(5) The time within which written appearances must be filed.

(6) The time (not earlier than 30 days after the date of publication of the notice of hearing in the FEDERAL REGISTER) when the hearing will commence. § 2.70

Time and place of hearing.

The hearing will commence at the place and time announced in the notice of hearing, but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without other notice than announcement thereof by the presiding officer at the hearing.

DESIGNATION, POWERS,

RESPONSIBILITIES

AND DUTIES OF PRESIDING OFFICER

§ 2.71 Presiding officer.

A presiding officer shall preside over all hearings held pursuant to section 701 of the act. The presiding officer shall be either the Commissioner or a hearing examiner qualified under section 11 of the Administrative Procedure Act and designated by the Commissioner to conduct the hearing.

§ 2.72 Commencement of functions.

The functions of the presiding officer shall commence upon his designation and terminate upon the certification of the record to the Commissioner.

§ 2.73

Authority of presiding officer.

Hearings shall be conducted in an informal but orderly manner in accordance with this Subpart F and the requirements of the Administrative Procedure Act, and where such sections or the Administrative Procedure Act are inapplicable or incomplete, in accordance with the directions of the presiding officer. The presiding officer shall have the duty to conduct a fair hearing, to take all necessary action to avoid delay, and to maintain order. He shall have all powers necessary to these ends, including (but not limited to) the power to:

(a) Arrange and issue notice of the date, time, and place of hearings and prehearing conferences, and, upon proper notice to change the date, time, and place of hearings and prehearing conferences previously set.

(b) Hold conferences to settle, simplify, or fix the issues in a proceeding, or to consider other matters that may aid in the expeditious disposition of the proceeding.

(c) Require parties to state their position with respect to the various issues in the proceeding.

(d) Administer oaths and affirmations. (e) Regulate the course of the hearing and the conduct of counsel therein. (f) Examine witnesses and direct witnesses to testify.

(g) Receive, rule on, exclude, or limit evidence.

(h) Fix the time for filing motions, petitions, briefs, findings, or other items in matters pending before him.

(1) Rule on motions and other procedural items pending before him.

(j) Take any action permitted to the presiding officer as authorized by this Subpart F or in conformance with the provisions of the Administrative Procedure Act (5 U.S.C. 1001 to 1011).

PREHEARING AND OTHER CONFERENCES

§ 2.74 Prehearing conference.

The presiding officer on his own motion, or on the motion of any party or his representative, may direct all parties or their representatives to appear at a specified time and place for a conference for:

(a) The simplification of the issues. (b) The possibility of obtaining stipulations, admission of facts, and documents.

(c) The possibility of limitation of the number of expert witnesses.

(d) The identification, and if practicable, the scheduling of witnesses to be called.

(e) The advance submission at the prehearing conference of all documentary evidence in quintuplicate to be marked for identification. (When portions only of a document are to be relied upon, the offering party shall prepare the pertinent excerpts thereof, adequately identified, and shall supply copies of such excerpts together with the original document to the presiding officer for examination and study by all other parties and for use by opposing counsel for purpose of cross-examination.)

(f) Such other matters as may aid in the expeditious disposition of the proceeding.

§ 2.75 Exclusion of witnesses and documentary evidence.

The failure to identify witnesses and submit documentary evidence at the prehearing conference in accordance with

The presiding officer may have the prehearing conference reported verbatim and shall make an order reciting the action taken at the conference, the agreements made by the parties or their representatives, the schedule of witnesses, and a statement of the issues for hearing. Such order shall control the subsequent course of the proceeding unless modified for good cause by subsequent order.

§ 2.77 Other conferences.

The presiding officer may also direct all parties and their representatives to appear at conferences at any reasonable time during the hearing, with a view to simplification, clarification, or shortening of the hearing.

HEARING PROCEDURES

§ 2.78 Statements of position.

The presiding officer may require parties to exchange written statements of position, with copies to all other parties, prior to the beginning of a hearing. These statements should include a showing of the theory of the party submitting this statement and will not be subject to cross-examination.

§ 2.79 Evidentiary purpose of hearing.

The hearing is directed to receiving factual evidence and expert opinion testimony related to the issues in the proceeding. Argument will not be received into evidence; rather, it should be presented in opening or closing statements of counsel, memoranda, or briefs, as determined by the presiding officer. § 2.80

Submission of documentary evidence and identification of witnesses subsequent to prehearing conference. (a) All documentary evidence not submitted at the prehearing conference shall be submitted to the presiding officer as soon as possible, with a showing that the offering party had good cause for failing to produce the documents at the prehearing conference. If the presiding officer determines that good cause does exist,

the documents shall be submitted to the parties sufficiently in advance of the offer of such documents for introduction into the record to permit study and preparation of cross-examination and rebuttal evidence.

(b) The authenticity of all published documents submitted in advance shall be deemed admitted unless written objection thereto is filed with the presiding officer upon notice to the other parties within the time specified by the presiding officer in accordance with this section, except that a party will be permitted to challenge such authenticity at a later time upon a showing of good cause for failure to have filed such written objection.

(c) Any witness identification not submitted at the prehearing conference shall be submitted to the presiding officer as soon as available, with a showing that the offering party had good cause for failing to produce the identification at the prehearing conference. If the presiding officer determines that good cause does exist, the identification shall be submitted to the parties to the hearing as soon as possible.

(a) Witnesses.

The presiding officer may direct that summaries of the direct testimony of witnesses be prepared in writing and served in advance of the hearing. If so directed, such summaries shall be served on all parties, a copy to the presiding officer as directed. Witnesses will not be permitted to read summaries of their testimony into the record and all witnesses shall be available for cross-examination. Each witness shall, before proceeding to testify, be sworn or make affirmation.

(b) Scope of testimony. When necessary to prevent undue prolongation of the hearing, the presiding officer may limit the number of times any witness may testify, the repetitious examination and cross-examination of witnesses, or the amount of corroborative or cumulative evidence.

(c) Evidence. The presiding officer shall admit only evidence that is relevant, material, reliable, and not unduly repetitious.

(d) Opinion testimony. Opinion testimony shall be admitted when the presiding officer is satisfied that the witness is properly qualified.

(e) Documents to be filed. The presiding officer shall file as exhibits copies of the following documents:

(1) The proposal to issue, amend, or repeal a regulation as published in the FEDERAL REGISTER, described in § 2.66(a).

(2) The order of the Commissioner as published in the FEDERAL REGISTER, described in § 2.66(c).

(3) The notice of receipt of objections as published in the FEDERAL REGISTER, described in § 2.67 (e).

(4) The notice of public hearing as published in the FEDERAL REGISTER, described in § 2.69.

(5) The prehearing order, if any, as described in § 2.76.

(6) Any other document necessary to show the basis for the hearing. § 2.82 Inspection of documents.

All documents constituting the record bearing on the matter or matters in controversy, and not entitled to protection under section 301(j) of the act, accumulated up to the start of the hearing shall be open for inspection by interested persons during office hours in the office of the hearing clerk.

Upon a showing of their relevancy, materiality, and competency, affidavits may be marked as exhibits at the prehearing conference. Every interested person shall be permitted to examine all affidavits that have been so filed and to file counteraffidavits with the presiding officer, within a period of time to be fixed by the presiding officer. not more than 15 days following the close of the hearing. Subject to the provisions of section 7(c) of the Administrative Procedure Act (5 U.S.C. 1006), these affidavits may be admitted into evidence. If so admitted, the Commissioner and

An offer of proof made in connection with an objection taken to any ruling of the presiding officer rejecting or excluding proffered oral testimony shall consist of a statement of the substance of the evidence which counsel contends would be adduced by such testimony; and, if the excluded evidence consists of evidence in documentary or written form, a copy of such evidence shall be marked for identification and shall accompany the record as the offer of proof. § 2.89 Appeal from ruling of presiding officer.

Rulings of the presiding officer may not be appealed to the Commissioner prior to his consideration of the entire proceeding, except with the consent of the presiding officer and where he certifies on the record or in writing that the allowance of an interlocutory appeal is clearly necessary to prevent exceptional delay, expense, or prejudice to any party, or substantial detriment to the public interest. If an appeal is allowed, any party may file a brief with the Commissioner within such period that the presiding officer directs. No oral argument I will be heard unless the Commissioner directs otherwise.

THE RECORD

§ 2.90 Official transcript; indexing of record.

(a) Official transcript. Testimony given at a public hearing shall be reported verbatim. The Department will make provision for a stenographic record of the testimony and for such copies of the transcript thereof as it requires for its own purposes. Any person desiring a copy of the transcript of the testimony and exhibits taken at the hearing or of any part thereof shall be entitled to the same upon application to the official reporter and upon payment of the costs thereof.

(1) When

(b) Indexing of record. ever it appears to the presiding officer that the record of hearing will be of such length that an index to the record will permit a more orderly presentation of the evidence and reduce delay, the presiding officer shall require counsel for the parties to prepare a daily topical index which will be available to the presiding officer and all parties. Preparation of such an index shall be apportioned among all counsel present in such manner as appears just and proper in the circumstances.

(2) The index should include each topic of testimony upon which evidence is taken, the name of each witness testifying upon the topic, the page of the record at which each portion of his testimony appeared, and the number of each exhibit relating to the topic. The index should also contain the name of each witness, followed by the topics upon which he testified and the page of the record at which such testimony appears. § 2.91 Exhibits.

All written statements, charts, tabulations, reports, documents, and similar data offered in evidence at the hearing shall be marked for identification, and upon a showing satisfactory to the presiding officer of the authenticity, relevancy, materiality, and reliability, shall be received in evidence, subject to section 7(c) of the Administrative Procedure Act (5 U.S.C. 1006(c)). Exhibits shall be submitted in quintuplicate. In case the required number of copies are not made available, the presiding officer shall exercise his discretion in determining whether the exhibit will be read in evidence or whether additional copies will be required to be submitted within a time

At the close of the hearing, the presiding officer shall afford witnesses and their counsel time (not longer than 30 days, except in unusual cases) in which to submit written proposed corrections of the transcript, pointing out errors that may have been made in transcribing the testimony. The presiding officer shall promptly thereafter order such corrections made as in his judgment are required to make the transcript conform to the testimony.

§ 2.94 Record for decision.

The transcript of testimony and exhibits together with any written arguments that may have been filed in the proceeding, including rulings, shall constitute the exclusive record for decision. BRIEFS, REQUESTS FOR FINDINGS, DECISIONS, EXCEPTIONS, ORAL ARGUMENT; FINAL ORDER

§ 2.95 Briefs.

The time for filing briefs and reply briefs (if permitted) with the presiding officer shall be fixed by him. The person submitting a brief shall file five copies with the hearing clerk. Briefs shall include a statement of position on each issue as supported by the evidence of record, together with specific and complete citations of the pages of the transcript and exhibits, together with citations of authorities relied upon. Briefs shall contain proposed findings of fact and conclusions of law when requested by the presiding officer.

As soon as practicable after the time for filing of briefs has expired, the presiding officer shall prepare a report and shall certify the record together with his report to the Commissioner.

§ 2.97 Tentative order.

(a) As soon as practicable thereafter the Commissioner shall prepare and cause to be published in the FEDERAL REGISTER his tentative order, including detailed findings of fact and conclusions upon which it is based.

(b) The tentative order shall specify a reasonable time (ordinarily not to exceed 60 days), within which any party of record may file exceptions to the proposed order. The exceptions shall point out with particularity the alleged errors in said order and shall contain a specific reference to the pages of the transcript of the testimony or to exhibits on which exceptions are based. Such exceptions may be accompanied by a memorandum or brief in support thereof and if oral argument on the exceptions is desired, such a request shall be made with the exceptions. The Commissioner will grant or deny oral argument in his discretion. § 2.98

Final order.

§ 2.101 Copies of petitions for judicial review.

The Assistant General Counsel, Food and Drug Division, Department of Health, Education, and Welfare, has been designated by the Secretary as the offcer upon whom copies of petitions for judicial review, filed pursuant to section 701(f) (1) of the act, shall be served. Such officer shall be responsible for filing in the court the record of the proceedings on which the final order is based. The record of the proceeding shall be certified by the Commissioner.

JUDICIAL STANDARDS OF PRACTICE

§ 2.102 Conduct.

Parties and their representatives appearing in hearings held pursuant to section 701 of the act, whether or not members of the bar, are expected to conduct themselves with honor and dignity and observe judicial standards of practice and ethics. They should not indulge in offensive personalities, unseemly wrangling, or intemperate accusations or characterizations. A representative of any party should use his best efforts to restrain his client from improprieties in connection with proceeding.

§ 2.103

§ 2.104

[Reserved]

Ex parte communications.

If any official of the Food and Drug Administration is contacted by any individual in private or public life concerning any matter which is the subject of a public hearing, the official who is contacted shall prepare a memorandum setting forth the substance of the conversation and shall file this memorandum in the appropriate public docket file.

Subpart G-Public Information § 2.115 Fee schedule for searching, supplying, and certifying records.

(a) Certain routine information is provided to the general public at no charge; however, special informational services involving more than routine investigation and allocation of staff time are subject to fees as necessary to recover costs to the Government.

(b) Charges for special services regarding Food and Drug Administration records are as follows:

(1) Search for records: $3 per hour. (2) Reproduction, duplication, or copying of records: 25 cents per page.

(3) Reproduction, duplication, or copying of microfilm: 50 cents per microfilm frame and 50 cents per microfiche.

(4) Certification or authentication of records: $5 per certification.

(5) Forwarding material to destinafees will be charged on an actual cost tion: Postage, insurance, and special basis.

(c) These charges are in agreement with charges for similar services by the Department of Health, Education, and Welfare as published in the FEDERAL REGISTER Of May 6, 1969 (34 F.R. 7348).