Additional Reporting Requirements

Hazardous Waste Annual Report Forms must be submitted annually to the USEPA or state EPA (State of Kentucky, 1992, chap. 31). The annual reporting form includes information on all the hazardous waste generated and shipped during the report year. All facilities that treat, dispose, or recycle hazardous waste on-site must complete the form. Waste minimization activities must be identified on the form. 

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The MIAME/Tox standard is being developed to address these concerns. Additional reporting requirements of the MIAME/Tox extension... 

In addition to the external reporting requirements mentioned in Section 13.3, there will... 

Only with propanal are very high conversions (99%) and selectivity (> 98 0) to MMA and MAA possible at this time. Although nearly 95% selective, the highest reported conversions with propionic acid or methyl propionate are only 30—40%. This results in large recycle streams and added production costs. The propanal route suffers from the added expense of the additional step required to oxidize methacrolein to methacrylic acid. 

Reportable releases under CERCLA must be reported to the National Response Center, at (800) 424-8802. Reporting under EPCRA requires notifying the facihty s LEPC (or relevant local emergency response personnel if there is no LEPC) and the SERC of any state likely to be affected. If a faciUty is near the border of another state, that state may have to be notified as well. Notification is required to be immediate, which is usually defined as within 30 minutes of the release. State or local authorities may have additional or different reporting requirements. Eailure to report release in a timely manner can result in severe penalties from the regulatory authorities. 

The concept of a safety case comes from the requirements of the European Union/European Community (EU/EC) Seveso Directive (82/501/EC) and, in particular, regulations that the United Kingdom and other member states used to implement that directive. United Kingdom regulations (Control of Industrial Major Accident Hazards [CIMAH], 1984 replaced by Control of Major Accident Hazards Involving Dangerous Substances [COMAH] in 1999) require that major hazardous facilities produce a safety report or safety case.64 The requirement for a safety case is initiated by a list of chemicals and a class of flammables. Like the hazard analysis approach (Section 8.1.2), experts identify the reactive hazards of the process if analysis shows that the proposed process is safe, it may be excluded from additional regulatory requirements. 

The Board shall prepare an annual report on its work containing an analysis of the information at its disposal and, in appropriate cases, an account of the explanations, if any, given by or required of Parties, together with any observations and recommendations which the Board desires to make. The Board may make such additional reports as it considers necessary. The reports shall be submitted to the Council through the Commission which may make such comments as it sees fit. 

Aerosol - Several serious adverse events occurred in severely ill infants with life-threatening underlying diseases, many of whom required assisted ventilation. Additional reports of worsening of respiratory status, bronchospasm, pulmonary edema, hypoventilation, cyanosis, dyspnea, bacterial pneumonia, pneumothorax, apnea, atelectasis, and ventilator dependence have occurred. Sudden deterioration of respiratory function has been associated with initiation of aerosolized ribavirin use in infants. If ribavirin aerosol treatment produces sudden deterioration of respiratory function, stop treatment and reinstitute only with extreme caution, continuous monitoring, and consideration of coadministration of bronchodilators. 

Although disclosure to patients is important, patients are generally ill suited to assess how a potential conflict of interest actually affects their treatment. In addition to disclosure to patients, we need rigorous reporting requirements for those engaged in drug studies. 

For the past several years, scientific debates within the pharmaceutical community on the topic of manufacturing changes have centered on the question of additional tests and reporting requirements needed to document unchanged quality and performance. The SUP AC approach focused this debate on the definitions of significant changes and what constitutes sufficient characterization. 

Diels-Alder additions provide one of the more extensively studied reactions of these heteroles, and many examples are listed in the reviews given at the beginning of this section. Typical additions often require heating, giving the 7-hetero-norbornenes and -norbor-nadienes as products of reaction with alkenes and alkynes (Scheme 209). The report that (131) resulted at room temperature from tolane and (120) was therefore surprising. Subsequent investigation showed it to be a 1 1 crystalline adduct from which tolane could be sublimed (Scheme 210) (72CC690). 

Panchromatic sensitization of vinyl addition polymerization requires the presence of suitable dyes as primary absorbers of radiation. In 1949 Bamford and Dewar (5) reported that styrene could be polymerized by irradiation of a variety of dyes. It was later shown by Koizumi, Watanabe, and Kuroda (6) that these reactions, and others uncovered by the Japanese group, were the result of photoinduced decomposition of the dyes rather than a true sensitization process. 

EPA. 1986i. Testing and reporting requirements for polyhalogenated dibenzo-p-dioxins/dibenzofurans Addition of chlorinated and brominated benzenes to list of precursor chemicals. U.S. Environmental Protection Agency. Federal Register 51 37612-37613. 

This guidance document describes the information required by 21 CFR 814.84(b), additional information requirements that may be imposed by approval order under 21 CFR 814.82, and our recommendations for the level of detail you should provide in your annual report. It also identifies the steps FDA staff generally takes when reviewing annual reports, the resources available to assist staff in their reviews, and the actions they may recommend in their conclusions. This guidance document is intended to help ensure that your annual reports are complete and that the actions of CDRH and CBER staff are consistent. 

As provided by 21 CFR 814.82(a)(2), the FDA may require continuing evaluation (post-approval study) and periodic reporting on the safety, effectiveness, and reliability of your device (post-approval study report), in addition to requiring annual reports under 21 CFR 814.82(a)(7). If your approval order identities post-approval studies you must conduct, the order will describe the purpose of the studies and how frequently you must submit post-approval study reports. 

The FDA s review of annual reports will allow the Agency to assess several important issues related to postmarket safety of approved devices. These issues include the nature and adequacy of reported modifications and the adequacy of report documentation. If, after reviewing your annual report, we need additional information or if we believe the device modifications you have reported require a PMA Supplement or a 30-Day Notice, we will notify you in writing. 

Problems in personal care were reported by eight respondents, and an additional 27 required help with their daily routines. No differences between test groups and either comparison group were noted. 

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