February 8, 2005 – Federal Register Recent Federal Regulation Documents

Notice is hereby given, pursuant to 25 CFR 514.1(a)(3), that the National Indian Gaming Commission has adopted preliminary annual fee rates of 0.00% for tier 1 and 0.059% (.00059) for tier 2 for calendar year 2005. These rates shall apply to all assessable gross revenues from each gaming operation under the jurisdiction of the Commission. If a tribe has a certificate of self-regulation under 25 CFR part 518, the preliminary fee rate on class II revenues for calendar year 2005 shall be one-half of the annual fee rate, which is 0.0295% (.000295).

Through this action, the Rural Housing Service (RHS) is revising and clarifying the definition for an existing dwelling and a new dwelling or unit, removing specific dollar limits with regards to insurance deductible clauses, and establishing the amount of insurance required to conform to industry standards. These changes are being made to make more clear what constitutes an existing and a new dwelling, and to conform insurance coverage requirements to industry standards. The intended effect is to improve the delivery and implementation of the Direct Single Family Housing programs.

The Federal Communications Commission is modifying a section of the Commission's rules that implement the Freedom of Information Act (FOIA) Fee Schedule. This modification pertains to the charge for recovery of the full, allowable direct costs of searching for and reviewing records requested under the FOIA and the Commission's rules, unless such fees are restricted or waived. The fees are being revised to correspond to modifications in the rate of pay approved by Congress.

The Federal Communications Commission (FCC) has received Office of Management and Budget (OMB) approval for the following public information collections pursuant to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid control number. In the 800 MHz Report and Order the Commission adopted certain information collection requirements and third party disclosures as part of its plan to abate interference to public safety communications, such as those of police, fire and emergency medical agencies. The information collection requirements and third-party disclosures will be used by the Commission to ensure that licensees of certain 800 MHz Commercial Mobile Radio Service systems abate interference to the reception of signals from public safety, Critical Infrastructure Industry (CII), and certain other 800 MHz communications systems. In a separate document published in the Final Rules section of this issue, the Commission also announces that the information collection requirements adopted in the 800 MHz Report and Order are effective upon publication of the aforementioned document in the Federal Register. A summary of the 800 MHz Report and Order was published in the Federal Register on November 22, 2004, 68 FR 67823. The summary stated that, with the exception of rules requiring OMB approval, the rules adopted in the 800 MHz Report and Order would become effective January 21, 2005. With regard to rules requiring OMB approval, the Commission stated it will publish a document in the Federal Register announcing the effective date of these rules. With publication of the aforementioned document in the Final Rules section, all rules adopted in the 800 MHz Report and Order are effective. The Commission obtained emergency clearance of the information collections adopted in the 800 MHz Report and Order pursuant to 5 CFR 1320.13(a)(2)(i) and waiver of the notice and comment provisions of 5 CFR 1320.8(d) and 1320.5(a)(iv). As a result, OMB approval for these requirements will expire June 30, 2005. The Commission will establish a period for public comment on these PRA matters before submitting its request for regular, three-year OMB approval of these collections.

This document clarifies and revises the technical and procedural measures that it adopted in a Report and Order on July 8, 2004 to address the ongoing and growing problem of interference to public safety communications in the 800 MHz band. In the Report and Order, the Commission concluded that a plan comprised of both long-term and short-term components represented the most effective solution to the public safety interference problem in the 800 MHz band. Subsequent to the release of the Report and Order, parties made a series of ex parte presentations which provided additional information. The Commission issued a public notice soliciting comment on certain ex parte presentations. Based on this supplementary record and review of the document, the Commission believes it appropriate to make the following clarifications of, and changes to, the provisions of the Report and Order and its accompanying rules. The Commission believe these changes will facilitate a more efficient and timely reconfiguration of the 800 MHz band.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S8 Immunotoxicity Studies for Human Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes a weight-of-evidence approach to determining whether additional immunotoxicity testing for nonbiological pharmaceuticals is appropriate when the findings from standard toxicity studies indicate signs of immunotoxicity. The draft guidance is intended to provide recommendations on nonclinical testing to identify compounds that have the potential to be immunosuppressive and guidance on a weight-of-evidence decision making approach for immunotoxicity testing.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Lactation StudiesStudy Design, Data Analysis, and Recommendations for Labeling.'' This guidance discusses agency recommendations on how and when to conduct clinical lactation studies and how to assess the influence of drugs or biologic products on lactation. The goals of this guidance are to provide the basic framework for designing, conducting, and analyzing clinical lactation studies and to stimulate further study and research to assist in rational therapeutics for lactating patients.

The International Code Council (ICC), under whose auspices the International Codes (``I-Codes'') are developed, maintains a process for updating these model codes based on receipt of proposals from interested individuals and organizations. The ICC's 14 separately published codes are comprehensively updated and re-published every three years with a Supplement published between each edition. The most current versions of the I-Codes are the 2003 Editions and 2004 Supplements. Each structured 18-month code development cycle includes two separate public sessions, both open to public participation and observation. The first of the two sessions is the Code Development Hearing during which balanced committees initially review, discuss and vote on an opinion on each proposal for change to the model codes. Attendees to this hearing are eligible to raise objection to and call for a vote of the ICC members assembled regarding the committee's opinion. The results of the Code Development Hearing are made available for public review and comment prior to the second public session. Public comments received by the ICC are published and distributed for public review. At the second session, entitled the Final Action Hearing, public comments are reviewed and discussed and final voting is conducted to determine which proposals are adopted into the I-Codes. The purpose of this notice is to invite the public participation in the Code Development Hearing. The publication of this notice by the National Institute of Standards and Technology (NIST) on behalf of ICC is being undertaken as a public service; NIST does not necessarily endorse, approve, or recommend any of the codes or standards referenced in the notice. Session Dates: The Code Development Hearings of the 2004/2005 Code Development Cycle will occur on February 22-March 4, 2005, at the Millennium Hotel, Cincinnati, Ohio. This will be followed by the Final Action Hearings scheduled for September-October 1, 2005, at the COBO Center in Detroit, Michigan. Proposed changes approved during this cycle, in addition to changes published in the 2004 Supplement, will constitute the 2006 Edition of the International Codes. The agenda for the hearing as well as updates to the schedule are also posted on the ICC Web site at: https://www.iccsafe.org.

We are approving, with certain exceptions, a proposed amendment to the West Virginia regulatory program (the West Virginia program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). West Virginia proposed revisions to the Code of State Regulations (CSR), as authorized by Committee Substitute for House Bill 4193. The State revised its program to be consistent with certain corresponding Federal requirements, and to include other amendments at its own initiative. The amendments include, among other things, new provisions to ensure reclamation and husbandry techniques that are conducive to the development of productive forestlands and wildlife habitat after mining.

We, the Office of Surface Mining Reclamation and Enforcement (OSM), are announcing receipt of a proposed amendment to the Illinois regulatory program (Illinois program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Illinois proposes revisions to its regulations and statutes to remove provisions relating to the Surface Mining Advisory Council, to update citation references, to correct typographical errors, to update procedures for relocating or closing public roads, and to clarify requirements for subsidence control. Illinois intends to revise its program to provide additional safeguards and to clarify ambiguities. This document gives the times and locations that the Illinois program and proposed amendment to that program are available for your inspection, the comment period during which you may submit written comments on the amendment, and the procedures that we will follow for the public hearing, if one is requested.

The Copyright Office of the Library of Congress is announcing the termination of the proceeding to determine reasonable rates and terms for two compulsory licenses for the period beginning January 1, 2005, and ending on December 31, 2006. One license allows public performances of sound recordings by means of eligible digital audio transmissions; the other permits the making of an ephemeral phonorecord of a sound recording in furtherance of making a permitted public performance of the sound recording. The rates and terms applicable to new subscription services, eligible nonsubscription services, and services that transmit performances to business establishments that were in effect on December 31, 2004, will remain in effect during 2005.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Securities and Exchange Commission (the Commission) is adopting revisions to the Electronic Data Gathering, Analysis, and Retrieval System (EDGAR) Filer Manual to reflect updates to the EDGAR system. The revisions are being made primarily to support a voluntary program that would allow the submission of eXtensible Business Reporting Language (XBRL) documents to assess the usefulness of data tagging in general and XBRL in particular. Revisions are also being made to provide support for the new requirement for filers to enter an effectiveness date on submission types 485BPOS and 486BPOS; addition of new Exhibit EX-99.Rule23C1 for Form N-CSR and rescinding of submission types N-23C-1 and N-23C-1/A; changes to submission form type 25, which the Commission has proposed to be filed electronically by a national securities exchange to delist and/or deregister a class of securities under Section 12(b) of the Exchange Act, and by an issuer to voluntarily remove a class of securities from listing on a national securities exchange and/or registration under Section 12(b); and the list of Self-Regulatory Organizations in Appendix C section C.1.5 of the EDGAR Release 8.10 EDGARLink Filer Manual has been updated to show the name change of Cincinnati Stock Exchange to National Stock Exchange. The revisions to the Filer Manual reflect changes within Volumes I, II and III, entitled ``EDGAR Release 8.10 EDGARLink Filer Manual,'' ``EDGAR Release 8.10 N-SAR Supplement Filer Manual,'' and ``EDGAR Release 8.10 OnlineForms Filer Manual'' respectively. The updated manual will be incorporated by reference into the Code of Federal Regulations.

The Agricultural Marketing Service published in the Federal Register on January 14, 2005, a Secretary's Decision and Referendum Order on proposed amendments to the Washington sweet cherry marketing order. This docket corrects the representative period for voting in the referendum from April 1, 2003, through March 31, 2004, to April 1, 2004, through February 28, 2005.

GIPSA requests comments on the applicant for designation to provide official services in Southwest Arizona.

The National Archives and Records Administration (NARA) publishes notice at least once monthly of certain Federal agency requests for records disposition authority (records schedules). Once approved by NARA, records schedules provide mandatory instructions on what happens to records when no longer needed for current Government business. They authorize the preservation of records of continuing value in the National Archives of the United States and the destruction, after a specified period, of records lacking administrative, legal, research, or other value. Notice is published for records schedules in which agencies propose to destroy records not previously authorized for disposal or reduce the retention period of records already authorized for disposal. NARA invites public comments on such records schedules, as required by 44 U.S.C. 3303a(a).