November 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance replaces the existing guidance entitled ``S5(R2) Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' The draft guidance is intended to align with other ICH guidances, elaborate on concepts to consider when designing studies, and identify potential circumstances in which a risk assessment can be made based on preliminary studies. It also clarifies the qualification and potential use of alternative assays.

The U.S. Nuclear Regulatory Commission (NRC) recently submitted a renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, Information Collection: Safeguards on Nuclear MaterialImplementation of United States/International Atomic Energy Agency Agreement.''

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Office of Procurement and Property Management's intention to request an extension of a currently approved information collection for Guidelines for the Transfer of Excess Computers or Other Technical Equipment Pursuant to Section 14220 of the 2008 Farm Bill.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Puerto Rico (FEMA-4339-DR), dated 11/02/2017. Incident: Hurricane Maria. Incident Period: 09/17/2017 and continuing.

We, the U.S. Fish and Wildlife Service (Service), announce that a Candidate Conservation Agreement (CCA) has been prepared for Chorizanthe parryi var. fernandina (San Fernando Valley spineflower). The CCA was developed as a collaborative effort between the Newhall Land and Farming Company (Newhall Land), a California limited partnership, and the Service to implement conservation measures for the species. With the release of the CCA, we are reopening for an additional 30 days the comment period on the proposed rule to list C. parryi var. fernandina as a threatened species. We will submit a final listing determination to the Federal Register on or before March 15, 2018.

The Department of Commerce, 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.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the SR 73 (Tacony-Palmyra) Bridge across the Delaware River, mile 107.2, in between Tacony, PA, and Palmyra, NJ. The deviation is necessary to facilitate routine maintenance. This deviation allows the bridge to remain in the closed- to-navigation position.

The Environmental Protection Agency has submitted an information collection request (ICR), ``Willingness to Pay Survey to Evaluate Recreational Benefits of Nutrient Reductions in Coastal New England Waters (New)'' (EPA ICR No. 2558.01, OMB Control No. 2080-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of a new collection. Public comments were previously requested via the Federal Register (81 FR 78809) on 11/09/2016 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Department of Transportation is amending its drug-testing program regulation to add hydrocodone, hydromorphone, oxymorphone, and oxycodone to its drug-testing panel; add methylenedioxyamphetamine as an initial test analyte; and remove methylenedioxyethylamphetamine as a confirmatory test analyte. The revision of the drug-testing panel harmonizes DOT regulations with the revised HHS Mandatory Guidelines established by the U.S. Department of Health and Human Services for Federal drug-testing programs for urine testing. This final rule clarifies certain existing drug-testing program provisions and definitions, makes technical amendments, and removes the requirement for employers and Consortium/Third Party Administrators to submit blind specimens.

The National Indian Gaming Commission proposes to amend its fee regulations. The proposed rule would require the Commission to adopt annual fee rates no later than November 1 of each year. In addition, the proposed rule defines the fiscal year of the gaming operation that will be used for calculating the fee payments. Finally, the proposed rule includes additional revisions intended to clarify the fee calculation and submission process for gaming operations.

VETS published a proposed rule implementing the Honoring Investments in Recruiting and Employing (HIRE) American Military Veterans Act of 2017 (HIRE Vets Act or Act). The HIRE Vets Act requires the Department of Labor (DOL or Department) to establish by rule a HIRE Vets Medallion Program (Medallion Program) and annually solicit and accept voluntary information from employers for consideration of employers to receive a HIRE Vets Medallion Award (the award). Under the Program, VETS will review applications and notify recipients of their awards, and announce their names at a time that coincides with Veterans Day. This final rule sets out the criteria for the different categories and levels of HIRE Vets Medallion Awards, the award application process, and the award fees. VETS invited written comments on the proposed rule, and any specific issues related to the proposal, from members of the public.