March 5, 2009 – Federal Register Recent Federal Regulation Documents

The National Aeronautics and Space Administration, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).

The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments on whether OHRP should pursue a notice of proposed rulemaking (NPRM) to enable OHRP to hold institutional review boards (IRB) and the institutions or organizations operating the IRBs, hereafter referred to as the IRB organizations (IORG), directly accountable for meeting certain regulatory requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects. OHRP is contemplating this regulatory change to encourage institutions to rely on IRBs that are operated by another institution or organization, when appropriate. Historically, OHRP has only enforced compliance with 45 CFR part 46 through the institutions that were engaged in human subjects research. This has been the case even in circumstances when a regulatory violation was directly related to the responsibilities of an external IRB that was designated on the engaged institution's assurance of compliance with OHRP. OHRP is considering whether to pursue a regulatory change that would enable the Department to hold IRBs and IORGs directly accountable for compliance with the provisions of 45 CFR part 46 that relate to an IRB's or IORG's responsibilities. OHRP believes that such a regulatory change in its enforcement authority may address one of the main disincentives institutions have cited as inhibiting them from exercising the regulatory flexibility that currently permits institutions to implement a variety of cooperative review arrangements and to rely on the review of an IRB operated by another institution or organization. If institutions become more willing to rely on cooperative review arrangements and on review of IRBs operated by other institutions or organizations, OHRP believes that this will reduce administrative burdens such as the time associated with IRB review for multi-site studies, the time devoted by IRB staff and investigators to duplicative IRB review, and the time and personnel costs associated with operating an IRB for those institutions that choose not to establish an internal IRBwithout diminishing human subject protections. This request for information and comments stems from interest in this issue from the Secretary's Advisory Committee on Human Research Protections (SACHRP) and others, as well as two meetings on alternative IRB models that OHRP co-sponsored in November 2005 and November 2006 along with the National Institutes of Health (NIH), the Association of American Medical Colleges (AAMC), and the American Society of Clinical Oncology (ASCO).

This notice announces a change in benefit period eligibility under the EB program for Nevada and Wisconsin. The following change has occurred since the publication of the last notice regarding the State's EB status: The 13-week insured unemployment rate (IUR) for Nevada and Wisconsin for the week ending February 07, 2009, rose above 5.0 percent and exceeded 120 percent of the corresponding average rate in the two prior years. Therefore, beginning the week of February 22, 2009, eligible unemployed workers will be able to collect up to an additional 13 weeks of UI benefits.

EPA is proposing national emission standards for hazardous air pollutants for existing stationary reciprocating internal combustion engines that either are located at area sources of hazardous air pollutant emissions or that have a site rating of less than or equal to 500 brake horsepower and are located at major sources of hazardous air pollutant emissions. In addition, EPA is proposing national emission standards for hazardous air pollutants for existing stationary compression ignition engines greater than 500 brake horsepower that are located at major sources, based on a new review of these engines following the first RICE NESHAP rulemaking in 2004. In addition, EPA is proposing to amend the previously promulgated regulations regarding operation of stationary reciprocating internal combustion engines during periods of startup, shutdown and malfunction.

On December 19, 2008, NOAA published a proposed rule in the Federal Register that makes technical corrections and minor modifications to the Florida Keys National Marine Sanctuary (FKNMS) regulations. The preamble of that document contained an inaccurate reference to U.S. Coast Guard regulations, which was a basis for one of the proposed modifications. This document eliminates that reference and clarifies the rationale for making this regulation change. The ONMS is preparing an environmental assessment pursuant to the National Environmental Policy Act.

The Financial Management Service, 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 a continuing information collection. By this notice, the Financial Management Service solicits comments concerning the form ``Voucher for Payment of Awards.''

This notice announces the bi-annual meeting of the Federal Aviation Administration (FAA) Aeronautical Charting Forum (ACF) to discuss informational content and design of aeronautical charts and related products, as well as instrument flight procedures development policy and design criteria.