May 10, 2018 – Federal Register Recent Federal Regulation Documents
Results 51 - 73 of 73
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Medical Office Survey on Patient Safety Culture Database.''
Safety Zones; Annual Events in the Captain of the Port Detroit Zone
The Coast Guard will enforce various safety zones for annual marine events in the Captain of the Port Detroit zone from 8:30 p.m. on May 27, 2018 through 10:30 p.m. on September 2, 2018. Enforcement of these zones is necessary and intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after these fireworks events. During the aforementioned period, the Coast Guard will enforce restrictions upon, and control movement of, vessels in a specified area immediately prior to, during, and immediately after fireworks events. During each enforcement period, no person or vessel may enter the respective safety zone without permission of the Captain of the Port or his designated representative.
Framework for Assessment of Drug-Drug Interactions for Therapeutic Proteins; Establishment of a Public Docket; Request for Information and Comments
The Food and Drug Administration (FDA or Agency) is establishing a public docket to assist with its development of a policy/guidance document on the assessment of drug-drug interactions (DDIs) for therapeutic proteins (TPs). The Agency split the 2012 DDI draft guidance into two draft guidance documents published in October 2017: ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies'' and ``Clinical Drug Interaction StudiesStudy Design, Data Analysis, and Clinical Implications.'' The two guidance documents focus on enzyme- and transporter-based DDIs and do not include a discussion on TPs, which was originally included in the 2012 guidance. The Agency is currently revisiting the framework for assessment of DDIs for TPs outlined in the draft 2012 DDI guidance to offer timely and actionable information pertaining to DDIs for TPs and is seeking public input to assist in updating or creating a new framework.
S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling-Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on MicrosamplingQuestions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This question-and-answer (Q&A) guidance provides additional information to facilitate interpretation of the guideline for industry ``S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies'' (S3A guidance), especially to address the benefit and use of microsampling techniques in main study animals. The Q&A guidance is intended to provide points to consider before incorporating the microsampling method in toxicokinetic studies and acknowledges the benefits (and some limitations) of the use of microsampling.
Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the development of new drugs for the treatment of uncomplicated urinary tract infections.
Intent To Request Revision From OMB of One Current Public Collection of Information: TSA Claims Application
The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0039, abstracted below that we will submit to OMB for a revision in compliance with the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves the submission of information from claimants in order to thoroughly examine and resolve tort claims against the agency.
Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Full-Capture Arrow Rests and Components Thereof, DN 3314; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.
Ketchikan Resource Advisory Committee
The Ketchikan Resource Advisory Committee (RAC) will meet in Ketchikan, Alaska. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following website: https://cloudapps-usda- gov.secure.force.com/FSSRS/RAC_Page?id=001t0000002JcvNAAS.
Safety Zone; Ohio River Mile Marker 27.8 to Mile Marker 28.2, Vanport, PA
The Coast Guard is establishing a temporary safety zone for all navigable waters of the Ohio River from mile marker 27.8 to mile marker 28.2 near the Vanport Highway Bridge. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by a cargo movement near the Vanport Highway Bridge in Vanport, PA. Entry of vessels or persons into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.
Land Acquisitions; the Muscogee (Creek) Nation
The Principal Deputy Assistant SecretaryIndian Affairs made a final agency determination to acquire 48.58 acres, more or less, of land near the City of Eufaula, McIntosh County, Oklahoma, (Fountainhead Site) in trust for the Muscogee (Creek) Nation for gaming and other purposes on April 30, 2018.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Health Message Testing System (HMTS). The Health Message Testing System (HMTS), a Generic information collection, that enables programs across CDC to collect the information they require in a timely manner.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Assisted Reproductive Technology (ART) Program Reporting'' that collects information on ART cycles to publish information on pregnancy success rates as required under Section 2(a) of the Federal Clinic Success Rate and Certification Act (FCSRCA).
Strategic Economic and Community Development-Reservation of Fiscal Year 2018 Program Funds
Section 6025 of the Agricultural Act of 2014 (2014 Farm Bill) provides the Secretary of Agriculture the authority to give priority to projects that support strategic economic development or community development plans. The Agency has the authority to reserve funds for those programs (referred to as the ``underlying programs'') included in Strategic Economic and Community Development (SECD), for projects that support multijurisdictional strategic economic and community development plans. This Notice supersedes the SECD fiscal year 2016 (FY) notice that published on March 17, 2016 and identifies that for FY 2018 the Agency will utilize priority points under the SECD provisions, as opposed to set-aside funding.
Rescission of Social Security Rulings Related to Special Payments at Age 72
In accordance with 20 CFR 402.35(b)(1), the Acting Commissioner of Social Security gives notice of the rescission of Social Security Rulings (SSR): SSR 67-28; SSR 68-13; SSR 68-36; SSR 68- 37; SSR 68-52; SSR 68-78; SSR 70-23c; SSR 72-27; and SSR 74-27c.
Removal of Special Payments at Age 72
We are removing from the Code of Federal Regulations our ``Special Payments at Age 72'' rules because they are obsolete. We are removing these rules in accordance with the requirements of Executive Order (E.O.) 13777.
Proposed Agency Information Collection Activities; Comment Request
Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, FRA is informing the public that FRA has made five proposed revisions to the Quarterly Positive Train Control (PTC) Progress Report Form (Form FRA F 6180.165) and Annual PTC Progress Report Form (Form FRA F 6180.166), which the Office of Management and Budget (OMB) previously approved on August 15, 2017, under its regular processing procedures. Before submitting this revised information collection request (ICR) to OMB for regular clearance and approval, FRA is soliciting public comment on specific aspects of the proposed ICR.
International Fisheries; Western and Central Pacific Fisheries for Highly Migratory Species; Fishing Limits in Purse Seine and Longline Fisheries, Restrictions on the Use of Fish Aggregating Devices in Purse Seine Fisheries, and Transshipment Prohibitions
NMFS seeks comments on this proposed rule issued under authority of the Western and Central Pacific Fisheries Convention Implementation Act (WCPFC Implementation Act). The proposed rule would implement recent decisions of the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (WCPFC or Commission). These decisions include the following management measures: limits on fishing effort by U.S. purse seine vessels in the U.S. exclusive economic zone and on the high seas between the latitudes of 20[deg] N and 20[deg] S in the area of application of the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Convention); restrictions regarding the use of fish aggregating devices (FADs) for U.S. purse seine fishing vessels; limits on the catches of bigeye tuna by U.S. longline vessels in the Convention area; prohibitions on U.S. vessels used to fish for highly migratory species from engaging in transshipment in a particular area of the high seas (the Eastern High Seas Special Management Area or EHSSMA); and removal of existing reporting requirements for vessels transiting the EHSSMA. The rule also would make corrections to outdated cross references in existing regulatory text. This action is necessary to satisfy the obligations of the United States under the Convention, to which it is a Contracting Party.
Allocations of Cross-State Air Pollution Rule Allowances From New Unit Set-Asides for 2018 Control Periods
The Environmental Protection Agency (EPA) is providing notice of the availability of data on emission allowance allocations to certain units under the Cross-State Air Pollution Rule (CSAPR) trading programs. EPA has completed preliminary calculations for the first round of allocations of allowances from the CSAPR new unit set-asides (NUSAs) for the 2018 control periods and has posted spreadsheets containing the calculations on EPA's website. EPA will consider timely objections to the preliminary calculations (including objections concerning the identification of units eligible for allocations) before determining the final amounts of the first-round allocations.
Air Plan Approval; Ohio; Regional Haze Plan and Prong 4 (Visibility) for the 2006 and 2012 PM2.5
The Environmental Protection Agency (EPA) is taking the following five actions: Approving the portion of Ohio's November 30, 2016 State Implementation Plan (SIP) submittal seeking to change from reliance on the Clean Air Interstate Rule (CAIR) to reliance on Cross-State Air Pollution Rule (CSAPR) for certain regional haze requirements; converting EPA's limited approval/limited disapproval of Ohio's March 11, 2011 regional haze SIP to a full approval; withdrawing the Federal Implementation Plan (FIP) provisions that address the limited disapproval; approving the visibility prong of Ohio's infrastructure SIP submittals for the 2012 annual and 2006 24-hour fine particulate matter (PM2.5), 2010 nitrogen dioxide (NO2), and 2010 sulfur dioxide (SO2) National Ambient Air Quality Standards (NAAQS); and converting EPA's disapproval of the visibility portion of Ohio's infrastructure SIP submittal for the 2008 ozone NAAQS to an approval.
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