Comments acceptance/rejection

The Committee developed and published a testing sequence organized into a decision tree in which each step integrated and applied the information previously gathered in reaching a decision to accept, reject, or further test the material in question. (1) Comments on this proposal were actively solicited, and two of the chapters of the proposal were then revised and again published. 

Assuming one wants to be certain that the risk of falsely declaring a good batch B to be different from the previous one A is less than 5%, the symmetrical 95% confidence limits are added to A (see Fig. 1.22) any value B in the shaded area results in the judgment B different from A, Hi accepted, Hq rejected , whereas any result, however suspect, in the unshaded area elicits the comment no difference between A and B detectable, H rejected, Hq retained . Note that the expression A is identical to B is not used by statistical means only deviations can be demonstrated, and similarities must be inferred from their absence. 

In the European Union there have been several petitions to approve stevia and its products. In 2000, the EU Commission refused marketing authorisation for Stevia rebaudiana Bertoni plants and dried leaves as a novel food or novel food ingredient (Official Journal of the European Communities, 2000). In October 2003, the SCF rejected a request to re-examine the restrictions on the uses of extracts of stevia. Its comment, after throroughly examining the evidence, was that the committee has serious doubts about the safety of stevioside and does not consider it acceptable for use in food (European Parliament, 2003). 

The associate editor collates the comments from each of the reviewers and sends these back to the authors, who then respond by submitting a revised manuscript (unless the paper has been rejected). The paper may be accepted upon... 

If, after discussion with the applicant, the problems have not been resolved, the assessor, cifter having obtained the approval of his or her Head of Department, informs the applicant that the product will be proposed for rejection. The rejection proposal is presented to the Executive Board and, if accepted, the applicant is given 30 days to comment. The response is reviewed by the Executive Board. If the matter has not been resolved, it is then referred to the Advisory Committee on Human Medicines. That Committee may conduct its own review, may refer the issue back to the Executive Board for re-evciluation or may endorse the rejection proposal, in which case it is sent to the Board. If the Board adopts the recommendation, then the applicant is notified of the rejection. Any appeal following rejection must be made to the Bocird. 

The reason for a signature, rejection, or modification can be selected from a pick list consisting of items of a predefined collection of acceptable reasons. The reason from the pick list may be set as mandatory. Optional comment fields are available. 

Once the company has compiled the necessary information, they submit the proposed monograph to USP so it may be adopted as an official standard. The appropriate USP expert committee reviews the information, to assess its completeness and scientific merit, and subsequently approves it for publication in Pharmacopeial Forum (PF), USP s bimonthly journal of scientific review and compendial revision. Once a monograph has been published in PF, any interested person, company, or regulatory authority, including USP Expert Committee members, may comment on the contents of the proposal. The USP may chose to accept the comments and revise the original proposal, or reject the comments and proceed to adopt the original submission as initially published. 

Acceptance and rejection of Road Safety Audit comments... 

The success of a Road Safety Audit can be measured not only by cost-benefit analysis but also by the proportion of problems and recommendations that are accepted by a client. Road Safety Audit recommendations should be relative to the problem and the stage of the design to ensure that a high percentage of comments are not rejected. 

Any action used to introduce the safety policy statement must be done after consideration of current and past policies, actions, and events that have been implemented. If other policies are not enforced, then the safety policy statement may also follow the same fate. In addition, be aware of resistance to following policy in the form of cynical comments by employees that can indicate lack of acceptance or rejection. The key to a successful safety policy statement is to periodically involve all employees in its review. 

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