Imágenes de página
PDF

pay period which begins on or after January 1, 1964, and a second new limitation effective on the first day of the first pay period which begins on or after January 1, 1964, and thereafter, which reflect the respective applicable increases provided by title II of this part in corresponding rates of compensation for officers and employees subject to the Classification Act of 1949, as amended.

Employees in the legislative branch

Sec. 1005. (a) Each oflicer and employee in or under the legislative branch of the Government whose rate of compensation is increased by section 5 of the Federal Employees Pay Act of 1946 shall be paid additional compensation at the rate of 7 per centum of his gross rate of compensation (basic compensation plus additional compensation authorized by law).

(b) The basic compensation of each employee in the ofi‘ice of a Senator is hereby adjusted, effective on October 16, 1962, to the lowest multiple of $60 which will provide a gross rate of compensation not less than the gross rate such employee was receiving immediately prior thereto, except that the foregoing provisions of this subsection shall not apply in the case of any employee if on or before the fifteenth day following the date of enactment of this Act the Senator by whom such employee is employed notifies the disbursing ol‘fice of the Senate in writing that he does not wish such provisions to apply to such employee. In any case in which, at the expiration of the time within which a Senator may give notice under this subsection, such Senator is deceased such notice shall be deemed to have been given.

(0) Notwithstanding the provision referred to in subsection (d), the rates of gross compensation of the elected 017icers of the Senate (except the Presiding Officer of the Senate), the Legislative Counsel of the Senate, the O17icial Reporters of Debates of the Senate, the Parliamentarian of the Senate, the Senior Counsel in the Olfice of the Legislative Counsel of the Senate, and the Chief Clerk of the Senate are hereby increased by 7 per centum.

(d) The paragraph imposing limitations on basic and gross compensation of officers and employees of the Senate appearing under the heading “Senate” in the Legislative Appropriation Act, 1956, as amended (74 Stat. 304; Public Law 86-568), is amended to read as follows:

“No ofl‘icer or employee whose compensation is disbursed by the Secretary of the Senate shall be paid basic compensation at a rate in excess of $8,880 per annum, or gross compensation at a rate in excess of $18,880 per annum, unless expressly authorized by law.”

(e) The limitation on gross rate per hour per person provided by applicable law on the efi‘ective date of this section with respect to the folding of speeches and pamphlets for the Senate is hereby increased by 7 per centum. The amount of such increase shall be computed to

72100—8 J——87-2——46

the nearest cent, counting one-half cent and over as a whole cent. The provisions of subsection (a) of this section shall not apply to employees whose compensation is subject to such limitation.

(f) Each officer or employee of the House of Representatives, whose compensation is disbursed by the Clerk of the House of Representatives and is not increased automatically, or is not permitted to be increased administratively, by reason of any other provision of this section, shall receive additional compensation of the rate of 7 per centum of the rate of his total annual compensation in effect immediately prior to the effective date of this section.

(0) The limitations on gross rate per thousand and gross rate per hour per person provided by applicable law on the effective date of this section with respect to the folding of speeches and pamphlets for the House of Representatives are hereby increased by 7 per centum. The amount of each such in— crease shall be computed to the nearest cent, counting one-half cent and over as a whole cent.

(h) The additional compensation provided by this section shall be considered a part of basic compensation for the purposes of the Civil Service Retirement Act (5 U.S.C. 2251 and the following).

(i) Notwithstanding any other provision of this section, no rate of compensation which exceeds $21,500 shall be increased by this section, and no increase provided by this section shall cause the gross rate of compensation (basic plus additional compensation authorized by law) or the total annual compensation of any officer or employee to exceed $21, 500.

(7') Insofar as the provisions of this section apply to oflicers and employees whose compensation is based on a monthly pay period which begins on the first day of the month, such provisions shall become effective on October 16, 1962.

Saving provision

Sec. 1006. Notwithstanding any provision of this Act, no rate of basic, gross, or total annual compensation or salary shall be reduced by reason of the enactment of this Act.

Absorption of cos ts

Sec.1007. (a) The departments,agencies, establishments, and corporations in the executive branch shall absorb the costs of the increases in basic compensation provided by this Act to the fullest extent possible without seriously affecting the immediate execution of essential functions.

(b) No request for additional or supplemental appropriations to meet the increases in basic compensation provided by this Act shall be transmitted to the Congress unless is is accompanied by a certification of the Director of the Bureau of the Budget that the amounts requested are necessary to provide for the continued execution of essential functions of the department, agency, or corporation concerned.

(c) Pursuant to the objective of this section, heads of the executive branch activities concerned are directed to review with meticulous care each vacancy resulting from voluntary resignation, retirement, or death and to determine whether the duties of the position can be reassigned to other employees or whether the position can be abolished without seriously afiecting the execution of essential functions.

(d) Nothing contained in subsection (a) of this section shall be held or considered to require (1) the separation from the service of any individual by reduction in force or other personnel action or (2) the placing of any individual in a leave-without-pay status.

Efiective date

Sec. 1008. Except as otherwise expressly provided, this title shall become effective on the first day of the first pay period which begins on or after the date of enactment of this Act.

Ceiling provision

Sec.1009. Except as provided in section 1005, no rate of compensation which exceeds $20,000 per annum shall be increased or established by or pursuant to this Act and no increase made by or pursuant to this Act shall cause any rate of compensation to exceed $20,000 per annum.

Part III—Adjustment of Annuities

Sec. 1101. (a) The annuity of each person who, on the effective date of this section, is receiving or entitled to receive an annuity from the civil service retirement and disability fund shall be increased by 5 per centum of the amount of such annuity.

(b) The annuity of each person who receives or is entitled to receive an annuity from the civil service retirement and disability fund commencing during the period which begins on the day following the effective date of this section and ends five years after such date, shall be increased in accordance with the following table:

The annuity shall be increased by— l/ the annuity commences between— January 2, 1963, and De

cember 31, 1963 _______ __ 4 per centum January 1, 1964, and De

cember 31, 1964 _______ __ 3 per centum January 1, 1965, and De

cember 31, 1965 _______ __ 2 per centum January 1, 1966, and De

cember 31, 1966 _______ __ 1 per centum

(c) In lieu of any other increase provided by this section, the annuity of a survivor of a retired employee or Member of Congress who received an increase under this section shall be increased by a percentage equal to the percentage by which the annuity of such employee or Members was so increased.

(d) No increase provided by this section shall be computed on any additional annuity purchased at retirement by voluntary contributions.

(6) The limitation reading “or (3) the sum necessary to increase such annuity, exclusive of annuity purchased by i-olu n ta ry contributions under the second paragraph ol section 10 0] this Act, to 82.160" contained in section dlcllli ol the Civil Sfft'lt‘t‘ Retirement Act of May 29, 1930, as amended by the Acts 0' July 16, 1952 (66 Stat. 722,‘ Public Lair 55$, Eighty-second Congrcssi and August 31, 1954 168 Stat. 1043; Public Lair 747, Eighty-third Congress), shall not be eflectii-e on or alter the etlective date or this section.

(I) The limitation contained in the next to the last sentence of section 8 idHii ot the Civil Serrice Retirement Act of May 79. 1930, as amended. as enacted by the Act 0! Aurrust 11, 1955 '69 Stet ‘92' "uh!" Um‘ "K9 Einhtu-tourth (‘n-rerun, do" not he eflectite on and after t‘;' ettectire date of t"is section.

("i The increases "YO"td"d by this section shall take efiect on the eflert'i-e date at this section, except that any increase under subsection lb) or tel shall take et'ect on the beginning date 0! the annufly

lb! The monthly installment of ann-"tu alter ad‘ittstment under this section s"all be fired at the nearest dol'ar

Sec "02 10\ Section 1 ot the Civil Set'fi'ce Retirement Jct is "mended l‘y adding at the end thereof the lollowing neu- subsection.‘

“(ti The term ‘price inder' shall mean the annual average Of" a colendar year 0! the Consumer Price Inder (all items-United States city areragei published monthly by the Bureau 0! Labor Statistics."

(b) Such Act is further amended by redesi'onatina section 18 as 19, and by inserting alter section 17 the lolloiring new section?

“Cost-ol-liri'ig adiustmeiit ol annuities

“Sec. 18. (at Atter January 1, 1964, and alter each succeeding January 1, the Commission shall determine the per centum change in the price Itldt‘I from the later 0! 1962 or the year preceding the most recent cost-ol-licing adjustment to the latest complete year. On the basis 0! such Commission determination the following adlustments shall be made:

"(1) Efltt‘ltl‘t' April 1, 1964, ll the change in the price index lroni 1962 to 1963 shall hai'c equaled a rise ol at least 3 per centum. each annuity payable lrom the lund which has a commencing date earlier than January 2, 1963. shall be increased by the per centum rise in the price index adiusted to the nearest one-tenth ol 1 per centum.

"(2) Efiectit'e April 1 0! any year other than 1964 alter the price index change shall have equaled a rise of at least 3 per centum, each annuity payable lrom the lund ii-hich has 0 commencing date earlier than January 2 o! the preceding year shall be increased by the per centum rise in the price ttldt‘I adjusted to the nearest one-tenth of l per centum.

"ibi Eligibility lor an annuity iiicrease under this section shall be gov

crned by the commencing date of each annuity payable train the land as 0! the eflcctire date 0] an increase, except as lollou's:

"(1) Eflt’t‘tll‘e [mm the date 0! the first increase under this section, an annuity payable lrom the land to an annuitant‘s survivor (other than a child entitled under section 101d", which annuity commenced the day alter the annuitant's death, shall be increased as provided in subsection (a)(1) or (01(2) il the commencing date ol annuity t0 the annuitant icas earlier than January 2 ol the year preceding the first increase.

"(2) Ellectirc lrom its commencing date, an annuity payable irom the land to an tintiuitant's Stlfl‘ll'Of (other than a child enitled under section IO'dH, which annuity commences the day alter the annuitant's death and alter the eflectire date of the first increase under this section, shall be increased by the total per centum increase the annuitant iras receii'inO under this section at death.

"(3) For purposes 0] computing an annuity ichich commences alter the edective date at the first increase under this section to a child under sot‘tion 101d), the items 8600. 8720. 81,800, and 82.160 appearing in section IOldi shall be increased by the total per centum increase allmred and in lorce under this section, and, in case 0/ a deceased aiinuitant, the items 40 per centum and $0 per centum appearing in section 10(d) shall be increased by the total per centum increase allowed and in lorce under this section to the aniiuitant at death, Etlcctii'e lroni the date of the first increase under this section, the proi'isions of this paragraph shall apply as it such first increase were in ettect inth respect to computation of a child's annuity under section IOtd) which commenced between January 2 ol the year preceding the first increase and the cflectii'e date 0] the first increase.

"iel N0 increase in annuity provided by this section shall be computed on any additional annuity purchased at ft‘tl'¢'ment by voluntary contributions

“id! The monthly installment of annuity alter adjustment under this section shall be fired at the nearest dollar "

Sec 1103. (a) Section 9'0) 0! the Cll‘ll St‘fl‘lt‘t' Retirement Act is amended to read as lolloirs:

"(gt The annuity as licreinbelore proi'i'ded (excluding any increase because 0! retirement under section 7) lor any married employee or Member retiring under this Act, or any portion of such annuity designated in tl‘t’ttttlt) lor purposes 0! section ioiaitii, shall be reduced by 3'5 per centum of so much thereof as does not exceed $3,600 and by 10 per centum of so much thereol as exceeds 83.600, unless the employee or Member notifies the Commission in icriting at the time of retirement that he does not desire his icile or husband to receive an annuity as prul‘ldt‘d in section 101g)(1)."

Ibl Section 1010"!’ a! such Act is amended to read as Iolloics:

"i ii I! an employee or Member dies alter having retired under any pm» cision at this Act and is united by a mile or husband to whom the employee or Member was married at the time o! retirement, such rile or husband shall be paid an annuir, equal to 55 per centum o! a’: rr't'zuff‘, computed as procided in subsections (a), (hi, it‘), idi, iei, and m o! w‘: r. 9. c,may apply It‘tth respect to ."'.e c'-.':'..:tant, or of such portion there‘' as "13'. hare been designated :-: such purpose by the r.’ er I" 5!": M at "it "I!!! 0/ "ft'c'rtc'zf, the employee or Member has 'i'rtzfied the Commission in icritinq a.’ 7'1» t:":e ol retirement that he does not desire his icile or husband to receire such annuity." 1e) Section lOibi ol such Act is

amended by striking out "50 per centum" and inserting in lieu thereof "55 per centum".

(di Section Mic) of such Act is amended by striking out "50 per centum" and inserting in lieu thereof "55 per centum".

tel Section 10ml 0! such Act is amended by striking out “50 per centum" and inserting in lieu thereof "55 per centum".

(lHAI Section 11h o! the Civil Serrice Retirement Act is amended by substituting a comma lor the period at the end thereol and adding the following; “or such unmarried child ‘wt; and twenty-one years 0! age u'ho is a student regularly pursuing a lull-time course 0! study or training in residence in a high school, trade school. technical or vocational institute, junior college. college, university, or comparable recognized educational institution. A child whose twenty-first birthday occurs prior to July 1 or alter August 31 0! any calendar year, and ichile he is regularly pursuing such a course 0! study or training, shall be deemed lor the purposes at this paragraph and section lltd) to have attained the age 0! twenty-one on {he first day 0! July lolloicing such birthday. A child who is a student shall not be deemed to have ceased to be a student during any interim between school years it the interim does not exceed four months and i! he shows to the satisfaction 0! the Commission that he has a bona fide intention of continuing to pur. sue a course 0! study or training in the same or digerent school during the school semester (or other period into which the school year is dirided) immediately lolloicing the interim.‘

(Bi The third sentence a! section midi ol the Act is amended to read cs lollouzs: "The child's annuity shall commence on the day alter the employee or Member dies, and such annuity granted under this Act or under the Act of May 29, 1930. as amended Irons and alter Vebruary 28, 1948, or any right thereto shall terminate on the last day of the month belore (II his attaining age eighteen unless incapable ol sell-support, age (2) his becoming capable oI sell-support

- ritz'zc ' -'

s0‘ __ , flI

""1 ezr't'. ‘re’: after eighteen, (3) his marriage, or (4) his death, except that the annuity of a child who is a student as described in section 1(7') shall terminate on the last day of the month before (1) his marriage, (2) his death, (3) his ceasing to be such a student, or (4) his attaining age twenty-one.”

[graphic]

Sec. 1104. Notwithstanding any other provision of law, the benefits made payable under the Civil Service Retirement Act by reason of the enactment of this part shall be paid from the civil service retirement and disability fund.

Sec. 1105. Section 1101 of this part shall take effect on January 1, 1963. The amendments made by section 1103 (except subsection (f)) shall not apply in the case of employees or Members retired or otherwise separated prior to the date of enactment of this Act, and the rights of such persons and their survivors shall continue in the same manner and to the same extent as if these amendments had not been enacted.

And the Senate agree to the same.

OLIN D. JOHNSTON,

MIKE MoNRoNEY,

FRANK CARLsoN, Managers on the Part of the Senate.

ToM MURRAY,

JAMEs H. MoRRIsoN,

ROBERT J. CoREE'r'r, Managers on the Part of the House.

The Senate proceeded to consider the said report; and

Resolved, That the Senate agree thereto.

Ordered, That the Secretary notify the House of Representatives thereof.

On motion by Mr. JOHNSTON to reconsider the vote agreeing to the report,

On motion by Mr. MANSFIELD,

The motion to reconsider was laid on

the table.

INVESTMENT BY CERTAIN BANKS IN CORPO

RATIONS PROVIDING CLERICAL sERvIcEs

On motion by Mr. MANSFIELD,

The Senate proceeded to consider the bill (HR. 8874) to authorize certain banks to invest in corporations whose purposes is to provide clerical services for them, and for other purposes; and having been amended on the motion of Mr. PROXMIRE.

Ordered, That the amendment be engrossed and the bill read a third time.

The said bill, as amended, was read the third time.

Resolved, That it pass.

Ordered, That the Secretary notify the House of Representatives thereof.

On motion by Mr. MANSFIELD to reconsider the vote on the passage of the bill,

On motion by Mr. PROXMIRE,

The motion to reconsider was laid on

the table.

MESSAGE FROM THE HOUSE

A message from the House of Representatives, by Mr. Bartlett, one of its clerks:

Mr. President: The House of Representatives insists upon its amendment to the bill (S. 3389) to promote the foreign commerce of the United States

through the use of mobile trade fairs, disagreed to by the Senate; it agrees to the conference asked by the Senate on the disagreeing votes of the two Houses thereon and has appointed Mr. BONNER, Mr. DOWNING, Mr. CASEY, Mr. MAILLIARD, and Mr. PELLY managers at the same on its part.

coNsIDERATIoN or UNOBJECTED BILLS 0N CALENDAR On motion by Mr. MANSFIELD, and by unanimous consent,

Ordered, That the calendar be called for the consideration of bills to which there is no objection, beginning with Order No. 2179.

The following bills were thereupon considered; and no amendment was made:

HR. 7791. An act to amend title 13 of the United States Code to provide for the collection and publication of foreign commerce and trade statistics, and for other purposes;

HR. 4034. An act for the relief of Lt. Comdr. David V. Kyrklund;

HR. 6386. An act for the relief of Cleo A. Dekat;

HR. 8321. An act for the relief of Maj. Clara May Matthews;

HR. 8662. An act for the relief of Jose Fuentes;

HR. 9128. An act for the relief of Sgt. Ernest I. Aguilar;

HR. 9199. An act for the relief of certain oflicers and enlisted personnel of 1202d Civil Affairs Group, Fort Hamilton, N.Y.;

HR. 9804. An act for the relief of Cuyahoga County, Ohio;

HR. 9894. An act for the relief of Loretta Shea, deceased, in full settlement of the claims of that estate;

H.R. 10002. An act for the relief of civilian employees of the New York Naval Shipyard, and for other purposes;

H.R. 10026. An act for the relief of Thomas J. Fitzpatrick and Peter D. Power;

H.R. 10199. An act for Lester A. Kicher;

H.R. 10415. An act for Earl T. Briley;

H.R. 10423. An act for Mrs. Dorothy H. Johnson;

H.R.11058. An act for Carl Adams;

HR. 11334. An act for Mary J. Papworth;

H.R.11578. An act for the relief of Don C. Jensen and Bruce E. Woolner;

H.R. 12090. An act for the relief of James Comeau;

H.R.-12539. An act for the relief of Leslie 0. Cox and other employees of the Federal Aviation Agency;

HR. 12701. An act for the relief of Catalina Properties, Inc.; and

HR. 12936. An act for the relief of Kenneth E. Foussé and others.

Ordered, That they pass to a third reading.

The said bills were severally read the third time.

Resolved, That they pass.

Ordered, That the Secretary notify the House of Representatives thereof.

the relief of the relief of the relief of the relief of

the relief of

The Senate proceeded to consider the following bills; and the reported amendments were agreed to:

S. 3631. A bill to amend title 13, United States Code, to preserve the confidential nature of copies of reports filed with the Bureau of the Census on a confidential basis;

S. 2478. A bill to amend section 144 of title 28 of the United States Code;

S. 2450. A bill for the relief of Major C. Todd, Jr., and the estate of Ira T. Todd, Sr.;

S. 2451. A bill for the relief of G. W. Todd and the estate of Lloyd Parks; and

S. 3371. A bill for the relief of Dr. James T. Maddux.

Ordered, That the bills be engrossed and read a third time.

The said bills were severally read the third time.

Resolved, That they pass and the respective titles thereof be as aforesaid.

Ordered, That the Secretary request the concurrence of the House of Representatives therein.

The Senate proceeded to consider the bill (S. 3375) for the relief of George Edward Leonard; and no amendment being made,

Ordered, That it be engrossed and read a third time.

The said bill was read the third time.

Resolved, That it pass and that the title thereof be as aforesaid.

Ordered, That the Secretary request the concurrence of the House of Representatives therein.

CONFERENCE REPORT ON S. 1552

Mr. KEFAUVER submitted the following conference report:

The committee of conference on the disagreeing votes of the two Houses on the amendments of the House to the bill (S. 1552) to amend and supplement the laws with respect to the manufacture and distribution of drugs, and for other purposes, having met, after full and free conference, have agreed to recommend and do recommend to their respective Houses as follows:

That the Senate recede from its disagreement to the amendment of the House to the text of the bill and agree to the same with an amendment as follows: In lieu of the matter proposed to be inserted by the House amendment insert the following: That this Act. divided into titles and sections according to the following table of contents, may be cited as the "Drug Amendments of 1962”.

TABLE OF CONTENTS Title l—Drugs Part A—Amendments to assure safety, efiectiveness, and reliability Requirement of adequate controls in manufacture. Effectiveness and safety of new drugs Records and reports as to experience on new drugs. New drug clearance procedure. Certification of antibiotics. Records and reports as to experience on antibiotics. Eflective dates and application of part A.

Sec. 101. Sec. 102. Sec. 103. Sec. 104. Sec. 105. Sec. 106.

Sec. 107.

Part 8—Standardization of drug names

Sec.lll. Review and designation of ofllcial names.

SectIZ. Name to be used on drug label.

Sec. II]. Exclusion of cosmetics.

See. I“. Information to physicians.

Part C—Amendments as to adiertmng Sec. I31. Prescription drug adi-eriuernents Title ll—Factory Inspection and L'Ject on

State Laws Sec. 201. Factory inspection. See 202 Sflectire on State law: See‘ 203 Eflectite date. Title Ill—Registration of Drug Establishmerits and Patent Information See JOI Findings and declaration Sec 30.’ Registration of producers of drugs Sec JOJ Transitional provisions. Sec. 304. Failure to Yt'gllltf, Sec 305 Drugs from nonregistered establishments misbranded. Samples of imported drugs. Definitions. Information on patents for drugs.

Tl TLS I—DRUGS

Part A—Amendments To Assure Safety, Et‘lectii'encss, and Reliability

Requirement of adequate controls in

manufacture

Sec. 101. Clause (2) of section 501(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(al) is amended to read as follows.‘ “(ZHA) if it has been prepared, packed. or held under insanitary conditions whereby it may have been wntaminated with filth, or whereby it may have been rendered infurious to health; or (Bi if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength and meets the quality and purity characteristics. which it purports or is represented to possess."'.

Effectiveness and safety of new drugs

Sec. 102. iaHI) Section 201(pHl) of the Federal Food. Drug, and Cosmetic Act iZI U.S.C. JZHpHI), defining the term “new drug", is amended by (A) inserting therein, immediately after the words "to evaluate the safety", the words "and eflectiveness", and (B) inserting therein, immediately after the words "as safe", the words "and eflectice".

(2) Section 201(pH2) of such Act (21 U.S.C. 32Hp)i2)) is amended by inserting therein, immediately after the word "safety", the words "and eflectiveness”.

(b) Section 5051b) of such Act (21 USC. 3551M) is amended by inserting therein, immediately after the words "is safe for use", the words "and whether such drug is eflectice in use".

(c) Section $0$idi of such Act (21 U.S.C. 35$(di) is amended to read as follows.‘

"idl If the Secretary finds, after due notice to the applicant in accordance with subsection 1c) and giving him an opportunity for a hearing, in accordance with said subsection, that (I) the in

Sec. 306. Sec. 307. Sec. 308.

I’t'stt‘lfllltflll, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended. or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions: (3) the methods used in. and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserre its identity, strength, quality, and purity; it) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions: or (5) evaluated on the basis of the information submitted to him as part of the application and any other information before him with respect to such drug, there is a lack of substantial evidence that the drug will have the eflect it purports or is represented to have under the conditions of use prescribed, recommended. or suggested in the proposed labeling thereof: or (6» based on a fair evaluation of all material facts, such labeling is false or misleading in any particular: he shall issue an order refusing to approve the application. If, after such notice and opportunity for hearing, the Secretary finds that clauses (I) through (6) do not apply, he shall issue an order approving the application. As used in this subsection and subsection (e), the term ‘substantial evidence‘ means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the eflectiveness of the drug involved. on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed. recommended. or suggested in the labeling or proposed labeling thereof."

(d) Section 505(e) of such Act (2! U.S.C. JSSie) is amended to read as follows.‘

"(c) The Secretary shall, after due notice and opportunity for hearing to the applicant, withdraw approval of an application with respect to any drug under this section if the Secretary flnds (I) that clinical or other experience, tests, or other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved: (2) that new evidence of clinical experience, not contained in such application or not available to the Secretary until after such application was approved. or tests by new methods. or tests by methods not deemed reasonably applicable when such application was approved. evaluated

together uith the cz'zdcnce azailable to the Secretary uhr'n the application was approved, shows that sis/‘h drag is not shown to be safe for are under the air‘.ditions of use upon the basis 0' u hich the application was aprro: cd, i-r IJI basis of new informtion before hz": :gzfh respect to such drug, eraluated b-cether with the ei'idence arailable to h:": a he! the application uai approred, that there is a lack of substantial evidence that the drug will hare the eflect it purports or is represented to have under the conditions of use prescribed, recommended. or suggested in the labeling thereof; or H! that the Cpl‘lll‘dlli'n contains any untrue statement of a material fact: Provided That if th" Secretary tor in his absence the ofllcer actzng as Secretary) finds that there is an imminent hazard to the public health, he may suspend the approral of such application immediately, and one the applzcarzt p'orript notice of his action and afford the applicant the opportunity for an expedited 'U'G'IYIO under this subsection; but the authority con-‘erred by this proviso to suspend the approval 0' an application shall not be delegated The Secretary may also, after due nrtwe and opportunity for hearing to the applicant, withdraw the approval of an application with respect to any drug under this section if the Secretary ‘.nds (I) that the applicant has fazled to establish a system for maintaimng required records, or has repeatedly or deliberately failed to ":Gtnltltn such records or to make required reports, in accordance with a regulation or order under subsection (7), or the ar-plzcant has refused to permit access to. or copying or rentedtion of, such records as reqazred by paragraph (2) of such subsection,‘ or (2‘) that on the basis of new information before him. evaluated together with the ei'idence before him when the application was approved, the methods used in. or the facilities and controls used for, the manufacture. processing, and packing of such drug are inadequate to assure and preserre its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (3) that on th" bans of new information before hzrrz, czaluctcd north" with the evidence before him when the application was approrcd, the labeling of such drug, based on a fair fl'dlttdltfifl of all material tarts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. Any order under this subsection shall state the findings upon which it is based."

Records and reports as to czperzence 4"‘. nczn drugs

Sec, 103 (a) Section 505 of the Federal Food. Drug, and Cormetic Ac.’ if! U S (' 355i is amended by afdzrzc a? the end thereof the following new sabsecfzon.‘

“ifHl) In the casr‘ of any drug for which an approval of an application filed pursuant to this section is in eflect, the

.r--, 1",,

applicant shall establish and maintain such records, and make such reports to the Secretary, of data relating to clinical experience and other data or information, received or otherwise obtained by such applicant with respect to such drug, as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (e) of this section: Provided, however, That regulations and orders issued under this subsection and under subsection ( i) shall have due regard for the professional ethics of the medical profession and the interests of patients and shall provide, where the Secretary deems it to be appropriate, for the examination, upon request, by the persons to whom such regulations or orders are applicable, of similar information received or otherwise obtained by the Secretary.

“(2) Every person required under this section to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such oflicer or employee at all reasonable times to have access to and copy and verify such records.”

(b) Section 505(i) of such Act (21 U.S.C. 355(i)) is amended (1) by inserting “the foregoing subsections of” immediately after “operation of”; (2) by inserting “and efi‘ectiveness” immediately after “safety”; and (3) by adding at the end thereof the following new sentences: "Such regulations may, within the discretion of the Secretary, among other conditions relating to the protection of the public health, provide for conditioning such exemption upon

“(1) the submission to the Secretary, before any clinical testing of a new drug is undertaken, of reports, by the manufacturer or the sponsor of the investigation of such drug, of preclinical tests (including tests on animals) of such drug adequate to justify the proposed clinical testing;

“(2) the manufacturer or the sponsor of the investigation of a new drug proposed to be distributed to investigators for clinical testing obtaining a signed agreement from each of such investigators that patients to whom the drug is administered will be under his personal supervision, or under the supervision of investigators responsible to him, and that he will not supply such drug to any other investigator, or to clinics, for administration to human beings; and

“(3) the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such drug, of data (including but not limited to analytical reports by investigators) obtained as the result of such investigational use of such drug, as the Secretary finds will enable him to evaluate the

safety and efi‘ectiveness of such drug

in the event of the filing of an applica

tion pursuant to subsection (b). Such regulations shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or t'ieir representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings. Nothing in this subsection shall be construed to require any clinical investigator to submit directly to the Secretary reports on the investigational use of drugs."

(c) Section 301(e) of such Act (21 U.S.C. 331(e)) is amended to read as follows:

“(e) The refusal to permit access to or copying of any record as required by section 703; or the failure to establish or maintain any record, or make any report, required under section 505 (i) or (9') , or the refusal to permit access to or verification or copying of any such required record.”

((1) Section 302(a) of such Act (21 U.S.C. 332(a)) is amended by striking out “(e) ,”.

New drug clearance procedure

Sec. 104. (a) Section 505(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a)), is amended to read as follows:

“(a) No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) is eflective with respect to such drug.”

(b) Section 505(0) of such Act (21 U.S.C. 355(c)) is amended to read as follows:

“(0) Within one hundred and eighty days after the filing of an application under this subsection, or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either—

“(1) approve the application if he then finds that none of the grounds for denying approval specified in subsection (d) applies, or

“(2) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable. If the applicant elects to accept the opportunity for hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary's order thereon shall be issued within

ninety days after the date fixed by the

Secretary for filing final briefs."

(0) Section 505(f) of such Act (21 U.S.C. 355(f)) is amended to read as follows:

“(f) Whenever the Secretary finds that the facts so require, he shall revoke any previous order under subsection ( d) or (e) refusing, withdrawing, or suspending approval of an application and shall approve such application or reinstate such approval, as may be appropriate.”

(d) ( 1) The first four sentences of section 505(k) of such Act (21 U.S.C. 355 (h)) are amended to read as follows: “An appeal may be taken by the applicant from an order of the Secretary refusing or withdrawing approval of an application under this section. Such appeal shall be taken by filing in the United States court of appeals for the circuit wherein such applicant resides or has his principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit, within sixty days after the entry of such order, a written petition praying that the order of the Secretary be set aside. A copy of such petition shall be forthwith transmitted by the clerk of the court to the Secretary, or any officer designated by him for that purpose, and thereupon the Secretary shall certify and file in the court the record upon which the order complained of was entered, as provided in section 2112 of title 28, United States Code. Upon the filing of such petition such court shall have exclusive jurisdiction to affirm or set aside such order, except that until the filing of the record the Secretary may modify or set aside his order.”

(2) The ninth sentence of such section 505 (h) is amended to read as follows: “The judgment of the court affirming or setting aside any such order of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 2154 of title 28 of the United States Code.”

(3) The amendments made by this subsection shall not apply to any appeal taken prior to the date of enactment of this Act.

(e) (1) Section 301(1) of such Act (21 U.S.C. 331(1)) is amended by (1) inserting "approval of” before “an application”, and (2) striking out "eflective” and inserting in lieu thereof “in effect”.

(2) Clause (C) of section 503(b) (1) of such Act (21 U.S.C. 353(b) (1)) is amended by striking out “eflective" and inserting in lieu thereof "approved”.

(f)(1) Clause (A) of paragraph (3) of section 409(0) of such Act (21 U.S.C. 348(0)) is amended by inserting before the semicolon at the end thereof the following: except that this proviso shall not apply with respect to the use of a substance as an ingredient of feed for animals which are raised for food production, if the Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed

« AnteriorContinuar »