21 C.F.R. § 16.1

Current through October 31, 2024

Section 16.1 - [Effective 12/18/2025] 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) The statutory provisions are as follows:

Table 1 to Paragraph (b)(1)

Section 304(g) of the Federal Food, Drug, and Cosmetic Act relating to the administrative detention of devices and drugs (see §§ 800.55(g) and 1.980(g) of this chapter).

Section 304(h) of the Federal Food, Drug, and Cosmetic Act relating to the administrative detention of food for human or animal consumption (see part 1, subpart k of this chapter).

Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act relating to the modification or revocation of a variance from the requirements of section 419 (see part 112, subpart P of this chapter).

Section 515(e)(1) of the Federal Food, Drug, and Cosmetic Act relating to the proposed withdrawal of approval of a device premarket approval application.

Section 515(e)(3) of the Federal Food, Drug, and Cosmetic Act relating to the temporary suspension of approval of a premarket approval application.

Section 515(f)(6) of the Federal Food, Drug, and Cosmetic Act relating to a proposed order revoking a device product development protocol or declaring a protocol not completed.

Section 515(f)(7) of the Federal Food, Drug, and Cosmetic Act relating to revocation of a notice of completion of a product development protocol.

Section 516(b) of the Federal Food, Drug, and Cosmetic Act regarding a proposed regulation to ban a medical device with a special effective date.

Section 518(b) of the Federal Food, Drug, and Cosmetic 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 Federal Food, Drug, and Cosmetic 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 Federal Food, Drug, and Cosmetic 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 Federal Food, Drug, and Cosmetic 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).

Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic Act relating to the misbranding of tobacco products.

Section 906(e)(2)(E) of the Federal Food, Drug, and Cosmetic Act relating to exemptions or variances from tobacco product manufacturing practice requirements.

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.

(2) The regulatory provisions are as follows:

Table 2 to paragraph (b)(2)

Sections 1.634 and 1.664 , relating to revocation of recognition of an accreditation body and withdrawal of accreditation of third-party certification bodies that conduct food safety audits of eligible entities in the food import supply chain and issue food and facility certifications.

Section 1.1173 , relating to the revocation of recognition of an accreditation body, and the disqualification of a laboratory, with respect to food testing conducted under part 1, subpart R of this chapter.

Section 1.1174 , relating to the issuance of a directed food laboratory order by FDA pursuant to § 1.1108 .

Section 56.121(a) , relating to disqualifying an institutional review board or an institution.

Section 58.204(b) , relating to disqualifying a testing facility.

Section 71.37(a) , relating to use of food containing a color additive.

Section 80.31(b) , relating to refusal to certify a batch of a color additive.

Section 80.34(b) , relating to suspension of certification service for a color additive.

Section 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.

Sections 112.201 through 112.213 , (see part 112, subpart R of this chapter), relating to withdrawal of a qualified exemption.

Sections 117.251 through 117.287 (part 117, subpart E of this chapter), relating to withdrawal of a qualified facility exemption.

Section 130.17(1) , relating to a temporary permit to vary from a food standard.

Section 170.17(b) , relating to use of food containing an investigational food additive.

Section 202.1(j)(5) , relating to approval of prescription drug advertisements.

Section 230.150(b), relating to revocation of the grant of a certification for a designated medical gas.

Section 312.70 , relating to whether an investigator is eligible to receive test articles under part 312 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.

Sections 312.70(d) and 312.44 , relating to termination of an IND for a sponsor.

Section 312.160(b) , relating to termination of an IND for tests in vitro and in laboratory research animals for a sponsor.

Section 507.60 through 507.85 (part 507, subpart D of this chapter) relating to withdrawal of a qualified facility exemption.

Section 511.1(b)(5) , relating to use of food containing an investigational new animal drug.

Section 511.1(c)(1) , relating to whether an investigator is eligible to receive test articles under part 511 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products; and any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.

Section 511.1(c)(4) and (d) , relating to termination of an INAD for a sponsor.

Section 812.119 , relating to whether an investigator is eligible to receive test articles under part 812 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.

Section 814.46(c) relating to withdrawal of approval of a device premarket approval application.

Section 822.7(a)(3) , relating to an order to conduct postmarket surveillance of a medical device under section 522 of the act.

Section 830.130 , relating to suspension or revocation of the accreditation of an issuing agency.

Section 895.30(c) , regarding a proposed regulation to ban a medical device with a special effective date.

Section 900.7 , relating to approval, reapproval, or withdrawal of approval of mammography accreditation bodies or rejection of a proposed fee for accreditation.

Section 900.14 , relating to suspension or revocation of a mammography certificate.

Section 900.25 , relating to approval or withdrawal of approval of certification agencies.

Section 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.

Section 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.

Section 1004.6 , relating to plan for repurchase, repair, or replacement of an electronic product.

Section 1107.1(d) , relating to rescission of an exemption from the requirement of demonstrating substantial equivalence for a tobacco product.

Section 1107.50 , relating to rescission of an order finding a tobacco product substantially equivalent.

Section 1210.30 , relating to denial, suspension, or revocation of a permit under the Federal Import Milk Act.

Section 1270.43(e), relating to the retention, recall, and destruction of human tissue.

Section 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.

21 C.F.R. §16.1

44 FR 22367, Apr. 13, 1979

81 FR 52995 , 8/11/2016; 82 FR 61446 , 1/29/2018; 86 FR 55224 , 11/4/2021; 86 FR 68728 , 2/1/2022; 89 FR 51766 , 12/18/2025; 89 FR 77023 , 2/3/2025; 89 FR 77023 , 12/18/2025

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.govinfo.gov.