[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: 21CFR16.1]

[Page 176-177]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 16.1  Scope.


    The procedures in this part apply when:
    (a) The Commissioner is considering any regulatory action, including 
a refusal to act, and concludes, as a matter of discretion, on the 
Commissioner's initiative or at the suggestion of any person, to offer 
an opportunity for a regulatory hearing to obtain additional information 
before making a decision or taking action.
    (b) The act or a regulation provides a person with an opportunity 
for a hearing on a regulatory action, including proposed action, and the 
act or a regulation either specifically provides an opportunity for a 
regulatory hearing under this part or provides an opportunity for a 
hearing for which no procedures are specified by regulation. Listed 
below are the statutory and regulatory provisions under which regulatory 
hearings are available:
    (1) Statutory provisions:

Section 304(g) of the act relating to the administrative detention of 
devices (see Sec. 800.55(g) of this chapter).
Section 515(e)(1) of the act relating to the proposed withdrawal of 
approval of a device premarket approval application.
Section 515(e)(3) of the act relating to the temporary suspension of 
approval of a premarket approval application.
Section 515(f)(6) of the act relating to a proposed order revoking a 
device product development protocol or declaring a protocol not 
completed.
Section 515(f)(7) of the act relating to revocation of a notice of 
completion of a product development protocol.
Section 516 of the act relating to a proposed banned device regulations 
(see Sec. 895.21(d) of this chapter).
Section 518(b) of the act relating to a determination that a device is 
subject to a repair, replacement, or refund order or that a correction 
plan, or revised correction plan, submitted by a manufacturer, importer, 
or distributor is inadequate.
Section 518(e) of the act relating to a cease distribution and 
notification order or mandatory recall order concerning a medical device 
for human use.
Section 520(f)(2)(D) of the act relating to exemptions or variances from 
device current good manufacturing practice requirements (see 
Sec. 820.1(d)).
Section 520(g)(4) and (g)(5) of the act relating to disapproval and 
withdrawal of approval of an application from an investigational device 
exemption (see Secs. 812.19(c), 812.30(c), 813.30(d), and 813.35(c) of 
this chapter).

    (2) Regulatory provisions:

Sec. 56.121(a), relating to disqualifying an institutional review board 
or an institution.
Sec. 71.37(a), relating to use of food containing a color additive.
Sec. 80.31(b), relating to refusal to certify a batch of a color 
additive.
Sec. 80.34(b), relating to suspension of certification service for a 
color additive.
Sec. 99.401(c), relating to a due diligence determination concerning the 
conduct of studies necessary for a supplemental application for a new 
use of a drug or device.
Sec. 130.17(1), relating to a temporary permit to vary from a food 
standard.
Sec. 170.17(b), relating to use of food containing an investigational 
food additive.
Sec. 202.1(j)(5), relating to approval of prescription drug 
advertisements.
Sec. 312.70, relating to whether an investigator is entitled to receive 
investigational new drugs.
Sec. 312.70(d) and 312.44, relating to termination of an IND for a 
sponsor.
Sec. 312.160(b), relating to termination of an IND for tests in vitro 
and in laboratory research animals for a sponsor.
Sec. 511.1(b)(5), relating to use of food containing an investigational 
new animal drug.
Sec. 511.1(c)(1), relating to termination of an INAD for an 
investigator.
Sec. 511.1(c) (4) and (d), relating to termination of an INAD for a 
sponsor.
Sec. 814.46(c) relating to withdrawal of approval of a device premarket 
approval application.
Sec. 900.7, relating to approval, reapproval, or withdrawal of approval 
of mammography accreditation bodies or rejection of a proposed fee for 
accreditation.

[[Page 177]]

Sec. 900.14, relating to suspension or revocation of a mammography 
certificate.
Sec. 900.25, relating to approval or withdrawal of approval of 
certification agencies.
Sec. 1003.11(a)(3), relating to the failure of an electronic product to 
comply with an applicable standard or to a defect in an electronic 
product.
Sec. 1003.31(d), relating to denial of an exemption from notification 
requirements for an electronic product which fails to comply with an 
applicable standard or has a defect.
Sec. 1004.6, relating to plan for repurchase, repair, or replacement of 
an electronic product.
Sec. 1210.30, relating to denial, suspension, or revocation of a permit 
under the Federal Import Milk Act.
Sec. 1270.15(e), relating to the retention, recall, and destruction of 
human tissue.

[44 FR 22367, Apr. 13, 1979, as amended at 45 FR 3750, Jan 18, 1980; 45 
FR 10332, Feb. 15, 1980; 46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 
27, 1981; 51 FR 26364, July 22, 1986; 54 FR 9037, Mar. 3, 1989; 57 FR 
58403, Dec. 10, 1992; 58 FR 65520, Dec. 14, 1993; 62 FR 40444, July 29, 
1997; 62 FR 55976, Oct. 28, 1997; 63 FR 26697, May 13, 1998; 63 FR 
64581, Nov. 20, 1998; 67 FR 5467, Feb. 6, 2002]