$ 345.15 Jeopardy assessment. CODIFICATION: In $ 345.15, the word "Board” was substituted for "Director of Unemployment Insurance", by Board Order 44289, May 11, 1944, 9 F.R. 5399.

$ 345.24 Records. Every employer subject to contributions for any calendar quarter shall, with respect to each such quarter, keep such permanent records as are necessary to establish the total amount of compensation payable to his employees, during each such quarter for services performed after June 30, 1939. The record should be in such form as to contain the information required to be

shown on the quarterly contribution report. All record: required by these regulations shall be kept at a safe and convenient location accessible to inspection by the board or any of its officers or employees thereto designated. Such records shall be at all times open for inspection by such officers or employees.

Records required by these regulations shall be maintained for a period of at least four years after the date the contribution to which they relate becomes due, or the date the contribution is paid, whichever is later. (52 Stat. 1094, 1107; 45 U.S.C. 362) [Board Order 44-289, May 11, 1944, 9 F.R. 5399]

Part 403 Federal old-age and survivors in

surance under Title II of the

Social Security Act. [Amended) PART 403—FEDERAL OLD-AGE AND

SURVIVORS INSURANCE UNDER TITLE II OF THE SOCIAL SECURITY ACT

Subpart G-Procedures Sec. 403.709 Hearing. (Amended] 403.710 Appeals Council proceedings on cer

tification and review. (Amended) $ 403.709 Hearing. (g) Conduct of hearing and evidence.

A complete stenographic record of the proceedings at the hearing shall be made. When directed by the Appeals Council or the referee, the record shall be transcribed where the case is certified to or reviewed by the Appeals Council (see paragraph (k) of this section and $ 403.710 (a) and (b)). (Last undesignated paragraph amended Mar. 14, 1944, 9 F.R. 2877]

also be given, upon their request, a reasonable opportunity to file briefs or other written statements of contentions. Where there is more than one party, copies of such a brief or written statement shall be filed in a sufficient number that they may be made available to any party requesting a copy or any other party designated by the Appeals Council.

Evidence in addition to the evidence introduced at the hearing before the referee, or the documents before the referee where the hearing is waived, may not be presented except where it appears to the Appeals Council that additional material evidence is vailable which may affect its decision. If it appears that such additional evidence is available, the Appeals Council shall receive such evidence or designate a referee or member of the Council before whom the evidence shall be introduced. Before additional evidence may be presented, as above provided, notice shall be mailed to the parties, unless such notice is waived, at their last known addresses, that evidence will be received with respect to certain matters, and the parties shall be given a reasonable opportunity to present evidence which is relevant and material to such matters. When the additional evidence is introduced before a referee or a member of the Appeals Council, a transcript or a condensed statement of such evi. dence shall be made available to any party upon request.

The decision of the Appeals Council, when a case has been certified to it by a referee, shall be made in accordance with the provisions of paragraph (d) of this section. (Paragraph (a) amended Mar. 14, 1944, 9 F.R. 2877]

§ 403.710 Appeals Council proceedings on certification and review (a) Procedure before Appeals Council on certification by the referee. The Appeals Council of the Social Security Board shall, when a case has been certified to it by a referee without decision (see § 403.709 (k)), mail notice of such action to the parties at their last known addresses. A copy of the transcript of evidence adduced at the hearing or a condensed statement thereof or, where the hearing before the referee has been waived (see $ 403.709 (i)), copies or a statement of the contents of the documents which are evidence in the case, shall be made available to any party upon request.

When a case has been certified to the Appeals Council for decision, the parties shall be given, upon their request, a reasonable opportunity to appear before the Appeals Council for the purpose of presenting oral argument. The parties shall

(c) Procedure before Appeals Council on review of referee's decision or Bureau's revised determination. Whenever the Appeals Council determines to review a referee's decision or the revised determination of the Bureau, the Council shall make available to any party upon request a copy of the transcript of evidence adduced at the hearing or a condensed statement thereof or, where the hearing before the referee was waived (see $ 403.709 (i)), copies or a statement of the contents of the documents upon which the referee's decision was based. The parties shall be given, upon their request, a reasonable opportunity to file briefs or other written statements of contentions. Copies of such brief or other written statement, where there is more than one party, shall be filed in a sufficient number that they may be made available to any party requesting a copy and to any other party designated by the Appeals Council.

Evidence in addition to the evidence introduced at the hearing before the referee, or the documents before the referee where the hearing is waived, may

not be presented except where it appears to the Appeals Council that additional material evidence is available which may affect its decision. If it appears that such additional evidence is available, the Appeals Council shall receive such evidence or designate a referee or member of the Council before whom the evidence shall be introduced. Before additional evidence may be presented, as above provided, notice shall be mailed to the parties, unless such notice is waived, at their last known addresses, that evidence will be received with respect to certain matters, and the parties shall be given a reasonable opportunity to present evidence which is relevant and material to such matters. When the additional evidence is introduced before a referee or a member of the Appeals Council, a transcript or a condensed statement of such evidence shall be made available to any party upon request. (Paragraph (c) amended Mar. 14, 1944, 9 F.R. 2877)

Part

2 205

Part 2 Regulations for the enforcement of

the Federal Food, Drug, and Cos

metic Act. (Amended] 14 Cacao products. [Added] 16 Alimentary pastes; definitions and

standards of identity; macaroni and noodle products. [Added]

Part 36 Shellfish: definitions and stand

ards of identity; quality; and fill

of container. (Amended] 120 · Tolerances for poisons in food.

[Added] 155 Sea food inspection. [Amended) 170 Regulations for the enforcement of

the Federal Tea Act. [Amended]

PART 2-REGULATIONS FOR THE

ENFORCEMENT OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

DRUGS AND DEVICES Sec. 2.106 Drugs and devices; directions for use.

(Amended) 2.110 New drugs; applications. (Amended] 2.112 Insufficient information in applica

tion. (Added] 2.113 Untrue statements in application.

(Added]

DRUGS AND DEVICES $ 2.106 Drugs and devices, directions for use.

(b) Except as otherwise provided by paragraphs (h) and (i) of this section, a shipment or other delivery of a drug or device shall be exempt from the requirements of section 502 (f) (1) of the act if it complies with all of the following conditions:

(1) Such drug or device, because of its toxicity or other potentiality for harmful effect or the method of its use or the collateral measures necessary to its use, is not generally recognized among experts qualified by scientific training and experience to evaluate its safety and efficacy, as safe and eficacious for use except by or under the supervision of a physician, dentist, or veterinarian.

(2) Such shipment or delivery is to be:

(i) Dispensed by physicians, dentists, or veterinarians in their professional practice;

(ii) Dispensed upon prescriptions issued by physicians, dentists, or veterinarians in their professional practice and under labeling bearing the directions for use specified in such prescriptions;

(iii) Compounded with other substances in filling such prescriptions; or

(iv) Used in the manufacture of another drug or device.

(3) Information adequate for the use of such drug or device by physicians, dentists, or veterinarians, as the case may be, is readily available.

(4) The label of such drug or device (other than surgical instruments and other devices to be used exclusively by physicians, dentists ,or veterinarians in their professional practice) bears the statement “Caution: To be dispensed only by or on the prescription of a

", or "Caution: To be dispensed only by or on the prescription of

or otherwise used only for manufacturing purposes”, the blank being filled in with one or more of the words “physician”, “dentist”, and “veterinarian", as the case may be.

(5) No representation with respect to the conditions for which a drug or device is to be used or how it is to be used appears in its labeling except representations:

(i) In printed matter supplied to a physician, dentist, or veterinarian separately from such drug or device;

a

a