May 18, 2007 – Federal Register Recent Federal Regulation Documents

The Committee is proposing to add to the Procurement List a product and services to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and to delete a service previously furnished by such agencies. Comments Must Be Received On Or Before: June 17, 2007.

EPA expressed environmental concerns about impacts to water quality and aquatic and terrestrial habitats. Rating EC2.

The Bureau of Land Management is publishing this notice under section 9(a)(2) of the Federal Advisory Committee Act, and BLM regulations found at 43 CFR Subpart 1784. The notice requests the public to submit nominations for membership on the Canyons of the Ancients Advisory Committee (Committee). The Committee is necessary to advise the Secretary and BLM on resource management issues associated with Canyons of the Ancients National Monument.

FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 22 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemptions will provide a level of safety that will be equivalent to, or greater than, the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.

This is an amendment of the Presidential declaration of a major disaster for the State of New Hampshire (FEMA-1695-DR), dated 04/ 27/2007. Incident: Severe Storms and Flooding. Incident Period: 04/15/2007 through 04/23/2007.

The President's Export Council (PEC) will hold a full Council meeting to discuss topics related to export expansion. The meeting will include discussion of trade priorities and initiatives, PEC subcommittee activity, and proposed letters of recommendation to the President. The PEC was established on December 20, 1973, and reconstituted May 4, 1979, to advise the President on matters relating to U.S. trade. It was most recently renewed by Executive Order 13316.

In accordance with section 102(2)(C) of the National Environmental Policy Act of 1969 and 43 CFR part 3809, the Bureau of Land Management (BLM) Butte Field Office will be directing the preparation of an Environmental Impact Statement (EIS) by a third-party contractor on the potential impacts of a proposed Plan of Operations for a proposed expansion of limestone mining operations by Graymont Western U.S., Inc.

On May 9, 2007, the Secretary published the Part C NPRM, proposing to amend the regulations governing the Early Intervention Program for Infants and Toddlers with Disabilities. The Secretary announces plans to hold a series of public meetings to seek comments and suggestions about the proposed rules. The proposed regulations would implement changes made to the Individuals with Disabilities Education Act (IDEA) by the Individuals with Disabilities Education Improvement Act of 2004.

The following paragraph has been added to the beginning of the Summary portion of the March 14, 2007, Federal Register Notice: The Risk Management Agency (RMA) did not receive complete and valid application packages for the State of Maine under the original Request for Application Notice published in the Federal Register on March 14, 2007, for the Crop Insurance Education in Targeted States Program (Targeted States Program). RMA is re-announcing its Funding OpportunityRequest for Applications under the Targeted States Program for the State of Maine. Applicants who previously submitted an application under the March 14, 2007, Targeted States Program Request for Applications Notice for Maine must reapply in accordance with the original Notice published in the Federal Register on March 14, 2007. All other portions and sections of the full text Notice remain unchanged.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Superior Equine Pharmaceuticals, Inc. The ANADA provides for the veterinary prescription use of phenylbutazone powder administered to horses in feed for the relief of inflammatory conditions associated with the musculoskeletal system.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for veterinary prescription use of butorphanol tartrate injectable solution in cats for the relief of pain.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's address for Modern Veterinary Therapeutics, LLC.

The IC Clearance Official, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.

Public Law 109-129 requires the Secretary of Health and Human Services to establish a 3-year demonstration project for qualified cord blood banks to collect and store at no charge to families, umbilical cord blood units for families where a first-degree relative has been diagnosed with a condition that may benefit from blood stem cell transplantation. Umbilical cord blood units collected through the demonstration project do not count toward the current National Cord Blood Inventory (NCBI) goal of 150,000 cord blood units to be made available through the C.W. Bill Young Cell Transplantation Program. Qualified umbilical cord blood banks participating in the demonstration project must provide assurances that the cord blood units will be available for directed transplantation until such time as the cord blood unit is needed. Within 90 days of the termination of the demonstration project, the Secretary will submit to Congress a report on the outcomes of the project including recommendations with respect to the continuation of such a project. HRSA's Healthcare Systems Bureau (HSB), Division of Transplantation (DoT) is in the process of information-gathering to assist in implementation of the related cord blood demonstration project. The purpose of this solicitation is to receive public input on the following: (1) The key questions that should be studied through this project; (2) the mechanism for funding this project; and, (3) umbilical cord blood bank liability. HRSA has identified the following key study questions to be considered in the design of this demonstration project: (1) What is the value and feasibility of implementing a long-term program modeled after this demonstration project; (2) how often and for what clinical indications are cord blood units banked through this project used for transplantation; (3) what is the breakdown of cord blood units collected, stored, and transplanted by race, ethnicity, and disease; (4) do those cord blood units, especially those released for transplant, represent rare Human Leukocyte Antigen (HLA) types such that the recipient would otherwise have been unable to find a matched unrelated donor; (5) how do transplant outcomes using these cord blood units compare to unrelated allogeneic umbilical cord blood transplants and unrelated allogeneic transplants using blood stem cells from adult donors; and, (6) what are the general physical characteristics of these units (e.g., total nucleated count, CD34+ content) and how does their quality compare to that of the general public inventory. HRSA proposes to invite the first cohort of umbilical cord blood banks receiving NCBI contracts to submit competitive proposals for participation in this demonstration project with an emphasis on: (1) Establishment of nationwide collections; and, (2) encouraging banks to subcontract with other experienced, high-quality cord blood banks to assist in their education, collection, processing, and storing efforts. HRSA has approximately $200,000 available for this demonstration project this fiscal year and anticipates selecting 2 or 3 banks to participate in this demonstration project to be funded through modification of their existing NCBI contracts with HRSA. HRSA recognizes the need for this service is likely greater than what can be satisfied in a limited demonstration project. Because of the great diversity in HLA types among African-Americans, HRSA recognizes that patients from this population are significantly less likely to find a suitably matched unrelated blood stem cell donor than patients from other racial or ethnic groups. Therefore, HRSA invites comments on the desirability of limiting participation to African- American families in which a first-degree relative has been diagnosed with a condition that may benefit from blood stem cell transplantation. HRSA understands that there may be special considerations associated with liability for those umbilical cord blood banks participating in this project. HRSA invites comment on how umbilical cord blood banks participating in this project may best address these concerns. Interested parties are invited to submit written comments on the key study questions, the funding approach, and umbilical cord blood bank liability for this demonstration project to the address below.

The Federal Crop Insurance Corporation (FCIC) proposes to amend 7 CFR part 400, subpart R to clarify existing administrative remedies, add additional administrative remedies that are available as a result of enactment of section 515(h) of the Federal Crop Insurance Act (Act) (7 U.S.C. 1515(h)), and make such other changes as are necessary to implement the provisions of section 515(h) of the Act.