130.1

130.2

130.3

130.4

130.5

130.6

130.7 130.8

130.9

Definitions and interpretations. Biologics; products subject to license control.

New drugs for investigational use; exemptions from section 505(a). Applications.

Reasons for refusing to file applica-
tions.

Comment on applications.
Amended applications.

Withdrawal of applications without
prejudice.

Supplemental applications.

130.10 Notification of applicant of approval of application.

130.11 Insufficient information in application.

130.12 Refusal to approve the application. 130.13 Records and reports concerning experience on drugs for which an approval is in effect.

130.14 Contents of notice of hearing. 130.15 Failure to file an appearance. 130.16 Appearance of applicant. 130.17 Hearing examiner.

130.18 Prehearing and other conferences. 130.19 Submission of documentary evidence in advance.

130.20 Excerpts from documentary evidence. 130.21 Submission and receipt of evidence. Transcript of the testimony. Oral and written arguments.

130.22

130.23

130.24

Tentative order.

130.25 Exceptions to the tentative order. 130.26 Issuance of final order.

130.27

Withdrawal of approval of an application. 130.28 Revocation of order refusing to approve application, or suspending or withdrawing approval of an application.

130.29 Service of notices and orders. 130.30 Untrue statements in application. 130.31 Judicial review.

130.32 Confidentiality of information contained in new-drug applications. 130.33 Notice of approval. 130.34 Notice of withdrawal of approval of application.

130.35 Records and reports on new drugs and antibiotics for use by man for which applications or certification forms 5 and 6 became effective or were approved prior to June 20, 1963.

Subpart B-Drugs Exempted From PrescriptionDispensing Requirements

130.101 Prescription-exemption procedure. 130.102 Exemption for certain drugs limited by new-drug applications to prescription sale.

AUTHORITY: The provisions of this Part 130 issued under secs. 503, 505, 701, 52 Stat. 1051, 1052, 1055, as amended; 21 U.S.C. 353, 355, 371, except as otherwise noted.

SOURCE: The provisions of this Part 130 appear at 28 F.R. 6377, June 20, 1963, unless otherwise noted.

NOTE: In the above revision of Part 130, § 130.3 (28 F.R. 179, Jan. 8, 1963, as amended) and 130.102 (21 F.R. 5582, July 25, 1956, as amended) were retained without change.

CROSS REFERENCES: For other regulations in this chapter concerning new drugs, see also §§ 1.106, 3.45, 3.511, 3.512, and 121.7.

Subpart A-Procedural and Interpretative Regulations

§ 130.1 Definitions and interpretations.

(a) As used in this part, the term "act" means the Federal Food, Drug, and Cosmetic Act approved June 25, 1938 (52 Stat. 1040 et seq., as amended; 21 U.S.C. 301-392).

(b) "Department" means the Department of Health, Education, and Welfare. (c) "Secretary" means the Secretary of Health, Education, and Welfare.

(d) "Commissioner” means the Commissioner of Food and Drugs.

(e) The term "person" includes individuals, partnerships, corporations, and associations.

(f) The definitions and intepretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part.

(g) "New-drug substance" means any substance that, when used in the manufacture, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substance.

(h) The newness of a drug may arise by reason (among other reasons) of:

(1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component.

(2) The newness for drug use of a combination of two or more substances, none of which is a new drug.

(3) The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new drug.

(4) The newness of use of such drug in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect another structure or function of the body.

(5) The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug.

§ 130.2 Biologics; products subject to license control.

(a) A new drug shall not be deemed to be subject to section 505 of the act if it is a drug licensed under the Public Health Service Act of July 1, 1944 (58 Stat. 682, as amended; 42 U.S.C. 201 et seq.) or under the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq.).

(b) A new drug produced and distributed in accordance with §§ 103.1 to 103.3 of Title 9 of the Code of Federal Regulations, issued under the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq.) shall not be deemed to be subject to section 505 of the Federal Food, Drug, and Cosmetic Act.

[29 F.R. 7820, June 19, 1964]

§ 130.3 New drugs for investigational

use; exemptions from section 505(a). (a) A shipment or other delivery of a new drug shall be exempt from section 505 (a) of the act if all the following conditions are met:

(1) The label of such drug bears the statement "Caution: New drug-Limited by Federal (or United States) law to investigational use."

(2) The person claiming the exemption has filed with the Food and Drug Administration a completed and signed "Notice of claimed investigational exemption for a new drug" in triplicate, with the following information:

1. The best available descriptive name of the drug, including to the extent known the chemical name and structure of any newdrug substance, and a statement of how it is to be administered. (If the drug has only a code name, enough information should be supplied to identify the drug.)

2. Complete list of components of the drug, including any reasonable alternates for inactive components.

3. Complete statement of quantitative composition of drug, including reasonable variations that may be expected during the investigational stage.

4. Description of source and preparation of any new-drug substances used as components, including the name and address of each supplier or processor, other than the sponsor, of each new-drug substance.

5. A statement of the methods, facilities, and controls used for the manufacturing, processing, and packing of the new drug to establish and maintain appropriate standards of identity, strength, quality, and purity as needed for safety and to give significance to clinical investigations made with the drug.

6. A statement covering all information available to the sponsor derived from preclinical investigations and any clinical studies and experience with the drug as follows:

a. Adequate information about the preclinical investigations, including studies made on laboratory animals, on the basis of which the sponsor has concluded that it is reasonably safe to initiate clinical investigations with the drug: Such information