February 6, 2014 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2014-02-06-ReaderAids
Type: Reader Aids
Date: 2014-02-06
Agency Information Collection Activities: Proposed Collection; Comment Request; Emergency Notification System (ENS)
Document Number: C1-2014-01789
Type: Notice
Date: 2014-02-06
Agency: Federal Emergency Management Agency, Department of Homeland Security
Sunshine Act Meeting
Document Number: 2014-02700
Type: Notice
Date: 2014-02-06
Agency: Broadcasting Board of Governors, Agencies and Commissions
The members of the Broadcasting Board of Governors (BBG) will meet in a special session, to be conducted telephonically, to discuss and approve the agency's Operating Plan for Fiscal Year 2014. The meeting will be available for public observation via a complete audio recording and a verbatim transcript of the meeting to be promptly posted on the BBG's public Web site at www.bbg.gov. Information regarding this meeting, including any updates or adjustments to its starting time, can also be found on the Agency's public Web site.
Farm Credit Administration Board; Sunshine Act; Regular Meeting
Document Number: 2014-02698
Type: Notice
Date: 2014-02-06
Agency: Farm Credit Administration, Agencies and Commissions
Notice is hereby given, pursuant to the Government in the Sunshine Act, of the regular meeting of the Farm Credit Administration Board (Board).
Sunshine Act Meeting Notice
Document Number: 2014-02682
Type: Notice
Date: 2014-02-06
Agency: Consumer Product Safety Commission, Agencies and Commissions
Sunshine Act Meetings
Document Number: 2014-02681
Type: Notice
Date: 2014-02-06
Agency: Consumer Product Safety Commission, Agencies and Commissions
Sunshine Act Notice
Document Number: 2014-02639
Type: Notice
Date: 2014-02-06
Agency: Commission on Civil Rights
Pacific Halibut Fisheries; Catch Sharing Plan
Document Number: 2014-02633
Type: Proposed Rule
Date: 2014-02-06
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes to approve changes to the Pacific Halibut Catch Sharing Plan (Plan) for the International Pacific Halibut Commission's (IPHC or Commission) regulatory Area 2A off Washington, Oregon, and California (Area 2A). In addition, NMFS proposes to implement the portions of the Plan and management measures that are not implemented through the IPHC. These measures include the sport fishery allocations and management measures for Area 2A. These actions are intended to enhance the conservation of Pacific halibut, provide greater angler opportunity where available, and avoid bycatch of overfished groundfish species.
Nonroad Technical Amendments
Document Number: 2014-02612
Type: Rule
Date: 2014-02-06
Agency: Environmental Protection Agency
EPA is adopting amendments to the technical hardship provisions under the Transition Program for Equipment Manufacturers related to the Tier 4 standards for nonroad diesel engines, and to the replacement engine exemption generally applicable to new nonroad engines. These provisions may have minor impacts on the costs and emission reductions of the underlying regulatory programs amended in this action, though in most cases these are simple technical amendments. For those provisions that may have a minor impact on the costs or benefits of the amended regulatory program, any potential impacts would be small and we have not attempted to quantify the potential changes.
Approval and Promulgation of Implementation Plans; Washington: Kent, Seattle, and Tacoma Second 10-Year PM10
Document Number: 2014-02609
Type: Proposed Rule
Date: 2014-02-06
Agency: Environmental Protection Agency
The EPA is reopening the public comment period on the notice of proposed rulemaking ``Approval and Promulgation of Implementation Plans; Washington: Kent, Seattle, and Tacoma Second 10-Year PM10 Limited Maintenance Plan'' published on December 26, 2013. A commenter requested additional time to review the proposal and prepare comments. In response to this request, the EPA is reopening the comment period.
Proposed CERCLA Settlements Relating to the Sherwin-Williams Site in Gibbsboro, Camden County, New Jersey
Document Number: 2014-02608
Type: Notice
Date: 2014-02-06
Agency: Environmental Protection Agency
In accordance with Section 122(i) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended (``CERCLA''), notice is hereby given by the U.S. Environmental Protection Agency (``EPA''), Region 2, of a proposed Administrative Settlement Agreement for Recovery of Past Response Costs (``Agreement'') pursuant to Section 122(h)(1) of CERCLA with the Sherwin-Williams Company (``Settling Party''). The Settling Party is a potentially responsible party, pursuant to Section 107(a) of CERCLA, and thus is potentially liable for response costs incurred at or in connection with the Sherwin-Williams Site (``Site''), located in Gibbsboro, Camden County, New Jersey. Under the Agreement, the Settling Party agrees to pay a total of $104,000.00 to EPA for past response costs. EPA will consider all comments received and may modify or withdraw its consent to the Agreement if comments received disclose facts or considerations that indicate that the proposed Agreement is inappropriate, improper, or inadequate. EPA's response to any comments received will be available for public inspection at EPA Region 2 offices, 290 Broadway, New York, New York 10007-1866.
Release of Draft Integrated Review Plan for the Primary National Ambient Air Quality Standards for Oxides of Nitrogen
Document Number: 2014-02607
Type: Notice
Date: 2014-02-06
Agency: Environmental Protection Agency
On or about February 10, 2014, the Environmental Protection Agency (EPA) is making available for public review the draft titled, Integrated Review Plan for the Primary National Ambient Air Quality Standards for Nitrogen Dioxide (draft IRP). This document contains the plans for the review of the air quality criteria for oxides of nitrogen and national ambient air quality standards (NAAQS) for nitrogen dioxide (NO2). The primary NO2 NAAQS provide for the protection of public health from exposure to oxides of nitrogen in ambient air.
Proposed Information Collection Request; Comment Request; Federal Implementation Plans To Reduce Interstate Transport of Fine Particulate Matter and Ozone (Renewal)
Document Number: 2014-02606
Type: Notice
Date: 2014-02-06
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ``Information Collection Request Renewal for the Federal Implementation Plans to Reduce Interstate Transport of Fine Particulate Matter and Ozone'' (EPA ICR Number 2391.03, OMB Control No. 2060-0667) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the Cross-State Air Pollution Rule ICR, which is currently approved through July 31, 2014. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Real Estate Activities of the Corps of Engineers in Connection With Civil Works Projects
Document Number: 2014-02604
Type: Rule
Date: 2014-02-06
Agency: Department of Defense, Department of the Army, Corps of Engineers
The U.S. Army Corps of Engineers is rescinding its regulation addressing Real Estate Activities of the Corps of Engineers in Connection with Civil Works Projects. Each rescinded section is obsolete, exempt from publication, or otherwise covers internal agency operations that have no public compliance component or adverse public impact. Regulations governing internal agency operations can be found on file with the agency.
Proposed Information Collection; 60-day Comment Request: Population Assessment of Tobacco and Health (PATH) Study
Document Number: 2014-02603
Type: Notice
Date: 2014-02-06
Agency: National Institutes of Health, Department of Health and Human Services, Department of Health and Human Service
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) The approaches used to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
International Fisheries; Pacific Tuna Fisheries; Establishment of Tuna Vessel Monitoring System in the Eastern Pacific Ocean
Document Number: 2014-02598
Type: Proposed Rule
Date: 2014-02-06
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes regulations under the Tuna Conventions Act to implement Resolution C-04-06 of the Inter-American Tropical Tuna Commission (IATTC). The regulations would establish requirements for a satellite-based vessel monitoring system (VMS) for U.S. commercial fishing vessels, 24 meters or more in overall length, used to target any fish of the genus Thunnus or of the species Euthynnus (Katsuwonus) pelamis (skipjack tuna) in the area bounded by the west coast of the Americas and on the north, south and west respectively, by the 50[deg] N. and 50[deg] S. parallels, and the 150[deg] W. meridian. This action is necessary for the United States to satisfy its obligations as a member of the IATTC.
60-Day Notice of Proposed Information Collection: Operating Fund Formula: Data Collection
Document Number: 2014-02596
Type: Notice
Date: 2014-02-06
Agency: Department of Housing and Urban Development
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
30-Day Notice of Proposed Information Collection: Delta Community Capital Initiative Application and Semi-Annual Reporting
Document Number: 2014-02595
Type: Notice
Date: 2014-02-06
Agency: Department of Housing and Urban Development
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
30-Day Notice of Proposed Information Collection: The Appalachia Economic Development Initiative Application and Semi-Annual Reporting
Document Number: 2014-02592
Type: Notice
Date: 2014-02-06
Agency: Department of Housing and Urban Development
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Draft Core Toll Concessions Public Private Partnership Model Contract Guide
Document Number: 2014-02589
Type: Notice
Date: 2014-02-06
Agency: Federal Highway Administration, Department of Transportation
The Moving Ahead for Progress in the 21st Century Act (MAP-21) requires DOT and FHWA to develop public-private partnership (P3) transaction model contracts for the most popular types of P3s for transportation projects. Based on public input on the most prevalent P3 transaction type and the need for an educational, rather than prescriptive contract model, the FHWA has developed a draft Core Toll Concession Model Contract Guide. The FHWA values public input in the development of the model contracts, and seeks continuing input. A draft of the Core Toll Concession Model Contract Guide is provided with this notice so that the general public and interested stakeholders may provide comments. This model contract guide has been prepared solely for informational purposes and should be not construed as a statement of DOT or FHWA policy.
Request for Comments and Notice of Roundtable Event on the Written Description Requirement for Design Applications
Document Number: 2014-02578
Type: Notice
Date: 2014-02-06
Agency: Department of Commerce, United States Patent and Trademark Office
The United States Patent and Trademark Office (Office) is hosting a roundtable event to solicit public opinions regarding the written description requirement as applied to design applications in certain limited situations. Members of the public are invited to participate. The roundtable will provide a forum for an informal discussion of the topics identified in this notice. Written comments in response to these topics also are requested.
Drawbridge Operation Regulation; Gulf Intracoastal Waterway, Galveston, TX
Document Number: 2014-02577
Type: Rule
Date: 2014-02-06
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has issued a temporary deviation from the operating schedule that governs the operation of the Galveston Causeway Railroad Vertical Lift Bridge across the Gulf Intracoastal Waterway, mile 357.2 west of Harvey Locks, at Galveston, Galveston County, Texas. The deviation is necessary in order to conduct repairs to the bridge. These repairs are essential for the continued safe operation of the bridge. This deviation allows the bridge to remain temporarily closed to navigation for three hours in the morning and three hours in the afternoon with an opening in the middle of the day to allow for the passage of vessels.
Proposed Information Collection Request; Comment Request; Information Collection Activities Associated With SmartWay Transport Partnership
Document Number: 2014-02575
Type: Notice
Date: 2014-02-06
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ``Information Collection Activities Associated with SmartWay Transport Partnership'' (EPA ICR No. 2265.02, OMB Control No. 2060-0663 to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through May 31, 2014. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Approval and Promulgation of Implementation Plans-Maricopa County PM-10 Nonattainment Area; Five Percent Plan for Attainment of the 24-Hour PM-10 Standard
Document Number: 2014-02574
Type: Proposed Rule
Date: 2014-02-06
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve a state implementation plan (SIP) revision submitted by the State of Arizona to meet Clean Air Act (CAA) requirements applicable to the Maricopa County (Phoenix) PM-10 Nonattainment Area. The Maricopa County PM-10 Nonattainment Area is located in the eastern portion of Maricopa County and encompasses the cities of Phoenix, Mesa, Scottsdale, Tempe, Chandler, Glendale, several other smaller jurisdictions, unincorporated County lands, as well as the town of Apache Junction in Pinal County. The Maricopa County PM-10 Nonattainment Area is designated as a serious nonattainment area for the national ambient air quality standards (NAAQS) for particulate matter of ten microns or less (PM-10). The submitted SIP revision is the Maricopa Association of Governments Five Percent Plan for PM-10 for the Maricopa County Nonattainment Area (2012 Five Percent Plan). Arizona's obligation to submit the 2012 Five Percent Plan was triggered by EPA's June 6, 2007 finding that the Maricopa PM-10 Nonattainment Area had failed to meet its December 31, 2006 deadline to attain the PM-10 NAAQS. The CAA requires a serious PM-10 nonattainment area that fails to meet its attainment deadline to submit a plan providing for attainment of the PM-10. NAAQS and for an annual emission reduction in PM-10 or PM-10 precursors of not less than five percent until attainment. EPA is proposing to approve the 2012 Five Percent Plan as meeting all relevant statutory and regulatory requirements.
Proposed Information Collection (Application for Ordinary Life Insurance) Activity: Comment Request
Document Number: 2014-02573
Type: Notice
Date: 2014-02-06
Agency: Department of Veterans Affairs
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each extension without change of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to determine eligibility for replacement insurance.
Notice of Applications for Deregistration Under Section 8(f) of the Investment Company Act of 1940
Document Number: 2014-02572
Type: Notice
Date: 2014-02-06
Agency: Securities and Exchange Commission, Agencies and Commissions
Each applicant seeks an order declaring that it has ceased to be an investment company. Applicants transferred their assets to series of Managers Trust I, and on October 1, 2013, made distributions to their shareholders based on net asset value. Expenses of approximately $790,000 incurred in connection with each reorganization were paid by Friess Associates, LLC, applicants' investment adviser, and Managers Investment Group LLC, investment adviser to the surviving fund. Filing Date: The applications were filed on December 30, 2013. Applicant's Address: P.O. Box 4166, Greenville, DE 19807.
Proposed Information Collection Request; Comment Request; Production Outlook Reports for Un-Registered Renewable Fuels Producers
Document Number: 2014-02571
Type: Notice
Date: 2014-02-06
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ``Production Outlook Reports for Un-Registered Renewable Fuels Producers'' (EPA ICR No. 2409.02, OMB Control No. 2060-0640 to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through May 31, 2014. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
60-Day Notice of Proposed Information Collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
Document Number: 2014-02567
Type: Notice
Date: 2014-02-06
Agency: Department of State
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
National Appeals Office Rules of Procedure
Document Number: 2014-02565
Type: Rule
Date: 2014-02-06
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
With this final rule, NMFS implements procedural regulations governing the National Appeals Office (NAO), a division of NMFS Office of Management and Budget within NOAA. NAO's central mission is to provide an efficient means of adjudicating appeals by providing due process and consistency to NMFS administrative decisions, particularly those involving Limited Access Privilege Programs (LAPPs) established pursuant to Section 303A of the Magnuson-Stevens Fishery Conservation and Management Act. The procedures contained herein could also be used to adjudicate appeals from other offices that incorporate these rules into their regulations or otherwise notify potential appellants of the procedures' applicability to their proceedings.
Final EPA Plan for the Federal Certification of Applicators of Restricted Use Pesticides Within Indian Country; Notice of Implementation
Document Number: 2014-02564
Type: Notice
Date: 2014-02-06
Agency: Environmental Protection Agency
In the Federal Register of May 18, 2011, EPA issued a notice of intent to implement a Federal program to certify applicators of restricted use pesticides (RUPs) in Indian country where no other certification plan applies. The program will be administered by EPA. In that notice, EPA solicited comments from the public on EPA's Proposed Federal Plan for Certifying Applicators of Restricted Use Pesticides within Indian Country (EPA plan). EPA received comments from four commenters. EPA also issued a notice of intent to implement a similar plan in EPA Region 8, the Proposed Federal Plan for Certification of Applicators of Restricted Use Pesticides Within EPA Region 8 Indian Country (EPA Region 8 plan) in the Federal Register of April 20, 2011. EPA received comments from seven commenters on the EPA Region 8 plan. A complete summary of the comments and the Agency responses is available in the docket. EPA has decided to merge these plans into one EPA plan and hereby implements the final EPA plan. Applicators must hold the appropriate Federal certification under the final EPA plan to apply RUPs in Indian country where no other EPA-approved or EPA-implemented certification plan applies.
Amendment of Class D and Class E Airspace; Grand Forks, ND
Document Number: 2014-02563
Type: Rule
Date: 2014-02-06
Agency: Federal Aviation Administration, Department of Transportation
This action corrects the geographic coordinates and adds the geographic coordinates of the Grand Forks International Airport ILS Localizer, and removes NOTAM information, in the regulatory text of a final rule that was published in the Federal Register of December 10, 2013, amending Class D and Class E airspace in the Grand Forks, ND area.
Unblocking of Three Individuals Blocked Pursuant to Executive Order 13219, as Amended
Document Number: 2014-02562
Type: Notice
Date: 2014-02-06
Agency: Department of the Treasury, Office of Foreign Assets Control
The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the name of three individuals whose property and interests in property are being unblocked pursuant to Executive Order 13219 of June 26, 2001 ``Blocking Property of Persons Who Threaten International Stabilization Efforts in the Western Balkans,'' as amended by Executive Order 13304 of May 28, 2003 ``Termination of Emergencies With Respect to Yugoslavia and Modification of Executive Order 13219 of June 26, 2001.''
Self-Regulatory Organizations; Topaz Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To More Specifically Address the Number and Size of Contra-Parties to a Qualified Contingent Cross Order; Correction
Document Number: 2014-02561
Type: Notice
Date: 2014-02-06
Agency: Securities and Exchange Commission, Agencies and Commissions
The Securities and Exchange Commission published a document in the Federal Register of December 31, 2013 concerning a Notice of Filing and Immediate Effectiveness of Proposed Rule Change to More Specifically Address the Number and Size of Contra-parties to a Qualified Contingent Cross Order. The document was dated incorrectly.
Agency Forms Submitted for OMB Review, Request for Comments
Document Number: 2014-02558
Type: Notice
Date: 2014-02-06
Agency: Railroad Retirement Board, Agencies and Commissions
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board (RRB) is forwarding 4 Information Collection Requests (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB). Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens. The RRB invites comments on the proposed collections of information to determine (1) the practical utility of the collections; (2) the accuracy of the estimated burden of the collections; (3) ways to enhance the quality, utility, and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to the RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if the RRB and OIRA receive them within 30 days of the publication date. 1. Title and purpose of information collection: Placement Service; OMB 3220-0057. Section 12(i) of the Railroad Unemployment Insurance Act (RUIA), authorizes the Railroad Retirement Board (RRB) to establish, maintain, and operate free employment offices to provide claimants for unemployment benefits with job placement opportunities. Section 704(d) of the Regional Railroad Reorganization Act of 1973, as amended, and as extended by the consolidated Omnibus Budget Reconciliation Act of 1985, required the RRB to maintain and distribute a list of railroad job vacancies, by class and craft, based on information furnished by rail carriers to the RRB. Although the requirement under the law expired effective August 13, 1987, the RRB has continued to obtain this information in keeping with its employment service responsibilities under Section 12(k) of the RUIA. Application procedures for the job placement program are prescribed in 20 CFR part 325. The procedures pertaining to the RRB's obtaining and distributing job vacancy reports furnished by rail carriers are described in 20 CFR 346.1. The RRB currently utilizes four forms to obtain information needed to carry out its job placement responsibilities. Form ES-2, Supplemental Information for Central Register, is used by the RRB to obtain information needed to update a computerized central register of separated and furloughed railroad employees available for employment in the railroad industry. Form ES-21, Referral to State Employment Service, and ES-21c, Report of State Employment Service Office, are used by the RRB to provide placement assistance for unemployed railroad employees through arrangements with State Employment Service offices. Form UI-35, Field Office Record of Claimant Interview, is used primarily by RRB field office staff to conduct in-person interviews of claimants for unemployment benefits. Completion of these forms is required to obtain or maintain a benefit. In addition, the RRB also collects Railroad Job Vacancies information received voluntarily from railroad employers. Previous Requests for Comments: The RRB has already published the initial 60-day notice (78 FR 66786 on November 6, 2013) required by 44 U.S.C. 3506(c)(2). That request elicited no comments.
Draft Guidance for Industry on Analgesic Indications: Developing Drug and Biological Products; Availability
Document Number: 2014-02557
Type: Notice
Date: 2014-02-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Analgesic Indications: Developing Drug and Biological Products.'' This guidance provides recommendations to sponsors on the development of prescription drugs for the management of acute and chronic pain, as well as the management of breakthrough pain. Specifically, this guidance focuses on drug development and trial design issues and chemistry, manufacturing, and controls concerns that are unique to the study of acute, chronic, and breakthrough pain and the labeling considerations for analgesic drugs.
National School Lunch Program: Independent Review of Applications Required by the Healthy, Hunger-Free Kids Act of 2010
Document Number: 2014-02556
Type: Rule
Date: 2014-02-06
Agency: Department of Agriculture, Food and Nutrition Service
This final rule requires certain local educational agencies participating in the National School Lunch Program to conduct an independent review of initial eligibility determinations for free and reduced price school meals. Additionally, this final rule requires each affected local educational agency to submit to the relevant State agency the results of the reviews including the number and percentage of reviewed applications for which the eligibility determinations changed and the type of change made. State agencies are required to submit to the Food and Nutrition Service, a report describing the results of the second reviews in their State. These changes respond to amendments made to the Richard B. Russell National School Lunch Act by section 304 of the Healthy, Hunger-Free Kids Act of 2010 which requires that local educational agencies demonstrating high levels of, or a high risk for, administrative error associated with certification, verification, and other administrative processes, have an individual or entity independently review the initial eligibility determinations for free and reduced price school meals for accuracy prior to sending out household notifications of eligibility or ineligibility. This final rule is expected to reduce administrative errors in eligibility determinations for free and reduced price school meals.
Revised Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Standardized Study Data; Availability
Document Number: 2014-02555
Type: Notice
Date: 2014-02-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data.'' The draft guidance announced in this notice is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on that topic. The draft guidance describes how FDA plans to implement the requirements for the electronic submission of standardized study data contained in certain submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) and is being issued for public comment. This document supersedes the guidance entitled ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data'' that was issued in February 2012.
Study Data Technical Conformance Guide and Data Standards Catalog; Availability
Document Number: 2014-02554
Type: Notice
Date: 2014-02-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a Study Data Technical Conformance Guide and an update to the Data Standards Catalog (formerly the Study Data Standards Catalog). The Study Data Technical Conformance Guide supplements the revised draft guidance for industry ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data'' and provides specifications, recommendations, and general considerations on submitting standardized study data using FDA supported data standards specified in the Data Standards Catalog.
Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2014-02553
Type: Notice
Date: 2014-02-06
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 ``Providing Regulatory Submissions in Electronic FormatSubmissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance announced in this notice sets forth FDA's interpretation of the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and the Public Health Service Act be submitted in electronic format specified by FDA, beginning no earlier than 24 months after publication of a final version of the draft guidance. This guidance describes how FDA interprets and plans to implement the electronic submission requirements.
Advancing the Development of Pediatric Therapeutics: Pediatric Bone Health; Public Workshop
Document Number: 2014-02552
Type: Notice
Date: 2014-02-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Pediatric and Maternal Health Staff in the Center for Drug Evaluation and Research and the Office of Pediatric Therapeutics are announcing a 1-day public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health.'' The purpose of this initial workshop is to provide a forum to consider issues related to advancing pediatric regulatory science in the evaluation of bone health in pediatric patients. Date and Time: The public workshop will be held on March 4, 2014, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held in the Pooks Hill Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814. The hotel's telephone number is 301-897-9400. Contact: Denise Pica-Branco, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1732, Fax: 301-796-9858, email: denise.picabranco@fda.hhs.gov.
Proposed Information Collection (Vocational Rehabilitation and Employment Longitudinal Study Survey) Activity: Comment Request
Document Number: 2014-02551
Type: Notice
Date: 2014-02-06
Agency: Department of Veterans Affairs
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each revision of a current approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments for information needed to determine the long-term outcomes of Veterans participating in VBA's Vocational Rehabilitation and Employment (VR&E) Program.
Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Reopening of the Comment Period
Document Number: 2014-02550
Type: Notice
Date: 2014-02-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is reopening the comment period for the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled ``Investigational New Drug Applications (INDs)Determining whether Human Research Studies can be Conducted without an IND,'' published in the Federal Register of September 10, 2013 (78 FR 55262). We are reopening the comment period only with respect to those subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements).
Notice of Determination of No Competitive Interest for the WindFloat Pacific Project Offshore Oregon; MMAA104000
Document Number: 2014-02549
Type: Notice
Date: 2014-02-06
Agency: Department of the Interior, Bureau of Ocean Energy Management
This notice provides BOEM's determination that there is no competitive interest in the area requested by Principle Power, Incorporated (PPI) to acquire an Outer Continental Shelf (OCS) commercial wind lease as described in the Potential Commercial Leasing for Wind Power on the Outer Continental Shelf (OCS) Offshore Oregon, Request for Interest (RFI) that BOEM published on September 30, 2013 (78 FR 59968). The RFI described the WindFloat Pacific Project proposal submitted to BOEM by PPI to acquire a commercial wind lease on the OCS offshore Oregon, and provided an opportunity for the public to submit comments about the proposal.
Final Theft Data; Motor Vehicle Theft Prevention Standard
Document Number: 2014-02548
Type: Rule
Date: 2014-02-06
Agency: National Highway Traffic Safety Administration, Department of Transportation
This document publishes the final data on thefts of model year (MY) 2011 passenger motor vehicles that occurred in calendar year (CY) 2011. The 2011 final theft data shows a decrease in the vehicle theft rate experienced in CY/MY 2011 compared to CY/MY 2010. The final theft rate for MY 2011 passenger vehicles stolen in CY 2011 is 0.99 thefts per thousand vehicles, a decrease of 15.38 percent from the rate of 1.17 thefts per thousand in 2010. Publication of these data fulfills NHTSA's statutory obligation to periodically obtain accurate and timely theft data and publish the information for review and comment.
Agency Information Collection (Notice-Payment Not Applied) Activity Under OMB Review
Document Number: 2014-02547
Type: Notice
Date: 2014-02-06
Agency: Department of Veterans Affairs
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Agency Information Collection (Recordkeeping at Flight Schools) Activity Under OMB Review
Document Number: 2014-02546
Type: Notice
Date: 2014-02-06
Agency: Department of Veterans Affairs
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Notice of Intent To Establish and Call for Nominations for the Northern California District Resource Advisory Council
Document Number: 2014-02544
Type: Notice
Date: 2014-02-06
Agency: Department of the Interior, Bureau of Land Management
The BLM is publishing this notice in accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act (FACA). The Bureau of Land Management (BLM) gives notice that the Secretary of the Interior is establishing the Northern California District Resource Advisory Council (RAC) to represent the district covering the northern portion of the state. This notice is also to solicit public nominations for the council. The RAC provides advice and recommendations on land use planning and management of public lands within its geographic area.
Agency Information Collection (Obligation To Report Factors Affecting Entitlement) Activity Under OMB Review
Document Number: 2014-02542
Type: Notice
Date: 2014-02-06
Agency: Department of Veterans Affairs
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
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