June 3, 2016 – Federal Register Recent Federal Regulation Documents

The Coast Guard is establishing a Special Local Regulation for all navigable waters within the Columbia River in the vicinity of Columbia Park, commencing at the Interstate 395 Bridge and continuing up river approximately 2.0 miles and terminating at the northern end of Wade Island, during the Tri-City Water Follies Spring Testing event. The special local regulation is needed to protect personnel, vessels, and the marine environment from potential hazards created by high-speed watercraft. Entry of vessels or persons into this area is prohibited unless specifically authorized by the Captain of the Port Columbia River or his designated representative.

This is a notice of the Presidential declaration of a major disaster for the State of Montana (FEMA-4271-DR), dated May 24, 2016, and related determinations.

This notice amends the notice of a major disaster declaration for the State of Mississippi (FEMA-4268-DR), dated March 25, 2016, and related determinations.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee. The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and make appropriate recommendations to the Agency. The meeting will be open to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Individual Patient Expanded Access Applications: Form FDA 3926.'' The guidance describes Form FDA 3926 (Individual Patient Expanded Access Investigational New Drug Application (IND)), which is available for licensed physicians to use for expanded access requests for individual patient INDs. Individual patient expanded access allows for the use of an investigational new drug outside of a clinical investigation, or the use of an approved drug where availability is limited by a risk evaluation and mitigation strategy (REMS), for an individual patient who has a serious or immediately life-threatening disease or condition when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. Form FDA 3926 provides a streamlined alternative for submitting an IND for use in cases of individual patient expanded access, including for emergency use. This guidance finalizes the draft guidance issued in February 2015.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Expanded Access to Investigational Drugs for Treatment UseQuestions and Answers.'' The guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA's regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND). FDA received a number of questions concerning implementation of its expanded access regulations and is providing guidance in a question and answer format to address the most frequently asked questions. This guidance finalizes the draft guidance issued in May 2013.

EPA received several comments during the open comment period on the March 23, 2016, proposed rule to authorize Nevada's changes to the State Hazardous Waste Management program. EPA is responding to one comment opposing the action and reaffirming the effective date of the direct final rule as June 6, 2016.

The Agency is announcing the availability of and seeking public comment on a draft Pesticide Registration Notice (PR Notice) entitled ``Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship.'' PR Notices are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration-related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. This draft PR Notice (2016-XX) communicates the Agency's approach to addressing herbicide-resistant weeds by providing guidance on labeling, education, training, and stewardship for herbicides undergoing registration review or registration (i.e., new herbicide and actives, new uses proposed for use on herbicide-resistant crops, or other case-specific registration actions.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Dental Craniofacial Research (NIDCR), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Sophia Jeon, Health Science Policy Analyst, Office of Science Policy and Planning, OSPP, NINDS, NIH, 31 Center Drive, Building 31, Room 8A03, Bethesda, MD 20892, or call non-toll-free number (301) 435-7571, or Email your request, including your address to: sophia.jeon@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, National Institute of Neurological Disorders and Stroke (NINDS), 0925-0678, Expiration Date 08/31/2016EXTENSION, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH). Need and Use of Information Collection: The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: the target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. OMB approval extension is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 5750.

We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits activities with listed species unless Federal authorization is acquired that allows such activities.

We propose special conditions for the BHTI Model 525 helicopter. This helicopter will have a novel or unusual design feature associated with the electronic CAS. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The Federal Aviation Administration (FAA) is considering a proposal to authorize the release of approximately 482.21 acres of the airport property at the Former Willmar Municipal Airport, Willmar MN. The acreage being released is not needed for aeronautical use as the City built a new replacement airport that became operational in 2006. The acreage was originally acquired with local, State of Minnesota, and federal funds. The federal funds associated with the land came from a Federal Aid to Airports Grant in 1957 (Grant Number 9-21-040-5702). The FAA approved a Finding of No Significant Impact for the release of the former Willmar Municipal Airport on September 20, 2013. Approval does not constitute a commitment by the FAA to financially assist in the disposal of the subject airport property nor a determination of eligibility for grant-in-aid funding from the FAA. The disposition of proceeds from the disposal of the airport property will be in accordance with FAA's Policy and Procedures Concerning the Use of Airport Revenue, published in the Federal Register on February 16, 1999. In accordance with section 47107(h) of title 49, United States Code, this notice is required to be published in the Federal Register 30 days before modifying the land-use assurance that requires the property to be used for an aeronautical purpose.

In compliance with the Paperwork Reduction Act of 1995 (PRA), FRA is forwarding the Information Collection Request (ICR) renewals abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICRs describe the nature of the information collections and their expected burden.

The Administration for Community Living (ACL) is amending its regulations to reflect the creation of ACL in 2012 and consolidate all of its regulations under a single subchapter. No substantive changes to the text of the regulations are being made by this rule.

The Department of Health and Human Services is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled ``State Health Insurance Assistance Program (SHIP).'' This final rule implements a provision enacted by the Consolidated Appropriations Act of 2014 and reflects the transfer of the State Health Insurance Assistance Program (SHIP) from the Centers for Medicare & Medicaid Services (CMS), in the Department of Health and Human Services (HHS) to the Administration for Community Living (ACL) in HHS. Prior to the interim final rule, prior regulations were issued by CMS under the authority granted by the Omnibus Budget Reconciliation Act of 1990 (OBRA), Section 4360.

The Commission is noticing a recent Postal Service filing concerning notice to enter into a Priority Mail International Regional Rate Boxes Contract 1 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The New England Fishery Management Council (Council, NEFMC) will hold a three-day meeting to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

In accordance with the National Environmental Policy Act of 1969, as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) has prepared a Draft Resource Management Plan (RMP) Amendment and Draft Environmental Assessment (EA) titled Medford District RMP Amendment and EA: Table Rocks Area of Critical Environmental Concern (ACEC) Proposed Boundary Change and Supplementary Rules and, by this notice, is announcing the opening of the comment period.

The Committee is proposing to add products and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and services previously furnished by such agencies.

The U.S. 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the Community Development Financial Institutions Fund (CDFI Fund), U.S. Department of the Treasury, is soliciting comments concerning the Secondary Loan Commitment Form (SLCF) for the CDFI Bond Guarantee Program (BG Program).