February 24, 2016 – Federal Register Recent Federal Regulation Documents
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Commercial Zones at International Border With Mexico
FMCSA issues a final rule establishing the New Mexico Commercial Zone in Dona Ana County and Luna County, NM. This action is required by the Transportation Equity Act for the 21st Century (TEA- 21). The Agency also issues an interim final rule establishing an expanded commercial zone for the City of El Paso, TX, which now includes the new Tornillo-Guadalupe international bridge and port of entry on the border with Mexico. Additionally, through this action, FMCSA provides clarification on the definition of the San Luis, AZ commercial zone. The Agency is interested in receiving public comments regarding what should constitute the eastern boundary for the FMCSA's commercial zone for the City of El Paso, TX, that would include the new Tornillo-Guadalupe international bridge, port of entry, and public access roads O.T. Smith Road and Texas Farm-to-Market Road 3380 (M.F. Aguilera Highway) to Interstate Highway 10.
30-Day Notice of Proposed Information Collection: Public Housing Agency (PHA) 5-Year and Annual Plan
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
30-Day Notice of Proposed Information Collection: Public Housing Capital Fund Program
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
NASA Advisory Council; Aeronautics Committee Meeting
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory Council (NAC). The meeting will be held for the purpose of soliciting, from the aeronautics community and other persons, research and technical information relevant to program planning.
30-Day Notice of Proposed Information Collection: Previous Participation Certification
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
30-Day Notice of Proposed Information Collection: Manufactured Housing Survey
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Request for Expressions of Interest From Coverage Organizations; Coverage Organizations Interested in Providing Input Regarding Private Payer Coverage to Medical Device Sponsors Who Request Their Participation in a Pre-Submission Meeting With the Food and Drug Administration
The Food and Drug Administration (FDA) is requesting expressions of interest from organizations that evaluate clinical evidence used to support private payer coverage decisions for medical devices (coverage organizations) that wish to provide input to medical device developers (sponsors) on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. These coverage organizations include third-party commercial health insurance organizations, payer/provider organizations, health technology assessment groups and various organizations that evaluate clinical evidence and make coverage recommendations to and decisions for private payers and health plans. The Center for Devices and Radiological Health (CDRH) is taking this step to assist sponsors in identifying such organizations and soliciting clinical trial design or other evidence-gathering input from them. If coverage organizations express interest, FDA intends to provide a mechanism for such organizations to identify themselves so that medical device sponsors who would like to obtain coverage input can voluntarily contact them to participate in a FDA Pre-Submission meeting. Early input from payers regarding their evidentiary needs can streamline the process from FDA approval or clearance to payer coverage and improve public health by facilitating earlier access to innovative, safe, and effective medical devices.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are require; to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Country-by-Country Reporting; Correction
This document contains corrections to a notice of proposed rulemaking (REG-109822-15) that was published in the Federal Register on Wednesday, December 23, 2015 (80 FR 79795). The proposed regulations would require annual country-by-country reporting by United States persons that are the ultimate parent entity of a multinational enterprise group.
Open Meeting of the Information Security and Privacy Advisory Board
The Information Security and Privacy Advisory Board (ISPAB) will meet Wednesday, March 23, 2016, from 8:30 a.m. until 5:00 p.m. Eastern Time, Thursday, March 24, 2016, from 8:30 a.m. until 5:00 p.m. Eastern Time, and Friday, March 25, 2016, from 8:30 a.m. until 12:00 p.m. Eastern Time. All sessions will be open to the public.
Human Factors Engineering
On August 10, 2015, the U.S. Nuclear Regulatory Commission (NRC) solicited comments on the draft NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition,'' Section 18.0, ``Human Factors Engineering.'' The public comment period closed on October 9, 2015. The NRC has decided to reopen the public comment period to allow more time for members of the public to develop and submit their comments and to hold a public meeting concerning the Standard Review Plan (SRP), Section 18.0.
National Advisory Committee for Implementation of the National Forest System Land Management Planning Rule
The Secretary of Agriculture has renewed the National Advisory Committee for Implementation of the National Forest System Land Management Planning Rule (Committee). In accordance with provisions of the Federal Advisory Committee Act (FACA), the Committee has been renewed to continue providing advice and recommendations on the implementation of the National Forest System Land Management Planning Rule (Planning Rule). The Committee will also deliberate and formulate advice for the Secretary to aid in the implementation of the new Planning Rule. The Committee is necessary and in the public interest.
Drawbridge Operation Regulation; Atchafalaya River, Morgan City, LA
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Morgan City Railroad Bridge across the Atchafalaya River (also known as Berwick Bay), mile 17.5 [Gulf Intracoastal Waterway (Morgan City-Port Allen Alternate Route), mile 0.3] in Morgan City, St. Mary Parish, Louisiana. This deviation is necessary to perform maintenance needed for the operation of the bridge. This deviation allows for the bridge to remain closed-to- navigation for eight-consecutive hours in the morning and five- consecutive hours in the evening with an opening in the middle to pass vessels for a five-day period.
Codex Alimentarius Commission: Meeting of the Codex Committee on Pesticide Residues
The Office of the Deputy Under Secretary for Food Safety, U.S. Department of Agriculture (USDA), and the U.S. Environmental Protection Agency (EPA) are sponsoring a public meeting on March 23, 2016. 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 48th Session of the Codex Committee on Pesticide Residues (CCPR) of the Codex Alimentarius Commission (Codex), taking place in Chongqing, China, April 25-29, 2016. The Deputy Under Secretary for Food Safety and EPA recognize the importance of providing interested parties the opportunity to obtain background information on the 48th session of the CCPR and to address items on the agenda.
New Postal Product
The Commission is noticing a recent Postal Service filing concerning the addition of First-Class Package Service Contract 44 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
New Postal Product
The Commission is noticing a recent Postal Service filing concerning the addition of First-Class Package Service Contract 43 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
New Postal Product
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 188 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
New Postal Product
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 187 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; The Declaration Process: Requests for Preliminary Damage Assessment (PDA), Requests for Supplemental Federal Disaster Assistance, Appeals, and Requests for Cost Share Adjustments
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 (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.
Technical Mapping Advisory Council Meeting
The Federal Emergency Management Agency (FEMA) Technical Mapping Advisory Council (TMAC) will meet via conference call on March 10 and 11, 2016. The meeting will be open to the public.
Culturally Significant Object Imported for Exhibition Determinations: “Fables Across Time: Kalila and Dimna” Exhibition
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257-1 of December 11, 2015), I hereby determine that the object to be included in the exhibition ``Fables Across Time: Kalila and Dimna,'' imported from abroad for temporary exhibition within the United States, is of cultural significance. The object is imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit object at The Children's Museum of Indianapolis, Indianapolis, Indiana, from on about March 18, 2016, until on or about June 12, 2016, 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 Federal Register.
Culturally Significant Objects Imported for Exhibition Determinations: “Gods and Mortals at Olympus: Ancient Dion, City of Zeus” Exhibition
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257-1 of December 11, 2015), I hereby determine that the objects to be included in the exhibition ``God and Mortals at Olympus: Ancient Dion, City of Zeus,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit objects at the Onassis Cultural Center, New York, New York, from on about March 24, 2016, until on or about June 18, 2016, 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 Federal Register.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Commerce Spectrum Management Advisory Committee Meeting
This notice announces a public meeting of the Commerce Spectrum Management Advisory Committee (Committee). The Committee provides advice to the Assistant Secretary of Commerce for Communications and Information and the National Telecommunications and Information Administration (NTIA) on spectrum management policy matters.
Notice of Annual Adjustment of the Cap on Average Total Assets That Defines Community Financial Institutions
The Federal Housing Finance Agency (FHFA) has adjusted the cap on average total assets that defines a ``Community Financial Institution'' to $1,128,000,000, based on the annual percentage increase in the Consumer Price Index for all urban consumers (CPI-U) as published by the Department of Labor (DOL). These changes took effect on January 1, 2016.
Privacy Act of 1974; System of Records
The Defense Threat Reduction Agency proposes to add a new system of records, HDTRA 028, entitled ``AtHoc Emergency Mass- Notification System'' will be used to notify the workforce quickly with information in times of emergency (snow, fire, hurricane or other unforeseen situations that cause the Fort Belvoir/McNamara Complex to be closed).
Fisheries of the Northeastern United States; Amendment 17 to the Atlantic Surfclam and Ocean Quahog Fishery Management Plan
NMFS announces that the Mid-Atlantic Fishery Management Council has submitted Amendment 17 to the Atlantic Surfclam and Ocean Quahog Fishery Management Plan for review and approval by the Secretary of Commerce. We are requesting comments from the public on the amendment. Amendment 17 would establish cost recovery provisions for these individual transferable quota clam fisheries, modify how biological reference points are incorporated into the Fishery Management Plan, and remove the Plan's optimum yield range.
Caribou-Targhee National Forest; Ashton/Island Park Ranger Station; Idaho; Buffalo TSI
This project proposes to reduce or prolong the overall susceptibility to mountain pine beetle attacks and crown fires in a subset of previously harvested areas within the analysis area. Precommercial thinning is proposed so trees within these stands maintain diameter and height growth as well as increased crown development and to move this project area toward meeting specific goals, and objectives outlined in the Targhee National Forest Revised Forest Management Plan (RFP) and the Properly Functioning Condition Assessment (PFC).
Meeting of the Judicial Conference Advisory; Committee on Rules of Appellate Procedure
The Advisory Committee on Rules of Appellate Procedure will hold a meeting on April 5, 2016, which will continue the morning of April 6, 2016, if necessary. The meeting will be open to public observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at: https:// www.uscourts.gov/rules-policies/records-and-archives-rules-co mmittees/ agenda-books.
Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in Statistical Area 630 in the Gulf of Alaska
NMFS is prohibiting directed fishing for pollock in Statistical Area 630 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2016 total allowable catch of pollock for Statistical Area 630 in the GOA.
Reauthorization of the United States Grain Standards Act; Extension of Comment Period
The Department of Agriculture (USDA) Grain Inspection, Packers and Stockyards Administration (GIPSA) is extending the comment period for its proposed rule addressing changes to the United States Grain Standards Act (USGSA), as amended, in order to comply with amendments to the USGSA made by the Agriculture Reauthorizations Act of 2015.
Availability of Draft Toxicological Profiles; Jet Fuels and 1-Bromopropane
This notice, prepared by the Agency for Toxic Substances and Disease Registry (ATSDR) for the Department of Defense, announces the availability of two new draft toxicological profile on unregulated hazardous substances for review and comment. All toxicological profiles issued as ``Drafts for Public Comment'' represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. We are seeking public comments and additional information or reports on studies about the health effects of Jet Fuels and 1- Bromopropane for review and potential inclusion in the profile. ATSDR remains committed to providing a public comment period for these documents as a means to best serve public health and our clients. Comments can include additional information or reports on studies about the health effects of Jet Fuels and 1-Bromopropane. Although ATSDR will consider key studies for these substances during the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile.
Establishment of the Lamorinda Viticultural Area
The Alcohol and Tobacco Tax and Trade Bureau (TTB) establishes the approximately 29,369-acre ``Lamorinda'' viticultural area in Contra Costa County, California. The viticultural area lies entirely within the larger San Francisco Bay viticultural area and the multicounty Central Coast viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.
Proposed Information Collections; Comment Request (No. 58)
As part of our continuing effort to reduce paperwork and respondent burden, and as required by the Paperwork Reduction Act of 1995, we invite comments on the proposed or continuing information collections listed below in this notice.
Community Broadband Summit
The National Telecommunications and Information Administration (NTIA), through the BroadbandUSA program, in conjunction with Next Century Cities will hold a one-day regional broadband summit, ``Digital Northwest,'' to share information to help communities build their broadband capacity and utilization. The summit will present best practices and lessons learned from broadband network infrastructure build-outs and digital inclusion programs from the State of Washington and surrounding states, including projects funded by NTIA's Broadband Technology Opportunities Program (BTOP) and State Broadband Initiative (SBI) grant programs funded by the American Recovery and Reinvestment Act of 2009.\1\ The summit will also explore effective business and partnership models and will include access to regional policymakers, federal funders and industry providers.
Manufacturer of Controlled Substances Registration: Chemtos, LLC
Chemtos, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Chemtos, LLC registration as a manufacturer of those controlled substances.
Bulk Manufacturer of Controlled Substances Application: Insys Therapeutics, Inc.
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA).
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