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arguments adduced, the Commissioner shall notify the proponent of his decision and the reasons therefor. Any person aggrieved by any order, rule, or decision of the Commissioner, or by his failure to rule upon or decide any matter presented to him by proper application, may appeal therefrom to the Secretary of the Treasury (§§ 301.1-301.7 of this chapter).

(c) Registration or reregistration under Internal Revenue Narcotic Law. (1) Applicants for registration or reregistration under the internal revenue narcotic law (68A Stat. 554; 26 U. S. C. 4721 et seq.) are required by that law, as a condition to registration, to be lawfully entitled to engaged in the busi

ness

or professional activity, involving the use of narcotics, for which registration is desired. Forms of application (678-A for initial registration and 678 for reregistration) may be obtained from the District Director of Internal Revenue of the applicant's district. Both forms require applicant to state his name, place of business, occupational tax classification, and to certify that under the laws of the jurisdiction in which he is operating or proposes to operate, he is legally qualified or lawfully entitled to engage in the activities for which registration is sought. (26 CFR 151.6.) All applications on Form 678-A are referred by the District Director to the appropriate District Supervisor of the Bureau of Narcotics for investigation, report and recommendation. Applications on Form 678 are also referred by the District Director to the appropriate District Supervisor for investigation, report and recommendation, if the District Director is in doubt as to the applicant's being lawfully entitled to engage in the activity for which he seeks registration. (26 CFR 151.5.) The District Supervisor, upon receipt of the referred application, investigates to ascertain whether the applicant is so lawfully entitled, usually involving a determination whether the applicant is currently licensed under the law of the State, Territory, or District of Columbia, if such law requires a license for the activity for which registration is sought. He returns the application to the District Director with recommendation for approval or disapproval according to whether he finds the applicant legally qualified or not. If disapproval is thus recommended, the District Director denies registration to the applicant.

(2) In the case of an applicant for reregistration so found not legally quali

fied therefor, no prior notice of denial of the application shall be given under section 9 (b) of the act of June 11, 1946 (60 Stat. 242; 5 U. S. C. 1008 (b)), since the necessity for prompt and continuous control of activities relating to these potentially dangerous narcotic drugs requires otherwise in the interest of the public health and safety.

(d) Licenses to import and export. (1) An application for initial authority to import crude opium or coca leaves under the Narcotic Drugs Import and Export Act, as amended, (35 Stat. 614, as amended; 21 U. S. C. 171185) must be made in writing and submitted to the Commissioner of Narcotics, Washington 25, D. C. No special form of application is required but the applicant must show evidence that he complies with the requirements of the pertinent regulations. (§§ 302.2 and 302.30 of this chapter). The provisions of paragraphs (a) and (b) of this section apply to such an application for initial authority to import.

(2) An applicant who has been granted initial authority to import crude opium and coca leaves must submit to the Commissioner of Narcotics at Washington 25, D. C., a special application for a formal permit to cover each proposed importation. The application to import crude opium or coca leaves for medical and legitimate purposes (sec. 2, 35 Stat. 614 as amended; 21 U. S. C. 173a) is made on Bureau of Narcotics Form No. 20, and the application to import special coca leaves (sec. 6, 46 Stat. 587, 21 U. S. C. 173a) is made on Bureau of Narcotics Form No. 20-A. Copies of both forms are obtainable from the Commissioner of Narcotics at Washington 25, D. C. It is required that both forms state the statistical and routing information described in §§ 302.3, 302.4 and 302.33 respectively, of this chapter. If the application, submitted by a qualified importer, is in due form, and the proposed importation will not result in an excess over the maximum quantity of crude opium and coca leaves allotted to the importer for the particular year, (§§ 302.3 and 302.32 of this chapter) the Commissioner of Narcotics will issue the formal import permit in sextuplicate, containing the information described in § 302.6 of this chapter, the disposition of the various copies being explained in § 302.10 of this chapter.

(3) Applications for in-transit shipments of narcotic drugs through the United States, and for export of narcotic drugs from the United States (35 Stat. 614 as amended; 21 U. S. C. 180-182) must be submitted to the Commissioner of Narcotics at Washington 25, D. C., on Bureau of Narcotics Form No. 161, copies of which form are obtainable from said Commissioner. The application must contain the statistical and routing information described in §§ 302.18 and 302.28 of this chapter and must show the registry number of the applicant under the internal revenue narcotic law. If the application as submitted by a qualified exporter, is found in due form, and supported by duly authenticated foreign import license or permit (§ 302.19 of this chapter) the Commissioner will issue a formal export or in-transit permit in sextuplicate, the permit containing the information, and the various copies being disposed of as described in § 302.21 of this chapter.

(e) Licenses to produce opium poppies and opium products. Applications for licenses to produce opium poppies, and to manufacture opium products therefrom, under the Opium Poppy Control Act of 1942 shall be made in writing to the Commissioner of Narcotics at Washington 25, D. C. No special form of application is provided, but the applicant must show evidence of qualifications and facilities described in §§ 302.3-302.9 of this chapter. No licenses are issuable unless the Commissioner of Narcotics shall determine such action to be appropriate to supply the medical and scientific needs of the United States for opium or opium products (§ 303.2 of this chapter) and since this contingency has not occurred, no licenses have been issued. No specific form of license has been provided; if in the remote contingency, it should be found appropriate to issue such a license to produce or to manufacture, the license would be issued in typewritten form, pursuant to the requirements of §§ 303.5, 303.8 and 303.9 of this chapter. In the event of revocation or refusal to renew such a license, the provisions of §§ 303.11 to 303.13 of this chapter, apply. No forms of returns to be required of producers and manufacturers have been provided (§§ 303.14 and 303.15 of this chapter) but if issuance of licenses were found appropriate, as explained herein, special forms to report the information

required by the regulations would be provided.

(f) Petitions for remission of forfeitures. With respect to vessels, vehicles and aircraft seized under the act of August 9, 1939 when the seizure is made in connection with a violation involving a contraband article covered by section 1 (b) (1) of said act the Secretary of the Treasury has designated as the custodial officer, the narcotic district supervisor for the district in which the seizure is made (26 CFR 466.2). Any person having an interest in such seized property may make a timely petition for restoration of the proceeds of sale, or for remission or mitigation of the forfeiture (Sec. 613, 46 Stat. 756, as amended (19 U. S. C. 1613) with sec. 618, 46 Stat. 757 (19 U. S. C. 1618) made applicable by sec. 4, 53 Stat. 1292 (49 U. S. C. 784)). No special form for the petition is provided, but it must be filed in duplicate, addressed to the Secretary of the Treasury, sworn to, and submitted to the district supervisor for the district in which the seizure occurred. The petition shall contain the information required by 26 CFR 153.8, and must be seasonably filed (26 CFR 153.9). If the petition is cognizable by the Secretary of the Treasury (26 CFR 153.10), it will be forwarded by the District Supervisor with his report of any investigation made, to the Commissioner of Narcotics, who will transmit the petition and report, with his recommendation, to the Secretary of the Treasury for decision, and such decision shall be communicated to the petitioner through the District Supervisor.

(g) Presidential function under Opiates Act. Under the act of March 8, 1946 (60 Stat. 38; 26 U. S. C. 3228 (f)), section 3228 of the Internal Revenue Code of 1939 (now section 4731 of the Internal Revenue Code of 1954) was amended by adding a new subsection (f) (now subsection g)) at the end thereof, this new subsection being a definition of the term "Opiate." The term "Opiate" is defined in the subsection to mean any drug (as defined in the Federal Food, Drug and Cosmetic Act (52 Stat. 1041; 21 U. S. C. 321 (g)) found by the Secretary of the Treasury, after due notice and opportunity for public hearing, to have an addiction-forming or addiction-sustaining liability similar to morphine or cocaine, and proclaimed by the President to have been so found by the Secretary. When the Secretary of the Treasury shall

find that a given drug has such addictionforming or addiction-sustaining liabilty, he shall report his finding to the President. If and when the President shall proclaim that the drug has been so found by the Secretary of the Treasury, the drug shall become an opiate under said section 4731 (g) of the Internal Revenue Code of 1954 from the date of the President's proclamation.

(38 Stat. 275, as amended; 21 U. S. C. 182) [11 F. R. 177A-72, 12044, Sept. 11, 1946. Redesignated at 13 F. R. 1559, Mar. 24, 1948; 13 F. R. 7671, Dec. 10, 1948; 20 F. R. 9504, Dec. 20, 1955]

CROSS REFERENCE: For orders proclaiming and making effective the findings of the Secretary of the Treasury with regard to certain drugs having addiction-forming and addiction-sustaining liability similar to morphine, see Proclamation 2738, 3 CFR, 1947 Supp.; Proclamations 2793 and 2807, 3 CFR, 1948 Supp.; Proclamation 2851, 3 CFR 1949 Supp.; Proclamation 2879, 3 CFR, 1950 Supp.; Proclamation 3022, 3 CFR, 1953 Supp.; Proclamation 3074, 3 CFR, 1954 Supp.; Proclamation 3082, 3 CFR, 1955 Supp.

Part 305-Hearings to Determine Addiction-Forming or Addiction-Sustaining Liability of Drugs

Sec.

305.1 Hearing; notice. 305.2 Procedure.

AUTHORITY: §§ 305.1 and 305.2 issued under 68A Stat. 557; 26 U. S. C. 4731 (g).

§ 305.1 Hearing; notice. (a) For the purpose of carrying out the provisions of section 1 of the act of March 8, 1946 (60 Stat. 38; 26 U. S. C. 3228 (f), now section 4731 (g) of the Internal Revenue Code of 1954), due notice shall be given, and opportunity for a public hearing to all interested parties shall be afforded to determine whether any drug as defined in the Federal Food, Drug and Cosmetic Act (sec. 201 (g), 52 Stat. 1041; 21 U. S. C. 321 (g)) has an addiction-forming or addiction-sustaining liability similar to morphine or cocaine. The Commissioner of Narcotics, designated in this part as the Commissioner, is authorized to conduct a hearing at a time and place to be announced in the notice.

(b) Not less than 20 days prior to the date set for a hearing, the Commissioner shall cause to be published in the FEDERAL REGISTER a notice setting forth the

date, time and place of the proposed hearing. The notice shall also identify the drug upon which evidence will be heard to determine its addiction-forming or addiction-sustaining liability. Any person desiring to be heard on the addiction-forming or addiction-sustaining liability of the particular drug shall furnish written notice to the Commissioner of Narcotics, Washington 25, D. C., not later than 20 days from the date notice of hearing is published in the FEDERAL REGISTER. If no written notice of a desire to be heard shall be received by the Commissioner within such period of 20 days, no hearing shall be held, but the Commissioner shall proceed to make a recommendation based upon the result of pharmacologic tests of the drug. This recommendation, together with a report of the results of pharmacologic tests upon which it is based, shall be transmitted promptly to the Secretary of the Treasury for a finding as to the addiction-forming or addiction-sustaining liability of the drug as compared to morphine or cocaine.

[T. D. 38, 12 F. R. 1480, Mar. 5, 1947. Redesignated at 13 F. R. 1559, Mar. 24, 1948; 13 F. R. 7671, Dec. 10, 1948; 20 F. R. 9504, Dec. 20, 1955]

§ 305.2 Procedure. (a) If written notice of a desire to be heard is received by the Commissioner within the prescribed period of 20 days, the hearing will be held in accordance with the original notice. Evidence, both documentary and oral, will be received, and argument will be heard, on the question whether the particular drug has an addictionforming or addiction-sustaining liability similar to morphine or cocaine, but all such evidence shall be based upon the result of pharmacologic tests of the drug.

(b) The Commissioner shall prepare a report containing the substance of all evidence adduced, including copies of documentary evidence, the arguments presented, and any briefs submitted and shall transmit the same, with his recommendation, to the Secretary of the Treasury within 30 days from the date of conclusion of the hearing. All persons who were parties to the hearing shall, at the same time, be notified of the Commissioner's recommendation.

(c) Within 10 days from the date of receipt of the Commissioner's recommendation, the Secretary of the Treasury shall make his finding, and if he finds

that the drug has an addiction-forming or addiction-sustaining liability similar to morphine or cocaine, he shall transmit such finding to the President for proclamation. If he finds that the drug has no such addiction-forming or addiction-sustaining liability, he shall so no

tify the Commissioner who shall communicate this finding to all persons who were parties to any hearing held under this section.

[T. D. 38, 12 F. R. 1480, Mar. 5, 1947. Redesignated at 13 F. R. 1559, Mar. 24, 1948; 13 F. R. 7671, Dec. 10, 1948; 20 F. R. 9504, Dec. 20, 1955]

INDEX

A

Addiction-forming drugs. See Drugs; and Narcotics.

Aircraft, forfeited because of transportation of narcotic drugs; petition for remission
of forfeiture, 21 § 304.1 (f)

Alimentary pastes (macaroni and noodles); definitions and standards of identity,
21 Part 16

Animal feeds, drugs in, to increase milk or egg production, or for fattening purposes;
use, etc., 21 § 3.7

Animals, use of antibiotics for, 21 §§ 3.8, 3.25, 146.25-146.28

Antibiotic drugs; certification, testing, etc. See Food and Drug Administration.
Apple butter or jelly; definitions and standards of identity, 21 §§ 29.1, 29.2
Apricots, canned, preserves, etc.; definitions and standards of identity:

Canned, 21 §§ 27.10-27.13

Preserves, jams, jelly, 21 Part 29

Artichokes, canned; definitions and standards of identity, 21 § 51.990
Asparagus, canned; definitions and standards of identity, 21 § 51.990.

B

Bacitracin (antibiotic drugs). See Drugs.

Bakery products (breads, rolls, buns); definitions and standards of identity, 21 Part 17
Bandages, gauze; notice to manufacturers, packers and distributors respecting indi-
vidual packaging, 21 § 3.5

Barbituric acid, derivatives:

Designation as habit-forming drugs, 21 § 165.1

Exemption from prescription requirements, under certain conditions, 21 § 1.108
Label requirements, 21 § 1.104

Bean sprouts, canned; definitions and standards of identity, 21 § 51.990

Beans (green, wax, shelled, lima, etc.); definition and standards of identity:
Green and wax beans, 21 §§ 51.10-51.16

Lima beans, 21 § 51.990

Shelled beans, 21 § 51.990

Beet greens, canned; definitions and standards of identity, 21 § 51.990

Beets, canned; definitions and standards of identity, 21 § 51.990

Berries; preserves, jams, jelly, definitions and standards of identity, 21 Part 29

Bile from condemned livers of slaughtered animals, with addition of sodium hydrox-

ide; notice to manufacturers, packers, and distributors respecting labeling, etc.,
21 § 3.16

Bonito, Peruvian, canned; notice to importers respecting labeling, 21 § 3.6
Broccoli, canned; definitions and standards of identity, 21 § 51.990
Bromal:

See also Drugs.

Designation as substance from which habit-forming drugs are derived, 21 § 165.1
Brussels sprouts, canned; definitions and standards of identity, 21 § 51.990

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