Regulatory Background. The Department of Health and Human Services (DHHS) regulations at 45 CFR 46.114 states: “Cooperative research projects are those projects covered by this policy which involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. With the approval of the department or agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.” The following standards apply where an institution holding an Office of Human Research Protections- approved Assurance wishes to avoid duplication of effort, in accordance with DHHS regulations at 45 CFR 46.114, by relying upon the IRB review of another Assurance-holding institution:
Regulatory Background. Congrass enacted Part II of the FPA in 1935 to regulate the inter- state transmission and sale at wholesale of electricity ‘‘in the public 7 Nev. Power Co. v. Enron Power Mktg., Inc., 103 F.E.R.C. ¶ 61,353, at 62,384 (2003) (‘‘Nevada Power Initial Order’’), reh’g denied, 105 F.E.R.C. ¶ 61,185 (2003) (‘‘Nevada Power Rehearing Order’’).
Regulatory Background. 1. EPA regulations require manufacturers to install on all new light-duty vehicles and trucks for 1994 and later model-years onboard diagnostic (“OBD”) systems that are capable of identifying emission system malfunctions that could cause emission increases above certain thresholds. 40 CFR § 86.094-17(a). The regulations also require manufacturers to equip those vehicles with a malfunction indicator light (“MIL”) to inform vehicle operators of a malfunction in the emissions control system. 40 CFR § 86.094-17(c) and (d)
Regulatory Background. This is the third of six long-term cleanup decisions planned for sites along the Columbia River. The 300 Area Record of Decision (ROD) was issued in November 2013 and the 100-F/IU ROD was issued in November 2014. Previous Cleanup Actions Waste site remediation in the 100-D/H Area began in 1995 under the Interim Remedial Action Record of Decision for the 100-BC-1, 100-DR-1, and 100-HR-1 Operable Units, Hanford Site, Xxxxxx County, Washington (EPA/ROD/R10-95/126). Interim actions consisted primarily of removal, treatment and disposal of contaminated soils, followed by backfill and revegetation. Contaminated material was excavated and transported to the Environmental Restoration and Disposal Facility (ERDF), located in the 200 Area of the Hanford Site. Between 1995 and November 2012, interim remove, treat and dispose (RTD) actions were completed for 180 waste sites in the 100-D/H Area. Post-cleanup confirmation sampling results at these sites were evaluated and demonstrate that the proposed cleanup levels identified in this Proposed Plan have been met. Groundwater remediation by extraction and treatment was initiated in 1997 under the interim action ROD (EPA/ROD/R10-96/134) with startup of the first pump-and-treat system (HR-3). The objective of the interim remediation was to remove Cr(VI) contamination from groundwater and address immediate threats to the Columbia River. A second pump-and-treat system (DR-5) began operating in 2004. The initial two pump-and-treat systems (DR-5 and HR-3) were expanded to include additional treatment capacity under the 2009 Explanation of Significant Differences for the OUs Interim Action ROD. About the 100-D/H Proposed Plan DOE has developed a proposed plan under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) to address remaining soil and groundwater contamination in the 100-D/H Area. The proposed plan addresses contaminated waste sites in four source OUs (100-DR-1, 100-DR-2, 100-HR-1, and 100-HR-2) and contaminated groundwater in the 100-HR-3 OU. These fives OUs are referred to collectively as 100-D/H. Preferred Alternative Based on the results of the detailed and comparative evaluation, Alternative 3 is the preferred alternative. For soil, Alternative 3 calls for RTD of contaminated soil and debris from waste sites with institutional controls (ICs) used to control access to residual contaminants in the soil. For groundwater, Alternative 3 calls for increased capacity pump-and-trea...
Regulatory Background. On February 27, 2008, the US Office of Orphan Products Development granted approval for orphan designation of MP-376 (levofloxacin inhalation solution) for “treatment of * Confidential treatment requested. pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis.“ MP-376 (levofloxacin hemihydrate) has also received an orphan medicinal product designation in the European Union (EU) on September 23, 2008 for the indication of treatment of cystic fibrosis.
Regulatory Background. During the relevant time period, the Commodity Futures Trading Commission (“CFTC”) was an independent federal regulatory agency charged with administering and enforcing the Commodity Exchange Act (“the Act”). The National Futures Association (“NFA”) was a not-for-profit membership corporation and self-regulatory organization registered with the CFTC. The NFA was headquartered in Chicago, in the Northern District of Illinois. The NFA conducted audits and investigations of NFA member firms, including registered commodity pool operators and commodity trading advisors, to monitor them for compliance with NFA rules. A commodity pool was any investment trust, syndicate or similar form of enterprise operated for the purpose of trading commodity futures. A commodity pool operator (“CPO”) was any person engaged in the business of a commodity pool, and who solicited, accepted or received from others, funds or securities for the purpose of trading in commodity futures. Unless exempted or excluded from registration, a CPO was required to be registered with the CFTC, and to be a member of the NFA, before it could act on behalf of another person in connection with commodity futures trading. A participant was any person who had any direct financial interest in a commodity pool. A commodity trading advisor (“CTA”) was any person who, for compensation or profit, engaged in the business of advising others, either directly or through publications, writings, or electronic media, as to the value of or the advisability of trading commodity futures and, as part of a regular business, issued analyses or reports concerning any of the activities referred to above. Unless exempted or excluded from registration, a CTA was required to be registered with the CFTC, and to be a member of the NFA, before it could act on behalf of another person in connection with commodity futures trading. The Act and CFTC regulations required CPO’s and CTA’s to maintain certain books and records and, upon request by the CFTC or the NFA, to make available for inspection those books and records. Lake Shore’s Operations During the relevant time period, defendant controlled the activities of various companies, including several that had the words “Lake Shore Asset Management” or “Lake Shore” in their names (collectively “Lake Shore”). Lake Shore engaged in the business of trading commodity futures on behalf of several pools of investors. For example, defendant established Lake Shore Alternative Financial Ass...
Regulatory Background. DOT Surveillance and Enforcement Measures4: The control of materials used on DOT projects is governed in general by various subsections of Section 100, General Provisions, of Standard Specifications. The various subsections include: ◆ 104, Scope of Work ◆ 105, Control of Work ◆ 106, Control of Material ◆ 107, Legal Relations and Responsibility to Public. Further, the DOT Manual for Uniform Record Keeping on Highway Contracts (MURK) instructs the Project Engineer on proper material control procedures and documentation.
Regulatory Background. HHS regulations at 45 CFR 46.103(a) require that each institution engaged in HHS-conducted or -supported human subjects research provide written assurance, satisfactory to HHS, that it will comply with the requirements of the HHS regulations for the protection of human subjects, unless the research is exempt under 45 CFR 46.101(b). HHS regulations at 45 CFR 46.103(b) require that each institution engaged in HHS- conducted or -supported human subjects research certify to the HHS funding agency that the research has been approved by an IRB designated in the assurance. Applicability Extension of an Assured institution’s FWA is permitted for any Department of Health and Human Services (HHS) conducted or supported human subjects research when the research is being conducted under the direction and supervision of a principal investigator from the assured institution. This mechanism provides an alternative to establishing additional FWAs for numerous institutions that do not hold FWAs (non-assured institutions) and do not routinely conduct human subjects research. Any non-assured institution may choose to submit an assurance to OHRP for approval rather than agree to the use of this mechanism that extends another institution’s FWA to cover a collaborating institutional investigator employed by the non-assured institution. If HHS-conducted or -supported human subjects research activities routinely occur at a non-assured institution, regulations recommend that the institution obtain an OHRP-approved FWA. Also, if the non-assured institution is the primary awardee for an HHS-supported award providing support for non-exempt human subjects research, the institution must obtain its own OHRP-approved FWA. If an institution is uncertain about the need for its own FWA, it should consult with OHRP. Two Types of Collaborating Individual Investigators Human subjects research conducted by an assured institution may involve two types of collaborating individual investigators. OHRP distinguishes these investigators as: A collaborating independent investigator or a collaborating institutional investigator (as defined above).
Regulatory Background. In 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities," Section 50.59, "Changes, Tests, and Experiments," contains requirements for the process by which licensees may modify their facilities and procedures, as described in the final safety analysis report (FSAR), without prior NRC approval under certain conditions. The objectives of 10 CFR 50.59 are to ensure that licensees (1) evaluate proposed changes to their facilities to determine their effects on the plant's licensing basis, as described in the FSAR; and (2) obtain prior NRC approval for changes that meet specified criteria as having a potential impact upon the basis for issuing the operating license. Any changes that affect the plant's FSAR will require the licensee to perform a safety evaluation, in accordance with 10 CFR 50.59. In Generic Letter (GL) 91-18, "Guidance on Resolution of Degraded and Nonconforming Conditions and on Operability," dated November 7, 1991, the NRC discussed the conditions under which manual actions may be substituted for automatic actions related to safety system operations. Information Notice (IN) 97-78, “Crediting of Operator Actions in Place of Automatic Actions and Modifications of Operator Actions, Including Response Times,” dated October 23, 1997, alerted licensees to the importance of considering the effects on human performance of such changes made to plant safety systems: The original design of nuclear power plant safety systems and their ability to respond to design-basis accidents are described in licensees' FSARs and were reviewed and approved by the NRC. Most safety systems are designed to rely on automatic system actuation to ensure that the safety systems are capable of carrying out their intended functions. In a few cases, limited operator actions, when appropriately justified, were approved. Proposed changes that substitute manual action for automatic system actuation or that modify existing operator actions, including operator response times, that were not reviewed and approved during the original licensing review of the plant, may raise the issue of an unreviewed safety question (USQ). Such changes must be evaluated under the criteria of 10 CFR 50.59 to determine whether a USQ is involved and whether NRC’s review and approval are required before implementation... In the NRC staff's experience, many of the changes involving operator actions proposed by licensees do involve a USQ. In ANSI/ANS-58.8, "Time Response Design Criteria ...
Regulatory Background a. CARB adopted “
