July 19, 2016 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2016-07-19-ReaderAids
Type: Reader Aids
Date: 2016-07-19
Sunshine Act Meeting
Document Number: 2016-17168
Type: Notice
Date: 2016-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Sunshine Act Meeting
Document Number: 2016-17167
Type: Notice
Date: 2016-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Privacy Act of 1974, as Amended; System of Records Notice
Document Number: 2016-17146
Type: Notice
Date: 2016-07-19
Agency: National Archives and Records Administration, Agencies and Commissions
The National Archives and Records Administration (NARA) published notice in the Federal Register on June 8, 2016 (81 FR 36959) of a proposed new system of records subject to the Privacy Act of 1974, as amended (5 U.S.C. 552(a)) (``Privacy Act''). The new system was NARA 45, Insider Threat Program records. In addition, NARA updated Appendix B to add the SORN's system manager to the list of system managers and their addresses. The system of records notice (SORN) included a comment period ending on July 8, 2016, and an automatic effective date of July 18, 2016. However, NARA is now withdrawing this SORN due to changes in the scope of the system and it will no longer be effective. We will reissue the SORN once we have revised it.
Sunshine Act; Notice of FRTIB Board Member Meeting
Document Number: 2016-17141
Type: Notice
Date: 2016-07-19
Agency: Federal Retirement Thrift Investment Board, Agencies and Commissions
Sunshine Act Meeting Notice
Document Number: 2016-17140
Type: Notice
Date: 2016-07-19
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Sunshine Act Meeting Notice
Document Number: 2016-17121
Type: Notice
Date: 2016-07-19
Agency: Department of Energy, Federal Energy Regulatory Commission
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-17070
Type: Notice
Date: 2016-07-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 required 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.
Agency Information Collection Activities: Proposed Collection; Comment Request-FDPIR Nutrition Paraprofessional Training Assessment for Indian Tribal Organizations
Document Number: 2016-17066
Type: Notice
Date: 2016-07-19
Agency: Department of Agriculture, Food and Nutrition Service
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a new information collection for the Food Distribution Program on Indian Reservations.
Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, From the People's Republic of China: Final Results of Countervailing Duty Administrative Review; 2013
Document Number: 2016-17064
Type: Notice
Date: 2016-07-19
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (the Department) has completed its administrative review of the countervailing duty (CVD) order on crystalline silicon photovoltaic cells, whether or not assembled into modules (solar cells), from the People's Republic of China (the PRC) for the period of review (POR) covering January 1, 2013, through December 31, 2013. On January 8, 2016, we published the preliminary results of this review.\1\
Air Plan Approval; New Hampshire; Regional Haze 5-Year Report
Document Number: 2016-17063
Type: Proposed Rule
Date: 2016-07-19
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of New Hampshire on December 16, 2014. New Hampshire's SIP revision addresses requirements of the Clean Air Act (CAA) and EPA's rules that require states to submit periodic reports describing progress toward reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of the State's existing Regional Haze SIP. In addition, the December 16, 2014 submittal includes a revised regulation that reduces the total suspended particulate (TSP) emission limit for the State's sole Tangential-Firing, Dry-Bottom Boiler.
Importer of Controlled Substances Application: Rhodes Technologies
Document Number: 2016-17062
Type: Notice
Date: 2016-07-19
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
Document Number: 2016-17061
Type: Notice
Date: 2016-07-19
Agency: Drug Enforcement Administration, Department of Justice
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-17059
Type: Notice
Date: 2016-07-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands Management Area; Amendment 113
Document Number: 2016-17051
Type: Proposed Rule
Date: 2016-07-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The North Pacific Fishery Management Council (Council) has submitted Amendment 113 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) to the Secretary of Commerce (Secretary) for review. If approved, Amendment 113 to the FMP would modify the Bering Sea and Aleutian Islands (BSAI) Pacific cod fishery to set aside a portion of the Aleutian Islands Pacific cod total allowable catch (TAC) for harvest by vessels directed fishing for Aleutian Islands Pacific cod and delivering their catch for processing to shoreside processors located on land west of 170 W. longitude in the Aleutian Islands (Aleutian Islands shoreplants). The harvest set-aside would apply only if specific notification and performance requirements are met, and only during the first few months of the fishing year. This harvest set-aside would provide the opportunity for catcher vessels operating in the Aleutian Islands Pacific cod fishery, Aleutian Islands shoreplants, and the communities where Aleutian Islands shoreplants are located to receive benefits from the Aleutian Islands Pacific cod fishery, while the notification and performance requirements would preserve an opportunity for the complete harvest of the BSAI Pacific cod resource. Amendment 113 is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the FMP, and other applicable laws.
Multilayered Wood Flooring From the People's Republic of China: Rescission of Antidumping Duty New Shipper Review; 2013-2014
Document Number: 2016-17050
Type: Notice
Date: 2016-07-19
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (``Department'') published its Preliminary Rescission for the new shipper review (``NSR'') of the antidumping duty order on multilayered wood flooring from the People's Republic of China (``PRC'') on June 2, 2016.\1\ The period of review (``POR'') is December 1, 2013 through November 30, 2014. As discussed below, we preliminarily found that the sale made by Qingdao Barry Flooring Co., Ltd. (``Qingdao Barry'') is not bona fide, and announced our preliminary intent to rescind its NSR. For the final results of this review, we continue to find Qingdao Barry's sale to be non-bona fide. Therefore, we are rescinding this NSR.
Multilayered Wood Flooring From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2013-2014
Document Number: 2016-17049
Type: Notice
Date: 2016-07-19
Agency: Department of Commerce, International Trade Administration
On January 8, 2016, the Department of Commerce (``the Department'') published the preliminary results of the third administrative review (``AR'') of the antidumping duty (``AD'') order on multilayered wood flooring (``MLWF'') from the People's Republic of China (``the PRC''), in accordance with sections 751(a)(1)(B) and 751(a)(2)(B) of the Tariff Act of 1930, as amended (``the Act'').\1\ The period of review (``POR'') for the AR is December 1, 2013 through November 30, 2014. The AR covers 107 companies. The mandatory respondents in this review are: (1) Dalian Penghong Floor Products Co., Ltd. (``Penghong''); and (2) Fine Furniture (Shanghai) Limited (``Fine Furniture''). We received comments from interested parties on our Preliminary Results. Based on our analysis of the comments received, we made changes to the margin calculations for the final results of this administrative review. The final dumping margins are listed below in the ``Final Results'' section of this notice.
Proposed Information Collection; Comment Request
Document Number: 2016-17048
Type: Notice
Date: 2016-07-19
Agency: Corporation for National and Community Service, Agencies and Commissions
The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, CNCS is soliciting comments concerning its proposed new application instructions for AmeriCorps Affiliate. Brief description: Applicants for the AmeriCorps Affiliate program will submit an application following the application instructions. Completion of the information collection is required to be considered for Education Awards. No grant funding is available through AmeriCorps Affiliate. Copies of the information collection request can be obtained by contacting the office listed in the ADDRESSES section of this Notice.
Guidance for Closure of Activities Related to Recommendation 2.1, Flooding Hazard Reevaluation
Document Number: 2016-17047
Type: Notice
Date: 2016-07-19
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing the final Japan Lessons-Learned Division Interim Staff Guidance (JLD-ISG), JLD-ISG-2016-01, ``Guidance for Activities Related to Near-Term Task Force Recommendation 2.1, Flooding Hazard Reevaluation; Focused Evaluation and Integrated Assessment.'' The JLD-ISG provides guidance and clarification to assist operating power reactor licensees and holders of construction permits under the NRC's regulations with the performance of the focused evaluations and revised integrated assessments for external flooding.
Meeting of the United States Manufacturing Council
Document Number: 2016-17046
Type: Notice
Date: 2016-07-19
Agency: Department of Commerce, International Trade Administration
The United States Manufacturing Council (Council) will hold an open meeting via livestream on Wednesday, August 3, 2016. The Council was established in April 2004 to advise the Secretary of Commerce on matters relating to the U.S. manufacturing industry. The purpose of the meeting is for Council members to review and deliberate a letter that summarizes the Council's recommendations and provides advice to the Secretary on the future of the Manufacturing Council. The final agenda will be posted on the Department of Commerce Web site for the Council at http://www.trade.gov/manufacturingcouncil/, at least one week in advance of the meeting.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products
Document Number: 2016-17044
Type: Notice
Date: 2016-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Reef Fish Fishery of the Gulf of Mexico; 2016 Recreational Accountability Measures and Closure for Gulf of Mexico Gray Triggerfish
Document Number: 2016-17043
Type: Rule
Date: 2016-07-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS implements accountability measures (AMs) for the gray triggerfish recreational sector in the exclusive economic zone (EEZ) of the Gulf of Mexico (Gulf) for the 2016 fishing year through this temporary rule. NMFS has determined that the 2015 recreational annual catch limit (ACL) for Gulf gray triggerfish was exceeded; therefore, NMFS reduces the gray triggerfish recreational ACL and annual catch target (ACT) in 2016. NMFS has also determined that the recreational ACT for Gulf gray triggerfish was reached prior to the June 1 annual season closure. Therefore, the gray triggerfish recreational season in the Gulf EEZ will remain closed and will not be re-opening on August 1, 2016. This closure is necessary to protect the Gulf gray triggerfish resource.
Agency Information Collection Activities: Petition for Nonimmigrant Worker, Form I-129; Extension, Without Change, of a Currently Approved Collection
Document Number: 2016-17042
Type: Notice
Date: 2016-07-19
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information or new collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.
Agency Information Collection Activities: Registration for Classification as a Refugee, Form I-590; Revision of a Currently Approved Collection
Document Number: 2016-17041
Type: Notice
Date: 2016-07-19
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.
Annual Determination of Average Cost of Incarceration
Document Number: 2016-17040
Type: Notice
Date: 2016-07-19
Agency: Department of Justice, Bureau of Prisons
The fee to cover the average cost of incarceration for Federal inmates in Fiscal Year 2015 was $31,977.65 ($87.61 per day). (Please note: There were 365 days in FY 2015.) The average annual cost to confine an inmate in a Residential Re-entry Center for Fiscal Year 2015 was $26,082.90 ($71.46 per day).
Safety Zone; Navy UNDET, Apra Outer Harbor, GU
Document Number: 2016-17036
Type: Rule
Date: 2016-07-19
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary safety zone for navigable waters within a 700-yard radius on the surface and 1400-yard radius underwater of the Navy underwater detonation operations in the waters of Apra Outer Harbor, Guam. The Coast Guard believes this safety zone regulation is necessary to protect all persons and vessel that would otherwise transit or be within the affected areas from possible safety hazards associated with underwater detonation operations. Entry of vessels or persons into these zones is prohibited unless specifically authorized by the Captain of the Port Guam.
State Alternative Plan Program (SAPP) and the First Responder Network Authority Nationwide Public Safety Broadband Network
Document Number: 2016-17034
Type: Notice
Date: 2016-07-19
Agency: Department of Commerce, National Telecommunications and Information Administration
The National Telecommunications and Information Administration (NTIA) publishes this Notice to provide preliminary guidance concerning how a qualified state may apply to NTIA for authority to enter into a spectrum capacity lease with the First Responder Network Authority (FirstNet) and receive a grant to construct its radio access network (RAN) should it opt to do so as allowed under the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96, Title VI, 126 Stat. 256 (codified at 47 U.S.C. 1401 et seq.) (Act). NTIA also seeks public comment on this preliminary guidance through this Notice.
Agency Information Collection Activities: Proposed Collection: Public Comment Request-Scholarships for Disadvantaged Students Program
Document Number: 2016-17031
Type: Notice
Date: 2016-07-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c) (2) (A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Program Fraud Civil Remedies: Civil Monetary Penalty Inflation Adjustment
Document Number: 2016-17026
Type: Rule
Date: 2016-07-19
Agency: Office of Personnel Management
This rule adjusts the level of civil monetary penalties contained in U.S. Office of Personnel Management regulations implementing the Program Fraud Civil Remedies Act of 1986, with an initial ``catch-up'' adjustment under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and Office of Management and Budget guidance.
Rio Grande LNG, LLC; Application for Long-Term, Multi-Contract Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement Nations
Document Number: 2016-17025
Type: Notice
Date: 2016-07-19
Agency: Department of Energy
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application, filed on December 23, 2015, amended on June 7, 2016 (Application), by Rio Grande LNG, LLC (Rio Grande LNG). Rio Grande LNG requests long-term, multi-contract authorization to export domestically produced liquefied natural gas (LNG) in a volume equivalent to approximately 1,318 billion cubic feet (Bcf) per year of natural gas (3.61 Bcf per day). Rio Grande LNG seeks to export the LNG by vessel from its proposed natural gas liquefaction and LNG export terminal to be located in Cameron County, Texas, along the north embankment of the Brownsville Ship Channel (Rio Grande LNG Project). Rio Grande LNG requests authorization to export this LNG to any country with which the United States does not have a free trade agreement (FTA) requiring national treatment for trade in natural gas, and with which trade is not prohibited by U.S. law or policy (non-FTA countries).\1\ Rio Grande LNG seeks authorization to export this LNG for (a) a single 20-year primary term applicable to the entire Rio Grande LNG Project consisting of six (6) liquefaction trains commencing on the earlier of (i) the date of first export from the first of the Rio Grande LNG Project's trains to be commissioned, or (ii) seven (7) years from the date of the DOE/FE order authorizing such exports, coupled with (b) a five (5) year Make-Up Period at the conclusion of the 20-year primary term.\2\ Rio Grande LNG seeks to export this LNG on its own behalf and as agent for other entities who hold title to the LNG at the time of export. The Application was filed under section 3 of the Natural Gas Act (NGA). Additional details can be found in Rio Grande LNG's Application, posted on the DOE/FE Web site at: https://cms.doe.gov/ sites/prod/files/2016/07/f33/Rio_Grande15_190-LNG_App.pdf and in the amendment to the Application, posted on the DOE/FE Web site at: https:/ /cms.doe.gov/sites/prod/files/2016/07/f33/RGLNG_Amend06_07_16 .pdf. Protests, motions to intervene, notices of intervention, and written comments are invited.
Excess Uranium Management: Effects of DOE Transfers of Excess Uranium on Domestic Uranium Mining, Conversion, and Enrichment Industries; Request for Information
Document Number: 2016-17024
Type: Notice
Date: 2016-07-19
Agency: Department of Energy
The U.S. Department of Energy (DOE) is preparing for a potential new Secretarial Determination covering transfers of uranium for cleanup services at the Portsmouth Gaseous Diffusion Plant and for down-blending of highly-enriched uranium to low-enriched uranium (LEU). This RFI solicits information from the public about the uranium markets and domestic uranium industries, and the potential effects of DOE transfers in the uranium markets and possible consequences for the domestic uranium mining, conversion and enrichment industries. DOE will consider this information as part of its analysis to determine whether its transfers would have an adverse material impact on the domestic uranium mining, conversion, or enrichment industry.
Notice of Proposed Reinstatement of Terminated Oil and Gas Lease WYW160587, Wyoming
Document Number: 2016-17023
Type: Notice
Date: 2016-07-19
Agency: Department of the Interior, Bureau of Land Management
Anadarko E&P Onshore, LLC and WPX Energy Rocky Mountain, LLC have filed a petition for reinstatement of competitive oil and gas lease WYW160587, which is located in Campbell County, Wyoming. The petition was filed on time and consistent with the Mineral Leasing Act of 1920. The lessee has paid the required rentals accruing from the date of termination. No leases that affect these lands were issued before the petition was filed.
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2016-17022
Type: Notice
Date: 2016-07-19
Agency: Federal Reserve System, Agencies and Commissions
Notice of Proposed Reinstatement of Terminated Oil and Gas Lease WYW178491, Wyoming
Document Number: 2016-17021
Type: Notice
Date: 2016-07-19
Agency: Department of the Interior, Bureau of Land Management
Hilcorp Energy I, L.P. has filed a petition for reinstatement of competitive oil and gas lease WYW178491, which is located in Crook County, Wyoming. The petition was filed on time and consistent with the Mineral Leasing Act of 1920. The lessee has paid the required rentals accruing from the date of termination. No leases that affect these lands were issued before the petition was filed.
Renewal of Approved Information Collection; OMB Control No. 1004-0132
Document Number: 2016-17020
Type: Notice
Date: 2016-07-19
Agency: Department of the Interior, Bureau of Land Management
In compliance with the Paperwork Reduction Act, the Bureau of Land Management (BLM) invites public comments on, and plans to request approval to continue, the collection of information from those who wish to participate in the exploration, development, production, and utilization of geothermal resources on BLM-managed public lands, and on lands managed by other Federal agencies. The Office of Management and Budget (OMB) has assigned control number 1004-0132 to this information collection.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2016-17019
Type: Notice
Date: 2016-07-19
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Lawrence Livermore National Laboratory in Livermore, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2016-17018
Type: Notice
Date: 2016-07-19
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Idaho National Laboratory in Scoville, Idaho, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2016-17017
Type: Notice
Date: 2016-07-19
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Argonne National Laboratory-West in Scoville, Idaho, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards
Document Number: 2016-17016
Type: Notice
Date: 2016-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information related to certain regulations that provide protection for human subjects of clinical investigations conducted in support of applications or submissions to FDA for FDA-regulated products. The regulations provide protection of the rights, safety, and welfare of human subjects involved in research activities within FDA's jurisdiction.
Pediatric Clinical Investigator Training Workshop; Correction
Document Number: 2016-17015
Type: Notice
Date: 2016-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 16, 2016 (81 FR 39271). The document announced a ``Pediatric Clinical Investigator Training'' workshop and contained an incorrect Web link for registration and an incorrect Web link for more information on the workshop. This document corrects those errors.
Certain Windscreen Wipers and Components Thereof; Notice of a Commission Determination Not To Review an Initial Determination Granting a Joint Motion To Terminate the Investigation Based on a Settlement Agreement
Document Number: 2016-17011
Type: Notice
Date: 2016-07-19
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 29) issued by the presiding administrative law judge (``ALJ'') granting a joint motion to terminate the investigation based on a settlement agreement.
Alaska Energy Authority; Notice of Availability of Final Environmental Assessment
Document Number: 2016-17010
Type: Notice
Date: 2016-07-19
Agency: Department of Energy, Federal Energy Regulatory Commission
E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report-Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability
Document Number: 2016-17009
Type: Notice
Date: 2016-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation ReportQuestions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.
Pre-Clinical Evaluation of Red Blood Cells for Transfusion; Public Workshop
Document Number: 2016-17008
Type: Notice
Date: 2016-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Pre-Clinical Evaluation of Red Blood Cells for Transfusion.'' The purpose of the public workshop is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red blood cell transfusion products. The workshop has been planned in partnership with the National Heart, Lung, and Blood Institute; National Institutes of Health (NIH); the Department of Defense; and the Office of the Assistant Secretary for Health, Department of Health and Human Services. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government Agencies.
Inspection of Towing Vessels
Document Number: 2016-17007
Type: Rule
Date: 2016-07-19
Agency: Coast Guard, Department of Homeland Security
The Coast Guard announces that the Office of Management and Budget (OMB) has approved the collection of information described in the Inspection of Towing Vessels final rule published on June 20, 2016. In that rule, which establishes safety regulations governing the inspection, standards, and safety management systems of towing vessels, we stated that before the Coast Guard could enforce the collection of information requirements in the rule, OMB would need to approve the Coast Guard's request to collect this information. This document announces that approval. On June 23, 2016, OMB approved this Coast Guard request and assigned this collection of information OMB control number 1625-0117.
Drawbridge Operation Regulation; State Boat Channel, Captree Island, NY
Document Number: 2016-17006
Type: Rule
Date: 2016-07-19
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Captree State Parkway Bridge across the State Boat Channel, mile 30.7 at Captree Island, New York. This deviation is necessary to allow the bridge owner to perform painting and steel repairs.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Care Coordination Network Partnership
Document Number: 2016-17005
Type: Notice
Date: 2016-07-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Approval of Barrios Measurement Services LLC, as a Commercial Gauger
Document Number: 2016-17004
Type: Notice
Date: 2016-07-19
Agency: Department of Homeland Security, U.S. Customs and Border Protection
Notice is hereby given, pursuant to CBP regulations, that Barrios Measurement Services LLC, has been approved to gauge petroleum and petroleum products for customs purposes for the next three years as of March 31, 2016.
Accreditation and Approval of Camin Cargo Control, Inc., as a Commercial Gauger and Laboratory
Document Number: 2016-17003
Type: Notice
Date: 2016-07-19
Agency: Department of Homeland Security, U.S. Customs and Border Protection
Notice is hereby given, pursuant to CBP regulations, that Camin Cargo Control, Inc., has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of July 15, 2015.