December 17, 2010 – Federal Register Recent Federal Regulation Documents

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Study of Substance Abuse doc.com Module Project. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a two-year generic clearance to a conduct research study to assess the efficacy of a specific interactive web-based teaching module in the field of professional education of healthcare providers. This online module was developed as a work product by the same team of investigators from Drexel University College of Medicine (DUCOM) and University of Pennsylvania School of Medicine (Penn Med) under a contract as part of NIDA's Center of Excellence (CoE) for Physician Information. This project will assess efficacy of the NIDA CoE online teaching module with educational interventions in enhancing: (1) The knowledge of healthcare professionals about substance use disorders; (2) attitudes of healthcare professionals toward patients with these disorders and (3) communication skills in providing assessment and referral to treatment for patients who abuse substances. The overall goal of this project is to assess the efficacy of an educational intervention, which should result in an increase in the involvement of primary care providers in the screening, managing and, when appropriate, referring patients with substance use disorders. This effort is made according to Executive Order 12862, which directs Federal agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. The project will utilize a randomized cluster controlled trial design that compares the group that receives educational exposure to the set of new educational interventions (NIDA online teaching module plus educational adjuncts) to a control group that receives exposure to the standard medical school or residency educational curriculum related to substance use disorders. The project will use a repeated measures approach to assess the educational intervention's efficacy (i.e., individuals will take surveys before and after exposure to the intervention or to the control curriculum). The outcomes of the study will be based on changes in knowledge, attitudes and indirect measures of communication skills before and after the intervention, compared to the changes in these parameters in the control group. Frequency of Response: This project will be conducted annually or biennially. Affected Public: Individuals and businesses. Type of Respondents: medical students and resident physicians. The annual reporting burden is calculated as follows: Estimated Total Annual Number of Respondents: 708; Estimated Number of Responses per Respondent: 4 for medical students; 2 for resident physicians; Average Burden Hours per Response: 0.17. Estimated Total Annual Burden Hours Requested: 377; There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on September 28, 2010, Volume 75, No. 187, pages 59724-59725 and allowed 60 days for public comment. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a current valid OMB control number. Proposed Collection: Title: Transfusion-transmitted retrovirus and hepatitis virus rates and risk factors: Improving the safety of the U.S. blood supply through hemovigilance. Type of Information Collection Request: NEW. Need and Use of Information Collection: Information on current risk factors in blood donors as assessed using analytical study designs is largely unavailable in the U.S. Studies of risk factor profiles among HIV-infected donors were funded by the CDC for approximately 10 years after implementation of serologic screening in the mid-1980s, whereas studies of HTLV- and HCV-seropositive (and indeterminate) donors, funded by NIH, were conducted in the early 1990s, but unfortunately, none of these studies is ongoing. Infection trend analyses have been conducted by the American Red Cross (ARC). The findings show continued HIV risk with the prevalence of HIV in first time donors hovering around 10 per 100,000 donations in each of the last 10 years and the incidence in repeat donors increasing from 1.49 per 100,000 person-years in 1999-2000 to 2.16 per 100,000 persons-years in 2007-2008. While the prevalence of HCV in first time donors decreased over this time interval from 345 to 163 per 100,000 donations, the incidence in repeat donors did not decrease and evidence of incident infection in first time donors increased. Moreover specific age, gender and race/ethnicity groups were over-represented. Significantly increased incidence of both HIV and HCV were observed in 2007/2008 compared to 2005/2006. Similar analyses for HBV have shown an incidence in all donors of 3.4 per 100,000 person-years which is lower than earlier estimates, but remains higher than for HIV and HCV. This project represents a collaborative pilot research study that will include a comprehensive interview study of viral infection positive blood donors at the American Red Cross (ARC), Blood Systems Inc. (BSI) and New York Blood Center (NYBC) in order to identify the current predominant risk factors for virus positive donations and will also establish a donor biovigilance capacity that currently does not exist in the U.S. At this time it is not easy to integrate risk factor data and disease marker surveillance information within or across different blood collection organizations because common interview procedures and laboratory confirmation procedures are not being used and so we cannot easily tabulate and analyze behavioral risks or viral infections in U.S. blood donors. This creates the potential for gaps in our understanding of absolute incidence and prevalence as well as risks that could lead to transfusion-transmitted disease. Combined data are critical for appropriate national surveillance efforts. For example, this information could be used to target educational interventions to reduce donations from persons with high risk behaviors. This is particularly important in the case of behaviors associated with incident (recently acquired) infections because these donations have the greatest potential transmission risk because they could be missed during routine testing. As part of the project a comprehensive research-quality biovigilance database will be created that integrates existing operational information on blood donors, disease marker testing and blood components collected by participating organizations into a research database. The combined database will capture infectious disease and risk factor information on nearly 60% of all blood donors and donations in the country. Following successful completion of the risk factor interviews and research database development, the biovigilance network pilot can be expanded to include additional blood centers and/or re-focused on other safety threats as warranted, such as XMRV. This pilot biovigilance network will thereby establish a standardized process for integration of information across blood collection organizations. The Specific Aims are to: (1) Define consensus infectious disease testing classification algorithms for HIV, HCV, HBV, and HTLV that can be used to consistently classify donation testing results across blood collection organizations in the U.S. This will allow for better estimates of infection disease marker prevalence and incidence in the U.S. (2) Determine current behavioral risk factors associated with prevalent and incident (when possible) HIV, HCV, HBV and HTLV infections in blood donors, including parenteral and sexual risks, across the participating blood collection organizations using a case- control study design. (3) Determine nationally-representative infectious disease marker prevalence and incidence for HIV, HCV, HBV, and HTLV overall and by demographic characteristics of donors. This will be accomplished by forming research databases from operational data at BSI and NYBC into formats that can be combined with the ARC research database. (4) Analyze integrated risk factor and infectious marker testing data together because when taken together these may show that blood centers are not achieving the same degree of success in educational efforts to prevent donation by donors with risk behaviors across all demographic groups. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult blood donors. The annual reporting burden is as follows: Estimated Number of Respondents:4150; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.58 and Estimated Total Annual Burden Hours Requested: 2407. The annualized cost to respondents is estimated at: $43,326 (based on $18 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

As part of the consolidated line item improvement process (CLIIP), the NRC is announcing the availability of the model application (with model no significant hazards consideration determination) and model safety evaluation (SE) for the plant-specific adoption of Technical Specifications Task Force (TSTF) Traveler TSTF- 514, Revision 3, ``Revise BWR [boiling water reactor] Operability Requirements and Actions for RCS [reactor coolant system] Leakage Instrumentation.'' TSTF-514, Revision 3, is available in the Agencywide Documents Access and Management System (ADAMS) under Accession Number ML103280389. The proposed changes revise the Standard Technical Specifications (STS) to define a new time limit for restoring inoperable RCS leakage detection instrumentation to operable status and establish alternate methods of monitoring RCS leakage when one or more required monitors are inoperable. Changes to the Technical Specifications (TS) Bases are included, which reflect the proposed changes and more accurately reflect the contents of the facility design bases related to the operability of the RCS leakage detection instrumentation. The CLIIP model SE will facilitate expedited approval of plant-specific adoption of TSTF-514, Revision 3. Documents: You can access publicly available documents related to this notice using the following methods: NRC's Public Document Room (PDR): The public may examine and have copied for a fee publicly available documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. NRC's Agencywide Documents Access and Management System (ADAMS): Publicly available documents created or received at the NRC are available electronically at the NRC's Electronic Reading Room at http:/ /www.nrc.gov/reading-rm/adams.html. From this page, the public can gain entry into ADAMS, which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC's PDR reference staff at 1-800-397-4209, 301-415-4737, or by e-mail at pdr.resource@nrc.gov. The model application (with model no significant hazards consideration determination) and model SE for the plant-specific adoption of TSTF-514, Revision 3, are available electronically under ADAMS Accession Number ML102300729. The NRC staff disposition of comments received on the Notice of Opportunity for Comment announced in the Federal Register on April 13, 2010 (75 FR 18907-18908), is available electronically under ADAMS Accession Number ML102300727. Federal rulemaking Web site: The public comments received and supporting materials related to this notice can be found at https:// www.regulations.gov by searching on Docket ID NRC-2010-0150.

The General Services Administration (GSA) will prepare an Environmental Assessment (EA) that will analyze and discuss the environmental impacts of constructing and operating a proposed new Downtown Federal Building in Kansas City, Missouri. Through the project, GSA proposes to relocate its current operations from the Bannister Federal Complex in Kansas City, Missouri, and co-locate with other federal tenants at a proposed new Downtown Federal Building. The target property(ies) subject to this proposed action are those within an area bounded by 11th Street on the north, 12th Street on the south, Charlotte Street on the east, and Cherry Street on the west (known as city blocks 99 and 100), and could also include some level of development of 701 E. 12th Street, bounded by 12th Street, on the north, 13th Street, on the south, Holmes Street, on the west and Charlotte Street on the east. City blocks 99 and 100 lie within the downtown East Village development and tax increment financing (TIF) district, on the East-side of downtown, in Missouri's 5th Congressional District. In the EA, GSA will discuss impacts that could occur as a result of the construction and operation of the proposed project. GSA will also evaluate the ``No Action'' and other reasonable alternatives to the proposed project, or portions of the project, and consider how to lessen or avoid impacts on the various resource areas.

The Export-Import Bank of the United States (Ex-Im Bank), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. Our customers will be able to submit this form on paper or electronically. This form is used when the beneficiary of the letter of credit, the recipient of a funding under a direct buyer credit loan, or the recipient of payment under a reimbursement loan or a payment under a supplier credit is not the exporter. If the need to use this form arises, the insured holds it in the event of a claim, at which time it would submit it to Export-Import Bank along with all other claim documentation. The form provides Export-Import Bank staff with the information necessary to make a determination of the eligibility of the claimed export transaction for coverage.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request extension of approval of an information collection to conduct surveys of customer/stakeholder satisfaction for both the National Animal Health Monitoring System and the National Veterinary Services Laboratories.

PHMSA is seeking comment on its intent to clarify its fireworks approvals policy whereby the Office of Hazardous Materials Safety (OHMS), Approvals and Permits Division will only accept fireworks approvals applications from manufacturers and grant approvals only to manufacturers of fireworks devices.

The Assistant Secretary of the Interior for Land and Minerals Management proposes to extend the duration of Public Land Order (PLO) No. 6845 for an additional 20-year term. PLO No. 6845 withdrew 200 acres of public land from settlement, sale, location, or entry under the general land laws, including the United States mining laws, to protect the archaeological values at the Arroyo del Tajo Pictograph Site. This notice gives an opportunity to comment on the proposed action and request a public meeting.

The Coast Guard announces that it is delaying the effective date of certain revisions in 46 CFR part 45 as amended by the final rule published in the November 18, 2010, Federal Register (75 FR 70595), and soliciting comments on those amendments.

The Department of Labor (DOL) hereby announces the submission of the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, ``Employer's First Report of Injury or Occupational Disease and Employer's Supplementary Report of Accident or Occupational Illness,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).

The SEDAR 22 assessments of the Gulf of Mexico stocks of yellowedge grouper and tilefish will consist of a series of workshops and webinars: a Data Workshop, a series of Assessment webinars, and a Review Workshop. See SUPPLEMENTARY INFORMATION.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. 3506(c)(2)(A)]. This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments concerning the extension of the information collection for applications for waiver of surface sanitary facilities' requirements at coal mines.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. 3506(c)(2)(A)]. This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments concerning the extension of the information collection for Request for MSHA Individual Identification Number (MIIN).

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. 3506(c)(2)(A)]. This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments concerning the extension of the information collection for 30 CFR 40.2, 40.3, 40.4, and 40.5, Representative of Miners; 30 CFR 41.20, Legal Identity Report; 30 CFR 56.1000 and 57.1000, Notification of Commencement of Operations and Closing of Mines.