September 13, 2010 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER), 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: Generic Clearance for Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of Health. Type of Information Collection Request: NEW. Need and Use of Information Collection: OER develops, coordinates the implementation of, and evaluates NIH-wide policies and procedures for the award of extramural funds . To move forward with our initiatives to ensure success in accomplishing the NIH mission, input from partners and customers is essential. Quality management principles have been integrated into OER's culture and these surveys will provide customer satisfaction input on various elements of OER's business processes. The approximately 14 (10 quantitative and 4 qualitative) customer satisfaction surveys that will be conducted under this generic clearance will gather and measure customer and partner satisfaction with OER processes and operations. The data collected from these surveys will provide the feedback to track and gauge satisfaction with NIH's statutorily mandated operations and processes. OER/OD/NIH will present data and outcomes from these surveys to inform the NIH staff, officers, leadership, advisory committees, and other decision-making bodies as appropriate. Based on feedback from these stakeholders, OER/ OD/NIH will formulate improvement plans and take action when necessary. Frequency of Response: 1 Response. Affected Public: Individuals. Type of Respondents: Science professionals (applicants, reviewers, Institutional Officials), adult science trainees, and the general public. The annual reporting burden is as follows: Quantitative surveys: Estimated Number of Respondents per Survey: 9,820; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.25; Estimated Total Annual Burden Hours Requested per Quantitative Survey: 2,455; Estimated Total Annual Burden Hours Requested for 10 Quantitative Surveys: 24,550. Qualitative surveys: Estimated Number of Respondents per Survey: 30; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 1.0; Estimated Total Annual Burden Hours Requested per Qualitative Survey: 30; Estimated Total Annual Burden Hours Requested for 4 Qualitative Surveys: 120. Based on an estimated 10 quantitative and 4 qualitative surveys per year: Estimated Total Combined Annual Hours of Burden Requested in Each of 3 years: 24,670. Estimated Total Combined Cost to Respondents: $728,326. Based on an estimated 10 quantitative and 4 qualitative surveys per year over 3 years: Estimated Total Hours of Burden to Respondents for 2011, 2012, and 2013 Combined: 74,010. Estimated Total Cost to Respondents for 2011, 2012, and 2013 Combined: $2,184,978. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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 July 13, 2010 (75 FR 39950) and allowed 60-days for public comment. There have been no public comments. 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 currently valid OMB control number. Proposed Collection: Title Cancer Trial Support Unit (CTSU). Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: CTSU collects annual surveys of customer satisfaction for clinical site staff using the CTSU Help Desk and the CTSU Web site. An ongoing user satisfaction survey is in place for the Oncology Patient Enrollment Network (OPEN). User satisfaction surveys are compiled as part of the project quality assurance activities and used to direct improvements to processes and technology. In addition, the CTSU collects standardized forms to process site regulatory information, changes to membership, patient enrollment data, and routing information for case report forms. This questionnaire adheres to The Public Health Service Act, Section 413 (42 U.S.C. 285a[dash]2) authorizes CTEP to establish and support programs to facilitate the participation of qualified investigators on CTEP- supported studies, and to institute programs that minimize redundancy among grant and contract holders, thereby reducing overall cost of maintaining a robust treatment trials program. Frequency of Response: The help desk and Web site survey are collected annually. The OPEN survey is ongoing. Submission of forms varies depending on the purpose of the form and the activity of the local site. Affected Public: CTSU's target audience is staff members at clinical sites and CTEP-supported programs. Respondent and burden estimates are listed in the Table below. The annualized burden is estimated to be 27,861 hours and the annualized cost to respondents is estimated to be $757,828. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

In accordance with 35 U.S.C. 209(e), and 37 CFR 404.7 (a)(1)(i) and 404.7(b)(1)(i), announcement is made of the intent to grant a field of use exclusive, revocable license for the field of prevention and/or therapeutic treatment of vaccinia virus infections or other orthopoxvirus infections to the inventions claimed in U.S. Patent No. 6,451,309 entitled ``Prophylactic and Therapeutic Monoclonal Antibodies,'' issued September 17, 2002, and U.S. Patent No. 6,620,412 entitled ``Prophylactic and Therapeutic Monoclonal Antibodies,'' issued September 16, 2003, which is a continuation of U.S. Patent No. 6,451,309, and related foreign patents and patent applications (PCT/ US2001/04520) to Biofactura, Inc., with its principal place of business at 9430 Key West Avenue, Suite 125, Rockville, MD 20850-6345.

The FDIC, 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 continuing information collections, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). Currently, the FDIC is soliciting comments on the renewal of the information collections described below.

The Assistant Secretary of Labor for Occupational Safety and Health (OSHA) invites interested parties to submit nominations for membership on ACCSH.

The Shoshone Resource Advisory Committee will meet in Thermopolis, Wyoming. The committee is meeting as authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110- 343) and in compliance with the Federal Advisory Committee Act. The purpose of the meeting is to convene the newly formed committee. The agenda includes dissemination of information on the responsibilities of the committee members and others involved.

On May 2, 2008, a Notice of Intent (NOT) to prepare an environmental impact statement (ElS) for the Crooked Creek Reservoir Repair project on the Sopris Ranger District of the White River National Forest was published in the Federal Register (86 FR 24215). The Forest Service has decided to cancel the preparation of this EIS. The NOT is hereby rescinded.

The information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

Notice is hereby given, in accordance with Public Laws 92-463 and 94-579, that the California Desert District Advisory Council to the Bureau of Land Management, U.S. Department of the Interior, will participate in a field tour of BLM-administered public lands on Friday, October 1, 2010, from 8 a.m. to 4:30 p.m. and will meet in formal session on Saturday, October 2, 2010, from 8 a.m. to 4:30 p.m. at the BLM Needles Field Office, 1303 S Highway 95, Needles, CA 92363. Agenda topics will include updates by Council members and reports from the BLM District Manager and five field office managers. Final agenda items, including details of the field tour, will be posted on the BLM California state Web site at https://www.blm.gov/ca/st/en/info/ rac/dac.html.

The Upper Rio Grande Resource Advisory Committee will meet in South Fork, Colorado. The committee is meeting as authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110- 343) and in compliance with the Federal Advisory Committee Act. The purpose is to review and recommend project proposals to be funded with Title II money.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 6, 2010, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Spansion LLC of Sunnyvale, California. Letters supplementing the complaint were filed on August 17 and August 20, 2010. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain flash memory chips and products containing the same by reason of infringement of certain claims of U.S. Patent No. 7,018,922 (``the `922 patent''); U.S. Patent No. 6,900,124 (``the `124 patent''); U.S. Patent No. 6,459,625 (``the `625 patent''); U.S. Patent No. 6,369,416 (``the `416 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainant requests that the Commission institute an investigation and, after the investigation, issue an exclusion order and a cease and desist orders.

The Health Resources and Services Administration (HRSA) will be transferring the Florida Family-to-Family Health Information Center (F2F HIC) grant (H84MC00006) from the Florida Institute of Family Involvement (FIFI) to the Family Caf[eacute] in Tallahassee due to financial difficulties resulting in closure of FIFI facilities and programs. This action ensures the continued provision of health resources, financing, related services and parent-to-parent support for families with children and youth with special health care needs (CYSHCN) in the state of Florida.