April 2008 – Federal Register Recent Federal Regulation Documents

Pursuant to the Notice of Consent Motion to Terminate the Panel Review by the case participants, the panel review is terminated as of April 18, 2008. A panel was appointed to this panel review and has been dismissed pursuant to Rule 71(2) of the Rules of Procedure for Article 1904 Binational Panel Review, effective April 18, 2008.

The public is invited to comment on the following applications to conduct certain activities with endangered species and/or marine mammals.

It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with Seena International Inc., containing a civil penalty of $35,000.00.

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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in PCT Application Serial No. PCT/US07/083027 and foreign equivalents thereof, entitled ``Smoothened Polypeptides and Methods of Use'' [HHS Ref. No. E-014-2007/0]; PCT Application Serial No. PCT/US07/083772 and foreign equivalents thereof, entitled ``Self-Assembling Nanoparticles Composed of Transmembrane Peptides and Their Application for Specific Intra- Tumor Delivery of Anti-Cancer Drugs'' [HHS Ref. No: E-256-2006/0]; and U.S. Patent No. 7,105,488, and foreign equivalents thereof, entitled ``G Protein-Coupled Receptor Antagonists'' [HHS Ref. No: E-290-1997/0] to Calidris Therapeutics which is registered in Japan. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive licensed territory may be worldwide and the field of use may be limited to peptidomimetic drugs for the treatment of cancer as claimed in the Licensed Patent Rights. These cancers may be limited to multiple myeloma, colon, lung, melanoma, liver, breast, prostate, ovarian, pancreatic cancers, ALL, AML, NHL, rhabdomyosarcoma, neuroblastoma, osteosarcoma and medulloblastoma. With respect to the GPCR technology, the exclusive license field of use may be limited to antagonists of the GPCR CXCR4.

It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally accepted Settlement Agreement with The Cayre Group, Ltd., containing a civil penalty of $40,000.00.

It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally accepted Settlement Agreement with The Neiman Marcus Group, Inc., containing a civil penalty of $50,000.00.

It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally accepted Settlement Agreement with True Religion Apparel, Inc., containing a civil penalty of $50,000.00.

EPA is approving a State Implementation Plan (SIP) revision submitted by the Commonwealth of Virginia. This revision pertains to a 10-year maintenance plan for the White Top Mountain 1-hour ozone nonattainment area located in Smyth County, Virginia. This action is being taken under the Clean Air Act (CAA).

It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with Gildan Activewear SRL, containing a civil penalty of $35,000.00.

Comments are requested on the proposed Base (1 percent annual- chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917-NEW, ``Behavioral Health Preventive Care Assessment Focus Group Guide.'' Type of Information Collection Request: Three-year approval of this new information collection, 0917-NEW, ``Behavioral Health Preventive Care Assessment Focus Group Guide.'' Form(s): None. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission, IHS uses the Government Performance Act (GPRA) to assess quality of care among its Federal, Urban, and Tribal health programs. The IHS has been largely successful in meeting GPRA targets for selected clinical performance measures at the national level. However, there is significant variability in performance among IHS and Tribal service units. Until this time, IHS has not undertaken any comprehensive studies to evaluate the reasons for that variability or the factors that contribute to high quality care at the local level. The IHS has three GPRA measures relating to behavioral health, a high priority for the Agency and one of the IHS Director's Initiatives. This study will focus on these three GPRA behavioral health measures: Depression Screening in adults age 18 and over, Domestic/Intimate Partner Violence screening in women ages 14-15, and Alcohol Screening (to prevent Fetal Alcohol Syndrome) in women ages 15-44. Tribal programs voluntarily report their GPRA results quarterly and annually for national reporting. GPRA data collected for these three behavioral health measures includes: the number of patients eligible for a screening (denominator), number of eligible patients who receive a screening (numerator), and the resulting screening rate (percentage). IHS has developed a methodology to identify superior and poor performers on these measures in both Tribal and Federal sites using fiscal year 2005, 2006, and 2007 GPRA performance results. IHS will convene focus groups with employees at 17 of these programs (7 IHS and 10 Tribal) in order to identify the factors contributing to (and when appropriate, the barriers preventing) the provision of high quality behavioral health care at the local level. These focus groups will allow employees to provide detailed data regarding program practices, screening and documentation procedures, initiatives, resources, and other factors relating to the provision of behavioral health preventive care at their health program. A total of two to three focus groups, organized by occupational specialty, will be convened at each program. Using the Chronic Care Model and Institute of Medicine recommendations, IHS will analyze the information collected during these site visits, along with background information that is publicly available (e.g., information found on clinic web pages), on other qualitative and quantitative features of individual programs, such as staffing and funding levels, community demographics, and organizational structure, to develop a behavioral health preventive care model relevant to the unique system of IHS delivery. Affected Public: Individuals. Type of Respondents: Tribal employees at Tribal health programs. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).

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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/855,422 and PCT Application Serial No. PCT/US07/083027 and foreign equivalents thereof, entitled ``Smoothened Polypeptides and Methods of Use'' [HHS Ref. No. E-014- 2007/0], to Lee's Pharmaceuticals, Ltd., which is located in Hong Kong, China. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive licensed territory may be Asia and the field of use may be limited to the use of Licensee's proprietary delivery formulation for the treatment of psoriasis as claimed in the Licensed Patent Rights.

The Indian Health Service published a document in the Federal Register (FR) on March 31, 2008. The document contained three errors.

The Indian Health Service published a document in the Federal Register (FR) on March 31, 2008. The document contained four errors.

Base (1% annual chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

To comply with the Paperwork Reduction Act of 1995 (PRA), we are notifying the public that we will submit to OMB a new information collection request (ICR) for approval of the paperwork requirements for the National Land Remote Sensing Education, Outreach and Research Program (NLRSEORP). To submit a proposal for the NLRSEORP three standard OMB forms and project narrative must be completed and submitted via Grants.gov. This notice provides the public an opportunity to comment on the paperwork burden of these forms. The forms are available at https://www07.grants.gov/agencies/approved standardforms.jsp.

We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on two petitions to list the Mono Basin area population of the greater sage-grouse (Centrocercus urophasianus) in the Bi-State area of California and Nevada as threatened or endangered under the Endangered Species Act of 1973, as amended (Act). We find that the petitions present substantial scientific or commercial information indicating that listing this population may be warranted. Therefore, with the publication of this notice, we are initiating a status review to determine if listing the Mono Basin area population of greater sage- grouse is warranted. To ensure that the status review is comprehensive, we are soliciting scientific and commercial data and other information regarding this population of the species. We will initiate a determination on critical habitat for this species if and when we initiate a listing action.

We, the U.S. Fish and Wildlife Service (Service), announce the extension of the period for submitting information that is pertinent to our status review of the greater sage-grouse (Centrocercus urophasianus). The extension will provide the public and Federal, State, and local agencies with an additional opportunity to submit information for the status review. Information previously submitted need not be resubmitted; it already has been incorporated into the public record and will be fully considered in the status review.