21 C.F.R. PART 1316—ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
Title 21 - Food and Drugs
Source: 36 FR 7820, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.
Authority: 21 U.S.C. 822(f), 830(a), 871(b), 880, 958(f), 965.
Procedures regarding administrative inspections and warrants pursuant to sections 302(f), 510, 1008(d), and 1015 of the Act (21 U.S.C. 822(f), 880, 958(d), and 965) are governed generally by those sections and specifically by the sections of this subpart. 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 Administration means the Drug Enforcement Administration. (c) The term controlled premises means— (1) Places where original or other records or documents required under the Act are kept or required to be kept, and (2) Places, including factories, warehouses, or other establishments and conveyances, where persons registered under the Act or exempted from registration under the Act, or regulated persons may lawfully hold, manufacture, or distribute, dispense, administer, or otherwise dispose of controlled substances or listed chemicals or where records relating to those activities are maintained. (d) 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). (e) The term inspector means an officer or employee of the Administration authorized by the Administrator to make inspections under the Act. (f) The term register and registration refer to registration required and permitted by sections 303 and 1008 of the Act (21 U.S.C. 823 and 958). (g) 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. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 60 FR 32465, June 22, 1995; 60 FR 36334, July 14, 1995; 62 FR 13969, Mar. 24, 1997] In carrying out his functions under the Act, the Administrator, through his inspectors, is authorized in accordance with sections 510 and 1015 of the Act (21 U.S.C. 880 and 965) to enter controlled premises and conduct administrative inspections thereof, for the purpose of: (a) Inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept or made under the Act and regulations promulgated under the Act, including, but not limited to, inventory and other records required to be kept pursuant to part 1304 of this chapter, order form records required to be kept pursuant to part 1305 of this chapter, prescription and distribution records required to be kept pursuant to part 1306 of this chapter, records of listed chemicals, tableting machines, and encapsulating machines required to be kept pursuant to part 1310 of this chapter, import/export records of listed chemicals required to be kept pursuant to part 1313 of this chapter, shipping records identifying the name of each carrier used and the date and quantity of each shipment, and storage records identifying the name of each warehouse used and the date and quantity of each storage. (b) Inspecting within reasonable limits and to a reasonable manner all pertinent equipment, finished and unfinished controlled substances, listed chemicals, and other substances or materials, containers, and labeling found at the controlled premises relating to this Act; (c) Making a physical inventory of all controlled substances and listed chemicals on-hand at the premises; (d) Collecting samples of controlled substances or listed chemicals (in the event any samples are collected during an inspection, the inspector shall issue a receipt for such samples on DEA Form 84 to the owner, operator, or agent in charge of the premises); (e) Checking of records and information on distribution of controlled substances or listed chemicals by the registrant or regulated person (i.e., has the distribution of controlled substances or listed chemicals increased markedly within the past year, and if so why); (f) Except as provided in §1316.04, all other things therein (including records, files, papers, processes, controls and facilities) appropriate for verification of the records, reports, documents referred to above or otherwise bearing on the provisions of the Act and the regulations thereunder. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 FR 5319, Feb. 13, 1986; 55 FR 50827, Dec. 11, 1990; 60 FR 32465, June 22, 1995] (a) Unless the owner, operator or agent in charge of the controlled premises so consents in writing, no inspection authorized by these regulations shall extend to: (1) Financial data: (2) Sales data other than shipping data; or (3) Pricing data. (b) [Reserved] An inspection shall be carried out by an inspector. Any such inspector, upon (a) stating his purpose and (b) presenting to the owner, operator or agent in charge of the premises to be inspected (1) appropriate credentials, and (2) written notice of his inspection authority under §1316.06 of this chapter, and (c) receiving informed consent under §1316.08 or through the use of administrative warrant issued under §§1316.09–1316.13, shall have the right to enter such premises and conduct inspections at reasonable times and in a reasonable manner. [36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973; 62 FR 13970, Mar. 24, 1997] The notice of inspection (DEA (or DNB) Form 82) shall contain: (a) The name and title of the owner, operator, or agent in charge of the controlled premises; (b) The controlled premises name; (c) The address of the controlled premises to be inspected; (d) The date and time of the inspection; (e) A statement that a notice of inspection is given pursuant to section 510 of the Act (21 U.S.C. 880); (f) A reproduction of the pertinent parts of section 510 of the Act; and (g) The signature of the inspector. In all cases where an inspection is contemplated, an administrative inspection warrant is required pursuant to section 510 of the Act (21 U.S.C. 880), except that such warrant shall not be required for establishments applying for initial registration under the Act, for the inspection of books and records pursuant to an administrative subpoena issued in accordance with section 506 of the Act (21 U.S.C. 876) nor for entries in administrative inspections (including seizures of property): (a) With the consent of the owner, operator, or agent in charge of the controlled premises as set forth in §1316.08; (b) In situations presenting imminent danger to health or safety; (c) In situations involving inspection of conveyances where there is reasonable cause to obtain a warrant; (d) In any other exceptional or emergency circumstance or time or opportunity to apply for a warrant is lacking; or (e) In any other situations where a warrant is not constitutionally required. (a) An administrative inspection warrant shall not be required if informed consent is obtained from the owner, operator, or agent in charge of the controlled premises to be inspected. (b) Wherever possible, informed consent shall consist of a written statement signed by the owner, operator, or agent in charge of the premises to be inspected and witnessed by two persons. The written consent shall contain the following information: (1) That he (the owner, operator, or agent in charge of the premises) has been informed of his constitutional right not to have an administrative inspection made without an administrative inspection warrant; (2) That he has right to refuse to consent to such an inspection; (3) That anything of an incriminating nature which may be found may be seized and used against him in a criminal prosecution; (4) That he has been presented with a notice of inspection as set forth in §1316.06; (5) That the consent is given by him is voluntary and without threats of any kind; and (6) That he may withdraw his consent at any time during the course of inspection. (c) The written consent shall be produced in duplicate and be distributed as follows: (1) The original will be retained by the inspector; and (2) The duplicate will be given to the person inspected. [36 FR 7820, Apr. 24, 1971, as amended at 37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] (a) An administrative inspection warrant application shall be submitted to any judge of the United States or of a State court of record, or any United States magistrate and shall contain the following information: (1) The name and address of the controlled premises to be inspected; (2) A statement of statutory authority for the administrative inspection warrant, and that the fact that the particular inspection in question is designed to insure compliance with the Act and the regulations promulgated thereunder; (3) A statement relating to the nature and extent of the administrative inspection, including, where necessary, a request to seize specified items and/or to collect samples of finished or unfinished controlled substances or listed chemicals; (4) A statement that the establishment either: (i) Has not been previously inspected, or (ii) Was last inspected on a particular date. (b) The application shall be submitted under oath to an appropriate judge or magistrate. [36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973; 60 FR 32466, June 22, 1995] If the judge or magistrate is satisfied that “administrative probable cause,” as defined in section 510(d)(1) of the Act (21 U.S.C. 880(d)(1)) exists, he shall issue an administrative warrant. Administrative probable cause shall not mean criminal probable cause as defined by Federal statute or case law. An administrative inspection warrant shall be executed and returned as required by, and any inventory or seizure made shall comply with the requirements of, section 510(d)(3) of the Act (21 U.S.C. 880(d)(3)). The inspection shall begin as soon as is practicable after the issuance of the administrative inspection warrant and shall be completed with reasonable promptness. The inspection shall be conducted during regular business hours and shall be completed in a reasonable manner. If a registrant or any person subject to the Act refuses to permit execution of an administrative warrant or impedes the inspector in the execution of that warrant, he shall be advised that such refusal or action constitutes a violation of section 402(a)(6) of the Act (21 U.S.C. 842(a)(6)). If he persists and the circumstances warrant, he shall be arrested and the inspection shall commence or continue. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13970, Mar. 24, 1997] Except where circumstances otherwise dictate, it is the intent of the Administration to inspect all manufacturers of controlled substances listed in Schedules I and II and distributors of controlled substances listed in Schedule I once each year. Distributors of controlled substances listed in Schedules II through V and manufacturers of controlled substances listed in Schedules III through V shall be inspected as circumstances may require, based in part on the registrant's history of compliance with the requirements of this chapter and maintenance of effective controls and procedures to guard against the diversion of controlled substances. [62 FR 13969, Mar. 24, 1997] Authority: 21 U.S.C. 830, 871(b).
As used in this part, the following terms shall have the meanings specified: (a) The term investigative personnel includes managers, Diversion Investigators, attorneys, analysts and support personnel employed by the Drug Enforcement Administration who are involved in the processing, reviewing and analyzing of declarations and other relevant documents or data relative to regulated transactions or are involved in conducting investigations initiated pursuant to the receipt of such declarations, documents or data. (b) The term law enforcement personnel means Special Agents employed by the Drug Enforcement Administration who, in the course of their official duties, gain knowledge of information which is confidential under such section. [54 FR 31670, Aug. 1, 1989] (a) Any person who is aggrieved by a disclosure of information in violation of subsection (c)(1) of Section 310 of the Controlled Substances Act (21 U.S.C. 830) may bring a civil action against the violator for appropriate relief. (b) Notwithstanding the provision of paragraph (a), a civil action may not be brought under such paragraph against investigative or law enforcement personnel of the Drug Enforcement Administration. [54 FR 31670, Aug. 1, 1989] (a) Any person conducting a bona fide research project directly related to the enforcement of the laws under the jurisdiction of the Attorney General concerning drugs or other substances which are or may be subject to control under the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) who intends to maintain the confidentiality of the identity of those persons who are the subjects of such research may petition the Administrator of the Drug Enforcement Administration for a grant of confidentiality: Providing, That: (1) The Attorney General is authorized to carry out such research under the provisions of Section 502(a) (2–6) of the Controlled Substances Act of 1970 (21 U.S.C. 872(a) (2–6)); and the research is being conducted with funds provided in whole or part by the Department of Justice; or (2) The research is of a nature that the Attorney General would be authorized to carry out under the provisions of Section 502(a) (2–6) of the Controlled Substances Act (21 U.S.C. 872(a) (2–6), and is being conducted with funds provided from sources outside the Department of Justice. (b) All petitions for Grants of Confidentiality shall be addressed to the Administrator, Drug Enforcement Administration, Washington, DC 20537, and shall contain the following: (1) A statement as to whether the research protocol requires the manufacture, production, import, export, distribution, dispensing, administration, or possession of controlled substances, and if so the researcher's registration number or a statement that an application for such registration has been submitted to DEA; (2) The location of the research project; (3) The qualifications of the principal investigator; (4) A general description of the research or a copy of the research protocol; (5) The source of funding for the research project; (6) A statement as to the risks posed to the research subjects by the research procedures and what protection will be afforded to the research subjects; (7) A statement as to the risks posed to society in general by the research procedures and what measures will be taken to protect the interests of society; (8) A specific request to withhold the names and/or any other identifying characteristics of the research subjects; and (9) Statements establishing that a grant of confidentiality is necessary to the successful completion of the research project. (c) The grant of confidentiality of identity of research subjects shall consist of a letter issued by the Administrator, which shall include: (1) The researcher's name and address. (2) The researcher's registration number, if applicable. (3) The title and purpose of the research. (4) The location of the research project. (5) An authorization for all persons engaged in the research to withhold the names and identifying characteristics of persons who are the subjects of such research, stating that persons who obtain this authorization may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding to identify the subjects of such research for which this authorization was obtained. (6) The limits of this authorization, if any. (7) A statement to the effect that the grant of confidentiality of identity of research subjects shall be perpetual but shall pertain only to the subjects of the research described in the research protocol, the description of the research submitted to DEA, or as otherwise established by DEA. (d) Within 30 days of the date of completion of the research project, the researcher shall so notify the Administrator. The Administrator shall issue another letter including the information required in paragraph (c) of this section and stating the starting and finishing dates of the research for which the confidentiality of identity of research subjects was granted; upon receipt of this letter, the research shall return the original letter of exemption. [42 FR 54946, Oct. 12, 1977. Redesignated at 54 FR 31670, Aug. 1, 1989, as amended at 62 FR 13970, Mar. 24, 1997] (a) Upon registration of an individual to engage in research in controlled substances under the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801), the Administrator of the Drug Enforcement Administration, on his own motion or upon request in writing from the Secretary or from the researcher or researching practitioner, may exempt the registrant when acting within the scope of his registration, from prosecution under Federal, State, or local laws for offenses relating to possession, distribution or dispensing of those controlled substances within the scope of his exemption. However, this exemption does not diminish any requirement of compliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301). (b) All petitions for Grants of Exemption from Prosecution for the Researcher shall be addressed to the Administrator, Drug Enforcement Administration, 1405 I Street NW., Washington, DC 20537 and shall contain the following: (1) The researcher's registration number if any, for the project; (2) The location of the research project; (3) The qualifications of the principal investigator; (4) A general description of the research or a copy of the research protocol; (5) The source of funding for the research project; (6) A statement as to the risks posed to the research subjects by the research procedures and what protection will be afforded to the research subjects; (7) A statement as to the risks posed to society in general by the research procedures and what measures will be taken to protect the interests of society; (8) A specific request for exemption from prosecution by Federal, State, or local authorities for offenses related to the possession, distribution, and dispensing of controlled substances in accord with the procedures described in the research protocol; (9) A statement establishing that a grant of exemption from prosecution is necessary to the successful completion of the research project. (c) Any researcher or practitioner proposing to engage in research requesting both exemption from prosecution and confidentiality of identity of research subjects may submit a single petition incorporating the information required in §§1316.23(b) and 1316.24(b). (d) The exemption shall consist of a letter issued by the Administrator, which shall include: (1) The researcher's name and address; (2) The researcher's registration number for the research project; (3) The location of the research project; (4) A concise statement of the scope of the researcher's registration; (5) Any limits of the exemption; and (6) A statement that the exemption shall apply to all acts done in the scope of the exemption while the exemption is in effect. The exemption shall remain in effect until completion of the research project or until the registration of the researcher is either revoked or suspended or his renewal of registration is denied. However, the protection afforded by the grant of exemption from prosecution during the research period shall be perpetual. (e) Within 30 days of the date of completion of the research project, the researcher shall so notify the Administrator. The Administrator shall issue another letter including the information required in paragraph (d) of this section and stating the date of which the period of exemption concluded; upon receipt of this letter the researcher shall return the original letter of exemption. [42 FR 54946, Oct. 12, 1977. Redesignated at 54 FR 31670, Aug. 1, 1989, as amended at 62 FR 13970, Mar. 24, 1997] Authority: 21 U.S.C. 871(b), 883.
A hearing may be ordered or granted by any Special Agent in Charge of the Drug Enforcement Administration, at his discretion, to permit any person against whom criminal and/or civil action is contemplated under the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951) an opportunity to present his views and his proposals for bringing his alleged violations into compliance with the law. Such hearing will also permit him to show cause why prosecution should not be instituted, or to present his views on the contemplated proceeding. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735, Sept. 22, 1982] Appropriate notice designating the time and place for the hearing shall be given to the person. Upon request, timely and properly made, by the person to whom notice has been given, the time or place of the hearing, or both, may be changed if the request states reasonable grounds for such change. Such request shall be addressed to the Special Agent in Charge who issued the notice. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735, Sept. 22, 1982] Presentation of views at a hearing under this subpart shall be private and informal. The views presented shall be confined to matters relevant to bringing violations into compliance with the Act or to other contemplated proceedings under the Act. These views may be presented orally or in writing by the person to whom the notice was given, or by his authorized representative. A formal record, either verbatim or summarized, of the hearing may be made at the discretion of the Special Agent in Charge. If a verbatim record is to be made, the person attending the hearing will be so advised prior to the start of the hearing. [37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735, Sept. 22, 1982] Authority: 21 U.S.C. 811, 812, 871(b), 875, 958(d), 965.
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, or §§1313.51–1313.57) apply. [36 FR 7820, Apr. 24, 1971, as amended at 37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13970, Mar. 24, 1997] 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, colmencing with the publication by the Administrator of the notice of proposed rule making 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] Information regarding procedure under these rules and instructions supplementing these rules in special instances will be furnished by the Hearing Clerk upon request. 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. 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, Department of Justice, Washington, DC 20537. 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. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 55 FR 27464, July 3, 1990] (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, Department of Justice, Washington, DC 20537. (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] (a) Any person entitled to a hearing and desiring a hearing shall, within the period permitted for filing, file a request for a hearing in the following form:
______ (Date) Administrator, Drug Enforcement Administration, United States Department of Justice, Washington, DC 20537, Attention: DEA Federal Register Representative. (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 Any person entitled to a hearing and desiring to appear in any hearing, shall, if he has not filed a request for hearing, file within the time specified in the notice of proposed rule making, a written notice of appearance in the following form:
______ (Date) Administrator, Drug Enforcement Administration, United States Department of Justice, Washington, DC 20537, Attention: DEA Federal Register Representative. (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) [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 40 FR 57210, Dec. 8, 1975] 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. 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] (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. 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] The hearing will commence at the place and time designated in the notice of hearing published in the 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. 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. At any hearing, the proponent for the issuance, amendment, or repeal of any rule shall have the burden of proof. 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. (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] (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. 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. 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. Rulings of the presiding officer may not be appealed to the Administrator prior to his consideration of the entire hearing, 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 in the hearing may file a brief in quintuplicate with the Administrator within such period that the presiding officer directs. No oral argument will be heard unless the Administrator directs otherwise. (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] 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. (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] (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] As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall cause to be published in the [44 FR 42179, July 19, 1979, as amended at 44 FR 55332, Sept. 26, 1979] 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] Authority: 21 U.S.C 871(b), 881, 965, 19 U.S.C. 1606, 1607, 1608, 1610, 1613, 1618, 28 U.S.C. 509, 510.
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 custodian means the officer required under §1316.72 to take custody of particular property which has been seized pursuant to the Act. (c) The term property means a controlled substance, raw material, product, container, equipment, money or other asset, vessel, vehicle, or aircraft within the scope of the Act. (d) The terms seizing officer, officer seizing, etc., mean any officer, authorized and designated by §1316.72 to carry out the provisions of the Act, who initially seizes property or adopts a seizure initially made by any other officer or by a private person. (e) The term Special Agents-in-Charge means Drug Enforcement Administration Special Agents-in-Charge or Resident Agents in Charge and Federal Bureau of Investigation Special Agents-in-Charge. (f) Any term not defined in this section 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. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 20096, Mar. 27, 1980; 47 FR 43370, Oct. 1, 1982; 49 FR 28701, July 16, 1984; 62 FR 13969, Mar. 24, 1997] For the purpose of carrying out the provisions of the Act, all special agents of the Drug Enforcement Administration and the Federal Bureau of Investigation are authorized and designated to seize such property as may be subject to seizure. [47 FR 43370, Oct. 1, 1982] An officer seizing property under the Act shall store the property in a location designated by the custodian, generally in the judicial district of seizure. The Special Agents-in-Charge are designated as custodians to receive and maintain in storage all property seized pursuant to the Act, are authorized to dispose of any property pursuant to the Act and any other applicable statutes or regulations relative to disposal, and to perform such other duties regarding such seized property as are appropriate, including the impound release of property pursuant to 28 CFR 0.101(c). [47 FR 43370, Oct. 1, 1982] The custodian shall appraise the property to determine the domestic value at the time and place of seizure. The domestic value shall be considered the price at which such or similar property is freely offered for sale. If there is no market for the property at the place of seizure, the domestic value shall be considered the value in the principal market nearest the place of seizure. (Authority: Sec. 606, 46 Stat. 754 (19 U.S.C. 1606)) [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 41418, Oct. 28, 1987] (a) If the appraised value does not exceed the monetary amount set forth in title 19, United States Code, Section 1607; the seized merchandise is any monetary instrument within the meaning of section 5312(a)(3) of title 31 of the United States Code; or if a conveyance used to import, export or otherwise transport or store any controlled substance is involved, the custodian or DEA Asset Forfeiture Section shall cause a notice of the seizure and of the intention to forfeit and sell or otherwise dispose of the property to be published once a week for at least 3 successive weeks in a newspaper of general circulation in the judicial district in which the processing for forfeiture is brought. (b) The notice shall: (1) Describe the property seized and show the motor and serial numbers, if any; (2) state the time, cause, and place of seizure; and (3) state that any person desiring to claim the property may, within 20 days from the date of first publication of the notice, file with the custodian or DEA Asset Forfeiture Section a claim to the property and a bond with satisfactory sureties in the sum of $5,000 or ten percent of the value of the claimed property whichever is lower, but not less than $250. (Authority: Sec. 607, 46 Stat. 754, as amended (19 U.S.C. 1607); Pub. L. 98–473, Pub. L. 98–573) [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 44 FR 56324, Oct. 1, 1979; 49 FR 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, 1984; 52 FR 24446, July 1, 1987; 56 FR 8686, Mar. 1, 1991] (a) The bond shall be rendered to the United States, with sureties to be approved by the custodian or DEA Asset Forfeiture Section, conditioned that in the case of condemnation of the property the obligor shall pay all costs and expenses of the proceedings to obtain such condemnation. When the claim and bond are received by the custodian or DEA Asset Forfeiture Section, he shall, after finding the documents in proper form and the sureties satisfactory, transmit the documents, together with a description of the property and a complete statement of the facts and circumstances surrounding the seizure, to the United States Attorney for the judicial district in which the proceeding for forfeiture is brought. If the documents are not in satisfactory condition when first received, a reasonable time for correction may be allowed. If correction is not made within a reasonable time the documents may be treated as nugatory, and the case shall proceed as though they had not been tendered. (b) The filing of the claim and the posting of the bond does not entitle the claimant to possession of the property, however, it does stop the administrative forfeiture proceedings. The bond posted to cover corts may be in cash, certified check, or satisfactory sureties. The costs and expenses secured by the bond are such as are incurred after the filing of the bond including storage cost, safeguarding, court fees, marshal's costs, etc. (Authority: Sec. 608, 46 Stat. 755 (19 U.S.C. 1608); Pub. L. 98–473, Pub. L. 98–573) [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 49 FR 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991] (a) For property seized by officers of the Drug Enforcement Administration, if the appraised value does not exceed the jurisdictional limits in §1316.75(a), and a claim and bond are not filed within the 20 days hereinbefore mentioned, the DEA Special Agent-in-Charge or DEA Asset Forfeiture Section shall declare the property forfeited. The DEA Special Agent-in-Charge or DEA Asset Forfeiture Section shall prepare the Declaration of Forfeiture and forward it to the Administrator of the Administration as notification of the action he has taken. Thereafter, the property shall be retained in the district of the DEA Special Agent-in-Charge or DEA Asset Forfeiture Section or delivered elsewhere for official use, or otherwise disposed of, in accordance with official instructions received by the DEA Special Agent-in-Charge or DEA Asset Forfeiture Section. (b) For property seized by officers of the Federal Bureau of Investigation, if the appraised value does not exceed the jurisdictional limits in §1316.75(a), and a claim and bond are not filed within the 20 days hereinbefore mentioned, the FBI Property Management Officer shall declare the property forfeited. The FBI Property Management Officer shall prepare the Declaration of Forfeiture. Thereafter, the property shall be retained in the field office or delivered elsewhere for official use, or otherwise disposed of, in accordance with the official instructions of the FBI Property Management Officer. (Authority: 28 U.S.C. 509 and 510; 21 U.S.C. 871 and 881(d); Pub. L. 98–473, Pub. L. 98–573) [48 FR 35087, Aug. 3, 1983, as amended at 49 FR 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991; 62 FR 13970, Mar. 24, 1997] If the appraised value is greater than the jurisdictional limits in §1316.75(a) or a claim and satisfactory bond have been received for property the jurisdictional limits in §1316.76, the custodian or DEA Asset Forfeiture Section shall transmit a description of the property and a complete statement of the facts and circumstances surrounding the seizure to the U.S. Attorney for the judicial district in which the proceeding for forfeiture is sought for the purpose of instituting condemnation proceedings. The U.S. Attorney shall also be furnished the newspaper advertisements required by §1316.75. The Forfeiture Counsel of DEA shall make applications to the U.S. District Courts to place property in official DEA use. (Authority: Sec. 610, 46 Stat. 755 (19 U.S.C. 1610); Pub. L. 98–473, Pub. L. 98–573) [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 44 FR 56324, Oct. 1, 1979; 49 FR 1178, Jan. 10, 1984; 49 FR 32174, Aug. 13, 1984; 49 FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991] (a) Any person interested in any property which has been seized, or forfeited either administratively or by court proceedings, may file a petition for remission or mitigation of the forfeiture. Such petition shall be filed in triplicate with the DEA Asset Forfeiture Section or Special Agent-in-Charge of the DEA or FBI, depending upon which agency seized the property, for the judicial district in which the proceeding for forfeiture is brought. It shall be addressed to the Director of the FBI or the Administrator of the DEA, depending upon which agency seized the property, if the property is subject to administrative forfeiture pursuant to §1316.77, and addressed to the Attorney General if the property is subject to judicial forfeiture pursuant to §1316.78. The petition must be executed and sworn to by the person alleging interest in the property. (b) The petition shall include the following: (1) A complete description of the property, including motor and serial numbers, if any, and the date and place of seizure; (2) the petitioner's interest in the property, which shall be supported by bills of sale, contracts, mortgages, or other satisfactory documentary evidence; and, (3) the facts and circumstances, to be established by satisfactory proof, relied upon by the petitioner to justify remission or mitigation. (c) Where the petition is for restoration of the proceeds of sale, or for value of the property placed in official use, it must be supported by satisfactory proof that the petitioner did not know of the seizure prior to the declaration of condemnation of forfeiture and was in such circumstances as prevented him from knowing of the same. (Authority: Secs. 613, 618, 46 Stat. 756, 757, as amended (19 U.S.C. 1613, 1618; 28 U.S.C. 509 and 510; 21 U.S.C. 871 and 881(d)); Pub. L. 98–473, Pub. L. 98–573) [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 48 FR 35088, Aug. 3, 1983; 49 FR 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991] (a) In order to be considered as seasonably filed, a petition for remission or mitigation of forfeiture should be filed within 30 days of the receipt of the notice of seizure. If a petition for remission or mitigation of forfeiture has not been received within 30 days of the notice of seizure, the property will either be placed in official service or sold as soon as it is forfeited. Once property is placed in official use, or is sold, a petition for remission or mitigation of forfeiture can no longer be accepted. (b) A petition for restoration of proceeds of sale, or for the value of property placed in official use, must be filed within 90 days of the sale of the property, or within 90 days of the date the property is placed in official use. (Authority: Secs. 613, 618, 46 Stat. 756, 757, as amended (19 U.S.C. 1613, 1618); Pub. L. 98–473, Pub. L. 98–573) [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 49 FR 50643, Dec. 31, 1984] Upon receipt of a petition, the custodian or DEA Asset Forfeiture System shall request an appropriate investigation. The petition and the report of investigation shall be forwarded to the Director of the FBI or to the Administrator of the DEA, depending upon which agency seized the property. If the petition involves a case which has been referred to the U.S. Attorney for the institution of court proceedings, the custodian or DEA Asset Forfeiture System shall transmit the petition to the U.S. Attorney for the judicial district in which the proceeding for forfeiture is brought. He shall notify the petitioner of this action. (Authority: 28 U.S.C. 509 and 510; 21 U.S.C. 871 and 881(d); Pub. L. 98–473, Pub. L. 98–573) [48 FR 35088, Aug. 3, 1983, as amended at 49 FR 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991; 62 FR 13970, Mar. 24, 1997] Authority: 21 U.S.C. 822, 871, 872, 880, 881, 881–1, 883, 958, 965; 19 U.S.C. 1606, 1607, 1608, 1610, 1613, 1618; 28 U.S.C. 509, 510; Pub. L. No. 100–690, sec. 6079, 6080.
Source: 54 FR 37610, Sept. 11, 1989, unless otherwise noted.
(a) The following definitions, regulations, and criteria are designed to establish and implement procedures required by sections 6079 and 6080 of the Anti-Drug Abuse Act of 1988, Public Law No. 100–690 (102 Stat. 4181). They are intended to supplement existing law and procedures relative to the forfeiture of property under the identified statutory authority. The provisions of these regulations do not affect the existing legal and equitable rights and remedies of those with an interest in property seized for forfeiture, nor do these provisions relieve interested parties from their existing obligations and responsibilities in pursuing their interests through such courses of action. These regulations are intended to reflect the intent of Congress to minimize the adverse impact on those entitled to legal or equitable relief occasioned by the prolonged detention of property subject to forfeiture due to violations of law involving personal use quantities of controlled substances, and conveyances seized for drug-related offenses. The definition of personal use quantities of a controlled substance as contained herein is intended to distinguish between those quantities small in amount which are generally considered to be possessed for personal consumption and not for further distribution, and those larger quantities generally considered to be subject to further distribution. (b) In this regard, for violations involving the possession of personal use quantities of a controlled substance, section 6079(b)(2) requires either that administrative forfeiture be completed within 21 days of the seizure of the property, or alternatively, that procedures are established that provide a means by which an individual entitled to relief may initiate an expedited administrative review of the legal and factual basis of the seizure for forfeiture. Should an individual request relief pursuant to these regulations and be entitled to the return of the seized property, such property shall be returned immediately following that determination, and the administrative forfeiture process shall cease. Should the individual not be entitled to the return of the seized property, however, the administrative forfeiture of that property shall proceed. The owner may, in any event, obtain release of property pending the administrative forfeiture by submitting to the agency making the determination, property sufficient to preserve the government's vested interest for purposes of the administrative forfeiture. (c) Section 6080 requires a similar expedited review by the Attorney General or his representative in those instances where a conveyance is being forfeited in a civil judicial proceeding following its seizure for a drug-related offense. As used in this subpart, the following terms shall have the meanings specified: (a) The term Appraised Value means the estimated domestic price at the time of seizure at which such or similar property is freely offered for sale. (b) The term Commercial Fishing Industry Vessel means a vessel that: (1) Commercially engages in the catching, taking, or harvesting of fish or an activity that can reasonably be expected to result in the catching, taking, or harvesting of fish; (2) Commercially prepares fish or fish products other than by gutting, decapitating, gilling, skinning, shucking, icing, freezing, or brine chilling; or (3) Commercially supplies, stores, refrigerates, or transports fish, fish products, or materials directly related to fishing or the preparation of fish to or from a fishing, fish processing, or fish tender vessel or fish processing facility. (c) The term Controlled Substance has the meaning given in section 802 of title 21, United States Code (U.S.C.). (d) The term Drug-Related Offense means any proscribed offense which involves the possession, distribution, manufacture, cultivation, sale, transfer, or the attempt or conspiracy to possess, distribute, manufacture, cultivate, sell or transfer any substance the possession of which is prohibited by Title 21, U.S.C. (e) The term Immediately means within 20 days of the filing of a petition for expedited release by an owner. (f) The term Interested Party means one who was in legal possession of the property at the time of seizure and is entitled to legal possession at the time of the granting of the petition for expedited release. This includes a lienholder (to the extent of his interest in the property) whose claim is in writing (except for a maritime lien which need not be in writing), unless the collateral is in the posession of the secured party. The agreement securing such lien must create or provide for a security interest in the collateral, describe the collateral, and be signed by the debtor. (g) The term Legal and Factual Basis of the Seizure means a statement of the applicable law under which the property is seized, and a statement of the circumstances of the seizure sufficiently precise to enable an owner or other interested party to identify the date, place, and use or acquisition which makes the property subject to forfeiture. (h) The term Normal and Customary Manner means that inquiry suggested by particular facts and circumstances which would customarily be undertaken by a reasonably prudent individual in a like or similar situation. Actual knowledge of such facts and circumstances is unnecessary, and implied, imputed, or constructive knowledge is sufficient. An established norm, standard, or custom is persuasive but not conclusive or controlling in determining whether an owner acted in a normal and customary manner to ascertain how property would be used by another legally in possession of the property. The failure to act in a normal and customary manner as defined herein will result in the denial of a petition for expedited release of the property and is intended to have the desirable effect of inducing owners of the property to exercise greater care in transferring possession of their property. (i) The term Owner means one having a legal and possessory interest in the property seized for forfeiture. Even though one may hold primary and direct title to the property seized, such person may not have sufficient actual beneficial interest in the property to support a petition as owner if the facts indicate that another person had dominion and control over the property. (j) The term Personal Use Quantities means possession of controlled substances in circumstances where there is no other evidence of an intent to distribute, of to facilitate the manufacturing, compounding, processing, delivering, importing or exporting of any controlled substance. Evidence of personal use quantities shall not include sweepings or other evidence of possession of quantities of a controlled substance for other than personal use. (1) Such other evidence shall include: (i) Evidence, such as drug scales, drug distribution paraphernalia, drug records, drug packaging material, method of drug packaging, drug “cutting” agents and other equipment, that indicates an intent to process, package or distribute a controlled substance; (ii) Information from reliable sources indicating possession of a controlled substance with intent to distribute; (iii) The arrest and/or conviction record of the person or persons in actual or constructive possession of the controlled substance for offenses under Federal, State or local law that indicates an intent to distribute a controlled substance; (iv) The controlled substance is related to large amounts of cash or any amount of prerecorded government funds; (v) The controlled substance is possessed under circumstances that indicate such a controlled substance is a sample intended for distribution in anticipation of a transaction involving large quantities, or is part of a larger delivery; or (vi) Statements by the possessor, or otherwise attributable to the possessor, including statements of conspirators, that indicate possession with intent to distribute. (2) Possession of a controlled substance shall be presumed to be for personal use when there are no indicia of illicit drug trafficking or distribution such as, but not limited to, the factors listed above and the amounts do not exceed the following quantities: (i) One gram of a mixture of substance containing a detectable amount of heroin; (ii) One gram of a mixture or substance containing a detectable amount of— (A) Coca leaves, except coba leaves and extracts of coca leaves frol which cocaine, ecgonine, and derivations of ecgonine or their salts have been removed; (B) Cocaine, its salts, optical and geometric isomers, and salts of isomers; (C) Ecgonine, its derivatives, their salts, isomers, and salts of isomers; or (D) Any compound, mixture or preparation which contains any quantity of any of the substances referred to in paragraphs (j)(2)(ii)(A) through (j)(2)(ii)(C) of this section; (iii) (iv) (v) 500 micrograms of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD); (vi) One ounce of a mixture of substance containing a detectable amount of marihuana; (vii) One gram of methamphetamine, its salts, isomers, and salts of its isomers, or one gram of a mixture or substance containing a detectable amount of methamphetamine, its salts, isomers, or salts of its isomers. (3) The possession of a narcotic, a depressant, a stimulant, a hallucinogen or cannabis-controlled substance will be considered in excess of personal use quantities if the dosage unit amount possessed provides the same or greater equivalent efficacy as described in paragraph (j)(2) of this section. (k) The term Property means property subject to forfeiture under title 21, U.S.C., sections 881(a) (4), (6), and (7); title 19, U.S.C., section 1595a, and; title 49, U.S.C. App., section 782. (l) The term Seizing Agency means the Federal agency which has seized the property or adopted the seizure of another agency, and has the responsibility for administratively forfeiting the property; (m) The term Statutory Rights or Defenses to the Forfeiture means all legal and equitable rights and remedies available to a claimant of property seized for forfeiture. (n) The term Sworn to as used in §§1316.92(e) and 1316.95(c) refers to the oath as provided by Title 28, U.S.C., section 1746. (a) Where property is seized for administrative forfeiture involving controlled substances in personal use quantities the owner may petition the seizing agency for expedited release of the property. (b) Where property described in paragraph (a) of this section is a commercial fishing industry vessel proceeding to or from a fishing area or intermediate port of call or actually engaged in fishing operations, which would be subject to seizure for administrative forfeiture for a violation of law involving controlled substances in personal use quantities, a summons to appear shall be issued in lieu of a physical seizure. The vessel shall report to the port designated in the summons. The seizing agency shall be authorized to effect administrative forfeiture as if the vessel had been physically seized. Upon answering the summons to appear on or prior to the last reporting date specified in the summons, the owner of the vessel may file a petition for expedited release pursuant to paragraph (a) of this section and the provisions of paragraph (a) of this section and other provishons in this subpart pertaining to a petition for expedited release shall apply as if the vessel had been physically seized. (c) The owner filing the petition for expedited release shall establish the following: (1) The owner has a valid, good faith interest in the seized property as owner or otherwise; (2) The owner reasonably attempted to ascertain the use of the property in a normal and customary manner; and (3) The owner did not know or consent to the illegal use of the property, or in the event that the owner knew or should have known of the illegal use, the owner did what reasonably could be expected to prevent the violation. (d) In addition to those factors listed in paragraph (c) of this section, if an owner can demonstrate that the owner has other statutory rights or defenses that would cause the owner to prevail on the issue of forfeiture, such factors shall also be considered in ruling on the petition for expedited release. (e) A petition for expedited release must be filed in a timely manner to be considered by the seizing agency. In order to be filed in a timely manner, the petition must be received by the appropriate seizing agency within 20 days from the date of the first publication of the notice of seizure. The petition must be executed and sworn to by the owner and both the envelope and the request must be clearly marked “PETITION FOR EXPEDITED RELEASE.” Such petition shall be filed in triplicate with the Special Agent in Charge of the Drug Enforcement Administration (DEA) or Federal Bureau of Investigation (FBI) field office in the judicial district in which the property was seized, depending upon which agency seized the property. The petition shall be addressed to the Director of the FBI or to the Administrator of the DEA, depending upon which agency seized the property. (f) The petition shall include the following: (1) A complete description of the property, including identification numbers, if any, and the date and place of seizure; (2) The petitioner's interest in the property, which shall be supported by title documentation, bills of sale, contracts, mortgages, or other satisfactory documentary evidence; and (3) A statement of the facts and circumstances, to be established by satisfactory proof, relied upon by the petitioner to justify expedited release of the seized property. (a) Upon receipt of a petition for expedited release filed pursuant to §1316.92(a), the seizing agency shall determine first whether a final administrative determination of the case, without regard to the provisions of this subpart, can be made within 21 days of the seizure. If such a final administrative determination is made within 21 days, no further action need be taken under this subpart. (b) If no such final administrative determination is made within 21 days of the seizure, the following procedure shall apply. The seizing agency shall, within 20 days after the receipt of the petition for expedited release, determine whether the petition filed by the owner has established the factors listed in §1316.92(c) and: (1) If the seizing agency determines that those factors have been established, it shall terminate the administrative proceedings and return the property to the owner (or in the case of a commercial fishing industry vessel for which a summons has been issued shall dismiss the summons), except where it is evidence of a violation of law; or (2) If the seizing agency determines that those factors have not been established, the agency shall proceed with the administrative forfeiture. (a) Where property is seized for administrative forfeiture involving controlled substances in personal use quantities, the owner may obtain release of the property by posting a substitute res with the seizing agency. The property will be released to the owner upon the payment of an amount equal to the appraised value of the property if it is not evidence of a violation of law or has design or other characteristics that particularly suit it for use in illegal activities. This payment must be in the form of a traveler's check, a money order, a cashier's check or an irrevocable letter of credit made payable to the seizing agency. A bond in the form of a cashier's check will be considered as paid once the check has been accepted for payment by the financial institution which issued the check. (b) If a substitute res is posted and the property is administratively forfeited, the seizing agency will forfeit the substitute res in lieu of the property. (a) Where a conveyance has been seized and is being forfeited in a judicial proceeding for a drug-related offense, the owner may petition the United States Attorney for an expedited release of the conveyance. (b) The owner filing the petition for expedited release shall establish the following: (1) The owner has a valid, good faith interest in the seized conveyance as owner or otherwise; (2) The owner has statutory rights or defenses that would show to a substantial probability that the owner would prevail on the issue of forfeiture; (3) The owner reasonably attempted to ascertain the use of the conveyance in a normal and customary manner; and (4) The owner did not know or consent to the illegal use of the conveyance; or in the event that the owner knew or should have known of the illegal use, the owner did what reasonably could be expected to prevent the violation. (c) A petition for expedited release must be filed in a timely manner in order to be considered by the United States Attorney. To be considered as filed in a timely manner, the petition must be received by the appropriate United States Attorney within 20 days from the date of the first publication of the notice of the action and arrest of the property, or within 30 days after filing of the claim, whichever occurs later. The petition must be executed and sworn to by the owner, and both the envelope and the request must be clearly marked “PETITION FOR EXPEDITED RELEASE.” Such petition shall be filed in triplicate and addressed to and filed with the United States Attorney prosecuting the conveyance for forfeiture with a copy to the seizing agency. (d) The petition shall include the following: (1) A complete description of the conveyance, including the identification number, and the date and place of seizure; (2) The petitioner's interest in the conveyance, which shall be supported by bills of sale, contracts, mortgages, or other satisfactory documentary evidence; and, (3) The facts and circumstances, to be established by satisfactory proof, relied upon by the petitioner to justify expedited release of the seized conveyance. (a) Upon receipt of a petition for expedited release filed pursuant to §1316.95, the United States Attorney shall rule on the petition within 20 days of receipt. A petition shall be deemed filed on the date it is received by the United States Attorney. (b) If the United States Attorney does not rule on the petition for expedited release within 20 days after the date on which it is filed, the conveyance shall be returned to the owner or interested party pending further forfeiture proceedings, except where it is evidence of a violation of law. Release of conveyance under provisions of this paragraph shall not affect the forfeiture action with respect to that conveyance. (c) Upon a favorable ruling on the petition for expedited release, the United States Attorney shall, where necessary, move to terminate the judicial proceedings against the conveyance and immediately direct the return of the conveyance except where it is evidence of a violation of law. (d) If, within 20 days, the United States Attorney denies the petition for expedited release, the government shall retain possession of the conveyance until the owner provides a substitute res bond pursuant to §1316.98 or the forfeiture is finalized. (a) The United States Attorney shall file a complaint for forfeiture of the conveyance within 60 days of the filing of the claim and cost bond. (b) Upon the failure of the United States Attorney to file a complaint for forfeiture of a conveyance within 60 days unless the court extends the 60-day period following a showing of good cause, or unless the owner and the United States Attorney agree to such an extension, the court shall order the return of the conveyance and the return of any bond. (a) Where a conveyance is being forfeited in a judicial proceeding for a drug-related offense, the owner may obtain release of the property by filing a substitute res bond with the seizing agency. The conveyance will be released to the owner upon the payment of a bond in the amount of the appraised value of the conveyance if it is not evidence of a violation of law or has design or other characteristics that particularly suit it for use in illegal activities. This bond must be in the form of a traveler's check, a money order, a cashier's check or an irrevocable letter of credit made payable to the Department of Justice or to the United States Customs Service depending on which agency seized the conveyance. A bond in the form of a cashier's check will be considered as paid once the check has been accepted for payment by the financial institution which issued the check. (b) If a substitute res bond is filed and the conveyance is judicially forfeited, the court will forfeit the bond in lieu of the property. (a) Special notice provision. At the time of seizure of property defined in §1316.91 for violations involving the possession of personal use quantities of a controlled substance and conveyances seized pursuant to §1316.95, written notice must be provided to the possessor of the property regarding applicable statutes and Federal regulations including the procedures established for the filing of a petition for expedited release and for the posting of a substitute res bond as set forth in sections 6079 and 6080 of the Anti-Drug Abuse Act of 1988 and implementing regulations. (b) Standard notice provision. The standard notice to the owner as required by title 19, U.S.C., section 1607 and applicable regulations, shall be made at the earliest practicable opportunity after determining ownership of the seized property or conveyance and shall include the legal and factual basis of the seizure.
Title 21: Food and Drugs
PART 1316—ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
Section Contents
§ 1316.01 Scope of subpart A.
§ 1316.02 Definitions.
§ 1316.03 Authority to make inspections.
§ 1316.04 Exclusion from inspection.
§ 1316.05 Entry.
§ 1316.06 Notice of inspection.
§ 1316.07 Requirement for administrative inspection warrant; exceptions.
§ 1316.08 Consent to inspection.
§ 1316.09 Application for administrative inspection warrant.
§ 1316.10 Administrative probable cause.
§ 1316.11 Execution of warrants.
§ 1316.12 Refusal to allow inspection with an administrative warrant.
§ 1316.13 Frequency of administrative inspections.
§ 1316.21 Definitions.
§ 1316.22 Exemption.
§ 1316.23 Confidentiality of identity of research subjects.
§ 1316.24 Exemption from prosecution for researchers.
§ 1316.31 Authority for enforcement proceeding.
§ 1316.32 Notice of proceeding; time and place.
§ 1316.33 Conduct of proceeding.
§ 1316.34 Records of proceeding.
§ 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 Appeal from ruling of 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.
§ 1316.71 Definitions.
§ 1316.72 Officers who will make seizures.
§ 1316.73 Custody and other duties.
§ 1316.74 Appraisement.
§ 1316.75 Advertisement.
§ 1316.76 Requirements as to claim and bond.
§ 1316.77 Administrative forfeiture.
§ 1316.78 Judicial forfeiture.
§ 1316.79 Petitions for remission or mitigation of forfeiture.
§ 1316.80 Time for filing petitions.
§ 1316.81 Handling of petitions.
§ 1316.90 Purpose and scope.
§ 1316.91 Definitions.
§ 1316.92 Petition for expedited release in an administrative forfeiture action.
§ 1316.93 Ruling on petition for expedited release in an administrative forfeiture action.
§ 1316.94 Posting of substitute res in an administrative forfeiture action.
§ 1316.95 Petition for expedited release of a conveyance in a judicial forfeiture action.
§ 1316.96 Ruling on a petition for expedited release of a conveyance in a judicial forfeiture action.
§ 1316.97 Initiating judicial forfeiture proceeding against a conveyance within 60 days of the filing of a claim and cost bond.
§ 1316.98 Substitute res bond in a judicial forfeiture action against a conveyance.
§ 1316.99 Notice provisions.
Subpart A—Administrative Inspections
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§ 1316.01 Scope of subpart A.
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§ 1316.02 Definitions.
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§ 1316.03 Authority to make inspections.
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§ 1316.04 Exclusion from inspection.
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§ 1316.05 Entry.
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§ 1316.06 Notice of inspection.
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§ 1316.07 Requirement for administrative inspection warrant; exceptions.
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§ 1316.08 Consent to inspection.
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§ 1316.09 Application for administrative inspection warrant.
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§ 1316.10 Administrative probable cause.
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§ 1316.11 Execution of warrants.
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§ 1316.12 Refusal to allow inspection with an administrative warrant.
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§ 1316.13 Frequency of administrative inspections.
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Subpart B—Protection of Researchers and Research Subjects
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§ 1316.21 Definitions.
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§ 1316.22 Exemption.
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§ 1316.23 Confidentiality of identity of research subjects.
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§ 1316.24 Exemption from prosecution for researchers.
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Subpart C—Enforcement Proceedings
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§ 1316.31 Authority for enforcement proceeding.
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§ 1316.32 Notice of proceeding; time and place.
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§ 1316.33 Conduct of proceeding.
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§ 1316.34 Records of proceeding.
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Subpart D—Administrative Hearings
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§ 1316.41 Scope of subpart D.
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§ 1316.42 Definitions.
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§ 1316.43 Information; special instructions.
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§ 1316.44 Waiver or modification of rules.
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§ 1316.45 Filings; address; hours.
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§ 1316.46 Inspection of record.
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§ 1316.47 Request for hearing.
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§ 1316.48 Notice of appearance.
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§ 1316.49 Waiver of hearing.
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§ 1316.50 Appearance; representation; authorization.
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§ 1316.51 Conduct of hearing and parties; ex parte communications.
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§ 1316.52 Presiding officer.
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§ 1316.53 Time and place of hearing.
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§ 1316.54 Prehearing conference.
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§ 1316.55 Prehearing ruling.
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§ 1316.56 Burden of proof.
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§ 1316.57 Submission of documentary evidence and affidavits and identification of witnesses subsequent to prehearing conference.
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§ 1316.58 Summary of testimony; affidavits.
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§ 1316.59 Submission and receipt of evidence.
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§ 1316.60 Objections; offer of proof.
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§ 1316.61 Exceptions to rulings.
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§ 1316.62 Appeal from ruling of presiding officer.
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§ 1316.63 Official transcript; index; corrections.
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§ 1316.64 Proposed findings of fact and conclusions of law.
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§ 1316.65 Report and record.
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§ 1316.66 Exceptions.
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§ 1316.67 Final order.
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§ 1316.68 Copies of petitions for judicial review.
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Subpart E—Seizure, Forfeiture, and Disposition of Property
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§ 1316.71 Definitions.
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§ 1316.72 Officers who will make seizures.
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§ 1316.73 Custody and other duties.
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§ 1316.74 Appraisement.
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§ 1316.75 Advertisement.
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§ 1316.76 Requirements as to claim and bond.
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§ 1316.77 Administrative forfeiture.
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§ 1316.78 Judicial forfeiture.
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§ 1316.79 Petitions for remission or mitigation of forfeiture.
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§ 1316.80 Time for filing petitions.
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§ 1316.81 Handling of petitions.
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Subpart F—Expedited Forfeiture Proceedings for Certain Property
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§ 1316.90 Purpose and scope.
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§ 1316.91 Definitions.
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§ 1316.92 Petition for expedited release in an administrative forfeiture action.
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§ 1316.93 Ruling on petition for expedited release in an administrative forfeiture action.
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§ 1316.94 Posting of substitute res in an administrative forfeiture action.
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§ 1316.95 Petition for expedited release of a conveyance in a judicial forfeiture action.
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§ 1316.96 Ruling on a petition for expedited release of a conveyance in a judicial forfeiture action.
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§ 1316.97 Initiating judicial forfeiture proceeding against a conveyance within 60 days of the filing of a claim and cost bond.
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§ 1316.98 Substitute res bond in a judicial forfeiture action against a conveyance.
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§ 1316.99 Notice provisions.
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