and to proposed exemptions from preemption of State and local device requirements under § 808.25(e).

(c) A person who has right to an opportunity for a formal evidentiary public hearing under part 12 waives that opportunity and instead requests under §12.32 a public hearing before the Commissioner, and the Commissioner, as a matter of discretion, accepts the request.

Subpart B-Procedures for Public Hearing Before the Commissioner

§ 15.20 Notice of a public hearing before the Commissioner.

(a) If the Commissioner determines that a public hearing should be held on a matter, the Commissioner will publish a notice of hearing in the FEDERAL REGISTER Setting forth the following information:

(1) If the hearing is under § 15.1 (a) or (b), the notice will state the following:

(i) The purpose of the hearing and the subject matter to be considered. If a written document is to be the subject matter of the hearing, it will be published as part of the notice, or reference made to it if it has already been published in the FEDERAL REGISTER, or the notice will state that the document is available from an agency office identified in the notice.

(ii) The time, date, and place of the hearing, or a statement that the information will be contained in a subsequent notice.

(2) If the hearing is in lieu of a formal evidentiary public hearing under information de

§15.1(c), all of the scribed in § 12.32(e).

(b) The scope of the hearing is determined by the notice of hearing and any regulation under which the hearing is held. If a regulation, e.g., § 330.10(a)(10), limits a hearing to review of an existing administrative record, information not already in the record may not be considered at the hearing.

(c) The notice of hearing may require participants to submit the text of their presentations in advance of the hearing if the Commissioner determines that advance submissions are necessary for the panel to formulate useful questions to be posed at the hearing under § 15.30(e). The notice may provide for

the submission of a comprehensive outline as an alternative to the submission of the text if the Commissioner determines that submission of an outline will be sufficient.

[44 FR 22366, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]

§ 15.21 Notice of participation; schedule for hearing.

(a) The notice of hearing will provide persons an opportunity to file a written notice of participation with the Dockets Management Branch within a specified period of time containing the information specified in the notice, e.g., name of participant, address, phone number, affiliation, if any, topic of presentation and approximate amount of time requested for the presentation. If the public interest requires, e.g., a hearing is to be conducted within a short period of time or is to be primarily attended by individuals without an organizational affiliation, the notice may name a specific FDA employee and telephone number to whom an oral notice of participation may be given or provide for submitting notices of participation at the time of the hearing. A written or oral notice of participation must be received by the designated person by the close of business of the day specified in the notice.

(b) Promptly after expiration of the time for filing a notice, the Commissioner will determine the amount of time allotted to each person and the approximate time that oral presentation is scheduled to begin. If more than one hearing is held on the same subject, a person will ordinarily be allotted time for a presentation at only one hearing.

(c) Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and to request time for a joint presentation. The Commissioner may require joint presentations by persons with common interests.

(d) The Commissioner will prepare a hearing schedule showing the persons making oral presentations and the time alloted to each person, which will be filed with the Dockets Management Branch and mailed or telephoned before the hearing to each participant.

(e) The hearing schedule will state whether participants must be present by a specified time to be sure to be heard in case the absence of participants advances the schedule.

§ 15.25 Written submissions.

A person may submit information or views on the subject of the hearing in writing to the Dockets Management Branch, under §10.20. The record of the hearing will remain open for 15 days after the hearing is held for any additional written submissions, unless the notice of the hearing specifies otherwise or the presiding officer rules otherwise.

§ 15.30 Conduct of a public hearing before the Commissioner.

(a) The Commissioner or a designee may preside at the hearing, except where a regulation provides that the Commissioner will preside personally. The presiding officer may be accompanied by other FDA employees or other Federal Government employees designated by the Commissioner, who may serve as a panel in conducting the hearing.

(b) The hearing will be transcribed.

(c) Persons may use their alloted time in whatever way they wish, consistent with a reasonable and orderly hearing. A person may be accompanied by any number of additional persons, and may present any written information or views for inclusion in the record of the hearing, subject to the requirements of § 15.25. The presiding officer may allot additional time to any person when the officer concludes that it is in the public interest, but may not reduce the time allotted for any person without the consent of the person.

(d) If a person is not present at the time specified for the presentation, the persons following will appear in order, with adjustments for those appearing at their scheduled time. An attempt will be made to hear any person who is late at the conclusion of the hearing. Other interested persons attending the hearing who did not request an opportunity to make an oral presentation will be given an opportunity to make an oral presentation at the conclusion of the hearing, in the discretion of the

presiding officer, to the extent that time permits.

(e) The presiding officer and any other persons serving on a panel may question any person during or at the conclusion of the presentation. No other person attending the hearing may question a person making a presentation. The presiding officer may, as a matter of discretion, permit questions to be submitted to the presiding officer or panel for response by them or by persons attending the hearing.

(f) The hearing is informal in nature, and the rules of evidence do not apply. No motions or objections relating to the admissibility of information and views may be made or considered, but other participants may comment upon or rebut all such information and views. No participant may interrupt the presentation of another participant at any hearing for any reason.

(g) The hearing may end early only if all persons scheduled for a later presentation have already appeared or it is past the time specified in the hearing schedule, under §15.21(e), by which participants must be present.

(h) The Commissioner or the presiding officer may, under §10.19, suspend, modify, or waive any provision of this part.

Subpart C-Records of a Public Hearing Before the Commissioner

§ 15.40 Administrative record.

(a) The administrative record of a public hearing before the Commissioner consists of the following:

(1) All relevant FEDERAL REGISTER notices, including any documents to which they refer.

(2) All written submissions under §15.25.

(3) The transcript of the oral hearing. (b) The record of the administrative proceeding will be closed at the time specified in § 15.25.

§ 15.45 Examination of administrative record.

Section 10.20(j) governs the availability for public examination and copying of each document in the administrative record of the hearing

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.

Subpart A-General Provisions § 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 § 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 §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). (2) Regulatory provisions:

§ 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.

§ 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.

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

§ 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]

EFFECTIVE DATE NOTE: At 67 FR 5467, Feb. 6, 2002, § 16.1 was amended in paragraph (b)(2) by numerically adding an entry for §900.25, effective May 7, 2002. For the convenience of the user, the added text is set forth as follows:

§ 16.5 Inapplicability and limited applicability.

(a) This part does not apply to the following:

(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.

(3) Factory inspections, recalls (except mandatory recalls of medical devices intended for human use), regulatory letters, and similar compliance activities related to law enforcement.

(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.

(b) If a regulation provides a person with an opportunity for hearing and specifies some procedures for the hearing but not a comprehensive set of procedures, the procedures in this part apply to the extent that they are supplementary and not in conflict with the other procedures specified for the hearing. Thus, the procedures in subpart A of part 108 relating to emergency permit control are supplemented by the nonconflicting procedures in this part, e.g., the right to counsel, public notice of the hearing, reconsideration and stay, and judicial review.

[44 FR 22367, Apr. 13, 1979, as amended at 57 FR 58403, Dec. 10, 1992; 65 FR 76110, Dec. 5, 2000]

Subpart B-Initiation of
Proceedings

§ 16.22 Initiation of regulatory hearing.

(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