Permit Requirements Required Filings

The responsibility for obtaining permits, required filings, and rights to review permits should be noted in the contract. Both parties are expected to be in compliance with all laws and permits applicable to the tolling operation. 

The employer issues a hot work permit for hot work operations conducted on or near a covered process. The permit documents that the fire prevention and protection requirements in 29 CFR 1910.252(a) have been implemented prior to beginning the hot work operations it indicates the date(s) authorized for hot work and identifies the object on which hot work is performed. The permit is kept on file until completion of the hot work operations. 

The availability of downloadable forms, files, permits, and publications with the URL for the download area and information on the formats used to determine if one will require any special software, such as Adobe Acrobat Reader for ".pdf files at Microsoft Word for ".doc files, etc. 

Adobe Acrobat Reader is software that permits users to view, navigate, search, and print Adobe PDF tiles on major computer platforms. The software is free and available from Adobe Systems Web site. Although useful, the Reader does not support all the functionality that OPP s reviewers require. For the pilots, OPP purchased Adobe Acrobat, Version 4.0, to support the review of studies submitted as PDF files. Adobe Acrobat permits review, mark-up, annotation, and extraction of text and tables for editing or other manipulations, in addition to basic viewing, navigation, and printing capabilities. 

In a nutshell, the law requires solid scientific evidence of safety and efficacy before a new drug will be permitted in clinical trials or (later) on the market. The INDA (covered in 21 CFR 310) is for permission to proceed with clinical trials on human subjects. Once clinical trials have been completed, the manufacturer or sponsor can then proceed to file an NDA (covered in 21 CFR 314) for permission to market the new drug. 

Exposed ordinary combustibles (Class A) should not be permitted to accumulate in the control room area. Process data printouts, batch records, shipping documents, and other paper in the open should be minimized, preferably limited to one-day s output. Where longer-term storage of such paper files or storage of supplies is required, closed-door metal cabinets should be provided. Metal file cabinets should be provided to store drawings, electrical diagrams, manuals, equipment catalogs, etc. 

Although not yet available, it is likely that Web-based performance testing systems will become available in the near future. Web-based systems will permit selected tasks to be presented on computers equipped with appropriate Web browser software. Hardware requirements include Internet access and appropriate memory and software to support Web-based applications. Depending on the design of the Web-based system, it is could be possible to tailor the specific tasks presented for the performance testing system from a menu of options. Alternatively, testing systems consisting of a standardized array of tasks can also be chosen. As such, the start-up costs of Web-based systems should be lower than with personal or handheld computer systems. Subject identification, date, and time can be recorded at the start of a test, and data from multiple subjects and test occasions can be stored in a central file for easy access to the data. 

An applicant should file a 505(b)(2) application if it is seeking approval of a change to an approved drug that would not be permitted under section 505(j), because approval will require the review of clinical data. However, section 505(b)(2) applications should not be submitted for duplicates of approved products that are eligible for approval under 505(j) [see 21 CFR 314.101(d)(9)],... 

Investigators are required to retain records for IND studies for 2 years after the date of marketing application approval of the drug for the indication for which it was being studied. If no application is filed or if the application is not approved for the indication, the records are retained for 2 years after the investigation is discontinued and the FDA has been notified of that fact. Retention of complete records is essential to establish validity and completeness of a report on a clinical investigation submitted to the FDA in support of an application for a research or marketing permit. 

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