[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10.50]

[Page 102-103]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
 
              Subpart B--General Administrative Procedures
 
Sec. 10.50  Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.

    (a) The Commissioner shall promulgate regulations and orders after 
an opportunity for a formal evidentiary public hearing under part 12 
whenever all of the following apply:
    (1) The subject matter of the regulation or order is subject by 
statute to an opportunity for a formal evidentiary public hearing.
    (2) The person requesting the hearing has a right to an opportunity 
for a hearing and submits adequate justification for the hearing as 
required by Secs. 12.20 through 12.22 and other applicable provisions in 
this chapter, e.g., Secs. 314.200, 514.200, and 601.7(a).
    (b) The Commissioner may order a formal evidentiary public hearing 
on any matter whenever it would be in the public interest to do so.
    (c) The provisions of the act, and other laws, that afford a person 
who would be adversely affected by administrative action an opportunity 
for a formal evidentiary public hearing as listed below. The list 
imparts no right to a hearing where the statutory section provides no 
opportunity for a hearing.
    (1) Section 401 on any action for the amendment or repeal of any 
definition and standard of identity for any dairy product (including 
products regulated under parts 131, 133, and 135 of this chapter) or 
maple sirup (regulated under Sec. 168.140 of this chapter).
    (2) Section 403(j) on regulations for labeling of foods for special 
dietary uses.

[[Page 103]]

    (3) Section 404(a) on regulations for emergency permit control.
    (4) Section 406 on tolerances for poisonous substances in food.
    (5) Section 409 (c), (d), and (h) on food additive regulations.
    (6) Section 501(b) on tests or methods of assay for drugs described 
in official compendia.
    (7) [Reserved]
    (8) Section 502(h) on regulations designating requirements for drugs 
liable to deterioration.
    (9) Section 502(n) on prescription drug advertising regulations.
    (10) [Reserved]
    (11) Section 507(f) on regulations for antibiotic drug 
certification.
    (12) Section 512(n)(5) on regulations for animal antibiotic drugs 
and certification requirements.
    (13) Section 721 (b) and (c) on regulations for color additive 
listing and certification.
    (14) Section 4(a) of the Fair Packaging and Labeling Act on food, 
drug, device, and cosmetic labeling.
    (15) Section 5(c) of the Fair Packaging and Labeling Act on 
additional economic regulations for food, drugs, devices, and cosmetics.
    (16) Section 505 (d) and (e) on new drug applications.
    (17) Section 512 (d), (e) and (m) (3) and (4) on new animal drug 
applications.
    (18) Section 515(g) on device premarket approval applications and 
product development protocols.
    (19) Section 351(a) of the Public Health Service Act on a biologics 
license for a biological product.
    (20) Section 306 on debarment, debarment period and considerations, 
termination of debarment under section 306(d)(3), suspension, and 
termination of suspension.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 58 
FR 49190, Sept. 22, 1993; 60 FR 38626, July 27, 1995; 63 FR 26697, May 
13, 1998; 64 FR 398, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 67 FR 
4906, Feb. 1, 2002]