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Title 21Chapter IIPart 1316 → Subpart D


Title 21: Food and Drugs
PART 1316—ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES


Subpart D—Administrative Hearings


Contents
§1316.41   Scope of subpart D.
§1316.42   Definitions.
§1316.43   Information; special instructions.
§1316.44   Waiver or modification of rules.
§1316.45   Filings; address; hours.
§1316.46   Inspection of record.
§1316.47   Request for hearing.
§1316.48   Notice of appearance.
§1316.49   Waiver of hearing.
§1316.50   Appearance; representation; authorization.
§1316.51   Conduct of hearing and parties; ex parte communications.
§1316.52   Presiding officer.
§1316.53   Time and place of hearing.
§1316.54   Prehearing conference.
§1316.55   Prehearing ruling.
§1316.56   Burden of proof.
§1316.57   Submission of documentary evidence and affidavits and identification of witnesses subsequent to prehearing conference.
§1316.58   Summary of testimony; affidavits.
§1316.59   Submission and receipt of evidence.
§1316.60   Objections; offer of proof.
§1316.61   Exceptions to rulings.
§1316.62   Interlocutory appeals from rulings of the presiding officer.
§1316.63   Official transcript; index; corrections.
§1316.64   Proposed findings of fact and conclusions of law.
§1316.65   Report and record.
§1316.66   Exceptions.
§1316.67   Final order.
§1316.68   Copies of petitions for judicial review.

Authority: 21 U.S.C. 811, 812, 871(b), 875, 958(d), 965.

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§1316.41   Scope of subpart D.

Procedures in any administrative hearing held under the Act are governed generally by the rule making and/or adjudication procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by the procedures set forth in this subpart, except where more specific regulations (set forth in §§1301.51-1301.57, §§1303.31-1303.37, §§1308.41-1308.51, §§1311.51-1311.53, §§1312.41-1312.47, §§1313.51-1313.57, or §§1315.50-1315.62) apply.

[73 FR 73556, Dec. 3, 2008]

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§1316.42   Definitions.

As used in this subpart, the following terms shall have the meanings specified:

(a) The term Act means the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).

(b) The term Administrator means the Administrator of the Administration. The Administrator has been delegated authority under the Act by the Attorney General (28 CFR 0.100).

(c) The term hearing means any hearing held pursuant to the Act.

(d) The term Hearing Clerk means the hearing clerk of the Administration.

(e) The term person includes an individual, corporation, government or governmental subdivision or agency, business trust, partnership, association or other legal entity.

(f) The term presiding officer means an administrative law judge qualified and appointed as provided in the Administrative Procedure Act (5 U.S.C. 556).

(g) The term proceeding means all actions involving a hearing, commencing with the publication by the Administrator of the notice of proposed rulemaking or the issuance of an order to show cause.

(h) Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[36 FR 7820, Apr. 24, 1971, as amended at 38 FR 757, Jan. 4, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13969, Mar. 24, 1997; 77 FR 4238, Jan. 27, 2012]

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§1316.43   Information; special instructions.

Information regarding procedure under these rules and instructions supplementing these rules in special instances will be furnished by the Hearing Clerk upon request.

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§1316.44   Waiver or modification of rules.

The Administrator or the presiding officer (with respect to matters pending before him) may modify or waive any rule in this subpart by notice in advance of the hearing, if he determines that no party in the hearing will be unduly prejudiced and the ends of justice will thereby be served. Such notice of modification or waiver shall be made a part of the record of the hearing.

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§1316.45   Filings; address; hours.

Documents required or permitted to be filed in, and correspondence relating to, hearings governed by the regulations in this chapter shall be filed with the Hearing Clerk, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in §1321.01 of this chapter for the current mailing address. This office is open Monday through Friday from 8:30 a.m. to 5 p.m. eastern standard or daylight saving time, whichever is effective in the District of Columbia at the time, except on national legal holidays. Documents shall be dated and deemed filed upon receipt by the Hearing Clerk.

[75 FR 10685, Mar. 9, 2010]

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§1316.46   Inspection of record.

(a) The record bearing on any proceeding, except for material described in subsection (b) of this section, shall be available for inspection and copying by any person entitled to participate in such proceeding, during office hours in the office of the Hearing Clerk, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in §1321.01 of this chapter for the current mailing address.

(b) The following material shall not be available for inspection as part of the record:

(1) A research protocol filed with an application for registration to conduct research with controlled substances listed in Schedule I, pursuant to §1301.32 (a)(6) of this chapter, if the applicant requests that the protocol be kept confidential;

(2) An outline of a production or manufacturing process filed with an application for registration to manufacture a new narcotic controlled substance, pursuant to §1301.33 of this chapter, if the applicant requests that the outline be kept confidential;

(3) Any confidential or trade secret information disclosed in conjunction with an application for registration, or in reports filed while registered, or acquired in the course of an investigation, entitled to protection under subsection 402(a) (8) of the Act (21 U.S.C. 842(a) (8)) or any other law restricting public disclosure of information; and

(4) Any material contained in any investigatory report, memorandum, or file, or case report compiled by the Administration.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13970, Mar. 24, 1997; 75 FR 10645, Mar. 9, 2010]

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§1316.47   Request for hearing.

(a) Any person entitled to a hearing and desiring a hearing shall, within the period permitted for filing, file a request for a hearing and/or an answer that complies with the following format (see the Table of DEA Mailing Addresses in §1321.01 of this chapter for the current mailing address):

(Date)

Drug Enforcement Administration, Attn: Hearing Clerk/OALJ

(Mailing Address)

Subject: Request for Hearing

Dear Sir:

The undersigned ______ (Name of the Person) hereby requests a hearing in the matter of: ______ (Identification of the proceeding).

(A) (State with particularity the interest of the person in the proceeding.)

(B) (State with particularity the objections or issues, if any, concerning which the person desires to be heard.)

(C) (State briefly the position of the person with regard to the particular objections or issues.)

All notices to be sent pursuant to the proceeding should be addressed to:

(Name)
(Street Address)
(City and State)

Respectfully yours,

(Signature of Person)

(b) The Administrative Law Judge, upon request and showing of good cause, may grant a reasonable extension of the time allowed for response to an Order to Show Cause.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]

Editorial Note: For Federal Register citations affecting §1316.47, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

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§1316.48   Notice of appearance.

Any person entitled to a hearing and desiring to appear in any hearing, shall, if he or she has not filed a request for hearing, file within the time specified in the notice of proposed rulemaking, a written notice of appearance in the following format (see the Table of DEA Mailing Addresses in §1321.01 of this chapter for the current mailing address):

(Date)

Drug Enforcement Administration, Attn: Hearing Clerk/OALJ

(Mailing Address)

Subject: Notice of Appearance

Dear Sir:

Please take notice that ______ (Name of person) will appear in the matter of: ______ (Identification of the proceeding).

(A) (State with particularity the interest of the person in the proceeding.).

(B) (State with particularity the objections or issues, if any, concerning which the person desires to be heard.).

(C) (State briefly the position of the person with regard to the particular objections or issues.).

All notices to be sent pursuant to this appearance should be addressed to:

(Name)
(Street Address)
(City and State)

Respectfully yours,

(Signature of Person)

[81 FR 97041, Dec. 30, 2016]

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§1316.49   Waiver of hearing.

Any person entitled to a hearing may, within the period permitted for filing a request for hearing or notice of appearance, waiver of an opportunity for a hearing, together with a written statement regarding his position on the matters of fact and law involved in such hearing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein.

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§1316.50   Appearance; representation; authorization.

Any person entitled to appear in a hearing may appear in person or by a representative in any proceeding or hearing and may be heard with respect to matters relevant to the issues under consideration. A representative must either be an employee of the person or an attorney at law who is a member of the bar, in good standing, of any State, territory, or the District of Columbia, and admitted to practice before the highest court of that jurisdiction. Any representative may be required by the Administrator or the presiding officer to present a notarized power of attorney showing his authority to act in such representative capacity and/or an affidavit or certificate of admission to practice.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]

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§1316.51   Conduct of hearing and parties; ex parte communications.

(a) Hearings shall be conducted in an informal but orderly manner in accordance with law and the directions of the presiding officer.

(b) Participants in any hearing and their representatives, whether or not members of the bar, shall conduct themselves in accordance with judicial standards of practice and ethics and the directions of the presiding officer. Refusal to comply with this section shall constitute grounds for immediate exclusion from any hearing.

(c) If any official of the Administration is contacted by any individual in private or public life concerning any substantive matter which is the subject of any hearing, at any time after the date on which the proceedings commence, 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. The presiding officer and employees of the Administration shall comply with the requirements of 5 U.S.C. 554(d) regarding ex parte communications and participation in any hearing.

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§1316.52   Presiding officer.

A presiding officer, designated by the Administrator, shall preside over all hearings. The functions of the presiding officer shall commence upon his designation and terminate upon the certification of the record to the Administrator. 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 change the date, time, and place of hearings (other than the time and place prescribed in §1301.56) and prehearing conferences and issue notice thereof.

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

(c) Require parties to state their position in writing with respect to the various issues in the hearing and to exchange such statements with all other parties.

(d) Sign and issue subpoenas to compel the attendance of witnesses and the production of documents and materials to the extent necessary to conduct administrative hearings pending before him.

(e) Examine witnesses and direct witnesses to testify.

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

(g) Rule on procedural items pending before him.

(h) Take any action permitted to the presiding officer as authorized by this part or by the provisions of the Administrative Procedure Act (5 U.S.C. 551-559).

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 42 FR 57457, Nov. 3, 1977; 62 FR 13970, Mar. 24, 1997]

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§1316.53   Time and place of hearing.

The hearing will commence at the place and time designated in the notice of hearing published in the Federal Register 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 notice other than announcement thereof by the presiding officer at the hearing.

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§1316.54   Prehearing conference.

The presiding officer on his own motion, or on the motion of any party for good cause shown, may direct all parties 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 limiting the number of expert witnesses.

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

(e) The advance submission at the prehearing conference of all documentary evidence and affidavits to be marked for identification.

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

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§1316.55   Prehearing ruling.

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

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§1316.56   Burden of proof.

At any hearing, the proponent for the issuance, amendment, or repeal of any rule shall have the burden of proof.

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§1316.57   Submission of documentary evidence and affidavits and identification of witnesses subsequent to prehearing conference.

All documentary evidence and affidavits not submitted and all witnesses not identified at the prehearing conference shall be submitted or identified to the presiding officer as soon as possible, with a showing that the offering party had good cause for failing to so submit or identify at the prehearing conference. If the presiding officer determines that good cause does exist, the documents or affidavits shall be submitted or witnesses identified to all parties sufficiently in advance of the offer of such documents or affidavits or witnesses at the hearing to avoid prejudice or surprise to the other parties. If the presiding officer determines that good cause does not exist, he may refuse to admit as evidence such documents or affidavits or the testimony of such witnesses.

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§1316.58   Summary of testimony; affidavits.

(a) The presiding officer may direct that summaries of the direct testimony of witnesses be prepared in writing and served on all parties in advance of the hearing. 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) Affidavits submitted at the prehearing conference or pursuant to §1316.57 with good cause may be examined by all parties and opposing affidavits may be submitted to the presiding officer within a period of time fixed by him. Affidavits admitted into evidence shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to statements made therein.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]

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§1316.59   Submission and receipt of evidence.

(a) The presiding officer shall admit only evidence that is competent, relevant, material and not unduly repetitious.

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

(c) The authenticity of all documents submitted in advance shall be deemed admitted unless written objection thereto is filed with the presiding officer, 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.

(d) Samples, if otherwise admissible into evidence, may be displayed at the hearing and may be described for purposes of the record, or may be admitted in evidence as exhibits.

(e) Where official notice is taken or is to be taken of a material fact not appearing in the evidence of record, any party, on timely request, shall be afforded opportunity to controvert such fact.

(f) The presiding officer shall file as exhibits copies of the following documents:

(1) The order to show cause or notice of hearing;

(2) Any notice of waiver or modification of rules made pursuant to §1316.44 or otherwise;

(3) Any waiver of hearing (together with any statement filed therewith) filed pursuant to §1316.49 or otherwise;

(4) The prehearing ruling, if any, made pursuant to §1316.55;

(5) Any other document necessary to show the basis for the hearing.

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§1316.60   Objections; offer of proof.

If any party in the hearing objects to the admission or rejection of any evidence or to other limitation of the scope of any examination or cross-examination, he shall state briefly the grounds for such objection without extended argument or debate thereon except as permitted by the presiding officer. A ruling of the presiding officer on any such objection shall be a part of the transcript together with such offer of proof as has been made if a proper foundation has been laid for its admission. 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 the party 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 records as the offer of proof.

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§1316.61   Exceptions to rulings.

Exceptions to rulings of the presiding officer are unnecessary. It is sufficient that a party, at the time the ruling of the presiding officer is sought, makes known the action that he desires the presiding officer to take, or his objection to an action taken, and his grounds therefor.

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§1316.62   Interlocutory appeals from rulings of the presiding officer.

Rulings of the presiding officer may not be appealed to the Administrator prior to his consideration of the entire hearing without first requesting the consent of the presiding officer. Within ten (10) business days of receipt of a party's request for such consent, the presiding officer shall certify on the record or in writing his determination of whether 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 the presiding officer denies an interlocutory appeal, he shall, within three (3) business days, transmit his determination and the parties' filings related to the interlocutory appeal to the Administrator for the Administrator's discretionary review. If an interlocutory appeal is allowed by the presiding officer or if the Administrator determines that an appeal is warranted under this section, any party to the hearing may file a brief in quintuplicate with the Administrator within such period that the Administrator directs. No oral argument will be heard unless the Administrator directs otherwise.

[84 FR 18140, Apr. 30, 2019]

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§1316.63   Official transcript; index; corrections.

(a) Testimony given at a hearing shall be reported verbatim. The Administration will make provision for a stenographic record of the testimony and for such copies of the transcript thereof as it requires for its own purpose.

(b) At the close of the hearing, the presiding officer shall afford the parties and witnesses 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.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 50 FR 2046, Jan. 15, 1985]

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§1316.64   Proposed findings of fact and conclusions of law.

Any party in the hearing may file in quintuplicate proposed findings of fact and conclusions of law within the time fixed by the presiding officer. Any party so filing shall also serve one copy of his proposed findings and conclusion upon each other party in the hearing. The party shall include a statement of supporting reasons for the proposed findings and conclusions, together with evidence of record (including specific and complete citations of the pages of the transcript and exhibits) and citations of authorities relied upon.

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§1316.65   Report and record.

(a) As soon as practicable after the time for the parties to file proposed findings of fact and conclusions of law has expired, the presiding officer shall prepare a report containing the following:

(1) His recommended rulings on the proposed findings of fact and conclusions of law;

(2) His recommended findings of fact and conclusions of law, with the reasons therefore; and

(3) His recommended decision.

(b) The presiding officer shall serve a copy of his report upon each party in the hearing. The report shall be considered to have been served when it is mailed to such party or its attorney of record.

(c) Not less than twenty-five days after the date on which he caused copies of his report to be served upon the parties, the presiding officer shall certify to the Administrator the record, which shall contain the transcript of testimony, exhibits, the findings of fact and conclusions of law proposed by the parties, the presiding officer's report, and any exceptions thereto which may have been filed by the parties.

[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 44 FR 55332, Sept. 26, 1979]

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§1316.66   Exceptions.

(a) Within twenty days after the date upon which a party is served a copy of the report of the presiding officer, such party may file with the Hearing Clerk, Office of the Administrative Law Judge, exceptions to the recommended decision, findings of fact and conclusions of law contained in the report. The party shall include a statement of supporting reasons for such exceptions, together with evidence of record (including specific and complete citations of the pages of the transcript and exhibits) and citations of the authorities relied upon.

(b) The Hearing Clerk shall cause such filings to become part of the record of the proceeding.

(c) The Administrative Law Judge may, upon the request of any party to a proceeding, grant time beyond the twenty days provided in paragraph (a) of this section for the filing of a response to the exceptions filed by another party if he determines that no party in the hearing will be unduly prejudiced and that the ends of justice will be served thereby. Provided however, that each party shall be entitled to only one filing under this section; that is, either a set of exceptions or a response thereto.

[44 FR 55332, Sept. 26, 1979]

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§1316.67   Final order.

As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall cause to be published in the Federal Register his final order in the proceeding, which shall set forth the final rule and the findings of fact and conclusions of law upon which the rule is based. This order shall specify the date on which it shall take effect, which date shall not be less than 30 days from the date of publication in the Federal Register unless the Administrator finds that the public interest in the matter necessitates an earlier effective date, in which event the Administrator shall specify in the order his findings as to the conditions which led him to conclude that an earlier effective date was required.

[44 FR 42179, July 19, 1979, as amended at 44 FR 55332, Sept. 26, 1979]

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§1316.68   Copies of petitions for judicial review.

Copies of petitions for judicial review, filed pursuant to section 507 of the Act (21 U.S.C. 877) shall be delivered to and served upon the Administrator in quintuplicate. The Administrator shall certify the record of the hearing and shall file the certified record in the appropriate U.S. Court of Appeals.

[36 FR 7820, Apr. 24, 1971. Redesignated at 44 FR 42179, July 19, 1979]

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