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Federal Register Highlights – 2/25/13

February 25, 2013

Unpublished, time sensitive and proposed rules for February 25, 2013:

TEMPORARY RULE: The Coast Guard is establishing a temporary safety zone in all navigable waters of the Captain of the Port Baltimore Zone. The temporary safety zone restricts vessels from transiting the zone during the effective period, unless authorized by the Captain of the Port Baltimore or his designated representative. This safety zone is necessary to protect mariners from the hazards associated with ice in the navigable waterways. This rule has been enforced with actual notice from January 26, 2013, until February 25, 2013. This rule is effective in the Federal Register on February 25, 2013 until April 15, 2013, unless cancelled earlier by the Captain of the Port.

PROPOSED RULE: The Department of Labor’s (Department’s) Employment and Training Administration proposes to designate in regulation data exchange standards, developed in consultation with an interagency work group established by the Office of Management and Budget (OMB), for Unemployment Insurance (UI) administration as required by amendments to Title IX of the Social Security Act (SSA) made by the Middle Class Tax Relief and Job Creation Act of 2012 (the Act). This proposed regulation would establish data exchange standards for three categories of information: real-time applications on the Interstate Connection Network (ICON); the State Information Data Exchange System (SIDES); and implementation of the standards identified for ICON and SIDES in major Information Technology (IT) modernization projects to upgrade UI Benefits and Tax systems by State Workforce Agencies (SWAs) using Federal funds. Submit comments on or before April 26, 2013. (To submit comments, visit, reference RIN 1205–AB64.)

PROPOSED RULE: EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 37 chemical substances which were the subject of premanufacture notices (PMNs). Seventeen of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action would require persons who intend to manufacture, import, or process any of these 37 chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments must be received on or before April 26, 2013. (To submit comments, visit, reference docket number EPA–HQ–OPPT–2012–0727.)

PROPOSED RULE: The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. We are proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects. The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. As part of this proposed rule, we are also proposing to amend the IDE and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type. Submit either electronic or written comments on the proposed rule by May 28, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 27, 2013, (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). (To submit comments, visit, reference docket number FDA–2013–N–0080.)

PROPOSED RULE: NMFS proposes to implement a temporary emergency action that would suspend existing monkfish possession limits for vessels issued both a Federal limited access Northeast multispecies permit and a limited access monkfish Category C or D permit that are fishing under a Northeast multispecies day-at-sea in the monkfish Northern Fishery Management Area for 180 days beginning on May 1, 2013. This action is necessary to help mitigate expected adverse economic and social harm resulting from substantial reductions to the 2013 annual catch limits for several groundfish stocks managed under the Northeast Multispecies Fishery Management Plan. The intended effect of this action is to provide additional fishing opportunities to vessels affected by reductions to groundfish catch limits, without resulting in overfishing monkfish within the Northern Fishery Management Area. Comments must be received by March 12, 2013. (To submit comments, visit, reference docket number NOAA–NMFS–2012–0240.)

PROPOSED RULE: This proposed rule would amend the timing requirements for submitting a Site Assessment Plan (SAP) or General Activities Plan (GAP) pursuant to the regulations governing renewable energy and alternate uses of existing facilities on the Outer Continental Shelf (OCS). Under this proposed rule, all OCS renewable energy leases and grants will have a preliminary term of 12 months in which a lessee or grantee must submit a SAP or a GAP. BOEM is taking this action because the current regulations provide timing requirements for submission of SAPs and GAPs that have proven to be impractical. Submit comments by March 27, 2013. BOEM may not fully consider comments received after this date. (To submit comments, visit, reference docket number BOEM–2012–0077.)

PROPOSED RULE: The U.S. Small Business Administration (‘‘SBA’’) has determined that changing conditions in the American economy and persistent high levels of unemployment compel the agency to seek ways to improve access to its two flagship business lending programs: the 504 Loan Program and the 7(a) Loan Program. The purpose of this proposed rulemaking is to reinvigorate these programs as vital tools for creating and preserving American jobs. SBA proposes to strip away regulatory restrictions that detract from the 504 Loan Program’s core job creation mission as well as the 7(a) Loan Program’s positive job creation impact on the American economy. The 504 Loan Program and 7(a) Loan Program are SBA’s two primary business loan programs authorized under the Small Business Investment Act of 1958 and the Small Business Act, respectively. This proposed rule will enhance job creation through increasing eligibility for loans under SBA’s business loan programs, including its Microloan Program, and by modifying certain program participant requirements applicable to the 504 Loan Program. In addition, SBA proposes to revise Certified Development Company (CDC) operational requirements to clarify certain existing regulations. SBA must receive comments to this proposed rule on or before April 26, 2013. (To submit comments, visit, reference RIN 3245–AG04.)



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