August 13, 2012 – Federal Register Recent Federal Regulation Documents

This document revises the Commission's list of Office of Management and Budget (OMB) approved public information collection requirements with their associated OMB expiration dates. This list will provide the public with a current list of public information collection requirements approved by OMB and their associated control numbers and expiration date as of June 30, 2012.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a premarket notification (510(k)) submission is administratively complete, which determines whether it should be accepted for substantive review. This guidance is applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). This draft guidance is not final nor is it in effect at this time.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Maryland (FEMA- 4075-DR), dated 08/02/2012. Incident: Severe storms and straight-line winds. Incident Period: 06/29/2012 through 07/08/2012. Effective Date: 08/02/2012. Physical Loan Application Deadline Date: 10/01/2012. Economic Injury (EIDL) Loan Application Deadline Date: 05/02/2013.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Wisconsin (FEMA- 4076-DR), dated 08/02/2012. Incident: Severe storms and flooding. Incident Period: 06/19/2012 through 06/20/2012. Effective Date: 08/02/2012. Physical Loan Application Deadline Date: 10/01/2012. Economic Injury (EIDL) Loan Application Deadline Date: 05/02/2013.

This is a notice of an Administrative declaration of a disaster for the State of Montana dated 08/06/2012. Incident: Dahl Fire. Incident Period: 06/26/2012 through 07/06/2012. Effective Date: 08/06/2012. Physical Loan Application Deadline Date: 10/05/2012. Economic Injury (EIDL) Loan Application Deadline Date: 05/06/2013.

This document amends the Commission's rules to provide a more efficient use of the 76-77 GHz band, and to enable the automotive and aviation industries to develop enhanced safety measures for drivers and the general public. Specifically, the Commission is eliminating the in- motion and not-in-motion distinction for vehicular radars, and instead adopting new uniform emission limits for forward, side, and rear- looking vehicular radars. This will facilitate enhanced vehicular radar technologies to improve collision avoidance and driver safety. The Commission is also amending its rules to allow the operation of fixed radars at airport locations in the 76-77 GHz band for purposes of detecting foreign object debris on runways and monitoring aircraft and service vehicles on taxiways and other airport vehicle service areas that have no public vehicle access. The Commission takes this action in response to petitions for rulemaking filed by Toyota Motor Corporation (``TMC'') and Era Systems Corporation (``Era'').

This document corrects a notice of public hearing on proposed rulemaking by cross-reference to temporary regulations (REG-112805-10) that was published in the Federal Register on Monday, August 6, 2012 (77 FR 46653) relating to the branded prescription drug fee imposed by the Affordable Care Act.

The Department of the Army announces the availability of the Draft Finding of No Significant Impact and the Final Programmatic Environmental Assessment (PEA) for Implementation of the Net Zero program at Army Installations. This PEA evaluates potential direct, indirect, and cumulative effects of the Net Zero Installation program at a programmatic (Army-wide) level; installation- or project-specific analysis will be performed and documented for proposed installation- level action. The Net Zero program is comprised of changes in management practices and behavior as well as multiple possible projects and technologies to enhance resource efficiency with a broad focus on increased sustainability. It is based on the following concepts: (1) Producing at least as much energy on the installation from renewable sources as it uses annually; (2) Limiting the consumption of freshwater resources and returning water back to the same watershed so as not to deplete the groundwater and surface water resources of that region in quantity or quality; and (3) Reducing, reusing, and recovering waste streams, converting them to resource value with zero solid waste disposed in landfills. The Army does not consider Net Zero as a stand- alone program and intends to leverage existing resources and collaborate with the private sector to strive toward the Net Zero program's energy, water, and waste reduction goals. The PEA assesses the potential environmental impacts from the range of energy, water, and waste projects that could be implemented in support of Net Zero. The Army evaluated three alternatives: (1) No action; (2) Implement Net Zero Army-wide; and (3) Strategically Implement Net Zero based on mission needs, consumption, and resource constraints (the preferred alternative). The Army identified no significant environmental effects associated with implementation of Net Zero that cannot be mitigated to a level of insignificance with site- specific best management practices or other mitigation measures. Native Americans, federal, state, and local agencies, organizations, and the public are invited to submit written comments. The document can be accessed at: https://www.army.mil/asaiee.

The Department of Homeland Security Science and Technology Directorate (DHS S&T), through its Plum Island Animal Disease Center (PIADC), is seeking collaborators to aid DHS S&T in conducting validation testing on the ability of VHP and ClO2 to achieve sufficient biological load reduction against live FMDV and ASFV. PIADC operates a Biosafety Level 3 (BSL-3) facility working primarily with high consequence foreign animal diseases. The nature of this work makes it paramount to ensure the effective and thorough decontamination of all material exiting the bio containment area within the facility. Rising health concerns and process efficiency/turn-around time with the use of formaldehyde gas (the current fumigation method used against FMDV and ASFV) are key driving factors in validating an alternative fumigation method. The fumigation method(s) will ultimately be used to decontaminate sensitive equipment and electronics, other material within the bio containment area, sealed portions of the facility, biological safety cabinets and perform in-place decontamination of heating, ventilation, and cooling (HVAC) HEPA filtration systems. The role of the collaborator(s) in this CRADA will be to provide PIADC with the materials, equipment, and technological expertise to support accurate and reliable efficacy testing using VHP and ClO2. DHS S&T is seeking CRADA collaborators that own the technological components for, have the technological expertise in, and have proven track records of success in the fields of VHP and ClO2 decontamination validation studies. The proposed term of the CRADA can be up to eighteen (18) months.

The Comptroller of the Currency has determined that the renewal of the Charter of the OCC Minority Depository Institution Advisory Committee (MDIAC) is necessary and in the public interest in order to provide advice and information about the current circumstances and future development of minority depository institutions, in accordance with the goals established by section 308 of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989 (FIRREA), Public Law 101-73, Title III, 103 Stat. 353, 12 U.S.C. 1463 note.

This notice amends the notice of a major disaster declaration for the State of Colorado (FEMA-4067-DR), dated June 28, 2012, and related determinations.

The Department of Labor (Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the 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 ensure 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, ETA is soliciting comments concerning the continuation of the collection of data on characteristics of the insured unemployed beyond the current expiration date of 11/30/2012.

The U.S. Department of Labor (Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the 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 ensure 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. ETA is soliciting comments concerning the continuation of the collection of data to support monitoring of implementation of changes to State UI Programs beyond the current expiration date of 12/31/2012.

The Department of Labor (Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the 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 ensure 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, ETA is soliciting comments concerning the continuation of the collection of data about the reemployment and eligibility assessments report beyond the current expiration date of 10/31/2012.

This action establishes Class E airspace at Fort Morgan, CO, to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Fort Morgan Municipal Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport.

The Commodity Futures Trading Commission (``CFTC'' or ``Commission'') published the Real-Time Public Reporting of Swap Transaction Data (``Real-Time Public Reporting'') rule and an accompanying preamble in the Federal Register on Monday, January 9, 2012 (77 FR 1182). This document makes an editorial correction to language of the preamble that conflicted with the rule text of the final rule.