2013 – Federal Register Recent Federal Regulation Documents

The African Growth and Opportunity Act Implementation Subcommittee of the Trade Policy Staff Committee (``Subcommittee'') is requesting written public comments for the annual review of the eligibility of sub-Saharan African countries to receive the benefits of the African Growth and Opportunity Act (AGOA). The Subcommittee will consider these comments in developing recommendations on AGOA country eligibility for calendar year 2014 for the President. Comments received related to the child labor criteria may also be considered by the Secretary of Labor in the preparation of the Department of Labor's report on child labor as required under section 412(c) of the Trade and Development Act of 2000. This notice identifies the eligibility criteria that must be considered under AGOA, and lists those sub- Saharan African countries that are currently eligible for the benefits of the AGOA and those that were ineligible for such benefits in 2013.

The Coast Guard is establishing a safety zone in Oregon City, OR. This safety zone is necessary to help ensure the safety of the maritime public during a fireworks display and will do so by prohibiting unauthorized persons and vessels from entering the safety zones unless authorized by the Sector Columbia River Captain of the Port or his designated representatives.

The Commander, Eighth Coast Guard District is extending the previously published stay (suspension) of reporting requirements under the Regulated Navigation Area (RNA) established by 33 CFR 165.830 for barges loaded with certain dangerous cargoes (CDC barges) in the inland rivers of the Eighth Coast Guard District. This extension is necessary because the Coast Guard continues to analyze future reporting needs and evaluate possible changes in CDC reporting requirements. This extension of the suspension of the CDC reporting requirements in no way relieves towing vessel operators and fleeting area managers responsible for CDC barges in the RNA from their dangerous cargo or vessel arrival and movement reporting obligations currently in effect under other regulations or placed into effect under appropriate Coast Guard authority.

The Office of the United States Trade Representative published a request for comments in the 2013 Special 301 Out-of-Cycle Review of Notorious Markets in the Federal Register of September 20, 2013. That notice provided a deadline for comments of October 11, 2013. This notice extends that deadline to October 25, 2013.

This notice amends the notice of a major disaster declaration for the State of Colorado (FEMA-4145-DR), dated September 14, 2013, and related determinations.

The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.

The Federal Emergency Management Agency (FEMA) National Advisory Council (NAC) will meet in person on October 16, 2013 in Philadelphia, PA. The meeting will be open to the public.

The Department of Health and Human Services (HHS) is accepting comments on proposed ``Guidance for Temporary Reassignment of State and Local Personnel during a Public Health Emergency.'' Section 201 of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), Public Law 113-5, amends section 319 of the Public Health Service (PHS) Act to provide the Secretary of HHS with discretion to authorize the temporary reassignment of state, tribal, and local personnel during a declared Federal public health emergency upon request by a state or tribal organization or their designee. This proposed guidance addresses that provision.

Summary of Application: Applicants request an order that would permit them to enter into and materially amend sub-advisory agreements with Wholly-Owned Sub-Advisers (as defined below) and non-affiliated sub-advisers without shareholder approval and would grant relief from certain disclosure requirements.

This is a notice of an Administrative declaration of a disaster for the State of California dated 09/24/2013. Incident: Clover Fire Incident Period: 09/09/2013 through 09/15/2013. Effective Date: 09/24/2013. Physical Loan Application Deadline Date: 11/25/2013. Economic Injury (EIDL) Loan Application Deadline Date: 06/24/2014.

Notice is hereby given of the appointment of members of the National Transportation Safety Board, Performance Review Board (PRB).

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a new information collection.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the approaches announced in this guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE regulations. Early feasibility studies allow for limited early clinical evaluations of devices to provide proof of principle and initial clinical safety data, often before the device design is finalized. This guidance addresses the information that should be provided to FDA in support of an early feasibility study IDE application and explains the requirements applicable to modifications to the device design or clinical study protocol during the early feasibility study.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA SubmissionsRefuse-to-Receive Standards.'' This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements (PASs) for new strengths). The guidance contains details on what should be included in these submissions and highlights serious deficiencies that may cause FDA to refuse to receive the submission.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on communication studies involving biological products that are regulated by FDA.