October 6, 2015 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 110
Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Generic Drug User Fee Cover Sheet
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.
Privacy Act of 1974; Privacy Act System of Records
Pursuant to the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), the National Aeronautics and Space Administration is issuing public notice of its proposal to update its standard Appendix A applicable to all NASA Systems of Records, as set forth below under the caption SUPPLEMENTARY INFORMATION.
Privacy Act of 1974; Privacy Act System of Records
In accordance with the Privacy Act of 1974, NASA is giving notice that it proposes to cancel the following Privacy Act systems of records, NASA Aeronautics Scholarship Program (October 17, 2011, 76 FR 64115) and Government Motor Vehicle Operators Permit Records. (September 30, 2009, 74 FR 50250).
Established Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the ``Established Conditions: Reportable Chemistry, Manufacturing, and Controls (CMC) Changes for Approved Drug and Biologic Products; Draft Guidance for Industry,'' published in the Federal Register of June 1, 2015. FDA is reopening the comment period to allow interested persons additional time to submit comments.
Controlled Group Regulation Examples; Correction
This document contains corrections to final regulations (TD 9737) that were published in the Federal Register on Tuesday, September 15, 2015 (80 FR 55243). The final rules are with revisions to examples that illustrate the controlled group rules applicable to regulated investment companies (RICs).
Agency Information Collection Activities; Comment Request; Application for Grants Under the Talent Search Program
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a reinstatement of a previously approved information collection.
Electronic Common Technical Document Technical Conformance Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Version 1.0. The eCTD Technical Conformance Guide supplements the guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specification'' and provides specifications, recommendations, and general considerations on how to submit eCTD-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Acceptability of Draft Labeling To Support Abbreviated New Drug Application Approval; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Acceptability of Draft Labeling to Support ANDA Approval.'' This guidance provides recommendations and information related to the submission of proposed labeling with abbreviated new drug applications (ANDAs). It explains FDA's interpretation of the regulatory provision related to submission of copies of applicants' proposed labeling and clarifies that FDA's Office of Generic Drugs (OGD) will accept draft labeling and does not require the submission of final printed labeling (FPL) in order to approve an ANDA.
Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project
The Food and Drug Administration (FDA or Agency) is announcing a pilot project for the submission of final approved Risk Evaluation and Mitigation Strategies (REMS) and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. Participation in the pilot is voluntary and is open to application holders of drugs with REMS. The pilot is intended to help application holders, FDA, and other interested stakeholders evaluate a potential approach to converting REMS into SPL format and evaluate the usefulness of the REMS information to be provided in SPL format. This project also will help provide FDA with feedback on these topics from pilot participants and other interested stakeholders.
Approval and Promulgation of Air Quality Implementation Plans; Maryland; Maryland's Negative Declaration for the Automobile and Light-Duty Truck Assembly Coatings Control Techniques Guidelines
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Maryland. This revision pertains to a negative declaration for the Automobile and Light-Duty Truck Assembly Coatings Control Techniques Guidelines (CTG). This action is being taken under the Clean Air Act (CAA).
Pearson Field Airport Special Flight Rules Area
The FAA is proposing to establish a Special Flight Rules Area in the vicinity of Pearson Field Airport, Vancouver, Washington. Pearson Field Airport is located approximately three nautical miles northwest of Portland International Airport, Portland, Oregon. The close proximity of the airport traffic patterns and approach courses create converging flight paths between traffic on approach to Portland International Airport and traffic at Pearson Field Airport, increasing the risk for near mid-air collision, mid-air collision and wake turbulence events. The intended effect of this action is to mitigate the identified risk by establishing operating requirements applicable to all aircraft when operating within a designated area at Pearson Field Airport, which would increase overall system efficiency and safety.
Approval and Promulgation of Implementation Plans; Texas; Revisions to the Minor New Source Review (NSR) State Implementation Plan (SIP) for Portable Facilities
The Environmental Protection Agency (EPA) is approving revisions to the Texas State Implementation Plan (SIP) submitted by the Texas Commission on Environmental Quality (TCEQ) on March 19, 2010 and July 2, 2010. These revisions to the Texas SIP revise the minor New Source Review (NSR) program to provide for the relocation and change of location of permitted portable facilities, establish definitions related to portable facilities, and establish public participation for changes of location to portable facilities. The EPA finds that these revisions to the Texas SIP comply with the Federal Clean Air Act (the Act or CAA) and are consistent with our regulations and policy for minor NSR. The EPA is finalizing this approval under section 110 of the Act.
Meeting of the Advisory Committee; Meeting
The Executive Director of the Joint Board for the Enrollment of Actuaries gives notice of a closed teleconference meeting of the Advisory Committee on Actuarial Examinations.
Information Collection: Packaging and Transportation of Radioactive Material
The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, ``Packaging and Transportation of Radioactive Material.''
Information Collection: Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, ``Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.''
Approval and Promulgation of Implementation Plans; Texas; Infrastructure and Interstate Transport State Implementation Plan for the 2010 Sulfur Dioxide National Ambient Air Quality Standards
Under the Federal Clean Air Act (CAA) the Environmental Protection Agency (EPA) is proposing to approve elements of a State Implementation Plan (SIP) submission from the State of Texas for the Sulfur Dioxide (SO2) National Ambient Air Quality Standards (NAAQS). The submittal addresses how the existing SIP provides for implementation, maintenance, and enforcement of the 2010 SO2 NAAQS (infrastructure SIP or i-SIP). This i-SIP ensures that the State's SIP is adequate to meet the state's responsibilities under the CAA.
Proposed Information Collection; Comment Request; Limits of Application of the Take Prohibitions
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.
Proposed Information Collection; Comment Request; Interim Capital Construction Fund Agreement, Certificate Family of Forms and Deposit/Withdrawal Report
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.
Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology
On July 2, 2015, the Executive Office of the President (EOP) issued a memorandum (Ref. 1) directing the primary agencies that regulate the products of biotechnologythe U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA)to update the Coordinated Framework for the Regulation of Biotechnology (51 FR 23302; June 26, 1986) (Ref. 2), develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort. The memorandum's objectives are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment. The purpose of this Request for Information (RFI) is to solicit relevant data and information, including case studies, that can assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (CF) to clarify the current roles and responsibilities of the EPA, FDA, and USDA and the development of a long-term strategy consistent with the objectives described in the July 2, 2015 EOP memorandum. In addition to this RFI, the update to the CF will undergo public comment before it is finalized.
Single Family Housing Guaranteed Loan Program
The Rural Housing Service (RHS or Agency) proposes to amend the current regulation for the Single Family Housing Guaranteed Loan Program (SFHGLP) on the subject of liquidation value appraisals. In order to reduce overall processing time, reduce cost, and expedite claim submission, lenders will order the liquidation value appraisal used to estimate a loss claim against the SFHGLP instead of the Agency. Currently, if a Real Estate Owned (REO) property remains unsold by the lender at the end of the permissible marketing period, the Agency will order a liquidation value appraisal and apply an acquisition and management resale factor to estimate holding and disposition cost. This amendment will require the servicing lender to order the liquidation value appraisal. The costs associated with obtaining the liquidation value appraisal can then be included in the liquidation costs paid under the guarantee.
Notice of Solicitation of Applications for the Rural Energy for America Program for Fiscal Year 2016
The Rural Business-Cooperative Service (the Agency) announces the acceptance of applications under the Rural Energy for America Program (REAP) which is designed to help agricultural producers and rural small businesses reduce energy costs and consumption and help meet the Nation's critical energy needs. REAP have two types of funding assistance: (1) Renewable Energy Systems and Energy Efficiency Improvements Assistance, and (2) Energy Audit and Renewable Energy Development Assistance Grants. The Renewable Energy Systems and Energy Efficiency Improvement Assistance provides grants and guaranteed loans to agricultural producers and rural small businesses to purchase and install renewable energy systems and make energy efficiency improvements to their operations. Eligible renewable energy systems for REAP provide energy from: Wind, solar, renewable biomass (including anaerobic digesters), small hydro-electric, ocean, geothermal, or hydrogen derived from these renewable resources. The Energy Audit and Renewable Energy Development Assistance Grant is available to a unit of State, Tribal, or local government; instrumentality of a State, Tribal, or local government; institution of higher education; rural electric cooperative; a public power entity; or a council, as defined in 16 U.S.C. 3451. The recipient of grant funds, grantee, will establish a program to assist agricultural producers and rural small businesses with evaluating the energy efficiency and the potential to incorporate renewable energy technologies into their operations.
Drawbridge Operation Regulation; Ebey Slough (Snohomish River), Marysville, WA
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Burlington Northern Santa Fe Railroad Company (BNSF) Bridge 38.3 across Ebey Slough (Snohomish River), mile 1.5 at Marysville, WA. The deviation is necessary to accommodate scheduled bridge rail joint maintenance and replacement. The deviation allows the bridges to remain in the closed-to-navigation position during the maintenance to allow safe movement of work crews.
Labor Surplus Area Classification Under Executive Orders 12073 and 10582
The purpose of this notice is to announce the annual list of labor surplus areas for Fiscal Year (FY) 2016.
Board of Overseers of the Malcolm Baldrige National Quality Award
The Board of Overseers of the Malcolm Baldrige National Quality Award (Board) will meet in open session on Wednesday, December 2, 2015. The purpose of this meeting is to review and discuss the work of the private sector contractor, which assists the Director of the National Institute of Standards and Technology (NIST) in administering the Malcolm Baldrige National Quality Award (Award), and information received from NIST and from the Chair of the Judges' Panel of the Malcolm Baldrige National Quality Award in order to make such suggestions for the improvement of the Award process as the Board deems necessary. Details on the agenda are noted in the SUPPLEMENTARY INFORMATION section of this notice.
Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978
The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated under the Antarctic Conservation Act of 1978. This is the required notice of a requested permit modification.
Application of Altius Aviation, LLC, for Commuter Authority
The Department of Transportation is directing all interested persons to show cause why it should not issue an order finding Altius Aviation, LLC fit, willing, and able, and awarding it a Commuter Air Carrier Authorization.
Airspace Designations; Incorporation by Reference Amendments
This action incorporates certain amendments into FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, for incorporation by reference in 14 CFR 71.1.
National Cybersecurity Center of Excellence (NCCoE) Domain Name System-Based Security (DNS) for Electronic Mail Building Block
The National Institute of Standards and Technology (NIST) invites organizations to provide products and technical expertise to support and demonstrate security platforms for the Domain Name System- Based (DNS) Security for Electronic Mail Building Block. This notice is the initial step for the National Cybersecurity Center of Excellence (NCCoE) in collaborating with technology companies to address cybersecurity challenges identified under the Domain Name System-Based Security for Electronic Mail Building Block. Participation in this building block is open to all interested organizations.
Agency Information Collection Activities: Proposed Collection; Comment Request; National Emergency Family Registry and Locator System
The Federal Emergency Management Agency, 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 an extension of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the FEMA National Emergency Family Registry and Locator System (NEFRLS), which allows adults that have been displaced by a Presidentially declared disaster or emergency to reunify with their families.
Consent Based Social Security Number Verification (CBSV) Service
We provide fee-based Social Security number (SSN) verification services to enrolled private businesses and government agencies who obtain a valid, signed consent form from the Social Security number holder. We originally published a notice announcing the CBSV service in the Federal Register on August 10, 2007. Based on the signed consent forms, we verify the number holders' SSNs for the requesting party. The Privacy Act of 1974 (5 U.S.C. 552a(b)), section 1106 of the Social Security Act (42 U.S.C. 1306) and our regulation at 20 CFR 401.100, establish the legal authority for us to provide SSN verifications to third party requesters based on consent. The CBSV process provides the business community and other government entities with consent-based SSN verifications in high volume. We developed CBSV as a user-friendly, internet-based application with safeguards that will protect the public's information. In addition to the benefit of providing high volume, centralized SSN verification services to the business community in a secure manner, CBSV provides us with cost and workload management benefits. New Information: To use CBSV, interested parties must pay a one- time non-refundable enrollment fee of $5,000. Currently, users also pay a fee of $3.10 per SSN verification transaction in advance of services. We agreed to calculate our costs periodically for providing CBSV services and adjust the fees as needed. We also agreed to notify our customers who currently use the service and allow them to cancel or continue using the service at the new transaction fee. Based on the most recent cost analysis, we will adjust the fiscal year 2016 fee to $1.40 per SSN verification transaction. New customers will still be responsible for the one-time $5,000 enrollment fee.
Endangered and Threatened Wildlife and Plants; Endangered Species Status for Trichomanes punctatum ssp. floridanum
We, the U.S. Fish and Wildlife Service (Service), determine endangered species status under the Endangered Species Act of 1973 (Act), as amended, for Trichomanes punctatum ssp. floridanum (Florida bristle fern), a plant subspecies from Miami-Dade and Sumter Counties, Florida. The effect of this regulation will be to add this subspecies to the Federal List of Endangered and Threatened Plants and extend the Act's protections to this subspecies.
Information Collection; Payment to Small Business Subcontractors
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB), a request to review and approve a new information collection requirement regarding Payment of Subcontractors.
Organization and Functions; Field Office Locations
The Farm Credit Administration (FCA, we, Agency or our) amended our regulations to change the address for a field office as a result of a recent office relocation. In accordance with the law, the effective date of the rule is no earlier than 30 days from the date of publication in the Federal Register during which either or both Houses of Congress are in session.
Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Sonoran Desert Tortoise as an Endangered or Threatened Species
We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the Sonoran desert tortoise (Gopherus morafkai) as an endangered or threatened species under the Endangered Species Act of 1973, as amended (Act). After review of the best available scientific and commercial data, we find that listing the Sonoran desert tortoise is not warranted at this time. However, we ask the public to submit to us any new information that becomes available concerning the threats to the Sonoran desert tortoise or its habitat at any time.
Amendment of Class D and Class E Airspace; Stockton, CA
This action modifies Class D airspace, Class E surface area airspace, and Class E airspace extending upward from 700 feet above the surface, at Stockton Metropolitan Airport, Stockton, CA. A review of the airspace and the decommissioning of the Manteca VHF omnidirectional radio range and distance measuring equipment (VOR/DME), has made it necessary to amend the airspace areas for the safety and management of the new Standard Instrument Approach Procedures (SIAPs) for Instrument Flight Rules (IFR) operations at the airport.
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