REGULATORY HISTORY. 6. On July 20, 1976 Waste Discharge Requirements were adopted for the site in Board Order No. 76-77. In that Order Parkwood 101, Limited (the previous landfill owner), was required to place “a final cover of at least four-feet of compacted inert fill material” over the waste disposal areas. Board Order No. 76-77 was subsequently revised on October 18, 1977 by Order No. 77-134, wherein a revised time schedule was adopted for compliance with site closure specifications. Closure activities at the site included placement of additional cover material over the waste disposal areas and grading to eliminate ponding.
REGULATORY HISTORY. Describe all permits requested or received, any enforcement actions taken by regulatory agencies and any closure activities that are planned or underway.
REGULATORY HISTORY. On December 27, 2004, the NTSB published a notice of proposed rulemaking (NPRM) titled, ‘‘Notification and Reporting of Aircraft Accidents or Incidents and Overdue Aircraft, and Preservation of Aircraft Wreckage, Mail, Cargo, and Records,’’ in the Federal Register (69 FR 77150). The December 2004 NPRM proposed various changes to 49 CFR Part 830, all of which affected is delayed in the performance of the work under this contract and if the types of accidents and incidents that individuals and entities must report additional funds are allotted, an equitable adjustment will be made in the price or prices (including appropriate target, billing, and ceiling prices where applicable) of the item(s), or in the time of delivery, or both. Failure to agree to any such equitable adjustment hereunder will be a dispute concerning a question of fact within the meaning of the clause entitled ‘‘Disputes.’’
REGULATORY HISTORY. A copy of all documents pertaining to the Rondec Products' and CCA Products' regulatory history including any existing correspondence with the FDA.
REGULATORY HISTORY. Beginning in the late 1970's and early 1980's, regulatory agencies in the U.S. and abroad frequently adopted a cancer risk criteria of one in a million (1 x 10-6) as a negligible (i.e., of no concern) risk when fairly large populations might be exposed to a suspect carcinogen. Unfortunately, theoretical increased cancer risks of one in a million are often incorrectly portrayed as serious public health risks. As discussed by Dr. Franx Xxxxx (0087), the commissioner of the FDA, this was not the intent of such estimates: 304 In applying the de minimis concept and in setting other safety standards, FDA has been guided by the figure of "one in a million." Other Federal agencies have also used a one in a million level, such as the Occupational Safety and Health Administration and the Environmental Protection Agency. Both agencies rely on the one in one million increased risk over a lifetime as a reasonable criterion for separating high-risk problems warranting agency attention from negligible risk problems that do not. The risk level of one in one million is often misunderstood by the public and the media. It is not an actual risk - i.e., we do not expect one out of every million people to get cancer if they drink decaffeinated coffee. Rather, it is a mathematical risk based on scientific assumptions used in risk assessment. FDA uses a conservative estimate to ensure that the risk is not understated. We interpret animal test results conservatively and we are extremely careful when we extrapolate risks to humans. When FDA uses the risk level of one in one million, it is confident that the risk to humans is virtually nonexistent. In short, a 'one in a million' cancer risk estimate, which is often tacitly assumed by some policy-makers to represent a trigger level for regulatory action, actually represents a level of risk that is so small as to be of negligible concern. Another misperception within the risk assessment arena is that all occupational and environmental regulations have as their goal a theoretical maximum cancer risk of 1 in 1,000,000. Travxx xx al. (1987) recently conducted a retrospective examination of the level of risk which triggered regulatory action in 132 decisions. Three variables were considered: 1) individual risk (an upper-limit estimate of the probability 305 that the most highly exposed individual in a population will develop cancer as a result of a lifetime exposure), 2) population risk (an upper-limit estimate of the number of additional...
REGULATORY HISTORY. 6.1 Historical regulatory confirmation attached: Yes Not relevant for this individual No (provide reasons):
REGULATORY HISTORY. 6.1 Historical regulatory confirmation attached: ❑ Yes ❑ Not relevant for this applicant ❑ No (provide reasons):
REGULATORY HISTORY. CuraGen has currently held two End-of-Phase 2 meetings with the FDA in conjunction with PXD101 (belinostat) for the treatment of Peripheral T-Cell Lymphoma (PTCL) and Cancer of Unknown Primary (CUP). Both meetings have yielded input into our clinical development plan and protocol designs. The following documentation and meetings should be referenced in association with the clinical development of belinostat. End-of-Phase 2 PTCL Meeting Minutes Received (11 Jan 2008) End-of-Phase 2 PTCL Meeting (29 Nov 2007) Supplemental PTCL Briefing Document Request (15 Nov 2007, SN 0106) End-of-Phase 2 PTCL Meeting Brief (31 Oct 2007, SN 0104) End-of-Phase 2 CUP Meeting Minutes Received (11 Apr 2007) End-of-Phase 2 CUP Meeting (27 Mar 2007) End-of-Phase 2 CUP Meeting Brief (23 Feb 2007, SN 0068) Exhibit B Assignment of Patents CuraGen Corporation, a Delaware corporation, hereby assigns to TopoTarget A/S, a company organized and existing under the laws of Denmark, the entire right, title and interest for the United States of America and its territorial possessions and all foreign countries, including all rights of priority, in all inventions disclosed in the patents and patent applications identified on Schedule A, and in and to such patents and patent applications and all Letters Patents of the United States and all foreign countries which may or shall be granted on said inventions or in respect of such patents and patent applications identified on Schedule A, or any parts thereof, or any divisional, continuing, reissue or other applications or patents based in whole or in part thereon including the right to recover for past, present and future infringement. CuraGen Corporation agrees to execute all applications, amended specifications, deeds or other instruments, and to do all acts necessary or proper to secure the grant of Letters Patent in the United States and in all other countries to TopoTarget A/S to vest and confirm in said corporation, its successors and assigns, the legal title to all such patents. Each of CuraGen Corporation and TopoTarget A/S does hereby authorize and request the competent authorities to grant and issue any and all such Letters Patent as shall be granted upon said inventions or applications based thereon in the United States and throughout the world to said TopoTarget A/S, its successors and assigns. Witness my hand and seal this 21st day of April, 2008. CURAGEN CORPORATION /s/ Xxxxxxx X. Xxxxxxx Name: Xxxxxxx X. Xxxxxxx Title: President & CE...
REGULATORY HISTORY. After discovery of PCE contamination on the neighboring UST site in 2000, Weldon‟s Cleaners joined DEQ‟s dry cleaner program. In exchange for liability relief from cleanups and cleanup costs, dry cleaners pay fees that go into a fund used to clean up solvent contamination at dry cleaner sites. The law protects dry cleaners, under specified circumstances, from individually having to pay for environmental damage caused by the use of dry cleaning solvents at their establishments. In 2001DEQ conducted a federal screening and prepared a strategy recommendation for the site (4). The site remains in good standing with DEQ‟s Dry Cleaner program. Since 1992 the site has been listed as a conditionally exempt generator according to DEQ‟s hazardous waste database. Based on a review of DEQ‟s Facility Profiler (May 12, 2010) there are 37 sites within 0.5 miles of the site, which are active in at least one DEQ program. There are 25 Leaking UST sites or events, nine regulated underground storage tanks, and one site with a stormwater permit. Xxxxxx‟s Cleaners is the only site in the area active with the Hazardous Waste or Cleanup Programs. A list of all DEQ facilities within 0.5 miles is included in Appendix A.
REGULATORY HISTORY. During the PA DEQ reviewed the following regulatory databases for the facilities listed above: DEQ’s underground storage tank (UST) and leaking underground storage tank (LUST) database, DEQ’s spills database, and the state fire marshal’s hazardous substance information survey (HSIS). The Oil Can Henry’s facility has an above ground storage tank (AST) for waste oil. It is listed in HSIS and spills databases. According to the HSIS, Oil Can Xxxxx uses antifreeze, transmission fluid, gear oil, motor oil, and waste oil. According to DEQ’s spills database, Oil Can Xxxxx’x had a small oil release (less than 20 gallons), in January 2004. There are active UST Cleanups at the Younger Oil station at 0000 Xxxxx Xxxx (DEQ USTC ID 24-03-0558) and Keizer Exxon at 0000 Xxxxx Xxxx (XXX XXXX ID 24-91-4141); low levels of TCE and decay products have been detected at or near both of these sites, but no PCE.
