March 2017 – Federal Register Recent Federal Regulation Documents
Results 1,151 - 1,200 of 2,440
Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments; Correction
The Food and Drug Administration is correcting a notice entitled ``Public Meeting on Patient-Focused Drug Development for Sarcopenia'' that appeared in the Federal Register of December 14, 2016 (81 FR 90361). The document announced a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Sarcopenia. The location of the meeting has changed and this document provides the updated meeting location.
Determination that CYANOCOBALAMIN INJECTION, 1 Milligram per Milliliter in a 10 Milliliter Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10 milliliter vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Product-Specific Guidances for Rifaximin; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic rifaximin oral tablets entitled ``Draft Guidance on Rifaximin.'' The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for rifaximin oral tablets.
Surface Transportation Project Delivery Program; Ohio Department of Transportation Audit Report
The Moving Ahead for Progress in the 21st Century Act (MAP-21) established the permanent Surface Transportation Project Delivery Program that allows a State to assume FHWA's environmental responsibilities for review, consultation, and compliance for Federal highway projects. When a State assumes these Federal responsibilities, the State becomes solely liable for carrying out the responsibilities it has assumed, in lieu of FHWA. This program mandates annual audits during each of the first 4 years of State participation to ensure compliance by each State participating in the Program. This notice announces and solicits comments on the first audit report for the Ohio Department of Transportation (ODOT).
Meetings of Humanities Panel
The National Endowment for the Humanities will hold twenty- three meetings of the Humanities Panel, a federal advisory committee, during April, 2017. 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.
Regulated Navigation Areas; Escorted Submarines Sector Jacksonville Captain of the Port Zone
The Coast Guard is establishing regulated navigation areas (RNA) covering the St. Marys Entrance Channel, portions of the Cumberland Sound, and the Atlantic Ocean that will be in effect whenever any Navy submarine (foreign or domestic) is escorted by the Coast Guard and operating within the jurisdictional waters of the Sector Jacksonville Captain of the Port Zone. These RNAs are necessary to help ensure the safety and security of submarines, their Coast Guard escorts, and the public. The RNAs will do so by requiring all persons and vessels located within an RNA to follow lawful orders and/or directions given to them by Coast Guard designated representatives. Additionally, these RNAs will supersede the current temporary safety/security zone for Cumberland Sound, Georgia and St. Marys River Entrance Channel.
Special Conditions: Embraer S.A., Model ERJ 190-300 Series Airplanes; Flight Envelope Protection: Pitch, Roll, and High-Speed Limiting Functions
These special conditions are issued for the Embraer S.A. Model ERJ 190-300 series airplanes. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is an electronic flight control system that contains fly-by-wire control laws, including flight envelope protection functions that impose pitch-angle, bank-angle, and high- speed limits during normal operation. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Filing of Plats of Survey, Wyoming
The Bureau of Land Management (BLM) is scheduled to file plats of survey 30 calendar days from the date of this publication in the BLM Wyoming State Office, Cheyenne, Wyoming. The surveys, which were executed at the request of the U.S. Forest Service and the BLM, are necessary for the management of these lands. The lands surveyed are: The plat and field notes representing the dependent resurvey of a portion of the north boundary and portions of the subdivisional lines, and the survey of the subdivision of section 3, Township 27 North, Range 71 West, Sixth Principal Meridian, Wyoming, Group No. 943, were accepted on December 13, 2016. The plat and field notes representing the dependent resurvey of a portion of the 1963-65 adjusted original meanders of the left bank of the Snake River, Township 41 North, Range 117 West, Sixth Principal Meridian, Wyoming, Group No. 946, were accepted on January 13, 2017.
Office of Policy and Strategic Planning; Construction of Pipelines Using Domestic Steel and Iron
The Department of Commerce is seeking information on the construction and maintenance of American pipelines. This information will help the Department develop a plan for the domestic sourcing of materials for the construction, retrofitting, repair, and expansion of pipelines inside the United States as directed by the January 24, 2017 Presidential Memorandum regarding ``Construction of American Pipelines'' (Presidential Memorandum). The Secretary of Commerce, in consultation with relevant agencies, is required to deliver this plan to the President by July 23, 2017. In response to this directive, the Department of Commerce is conducting industry outreach to better understand: Current pipeline construction technology and requirements; potential advances in pipeline technology; domestic and foreign supply chain for pipeline materials; and all other information respondents consider pertinent to the development of the domestic sourcing plan. Responses to this notice (posted at https://www.regulations.gov) will inform the Secretary's plan for the domestic sourcing of materials used in pipelines within the boundaries of the United States.
Petition for Clarification, or in the Alternative Reconsideration of Action in Rulemaking Proceeding
A Petition for Clarification, or in the Alternative Reconsideration (Petition) has been filed in the Commission's rulemaking proceeding by T-Mobile USA, Inc.
Information Collection Being Submitted for Review and Approval to the Office of Management and Budget
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
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