21 C.F.R. § 12.45
(a) Within 30 days after publication of the notice of hearing under § 12.35, a person desiring to participate in a hearing is to file with the Dockets Management Staff under § 10.20 a notice of participation in the following form:
(Date) Dockets Management Staff, Food and Drug Administration, Department of Health and Human Services, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Notice of Participation Docket No. ____ Under 21 CFR part 12, please enter the participation of: (Name) (Street address) (City and State) (Telephone number) Service on the above will be accepted by: (Name) (Street address) (City and State) (Telephone number) The following statements are made as part of this notice of participation: A. Specific interests. (A statement of the specific interest of the person in the proceeding, including the specific issues of fact concerning which the person desires to be heard. This part need not be completed by a party to the proceeding.) B. Commitment to participate. (A statement that the person will present documentary evidence or testimony at the hearing and will comply with the requirements of 21 CFR 12.85, or, in the case of a hearing before a Public Board of Inquiry, with the requirements of 21 CFR 13.25.) (Signed)
[44 FR 22339, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 59 FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, 2003]