Title 21 CFR reference

The procedures in this part apply when— (a) A person has a right to an opportunity for a hearing under the laws specified in § 10.50; or (b) The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA.

(a) The record of a hearing consists of— (1) The order or regulation or notice of opportunity for hearing that gave rise to the hearing; (2) All objections and requests for hearing filed by the Division of Dockets Management under §§ 12.20 through 12.22; (3) The notice of hearing published under § 12.35; (4) All notices of participation filed under § 12.45; Federal Register04(5) All notices pertinent to the proceeding; (6) All submissions filed under § 12.82, e.g., the submissions required by § 12.85, all other documentary evidence and written testimony, pleadings, statements of position, briefs, and other similar documents; (7) The transcript, written order, and all other documents relating to the prehearing conference, prepared under § 12.92; (8) All documents relating to any motion for summary decision under § 12.93; (9) All documents of which official notice is taken under § 12.95; (10) All pleadings filed under § 12.96; (11) All documents relating to any interlocutory appeal under § 12.97; (12) All transcripts prepared under § 12.98; and (13) Any other document relating to the hearing and filed with the Division of Dockets Management by the presiding officer or…

Documents in the record will be publicly available in accordance with § 10.20(j). Documents available for examination or copying will be placed on public display in the office of the Division of Dockets Management promptly upon receipt in that office.

(a) The presiding officer shall prepare and file an initial decision as soon as possible after the filing of briefs and oral argument. (b) The initial decision must contain— (1) Findings of fact based issued upon relevant, material, and reliable evidence of record; (2) Conclusions of law; (3) A discussion of the reasons for the findings and conclusions, including a discussion of the significant contentions made by any participant; (4) Citations to the record supporting the findings and conclusions; (5) An appropriate regulation or order supported by substantial evidence of record and based upon the findings of fact and conclusions of law; and (6) An effective date for the regulation or order. ab(c) The initial decision must refrain from disclosing specific details of matters specified in § 10.20(j)(2)(i) () and (), except as specifically authorized in a protective order issued pursuant to § 10.20(j)(3). (d) The initial decision is to be filed with the Division of Dockets Management and served upon all participants. Once the initial decision is filed with the Division of Dockets Management, the presiding officer has no further jurisdiction over the matter, and any motions…

(a) A participant may appeal an initial decision to the Commissioner by filing exceptions with the Division of Dockets Management, and serving them on the other participants, within 60 days of the date of the initial decision. (b) Exceptions must specifically identify alleged errors in the findings of fact or conclusions of law in the initial decision, and provide supporting citations to the record. Oral argument before the Commissioner may be requested in the exceptions. (c) Any reply to the exceptions is to be filed and served within 60 days of the end of the period for filing exceptions. (d) The Commissioner may extend the time for filing exceptions under paragraph (a) of this section or replies to exceptions under paragraph (c) of this section only upon a showing by a participant of extraordinary circumstances. Such an extension shall be requested by filing a written request with the Commissioner's Executive Secretariat (HF-40) and serving copies of the request on the Division of Dockets Management (HFA-305), the Chief Counsel (GCF-1), and all hearing participants. (e) If the Commissioner decides to hear oral argument, the participants will be informed of the date, time,…

(a) On appeal from or review of the initial decision, the Commissioner has all the powers given to make the initial decision. On the Commissioner's own initiative or on motion, the Commissioner may remand the matter to the presiding officer for any further action necessary for a proper decision. (b) The scope of the issues on appeal is the same as the scope of the issues at the public hearing unless the Commissioner specifies otherwise. (c) As soon as possible after the filing of briefs and any oral argument, the Commissioner will issue a final decision in the proceeding, which meets the requirements established in § 12.120 (b) and (c). (d) The Commissioner may adopt the initial decision as the final decision. Federal Register,04(e) Notice of the Commissioner's decision will be published in the or the Commissioner may publish the decision when it is of widespread interest.

Following notice or publication of the final decisions, a participant may petition the Commissioner for reconsideration of any part or all of the decision under § 10.33 or may petition for a stay of the decision under § 10.35.

(a) The Commissioner's final decision constitutes final agency action from which a participant may petition for judicial review under the statutes governing the matter involved. Before requesting an order from a court for a stay of action pending review, a participant shall first submit a petition for a stay of action under § 10.35. (b) Under 28 U.S.C. 2112(a), FDA will request consolidation of all petitions related to a particular matter.

The Chief Counsel for FDA has been designated by the Secretary as the officer on whom copies of petitions of judicial review are to be served. This officer is responsible for filing the record on which the final decision is based. The record of the proceeding is certified by the Commissioner.

(a) A proceeding under section 409(f), 502(n), 512(n)(5), 701(e), or 721(d) of the act or section 4 or 5 of the Fair Packaging and Labeling Act may be initiated— (1) By the Commissioner on the Commissioner's own initiative, e.g., as provided in § 170.15 for food additives; or (2) By a petition— (i) In the form specified elsewhere in this chapter, e.g., the form for a color additive petition in § 71.1; or (ii) If no form is specified, by a petition under § 10.30. (b) If the Commissioner receives a petition under paragraph (a)(2) of this section, the Commissioner will— (1) If it involves any matter subject to section 701(e) of the act or section 4 or 5 of the Fair Packaging and Labeling Act, and meets the requirements for filing, follow the provisions of § 10.40 (b) through (f); (2) If it involves a color additive or food additive, and meets the requirements for filing in §§ 71.1 and 71.2, or in §§ 171.1, 171.6, 171.7, and 171.100, publish a notice of filing of the petition within 30 days after the petition is filed instead of a notice of proposed rulemaking. (c) [Reserved] (d) The notice promulgating the regulation will describe how to submit objections and requests for…

(a) A proceeding under section 505 (d) or (e), 512 (d), (e), (m) (3) or (4), of section 515(g)(1) of the act, or section 351(a) of the Public Health Service Act, may be initiated— (1) By the Commissioner on the Commissioner's own initiative; (2) By a petition in the form specified elsewhere in this chapter, e.g., § 314.50 for new drug applications, § 514.1 for new animal drug applications, or § 601.3 for licenses for biologic products; or (3) By a petition under § 10.30. (b) A notice of opportunity for hearing on a proposal to deny or revoke approval of all or part of an order will be published together with an explanation of the grounds for the proposed action. The notice will describe how to submit requests for hearing. A person subject to the notice has 30 days after its issuance to request a hearing. The 30-day period may not be extended. (c) The Commissioner may use an optional procedure specified in § 10.30(h) to consider issuing, amending, or revoking an order. (d) In a proceeding under sections 505(e), 512(e) or (m), or 515(e) of the act in which a party wishes to apply for reimbursement of certain expenses under the Equal Access to Justice Act (5 U.S.C. 504 and 504…

(a) Objections and requests for a hearing under § 12.20(d) must be submitted to the Division of Dockets Management and will be accepted for filing if they meet the following conditions: (1) They are submitted within the time specified in § 12.20(e). (2) Each objection is separately numbered. (3) Each objection specifies with particularity the provision of the regulation or proposed order objected to. (4) Each objection on which a hearing is requested specifically so states. Failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection. (5) Each objection for which a hearing is requested includes a detailed description and analysis of the factual information to be presented in support of the objection. Failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection. The description and analysis may be used only for the purpose of determining whether a hearing has been justified under § 12.24, and do not limit the evidence that may be presented if a hearing is granted. (i) A copy of any report, article, survey, or other written document relied upon must be submitted,…

Federal Register04As soon as practicable after the expiration of the time for filing objections to and requests for hearing on agency action involving the issuance, amendment, or revocation of a regulation under sections 502(n), 701(e), or 721(d) of the act or sections 4 or 5 of the Fair Packaging and Labeling Act, the Commissioner shall publish a notice in the specifying those parts of the regulation that have been stayed by the filing of proper objections and, if no objections have been filed, stating that fact. The notice does not constitute a determination that a hearing is justified on any objections or requests for hearing that have been filed. When to do so will cause no undue delay, the notice required by this section may be combined with the notices described in §§ 12.28 and 12.35.

(a) As soon as possible the Commissioner will review all objections and requests for hearing filed under § 12.22 and determine— (1) Whether the regulation should be modified or revoked under § 12.26; (2) Whether a hearing has been justified; and (3) Whether, if requested, a hearing before a Public Board of Inquiry under part 13 or before a public advisory committee under part 14 or before the Commissioner under part 15 has been justified. (b) A request for a hearing will be granted if the material submitted shows the following: (1) There is a genuine and substantial issue of fact for resolution at a hearing. A hearing will not be granted on issues of policy or law. (2) The factual issue can be resolved by available and specifically identified reliable evidence. A hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions. (3) The data and information submitted, if established at a hearing, would be adequate to justify resolution of the factual issue in the way sought by the person. A hearing will be denied if the Commissioner concludes that the data and information submitted are insufficient to justify the…

Federal Register.04If the Commissioner determines upon review of an objection or request for hearing that the regulation or order should be modified or revoked, the Commissioner will promptly take such action by notice in the Further objections to or requests for hearing on the modification or revocation may be submitted under §§ 12.20 through 12.22 but no further issue may be taken with other provisions in the regulation or order. Objections and requests for hearing that are not affected by the modification or revocation will remain on file and be acted upon in due course.

If the Commissioner determines upon review of the objections or requests for hearing that a hearing is not justified, in whole or in part, a notice of the determination will be published. (a) The notice will state whether the hearing is denied in whole or in part. If the hearing is denied in part, the notice will be combined with the notice of hearing required by § 12.35, and will specify the objections and requests for hearing that have been granted and denied. (1) Any denial will be explained. A denial based on an analysis of the information submitted to justify a hearing will explain the inadequacy of the information. (2) The notice will confirm or modify or stay the effective date of the regulation or order involved. (b) The record of the administrative proceeding relating to denial of a public hearing in whole or in part on an objection or request for hearing consists of the following: (1) If the proceeding involves a regulation— (i) The documents specified in § 10.40(g); (ii) The objections and requests for hearing filed by the Division of Dockets Management; (iii) If the proceeding involves a color additive regulation referred to an advisory committee in accordance…

(a) A person with a right to submit objections and a request for hearing under § 12.20(d) may submit objections and waive the right to a hearing. The waiver may be either an explicit statement, or a failure to request a hearing, as provided in 12.22(a)(4). (b) If a person waives the right to a hearing, the Commissioner will rule upon the person's objections under §§ 12.24 through 12.28. As a matter of discretion, the Commissioner may also order a hearing on the matter under any of the provisions of this part. (c) If the Commissioner rules adversely on a person's objection, the person may petition for judicial review in a U.S. Court of Appeals under the act. (1) The record for judicial review is the record designated in § 12.28(b)(1). (2) The time for filing a petition for judicial review begins as of the date of publication of the Commissioner's ruling on the objections.

(a) A person with a right to request a hearing may waive that right and request one of the following alternatives: (1) A hearing before a Public Board of Inquiry under part 13. (2) A hearing before a public advisory committee under part 14. (3) A hearing before the Commissioner under part 15. (b) The request— (1) May be on the person's own initiative or at the suggestion of the Commissioner. (2) Must be submitted in the form of a citizen petition under § 10.30 before publication of a notice of hearing under § 12.35 or a denial of hearing under § 12.28; and (3) Must be— (i) In lieu of a request for a hearing under this part; or (ii) If submitted after or with a request for hearing, in the form of a waiver of the right to request a hearing conditioned on an alternative form of hearing. Upon acceptance by the Commissioner, the waiver becomes binding and may be withdrawn only by waiving any right to any form of hearing unless the Commissioner determines otherwise. (c) When more than one person requests and justifies a hearing under this part, an alternative form of hearing may by used only if all the persons concur and waive their right to request a hearing under this part.…

(a) If the Commissioner determines upon review of the objections and requests for hearing that a hearing is justified on any issue, the Commissioner will publish a notice setting forth the following: (1) The regulation or order that is the subject of the hearing. (2) A statement specifying any part of the regulation or order that has been stayed by operation of law or in the Commissioner's discretion. (3) The parties to the hearing. (4) The issues of fact on which a hearing has been justified. (5) A statement of any objections or requests for hearing for which a hearing has not been justified, which are subject to § 12.28. (6) The presiding officer, or a statement that the presiding officer will be designated in a later notice. (7) The time within which notices of participation should be filed under § 12.45. (8) The date, time, and place of the prehearing conference, or a statement that the date, time, and place will be announced in a later notice. The pre-hearing conference may not commence until after the time expires for filing the notice of participation required by § 12.45(a). (9) The time within which participants should submit written information and views under §…

(a) If no objections are filed and no hearing is requested on a regulation under § 12.20(e), the regulation is effective on the date specified in the regulation as promulgated. Federal Register04(b) The Commissioner shall publish a confirmation of the effective date of the regulation. The document confirming the effective date of the regulation may extend the time for compliance with the regulation.

(a) If a person who is subject to a notice of opportunity for hearing under § 12.21(b) does not request a hearing, the Commissioner will— (1) Publish a final order denying or withdrawing approval of an NDA, NADA, device premarket approval application, or biologics license, in whole or in part, or revoking a device product development protocol or notice of completion, or declaring that such a protocol has not been completed, and stating the effective date of the order; and (2) If the order involves withdrawal of approval of an NADA, forthwith revoke, in whole or in part, the applicable regulation, under section 512(i) of the act. (b) If a person who is subject to a notice of opportunity for hearing under § 12.21(b) requests a hearing and others do not, the Commissioner may issue a final order covering all the drug or device products at once or may issue more than one final order covering different drug or device products at different times.

(a) A person who has filed a notice of participation under § 12.45 may appear in person or by counsel or other representative in any hearing and, subject to § 12.89, may be heard concerning all relevant issues. (b) The presiding officer may strike a person's appearance for violation of the rules of conduct in § 12.90.

(a) Within 30 days after publication of the notice of hearing under § 12.35, a person desiring to participate in a hearing is to file with the Division of Dockets Management under § 10.20 a notice of participation in the following form: (b) An amendment to a notice of participation should be filed with the Division of Dockets Management and served on all participants. (c) No person may participate in a hearing who has not filed a written notice of participation or whose participation has been stricken under paragraph (e) of this section. (d) The presiding officer may permit the late filing of a notice of participation upon a showing of good cause. (e) The presiding officer may strike the participation of a person for nonparticipation in the hearing or failure to comply with any requirement of this subpart, e.g., disclosure of information as required by § 12.85 or the prehearing order issued under § 12.92. Any person whose participation is stricken may petition the Commissioner for interlocutory review. (Date) Division of Dockets Management, Food and Drug Administration, Department of Health and Human Services, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Under 21 CFR…

Designated agency contact.(a) All inquiries from the public about scheduling, location, and general procedures should be addressed to the Deputy Commissioner for Policy (HF-22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or telephone 301-443-3480. The staff of the Associate Commissioner for Regulatory Affairs will attempt to respond promptly to all inquiries from members of the public, as well as to simple requests for information from participants in hearings. Hearing schedule changes.(b) Requests by hearing participants for changes in the schedule of a hearing or for filing documents, briefs, or other pleadings should be made in writing directly to the Administrative Law Judge (HF-3), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Legal advice to individuals.(c) FDA does not have the resources to provide legal advice to members of the public concerning participation in hearings. Furthermore, to do so would compromise the independence of the Commissioner's office and invite charges of improper interference in the hearing process. Accordingly, the Deputy Commissioner for Policy (HF-22) will not answer questions about the…

The presiding officer in a hearing will be the Commissioner, a member of the Commissioner's office to whom the responsibility for the matter involved has been delegated, or an administrative law judge qualified under 5 U.S.C. 3105.

The functions of the presiding officer begin upon designation and end upon the filing of the initial decision.

The presiding officer has all powers necessary to conduct a fair, expeditious, and orderly hearing, including the power to— (a) Specify and change the date, time, and place of oral hearings and conferences; (b) Establish the procedures for use in developing evidentiary facts, including the procedures in § 12.92(b) and to rule on the need for oral testimony and cross-examination under § 12.87(b); (c) Prepare statements of the areas of factual disagreement among the participants; (d) Hold conferences to settle, simplify, or determine the issues in a hearing or to consider other matters that may expedite the hearing; (e) Administer oaths and affirmations; (f) Control the course of the hearing and the conduct of the participants; (g) Examine witnesses and strike their testimony if they fail to respond fully to proper questions; (h) Rule on, admit, exclude, or limit evidence; (i) Set the time for filing pleadings; (j) Rule on motions and other procedural matters; (k) Rule on motions for summary decision under § 12.93; (l) Conduct the hearing in stages if the number of parties is large or the issues are numerous and complex; (m) Waive, suspend, or modify any rule in this…

(a) A participant may request the presiding officer to disqualify himself/herself and withdraw from the proceeding. The ruling on any such request may be appealed in accordance with § 12.97(b). (b) A presiding officer who is aware of grounds for disqualification shall withdraw from the proceeding.

(a) If the presiding officer is unable to act for any reason, the Commissioner will assign the powers and duties to another presiding officer. The substitution will not affect the hearing, except as the new presiding officer may order. (b) Any motion based on the substitution must be made within 10 days.

(a) Submissions, including pleadings in a hearing, are to be filed with the Division of Dockets Management under § 10.20 except that only two copies need be filed. To determine compliance with filing deadlines in a hearing, a submission is considered submitted on the date it is actually received by the Division of Dockets Management. When this part allows a response to a submission and prescribes a period of time for the filing of the response, an additional 3 days are allowed for the filing of the response if the submission is served by mail. (b) The person making a submission shall serve copies of it on the other participants. Submissions of documentary data and information are not required to be served on each participant, but any accompanying transmittal letter, pleading, summary, statement of position, certification under paragraph (d) of this section, or similar document must be served on each participant. (c) Service is accomplished by mailing a submission to the address shown in the notice of participation or by personal delivery. (d) All submissions are to be accompanied by a certificate of service, or a statement that service is not required. (e) No written…

(a) A participant who believes that compliance with the filing and service requirements of this section constitutes an unreasonable financial burden may submit to the Commissioner a petition to participate in forma pauperis. (b) The petition will be in the form specified in § 10.30 except that the heading will be “Request to Participate in Forma Pauperis, Docket No. ____.” Filing and service requirements for the petition are described in paragraph (c) of this section, whether or not the petition is granted. The petition must demonstrate that either: (1) The person is indigent and a strong public interest justifies participation, or (2) the person's participation is in the public interest because it can be considered of primary benefit to the general public. (c) The Commissioner may grant or deny the petition. If the petition is granted, the participant need file only one copy of each submission with the Division of Dockets Management. The Division of Dockets Management will make sufficient additional copies for the administrative record, and serve a copy on each other participant.

Before or during a hearing, a person may, under § 10.85, request the Commissioner for an advisory opinion on whether any regulation or order under consideration in the proceeding applies to a specific situation.

(a) Before the notice of hearing is published under § 12.35, the director of the center responsible for the matters involved in the hearing shall submit the following to the Division of Dockets Management: (1) The relevant portions of the administrative record of the proceeding. Portions of the administrative record not relevant to the issues in the hearing are not part of the administrative record. Files(2) All documents in the director's files containing factual information, whether favorable or unfavorable to the director's position, which relate to the issues involved in the hearing. means the principal files in the center in which documents relating to the issues in the hearing are ordinarily kept, e.g., the food additive master file and the food additive petition in the case of issues concerning a food additive, or the new drug application in the case of issues concerning a new drug. Internal memoranda reflecting the deliberative process, and attorney work product and material prepared specifically for use in connection with the hearing, are not required to be submitted. (3) All other documentary data and information relied upon. (4) A narrative position statement on the…

(a) The objective of a formal evidentiary hearing is the fair determination of relevant facts consistent with the right of all interested persons to participate and the public interest in promptly settling controversial matters affecting the public health and welfare. (b) Accordingly, the evidence at a hearing is to be developed to the maximum extent through written submissions, including written direct testimony, which may be in narrative or in question-and-answer form. (1) In a hearing, the issues may have general applicability and depend on general facts that do not concern particular action of a specific party, e.g., the safety or effectiveness of a class of drug products, the safety of a food or color additive, or a definition and standard of identity for a food; or the issues may have specific applicability to past action and depend upon particular facts concerning only that party, e.g., the applicability of a grandfather clause to a particular brand of a drug or the failure of a particular manufacturer to meet required manufacturing and processing specifications or other general standards. (i) If the proceeding involves general issues, direct testimony will be submitted…

(a) A nonparty participant may— (1) Attend all conferences (including the prehearing conference), oral proceedings, and arguments; (2) Submit written testimony and documentary evidence for inclusion in the record; (3) File written objections, briefs, and other pleadings; and (4) Present oral argument. (b) A nonparty participant may not— (1) Submit written interrogatories; and (2) Conduct cross-examination. (c) A person whose petition is the subject of the hearing has the same right as a party. (d) A nonparty participant will be permitted additional rights if the presiding officer concludes that the participant's interests would not be adequately protected otherwise or that broader participation is required for a full and true disclosure of the facts, but the rights of a nonparty participant may not exceed the rights of a party. [44 FR 22339, Apr. 13, 1979, as amended at 48 FR 51770, Nov. 14, 1983]

All participants in a hearing will conduct themselves with dignity and observe judicial standards of practice and ethics. They may not indulge in personal attacks, unseemly wrangling, or intemperate accusations or characterizations. Representatives of parties shall, to the extent possible, restrain clients from improprieties in connection with any proceeding. Disrespectful, disorderly, or contumacious language or conduct, refusal to comply with directions, use of dilatory tactics, or refusal to adhere to reasonable standards of orderly and ethical conduct during any hearing, constitute grounds for immediate exclusion from the proceeding by the presiding officer.

A prehearing conference will commence at the date, time, and place announced in the notice of hearing, or in a later notice, or as specified by the presiding officer in a notice modifying a prior notice. At that conference the presiding officer will establish the methods and procedures to be used in developing the evidence, determine reasonable time periods for the conduct of the hearing, and designate the times and places for the production of witnesses for direct and cross-examination if leave to conduct oral examination is granted on any issue, as far as practicable at that time.

(a) Participants in a hearing are to appear at the prehearing conference prepared to discuss and resolve all matters specified in paragraph (b) of this section. (1) To expedite the hearing, participants are encouraged to prepare in advance for the prehearing conference. Participants should cooperate with each other, and request information and begin preparation of testimony at the earliest possible time. Failure of a participant to appear at the prehearing conference or to raise matters that could reasonably be anticipated and resolved at that time will not delay the progress of the hearing, and constitutes a waiver of the rights of the participant regarding such matters as objections to the agreements reached, actions taken, or rulings issued by the presiding officer and may be grounds for striking the participation under § 12.45. (2) Participants shall bring to the prehearing conference the following specific information, which will be filed with the Division of Dockets Management under § 12.80: (i) Any additional information to supplement the submission filed under § 12.85, which may be filed if approved under § 12.85(c). (ii) A list of all witnesses whose testimony will be…

(a) After the hearing commences, a participant may move, with or without supporting affidavits, for a summary decision on any issue in the hearing. Any other participant may, within 10 days after service of the motion, which time may be extended for an additional 10 days for good cause, serve opposing affidavits or countermove for summary decision. The presiding officer may set the matter for argument and call for the submission of briefs. (b) The presiding officer will grant the motion if the objections, requests for hearing, other pleadings, affidavits, and other material filed in connection with the hearing, or matters officially noticed, show that there is no genuine issue as to any material fact and that a participant is entitled to summary decision. (c) Affidavits should set forth facts that would be admissible in evidence and show affirmatively that the affiant is competent to testify to the matters stated. When a properly supported motion for summary decision is made, a participant opposing the motion may not rest upon mere allegations or denials or general descriptions of positions and contentions; affidavits or other responses must set forth specific facts showing that…

(a) A hearing consists of the development of evidence and the resolution of factual issues as set forth in this subpart and in the prehearing order. (b) All orders, transcripts, written statements of position, written direct testimony, written interrogatories and responses, and any other written material submitted in the proceeding is a part of the administrative record of the hearing, and will be promptly placed on public display in the office of the Division of Dockets Management, except as provided in § 12.105. (c) Written evidence, identified as such, is admissible unless a participant objects and the presiding officer excludes it on objection of a participant or on the presiding officer's own initiative. (1) The presiding officer may exclude written evidence as inadmissible only if— (i) The evidence is irrelevant, immaterial, unreliable, or repetitive; (ii) Exclusion of part or all of the written evidence of a participant is necessary to enforce the requirements of this subpart; or (iii) The evidence was not submitted as required by § 12.85. (2) Items of written evidence are to be submitted as separate documents, sequentially numbered, except that a voluminous document…

(a) Official notice may be taken of such matters as might be judicially noticed by the courts of the United States or of any other matter peculiarly within the general knowledge of FDA as an expert agency. (b) If official notice is taken of a material fact not appearing in the evidence of record, a participant, on timely request, will be afforded an opportunity to show the contrary.

(a) Promptly after the taking of evidence is completed, the presiding officer will announce a schedule for the filing of briefs. Briefs are to be filed ordinarily within 45 days of the close of the hearing. Briefs must include a statement of position on each issue, with specific and complete citations to the evidence and points of law relied on. Briefs must contain proposed findings of fact and conclusions of law. (b) The presiding officer may, as a matter of discretion, permit oral argument after the briefs are filed. ab(c) Briefs and oral argument are to refrain from disclosing specific details of written and oral testimony and documents relating to matters specified in § 10.20(j)(2)(i)() and (), except as specifically authorized in a protective order issued under § 10.20(j)(3).

(a) Except as provided in paragraph (b) of this section and in §§ 12.35(b), 12.45(e), 12.93(f), and 12.99(d), when an interlocutory appeal is specifically authorized by this subpart, rulings of the presiding officer may not be appealed to the Commissioner before the Commissioner's consideration of the entire record of the hearing. (b) A ruling of the presiding officer is subject to interlocutory appeal to the Commissioner if the presiding officer certifies on the record or in writing that immediate review is necessary to prevent exceptional delay, expense, or prejudice to any participant, or substantial harm to the public interest. (c) When an interlocutory appeal is made to the Commissioner, a participant may file a brief with the Commissioner only if specifically authorized by the presiding officer or the Commissioner, and if such authorization is granted, within the period the Commissioner directs. If a participant is authorized to file a brief, any other participant may file a brief in opposition, within the period the Commissioner directs. If no briefs are authorized, the appeal will be presented as an oral argument to the Commissioner. The oral argument will be…

(a) The presiding officer will arrange for a verbatim stenographic transcript of oral testimony and for necessary copies of the transcript. (b) One copy of the transcript will be placed on public display in the office of the Division of Dockets Management upon receipt. (c) Except as provided in § 12.105, copies of the transcript may be obtained by application to the official reporter and payment of costs thereof or under part 20. (d) Witnesses, participants, and counsel have 30 days from the time the transcript becomes available to propose corrections in the transcript of oral testimony. Corrections are permitted only for transcription errors. The presiding officer shall promptly order justified corrections.

(a) A motion on any matter relating to the proceeding is to be filed under § 12.80, and must include a draft order, except one made in the course of an oral hearing before the presiding officer. (b) A response may be filed within 10 days of service of a motion. The time may be shortened or extended by the presiding officer for good cause shown. (c) The moving party has no right to reply, except as permitted by the presiding officer. (d) The presiding officer shall rule upon the motion and may certify that ruling to the Commissioner for interlocutory review.