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scribing each research project involving substances listed in schedule I attached to the form;

(7) To conduct instructional activities with controlled substances listed in schedule I, he shall apply as a researcher on BND Form 225 with two copies of a statement describing the nature, extent, and duration of such instructional activities attached to the form; and

(8) To conduct chemical analysis with controlled substances listed in any schedule, he shall apply on BND Form 225.

(b) If any person is registered and is applying for reregistration:

(1) To manufacture or distribute controlled substances, he shall apply on BND Form 227;

(2) To dispense controlled substances listed in schedules II through V, he shall apply on BND Form 226;

(3) To conduct instructional activities with controlled substances listed in schedules II through V, he shall apply on BND Form 226;

(4) To conduct research with controlled substances listed in schedules II through V (other than research described in § 301.22(a) (6), he shall apply on BND Form 227;

(5) To conduct research with narcotic drugs listed in schedules II through V, as described in § 301.22(a) (4), he shall apply on BND Form 227;

(6) To continue to conduct research with controlled substances listed in schedule I under one or more approved research protocols, he shall apply on BND Form 227;

(7) To continue to conduct instructional activities with controlled substances listed in schedule I under one or more approved instructional statements, he shall apply as a researcher on BND Form 227; and

(8) To conduct chemical analysis with controlled substances listed in any schedule, he shall apply on BND Form 227.

(c) BND Forms 224 and 225 may be obtained at any regional office of the Bureau or by writing to the Registration Branch, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Post Office Box 28083, Central Station, Washington, D.C. 20005. BND Forms 226 and 227 will be mailed, as applicable, to each registered person approximately 60 days before the expiration date of his registration; if any registered person does not receive such forms within 45 days before the expiration date of his registration, he must

promptly give notice of such fact and request such forms by writing to the Registration Branch of the Bureau at the foregoing address.

(d) Each application for registration to handle any basic class of controlled substance listed in schedule I (except to conduct chemical analysis with such classes), and each application for registration to manufacture a basic class of controlled substance listed in schedule II, or to conduct research with any narcotic controlled substance listed in schedule II, shall include the Bureau Controlled Substances Code Number, as set forth in Part 308 of this chapter, for each basic class or substance to be covered by such registration.

(e) Each application shall include all information called for in the form, unless the item is not applicable, in which case this fact shall be indicated.

(f) Each application, attachment, or other document filed as part of an application, shall be signed by the applicant, if an individual; by a partner of the applicant, if a partnership; or by an officer of the applicant, if a corporation, corporate division, association, trust or other entity. An applicant may authorize one or more individuals, who would not otherwise be authorized to do so, to sign applications for the applicant by filing with the Registration Branch of the Bureau a power of attorney on BND Form 231a for each such individual. The power of attorney shall be signed by a person who is authorized to sign applications under this paragraph and shall contain the signature of the individual being authorized to sign applications. The power of attorney shall be valid until revoked by the applicant.

[36 F.R. 7778, Apr. 24, 1971, as amended at 36 F.R. 18729, Sept. 21, 1971]

§ 301.33

Application to manufacture a new narcotic controlled substance. Any application for registration to manufacture a narcotic controlled substance subject to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) after May 1, 1971, where the manufacturing process involves chemical synthesis (whether from narcotic materials or not) shall be accompanied by an outline of the process of synthesis on BND Form 130, identifying the substances from which the substance is to be made and the substances resulting from each successive stage of the process and indicating in each instance whether the

substance is isolated and weighed or measured or remains in solution in a continuing process of manufacture. The applicant need not disclose any technical detail of the process which he regards as a trade secret (including temperature, pressure, volume, and catalyst used to aid the process), but must identify each substance used in or resulting from successive stages of manufacture in order to notify the Bureau of narcotic precursors and byproducts. BND Form 130 will, if requested by the applicant, be treated as confidential and subject to the protection provided in section 402 (a) (8) of the Act (21 U.S.C. 842(a) (8)).

§ 301.34 Filing of application; joint filings.

(a) All applications for registration shall be submitted for filing to the Registration Branch, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Post Office Box 28083, Central Station, Washington, D.C. 20005. The appropriate registration fee and any required attachments must accompany the application.

(b) Any person required to obtain more than one registration may submit all applications in one package. Each application must be complete and should not refer to any accompanying application for required information.

§ 301.35

Acceptance for filing; defective applications.

(a) Applications submitted for filing are dated upon receipt. If found to be complete, the application will be accepted for filing. Applications failing to comply with the requirements of this part will not generally be accepted for filing. In the case of minor defects as to completeness, the Director may accept the application for filing with a request to the applicant for additional information. A defective application will be returned to the applicant within 10 days following its receipt with a statement of the reason for not accepting the application for filing. A defective application may be corrected and resubmitted for filing at any time; the Director shall accept for filing any application upon resubmission by the applicant, whether complete or not.

(b) Accepting an application for filing does not preclude any subsequent request for additional information pursuant to § 301.36 and has no bearing on whether the application will be granted.

§ 301.36

Additional information.

The Director may require an applicant to submit such documents or written statements of fact relevant to the application as he deems necessary to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable time after being requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consideration by the Director in granting or denying the application.

§ 301.37 Amendments to and withdrawal of applications.

(a) An application may be amended or withdrawn without permission of the Director at any time before the date on which the applicant receives an order to show cause pursuant to § 301.48, or before the date on which a notice of hearing on the application is published pursuant to § 301.43, whichever is sooner. An application may be amended or withdrawn with permission of the Director at any time where good cause is shown by the applicant or where the amendment or withdrawal is in the public interest.

(b) After an application has been accepted for filing, the request by the applicant that it be returned or the failure of the applicant to respond to official correspondence regarding the application, when sent by registered or certified mail, return receipt requested, shall be deemed to be a withdrawal of the application.

ACTION ON APPLICATIONS FOR REGISTRATION: REVOCATION OR SUSPENSION OF

REGISTRATION

§ 301.41 Administrative review generally.

The Director may inspect, or cause to be inspected, the establishment of an applicant or registrant, pursuant to Subpart A of Part 316 of this chapter. The Director shall review the application for registration and other information gathered by the Bureau regarding an applicant in order to determine whether the applicable standards of section 303 of the Act (21 U.S.C. 823) have been met by the applicant.

§ 301.42 Applications for research in schedule I substances.

(a) In the case of an application for registration to conduct research with

controlled substances in schedule I, the Director shall refer such application to the Secretary, who shall determine the qualifications and competency of the applicant as well as the merits of the research protocol. The Secretary, in determining the merits of a research protocol, shall consult with the Director as to effective procedures to safeguard adequately against diversion of such controlled substances from legitimate medical or scientific use. If the Secretary finds the applicant qualified and competent and the research protocol meritorious and adequately safeguarded, he shall so notify the Director, and the Director shall register the applicant unless he finds registration should be denied on a ground specified in section 304 (a) of the Act (21 U.S.C. 824(a)).

(b) If the Secretary is unable to find the applicant qualified or the Director finds that grounds exist for the denial of the application, the Director shall issue an order to show cause pursuant to § 301.48 and, if requested by the applicant, hold a hearing on the application pursuant to § 301.51.

§ 301.43 Application for bulk manufacture of schedule I and II substances. (a) In the case of an application for registration or reregistration to manufacture in bulk a basic class of controlled substance listed in schedule I or II, the Director shall, upon the filing of such application, publish in the FEDERAL REGISTER a notice naming the applicant and stating that such applicant ha applied to be registered as a bulk manufacturer of a basic class of narcotic or nonnarcotic controlled substance, which class shall be identified. A copy of said notice shall be mailed simultaneously to each person registered as a bulk manufacturer of that basic class and to any other applicant therefor. Any such person may, within 30 days from the date of publication of the notice in the FEDERAL REGISTER, file with the Director written comments on or objections to the issuance of the proposed registration, and may, at the same time, file a written request for a hearing on the application in accordance with § 301.54. If a hearing is requested, the Director shall hold a hearing on the application pursuant to § 301.51. Any such person may participate in the hearing by filing a notice of appearance in accordance with § 301.54. Notice of the hearing shall be published in the FEDERAL REG

ISTER and shall be mailed simultaneously to the applicant and to all persons to whom notice of the application was mailed. Notice of the hearing shall contain a summary of all comments and objections filed regarding the application and shall state the time and place for the hearing, which shall not be less than 30 days after the date of publication of such notice in the FEDERAL REGISTER. A hearing pursuant to this section may be consolidated with a hearing held pursuant to § 301.44 or § 301.45.

(b) In order to provide adequate competition, the Director shall not be required to limit the number of manufacturers in any basic class to a number less than that consistent with maintenance of effective controls against diversion solely because a smaller number is capable of producing an adequate and uninterrupted supply.

(c) This section shall not apply to the manufacture of basic classes of controlled substances listed in schedules I or II as an incident to research or chemical analysis as authorized in § 301.22(b). [36 F.R. 7778, Apr. 24, 1971, as amended at 36 F.R. 18729, Sept. 21, 1971]

§ 301.44 Certificate of registration; denial of registration.

(a) The Director shall issue a Certificate of Registration (BND Form 223) to an applicant if the issuance of registration or reregistration is required under the applicable provisions of section 303 of the Act (21 U.S.C. 823). In the event that the issuance of registration or reregistration is not required, the Director shall deny the application. Before denying any application, the Director, shall issue an order to show cause pursuant to § 301.48 and, if requested by the applicant, shall hold a hearing on the application pursuant to § 301.51.

(b) The Certificate of Registration (BND Form 223) shall contain the name, address, and registration number of the registrant, the activity authorized by the registration, the schedules and/or Bureau Controlled Substances Code Number (as set forth in Part 308 of this chapter) of the controlled substances which the registrant is authorized to handle, the amount of fee paid (or exemption), and the expiration date of the registration. The registrant shall prominently display the Certificate of Registration at the registered location.

§ 301.45 Suspension or revocation of

registration.

(a) The Director may suspend any registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)) for any period of time he determines.

(b) The Director may revoke any registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)).

(c) Before revoking or suspending any registration, the Director shall issue an order to show cause pursuant to § 301.48 and, if requested by the registrant, shall hold a hearing pursuant to § 301.51. Notwithstanding the requirements of this section, however, the Director may suspend any registration pending a final order pursuant to § 301.46.

(d) Upon service of the order of the Director suspending or revoking registration, the registrant shall immediately deliver his Certificate of Registration and any order forms in his possession to the nearest office of the Bureau. The suspension or revocation of a registration shall suspend or revoke any individual manufacturing or procurement quota fixed for the registrant pursuant to Part 303 of this chapter. Also, upon service of the order of the Director revoking registration, the registrant shall, as instructed by the Director.

(1) Deliver all controlled substances in his possession to the nearest office of the Bureau or to authorized agents of the Bureau; or

(2) Place all controlled substances in his possession under seal as described in section 304(f) of the Act (21 U.S.C. 824(f)).

(e) In the event that revocation or suspension is limited to a particular controlled substance or substances, the registrant shall be given a new Certificate of Registration for all substances not affected by such revocation or suspension; no fee shall be required to be paid for the new Certificate of Registration. The registrant shall deliver the old Certificate of Registration and, if appropriate, any order forms in his possession to the nearest office of the Bureau. The suspension or revocation of a registration, when limited to a particular basic class or classes of controlled substances, shall suspend or revoke any individual manufacturing or procurement quota fixed for the registrant for such class or classes pursuant to Part 303 of this chapter. Also, the registrant shall, as instructed by the Director.

(1) Deliver to the nearest office of the Bureau or to authorized agents of the Bureau all of the particular controlled substance or substances affected by the revocation or suspension which are in his possession; or

(2) Place all of such substances under seal as described in section 304 (f) of the Act (21 U.S.C. 824(f)).

§ 301.46 Suspension of registration pending final order.

(a) The Director may suspend any registration simultaneously with or at any time subsequent to the service upon the registrant of an order to show cause why such registration should not be revoked or suspended, in any case where he finds that there is an imminent danger to the public health or safety. If the Director so suspends, he shall serve with the order to show cause pursuant to § 301.48 an order of immediate suspension which shall contain a statement of his findings regarding the danger to public health or safety.

(b) Upon service of the order of immediate suspension, the registrant shall promptly return his Certificate of Registration and any order forms in his possession to the nearest office of the Bureau. The suspension of any registration under this section shall suspend any quota fixed for the registrant pursuant to Part 303 of this chapter. Also, upon service of the order of the Director immediately suspending registration, the registrant shall, as instructed by the Director.

(1) Deliver all affected controlled substances in his possession to the nearest office of the Bureau or to authorized agents of the Bureau; or

(2) Place all of such substances under seal as described in section 304(f) of the Act (21 U.S.C. 824(f)).

(c) Any suspension shall continue in effect until the conclusion of all proceedings upon the revocation or suspension, including any judicial review thereof, unless sooner withdrawn by the Director or dissolved by a court of competent jurisdiction. Any registrant whose registration is suspended under this section may request a hearing on the revocation or suspension of his registration at a time earlier than specified in the order to show cause pursuant to § 301.48, which request shall be granted by the Director, who shall fix a date for such hearing as early as reasonably possible.

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In the event that an applicant for reregistration (who is doing business under a registration previously granted and not revoked or suspended) has applied for reregistration at least 45 days before the date on which the existing registration is due to expire, and the Director has issued no order on the application on the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue in effect until the date on which the Director so issues his order. The Director may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for reregistration at least 45 days before expiration of the existing registration, with or without request by the registrant, if the Director finds that such extension is not inconsistent with the public health and safety.

§ 301.48 Order to show cause.

(a) If, upon examination of the application for registration from any applicant and other information gathered by the Bureau regarding the applicant, the Director is unable to make the determinations required by the applicable provisions of section 303 of the Act (21 U.S.C. 823) to register the applicant, the Director shall serve upon the applicant an order to show cause why the registration should not be denied.

(b) If, upon information gathered by the Bureau regarding any registrant, the Director determines that the registration of such registrant is subject to suspension or revocation pursuant to section 304 of the Act (21 U.S.C. 824), the Director shall serve upon the registrant an order to show cause why the registration should not be revoked or suspended.

(c) The order to show cause shall call upon the applicant or registrant to appear before the Director at a time and place stated in the order, which shall not be less than 30 days after the date of receipt of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.

(d) Upon receipt of an order to show cause, the applicant or registrant must, if he desires a hearing, file a request for a hearing pursuant to § 301.54. If a hear

ing is requested, the Director shall hold a hearing at the time and place stated in the order, pursuant to § 301.51.

(e) When authorized by the Director, any agent of the Bureau may serve the order to show cause.

[36 F.R. 7778, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971]

HEARINGS

§ 301.51 Hearings generally.

(a) In any case where the Director shall hold a hearing on any registration or application therefor, the procedures for such hearing shall be governed generally by the adjudication procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by sections 303 and 304 of the Act (21 U.S.C. 823-824), by §§ 301.52-301.57, and by the procedures for administrative hearings under the Act set forth in 88 316.41-316.67 of this chapter.

(b) Any hearing under this part shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under the Act or any other law of the United States.

§ 301.52 Purpose of hearing.

If requested by a person entitled to a hearing, the Director shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation, or suspension of any registration, and the granting of any application for registration to manufacture in bulk a basic class of controlled substance listed in schedule I or II. Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law.

§ 301.53 Waiver or modification of rules.

The Director or the presiding officer (with respect to matters pending before him) may modify or waive any rule in this part 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.

§ 301.54 Request for hearing or appearance; waiver.

(a) Any person entitled to a hearing pursuant to §§ 301.42-301.45 and desir

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