§13.5. Notice of a hearing before a Board. — Inbound Citations

(a) Before the notice of hearing is published under § 13.5, the director of the center responsible for the matters involved in the hearing must submit to the Dockets Management Staff—

(1) Portions of the administrative record not relevant to the issues in the hearing are not part of the administrative record;

(2) A list of all persons whose views will be presented orally or in writing at the hearing;

(3) All documents in the director's files containing factual information, whether favorable or unfavorable to the director's position, which relate to the issues involved in the hearing. Files means the principal files in the center in which documents relating to the issues in the hearing are ordinarily kept, e.g., the food additive master file and the food additive petition in the case of issues concerning a food additive, or the new drug application in the case of issues concerning a new drug. Internal memoranda reflecting the deliberative process, and attorney work product and material prepared specifically for use in connection with the hearing, are not required to be submitted;

(4) All other documentary information relied on; and

(5) A signed statement that, to the best of the director's knowledge and belief, the submission complies with this section.