January 2008 – Federal Register Recent Federal Regulation Documents

Section 101(c) of the Federal Mine Safety and Health Act of 1977 and 30 CFR Part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification filed by the parties listed below to modify the application of existing mandatory safety standards published in Title 30 of the Code of Federal Regulations.

The following represents a series of respondents' comments and the Health Resources and Services Administration's (HRSA) responses to the comments regarding the Federal Register notice (FRN): September 19, 2006 (71 FR 54829). The FRN proposed strategies to support health information technology (HIT) among safety net providers, and requested comments on HIT topic areas addressing quality improvement, collaboration, general network-related issues, specific health center controlled network (HCCN) related issues, sustainability and building HIT capacity. HRSA received a total of 53 comments from a broad range of stakeholders, including State health departments, non-profit organizations, individual healthcare providers and the health information technology industry. HRSA's responses reflect activities within the Office of Health Information Technology (OHIT) that include, but are not limited to, the development of an HRSA HIT strategic plan, technical assistance resources including the establishment of the HRSA HIT virtual community, the development of HIT online toolboxes tailored to the needs of various HRSA programs, a TA resource center, and the development of funding opportunities. The comments have helped, in part, to shape the direction and activities of OHIT.

The Food and Drug Administration (FDA) has determined that SEROQUEL (quetiapine fumarate) tablets, 150 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for quetiapine fumarate tablets, 150 mg, if all other legal and regulatory requirements are met.

The Fish and Wildlife Service announces that the Draft Comprehensive Conservation Plan and Environmental Assessment (Draft CCP/EA) for Logan Cave National Wildlife Refuge in Benton County, Arkansas, is available for review and comment. This document was prepared pursuant to the National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997, and the National Environmental Policy Act of 1969. The Draft CCP/EA describes the Service's proposal for management of the refuge for 15 years.

We, the Fish and Wildlife Service, announce that the Draft Environmental Impact Statement (DEIS) for a Proposed Land Exchange in the Yukon Flats National Wildlife Refuge, Alaska, is available for public comment. We prepared this DEIS pursuant to the National Environmental Policy Act of 1969 (NEPA) and its implementing regulations. The Service is furnishing this notice to advise the public and other agencies of the availability of the DEIS and to solicit comments. We have amended our original schedule to provide 60 days for public comment, rather than the minimum 45 days required by regulation. This extension provides the latest date we can accept public comment and still meet our obligation to complete the EIS within the fiscal year. We believe that 60 days is adequate to meet the needs for public review. Public hearings will be held in February and March in the cities of Anchorage and Fairbanks, and the communities of Arctic Village, Beaver, Birch Creek, Central, Chalkyitsik, Circle, Fort Yukon, Stevens Village, and Venetie. In conjunction with the public hearings, we will hold subsistence hearings under Section 810 of the Alaska National Interest Lands Conservation Act (ANILCA) in the affected communities. The schedule for the hearings will be highly dependent on local weather conditions and other community activities and commitments. Dates, times, and locations will be announced locally at least two weeks prior to each hearing.

The Bureau of Land Management (BLM) proposes to sell 40 acres of public lands near Wamsutter, Wyoming, Sweetwater County, to the Town of Wamsutter for current and future affordable housing purposes. These lands consist of one parcel totaling 40.00 acres more or less, which has been identified for disposal in the Great Divide Resource Management Plan, dated November 9, 1990. The sale will be conducted using modified competitive bidding procedures in accordance with and under the applicable provisions of sections 203 of the Federal Land Policy and Management Act of 1976 (FLPMA) (43 U.S.C. 1713), its implementing regulations, and in accordance with 43 CFR 2711.3-2, BLM land sale regulations at 43 CFR Part 2710 and the Federal Land Transaction Facilitation Act of 2000, Public Law 106-248, July 25, 2000.

The NIOSH, National Personal Protective Technology Laboratory (NPPTL), is currently reevaluating its limitations on and precaution for safe use of positive-pressure closed-circuit self-contained breathing apparatus. As stated in the Federal Register (Vol. 50, No. 222, pages 47456-47457 dated Monday, November 18, 1985) NIOSH's position on this topic is that:

The Commission hereby gives notice of the institution of an investigation and commencement of preliminary phase antidumping investigation No. 731-TA-1143 (Preliminary) under section 733(a) of the Tariff Act of 1930 (19 U.S.C. 1673b(a)) (the Act) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports from China of small diameter graphite electrodes, provided for in subheading 8545.11.00 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value. Unless the Department of Commerce extends the time for initiation pursuant to section 732(c)(1)(B) of the Act (19 U.S.C. 1673a(c)(1)(B)), the Commission must reach a preliminary determination in antidumping investigations in 45 days, or in this case by March 3, 2008. The Commission's views are due at Commerce within five business days thereafter, or by March 10, 2008. For further information concerning the conduct of this investigation and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207).

On January 14, 2008, the Chairman of CITA received a request from Glen Raven Custom Fabrics LLC, alleging that certain solution dyed, wet spun acrylic fibers, not carded, combed or otherwise processed for spinning, classified under subheading 5503.30 of the Harmonized Tariff Schedule of the United States (HTSUS), cannot be supplied by the domestic industry in commercial quantities in a timely manner and requesting that CITA consider whether the North American Free Trade Agreement (NAFTA) rule of origin for warp pile fabrics, classified under HTSUS subheading 5801.35, should be modified to allow the use of non-North American solution dyed, wet spun acrylic fiber. The President may proclaim a modification to the NAFTA rules of origin only after reaching an agreement with the other NAFTA countries on the modification. CITA hereby solicits public comments on this request, in particular with regard to whether solution dyed, wet spun acrylic fiber of HTSUS subheading 5503.30 can be supplied by the domestic industry in commercial quantities in a timely manner. Comments must be submitted by February 25, 2008 to the Chairman, Committee for the Implementation of Textile Agreements, Room 3001, United States Department of Commerce, Washington, DC 20230.

In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel.

Effective with publication of this Notice in the Federal Register, research agencies will be able to utilize a new standard core set of administrative terms and conditions on research and research- related awards that are subject to OMB Circular A-110, ``Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations'' (2 CFR part 215). This resulted from an initiative of the Research Business Models (RBM) Subcommittee of the Committee on Science (CoS), a committee of the National Science and Technology Council (NSTC). One of the RBM Subcommittee's priority areas is to create greater consistency in the administration of Federal research awards. Given the increasing complexity of interdisciplinary and interagency research, it has become increasingly important for Federal agencies to manage awards in a similar fashion. In 2000, the Federal Demonstration Partnership (FDP), a cooperative initiative among 10 Federal agencies and 98 institutional recipients of research funds, developed Standard Terms and Conditions as a model implementation of OMB Circular A-110. It was demonstrated that these terms were an effective set of requirements for many agency research awards. In 2005, following public and agency comment on the original FDP terms, final standard terms and conditions were developed by RBM. With this final notice, research agencies and awarding offices that participate in the FDP, must use the core set of administrative requirements, to the maximum practicable extent, in research and research-related grant awards to organizations that are subject to 2 CFR part 215. Likewise, agencies that have not participated in the FDP may elect to use these terms on selective awards to their research recipients. The Government-wide core set of administrative requirements are posted on the NSF Web site at: https://www.nsf.gov/bfa/dias/policy/rtc/ index.jsp. As changes are made in the future, NSF will maintain both the current version and an archive of earlier versions. Research agencies will post their plans for implementing the administrative requirements either on the RBM subcommittee Web site, https:// rbm.nih.gov, or on their own Web site, in which case the RBM subcommittee will provide a link from its site to the agency's location.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: 1. U.S. Provisional Patent Application S/N 60/329,709 (E-130-2001/ 0-US-01). PCT/US02/33165 was filed on October 16, 2002 (E-130-2001/0- PCT-01) and converted into 02773789.9 (E-130-2001/0-EP-03) filed in Europe on May 12, 2004, 2002337885 (E-130-2001/0-AU-02) filed in Australia on March 29, 2004, 10/492,729 (E-130-2001/0-US-05) filed in the U.S. on April 15, 2004, divisional application 11/748,992 (E-130- 2001/0-US-07) filed in the U.S. on May 15, 2007, and 2,463,931(E-130- 2001/0-CA-04) filed in Canada on April 15, 2004; entitled ``Broadly Cross-Reactive Neutralizing Antibodies Against Human Immunodeficiency Virus Selected By Env-CD4-Co-Receptor Complex.'' Inventor(s): Dimiter S. Dimitrov (NCI), Maxime Moulard (EM), Xiadong Xiao (NCI), Yuuei Shu (NCI), Sanjay K. Phogat (IAVI), Mei-Yun Zhang (NCI), and Dennis Burton (Scripps Inst.) 2. U.S. Provisional Patent Application S/N 60/623,394 (E-251-2004/ 0-US-01). PCT/US2005/39175 (E-251-2004/0-PCT-02) filed on October 28, 2005 and converted into 2,585,574 (E-251-2004/0-CA-04) filed in Canada on October 28, 2005, 05819487.9 (E-251-2004/0-EP-05) filed in Europe on April 27, 2007, 2005302416 (E-251-2004/0-AU-06) filed in Australia on October 28, 2005, and 11/718,202 (E-251-2004/0-US-03) filed in the U.S. on August 10, 2007; entitled ``Novel Broadly Cross-Reactive HIV Neutralizing Human Monoclonal Antibodies Selected From Phage Display Libraries Using Novel Strategy Based On Competitive Antigen Panning.'' Inventor(s): Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC) to Profectus Biosciences, Inc. (hereafter Profectus) having a place of business in Baltimore, Maryland. The patent rights in these inventions have been assigned to the United States of America.