August 2016 – Federal Register Recent Federal Regulation Documents

The Board of Trustees of the Iron Workers Local 17 Pension Fund, a multiemployer pension plan, has submitted a revised application to the Department of the Treasury (Treasury) to reduce benefits under the plan in accordance with the Multiemployer Pension Reform Act of 2014 (MPRA). This revised application was submitted on July 29, 2016, by the Board of Trustees of the Iron Workers Local 17 Pension Fund following the withdrawal of the application that it submitted on December 23, 2015. The purpose of this notice is to announce that the revised application has been published on the Treasury Web site and to request public comments on the application from interested parties, including participants, beneficiaries, employee organizations, and contributing employers of the Iron Workers Local 17 Pension Fund.

This notice announces a meeting of the Environmental Management Advisory Board (EMAB). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

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 report of shipment. A notice was published in the Federal Register at 81 FR 39052 on June 15, 2016. No comments were received.

FMCSA confirms its decision to exempt 70 individuals from its rule prohibiting persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions enable these individuals to operate CMVs in interstate commerce.

The Food and Drug Administration (FDA or we) is extending the comment periods for the Draft Guidance entitled, ``Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods'' that appeared in the Federal Register of June 2, 2016. In the notice, we requested comments on developing the sodium targets and for implementation of the guidance document. We are taking this action in response to requests to extend the two comment periods to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on generic risperidone injection, entitled ``Bioequivalence Recommendations for Risperidone.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for risperidone injection.

FMCSA confirms its decision to exempt 57 individuals from its rule prohibiting persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions enable these individuals to operate CMVs in interstate commerce.

The Coast Guard will enforce regulations for a safety zone for an annual fireworks event in the Captain of the Port Delaware Bay zone from 8 p.m. to 10 p.m. on September 16, 2016, with a rain date of September 18, 2016. Enforcement of this zone is necessary and intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after these fireworks events. During the enforcement periods, no vessel may transit this regulated area without approval from the Captain of the Port or a designated representative.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on June 7, 2016, at 81 FR 36556, allowing for a 60-day public comment period. USCIS did receive six comments in connection with the 60-day notice.

This document announces the date of the next meeting of the Commission's Disability Advisory Committee (Committee or DAC). The meeting is open to the public. During this meeting, members of the Committee will receive and discuss summaries of activities and recommendations from its subcommittees.

The Farm Credit System Insurance Corporation (Corporation) issues a final rule amending its regulations to reflect changes to the Freedom of Information Act (FOIA). The FOIA Improvement Act of 2016 requires the Corporation to amend its FOIA regulations to extend the deadline for administrative appeals, to add information on dispute resolution services, and to amend the way the Corporation charges fees.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

We are amending the Virus-Serum-Toxin Act regulations regarding the packaging and labeling of veterinary biological products to provide for the use of an abbreviated true name on small final container labeling for veterinary biologics; require labeling to bear a consumer contact telephone number; change the format used to show the establishment or permit number on labeling and require such labeling to show the product code number; change the storage temperature recommended in labeling for veterinary biologics; require vaccination and revaccination recommendations in labeling to be consistent with licensing data; require labeling information placed on carton tray covers to appear on the outside face of the tray cover; remove the restriction requiring multiple-dose final containers of veterinary biologics to be packaged in individual cartons; require labeling for bovine virus diarrhea vaccine containing modified live virus to bear a statement warning against use in pregnant animals; reduce the number of copies of each finished final container label, carton label, or enclosure required to be submitted for review and approval; require labels for autogenous biologics to specify the organism(s) and/or antigen(s) they contain; and require labeling for conditionally licensed veterinary biologics to bear a statement concerning efficacy and potency requirements. In addition, we are also amending the regulations concerning the number of labels or label sketches for experimental products required to be submitted for review and approval, and the recommended storage temperature for veterinary biologics at licensed establishments. These changes are necessary in order to update and clarify labeling requirements and to ensure that information provided in labeling is accurate with regard to the expected performance of the product.

The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is proposing to amend its regulations to enhance the process for reviewing whistleblower claims and to make related changes to clarify staff authority to administer the whistleblower program. The Commission also is reinterpreting its anti-retaliation authority and proposing appropriate rule amendments to implement that authority.