2012 – Federal Register Recent Federal Regulation Documents

In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting the information collection FERC-715 (Annual Transmission Planning and Evaluation Report) to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission issued a Notice in the Federal Register (77 FR 53877, 9/4/2012) requesting public comments. FERC received no comments on the FERC-715 and is making this notation in its submittal to OMB.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed.'' The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed in order to assure the protection of the rights and welfare of human subjects in clinical investigations.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.

Under the provisions of section 724 of the National Defense Authorization Act for Fiscal Year 2010 (Pub. L. 111-84), the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), and 41 CFR 102-3.50(a), the Department of Defense gives notice that it is renewing the charter for the Department of Defense Task Force on the Care, Management, and Transition of Recovering Wounded, Ill, and Injured Members of the Armed Forces (hereafter referred to as ``the Task Force''). The Task Force is a non-discretionary federal advisory committee that shall (a) assess the effectiveness of the policies and programs developed and implemented by the Department of Defense (DoD), and by each of the Military Departments, to assist and support the care, management, and transition of recovering wounded, ill, and injured members of the Armed Forces; and (b) make recommendations for the continuous improvements of such policies and programs. Pursuant to section 724(c) of Public Law 111-84, the Task Force shall, no later than 12 months after the date on which all Task Force members have been appointed and each year thereafter for the life of the Task Force, submit an annual report to the Secretary of Defense on the activities of the Task Force and on the activities of the DoD, to include the Military Departments, to assist and support the care, management, and transition of recovering wounded, ill, and injured members of the Armed Forces. At a minimum, the Task Force's report shall include the following: a. The Task Force's findings and conclusions as a result of its assessment of the effectiveness of developed and implemented DoD policies and programs, to include those of the Military Departments, to assist and support the care, management and transition of recovering wounded, ill, and injured members of the Armed Forces. b. A description of best practices and various ways in which the DoD, to include the Military Departments, could more effectively address matters relating to the care, management, and transition of recovering wounded, ill, and injured members of the Armed Forces, including members of both the Regular and the Reserve Components, and support for their families. c. A plan listing and describing the Task Force's activities for the upcoming year covered by its annual report. d. Such recommendations for other legislative or administrative action as the Task Force considers appropriate for measures to improve DoD-wide policies and programs in (a) above.

This action proposes special conditions for the Embraer S.A. Model EMB-550 airplane. This airplane will have a novel or unusual design feature, specifically an electronic flight control system which contains fly-by-wire control laws, including envelope protections, for the overspeed protection and roll limiting function. 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 Coast Guard proposes to modify the operating schedule that governs the Murray Morgan Bridge, also known as the South 11th Street Bridge, across Thea Foss Waterway, mile 0.6, previously known as City Waterway, at Tacoma, WA. This proposed rule would allow more efficient staffing of the bridge operating crew by requiring advance notification for bridge openings during designated hours. This proposed rule will also remove existing authorized closure periods for the bridge to better reflect present day transportation needs. Lastly, this proposed change will update contact information for requesting emergency bridge openings.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Burlington Northern Santa Fe (BNSF) Railway Company swing span bridge across Bayou Boeuf, mile 10.2, at Amelia, St. Mary Parish, Louisiana. The deviation is necessary to complete scheduled repairs necessitated by a bridge allision. This deviation allows the bridge to remain in the closed-to-navigation position for sixteen consecutive hours.

As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Holders or Containers which Enter the United States Duty Free. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13).

This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https://www.fema.gov/fema/csb.shtm.

This is a notice of the Presidential declaration of an emergency for the State of Maryland (FEMA-3349-EM), dated October 28, 2012, and related determinations.