October 2005 – Federal Register Recent Federal Regulation Documents

This notice describes the changes made to the TRICARE DRG- based payment system in order to conform to changes made to the Medicare Prospective Payment System (PPS). It also provides the updated fixed loss cost outlier threshold, cost-to-charge ratios and the Internet address for accessing the updated adjusted standardized amount and DRG relative weights to be used for FY 2006 under the TRICARE DRG- based payment system.

NMFS announces the end of the 2005 Pacific whiting (whiting) primary season for the catcher/processor sector at 1800 local time (l.t.) October 18, 2005, because the allocation for the catcher/ processor will be reached by that time. This action is intended to keep the harvest of whiting within the 2005 allocation levels.

The FHWA is issuing this notice to advise the public that a Record of Decision (ROD) has been made following a Final Environmental Impact Statement prepared for the Southern Corridor project within Washington County, Utah. The ROD approves a location proposed for transportation improvements for the Southern Corridor project Washington County, Utah. The Southern Corridor Study Area includes an area in southern Washington County south and southeast of Interstate 15 (I-15) and State Route 9 (SR 9) including the cities of St. George, Washington, and Hurricane. The Selected Alternative (2800 West Alternative) includes a new interchange with I-15 at Reference Post 2 (Atkinville) and a new four-lane highway extending 26 miles to the intersection of 2800 West with SR 9. Selection of the Preferred Alternative was based on the best overall public interest to provide a safe and efficient transportation system and the social, economic, and environmental impacts. In addition, the project team considered public and resource agency input and city council recommendations or resolutions regarding the project. This project requires Federal approval of a proposed new Interstate access and Federal Highway Administration funding as authorized by Title 23 of the United States Code. Consequently, pursuant to the National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.), the Federal Highway Administration (FHWA) in coordination with the Utah Department of Transportation (UDOT), prepared an Environmental Impact Statement (EIS) for the project's impact on the human environment. The Final EIS (FEIS) was issued on April 22, 2005. Pursuant to Section 6002 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users [23 U.S.C. 139(l)] any person or entity wishing to file a claim for judicial review challenging this decision must do so within 180 days of the publication of this notice.

This notice advises the public that the owners of the Burrows Ranch and Big Bluff Ranch (Applicants) have applied to the Fish and Wildlife Service (Service) for an enhancement of survival permit pursuant to section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.) (Act). The permit application includes a proposed Safe Harbor Agreement (Agreement) between the Applicants and the Service for the threatened California red-legged frog (CRLF, Rana aurora draytonii) and the valley elderberry longhorn beetle (VELB, Desmocerus californicus dimorphus). The Agreement and permit application are available for public comment.

We are amending the Asian longhorned beetle regulations by adding a portion of Middlesex and Union Counties, NJ, to the list of quarantined areas and restricting the interstate movement of regulated articles from those areas. This action is necessary to prevent the artificial spread of the Asian longhorned beetle to noninfested areas of the United States. We are also removing the areas within Hudson County, NJ, from the list of quarantined areas and removing restrictions on the interstate movement of regulated articles from those areas. We have determined that the Asian longhorned beetle no longer presents a risk of spread from those areas and that the quarantine and restrictions are no longer necessary.

This notice announces the creation of Non-portal Accounts for importers wishing to participate in the Automated Commercial Environment (ACE) test, but not seeking the benefits that inure to parties that establish Portal Accounts. This notice also announces that all importers who are certified partners in the voluntary Customs-Trade Partnership Against Terrorism (C-TPAT) Program, and are not holders of ACE Portal Accounts, are automatically established as ACE Non-portal Accounts and are eligible to participate in the Periodic Monthly Statement test. This Notice further announces that importers who are not certified partners in C-TPAT may still become Non-portal Accounts by accurately completing a Customs and Border Protection Form (CBP Form) 5106 and then submitting that document to a customs broker who is participating in ACE via a Portal Account. The broker will then submit that information to CBP. Finally, the document states that any current C-TPAT certified partners who are owners of Portal Accounts and are not participating in Periodic Monthly Statement (PMS) may immediately participate in PMS directly with CBP, or through a customs broker with an ACE Portal Account, by providing to CBP those importer of record numbers that are part of the Portal Account and that have been previously designated to C-TPAT.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in the guidance for industry on formal dispute resolution for appeals above the division level.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``MicroArray Quality Control (MAQC) Project Meeting on MicroArray Quality Control.'' The focus of the 2-day meeting will be to review the datasets generated by the MAQC study. Date and Time: The meeting will be held on Thursday, December 1, 2005, from 8 a.m. to 5 p.m. and Friday, December 2, 2005, from 8 a.m. to 2 p.m. Location: The meeting will be held at the Crowne Plaza Cabana Portofino Room on December 1, 2005, and the St. Tropez Room on December 2, 2005, 4290 El Camino Real, Palo Alto, CA 94306, 650-857-0787, FAX: 650-496-1939, Web site: https://www.cppaloalto.crowneplaza.com/. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Contact: Leming Shi, National Center for Toxicological Research, Food and Drug Administration, 3900 NCTR Rd., Jefferson, AR 72079, 870- 543-7387, FAX: 870-543-7686, e-mail: leming.shi@fda.hhs.gov. Registration: There will be no registration fee for attending the meeting. However, interested parties should send registration information (including name, title, firm name, address, telephone, and fax number), and written material and requests to make oral presentations, to the contact person (see Contact) at least 15 days in advance of the meeting. Participants are responsible for their own costs of travel, lodging, and meals. FDA welcomes the attendance of the public at this meeting and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Jeannette Coleman at 870-543-7087, e-mail: jeanette.coleman@fda.hhs.gov, at least 7 days in advance of the meeting.

Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case: Xiaowu Li, MD, PhD, The University of California at San Francisco: On September 16, 2005, the U.S. Public Health Service (PHS) entered into a Voluntary Exclusion Agreement with the University of California at San Francisco (UCSF) and Xiaowu Li, MD, PhD, former postdoctoral fellow at UCSF. Based on the UCSF report and additional analysis conducted by ORI in its oversight review, PHS found that Dr. Li engaged in scientific misconduct in reporting research supported by grants P01 DE13904, ``Adhesion and proliferation in oral cancer progression,'' R01 DE12856, ``Oral melanoma alpha v beta 3 expression and metastasis,'' and R01 DE011930, ``Regulatory function of fyn in oral SCC invasion,'' all funded by the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH). Specifically, PHS found that Dr. Li falsified three images in Figure 5B of a paper, ``Laminin-5 promotes cell motility by regulating the function of the integrin [alpha]6[beta]1 in pancreatic cancer,'' published online in Carcinogenesis Advance Access, reporting studies on the role of integrin [alpha]6[beta]1 and laminin on the invasiveness of pancreatic cancer cells and their ability to metastasize. In all three images, mouse melanoma cells were falsely represented as being human pancreatic carcinoma cells; the cancer cells were falsely represented as having been plated on medium with laminin-1, whereas they were in fact plated on medium with vitronectin; and for two of the three images, the cancer cells were falsely represented as having been stained with anti-integrin [beta]1, whereas they were actually stained with anti-integrin [beta]3. The misconduct was significant because pancreatic cancer has a poor prognosis for patients, since it tends to invade other tissues and to metastasize early in its course. Knowledge of the factors that facilitate cancer cell invasion and metastasis, which was the focus of the questioned figure and paper, is crucial to attempts to develop better treatments for pancreatic and other cancers. Thus, the falsified figure could have misled other investigators in this important area of medical research. Dr. Li has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed, for a period of three (3) years, beginning on September 16, 2005: (1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' as defined in the debarment regulations at 45 CFR Part 76; and (2) To exclude himself from serving in any advisory capacity to PHS including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as consultant.

In accordance with the requirements of the Paperwork Reduction Act of 1995, the Federal Housing Finance Board (Finance Board) has submitted the information collection entitled ``Advances to Housing Associates'' to the Office of Management and Budget (OMB) for review and approval of a 3 year extension of the OMB control number, 3069- 0005, which is due to expire on November 30, 2005.

The Coast Guard is revising the operating regulations for the Michigan Street and Bayview drawbridges, both in Sturgeon Bay, WI, by establishing a permanent winter operating schedule while still providing for the reasonable needs of navigation.

This action extends Federal Airway V-343 from the Bozeman, MT, Very High Frequency Omni-directional Range/Tactical Air Navigation (VORTAC) to the initial approach fix for the Area Navigation (RNAV) runway 15 approach to the Bert Mooney Airport (BTM), MT. Specifically, this action will enhance the management of air traffic arrivals at BTM.

This notice requests public participation in the Office of Management and Budget (OMB) approval process for the renewal of an existing PHMSA information collection. In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) described below has been forwarded to OMB for extension of the currently approved collection. The ICR describes the nature of the information collection and the expected burden. PHMSA published a Federal Register Notice soliciting comments on the following information collection and received none. The purpose of this notice is to allow the public an additional 30 days from the date of this notice to submit comments.

This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If FEMA receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date.

This is a notice of the Presidential declaration of a major disaster for the State of North Carolina (FEMA-1608-DR), dated October 7, 2005, and related determinations.

The purpose of this notice is to announce that the National Institutes of Health (NIH) will hold a Town Hall meeting to hear comments and insights concerning possible revisions to certain fiscal policies that govern the Ruth L. Kirschstein National Research Service Awards (NRSA), which comprise institutional training grants (T32 and T34s) and individual fellowships (F30, F31, F32, F33). The meeting which is open to the public will focus primarily on the funding of educational costs such as tuition, fees and health insurance provided through institutional training grants. The meeting will be held November 30, 2005 in the Natcher Conference Center, Room E1/E2 on the NIH campus in Bethesda, Maryland. Background: NRSA programs currently support over 17,000 predoctoral and postdoctoral research training positions mostly in the nation's academic laboratories. While the budget for the NRSA programs grew smartly during the five years in which the overall appropriation for the NIH was doubled, since fiscal 2003, the last of the growth years, the appropriation for NRSA training programs has grown rather modestly. Given this reality, the NIH must re-examine aspects of its NRSA policies that may not be sustainable in a period of limited budget expansion. The largest of the NRSA programs funds institutional training grants that use the T32 mechanism to support both pre- and post- doctoral research training. Currently, the direct cost funding of these programs is segmented into four categories: stipend, tuition/fees/ health insurance (referred to collectively as tuition), travel, and training related expenses. The funding levels for three of these (stipend, travel, and training related expenses) are stipulated and controlled by NIH, although each can be adjusted as fiscal circumstances and program needs evolve. The funding for tuition, on the other hand, is not fully controlled by NIH; the funding for tuition is governed by a formula tied to the amount each institution requests for this expense. The formula provides for each T32 trainee the sum of $3,000 plus sixty percent of the requested tuition in excess of $3,000. This formula is used to determine the tuition level provided via each competing grant; that level, once established for a given competing grant, is used for the subsequent non-competing renewal awards during the project period. This formula has been employed since fiscal 1996 and has been modified once. During the five year growth period, the increased funding devoted to NRSA activities was used for meaningful, and long overdue, trainee stipend increases and for covering some of the escalating requests in the tuition category of training grants. However, in fiscal 2004 and 2005, when there was limited NRSA budget growth, the requests and outlays for tuition continued to rise substantially. Barring other adjustments, the continuation of this trend in tuition growth will result in a significant annual decrease in the number of NRSA trainee positions, and to fewer programs supported by T32 training grants. Since these outcomes could have a substantial disruptive effect on biomedical research training, NIH has frozen the tuition expenses on competing renewals of T32 awards in fiscal 2006. (See https:// grants.nih.gov/grants/guide/notice-files/NOT-OD-05-059.html) Moreover, NIH training officials have decided to study various options for handling the funding of trainee tuition in the future. The goal of this effort is to find an approach that equips the agency both to adjust to budgetary challenges and to continue to provide appropriate support to institutions to help defray the educational costs of NRSA trainees. This town hall meeting is being held to gather the views of the training community on this issue. Among the options that will be studied are the following: 1. The current tuition formula could be applied in conjunction with a ceiling; the funds provided would be the amount dictated by the currently-used formula or the amount dictated by the ceiling, whichever is less. The magnitude of the ceiling would be based on the fiscal resources available as well as on applicable data. For the sake of discussion, those offering comments may assume the ceiling could be in the range of $16,000 to $18,000. 2. A fixed allowance could be provided for tuition; the same allowance per trainee would be provided to each grantee institution. This approach is employed by the National Science Foundation for its graduate research fellowship program. For the sake of discussion, those offering comments may assume the allowance could be in the range of $16,000 to $18,000. The allowance could be adjusted periodically by the NIH as fiscal circumstances warranted. 3. The current tuition formula could be retained without modification. Those offering comments may assume that under this option the number of NRSA trainees and funded training grant programs will likely experience a series of year-to-year decreases as long as the current fiscal patterns prevail. Participation: Those who wish to attend the Town Hall meeting are invited to submit a brief statement, not to exceed two pages, summarizing views and experiences relevant to the topic of the meeting. Some of those submitting statements will be asked to make brief oral presentations at the meeting. In selecting those to make presentations and in allocating time, the organizers hope to ensure that a full range of opinions is heard and that all parts of the NRSA constituency are represented. Those not asked to present will be welcome at the meeting and will be given a brief opportunity to contribute during two ``open mike'' sessions. Individuals should submit their statements along with their name, affiliation, and contact information to NRSATownHall@mail.nih.gov by November 4, 2005. Individuals chosen to make presentations at the Town Hall meeting will be notified on or around November 14, 2005. Those unable to attend but who wish to provide statements are welcome to do so. All statements will be considered by NIH staff. Those who do not submit statements but wish to observe the meeting will be admitted on a space-available basis. An NIH official will present background information on NRSA tuition support at the outset of the meeting. All individuals who wish to attend the meeting should register through the Town Hall meeting's Web site at https://pub.nigms.nih.gov/ nrsameeting, available on or about October 24, 2005. The detailed schedule for the meeting, when completed, will be posted on this Web site along with any meeting updates. Participants are responsible for their own expenses associated with participating in this meeting, such as for travel. Inquiries: Questions concerning this notice should be directed to: Dr. Warren Jones, National Institute of General Medical Sciences, National Institutes of Health, 301-594-3827, jonesw@nigms.nih.gov.

The NTP has developed and refined a vision for toxicology in the 21st century (``NTP Vision'') and a roadmap for implementing its vision (``NTP Roadmap'') to strategically place the program at the forefront of providing scientific data and its interpretation for use in public health decision-making (see NTP Web site https:// ntp.niehs.nih.gov select ``NTP Vision and Roadmap''). As part of the NTP Roadmap, the NTP will convene a series of workshops, including the High Throughput Screening Assays Workshop, to discuss test methods and approaches that will enhance the program's ability to efficiently evaluate the large number of substances in our environment for which there is little or no information about their potential hazard for human health. This workshop is scheduled for December 14-15, 2005, at the Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA and will focus on providing information about high throughput screening techniques and the potential utility of this technology for toxicology and the NTP. This meeting is open to the public and attendance is limited only by the space available. Individuals may register to attend the workshop on a first-come, first- served basis per the procedures outlined below. A copy of the agenda and any additional information about the workshop, including background materials and participants, will be posted on the NTP Web site when available (see NTP Web site https://ntp.niehs.nih.gov select ``Meetings and Workshops'').