21 CFR 16.1 - Scope.
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§ 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:
Section 304(g) of the act relating to the administrative detention of devices (see § 800.55(g) of this chapter).
Section 304(h) of the act relating to the administrative detention of food for human or animal consumption (see part 1, subpart k 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 § 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 § 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 §§ 812.19(c), 812.30(c), 813.30(d), and 813.35(c) of this chapter).
§ 56.121(a), relating to disqualifying an institutional review board or an institution.
§ 71.37(a), relating to use of food containing a color additive.
§ 80.31(b), relating to refusal to certify a batch of a color additive.
§ 80.34(b), relating to suspension of certification service for a color additive.
§ 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.
§ 130.17(1), relating to a temporary permit to vary from a food standard.
§ 170.17(b), relating to use of food containing an investigational food additive.
§ 202.1(j)(5), relating to approval of prescription drug advertisements.
§ 312.70, relating to whether an investigator is entitled to receive investigational new drugs.
§ 312.70(d) and 312.44, relating to termination of an IND for a sponsor.
§ 312.160(b), relating to termination of an IND for tests in vitro and in laboratory research animals for a sponsor.
§ 511.1(b)(5), relating to use of food containing an investigational new animal drug.
§ 511.1(c)(1), relating to termination of an INAD for an investigator.
§ 511.1(c) (4) and (d), relating to termination of an INAD for a sponsor.
§ 814.46(c) relating to withdrawal of approval of a device premarket approval application.
§ 900.7, relating to approval, reapproval, or withdrawal of approval of mammography accreditation bodies or rejection of a proposed fee for accreditation.
§ 900.14, relating to suspension or revocation of a mammography certificate.
§ 900.25, relating to approval or withdrawal of approval of certification agencies.
§ 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.
§ 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.
§ 1004.6, relating to plan for repurchase, repair, or replacement of an electronic product.
§ 1107.1(d), relating to rescission of an exemption from the requirement of demonstrating substantial equivalence for a tobacco product.
§ 1210.30, relating to denial, suspension, or revocation of a permit under the Federal Import Milk Act.
§ 1270.43(e), relating to the retention, recall, and destruction of human tissue.
§ 1271.440(e) relating to the retention, recall, and destruction of human cells, tissues, and cellular and tissue-based products (HCT/Ps), and/or the cessation of manufacturing HCT/Ps.
[44 FR 22367, Apr. 13, 1979]
Editorial Note:
For Federal Register citations affecting § 16.1
, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.
Effective Date Note:
At 77 FR 5176, Feb. 2, 2012, § 16.1 was amended by adding new statutory provisions to the end of paragraph (b)(1), effective Apr. 2, 2012. For the convenience of the user, the added text is set forth as follows:
§ 16.1
Scope.
Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic Act relating to the misbranding of tobacco products.
Section 906(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act relating to the establishment of good manufacturing practice requirements for tobacco products.
Section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act relating to the withdrawal of an order allowing a new tobacco product to be introduced or delivered for introduction into interstate commerce.
Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating to the withdrawal of an order allowing a modified risk tobacco product to be introduced or delivered for introduction into interstate commerce.
Title 21 published on 2012-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 16 after this date.
