2013 – Federal Register Recent Federal Regulation Documents
Results 401 - 450 of 30,620
Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment
The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled ``PDUFA V Information Technology Plan.'' This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.
Submission for OMB Review; 30-Day Comment Request: Early Career Reviewer Program Online Application System-Center for Scientific Review (CSR)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Center for Scientific Review, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on March 13, 2013, page 15959 and allowed 60days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number Proposed Collection: Early Career Reviewer Program Online Application SystemExisting collection in use without an OMB number Center for Scientific Review (CSR), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Scientific Review (CSR) is the portal for NIH grant applications and their review for scientific merit. Our mission is to see that NIH grant applications receive fair, independent, expert, and timely reviewsfree from inappropriate influencesso NIH can fund the most promising research. To accomplish this goal, Scientific Review Officers (SRO) form study sections consisting of scientists who have the technical and scientific expertise to evaluate the merit of grant applications. The CSR Early Career Reviewer (ECR) program was developed to identify and train qualified scientists who are early in their scientific careers and who have not had prior CSR review experience. Currently, the application process involves repeated email interactions with potential applicants and manual management of information. To make the application process more efficient for applicants and for CSR staff, we have collaborated with the Information Management Branch at CSR to develop online application software which includes the collection of applicants' names, contact information, and professional CVs. This PRA clearance request is to deploy the online application software for ECR program applicantsthe Early Career Reviewer Application and Vetting System (EAVS). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 650.
Value Engineering
The Office of Federal Procurement Policy (OFPP) in the Office of Management and Budget (OMB) is publishing final revisions to OMB Circular A-131, Value Engineering, to update and reinforce policies associated with the consideration and use of value engineering (VE). VE is a well-established commercial practice for cutting waste and inefficiency that can help Federal agencies reduce program and acquisition costs, improve the quality and timeliness of performance, and take greater advantage of innovation to meet 21st century expectations and demands. The revisions are designed to ensure that the Federal Government has the capabilities and tools to consider the use of VE for new and ongoing projects, whenever appropriate.
Revision of the Land Management Plans for the Inyo, Sierra and Sequoia National Forests
The Pacific Southwest Region (Region 5) has initiated land management plan revisions for the Inyo, Sierra, and Sequoia National Forests. The Final Assessments and other related information for these forests have been posted to the Region 5 Web site at https:// www.fs.usda.gov/main/r5/landmanagement/planning. The Forest Service invites the public to help develop a ``need for change'' and desired conditions that will lead to a proposed action for the land management plan revisions.
60-Day Notice of Proposed Information Collection: Certification of Domestic Violence, Dating Violence, Sexual Assault, or Stalking
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.
60-Day Notice of Proposed Information Collection: Exigent Health and Safety Deficiency Correction Certification
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.
Agency Information Collection Activities; Submission for OMB Review; Comment Request: Definition and Requirements for a Nationally Recognized Testing Laboratory
On December 31, 2013, the Department of Labor (DOL) will submit the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) revision titled, ``Definition and Requirements for a Nationally Recognized Testing Laboratory'' to the Office of Management and Budget (OMB) for review and approval for use, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq.
Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2014
According to data from FRA's Management Information System, the rail industry's random drug testing positive rate has remained below 1.0 percent for the last two years. FRA's Administrator has therefore determined that the minimum annual random drug testing rate for the period January 1, 2014, through December 31, 2014, will remain at 25 percent of covered railroad employees. In addition, because the industry-wide random alcohol testing violation rate has remained below 0.5 percent for the last two years, the Administrator has determined that the minimum random alcohol testing rate will remain at 10 percent of covered railroad employees for the period January 1, 2014, through December 31, 2014. Railroads remain free, as always, to conduct random testing at higher rates.
Open Government: Use of Genetic Information in Documenting and Evaluating Disability; Extension of Comment Period
On November 26, 2013, we announced in the Federal Register that we were soliciting ideas and comments about the use of genetic information in the disability determination process via an online forum. We stated that the forum would be open until December 26, 2013. We are extending that deadline until January 16, 2014.
Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Community
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements in implementing the lists of United States (U.S.) firms/processors exporting shell eggs, dairy products, game meat, game meat products, animal casings, gelatin, and collagen to the European Community (the EC).
Privacy Act of 1974, as Amended; System of Records
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a the Department of the Treasury, Bureau of Engraving and Printing, proposes to establish a new Privacy Act of 1974 system of records titled ``Treasury/BEP .049Bureau of Engraving and Printing Tour Scheduling System'' also known as BEP Tour Scheduling System.
Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Naming of Drug Products Containing Salt Drug Substances.'' The United States Pharmacopeial (U.S.P.) Convention has adopted a monograph naming policy that changed the nomenclature for compendial drug products that contain a salt. Under the new policy, drug names and strengths for new compendial drug products will be based on the active moiety. The name and strength of the active ingredient (e.g., salt) will appear elsewhere on the drug product label and labeling. The policy became official on May 1, 2013. This draft guidance describes the U.S.P. policy, discusses the Center for Drug Evaluation and Research's (CDER's) application of the policy, and recommends how CDER and industry can implement the policy.
Petitions for Modification of Application of Existing Mandatory Safety Standards
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and 30 CFR Part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below to modify the application of existing mandatory safety standards codified in Title 30 of the Code of Federal Regulations.
Certain Tires and Products Containing Same; Commission Determination Not to Review an Initial Determination Granting-In-Part Complainants' Motion to Amend the Complaint and Notice of Investigation To Add Respondents
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 11) of the presiding administrative law judge (``ALJ'') granting-in-part complainants' motion to amend the complaint and notice of investigation to add respondents.
Removal of Procedures for Delegation of Administration of Grants and Cooperative Agreements
This document corrects the preamble to a proposed rule published in the Federal Register of November 14, 2013, regarding Procedures for Delegation of Administration of Grants and Cooperative Agreements. This correction provides the correct regulatory identification number (RIN) for the proposed rule.
Notice of January 10, 2014, Meeting of the Fort Hancock 21st Century Advisory Committee
This notice sets forth the date of the seventh meeting of the Fort Hancock 21st Century Advisory Committee.
Proposed Information Collection-2014 Election Administration and Voting Survey; Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, EAC announces an information collection and seeks public comment on the provisions thereof. The EAC, pursuant to 5 CFR 1320.5(a)(iii), intends to submit this proposed information collection (2014 Election Administration and Voting Survey) to the Director of the Office of Management and Budget for approval. The 2014 Election Administration and Voting Survey (Survey) asks election officials questions concerning voting and election administration. These questions request information concerning ballots cast; voter registration; overseas and military voting; Election Day activities; voting technology; and other important issues. The EAC issues the survey to meet its obligations under the Help America Vote Act to serve as national clearinghouse and resource for the compilation of information with respect to the administration of Federal elections; to fulfill both the EAC's and the Department of Defense Federal Voting Assistance Programs' quantitative State data collection requirements under the Uniformed and Overseas Citizens Absentee Voting Act (UOCAVA); and meet its National Voter Registration Act (NVRA) mandate to collect information from states concerning the impact of that statute on the administration of Federal Elections.
Research and Development; Public Meeting
This notice is to advise interested persons that PHMSA will conduct a public meeting for the Research and Development Forum to be held January 17, 2014, in Washington, DC. During this meeting, PHMSA will host the session to present the results of recently completed and current research projects. In addition, PHMSA will solicit comments relative to potential new research projects which may be considered for inclusion in its future work.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Regulations Governing the Administration of the Longshore and Harbor Workers' Compensation Act
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, ``Regulations Governing the Administration of the Longshore and Harbor Workers' Compensation Act,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501 et seq.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Occupational Safety and Health Administration Conflict of Interest and Disclosure Form
The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Occupational Safety and Health Administration Conflict of Interest and Disclosure Form,'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq.
Notice of 2014 Meetings for the Paterson Great Falls National Historical Park Advisory Commission
As required by the Federal Advisory Committee Act (5 U.S.C. Appendix 1-16) the National Park Service is hereby giving notice for the 2014 schedule of meetings for the Paterson Great Falls National Historical Park Advisory Commission. The Commission was authorized by Congress and signed by the President on March 30, 2009, (Pub. L. 111- 11, Title VII, Subtitle A, Section 7001, Subsection e), ``to advise the Secretary in the development and implementation of the management plan.'' Agendas for these meetings will be provided on the Paterson Great Falls National Historical Park Web site: https://www.nps.gov/pagr/ parkmgmt/federal-advisory-commission.htm.
Agency Information Collection Activities: Proposed Collection; Comment Request
NARA is giving public notice that the agency proposes to request extension of two currently approved information collections. The first is used by researchers who wish to do biomedical statistical research in archival records containing highly personal information. The second is used by customers/researchers for ordering reproductions of NARA's motion picture, audio, and video holdings that are housed in the Washington, DC, area of the National Archives and Records Administration. The second is prepared by organizations that want to make paper-to-paper copies of archival holdings with their personal copiers. The public is invited to comment on the proposed information collection pursuant to the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Asbestos in General Industry Standard
On December 31, 2013, the Department of Labor (DOL) will submit the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Asbestos in General Industry Standard'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq.
Mechanical and Digital Phonorecord Delivery Compulsory License
The U.S. Copyright Office (``Office'' or ``Copyright Office'') of the Library of Congress requests additional public comments on clarifying the terms in the Monthly and Annual Statements of Account for the making and distribution of phonorecords.
Verification of Statements of Account Submitted by Cable Operators and Satellite Carriers
The U.S. Copyright Office is adopting an interim regulation that implements certain aspects of the Satellite Television Extension and Localism Act of 2010 (``STELA''). Cable operators and satellite carriers must file statements of account (``SOAs'') and deposit royalty fees with the Office in order to use the statutory licenses that allow for the retransmission of over-the-air broadcast signals. The Office published two notices of proposed rulemaking concerning a new process to allow copyright owners to audit the SOAs and associated royalty payments. The Office received extensive comments on its proposed audit procedures and is carefully reviewing these comments to address them as appropriate in a final rule. In the meantime, the Office is issuing an interim rule to establish the procedure for filing a notice of intent to audit one or more SOAs.
Duty Periods for Establishing Eligibility for Health Care
The Department of Veterans Affairs (VA) is amending its medical regulations concerning eligibility for health care to re- establish the definitions of ``active military, naval, or air service,'' ``active duty,'' and ``active duty for training.'' These definitions were deleted in 1996; however, we believe that all duty periods should be defined in part 17 of the Code of Federal Regulations (CFR) to ensure proper determination of eligibility for VA health care. We are also providing a more complete definition of ``inactive duty training.''
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