April 18, 2016 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2016-04-18-ReaderAids
Type: Reader Aids
Date: 2016-04-18
Sunshine Act Meeting
Document Number: 2016-09039
Type: Notice
Date: 2016-04-18
Agency: National Credit Union Administration, Agencies and Commissions
Sunshine Act Meeting
Document Number: 2016-09035
Type: Notice
Date: 2016-04-18
Agency: Federal Election Commission, Agencies and Commissions
Notice of Availability of the Final Environmental Impact Statement for the Continental Divide-Creston Natural Gas Development Project, Wyoming
Document Number: 2016-09010
Type: Notice
Date: 2016-04-18
Agency: Department of the Interior, Bureau of Land Management
In accordance with the National Environmental Policy Act of 1969 (NEPA), as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Rawlins Field Office has prepared a final environmental impact statement (EIS) for the proposed Continental Divide-Creston Natural Gas Development Project (CD-C) in Rawlins, Wyoming, and by this notice announces its availability.
Sunshine Act Meeting
Document Number: 2016-09002
Type: Notice
Date: 2016-04-18
Agency: Federal Maritime Commission, Agencies and Commissions
Sunshine Act Meeting; Board Member Meeting
Document Number: 2016-08999
Type: Notice
Date: 2016-04-18
Agency: Federal Retirement Thrift Investment Board, Agencies and Commissions
Announcement of Grant Application Deadlines and Funding Levels
Document Number: 2016-08931
Type: Notice
Date: 2016-04-18
Agency: Department of Agriculture, Rural Utilities Service
The Rural Utilities Service (RUS), an agency of the United States Department of Agriculture (USDA), herein referred to as RUS or the Agency, announces its Community Connect Grant Program application window for Fiscal Year (FY) 2016. This notice is being issued in order to allow potential applicants time to submit proposals and give the Agency time to process applications within the current fiscal year. In addition to announcing the application window, RUS announces the minimum and maximum amounts for Community Connect grants applicable for the fiscal year. The Community Connect Grant Program regulation can be found at 7 CFR part 1739 (Subpart A).
Accreditation of Dixie Services Inc., as a Commercial Laboratory
Document Number: 2016-08930
Type: Notice
Date: 2016-04-18
Agency: Department of Homeland Security, U.S. Customs and Border Protection
Notice is hereby given, pursuant to CBP regulations, that Dixie Services, Inc., has been accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of September 9, 2015.
Announcement of an Open Public Meeting
Document Number: 2016-08929
Type: Notice
Date: 2016-04-18
Agency: Department of Education
This notice sets forth the schedule of an upcoming public meeting conducted by the National Advisory Council on Indian Education (NACIE). Notice of the meeting is required by section 10(a)(2) of the Federal Advisory Committee Act and intended to notify the public of its opportunity to attend. In order to facilitate the Secretary's attendance, this notice is being published less than 15 days prior to the scheduled meeting date.
Accreditation and Approval of Oiltest, Inc., as a Commercial Gauger and Laboratory
Document Number: 2016-08928
Type: Notice
Date: 2016-04-18
Agency: Department of Homeland Security, U.S. Customs and Border Protection
Notice is hereby given, pursuant to CBP regulations, that Oiltest, Inc., has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of December 11, 2014.
National Commission on Forensic Science Solicitation of Applications for Additional Commission Membership To Support Digital Evidence
Document Number: 2016-08926
Type: Notice
Date: 2016-04-18
Agency: Department of Justice
Pursuant to the Federal Advisory Committee Act, as amended, this notice announces the solicitation of applications for additional Commission membership to fill a current vacancy to support digital evidence.
Order Denying Export Privileges
Document Number: 2016-08920
Type: Notice
Date: 2016-04-18
Agency: Department of Commerce, Bureau of Industry and Security
Order Denying Export Privileges
Document Number: 2016-08919
Type: Notice
Date: 2016-04-18
Agency: Department of Commerce, Bureau of Industry and Security
Marine Highway Projects Open Season
Document Number: 2016-08918
Type: Notice
Date: 2016-04-18
Agency: Maritime Administration, Department of Transportation
The U.S. Department of Transportation (DOT) and Maritime Administration (MARAD) announce that the period for Marine Highway project submissions is being extended to December 31, 2018 (Open Season). The purpose of this notice is to extend the invitation to interested organizations to submit Marine Highway project applications to DOT for review and consideration.
National Wetland Plant List
Document Number: 2016-08917
Type: Notice
Date: 2016-04-18
Agency: Department of Defense, Department of the Army, Corps of Engineers
The U.S. Army Corps of Engineers (Corps), as part of an interagency effort with the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS) and the U.S. Department of Agriculture Natural Resources Conservation Service (NRCS), is announcing the availability of the final 2016 National Wetland Plant List (NWPL). The NWPL is used to determine whether the hydrophytic vegetation parameter is met when conducting wetland determinations under the Clean Water Act and the Wetland Conservation Provisions of the Food Security Act. Other applications of the list include wetland restoration, establishment, and enhancement projects. The list will become effective on May 1, 2016 and will be used in any wetland delineation performed after this date. Delineations received prior to this date may still use the 2014 NWPL, or you may choose to use the 2016 list. Always reference the list used on any wetland delineation/ determination forms.
Agency Information Collection Activities: Prior Disclosure
Document Number: 2016-08910
Type: Notice
Date: 2016-04-18
Agency: Department of Homeland Security, U.S. Customs and Border Protection
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Prior Disclosure. This is a proposed extension of information collection requirements that were previously approved. CBP is proposing these requirements be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Calcium Hypochlorite From the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2014-2015
Document Number: 2016-08907
Type: Notice
Date: 2016-04-18
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (``the Department'') is rescinding the administrative review of the countervailing duty order on calcium hypochlorite from the People's Republic of China (``PRC'') for May 27, 2014 through December 31, 2015.
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2016-08906
Type: Notice
Date: 2016-04-18
Agency: Federal Reserve System, Agencies and Commissions
Endangered and Threatened Species; Take of Anadromous Fish
Document Number: 2016-08905
Type: Notice
Date: 2016-04-18
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that NMFS has received an update to an application for a direct take permit, in the form of a Hatchery and Genetic Management Plan (HGMP), from the Chelan County Public Utility District (PUD) pursuant to the Endangered Species Act (ESA). The HGMP specifies the operation of a portion of a hatchery program rearing salmon in the Methow Basin within the State of Washington. This document serves to notify the public of the availability of the update to the existing permit application for comment prior to a decision by NMFS whether to issue the permit for the proposed hatchery program. NMFS also notifies the public of the intention to issue a separate ESA permit to the Confederated Tribes and Bands of the Yakama Nation for operation of a component of the program described in the application update.
Narrow Woven Ribbons With Woven Selvedge From Taiwan; Final Results of Antidumping Duty Administrative Review; 2013-2014
Document Number: 2016-08904
Type: Notice
Date: 2016-04-18
Agency: Department of Commerce, International Trade Administration
On October 7, 2015, the Department of Commerce (the Department) published the Preliminary Results of the fourth administrative review of the antidumping duty (AD) order on narrow woven ribbons with woven selvedge (NWR) from Taiwan.\1\ The review covers two producers/exporters of the subject merchandise, Roung Shu Industry Corporation (Roung Shu) and A-Madeus Textile Ltd. (A-Madeus). The period of review (POR) is September 1, 2013, through August 31, 2014. We gave interested parties an opportunity to comment on the Preliminary Results and, based upon our analysis of the comments, we continue to find that sales of subject merchandise to the United States have been made at prices below normal value (NV). The final dumping margins for the reviewed companies are listed below in the section entitled ``Final Results of the Review.''
Orders: Reporting by Regulated Entities of Stress Testing Results as of December 31, 2015; Summary Instructions and Guidance
Document Number: 2016-08903
Type: Rule
Date: 2016-04-18
Agency: Federal Housing Finance Agency
In this document, the Federal Housing Finance Agency (FHFA) provides notice that it issued Orders, dated March 2, 2016, with respect to stress test reporting as of December 31, 2015, under section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). Summary Instructions and Guidance accompanied the Orders to provide testing scenarios.
Notice of Request To Release Airport Property
Document Number: 2016-08902
Type: Notice
Date: 2016-04-18
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to rule and invites public comment on the release of land at the Hebron Municipal Airport (HJH), Hebron, Nebraska, under the provisions of 49 U.S.C. 47107(h)(2).
Tobacco Farm Site Tours Program
Document Number: 2016-08900
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing an invitation for participation in its voluntary Tobacco Farm Site Tours Program. This program is intended to give CTP staff an opportunity to visit farms that grow tobacco for sale to tobacco product manufacturers in order to gain a better understanding of tobacco farming and the processes involved in curing and preparing tobacco intended for sale to tobacco product manufacturers. This program is not an FDA regulatory inspection, and tobacco farms are not regulated entities unless they are also a tobacco product manufacturer or controlled by a tobacco product manufacturer. The purpose of this notice is to invite parties interested in participating in the Tobacco Farm Site Tours Program to submit requests to CTP.
Radiation Biodosimetry Medical Countermeasure Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-08899
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Radiation Biodosimetry Medical Countermeasure Devices.'' FDA has developed this guidance to provide industry and Agency staff with recommendations for the types of information that should be submitted to support marketing authorization for radiation biodosimetry medical countermeasure devices.
Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers
Document Number: 2016-08898
Type: Rule
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls) based on new information and subject to premarket notification. This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments class III devices, into that new classification regulation.
Agency Information Collection Activities: Application for Travel Document (Carrier Documentation), Form I-131A; New Collection
Document Number: 2016-08897
Type: Notice
Date: 2016-04-18
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on October 2, 2015, at 80 FR 59805, allowing for a 60-day public comment period. USCIS did receive two comments in connection with the 60-day notice.
Drawbridge Operation Regulation; Isle of Wight (Sinepatuxent) Bay, Ocean City, MD
Document Number: 2016-08896
Type: Rule
Date: 2016-04-18
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has issued a temporary deviation from the operating schedule that governs the US 50 (Harry W. Kelly Memorial) Bridge across the Isle of Wight (Sinepatuxent) Bay, mile 0.5, at Ocean City, MD. The deviation is necessary to accommodate participants of the 2016 ``Island 2 Island'' Half Marathon.
Notice of Realty Action: Recreation and Public Purposes Act Classification, Clark County, NV (N-80613)
Document Number: 2016-08895
Type: Notice
Date: 2016-04-18
Agency: Department of the Interior, Bureau of Land Management
The Bureau of Land Management (BLM) has examined and found suitable for classification under the Taylor Grazing Act, and for lease and conveyance under the provisions of the Recreation and Public Purposes (R&PP) Act, as amended, approximately 17.5 acres of public land in Clark County, Nevada. Clark County proposes to use the land for a community park. The 17.5-acre park will help meet future expanding needs in the southwestern part of Las Vegas Valley.
AbbVie Inc.; Withdrawal of Approval of New Drug Applications for ADVICOR and SIMCOR
Document Number: 2016-08894
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug applications (NDAs) for ADVICOR (niacin extended-release (ER) and lovastatin) tablets and SIMCOR (niacin ER and simvastatin) tablets. The holder of these two applications, AbbVie Inc., has requested that FDA withdraw approval of the applications and has waived its opportunity for a hearing. The Agency has also determined that ADVICOR and SIMCOR were withdrawn from sale for reasons of safety and effectiveness, and FDA will not accept or approve abbreviated new drug applications (ANDAs) that reference ADVICOR or SIMCOR.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program
Document Number: 2016-08893
Type: Notice
Date: 2016-04-18
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.
Proposed Agency Information Collection Activities; Comment Request
Document Number: 2016-08892
Type: Notice
Date: 2016-04-18
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions, Federal Reserve System, Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury
In accordance with the requirements of the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. chapter 35), the OCC, the Board, and the FDIC (the agencies) may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The agencies, under the auspices of the Federal Financial Institutions Examination Council (FFIEC), have approved the publication of proposed revisions to the Regulatory Capital Reporting for Institutions Subject to the Advanced Capital Adequacy Framework (FFIEC 101) for public comment. The proposed revisions to the FFIEC 101 are consistent with the revised regulatory capital rule approved by the agencies in July 2013 (regulatory capital rule), as amended by subsequent revisions to the supplementary leverage ratio (SLR). The proposed collection of SLR data in Tables 1 and 2 of FFIEC 101 Schedule A would apply to all banking organizations subject to the advanced approaches risk-based capital rule (generally, banking organizations with $250 billion or more in total consolidated assets or $10 billion or more in on-balance sheet foreign exposures) (advanced approaches banking organizations), unless the advanced approaches banking organization is (i) a consolidated subsidiary of a bank holding company (BHC), savings and loan holding company (SLHC), or depository institution that is subject to the disclosure requirements in Table 13 of section 173 of the advanced approaches risk-based capital rule (advanced approaches rule), or (ii) a subsidiary of a non-U.S. banking organization that is subject to comparable public disclosure requirements in its home jurisdiction. Advanced approaches banking organizations would begin reporting the proposed SLR data items in FFIEC 101 Schedule A, Tables 1 and 2, effective with the September 30, 2016, reporting date. Separately, the proposed collection of SLR data in Tables 1 and 2 of FFIEC 101 Schedule A would apply to any U.S. intermediate holding companies (IHCs) formed or designated for purposes of compliance with the Board's Regulation YY (12 CFR 252.153) that are advanced approaches banking organizations, effective with the March 31, 2018, reporting date. Any subsidiary BHC controlled by a foreign banking organization (FBO) that was subject to the SLR requirements prior to the formation of an IHC would complete FFIEC 101 Schedule A, Tables 1 and 2, through the December 31, 2017, reporting date. The agencies would release publicly Tables 1 and 2 of FFIEC 101 Schedule A for all covered banking organizations, including IHCs that are required to complete Schedule A. At the end of the comment period, the comments will be analyzed to determine the extent to which the FFIEC and the agencies should modify the proposed revisions. The agencies will then submit the proposed revisions to OMB for review and final approval.
Energy Conservation Program for Consumer Products and Certain Commercial and Industrial Equipment: Determination of Portable Air Conditioners as a Covered Consumer Product
Document Number: 2016-08891
Type: Rule
Date: 2016-04-18
Agency: Department of Energy
The U.S. Department of Energy (DOE) is classifying portable air conditioners (ACs) as a covered product under the Energy Policy and Conservation Act (EPCA), as amended. This classification is based on DOE's determination that portable ACs are a type of consumer product that meets the requisite criteria specified in EPCA. Specifically, DOE has determined that classifying portable ACs as a covered product is necessary or appropriate to carry out the purposes of EPCA, and that average U.S. household energy use by portable ACs is likely to exceed 100 kilowatt-hours (kWh) per year.
Information Collection Being Submitted for Review and Approval to the Office of Management and Budget
Document Number: 2016-08890
Type: Notice
Date: 2016-04-18
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Information Collections Being Reviewed by the Federal Communications Commission Under Delegated Authority
Document Number: 2016-08889
Type: Notice
Date: 2016-04-18
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of the Comment Period
Document Number: 2016-08888
Type: Proposed Rule
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule, published in the Federal Register of December 23, 2015 (80 FR 79776), revising its regulations on prescription and nonprescription fixed-combination and co-packaged drugs and on combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. FDA is reopening the comment period to permit time for additional comments.
AbbVie Inc. et al; Withdrawal of Approval of Indications Related to the Coadministration With Statins in Applications for Niacin Extended-Release Tablets and Fenofibric Acid Delayed-Release Capsules
Document Number: 2016-08887
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the indications related to the coadministration with a statin for niacin extended-release (ER) tablets and fenofibric acid delayed-release (DR) capsules. Affected applications include one new drug application (NDA) and seven abbreviated new drug applications (ANDAs) for niacin ER tablets, and one NDA and three ANDAs for fenofibric acid DR capsules. The holders of these applications have requested that FDA withdraw approval of the indications and have waived their opportunities for a hearing.
Appliance Standards and Rulemaking Federal Advisory Committee: Notice of Open Meetings for the Dedicated Purpose Pool Pumps (DPPP) Working Group To Negotiate a Notice of Proposed Rulemaking (NOPR) for Energy Conservation Standards
Document Number: 2016-08886
Type: Proposed Rule
Date: 2016-04-18
Agency: Department of Energy
The Department of Energy (DOE) announces public meetings and webinars for the DPPP Working Group. The Federal Advisory Committee Act requires that agencies publish notice of an advisory committee meeting in the Federal Register.
SeaOne Gulfport, LLC; Application for Long-Term, Multi-Contract Authorization To Export Natural Gas Contained in Compressed Gas Liquid to Non-Free Trade Agreement Countries
Document Number: 2016-08884
Type: Notice
Date: 2016-04-18
Agency: Department of Energy
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application (Application), filed on September 18, 2015, by SeaOne Gulfport, LLC (SeaOne), requesting long- term, multi-contract authorization to export up to a total of 1.0 billion cubic feet per day (Bcf/d) of natural gas contained in Compressed Gas Liquid (CGL) by vessel \1\ to any country located in or adjoining the Caribbean Basin and the Gulf of Mexico 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).\2\ SeaOne requests the authorization for a 30-year term to commence on the date of first commercial export. The Application was filed under section 3 of the Natural Gas Act (NGA), 15 U.S.C. Section 717b, and Part 590 of the Department of Energy's (``DOE'') regulations, 10 CFR part 590 (2011). SeaOne seeks to export the CGL from its proposed Gulfport CGL production facility, currently being developed within the existing Port of Gulfport, Mississippi. Additional details can be found in SeaOne's Application, posted on the DOE/FE Web site at http://energy.gov/sites/ prod/files/2016/04/f30/16-22-cgl.pdf and in SeaOne's response to questions, posted on the DOE/FE Web site at http://energy.gov/sites/ prod/files/2016/04/f30/Supplement.pdf. Protests, motions to intervene, notices of intervention, and written comments in response to the Application are invited.
Country-by-Country Reporting; Hearing
Document Number: 2016-08882
Type: Proposed Rule
Date: 2016-04-18
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document provides a notice of public hearing on proposed regulations that would require annual country-by-country reporting by certain United States persons that are the ultimate parent entity of a multinational enterprise group.
Public Meeting on Patient-Focused Drug Development for Neuropathic Pain Associated With Peripheral Neuropathy
Document Number: 2016-08881
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for neuropathic pain associated with peripheral neuropathies. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of neuropathic pain associated with peripheral neuropathies, patient views on treatment approaches, and decision factors taken into account when selecting a treatment.
Public Meeting on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Document Number: 2016-08880
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The meeting will take place on the FDA campus and also be broadcast on the Internet. The goal of this meeting is to provide information and receive comments on the ICH, as well as information related to the upcoming ICH meetings in Lisbon, Portugal, in June 2016. The topics to be discussed in the regional public meeting are the topics for discussion at the forthcoming ICH Assembly Meeting. The purpose of this regional public meeting is to solicit public input prior to the next Assembly and Expert Working Group meetings in Lisbon, Portugal, scheduled for June 11 through 16, 2016, at which the discussion of the topics underway and ICH reforms will continue to progress.
Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
Document Number: 2016-08879
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.'' This guidance describes how FDA intends to apply the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to drugs compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies.
Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2016-08878
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Section 503B defines an outsourcing facility, in part, as ``a facility at one geographic location or address.'' FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this draft guidance to answer these questions.
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
Document Number: 2016-08877
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use.
Agency Information Collection Activities; Proposed Collections; Comment Request
Document Number: 2016-08876
Type: Notice
Date: 2016-04-18
Agency: National Credit Union Administration, Agencies and Commissions
NCUA, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on these reinstatements of previously approved collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35).
Special Local Regulation, Daytona Beach Grand Prix of the Seas; Atlantic Ocean, Daytona Beach, FL
Document Number: 2016-08875
Type: Rule
Date: 2016-04-18
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a special local regulation on the waters of the Atlantic Ocean east of Daytona Beach, Florida during the Daytona Beach Grand Prix of the Seas, a series of high-speed personal watercraft boat races. This action is necessary to provide for the safety of life on the navigable waters surrounding the event. This special local regulation will be enforced daily 8 a.m. to 5 p.m., from April 22 through April 24, 2016. This rulemaking prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port (COTP) Jacksonville or a designated representative.
Agency Information Collection Activities: Account Based Disclosures in Connection With Truth in Savings; Comment Request
Document Number: 2016-08874
Type: Notice
Date: 2016-04-18
Agency: National Credit Union Administration, Agencies and Commissions
NCUA, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the submission for reinstatement of a previously approved collection, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). NCUA is soliciting comment on the reinstatement of the information collection described below.
Submission for OMB Review; Use of Project Labor Agreements for Federal Construction Projects
Document Number: 2016-08873
Type: Notice
Date: 2016-04-18
Agency: Department of Defense, General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration
Under the provisions of the Paperwork Reduction Act of 1995, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a new information collection requirement regarding Use of Project Labor Agreements for Federal Construction Projects. A notice published in the Federal Register at 81 FR 6516 on February 8, 2016. No comments were received.