June 11, 2019 – Federal Register Recent Federal Regulation Documents

In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, the Food Safety and Inspection Service (FSIS) is announcing its intention to collect information on the FSIS Form PY-200 ``Egg Products Inspection Certificate.'' FSIS is seeking approval for the FSIS Form PY-200, so that industry personnel can assist FSIS with its completion. This is a new information collection with an estimated annual burden of 96,360 hours.

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), is announcing a public workshop entitled ``Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making.'' The purpose of this public workshop is to discuss best practices and evidentiary criteria in the use of physiologically based pharmacokinetic (PBPK) modeling approaches to support regulatory decision-making; share experiences and cases where applying PBPK modeling and simulation highlight the opportunities and limitations of this approach; obtain input from stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making; and discuss the knowledge gaps and research needed to advance PBPK modeling sciences in drug development to support regulatory decisions. This public workshop is also being conducted to satisfy one of FDA's performance goals included in the sixth reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD).

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

We, the U.S. Fish and Wildlife Service (Service), are initiating 5-year status reviews for 91 species in Oregon, Washington, Hawaii, and American Samoa under the Endangered Species Act of 1973. Three of these species also occur outside U.S. jurisdiction in Canada and the South Pacific. A 5-year review is based on the best scientific and commercial data available at the time of the review; therefore, we are requesting submission of any new information on these species that has become available since the last review.

This notice announces the cancellation of GSA Federal Management Regulation (FMR) Bulletin B-32.

NMFS announces that the Pacific Fishery Management Council submitted Amendment 28 to the Pacific Coast Groundfish Fishery Management Plan to the Secretary of Commerce for review. If approved, Amendment 28 would establish new and revised areas closed to bottom trawling to conserve and protect Pacific coast groundfish essential fish habitat, and would re-open areas that were closed to bottom trawling to rebuild previously-overfished groundfish stocks. Combined, these two changes are anticipated to increase protections for groundfish essential fish habitat and provide additional flexibility to participants fishing with bottom trawl gear in the groundfish trawl rationalization program. Amendment 28 would also close deep-water areas off the coast of California to bottom contacting gear to protect deep- water habitats, including deep-sea corals using discretionary fishery management plan provisions in the Magnuson-Stevens Fishery Conservation and Management Act.

The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services Division (CJIS), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

The Coast Guard will enforce certain safety zones located in the federal regulations for Annual Events in the Captain of the Port Buffalo. This action is necessary and intended to protect the safety of life and property on navigable waters prior to, during, and immediately after these events. During each enforcement period, no person or vessel may enter the respective safety zone without the permission of the Captain of the Port Buffalo.

The Environmental Protection Agency (EPA) is proposing approval of a State Implementation Plan (SIP) revision submitted by the State of Missouri on January 14, 2019. The revision submitted by the state is an amendment to a rule relating to reference methods for determining ambient air/atmosphere data and information necessary for the enforcement of air pollution control regulations throughout Missouri. The revision is administrative in nature and either incorporates by reference or updates state rules to match Federal regulations. This revision does not have an adverse effect on air quality. The EPA's proposed approval of this rule revision is being done in accordance with the requirements of the Clean Air Act (CAA).

The Environmental Protection Agency (EPA) is proposing approval of a State Implementation Plan (SIP) and Operating Permits Program revision submitted by the State of Missouri on January 15, 2019. The revisions add definitions, removes language referring to outdated emission fees, and updates incorporations by reference in the rule. The revision is administrative in nature and does not have an adverse effect on air quality. The EPA's proposed approval of this rule revision is being done in accordance with the requirements of the Clean Air Act (CAA).

CMS is committed to transforming the health care delivery systemand the Medicare and Medicaid programsby putting additional focus on patient-centered care, innovation, and outcomes. As part of our continuing Patients over Paperwork initiative, we have actively solicited feedback from the medical community through Requests for Information (RFIs), listening sessions, and clinical onsite engagements with front-line clinicians and staff to learn how our administrative requirements and processes affect their daily work and ability to innovate in care delivery. This RFI solicits additional public comment on ideas for regulatory, subregulatory, policy, practice, and procedural changes that reduce unnecessary administrative burdens for clinicians, providers, patients and their families. Through these efforts, we aim to increase quality of care, lower costs, improve program integrity, and make the health care system more effective, simple, and accessible.

In accordance with the Paperwork Reduction Act of 1995, CNCS is proposing to renew an information collection.

In accordance with the Paperwork Reduction Act of 1995, CNCS is proposing to renew an information collection.

In accordance with the Paperwork Reduction Act of 1995, CNCS is proposing to renew an information collection.

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.