March 8, 2005 – Federal Register Recent Federal Regulation Documents

The National Aeronautics and Space Administration, 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 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).

In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the Search for Earth-Like Planets Strategic Roadmap Committee.

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, 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.

This document corrects temporary regulations (TD 9164) that were published in the Federal Register on Friday, December 17, 2004 (69 FR 75455) concerning requirements for employee stock ownership plans (ESOPs) holding stock of Subchapter S corporations.

This document contains corrections to (TD 9176), which were published in the Federal Register on Tuesday, January 25, 2005 (70 FR 3475). These final regulations would modify the circumstances under which certain forms of distribution previously available are permitted to be eliminated from qualified defined contribution plans.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent Application No. 60/504,724 filed September 17, 2003, entitled ``Thalidomide Analogs'' (DHHS Reference E- 189-2003/0-US-01) and PCT Application No. PCT/US2004/030506 filed September 17, 2004, entitled ``Thalidomide Analogs'' (DHHS Ref. E-189- 2003/0-PCT-02) to Phase 2 Discovery, Inc. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be United States, Denmark, Italy, Ireland, United Kingdom, Germany, France, Sweden, Switzerland, Spain, Czech Republic, Greece, Russia, Australia, Japan, Taiwan, Singapore, China, Argentina and Brazil, and the field of use may be limited to development and sale of a pharmaceutical product useful in treating Amyotrophic Lateral Sclerosis (ALS) and Attention Deficit Hyperactivity Disorder (ADHD).

The changing dynamics of emerging technology, and the complexity of genetics require an assessment of the state of the art in newborn screening and a perspective on the future directions such programs should take. In 1999, the American Academy of Pediatrics Newborn Screening Task Force recommended that ``HRSA should engage in a national process involving government, professionals, and consumers to advance the recommendations of this Task Force and assist in the development and implementation of nationally recognized newborn screening system standards and policies.'' In response to this need, pursuant to 42 U.S.C. 701(a)(2), the Maternal and Child Health Bureau (MCHB) of HRSA commissioned the American College of Medical Genetics (ACMG) to conduct an analysis of the scientific literature on the effectiveness of newborn screening and gather expert opinion to delineate the best evidence for screening specified conditions and develop recommendations focused on newborn screening, including but not limited to the development of a uniform condition panel. It was expected that the analytical endeavor and subsequent recommendations be based on the best scientific evidence and analysis of that evidence. ACMG was specifically asked to develop recommendations to address: A uniform condition panel (including implementation methodology); Model policies and procedures for State newborn screening programs (with consideration of a national model); Model minimum standards for State newborn screening programs (with consideration of national oversight); A model decision matrix for consideration of State newborn screening program expansion; and The value of a national process for quality assurance and oversight. The ACMG report is a response to the HRSA/MCHB request. The ACMG report, Newborn Screening: Toward a Uniform Screening Panel and System is available at https://mchb.hrsa.gov/screening. In the report, 29 conditions were identified as primary targets or core panel conditions for screening; an additional 25 conditions were listed as conditions that could be identified in the course of screening for core panel conditions. Many of these 25 additional conditions are included in the differential diagnosis of the conditions including in the primary target list. With additional screening, an improvement in the infrastructure for appropriate follow-up and management throughout the lives of children who have been identified as having one of these rare conditions will be needed. A cost analysis for the State of California indicates newborn screening is beneficial to patients and may have some net costs or net savings over time depending on assumptions of expected lifetime costs of medical care. HRSA is now seeking public comments on the report and its recommendations.

The Indian Health Service published a document in the Federal Register on January 19, 2005. The document contained one error.

NMFS will accept applications to receive quota share (QS) and processor quota share (PQS) for the Crab Rationalization Program (Program) from participants in the Bering Sea and Aleutian Islands (BSAI) king and Tanner crab fisheries through June 3, 2005, consistent with the regulations implementing the program. Any applications received by NMFS after this date will be considered untimely and will be denied.

The U.S. Environmental Protection Agency (EPA) is announcing that the Oak Ridge Institute of Science and Education (ORISE), Department of Energy, under an Interagency Agreement with EPA, will organize and conduct a workshop to seek expert opinion on the research needs related to the mode of action of the inhalation carcinogenicity of naphthalene. Meeting participants will be provided with the ``Final Report on the External Peer Review for the IRIS Reassessment of the Inhalation Carcinogenicity of Naphthalene (August 2004),'' the external review draft document entitled, ``Toxicological Review of Naphthalene: In Support of Summary Information on the Integrated Risk Information System (IRIS)'' (NCEA-S-1707), and a list of recent naphthalene publications. Members of the public may attend as observers. EPA will consider the comments and recommendations from the expert panel in determining a future course of action for assessing potential health risks associated with naphthalene exposure.

The EPA invites public comment on its proposal to approve Washington State Implementation Plan (SIP) revisions submitted to EPA by the State of Washington on September 20, 2001, September 26, 2001 and November 22, 2004. The revisions consist of changes to the State of Washington Inspection and Maintenance Program and a Plan for attaining carbon monoxide (CO) National Ambient Air Quality Standards (NAAQS) in the Spokane Serious CO Nonattainment Area. The EPA also invites public comment on its proposal to approve certain source-specific SIP revisions relating to Kaiser Aluminum and Chemical Corporation.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236 of October 19, 1999, as amended, and Delegation of Authority No. 257 of April 15, 2003 [68 FR 19875], I hereby determine that the object to be included in the exhibition ``Printing the Talmud: From Bomberg to Schottenstein,'' imported from abroad for temporary exhibition within the United States, is of cultural significance. The object is imported pursuant to a loan agreement with the foreign owner. I also determine that the exhibition or display of the exhibit object at the Yeshiva University Museum, New York, NY, from on or about April 10, 2005, to on or about August 28, 2005, and at possible additional venues yet to be determined, is in the national interest. Public Notice of these Determinations is ordered to be published in the Federal Register.

The International Telecommunication Advisory Committee announces additional April meetings to prepare positions for the next meeting of the ITU-T Study Groups 11 (Signalling requirements and protocols), 13 (Next Generation Networks), and 15 (Optical and other transport network infrastructures). Members of the public will be admitted to the extent that seating is available, and may join in the discussions, subject to the instructions of the Chair. Directions to the meeting location are available to the public on the Internet and conference bridge information (if any) may be obtained from marcie.g@comcast.com. The International Telecommunication Advisory Committee (ITAC) will meet on Friday, April 15, 2005 to prepare U.S. and company contributions to ITU-T Study Groups 11 and 13. The meeting will be held at the Double Tree Hotel Denver North, 8773 Yates Drive, Westminster, CO 80031 starting 30 minutes after the close of the plenary meeting of the Packet Technologies and Systems Committee (PTSC) of the Alliance for Telecommunications Solutions (ATIS), being held at the same venue. The International Telecommunication Advisory Committee (ITAC) will meet on Friday, April 22, 2005 to prepare U.S. and company contributions to ITU-T Study Group 15. The meeting will be held at the Double Tree Hotel Denver North, 8773 Yates Drive, Westminster, CO 80031 starting 30 minutes after the close of the plenary meeting of the Optical Transport and Synchronization Committee (OTSC) of the Alliance for Telecommunications Solutions (ATIS), being held at the same venue.

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EMSSAB), Savannah River. 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.

The Leader, Information Management Case Services Team, Regulatory Information Management Services, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.