November 25, 2013 – Federal Register Recent Federal Regulation Documents

The Pacific Fishery Management Council's (Pacific Council's) Scientific and Statistical Committee (SSC) Groundfish Subcommittee will hold an online webinar to review a final draft of the 2013 cowcod rebuilding analysis, data-poor overfishing limit (OFL) estimates for kelp greenling and the Washington stock of cabezon, and other business in preparation for the SSC's March 2014 meeting. The online SSC Groundfish Subcommittee webinar is open to the public.

USDA announces the availability of competitive grant funding through the Value-Added Producer Grant (VAPG) program. Approximately $10.5 million in carry over funding from fiscal year (FY) 2013 is available to help agricultural producers enter into value-added activities. This NOFA is being published prior to the Congressional enactment of a full-year appropriation for FY 2014. Should additional funding be made available during FY 2014 for this program RBS will continue to fund applications received under this announcement based upon the applications score. At this time, the exact amount of funding that will be made available to this program for FY 2014 is unknown. Anyone interested in submitting an application for funding under this program should consult the Rural Development Value Added Producer Grant Program Web site at https://www.rurdev.usda.gov/BCP_VAPG.html periodically for updated information regarding any FY 2014 funding for the program. The program purpose is to help U.S. agricultural producers enter into value-added activities. Awards may be made for either economic planning or working capital activities related to the processing and/or marketing of valued-added agricultural products. The maximum grant amount for a planning grant is $75,000 and the maximum grant amount for a working capital grant is $200,000. There is a matching funds requirement of at least $1 for every $1 in grant funds provided by the Agency (matching funds plus grant funds must equal proposed total project costs). Matching funds may be in the form of cash or eligible in-kind contributions and may be used only for eligible project purposes. Matching funds must be available at time of application and must be certified and verified as described in 7 CFR 4284.931(b)(3) and (4). 7 CFR 4284.925 and 7 U.S.C. 1632(a) provide for the reservation of ten percent of available funds for applications submitted by Beginning and Socially Disadvantaged Farmers or Ranchers, and an additional ten percent of available funds for applications from farmers or ranchers proposing development of Mid-Tier Value Chains. For this announcement, Reserved Funds were not obligated prior to June 30, 2013 as required by 7 CFR 4284.925 and 7 U.S.C. 1632(a). Therefore, no reserves are available to fund these categories from FY 2013 carry over monies. However, 7 CFR 4284.925 and 7 U.S.C. 1632(a) allow the Secretary to repurpose and reuse these funds for the general VAPG competition. Beginning and Socially-Disadvantaged Farmers or Ranchers and applicants proposing Mid-Tier Value Chains can still compete and benefit by receiving priority through the award of Priority Points. Should FY 2014 funds become available, 20 percent of those funds will be reserved for these categories.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products'' dated November 2013. The guidance document provides sponsors and individuals that design and implement preclinical studies with recommendations on the substance and scope of preclinical information needed to support clinical trials for investigational products reviewed by the Office of Cellular, Tissue and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, xenotransplantation, and certain biologic-device combination products, which OCTGT reviews. The guidance clarifies current expectations regarding the preclinical information that would support an investigational new drug application (IND) and a biologics license application (BLA) for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2012, and supersedes the recommendations in Section VIII in the guidance entitled ``Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy'' dated March 1998.

In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected burden. The Federal Register notice with a 60-day comment period soliciting comments on the following collections of information was published on September 16, 2013 (78 FR 56995).

The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

West Virginia has applied to EPA for final authorization of revisions to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA proposes to grant final authorization to West Virginia. In the ``Rules and Regulations'' section of this Federal Register, EPA is authorizing the revisions by an immediate final rule. EPA did not make a proposal prior to the immediate final rule because we believe this action is not controversial and do not expect comments that oppose it. We have explained the reasons for this authorization in the preamble to the immediate final rule. Unless we receive written comments that oppose this authorization during the comment period, the immediate final rule will become effective on the date it establishes, and we will not take further action on this proposal. However, if we receive comments that oppose this action, or portions thereof, we will withdraw the relevant portions of the immediate final rule, and they will not take effect. We will then respond to public comments in a later final rule based on this proposal. You may not have another opportunity for comment. If you want to comment on this action, you must do so at this time.

The U.S. Environmental Protection Agency Region 5 is publishing a direct final Notice of Deletion of the Columbus Old Municipal Landfill 1 Superfund Site (Site) located in Bartholomew County, Indiana from the National Priorities List (NPL). The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). This direct final deletion is being published by EPA with the concurrence of the State of Indiana, through the Indiana Department of Environmental Management (IDEM), because EPA has determined that all appropriate response actions under CERCLA, other than operation, maintenance, and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.

This notice concerns a petition for waiver submitted to the Federal Aviation Administration (FAA) by Orbital Sciences Corporation (Orbital) to waive, in part, the requirement that a launch operator enter into a reciprocal waiver of claims with each customer. The FAA grants the petition on the condition that no employees of NASA- sponsored CubeSat operators will be inside a hazard area associated with the Minotaur I launch.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Scion Cardio-vascular (``Scion'') located in Miami, FL, USA.

In this document, the Federal Communications Commission (Commission) announces that the Office of Management and Budget (OMB) has approved, until October 31, 2016, the information collection associated with the Commission's Connect America Fund, Order, (Order), released on April 3, 2013. The Commission submitted a request for approval of a new collection under control number 3060-1192 to the OMB for review and approval, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). This notice is consistent with the Order, which stated that the Commission would publish a document in the Federal Register announcing the effective date of those rules once it receives OMB approval.

The Federal Emergency Management Agency (FEMA) National Advisory Council (NAC) will meet via conference call on December 3, 2013 at 4:00 p.m. EST. The meeting will be open to the public.

This notice announces T[Uuml]V S[Uuml]D Product Services GmbH's application containing a request for renewal of recognition as a Nationally Recognized Testing Laboratory (NRTL) under 29 CFR 1910.7.