Information collection provisions

In the Federal Register of October 30,2006 (71 FR 63325), the FDA published a 60-day notice requesting public comment on the information collection provisions. The FDA received one comment related to the information collection. 

Article 102 includes a provision that requires Member States to share information collected through their pharmacovigilance system with other Member States and the EMEA. The central database EudraVigilance has been developed to allow Member States and the EMEA to share information on adverse drug reactions once all Member States have populated it. 

Under the new RCRA/MACT regulations, when a RCRA incinerator facility demonstrates compliance with MACT air emission standards and limitations by conducting a CPT and submitting an NOC, duplicate RCRA emission requirements no longer apply. Nevertheless, the state agency may continue to apply the RCRA permit emission provisions on a case-by-case basis for purposes of information collection. RCRA permit provisions for all other aspects of the combustion unit and the facility are still applicable (40 CFR 270.10(k) and 270.32(b)(2)). 

In the 1984 proposal, changes were also made to inform collection requirements subject to the Paperwork Reduction Act of 1980. Modifications were made to the provisions regarding animal care, animal supply, and administrative and... 

The FOI Online Web site (cited previously) also enables keyword searching of a huge retrospective collection of FDA Warning Letters, as well as FDA Guidance documents. Both of these compilations complement those offered on the FDA web site. Since the database supplier is also a document delivery service, the online file serves as a catalog of materials stored in-house after being obtained through Freedom of Information Act provisions. This means that items not separately listed or readily searchable on the FDA Web site are indexed at FOI Online. For example, the database provides separate... 

A program shall be developed and implemented to provide for a systematic analysis to determine the root causes of unplanned occurrences related to maintenance. Root cause determinations shall be performed on, equipment failures not haying a clearly identifiable, and/or understood cause of failure.. This pr ogram shall have provisions for information collection, information.analysis, cause, determination, corrective action, and corrective action follow-up. 

The filing provisions you have made should enable your records to be readily retrievable however, you need to maintain your files if the stored information is to be of any use. In practice, records will collect at the place they are created and unless promptly removed to secure files may be mislaid, lost, or inadvertently destroyed. Once complete, quality records should not be changed. If they are subsequently found to be inaccurate, new records should be created. Alterations to records should be prohibited as they bring into doubt the validity of any certification or authentication as no one will know whether the alteration was made before or after the records were authenticated. In the event that alterations are unavoidable due to time or economic reasons, errors should be struck through in order that the original wording can still be read, and the new data added and endorsed by the certifying authority. 

This information is likely to be recorded at the time the service is carried out and may well be remote from the parent plant therefore allowance for this should be made in the procedures. Provision needs to be made for this information to be collected, stored, and any corrective actions taken as a result of unusual trends being detected (see Part 2 Chapter 14). 

Approved IVD tests are required to have standard product labeling. The current labeling requirements include provisions dealing with intended use(s), summary and explanation of test, information on specimen collection and preparation, procedures, results, limitations of the procedure, expected values, and specific performance characteristics. 

Informed consent will be obtained from each prospective participant or the participant s legally authorized representative and will be documented in accordance with IRB, FDA, and ICH informed consent regulations and guidelines. Adequate provisions are made for monitoring the data collected to ensure the safety of participants. 

More sophisticated Instruments (such as the Technicon InfraAlyzer 500 system) employ a scanning monochromator so that data can be collected at up to 700 different wavelengths. In most instruments data are collected between 1100 and 2500 nm, although provision is made for observations which begin in the visible region when useful information is there. 

The collected samples must be identified with unique sample numbers efficiently tracked in the field stored in a secure location for the preservation of sample integrity and transferred to the laboratory with the information on their identification (ID) and the requested analysis. The provisions for sample numbering, labelling, storage in the field tracking and transfer to the laboratory are set forth in the SAP. 

An Interactive Voice Response-System (IVRS) is a communications platform based upon the telephone network used to coordinate key clinical trial activities and provide real-time information for study managers. By utilizing the telephone network, the system provides for a direct connection between the clinical trial patient and the central study-specific database. This permits the collection of data in response to preprogrammed prompts from the system, ensuring the recording of key trial events and the provision of information critical to the successful conclusion of the trial. Most IVR systems are individually tailored to each specific study based upon requirements defined by the Sponsor. 

The premise of corporate responsibility auditing is the recognition by executives that the information provided to shareholders, as well as other stakeholders, on a corporation s performance needs to be truthful and reliable. Inherent in the auditing process is the provision of crucial knowledge that will sustain the public s trust and sharpen managements s collective focus on key nonfinancial value drives (e.g.,... 

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