April 2017 – Federal Register Recent Federal Regulation Documents

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.

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.

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.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entitled ``Draft Guidance on Naloxone Hydrochloride.'' The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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).

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.

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.

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.

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.

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.