Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=pt21.1.16&rgn=div5
Timestamp: 2020-02-25 22:36:25
Document Index: 287612310

Matched Legal Cases: ['art 16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§800', '§820', '§812', '§1', '§56', '§58', '§71', '§80', '§80', '§99', '§112', 'art 112', '§117', 'art 117', '§130', '§170', '§202', '§312', 'art 312', '§312', '§312', '§507', 'art 507', '§511', '§511', 'art 511', '§511', '§812', 'art 812', '§814', '§822', '§830', '§895', '§900', '§900', '§900', '§1003', '§1003', '§1004', '§1107', '§1210', '§1270', '§1271', '§16', '§1210', '§1', '§1005', '§101', '§118', 'art 10', '§16', '§16', '§16', '§16', '§16', '§10', '§16', '§20', '§20', '§20', '§10', '§16', '§16', '§16', '§16', '§16', '§16', '§10', '§10', '§10']

Title 21 → Chapter I → Subchapter A → Part 16
§16.1 Scope.
§16.5 Inapplicability and limited applicability.
§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.
§16.120 Judicial review.
Source: 44 FR 22367, Apr. 13, 1979, unless otherwise noted.
Section 304(g) of the act relating to the administrative detention of devices and drugs (see §§800.55(g) and 1.980(g) of this chapter).
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).
§§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.
§56.121(a), relating to disqualifying an institutional review board or an institution.
§58.204(b), relating to disqualifying a testing facility.
§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.
§§112.201 through 112.213, (see part 112, subpart R of this chapter), relating to withdrawal of a qualified exemption.
§§117.251 through 117.287 (part 117, subpart E of this chapter), relating to withdrawal of a qualified facility exemption.
§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 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.
§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.
§§507.60 through 507.85 (part 507, subpart D of this chapter) relating to withdrawal of a qualified facility exemption.
§511.1(b)(5), relating to use of food containing an investigational new animal drug.
§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.
§511.1(c) (4) and (d), relating to termination of an INAD for a sponsor.
§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.
§814.46(c) relating to withdrawal of approval of a device premarket approval application.
§822.7(a)(3), relating to an order to conduct postmarket surveillance of a medical device under section 522 of the act.
§830.130, relating to suspension or revocation of the accreditation of an issuing agency.
§895.30(c), regarding a proposed regulation to ban a medical device with a special effective date.
§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.
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.govinfo.gov.
(1) Informal presentation of views before reporting a criminal violation under section 305 of the act and section 5 of the Federal Import Milk Act and §1210.31.
(2) A hearing on a refusal of admission of a food, drug, device, or cosmetic under section 801(a) of the act and §1.94, or of an electronic product under section 360(a) of the Public Health Service Act and §1005.20.
(4) A hearing on an order for relabeling, diversion, or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264) and §§101.17(h) and 115.50 of this chapter.
(5) A hearing on an order for diversion or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264), and §118.12 of this chapter.
[44 FR 22367, Apr. 13, 1979, as amended at 57 FR 58403, Dec. 10, 1992; 65 FR 76110, Dec. 5, 2000; 74 FR 33095, July 9, 2009]
(a) A regulatory hearing is initiated by a notice of opportunity for hearing from FDA. The notice will—
(1) Be sent by mail, telegram, telex, personal delivery, or any other mode of written communication;
(2) Specify the facts and the action that are the subject of the opportunity for a hearing;
(3) State that the notice of opportunity for hearing and the hearing are governed by this part; and
(4) State the time within which a hearing may be requested, and state the name, address, and telephone number of the FDA employee to whom any request for hearing is to be addressed.
(5) Refer to FDA's guideline on electronic media coverage of its administrative proceedings (21 CFR part 10, subpart C).
(b) A person offered an opportunity for a hearing has the amount of time specified in the notice, which may not be less than 3 working days after receipt of the notice, within which to request a hearing. The request may be filed by mail, telegram, telex, personal delivery, or any other mode of written communication, addressed to the designated FDA employee. If no response is filed within that time, the offer is deemed to have been refused and no hearing will be held.
(c) If a hearing is requested, the Commissioner will designate a presiding officer, and the hearing will take place at a time and location agreed upon by the party requesting the hearing, the FDA, and the presiding officer or, if agreement cannot be reached, at a reasonable time and location designated by the presiding officer.
(d) A notice of opportunity for hearing under this section will not operate to delay or stay any administrative action, including enforcement action by the agency unless the Commissioner, as a matter of discretion, determines that delay or a stay is in the public interest.
[44 FR 22367, Apr. 13, 1979, as amended at 49 FR 32173, Aug. 13, 1984]
(a) A regulatory hearing required by the act or a regulation under §16.1(b) will be initiated in the same manner as other regulatory hearings subject to the additional procedures in this section.
[44 FR 22367, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982; 54 FR 9037, Mar. 3, 1989]
(b) After a hearing commences, the presiding officer may issue a summary decision on any issue in the hearing if the presiding officer determines from the material submitted in connection with the hearing, or from matters officially noticed, that there is no genuine and substantial issue of fact respecting that issue. For the purpose of this paragraph, a hearing commences upon the receipt by FDA of a request for hearing submitted under §16.22(b).
(c) The Commissioner or his or her delegate may review any summary decision of the presiding officer issued under paragraph (b) of this section at the request of a party or on the Commissioner's or his or her delegate's own initiative.
[69 FR 17290, Apr. 2, 2004]
(a) An FDA employee to whom the Commissioner delegates such authority, or any other agency employee designated by an employee to whom such authority is delegated, or, consistent with 5 CFR 930.209(b) or (c), an administrative law judge to whom such authority is delegated, may serve as the presiding officer and conduct a regulatory hearing under this part.
(b) In a regulatory hearing required by the act or a regulation, the presiding officer is to be free from bias or prejudice and may not have participated in the investigation or action that is the subject of the hearing or be subordinate to a person, other than the Commissioner, who has participated in such investigation or action.
(c)(1) The Commissioner or the delegate under §16.40 is not precluded by this section from prior participation in the investigation or action that is the subject of the hearing. If there has been prior participation, the Commissioner or the delegate should, if feasible, designate a presiding officer for the hearing who is not a subordinate. Thus, if the Commissioner's authority to make a final decision has been delegated to a center director, the presiding officer may be an official in another center or the office of the Commissioner. The exercise of general supervisory responsibility, or the designation of the presiding officer, does not constitute prior participation in the investigation or action that is the subject of the hearing so as to preclude the Commissioner or delegate from designating a subordinate as the presiding officer.
(2) The party requesting a hearing may make a written request to have the Commissioner or the delegate under §16.40 be the presiding officer, notwithstanding paragraph (c)(1) of this section. If accepted, as a matter of discretion, by the Commissioner or the delegate, the request is binding upon the party making the request.
(3) A different presiding officer may be substituted for the one originally designated under §16.22 without notice to the parties.
[44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989; 67 FR 53306, Aug. 15, 2002]
(a) Regulatory hearings are not subject to the separation of functions rules in §10.55.
(b) Those persons who are directly involved in the investigation or presentation of the position of FDA or any party at a regulatory hearing that is required by the act or a regulation should avoid any off-the-record communication on the matter to the presiding officer or the Commissioner or their advisors if the communication is inconsistent with the requirement of §16.95(b)(1) that the administrative record be the exclusive record for decision. If any communication of this type occurs, it is to be reduced to writing and made part of the record, and the other party provided an opportunity to respond.
(c) A copy of any letter or memorandum of meeting between a participant in the hearing and the presiding officer or the Commissioner, e.g., a response by the presiding officer to a request for a change in the time of the hearing, is to be sent to all participants by the person writing the letter or the memorandum.
(a) A regulatory hearing is public, except when the Commissioner determines that all or part of a hearing should be closed to prevent a clearly unwarranted invasion of personal privacy; to prevent the disclosure of a trade secret or confidential commercial or financial information that is not available for public disclosure under §20.61; or to protect investigatory records complied for law enforcement purposes that are not available for public disclosure under §20.64.
(2) If the hearing is a private hearing, no persons other than the party requesting the hearing, counsel and witnesses, and an employee or consultant or other person subject to a commercial arrangement as defined in §20.81(a) and FDA representatives with a direct professional interest in the subject matter of the proceeding are entitled to attend.
(h) The Commissioner or the presiding officer has the power under §10.19 to suspend, modify, or waive any provision of this part.
Any party to a hearing under this part has the right at all times to be advised and accompanied by counsel.
(4) The presiding officer's report of the hearing and comments on the report under §16.60(e).
(5) All letters and memoranda of meetings or communications between participants and the presiding officer or the Commissioner referred to in §16.44(c).
(a) With respect to a regulatory hearing at the Commissioner's initiative under §16.1(a), the Commissioner shall consider the administrative record of the hearing specified in §16.80(a) together with all other relevant information and views available to FDA in determining whether regulatory action should be taken and, if so, in what form.
(b) With respect to a regulatory hearing required by the act or a regulation under §16.1(b)—
(1) The administrative record of the hearing specified in §16.80(a) constitutes the exclusive record for decision;
(2) On the basis of the administrative record of the hearing, the Commissioner shall issue a written decision stating the reasons for the Commissioner's administrative action and the basis in the record; and
(3) For purposes of judicial review under §10.45, the record of the administrative proceeding consists of the record of the hearing and the Commissioner's decision.
After any final administrative action that is the subject of a hearing under this part, any party may petition the Commissioner for reconsideration of any part or all of the decision or action under §10.33 or may petition for a stay of the decision or action under §10.35.
Section 10.45 governs the availability of judicial review concerning any regulatory action which is the subject of a hearing under this part