[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR16.1] [Page 196-197] 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. Subpart A_General Provisions Sec. 16.1 Scope. 16.5 Inapplicability and limited applicability. Subpart B_Initiation of Proceedings 16.22 Initiation of regulatory hearing. 16.24 Regulatory hearing required by the act or a regulation. 16.26 Denial of hearing and summary decision. Subpart C_Commissioner and Presiding Officer 16.40 Commissioner. 16.42 Presiding officer. 16.44 Communication to presiding officer and Commissioner. Subpart D_Procedures for Regulatory Hearing 16.60 Hearing procedure. 16.62 Right to counsel. Subpart E_Administrative Record and Decision 16.80 Administrative record of a regulatory hearing. 16.85 Examination of administrative record. 16.95 Administrative decision and record for decision. Subpart F_Reconsideration and Stay 16.119 Reconsideration and stay of action. Subpart G_Judicial Review 16.120 Judicial review. Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364. Source: 44 FR 22367, Apr. 13, 1979, unless otherwise noted. 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 [[Page 197]] 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 Sec. Sec. 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. 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. 1240.63(c)(3), relating to a written order to cause an animal to be placed in quarantine or to cause an animal to be destroyed. 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; 68 FR 62368, Nov. 4, 2003] [[Page 198]]