July 21, 2011 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Mobile Medical Applications.'' FDA is issuing this draft guidance to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or ``mobile apps''). At this time, FDA intends to apply its regulatory requirements solely to a subset of mobile apps that the Agency is calling mobile medical applications (mobile medical apps). This draft guidance is not final nor is it in effect at this time.
Proposed Amendment of Class E Airspace; Spearfish, SD
This action proposes to amend Class E airspace at Spearfish, SD. Additional controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAP) at Black Hills Airport- Clyde Ice Field. The geographic coordinates of the airport also would be updated. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.
Proposed Amendment of Class E Airspace; Evansville, IN
This action proposes to amend Class E airspace at Evansville, IN. Additional controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures at Evansville Regional Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.
Proposed Amendment of Class E Airspace; Bryan, OH
This action proposes to amend Class E airspace at Bryan, OH. Decommissioning of the Bryan non-directional beacon (NDB) at Williams County Airport, Bryan, OH, has made this action necessary for the safety and management of Instrument Flight Rules (IFR) operations at Williams County Airport.
Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands Crab Rationalization Cost Recovery Program
NMFS publishes a notification of a 1.23-percent fee for cost recovery under the Bering Sea and Aleutian Islands Crab Rationalization Program. This action is intended to provide holders of crab allocations with the fee percentage for the 2011/2012 crab fishing year so they can calculate the required payment for cost recovery fees that must be submitted by July 31, 2012.
Funding Down Slate; Training for Real-Time Writers (TRTW) Program
The Secretary intends to use the grant slate developed in FY 2010 for the TRTW Program authorized by Section 872 of the Higher Education Act of 1965, as amended (HEA), 20 U.S.C. 1161s, to make new grant awards in FY 2011. The Secretary takes this action because a significant number of high-quality applications remain on the FY 2010 grant slate and limited funding is available for new grant awards in FY 2011. Specifically, we expect to use an estimated $998,000 for new awards in FY 2011.
BOEMRE Information Collection Activity: Coastal Impact Assistance Program (CIAP), Renewal of a Collection; Submitted for Office of Management and Budget (OMB) Review; Comment Request
To comply with the Paperwork Reduction Act of 1995 (PRA), we are notifying the public that we have submitted to OMB an information collection request (ICR) to renew approval of the paperwork requirements that address the BOEMRE's Coastal Impact Assistance Program (CIAP), which is a grant program. This notice also provides the public a second opportunity to comment on the paperwork burden of these requirements.
Proposed Amendment of Class E Airspace; Valley City, ND
This action proposes to amend Class E airspace at Valley City, ND. Decommissioning of the Valley City non-directional beacon (NDB) at Barnes County Municipal Airport, Valley City, ND, has made this action necessary for the safety and management of Instrument Flight Rules (IFR) operations at the airport.
Withdrawal of Notices Inviting Applications for New Awards for Fiscal Year (FY) 2011; European Union-United States Atlantis (Atlantis) Program, et al.
On April 1, 2011 (76 FR 18198) (Atlantis); March 29, 2011 (76 FR 17391) (U.S.-Brazil); and March 25, 2011 (76 FR 16743) (NAM), the Department published in the Federal Register notices inviting applications for new awards for each of the programs identified. On April 15, 2011, the President signed Public Law 112-10, the Department of Defense and Full-Year Continuing Appropriations Act, 2011, which substantially reduced funds available for the Department's Higher Education account. This account is the source of funding for grants in these programs under the Fund for the Improvement of Postsecondary Education. Therefore, no new grants will be made under the Atlantis, U.S.-Brazil, or NAM programs in FY 2011. As such, the Department withdraws these notices inviting applications for new awards for FY 2011.
Arbitration Panel Decision Under the Randolph-Sheppard Act
The Department of Education (Department) gives notice that on March 18, 2011, an arbitration panel rendered a decision in the matter of Sam Tocco v. Michigan Commission for the Blind, Case no. R-S/08-6. This panel was convened by the Department under 20 U.S.C. 107d-1(a), after the Department received a complaint filed by the petitioner, Sam Tocco.
Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled In Re Certain Light- Emitting Diodes and Products Containing Same, DN 2831; the Commission is soliciting comments on any public interest issues raised by the complaint.
In the Matter of Certain Digital Imaging Devices and Related Software; Notice of Commission Decision Not To Review the ALJ's Final Initial Determination Finding No Violation of Section 337; Termination of Investigation
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ'') final initial determination (``ID'') issued on May 12, 2011, finding no violation of section 337 of the Tariff Act of 1930, 19 U.S.C. 1337, in this investigation.
List of Additional Lands Affected by White Earth Reservation Land Settlement Act of 1985
This notice lists additional allotments or interest therein on the White Earth Chippewa Reservation in Minnesota which have been determined to fall within the scope of sections 4(a), 4(b), or 5(c) of the White Earth Reservation Land Settlement Act of 1985 (the Act). This notice is required by section 7(e) of the Act, as amended.
30-Day Notice of Proposed Information Collection: Form DS-4155, Vendor Application for OFM Web Site Account; & Form DS-7576, Foreign Mission Emergency Afterhours Contact for Foreign Diplomatic Services Applications
The Department of State has submitted the following information collection request to the Office of Management and Budget (OMB) for approval in accordance with the Paperwork Reduction Act of 1995. Title of Information Collection: Vendor Application for OFM Website Account. OMB Control Number: 1405-0105. Type of Request: Extension of Currently Approved Collection. Originating Office: Diplomatic Security/Office of Foreign Missions (DS/OFM). Form Numbers: DS-4155. Respondents: Foreign government representatives assigned to the U.S. and bonded warehouse vendors. Estimated Number of Respondents: 1,005 missions. Estimated Number of Responses: 3,015 responses. Average Hours per Response: 20 minutes. Total Estimated Burden: 1,005 hours divided among the missions. Frequency: On occasion. Obligation to Respond: Required to obtain or retain a benefit. Title of Information Collection: Foreign Mission Emergency Afterhours Contact. OMB Control Number: 1405-0105. Type of Request: Extension of Currently Approved Collection. Originating Office: Diplomatic Security/Office of Foreign Missions (DS/OFM). Form Number: DS-7675. Respondents: Foreign government representatives assigned to the United Sates. Estimated Number of Respondents: 737 missions. Estimated Number of Responses: 737 forms per year. Average Hours per Response: 15 minutes. Total Estimated Burden: 184 hours divided among the missions. Frequency: Annually. Obligation to Respond: Required to obtain or retain a benefit.
Renewal of Agency Information Collection for Tribal Probate Codes
The Bureau of Indian Affairs (BIA) is proposing to submit the information collection titled ``Tribal Probate Codes, 25 CFR 18'' to the Office of Management and Budget (OMB) for renewal pursuant to the Paperwork Reduction Act. The information collection is currently authorized by OMB Control Number 1076-0168, which expires November 30, 2011. The information collection requires Indian tribes to submit their tribal probate codes to the Secretary of the Interior for approval in accordance with the American Indian Probate Reform Act of 2004.
Renewal of Agency Information Collection for Probate of Indian Estates
The Bureau of Indian Affairs (BIA) is proposing to submit the information collection titled ``Probate of Indian Estates, Except for Members of the Osage Nation and the Five Civilized Tribes, 25 CFR 15'' to the Office of Management and Budget (OMB) for renewal pursuant to the Paperwork Reduction Act. The information collection is currently authorized by OMB Control Number 1076-0169, which expires November 30, 2011. The information collection addresses information that individuals and tribes provide to allow administration of the trust estates of Indian individuals in accordance with the American Indian Probate Reform Act of 2004.
Approval and Promulgation of Air Quality Implementation Plans; West Virginia and Ohio; Determinations of Attainment of the 1997 Annual Fine Particle Standard for the Parkersburg-Marietta and Wheeling Nonattainment Areas
EPA is proposing to make a determination that the Parkersburg- Marietta, West Virginia-Ohio (WV-OH) nonattainment area and the Wheeling, WV-OH fine particle (PM2.5) nonattainment areas (hereafter referred to as ``Areas'') have attained the 1997 annual PM2.5 National Ambient Air Quality Standard (NAAQS) by the applicable attainment date of April 5, 2010. These determinations are based upon complete, quality-assured, and certified ambient air monitoring data for the 2007-2009 monitoring period. EPA is finding these Areas to be in attainment, in accordance with the requirements of the Clean Air Act (CAA).
Identification of Enforceable Rules and Orders
Section 1063(i) of the Consumer Financial Protection Act of 2010 (``Act'')\1\ requires the Bureau of Consumer Financial Protection (``CFPB'') to publish in the Federal Register not later than the designated transfer date a list of the rules and orders that will be enforced by the CFPB. This document sets forth that list.
Designation of an Ocean Dredged Material Disposal Site (ODMDS) in the Gulf of Mexico Off the Mouth of the Atchafalaya River, St. Mary Parish, LA
The U.S. EPA, Region 6, in accordance with EPA's October 29, 1998 Notice of Policy and Procedures for Voluntary Preparation of National Environmental Policy Act (NEPA) Documents (63 FR 58045), and in cooperation with the U.S. Army Corps of Engineers, New Orleans District (the Corps), will prepare an EIS for the designation of an ODMDS in the Gulf of Mexico off the mouth of the Atchafalaya River, St. Mary Parish, Louisiana. An EIS is needed to provide the information necessary to designate an ODMDS. This Notice of Intent is issued Pursuant to Section 102(c) of the Marine Protection, Research and Sanctuaries Act of 1972 (MPRSA), and 40 CFR Part 228 (Criteria for the Management of Disposal Sites for Ocean Dumping).
Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for Public Service Company of Colorado dba Xcel Energy-Pawnee Power Station
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.
Nationwide Cyber Security Review (NCSR) Assessment
The Department of Homeland Security (DHS), National Protection and Programs Directorate (NPPD), Office of Cybersecurity and Communications (CS&C), National Cyber Security Division (NCSD), Cyber Security Evaluation Program (CSEP), will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35): New Information Collection Request, Nationwide Cyber Security Review (NCSR) Assessment. DHS previously published this ICR in the Federal Register on April 21, 2011, for a 60-day public comment period. DHS received no comments. The purpose of this notice is to allow an additional 30 days for public comments.
Notice of Request for Extension of Approval of an Information Collection; Infectious Salmon Anemia; Payment of Indemnity
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.
Notice of Request for Extension of Approval of an Information Collection; Scrapie in Sheep and Goats; Interstate Movement Restrictions and Indemnity Program
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 interstate movement of sheep and goats and an indemnity program to control the spread of scrapie.
Solicitation for a Cooperative Agreement: Developing a Method for Conducting an Internal Evaluation of Gender-Informed Policy and Practice
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.
Revision of the Materiality to Patentability Standard for the Duty To Disclose Information in Patent Applications
The United States Patent and Trademark Office (Office or PTO) is proposing to revise the standard for materiality for the duty to disclose information in patent applications and reexamination proceedings in light of the decision by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit or Court) in Therasense, Inc. v. Becton, Dickinson & Co. Specifically, the Office is proposing to revise the materiality standard for the duty to disclose to match the materiality standard, as defined in Therasense, for the inequitable conduct doctrine. While Therasense does not require the Office to harmonize the materiality standards underlying the duty of disclosure and the inequitable conduct doctrine, the Office believes that there are important reasons to do so. The materiality standard set forth in Therasense should reduce the frequency with which applicants and practitioners are being charged with inequitable conduct, consequently reducing the incentive to submit information disclosure statements containing marginally relevant information and enabling applicants to be more forthcoming and helpful to the Office. At the same time, it should also continue to prevent fraud on the Office and other egregious forms of misconduct. Additionally, harmonization of the materiality standards is simpler for the patent system as a whole.
Renewal of Department of Defense Federal Advisory Committee
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.
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