January 2018 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Comprehensive Addiction and Recovery Act (CARA) of 2016, which became law on July 22, 2016, amended the Controlled Substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Separately, the Department of Health and Human Services, by final rule effective August 8, 2016, increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA for that purpose. The Drug Enforcement Administration (DEA) is hereby amending its regulations to incorporate these statutory and regulatory changes.

The Department of Defense is issuing this final rule to adjust each of its statutory civil monetary penalties (CMP) to account for inflation. The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), requires the head of each agency to adjust for inflation its CMP levels in effect as of November 2, 2015, under a revised methodology that was effective for 2016 and for each year thereafter.

Whenever a new or revised National Ambient Air Quality Standard (NAAQS) is promulgated, the Clean Air Act (CAA) requires states to submit a plan for the implementation, maintenance, and enforcement of the standard, commonly referred to as infrastructure requirements. The Environmental Protection Agency (EPA) is proposing to approve the Alaska State Implementation Plan (SIP) as meeting specific infrastructure requirements for the fine particulate matter (PM2.5) NAAQS.

HUD submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for 30 days of public comment.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Oregon Advisory Committee (Committee) to the Commission will be held at 1:00 p.m. (Pacific Time) Tuesday, February 6, 2018 and 1:00 p.m. (Pacific Time) Tuesday, March 6, 2018. The purpose of the meeting is for the Committee to continue planning to collect testimony focused on human trafficking in Oregon.

The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-593-596 and 731-TA-1401- 1406 (Preliminary) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of large diameter welded pipe from Canada, China, Greece, India, Korea, and Turkey, provided for in subheadings 7305.11, 7305.12, 7305.19, 7305.31, and 7305.39 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Governments of China, India, Korea, and Turkey. Unless the Department of Commerce extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by March 5, 2018. The Commission's views must be transmitted to Commerce within five business days thereafter, or by March 12, 2018.

Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ'') initial determination (``ID'') (Order No. 27), which terminated the investigation on the basis of settlement.

The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to revise, without extension, the Annual Report of Foreign Banking Organizations (FR Y-7). The revisions to the mandatory FR Y-7 information collection are effective beginning with FR Y-7 reports for fiscal year-ends that end on or after March 1, 2018.

The Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers and exporters of fine denier polyester staple fiber (fine denier PSF) from India. The period of investigation is January 1, 2016, through December 31, 2016. For information on the estimated subsidy rates, see the ``Final Determination and Suspension of Liquidation'' section of this notice.

The Department of Health and Human Services (HHS) announces the third meeting of the Tick-Borne Disease Working Group (Working Group) on February 12, 2018, from 12:00 p.m. to 4:00 p.m., Eastern Time. For this third meeting, the Working Group will focus on mapping out the work of the six Subcommittee Meeting Working Groups that were established on December 12, 2017. These subcommittees were established to assist the Working Group with the development of the report to Congress and the HHS Secretary as required by the 21st Century Cures Act. The subcommittees are: 1. Disease Vectors, Surveillance and Prevention (includes epidemiology of tick-borne diseases); 2. Pathogenesis, Transmission, and Treatment; 3. Testing and Diagnostics (including laboratory-based diagnoses and clinical-diagnoses); 4. Access to Care Services and Support to Patients; 5. Vaccine and Therapeutics; and 6. Other Tick-Borne Diseases and Co-infections.

The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers/ exporters of stainless steel flanges from the People's Republic of China (China). The period of investigation is January 1, 2016, through December 31, 2016. We invite interested parties to comment on this preliminary determination.

The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. This meeting will be held online via webinar and is open to the public. The Committee will discuss the nation's health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will develop recommendations regarding: Leading Health Indicators; the setting of targets for a more focused set of measurable, nationally representative objectives; the roles of health and well-being, health equity, and law in Healthy People 2030; and the creation of a logic model for communicating the role of Healthy People 2030, disease prevention, and health promotion. Pursuant to the Committee's charter, the Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.

The U.S. Nuclear Regulatory Commission (NRC) will convene a teleconference meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on February 15, 2018, to discuss the revised draft report of the ACMUI Nursing Mother Guidelines for the Medical Administration of Radioactive Materials and the revised draft report of the ACMUI Physical Presence Requirements for the Leksell Gamma Knife[supreg] IconTM. The Nursing Mother Guidelines report will include the subcommittee's recommendations on the cessation of breastfeeding for various radionuclides. The Physical Presence Requirements report will include the subcommittee's recommendations for the physical presence of authorized users and authorized medical physicists during treatments using the IconTM unit. The NRC will also convene another teleconference meeting on March 1, 2018, to discuss the draft report of the Standing ACMUI Training and Experience Subcommittee. This report will include the subcommittee's recommendation for the total number of training and experience hours for authorized users under title 10 Code of Federal Regulations (10 CFR) 35.300 that is necessary for safety. Meeting information, including a copy of the agendas and handouts, will be available at https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/ 2018.html. The agenda and handouts may also be obtained by contacting Ms. Sophie Holiday using the information below.

The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for a new information collection, which is summarized below under Supplementary Information. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.

The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for renewal of an existing information collection that is summarized below under SUPPLEMENTARY INFORMATION. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 12) of the presiding administrative law judge (``ALJ''), granting a joint motion to terminate the above-captioned investigation based on settlement and license agreements.

We, the U.S. Fish and Wildlife Service (Service), determine the eastern puma (=cougar) (Puma (=Felis) concolor couguar) to be extinct, based on the best available scientific and commercial information. This information shows no evidence of the existence of either an extant reproducing population or any individuals of the eastern puma subspecies; it also is highly unlikely that an eastern puma population could remain undetected since the last confirmed sighting in 1938. Therefore, under the authority of the Endangered Species Act of 1973 (Act), as amended, we remove this subspecies from the Federal List of Endangered and Threatened Wildlife.

The United States Trade Representative (Trade Representative) and the Secretary of Commerce (Secretary) plan to establish a new four- year charter term for the Industry Trade Advisory Committees (ITACs) beginning in February 2018. As part of the re-chartering process, the Secretary and the Trade Representative are proposing changes to the current slate of ITACs and invite interested parties to submit their view on these changes.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 15, 2017. In the notice of availability, FDA requested comments on the draft guidance for industry and FDA staff entitled ``The Least Burdensome Provisions: Concept and Principles.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). At least one portion of the meeting will be closed to the public. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. FDA is establishing a docket for public comments on this document.

The Food and Drug Administration (FDA and Agency) is withdrawing approval of an abbreviated new drug application (ANDA), held by Watson Laboratories, Inc. (Watson), for prescription pain medications that contain more than 325 milligrams (mg) of acetaminophen. Watson has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing.