July 2011 – Federal Register Recent Federal Regulation Documents

This document announces that the EPA Administrator has responded to a citizen petition asking EPA to object to an operating permit issued by the Colorado Department of Public Health and Environment (CDPHE). Specifically, the Administrator has partially granted and partially denied the February, 2010, Petition, submitted by WildEarth Guardians (Petitioner), to object to CDPHE's January 1, 2010, title V permit issued to Public Service Company of Colorado dba Xcel Energy (Xcel)Pawnee Power Station. Pursuant to section 505(b)(2) of the Clean Air Act (Act or CAA), Petitioners may seek judicial review of those portions of the petition that EPA denied in the United States Court of Appeals for the appropriate circuit. Any petition for review shall be filed within 60 days from the date this notice appears in the Federal Register, pursuant to section 307 of the Act.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with regulations for the payment of indemnity due to infectious salmon anemia.

The National Institute of Corrections (NIC) is seeking applications from organizations, groups, or individuals to enter into a cooperative agreement for an 18-month period to develop and pilot a methodology for correctional organizations to conduct an internal evaluation of their current policy and practice for working with women offenders. This methodology must cover a broad range of domains, such as leadership, external collaboration, management and operations, sanctions, assessment and case planning, and programs and services. The methodology must be concise but informative enough to be used by an organization with an understanding of evidence-based practices that incorporate gender-informed research and information. Additional consideration may be given to an applicant who can incorporate into the methodology those elements applicable to institutional and community corrections environments. The methodology should also include supplemental information that addresses an organization's readiness for change and a template that will help organizations initiate an internal strategic planning process. This award will also cover the piloting of the methodology, which should include both onsite work and use of Web- based technology, post-pilot revisions to the methodology based on feedback, and a design for conducting a process evaluation to measure the efficacy of the methodology. The goal of this solicitation is to create and provide a methodology for organizations to (1) Conduct an abbreviated internal evaluation of their policies and practices specific to women and (2) begin to plan strategically to initiate the type of change required within their agency to reach their desired objectives. Information gathered by organizations using this methodology could also form the basis for resource requests from funding entities, formulation of technical assistance requests to external sources, and a vehicle to advance internal quality assurance. The awardee will work closely with designated NIC staff on all aspects of the project to ensure understanding of and agreement on the scope of work to be performed, and to work with other identified experts as well who are recognized for their expertise and practical experience in working with justice- involved women. To be considered, applicants must demonstrate, at a minimum: In- depth knowledge of research and practice regarding gender-informed (women) and evidence-based practices, organizational readiness, strategic planning, and process evaluation; In-depth knowledge of the practices, programs, and complexities specific to the operation of women's correctional facilities and awareness of the issues relevant to women on community release and under supervision; In-depth knowledge about the risks, needs, strengths, and capacity for resiliency with justice-involved women; Specific examples of expertise in directing project design and implementation; Demonstrated ability to work collaboratively with other experts in the field of gender-informed practices; Ability and capacity to conduct Web-based events.

Under the provisions of 10 U.S.C. 2904, the Federal Advisory Committee Act of 1972, (5 U.S.C. Appendix), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), and 41 CFR 102-3.50, the Department of Defense (DoD) gives notice that it is renewing the charter for the Strategic Environmental Research and Development Program Scientific Advisory Board (hereafter referred to as the ``Board''). Pursuant to 10 U.S.C. 2904(a), the Secretary of Defense and the Secretary of Energy, in consultation with the Administrator of the Environmental Protection Agency, shall jointly establish the Strategic Environmental Research and Development Program Scientific Advisory Board. The Advisory Board, pursuant to 10 U.S.C. 2904, shall operate and comply with the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix), and 41 CFR 102-3.50(a). Pursuant to 10 U.S.C. 2902 and 2904(e), the Strategic Environmental Research and Development Program Council (hereafter referred to as the Council), shall refer to the Advisory Board, and the Advisory Board shall review, each proposed research project including its estimated cost, for research in and development of technologies related to environmental activities in excess of $1,000,000. The Council, pursuant to its responsibilities under 10 U.S.C. 2902(d)(1) and in an effort to enhance the Advisory Board's review process, has lowered the Advisory Board's dollar threshold to any proposed research projects in excess of $900,000. The Advisory Board shall make any recommendations to the Council that the Advisory Board considers appropriate regarding such project or proposal. The Advisory Board may make recommendations to the Council regarding technologies, research, projects, programs, activities, and, if appropriate, funding within the scope of the Strategic Environmental Research and Development Program. In addition, the Advisory Board shall assist and advise the Council in identifying the environmental data and analytical assistance activities that should be covered by the policies and procedures prescribed pursuant to 10 U.S.C. 2902(d)(1). Pursuant to 10 U.S.C. 2904(e), the Advisory Board shall make any recommendations to the Council that the Advisory Board considers appropriate regarding projects or proposals. The Advisory Board, pursuant to 10 U.S.C. 2904(a), shall be comprised of not more than 14 members. Pursuant to 10 U.S.C. 2904(b), the Advisory Board membership shall be comprised of the following: a. Permanent members of the Advisory Board are the Science Advisor to the President, the Administrator of the National Oceanic and Atmospheric Administration, or their designees; b. Non-permanent members of the Advisory Board shall be appointed from among persons eminent in the fields of basic sciences, engineering, ocean and environmental sciences, education, research management, international and security affairs, health physics, health sciences, or social sciences, with due regard given to the equitable representation of scientists and engineers who are women or who represent minority groups. One such member of the Advisory Board shall be a representative of environmental public interest groups, and one such member shall be a representative of the interests of State governments. Pursuant to 10 U.S.C. 2904(b)(3), the Secretary of Defense and the Secretary of Energy, in consultation with the Administrator of the Environmental Protection Agency, shall request that the: a. Head of the National Academy of Science, in consultation with the head of the National Academy of Engineering and the head of the Institutes of Medicine of the National Academy of Sciences, nominate persons for appointment to the Advisory Board; b. Council of Environmental Quality nominate for appointment to the Advisory Board at least one person who is a representative of environmental public interest groups; and c. National Association of Governors nominate for appointment to the Advisory Board at least one person who is a representative of the interests of State governments. The Advisory Board, pursuant to 10 U.S.C. 2904(d), shall develop procedures for carrying out its responsibilities. Such procedures shall define a quorum as a majority of the members, and shall provide for the annual election of the Advisory Board's chairperson. The permanent Advisory Board members, defined above, shall be appointed as regular government employee members, and their appointments shall be based upon their official position in the Federal government. Both individuals may designate another regular government officer or employee from their offices to represent their interests before the Advisory Board. Advisory Board members appointed by the Secretary of Defense and the Secretary of Energy, who are not full-time or permanent part-time Federal officers or employees, shall be appointed as experts and consultants under the authority of 5 U.S.C 3109, and serve as special government employee members. While the Council of Environmental Quality and the National Association of Governors nominate individuals to represent certain interests, these individuals are appointed by the Secretary of Defense and, these individuals, along with the other members, to include the regular government employee members, are appointed to provide advice on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Pursuant to 10 U.S.C. 2904(h), each member of the Advisory Board shall be required to file a financial disclosure report under title I of the Ethics in Government Act of 1978 (5 U.S.C. App.). With the exception of those experts and consultants that are appointed members of the Advisory Board, all others, to include subject matter experts that are invited by the Advisory Board or experts and consultants that are from the general public attending meetings are not authorized to participate in the Advisory Board's deliberations. The terms of member appointments shall not be less than two but not more than four years, as provided in 10 U.S.C. 2904(b)(4) and approved by the Secretary of Defense. All appointments shall be reviewed by the Secretary of Defense on an annual basis. With the exception of travel and per diem for official travel, Advisory Board members shall serve without compensation. With DoD approval, the Advisory Board is authorized to establish subcommittees, as necessary and consistent with its mission, and these subcommittees shall operate under the provisions of the Federal Advisory Committee Act of 1972, the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), and other appropriate Federal regulations. Such subcommittees shall not work independently of the chartered Advisory Board, and shall report all their recommendations and advice to the Advisory Board for full deliberation and discussion. Subcommittees have no authority to make decisions on behalf of the chartered Advisory Board; nor can they report directly to the Department of Defense or any Federal officers or employees who are not Advisory Board members. Subcommittee members, who are not Advisory Board members, shall be appointed in the same manner as the Advisory Board members. Such individuals, if not full-time or part-time government employees, shall be appointed to serve as experts and consultants under the authority of 5 U.S.C. 3109, and serve as special government employee members, whose appointments must be renewed on an annual basis. With the exception of per diem for official travel, subcommittee members shall serve without compensation.

Under the provisions of Section 1082 of Public Law 110-181, the Federal Advisory Committee Act of 1972, (5 U.S.C. Appendix), 41 CFR 102-3.55(a)(1), and the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), effective June 22, 2011 the Department of Defense gives notice that it is terminating the Advisory Panel on DoD Capabilities for Support of Civil Authorities After Certain Incidents.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

The Office of the Secretary of Defense proposes to alter a system of records in its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

The U.S. Nuclear Regulatory Commission (NRC or the Commission) is amending its regulations governing the fitness for duty of workers at nuclear power plants. These amendments allow holders of nuclear power plant operating licenses the option to use a different method from the one already prescribed in the NRC's regulations for determining when certain nuclear power plant workers must be afforded time off from work to ensure that such workers are not impaired due to cumulative fatigue caused by work schedules.

The Food and Drug Administration (FDA) is classifying the electrocardiograph electrode, intended to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram, into class II (special controls). FDA is also exempting this device from the premarket notification requirement.

The Food and Drug Administration (FDA) is announcing the availability of the standard operating procedure (SOP) for ``Notice to Industry'' Letters. The SOP describes the Center for Devices and Radiological Health's (CDRH) process to clarify and more quickly inform stakeholders when CDRH has changed its expectations relating to, or otherwise has new scientific information that could affect, data submitted as part of an Investigational Device Exemption (IDE) or premarket submission that needs to be disseminated in a timely manner.

As required by the Paperwork Reduction Act, the Bureau of Indian Affairs (BIA) is submitting a request for renewal of OMB approval to collect information for the BIA Housing Improvement Program. The information collection is currently authorized by OMB Control number 1076-0084, which expires August 31, 2011.

In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Dakotas Resource Advisory Council (RAC), will meet as indicated below.

DOE will host public scoping meetings in western Colorado to receive comments on the scope of the DOE Uranium Leasing Program (ULP) Programmatic Environmental Impact Statement (hereinafter referred to as the ULP PEIS). The PEIS will analyze the reasonably foreseeable environmental impacts, including the site-specific impacts, of the range of reasonable alternatives for the management of DOE's ULP. On June 21, 2011, DOE announced in the Federal Register (76 FR 36097) its intention to prepare the PEIS and opened a scoping period which would have closed August 22, 2011. The scoping period has been extended and will now close on September 9, 2011. DOE invites the public to submit written comments by any of the means listed in the ADDRESSES section. Oral as well as written comments may also be provided at the public scoping meetings to be held as listed under SUPPLEMENTARY INFORMATION.

The Food and Drug Administration (FDA) is announcing a public workshop on the adoption, implementation, and use of unique device identifiers (UDIs) in various health-related electronic data systems. The purpose of this workshop is to engage multiple stakeholders to obtain information and comments on issues confronting the effective and efficient incorporation of UDIs into appropriate data sets, to identify barriers and incentives to their adoption and use, and to understand the best solutions and practices to resolve open issues. Dates and Times: The public workshop will be held on September 12, 2011, from 1 to 5 p.m. and on September 13, 2011, from 9 a.m. to 5 p.m. Submit electronic and written comments by October 13, 2011. Location: The public workshop will be held at the Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, Bethesda, MD 20852; 301-822-9200. Contact Person: Jay Crowley, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301-980-1936, e-mail: jay.crowley@fda.hhs.gov Registration: Registration is free and will be on a first-come, first-served basis. To register for the public workshopwhether attending in person or for the Web castplease visit https:// www.fda.gov/UDI (or go the FDA Medical Devices News & EventsWorkshops & Conferences calendar and select this public workshop from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, e-mail, and telephone number. For those without Internet access, please contact Jay Crowley (see Contact Person) to register. Registration requests should be received by 5 p.m. on September 5, 2011. Early registration is recommended because seating is limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 11 a.m. Hotel reservations can be made by calling the hotel and requesting the group rate for the ``FDA UDI Public Workshop'' room block. If you need special accommodations due to a disability, please contact Jay Crowley (jay.crowley@fda.hhs.gov) at least 7 days in advance. The meeting will also be Web cast. Persons interested in participating by Web cast must register online by 5 p.m. on September 5, 2011. Web cast participants will be sent connection requirements. More information on the Web cast can be found on our Web site at http:/ /www.fda.gov/UDI. By August 12, 2011, and then as available, FDA will post the workshop agenda and discussion topics, registration information, information about lodging, and other relevant information on the Internet at https://www.fda.gov/UDI. Comments: Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments by October 13, 2011. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The U.S. Department of Agriculture, Forest Service, Gila National Forest and the Field Museum of Natural History have completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian tribes, and have determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian tribes. Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary objects may contact the U.S. Department of Agriculture, Forest Service, Gila National Forest. Repatriation of the human remains and associated funerary objects to the Indian tribes stated below may occur if no additional claimants come forward.

The University of Colorado Museum has completed an inventory of human remains and an associated funerary object, in consultation with the appropriate Indian tribes, and has determined that there is no cultural affiliation between the human remains and associated funerary object and any present-day Indian tribe. Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary object may contact the University of Colorado Museum. Disposition of the human remains and associated funerary object to the Indian tribes stated below may occur if no additional requestors come forward.

The Fowler Museum at UCLA, in consultation with the appropriate Indian tribes, has determined that the cultural items meet the definition of unassociated funerary objects and repatriation to the Indian tribes stated below may occur if no additional claimants come forward. Representatives of any Indian tribe that believes itself to be culturally affiliated with the cultural items may contact the Fowler Museum at UCLA.

The Department of Labor (DOL or the Department) is prepared to conduct an evaluation to provide rigorous, nationally representative estimates of the net impacts of intensive services and training provided under the Workforce Investment Act (WIA) Adult and Dislocated Worker Programs. The Department has determined that it is in the public interest to use a random assignment impact methodology for the study. In the local workforce investment areas (LWIAs) randomly selected to participate in this evaluation, all applicants for intensive services and training under the WIA Adult and Dislocated Worker programs will be required to participate in the study during a 12-18 month period. The Department is soliciting comments concerning the Department's plan to carry out the study.