February 2013 – Federal Register Recent Federal Regulation Documents

The Department of Veterans Affairs (VA) publishes this Request for Information (RFI) on public-private collaborations in pain research, seeking to connect the Veterans Health Administration's (VHA) Office of Research and Development (ORD) with commercial organizations that are conducting, or have an interest in conducting, pain research through a Cooperative Research and Development Agreement (CRADA). The CRADA is to develop public-private collaborations in pain research with the intent of developing novel therapies that will benefit Veterans suffering from chronic pain conditions.

This notice provides information regarding the FHWA's finding that a Buy America waiver is appropriate for the use of non-domestic iron and steel products in (1) Auxiliary two speed motor, (2) Auxiliary back up drive clutch, (3) Main span and backup span motor, and (4) Brakes for the Memorial Bridge project in the State of New Hampshire.

The Alcohol and Tobacco Tax and Trade Bureau is amending the regulations setting forth the standards of identity for distilled spirits to include ``Cacha[ccedil]a'' as a type of rum and as a distinctive product of Brazil. This amendment follows requests received from the Government of Brazil and subsequent discussions with the Office of the United States Trade Representative.

We, the U.S. Fish and Wildlife Service (Service), have issued the following permits to conduct certain activities with endangered species, marine mammals, or both. We issue these permits under the Endangered Species Act (ESA) and Marine Mammal Protection Act (MMPA).

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Oak Ridge Reservation. 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.

Notice is hereby given that the Federal Deposit Insurance Corporation (Corporation) has been appointed the sole receiver for the following financial institutions effective as of the Date Closed as indicated in the listing. This list (as updated from time to time in the Federal Register) may be relied upon as ``of record'' notice that the Corporation has been appointed receiver for purposes of the statement of policy published in the July 2, 1992 issue of the Federal Register (57 FR 29491). For further information concerning the identification of any institutions which have been placed in liquidation, please visit the Corporation Web site at www.fdic.gov/ bank/individual/failed/banklist.html or contact the Manager of Receivership Oversight in the appropriate service center.

We propose to adopt a new airworthiness directive (AD) for Agusta S.p.A. (Agusta) Model AB412 and AB412 EP, and Bell Helicopter Textron (Bell) Model 412, 412CF, and 412EP helicopters with certain DART Aerospace Ltd. (Dart) high gear aft crosstubes (crosstube) installed. This proposed AD would require adding a life limit of 10,000 landings to the crosstube and removing from service any crosstubes with more than 10,000 accumulated landings. This proposed AD is prompted by five separate reports of crosstube failures. The actions in this proposed AD are intended to prevent failure of the crosstube and subsequent collapse of the landing gear.

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.

To comply with the Paperwork Reduction Act of 1995 (PRA), the U.S. Geological Survey (USGS) is inviting comments on an information collection request (ICR) that we have sent to the Office of Management and Budget (OMB) for review and approval. The Information Collection, which is summarized below, describes the nature and the estimated burden of the collection. As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this ICR. This collection is scheduled to expire on February 28, 2013.

We propose to supersede an existing airworthiness directive (AD) for Robinson Helicopter Company (Robinson) Model R22, R22 Alpha, R22 Beta, R22 Mariner, R44, and R44 II helicopters with certain main rotor blades (blade) installed. The existing AD currently requires inspecting each blade at the skin-to-spar line for debonding, corrosion, a separation, a gap, or a dent and replacing any damaged blade with an airworthy blade. Since we issued that AD, a terminating action for the inspection requirements of that AD has been developed. The proposed actions are intended to detect debonding of the blade skin, which could result in blade failure and subsequent loss of control of the helicopter, and to correct the unsafe condition by replacing the main rotor blades with new blades that do not require the AD inspection.

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.