April 2017 – Federal Register Recent Federal Regulation Documents
Results 451 - 500 of 2,204
Notice of Request for Revision to and Extension of Approval of an Information Collection; Phytophthora Ramorum; Quarantine and Regulations
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the interstate movement of regulated articles to prevent the spread of Phytophthora ramorum.
Special Local Regulation; Bush River, Harford County, MD
The Coast Guard is establishing special local regulations for certain waters of the Bush River, including Otter Point Creek. This action is necessary to provide for the safety of life on these navigable waters located near Flying Point Park in Harford County, MD, during a high-speed power boat racing event on May 6, 2017, and May 7, 2017. This rulemaking would prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Maryland-National Capital Region or Coast Guard Patrol Commander.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple IRS Information Collection Requests
The Department of the Treasury will submit the following information collection request(s) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on the collection(s) listed below.
Qualification of Drivers; Exemption Applications; Vision
FMCSA announces its decision to exempt 14 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs). They are unable to meet the vision requirement in one eye for various reasons. The exemptions will enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye. The Agency has concluded that granting these exemptions will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these CMV drivers.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for revision of the approved information collection assigned OMB control number 0990-0452, scheduled to expire on January 31, 2020. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Product-Specific Guidance for Naloxone Hydrochloride; New Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entitled ``Draft Guidance on Naloxone Hydrochloride.'' The new 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 naloxone hydrochloride nasal spray.
Annual Civil Monetary Penalties Adjustment
The Maritime Administration (MARAD) is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvement Act of 2015. This final rule adjusts civil penalty amounts for violations of procedures related to the American Fisheries Act, certain regulated transactions involving documented vessels, the Automated Mutual Assistance Vessel Rescue program (AMVER) and the Defense Production Act. MARAD finds that good cause exists for immediate implementation of this final rule because prior notice and comment are unnecessary, per the specific provisions of the 2015 Act.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: AIDS Drug Assistance Program Data Report, OMB No. 0915-0345-Extension
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Qualification of Drivers; Exemption Applications; Diabetes
FMCSA announces its decision to renew exemptions of 152 individuals from its prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions enable these individuals with ITDM to continue to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Vision
FMCSA announces receipt of applications from 10 individuals for exemption from the vision requirement in the Federal Motor Carrier Safety Regulations. They are unable to meet the vision requirement in one eye for various reasons. The exemptions will enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye. If granted, the exemptions would enable these individuals to qualify as drivers of commercial motor vehicles (CMVs) in interstate commerce.
Qualification of Drivers; Exemption Applications; Diabetes Mellitus
FMCSA announces its decision to exempt 28 individuals from its rule prohibiting persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions enable these individuals to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Vision
FMCSA announces its decision to exempt 17 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs). They are unable to meet the vision requirement in one eye for various reasons. The exemptions will enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye. The Agency has concluded that granting these exemptions will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these CMV drivers.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Delta States Rural Development Network Grant Program, OMB No. 0915-0386-Revision
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Notice of Intent To Grant Exclusive Patent License; Per Vivo Labs, Inc.
The Department of the Navy hereby gives notice of its intent to grant to Per Vivo Labs, Inc., a revocable, nonassignable, exclusive license to practice in the field of use of explosive ordnance detection and disposal in the United States, the Government-owned invention described in U.S. Patent Application No. 14/978,040 entitled ``Mixed Odor Delivery Device (MODD)'', Navy Case No. 103,340 and any continuations, divisionals or re-issues thereof.
Training Program for Regulatory Project Managers; Information Available to Industry
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research, Professional Affairs and Stakeholder Engagement Staff (PASES), is hosting a 1-day public symposium entitled ``Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting.'' The purpose of this symposium is to discuss sources of preventable harm from drugs in the outpatient setting and to stimulate the exchange of ideas among thought leaders on interventions to reduce preventable harms and how these interventions can be studied.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information From United States Firms and Processors That Export to the European Union
The Food and Drug Administration (FDA or we) 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.
Guerbet Group; Withdrawal of Approval of Two New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of two new drug applications (NDAs) held by Guerbet Group. Guerbet Group notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; Public Workshop
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), Professional Affairs and Stakeholder Engagement Staff (PASES), is announcing a 1-day public workshop entitled ``Reducing the Risk of Preventable Adverse Drug Events Associated with Hypoglycemia in the Older Population.'' The purpose of this workshop is to discuss the importance of individualized glycemic control targets for older patients with diabetes; to reduce the risk of serious hypoglycemia; identify and discuss medication safety efforts, both those that are part of the Safe Use Initiative and those external to FDA, that are of direct relevance and importance to older patients living with the disease; discuss future areas of research which could be explored to reduce the risk of serious hypoglycemia in older diabetic patients; and disseminate the results of this discussion to inform patients, patient advocates, and health care practitioners.
Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Board to the FDA. The general function of the committee is to provide advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency's research agenda and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. This meeting is open to the public.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Certain Cut-To-Length Carbon-Quality Steel Plate From India, Indonesia, and the Republic of Korea: Final Results of the Expedited Sunset Reviews of the Antidumping Duty Orders
As a result of these sunset reviews, the Department of Commerce (the Department) finds that revocation of the antidumping duty (AD) orders on certain cut-to-length carbon-quality steel plate (CTL plate) from India, Indonesia, and the Republic of Korea (Korea) would be likely to lead to continuation or recurrence of dumping at the levels indicated in the ``Final Results of Sunset Reviews'' section of this notice.
Agency Requests for Renewal of a Previously Approved Information Collection(s): Uniform Financial Reporting Requirements
The Maritime Administration (MARAD) invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The information collection is necessary for MARAD to evaluate the financial condition of entities borrowing funds from or receiving financial benefits from MARAD. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.
Request for Comments of a Previously Approved Information Collection
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comments. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on December 28, 2016 (Federal Register 95729, Vol. 81, No. 249).
Agency Requests for Renewal of a Previously Approved Information Collection(s): Automated Mutual Assistance Vessel Rescue System
The Maritime Administration (MARAD) invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995, Public Law 104-13.
Request for Comments of a Previously Approved Information Collection
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comments. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published in the Federal Register on January 19, 2017 (Volume 82, Number 12; Page 6723).
Agency Information Collection Activities: Notice of Intent To Renew Collection Number 3038-0091, Disclosure and Retention of Certain Information Relating to Cleared Swaps Customer Collateral
The Commodity Futures Trading Commission (``CFTC'' or ``Commission'') is announcing an opportunity for public comment on the proposed renewal of a collection of certain information by the agency. Under the Paperwork Reduction Act (``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. This notice solicits comments on the collections of information provided for by the Commission's regulations under the Commodity Exchange Act (``CEA'') relating to the protection of customer collateral held by futures commission merchants (``FCM'') and derivatives clearing organizations (``DCO'') to serve as margin in cleared swaps transactions.
Request for Comment on Possible Changes to Industry Guide 3 (Statistical Disclosure by Bank Holding Companies); Extension of Comment Period
The Securities and Exchange Commission is extending the comment period for its request for comment seeking public input as to the disclosures called for by Industry Guide 3, Statistical Disclosure by Bank Holding Companies. The original comment period is scheduled to end on May 8, 2017. The Commission is extending the time period in which to provide the Commission with comments until July 7, 2017. This action will allow interested persons additional time to analyze the issues and prepare their comments.
Proposed Agency Information Collection Activities; Comment Request: Cab Technology Integration Lab (CTIL) Head-up Display Survey
Under the Paperwork Reduction Act of 1995 (PRA), this notice announces that FRA is forwarding the new Information Collection Request (ICR) abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICR describes the information collection and its expected burden. On November 2, 2016, FRA published a notice providing a 60-day period for public comment on the ICR.
Internal Revenue Service Advisory Council (IRSAC); Nominations
The Internal Revenue Service (IRS) requests nominations of individuals to be considered for selection as members of the Internal Revenue Service Advisory Council (IRSAC). Nominations should describe and document the proposed member's qualification for IRSAC membership, including the applicant's knowledge of Treasury Circular 230 regulations, the applicant's past and current affiliations, digital industry experience to include online services for tax professionals, experience working with software developers on tax-related applications, financial applications, software development and user experience design, and dealings with a particular tax segment of the community that he/she wishes to represent on the Council. Nominations will be accepted from qualified individuals and from professional and public interest groups that wish to have representatives on the IRSAC. The IRSAC is comprised of up to thirty- five (35) members. Nominations are currently being accepted for approximately nine appointments that will begin in January 2018. It is important that the IRSAC continue to represent a diverse taxpayer and stakeholder base. Accordingly, to maintain membership diversity, selection is based on the applicant's qualifications as well as areas of expertise, geographic diversity, major stakeholder representation and customer segments. The IRSAC provides an organized public forum for IRS officials and representatives of the public to discuss relevant tax administration issues, and it advises the IRS on issues that have a substantive effect on federal tax administration. As an advisory body designed to focus on broad policy matters, the IRSAC reviews existing tax policy and/or recommends policies with respect to emerging tax administration issues. The IRSAC suggests operational improvements, offers constructive observations regarding current or proposed IRS policies, programs, and procedures and advises the IRS with respect to issues having a substantive effect on federal tax administration.
Tax Counseling for the Elderly (TCE) Program Availability of Application Packages
This document provides notice of the availability of Application Packages for the 2018 Tax Counseling for the Elderly (TCE) Program.
Proposed Collection; Comment Request for United States Gift (and Generation-Skipping Transfer) Tax Return
The Department of the Treasury, 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. Currently, the IRS is soliciting comments concerning United States Gift (and Generation-Skipping Transfer) Tax Return.
Proposed Collection; Comment Request for Regulation Project
The Department of the Treasury, 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. Currently, the IRS is soliciting comments concerning, Re- characterizing Financing Arrangements Involving Fast-Pay Stock.
Proposed Collection; Comment Request for Regulation Project
The Department of the Treasury, 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. Currently, the IRS is soliciting comments concerning the VITA/TCE Volunteer Program.
Notice of Request for Extension or Renewal of a Currently Approved Information Collection
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Office of the Assistant Secretary for Civil Rights to request a renewal to a currently approved information collection for race, ethnicity, and gender along with comments.
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