Request for Information

Aside from the actions already initiated by EPA under Section 6 to restrict exposures to polychlorinated biphenyls and to chlorofluorocarbons in certain uses, no other actions have been taken against specific chemical substances, nor has an imminent hazard been identified for appropriate action. Less than a dozen proposed orders have been issued under Section 5(e) requesting further information to assess the risks of as many new substances. Perhaps 80 informal requests for further information on such substances have been made and satisfied voluntarily. Testing programs for a substantial number of existing substances have been started and more are planned. In addition, of course, the monumental task of creating an inventory of some 55,000 existing chemicals was completed. 

Beginning with PMN forms, our current plans are to require only that information clearly spelled out in the statute with all other information being optional. Our experience with submitters to date is that informal requests for additional information have generally proved adequate for our risk assessment needs so we will continue to rely on this approach. This should clear up the uncertainty on the PMN review process and reduce the burden on industry. 

If the review result is not what was anticipated or expected, there are several levels of response that are possible. The first, and generally most successful, is a conversation to pinpoint the problem, followed by a clarification (if the adverse result is due to a simple misunderstanding), submission amendment (if more detail or support is requested), or resubmission (if significant issues need to be addressed). These informal requests for reconsideration are often successful, particularly if approached in a cooperative framework. 

Requirements traceability should also ease inspections by facilitating the rapid location of any specification-to-test information requested. For many organizations, this forward tracking of requirements can be quite cumbersome if they rely solely on reverse tracking offered by test documentation referencing requirements and specifications. 

Note If more than one stream ig to be Considered, please mdchin copy this form and complete the information requested for each stream... 

Draw Lewis structures and give the other information requested for the following molecules (a) BF3. Shape planar or nonplanar (b) CIO. Shape planar or nonplanar (c) H2O. Show the direction of the resultant dipole moment, (d) OF2. Polar or nonpolar molecule (e) NO2. Estimate the ONO bond angle. 

Draw Lewis structures and give the other information requested for the following molecules (a) BF3. Shape planar or nonplanar ... 

The Chinese patent file with its abstracts can be used to supplement WPI, which at this writing has only tides for Chinese patents. JAPIO provides abstracts based ia particular oa pateat claims, and can help to clarify uncertainties with Japanese abstracts from Derwent and/or CA. PATOLIS, ia Japanese, is a unique source of Japanese legal status information (37). EPIDOS staff carry out PATOLIS searches on request for those with sufficient need to search the PATOLIS database, software is available to enable those who cannot read Japanese to extract key data. 

Cost reports should be brief but informative, preferably in sum-maiy form. They should report expenditures and commitments, estimated costs to complete, and expected overruns or underruns of the authorized budget for each important item of cost. Brief notes should emphasize significant deviations from predicted cost. Any large, persistent overrun should have already been investigated and reported to the project and construc tion managers for immediate attention. If an expected overrun cannot be avoided, the current summaiy cost report should serve as justification for a request for additional funds. 

Section 6. Regulatory Requirements. This section describes a few of the ways that a software application can explain the requirements under Title III and assist in compliance with requirements, such as tracking deadlines and responding to requests for information. 

Obiective Track regulatory deadlines and assist in the assessment of compliance with reporting requirements, as well as record the status of required information and log requests for information. 

Addresses public requests for information under Title III of SARA Record type and number of requests and provide information to answer them. 

Reproduction or translation of any part of this work beyond that permitted by Section 107 or 108 of the 1976 United States Copyright Act without the permission of the copyright owner is unlawful. Requests for permission or further information should be addressed to the Permissions Department, John Wiley Sons, Inc. 

The following listing of data to be supplied to manufacturers when ordering motors or requesting bids is based on the requirements and recommendations of a number of representative manufacturers. This list is split into vital and desirable information and is intended as a checklist in preparing both requisitions and purchase orders. By using this list, you will give the manufacturer a clear picture of your needs for most motor applications in the oil and petrochemical industries and eliminate call-backs, requests for supplementary information, and so on. 

Records. The manufacturer shall keep records of all calculations and tests. When requested by prospective purchaser or by a user of the equipment, the manufacturer shall examine the details of computations, drawings, tests, or other supporting data necessary to demonstrate compliance with the specification. It shall be understood that such information is for the sole use of the user or prospective purchaser for checking the API rating, and the manufacturer shall not be required to release the information from his custody. 

Environmental assessment or request for categorical exclusion Statements of claimed exclusivity and associated certifications b Prescribing information 0. Annotated labeling text d. Labeling comparison (for ANDA)... 

REASON FOR SUBMISSION This section should contain a brief explanation of the submission, e.g., "manufacturing change from roller bottle to cell factory" or "response to Information Request Letter of 1/9/97" or "Pediatric exclusivity determination request" or "to satisfy a subpart H postmarketing commitment". 

Figure 7.2 Information supplied to the CVB in support of a request for authorisation to ship an experimental biologic product.

Responding to requests for further information from the Competent Authorities. 

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