March 9, 2016 – Federal Register Recent Federal Regulation Documents

This action adjusts initial 2016 annual catch limits for the Atlantic herring fishery to account for the under-harvest and overages of fishing year 2014 sub-annual catch limits. The 2015 specifications will remain in place after December 31, 2015, until NMFS sets new specifications through a 2016-2018 fishery specifications final rule, which NMFS expects to publish in the spring of 2016. In accordance with the regulations implementing the Atlantic Herring Fishery Management Plan, this action uses final herring catch data from 2014 for determining what under-harvest and overages occurred in fishing year 2014, and adjusts the initial 2016 annual catch limits for the four management areas (Areas 1A, 1B, 2, and 3). In addition, this action adjusts the initial 2016 stock-wide annual catch limit to account for any management area overages incurred in 2014. In order to ensure that carryover pounds do not cause overfishing of the herring resource, area-specific carryover does not increase the initial stock-wide catch allocation. This action is necessary to ensure that NMFS accounts for herring catch consistent with the requirements of the Atlantic Herring Fishery Management Plan.

The Department of Transportation, through the Office of the Assistant Secretary for Research and Technology (OST-R), will begin testing Global Positioning System/Global Navigation Satellite System (``GPS/GNSS'') receivers this April pursuant to the DOT Adjacent Band Compatibility Study (``the Study'') test plan published with this notice. Device testing will take place at the U.S. Army Research Laboratory at the White Sands Missile Range (WSMR) facility in New Mexico. The Study provides for testing categories of receivers that include aviation (non-certified), cellular, general location/navigation, high precision, timing, networks, and space-based receivers. DOT seeks to include a broad range of devices used in rail, aviation, motor vehicle, maritime, and space transportation safety systems, among a number of other applications of GPS/GNSS. The goal of the Study is to evaluate the adjacent radio frequency band power levels that can be tolerated by GPS/GNSS receivers, and advance the Department's understanding of the extent to which such power levels impact devices used for transportation safety purposes, among other GPS/GNSS applications. The Study will involve testing of receivers provided by government agencies. In addition, to maximize diversity in the devices tested and breadth of relevant data collected for analysis in the Study, the Department requests voluntary participation in this Study by any interested GPS/GNSS device manufacturers or other parties whose products incorporate GPS/GNSS devices. Such participation could involve provision of GPS/GNSS receivers to DOT for use in testing, provision of data on receiver design to facilitate data collection pursuant to the test plan, and/or on-site commitment and support from manufacturers and other entities providing GPS/GNSS receivers for testing. DOT expects that any onsite commitment and support would take approximately one work week.

FMCSA announces that it has accepted the request of Atlantic and Pacific Freightways, Inc. (A&P) to withdraw its application for exemption from the Agency's regulation requiring motor carriers to obtain updated medical certification information when a driver holding a commercial driver's license (CDL) undergoes a new driver medical examination (49 CFR 391.51(b)(7)(ii)). A&P no longer needs the exemption.

FMCSA announces receipt of applications from 31 individuals for an exemption from the prohibition against persons with a clinical diagnosis of epilepsy or any other condition that is likely to cause a loss of consciousness or any loss of ability to operate a commercial motor vehicle (CMV) in interstate commerce. If granted, the exemptions would enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs for up to 2 years in interstate commerce.

National Aeronautics and Space Administration (NASA) is issuing a final rule to amend the NASA FAR Supplement (NFS) to change the role of NASA suspending and debarring official from the Assistant Administrator for Procurement to the Deputy General Counsel and to make other editorial changes.

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 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 Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use.'' This draft guidance provides a statement of qualification for exploratory use for the evaluating respiratory symptoms in chronic obstructive pulmonary disease (E-RS: COPD), a patient-reported outcome instrument, and summarizes the concept of interest and context of use (COU) for which the tool is qualified through the Center for Drug Evaluation and Research's (CDER's) drug development tool (DDT) qualification program. Qualification for exploratory use of the E-RS: COPD represents a conclusion that within the stated COU, the instrument can be relied on to have a specific interpretation and application in drug development and regulatory review. This draft guidance is an attachment to the guidance for industry entitled ``Qualification Process for Drug Development Tools.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) # 203 entitled ``Ensuring Safety of Animal Feed Maintained and Fed On-Farm.'' This guidance is intended to help animal producers (persons who feed animals) develop and implement on-farm practices to ensure the safety of animal feed maintained and fed to animals on the farm.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.'' The topics to be discussed are the specific analytical and clinical study designs and considerations for validation and use of liquid chromatography/mass- spectrometry (LC/MS)-based in vitro diagnostic devices (IVDs) in the clinical laboratory. The primary focus will be on the validation considerations with protein- and peptide-based LC/MS devices.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Guidance for Industry.'' The guidance document provides establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) for which no premarket submissions are required because they are not also regulated as drugs, devices, and/or biological products, with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable disease in recipients of these HCT/Ps. The guidance also provides updated information specific to reporting adverse reactions related to HCT/Ps to supplement the general instructions accompanying the MedWatch mandatory reporting form, Form FDA 3500A. The guidance supplements section XXII of FDA's guidance entitled ``Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated December 2011 and supersedes the guidance entitled ``Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated November 2005. The guidance announced in this notice finalizes the draft guidance of the same title dated February 2015.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on March 29, 2016. The subject of the meeting will be initiatives in natural experiments for diabetes prevention and control being sponsored by the Centers for Disease Control and Prevention, the National Institute of Diabetes and Digestive and Kidney Diseases, and the Patient-Centered Outcomes Research Institute. The meeting is open to the public.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Georgia (FEMA- 4259-DR), dated 02/26/2016. Incident: Severe Storms and Flooding. Incident Period: 12/22/2015 through 01/13/2016. Effective Date: 02/26/2016. Physical Loan Application Deadline Date: 04/26/2016. Economic Injury (EIDL) Loan Application Deadline Date: 11/28/2016.

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning the Make-or-Buy Program.

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 Hawai[revaps]i State Advisory Committee (Committee) to the Commission will be held at 2:00 p.m. (Hawaiian Time) Thursday, March 24, 2016, for the purpose of considering the Committee's report on Micronesian immigration to Hawai[revaps]i. This meeting is available to the public through the following toll- free call-in number: 888-299-7209; when prompted, please provide conference ID number: 1427558. Any interested member of the public may call this number and listen to the meeting. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977- 8339 and providing the Service with the conference call number and conference ID number. Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting. Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments. The comments must be received in the Western Regional Office of the Commission by Monday, April 18, 2016. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Angela French-Bell, Regional Director, Western Regional Office, at abell@usccr.gov. Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https:// facadatabase.gov/committee/meetings.aspx?cid=244. Please click on the ``Meeting Details'' and ``Documents'' links. Records generated from this meeting may also be inspected and reproduced at the Western Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, https://www.usccr.gov, or may contact the Western Regional Office at the above email or street address.