Mr. LEA introduced the following bill; which was referred to the Committee on Interstate and Foreign Commerce DECEMBER 17, 1941 12/18/4 Reported with an amendment, Committed to the Committee of the Whole House DEC 181941 on the state of the Union, and ordered to be printed D WIN AMENDMENT [Insert the part printed in italic] HUREN SHOWN A BILL To amend the Federal Food, Drug, and Cosmetic Act of June 25, 1938, as amended, by providing for the certification of batches of drugs composed wholly or partly of insulin, and for other purposes. 1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 3 That section 301 (i) of the Federal Food, Drug, and Cosmetic 4 Act of June 25, 1938, as amended, is amended by inserting 5 "506," before the phrase "or 604." at the end thereof. 6 SEC. 2. Section 502 of such Act, as amended, is amended 7 by inserting a new paragraph at the end thereof, as follows: "(k) If it is, or purports to be, or is represented as a drug 8 9 composed wholly or partly of insulin, unless (1) it is from a 2 1 batch with respect to which a certificate or release has been 2 issued pursuant to section 506, and (2) such certificate or 3 release is in effect with respect to such drug." 4 SEC. 3. Chapter V of such Act, as amended, is amended 5 by adding a new section at the end thereof, as follows: "CERTIFICATION OF DRUGS CONTAINING INSULIN 6 7 "SEC. 506. (a) The Federal Security Administrator, 8 pursuant to regulations promulgated by him, shall provide 9 for the certification of batches of drugs composed wholly or 10 partly of insulin. A batch of any such drug shall be certified 11 if such drug has such characteristics of identity and such batch 12 has such characteristics of strength, quality, and purity, as 13 the Administrator prescribes in such regulations as necessary 14 to adequately insure safety and efficacy of use, but shall not 15 otherwise be certified. Prior to the effective date of such 16 regulations the Administrator, in lieu of certification, shall 17 issue a release for any batch which, in his judgment, may 18 be released without risk as to the safety and efficacy of its use. 19 Such release shall prescribe the date of its expiration and 20 other conditions under which it shall cease to be effective as 21 to such batch and as to portions thereof. 22 "(b) Regulations providing for such certification shall 23 contain such provisions as are necessary to carry out the 24 purposes of this section, including provisions prescribing (1) 25 standards of identity and of strength, quality, and purity; 26 (2) tests and methods of assay to determine compliance with 3 1 such standards; (3) effective periods for certificates, and 2 other conditions under which they shall cease to be effective 3 as to certified batches and as to portions thereof; (4) ad4 ministration and procedure; and (5) such fees, specified in 5 such regulations, as are necessary to provide, equip, and 6 maintain an adequate certification service. Such regulations 7 shall prescribe no standard of identity or of strength, quality, 8 or purity for any drug different from the standard of iden 9 tity, strength, quality, or purity set forth for such drug in an 10 official compendium. 11 66 (c) Such regulations, insofar as they prescribe tests or 12 methods of assay to determine strength, quality, or purity of 13 any drug, different from the tests or methods of assay set forth 14 for such drug in an official compendium, shall be prescribed, 15 after notice and opportunity for revision of such compendium, 16 in the manner provided in the second sentence of section 17 501 (b). The provisions of subsections (e), (f), and (g) 18 of section 701 shall be applicable to such portion of any 19 regulation as prescribes any such different test or method, 20 but shall not be applicable to any other portion of any such 21 regulation." 22 SEC. 4. Regulations initially prescribed under section 506 23 of such Act, as amended, shall be promulgated and made effeo24 tive within forty-five days after the date of enactment of this 25 Act. To amend the Federal Food, Drug, and Cosmetic Act of June 25, 1988, as amended, by providing for the certification of batches of drugs composed wholly or partly of insulin, and for other purposes. Reported with an amendment, committed to the Committee of the Whole House on the state of the Union, and ordered to be printed 1941 CONGRESSIONAL RECORD-SENATE of executive papers by the Office of Produc1.on Management. exccutive office of the President. Ordered to be printed. Mr. ELLIOTT of California: Committee on the Disposition of Executive Papers. House Report No. 1539. Report on the disposition of executive papers by the Department of the Navy. Ordered to be printed. Mr. OLEARY: Committee on Expenditures in the Executive Departments. H. R. 6220. A bill to amend section 3 of the Subsistence Expense Act of 1926. as amended; without amendment (Rept. 1540). Referred to the Committee of the Whole House on the state of the Union. Mr. O'LEARY: Committee on Expenditures in the Executive Departments. 8. 2087. An act to extend the time for examination of mcnthly accounts covering expenditures by disbursing officers of the United States Marine Corps: without amendment (Rept. No. 1541). Referred to the Committee of the Whole House on the state of the Union. Mr. LEA: Committee on Interstate and Foreign Commerce. H. R 6251. A bill to amend the Federal Focd. Drug. and Cosmetic Act of June 25, 1938, as amended. by providing for the certification of batches of drugs composed wholly or partly of insulin, and for other purposes; with amendment (Rept. No. 1542). Referred to the Committee of the Whole House on the state of the Union. Mr. NICHOLS: Select Committee to Investigate Air Accidents House Resolution 125. Resolution creating a Select Committee to Investigate Air Accidents; with amendment (Rept. No. 1543). Referred to the Committee of the Whole House on the state of the Union. Mr. MASON: Committee on Immigration and Neutralization. H. R. 6250. A bill to amend the Nationality Act of 1940; without amendment (Rept. No. 1544). Referred to the Ccmmittee of the Whole House on the state of the Union. Mr. SABATH: Committee on Rules. House Resolution 393. Resolution for the consideration of H. R. 6250, e bill to amend the Nationality Act of 1940; with amendment (Rept. No. 1545). Referred to the House Calendar. By Mr. MANASCO: HR 6258. A bill to require certain persons thin the United States and its territories and insular possessions to carry identification rds and to be fingerprinted, and for other purposes; to the Committee on Immigration and Naturalization. By Mr RANKIN of Mississippi: H.R. 6259. A bill making an appropriation to enable the Tennessee Valley Authority to begin construction of the Douglas Dam on the French Broad River near Dandridge, Tenn; to the Committee on Appropriations. By Mr ROBERTSON of North Dakota: HR. 6260. A bill suspending collections of certain seed and feed loans; to the Committee on Agriculture. By Mr. RANDOLPH: H. R. 6261. A bill to amend the District cf Columbia Traffic Act of 1925; to the Committee on the District of Columbia. By Mr. ANDERSON of California: H. R. 6262. A bill to provide for the planting of 45,000 acres of guayule in order to Under clause 1 of rule XXII, petitions and papers were laid on the Clerk's desk and referred as follows: 2184. By Mr. HOFFMAN: Resolution of the common council of the city ci Niles, Mich., pledging the whole-hearted cooperation and support of the citizens cf Niles to their Government and its duly elected and appointed representatives to the end that our form of government shall not perish; the Committee on the Judiciary. 2185. By Mr. KEOGH: Petition of the Brooklyn Concourse Association of Homing Pigeon Flyers, favoring the Pfeifer bill, safeguarding of the valuable homing pigeons, signed by 120 members of the association; to the Committee on Agriculture 2186. By Mr. KRAMER: Petition of the Los Angeles County District Council of Carpenters in meeting, most vigorously opposing any further taxes on pay rolls or otherwise, feeling that they would lower the standard of living; to the Committee on Ways and Means. 2187. By Mr. SMITH cf Wisconsin: Resolution of the first district conference, Disabled American Veterans of the World War, assembled in the city of Kenosha, Wis., pledging their support whether it be physical, moral, or financial, to the Congress and to the President as Commar.der in Chief of the armed forces of America; to the Committee on Military Affairs. SENATE 9949 THURSDAY, DECEMBER 18, 1941 (Legislative day of Tuesday, December 16, 1941) The Senate met at 12 o'clock meridian on the expiration of the recess. The Very Reverend ZeBarney T. Phillips, D. D., Chaplain of the Senate, offered the following prayer: Almighty God, from whom we spring and to whom we tend, help us this day that we may endeavor to be that which Thou wouldst have us to be, and to do that which Thou commandest, for Thou, O God, art the way, the motive. the guide, the beginning and end of all conduct. And so we ask Thee to bring us into Thine eternal and abiding order where right is right because it is Thy nature, the secret and method of the universe, where righteousness becomes imperative as it lays hold of our inmost nature and binds us to duty by every law of our being. And, as we dedicate ourselves and our country which Thou hast given us to this solemn task which now is ours, may we leave no unrepented fault, no uncleansed spot, sparing least of all that sin which doth so easily beset us, that, as we offer Thce a pure life, a more unselfish patriotism, and a deeper loyalty to the Kingship of Thy Son, we may never cast a backward glance, nor lean on mortal mar. but only on the Rock of Ages who standeth fast forever and will make all things work together for good, for the everlasting good of all the children of men, who trust in Thee as their Lord, their Father, and their God. Amen. THE JOURNAL On request of Mr. BARKLEY, and by unanimous consent, the reading of the Journal of the calendar day Wednesday, December 17, 1941, was dispensed with, and the Journal was approved. MESSAGES FROM THE PRESIDENT- Messages in writing from the President of the United States were communicated to the Senate by Mr. Miller, one of his secretaries, who also announced that on December 17, 1941, the President had approved and signed the act (S. 1190) for the relief of the estate of Julia Neville. MESSAGE FROM THE HOUSE A message from the House of Representatives, by Mr. Chaffee, one of its reading clerks, announced that the House had agreed to the amendment of the Senate to the bill (H. R. 6233) to expedite the prosecution of the war effort. The message also announced that the House had passed the following bills, in which it requested the concurrence of the Senate: H. R. 5822. An act to establish a military code for the Territory of Alaska; and H. R. 6215. An act to amend the Selective Training and Service Act of 1940 by providing for the extension of liability for military service and for the registration of the manpower of the Nation, and for other purposes. |