Code of Federal Regulations Title 21. Food and Drugs § 21.1401.8 Expedited process

(a) A request for expedited processing may be made at any time. ONDCP must process requests and appeals on an expedited basis whenever it is determined that they involve:

(b) A requester who seeks expedited processing must submit a statement, certified to be true and correct, explaining in detail the basis for requesting expedited processing. For example, under paragraph (a)(2) of this section, a requester who is not a full-time member of the news media must establish that the requester is a person who is primarily engaged in information dissemination, though it need not be the requester's sole occupation. Such a requester also must establish a particular urgency to inform the public about the government activity involved in the request, beyond the public's right to know about government activity generally. The existence of numerous articles published on a given subject can be helpful in establishing the requirement that there be an “urgency to inform” the public on the topic. The formality of certification may be waived as a matter of administrative discretion.

(c) Within 10 days of receipt of a request for expedited processing, ONDCP will decide whether to grant it and will notify the requester of the decision. If a request for expedited treatment is granted, the request will be given priority and will be processed as soon as practicable. If a request for expedited processing is denied, any appeal of that decision will be acted on expeditiously.