may result from their exposure to cadmium. The major information collection requirements of the standard include: conducting worker exposure monitoring, notifying workers of their cadmium exposures, implementing a written compliance program, implementing medical surveillance of workers, providing examining physicians with specific information, ensuring that workers receive a copy of their medical surveillance results, maintaining workers' exposure monitoring and medical surveillance records for specific periods, and providing access to these records to the workers who are the subject of the records, the worker's representative, and other designated parties.
The agency is requesting a burden hour adjustment decrease of 2,636 (from 75,998 to 73,362 hours). The agency estimates a decrease of exposed workers in the cross-industry sectors as well as in the specific-industry sectors. On the other hand, the number of plants is estimated to increase slightly in both sectors. As a result, the operation and maintenance costs have increased from $4,799,475 to $5,453,858, a total increase of $654,383, due to increased costs for exposure monitoring sampling and medical exams.
You may submit comments in response to this document as follows: (1) Electronically at
Because of security procedures, the use of regular mail may cause a significant delay in the receipt of comments. For information about security procedures concerning the delivery of materials by hand, express delivery, messenger, or courier service, please contact the OSHA Docket Office at (202) 693-2350; TTY (877) 889-5627.
Comments and submissions are posted without change at
Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
Occupational Safety and Health Administration (OSHA), Labor.
Notice of public meeting.
The Occupational Safety and Health Administration (OSHA) is announcing a public meeting to solicit comments and suggestions from stakeholders in the financial industry, including employers, employees, and representatives of employers and employees, on issues facing the agency in its administration of the whistleblower protection provisions of the Consumer Financial Protection Act of 2010, Section 1057 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, and the Sarbanes-Oxley Act.
The public meeting will be held on October 16, 2018, from 1:00 p.m. to 3:00 p.m. ET. Persons interested in attending the meeting must register by September 30, 2018. In addition, comments relating to the “Scope of Meeting” section of this document must be submitted in written or electronic form by October 9, 2018.
The public meeting will be held in Room N-4437 A-B, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210.
OSHA is interested in obtaining information from the public on key issues facing the agency's whistleblower program. This meeting is the second in a series of meetings requesting public input on this program. For this meeting, OSHA is focusing on issues relating to whistleblower protection in the financial industry. In particular, the agency invites input on the following:
1. How can OSHA deliver better whistleblower customer service?
2. What kind of assistance can OSHA provide to help explain the whistleblower laws it enforces?
Regardless of attendance at the public meeting, interested persons may submit written or electronic comments (see
Electronic copies of this
Loren Sweatt, Deputy Assistant Secretary for Occupational Safety and Health, authorized the preparation of this notice under the authority granted by Secretary's Order 01-2012 (Jan. 18, 2012), 77 FR 3912 (Jan. 25, 2012); 29 U.S.C. 660(c); 49 U.S.C. 31105; 49 U.S.C. 20109, and 6 U.S.C. 1142.
9:00 a.m., Tuesday, September 25, 2018.
NTSB Conference Center, 429 L'Enfant Plaza SW, Washington, DC 20594.
The two items are open to the public.
Telephone: (202) 314-6100.
The press and public may enter the NTSB Conference Center one hour prior to the meeting for set up and seating.
Individuals requesting specific accommodations should contact Rochelle McCallister at (202) 314-6305 or by email at
The public may view the meeting via a live or archived webcast by accessing a link under “News & Events” on the NTSB home page at
Schedule updates, including weather-related cancellations, are also available at
Candi Bing at (202) 314-6403 or by email at
Christopher O'Neil at (202) 314-6100 or by email at
Nuclear Regulatory Commission.
License renewal application; opportunity to request a hearing and to petition for leave to intervene.
The U.S. Nuclear Regulatory Commission (NRC) is considering an application for the subsequent license renewal of Renewed Facility Operating License Nos. DPR-44 and DPR-56, that authorizes Exelon Generation Company, LLC (Exelon or the applicant) to operate Peach Bottom Atomic Power Station Units 2 and 3 (Peach Bottom). The renewed licenses would authorize the applicant to operate Peach Bottom for an additional 20 years beyond the period specified in each of the current renewed licenses. The current renewed operating licenses for Peach Bottom expire as follows: Unit 2 on August 8, 2033, and Unit 3 on July 2, 2034.
Requests for a hearing or petition for leave to intervene must be filed by November 5, 2018.
Please refer to Docket ID NRC-2018-0130 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:
•
•
•
Bennett M. Brady, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2981, email:
By letter dated July 10, 2018 (ADAMS Package Accession No. ML18193A689); the NRC received an application from Exelon, filed pursuant to Section 103 of the Atomic Energy Act of 1954, as amended (the Act), and part 54 of title 10 of the
By letter, dated August 27, 2018 (ADAMS Accession No. ML18191B085, the NRC staff determined that Exelon has submitted sufficient information in accordance with 10 CFR 54.19, 54.21, 54.22, 54.23, 51.45, and 51.53(c), to enable the staff to undertake a review of the application, and that the application is, therefore, acceptable for docketing (ADAMS Accession No. ML18191B085). The current Docket Nos. 50-277 and
Before issuance of the requested subsequent renewed licenses, the NRC will have made the findings required by the Act, and the Commission's rules and regulations. In accordance with 10 CFR 54.29, the NRC may issue a subsequent renewed license on the basis of its review if it finds that actions have been identified and have been or will be taken with respect to: (1) Managing the effects of aging during the period of extended operation on the functionality of structures and components that have been identified as requiring aging management review; and (2) time-limited aging analyses that have been identified as requiring review, such that there is reasonable assurance that the activities authorized by the renewed licenses will continue to be conducted in accordance with the current licensing basis and that any changes made to the plant's current licensing basis will comply with the Act and the Commission's regulations.
Additionally, in accordance with 10 CFR 51.95(c), the NRC will prepare an environmental impact statement as a supplement to the Commission's NUREG-1437, “Generic Environmental Impact Statement for License Renewal of Nuclear Power Plants,” dated June 2013. To issue the renewed license, the Commission must determine whether applicable requirements of subpart A of 10 CFR part 51 have been satisfied, and whether any matters raised under 10 CFR 2.335 have been addressed. Pursuant to 10 CFR 51.26, and as part of the environmental scoping process, the NRC staff intends to hold a public scoping meeting. Detailed information regarding the environmental scoping meeting will be the subject of a separate
Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's website at
As required by 10 CFR 2.309, a petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.
In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.
Petitions must be filed no later than 60 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.
A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission no later than 60 days from the date of publication of this notice. The petition must be filed in accordance with the filing instructions in the “Electronic Submission (E-Filing)” section of this document and should meet the requirements for petitions set forth in this section, except that under 10 CFR 2.309(h)(2) a State, local governmental body, or Federally-recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. Alternatively, a State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).
If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, in the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.
All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email mail at
Information about applying for a digital ID certificate is available on the NRC's public website at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public website at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing adjudicatory documents in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted a request for exemption from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
Detailed information about the subsequent license renewal process can be found under the Nuclear Reactors icon at
The NRC staff has verified that a copy of the SLRA is also available for inspection near the site at the Harford County Public Library: Whiteford Branch, 2407 Whiteford Rd, Whiteford, MD 21160.
For the Nuclear Regulatory Commission.
In notice document C1-2018-18758, appearing on page 44680 in the Issue of Friday, August 31, 2018, the subject line is corrected to read as set forth above.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
1.
2.
This Notice will be published in the
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 30, 2018, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 30, 2018, it filed with the Postal Regulatory
On June 27, 2018, The Nasdaq Stock Market LLC (“Nasdaq”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
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 adopt listing and trading requirements and fees for non-convertible corporate bonds.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Nasdaq is amending its rules to permit the initial and continued listing of and trading of non-convertible corporate debt securities (referred to herein as “bonds” or “non-convertible bonds”) on Nasdaq and to establish fees for listing those bonds. While Nasdaq rules currently provide for the initial and continued listing of convertible bonds, Nasdaq believes that there may be a demand from certain types of investors for Exchange-listed non-convertible bonds. Nasdaq also believes that this proposal will improve the public market for non-convertible bonds by promoting the fair and orderly operation of that market and by increasing the transparency of that market for securities that are listed pursuant to this proposal. Nasdaq is therefore amending the relevant listing and trading rules accordingly.
First, Nasdaq proposes to adopt Rule 5702 to permit the initial listing of non-convertible bonds. For non-convertible bonds, Nasdaq proposes to require a minimum principal amount outstanding or market value of at least $5 million, instead of the minimum $10 million principal amount outstanding required for convertible debt under Rule 5515(b). Nasdaq notes that this requirement is the same as the initial listing requirement for bonds on the New York Stock Exchange LLC (“NYSE”) and NYSE American LLC (“NYSE American”), which both require that the debt issue have an aggregate market value or principal amount of no less than $5 million.
In addition to Rule 5702(a)(1), Nasdaq also proposes to require satisfaction of the condition set forth in Rule 5702(a)(2) for non-convertible bonds to be eligible for listing on the Exchange. This condition is that the issuer of the bond must have one class of equity security that is listed on Nasdaq, NYSE, or NYSE American. This condition is similar to one that NYSE and NYSE American impose.
Nasdaq also proposes to add continued listing requirements under Rule 5702(b). Proposed Rule 5702(b)(1) would require, for continued listing, that a non-convertible bond issuance maintain a market value or principal amount outstanding of at least $400,000.
In addition to these quantitative requirements for listing non-convertible bonds, the issuer of listed bonds would also have to comply with other requirements that are generally applicable to companies listed on Nasdaq pursuant to Rule 5250. Specifically, Rule 5250(a) allows Nasdaq to request additional information, either public or non-public, deemed necessary to make a determination regarding a company's continued listing. Rule 5250(b) requires issuers to make public disclosure of material information, disclosure of notification of deficiency, and disclosure of third party director and nominee compensation. Rule 5250(c) requires companies to file all required periodic financial reports. Rule 5250(d) requires the distribution of annual and interim reports. Rule 5250(e) sets forth various corporate events resulting in material changes that trigger the requirement for the issuer to submit certain forms to Nasdaq.
In addition to the Exchange's rules that would apply to an issuer of non-convertible bonds that list on Nasdaq,
The Exchange proposes to include language to this effect in the rule text, which it will then propose to remove after the Exchange begins listing and trading non-convertible bonds of issuers with equity securities listed on NYSE and NYSE American.
Nasdaq proposes to amend Rule 5515(b)(4) to change references from the American Stock Exchange to NYSE American to reflect the name change of that exchange.
Nasdaq also proposes to amend the definition of a “substitution listing event” in Rule 5005 to include an additional event related to the listing of bonds. Specifically, Rule 5005(a)(40) will include a change in the obligor of a listed debt security as a “substitution listing event.” A Substitution Listing Event triggers certain reporting requirements to the Exchange.
Nasdaq proposes to add fees in connection with listing non-convertible bonds. Specifically, Nasdaq proposes to add Rule 5935 to impose a non-refundable application fee of $5,000 to list a class of non-convertible bonds pursuant to Rule 5702. Nasdaq proposes to waive this application fee if, in connection with a company's application to list non-convertible bonds on Nasdaq, the company will be switching the listing market for such bonds from NYSE or NYSE American to Nasdaq. Nasdaq notes that NYSE American imposes an initial listing fee of $100 per $1 million principal amount (or fraction thereof) for listed bonds, with a minimum fee of $5,000 and a maximum fee of $10,000,
Nasdaq also proposes to add an annual fee in connection with listing non-convertible bonds. Nasdaq proposes to add Rule 5935(b) to state that the issuer of each class of non-convertible bonds listed pursuant to Rule 5702 shall pay to Nasdaq an annual fee of $5,000. Moreover, the proposed Rule states that a company that switches its listing market for its non-convertible bonds from the New York Stock Exchange or NYSE American to Nasdaq will not be liable for the annual fee until January 1 of the calendar year following the effective date of the non-convertible bonds listing on Nasdaq. Nasdaq notes that NYSE American assesses an annual listing fee of $5,000 for listed bonds and debentures of companies whose equity securities are not listed on NYSE American,
Nasdaq also proposes to clarify rule text relating to the listing fees for convertible bonds. Specifically, Rule 5920(a)(2) specifies a fee of $1,000 or $50 per million dollars face amount of bonds outstanding, whichever is higher. Nasdaq proposes to clarify that this is an entry fee, and that it applies to convertible bonds only. Nasdaq is not charging an entry fee for non-convertible bonds, as it believes that the proposed application fee will allow the Exchange to adequately recoup the expenses incurred by the Exchange in processing an issuer's application to list those securities.
Nasdaq believes that this proposal will improve the public debt market by increasing transparency for non-convertible bonds that are listed pursuant to this proposal and the orderliness of the market for those securities. For example, Rule 5250(b)(1) requires listed companies to, except in unusual circumstances, disclose promptly to the public through any Regulation FD compliant method (or combination of methods) any material information that would reasonably be expected to affect the value of their securities or influence investors' decisions.
Nasdaq's MarketWatch Department monitors real time trading in all Nasdaq securities during the trading day for price and volume activity. In the event of certain price and volume movements, the MarketWatch Department may contact a company in order to ascertain the cause of the unusual market activity.
For non-convertible bonds that are listed under this proposal, the issuer will be required to comply with these disclosure requirements and to update Nasdaq accordingly on any material information that would reasonably be expected to affect the value of their bonds or influence investors' decisions. Depending on the nature of the event and the company's views regarding the business advisability of disclosing the information, the MarketWatch Department may work with the company to accomplish a timely release of the information. Furthermore, depending on the materiality of the information and the anticipated effect of the information on the price of the Company's bonds, the MarketWatch Department may advise the Company that a temporary trading halt is appropriate to allow for full dissemination of the information and to maintain an orderly market. For non-convertible bonds that are listed on Nasdaq pursuant to this proposal, a trading halt will be initiated by the Exchange, pursuant to proposed Rule 4000B(i). In these ways, Nasdaq believes that the proposal will increase transparency for bonds that are listed pursuant to this proposal and the orderliness of the market for those bonds.
Nasdaq also believes that this proposal will benefit market participants by making non-convertible bonds more accessible to certain kinds of investors. For example, in the European Union, certain investors, such as so-called UCITS investment funds,
In conjunction with its proposal to adopt rules to list non-convertible bonds on Nasdaq, the Exchange also proposes rules that will provide for the trading of such listed bonds. The Exchange notes that its proposed non-convertible bond trading system—to be known as the “Nasdaq Bond Exchange”—will offer Members,
In many respects, the proposed trading system and the proposed rules that govern it are a pared down version of the NYSE Bonds system and NYSE Rule 86. That is, like NYSE Bonds, the Nasdaq Bond Exchange will be an electronic system for receiving, processing, executing, and reporting bids, offers and executions in bonds. Like NYSE Bonds, the Nasdaq Bond Exchange will display, match, and execute buy and sell orders on a price/time basis. The Exchange, like NYSE and NYSE American, will also accept good-for-day limit orders and fill-or-kill orders, and it will trade bonds of issuers that have at least one class of equity securities listed on Nasdaq and NYSE or NYSE American.
The proposed rules designate the types of orders that could be entered into the Nasdaq Bond Exchange. Initially, Users
The minimum unit of trading in the Nasdaq Bond Exchange is one bond unless the issuer otherwise specifies a larger minimum unit of trading in the bond indenture agreement. The Nasdaq Bond Exchange will accept and display bids and offers in bonds priced to three decimal places, as per market standard.
To post an order in a particular bond on the Nasdaq Bond Exchange, a User will be required to enter certain basic information including: CUSIP number, order quantity, order type (
The Nasdaq Bond Exchange will be an electronic order-driven matching system. Nasdaq Bond Exchange orders submitted by Users will be displayed, matched, and executed on a price/time priority basis. Orders that are marketable at the time of entry will be matched and executed. An order will be marketable when it entered the Nasdaq Bond Exchange system if contra side interest is available at that price or a better price. Nasdaq Bond Exchange Good for Day Limit Orders that are not marketable at the time of entry would post to the Nasdaq Bond Exchange order “book.”
The Nasdaq Bond Exchange will provide an exception to its normal price/time system to allow Users to avoid internalizing orders. Users may be interested in self-match prevention in order to run multiple strategies at once that may sit on opposite sides of the book. Pursuant to the proposed Rule 4000B(h)(1)(C), which the Exchange adapts from Nasdaq Rule 4757(a)(4), Nasdaq will permit Users to direct that orders entered into the Nasdaq Bond Exchange will not execute against orders entered under the same MPID. In addition, the proposed Rule provides that Users using the FIX order entry protocol (discussed below) may assign to orders entered through a specific order entry port a unique group identification modifier that will prevent orders with such modifier from executing against each other. In such a case, the proposed Rule states that a User may elect from the following options: (i) Regardless of the size of the interacting orders, cancelling the oldest order in full; or (ii) regardless of the size of the interacting orders, cancelling the most recent of the orders in full. The foregoing options may be applied to all orders entered through a specific order entry port.
An order designated for execution in the Bond Trading Session may be cancelled at any time as long as the order had not been executed.
The Exchange will charge no fees for posting orders or executing trades on the Nasdaq Bond Exchange. If the Exchange decides to charge any such fees in the future, then the Exchange will submit a rule filing proposal to that effect to the Commission.
Most orders matched on the Nasdaq Bond Exchange will be locked-in trades and will be submitted without an omnibus account to the National Securities Clearing Corporation using Universal Trade Capture and then to the Depository Trust Company (“DTC”) for clearance and settlement. Settlement of corporate bond trades will be consistent with current convention,
The Nasdaq Bond Exchange would have one trading session per trading day from 8:30 a.m. until 4:00 p.m. E.T. (the
Bond trades on the Nasdaq Bond Exchange would be made subject to Exchange Rule 11890, which governs the process for addressing clearly erroneous trades. Within the context of bond trading on the Nasdaq Bond Exchange, a “clearly erroneous execution” will be one where there is an obvious error in any term, such as price, unit of trading, or identification of the bond.”
If the reviewer determines that the execution was not clearly erroneous, then no corrective action will be taken in relation to the transaction. If the reviewer determines that the transaction were clearly erroneous, the transaction will be deemed null and void.
Rule 11890(b) further provides that, in the event of any system disruption, malfunction, or equipment changeover in the Nasdaq Bond Exchange trading facility, a Senior Official may, without the need for a request for review, review transactions affected by a system disruption, malfunction, or equipment changeover and decide if any transactions are erroneous.
Proposed Rule 4000B(i)(1) provides that the Exchange may halt or suspend trading in non-convertible bonds listed on the Nasdaq Bond Exchange when: (1) In the Exchange's regulatory capacity, it is necessary or appropriate to maintain a fair and orderly market, to protect investors, or is in the public interest, due to extraordinary circumstances or unusual market conditions; (2) a class of equity that is issued by the same issuer as the non-convertible bond has been halted or suspended by, or de-listed from, the Exchange or by its primary listing market (NYSE or NYSE American), as applicable, for regulatory purposes; (3) news reports have a material impact on a non-convertible bond, its issuer, or related stock of its issuer; or (4) the non-convertible bond is to be called for redemption or will mature or become subject to retirement, and thereafter it will be subject to de-listing, in which case the Exchange shall cease trading the non-convertible bond, effective not less than 10 days before the date when such de-listing becomes effective, pursuant to a de-listing application that the Exchange submits to the Commission on Form 25 and consistent with SEC Rule 12d2-2
Pursuant to proposed Rule 4000B(i)(2), when bond trading is halted under any of the circumstance described above, a halt message at the beginning and end of the halt will be disseminated to all Nasdaq Bond Market Users. This trading halt will be referred to as a “Bond Halt.”
The Exchange proposes to publicly disseminate a real-time bond data feed,
Only Members of the Exchange that have entered into a written service agreement with the Exchange (
Users of the Nasdaq Bond Exchange will gain access to the system via direct or indirect electronic linkages utilizing the Financial Information Exchange or “FIX” protocol. The FIX protocol is already used and widely accepted by Nasdaq market participants and will be used by the Nasdaq Bond Exchange Users for order entry, modification and cancellation, and message transmittal for all non-convertible bonds traded through the Nasdaq Bond Exchange. All of the communications protocols will be publicly available to allow Users and service bureaus to develop their own front-end software. Users will have the ability to establish connectivity to the Nasdaq Bond Exchange directly or through third-party connectivity providers, including a range of extranets and service bureaus, as set forth in General 8 of the Nasdaq Rules.
Users of the Nasdaq Bond Exchange would have to comply with all relevant rules of the Exchange and the Commission in relation to reports and recordkeeping of transactions on the Nasdaq Bond Exchange, including Rules 17a-3 and 17a-4 under the Act.
The Exchange will leverage its existing infrastructure to operate a national securities exchange in compliance with Section 6 of the Exchange Act, and Section 6(b)(7) in particular,
In particular, MarketWatch will perform real-time surveillance of the Nasdaq Bond Exchange for the purpose of maintaining a fair and orderly market at all times. As it does with Nasdaq's equities trading, MarketWatch will monitor trading on the Nasdaq Bond Exchange market on a real-time basis to identify unusual trading patterns and determine whether particular trading activity requires further regulatory investigation. In addition, Nasdaq Regulation will oversee the process for determining and implementing trade halts and identifying and responding to unusual market conditions.
The Nasdaq Bond Exchange will operate out of the same data center in Carteret, New Jersey as does the Nasdaq Stock Market and other exchanges owned by Nasdaq, Inc., but it will use equipment that is separate from the equipment used by those exchanges. In addition, the Nasdaq Bond Exchange will have a backup data center that will be geographically diverse from the Carteret data center and that will be designed to resume operations of the Nasdaq Bond Exchange, in the event of a system failure, in accordance with the requirements of Regulation Systems Compliance and Integrity.
Section 11(a) of the Act
Nasdaq believes that its proposal is consistent with Section 6(b) of the Act
The Exchange believes that its proposal to list non-convertible bonds will improve the quality of the public market for bonds by improving the transparency and the orderliness of the market. As discussed above, an issuer that lists bonds pursuant to this proposal will be required to disclose any material information that would reasonably be expected to affect the value of their securities or influence investors' decisions, except in unusual circumstances.
Nasdaq also believes that its proposed listing standards are consistent with the Act. Nasdaq notes that its proposed initial listing standards, set forth in Rule 5702(a)—which require a minimum principal amount outstanding of the non-convertible bond or a market value of at least $5 million and the issuer of the non-convertible bond also having a class of equity listed on Nasdaq, NYSE, or NYSE American—are similar to the initial listing requirements for bonds listed on NYSE and NYSE American. Similarly, the continued listing requirement under Rule 5702(b)(1) that a non-convertible bond maintain a market value or principal amount of bonds outstanding of at least $400,000 is similar to the listing requirement for bonds imposed by NYSE American. Nasdaq notes that, pursuant to Rule 5702(b)(2), an issuer would also be required to meet its obligations on the listed non-convertible bonds, and that Nasdaq would initiate proceedings immediately under Rule 5810 (Notification of Deficiency by the Listing Qualifications Department) if the issuer were unable to meet its obligations on its non-convertible bonds. Nasdaq believes that it is consistent with the Act to immediately institute immediate de-listing proceedings in this instance, rather than to first afford the issuer a time period during which it may regain compliance (
Nasdaq also believes that the change to the definition of a “substitution listing event” to include a change in the obligor of a listed non-convertible bond is consistent with the Act. Nasdaq is proposing to make this change to both convertible and non-convertible bonds, as both types of securities could potentially be subject to a change in the obligor of that bond, which Nasdaq believes should qualify as a substitution listing event.
Likewise, it is consistent with the Act to amend Rule 5515(b)(4) to change existing references from the American Stock Exchange to NYSE American to ensure that our Rules regarding convertible debt are current and accurate with respect to the names of the exchanges they reference.
Nasdaq believes that the proposed rule change is consistent with Section 6(b)(4) in that it provides for the equitable allocation of reasonable dues, fees, and other charges among its members, issuers and other persons using its facilities. The proposed $5,000 application fee and $5,000 annual fee will be equally applicable to any issuer seeking to list non-convertible bonds on Nasdaq, other than for those issuers that propose to switch their listings from NYSE or NYSE American to Nasdaq. Nasdaq's proposal to waive the application fee and the first year's annual fee for issuers that switch their listings to Nasdaq from NYSE or NYSE American is reasonable and equitable because such fees will otherwise serve as disincentives for issuers to switch their listings, particularly if they have already paid their annual fees to NYSE or NYSE American for the year in which a switch would otherwise occur.
The proposed application and annual fees are competitive with the initial and annual fees that are currently assessed by NYSE and NYSE American for the listing of bonds.
Nasdaq also notes that the proposed $5,000 initial listing fee is the same as the application fee it charges for convertible bonds. However, Nasdaq will not charge an entry fee (as it does for convertible bonds under the
These proposed listing fees for non-convertible bonds are lower than Nasdaq's initial and annual fees for equity securities, which range from $50,000—$75,000 for initial listing of equity securities, and from $32,000—$45,000 for annual listing of equity securities.
Nasdaq also believes that the proposed listing rules are consistent with Section 6(b)(5) of the Act
Finally, Nasdaq notes that it will apply the surveillance and enforcement infrastructure that it utilizes for listings on its other markets to ensure that issuers comply with initial and continuing listing requirements for non-convertible corporate bonds and that the Exchange will take fair and appropriate action under the Nasdaq Rule 5800 Series to address violations of those listing Rules.
Nasdaq's proposal to establish the Nasdaq Bond Exchange system to trade non-convertible corporate bonds listed on Nasdaq is also consistent with the Act. Nasdaq has designed the Nasdaq Bond Exchange to operate in accordance with the Act, the applicable rules of the Commission and of the Exchange, and the high standards that Nasdaq believes to be in evidence at all of Nasdaq, Inc.'s exchanges. The proposal will offer Users opportunities to trade non-convertible bonds through a fair, open, and well-regulated market. The proposal will promote the interests of the public and investors by providing for the entry into the marketplace of a new exchange venue for trading non-convertible corporate bonds. Such bonds presently are tradeable, other than on an over-the-counter basis, only on NYSE and NYSE American. The Nasdaq Bond Exchange will introduce competition into this space, and that competition will spur innovation, which in turn will benefit issuers, traders, and investors alike.
The Nasdaq Bond Exchange is also designed to be a free, open, and fair marketplace. All Nasdaq Members will be eligible to become Users simply by electing to receive access. Moreover, Nasdaq proposes simple and straightforward rules to govern the operation of the Bond Exchange, including a familiar price-time allocation methodology, two basic order types, a single Bond Trading Session with no after-hours trading, and market data feed that will be disseminated, for free, to any member of the public that requests it and agrees to the Exchange's terms and conditions of use. At the same time, the proposal will also include provisions that are endemic to orderly and well-regulated markets, including authority to impose trading halts and suspensions, in appropriate circumstances, and to unwind clearly erroneous trades pursuant to established procedures under Nasdaq Rule 11890 and bond-specific criteria adapted from NYSE Rule 86.
Nasdaq will also leverage the conduct rules, surveillance technology, and enforcement infrastructure that it utilizes with respect to its other markets to ensure that the Nasdaq Bond Exchange operates in a fair and orderly fashion and that Nasdaq prevents, detects, and addresses fraudulent and manipulative acts and practices. For example, Nasdaq's MarketWatch Department will surveil the market and employ its SMARTS technology to detect suspicious or non-compliant behavior. Nasdaq's existing disciplinary rules, as set forth in the Nasdaq Rule 8000 and 9000 Series, will apply to Users of the Nasdaq Bond Exchange, and Nasdaq's Regulation Department will, pursuant to these disciplinary rules, investigate and take fair and appropriate enforcement action to address violations of rules relevant to trading on the Nasdaq Bond Exchange or the conduct of Users.
Moreover, the proposal provides for the equitable allocation of reasonable dues, fees, and other charges among its members, issuers and other persons using its facilities. Nasdaq will charge no fees to trade non-convertible bonds on the Nasdaq Bond Exchange, to obtain the FIX ports that are necessary to connect to the Nasdaq Bond Market, or to receive the Nasdaq Corporates Totalview data feed product. Additionally, to the extent that a User already purchases physical connectivity to Nasdaq pursuant to General 8, Sections 1 and 2 of the Nasdaq Rules, such a User could utilize its existing connectivity to connect to the Bond Exchange without any incurring additional fees to do so.
Finally, Nasdaq notes that it has designed the Nasdaq Bond Exchange system to facilitate transactions in corporate bonds in a manner that is similar to, and competitive with, the existing NYSE Bonds trading system. The Commission has already deemed the design of NYSE Bonds to be consistent with the Act.
To the extent that the Nasdaq Bond Exchange will differ from NYSE Bonds, these differences will render the Nasdaq Bond Exchange simpler than NYSE Bonds. At its inception, the Nasdaq Bond Exchange will not have—as does NYSE Bonds—market makers, sponsored access, auctions, price collars, or certain order types (
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. Rather, the proposed rule change will promote competition among exchanges by allowing Nasdaq to list and trade non-convertible bonds, which can currently be listed only on NYSE and NYSE American. The proposals will have the pro-competitive effect of spurring further initiative and innovation among market centers and market participants.
Nasdaq notes that its proposed listing standards are consistent with the standards for initial and continued listing of bonds on NYSE and NYSE American. If issuers are unsatisfied with Nasdaq's listing program or the fees charged for that program, these issuers can choose to list on these other markets.
Likewise, the Exchange notes that its proposed system for trading non-convertible bonds listed on Nasdaq—the Nasdaq Bond Exchange—will be competitive with NYSE Bonds. Although initially, the Nasdaq Bond Exchange will have more limited functionality than does NYSE Bonds, including with respect to order types, auctions, the number of trading sessions, and the use of market makers, the Exchange believes that the Nasdaq Bond Exchange will be competitive with NYSE Bonds because the Exchange has incorporated into the Nasdaq Bond Exchange those features of NYSE Bonds that its Users actually want and need when trading bonds and it excluded those they do not actually utilize. That said, the Exchange will add additional functionality and features to the Nasdaq Bond Exchange as demand warrants it to do so and to the extent that the Exchange deems it necessary to remain competitive with NYSE Bonds.
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
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.
Acting under the authority of and in accordance with section 1(b) of Executive Order 13224 of September 23, 2001, as amended by Executive Order 13268 of July 2, 2002, and Executive Order 13284 of January 23, 2003, I hereby determine that the person known as Jama'at Nusrat al-Islam wal-Muslimin (JNIM), also known as Jamaat Nosrat al-Islam wal-Mouslimin, also known as Group for the Support of Islam and Muslims, also known as Group to Support Islam and Muslims, also known as GSIM, also known as GNIM, also known as Nusrat al-Islam wal-Muslimeen, committed, or poses a significant risk of committing, acts of terrorism that threaten the security of U.S. nationals or the national security, foreign policy, or economy of the United States.
Consistent with the determination in section 10 of Executive Order 13224 that prior notice to persons determined to be subject to the Order who might have a constitutional presence in the United States would render ineffectual the blocking and other measures authorized in the Order because of the ability to transfer funds instantaneously, I determine that no prior notice needs to be provided to any person subject to this determination who might have a constitutional presence in the United States, because to do so would render ineffectual the measures authorized in the Order.
This notice shall be published in the
Based upon a review of the Administrative Record assembled in this matter, and in consultation with the Attorney General and the Secretary of the Treasury, I conclude that there is a sufficient factual basis to find that the relevant circumstances described in section 219 of the Immigration and Nationality Act, as amended (hereinafter “INA”) (8 U.S.C. 1189), exist with respect to Jama'at Nusrat al-Islam wal-Muslimin (JNIM), also known as Jamaat Nosrat al-Islam wal-Mouslimin, also known as Group for the Support of Islam and Muslims, also known as Group to Support Islam and Muslims, also known as GSIM, also known as GNIM, also known as Nusrat al-Islam wal-Muslimeen.
Therefore, I hereby designate the aforementioned organization and its aliases as a foreign terrorist organization pursuant to section 219 of the INA.
This determination shall be published in the
A meeting of the Department of State's Advisory Committee on International Law will take place on Thursday, September 27, 2018, from 9:30 a.m. to 5:00 p.m. at the George Washington University Law School, Michael K. Young Faculty Conference Center, 716 20th St. NW, 5th Floor, Washington, DC. Legal Adviser Jennifer Newstead will chair the meeting, which will be open to the public up to the capacity of the meeting room. It is anticipated that the meeting will include discussions on international law and contemporary issues in outer space, the role of economic security considerations in international and domestic trade law, international law and privacy in the context of data transfers, and the work of the International Law Commission.
Members of the public who wish to attend should contact the Office of the Legal Adviser by September 21 at
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “The Charterhouse of Bruges: Jan Van Eyck, Petrus Christus, and Jan Vos,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Frick Collection, New York, New York, from on or about September 18, 2018, until on or about January 13, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the
Elliot Chiu, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made
Federal Highway Administration (FHWA), DOT.
Notice of Intent.
The FHWA is issuing this Notice of Intent (NOI) to advise the public that a supplement to the final environmental impact statement will be prepared to address impacts of proposed improvements to a section of K-10 Highway South Lawrence Trafficway, located within the south and west limits of the City of Lawrence, in Douglas County, Kansas.
The FHWA, in cooperation with the Kansas Department of Transportation (KDOT), will prepare a Supplemental Environmental Impact Statement (SEIS) on a proposal to improve K-10/South Lawrence Trafficway (SLT) located in Douglas County, Kansas. The overall project study limits begin just north of Interstate 70 at North 1800 Road/Farmer's Turnpike to just east of the existing K-10/23rd Street system interchange. The overall length is 19.0 miles and i5 broken down as follows: The West Section begins just north of Interstate 70 at North 1800 Road/Farmer's/Turnpike to US-59/Iowa Street (approximately 8.7 miles). The East Section begins at US-59/Iowa Street and continues to the existing K-10/23rd Street system interchange. The project study area also includes East 600 Road/Lecompton Road at Interstate 70 (approximately 0.6 mile), and U.S. 40 from K-10 to E 600 Road (approximately 4.1 miles).
A previous Environmental Impact Statement (EIS) was prepared in 1990 for the overall SLT study area. The Purpose and Need stated in that EIS was to relieve congestion on existing 23rd Street and Iowa Street by diverting through and local traffic from these two existing streets and Clinton Parkway, thereby achieving an improved level of traffic service on the local street network. The goals of the current proposed project on the West Section are to increase capacity, enhance safety, and address access while balancing sensitive project environmental features within the project footprint. Also, the project will provide an efficient and cost-effective transportation facility for users of K-10 Highway and the surrounding state highway system.
As an outcome of the approved 1990 EIS, two expressway lanes of the West Section were constructed and opened to traffic in each direction in 1996. The East Section was not constructed and a subsequent SEIS with a “No Build” decision was approved in 2000. A subsequent EIS, in conjunction with a USACE 404 Permit, was completed in 2002 and adopted and approved by FHWA in November 2007. The FHWA then issued a Record of Decision (ROD) in May 2008. Since the completion of the ROD, the East Section four-lane freeway was constructed and opened to traffic in 2016.
The current SEIS, as a supplement to the original 1990 EIS, will evaluate a `No Action' alternative as well as a combination of toll-free and tolled build alternatives for the entire SLT study area. Roadway configuration options will be evaluated for the West Section, including upgrading the West Section as a four-lane freeway with controlled access and interchanges at West 6th Street/U.S. 40, Bob Billings Parkway, Clinton Parkway, an interchange between Wakarusa Drive and Kasold Drive, and at U.S. 59/Iowa Street. Also, there will be discussions about interchange alternatives at I-70/East 600 Road/Lecompton Road and K-10/I-70/North 1800 Road.
A formal scoping process will be initiated that involves appropriate Federal, State, and local agencies, as well as stakeholders and the public. This will continue throughout the study to engage the local and regional community, to obtain public input and to keep the public informed. Coordination meetings will be held as needed with affected/concerned local, State, Tribal, and Federal governmental entities. Public hearings will be held to present the findings of the SEIS. The SEIS will be made available for public and agency review and comment prior to the public hearings.
The FHWA and KDOT plan to prepare a combined Final SEIS/Record of Decision for the project. The SEIS will analyze the potential social, economic, and environmental impacts resulting from the proposed project. The following issues will be specifically analyzed as part of the SEIS: Impacts to the aquatic ecosystem; impacts to cultural resources; impacts to threatened and endangered species; impacts to floodplains; impacts to transportation; impacts to parks/recreation; environmental justice; secondary and cumulative impacts; and socioeconomics. This analysis will include a detailed examination of direct, indirect and cumulative impacts that could result from the construction of a selected alternative emanating from this SEIS. Other Federal approvals or permits that may be required include a Section 404 Permit from the U.S. Army Corps of Engineers (USACE), a floodplain development permit from the state office of the Federal Emergency Management Agency (FEMA), as well as water resource and floodplain permits from the Kansas Division of Water Resources.
To ensure that the full range of issues related to the proposed action are addressed and all significant issues defined, comments and suggestions are invited from all interested parties. Comments or questions concerning the proposed action and the SETS should be directed to FHWA or KDOT at the addresses provided above.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of application for exemption; request for comments.
FMCSA announces that it has received an application from the American Concrete Pavement Association, Inc. (ACPA) requesting exemptions from two requirements of the hours-of-service (HOS) regulations for drivers of certain commercial motor vehicles (CMVs) operated by ACPA members: The 30-minute rest break provision; and the requirement that short-haul drivers utilizing the record of duty status (RODS) exception return to their work-reporting location within 12 hours of coming on duty. The first exemption would enable drivers engaged in the transportation of ready-mixed concrete in vehicles, other than those outfitted with rotating mixer drums, and related materials and equipment to use 30 minutes or more of on-duty “waiting time” to satisfy the requirement for the 30-minute rest break, provided they do not perform any other work during the break. The second exemption would allow these drivers to use the short-haul exception but return to their work-reporting location within 14 hours instead of the usual 12 hours. FMCSA requests public comment on ACPA's application for exemptions.
Comments must be received on or before October 9, 2018.
You may submit comments identified by Federal Docket Management System Number FMCSA-0237-0237 by any of the following methods:
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Each submission must include the Agency name and the docket number for this notice. Note that DOT posts all comments received without change to
For information concerning this notice, please contact Mr. Richard Clemente, FMCSA Driver and Carrier Operations Division; Telephone: (202) 366-2722; Email:
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2018-0237), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
ACPA seeks exemptions for all drivers of member companies transporting ready-mixed concrete and related materials and equipment from the HOS 30-minute rest break provision in 49 CFR 395.3(a)(3)(ii) and the restriction of the RODS exception for short-haul operations to drivers who return to their normal work-reporting location within 12 hours [49 CFR 395.1(e)(1)(ii)(A)].
The first exemption from the HOS rest break provision, if granted, would enable drivers engaged in the transportation of ready-mixed concrete in vehicles, other than those outfitted with rotating mixer drums, and related materials to use 30 minutes or more of
The second exemption, if granted, would allow these same drivers to use the short-haul RODS exception, but with a 14-hour duty period instead of 12 hours. ACPA advises that, while some short-haul drivers will be able to take advantage of the exception from the 30-minute break, other drivers are often required to be on duty more than 12 hours in a day and therefore are not eligible to use the short-haul exception.
Although drivers using the short-haul exception in 49 CFR 395.1(e)(1) are not required to take the minimum 30-minute rest break [49 CFR 395.3(a)(3)(ii)], the extension of the short-haul 12 hour limit to 14 hours, if granted, might be construed by some to require the 30-minute break; therefore, ACPA is requesting the second exemption from the rest break requirement.
ACPA mentioned that drivers of ready-mixed concrete delivery vehicles were previously granted an exemption from the minimum 30-minute rest break provision.
ACPA states in its application that the exemptions would not have any adverse impacts on operational safety, as drivers would remain subject to the HOS regulations in 49 CFR 395.3, and would receive sufficient rest due to the nature of their operations that limit driving to an average of only 80-100 miles per day during the paving season. ACPA believes that granting these exemptions would achieve the same level of safety provided by the two HOS rules. The term of the requested exemptions is for 5 years, subject to renewal upon application. A copy of ACPA's application for exemptions is available for review in the docket for this notice.
Federal Transit Administration, DOT.
Notice of request for comments.
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Requirements (ICRs) abstracted below have been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and their expected burdens. The
Comments must be submitted on or before October 9, 2018.
Tia Swain, Office of Administration, Management Planning Division, 1200 New Jersey Avenue SE, Mail Stop TAD-10, Washington, DC 20590, (202) 366-0354 or
The Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, Section 2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1), 1320.12. On May 31, 2018, FTA published a 60-day notice (83 FR 25103) in the
Before OMB decides whether to approve these proposed collections of information, it must provide 30 days for public comment. 44 U.S.C. 3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d);
The summaries below describe the nature of the information collection requirements (ICRs) and the expected burden. The requirements are being submitted for clearance by OMB as required by the PRA.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of actions on special permit applications.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.
Comments must be received on or before October 9, 2018.
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hazardous Materials Approvals and Permits Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington DC or at
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications for special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety
Comments must be received on or before October 9, 2018.
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hazardous Materials Approvals and Permits Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington DC or at
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications for modification of special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Comments must be received on or before September 21, 2018.
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hazardous Materials Approvals and Permits Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington DC or at
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Office of the Secretary, Department of Transportation (DOT).
Notice of Performance Review Board (PRB) appointments.
DOT published the names of the persons selected to serve on Departmental PRBs as required.
Lisa M. Williams, Director, Departmental Office of Human Resource Management (202) 366-4088.
The persons named below may be selected to serve on one or more Departmental PRBs.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, 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. Currently, the IRS is soliciting comments concerning Form 5884, Work Opportunity Credit.
Written comments should be received on or before November 5, 2018 to be assured of consideration.
Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW, Washington, DC 20224. Please send separate comments for each specific information collection listed below. You must reference the information collection's title, form number, reporting or record-keeping requirement number, and OMB number (if any) in your comment.
Requests for additional information or copies of the collection tools should be directed to Alissa Berry, at (901) 707-4988, at Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet at
Currently, the IRS is seeking comments concerning the following information collection tools, reporting, and record-keeping requirements:
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Departmental Offices, U.S. Department of the Treasury.
Notice of open meeting.
This notice announces that the Department of the Treasury's Federal Advisory Committee on Insurance (“Committee”) will convene a meeting on Tuesday, September 18, 2018, in the Cash Room, 1500 Pennsylvania Avenue NW, Washington, DC 20220, from 2:30-4:30 p.m. Eastern Time. The meeting is open to the public, and the site is accessible to individuals with disabilities.
The meeting will be held on Tuesday, September 18, 2018, from 2:30-4:30 p.m. Eastern Time.
The Federal Advisory Committee on Insurance meeting will be held in the Cash Room, Department of the Treasury, 1500 Pennsylvania Avenue NW, Washington, DC 20220.
The meeting will be open to the public. Because the meeting will be held in a secured facility, members of the public who plan to attend the meeting must register online at
Requests for reasonable accommodations under Section 504 of the Rehabilitation Act should be directed to Mariam G. Harvey, Office of Civil Rights and Diversity, Department of the Treasury, at 202-622-0316 or
Lindsey Baldwin, FIO, Room 1410, Department of the Treasury, 1500 Pennsylvania Avenue NW, Washington, DC 20220 at 202-622-3220 (this is not a toll-free number). Persons who have difficulty hearing or speaking may access this number via TTY by calling the toll-free Federal Relay Service at (800) 877-8339.
Notice of this meeting is provided in accordance with the Federal Advisory Committee Act, 5 U.S.C. App. II, 10(a)(2), through implementing regulations at 41 CFR 102-3.150.
• Send electronic comments to
• Send paper statements triplicate to the Federal Advisory Committee on Insurance, Room 1410, Department of the Treasury, 1500 Pennsylvania Avenue NW, Washington, DC 20220.
In general, the Department of the Treasury will post all statements on its website (
Notice.
The United States Mint announces the Citizens Coinage Advisory Committee (CCAC) public meeting scheduled for September 27, 2018.
Interested members of the public may either attend the meeting in person or dial in to listen to the meeting at (866) 564-9287/Access Code: 62956028.
Interested persons should call the CCAC HOTLINE at (202) 354-7502 for the latest update on meeting time and room location.
Any member of the public interested in submitting matters for the CCAC's consideration is invited to submit them by email to
The CCAC advises the Secretary of the Treasury on any theme or design proposals relating to circulating coinage, bullion coinage, Congressional Gold Medals, and national and other medals; advises the Secretary of the Treasury with regard to the events, persons, or places to be commemorated by the issuance of commemorative coins in each of the five calendar years succeeding the year in which a commemorative coin designation is made; and makes recommendations with respect to the mintage level for any commemorative coin recommended.
Members of the public interested in attending the meeting in person will be admitted into the meeting room on a first-come, first-serve basis as space is limited. Conference Room A&B can accommodate up to 50 members of the public at any one time. In addition, all persons entering a United States Mint facility must adhere to building security protocol. This means they must consent to the search of their persons and objects in their possession while on government grounds and when they enter and leave the facility, and are prohibited from bringing into the facility weapons of any type, illegal drugs, drug paraphernalia, or contraband.
The United States Mint Police Officer conducting the screening will evaluate whether an item may enter into or exit from a facility based upon Federal law, Treasury policy, United States Mint Policy, and local operating procedure; and all prohibited and unauthorized items will be subject to confiscation and disposal.
Betty Birdsong, Acting United States Mint Liaison to the CCAC, 801 9th Street NW, Washington, DC 20220; or call 202-354-7200.
31 U.S.C. 5135(b)(8)(C).
(1) clarify and expand the circumstances under which United States employers, especially small and mid-sized businesses, may sponsor or
(2) increase retirement security for part-time workers, sole proprietors, working owners, and other entrepreneurial workers with non-traditional employer-employee relationships by expanding their access to workplace retirement plans, including MEPs.
(b)
(c)
(d)
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
| 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 |