Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a provision to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.
Determination of Regulatory Review Period for Purposes of Patent Extension; CARBON DIOXIDE LASER
The Food and Drug Administration (FDA) has determined the regulatory review period for CARBON DIOXIDE LASER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the United States Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that food additive.
Agency Information Collection Activities: Application for Regional Center Under the Immigrant Investor Program and Supplement, Form I-924 and I-924A; Revision of a Currently Approved Collection
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (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.
Agency Information Collection Activities; Comment Request; College Affordability and Transparency Explanation Form (CATEF) 2015-2017
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection
The Department of Justice, Civil Rights Division, Office of Special Counsel for Immigration-Related Unfair Employment Practices, will be submitting the following information collection request to the Office of Management and Budget for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the Federal Register, Volume 79, Number 159, page 48765, on August 18, 2014, allowing for a 60-day comment period.
Proposed Information Collection; Comment Request; Non-Economic Valuation of Subsistence Salmon in Alaska
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Endangered and Threatened Species; Initiation of a Status Review for the Guadalupe Fur Seal
The National Marine Fisheries Service (NMFS) announces a status review of the Guadalupe fur seal (Arctocephalus townsendi) under the Endangered Species Act of 1973 (ESA). A status review is a periodic undertaking conducted to ensure that the listing classification of a species is accurate. A status review is based on the best scientific and commercial data available at the time of the review; therefore, we are requesting submission of any such information on the Guadalupe fur seal population in the eastern Pacific waters that has become available since the last Guadalupe fur seal status review in 1984.
New Postal Product
The Commission is noticing a recent Postal Service filing concerning the contingency prices pursuant to an existing International Business Reply Service (IBRS) Competitive Contract 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Releasing Information; General Provisions; Accounting and Reporting Requirements; Reports of Accounts and Exposures
The Farm Credit Administration (FCA, we, or our) issued a final rule on December 24, 2013, to establish a regulatory framework for Farm Credit System (System) banks and associations to report their accounts and exposures to the FCA. The final rule required compliance as of the effective date, which was February 21, 2014, except for certain Reporting Entity's requirements. The compliance date for those requirements was delayed to allow for the development of and transition to the System's central data repository. This document provides the compliance date for the Reporting Entity requirements.
Approval and Promulgation of Implementation Plans; North Dakota; Revisions to the Air Pollution Control Rules
EPA is approving changes to North Dakota's State Implementation Plan (SIP). On January 23, 2013, the Governor of North Dakota submitted to EPA revisions to several chapters of the North Dakota SIP. These revisions included the removal of subsections 33-15- 03-04.4 and 33-15-05-01.2.a(l) of the North Dakota Administrative Code (NDAC). In this action, EPA is approving the removal of these subsections from the SIP because it is consistent with Clean Air Act (CAA) requirements. The State's submission corrects certain deficiencies related to the treatment of excess emissions from sources. EPA will address the remaining revisions from North Dakota's January 23, 2013 submission in other actions.
Benefits of Neonicotinoid Seed Treatments to Soybean Production; Notice of Availability
This notice announces the availability of EPA's Benefits of Neonicotinoid Seed Treatments to Soybean Production document, and opens a public comment period on that document. The Agency has conducted this assessment as part of its ongoing re-evaluation of clothianidin, imidacloprid, and thiamethoxam under the registration review program. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, that the pesticide can perform its intended function without causing unreasonable adverse effects on human health or the environment. Through this program, EPA considers both potential risks and benefits of pesticides. This assessment examines the use of clothianidin, imidacloprid, and thiamethoxam seed treatments in terms of the extent of use and the pests targeted in order to characterize overall benefits to soybean production nationwide.
Direct Grant Programs and Definitions That Apply to Department Regulations
On August 13, 2013, the Department of Education (the Department) published a notice of final regulations in the Federal Register to amend our Education Department General Administrative Regulations (EDGAR). In this document, the Department proposes to further amend EDGAR to add a definition of ``What Works Clearinghouse Evidence Standards'' (WWC Evidence Standards) in our regulations to standardize references to this term. In addition, the Department proposes to amend the definition of ``large sample'' in our regulation. We also propose technical edits to our regulations to improve the consistency and clarity of the regulations. Finally, we propose to redesignate our regulations and to include in that redesignated section an additional provision that would allow the Secretary to give special consideration to projects supported by evidence of promise.
Renaming of Express Mail® to Priority Mail Express®
The United States Patent and Trademark (Office) is revising the rules of practice to change the phrase Express Mail or EXPRESS MAIL[supreg] to Priority Mail Express[supreg] due to the United States Postal Service (USPS) renaming Express Mail[supreg] to Priority Mail Express[supreg] on July 28, 2013, and to make other changes to conform the nomenclature used in the rules of practice to the current nomenclature used by the USPS.
Approval and Promulgation of Implementation Plans; State of Kansas; Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standard
The Environmental Protection Agency (EPA) is taking final action to approve elements of a State Implementation Plan (SIP) submission from the State of Kansas addressing the applicable requirements of Clean Air Act (CAA) section 110 for the 2010 National Ambient Air Quality Standards (NAAQS) for Nitrogen Dioxide (NO2), which requires that each state adopt and submit a SIP to support implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by EPA. These SIPs are commonly referred to as ``infrastructure'' SIPs. The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA.
Call for Applications for the International Buyer Program Calendar Year 2016
In this notice, the U.S. Department of Commerce (DOC) International Trade Administration (ITA) announces that it will begin accepting applications for the International Buyer Program (IBP) for calendar year 2016 (January 1, 2016 through December 31, 2016). The announcement also sets out the objectives, procedures and application review criteria for the IBP. The purpose of the IBP is to bring international buyers together with U.S. firms in industries with high export potential at leading U.S. trade shows. Specifically, through the IBP, the ITA selects domestic trade shows which will receive ITA assistance in the form of global promotion in foreign markets, provision of export counseling to exhibitors, and provision of matchmaking services at the trade show. This notice covers selection for IBP participation during calendar year 2016.
Requirements for the Distribution and Control of Donated Foods
This rule proposes to revise and clarify requirements to ensure that USDA donated foods are distributed, stored, and managed in the safest, most efficient, and cost-effective manner, at State and recipient agency levels. The rule would also reduce administrative and reporting requirements for State distributing agencies, revise or clarify regulatory provisions relating to accountability for donated foods, and rewrite much of the regulations in a more user-friendly, ``plain language,'' format. Lastly, the rule proposes to revise and clarify specific requirements to conform more closely to related requirements elsewhere in the Code of Federal Regulations. In formulating the proposals, the Food and Nutrition Service (FNS) has utilized input received from program administrators, industry representatives, and other organizations at national conferences and other meetings, and through email or other routine communications with such parties.
Proposed Removal of Certain Inert Ingredients From Approved Chemical Substance List for Pesticide Products
EPA is proposing to remove certain chemical substances from the current listing of inert ingredients approved for use in pesticide products because the inert ingredients are no longer used in any registered pesticide product.
Effluent Limitations Guidelines and Standards for the Dental Category
EPA is proposing technology-based pretreatment standards under the Clean Water Act (CWA) for discharges of pollutants into publicly owned treatment works (POTWs) from existing and new dental practices that discharge dental amalgam. Dental amalgam contains mercury in a highly concentrated form that is relatively easy to collect and recycle. Dental offices are the main source of mercury discharges to POTWs. Mercury is a persistent and bioaccumulative pollutant in the environment with well-documented neurotoxic effects on humans. Mercury pollution is widespread and comes from many diverse sources such as air deposition from municipal and industrial incinerators and combustion of fossil fuels. Mercury easily becomes diffuse in the environment and mercury pollution is a global problem. Removing mercury from the waste stream when it is in a concentrated and easy to handle form like in waste dental amalgam is an important and commonsense step to take to prevent that mercury from being released back into the environment where it can become diffuse and a hazard to humans. The proposal would require dental practices to comply with requirements for controlling the discharge of mercury and other metals in dental amalgam into POTWs based on the best available technology or best available demonstrated control technology. Specifically, the requirements would be based on the use of amalgam separators and best management practices (BMPs). Amalgam separators are a practical, affordable and readily available technology for capturing mercury and other metals before they are discharged into sewers and POTWs. EPA is also proposing to amend selected parts of the General Pretreatment Regulations to streamline oversight requirements for the dental sector. EPA expects compliance with this proposed rule would reduce the discharge of metals to POTWs by at least 8.8 tons per year, about half of which is mercury. EPA estimates the annual cost of the proposed rule would be $44 to $49 million.
Airworthiness Directives; Airbus Airplanes
We propose to supersede Airworthiness Directive (AD) 2011-19- 04, for all Airbus Model A318, A319, A320, and A321 series airplanes. AD 2011-19-04 currently requires repetitive inspections of the left- hand and right-hand inboard and outboard elevator servo-control rod eye-ends for cracking, and corrective actions if necessary. Since we issued AD 2011-19-04, we have determined that certain elevator servo- control parts that do not conform to the approved type design have been installed and may have the potential of cracks in the rod eye-end. This proposed AD would also require an inspection to determine if certain elevator servo-control parts are installed, and replacement if necessary. We are proposing this AD to detect and correct rod eye-end cracking, which could result in an uncontrolled elevator surface and consequent reduced control of the airplane.
Drawbridge Operation Regulations; Long Island, New York Inland Waterway From East Rockaway Inlet to Shinnecock Canal, Nassau, NY
The Coast Guard has issued a temporary deviation from the operating schedule that governs the operation of the Long Beach Bridge, across Reynolds Channel, mile 4.7, at Nassau, New York. This deviation is necessary to allow the bridge to remain in the closed position for thirty days to facilitate scheduled bridge maintenance, the replacement of the concrete bridge deck.
Drawbridge Operation Regulations; Newtown Creek, Dutch Kills, English Kills and Their Tributaries, NY
The Coast Guard has issued a temporary deviation from the operating schedule that governs the operation of the Metropolitan Avenue Bridge across English Kills, mile 3.4, at Brooklyn, New York. The bridge owner, New York City Department of Transportation, will be performing electrical repairs at the bridge. This deviation is necessary to allow the bridge to remain in the closed position for three days to facilitate scheduled bridge maintenance.
Drawbridge Operation Regulation; Houma Navigation Canal, Houma, Terrebonne Parish, LA
The Coast Guard has issued a temporary deviation from the operating schedule that governs the SR 661 Swing Bridge across the Houma Navigation Canal, mile 36.0, in Houma, Terrebonne Parish, Louisiana. This deviation allows the bridge to remain closed to navigation for up to four hours at a time during daylight hours for the purpose of conducting necessary maintenance and repairs to the drawbridge.
Drawbridge Operation Regulations; Cheesequake Creek, NJ
The Coast Guard has issued a temporary deviation from the operating schedule that governs the operation of the New Jersey Transit Rail Operations (NJTRO) railroad bridge across Cheesequake Creek, mile 0.2, at Morgan, New Jersey. The bridge owner will be performing structural repairs at the bridge. This deviation is necessary to allow the bridge to have only scheduled openings for two weekends to facilitate scheduled bridge maintenance.
Regulated Navigation Area; Slip 4 Early Action Area Superfund Site, Lower Duwamish Waterway, Seattle, WA
The Coast Guard is establishing a regulated navigation area (RNA) on a portion of the Lower Duwamish Waterway in Seattle, Washington. The RNA will protect the riverbed in the U.S. Environmental Protection Agency's (EPA) Slip 4 Early Action Area (EAA). This RNA would prohibit activities that could disrupt the integrity of the engineered sediment and slope caps that have been placed within the Slip 4 EAA. These activities include vessel grounding, anchoring, dragging, trawling, spudding or other such activities that would disturb the riverbed. It will not affect transit or navigation of this area.
Notification of a Closed Teleconference of the Science Advisory Board's Scientific and Technological Achievement Awards Committee
The Environmental Protection Agency's (EPA), Science Advisory Board (SAB) Staff Office is announcing a teleconference of the SAB's Scientific and Technological Achievement Awards (STAA) Committee to discuss draft recommendations for the chartered SAB regarding the Agency's 2013 and 2014 STAA recipients. The STAA Committee teleconference will be closed to the public.
Projects Approved for Consumptive Uses of Water
This notice lists the projects approved by rule by the Susquehanna River Basin Commission during the period set forth in DATES.
Notice of Filing of Plats of Survey; Arizona
The plats of survey of the described lands were officially filed in the Arizona State Office, Bureau of Land Management, Phoenix, Arizona, on dates indicated.
Notice of Meeting
The Privacy and Civil Liberties Oversight Board will conduct a public meeting with industry representatives, academics, technologists, government personnel, and members of the advocacy community, on the topic: ``Defining Privacy.'' While the Board will address the definition of privacy in the context of government counterterrorism programs, it is also interested in what conceptual interests are involved in the protection of privacy, how the impact of technology has affected privacy, what privacy interests have been identified by government privacy officials, what lessons have been learned in the private sector, and what the best way is for government to address privacy concerns. Interested parties are encouraged to attend and to submit comments. The meeting and comments will inform the Privacy and Civil Liberties Oversight Board's approach to privacy issues within its statutory purview. Visit www.pclob.gov for a list of panelists closer to the meeting date.
General Services Administration Acquisition Regulation; (GSAR); Qualifications of Offerors
The General Services Administration (GSA) is amending the General Services Administration Acquisition Regulation (GSAR) to remove the GSAR provision Qualifications of Offerors.
Meetings of Humanities Panel
The National Endowment for the Humanities will hold sixteen meetings of the Humanities Panel, a federal advisory committee, during November, 2014. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965.
Open Meeting of the Federal Advisory Committee on Insurance
This notice announces that the Department of the Treasury's Federal Advisory Committee on Insurance will convene a meeting on Thursday, November 6, 2014, in the Cash Room, 1500 Pennsylvania Avenue NW., Washington, DC 20220, from 1:00 to 4:00 p.m. Eastern Time. The meeting is open to the public, and the site is accessible to individuals with disabilities.
Protection of Stratospheric Ozone: Determination 29 for Significant New Alternatives Policy Program
This Determination of Acceptability expands the list of acceptable substitutes for ozone-depleting substances under the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy (SNAP) program. This action lists as acceptable additional substitutes for use in the refrigeration and air conditioning, foam blowing, and fire suppression and explosion protection sectors.
Sanctions Actions Pursuant to Executive Orders 13660, 13661 and 13662
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is providing additional notice of the following actions, which were taken between March 20, 2014 and October 6, 2014 to address the national emergency declared by the President with respect to situation in Ukraine: (1) Blocking of property and interests in property of certain persons pursuant to Executive Orders (E.O.s) 13660 or 13661 (the names of these persons have been added to OFAC's Specially Designated Nationals and Blocked Persons List (SDN List)); (2) sectoral determinations by the Secretary of the Treasury pursuant to E.O. 13662; (3) Original Directive 1 (July 16, 2014) under E.O. 13662 and determinations that certain persons are subject to Original Directive 1 (the names of these persons have been added to the Sectoral Sanctions Identifications List (SSI List)) (this directive has been superseded as noted below and is being provided for historical reference purposes only); (4) Original Directive 2 (July 16, 2014) under E.O. 13662 and a determination that certain persons are subject to Original Directive 2 (the names of these persons have been added to the SSI List) (this directive has been superseded as noted below and is being provided for historical reference purposes only); (5) Directive 1 (as amended) (September 12, 2014) under E.O. 13662 and a determination that certain persons are subject to Directive 1 (as amended) (the names of these persons have been added to the SSI List); (6) Directive 2 (as amended) (September 12, 2014) under E.O. 13662 and a determination that certain persons are subject to Directive 2 (as amended) (the names of these persons have been added to the SSI List); (7) Directive 3 (September 12, 2014) under E.O. 13662 and a determination that certain persons are subject to Directive 3 (the names of these persons have been added to the SSI List); (8) Directive 4 (September 12, 2014) under E.O. 13662 and a determination that certain persons are subject to Directive 4 (the names of these persons have been added to the SSI List); (9) General License 1 (July 16, 2014) (this general license has been superseded as noted below and is being provided for historical reference purposes only); (10) General License 1A (September 12, 2014); (11) General License 2 (September 12, 2014) (this general license was time limited, has expired as noted below, and is being provided for historical reference purposes only); and (12) General License 3 (October 6, 2014).
Proposed Agency Information Collection Activities; Comment Request
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the renewal Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected burden. The Federal Register notice with a 60-day comment period soliciting comments on the following collection of information was published on August 5, 2014 (79 FR 45585).
Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Uinkaret Mountains Landscape Restoration Project, Arizona Strip, Mohave County, AZ
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Grand Canyon- Parashant National Monument and Arizona Strip Field Office, St. George, Utah, intend to prepare an Environmental Impact Statement (EIS) for the Uinkaret Mountains Landscape Restoration Project and by this notice is announcing the beginning of the scoping process to solicit public comments and identify issues.
Energy Conservation Program: Test Procedures for Fluorescent Lamp Ballasts; Correction
The U.S. Department of Energy (DOE) proposes to amend its test procedures for fluorescent lamp ballasts. Proposed changes include adopting text at its regulations concerning test procedures for the measurement of energy and water consumption to clarify the requirement to use the test procedures in Appendix Q1 to demonstrate compliance with the new and revised energy conservation standards that apply to fluorescent lamp ballasts manufactured on or after November 14, 2014. These revisions follow the intent of the fluorescent lamp ballast test procedure final rule to support any new or revised energy conservation standards at the time those standards require compliance. This notice of proposed rulemaking (NOPR) would also correct the formula for power factor, which contained a mathematical error as adopted in that final rule.
Environmental Management Site-Specific Advisory Board, Portsmouth
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act (Pub. L. No. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.
Energy Conservation Program for Certain Industrial Equipment: Energy Conservation Standards for Commercial Water Heating Equipment
The U.S. Department of Energy (DOE) is initiating a rulemaking to consider amended energy conservation standards for commercial water heaters, hot water supply boilers, and unfired hot water storage tanks (commercial water heating equipment). Once completed, this rulemaking will fulfill DOE's statutory obligation to either propose amended energy conservation standards for commercial water heating equipment or to determine that the existing standards do not need to be amended. This notice seeks to solicit information to help DOE determine whether national standards more stringent than those currently in place would result in a significant amount of additional energy savings and whether such amended national standards would be technologically feasible and economically justified. In overview, this document presents a brief description of the analysis DOE plans to perform for this rulemaking and requests comment on various issues relating to each of the analyses (e.g., market assessment, engineering analysis, energy use analysis, life-cycle cost and payback period analysis, and national impact analysis). Although this document contains several specific topics on which DOE is particularly interested in receiving written comment, DOE welcomes suggestions and information from the public on any subject within the scope of this rulemaking, including topics not raised in this RFI.
Energy Conservation Program for Certain Commercial Industrial Equipment: Conservation Standards for Commercial Pre-Rinse Spray Valves
This document announces an extension of the time period for submitting comments, data, and information on the framework document for commercial pre-rinse spray valves, published on September 11, 2014. The comment period is extended to November 12, 2014.