2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Data Integrity and Compliance With Drug CGMP: Questions and Answers.'' The purpose of the guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. (Unless otherwise noted, the term CGMP refers to CGMPs for drugs, including biologics.) The guidance has been developed in response to an increase in findings of data integrity lapses in recent inspections. FDA expects that all data be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.

The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of the firms contributed importantly to the total or partial separation of the firms' workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.

This notice amends the notice of a major disaster declaration for the State of Kansas (FEMA-4403-DR), dated October 19, 2018, and related determinations.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

This is a notice of the Presidential declaration of a major disaster for the Commonwealth of Pennsylvania (FEMA-4408-DR), dated November 27, 2018, and related determinations.

The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.

Following receipt on November 9, 2018, of a request from the United States Trade Representative (USTR) for a report containing advice and an assessment, the Commission instituted Investigation Nos. TA-131-045 and TPA-105-006, U.S.-UK Trade Agreement: Advice on the Probable Economic Effect of Providing Duty-free Treatment for Currently Dutiable Imports.

The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR), OMB control number 1652-0053, abstracted below that we will submit to the Office of Management and Budget (OMB) for a revision in compliance with the Paperwork Reduction Act. The ICR describes the nature of the information collection and its expected burden. The collections of information that make up this ICR include: (1) Applications from entities that wish to become Certified Cargo Screening Facilities (CCSFs), Third-Party Canine-Cargo (3PK9-C) Certifiers or Certified Cargo Screening Program-Canine (CCSP-K9) Holders; (2) personally identifiable information to allow TSA to conduct security threat assessments (STA) on certain individuals employed by the CCSFs, 3PK9-C Certifiers, Certified Cargo Screening Facilities-K9 (CCSF-K9) and those authorized to conduct 3PK9-C Program activities; (3) standard security program or submission of a proposed modified security program or amendment to a security program by CCSFs and CCSF-K9s; or standards provided by TSA or submission of a proposed modified standard by 3PK9-C Certifiers; (5) recordkeeping requirements for CCSFs, CCSF-K9s and 3PK9-C Certifiers; (6) designation of a Security Coordinator (SC) by CCSFs and CCSF-K9s; and (7) significant security concerns detailing information of incidents, suspicious activities, and/or threat information by CCSFs, 3PK9-C Certifiers, and CCSP-K9 Holders.

The plat of survey of the following described lands was officially filed in the Bureau of Land Management (BLM), Arizona State Office, Phoenix, Arizona, on the date indicated. The survey announced in this notice is necessary for the management of lands administered by the agency indicated.

The Environmental Protection Agency (EPA) is proposing to approve a request submitted by the Michigan Department of Environmental Quality (MDEQ) on December 12, 2017, and supplemented on August 9, 2018, as a revision to Michigan's state implementation plan (SIP). The SIP submission incorporates several revisions to Michigan's Air Pollution Control Rules entitled ``Part 1General Provisions.'' The revisions include administrative changes to the existing rule.

The Environmental Protection Agency (EPA) is finalizing action on three state implementation plan (SIP) revisions submitted by the State of California addressing the nonattainment new source review (NNSR) requirements for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS). These SIP revisions address the South Coast Air Quality Management District (SCAQMD), San Joaquin Valley Air Pollution Control District (SJVAPCD) and Yolo-Solano Air Quality Management District (YSAQMD) portions of the California SIP.

The Environmental Protection Agency (EPA) is proposing to establish a federal Clean Water Act (CWA) selenium water quality criterion applicable to California that protects aquatic life and aquatic-dependent wildlife in the fresh waters of California. In 2016, the EPA published a revised recommended aquatic life selenium criterion for freshwater based on the latest scientific knowledge. The EPA is proposing to amend the California Toxics Rule to include a revised statewide chronic selenium water quality criterion for California fresh waters to protect aquatic life and aquatic-dependent wildlife which builds upon the science in the EPA's 2016 Final Aquatic Life Ambient Water Quality Criteria for SeleniumFreshwater.

NMFS has received a request from the National Park Service (NPS) for authorization to take marine mammals incidental to research and monitoring activities in southern Alaska over the course of five years (2019-2024). These activities include glaucous-winged gull and climate monitoring activities in Glacier Bay National Park (GLBA NP), Alaska and marine bird and mammal survey activities conducted by the Southwest Alaska Inventory and Monitoring Network (SWAN) in national parks and adjacent lands. As required by the Marine Mammal Protection Act (MMPA), NMFS is proposing regulations to govern that take and requests comments on the proposed regulations.

The Department of State (the Department) updates and revises the rules that implement Section 508 of the Rehabilitation Act of 1973, consistent with a recent update to accessibility standards from the U.S. Access Board.

Due to inclement weather on November 15, 2018, the FAA announces a replacement public meeting to solicit feedback concerning the New York North Shore Helicopter Rule (``the Rule''). This meeting is being held pursuant to Section 182 of the FAA Reauthorization Act of 2018. The Rule requires civil helicopter pilots operating under Visual Flight Rules (VFR), whose route of flight takes them over the north shore of Long Island between the Visual Point Lloyd Harbor (VPLYD) waypoint and Orient Point (VPOLT), to use the North Shore Helicopter Route.