Under certain circumstances, we may need to disseminate information without fully applying the principles for ensuring the quality, objectivity, utility and integrity of the information outlined above. Even in these cases, however, FDA intends to use its internal review process to evaluate the data received and the information it plans to disseminate to ensure to the degree practicable the accuracy, objectivity, and transparency of the relevant information, and will entertain requests for correction after the exigent circumstances have passed. The specific situations where this may occur are as follows:
- Public Health Emergencies: In the case of a public health emergency, there may not be time for the Agency to submit relevant information to all levels of review or review by an Advisory Committee prior to dissemination of the information.
- Statutory or Other Legal Requirement: If a statutory requirement, Executive Order, or court order requires immediate implementation of a policy, we may have insufficient time to apply the OMB requirements prior to disseminating information relevant to that policy.
- Other Circumstances: There may be unforeseen circumstances in carrying out our mission that could prevent the Agency from applying all of the OMB guidelines when disseminating information to the public.
As mentioned above, in all such special circumstances, the Agency will be particularly careful to use its internal review processes to the extent practicable when considering the dissemination of relevant information to the public.