Public Law 95-623 An Act - Office of NIH History - National Institutes ...

PUBLIC LAW 95-623-NOV. 9,1978 92 STAT. 3449the project ~ ~ith respect to which the grant or contract is t,o be madeor entered into."(e) To assist in carrying out this section, the Secretary, actingthrough the Center, shall cooperate and consult. with the NationalInstitutes of Health, the Veterans' Xdministratlon, and any otherinterested Federal departments or agencies - and with State and localhealth departments aid agencies."(f)(1) There is established the Kational C,ouncil on Health Care National CouncilTechnology (hereinafter in this subsection referred to as the 'Council'). on Health CareThe Council shall-Technology."(A) advise the Secretary and the Director of the Center withrespect to the performance of the functions prescribed by thissection ;"(B) review applications for grants and contracts under thissection in excess of $35,000 and provide the Secretary its recommendationrespecting the approval of such applicat~ons;"(C) after consultation with appropriate public and privateentities, advise the Secre,tary respecting the safety, efficacy, effectiveness,cost effectiveness, and the social and economic impactsof particular health care technologies ;"(D) after consultation with appropriate public and privateentities, develop, when appropriate and to the extent practicable.exemplary standards, norms, and criteria concerning the use ofparticular health care technologies; and"(E) promptly publish. disseminate, and otherwise make available,through the National Library of Medicine, standards, norms,and criteria developed under subparagraph (D) ." (2) The Council shall consist of- Membership."(A) the Director of the National Institutes of Health, theChief Medical Officer of the Veterans7 Administration, the. AssistantSecretary for Health and Environment of the Department ofDefense, the Chairman of the National Professional StandardsReview Council, a member of the National Council on HealthPlanning and Development (established under section 1503), the 42 USC 300k-3.Director of the Office of Science and Technology Policy, the headof the Food and Drug ,Qdministration (or the successor to suchentity), the head of the Center for Disease. Control (or the successorto such entity). and the head of the Health Care FinancingAdministration (or the sllccessor to sach entit,y) who (or theirdesignees) shall be ex oficio members, and"(B) eighteen members appointed by the Secretary.The Secretary shall make his initial appointments to the Councilwithin one hundred and twenty days of the date of the enactment ofthis section. Six of the appointed members shall be selected from individualswho are distinguished in the fields of medicine, engineering,or science (including social science). Of such six members, at least twoshall be selected from individuals who are representatives o,f businessentities engaged in the development or production of health care technology,Two of the appointed members shall be physicians, two ofthe appointed members shall be selected from individuals who arehospital administrators, two of the appointed members shall be selectedfrom individuals who are distinguished in the field of economics, twoof the appointed members shall be selected from individuals who aredistinguished in the field of law, one of the appointed members shall beselected from individuals who are distinguished in thc field ob et,hics,

92 STAT. 3450 PUBLIC LAW 95-623-NOV. 9, 1978Councilmembers, termsof office.Compensation.and three of the appointed members shall be selected from membersof the general public who represent the interests of consumers of healthcare."(3) (A) Each appointed member of the Council shall be appointedfor a term of four years, except that-"(i) any member appointed to fill a vacancy occurring priorto the expiration of the term for which his predecessor wasap ointed shall be appointed for the remainder of such term; and'(ii) of the members first appointed after the date of the enactmentof this section, four shall be appointed for a term of fouryears, four shall be appointed for a term of three years, four shallbe appointed for a term of two years, and four #hall be appointedfor a term of one year, as designated by the Secretary at the timeof appointment.Appointed members may serve after the expiration of their terms untiltheir successors have taken office."(B) Members of the Council who are not officers or employees ofthe United States shall receive for each day they are engaged in theperformance of the functions of the Council compensation at rates notto exceed the daily equiva,lent of the annual rate in effect for grade5 USC 5332 note. GS-18 of the General Sched~lle, including traveltime; and all members,while so serving away from their homes or regular places of busness,may be alllowed travel expenses, including per diem in lieu ofsubsistence, in the same manner as such expenses are authorized bysection 5703 of title 5, United States Code, for persons in the Governmentservice employed intermittently."Health caretechnology."Appropriationauthorization."(4) The Counc~l shall annually elect one of its appointed membersto serve as Chairman until the next election."(5) The Council shall meet at the call of the Chairman, but not lessoften tihan four times a year."(6) The Director of the Center shall1 (1) designate a member of thestaff of the Center to act as Executive Secretary of the Council, and(2) make available to the Council such staff, information, and otherassistance as it may require to ca~ry out its functions."(7) The Council shall be subject to the Federal Advisory CommitteeAct, except that the Council shall terminate September 30,1981."(g) The Director of the National Institutes of Healbh, the head ofthe Food and Drug Administration (or the successor t~ such entity),the head of the Center for Disease Control (or the successor to suchentity), the head of the Health Care Financing Administration (orthe successor to such entity), and the (head of any other entity of theDepartment of Health, Education, and Welfare designated by theSecretary shall each make available annually to the Center and theCouncil a listing of all healhh care technologies of which he is awarethat are under development and appear likely to be used in the practiceof medicine."(h) For purposes of this section, the term Ghealth care technology'means any discrete and identifiable regimen or modality used to diagnoseand treat illness,.prevent disease, maiqtain patient well-being,or facilitate the provision of health care services."(i) There are authorized to be appropriated to carry out this section$15,000.000 for the fisca,l year ending September 30, 1979,

PUBLIC LAW 95-623-NOV. 9, 1978 92 STAT. 3453tion of persons afflicted by such diseases, costs reasonably attributableto pain and suEering from such diseases and effects, loss of income andfuture earnings resulting from such diseases and effects, adverse effectson productivity (and thus increases in production costs and consumerprices) resulting from such diwases and effects, loss of tax revenuesresulting from such decreases in earnings and productivit , costs tothe welfare and unemployment compensation systems an8 the programsof health benefits under titles XVIII and XIX of the SocialSecurity Act resultilig from such diseases and effects, the overall 42 USC 1395,increases in costs throughout the economy resulting from such diseases 1396.and effects, and other related direct, and indirect costs.".INFORMATION ON EFFECEJ ON HEALTII OF THE ENVIRONMENT ANDEMPLOYMENT CONDITIONSSEC. 8. (a) Section 806 (as amended by section 5) is amended by 42 usc 242k.inserting after subsection (k) the following new subsection :"(1) (1) The Secretary, acting through the Center, shall develop a Plan.plan for the collection and coordination of statistical and epidemiologicaldata on the effects of the environment on health. Such plan shallinclude a review of the data now available on health effects, deficienciesin such data, and methods by which existing data deficiencies can becorrected. The Secretary shall submit such plan to the Congress not, Submittal tolater than .January 1,1980.Congress."(2) (A) The Secretary, acting through the Center, shall establish, Guidelines.not later than two years after the date of the eimctment of thissubsection, guidelines for the collection, compilation, analysis, publication,and distribution of statistics and information necessary fordetermining the effects of conditions of employment and indoor andoutdoor environn~ental conditions on the public health. Guidelinesestablished under this subparagraph shall not (i) author.ize or requirethe disclosure of any matter described in section 552(b) (6) of title 5,United States Code, and (ii) authorize or require the disclosure of anystatistics or other information which is exempt from disclosure pursuant,to subsection (a) of section 552 of title 5, United States Code, byreason of subsection (b) (4) of such section. The guidelines shall berevie\\-rd and, if appropriate. revised at least every three years afterthe date they are initially established. Guidelines shall take effect ontho date of the promulgation of the regulation establishing or revisingthe guidelines or such later date as nlay be specified in the guidelines.('(B) The guidelines shall be designed-"(I) to improve coordination of environmental and healthstudies, statistics,. and information, and to prevent overlap andunnecessary duplication with respect to such studies, statistics,and information ;"(ii) to assure that such studies, statistics, and information willbe available to executive departments responsible for the administrationof laws relating to the protection of the public healthand safety or the environment ;"(iii) to encourage the more effective use by executive departmentsof such studies, statistics, and information ;(iv) to improve the statistical validity and reliability of suchstudies, statistics, and information ; and

92 STAT. 3454 PUBLIC LAW 95-623-NOV. 9, 1978Guidelines,compliance.Exemptions."Guidelines."Study.Report toCongress."(v) to assure greater responsiveness by the Department ofHealth, Education, and Welfare and other executive departmentsin meeting informational and analytical needs for determininthe effects of employment and indoor and outdoor environmentafconditions on public health."(C) In establishing and revising guidelines under subparagraph(A), the Secretary shall take into consideration the plan developedpursuant to paragraph (1)."(D) The Center shall serve as a clearinghouse for statistics andinformation with respect to which guidelines have been establishedunder subparagraph (A) and shall assist executive departments inobtaining such statistics and information for purposes of administeringlaws under their jurisdiction relating to environmental healthprotection or the safety and health of employees."(E) (i) Each executive department shall comply with the substantiveand procedural requirements of the guidelines." (ii) The President shall by Executive order require each executivedepartment t,o comply with requests, made in accordance with theguidelines, by the Secretary, the Administrator of the EnvironmentalProtection Agency, the Consumer Product Safety Commission, or theSecretary of Labor for statistics and information." (iii) The President may by Executive order exempt any executivedepartment from compliance with a requirement of the guidelinesrespecting specific statistics or other information if the Presidentdetermines that the exemption is necessary in the interest of nationalsecurity."(F) In carrying out his duties under this paragraph, the Secretary,acting through the Center, shall, insofar as practicable, provide forcoordination of his activities with those of other Federal agencies andinteragency task forces relating to the collection, analysis, publication,or distribution of statistics and i~lformation necessary for determiningthe effects of conditions of employment and indoor and outdoorenvironmental conditions on the public health." (6) For purposes of this paragraph, the term 'guidelines' meansthe guidelines, either as initially established or as revised, in effectunder this paragraph.'' (3) The Secretary, acting through the Center, shall conduct a studyof the issues respecting, and the recommendations for, establishing aFederal system to assist, in a manner designed to avoid invasion ofpersonal privacy, Federal, State, and other entities in locating individualswho have been or many have been exposed to hazardous substancesto determine the effect on their heaIth of such exposure and to assistthem in obtaining appropriate medical care and treatment. In conductingsuch study, the Secretary may consult with any public andprivate entity which it determines has expertise on any matter to beconsidered in the study. Not later than one year after the date of theenactment of this subsection, the Secretary shall complete the study andreport to the Congress the results of the study and any reoommendationsfor legislation or administrative action.L'(4) In carrying out paragraphs (I), (2), and (3), the Secretaryshall consuIt with and take into consideration any recommendationsof the Task Force on Environmental Cancer and Heart and Lung

92 STAT. 3456 PUBLIC LAW 95-623-NOV. 9, 1978(A) by striking out "and" at the end of clause (iii),(B) by redesignating clause (iv) as clause (vii) ,(C) by inserting after clause (iii) the. following:"(iv) research at the National Center for Health ServicesResearch, the National Center for Health Statistics, and theNational Center for Health Care Technology,"(v) training at such Centers to undertake such research,"(vi) research on the matters set forth in section 304(a)(2) at public institutions and at nonprofit private institutions,and", and(D) by striking out "such research" in clause (vii) (as soredesignated) and inserting in lieu thereof 'Lbiomedical andbehavioral research and the research described in clause (vi)".42 USC 2891-1. (2) Section 472(a) (1) (B) is amended by striking out "suchresearch" and inserting in lieu thereof "biomedical and bfthavioralresearch and the research described in subparagraph (A) (71)".42 USC 219. (e) Title V is amended by adding at the end the following:"CONTRACTAUTHORITY42 USC 229c. L'S~~. 514. The authority of the Secretary to enter into contractsunder this ,4ct shall be effective for any fiscal year only to such extentor in such amounts as are provided in advance by approprlat~onActs.".Record(f) (1) The second sentence of subsection (a) of section 705 ismaintenance. amended to read as follows: "Such records shall include records which42 USC 292e. fully disclose (A) the amount and disposition by such entity of thefunds paid to it under such grant, loan, loan guarantee, interest subsidy,or contract, (B) the total cost of the project or undertaking forwhich such grant, loan, loan guarantee, interest subsidy, or contract lamade, (C) the amount, of that port,ion of the cost of the projec,t orundertaking received by or allocated to such entity from other sources,and (D) such other records as will facilitate an audit conducted inaccordance with generally accepted auditing standards.".Biennial financial (2) Subsection (b) of section 705 is a.mended to read as follows :audit."(b) E'ach entity which received a grant or entered into a contractunder this title shall provide for a biennial financial audit of anybooks, accounts, financial records, files, and other papers and propertywhich relate to the disposition or use of the funds received under suchgrant or contl-act and such other funds received by or allocated to theproject or undertaking for which such grant or contract was made.For purposes of assuring accurate, current, and complete disclosureof the dis osition or use of the funds rece~ved, each such audit-shall beconductetf in accordance with such requirements concerning theindividual or agency which conducts the.audit, and such standardsapplicable to the performance of the aud~t, as the Secretary may byregulation provide. A report of each such audit shall be filed withthe Secretary at such time and in such manner as he mlay require.".Waiver.(g) Section 771(d) is amended by adding at the end the following:42 USC 295f-1. L'(5) The Secretary may waive (in whole or in part) application toa school of dentistry of the requirement of any paragraph of thissubsection if the Secretary determines, after rece~ving the writtenrecommendation of the appropriate accreditation body or bodies

PUBLIC LAW 95-623-NOV. 9,1978 92 STAT. 3457(approved for such purpose by the Commissioner of Education) thatcompliance by such school with such requirement will prevent it frommaintraining its accreditation.".HEALTH PROFESSIOKS REPORTS AND PROCRAMSSEC. 12. (a) Section 708(d) of the Public Health Service Act is 42 USc 29213.amended (1) by striking out "not later than September 1 of eachyear", and (2) by inserting at the end the following: "Such reportshall be submitted biennially, and the first such report shall be duenot later than October 1,1979.".(b) Section 709 (b) of such Act is amended by striking out "Janu- 42 USC 292i.ary 1, 1979" and inserting in lieu thereof ''February 1,1980".(c) Section 751(i) of such Act is amended by striking out "Decem- 42 USC 294t.ber" and inserting in lieu thereof "March".(d) Section 771 (b)(2) (B) of such Act is amended by striking out 42 -2% 295f-1.LL45 days after the date for which the determination is made" andinserting in lieu thereof Yhe first December 31 occurring afte.r the datefor which the determination is made".(e) Section 782(c) of such Act is amended by striking out "Sep- 42 USC 295g-2.tember 30, 1979" and inserting in lieu thereof LLMarch 1,1980".(f) Section 788(b) (6) of such Act is amended by striking out "Sep- 42 USC 295g-8.tember 30,1978" and inserting in lieu thereof "October 1,1979".(g) Section 7'93 (c) of such Act is amended (1) by striking out 42 USC 295h-2."annually" and inserting in lieu thereof "biennially", and (2 bystriking out "December 1, 1978" and inserting in lieu thereof "&dober1,1979".(h) Section 951 (b) of the Nurse Training Act of 1975 is amended 42 USC 296 note.by striking out, "Not later than February 1, 1977, and February 1 ofeach succeeding year" and inserting in lieu thereof "Not later thanOctober 1,1979, and October 1 of each odd-numbered year thereafter".(i) (1) Section 702(d) of the Health Professions EducationalAssisbance Act of 1976 is amended by striking out "not later than two 42 usc 295114years after the date of enactment of this Act" and inserting in lieu note.thereof "not later than October 1,1979".(2) 'Section 903 (a) (2) of the Health Professions Educational 4.2 USC 292hAssisbance Act of 1976 is amended by striking out "January 1,1979" note.and inserting in lieu thereof "April 1,1979".(j) Section 772 (e) of the Public Wealth Service Act is amended by 4.2 usc 29552.inserting before the period a comma and the following: "except thata student 11-110. for other than academic reasons, withdraws from a yearclass before the end of an academic year or does not complete an academicyear shall not be considered as having been enrolled in a yearclass in that academic year".MISCELLANEOUSSEC. 13. (a) (1) Section lll(h) (42 U.S.C. 7411) of the Act ofJuly 14,1?55, as amended by Public Law 95-95, is amended by addingthe following at the end thereof :" (5) Any design, equipment, work practice, or operational standard,or any combination thereof, described in this subsection shall be treatedas a standard of performance for purposes of the provisions of thisAct (other thnn the provisions of subsection (a) and this subsection) .".

92 STAT. 3458 PUBLIC LAW 95-623-NOV. 9,1978(2) Subsections (d) (1) (A) and (g) (4) (Bb of such section are eachamended by striking out "under subsect~on ( )" and inserting in lieuthereof "under this section".(3) Subsection (j) of such section is amended by strikin out %subsection(b) of" in paragraphs (I) (A) and (2) (A) thereof(b) Section 112(e) of such Act (42 U.S.C. 7412) is amended byadding the following at the end thereof :" (5) An design, equipment, work practice, or operational standard,or any corngination thereof, described in this subsection shall be treatedas an emission standard for purposes of the provisions of this Act(other than the provisions of this subsection) ."(c) Section 117(c) (3) of such Act (42 U.S.C. 7417) is amended bystr* out "(b)(1)(B)" in each place it a(d) gection 317(s) (1) of such Act (42 82?%61'7) is amended bystmkmg out "(b)'?Approved November 9, 1978.LEGISLATIVE HISTORY:HOUSE REPORTS: No. 95-1190 accompanying H.R. 12584 (Comm. on Interstate andForeign Commerce) and No. 95-1783 (Comm. of Conference).SENATE REPORT No. 95-839 (Comm. on Human Resources).CONGRESSIONAL RECORD, Val. 124 (1978):June 26, considered and failed of passage in Senate.Aug. 9, considered and passed Senate.Sept. 25, H.R. 12584 considered and passed House; passage vacated, andS. 2466, amended, passed in lieu.Oct. 13, House agreed to conference report.Oct. 15, Senate agreed to conference report.