September 8, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity StudiesQuestions and Answers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This question and answer (Q&A) guidance provides additional information to facilitate interpretation of the ``S3A Guidance: The Assessment of Systemic Exposure in Toxicity Studies'' (S3A guidance), especially to address the benefit and use of microsampling techniques in main study animals. The Q&A guidance is intended to provide points to consider before incorporating the microsampling method in toxicokinetic studies, and acknowledges the benefits (and some limitations) of the use of microsampling.

The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until September 1, 2018.

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0056, Labeling Required in 33 Code of Federal Regulation parts 181 and 183 and 46 Code of Federal Regulation 25.10-3. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0049, Waterfront Facilities Handling Liquefied Natural Gas (LNG) and Liquefied Hazardous Gas (LHG). Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.

The Bureau of Industry and Security (BIS) is seeking public comments on the effect of existing foreign policy-based export controls in the Export Administration Regulations. Section 6 of the Export Administration Act requires BIS to consult with industry on the effect of such controls and to report the results of the consultations to Congress. BIS is conducting the consultations through this request for public comments. Comments from all interested persons are welcome. All comments will be made available for public inspection and copying and included in a report to be submitted to Congress.

The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, NRC Form 136, ``Security Termination Statement.''

This notice lists the membership of the National Institute of Standards and Technology Performance Review Board (NIST PRB) and supersedes the list published on September 3, 2014.

The Board of Governors of the Federal Reserve System (Board or Federal Reserve) is adopting a proposal to revise, with extension, the mandatory Consolidated Financial Statements for Holding Companies (FR Y-9C). The Board also proposes to extend, without revision, the other forms that make up the family of FR Y-9 reporting forms. These are: The Parent Company Only Financial Statements for Large Holding Companies (FR Y-9LP) The Parent Company Only Financial Statements for Small Holding Companies (FR Y-9SP) The Financial Statements for Employee Stock Ownership Plan Holding Companies (FR Y-9ES) The Supplement to the Consolidated Financial Statements for Holding Companies (FR Y-9CS). The revisions to this mandatory information collection become effective on September 30, 2016, and March 31, 2017. The Board is also adopting a proposal to extend, without revision, the other reports that are part of this information collection. On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

The Alcohol and Tobacco Tax and Trade Bureau (TTB) is reopening the comment period for Notice No. 160, Proposed Revisions to Wine Labeling and Recordkeeping Requirements, a notice of proposed rulemaking published in the Federal Register on June 22, 2016. In Notice No. 160, TTB proposed to amend its labeling and recordkeeping regulations in 27 CFR part 24 to provide that any standard grape wine containing 7 percent or more alcohol by volume that is covered by a certificate of exemption from label approval may be labeled with a varietal (grape type) designation, a type designation of varietal significance, a vintage date, or an appellation of origin only if the wine is labeled in compliance with the standards set forth in the appropriate sections of 27 CFR part 4 for that label information. TTB also proposed to amend its part 4 wine labeling regulations to include a reference to the new part 24 requirement. TTB is reopening the comment period in response to requests from two wine industry trade associations. In addition, this reopening of the comment period solicits comments from the public on issues that were raised in comments received in response to Notice No. 160.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Kentucky (FEMA- 4278-DR), dated 08/26/2016. Incident: Severe Storms, Tornadoes, Flooding, Landslides, and Mudslides. Incident Period: 07/02/2016 through 07/09/2016. Effective Date: 08/26/2016. Physical Loan Application Deadline Date: 10/25/2016. Economic Injury (EIDL) Loan Application Deadline Date: 05/26/2017.

The Coast Guard will enforce various safety zones within the Captain of the Port New York Zone on the specified dates and times. This action is necessary to ensure the safety of vessels and spectators from hazards associated with fireworks displays. During the enforcement period, no person or vessel may enter the safety zones without permission of the Captain of the Port (COTP).

On August 30, 2016, at 81 FR 59649, HUD published the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment. This correction is updating the burden chart with the accurate calculation of burden hours.